Minutes of the PPE Working Group meetings from 2002 onwards

Minutes of the PPE Working Group meetings from 2002 onwards

MEETING REPORT OF THE PPE WORKING GROUP OF 5-6 DECEMBER 2002 ....................... 2

MEETING REPORT OF THE WORKING GROUP “PPE” OF10-11TH JUNE 2003 ......................21

MINUTES OF THE MEETING - WORKING GROUP “PPE” OF 13-14 JANUARY 2004 ...............42

MINUTES OF THE MEETING - WORKING GROUP “PPE” OF 29-30 SEPTEMBER 2004 .........67

MINUTES OF THE PPE WORKING GROUP MEETING HELD ON 18 NOVEMBER 2005 ..........90

MINUTES OF THE PPE WORKING GROUP MEETING HELD ON 23 MAY 2006.....................100

MINUTES OF THE PPE WORKING GROUP MEETING HELD ON 20 NOVEMBER 2007 ........111

MINUTES OF THE PPE WORKING GROUP MEETING HELD ON 12 JUNE 2008 ...................124

MINUTES OF THE PPE WORKING GROUP MEETING HELD ON 5 NOVEMBER 2008 ..........143

MINUTES OF THE PPE WORKING GROUP MEETING HELD ON 25-26 MAY 2009 ...............160

MINUTES OF THE PPE WORKING GROUP MEETING HELD ON 29 APRIL 2010 ..................192

MINUTES OF THE PPE WORKING GROUP MEETING HELD ON 10 NOVEMBER 2010 ........219

MINUTES OF THE MEETING HELD IN BRUSSELS, 4 OCTOBER 2011 ..................................231

MINUTES OF THE MEETING HELD IN BRUSSELS, 7 JUNE 2012 ...........................................244

MINUTES OF THE MEETING HELD IN BRUSSELS, 24 OCTOBER 2012 ................................257

MINUTES OF THE MEETING HELD IN BRUSSELS, 25 APRIL 2013 ........................................271

MINUTES OF THE MEETING HELD IN BRUSSELS, 11 NOVEMBER 2013 .............................277

MINUTES OF THE MEETING HELD IN BRUSSELS, 8 APRIL 2014 ..........................................289

MINUTES OF THE MEETING HELD IN BRUSSELS, 18 SEPTEMBER 2014 ............................300

MINUTES OF THE MEETING HELD IN BRUSSELS, 21 APRIL 2015 ........................................311


MINUTES OF THE MEETING HELD IN BRUSSELS, 5 APRIL 2016 ..........................................332


MINUTES OF THE MEETING HELD IN BRUSSELS, 14 MARCH 2017 .....................................351

MINUTES OF THE MEETING HELD IN BRUSSELS, 6 NOVEMBER 2017 ...............................360




MINUTES OF THE MEETING HELD IN BRUSSELS, 7 OCTOBER 2019 ..................................411


Ref. Ares(2021)5168240 - 18/08/2021

Page 2 of 431 PPE Working Group Meetings from 2002 onwards

EUROPEAN COMMISSION

ENTERPRISE DIRECTORATE-GENERAL

Single Market : regulatory environment, standardisation & New Approach

Mechanical and electrical engineering, and radio and telecom terminal equipment

industries

Brussels, 27.01.2003

ENTERPRISE/G/3 CD:ck D (03) 835057

WORKING GROUP OF COMMITTEE 98/37/EC IN RELATION TO THE PERSONAL PROTECTIVE

EQUIPMENT (PPE) DIRECTIVE 89/686/EEC

Meeting Report of the PPE working group of 5-6 December 2002

List of participants: See list on Circa

Point 1 Welcome and Approval of Draft Agenda

Welcome

Mr Montoya (Head of Unit, Directorate-General Enterprise, G3) welcomed those present

including the representatives from the CZECH REPUBLIC, HUNGARY and POLAND.

Mr Montoya set out the background for the meeting. He pointed out that the PPE Directive was now

over ten years old, and that experience over that time had led the Commission and other

stakeholders to believe that the text required amendment. It was pointed out that the process was to

amend and not to review, as the objective was to improve the text in a few areas where a need for

such action had been identified.

As a consequence, it was considered that the amendment should be limited.

Mr Montoya went on to say that, in his opinion, one more meeting would be required to finalise the

proposal, and that those involved should be aware of other parallel initiatives to increase the

efficiency of the internal market, such as the forthcoming Communication on the workings of the

“New Approach”.

He passed the Chairpersonship to Mr Norbert Anselmann (Deputy Head of Unit, Directorate-

General Enterprise, G3).

The Chairperson introduced Mr Dirscherl, the successor to Mr Pelayo. Mr Dirscherl went through

the documents to be considered. Mr Dirscherl pointed out that one or two documents had been sent

in late and although these had been circulated it was unlikely that they could be discussed in detail.

He reminded those present that sufficient time was needed to allow those present to liaise with their

stakeholders in order to provide a considered response.

Approval of the draft Agenda – Doc 02.1

The Chairperson asked for comments on the proposed Agenda.

SPAIN asked for consideration of:

Eye -protection of new born infants and protective devices affixed to mobile phones

The Chairperson agreed to add both points at Agenda item 3.


In response to an intervention by GERMANY, it was also agreed to consider “warning accessory

reflectors” at the same item.

FESI asked that the item at point 3. “safety ski bindings” be amended to “releasable ski bindings”.

This was also accepted.

Approval of the draft minutes of the meeting of 22 October 2001, – Doc 02.2

Minutes approved with amendments as follows:

- 10.5.1 – amend to show Working Group 4, which met in May.

- “pole climbers” Germany did not consider pole climber to be PPE

Point 2 - Draft text for a proposal to amend Directive 89/686/EEC and corrigendum – Doc

02.3 and 02.3bis

2.1 Introduction and general aspects

(1) The Chairperson indicated that the current text had been amended during the

Summer break to take into account comments and previous discussion but also

contained some new elements. The presented document was structured as

required to show that the future proposal would be an amending Directive. He

said that the Commission services considered the document to be at an advanced

stage and that, for reasons of consultation and transparency, once the text had

“stabilised” it would be placed onto the internet for public viewing and

comments.

(2) It was anticipated that, following incorporation of comments during the meeting,

and this proposed public consultation, a final meeting would be convened in June

2003 and a final text available before the end of 2003.

(3) AUSTRIA pointed out that a “Tour de table” had taken place at the previous

meeting and the views expressed at that time were still relevant. The delegation

said that it was in favour of the process but considered that the amendment was a

full review. One outstanding concern was the need for traceability and the

possibility for the declaration to accompany the product.

(4) ITALY suggested that the Commission needed to “take a step back” and

consider whether it might be possible to merge the Medical Devices Directive

with the PPE proposal.

(5) COMM pointed out that there appeared to be only one outstanding issue in

respect of the interface between the two Directives, and this was the exclusion

clause which did not allow PPE to also be a medical device. On an informal

basis, it was understood that the manager of the MDD was going to propose that

this exclusion be deleted in any future revision, and so this problem was

considered to be dealt with.

(6) The Chairperson said that the report containing this recommendation would be

circulated as soon as it became available.

(7) The NETHERLANDS highlighted the interface between the PPE Directive and

the GPSD Directive and the view that the latter had more prescriptive provisions

for consumer which PPE would also need to be applied. They considered that the


inter-relationship as to how the two Directives applied to consumer products

would need to be explained.

(8) FRANCE said that it was in favour of the modifications although certain parts of

the text were not as clear as they could be. The delegation said that it would

provide further comments during the discussion. In respect of transversal issues

they mentioned the GPSD and considered that there might either be a need to

introduce some of its provisions or to make reference to the GPSD text.

(9) The Chairperson responded to the effect that there might be a need to re-

consider the possibility of the declaration of conformity (DoC) to accompany the

product. With reference to the interface between the PPE and GPS Directives it

was admitted that the solution was not yet agreed but that this needed to be

considered in the light of the future Communication on the New Approach. This

document would also look at issues such as market surveillance, information

exchange and safeguard procedures. The Committee was informed that for

immediate purposes a guide was under development clarifying the application of

the GPSD alongside specific directives and this would be circulated as soon as

the text was finalised.

(10) Given that there were no further general comments the Chairperson asked the

Committee to consider the modifications as presented in docs 02.3 and 02.3bis:

working paper– draft text of a proposal for an amending directive to directive

89/686/EEC proposal

2.2 Definitions (proposal, art. 2)

(11) A short discussion was initiated suggesting that the word “intended” should be

replaced by either “designed” or “designated for”. The Chairperson pointed out

that the word “intended” was generally accepted terminology to be found in a

number of other “New Approach” Directives.

(12) SPAIN said that whilst it agreed with the definitions at Art 2 (b-d) it would

appear reasonable to combine this wording with Art 2 (a).

(13) AUSTRIA proposed to replace “individual” with “person”. The European Safety

Federation (ESF) considered that “user” would be more appropriate.

(14) The NETHERLANDS asked that the acronym PPE be spelt out (the delegation

was referred to the first Article). In addition, they suggested that the definition of

“Assembly” should also include the need for such PPE to be held or worn.

(15) In response to AUSTRIA and ESF, the UNITED KINGDOM explained that

“individual” related to a single person and that in the English text this was well-

understood. BELGIUM agreed.

(16) FRANCE asked that the wording “as marked by the manufacturer” be

incorporated and said that they considered Art 2.1. (c) not to be sufficiently

robust. It also stressed that the content of Article 1, paragraph 3 should not be

lost.

(17) SPAIN agreed with FRANCE that the manufacturer should be mentioned to

show their responsibility for assemblies and integrated equipment.


(18) BELGIUM asked whether integrally combined equipment also included PPE to

protect against falls from a height.

(19) CEN asked for clarification of “integrated equipment”, in particular with respect

to non-PPE. An example was subsequently provided by Spain of safety armour

incorporated into motorcyclist jackets.

2.3 Scope (proposal, art. 1) and interface with other directives

(20) FRANCE suggested that the word “immediate” should be removed, as in the

case (for example) of radiation exposure the effect might be evident only after

time.

(21) The NETHERLANDS suggested that terminology be aligned with that of the

GPSD, and agreed with FRANCE that the word “immediate” should be deleted.

(22) AUSTRIA said that it did not consider necessary the reference to the

manufacturer in either Category 1 or 3. In addition, that there was a need for an

exclusive list of PPE falling under Category 2.

(23) GERMANY disagreed, as it was considered relevant to highlight that it was the

manufacturer’s responsibility to categorise. In addition, the delegation saw no

need for a further exclusive list.

(24) The Chairperson pointed out that the current framework of two lists allowed for

greater flexibility whilst enabling the proposed method of Comitology to

function.

(25) The Federation of the European Sporting Goods Industry (FESI) supported the

Austrian proposal for a further exclusive list under Category 2 in order to give

manufacturers legal security.

(26) DENMARK disagreed with AUSTRIA and FESI. The delegate said that the

definitions at Art 2.2 (a) and (c) were necessary but that a further list for

Category 2 would lead to confusion.

(27) SPAIN supported the view of DENMARK. No positive contribution would be

made by another list and it would create more problems than it solved. The

delegation strongly supported the French proposal to delete “immediate” from

the definition of Category 3 PPE.

(28) ITALY agreed with FRANCE and SPAIN with respect to the deletion of

“immediate”. It was the view of Italy that it was very important to maintain the

present Categories and that it would be impossible to maintain lists covering all

of the scope. The delegation said that it would look for inclusion of “high

visibility clothing” into the list for Category 3.

(29) ESF said that it was important to remember that it was the manufacturer doing an

assessment of the potential risks before designing the device. The design would

consider the findings of the risk assessment, these processes engaged the

manufacturer’s responsibility. ESF agreed with DENMARK, ITALY and SPAIN

that it would be impossible to maintain a further list of PPE.


(30) The UNITED KINGDOM agreed with this position regarding listing

highlighting that this was a “New Approach” Directive, and also supported the

French proposal for the deletion of “immediate”.

(31) AUSTRIA indicated its surprise regarding the lack of support for listing category

2 PPE and suggested that this might give too much flexibility for manufacturers

as to their decision on categorisation.

(32) The Chairperson said that the principles of allocating PPEs to a category were

clear, although there was nothing to stop an informal list being provided should

this be considered helpful. He took note of the general concern that

manufacturers had too much freedom as to allocate their products to one of the

categories and stressed that the manufacturer cannot ignore the classification of

the group of products listed in Annex I. It was also mentioned that the sections a)

and b) of Annex I reiterate the guiding principles for classification.

(33) The representation of the co-ordination of the Notified Bodies in the field of PPE

CO-NB agreed with this summary and the proposal to delete “immediate”. In

addition, the need for the manufacturer to undertake a risk analysis was re-

affirmed.

(proposal, art. 2.3 and 2.4)

(34) The NETHERLANDS asked for clarification on the relevant responsibilities of

the various parties, in particular the importer of PPE and asked the Commission

services as to where this was dealt within the text.

(35) FRANCE supported this view, and suggested the sentence “Where neither the

manufacturer or his authorised representative are present in the Community, the

obligations under … shall fall to the responsible person for placing the PPE on

the market.” In addition, France recommended that “putting into service” be

deleted.

(36) COMM explained that, under the PPE Directive, the importer could not

undertake some of the responsibilities that were reserved solely for the

manufacturer or his authorised representative. At present the only requirement

was that in such cases as described by the French authorities the importer was

responsible for giving access to the technical documentation.

(37) The NETHERLANDS considered that this should be looked at in more detail to

make it clear the various responsibilities and, hence, the direction of enforcement

measures.

(38) BELGIUM supported FRANCE and the NETHERLANDS, and suggested that

the pre-conditions for defining the manufacturer may not always be met.

(39) The Chairperson agreed to re-consider the text and also to look again at the

information requirements to assist traceability. Solutions as to the issue of

“responsibility” could be found (extension of the concept of “manufacturer”,

introduction of a “person responsible for giving access to the technical

documentation”). In response to the Belgian comments the Chairperson indicated

that the manufacturer had to have control of the design process.


(40) SPAIN said that it also defined national provisions allocating responsibilities to

those throughout the supply chain, including retailers. Those present confirmed

that this was a pre-requisite to ensure enforcement.

(41) ITALY suggested that the definitions contained in the General Product Safety

Directive be adopted.

(42) In response to this and an intervention by the NETHERLANDS, the

Chairperson pointed out that some of these definitions may not be suitable, as

the PPE Directive contained conformity assessment procedures and so placed

distance between itself and the supply chain. In this respect the term “supplier”

was not relevant for the text.

(43) AUSTRIA asked for the Commission to look again at the text describing

harmonised standards. The Chairperson’s response stressed that the definition

contained the necessary elements.

(44) FRANCE did not have difficulties with the definition but asked that the wording

at Article 6 be re-drafted in line with the latest developments with reference to

the Machinery Directive. FRANCE accepted to provide a draft to be circulated.

This was accepted.

(45) At the request of SWEDEN, the NETHERLANDS, FRANCE and

DENMARK, it was also agreed to consider how best to deal with the “rescue”

aspects of PPE.

(46) FRANCE requested that the terminology at Annex 2 and throughout the text be

amended to show “Essential Health and Safety Requirements”. This was

accepted.

2.4 Classifications

The Committee considered the amendments to the list of Category-1 PPE (Annex I a).

(47) ESA (European Sunglasses Association) introduced itself to those present. It

presented the viewpoint that it would be very problematical for sunglasses for

highly reflecting environments or at altitude to be considered as a different

category from other sunglasses. This argument was supported by the following

considerations:

almost all sunglasses blocking out UV light fully;

the definitions for ‘highly reflecting environments’ being unclear;

no empirical evidence to support the need for this re-categorisation, which would

place additional burdens on manufacturers.

(48) AUSTRIA agreed, also saying that it would be difficult for the consumer to

make a distinction. It highlighted that the terms used in Annex I were imprecise

and clear criteria/parameters should be laid down.

(49) CEN sector rapporteur, Mr Mayer, pointed out that there were two relevant

standards for consideration, a so-called “general use” standard and “sunglasses


for industrial protection”. It was his view that it would be difficult to make a

distinction in technical terms.

(50) SPAIN said that whether the sunglasses were determined either Category -1 or -2

there would still only be the CE marking and as such distinction might be

difficult. However, there were certain applications which might be considered as

requiring a higher categorisation, including eye protection in environments such

as “sun beds” used for babies under “photo-therapy”.

(51) SPAIN also presented the following comments regarding the proposed lists:

the difficulty in determining the level of risk associated with “mechanical

action whose effects are superficial”;

“protection against dangerous chemicals and biological agents” needed to be

quantified further, a proposal was made to link this to the toxic substances

directive;

(52) SPAIN did not agree with the Italian proposal to add high-visibility clothing to

the list of Category 3 PPE.

(53) ITALY considered sunglasses to be Category 2.

(54) The Chairperson noted the comments made, and questioned whether any added

value would be bought for re-categorisation of certain types of sunglasses.

However, given the comments provided by the Spanish delegation it did appear

that there were certain types of eye-protection that might need to be excluded

from the list of Category 1 PPE.

(55) In respect of the further addition to the list of PPE under Category-1 FRANCE

referred to “benign thermal risks encountered in diving in tropical waters” and

remarked that the wording required further consideration in particular with

respect to the term “tropical waters”.

(56) The UNITED KINGDOM suggested that this should be put in terms of the

temperature of the water, and agreed with FRANCE that further consideration

should be given to the terminology.

(57) ITALY pointed out that the type of accidents occurring in respect of “vehicle-

type” collisions with workers was such that 80-90% led to permanent disabilities.

This consideration warranted that high visibility clothing be added to the highest

Category of PPE.

(58) BELGIUM thought that this would be going too far as the clothing in question

only allow the worker to be seen more easily and did no mitigate the effects of a

collision. The delegation requested statistics to show how a change in

categorisation might lead to increased safety. ESF supported BELGIUM.

(59) DENMARK said that the problem with this type of equipment was mainly in

respect of “used” high visibility clothing whose reflective characteristics

deteriorated with age.

(60) SWEDEN asked for the discussion to incorporate highly reflective devices, at

which point GERMANY pointed out that the discussion on such devices had not


been finalised. GERMANY also said that it supported the view of the Belgium

delegation.

(61) The Chairperson said that it would consider the merits of the arguments

presented which appeared to suggest that the majority consensus be for such

equipment to remain as Category 2 PPE.

(62) At this point in the proceedings NORWAY (supported by FESI) pointed out the

continuing need for an update of the guide to the Directive. In response the

Chairperson said that it would appear more pragmatic to wait until the shape of

the amending directive became more clear before proceeding in this direction.

(63) “Dry suits and similar equipment….”. It was noted that the term “similar

equipment” might be problematic and clarification, or even amendment of the

text was required.

(64) “Clothing ..protecting against…chainsaws…”

GERMANY asked if there would be greater safety in this respect if it was included in

the list of PPE under Category 3.

(65) CO-NB considered that due to the nature of risk involved then this would be a

correct classification.

(66) The Chairperson agreed and pointed to the serious nature of accidents that had

occurred.

(67) “Ear Muffs and ear plugs”. The UNITED KINGDOM said that this was unclear

and required clarification. In English “ear muffs” was the general terminology for

equipment, which was used to protect the ears against cold, rather than noise.

(68) GERMANY was of the opinion that the term was clear, although recognised that

it would be more clear if the risk of noise was also explicit.

(69) The Chairperson said that this would be considered.

(70) “PPE against electrical risk and dangerous voltages”. BELGIUM recommended

the use of the correct scientific wording, “differential of potentials”. The

UNITED KINGDOM supported the idea to use more precise wording and

suggested that the technical vocabulary of CEN standards could provide a clear

and internationally accepted terminology.

(71) “Eye protection for laser radiation and solar eclipse”. The NETHERLANDS

pointed out that solar eclipses were a very rare natural event and when a solar

eclipse is total there is not light to damage the retina. The terminology was

therefore imprecise, and amendment might be required.

(72) GERMANY supported this view given the impracticality of such exclusion and

pointed out that if not in this list then such PPE would still require a type-

examination.

Proposal, Article 1

(73) DENMARK recommended that the word “private” should be deleted from Art

1.3 (b), as it made no sense to exclude certain products for private use but have


such items under the Directive for professional use. This was supported by

SWEDEN and the NETHERLANDS given the need for the same level of safety

independent from the user’s status and the practical difficulties of enforcement.

(74) GERMANY did not agree with this approach and also requested that the terms

“heat” be clarified in the same Article (interval : –50 to +50° C).

(75) SPAIN and the NETEHRLANDS supported GERMANY with respect to the

sole exclusion of “private” PPE for such uses.

(76) FRANCE agreed and asked if a more prescriptive exclusion could be given, as

there were problems with excluded PPE such as oven gloves. They also asked for

an explanation of the deletion of the exclusion of “PPE for self-defence”.

(77) DENMARK agreed with GERMANY. It was suggested to include wording

“adverse atmospheric agents” from Annex IA but delete the rest of the Article 3

(b) from the text. In addition, it was suggested to delete this wording from the list

of PPE under Category 1.

(78) The NETEHRLANDS stressed that the duration of a professional exposition to

adverse atmospheric conditions was the element to be considered, there was

consensus that “normal“ protective clothing should not fall under the directive.

(79) The European Footwear industry asked for clarification with respect to safety

shoes, as some manufacturers considered that they were excluded from the

Directive if offered to consumers (for example if sold in shops not specialised in

PPE).

(80) The Chairperson agreed to consider the word “private” and also see if further

clarification of the term “heat” could be provided. It was recommended that

Article 3 should exclude certain “products” from the scope of the Directive thus

the term “PPE” to be deleted. It proposed that different alternatives would be

given at the next meeting for consideration.

(81) FESI asked for a further indent to be given in the list of exclusions for sports

equipment, which do not provide a protective function “per se”.

(82) FRANCE pointed out that equipment not designed to protect the individual were

already excluded. The Chairperson agreed with this point of view.

(83) In respect of point Art 1.3 (g) it was explained that this had been introduced

following the lengthy discussion on assemblies affixed to a structure and the

question as to where the PPE “stopped”. It was hoped that this had taken into

account the previous discussion.

(84) BELGIUM asked for clarification and asked for Article 1.3 of the present

Directive to be re-inserted. The delegation agreed to provide alternative text.

(85) ESF suggested that the word “fixed” be placed before “structure”. This was

agreed by the majority of those present.

(86) FRANCE asked for an explanation for the deletion of the current text excluding

PPE for self-defence.


(87) In response, the Chairperson explained that, given the nature of the examples

provided, it appeared clear that such items were not PPE, but agreed to report on

the reasons for this action and possibly to deal with this change in wording in the

recitals. It was suggested that there might still be a need for wording on this issue

so as to exclude only PPE which dealt specifically with risks which were only

met by the armed forces executing their core duties.

2.5 Conformity Assessment Procedures (proposal, art. 8 and following)

COMM explained the proposed wording and procedures.

(88) AUSTRIA considered there were two main difficulties with the proposed

changes:

- Annex V did not give sufficient detail of the internal procedures to be followed under

the “self-declaration” route;

- Module H now gave an equal “footing” to PPE in both Category -2 and Category -3.

(89) SPAIN proposed that a cross-reference be provided at Article 8 (a) to Annex 1.

The delegation also pointed out that Member States had been consistently against

the incorporation of Module H.

(90) The Chairperson responded that so long as Module H covered both the design

and production this should not present any problems and it was Commission

policy to provide the manufacturer with the widest range of options. In addition,

it was pointed out that Member States had already accepted Module H in both the

Recreational Craft Directive and the Medical Devices Directive.

(91) CEN suggested that Art 8 (a) and (b) should be reversed in order.

(92) FRANCE proposed that Art 8 (f) be moved to before Art 8 (c). The delegation

also pointed out their repeated opposition to Module H and the possibility of

unfair competition between large and small producers if it was introduced.

(93) ESI highlighted their opposition to the proposal to introduce traceability

requirements, whereas the Spanish delegation requested that an identifying mark

be placed onto the PPE to enable traceability to the manufacturer.

(94) DENMARK suggested that Module F be added to the list of procedures for

Category -2 and 3.

(95) COMM said that the Commission had looked at this alongside the current

regime and there was not an exact “match”. However, it was agreed that he

would take contact with Denmark to pursue this possibility.

(96) SPAIN agreed with COMM that these two procedures were not very similar as

the Module required individual product or batch sampling which was not

required under the current Article 11(a).

(97) The Chairperson pointed to the requirement for solid reasons to amend before

introducing a proposal, and asked if such a rationale existed in this case.

(proposal, art. 11)


(98) CO-NB said that time limitation as proposed in art. 11 should be referenced to

the updates of the standards.

(99) COMM pointed that the validity of the Certificate was not related to standards

but to the state of the art. The link between the two did not reflect the New

Approach where only alignment to the EHSRs was mandatory.

(100) FRANCE supported this Article although suggested that the term “prolongation”

may be better to clearly show that a full re-examination might not be required (fr:

“re-conduction”).

(101) CO-NB agreed with this assessment and said that it was a useful provision.

However, it was requested that the option be given for a shorter validity-period.

(102) ESF said that there was opposition by its members to this development as it was

considered an additional burden on manufacturers.

(103) GERMANY reminded those present that this had already been the subject of

lengthy discussion and said that it supported the text so long as it was clear for

everyone that it did not automatically mean mandatory re-certification.

(104) The Chairperson pointed to the additional legal certainty that this would bring

to manufacturers as to the validity of the certificates.

(105) AUSTRIA pointed out an error in the text that referred to Annex 6.

2.6 Notified Bodies (proposal, art. 10)

(106) FRANCE said that it had already indicated that it would support more detailed

provisions under this Article and had submitted a paper on this subject. In respect

of the text France recommended

the relevant Member State only to notify the Commission,

who would then pass on the details to other Member States;

that the publication in the OJEC show the date of notification;

that Member States apply the given criteria as minimum criteria;

in the application of article 10.4 – if a Notified Body is de-notified the Commission

should publish the name of the Body and the reason for this action.

(107) The Chairperson informed those present that the discussions at the Council

discussions regarding the Machinery Directive had now gone further than the

proposed text on this issue. He went on to say that once this had been formalised

it was likely that this direction would also be taken up under the PPE revision.

(108) The issue of participation at meetings organised by the Horizontal Committee of

the PPE-group of Notified Body and the alignment of practice to the agreed

decision sheets was also raised as an issue for potential inclusion. In response the

Chairperson said that this was already recognised as an issue and might also be

considered.

2.7 Custom-made Devices (art. 9)


The “new” conformity assessment regime as proposed for custom-made devices was outlined by

COMM.

(109) It was further clarified that the scope of this possible derogation from the formal

conformity assessment procedures was foreseen for all PPE with specific design

requirements tailor-made to the morphological or physical characteristics of an

identified person and hence “one-off” PPE. In addition, it was re-assured that

such PPE would need to meet the EHSRs and be clearly labelled as custom-made

for market surveillance purposes.

(110) DENMARK welcomed this development as it considered this issue as one of the

most problematic. The representative also pointed out a typing error, as the

reference should be to Article 8, not Article 10.

(111) In response to a question raised by AUSTRIA it was confirmed that such PPE

would bear the CE marking.

(112) SPAIN requested that consideration be given to make the Article more specific

as the original idea was to assist those disabled into employment. As it stood it

could lead to confusion on the part of the manufacturer and lead to a possible

“loophole”.

(113) FRANCE fully supported this view of the Spanish authorities. It considered that

a solution was necessary but that it should be clear that this was for exceptional

circumstances and not for a variant to a type.

(114) The Chairperson accepted that it was the view of the Committee that the criteria

should be more prescriptive, and said that the Commission would consider how

to approach this issue.

(115) DENMARK said that the present draft was quite clear, and it was a matter for

the Member States to interpret it correctly.

(116) GERMANY did not agree with DENMARK and highlighted the potential

problems with ear protectors that were adapted to the individual bearer and as for

such adaptations there was not the usual and transparent ‘placing on the market’.

SPAIN concurred.

(117) NORWAY pointed out that such products should not be placed onto the market.

In response to which DENMARK pointed out that if this were the case then the

national authorities should take the relevant action.

(118) The Chairperson suggested that the situation might be improved if a declaration

were issued with the custom made PPE. He noted the comments by France and

Spain and said that the Commission services would consider how best to deal

with the potential incorrect application of this Article.

2.8 “Specific Measures” (art. 14) and

2.9 “Other Provisions” (art 15-21) / General Comments

The Chairperson invited to discuss the items mentioned above as a block.

(119) FESI said that it and other industrial organisations would like to see measures to

avoid the requirement of additional marking.


(120) SPAIN asked for clarification as to which “specific measures” could be

considered by the Committee and asked that “potentially” be deleted at Article

14.

(121) In reference to Articles 13, 15 and 18 FRANCE said that some proposals had

been made in the last administrative co-operation meeting and asked for these to

be considered. The French delegation would make this paper available.

(122) The Chairperson noted these comments and said that the wording would be

looked at again. He went on to say that the text needed to take into account the

common policies on this issue and there might be movement towards the text

currently under scrutiny in the machinery sector. He invited the delegation to also

provide written comments concerning the articles under discussion 13-16 as well

as for the articles 17-21 (A).

(123) SPAIN asked for the wording at Article 3.1 to be amended to align with the

GPSD text “under reasonably foreseeable conditions.

(124) The Chairperson said that this would be considered.

Point 3 - Management of Directive 89/686/EEC

3.1 Doc 02.4 - “Protectors to be inserted into motorcyclists clothing”

COMM introduced the subject by saying that the proposed text was amalgam of two previous

questions with only slight amendment. The issue had been raised given the need to deal with

protectors (PPE) inserted into private weather clothing (non-PPE).

(125) The UNITED KINGDOM, BELGIUM and FRANCE agreed with the

proposal. However, FRANCE asked that it be clarified that clothing with a

protective function is PPE.

(126) GERMANY pointed out that the original text had been amended and a paragraph

was missing.

(127) ESF said that there was a parallel between this and high-visibility clothing.

(128) COMM accepted the comments made and said that the previous paragraph

would be re-inserted. The respective Q/A would be amended along the comments

and published on the web.

3.2 Doc 02.5 - “Releasable Ski Bindings”

COMM said that the issue had been open for some time as to whether such bindings were to be

considered PPE.

FESI gave presentation arguing that such items were not PPE. Reference was also made to the

position paper from FESI supporting this view.

(129) SWEDEN accepted that although there were good reasons why such products

should be included within the scope of the Directive there were problems trying

to fit it into the definition.

(130) SPAIN did not consider that such bindings were PPE given that they did not

have a protective function and their main intended purpose was the activity itself.


(131) AUSTRIA and FRANCE agreed with SPAIN and FESI.

(132) GERMANY and the NETHERLANDS considered that they could be PPE.

(133) COMM asked those present to consider which, if any, of the hazards listed in the

Directive the binding protected the individual against.

(134) The Chairperson pointed out that the intended purpose of such equipment was

not that contained within the defined scope of the PPE Directive.

(135) COMM summarised to the effect that the majority consensus was that such items

were not PPE.

3.3 Doc. 02.6 - “Pole Climbers”

(136) GERMANY pointed out that it had not agreed that such items were PPE at the

previous meeting and asked for the minutes to be amended.

(137) BELGIUM said that it had considered the question in some depth given that the

Belgian rail authorities used the same type of equipment. The question appeared

to be whether equipment to enable a worker to operate at height fell within the

definition of the Directive?

(138) DENMARK said that from the description provided such items did not fall

within the scope of the Directive.

(139) The UNITED KINGDOM, SWEDEN and ESF agreed with GERMANY and

DENMARK.

(140) In light of the discussion the Chairperson indicated that “pole climbers” as such

were not PPE given that their prime intended function was to enable a worker to

operate at height but not to stop falls from a height.

3.4 Docs 02.7 & 02.8 - “Appropriate categories for rugby equipment”

(141) FRANCE said that this issue had been raised as manufacturers had claimed that

such items, including helmets, were Category 1 PPE. This was found to be

particularly problematic given the claims by the manufacturer in respect of the

level of protection provided. It was generally understood that some items, not

protecting vital parts of the body, may be Category 1 but there was an issue

concerning head protection.

(142) The UNITED KINGDOM said that it had discussed this item with a number of

Notified Bodies and highlighted that the French authorities had already

challenged this categorisation, the details of which had been uploaded to the

CIRCA site. On the basis of the information provided the UK authorities

believed that such items providing head protection should be placed in Category

2. This was particularly important given the level of risk involved, the dangerous

nature of the sport and that hearsay evidence had indicated that the prime

function of the headgear was to stop damage to the ear.

(143) NORWAY highlighted that the “useful facts” guide to the Directive placed “all

helmets, including sports helmets” into Category 2.


(144) GERMANY asked for a distinction to be made between helmets to prevent

minor vibration and impact and those with a hard shell to combat against more

serious dangers.

(145) SWEDEN pointed to a parallel between these and those provided for canoeing,

summarising that such helmets were Category 2.

(146) SPAIN agreed that, given the level of risks involved with potential impacts to the

head and the fact that Category 1 only covered minor impacts the head gear as

described in the presentation should generally be deemed to be Category 2 PPE.

(147) The Chairperson agreed that there should be a clear distinction between so-

called “anti-scalping” helmets providing protection against minor impacts and

those described as providing protection against major impacts that my lead to

irreversible lesions or major impact to the head, a vital part of the body area.

(148) FESI asked if it could raise the subject of compulsory licensing of such

equipment to which the Commission services indicated that it was currently

unable to comment given other associated activities.

3.5 Doc 02.9 - Interface between directives: Toys / PPE

COMM presented the relevant document which sought to clarify the interface between the two

Directives. He explained the problems arose when products were being sold as toys but were

evidently purporting to provide protective properties (e.g. roller-blade knee-pads). In such cases

it was recommended that such products needed to fulfil the requirements of both Directives.

(149) Given the example of sunglasses at (c), both ESI and SWEDEN agreed that

these would always fall within scope of 89/686/EEC.

(150) The UNITED KINGDOM said that it supported the reasoning at (b) where toys

had protective properties.

(151) The NETHERLANDS fully agreed with the paper but suggested an alternative

example – cycle helmets. However, the representative asked for clarification on

where a PPE is excluded by application of a specific directive.

(152) The Chairperson agreed that the wording at article 1.4 of the current working

paper could be improved to show that a product may not be completely excluded

but only exempted with respect to the treatment of certain hazards. It was

recommended that this be re-considered. He supported the view that if there was

an implicit presentation of toys as PPE then both Directives should be applied.

(153) FRANCE proposed that PPE imitating toys should be considered as PPE.

(154) In response the Chairperson said that such PPE might also need to be

considered with respect to the different risks associated with toys (e.g.

swallowing), and hence both sets of provisions needed to apply.

(155) ESF supported the positions of the UNITED KINGDOM and FRANCE.

(156) The UNITED KINGDOM also pointed out that the CE marking provided a

declaration that the product complied with all relevant New Approach Directives.

Roller blade helmets were provided as an example of equipment falling under

both.


(157) SPAIN suggested “knee-pads” as being a better example under point (b).

3.6 Doc 02.10 - “Question/Answer 31” related to the withdrawal of the certificate due to the

revision of a standard

(158) (The full text of the question is hereby recalled: “Does the release of a revised

standard imply the withdrawal of the presumption of conformity of PPE built

under the old standard?”)

Mr Noetel presented the answer proposed by CO-NB (doc. 20.10).

(159) After some exchange of opinions, the Chairperson explained his understanding

of the responsibility of both the manufacturer and the notified bodies. The

manufacturer’s obligation was to follow-up the development of standards against

which his product had been tested. Any standard modification reducing the range

of EHSRs covered by its previous version voided the basis upon which the type-

examination was based. Once the factual basis for a certificate ceased to exit, the

certificate itself loses its validity. It appeared logical that a notified body that is

empowered to issue a certificate with unlimited validity could also release a

certificate the validity of which would be time-limited.

(160) The notified body being the owner of the certificate must also continuously

monitor in order to timely detect when the modification of standards would

challenge the basis upon which he had issued a type-examination certificate. In

such circumstances the notified body would have to liaise with the manufacturer

concerned in order to decide about the appropriate course of actions. The latter

could range from editorial changes to the certificate to the full repetition of tests

depending on the type of modification to the standard.

(161) DENMARK and the NETHERLANDS agreed concluded that art.10.6 of

directive 89/686/EEC empowered a notified body to also withdraw a certificate.

CO-NB agreed that major changes to a standard could impose the obligation of

withdrawal of a certificate.

(162) On specific request of ESF the Chairperson made clear that a manufacturer had

to ensure to have a valid certificate at all instances of putting his product on the

market. The need for the repetition of testing of the product would result from the

importance of the modifications to the standard.

(163) The delegations mentioned a series of technical issues linked this issue of time-

limited validity of EC type-examination certificates or their withdrawal. SPAIN

wondered whether CEN could not provide for any transparent and foreseeable

timing for the routine revision of standards. Similar importance was given to the

need for the definition of the duration of a transitional phase before a modified

standard replaced its previous version. Manufacture needed this information

timely in order to organise the implementation. CEN promised to provide clear

information as to the transitional phase applied when standards had been

modified (A).

(164) The Chairperson concluded that the answer proposed for Q 31 was not fully

adequate and that the Commission would have to redraft it taking into account


the results of the discussion, the inquiries on the subject at the level of both, CEN

and the Commission.

3.7 Doc 02-12 - “Eye protectors against exposure to photons”

SPAIN presented an info flyer on eye protectors against the exposure to photons. It was

emphasised that the wording “radiation protection” did not exclusively refer to sunlight,

much attention should be paid to the wording describing the categories of sunglasses (see

also 50).

3.8 Protection mounted on to mobile phones

(165) SPAIN wanted to follow-up the issue above which had been presented at the

occasion of a previous meeting. UK commented that the respective experts were

about to study the issue and a conclusion could be presented at the forthcoming

meeting (A).

3.9 Doc 02-13 - Visibility accessories

(166) GERMANY reported on “visibility accessories” (to be fixed to cloths) that there

was uncertainty whether or not they were PPE devices. The fact that CEN had

prepared a related standard (EN 13355) covered by a Commission’s mandate

gave the impression that they were PPE.

(167) The Chairperson agreed to put such devices mentioned above on the agenda of

the next meeting (A) and thanked the UK for providing for factual information

about the protection mounted on the mobile phones. He also stressed that the

existence of a (mandated) standard never modified the scope of the underlying

Directive. Both the Commission and CEN would be investigating the case (A).

Point 4 - Reports from the European Standard Organisations

Only CEN sent a delegation, the activities related to the PPE sector were presented by Mr

Bahima (CEN expert) and Mrs Héloire (CEN) replacing Mr Mayer (CEN PPE Rapporteur).

(168) The main issues presented were:

180 the 300 standards being under revision

the need for improving standards as to the unambiguous description of test

methods and the estimation of uncertainty linked to measurement methods

the validation of standards being impeded; due to the lack of funding no

intercomparison exercises (when necessary) could be organised

(169) Mrs Héloire (CEN, replacing Mr Mayer) informed about the meetings organised

and the personnel resources for the PPE sector during the past year. The strict

time limit of 3 years for the production of a standard was referred to as one of the

CEN measures taken in order to streamline the standard development. The

activity of several TCs was reported.

(170) Mrs Héloire added that CEN considered the concept of uncertainty of

measurements to be an important one and that the PPE sector had been chosen to

implement this concept in the standards. For 2003 CEN would particularly

promote the issue of “information for use”.


(171) The Chairperson thanked CEN and in particular the representatives dealing with

the PPE sector for their active and fruitful activities.

Point 5 - Doc 02.10 “Report from the Co-ordination of the group of Notified Bodies/PPE

CO-NB reported activities throughout 2002.

(172) The audience was provided with a written report, therefore Mr Noetel

concentrated in his presentation on only the salient points

– the invitation of the MSs’ representative to the horizontal meeting of the

group of notified bodies/PPE reinforced the links between them and their

appointing authorities; the positive experience recommended to repeat that

approach

– the fact that the conclusions and the recommendations of the CO-NB

meeting were not compulsory

– the lack of participation of many notified bodies in the meetings, exchange

of experience and inter-comparisons despite of their formal obligation to

participate in that type of event.

(173) Mr Noetel informed about the edition of a new series of “recommendation for

use sheets” that would be distributed to via CIRCA for consultation. He also

announced to add a new question to the collection of “Question/Answers” the full

phrasing of which would be prepared for the forthcoming meeting. The problem

related to the possibility to define different categories for one and the same

products according to its properties that might belong to different classes of risks

(A).

Point 6 - Doc 02.11 “Notification of Notified Bodies: A proposal to rationalise the description

of their competence”

(174) COMM pleaded for reconsidering the issue of rationalising the appointment

documents as to the wording describing their competencies of notified body.

(175) The meeting expressed its approval and reminded that several appeals had been

launched in the past, none of which had led to any result.

(176) GERMANY made mention of doc. 2001/12 rev. FRANCE informed that

contacts had been established with the appointing authorities and that that

consultation has not been accomplished yet (A).

Point 7 – Information about the CIRCA information system

(177) COMM informed the participants about some basic technicalities of the CIRCA

system. The participants were reminded that it was their responsibility to

undertake the necessary that the CIRCA links were operational. That issue should

not be forgotten when members of this group changed responsibility. The

Commission would help and give assistance for trouble shooting.

Closing of the meeting


The Chairperson informed that all documents distributed during the meeting would be

uploaded on to CIRCA.

The Chairperson proposed the following timing for the imminent course of actions:

by 15.02.2003 : all written comments to be sent to the Commission

by end of March 2003 : the Commission to produce a consolidated version of the

working paper integrating the comments submitted

June 2003 : next meeting

The Chairperson closed the meeting by thanking those present for their active participation.


EUROPEAN COMMISSION

ENTERPRISE DIRECTORATE-GENERAL



industries

Brussels25.07.2003

ENTR/G/3 CD/DE:ck D (03) 835494

Working Group on Personal Protective Equipment (PPE) Directive 89/686/EEC

Meeting Report of the Working Group “PPE” of10-11th June 2003

(Brussels)

List of participants, list of working documents and meeting agenda: see on CIRCA

The minutes consist of Part 1 (Management of Directive 89/686/EEC), Part 2 (Project “Amending Directive) and one Attachment, an individual e-file has been created for each of these elements.

Part 1: Management of Directive 89/686/EEC

1.1. Points 1 and 2: Welcome and Approvals

Mr Dirscherl (Chairperson – Directorate-General Enterprise, G3) welcomed those present, in particular the many representatives from the candidate countries.

The Chairperson indicated Point 3.1 of the Agenda would be taken on the arrival of colleagues from Directorate-General Health and Consumer Protection (DG SANCO). The following items were added: 5.5, 6, 7.4.

The urgent request of FRANCE to seek the group’s opinion concerning certain products whose function are close to that of buoyancy aids was accepted as ad-hoc item replacing item 7.5.

SPAIN informed those present that it had sent in a paper on the extension of certificates. However, given the length of the list for discussion, it was accepted that this would wait until the next meeting.


In reply to FESI’s request to re-discuss “rugby headgear’, the Chairperson indicated that the results of the last meeting as to specific products would be discussed at Point 8.

The modified meeting agenda had been approved by the members of the Working Group on PPE (Group) approved the agenda.

1.2. Approval of the draft minutes of the meeting of 5- 6 December 2002

The Chairperson asked for comments on the minutes of the last meeting

In response to a query raised by GERMANY, it was agreed to make available the list of participants of the December meeting.

Upon request of SPAIN, item 2.4.51 (category of high visibility clothing) will record that they did not agree with Italy on the point in question.

Minutes approved with amendments as requested.

1.3. Point 3: Reports from the Commission

(I/ 1) It was recalled that in the December meeting the Commission undertook a commitment to inform delegates about a series of developments linked to Community legislation. The relevant documents had been put on CIRCA. Presentations of selected items were to follow under this point.

3.1 Directive 2001/95/EC (GPSD) – Guide for application and borderline with the PPE Directive (w-doc 2003-03: GPS-D., 2003-04:draft Guidance Document GPSD/PPE)

(I/ 2) Mr Hansson (COMM, DG SANCO) briefly introduced GPSD legislation having a

supplementary function with respect to the sectoral Directives, in particular PPE. The latter covered all safety-related aspects, hence only the provisions applied which were more specific than those of PPE. Mr Kroepelien (COMM, DG SANCO) presented the “draft Guidance Document on the Relationship between GPSD and Certain Sector Directives with Provisions on Product Safety” highlighting in particular which of the GPSD provisions were applicable to the PPE products. The decisive criterion was that the PPE was intended for or likely, under reasonably foreseeable conditions, to be used by consumers

(I/ 3) GERMANY asked whether the requirement to identify the PPE on the EC Declaration of Conformity would be superseded by the need to provide identification on the equipment itself. This was taken into consideration

(I/ 4) AUSTRIA considered whether the provisions of the GPSD would supplant those in the PPE relating to the details which are left to the Member States. Some confusion over the definition of “consumer” was noted. SPAIN and AUSTRIA remarked that the definition of “consumer” needed clarification, in particular as to whether this meant “possible use” or “manufacturer’s intended use”.

(I/ 5) The NETHERLANDS asked for clarification as to co-ordination between the consumer safety groups foreseen under the GPSD and the Administrative Co-operation Groups under the sectoral Directives.


(I/ 6) FRANCE suggested to only consider the “intention of the manufacturer” and pointed out that there were also “dual purpose” products to be considered.

(I/ 7) MALTA asked for clarification with respect to the relationship between notifications under the relevant safeguard procedure and the RAPEX system.

(I/ 8) COMM (DG SANCO) replied that the GPSD had to take into account the specificity of the various provisions, although it was clear that GPSD only referenced “consumers” and exclusively applied with respect to aspects of “safety”. He agreed that contact between the various networks would be desirable. The matter of safeguards was somewhat problematical, and further consideration would be necessary before guidance could be provided.

(I/ 9) GERMANY pointed out that the definition of consumer products was given by the GPSD by means of intended purpose. Whereas the intended purpose of PPE products is safety, this safety aspect is independent from user’s status be it a company be it a private person.

3.2 Commission Communication – Enhancing the Implementation of the New Approach Directives (w-doc 2003-05: Commission Communication “New Approach”) (I/ 10) The Chairperson gave a brief overview on the main components of the

Commission Communication. Mrs Wilkinson (COMM, DG ENTR – G1) informed that the document had already been subject to discussion at Council (2nd June).

(I/ 11) In response to a general call for comments, FRANCE explicitly supported the items addressed in the Communication, in particular – “CE marking”, “safeguard procedure” and “Notified Bodies”, the latter being very close to the position of the FR authorities. There were, however, two points of concern: the potential unreliability and the legal aspects of using electronic media to notify bodies to the Commission and the weak proposal as to ensuring administrative co-operation between Notified Bodies.

(I/ 12) HC-NB supported the principle of strengthening co-operation between Notified Bodies.

(I/ 13) GERMANY welcomed the Communication but asked for consideration on how this would be considered alongside the re-drafting of the PPE Directive.

(I/ 14) The Chairperson proposed that the PPE amendment process should mainly focus on those items not being covered by the Communication, leaving aside topics such as safeguard clause and the so-called “new approach” definitions.

3.3 Directive 93/42/EC (Medical Devices Directive) (w-doc 2003-06-01: Remarks, w-doc 2003-06-02: Medical Device D.)

(I/ 15) The Chairperson informed that the exclusion of products falling under the PPE-D

from the Medical Device D. (art. 1.6, 93/42/EEC) would expire by the end of 2003. Hereafter such equipment would then be covered by both the Medical Device D. and PPE D., depending on the type of safety aspects. The consequences would need further consideration given the number of products still exclusively under MDD (e.g. surgical and examination gloves, face masks, surgeon gowns, hats and gloves, corrective sunglasses)

3.4 Report on Administrative Co-operation Meeting (Madrid, May 2003)


(w-doc 2003-20: ADCO results/conclusions , w-doc 2003-21: terminology / technical competence of NB) (I/ 16) The Chairperson summarised the results from the ADCO meeting of PPE market

surveillance authorities.

(I/ 17) He reported back that the ADCO group is urging the Working Group PPE to push forward and to convince the MS to use harmonised terminology describing the fields of technical competence in the context of notification. The w-doc 2003-21 was a further elaborated proposal distributed for consideration and comment as to implementation possibilities.

(I/ 18) Action: Follow-up / Group to report about progress

3.5 Study on market surveillance in the LVD and PPE sectors (w-doc 2003-22: scope of the study)

(I/ 19) The Chairperson informed briefly about the scope of the study. The survey would

cover ten Member states. The Steering Group had so far met twice. Those present were kindly requested to co-operate if addressed by the contractors.

3.6 European Commission’s commitment to contact Member States regarding “safety anchors”

(w-doc 2003-07: Excerpt of minutes of 30.11.1998)

(I/ 20) In November 1998 at the meeting of the “Working Group-PPE” (30.11.1998) the Commission had agreed to send a letter to Member States to request that they ask their Notified Bodies to withdraw EC type-certificates for safety anchors that did not fall under the Directive. It remained ambiguous whether or not this letter had been sent.

(I/ 21) COMM reminded those present that the basis for this had been an agreement that a number of classes of safety anchors referred to in EN 795 and EN 959 were not considered PPE.

(I/ 22) The meeting agreed that no further action was necessary.

Point 4: Report from Horizontal Committee - Notified Bodies/PPE (HC-NB) (w-doc 2003-17: European Co-ordination of NB – Activity Report )

The above w-document contains the full text of the report. The main items of the report were: - Withdrawal of certificates -Art.11A, PPE-D -“Recommendation for Use” Sheets -Organisation of the Co-ordination & Information on NB’s activities -Work in the Vertical groups -Round Robin Tests -Consensus of NBs regarding the Amending Directive -Next meeting of HC-NB: 16-20.02.2004, Brussels (I/ 23) Following the presentation of the report and regarding the modules for conformity

assessment, ESF and SPAIN re-emphasised their objection to the introduction of Module H. The UNITED KINGDOM agreed that there appeared to be little support for the introduction of this Module.


(I/ 24) The Chairperson noted the recommendation to additionally include Module F. In reply to the general reluctance expressed as to the module H he invited the participants to collect hard facts for non-compliant products due to the use of module H for quality assurance.

Point 5: Reports from CENELEC and CEN (w-doc 2003-08: CENELEC presentation, w-doc 2003-09: CEN presentation)

The Chairperson recalled that at the December meeting information about the management of standards was requested (December 02/163). He thanked CENELEC and CEN for having accepted to give a presentation about their procedures concerning amendments and replacements of standards. These presentations dealing with issues such transition periods (TP) and withdrawal of standards (STD) could be additionally instructive for elaborating the answer to Q 31. The Chairperson informed that the CEN-CENELEC Consultant/sector PPE was unable to join the meeting, respective questions could be addressed to the CEN representative. A summary of the CENELEC (responsible for ca.5% of the STD supporting the PPE-D) and CEN (responsible for ca. 95% of the STD supporting the PPE-D) presentations together with some considerations about the way of publishing these STD in the OJ is attached to these minutes (Attachment 1). (I/ 25) AUSTRIA: The ESOs and the Commission services should recognise that many

STD, whilst being voluntarily developed, were now used in the legal area. It appeared that they did not fully realise the consequences.

(I/ 26) The NETHERLANDS: TPs meant for the market surveillance that there could be

two co-existing editions of one standard for one type of product. It should be made clear that after expiry of the TP the products would have to comply with one, the most recent, -the superseding - standard edition. Short TPs should be defined when the standard modifications concerned important safety and health issues, under such circumstances a TP of 3 years was too long.

(I/ 27) As regards the availability of information about the development, adoption or

amendments of standards the participants had different opinions. (I/ 28) GERMANY felt that respective information was available at two instances: the

development phase and the voting. The working group members knew the standard under development. As a working group included members from industry and NB, the main players were sufficiently informed. It also pleaded to adjust the duration of the TP according the importance of the modification, which could range from marginal to substantial. Therefore CEN’s flexible handling of the duration of TPs was preferred. The ESOs themselves should never impose rigid TPs. These should be agreed within the working group which then recommends an appropriate TP to CEN.

(I/ 29) European Confederation of Footwear Industry not agreeing to that statement

explained that the voting of a standard was not a sufficiently reliable information for industry to take action. Still at this instance, there was the possibility that the standard might not be adopted. Whenever the modifications of a standard addresses fundamental issues such as health and safety TPs were indispensable for industry in order to adapt the product to


the new requirements. A reasonable duration could be 1.5 years, 6 months was certainly a too short period!

(I/ 30) SPAIN supported the opinion that the information about the various steps in the

lifetime of standard needed to be enhanced. It stressed that the sector involvement in standardisation did not guarantee timely information of all industrial branches.

(I/ 31) The Chairperson inquired about the possibility to get early and easy access to the

information related to standards: standards formally eligible for revision, those standards for which revision work would be undertaken. He also reported the request to optically highlight the modifications in order to make them more visible.

(I/ 32) CEN accepted to provide the information requested via e-exchange of data and /or

link to the relevant CEN web sites. Moreover, CEN advised to formalise the request for editorial highlighting of the modified parts of a standard in a letter, the feasibility of the issue would then be discussed at the PPE Sector Forum.

(I/ 33) As to the duration of a TP, the CEN delegate informed about the possibility to

modify it. Upon reasoned request from industry or the Commission more appropriate TPs could be defined. The Directive on construction products was quoted as example. Here the DoW1 / CoC2 applicable to the harmonised standards was set to DAV3+21 months, leading to a TP taking into account the needs of the industry. An urgency procedure could be defined for the few exceptional cases when modifications concerned core health and safety issues.

(I/ 34) CENELEC referred to its consolidated lists of harmonised standards indicating the TPs and DoW / DoC. CENELEC did not wish to tackle the issue of “Annex ZA” in this context referring to the ongoing discussions with the Commission.

(I/ 35) Action:

COMM: to submit formal request to CEN and to exchange web links

Point 6: Recommendation for Use Sheets (RfU-sheets) (w-doc 2003-11: “Recommendation for Use” sheets)

Six new RfU-sheets, prepared by the HC-NB, had been circulated previously to this meeting, soliciting requests for amendments if necessary. No such request had been put forward. (I/ 36) The Group adopted the sheets unanimously. Point 7: The compilation “Questions & Answers” (w-doc 2003-12: Commission’s draft-answers )

1 Date of withdrawal (non-regulated area)

2 Date of Cessation of conferring the conformity presumption (legal area)

3 Date of Availability , see Attachment 1


The Chairperson, introducing this agenda item, proposed to revise the entire compilation. Several of the "Q/A" paragraphs could be published in a more condensed fashion and the information content of some "Q/A" could benefit from being revised.

(I/ 37) The Group agreed to embark one the revision work. FRANCE suggested to undertake the revision work in conjunction to of new questions and problems arising. It also approved the Chair’s proposal to condense into in a simple table format those “Q & A” which merely seek clarification as to whether or not a product was a PPE. The NETHERLANDS requested to suppress the line concerning clogs, that request was accepted.

The Group debated the status of this compilation.

(I/ 38) FRANCE: this compilation formed together with the “Guide for Categorisation” a tool providing for interpretations of the Directive whenever the previsions were not sufficiently explicit. These interpretations commonly accepted by government experts and the stakeholders were good tools to assure uniform application. That toolbox would gain importance with respect to the forthcoming enlargement of the EU. Legally binding, however, were only the Directive, its transpositions and court rulings.

(I/ 39) GERMANY expected that the Group’s interpretations would be granted a particular

standing since it acted according to art. 6 of PPE-D. Against that background it was difficult to accept that any lawyer could challenge the validity of those interpretations (see “Q/A 34”). DE agreed that erroneous or wrong interpretations had to be corrected.

(I/ 40) Action

COMM: to up-load on the web a foreword to the “Q/A” along the opinions above & to propose the valid reference compilations

7.1: Question & Answer n° 31

Q/A 31: “Does the release of a revised harmonised standard imply

the withdrawal of the presumption of conformity of PPE built under

the old standard?”

(I/ 41) The Group did not approve the draft “Answer” proposed by the Commission. (I/ 42) The discussion gave valuable hints of issues to be considered for elaborating a new

draft. (I/ 43) It recommended to treat “Q/A 31 & 32” separately and not to fuse them. (I/ 44) Regarding Q32 it suggested to render the phrasing of the answer more precise by

introducing the aspect of “performance”. (“Q 32: When minor changes in production that do

not alter the performance of a PPE as to its health & safety characteristic …”)

(I/ 45) It was suggested to add to the reasons which oblige to withdraw a standard the mention of ‘substantial progress of the state-of-the-art’. AT commented that this was correct from a theoretical point of view, daily routine however would exclusively operate on the basis of standards.


(I/ 46) CEN expressed its reservation concerning those conclusions of the draft defining obligations for standardisation organisation. It would submit a written comment after internal consultation.

(I/ 47) CENELEC commented that the draft implied that the superseded standard

suddenly ceased to confer the conformity presumption. Such a regulation would be unacceptable for the standardisers and the manufacturers.

(I/ 48) Action:

COMM: to prepare new draft & to follow-up CEN to reply.

7.2: Question & Answer n° 34

«Q 34: How should gloves protecting against temperatures of more than

50°C intended for private users be treated under the PPE Directive ? »

A 34: PPE designed for private use against heat are excluded from the

scope of the Directive (Annex I point 3 and categorisation guide point 9.10).

However, the categorisation guide places PPE designed for protection

against heat above 50°C in cat. II (point 9.8). It follows from the

interpretation at point 9.10 that protection above 50°C is the threshold above

which PPE for private use will fall under cat. II.”

(I/ 49) GERMANY reported about its experience concerning the interpretation delivered by

Q/A 34. The lawyer of a distribution company drew the attention to the incompatibility between the “Q/A 34” and the provisions of the Directive, only the latter being legally binding.

(I/ 50) Annex I.3, PPE-D stipulates that products « designed and manufactured for private

use against heat » are not PPE. Subsequently 9.10 of the “Categorisation Guide reports ‘cat 0’ for gloves protecting against heat for private use. (‘Cat 0‘ is synonym for not falling under the PPE-D)

(I/ 51) The interpretation furnished by “Q/A 34” is in contradiction with the provision of the

directive, the latter being legally binding. Against this background the interpretation has to be revised.

(I/ 52) Action: Immediate: COMM to do not up-load “Q/A 34” on to web. Next meeting: COMM to formally propose the deletion of this Q/A

7.3: Candidate “Q/A” announced by HC-NB at the meeting in December 2002. (I/ 53) HC-NB withdraws this “Q/A”. The adoption of RfU-sheet n°120 makes this “Q/A”

redundant. This Q/A will not be inserted into the compilation.

7.4: Candidate “Q/A” proposed by FRANCE


(w- doc: 2003-19: Avalanche life jacket)

FRANCE presented the candidate question: “Is an avalanche life-jacket a PPE”.

The Group embarked on a controversial debate but could not agree on a common answer.

(I/ 54) The core problem was that the product offered protection only after having been initiated by the user (“pulling on a handle’). It was recognised that the product claims to provide for ‘mechanical protection’ against crushing, mechanical protection corresponds to 3.1, Annex II BHSRs of the PPE-D.

(I/ 55) Action: All: to investigate whether there were other PPE the protective action of which has to be triggered by the user.

The protracted discussion on this issue generated a series of interesting general considerations.

(I/ 56) The Group gives guidance as to whether or not a product should be considered “PPE”. This recommendation should build the common basis for coherent implementation and enforcement of the Directive. The Blue Guide, however states, that the manufacturer has the sole and ultimate responsibility for the conformity of the product to the applicable Directive. The Group does not agree on the interpretation that this meant that only the manufacturer decided which Directive would be applicable.

(I/ 57) It is reiterated that the Group’s consensus would give valuable orientation.

Ultimately, however, all guidance documents could be challenged and only the provisions of the Directive and their transpositions were legally binding.

(I/ 58) The correct way of decision making whether or not a product is a PPE is to first

characterise the type of hazard against which the product claims to protect and then to check if this hazard is covered by the BHSRs.

(I/ 59) It is not the responsibility of Notified Bodies to decide whether or not a product

would was a PPE. Notified Bodies have to check the compliance of the product with the BHSRs.

(I/ 60) The “willingness” of a Notified Body to accept a product for type-examination is not

a criterion to consider a product to be a PPE (GERMANY). (I/ 61) The performance of a product as to effectively protect or its failure must not be used

as a criterion for its classification as PPE. 7.5: (Original issue “buoyancy aids” replaced!) FR - seeking advice concerning three products and their coverage by Directives (PPE-D, Toys-D,GPSD) (I/ 62) (w-doc 2003-24 : FRANCE requesting Commission’s position) (I/ 63) The Chairperson accepts that the French delegation presents an additional issue

for which the French consumer protection needs a rapid reply. Moreover, the French issue also contributes to bring light to area of “buoyancy aids”, the item originally scheduled.


(I/ 64) FRANCE presents three product and inquires whether the Group considered them to be PPE:

1) buoys made up of rubber ring or tire-shaped inflatable plastics (Bouées constituées d’un anneau de caoutchouc ou de plastique gonflable en forme de pneu) 2) floating seats or buoys seats (Sièges flottants / bouées sièges) 3) arm rings (Brassards de natation).

(I/ 65) The majority of Group does not consider any of these products to be PPE. It is recalled that their main function is not to provide protection against the specific risk of drowning.

(I/ 66) The UNITED KINGDOM supports this statement referring to a similar result

obtained from one of its CIRCA inquiry. DE supports the conclusion making reference to the BHSRs 3.4.1, Annex II PPE-D.

(I/ 67) The NETHERLANDS confirms that floating seats were not PPE. (I/ 68) SWEDEN referring to arm rings stresses that this position means that the Group

withdraws a former common interpretation (Categorisation Guide, 10.1); this fact could generate irritation at the level of industry and consumers.

(I/ 69) HC-NB recalls that art.1 together with Annex II of the PPE Directive helped to

decide whether a product is a PPE or not. The arm rings cannot protect from drowning, hence they are not PPE. HC-NB further explains that there are specific arm rings designed to deflate in order to accustom the user to actively swim.

The Chairperson informs that the French request together with the Group’s opinion will be passed on to the Commission services responsible for Toy-D and GPSD in order to learn about their positions.

The Chairperson offers the Group additional reflection time inviting to submit additional comments until 16.06.2003 (17.00h) by e-mail.

Remark: Three e-mails were received by the Commission, two of which fully supporting the Group’s conclusion. SE repeated its opinion that “armbands for swimming” were PE.

(I/ 70) Action: Amend Categorisation Guide 10.1 Immediate: COMM to introduce remark on web-site that issue is under discussion

Next meeting: COMM to formally propose to delete the wording “…or for use as buoyancy aids, including swimming aids…..” from Cat. Guide, 10.1.

Point 8: Problems related to PPE, products & categorisation

8.1 Synthesis of results achieved at the Group’s Meeting of Dec. 2002

This issue is discussed together with issues of point 7, see point 7.

8.2 Intervention of ITALY: PPE enhancing the visibility on roads


(w-doc 2003-25 : IT position paper and its translation)

ITALY was invited to build on its comments delivered at the meeting in December 2002. The Italian opinion was that a PPE either had a protective function or contributed to reduce the risk of being exposed to or becoming victim of a specific hazard.

(I/ 71) The Italian presentation mainly furnishes background information and data in order to convince the Group that high visibility clothing is an important tool to combat mortal accidents of road workers. Hence PPE protects against a typical category III risk.

(I/ 72) Subsequently, ITALY proposes a change of category for these products, from II to

III, asking the Spanish delegation to reconsider its respective point of view of this issue. (I/ 73) The discussion shows very controversial opinions. It is doubted if this type of

product would at all fall under the PPE-D. There is no consensus that ‘signalling ’ was protection in the sense of the PPE-D.

(I/ 74) It is recalled that point 2.13, Annex II (BHSRs), stipulates ‘signalling’ and defines

specific requirements for it. Hence it was the legislator’s wish to consider ‘signalling’ as ‘protection’ and to cover the relevant products by the Directive. Against this background, the various pros and cons are not recorded.

(I/ 75) The Chairperson states that the Group is not ready to support the requested

modification of category. (I/ 76) Action:

ITALY: to prove that the present classification caused problems and that the application of the conformity assessment procedures for class III would solve them.

COMM: to re-table IT request

8.3 GERMANY remark concerning the “Visibility Accessories (EN 13356:2001)

The Chairperson recalls the comment of GERMANY at the meeting in December 2002. DE observed the opinion that visibility accessories had to be PPE due to the publication of the relevant CEN standard in the OJ as HST under the PPE-D.

It was requested to investigate about the justification that this standard was published as a ‘harmonised standard’ in the OJEU.

(I/ 77) The Chairperson informs that the Commission mandated under BC/CEN/93/30.1000M/03, WI 00162117, the development of this standard.

(I/ 78) CEN-CENELEC remarked that this standard had passed all the formal instances of

a HST: mandate – annex ZA – check by CEN-CENELEC Consultant – and this publication in the OJEU.

(I/ 79) The German comments reveal that the Commission had mandated the standard

development against the Group’s advice. Several delegations doubt that the products covered by this standard were true PPE.


(I/ 80) BELGIUM considers it as a horizontal standard to which accessories must comply with regard to general requirements such as surface properties and tests for product verification. SPAIN expressed sympathy for this interpretation.

(I/ 81) SWEDEN stresses that in Sweden these products are considered to be PPE and

are frequently used by consumers. These products were very important under the local, seasonal conditions of early and long lasting darkness (kids, joggers, skiers). “Signalling effect “ is surely a protective element (see point 2.13, Annex II, PPE). SE adds that the consumer protection was as important as worker protection, the PPE-D covered the products independently of their use be it private be it professional. IT supports the opinion that visibility accessories were PPE.

(I/ 82) The NETHERLANDS refers to the importance of the manufacture’s intention. If the

manufacturer claims that such visibility accessory protects then this protective feature had to be verified by tests. If the product failed the test necessary action would have to be taken against it. NL agrees that arguments such as private/professional use and/or unsatisfactory performance of the product were out of scope.

(I/ 83) SPAIN could accept those products as PPE subject to the condition that they met

the same visibility requirement as defined by EN 471 which is highly elaborated and demanding.

(I/ 84) SWEDEN agrees with SPAIN proposing however to first observe the efficiency of

this harmonised standard (HSTD) supporting the PPE-D and to request remedy actions if necessary.

(I/ 85) The Chairperson summarises. The publication of EN 13356 in the OJ as HSTD

under the PPE-D is a matter of fact. The Group is asked to attentively observe the development of products under this standard during the coming year.

(I/ 86) Action: CEN-consultant: to examine if requirements defined by EN 13356 meet the BHSRs of Annex II, PPE-D. A negative result would justify to request from CEN further explanation.

COMM: to re-table issue within one year’s time

8.4 UNITED KINGDOM: Protection mounted on to mobile phones

Further considerations whether or not this product was a PPE had become redundant. The product is now covered by the GPSD, the manufacturer had done the necessary changes of the information to the user and for use.

8.5 - 8.9 “Matters arisen”

These matters were not dealt with due to their relatively limited importance and lack of time.


(I/ 87) Action: COMM: to inform about issues at next meeting.


Minutes: Working Group PPE, meeting 10-11.06.2003

Part 2: Project “Amending Directive”

Point 9: Project “Amending Directive” (WP-DAD)

9.1and 9.2: Examination of impact of the use of modules for

conformity assessment – analysis of art. 8, WP-DAD

(w-doc 2003-14: module decision; w-doc 2003-15-01: WP-DAD, art.8, annexes;

w-doc 03-15-02: WP-DAD, Technical Documentation, w-doc 03-15-02 to 09: WP-DAD,

annexes/modules)

(II/ 1) The Chairperson recalls that the alignment of the certification procedures (CAP) of the PPE-D to the module decision was one of the targets of the amendment project. The Chairperson explains that the module decision was taken after the adoption of the PPE-D a fact that explained the discrepancies. The Group had not yet discussed the modules. The WP-DAD should include the modules A, the combination B-C and the quality assurance systems D,E and H. The linked module B-C appears necessary in order to ensure that the manufacture process continues to generate products in conformity with the (proto-)type which had been CE type-examined and certified. Recent feedback from the HC-NBs suggested adding module F and the CAP provisions corresponding to art.11A, PPE-D.

The use of the harmonised modules also imposed a common format for “Technical Documentation” which would additionally cover the phase of manufacture.

The Chairperson proposes as working strategy to examine the provisions of article 8 WP-DAD together with respective annexes.

(II/ 2) Art. 8, WP-DAD lists the procedural requirements to be followed before placing a product on the market (putting it into service) synoptically despite of the fact that each module also sets out these elements. The Group supports this repetition of procedural steps as being “user friendly.

(II/ 3) “Categories”: The Group insists to include the definitions of the categories in the

main body of the Directive. (II/ 4) It is clarified that “category” stands for the category of a risk leading to injury. To the

3 degrees of injury, minor – medium – and high leading to irreversible harm and dead, correspond 3 categories (I, II, III).

(II/ 5) The Group firmly recommends not to change the terms: “category I PPE” etc.; the

profession uses it, there is no evident reason for modification.


(II/ 6) DENMARK underlines that the directive defines one standard set of requirements to which PPEs had to comply, e.g. the “CE” marking, conformity assessment. The procedures for conformity assessment do vary depending from the risk category associated with the type of protection delivered by a given PPE.

(II/ 7) The Modules and procedure of article 11 A, PPE-D: The Group supports the

modules proposed: Module A (for cat I); Module B in conjunction with C (B-C) (for cat II), Modules D,E,F (for cat III). Module F is included upon the recommendation by HC-NB stressing the usefulness for manufacturers producing only few batches of PPE per year.

(II/ 8) The addition of a CAP according to the main elements of art.11 A of the PPE-D is

commonly supported, this allows for continuity in the sector. (II/ 9) HC-NB supports the Commission’s position that some of the provisions of art.11 A

needed to be improved. A more clear wording should put emphasis on the manufacturer’s obligations as to ensure a homogeneous production during the manufacture phase. On the other hand the inspection obligations for NB bodies should also become more explicit as to the aspects of third party sampling and its frequency.

(II/ 10) The Group does not support the Commission’s proposal to include Module H for cat

III. Some participants propose Module H1 as fair compromise reconciling both positions. NL informs that Module H was being used for the gas appliances.

(II/ 11) FRANCE strongly insists that transparency commanded that each category had its

specific module or modules. The module(s) defined for a specific category must not be shared with any other category. A higher risk category requests a more demanding CA-procedure.

(II/ 12) The situation by which a “category II - PPE” would be submitted to a CAP foreseen

for category III had to be avoided. The example showed that overlapping modules led to the co-existence of different “CE” markings for one type of product associated with the same category (“CE” and “CE + number of the intervening NB”). This could confuse the market and generated wrong expectations related to the quality of the product at the user’s side.

(II/ 13) AUSTRIA develops an alternative approach. The modules associated to the

categories could be understood as defining the minimal module(s) per category. The (more demanding) modules foreseen for a higher category could also be used for products belonging to an inferior category.

(II/ 14) The definition of such minimal requirements for CAP per category still contained two

possibilities: a) the manufacturer is obliged to carry out the obligatory minimal requirement, independently and in addition he has the freedom to apply other modules (foreseen for a higher risk category) or other types of product certification;

b) the CAP defined for a higher risk can replace the CAP defined as minimal and obligatory requirement for an inferior category.


(II/ 15) The UNITED KINGDOM admits that the recreational craft Directive explicitly permits the use of CAPs defined for higher classes for inferior classes. It, however, recalls that UK’s intention is to modify the PPE-D as little as possible.

(II/ 16) SPAIN doubts whether or not the Group rejected this possibility of overlapping

CAPs by voting. None of the Group members reacts on the ES comment. (II/ 17) The Chairperson refers to the Communication on the “New Approach” which

reflected that the Commission was going to take a new position. FR draws the Group’s attention to the fact that the Communication does not discuss the shared use of CAP for different categories.

(II/ 18) AUSTRIA differentiated between the Directive explicitly mentioning that possibility

and its implicit acceptance. The consequences would be different. It also reminds that NBs mainly ran the activity of a testing house, they might not be prepared to decide about quality systems.

(II/ 19) GERMANY remarks that the PPE Directive has never excluded that manufactures

undertook additional efforts on top of the obligatory ones. (II/ 20) Following-up a remark from FESI, several delegations insisted on the fundamental

difference between the obligatory requirements set by the Directive and voluntary measures undertaken by industry. The quality assurance modules of a Directive were obligatory they could never be replaced by ISO quality assurance programme.

(II/ 21) The Chairperson states a very controversial discussion on the use of modules of a

higher category for inferior ones. This issue would be re-tabled at the next meeting. (II/ 22) Aware of the general reluctance regarding the introduction of module H, the

Chairperson asks the participants to substantiate their concerns. They should report back facts and cases which demonstrated that a PPE has become non-compliant as a consequence of the application of module H. (H being inappropriate for PPEs or being unsatisfactorily applied).

(II/ 23) There, however is agreement,

-to offer the modules A, B-C, D, E and F in the WP-DAD

-concerning their association to categories

-to insert the provisions corresponding to art.11A PPE-D (after modification) in addition to the modules D, E and F.

(II/ 24) Action: COMM: to compare modules and their use in different directives (overlapping) & to re-iterate solicitation for submitting written comments whenever there are doubts about the suitability of specific modules and / or its provisions for PPE

All: to report back the findings that module H is not appropriate for PPE.


(II/ 25) “User information”: The Chairperson explains that this wording refers to Annex II, 1.4 of PPE-D “Information supplied by the manufacturer”.

(II/ 26) AUSTRIA comments referring to the draft. The main issue is to link the information

inseparably with the product. This should be spelled out in the first phrase of this paragraph, subsequently the special issue of “bulk” should be treated. The proposed word “printing” would not enhance the clarity and may unnecessarily impose restrictions of the text regarding future developments.

(II/ 27) ESF: questioned the meaning of “bulk”. HC-NB recalls that the intention was to link

the requirement for information to ‘the smallest commercial packaging available“, expression recommended by RfU Sheet n°8.

(II/ 28) FINLAND proposes to include an additional requirement. Each PPE should bear a

specific identifier (name of the model, manufacturer’s name or trademark, see also: GPSD, art. 5.1 or the Toys-D) in order to establish the aforementioned link. The sales packaging itself shall bear basic information on the intended use and protection performance level, this information was indispensable for selecting the appropriate PPE. This proposal combines better product identification, improved traceability and linking essential information with the product.

(II/ 29) Several delegations explicitly welcomed this proposal (The NETHERLANDS,

BELGIUM, DENMARK). BELGIUM specified that Annex II 1.4 did not make any reference to the product itself.

(II/ 30) The Chairperson promised to propose a new draft, he also noted the request for a better product identification.

(II/ 31) Action: COMM: to re-draft provision, to examine the feasibility of FIN proposal

(II/ 32) “Technical Documentation” (TD): the Chairperson introduces the issue and explains that the requirement for the TD had to adapted to the introduction of the modules which all referred to one single version of TD. This version explicitly considered the ‘phase of manufacture’ in addition to ‘concept/design’ and ‘operation’ (as already requested by the preceding version of TD).

(II/ 33) The issue is controversially discussed. HC-NB, representing the experts dealing

with this type of documentation on a routine basis fully, supports the proposed modifications. In particular, the level of detailed requirements was qualified as being helpful since the lack of precision (of the current version) had generated operational difficulties. The high number of RfU-sheets mirrored the uncertainty governing the area.

(II/ 34) In the opinion of FRANCE and GERMANY the current format of the TD had never

caused any problems, they judge the modification to be redundant. (II/ 35) The UNITED KINGDOM takes the position to modify as little as possible proposing

a guidance document to deal with this issue in greater detail. ESF is intrigued by the level of details and reminds the cost for such a document.

(II/ 36) SPAIN recalls that it is up to the manufacture to decide the level of details ne-

cessary to demonstrate that the BHSRs are met and to allow the NB to do its job.


(II/ 37) The NETHERLANDS points to the extreme broad range of different products

representing PPE. (II/ 38) The Chairperson accepts to review the proposal. Effort would be undertaken to

highlight the flexibility of the TD to adapt to the different levels of complexity of products. He, however, insists on having one common format for all PPE categories in view of making legislation less complex.

(II/ 39) Action:

COMM: to re-iterate solicitation for submitting written comments whenever there are doubts about the suitability of specific modules and / or its provisions for PPE

9.3 WP-DAD provisions concerned by the Communication on “New Approach” - Review of some definitions

(w-doc 2003-16-01: draft articles 1&2 for WP-DAD, w-doc 2003-16-02: Impact of communication “New Approach”)

(II/ 40) The Chairperson proposes to exclude from the discussion the so-called group of “New Approach” definitions, the Commission services were likely to prepare a common set of definitions for all “NA”-Directives (WP-DAD 4a-d). The Group is invited to examine the remaining definitions and to comment on the alternative wording tabled in the working document 2003-16-1.

(II/ 41) The Chairperson introduces the draft modifications for art. 2 questioning the need

for defining terms (assembly, integrated equipment…) which were never again used in any provisions.

(II/ 42) The Group expresses a general caveat as to modifying the provisions of the

Directive. It recommends to strictly restrict the modifications to points which caused problems, this was a decision taken by the former working party on “directive revision”.

(II/ 43) The Group is aware that some of the provisions are not understandable for the

inexperienced reader. Several delegations (the UNITED KINGDOM, SPAIN, FRANCE) recommend to develop a guidance document which would explain the individual provisions. FRANCE indicates that the recitals could be efficiently used in order to give guidance, the existence of the documents like “Guide for Categorisation”, “Recommendation for Use Sheets” would impose a certain hierarchical order within those documents.

(II/ 44) DENMARK, supported by MALTA, stresses that the provisions of a directive should

be clear from the beginning, explanatory guides are not the first choice. The following issues and problems are discussed examining text of the definitions and the proposed modifications.

(II/ 45) ESF supports the Commission proposal to replace “device or appliance” by “product”, the former wording did confuse manufacturers.


(II/ 46) The term “assembly” is discussed. The NETHERLANDS insists on its importance since it covers PPE placed on the market as kits, where the user assembled parts to prepare a PPE ready for use. The Chairperson recalls the phrasing of amendment as decided during the last meeting being more restrictive assembled by the manufacturer”.

(II/ 47) AUSTRIA explains that “assemblies” was tacitly understood as a product. It

originally referred to the combinations of different PPEs in the sense of BHSR 2.14. which were combined to one piece of equipment (helmet with mounted eye protection).

(II/ 48) BELGIUM supports the preservation of “assemblies” associating it to “putting into

service”, the new element in this WP-DAD. BELGIUM quotes as an example the protection from falling from height. It was current practice that the user bought different elements for its protection and combined them. In this case the user was responsible for the functioning of the PPE.

(II/ 49) AUSTRIA adds that both, user and manufactured, could assemble parts in order to

prepare a PPE. SPAIN refers to point 3.5 of the Blue Guide, the professional assembler.

(II/ 50) The NETHERLANDS recommends a prudent use of the word “product”. Its

meaning needed to be restricted to “moveable”, “unmoveable” products in order to exclude “real estate” which could fall under the Directive fulfilling the conditions to “protect” and to “be held”.

(II/ 51) The Chairperson proposes to table a new proposal for article 2, taking into account

both the Group’s general advice of preserving as much as possible the original text and the detailed discussion, in particular the problem related to “assemblies” and the NETHERLANDS request to cover the kit-type PPE. He thanked for the suggestion to draw up a guidance document for PPE and for the support offered. An operational scenario would be proposed at the forthcoming meeting (development parallel to or following the amending process, working method).

(II/ 52) Action: COMM: to re-draft proposal considering comments & to develop working method for guidance doc.

9.4 Examination of art 9. WP-DAD (special provisions for PPE adapted to anatomic abnormalities)

(w-docs 2003-06: read me; 2003-18: procedure for made-to-measure safety shoes)

(II/ 53) The Chairperson explains that this session should inform about experience related to PPE adapted to specific individual anatomic requirements. Participants are also invited to quote examples of PPE for which adaptation is requested. Against this background the provision of art. 9 WP-DAD should be examined.

(II/ 54) Two interventions are scheduled. Regrettably the Polish delegation declares not to

be in the position to comment about their experience. (II/ 55) Mr PRÖVE (German Federation of Orthopaedics, ~ 2500 SMEs) invited as second

expert speaker to this topic, contributed recalling the procedure which had been developed by the Working Group “PPE” in 1998 and its application in Germany.


His presentation focuses on the protective working shoes adapted to anatomic malformation, no other types of PPE are identified for which made-to-measure adaptation are requested. A full system of certification (material, procedure, atelier) and training requirements ensures best practise and a high quality product for the protective safety shoe.

(II/ 56) Interesting to be emphasised is the issue of responsibility. It appears that the master craftsman has the delegation to affix the CE marking to his product, he bears the responsibility for the product. It, however, is also mentioned that the CE type-examination certificate always indicated the manufacturer, the NB and the craftsman having executed the adaptation.

(II/ 57) The presentation does not inform about the situation in and the experience of other

MS. The Group is not ready to comment whether the MS have sufficiently similar training structures in order to guarantee comparable implementation of the procedure.

(II/ 58) Upon Spanish question it is explained that the medical prescription was not

mandatory, it, however, simplified the work. (II/ 59) The Group confirms that in addition to the protective shoes, mouth-guards, hearing

protection, goggles with corrective glasses were PPE susceptible for adaptation to anatomy. This listing does not contain any new element.

(II/ 60) The Chairperson proposes to consider the terms and definition as used by the

medical device directive. Several delegations agree that the wording of the definition of the MED-DEV could be of help but stress at the same time that “protective aspects” are covered by PPE-D (FRANCE, SPAIN, GERMANY).

(II/ 61) The Chairperson invites to examine whether the term “custom-made” was

sufficiently clear, it still covered two situations, the adaptation of products and the building from scratch of a product according to the specific requirements of the user.

(II/ 62) ESF intervention appears to void this distinction as far as safety shoes are

concerned, current practise was to build the shoes from scratch mimicking a CE-marked shoe model taken from mass production. It remains unclear whether the re-built shoe has to be produced in duplicate in order to allow (destructive) testing. As alternative the test of the CE-marked prototype could be considered to be sufficient.

(II/ 63) The UNITED KINGDOM shares the opinion that “custom-made” is not a sufficiently

clear term. The distinction between “one-off not including adaptation” and “adapted” is proposed but not commonly shared.

(II/ 64) The Chairperson states that an inquiry had to be launched as to comprehensively

list PPE products which after modification could be of use for people with anatomic abnormality. Art. 9 WP-DAD would be re-drafted in the light of the discussion.

(II/ 65) The specific procedure as described in Annex IV would be re-tabled for discussion.

These provisions exempted the specifically modified PPE from all CAPs and the declaration of conformity. The “statement” and the “Technical Documentation” become the main elements of the particular procedure.

(II/ 66) Action:


All: to identify PPE used after adaptation to anatomic abnormality &

to investigate about new needs

COMM: to re-draft art. 9, to re-table Annex IV WP-DAD

to follow-up the handling of adaptation proc. throughout EU (ADCO group)

9.5 Tabled Comments submitted following the meeting in Dec. 2002

(w-doc 2003-17: tabled comments)

The Chairperson informs the Group that their comments on the provisions of WP-DAD are tabled and available for proof reading. The next edition of WP-DAD , WP-DAD- 1 will have integrated them.

Point 10: A.O.B.

The items foreseen will have to be discussed at the forthcoming meeting or by correspondence.

The participants are informed that the forthcoming meeting is scheduled for 17-18.11.2003 (provisional date).

Point 11: Closure of the Meeting

The Chairperson thanks the participants for their active collaboration. He also expressed his thanks to the interpreters.


EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single Market : regulatory environment, standardisation and New Approach Mechanical and electrical engineering, and radio and telecom terminal equipment industries

Brussels, ENTR/G3/CD D(2004) 750348

WORKING GROUP ON PERSONAL PROTECTIVE EQUIPMENT (PPE) DIRECTIVE 89/686/EEC

Minutes of the Meeting - Working Group “PPE” of 13-14 January 2004

(Luxembourg)

Table of contents:

Preliminary remark……….page 2

Minutes………….……..….page 3 to 20

Attachment 1………………page 21 to 26

Attachment 2………………page 26 to 27

It is to be noted that previous to this comprehensive minutes short versions were circulated summarising the most salient issues of the meeting. The objective was to give participants the opportunity to compare the summaries with their meeting impressions still freshly in mind:

– Circular letter 2004-01 of January 2004 - Flash conclusions – Circular letter 2004-02 of 10 March 2004 – Newsletter

These documents also invited the members of the Group to react, respecting certain deadlines their comments could be integrated into the amending document; the absence of comments is understood as tacit approval.

The list of participants and the list of working documents are to be found on CIRCA


Points 1 and 2: Welcome and approvals (W-Doc 2004-00-01&02: Draft minutes; W-Doc 2004-0: Draft agenda)

Mr Dirscherl (Chairperson – Directorate-General Enterprise G3) welcomes the participants and thanks them for having accepted the travel to Luxembourg.

1) Approval of the draft- Agenda (W-Doc 2004-01) is granted subject to the distribution of additional working documents introduced by FR (W-Doc 2004-23), HC-NB (W-Doc 2004-21, W-Doc 2004-22, FESI (W-Doc 2004-18).

2) Approval of Minutes (W-Doc 2004-00-1 & W-Doc 2004-00-2) of the previous Meeting held in June is granted, no amendment is requested.

The Group is informed about other meetings taking place in Luxembourg in conjunction with the present meeting: 15.01.2004 ADCO Group PPE and 16.01.2004 workshop jointly set up by the DG ENTR and DG EMPL with the objective to define structural elements of an e-tool advising SME which PPE fits best for a defined working situation/exposure.

The Chairperson encourages in particular the future New Member States to register for access to CIRCA.

Points 3: Drafting Group for “Guidance Document”

3) The Chairperson informs the Group about the project to develop a comprehensive guidance document. For this undertaking a drafting group is to be established. Its composition should reflect the main domains covered by the PPE-D, such as protection at the workplace, consumer interests, industry, Member States including the new MS and EFTA countries etc.

The comprehensive guidance should be in support of the amended PPE Directive. The start of the work, however, is independent from the amending project. Many provisions will remain stable or have reached maturity and allow starting initial work. The guide would also include the already existing documents (Categorisation Guide, Questions and Answers, Recommendations for Use Sheets).

The target user group are professionals applying the Directive.

The drafting languages are English and French.

4) The draft committee will use remote networking (CORDIS, virtual meeting) and meetings shall be held in tandem with the meetings of the Working Group, PPE-ADCO and the Co-ordination of Notified Bodies; main objectives is to reduce the travelling time.

The Group submits the following nominations for participation:

MS and EFTA countries:

GERMANY: Dr. Christ

UNITED KINGDOM: Mrs Finch and Mrs Girdharree

FRANCE: Mrs Koufane

SPAIN: Mr Caceres

AUSTRIA: envisages participation

The group of Nordic countries (emphasis on consumer aspects): Mr Andersen


The group of New Member States: the Chairperson proposes to kindly accept this co-ordination role in order to co-ordinate any specific need of the new MS including their market surveillance services

Organisations supporting the implementation of the Directive:

HCNB: E. Korhonen

CEN: Mr Mayer volunteered, and considered that the target user group should also include notified bodies and market surveillance authorities

Stakeholders:

The industrial associations ESF and FESI will nominate candidates later

The Chairperson thanks for these nominations and stresses that further nominations are still receivable if they add the representations of additional interest groups. The number of drafters, however, has to remain within an operational seize. A revised mandate will be circulated, at the same time first contacts between the drafting group members shall be established.

Point 4: Amending of PPE-D (W-Doc 2004-0: WP-DAD 2.0 Provisions; W-Doc 2004-03: WP-DAD 2.0 Annexes)

4.1 Amending Directive (WP-DAD) to Directive 89/686/EEC State of the play and the way ahead (W-Doc 2004-15: New Approach- Council Resolution)

5) The Chairperson informs about Council Resolution on strengthening the New Approach. Three issues of this paper relate directly to the amendment of PPE-D: the appointment/ monitoring of activities of NBs, the national market surveillance and the modules to be used for conformity assessment procedures (CAP). In response the Commission will undertake a major, horizontally organised revision of all NA-Directives aiming at trans-sectoral harmoni-sation. The full repercussion of this horizontal revision on to the sectoral activities is not yet fully clear.

Against this background, however, the amending work for PPE shall not consider the articles of typically horizontal nature such as: 2.3 (NA definitions), 10, 18 & 19 WP DAD)

4.2 Main modifications since June 2003 meeting & general discussion (W-Doc 2004-24: progress & modified details)

6) The Chairperson presents slides summarising the consensus achieved during the June

2003 meeting of the group and refers to the amendments incorporated in the WP-DAD since the previous June 2003 meeting.

Annex I, a) & b) Partial minutes of Part 1, point 4 (W-DOC 2004 – 03: WP-DAD 2.0 – Annexes)

7) Two discussion rounds (end of day one and end of day 2) are dedicated to sharpen the criteria used for the categorization of PPE / the hazards against which they protect.

8) The detailed comments and the revised wording of Annex I, a) & b) are reproduced in attachment 1.

9) The Chairperson informs that this revised version will be circulated to the different CEN TCs in order to adapt as much as possible to the technical terminology used in the ENs.


This is to ease the future translation work and to exploit CEN’s corpus of harmonised technical terminology.

(Remark introduced in May 2004: disappointing low response from CEN TCs, exercise to be repeated)

Definitions (WP) (W-Doc 2004-06: Understanding of definitions)

10) The Chairperson points to a problem arising from the definitions of art. 2, WP-DAD (see respective text analysis).

In a nutshell, the definition of “Integrated Equipment” (WP-DAD, art. 2.1.c) and its assimilation with PPE may lead to absurd consequences: the entity consisting of any device linked to a PPE product becomes a PPE itself. This is not in line with the legislator’s original will.

11) The provision of current art.1.3 (89/686/EEC) needs to be transferred to WP-DAD: it defines in complex systems the borderline between PPE and any external device not qualifying as PPE. Furthermore it introduces the aspect “system”. The latter term however is not defined. The combination of WP DAD art.1.3 (g) and the re-inserted art. 1.3 PPE-D define which products used for the protection from falling from the height are within the scope and which ones are out of the scope of the Directive.

12) CEN RP4 remarks that the ‘integrated equipment’ (WP-DAD art. 2.1c) refers to PPE inserted into another product. The latter may influence the performance of the PPE, this aspect is to be taken into consideration when certifying integrated PPE.

13) UK reminds of the use of a guidance document to exemplify the definitions by naming the PPEs concerned. This is the only way to ensure common understanding.

14) ES doubts has doubts about the phrasing proposed to exclude personal, every days-clothing from the Directive, but does not propose an alternative.

D/04/1 The Group supports the re-introduction of the structure of definitions as in 89/686/EEC together with the provision of art 1.3.

4.4 Problem area: anchor devices – reiterated request to include Art. 1.3

(W-Doc 2004-04 Anchor devices)

15) As far as the scope of the directive is concerned see 4.3. The problems related to standardisation are to be found at 7.3.

4.5 Modules for conformity assessment procedures (W-Doc 2004-24 – Progress and modified details)

16) The Chairperson takes stock of decisions related to the procedures for conformity assessment; the achievements are screen-projected in order to involve all delegations in the discussion.

17) The Chairperson explains that certain parameters (statistical sampling strategy) need to be defined before module F and the provision of art.11A PPE-D (transferred into WP-DAD) could be applied.

4 CEN PPE Sector Rapporteur: Mr. Alain Mayer


18) HC-NB5 reports about activities related to an overhaul of the application of art. 11 A, thus confirming the need for corrective measures.

19) According to FESI the quality assurance based certification procedures may face increasing application difficulties due to the transfer of the production sites outside Europe. These procedures request on-site inspections; if not done, the risk of “wild EC marking” is evident.

The discussion leads to the following decision:

D04/2 The Group mandates to the HC-NB:

i. the definition of the details necessary for the application of both, module F(statistically based sampling) and art. 10 PPE-D, (manufacturer’s proof of production homogeneity and NB’s sampling/testing obligations)

ii. to assess the compatibility between the art. 10 PPE-D, 89/686/EEC, and

the combination of modules “B-C++ ” iii. to examine whether module G is suitable to ensure the conformity of

made-to-measure PPE (see also 4.5.2) iv. to collect experience concerning the application of modules D, E and H

( e.g. contacting NBs operating such modules in other areas)

HC-NB kindly accepts these tasks and will pass them on to the working groups. Their result will be discussed in the HC-NB plenary meeting of February 2004.

In this context the BE delegation offers to attend the meeting of HC-NB and to report back to the Group in order to strengthen the link between the two parties.

4. 5. 2 Need for specific provision for “Accessibility to PPE for disabled”

20) The Chairperson recalls the intention to improve the availability of PPE taking into account the specific needs of disabled people. He remarks that the trade-off between availability of PPE and the strict application of conformity assessment must not lead to reduced level of protection. Two terms shall be agreed in order to ensure clear understanding:

“adapted PPE”: a mass produced PPE, ex-post adapted to the particular needs / anatomy of an individual

“made-to-measure PPE”: a PPE particularly designed and manufactured for an identified individual fully matching the form of the body part to be protected

21) The Chairperson reports about his inquiry which did not demonstrate the need for such an

amendment. In this context contacts had been established to associations such as EDF6,

5 Horizontal Committee of Notified Bodies

6 European Federation of Disabled People


ANEC7, sport associations for disabled people, to CEN and HC-NB and to Commission services (Directorate-General Employment, unit for disabled persons). The result of this inquiry does not justify the introduction of particular provisions considering the concurring risk to create a loophole which could be used to bypass the regular CAP for PPE.

22) The few types of PPE which are frequently “adapted” or “made-to-measure” are already known to Group and the current provisions can regulate them adequately. The Chairperson tables the following regulatory solutions for discussion:

- deletion of “customised PPE” (art. 9, WP- DAD (version 1.52)

- “adapted PPE” is covered by “putting into service”, the “Blue Guide” explains that it is up to national market surveillance to control that a product that had undergone important modifications, which could influence its safety performance, still fits for purpose;

- “made-to-measure” PPE to be assimilated to “placing on the market” of a unique fabric.

UK confirms that the proposal is in full agreement with the Blue Guide.

AT, however, wonders whether Module G would be a suitable conformity assessment procedure for this type of unique fabrics (4.5.1, mandate to HC-NB).

CEN-RP informs that an increasing number of manufacturer integrate the adaptation and the making-to-measure of PPE in their service offer. He adds that one common procedure of conformity assessment for PPE of type a) and b) could also generate conflict if they belong to different hazard categories.

D/04/3 The Group supports the Chair’s proposal: no specific provisions for “adapted” and “made-to-measure” PPE to be introduced in WP-DAD.

The future guidance document shall explain the solution found for the “made-to-measure” protective orthopaedic shoes and their placing on the market” referring to the “DE” approach. Depending on the availability of a similar infrastructure as developed by the guild of orthopaedic shoemakers this approach could be applied for other “made-to-measure” PPE

23) The Group confirms the listing of type a) and b) PPE products:

1) Orthopaedic safety shoes (the safety aspects qualify for PPE)

2) Protective goggles with sight correcting glasses

3) Helmets for head injured people

4) Protective working gloves

5) Mouth guards

6) Moulded ear plugs

24) HC-NB referring to the procedure for protective and sight correcting glasses recalls the approach to test the two extremes, e.g. the thickest and the thinnest lens resulting from the

7 European Association for Co-ordination of Consumer Representation in Standardisation


sight-correction of protective glasses. All the variations between those extremes are considered as being covered by the tests and compliant with the Directive.

4.6 Continuation of the screening of provisions, in particular of Chapters IV and V of

WD-DAD (W-DOC 2004 – 02: WP-DAD 2.0 – Provisions; W-DOC 2004 – 03: WP-DAD 2.0 – Annexes)

The Chairperson guides through the WP- DAD, the Group is invited to comment article by article. The detailed comments are recorded in attachment 2; the comments of general interest are reported here.

25) Art. 6 WP-DAD gives rise to discussion; several delegates make a strong plea for the development of standards which cover all BHSRs applicable to a product. The formula “one standard for one product” reflects the expectation of the standard user (FR, ES).

26) Delegates regret that the Commission does not urge the ESO to change their policy.

27) CEN-RP recommends to start to expand Annex ZA. It should list all the Essential Requirements (ER) applicable to the type of product and indicate whether or not they are covered by the standard concerned. This approach could pave the way towards product standards covering all ERs applicable.

28) CEN-Consultant remarks that the Blue Guide refers to the partial coverage of a standard. It is up to the ESO to decide on the technical content of a standard. It is a second decision whether a standard qualifies as a harmonised standard in the sense of N-A (procedural requirements observed, etc.).

29) FR suggests extending the range of criteria to be met by bodies in order to become eligible notification to the Commission, e.g. “participation in the European forum of sectoral NBs”.

30) HC-NB suggests to define the term “proportionality” in order to narrow the room for interpretation.

31) The Chairperson promises to pass on the recommendations.

A/04/1 Chairperson to act and to report back to Group

Point 5: Coaching activities relating to PPE Directive

5.1 Harmonised terminology for Notified Bodies’ technical competence

32) The Chairperson informs that the service concerned will inform the Senior Official Groups for Standardisation (SOGS) about the need to harmonise the terminology used by MS when describing the fields of nomination.

33) FR refers to a recently received NANDO documentation and recommends its distribution.

(ex-post remark: For the delegates’ convenience the e-link is: http://europa.eu.int/comm/enterprise/nando-is/home/index.cfm)

5.2 “To be or not to be PPE”

5.2.1 Automatic controls triggering the protective function of PPE

D/04/4 Decision postponed.

http://europa.eu.int/comm/enterprise/nando-is/home/index.cfm


34) The Chairperson introduces the item, the principal question being whether a PPE has to protect instantaneously, or whether PPE covers also equipment the protective function of which has to be triggered by its user.

35) The CEN-CENELEC Consultant states that several types of products the protective action of which has to be triggered are accepted as PPE, for example respiratory equipment. ES agrees with the view that “triggered” equipment is PPE.

36) FRANCE recalls point 3.4 of Annex II (setting the requirement that the PPE must return to the surface as quickly as possible without any user’s intervention). The technical realisation is not regulated (the PPE “may be wholly, or partially inherently buoyant or may be inflated …, “manually or automatically..”).

37) GERMANY quotes the example of hearing protection. This PPE is – automatically - activated at 85 db in order to allow for normal communication.

38) ESF distinguishes between “triggering” that has a direct effect and “triggering” that merely starts a system that triggers the protective function. .

39) FESI agrees and points out that any manual action would have to be time-defined.

40) The discussion reveals that “triggering” may not be the core problem. Technology will develop systems triggering the protection and render manual triggering obsolete (CEN-RP). The moment of activation appears to be important. It is important whether the protection is activated before the user’s exposure to a situation during which a hazard can occur or immediately after a hazard had occurred (avalanche in motion) to protect him from consequences.

5.2.2 Avalanche life jackets

(W-Doc 2004-07 Avalanche)

D/04/5 Decision postponed

41) The Group does not take any decision whether or not the product is a PPE, the discussion will be re-opened in the light of more information.

Some opinions are expressed.

42) FESI believes that such equipment should not be considered to be PPE. FESI representative reports on his own experience that the wearer would have neither the time nor presence of mind to activate this safety device at good time once being threatened by an avalanche. The annotation “PPE” could convene confidence in a potentially dangerous product.

43) CEN-RP agrees that manually triggered avalanche life jackets are dangerous, and should not be classified as PPE. The development of automatic triggering would be necessary before such equipment could be classified as PPE.

5.2.3 Secondary automatic parachute (W-Doc 2004-08 Parachutes)

D/ 04/6 The Group states that secondary automatic parachutes

are not PPE.


44) CEN-CENENEC Consultant believes that such equipment is not PPE as there was no reliable anchorage point following the answer already given under at Q/A 14. FR agrees.

5.2.4 Emergency breathing systems in helicopters (Doc 2003-13 – Emergency breathing Eq. in helicopters) D/04/7 Decision postponed

UK, having tabled the item, agrees to provide more information for the forthcoming meeting

A/04/2: UK to provide product info (collective/individual PPE)

5.2.5 Bungee-jumping equipment

(W-Doc 2004-09: Bungee jumping)

D/04/8 The Group states that bungee-jumping equipment is not PPE, its primary intended use is to do a specific kind of sport and not protection

45) The majority of delegates consider that such equipment is primarily used to participate in a sport activity. The user does not protect himself from falling from the height; the latter is the primary objective. The harness is PPE. “Bungee-jumping equipment” may be classified under the General Product Safety Directive, since it needed to be fixed to a structure.

A/04/3: Chairperson to liaise with SANCO

5.2.6 Depth gauges (W-Doc 2004-10 Depth gauges)

D/04/9 No decision; question is withdrawn.

46) France clarifies that it had not been intended to discuss this item.

5.3 Categorisation Guide

Link http://europa.eu.int/comm/enterprise/mechan_equipment/ppe/categorizationguide

5.3.1 Change of category for high visibility clothing

D04/10 Category II is confirmed for “high visibility” PPE. No change of category (see 6.3.3.)

5.3.2 Modification of 10.1/Categorisation Guide

47) The proposal to adapt the wording of point 10.1, Categorisation Guide to the Group’s decision taken in June 2003 is not discussed given the Group’s inclination to rethink its position.

http://europa.eu.int/comm/enterprise/mechan_equipment/ppe/categorizationguide


The suspension warning indicated in 10.1 will be maintained.

Point 6: Interpretation of PPE Directive

6.1 ES’s request for opinion (W-Doc 2004-05 one PPE one NB)

48) ES’s question “extension of existing EC type certificates” is transferred to the HC-NB and the ADCO Group. The answers will be compiled for the forthcoming meeting.

A/04/4 Chairperson to prepare w-doc, collect info from HC-

NB/ADCO

6.2 “Question - Answers”

6.2.1 Proposed draft answer to “Question 31” (W-Doc 2004-17 Draft Q31)

49) The draft of “Q/A 31” is accepted. The Group, however, recommends adding a paragraph

explaining the consequences for National Market Surveillance, FR volunteers to provide a draft.

50) The draft “Q/A 31” answers ES’s question relating to the revision of harmonized standards. This topic will also be discussed in the ADCO meeting.

A/04/5 FR and ADCO to submit drafts

6.2.2 Buoyancy aids - state of play (W-Doc 2004-14 : EN 13138-1 Buoyancy aids)

51) The Chairperson introduced this item referring to the June 2003 meeting of the Group where it supported the proposed position that the products such as floating seats, rubber-rings and inflatable armbands were not PPE. The Commission communicated this decision to the FR authorities.

First contacts with DG SANCO have been established in order to see whether buoys could be covered by GPS-D.

DG SANCO presented the issue to its Directive Committee which concluded that any decision on whether such equipment came within the scope of the PPE Directive should depend on the degree of safety offered rather than its generic description.

52) FRANCE explains that they want to exclude floating seats and rubber-rings from the scope of the PPE Directive, but to include inflatable armbands. The current debate is welcome, but there is disappointment with both the slowness and the content of the Commission's reply. FR had since met with market surveillance authorities, notified bodies and consumer associations. It had been made aware of the technical progress towards further developing the safety of inflatable armbands. It would therefore be greatly appreciated if this question were resubmitted to the Working Group.

53) SWEDEN considers inflatable armbands to be PPE. Q/A 20 and the discussion at the meeting of TC 162 on 2nd September 2003 support this assessment.

54) AUSTRIA remarks that, if inflatable armbands were reclassified under the General Product Safety Directive, there would be no CE mark affixed. Any decision to exclude this


equipment from the scope of the PPE Directive would lead to confusion amongst market surveillance authorities. NE agrees.

55) The Chairperson closes the debate stating not to be prepared to re-open the discussion on the basis of the information available (“arm-rings” are not within the scope of PPE-D, their primary intended use being swimming aids)

A/04/6 EC to gather new information to be tabled at a forthcoming meeting (TC 162), letter to CEN concerning suspended OJ publication of standards.

6.2.3 High-visibility Clothing

56) The Group considers category II to be adequate for high-visibility clothing: “signalling” is of a preventive nature, but is does not mitigate itself the effects of a collision with an automobile.

57) The Chairperson concludes that this issue is been solved via Annex I which allocates to the hazard/essential requirement “high visibility” the category II.

6.3 Application of several Directives to one PPE product (Medical Device Directive 93/42/EEC (Med-Dev), Pressure Equipment Directive 97/23/EC (PED))

58) The Chairperson highlights the issue and request the Group to proactively inform the sectors concerned that several directives may apply to one PPE product. The implementation of the PED / national transposition appears to create some ambiguity.

59) The withdrawal of art.6, Med-Dev, which still excludes the simultaneous application of the PPE is being delayed (new target: end of 2004).

Point 7: Standardisation

The Chairperson explicitly thanks for the presence of CENELEC and CEN, including the CEN-CENELE Consultant and CEN-RP. This forms a unique channel of direct communication from and to the ESOs.

7.1 Achieved since last meeting:

7.1.1 Periods of co-existence of the two versions of a standard: negotiable and flexible.

(W-Doc 2004-17: Draft Q31)

60) ESOs stress the difference between the regulated and non-regulated areas when examining issues related to the administration of standards.

61) Standardisers define transition periods in order to give manufacturers adequate time to adapt their production.

62) CEN gives a six month period starting from the date of availability of a standard (DoA) during which National standardization organisations withdraw conflicting regulations. Longer transitional period can be arranged upon request.


63) CENELEC has fixed three years as transition period, during which the superseded and superseding could exist at the same time.

64) As already emphasised in previous meetings, FR repeats that any transitional period should reflect the health and safety implications of the amendment concerned. A fundamentally flawed standard should be replaced as soon as possible. FR clarifies for manufacturer that a new standard only affects new production; notified bodies would only become involved in withdrawal of certificates if there is a serious health and safety defect in the previous standard.

7.1.2 Web-link to CEN information about standards under revision/development

(W-Doc 2004-20 – CENELEC status report)

65) CEN provides easy access to the information as requested during the past meetings. This link allows the follow-up of the development and revision of standards. This timely information allows the users of standards to get prepared for the change and to investigate about the nature of the modifications.

(ex-post remark: after connecting to the above address the page as shown below pops up:

The user has to select the appropriate CEN TC dealing with the type of product concerned: TC 79: Respiratory protective devices, TC 85: Eye protective devices, TC 158: Head protection, TC 159: Hearing protectors, TC 160: Falling from height, TC 161: Foot and leg protectors, TC 162: Protective clothing, hand and arm protection & lifejackets, TC 122 Ergonomics;

66) !!

http://www.cenorm.be/CENORM/BusinessDomains/technicalcommitteesworkshops/centechnicalcommittees/index.asp




67) CENELEC provides similar information in its status report.

7.2 Items under discussion

The discussion identifies room for improvement.

7.2.1 Visibility of the parts modified in a revised standard

68) HC-NB referring to the link between modified standards and the validity of conformity certificates repeats its appeal to CEN for to find ways to communicate whether the change in a standard is merely editorial, or whether there are safety implications.

69) CEN explains that the request for rapid information about the nature of amendments to standard requires a change in CEN procedures: the Commission should produce the exact requirements. It also warns that any additional work could delay the delivery of standards, which seems to be contradictory to the Commission's request to speed up delivery.

A/04/7: Group to send comments to EC, EC to produce a common view to be circulated before the next meeting of the Group.

EC to also consider the OJ publication of standard references (inclusion of information about the transitional period).

70) FESI welcomes CEN’s flexibility for adjusting the transition periods upon request. It, however, points to the long decision-making at CEN. They had requested CEN to provide a 12 months transitional period for a replacement standard more than six months ago. Unfortunately, CEN has not yet been able to implement it. CEN ensures that the problem is being resolved at TC level.

A/04/8: CEN to report on progress in the next meeting

7.2.2 Period between “DOA” of an EN standard and the OJ publication of its reference

71) The presumption of conformity starts with the date of publication in the Official Journal; the transition periods resulting in the legal field are shorter than the periods in the non-regulated area due to structural delays (processing of information, reasoned decisions to postpone publications).

72) It is recalled that a standard has to meet 2 conditions before conferring the conformity presumption: publication/endorsement by at least one National Standardizing Organisation and the OJ EU publication of its references.

73) For clarity reasons the Commission endeavours not to publish the references of a CEN standard during the six months of transition period.

74) ES reports that manufacturers are waiting for publication in the Official Journal of the revised standard EN 471, which is less demanding than its predecessor. The manufacturer is unable to use amended version within the scope of the directive as there is still no presumption of conformity.

7. 3 Problematic areas


7.3.1 Standardization and Ergonomic Principles (W-Doc 2004-11: Ergonomics)

75) The Commission informed about CEN TC 122 which had recently assumed horizontal responsibility in order to promote ergonomic principles in standardisation. The Group is encouraged to identify specific areas where ergonomic aspects could improve the use of PPE.

76) In this context the Group is informed that that CEN cancelled the issue ”Ergonomic principles for the design of PPE head forms and facial features” due to lack of expertise.

A/04/9 The Group is invited to identify both, PPE, for which ergonomic aspects need to be studied, and experts at national level.

7.6.2 Revision of EN 795 (see also point 4.4) (W-Doc 2004-04 Anchor devices)

77) The Chairperson introduces the complex problem.

a) Art.1.3, PPE-D draws a line between PPE and its integral elements at the one side and the external device at the other.

b) EN 795 comprises different the product classes A, B, C, D and E.

c) The standard only confers conformity presumption to the product classes B and E (transportable anchors), whereas not for the product classes “fixed anchors” A, C and D.

d) The apparent contradiction with respect to “vertical” equipment preventing from fall.

e) Class A covers two subspecies of products:

subspecies 1: consisting of two separable units, the part of the anchor which is permanently fixed in a structure (of known and verifiable composition) and the removable “anchor point“

subspecies2: a “mono-block” version, integrating the two aforementioned elements in one single unit

78) The Commission mandated the revision of EN 795 with the request to respect the restrictions regarding the presumption of conformity. The convenor of the working group informed that the standardizers challenged this mandate.

79) FRANCE explains that historically the Commission and the Group had decided to exclude all fixed (structural) anchors. FR pointed out that classes A, C and D anchors are excluded as they are attached to the structure, even if they can be moved. A, C and D anchors should come under the Construction Products Directive (CP-D).

80) The Chairperson stresses that the current situation leads to confusion. The application of the PPE-D fails to meet its two core objectives: the protection of health and safety at the highest level and the provision of a level playing field for sound market competition:

- Some MS consider this PPE within the scope of PPE-D, some do not; some MS instruct their NBs on the issue

- If PPE: NBs test the product applying different methods, even the test samples are different: the functional whole of the device or the removable part (different fees)


- If not PPE: lack of an alternative regulation for this device, there is no documentary evidence that it is dealt with by the CP-D (which deals with ordinary bolts not applying any

dynamic stress test).

81) The Group disregards the proposal to consider class C and D as “connectors” rather than anchors with the consequence that only class A anchors would come under the Construction Products Directive.

D/04/11 The Group supports the Chair’s initiative to investigate:

- whether the CP-D could cover the Class A products (mono- and 2-parts anchors) and which procedures to start an order to arrive at a clear and durable regulation

- whether the exclusion of the product classes A, C and D form the conformity presumption is still justified. It appears that industry replaced the mono-block version by the 2-part version.

82) It is recorded that the issue of “safe installation” is not yet satisfactorily covered.

83) FRANCE pointing to EN 5178 recommends ensuring trans-sectional consistency for any remedy action.

(ex-post remark: For the delegates convenience all EN standards concerning ‘falling from

height’ are listed in the footnote9)

84) AUSTRIA reminds of the standards for removable climbing anchors which appear to be in support of the GPSD and points out that that the protection of health and safety at the working place could also be concerned.

85) CEN mentioned that an informal evaluation of the draft standard by a construction consultant could be carried out.

A/04/10 EC to report results, and to liaise with DG SANCO and DG EMPL

7.6.2 EN 1078- protection helmets for cyclists (W-Doc 2004-12 EN1078 Bicycle helmets)

86) The Group is informed that a BE research group is studying the head injuries of bicycle riders. It appears that the design of helmets needs to be improved, concise improvements are proposed.

87) CEN states that, as EN 1078 is being amended, it is time to make proposals. CEN document Doc12/TC158/WG4 gives details.

8 (a standard which is likely to become a “harmonised standard supporting the CP-D”)

9 EN 341 – descender devices, prEN 341, EN 353-1 – fall arresters, EN 353-2 – fall arresters, EN 354 - lanyards, EN

355 – energy absorbers, EN 358 – belts and lanyards, EN 360 – retractable type fall arresters, EN 361 – full body

harnesses, EN 362 - connectors, prEN362, EN 363 – fall arrest systems, EN 364 – test methods, EN 365 –

instructions for use, prEN 365, EN 516 - walkways, EN 517 – roof safety hooks, EN 795 – anchor devices, EN

795-A1 – anchor devices, prEN 795, EN 813 – sit harnesses, prEN 813, EN 1095 – deck safety harness, EN 1496 –

rescue lifting, prEN 1496, EN 1497 – rescue harnesses, prEN 1497, EN 1498 – rescue loops, prEN 1498, EN 1868

- definitions, prEN 1868, EN 1891 – kern-mantel ropes, prEN 12841 – rope access system, prEN ISO 14122-4 –

fixed ladders


A/04/11 EC to trigger MS comments

7.6.3 EN 143 (149, 13274-7) - Respiratory protective devices (W-Doc 2004-16 Respiratory flow patterns, W-Doc 2004-23 Electrostatic filters)

88) W-doc informs about a SE study putting in evidence the difference between the conditions in a testing laboratory and a real workplace.

89) The FR delegation circulates to participants a paper identifying shortcoming of the standard for the so-called “electrostatic” filters. FR stresses the urgency of resolving the problems of respiratory protective equipment.

90) CEN explains that TC 79 had been informed. Mr Mayer states that there had been no progress in TC 79. The Commission should send a letter to CEN requesting that the standard be improved.

A/04/12 EC to follow-up.

Point 8: Harmonised standards / EC publication of references of ENs in OJ (W-Doc 2004-14 EN 13138-1 Buoyant aids)

91) The Chairperson informs that the references of EN 13 138- 2 will not be published, there is agreement that the products covered are not PPE.

92) The publication of the references of 13.138 -1 has been suspended. It is under scrutiny whether particular parts of this standard cover products being PPE; in this case selected parts of the standards could be referenced. The foreword of EN 13138-1 refers to swimming aids and stresses several times that these products do not protect from drowning. It is recalled that the essential requirements for buoyancy aids refer to “clothing”. Applied to arm rings, this would at least guarantee a stable positioning of the armbands.

93) CEN requests clear indication from of the Commission once a decision had been taken.

Point 9: Reports from CEN and CENELEC

see point 7 and working documents

Point 10: Report from HC-NB (W-DOC 2004 – 21) see working documents

Point 11: Forthcoming meetings A date for the forthcoming meeting will be proposed by e-mail. The meeting of the ADCO in Germany scheduled for autumn is mentioned

Point 12: AOB : Nothing

Closure of the meeting at 16.00 h.


ATTACHMENTS 1 AND 2

Minutes of the Meeting – Working Group “PPE”, 13,14 JANUARY 2004 (LUXEMBOURG)

Attachment 1 :

Detailed comments concerning Annex I, a) & b) and revised Table

Due to its importance this issue was discussed at two instances, a first round took place at day 1 followed by a revision of the modified version at day 2.

The Chairperson presenting the WP informs that the introductory remarks to the tabled items repeat the definitions of “category I” and “category III” PPE respectively. Both definitions have been phrased more simply. The following is acted:

(1) Annex I a (A I a)

(1.1) A I a – 3): The reference to “atmospheric agents …” is retained since it will be needed for the categorisation of certain clothing the protective function of which is made explicit by the manufacturer; it therefore will fall under the Directive.

(1.2) A I a – 6): Sunlight will be “characterised as “natural sunlight” distinguishing it from “artificial” sunlight. This is in accordance with expert terminology (CEN).

ES’s concern relating to eye protection used in sun beds and for newborns during light treatment (hypo-melanin production) is replied by the DE comment that the protection against other than “natural” sunlight is allocated to category II since category III does not apply.

(1.3) A I a -7) (benign thermal risks) is deleted and not replaced.

(2) Annex I b (A I b)

(2.1) A I b -3): ES points to ambiguous phrasing, in particular to “chemical” and “dangerous” and the type of protection.

The reference to “skin protection” is judged not to be sufficiently clear (different specialised types of skin protect the human body). The introduction to Annex I b sufficiently defines “dangerous” by the effect generated: ‘mortal or serious and irreversible harm to health”

Commission remark whilst compiling the minutes:

‘Chemicals’ could be replaced by substances; this term is used and defined in other Directives:

- Definition of “substance” according to 88/364/EEC: “chemical element and their compounds ….including any additives

- Dir. 67/548/EEC refers to ”substances, compounds and liquids”


(2.2) A I b -5): The CEN-CENELEC Consultant confirms that the origin of the wording is unknown. He remarks that the mention of “air temperature = / > 100 °C” could be understood as a measure of precaution. In fact second level burns are observed after 30 sec of exposure to an air temperature of 160 ° C. The mention may also mark the difference between good heat energy conductors and bad ones (air).

It is agreed to explicitly mention “molten material”, the remaining examples (version 2.0: strikeout mode) will be transferred to the ‘PPE-Guide’

(2.3) A I b - 6): FIN recommends to change the temperature reference to -30°C and to qualify air as “calm air”.

(2.4) A I b - 9): It is agreed that the protection against high mechanical impact allocates a PPE to category III (including knife stabs) whereas low mechanical impact qualifies for category I.

The list of examples shall be dropped since listing could generate unwanted lacunas. It is agreed to transfer the examples (see version 2.0: clothing and gloves for high mechanical protection including bullet- proof clothing and jackets protecting against knife attacks, butcher gloves, protective aprons) in the future PPE-Guide.

The term “knife stabs” does not make clear if it refers to high or low mechanical impact; it shall be improved (CEN-CENELEC Consultant)

(2.5) A I b – 10) DE points to “chain-saws” as an example for item 9) rather than qualifying as a specific item (n° 10).

(2.6) A I b 14): The group does not support the proposal to move “high visibility garment” (from category II) to category III. The comments range from “too demanding” (BE) and “unjustified additional burden for manufacturer considering that the fabric and its properties have never been challenged” (AT).

The Chairperson stresses that “signalling” is an essential requirement but its action is of a preventive nature (mitigating) but not directly protecting a person from/during a collision with an automobile. Category II mirrors that situation appropriately.

After the implementation of the suggestions the listed items number consecutively: I a: “1- 6”; I b: “1- 13”).

New version WP-DAD, 2.1 (Jan. meeting comments included)


Annex I

Categories of PPE

IA/0

ANNEX I “Categories of PPE”

A) List of “Category I PPE”

(a) (b) “Category I PPE” shall cover exclusively PPE

which protect against one or several minimal hazards. The manufacturer or his authorised representative can assume that the intended user can assess the level of protection and safely identify the effects concerned good time.

(c) “Category I PPE” covers the following hazards or types of PPE:

EC remark:

Under scrutiny whether the auth. representative is qualified to take this decision

1) mechanical action whose effects are superficial;

2) cleaning materials of weak action and easily reversible effects;

EC remark:

why restrict to cleaning? better substances

3) risks encountered in the handling of hot components which do not expose the user to a temperature exceeding 50° C or to dangerous impacts;

EC remark:

a) 50 °C can cause skin burns, set limit closer to temperatures still tolerated by tissue 42 °C

b) “dangerous impact” too imprecise

4) atmospheric agents of a neither exceptional nor extreme nature;

5) minor impacts and vibrations which do not affect vital areas of the body and whose effects

EC remark:


cannot cause irreversible lesions unnecessary rep. already excluded by introductory comment

6) natural sunlight;

- End of listing

IB/0

B. List of “Category III PPE”

1 Category 3 PPE” shall cover exclusively PPE intended to protect against the risk of mortal danger or against hazards that may seriously and irreversibly harm the health.

The manufacturer or his authorised representative AR assumes that the intended user cannot identify their effects in sufficient time.

“Category III PPE” covers the following hazards or types of PPE:

EC remark:

Under scrutiny whether the auth. representative is qualified to take this decision

1)Filtering devices for the protection of the respiratory

system

2) Devices providing full insulation from the atmosphere,

including those used for diving

3) PPE providing protection against dangerous substances

chemicals and dangerous biological agents

EC remark:

a) “dangerous” is defined by the result: “mortal danger or irr. harm to health”

b) is “contact” only contact to skin/ similar tissue, tissue of the respiratory tract as mentioned under 1).

“Chemicals” replaced by substances as in other directives 67/548/EEC , 88/364/EEC;

4) PPE providing protection against ionizing radiation


Attachment 2

Detailed comments and suggestions referring to the provisions of WP-DAD

Art 2: Introduction of “person responsible for giving access to “Technical Documentation” necessary , manufacturers established outside EU are not obliged to appoint an A/R whose responsibilities could comprise responsible to give access to. This is of particular importance for category I PPE. For category II- and III PPE the ‘T’ can be obtained with the help of the NBs involved in the CAP.

Art 6: ES reminds to harmonise the wording of art. 6 and 7 as far as standards are concerned. It has to be taken into account that one standard may not address all ERs applicable to a product type.

Solution proposed: Where a Member State or the Commission considers that a harmonised standard referred to in Article6 does not entirely satisfy the essential health and safety requirements which it covers and which are set out in Annex II.

5) PPE

- for use in high-temperature environments the effects of

which are comparable to those of an air temperature of 100

°C and more

- against the projection of molten material

6) PPE for use in low-temperature environments the

cooling effect of which are comparable to those of calm air

having a temperature of -30 °C or below.

7) PPE to protect against falls from heights

8) PPE against electrical risks and dangerous voltages

9) Diving suits of the type "dry-suits" and “actively heated

or cooled suits”

10) Hazards caused by high energy mechanical impact

11) PPE against drowning

12) Ear muffs and ear plugs against noise

13) Eye protection for laser radiation and solar eclipse

viewing

- End of listing


Art 8: It is recalled that the objective is to provide full guidance for manufacturers’ obligation, the resulting repetitions deem to be acceptable.

- (a): “Technical Documentation”: UK proposes to only oblige the manufacture to list those ERs applicable to the intended product.

- (d): Reference is to be made to all sections of Annex II, the general elements are to be found in section 1 and in particular in 1.1.4, the more product specific ones are all over in section 1 and 2.

The word “printing” is avoided in order to remain compatible with new technology.

- (e): The term “bulk” is avoided, alternative wording shall facilitate future translations work. CEN-Rapp suggests to refer to “smallest” commercial packaging.

- (h): The obligation of an additional marking is introduced, see also art. 12

Referring to “ear plugs” it is recalled that at the workplace the “user” is the employer (purchasing them for protection of workers), the worker wearing the protection is the end user

Art. 12:

- (1): HC-NB reminds to establish consistency between the listing of CAPs and the content of the provisions elsewhere.

- (3): “Additional marking”: ES, FIN suggest not to make mandatory the indication of the manufacturer’s address if there is other information which can establish “traceability” product to its origin: brand name etc.

Art. 11: EC looks for an alternative, more precise replacing the term “state-of-the art”.

Art 13: EC informs that the type of measures will become more precisely defined. It remains to be examined whether the concept of “family of potentially dangerous products” is necessary. MS can launch safeguard clauses against a specific product or against a range of products.

Art. 13: “Confidentiality”: Guidance document to explain that this provision still allows the exchange of information between authorities, whereas it cannot be released to public.

Art. 21: “Penalties”: the origin of this provision remains unknown. UK remarks that the recreational craft contains the same provision.


EUROPEAN COMMISSION

ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL



industries

PPE/05/1/2

Brussels 31.12.2004

ENTR/G/3 CD/ck (2005) - 140

Follow-up of the Meeting of the Working Group on Personal Protective Equipment (PPE) – Directive 89/686/EEC

This document contains both the evaluation of the positions of the MS/EFTA countries (I)

concerning the agenda items 2.2 (Protection from falling from a height) and 2.3.1 (arm rings/arm

bands) and the draft minutes of the meeting of the Working Group “PPE” (II) of 29/30.10.2004.

I. Evaluation of the positions of the MS / EFTA countries (I) concerning the agenda items 2.2 and 2.3.1

The evaluation of the positions submitted after the meeting replaces the decision making which did

not happen during the meeting. These results are the outcome of the discussions which started in the

second half of 2002 and since they represent some core items of the agenda of the recent Working

Group meeting it was decided to disseminate the results together with the minutes of the meeting.

Some delay occurred due to the fact that the deadline for the submission of the written positions had

to be extended twice in order to at least achieve the “critical mass”.

The full individual positions will be found under w-doc 2004 – 46.

I.1 Agenda point 2.2 – “Protection from falling from the height”

Position papers were received form:

Member States / EFTA: BE, CZ, FIN, PL, LT, SL, SV, SE, UK / CH, IS, NE;

Stakeholders: CEN and CEN-CENELEC Consultant, Horizontal Committee of NB/PPE, ESF;

Consensus is that:

- body harness and attachment system are PPE

- anchorage point is not PPE.

Draft Consideration paper

Products designed and manufactured to protect against falls from a height and in accordance with

the definitions of Article 1.3 are considered to be PPE when first placed onto the market or put into


service. This means that all elements establishing the system “protecting from falling a height” are

PPE, these products are referred to as “anchor devices” (new definitions, CEN/ TC 160 WG1 see

below).

Products, however, that are part of a structure as from the conception stage of the latter, are not

a PPE: they are considered as “anchorage points”.

The “anchorage point” is the "external device" referred to in Article 1.3 of the Directive. “Anch-

orage points” themselves are not covered by the PPE Directive but are dealt with under the

Construction Products Directive where reference is made to European Technical Agreements.

The above interpretation will ensure the best protection possible since all elements of the system

“protection from falling from a height” are covered by the PPE-D (e.g.: harness, connectors,

lanyard, shock absorbers, anchor points) and subject to EC type-examination.

The Commission services (Construction Product-D and PPE-D) will undertake the necessary to

bring the publication of the references to relevant harmonised EN standards and in particular to EN

795 in line10.

This interpretation shall also ensure that in future all MS will apply the respective provisions of the

PPE-D in the same fashion and thus help to re-establish a level playing field for the sector industry.

The below definitions (kindly provided together with the UK position) as well the two pictures of

the product “anchor points” (kindly provided together with the BE position) shall underpin the

common understanding of an issue where linguistic traditions threaten to hamper progress. The

challenge to adapt the French terminology is recognised, the ongoing work at CEN level will give

the necessary support.

Definitions: EN: “anchorage” : a safe place for anchoring

FR: to be defined

EN: “anchorage point”: a point on the anchorage at which or to which the “anchor

device” is fixed or attached

FR: to be defined

EN: “anchor device” : assembly of elements, components or assembly of components at

a point of sale which incorporates one or more anchor points

FR: to be defined

EN: “anchor point” : element to which personal fall protections can be attached to

after installation

FR: to be defined

Examples of product “anchor point”

10 Considering the BE comment that EN 363 describes the compatibility requirements for the elements of the system

“protecting from falling from the height” itself and that EN 795 covers the product “anchor points”


1) version “monobloc” 2) version “two elements”,

= the “anchor point” = the “anchor point”

(b) indicates the part connecting the device to the support

I.2 Agenda point 3.2.1 - “arm bands” or “arm rings”

Position papers were received from:

Member States / EFTA : CZ , FIN, PL, LT, SL, SV, SE, UK / CH, IS, NE

Stakeholders: CEN and CEN-CENELEC Consultant, Horizontal Committee of NB/PPE, ESF

Consensus is that:

the product type known as “arm bands” or “arm rings” and used as inflatable swimming aids

worn tightly on both upper arm of persons, is considered to be PPE and has to meet the

BHSR 3.4.1, Annex II of Directive 89/686/EEC

All but one submitted positions support the above conclusion.

This interpretation allows combining the following advantages:

- The product can be kept in PPE category II, the subsequently obligatory EC type-examination will

ensure that only products of a proven quality will be put on the market.

- EN 13 138-1 can be used as common orientation, the part referring to “arm bands (pairs)” could

be considered to be published as harmonised standard supporting the PPE-D. The acceptance as

harmonised standard of the entire EN 13 138-1 will request further consideration.

- The consumer expectation is met, best effort is undertaken in order to protect children, the

particularly fragile end user of this product. This fully matches with the spirit to explicitly open the

PPE-D for the protection in private life and at leisure and the resulting consequences.

- Preservation of continuity and a stable environment for the manufactures concerned (n° 10.1 of

categorisation guidelines will remain valid).


Minutes of the Meeting - Working Group “PPE” of 29-30 September 2004

(Brussels)

Please consult CIRCA for the list of participants, list of working documents, meeting agenda and the approved minutes of the meeting in January 2004.

0 Procedural items

0.1 Opening of the meeting

Mr Dirscherl (Chair) welcomed those present, in particular the representative from Turkey and

ANEC. He explained that Turkey had been admitted to the meeting under the terms of the EU-

Turkey Customs Union Agreement.

0.2 Adoption of the agenda W-DOC 2004 – 25

France asked that the subject of electro-static filters (Agenda Item 3.3.5) be raised in the afternoon

of the first day, as a French expert would be present to give a presentation.

Poland informed not to be prepared to present the issue “Barrier Creams” and referred to its w-doc

2004-33.

These amendments were agreed. In order recuperate the time to be dedicate to the presentation there

was consensus to fuse some agenda points and others not to open points 2.4 and 7 for discussion,

the delegates were invited to study the respective information to be found on either CIRCA or in the

delegates were encouraged to submit written comments.

0.3 Approval of the minutes of meeting January 2004 Meeting Minutes

13&14/01/200411

DE asked that the minutes be amended: a) CEN TC 122 has recently become a committee action on

a horizontal level, it had been set up long time ago [7.3.1.]; b) “ear protection” discussed meant

protection against noise.

Subject to the amendments as requested the minutes were approved.

1 Introduction, news and follow-up actions (meeting of January 04)

report / EC

W-DOC-PERMANENT1, - 2

The Chairperson informed about new developments and followed up the issues of the last

meeting:

11 See the Circa library : Meetings / 2004-01-13/14 / 2004-01-13&14 –Minutes


- Two new and permanent working documents, “w-doc Permanent1 - Follow-up actions” and “w-

doc Permanent2 – Decisions” had been introduced in order to optimise the efficiency of the work

by ensuring a synopsis of a) all follow-up actions and b) decisions taken at the meetings. These

instruments should help to enhance the meeting efficiency. The Commission services would keep

them up to date, the delegations were invited to consult the compilations for their preparations for

meeting participation.

- The Legal Service of the Commission delivered the following clarification which might be of

particular interest for the new MS. From 1.05.2004 onwards the “acquis communautaire” is fully

applicable in the new Member States: PPE placed on the market in the new Member States have to

comply with the relevant Community legislation; PPE which had been placed on the national

markets of the new Member States before 1 May 2004 did not have to comply with the relevant

Community legislation. A respective written communication should be made available to the MS.

(I/ 88) Action: EC to provide written EC position on the issue

- There was progress with respect to the EC of co-funding of a new round of inter-comparisons for

the laboratories involved in product certification, an amount of 60000 € was earmarked for this

activity, the call for proposals would either be launched in late 2004 or early 2005 .

- The call for tender for the project “European PPE database” was imminent to be launched, more

details reported in w-doc 2004-28.

- Recent press articles reported about PPE:

a) the German TV (ARD reported that certain types of protective leather gloves contained a level of

chromate causing dermatitis, the Chairperson informed that the Commission recently instructed a

safeguard clause against protective leather gloves leather with a Cr(VI) residue concentration of

approximately 100 mgkg-1.

b) particle filters had been in the French press, the deficient protection delivered by the species of

electro-static filters’ and the non- reaction of public authorities were criticised (see also point 3.3.5 )

- Safeguard clauses according to Art 7 PPE-D: the Chairperson admitted that their processing was

protracted, the need for translation into all Community languages became an additionally obstacle.

With respect to the important backlog of untreated notifications good progress had been achieved.

The majority of notifications have been processed, the remaining ones related to 2 types of

products, eye protection and safety boots will be instructed soon. The progress could be monitored

on the PPE ADCO CIRCA site.

- Development of other European legislation related to PPE: Directive 2001/45/EC came into force

on 19.07.2004 amending Directive 89/655. The Commission proposal on protection at the

workplace against optical radiation was being discussed at the Council. Both initiatives were

launched by DG EMPL.

- The Chairperson ended the introductive reporting considering his responsibility to ensure well

balanced meeting participation, this aspect was of particular importance after the recent

enlargement of the EU. He therefore proposed to do an informative “tour de table” during which the

delegations were ask to present themselves using the format previously circulated (w-doc 2004-35).

The objective was that the delegations exchanged mutually information about the ministry they

represented and the national authority responsible for the implementation of the directive. They

should also highlight where there were specific linkages to consumer associations.


2 Management of the PPE – D

2.1 Explicit opening of the PPE-D for consumer protection and the consequences at several levels

W-DOC 2004 - 26

The Chairperson introduced w-doc 2004-26 as reflection paper having two main purposes. First to

explore whether there was agreement about the need to make explicit that the Directive covered

PPE for both, professional and for private use. Secondly, to list some consequences deriving from

such a decision. It is a matter of fact that modern product distribution makes products accessible

independently from the primary intended use (for professionals or laymen) as defined by the

manufacturer.

(04-II/ 1) Decision: The delegations welcome the proposal to make explicit

that the directive covered both PPE products be they used at the work

place or for private purpose.

The following general comments were made:

FRANCE considered that the paper underscored the risks for consumers and pointed out

that there were no “use” directives for consumers.

SWEDEN welcomed the document agreeing on the need for more information when PPE

was also used by consumers. It pointed to some discrepancies since the w-doc referred to the

“placing on the market” and to the “co-operation with customs”. The lack of guidelines for PPE was

mentioned and that there should be more information about “foreseeable misuse”.

SPAIN concurred emphasising that the PPE directive covered both professional and private

use and that the directive should become more explicit in this respect.

The NETHERLANDS supported the content of the w-paper agreeing about the fact that

professional PPE can be bought by laymen and vice-versa, adding that the aspects of fashion were

now coming more to the fore for consumer PPE.

AUSTRIA and DENMARK express their support to the w-doc.

ANEC welcomed the clarification envisaged which was instrumental in increasing the

protection for consumers.

A second round of discussion focussed on more on details:

- the need to improve the quality of the information for intended users , e.g. the potential hazards

generated by the use of the equipment itself and the type of protection provided (DK);

- this information should be available at the moment of purchase (DE) and at the point of retail

(ANEC);

- NL recommends to reconsider the term “intended by the manufacturer” [3.1.2] aligning it to the

terms used in other directives (e.g. toys) and to address the administrative co-operation;

- the responsibilities of the consumer as well as those of the manufacturer should be made clear by

amending the text (FESI);


- SPAIN reported about the difficulties encountered when equipment was excluded from the

directive by means of a declaration by the manufacturer stating that the product concerned was not

PPE; a national measure had been taken to prevent sale of such a product;

- SPAIN felt the need to improve both the scope and the definitions of the directive: explicit

reference could be made to consumers, workers and the intention of the manufacturer; GERMANY

supports the opinion of SPAIN;

- GERMANY and AUSTRIA advocated for the modification of the procedure related the

safeguard notification; suggestions were made to amend it mirroring those under the LVD

73/23/EEC;

- SWEDEN stressed that the laymen consumer lacks specific knowledge, hence the need to ensure

the safety of products.

The Chairperson thanked for the contributions agreeing that the current requirements for

information could be improved. He questions whether this aspect could be resolved by means of

guidance or whether amendments to the directive were necessary.

COMM pointed out that there is the possibility to revise the text so as to request further

information on the packaging. In relation to the “grey area” between different types of PPE the

solution had already been found for toys that may appear to be PPE: a specific declaration states

clearly that the product does not protect. With respect to hazards presented by equipment that was

misleading in its representation it was clear that there was already national legislation to deal with

such occurrences outside of the provisions of the PPE Directive.

(I/ 89) Action: All delegates to submit comments (2nd wave), EC to forward

to drafting group then issue “product information to be improved”

2.2 Establishment of clarity for the area of “protection from falling from height” – proposal

W-DOC 2004 - 27

The Chairperson informed to have the strong will to fight the fog around this subject. To this end

he had prepared the w-paper. A clarification was necessary, even the attempt to clarify the issue via

the forthcoming revision which of the elements of the system were PPE and which one were not

PPE had failed. The w-doc 2004- 27 reflects the information obtained from two topical meetings the

Commission had organised with manufacturers, representatives of relevant CEN sub-committee,

CEN-CENELEC Consultant, EOTA organisation and of the DG ENTR construction product sector.

The objective was to make the delegations choose between the two options described in the

document. The decision should be taken duly considering the inherent consequences. The goal is to

finally install a level playing field for industry and other stake-holders as far as this family of PPE is

concerned.

The participants welcomed the clarity of the w-doc. Some delegations explained that they had not

yet terminated their consultations.

The UNITED KINGDOM asked their national industry representatives for opinion, the overall

response was positive but the wording “placing on the market in conjunction with ” did lead to

uncertainty. FESI wanted to contact its members and investigate the issue in more detail.

The discussion replaced the 1st option of the w-paper by the ES proposal, the 2nd scenario remained

unaltered. The Group, however, was reluctant to take a final decision at that very meeting. The


Chairperson requested that the delegates would make their choice between the two scenarios

sketched out below and submit in writing their reasoned position, duly considering the possible

consequences. The deadline was set for 15 working days following the meeting.

The scenarios were the following:

1 a) Position proposed by the Spanish delegation:

The Essential Requirement « Prevention from falling from a height » (3.1.2.2, Annex II, 89/686/PPE) quotes “ … PPE designed to prevent falls from a height or their effect must incorporate a body harness and an attachment system which can be connected to a reliable anchorage point”.

From that follows:

- body harness and attachment system are PPE

- anchorage point is not PPE.

1 b) Alternative position according to w-document 2004-27:

At present there are two main groups of standards, short-named “vertical” and “horizontal”. Both include products or product parts which are neither held nor worn.

The entire group of “vertical protection standards” has been accepted as harmonised standards. The standard grouping “horizontal” has been treated differently, e.g. of EN 798 “horizontal standard” only the product types B and E are harmonised standards, the types A, C, D are not recognised as such.

Some delegations insisted on commenting the issue.

ESF emphasized the distinction between an “anchorage point” and an “anchor point”. It considered

that the external anchor point was not PPE if it was a part of a permanent structure.

FRANCE invited to revert to the definitions of the directive and considered that if the anchorage

point and equipment were worn or held then it was PPE, it non-removable and permanently fixed to

a structure then it was not.

The NETHERLANDS remarked that the criterion used of “whether the device was on the body of

an individual” now appeared to be “whether it was fixed or removable”.

COMM reminded that the committee supported the consensus of several years ago and the defining

point was whether the anchor point was permanently affixed to a structure. The system linked to

this anchor was PPE, the anchor point itself was not.

ESF, however, qualified this consensus to be the example of particularly bad consensus.

The Chairperson reported that the point 3.1.2.2 BHSRs appeared to also cover the requirement of

a proper installation of the anchor point. He pointed to the Art 1.3 which voids the requirement of

being held or worn for certain systems of PPE.

(I/ 90) Action: All delegates to submit comments (1st wave) by 25.10.2004,

central evaluation by EC; to check with DG EMPL whether Dir 2001/45

could cover “installation”


2.3 Scope of the directive – consensual interpretations: Criteria for rational decision whether or not a product is to be considered PPE.

W-DOC 2004 – 31

NO delegation

The Chairperson thanked the NETHERLANDS for its comments submitted which stressed the

importance that the Group applied a structured approach for decision making whether or not a

product was a PPE.

The Chairperson referred to w-doc 2004-31 which collected relevant statements made during

previous meetings of the Group; there were 4 key aspects to be considered:

whether the equipment fulfilled the criteria of Article 1(2) of PPE-D;

the claim of the manufacturer concerning the protection provided;

the perceived intended use by the consumer.

the functionality of an equipment was not a criterion for the decision whether or not to be a PPE.

The UK agreed with NE, to first determine whether a product is in scope by asking if it is held,

worn and had protective features.

DE recalled that the question should be examined in respect of the text of the directives itself, all

other elements being guidance with no legal effect.

FR considered as non-compliance and take action against when a manufacturer simply denies by

declaration that a product was a PPE despite of its clear PPE character.

(04-II/ 2) Decision: The Group approved the elements of the decision tree.

2.3.1 Protection against drowning: arm rings – progress, outcome of product inquiry, conclusion

W-DOC 2004 - 30

The Chairperson informed that the Commission services had identified an inconsistency in the

English translation compared to original French working text.

Only the EN version refers to “arm band”, the French original working text together with all the

other linguistic versions quoted terms which described some sort of “sleeved vest”. The

Commission has referred the matter to SG which will undertake the necessary, probably preparing a

corrigendum.

Hence the argument that “arm band or arm rings” were PPE because the Directive quoted that term

under BHSR 3.4 of Annex II, PPE-D had to be abandoned. However the decision whether or not to

consider “arm rings” as PPE had to be taken in order to establish certainty.

A series of arguments had to be taken into account. The ‘explicit’ opening of the Directive to PPE

for consumers might lead to the need to consider the consumer’s expectation. Indeed there was the

perceived intended use by the consumer that the “arm rings” were PPE. Some manufactures, ANEC

as well as the Group (see 10.1 guidelines for categorisation) appeared to consider such products as

PPE (category II PPE) despite the manufacturer’s warning that these devices would not protect from

drowning.

He informed those present that DG SANCO were in the process of drafting a Communication on

inflatable floatable devices under the GPSD and recalled the existence of CEN 13138-1.


The Chairperson proposed the scenario as shown below to the Group by which “swim rings”

could be considered to be within scope of the PPE-D. He formally invited the delegations to submit

their written positions as to accept or to refuse the scenario.

Scenario:

“ a) Working hypothesis is that the essential requirement 3.4.1 “Buoyancy Aids” is a requirement on its own, less demanding than n° 3.4 “Prevention from Drowning”.

b) It follows that “arm rings” could be considered as PPE if the manufacturer guarantees that his product provides for a certain level of buoyancy sufficient for the intended use.

c) EN 13138-1, for which CEN requests publication in the OJ EU as harmonised standard, provides for the visible quantification of the buoyancy expressed in kg body mass supported.

Please consider that this interpretation is in line with the categorisation guide which assigns category II to this product type. It preserves a stable business environment for industry. It also ensures high quality products via obligatory third party testing; this aspect is particularly important since the children, the most fragile societal group, uses this product.”

(I/ 91) Action: All delegates to submit comments (1st wave), central

evaluation by EC

The following was commented on the issue.

FR said that its authorities made the distinction between “sleeved vest” which may protect against

drowning and “floatation devices” which did not. FR judged the issue of importance and pointed

out that this had been under discussion since 1999.

DE welcomed to clarify the issue and referred to the decision-making “tree” as discussed against

which one may judge that such products did not fall within scope: arm rings were not PPE.

ANEC considered that, in order to best protect the consumer, arm rings should fall within scope.

ES judged that if such devices were only buoyancy aids and did not protect against drowning they

were not PPE but suggested that arm rings should be PPE. If not then they would be covered by the

GPSD which could not ensure the same level of safety. ES referred to Annex II which indicated that

the protection from drowning was a “specific requirement” whereas visibility was an “additional

requirement”. It would therefore be difficult to categorise arm rings as PPE if only the latter were to

be considered.

SE supported this opinion in view of the fact that the wording of the directive was quite clear in its

mention of “swimming aids”. UK supported this view.

(I/ 92) Action: All delegates to submit comments (1st wave), central

evaluation by EC; EC to note the need to amend BHSR 3.4.1

2.4 Interface PPE / other Directives info / EC


- 97/23/EC PE-D (pressure equipment & diving-/ respi-ratory equipment)

- series of “safety at work” directives

- - 89/656/EEC;

- - Comm. Communication (89/C 328/EEC): selection & use of PPE at work

CIRCA- library or

http://europa.eu.int/eur-lex/index.html

- 2001/45/EC (issue: “scaffolding”)

- Commission’s proposal on “optical radiation”

The Chairperson reminded the delegates that the PPE-Directive is one element of a complex

legislative system. The most relevant pieces of legislation will be up-loaded on to CIRCA.

2.5 Interpretation of Directive : Q/A

2.5.1 Answers to ES questions:

Subject 1: Extension of an existing EC type-examination certificate

Subject 2: Superseding standard version – less demanding tech. requirements

W – DOC 2004 – 32-1

W – DOC 2004 – 32-2

(DE delegation)

Subject 1: Extension of an existing EC type-examination certificate

The Group thanked the DE delegation for the draft.

After discussion it was concluded that the draft text proposed the correct solution which reflected

common practice although not dealt with in the directive. It was agreed that the certificates and

product documents had to provide for traceability to the original EC conformity certificate. It was

agreed that the PPE NBs would reconsider, if applicable, their RfU sheets, taking into account the

above comments and present revised versions.

(I/ 93) Action: EC to set delivery date with NB, to include into agenda of

forthcoming meeting

Subject 2: Superseding standard version – less demanding technical requirements

ES requested certainty as to when a standard applies where the superseding standard had

requirements which are less demanding than the version it replaces. This had been identified in the

future edition of EN 471.

NE wondered about the consequence for the market surveillance. In principle different levels of

protection requirements could be applied to the stocks of shops depending on the production date. It

was suggested that the guidance drafting group could considered this issue.

(I/ 94) Action: EC to ensure follow-up by guidance drafting group


2.5.2 Q/A 31 (subject: superseded standard version – validity of presumption of conformity)

W – DOC 2004 – 36

The issue was discussed in conjunction with point 3.1. The new lay-out explicitly indicated the date

by which the superseded standard would cease to confer the presumption of conformity.

It therefore was agreed that

- the content of w-doc 2004-36 had to align to that Commission ruling,

- that the draft of Q/A 31 could be accepted after up-dating of its version of January 2004 without

integrating the FR comments concerning market surveillance which had become redundant.

“Q 31”: Does the publication in the OJEU of a revised harmonised standard imply that the superseded standard ceases to confer the presumption of conformity to the essential health and safety requirements it covers?

What are the consequences for a PPE which had been built according to the superseded harmonised standard?

Yes. The Commission communication clearly indicates together with the reference of the EN concerned the date of cessation of the presumption of conformity conferred by the superseded standard.

The consequences are for:

- the manufacturer :

A manufacturer wishing to benefit from the “presumption of conformity” has to fulfil the requirements of the revised version standard as from the date as specified in the Commission Communication. The manufacturer has to amend the declaration of conformity (DoC) for the product concerned accordingly. He needs to regularly follow the development concerning standards which may concern his product. The information systems put in place by the ESOs or the National Standardisation Organisations may make the information accessible.

If the product belongs to a PPE category for which a valid EC type-examination certificate is obligatory, the manufacturer is advised to consult the NB which issued this document. The need to repeat the EC-type examination depends on the importance of the modifications with respect to the essential health and safety requirements.

- the notified body:

The Notified Body is owner of the EC type-examination certificate. It‘s responsibility is to assure the validity of the basis upon which the certificate was issued. It therefore has to continuously monitor the development of standards in order to detect when modifications of standards could challenge the certificates it had issued.

In case of severe modifications the notified body has to liaise with the manufacturer concerned in order to decide on the appropriate course of action. The latter could range from mere editorial changes to the EC type-examination certificate to the full resubmission of a PPE to the EC type-examination.

If a Notified Body concludes to withdraw a certificate it should proceed according to art.10.6 PPE-D. A certificate is annulled once the basis upon which it had been issued becomes invalid.


It should be noted that the ESOs have rules concerning the routine revisions of standards and the duration of a transitional phase before a modified standard replaces its previous version. The ESOs maintain e-based information systems for stakeholders’ information:

CEN:

http://www.cenorm.be/cenorm/businessdomains/businessdomains/healthandsafety/personal+protective+equipment/index.asp

CENELEC: (general access: www.cenelec.org, no specific site available)

Remarks:

For the non-regulated area it is worthwhile noting that CEN has established a period of 6 months during which the CEN member countries must undertake the necessary for the implementation of a new or a revised version. The transition period starts at the date on which the organisation had made available the text to its members (DAV), the duration of this transition period can be adjusted to the specific needs of the sector subject to mutual agreement.

The CENELEC system sets a fixed transitional period the duration of 36 months.

(04-II/ 3) Decision: The new format was approved by the Group.

(I/ 95) Action: EC to request MS’ comments (2nd wave)

2.5.3 Interpretation of art. 11A PPE-D – proposal for corrective measures

HC-PPB (doc to come)

This issue was discussed under point 5.

2.5.4 PPE- Guidance Document: first steps &progress w-doc 2004 - 40

The Chairperson informed the Group that the project ‘Guidance document PPE’ had been started.

Since the nomination of members to drafting group by the Group (PPE meeting in January 2004)

the Commission organised a series of virtual meetings by internet/ CIRCA for developing the

working strategy.

In a first face-to-face meeting (Brussels, 27.10.2004) the starting task was defined consisting of the

exhaustive collection of information available at national level. Each member would paste his

findings the under the respective provisions of the PPE-D. This would become the basis for the

future work.

The drafting group had further developed its mandate and presented it to the Group for approval (w-

doc 2004-40).

(04-II/ 4) Decision: The Group approved the mandate for drafting group

“Guidance Document PPE”

3 Standardisation



http://www.cenelec.org/


3.1 New lay-out for the list of harmonised standard published in the OJ EU (major changes)

W – DOC 2004 – 34

The Chairperson informed that the obligation to translate into all official EU languages the

Commission Decision by which the references of certain EN standards were published (in pursuit of

art. 5 of PPE-D) imposed a change in the process.

The Commission and CEN had agreed about a new format. This template was presented to the

Group (w-doc 2004-36). The substantial changes with respect to the previous tables were 1) the

inclusion of “the date of cessation of presumption of conformity (doc)” of the superseded version

and 2) the suppression of “the date of 1st publication”.

The clear indication of “doc” will also solve the remaining ambiguity relating to the draft of Q/A

31.

The NETHERLANDS highlighted the importance of “the date of 1st publication” for the market

surveillance authorities; the Chairperson pointed to the availability of this information via the

printed OJEU or web.

FRANCE highlighted the importance of the cross-reference in the EN standard to all the BHSRs

relevant including those ones not covered by the standard; FESI supported this request referring to

one of its position papers.

(04-II/ 5) Decision: The new format was approved by the Group.

3.2 CEN

3.2.1 Current PPE mandates for standards info / EC

The Chairperson recalled the current three mandates to ESOs under the directive:

- Mandate to CEN/CENELEC M 31 (general mandate)

- Mandates to CEN M 207 (revision of EN 795) and

- M 281 (development of a standards for high performance riding helmets).

3.2.2 Report on recent developments Info / EC and ESOs

The Chairperson invited CEN to present its report proposing to include:

- the progress of the mandated work,

- activities of neighbour Technical Committees such as TC 136, dealing with sports

equipment and ergonometrics

- revisions of standards which led to substantial modifications related to the essential

requirements of the PPE-D

CEN suggested to invite the convenor of the respective CEN TC to the meeting, he would be the

best placed to give technical information, the necessary could be arranged subject to sufficient lead

time.

This would also be the way to deal with the requested details concerning the amendments to EN

420 (protective gloves, version 2003). For the latter the Chairperson pointed to the increased


tolerated Cr(VI) concentration in leather, that did appear not to be in line with the principle of the

best possible protection of human health.

SPAIN said that although the new standard did foresee Cr(VI) levels of 10 mg kg -1 in contrast to

the 2 mg kg -1 of the previous version, one should also take into account that these results were

method-dependent.

DENMARK asked the Commission to pass a clear message to both CEN and the CEN consultant.

In that context AUSTRIA handed to the Chair the CEN consultant’s report on the quality of

standards developed within TC 162, requesting to file it as w-doc (w-doc 2004 - 41) and to schedule

the discussion of this paper for the forthcoming meeting of the Group.

(I/ 96) Action: EC to act concerning EN 420 versions

(I/ 97) Action: EC to schedule discussion of paper for next meeting, to

liaise with CEN for inviting TC convenor, to request to include

permanent issues in CEN reporting

The CEN representative delivered the report ( the full version of which is to be found in w-doc

2004-42) the main issues are summarised below:

- A total of 332 PPE related standards came under the three mandates.

- TC 136, dealing with sports equipment, was developing 16 standards under the PPE

directive with further 2 working items in the pipeline.

- The possibility of making the text changes introduced by revision process visible continues

to be discussed.

- In relation to subjects under scrutiny:

Technical Committee responsible for EN 795 had been waiting for a clear line from

the Commission services;

A new document had been prepared for the testing of equestrian helmets;

The standard for cycling helmets was being revised, with two papers to be circulated

for public consultation.

(I/ 98) Action: EC and CEN to follow-up “visibility of modifications of the

text” of standards in revised versions.

3.2.3 Request for making modified text of superseding std.- versions visible

(A/04/7)

The issue has been dealt with by the CEN report (see above)

3.3.4 IRL – request for standardisation-project w-doc 2004- 39

IRL delegation


Following-up mandate M 281 (see above) the Chairperson invited IRELAND to comment the

progress achieved. It appeared that the IE delegate to working group 5 / TC 158, which elaborated

the prEN1384, criticised that the mandated programme had not been fully executed.

For information of the Group IRELAND gave a presentation on the reasons why a specific

standard for equestrian helmets had been developed (full version of the IE presentation, w-doc

2004-39).

The CEN-CENELEC Consultant pointed out that there were no standards which provided for full

protection. He considered the new standard developed to be an improvement, in particular with

respect to the protection against lateral impact. He went on to explain that the fact that the test

method defined by this standard had not been validated was some sort of deficiency shared with

most of the test methods of other standards. All the standard was required to do was to show that

the relevant BHSRs had been covered.

He considered the standard to be an acceptable solution. He, however, accepted to meet with the IE

delegation in order to scrutinize whether the standard delivered covered the elements as specified in

the Commission’s mandate.

(I/ 99) Action: EC to record judgement of CEN consultant/IE

3.3.5 FR observation EN 143, 149, 405, 1827 and 13274 – 7: some product types meet EN requirement but fail to deliver the protection expected

A/04/12

FR delegation

W-DOC 2004-23

The Chairperson explained that this agenda point followed-up the information provided by FR at

the January 2005 meeting. He also informed that TC 79, subcommittee 4 met in Rome (Mai 2005)

where the issue of a potential deficiency of the test method as defined in EN 149 when applied for a

specific make of particle filters was discussed. The meeting failed taking any immediate action. The

TC decision was postponed for late November 2004. CEN confirmed the TC meeting for the

9.12.2004.

In the meantime the Commission services had expressed in writing their concern to CEN about the

lengthy procedures to remedy the deficiency of standard also when health and safety of the users

could be at stake. CEN was invited to reflect about the possibility to set up an emergency procedure

for such particularly urgent cases.

The Chairperson informed that the Commission intended to exclude the electro-static filters from

the scope of products to which EN 143 could confer the conformity resumption, this would have

also impact on all other standards referring to EN 143. The issue would be discussed at the ADCO

meeting held in conjunction with the present meeting.

Mr Iotti, researcher in INRS and acting expert for the French delegation gave a presentation

explaining the type of particle filters concerned and the details of the test method (for full

presentation see w-doc 2004-48).

The core issues of the presentation were:


The “electrostatic” particle filters did not fulfil the BHSR of the Directive whilst

fulfilling those of the relevant European harmonised standards, references of

which have been published in the OJEU.

Their filter efficiency did not remain constant over the period of use. This has

led to the conclusion that, after some period of use, the intended user is no

longer appropriately protected.

The harmonised standard was therefore considered deficient with respect to the

electrostatic filters, the traditional ”mechanical filters” remain unchallenged

3.3.6 Input for standard under revision: EN 1078;

how to push use of EN 1080 (“safety buckles” for children helmets)

A/04/11

The Chairperson informed that EN 1078 was not suitable for helmets intended for use by young

children (under seven years) due to the hazard of strangulation. Despite the availability of standard

EN 1080 which was specifically devised for impact protection helmets for young children

manufacturer providing for a “snap release” which efficiently excluded the hazard of strangulation.

The Chairperson informed that the Commission intends to exclude the impact protection helmets

from the scope of products to which EN 1078 could confer the conformity presumption

(04-II/ 6) Decision: The Group supported the action proposed by EC

3.3.7 Accessibility of CEN information – e-link as circulated (revision, projects),

A/04/8

The Chairperson solicited the participants and in particular the new Member States to make use of

the guide to CEN website in order to find the PPE related information. This guide had been

integrated in the minutes on the January 2004.

3.4 CENELEC

Series of EN 61331 (Protection against diagnostic medical X-radiation) – status

W – DOC 2004-37

CENELEC informed that it now had to follow the “Dresden Agreement” and as such the

programming of the “International Electrotechnical” Committee (IEC). At the present time there

were no work items registered for PPE.

In relation to EN 61331-1/2/3, which had been overlooked, CENELEC was happy to offer them to

the Commission. Part 3 of this standard was considered the most difficult one and the comments of

the consultant would have still to be taken into account. A report would be sent to the Commission

services in the near future.

(I/ 100) Action: EC to follow-up and to ensure publication of the references

in the OJEU.


4 Product related questions

4.1 Avalanche lifejacket CH delegation

W-DOC 2004-XX

The Chairperson thanked SWITZERLAND for having accepted to present (w-doc 2004-47) the

four different types of product put so far on the market.

The results of the discussion are summarized in the table below. On the basis of the information

available the Group did not reach an agreement. The manufacturers’ declaration of the type of

protection provided by the equipment was lacking for several products.

Type 1: life

jacket

Type 2:

collar

Type 3

balloon

Type 4:

breathing

apparatus

AT PPE, cat 2

FR PPE, cat 2 PPE, cat 2 PPE, cat 2

FESI Not PPE Not PPE Not PPE Not PPE

AT considered the avalanche lifejacket to be a category 2 PPE, alternatively it could be dealt with

under the GPSD.

FR was of the opinion that lifejacket and collar were PPE of category 2, and suggested that the

breathing apparatus might be category 3.

FESI judged that none of the products were PPE as they required a manual release of the protection

mechanism and did not work automatically.

CH recalled that these products appeared to save lives.

(I/ 101) Action: All delegations to identify the manufacturers’ declaration

of the type of protection provided by the equipment for forthcoming

meeting (“decision tree” to be applied)

4.2 Emergency breathing systems in helicopters (A/04/2)

UK delegation

Due to lack of product information this item had been postponed for a further meeting.

(I/ 102) Action: UK as initiator of the question to provide info (“decision

tree” to be applied)


4.3 Bungee – jumping equipment A/04/3

The Chairperson informed that the relevant services of DG SANCO considered this product to be

covered by GPS-D.

(04-II/ 7) Decision: Bungee – jumping equipment is as not PPE

(I/ 103) Action: EC to follow-up and enter in table

4.4 Category for padded headgear (light, soft ) for soccer players

w-doc 2004-43

SE delegation

SWEDEN having tabled the question considered that the padded headgear was a category 1 PPE

and asked for opinion. BELGIUM, GERMANY and the UNITED KINGDOM supported that

classification.

Applying the “decision tree, the Chairperson reminded that the manufacturer had to provide

information about to level of protection intended, the reference of the promotion text that the

product could also be used for medical treatment had to be investigated.

(I/ 104) Action: SE to provide missing product information

4.5 Leather gloves – Cr (VI) in leather Info/ EC

This item was discussed under point 3.2.2

4.6 Protective helmets (new studies) Info/ EC

The Chairperson reminded that there were results elaborated by a BE research group which

recommended a different concept for helmets in order to improve the impact absorption. He invited

the CEN representative to pass on the information to the TC concerned, more information and the

researchers’ co-ordinates were to be found in w-doc 2004-44.

5 Notified Bodies

5.1 Report on the last meeting of the coordination group (Brussels, 1.10.2004)

Report: HC-NB to come

The Horizontal Committees of Notified Body (HC-NB) delivered its activity report which can be

found under w-doc 2004-38.

The HC-NB observed with regret the low number of NB participating in the horizontal meetings, a

structured system of representation of national NB could be an economic alternative ensuring at the

same a coherent way of operating. The MS delegations were invited to encourage the attendance of

the NBs under their authority.


It was noted that the “Recommendation for Use Sheets (RfU) dealing with “horizontal” issues were

published on the Commission’s PPE web site. New RfU would be submitted to the Group for the

forthcoming meeting.

The question whether and how the RfU sheets of the vertical groups of NB could be made

accessible would need to be looked at again.

(I/ 105) Action: EC to clear issue of publication of RfU of vertical with

NB, to follow-up submission of RfU for next; to follow-up MS’s actions

soliciting NBs’ participation in HC-NB meetings

5.2 Report – Findings in reply to mandate issued by Working Group ‘PPE’

Report: HC-NB to come

5.2.1 See 6.2 (modules for conformity certification, revision project)

The Chairperson presented w-doc 2004-45 (see below), comparing the selection of “Modules” for

conformity assessment, which had been the outcome of the Group’s work during 2003 and 2004

(green column) with the recommendations elaborated by the NB in response to the mandate of the

Group (issued, meeting of January 2004). Moreover it was mentioned that the terminology for some

issues would be verified by the industrial stakeholder.

For “Module F” the NB defined some statistical parameters essential for the its application and in

particular for the sampling of PPE to be examined.

“Module D” was recognised as useful, whereas NB did not support “Module E” since it did not

match the needs of the PPE-D.

The NB substantiated their refusing of “Module H”: about 60% of the first application for product

verification in view of EC type-examination had to be refused because of product failures. The

introduction of Module H would eliminate the filter function of EC type-examination and lead to an

elevated risk for the user.

Technical Documentation:

+++ … to identify manufacturing procedures critical with respect to the product meeting the BSHRs applicable

Category - specific Certification Procedures

(except : H)

Cat I: A

Cat II: B+C (Conformity to type)

Technical Documentation:

+++ … to identify manufacturing procedures critically with respect to the product meeting the BSHRs applicable

Category - specific Certification Procedures

(except : H)

Cat I: A

Cat II: B+C (Conformity to type)


H ……. ( B+C+)

Cat III: B+C++ specific provision (similar

to art. 11 A, PPE-D)

B + F (Product Verification)

B + D (Production Quality Ass.)

B + E (Product Quality Ass.)

H

H ……. ( B+C+)

Cat III: B+C++ = specific provision (similar

to art. 11 A, PPE-D)

B + F (Product Verification)

+ AQL 95% using recognised sampling tables covering inspection & testing of attributes

B + D (Production Quality Ass.)

B + E (Product Quality Ass.)

H (outside mandate)

Unambiguous marking of the product / “traceability”

Exclusion of clothing for private use: EC proposal:

Terminology check by FESI and ESF

(reporting target: end 2004)

FESI impact assessment (reporting target: Jan. 2005

Information supplied by the manufacturer / “bulk”

No follow-up necessary

The NETHERLANDS was afraid that Module “F” could require market surveillance authorities to

test huge number of samples before being able to identify non-compliances. The Chairperson

proposed to the NETHERLANDS the exchange the detailed information about statistically based

sampling procedures, he further clarified that the choice of modules had been made and was not to

be opened for discussion . Module “F” had been accepted by the Group and was a convenient

module for some specific production organisations (seasonal batch production).

It was repeated that the accreditation of an production organisation could never replace the formal

conformity assessment system as laid down in the PPE-D be it in its current, be it in its revised

version.


(I/ 106) Action: EC to provide NL with the sampling statistics and to

follow-up NL’s conclusions

5.2.2 Interpretation of Art.11 A discussion also covers 2.5.3 Application of Art. 11A & B)

w-doc 2004 - 38

The work of the HC-NB ad-hoc group “Art.11 A and B” was referred to. The Chairperson pointed

to the fact that some 40% of the RFU sheets related to question of how to apply Art.11A. This

figure was a parameter for application problems. The HC-NB observed that many NBs had adopted

a too flexible interpretation of the provisions of Art. 11 A leading to different ways of

implementation, sometimes in-compatible with the provisions as laid down in the Directive. HC-

NB saw need to react in order to remedy the situation as far the correct application of the PPE-D

was concerned. Correct and detailed instructions had been elaborated.

The NB ad-hoc working group 11A&B, however, recommended not to transfer these schemes into

the revised version of the Directive, only a clear break with the past could stop the habits of

incoherent application.

5.3 Update of the list of NB – description of scope of nomination

The Chairperson mentioned that the harmonisation of the description of the fields of technical

competences of NB was still under consideration. This aspect is likely to be tackled within the

general overhaul of the New Approach Directives.

(I/ 107) Action: DE, FR: information whether and how the appointing

authorities have implemented the proposed nomenclature still

outstanding;

HC-NB PPB to disseminate approach via the national NBs or to refine it;

EC to forward issue to G1/horizontal harmonisation of NA Directives

6 Project “Revision of PPE – D”

6.1 Commission report: follow-up, current situation – how to make progress

The Chairperson explained that in response to the Council Resolution “Enhancing the

Implementation of the New Approach Directives” the work of the Group had to be refocused

with respect to the initial, more ambitious agenda of revising the entire PPE-D. Now the task of

the Group related to the “vertical issues” – provisions and technicalities particular to the PPE-D

– which had to be considered and reworked and for which concise solutions had been elaborated.

Some proposals for the wording of very technical issues were currently under consultation with

the stakeholders concerned (see 5.2 and w-doc 2004-45).

Whereas the Commission services were in the process of reviewing the horizontal aspects of the

“New Approach” Directives in order to improve the coherence within this group of Directives.


At UK’s request for timing of further actions, Mrs Spiliopoulou (COMM - ENTR, deputy head of

unit G 3) said that it was not sure whether to proceed with the revision of the directive until this

“horizontal” review would be completed. A final decision on this would be taken by the end of the

year.

The following had to be considered:

1) could two transpositions concerning the same piece of European legislation, following each other

at very short interval, be justified, would this be accepted by the MS;

2) in any case the Commission was obliged to assess the impact of the amendments proposed, such

a study would be likely to take up to a year.

In response to FR and UK requesting a clear time schedule, the Commission ensured the Group to

be informed about the road map for the revision towards the end of the year.

The NL asked to systematically consider the GPSD for any revision.

(I/ 108) Action: EC to inform Group about road map for revision decision.

6.2 Modules for product certification – update

The agenda point was discussed under 5.2

6.3 Scope/ excluded product groups: “barrier creams” W-DOC 2004 – 33

The Chairperson informed about “barrier creams”, a subject raised by PL. Given that the Annex II

giving guidelines to the “use” directive for PPE (89/656/EEC) specifically named barrier creams as

PPE, it was wondered whether the exclusion of those products from the scope of the PPE-D was

justified.

COMM recalled that Art.1.3 of the WP-DAD specifically excluded such products given that they

did not appear to be “equipment”, the difficulties in testing such products and their effective use.

There were comments made stressing that such creams were not PPE, if barrier creams fell within

scope of the directive a number of cosmetic products, e.g. sun creams, would also be covered by the

PPE-D.

The Chairperson, noting the concern, said that legal advice would be requested on the issue of

principle, two directives containing contradicting provisions. He also requested input from ESF.

(I/ 109) Action: EC to refer matter to LS, and to follow-up of ESF input.

6.4 Essential Requirements: need for targeted amend-ments (1.4i “design stage”; 3.4: “drowning”, …)

The Chairperson explained that the revision work had been started under the strict mandate not to

open for discussion the Basic Health and Safety Requirements (BHSR). During the course of work,


however, several issues popped up which appeared to justify some targeted amendments of BHSR.

At the present “candidate” issues were:

- BHSR 1.4, intervention of NB at the design stage of products;

- the presentation of the specific requirements 3.4 for the PPE against drowning.

The rules for drafting European legislation request individual and subsequent numbering of

paragraphs. At present the buoyancy aids (3.4.1) were made dependent from 3.4. If “buoyancy”

was recognised as a self-standing, fully fledged BHSR requirement, the problem to whether or not

“arm rings/ swim rings” could be better tackled.

- deletion of all examples

(I/ 110) Action: EC to include these issued in the revision process for PPE-

D

7 RTD - research & tech. development

7.1 Follow-up: Commission- funded intercomparison (CrVI): Preliminary result

(VA)

Mention was made of the Commission’s funded inter-comparison related to the measurements as

required by the standard for safety shoes at work (physical and chemical parameters) which was

advancing smoothly. Some preliminary results about Cr(VI) were already available, a full report

could be expected for the forthcoming meeting, Dr. Cannot, the co-ordinator, would be invited for

reporting.

(I/ 111) Action: EC to invite Dr. Cannot for reporting

7.2 Need / support for research W-DOC 2004 – 29

The Chairperson explained that Commission intention was to regularly inquire about the sectoral

needs for research. The Group was in a favourite position to help that research need for the PPE

sector would be taken up in the Commission future RDT funding programme (see website:

http://europa.eu.int). The Group could support national and supranational research projects by

channelling to DG ENTR the topics or work areas which needed funding. DG ENTR would insert

those suggestions in its research priorities to be negotiated with DG RESEARCH.

The Chairperson recalled the strong interest for funding of laboratory inter-comparisons which

clearly showed the need for co-normative research. That area needed a proper infrastructure; the

realisation of some call for proposals could only help to solve the one or other particular problem.

Only a specific infrastructure supporting proficiency testing for test laboratories could achieve

tangible impact. A “European Metrology Infrastructure” could give the necessary support to

measurements essential for the implementation of the New Approach Directives. DG ENTR had

informed DG RESEARCH about this need.

Also pre-normative research could also benefit from a RTD push. In this context reference was

made to new studies, e.g. the efficiency of impact protection helmets (see point 4.6) and the

application of bio-/ergonometric knowledge for protective shoes (for more information contact: Dr.

Georg Ahlbäumer, Orthopaedic Surgeon at Klinik Gut St. Moritz -The Swiss Leading Hospital for


Accident Care, Orthopaedics and Sports, Via Arona 34, CH - 7500 St. Moritz, tel: + 41 81 8334141,

fax: + 41 81 8363435)

The Chairperson invited then CEN-CENELEC representation to pass the information to the TC

concerned and to consider the issues at the level of the PPE Forum. He recommended the study of

w-doc 2004 – 29 and invited the delegations to prepare input for the forthcoming meeting.

(I/ 112) Action: EC to recall request for RDT input

6 Miscellaneous

International events: China (CCC), Turkey (PPE workshop)

Info/EC

COMM informed that a dialogue had started with Chinese AQSIQ, organisation responsible for

import/export control and the Chinese conformity certification scheme). At present the discussions

focussed on electrical equipment rather than PPE. A workshop on EU legislation would be

organised for Chinese authorities and manufacturers.

Moreover, COMM reported that other work was running in parallel, in particular under the so-

called “European Neighbourhood Policy” where dialogues had started with territories on the

Mediterranean rim where alignment to European technical legislation was foreseen over the coming

years.

Croatia and FYROM had applied for EU membership and their technical legislation was expected

to align in the near future, whereas Turkey had already made good progress under the EU-Turkey

Joint Customs Union. The Turkish representative added that the market for PPE accounted for

about 86 M€ of which products for some 65 M€ were imported.

7 AOB & future meetings

The scheduling of the forthcoming meeting was postponed since it depends on the roadmap to be

decided for the revision work.

8 Closure of the meeting

The Chairperson recalled the deadline of 25.10.2004 for the submission of the 1st wave of

comments concerning the points 2.1 & 2.2 the objective being to include the analysis of the MS

positions in the minutes of this meeting.

The deadline for the 2nd wave of submissions would be communicated to the delegations separately,

at a later instance.

The Chairperson tanked the participants for their collaboration. The meeting was closed at 15.30

p.m.; the MS delegations were invited to participate in the PPE ADCO meeting starting at 16.00

p.m.

(I/ 113) Action: EC to define and to communicate deadline for the

submission of comments (2nd wave).



EUROPEAN COMMISSION ENTERPRISE and INDUSTRY DIRECTORATE-GENERAL Aerospace, security, defence and equipment Mechanical and electrical equipment

MINUTES OF THE PPE WORKING GROUP MEETING HELD ON 18 NOVEMBER 2005

Subject: Directive 89/686/EEC

Place: Albert Borschette Centre, Brussels

Chair: Mr David EARDLEY (EC ENTR/H5)

EC Participants: Mr Elod Ajtony DUDAS, Mr Mario GABRIELLI COSSELLU (ENTR/H5)

1. Welcome by the Chair

The Chairperson welcomed those present, introducing Mr Dudas as the next responsible person

for the PPE Directive. After opening the meeting he gave a short summary of the work currently

undertaken by COMM.

2. Approval of the draft agenda (Doc. PPE/05/1/1)

FRANCE asked that a paper on the list of references of harmonised standards (Doc. PPE/05/1/7.4)

be added to the agenda.

With this addition, the Agenda was approved.

3. Approval of minutes of the last PPE Working Group meeting (9/04) (Doc. PPE/05/1/2)

FESI asked that FESI be included in the reference at point I.1 of the “Follow-up” of the meeting of

the Working Group on Personal Protective Equipment (PPE) – Directive 89/686/EEC.

ANEC requested that ANEC be included in the list of stakeholders mentioned in point I.2 of the

“Follow-up”, as they had been involved in this discussion. She also asked for a response to the issue

concerning “arm bands” and “arm rings” described in the point concerned, raising the question

whether it could be considered as a decision.

The Chairperson said that yes it was a decision, a reply on Commission position had already been

sent describing the relationship between the Toys Directive, the General Product Directive and the

Personal Protective Directive in relation to inflatable toys, arm bands and arm rings. But, if

necessary, the papers would be sent to ANEC again.

AUSTRIA suggested that minutes of the meeting should be more structured, by listing action

points at the end of the minutes.

The Chairperson agreed with AUSTRIA and indicated that the current minutes would be

structured in that way.

With these corrections, the minutes of the meeting held on 29-30 September 2004 were approved.


4. Draft PPE Guide (Working Paper) (Doc. PPE/05/1/3)

The Chairperson explained that the work on the Guide has started in March 2005, with two

meetings, held in Warsaw and Paris and that the Guide was 90% complete. After thanking all

contributors, he added that the Legal Service and the Unit responsible for horizontal issues in DG

ENTR would carry out a general review of its structure and contents.

The Guide would be available only in English; nevertheless the Chairperson highlighted that MS

and other stakeholders could have a specific “Licence Agreement” with the Commission in order to

translate the Guide into other languages. Furthermore, the Guide would be available in electronic

format - on the EUROPA PPE website12 -, including hyperlinks to other documents such as lists of

harmonised standards, notified bodies etc., so providing the opportunity to keep these lists updated.

ITALY considered the new Guide favourably, but asked about the work concerning the revision of

the PPE Directive.

SWEDEN also supported the draft Guide, but requested that the categorisation list be added.

SPAIN agreed with the previous comments but stated that they had not enough time to read it

through, in order to provide more specific comments.

FRANCE appreciated the document and stressed the need of its availability in other community

languages other than English.

The Chairperson replied that the purpose of the Guide was to create a good and comprehensive

document; with respect to other languages the “Licence Agreement” would be available. In

response to Sweden the categorization guide would be annexed to the Guide.

FRANCE presented five specific comments to the contents of the draft Guide, as follows:

1) In the “Notes” (page 2), the Guide was presented in a too restrictive way, as “not necessarily

comprehensive, complete, accurate or up to date”. As well as in Annexes etc., it was perhaps too

prudence.

2) In the “Introduction”, about the “Use” Directives, framework directives referred to PPE, such as

from DG EMPL, should be included.

3) On page 16, dealing with safeguard clause procedure, the Guide should clearly indicate where

such safeguard clauses would be published: on CIRCA, on EUROPA, in the OJEU?

4) On page 38, Annex II, 1.1.1, practical application of ergonomics principles of design should be

included, taking into account experiences from manufacturers and other interested parties.

5) The existence, role and activities of the Committee to follow-up the Directive should be clearly

described in the Guide.

These comments would be provided by FRANCE in written form.

AUSTRIA thought that the Guide would be more comprehensible if references to Notified Bodies,

Recommendations for Use, as well as lists of harmonised standards and other horizontal issues,

were added, in order to provide an exhaustive collection of information, not just an interpretation of

the Directive.

MALTA said that the Guide could be affected by horizontal changes related to the revision of the

New Approach, concerning for example definitions, placing on the market, authorised

representatives, accreditation, safeguard clauses, CE marking, administrative cooperation, and so

on. For that, it could be better to keep these issues open for possible future adaptations.

FESI raised a question concerning the integration of the categorisation list in the Annexes to the

Guide.

The Chairperson reaffirmed that the Guide in electronic format would be easily updated when

necessary, by using hyperlinks to the specific lists. About French comments, a level of “prudence”

had been considered necessary, taking into account disclaimers and clauses on responsibility

12 http://europa.eu.int/comm/enterprise/mechan_equipment/ppe/index.htm

http://europa.eu.int/comm/enterprise/mechan_equipment/ppe/index.htm


currently used by the Commission, and the use of terms such as “shall”, “would”, “could”, were

related to the nature of the Guide, as not legally binding. Categorization would be updated on the

basis of decisions adopted by the Working Group.

Member States were requested to provide their written comments within 8 weeks. After this the

Draft WG would complete its work and the final document would be submitted for approval by

written procedure in a further term of 4 weeks. Once endorsed, the Guide would be made available

on the CIRCA website.

The CEN-CENELEC Consultant raised an issue related to equipment for protection against heat

and their categorization, such as oven gloves.. In addition, he said that the requirements laid down

in the Directive for the Technical File to be created by the manufacturer was not fully in line with

the description included in the Guide for the Technical File.

The Chairperson replied that there was no legal base in the Directive to make such a distinction on

gloves, whilst on the other hand it was emphasised that “oven gloves” were not considered as PPE.

5. Scope of Directive (Questions)

Car racing helmets

The Chairperson asked the question as to whether car racing helmets could be considered as

covered by the PPE Directive, taking into account that some European manufacturers referred to a

USA standard.

FRANCE thought that car racing helmets were not excluded from the PPE Directive.

ITALY asked why motor cycle helmets had been excluded from the scope of the Directive, and not

car racing helmets.

The Chairperson explained that helmets for 2 or 3 wheeled motor vehicles were excluded, as

stated in Annex I of the PPE Directive13.

GERMANY said that cord-bike helmets for four wheeled motor vehicles were also PPE.

AUSTRIA asked whether there was any harmonised European standard on helmets available, in

order to consider them as PPE.

CEN-CENELEC explained there were no harmonised European standard available at that point for

helmets. They already contacted the relevant TC 158, waiting for their answer.

The CEN-CENELEC Consultant mentioned the possible confusion in the market and danger in

use with motor cycle and car helmets, with different provisions, and even 22 harmonised standards

available so far.

The Chairperson summarized stating that car racing helmets were covered by the PPE Directive. If

necessary, a specific mandate to CEN would be issued. Market surveillance authorities should take

adequate measures.

FESI drew the participants’ attention to a sensitive issue regarding the application of standards. The

International Sport Federation required manufacturers to apply international technical safety

standards during their production phase, putting its logo on the products in question certifying that

they complied with the mentioned international technical safety standards. In addition, the

Federation required payment from the manufacturers for the utilisation of its logo; nevertheless,

some of those products were covered by the PPE directive.

The Chairperson replied that he was aware of such practice: for example the Rugby Federation

had required a testing body’s certification on the products used by the players. In any case, so long

as there was no interference with compliance with the PPE Directive, or confusion with CE marking

this was not a problem.

13 “Exhaustive list of PPE classes not covered by this [PPE] Directive: (…) 5. Helmets and visors intended for users of

two- or three-wheeled motor vehicles.”


Racing Neck Braces

FRANCE proposed to discuss this issue in order to clarify the categorisation of racing neck braces,

as PPE or medical devices. As these products were exclusively used on racecourses in order to

counter the centrifugal force exerted on the drivers’ head during the race, thus providing protection

against mechanical impact, FRANCE suggested considering these products as PPE, category II.

The UNITED KINGDOM reaffirmed the opinion expressed at PPE ADCO meeting, considering

racing neck braces as PPE, category II.

GERMANY said these products were used for medical and curative purposes, not for protection, so

they should be covered by the Medical Devices Directive.

The Chairperson added that these equipments were used for example, by F-1 pilots to protect their

necks.

AUSTRIA agreed with GERMANY: such equipment was used for protection purposes after certain

injury, so they were medical devices and not PPE.

MALTA quoted the definition of the medical devices given in the Medical Devices Directive:

according to that, racing neck braces were PPE.

IRELAND agreed with racing neck braces as PPE. Nevertheless they mentioned two different

kinds of such equipment: for racecourses to prevent an impact, and for medical purposes.

SPAIN said that it was a complex question. Manufacturers should design their products for specific

hazards and then they would submit them to conformity assessment procedure. If the BHSRs of the

Directive would be fulfilled, the product could be considered as PPE, category II.

BELGIUM agreed with MALTA, recognizing the preventive purpose of such equipment. In any

case, a picture would be very useful to get a clearest idea of the issue and for being able to take a

decision.

SWEDEN said that it could be PPE, but it depended on the information given by the

manufacturers, for preventive purposes or after an accident.

NORWAY and FINLAND considered racing neck braces as PPE, category II.

CYPRUS also considered such products as PPE, and asked what harmonised standards were used

by manufacturers to produce such equipment in compliance with the BHSRs of PPE or Medical

Devices Directive.

SPAIN argued that a product should be considered as PPE without having taken into account the

risks they could provide protection against.

The Chairperson emphasised the importance of the intended use of products given by the

manufacturer in order to define the category to which a certain product belonged. Furthermore, the

manufacturer should clearly indicate the intended purpose of its product, not delegating its

responsibility to the user. There was also the question of what might reasonably be assumed by the

potential user.

FRANCE said that manufacturers should determine more specifically the risk and the protection

effectively provided, not just the information on intended use given, especially in such cases, when

there were different products available on the market, for prevention or for medical purposes after

an accident.

CEN-CENELEC explained that there were two types of collar available on the market, one for

medical purposes and one for protection against shocks: the latter should be considered as PPE.

There was no harmonised standard concerning these collars available at that moment.

FESI added that not only the information by manufacturers, but also expectations of users should

be taken into consideration.

The Chairperson explained that so far, according to directives in force, if a product was considered

as PPE, then it could not be considered as a medical device also: therefore categorization under one

directive was exclusive - but this situation could probably change in the future.

He concluded that, according to the majority of the WG, racing neck braces should be considered as

PPE, category II, requiring EC-type examination. Furthermore, he invited FRANCE to provide

examples, pictures and/or hyperlinks, so all participants could have a look on the product in

question; in 4 weeks, MS could produce their comments.


Categorisation of diving equipment (Doc. PPE/05/1/4 (AT))

AUSTRIA submitted a paper asking for reconsideration of the categorisation of diving suites, as

stated in question/answer 18. The representative requested that a distinction be made between “wet

suits” and “dry suits”, proposing that wet suits should be considered under category I, dry suits

under category II, and if dry suits were assembled with respiratory protection devices, for

professional use, then those should fall under category III.

SWEDEN, NORWAY, the UNITED KINGDOM, FRANCE and GERMANY thought that

question/answer 18 was adequate, without any need to change, taking into account that cold water

could be easily found, especially in northern seas.

The Chairperson concluded that the majority of the WG did not see any reason to change the

categorisation of diving suits as it was agreed earlier under question/answer 18.

Categorisation Guide (Review) (Doc. PPE/05/1/5 (IT))

The Chairperson introduced the document produced by an Italian manufacturer, which could be

considered a good and useful working material, apart some inaccuracies, for example about

“swimming and/or diving goggles and masks”, classified as category I without considering size,

with regard to the different mechanical and chemical effects.

AUSTRIA suggested that FESI could examine the document, in view of its possible diffusion.

The Chairperson invited FESI and all participants of the WG to express their opinion on the

document and submit their comments in 4 weeks. After that period, taking into consideration the

results, the document could be integrated in the Guide to PPE Directive that was going to be

finalised and made available in electronic format in EUROPA website. This was subject to

agreement by the manufacturer concerned.

6. Standardisation (WG 2005.65)

Report by CEN Secretariat (Doc. PPE/05/1/6)

CEN-CENELEC presented the report on standardisation, mentioning the PPE sectorial forum with

social and technical stakeholders, the evolution and improvement of standardisation activities, the

elaboration of specific guidelines for manufacturers and Annex Z, and the cooperation with ISO

with regard to internationalisation of PPE standards. Furthermore, they reported the last activities of

CEN TC 79 dealing with respiratory devices – next meeting to be held on 8 December – and TC

158 dealing with cycling helmets. Statistics on CEN standardisation work were available in the

document submitted to the WG.

AUSTRIA asked CEN about their participation to ADCO meetings in order to provide information

to market surveillance authorities.

ANEC mentioned the issue on chemical requirements for helmets and the funding of a project for

the revision of concerned standards.

COMM asked for clarification about the guidelines on Annex Z, as mentioned by CEN, with regard

to the document agreed between the Commission and the ESOs on Annex Z14.

CEN-CENELEC agreed on participation in ADCO meetings, and said that they had been

examining the issue of chemical requirements.

The CEN-CENELEC Consultant said that some aspects related to Annex Z were not totally clear

yet, with regard to complete fulfilment of the BHSRs by specific clauses of a standard.

14 “Indication of the relationship to essential requirements in harmonised standards (Annex Z) - Implementation by the

European Standard Organisations” (Doc. 35/2004-EN, 31 August 2004)


The Chairperson replied that Annex Z should clearly indicate the correspondence between the

clauses of a European standard and the BHSRs of the Directive, and no requirement could be

“partially” covered: expressions like “the clauses of this standard are likely to support

requirements…” were not acceptable.

Report by CEN Consultant

The CEN-CENELEC Consultant gave a short summary on the work currently carried out under

his responsibility: in particular, there were 98 harmonised standards assessed, including positive and

negative assessments.

AUSTRIA considered that transitional periods of standards were too short, and invited CEN to

examine the issue, in view of the next publication of the list of harmonised standards in the OJEU.

The Chairperson thanked the reports and the information provided.

Commission objections

(i) EN 107815 and EN 108016

The Chairperson recalled the Commission objections on standards EN 1078 and EN 1080

presented at the 98/34 Committee meeting in March 2005, including the background and

motivations, related to accidents occurred. Some amendments to these standards had been proposed

by the concerned CEN TC 158. This subsequently found agreement by the Commission and MS

market surveillance authorities.

AUSTRIA asked for a clear calendar for implementation of those measures and the amendments of

the standards.

CEN-CENELEC recalled the state of the amendments in progress, in principle to be submitted to

the formal vote.

The Chairperson asked CEN to send a detailed calendar on the amendments of the standards, in

order to be distributed to all MS and interested parties.

(ii) EN 143:200017

The Chairperson explained that on the basis of the results of tests on the filtering efficiency of the

various types of particle filters, there was substantive evidence that the test procedure for the

measuring of filter penetration set out in clauses 8.7.2.4, last sentence, and 8.7.3.4, last sentence, of

standard EN 143:2000, according to which the measurement of penetration was taken three minutes

after the start of the aerosol test, failed to ensure compliance with basic health and safety

requirement 3.10.1 (“Respiratory Protection”) of Annex II to Directive 89/686/EEC with respect to

electrostatic filters.

Therefore the Commission brought the case before the 98/34 Committee, where a decision was

reached according to which the presumption of conformity would be withdrawn in relation to those

parts of the standard concerning electrostatic filters. The only remaining step was to publish that

decision (probably in January-February 2006). The Chairperson apologised for the delay in

publication.

However, in the meantime the majority of the MS had indicated reluctance to take measures against

products found not to be in line with harmonised standards, as they had been waiting for the

15 EN 1078:1997 Helmets for pedal cyclists and for users of skateboards and roller skates. prA1: FD August 2005

16 EN 1080:1997 Impact protection helmets for young children + A1:2002. prA2: FD August 2005

17 EN 143:2000 Respiratory protective devices - Particle filters - Requirements, testing, marking


Commission to publish the decision. The issue of taking measure against products by national

market surveillance authorities was a matter of national competency to be dealt with at national

level: therefore the Commission had decided to send a letter to all MS to reassure them that action

could be taken against any product they had substantive concerns over with respect to health and

safety even if compliant to a harmonised standard.

CEN-CENELEC indicated that TC 79 had decided in 2004 to elaborate a document on EN 143,

and at present the modification of the standard was at a final stage: it was expected to be published

soon.

FRANCE recalled that French authorities had already asked the Commission to publish without

any delay the decision on withdrawing of presumption of conformity for the standard. They

complained that the Commission took too long time to handle the case and to publish such decision

(6 months from the 98/34 Committee meeting), taking into account the importance of the question

and its responsibility. FRANCE also added that they created a national “test code” to solve the

problem of EN 143, which they already notified via the 98/34 Committee.

AUSTRIA asked CEN to provide a timetable to exactly indicate when the modification was

expected to be published.

The Chairperson recognized concerns from FRANCE and supported the request addressed to

CEN.

(iii) EN 420:200318

The Chairperson explained that there were two options to proceed against a standard for which

substantive concerns had been raised: to issue an objection via the 98/34 Committee; or not to

publish the reference to the standard. The Commission had decided the latter option, subsequently

deciding to publish EN 420:2003 together with a note clarifying that the content of Cr VI of the

glove materials would be subjected to the detection limit of 3 mg/kg.

AUSTRIA noted that the old EN 420:1999 was missing from the list, so they raised the question

whether that meant it did not provide presumption of conformity either.

FRANCE insisted there was a technical sheet available on EN 420 which defined the minimum Cr

VI level to 5 mg/kg.

The Chairperson asked the NBs how they tested the Cr VI level and what limit had been applied

to detect it.

HCNB replied that they had no knowledge on any existing technical sheet setting the detection

limit for Cr VI to 5 mg/kg.

The Chairperson said that there was an inter-comparison test on the issue, but at the moment there

was no enough information at the Commission’s disposal on how to use it legally. The legal service

had been contacted and once they could approve its release, it would be sent to the NBs. With

respect to the issue raised by Austria, COMM understood that this previous edition was no longer to

be published as its DoC/ DoW had now passed.

(iv) EN 353-1:200219 (Docs. PPE/05/1/7.1, PPE/05/1/7.2, PPE/05/1/7.3)

The UNITED KINGDOM expressed their concerns on the drop-test requirement within the

standard in question (and the corresponding test method in EN 36420), considering that it was

unable to detect possible life-threatening design deficiencies. They asked whether other MS had

18 EN 420:2003 Protective gloves - General requirements and test methods

19 EN 353-1:2002 Personal protective equipment against falls from a height - Part 1: Guided type fall arresters

including a rigid anchor line

20 EN 364:1992 Personal protective equipment against falls from a height - Test methods


come across with this problem, and whether CEN was planning to examine the issue. The UK also

asked whether the same question could involve EN 36021: they would participate to the meeting on

8 December 2005 in order to decide on how to proceed, being possible to bring the case to the 98/34

Committee.

The CEN-CENELEC Consultant said that the questions concerning EN 360 and EN 353-1 were

different: the first case was related to incorrect use of the product, while in the second case there

was a real problem with the assembly by the user, on the basis of the instructions by the

manufacturer and the compatibility of the elements.

The Chairperson asked the UNITED KINGDOM to report back on the information it receives

from other MS and to inform the Commission about their intention to produce an objection against

the standards EN 353-1 and EN 360 via the 98/34 Committee. Other remarks could also be

produced in the framework of the 98/34 Committee procedures.

Information on latest publication (Doc. PPE/05/1/7.4)

The Chairperson explained that the last publication on the OJEU of the consolidated lists of

harmonised standards took place on October 2005, and that the next publication – containing the

reference to EN 420 as well – had been expected on 12 November 2005; but for some reason yet to

be explained did not happen. With regard to the document produced by FRANCE, with comments

and questions on the new publication of PPE standards in the OJEU, the Chairperson invited those

present to send their comments on the issue within the following next two weeks, after which the

Commission would organise a meeting with CEN in order to fully answer the questions.

7. Notified Bodies (Docs. PPE/05/1/8.1, PPE/05/1/8.2)

Report by NB Chair

HCNB presented the report from the last meeting, including the following issues:

- Recommendation for Use sheets: 8 RfUs were to be approved by the Horizontal Group. On the

other hand, while the horizontal sheets appeared on the Internet, there was no place to post the

vertical sheets at that moment;

- Time limitation of certificates: if a product was manufactured and then certified according to a

harmonised standard which no longer provided presumption of conformity regarding the BHSRs,

then the EC type-examination certificate issued by a certain NB probably should be withdrawn. In

any case, until the moment, no time limitation had been established;

- Monitoring products finished outside of the EU: it was a growing problem of how to monitor the

products that manufacturers brought outside of the EU to finish or complete them;- Certification of

manufacturers: there were more and more products on the market which appeared under someone

else’s brand than the certain product was certified by. The question had been discussed at the last

meeting but the NBs could not reach a decision on that so far;

- Preparation of a guidance document for the RfUs: the NBs could only partially influenced the

work concerning the matter.

Finally, she announced that the next meeting of NB-C would probably be held at beginning of May,

before the next WG meeting.

The Chairperson thanked HCNB for the report, remarking that it was up to MS to decide on time

limitation of certificates, as on that particular field, national law should be applied. However, if

there was substantive changes to the state of the art such that the Certificate was no longer valid

notification would have to be given that it was no longer valid.

21 EN 360: 2002 Personal protective equipment against falls from a height - Retractable type fall arresters


About certification of manufacturers, it was repeated that if someone puts his own brand name on a

product and places it on the market, he would become responsible as a manufacturer.

AUSTRIA raised a question on the guidance document and the RfUs, related to the global

presentation of them, suggesting to provide links in order to have access directly to their content.

The Chairperson confirmed that the publication in the Internet was oriented to provide an easy

access to the RfUs and such a link could be useful also to keep them updated.

Vertical Group sheets (for discussion only)

The Chairperson said that vertical RfU sheets were presented at the WG meeting for the first time,

but for discussion only and not for approval, due to their technical nature.. If there were any

comment on the content of the vertical RfUs, they could be produced at the meeting or be sent later,

according to the usual communication.

FRANCE considered that all the sheets, both horizontal and vertical, should be discussed and also

approved by the WG, taking into account the relation of some of them with specific standards.

AUSTRIA supported the French opinion.

The Chairperson recalled the procedure for presentation and approbation of RfU vertical sheets,

having made them available for more than 4 months in CIRCA PPE ADCO Group, after the last

meeting held in Vienna, but COMM received no comments. Therefore, they had been presented at

the WG meeting and a further period of 4 weeks would be opened, in order to receive any possible

comments and remarks. After that, the RfU sheets would be published on the Internet.

8. ADCO

AUSTRIA, as Chair of ADCO PPE, reported on the last meetings held in Vienna and in Brussels,

previous to the WG meeting. Unfortunately not all MS had participated in these meetings. They

presented the main points discussed there: two resolutions were adopted, on the publication on the

OJEU of the opinions produced on safeguard clauses, in order to communicate them to all interested

parties; and on the withdrawal of presumption of conformity of certain clauses of EN 143. The

ADCO shared the opinion expressed by FRANCE about the long time for action by the

Commission. At the ADCO meeting Mr Sacchetti (COMM) announced consultations with the

Legal Service of the Commission about the possible publication on the OJEU of the opinions on

safeguard clauses.

Furthermore, a common document on notification on safeguard clause was adopted and, as agreed,

the Commission would provide help for the translation in different languages; the importance of

normalization work had been recognized, as well as the definition of test protocols and

requirements; the CIRCA ADCO website needed to be better structured, also with the help from the

Commission. Finally, the next presidency for ADCO Group had not been identified.

The Chairperson thanked AUSTRIA for the report as well as the work over the past year, and

invited those present to offer their candidacies for the ADCO Group presidency.

9. AOB

Implementation of the PPE Directive

The Chairperson gave a short description on the current state of play regarding the implementation

of the PPE Directive in the Candidate Countries. According to the Commission knowledge, good

progress was made in Bulgaria and in Romania.

TURKEY introduced their representatives in the WG, Mr Umut Can Gök from the Under-

secretariat for Foreign Trade (UFT) and Mr Bülent Gün from the Ministry of Labour and Social

Security (MLSS), and explained that Turkey had already implemented the PPE Directive which was


in force from February 2005. Participation to ADCO and WG meetings was considered very

interesting and useful in order to get experience and exchange information.

SPAIN and AUSTRIA asked for clarification of some aspects of the Custom Union between EU

and Turkey, as well as the effective implementation of the PPE Directive with regard to the

products placed on the market in Turkey and the declaration of conformity of manufacturers, as

well as the designation of Notified Bodies and the market surveillance activities in Turkey.

The Chairperson clarified that implementation was a gradual process, including horizontal issues

such as those related to Notified Bodies.

TURKEY said that the market surveillance authority for the PPE Directive in Turkey was the

Ministry of Social Security and Labour. They would provide more detailed information.

The Chairperson welcomed the Turkish representatives.

10. Date of next meeting and close

The Chairperson closed the meeting, announcing that the next meeting would be held on 22-23

May 2006.

Summary of Action Points to be followed-up at the next meeting

No. Agenda

item

Subject Action

by

Action required

1 4 Draft PPE Guide (Working Paper) COMM After having waited 8 weeks for participants’

comments to be submitted to the Commission,

the Commission to upload the Guide on the

CIRCA and EUROPA websites in a further 4

weeks

2 6 Standardisation - Commission

objections: (ii) EN 143:2000

COMM The Commission to publish the decision on

withdrawal of the presumption of conformity

of EN 143 standard’s parts concerning

electrostatic filters as a matter of urgency


objections: (ii) EN 143:2000

COMM The Commission to issue a letter to all MS on

encouraging them to take action against any

product they might find non-compliant to

BHSRs even if compliant to harmonised

standards


objections: (iv) EN 353-1:2002

UK The UNITED KINGDOM to report back on

the information they receive from other MS

concerning EN 353-1 and EN 360

5 6 Standardisation - Information on

latest publication

COMM,

CEN

The Commission to organize a meeting with

CEN on the comments produced by the WG

on the list of references of harmonised

standards

6 7 Notified Bodies - Vertical Group

Sheets (for discussion only)

COMM The Commission to publish vertical RfU

sheets on the PPE webpage on EUROPA


EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Aerospace, security, defence and equipment Mechanical and electrical equipment

MINUTES OF THE PPE WORKING GROUP MEETING HELD ON 23 MAY 2006

Subject: Personal Protective Equipment (PPE) Directive 89/686/EEC Working Group


Chair: Ms Maria SPILIOPOULOU-KAPARIA (EC ENTR/H5)

EC Participants: Mr Elöd DUDAS, Mr David EARDLEY, Mr Mario GABRIELLI COSSELLU,

Ms Elzbieta PAPRZYCKA (ENTR/H5)


The Chairperson welcomed those present.


SPAIN asked to include a reference to the revision of the PPE Directive. Furthermore, they

suggested discussing the cancellation of EC-type examination certificates, as discussed at the last

Horizontal Committee for Notified Bodies (HCNB) meeting.

AUSTRIA proposed discussing the issue of “considerable” or “substantive” changes made in

products and the consequences with regard to the original certificates issued by the Notified Bodies

(NBs) as well as for market surveillance activities.

IRELAND raised the question of implementation of EN 1457222 on helmets for equestrian

activities: its reference was published in the OJEU last year but to-date no helmets had been

manufactured according to this standard.

The Chairperson suggested that the cancellation of certificates be discussed at item 9 “Any Other

Business”. Although no amendments to the PPE Directive was being considered at present the

Chairperson would give a short explanation on the current situation at item 4.

With these additions, the Agenda was approved.

3. Approval of the draft minutes of the PPE Working Group 18th November 2005 (Doc.

PPE/06/1/2)

The minutes of the meeting held on 18 November 2005 were approved.

4. Draft PPE Guide (Approval) (Doc. PPE/06/1/3)

22 EN 14572:2005 High performance helmets for equestrian activities


COMM explained that the first draft of the Guide had been presented at the last PPE WG in

November 2005. Since then approximately two hundred comments had been received. These and

other legal issues raised had been taken into account as far as possible by the Drafting Group.

The draft Guide was presented for endorsement by the Working Group although there would be a

six week period for any further minor comment/clerical errors. It would then be uploaded onto the

Europa Internet site. The categorization guide (to be annexed) would be discussed separately.

He thanked to all who helped this work in particular the members of the Drafting Group.

FESI referred to Annex 223, page 43, statement “(…) in addition to the application of the general

requirements, manufacturers need to clearly identify: (…) - the foreseeable conditions of use and

possible misuse of their product”, and asked whether it is actually possible to consider all possible

misuses. He mentioned that CEN had created an information guide for the manufacturer where

there was also reference on the possible misuse of the product,. He said that identification of

obvious misuses was possible but all highly unlikely.

FRANCE considered the draft Guide a useful document that should be published. It was pointed

out that at page 11, the Essential Health and Safety Requirements in the English version were

slightly different from the reference text, in French, as “essential” was not exactly the same as

“basic”; and in the French version there was “foreseeable misuse”, such as in the Machinery

Directive.

SPAIN said that they had several comments on the draft Guide, yet to be taken into consideration.

In particular, about certificates issued by NBs, they should specify any references to standards and

the requirements fulfilled by the product, as sometimes a standard did not cover all the essential

requirements.

The Chairperson took the comments and suggested making a hyperlink to the CEN information

guide to be published on the Commission website. The linguistic discrepancy pointed out by

FRANCE was not viewed as problematic.

FESI supported the idea to keep both guides as separated documents and to include a link to the

CEN guide in the PPE Guide.

COMM said that the PPE Guide should be published as soon as possible. With respect to the

question raised by FESI, he considered it as a standardization matter: international standardization

had moved from “intended use” to “foreseeable use” which would determine broader obligations

for manufacturers than before. He suggested recording the fact that it could only be assumed that

reasonably foreseeable misuse would be identified by manufacturers in the minutes which then

could be referred to by manufacturers.

In response to FRANCE, he suggested adding a statement in the draft Guide (page 11) clarifying

that the expressions “essential” and “basic” were substantially identical. Furthermore, he supported

to put a hyperlink referring to the CEN Guide, but keeping it separated and distinguished from the

PPE Guide. Replying to Spain, he explained that most comments had been already included in the

draft Guide. Others could possibly be entertained in the next few weeks although major

amendments would need to wait for a second edition.

The endorsement was presently requested for the main body of the draft Guide, not the annexes,

which were to be discussed separately.

FESI agreed with COMM as well as on the good quality of the document, but asked to insert word

“foreseeable” in the sentence (page 43): “the foreseeable conditions of use and possible foreseeable

misuse of their product”.

COMM agreed on the proposal.

SPAIN appreciated the consideration of most of their comments, but thought that there would be

further remarks to be included in the Guide, in order to preserve the “spirit of the Directive”.

FRANCE also pointed out that there were still some points to cover, such as the EC-type approval

certification and the issue of certificates by NBs covering the BHSRs of the Directive.

23 Annex II: Essential requirements of health and safety


COMM said that there were no “contradictions” with the Directive. About French remarks, the

Working Group could ask the NBs to answer, as they had the possibility to produce clarification

sheets. He suggested endorsing the Guide as it was: to be published in electronic format so that any

future amendments could be incorporated easily.

The Chairperson asked the members of the Group to provide their written comments on the draft

Guide within six weeks. After taking theses into account the Guide would be uploaded to the

CIRCA and EUROPA websites.

The draft PPE Guide was unanimously endorsed by the WG. Member States(MS) to provide

further minor comments in six weeks.

Future revision of the Directive

The Chairperson said that there were no immediate plans for future revision of the PPE Directive,

as it worked quite well, new Guide would be available and the revision of the New Approach was

under way. The Commission had concluded that it was reasonable to wait for the completion of the

revision on the New Approach, which included many issues (definitions, conformity assessment

procedures, safeguard clauses etc.) that should be taken into account in future amendments of the

Directive. Furthermore, the Chairperson said that the first results of the work carried out by the

responsible Unit (DG ENTR/C1) were expected in the fourth quarter of 2006.

5. Scope of Directive (Questions)

COMM thanked ESF for updating the Categorisation guide. He gave a four week period to submit

comments and proposed to endorse the paper apart from point 8.6 (to be discussed later in the day).

FRANCE reminded those present of the questions taken up at the ADCO meeting concerning

categorisation of knee guards, nose plugs, ear plugs for swimming purposes, to define if they had

protection function. They asked for the response of FESI on these issues.

COMM agreed that the subject should be taken into consideration and proposed to discuss it at item

9 “Any other business”.

FRANCE agreed with this proposal.

Categorisation of football-shin-guards and ice hockey protective equipment (Doc. PPE/06/1/4)

The ADCO Group conclusions regarding football-shin-guards and ice hockey protective equipment

were presented: these products should be considered as Category II,

The Commission would modify point 8.6. of the already endorsed categorization guide accordingly.

BELGIUM (ADCO Chair) said that they suggested changing the categorization because it could

be dangerous regarding sporting shoes. They proposed to eliminate point 8.6 in order to avoid

confusion, as point 8.1 would cover the issue adequately.

COMM replied that point 8.1 would not solve the problem, because all equipment moved to point

8.1 would become Category II. It would be better to keep 8.6 in place but suggested to change the

reason from 3.1.5 to 3.1.1.

FESI asked that any reference to shoes be taken out from this categorisation list at point 8.6;

provided that, the categorization guide could be endorsed.

COMM said that a specific reference could be made as a footnote or something similar, stating that

for categorisation of PPE the level of risk it provides protection evidently needs to be considered.

He disagreed on the exclusion of sport shoes as there were certain types of shoes (e.g. shoes for

rugby players with steel toe-cap) giving protection against that level of risks which justify them

belonging into a higher category.

SWEDEN agreed: it would be essential taking the risk into account.


SPAIN also agreed with COMM. When a personal protective equipment was designed, it should be

clearly defined what level of risk it protected against; whether it could be classified in Category I or

II according to specific sport activity, with protection against of superficial risks or not.

FRANCE pointed out the difficulty to reach an agreement and suggested discussing on the basis of

the paper produced at the previous ADCO meeting.

COMM suggested a common solution in the introduction of the categorization guide, regarding the

consideration of level of risk. The point concerning results of ADCO meeting had not been included

into the Agenda, but relevant documents could be sent to the Commission.

FRANCE thought that it could be extremely dangerous make distinctions according to sports such

as football, rugby and so on, with regard to risk assessment for categorization. The aim would be to

have the same categorization everywhere, not only for given sports.

GERMANY proposed to change 8.6 to Category II, looking at the risk, taken into account the

debate at the ADCO meeting.

COMM proposed that equipment of type 8.6 be moved from Category I to Category II,;

Nevertheless if it was designed to be used against minor impact and vibration not affecting vital

body parts, than it would stay in Category I.

SPAIN supported the opinion expressed by FRANCE. It would be important to consider not the

sport itself, but the level of risk the equipment protected against, for Category I or II. Categorization

should be determined by the risk assessment, according to the Directive.

COMM said that market surveillance authorities were oriented to Category II, when manufacturers

to Category I. They pointed out the practical difficulties related to the issue and suggested clarifying

different cases for external impacts, stating that what would not be Category I should be considered

Category II.

The Chairperson concluded announcing that COMM would send to Member States a clear

drafting suggestion on the line as agreed by the Working Group: football-shin-guards and ice-

hockey protective equipment were (in general) Category 2 PPE.

Categorisation of diving equipment (Doc. PPE/06/1/11 (draft), PPE/06/1/12, PPE/05/1/5)

COMM introduced this issue which had already been submitted to the PPE WG in November 2005,

where it was agreed that FESI should examine the document first, and MS invited to submit their

comments to the Commission. So far only FESI and Spain communicated their comments to the

Commission. Therefore, the issue would not be discussed at the meeting. COMM invited all

participants to express their views on the issue in order to get a broader picture of WG members’

opinions. Then, the subject would be discussed again.

Categorisation Guide of a safety system for operators of working platforms (Doc. PPE/06/1/13)

COMM presented a question/answer issue, submitted by GERMANY, on a safety system for

operators of working platforms, as a parachute for emergency situations. The question was raised

whether it was PPE or not? COMM recalled that this question had already been answered in the

“Question and Answers” point 14 according to which parachutes are not PPE.

FRANCE thought that it did not fall in the scope of the PPE Directive.

COMM concluded that, according to the WG general agreement, this equipment was not PPE.

6. Standardisation

Report by CEN Secretariat (Doc. PPE/06/1/6)

CEN-CENELEC presented the report on standardisation, including the discussion at the PPE

sectoral meeting held in February 2006.


The CEN technical bureau prepared a guide on drafting Annex ZA to correctly reflect the Basic

Health and Safety Requirements (BHSRs) of the Directive; this guide included contributions from

the Notified Bodies (NBs), the Commission services and standardisers. The information guide on

information to be supplied by manufacturers for PPE sector was under discussion, with a deadline

for comments fixed for the end of June. She went on mentioning the current situation about

chemical requirements for helmets (with ANEC). Another issue was the amendment of EN 14324

being under elaboration which was expected to be published at the end of May. Finishing the report

she said that a call for tenders for the selection of new PPE consultants was published and recently

finalised. As a result of this process the current CEN consultant was awarded with a contract for

another year.

Report by CEN Consultant (Doc. PPE/06/1/7)

The CEN-CENLEC Consultant presented the report on the work currently carried out under his

responsibility in particular, there were forty-two harmonised standards assessed, including positive

and negative assessments. He mentioned the differences between CEN and ISO philosophy on

drafting standards with options. These options were intended to reflect market differences which

could create a problem with regard to the presumption of conformity.

CEN-CENELEC mentioned the survey by the Commission on the revision of New Approach, as

well as the study on evaluation of standardisation consultants. They would report on this subject at

the end of the year.

FRANCE considered the work of the consultant very important and positive. “Global relevance”

issues mentioned by the CEN-CENELEC Consultant should be discussed in depth. They pointed

out that standards with options had destabilising influence on manufacturers, Notified Bodies, end-

users etc., and it would be unacceptable to work with standards with different levels of safety.

COMM informed the Group that DG ENTR had sent a letter to CEN presented the position of the

Commission on Global relevance. The Commission supported international standardisation as long

as it respected European legislation. CEN had replied along the same lines and made a proposal for

a possible solution.

The Chairperson said this was a horizontal issue and as such was being dealt by DG ENTR/C/2

responsible for standardisation issues in DG ENTR.

ETUI-REHS asked whether discussion on Global relevance would have an impact on the revision

of the New Approach.

The Chairperson replied that the DG ENTR/H5 was not directly dealing with these issues, but

monitored the process closely.

FRANCE asked whether CEN intended to publish standards not giving presumption of conformity

with respect to all the requirements of the Directive, or they could be published with appropriate

warning or restrictions which would inform about any requirement not covered by the standard.

The CEN-CENELEC Consultant answered that it was stated in the Directive (Article 5 and

others) and in the “Blue Book” that Annex ZA contained a list of essential requirements covered by

the standard. NBs role would be to verify if manufacturers had considered all the essential

requirements applicable to the PPE.

FRANCE expressed concerns on the effective application of these provisions, by NBs and market

surveillance authorities. They thought that it was a problem of standardisation: standards not

covering all the risks should not be published, in order to avoid confusion and differences in

interpretation.

COMM did not agree that it was a problem of standardisation. It was known that some harmonised

standards did not cover all the essential requirements, and their scope was indicated in the text of

such standards.



FRANCE stated that in case of standard with options Commission should take clear position and

not publish them.

The UNITED KINGDOM supported FRANCE, and announced that they would write a letter to

the Commission services, with concern of inconsistencies of how Annex ZA could be differently

interpreted by NBs.

The Chairperson said that it was a horizontal issue, already discussed. Regarding “Global

relevance” the Chairperson stated that the Commission reserved the right not to publish references

of standards in the OJEU which did not respect European legislation. These issues would be taken

up again in the future.

Report by UK on EN 353-125

The UNITED KINGDOM gave a short report on the state of progress of test requirements of

standard EN 353-1. The concerned CEN TC 160 met in January 2006 and agreed to use a British

falling backward test as a base for amending the above mentioned standard. Report from

observations of testing devices would be sent to CEN in July, and could be uploaded in CIRCA.

CEN-CENELEC asked the UK whether they were satisfied with the revision of the standard.

The UNITED KINGDOM replied that the issue was difficult to address. They would inform on

their intentions with regard to next steps to be taken, with possible submission of the case to the

98/34 Committee.

COMM asked CEN-CENELEC whether there were any time frame to proceed with the revision of

the standard.

HCNB answered that the next CEN TC 160 meeting was planned for September 2006. They

expected to come forward with proposal on how to deal with the standard and to find an agreement

on reproducibility of test processes.

The Chairperson asked the UNITED KINGDOM to report back at the next WG meeting, on the

state of progress.

Report by COMM on objection against EN 143:200026 (Doc. PPE/06/1/14)

The Chairperson informed that the Commission decision concerning objections against EN

143:2000 (filters) and all related standards was published in the OJEU in March 2006, and was also

placed on the Internet and CIRCA websites.

AUSTRIA asked whether the same text of the warning for EN 143 should apply also to the other

concerned standards; it should be clarified. Furthermore AUSTRIA addressed CEN whether the

related standards were under also revision.

CEN-CENELEC replied that CEN had identified the standards involved in the Commission

warning, as well as EN 14387, in order to carry out revisions and amendments. The work was in

progress; after the next CEN Technical Committee meeting in June, more information could be

provided.

The Chairperson explained that the current form of warning had been agreed with the Legal

Service of the Commission, in order to have a satisfactory and time-saving solution in comparison

with a separate procedure against each standard. For the time being the situation would be kept as it

was, taking into account that revision process could take a long time.

Report by FR (market surveillance) (Doc. PPE/06/1/9)





FRANCE gave a presentation concerning their market surveillance campaign regarding Respiratory

Protective Devices. The report included actions taken by the French authorities, the management of

EC-type examination certificates as well as follow up actions to be carried out.

COMM found the presentation very interesting and asked whether safeguard clauses were already

in the pipeline. The answer was positive.

He suggested it would be useful if FRANCE could make this presentation on NB meeting and

asked the representative of the NBs to respond to the questions raised by FRANCE, in particular

those related to certificates.

HCNB found several points related to the role of Notified Bodies as very important, underlining the

importance of cooperation between Member States and NBs.

7. Notified Bodies

Uniform designation of Notified Bodies (Doc. PPE/06/1/05, PPE/06/1/10)

COMM presented the list “Set of common denominations for the notification of Conformity

Assessment Bodies under Directive 89/686/EEC” based on previous WG and ADCO materials. The

current list of NBs with their competences had not been normalised which made it difficult to make

comparison between the areas of competence. The aim was to provide a uniform way of designation

of NBs to tackle with this issue. COMM asked those present to send comments in within four

weeks after which the Commission would create the final version of the document in order to be

used when notifying bodies by Member States.

Report by NB Chairperson (Doc. PPE/06/1/15)

HCNB presented the report from the last meeting of the Horizontal Committee of Notified Bodies

held in May 2006, including the following issues:

- Involvement of NBs in coordination meetings: levels of participation reflected in a list according

to 3 “code colours” groups. This statistic could be interesting and would be available for

Commission and Member States;

- Commission objection against EN 143: it was needed to agree on a transitional period to allow for

retesting, amending the certificates etc.

- Cancellation of certificates, raised by SPAIN: cancellation should be done automatically in the

situation when the certificate was withdrawn because there were shortcomings or defects;

- Guidelines for manufacturers: the most basic information should be given as a printed document;

- Seven horizontal Recommendation for use sheets (RfUs) were elaborated by HCNB which waited

for endorsement by the WG.

HCNB also mentioned the publication of vertical Recommendation for Use sheets on the

Commission PPE website and a question from FRANCE about certificates. They would prepare a

specific RfU sheet on that and it would be submitted to the Working Group.

COMM recalled the question on withdrawing certificates and asked HCNB whether there were any

activities carried out by NBs concerning test methods of standard EN 143, changes etc.

HCNB did not have detailed information about retesting test methods.

FRANCE asked for more clarification on withdrawal of certificates.

HCNB said that NBs had discussed on how to deal with the issue. No more certificates would be

issued on the bases of these standards, taking into account questions on procedure, transitional

periods, etc.

The UNITED KINGDOM recalled the English procedures to deal with the question of

withdrawing certificates - such as the ones related to EN 143, and proposed to send to the

Commission a two-page summary paper, to be distributed among the WG Members. The key points

of such a document were: the Notified Body would inform the company; twelve months to

withdraw the EC-type examination certificate; two months for rectification and the Certificate to be


re-issued, at the end of the twelve-month period. The same would be applied for the other

associated standards.

FRANCE said that it was MS responsibility. They had reinforced requirements some time ago,

manufacturers were ready to adapt; they could not wait and as such, the twelve months period

indicated by the UNITED KINGDOM was unrealistic.

ESF said that the vast majority of manufacturers of this type of equipment would need new test

methods for new certificates. Also mentioned the issue of withdrawal of certificates based on EN

143 and related standards, which was going on, but could not be carried out “overnight”.

The UNITED KINGDOM explained that they had provided just a summary. They would send it to

the Commission in order to distribute it to the members of the Working Group.

The Chairperson thanked the UK for the proposal to provide the paper, as it would give the

opportunity to develop an interesting discussion. When the Commission received the UK paper, it

would then distribute it to the WG members, and a six-week period would be given for comments.

Later, the paper could be presented at the next ADCO and WG meetings.

ETUI-REHS asked about consequences followed by discussion on EN 143 and the Commission

decision, for workers, for products in the market, for employers, at national level for the Member

States and about lessons for the future.

COMM asked Member States to send a short summary report within six weeks on their market

surveillance activities in the light of the publication of Commission decision on EN 143 and the

other related standards

Horizontal recommendation for use sheets (Doc. PPE/06/1/8)

The Chairperson opened the discussion on the horizontal RfUs in the Agenda (seven sheets).

HCNB proposed to ask for written comments on these RfUs, to be provided within six weeks, in

order to draft more appropriate answers.

Those present agreed with the proposal. A preliminary discussion could be held on each sheet, but

then a six-week period for comments would be provided after which the RfUs would either be

endorsed or sent to the NBs for re-drafting.

- RfU 00.126: SPAIN requested an addition to the effect that uncertainty of measurements should

be given not only for laboratories (sub-contracted bodies) but also for Notified Bodies themselves.

FRANCE said the interpretation could be the opposite: the question could not be resolved as in the

sheet; it should be re-worded including other cases. COMM thought that the RfU represented a first

step in the right direction so could be endorsed and be improved later.

COMM took the comments from SPAIN and FRANCE and proposed to re-submit the sheet.

- RfU 00.127: The CEN-CENELEC Consultant did not agree with the solution proposed: it could

not be considered acceptable that when test method standards had changed, but the product standard

not revised, the old test method could still be used. COMM underlined that whilst an old standard

no longer providing presumption of conformity it could still be used.

- RfU 00.128: no comment.

- RfU 00.129: FRANCE asked for clarification of the problem with interchangeable components.

HCNB explained that the question concerned equipment that was placed on the market before the

PPE Directive existed. FRANCE considered the answer acceptable and useful, putting the question

in its context.

- RfU 00.130: no comment.

- RfU 00.077: ETUI- REHS said that the foreseeable misuse should be provided by manufacturers

and checked by NBs and that was not included in the RfU. HCNB replied that it was already

included in the answer, according to the English text of the Guide.

- RfU 00.109: FRANCE had difficulties to interpret the expression “should be against the

edition…”. COMM proposed to change it to “according to the new edition…”. HCNB explained

that the question was related to withdrawing of type-examination certificates. SPAIN expressed

opinion similar to RfU 00.127: in case the standard had changed, it could not provide presumption


of conformity and not be used any more. Mr Noetel (HCNB) said that it was a question related to

“serious” or “considerable” changes. COMM asked SPAIN to send comments on that question.

COMM closed the discussion on RfU sheets indicating a six week period in which to receive

comments.

8. ADCO

Report by Chairperson

BELGIUM, as ADCO Chair, reported on the meeting held on 22 May 2006 in Brussels. They

went through action points from ADCO WG meeting and presented the result of an enquiry send to

Member States, he also made a comment on the results on the questionnaire concerning

administrative cooperation under the PPE Directive and the question of the re-structuring of CIRCA

ADCO site that still needed to be addressed.

The ADCO Chair asked the Commission to inform the group in more detailed way on the New

Approach process at the next meeting. It was also mentioned that there were some categorisation

issues on which the ADCO group could not agree as, for example, the intended use of those

products or the risk they provided protection against were unclear. Such products were e.g.

volleyball kneepads, nose – ear plugs etc. Belgium proposed to contact FESI for their comments on

this and then the issue would be submitted to the Commission with all the comments received to be

approved by written procedure.

COMM thanked the report and said that the information concerning the New Approach was

available on the internet website, but also said that he would ask a colleague at the horizontal unit

dealing with the issue to come to the next meeting. COMM mentioned that he was waiting for the

proposal on products categorisation mentioned by the ADCO chair.

9. AOB

IRELAND recalled the question of the availability on the market of helmets for equestrian

activities, covered by the standard EN 14572:20051. The riding helmets being on the market were

manufactured according to EN 1384. Therefore Ireland proposed to amalgamate these two

standards into one. There was a meeting of CEN TC 158 on 19th June where IRELAND proposed to

raise this issue.

COMM asked whether IRELAND was planning to raise an objection against EN 14572:2005 via

the 98/34/EC Committee. The answer was negative.

AUSTRIA returned to the question concerning recommendations in case of cancellation of EC-type

examination certificates, as well as the consequences of “considerable” or “substantive” changes in

products with regard to availability of standards for manufacturers, the original certificates issued

by NBs and market surveillance activities.

SPAIN suggested that HCNB should put forward a proposal on the cancellation of EC-type

examination certificate and then the WG could discuss the issue again.

COMM agreed with AUSTRIA and SPAIN and suggested to put these issues on the next meeting

agenda.

BELGIUM highlighted the need for “standard” EC-type examination certificate. This was a

problem for market surveillance authorities as it was difficult to link a certificate to a product.

Therefore a possible solution would be if the certificates contained pictures of the product,

COMM suggested that BELGIUM could, together with the other national authorities, come up with

a proforma which then could be sent to the HCNB for discussion in order to find a common

solution for the problem mentioned by BELGIUM.



The Chairperson closed the meeting, announcing that another WG meeting was not in principle

foreseen in 2006. It might be organised however if there was an urgent issue needed the attention of

the WG.


Summary of Action Points to be followed-up at the next meeting

No. Agenda

item

Subject Action

by

Action required

1 4 Draft PPE Guide (Approval) All

ES

COMM

Provide further comments in 6 weeks on the

draft PPE Guide (clerical or administrative

only)

Spain to send its final comments on PPE Guide

Following this, the Commission to upload the

PPE Guide on the CIRCA and EUROPA

websites within a further 4 weeks

2 5 Scope of Directive (Questions) -

Categorisation guide point 8.6.

(football-shin-guards and ice-

hockey protective equipment)

COMM Circulate a clear suggestion on agreed line:

sports-shin-guards and protective equipment re

generally category 2 unless for protection

against minor risks

3 5 Scope of Directive (questions) All

COMM

FESI

Proposal for categorisation discussed at ADCO

but not presented at WG to be sent to COMM

by ADCO Chair

To be endorsed by written procedure

FESI also to contribute

4 5 Scope of Directive (Questions) -

Categorisation of diving equipment

All Provide comments

5 6 Standardisation - Report by UK on

EN 353-1

UK Report back at the next meeting

6 6 Standardisation - Report by

COMM on objection against EN

143:2000

UK

COMM

Submit paper concerning EN 143 within 6

weeks to COMM

COMM to send paper to all interested parties

7 6 Standardisation - Report by

COMM on objection against EN

143:2000

All Member States to provide COMM with a short

summary of their market surveillance activity in

the light of the publication of Commission

objection against EN 143 and its related

standards within six weeks

8 7 Notified Bodies

Uniform designation of Notified

Bodies

All Provide comments to the table being distributed

among the working group’s documents

After six weeks the table to be finalised by

COMM

9 7 Notified Bodies - Horizontal

recommendation for use sheets

All

COMM

Provide comments and remarks on the

horizontal RfUs within 6 weeks

COMM to then send all comments received to

HCNB for consideration

10 7 Notified Bodies HCNB

COMM

Horizontal Committee for Notified Bodies to

submit documents on cancellation of EC-type

examination certificates to COM

COMM to distribute them. Point to be raised at

the next meeting

11 8 ADCO

Report by Chairperson

ADCO

Chair

COMM

To send categorisation proposal on ear-nose

plugs, volleyball kneepads to COMM.

COMM to have it endorsed by written

procedure.

12 9 AOB - Addition to EC Certificate

when product considerably

changed

HCNB Provide documents to COMM which will then

be distributed. Point to be raised at the next

meeting.





Meeting – 20 November 2007


Chairperson: Ms Maria SPILIOPOULOU-KAPARIA (EC ENTR/I4)

EC Participants: Mr Elöd DUDÁS, Ms Elzbieta PAPRZYCKA (ENTR/I4)



2. Approval of the draft agenda (Doc. PPE /07/1/1

FRANCE proposed to add two additional points under AOB. These were mouthguards and ear

protectors.

The Chairperson agreed with the proposal.

She informed the participants that a presentation was scheduled in the afternoon on the relationship

between the PPE Directive and the Medical Devices Directive which then would be followed by an

update on the New Approach revision.

GERMANY asked to discuss the categorisation of dry gloves for divers.

COMM informed that this subject was foreseen under item 5 – categorisation issue.

Further he explained that the UNITED KINGDOM was going to give an update on possible formal

objections (originally foreseen under item 8) under item 6 of “Follow up of action points from

meeting of 23 May 2006”.

With the modifications above the agenda was approved.

3. Approval of the minutes of meeting of May 2006 (Doc. PPE/07/1/2)

COMM informed that the Commission received comments from Germany only, which was

inserted in the text.

As there were no further comments raised the minutes was approved.

4. Follow-up of action points from meeting of 23 May 2006


COMM summarised the current state of play regarding the action points from the previous

meeting:

1) Draft PPE Guide (Approval) – The Commission as agreed waited 6 weeks for comments after

which the PPE Guide was published. He added that the last comments from Spain would be taken

up later on the day.

2) Scope of Directive Categorisation guide point 8.6 – The text agreed was sent to the

stakeholders.

3) Scope of Directive – The issue would be discussed under point 5.

4) Scope of Directive – diving equipment – as the Commission has received comments from FESI

and Spain only, all stakeholders were again invited to provide comments on the relevant document

PPE/05/1/5. The point would be followed up at the next WG meeting.

5) Standardisation – Report by UK on EN 353-1

The UNITED KINGDOM informed that in parallel with EN353-1&2 they were considering also

formal objection actions against the following harmonised European standards: EN 361:2002

Personal protective equipment against falls from height – Full body harnesses, EN 360:2002

Personal protective equipment against falls from height – Retractable type fall arresters, EN

354:2002 Personal protective equipment against falls from height – Lanyards and EN 355:2002

Personal protective equipment against falls from height – Energy absorbers.

As regards EN 353-1&2 the main concern was that this standard did not take into consideration

several foreseeable conditions of use such as fall backs or sideway falls. He also mentioned that the

investigation was triggered by a fatal accident occurred in Scotland. Nevertheless at that moment

they were still analysing data in order to determine the proper way forward.

In the meantime the UNITED KINGDOM invited the Member States to inform about their

experience/comments regarding the matter.

AUSTRIA asked whether the accident could be due to rope tiring or to a human error.

The UNITED KINGDOM replied that the exact conditions of the accident were still under

investigation.

ITALY informed that similar accidents happened in Italy and would share their information with

the UK authorities. He also mentioned that they were also checking the deficiency of the standard.

COMM asked IT to contribute with background information on similar cases.

6) Standardisation – Report by COMM on objections against EN 143:2000 – UK

COMM informed that the UK paper on how their authorities were handling the checking of EC-

type examination certificates of the concerned PPE was received by COMM and circulated to all

stakeholders.

7) Standardisation – Report by COMM on objections against EN 143:2000

COMM introduced the subject and the responses which were summarised in document no. ADCO

PPE 14-22. According to that altogether 20 responses were received by COMM, out of which 17

were from Member States. Based on the information provided it could be said that on one hand the

NB did not find non-compliant PPE (after checking those PPE already obtained an EC-type

examination certificate) and on the other hand nor did the Member States on their territory. So the

exercise could be considered successful.

FRANCE would not agree with such an interpretation as in their opinion there were still many such

products on the market.

The Chairperson asked all Member States to participate in the exercise.

8) Uniform Designation of Notified Bodies


COMM introduced the topic and recalled that this issue was discussed at several forums as well as

at the PPE ADCO meeting the day before. The issue at stake was that in the NANDO database it

was very hard to compare the competences of Notified Bodies because of the wide range of terms

used by Member States. Therefore the table in hand attempted to harmonise this description. He

also mentioned that since the previous meeting COMM had hardly received any comments on the

table.

The UNITED KINGDOM mentioned that the table was based on consensus and that could be the

reason for the “lack of comments” from the Member States.

COMM concluded that after an additional 6 weeks for comments the table would be finalised and

an official letter would be sent out on requesting the Member States to re-notify their Notified

Bodies according to the finalized table.

9) Notified Bodies - Horizontal recommendation for use sheets COMM informed that COMM received no comments on the sheets within the period for comments

so those were published on the Commission’s website, EUROPA:

http://ec.europa.eu/enterprise/mechan_equipment/ppe/nb.htm

10) Notified Bodies

COMM said that the Commission received no documents on this issue till date.

HCNB informed that the NB and the PPE ADCO (in 2006) as well discussed the situation. The

cancellation of EC-type examination certificates was not the same as withdrawal.

COMM asked the HCNB to submit relevant information to COMM so it could be distributed.

HCNB stated that information should be in the minutes of the NB Horizontal Committee meeting

and would be able to send that document.

FRANCE asked if there was a list of cancelled EC-type examination certificates?

HCNB responded there was no such list available.

GERMANY mentioned that the Directive said that if a certificate was withdrawn or cancelled,

notification was required.

COMM responded that the Directive only dealt with the withdrawn certificates.

ITALY said that in Italy the relevant authority required the same data in case of withdrawal or

cancellation of certificate.

GERMANY commented that the mentioned situation was specific for Italy.

COMM asked the representative of HCNB to provide documents to the Commission on how they

handle the issue in hand, which then would be distributed to the stakeholders. This point would be

raised at the next meeting. Nevertheless he pointed out that this issue needed to be discussed in the

ADCO first and then the outcome of that discussion could be presented in the WG.

11) ADCO report by Chairperson (on categorisation issues) – point was moved to point 5.

12) AOB – Addition to EC Certificate when product considerably changed

COMM informed that the Commission did not receive the document(s) concerning this topic.

HCNB responded that this point would be discussed at the next NB Horizontal Committee meeting

and it could be presented at next WG meeting.

COMM asked the HCNB to provide the relevant document as soon as possible. In case of receiving

that the Commission would distribute and discuss at the next WG meeting.

5. Scope of Directive

Proposal for categorisation (result of written enquiry (Doc. PPE/07/1/3, Doc. PPE/07/1/3 bis,

Doc. PPE/07/1/3 ter.

http://ec.europa.eu/enterprise/mechan_equipment/ppe/nb.htm


COMM introduced the table summarizing responses from stakeholders. He added that there were

some items already discussed for several years. Therefore it was the Commission’s intention to take

a decision regarding those on the day.

Reflective stickers

COMM mentioned that the Commission received a position paper (PPE/07/1/3ter) from CEN/TC

162/WG7/PG1 claiming that according to EN 13356 – Visibility accessories for non-professional

use - Test methods and requirements such stickers had to be either classified as Type 2 (removable

accessories) or Type 3 (mounted accessories) depending on the intended use; while recalling that

the said standard gave very restrictive conditions for the certification of these accessories.

The conclusion of the said position paper from the CEN/TC was that reflective stickers were

category 2 PPE.

FRANCE stated that it should not be PPE as it did not come under the PPE definition.

SPAIN stated nevertheless that such stickers had protective function and therefore they should be

under the scope of the PPE Directive. He added that this problem was already discussed many years

before and it was agreed that stickers were PPE.

GERMANY agreed that the subject was already discussed and said it was category 2. PPE.

SPAIN recalled that there was also the harmonised European standard EN 13356 in the field

suggesting that such stickers were PPE and following that analogy they were category 2 PPE.

The CEN-CENELEC Consultant did not agree and said that the existence of a standard did not

mean that the stickers had to be accepted as PPE. He also added that even though discussions took

place in 2005 decision was never taken.

FRANCE was wandering whether all reflective stickers should be excluded.

GERMANY coming back to the CEN-CENELEC Consultant 's opinion reminded that DE

suggested that it was not PPE while Scandinavian countries had different opinions.

FRANCE agreed with GERMANY that if decision was already taken, it should not be revised. She

also recalled that such stickers should not be PPE.

COMM mentioned that he did not find decision already taken in previous minutes and asked

GERMANY and FRANCE to send information / document to the Commission.

COMM concluded that this issue would be taken up at the next PPE WG in the light of the

information received from GERMANY and FRANCE.

Reflective key rings

SWEDEN stated that the attached picture did not show a key ring.

COMM said it seemed logical what CEN/TC 162/WG7/PG1 suggested in their position paper

according to which there was only a problem of product description rather than categorisation.

He also recalled the fact that key rings were meant to put in pockets e.g. which would rule out the

compliance of key rings with the PPE definition.

BELGIUM said she had example of key rings which did not necessary have to be attached to keys

but to the jacket and then that would improve visibility.

COMM said that it was logical to assume that the main purpose of key rings was to hold keys and

they should be considered in that context.

BELGIUM (presenting product) stated that although the product looked like a key ring, the

manufacturer indicated it had different ways of application.

COMM suggested that the manufacturer should give a different name to his product. As the

CEN/TC position paper suggested the differences between key rings and the so called dangle tags.

COMM asked the WG whether they agreed with the CEN TC´s opinion and the answer was yes.

He concluded that key rings were not PPE.

Reflective bags

COMM recalled the CEN/TC position paper saying that such reflective bags were not PPE.

As this opinion was shared by the stakeholders he concluded that reflective bags were not PPE.


Allround Patch

The WG agreed that Allround Patch was category 1 PPE.

Bike Patch

The WG agreed that Bike Patch was category 1 PPE.

Back protector backpack

FESI reminded that there could be many different backpacks and not all should automatically be

classified as category 2 PPE.

The UNITED KINGDOM said the equipment was foreseen to carry things rather than to protect

so it was not clear if it should be category 2 PPE.

GERMANY recalled that the product –under discussion– was presented in Helsinki at the PPE

ADCO meeting where there was a consensus of being category 2. PPE. He also added that it was

used by extreme bikers. For carrying things other equipment was used.

COMM asked the WG if they agreed with the outcome of the ADCO´s discussion and the answer

was yes. He concluded that the product in question was category 2 PPE. Nevertheless he added

it was important to make the difference between the wide range of backpacks, as not all was PPE.

Boxing gloves, Bag gloves

COMM introduced the topic. This issue was being dealt with since long time but no decision was

taken so far.

The WG agreed that boxing gloves were not PPE, while bag gloves –intended to protect the

wearer– were category 1. PPE.

COMM though added the possible difficulties for market surveillance authorities to make a

distinction between the two types of gloves.

FRANCE asked if the Categorisation Guide was to be updated in the light of the WG´s decisions

on categorisation.

COMM replied yes.

Ice tools (Doc. PPE/07/1/11)

COMM informed that this equipment was already decided as being not a PPE and asked FESI what

the purpose was to modify the situation and start a new discussion.

FESI explained that ice-tools were considered by mountain professionals as PPE while the PPE

Guidelines classified them as "progressing aids". According to expert members of the

standardization working group CEN/TC 136/WG 5 and also taking into account the definition of

standard EN-13089, ice tools should be category 3 PPE and the aforementioned standard should be

recognized as a harmonized standard in application of the PPE Directive.

He also insisted that while ice pitons were category 3 PPE according to 3.1 of the Categorisation

Guide; ice axes were excluded from the scope of the PPE directive – according to point 3.4 of the

said Guide – although they both served as anchor points. He added that “ice-axes” in the Guide

were the same as “ice-tools” according to EN 13089.

The CEN-consultant explained that anchorage devices remained on the shaft. Anchorage devices

were excluded from the scope of the Directive; ice axe was not PPE.

FESI recalled the fact that there were some types of anchorage devices on the market already

bearing the CE marking.

The CEN Rapporteur said that the Categorization Guide stated that ice pitons were transportable

and were category 3 PPE.

FESI recalled that ice pitons were used for climbing and speleology as anchors points and that ice

axes can be used similarly in hard snow, i.e. as anchors points. COMM wondered if there was a

translation mistake which added to the confusion.

FRANCE stated that the situation was different depending on how the equipment was placed in the

rock or ice or taking into account the shape of the shaft – curved or straight or taking into account

its function (like in the case with gloves)


The CEN-CENELEC Consultant said that the shape of the equipment did not contribute to its

categorisation.

COMM requested FESI to submit a document on explaining the differences between ice-axes, ice

pitons and ice tools so the subject could be discussed at the following meeting.

Action point 3, moved from "Follow up of action points from meeting of 23 May 2006" (Doc.

PPE/07/1/10; PPE/07/1/10bis; ADCO PPE 15-18)

Motorcycle gloves

BELGIUM stated that it was decided during the last PPE ADCO meeting that motor cycle gloves

were PPE category 2.

COMM reminded that the PPE WG was the right forum for taking decisions regarding

categorisation of PPE.

FRANCE informed that the discussion did not concern all types of motor cycle gloves but only

those which had “built in” protection that cannot be separated/detached form the glove itself. She

reminded that such gloves were considered as category 2 PPE by the PPE ADCO group on the

bases of the level of risk that provided protection against. She asked for the support of the WG to

make that decision official.

COMM asked the WG if they agreed with the outcome of the ADCO´s discussion and the answer

was yes. He concluded that motorcycles gloves with “built in” protection that cannot be

separated/detached form the glove itself were category 2 PPE. He also stated that the

Categorisation Guide was to be updated accordingly along with all the categorisation decisions

made on the day.

Double lanyards

FESI reminded that some double lanyards were homemade and in that case it was hard to ask for an

EC-type examination certificate.

COMM stated that the same requirements applied to homemade and factory made double lanyards.

FRANCE said that there were a whole range of activities that could be taken up, such as – testing

samples, etc.

COMM asked the WG if they agreed that double lanyards were category 3 PPE and the answer was

yes. He concluded that double lanyards were category 3 PPE.

Karting collar

COMM informed that FESI was asked to deliver additional information concerning karting collar

but nothing was received.

FESI responded that no new information was received from Member States.

COMM enquired whether the manufacturer was contacted for description of the product.

FRANCE informed that the manufacturer claimed they protected the wearer from physical shocks

on the karting circuits. Nevertheless there were products on the market without CE marking

contrary to their obvious function that was to provide protection against mechanical impacts such as

acceleration, deceleration and centrifugal forces on the neck.

She also added that the wearing of such karting collar was obligatory in karting competitions in

France. FR considered such collars to be category 2 PPE.

GERMANY thought that such equipment could be a medical device.

COMM emphasised that the function of a crating collar was not to heal an injury (as it was the

purpose in case of a medical device) but to protect the wearer from certain risks, as explained

before. Therefore this was not a medical device. He considered that the only question was that what

PPE category the equipment belonged to.

The CEN-CENELEC Consultant said that not only the manufacturer’s claim counted when it was

about its categorisation. It was very important to take into account of what the equipment was

meant to be used for.


COMM asked the WG if they agreed that carting collars were category 2 PPE and the answer was

yes. He concluded that karting collars were category 2 PPE and subject to EC-type examination.

Clothing against UV radiation

COMM informed that the matter was preliminary discussed at the previous PPE ADCO meeting. It

was then suggested that clothing against UV radiation could only be category 1 PPE if the

manufacturer claims it used special material during production. This was very important to

emphasize in order to avoid categorizing ordinary clothing as personal protective equipment.

The CEN-CENELEC Consultant reminded that clothing for private use should be excluded from

the scope of the Directive in any case.

FINLAND reminded that this item was tabled by their consumer agency. The product was to be

used in normal/ordinary situations.

COMM said that it was intended to provide protection against sun light and no other kinds of

radiation. He asked Finland to provide further information concerning this item so that the

discussion could be continued at the next PPE WG meeting.

6. Update on Directive 2007/47/EC- Amendment to the Medical Devices Directive (93/42/EEC)

COMM (from Unit F3 of DG Enterprise and Industry dealing with the Medical Devices Directive

93/42/EEC) presented the background of the modification of the Directive. The latest amendment

enabled products to be a medical device and a personal protective equipment at the same time.

Those were called dual used products. He also informed the WG that the interpretation of the text

was still underway.

BELGIUM pointed out the problem of conformity assessment procedures of dual use products. She

also mentioned that some devices which belonged to category 1 according to the MDD should be

classified as category 2 or 3 according to the PPE Directive.

FRANCE raised the question regarding masks that could be PPE and MDD. She asked what

criteria should be taken into consideration under which directive?

COMM explained that the text of the amendment allowed the parallel application of both

directives. This meant that the relevant requirements of both directives needed to be taken into

consideration and only the conformity assessment procedure in the MDD had to be carried out.

SPAIN argued that certification was possible according to both directives.

GERMANY recalled that according to Art 1 par 4 of the PPE Directive, it did not apply to PPE

covered by another directive designed to achieve the same objective as the PPE Directive with

regard to the placing on the market.

ITALY said that some part of the market surveillance was consolidated which was positive but

raised concern on products categorised differently according to the MD and PPE Directives. He also

added that the relevant part of the modification should be repealed.

FRANCE expressed that some products had potential users from the field of PPE or MD directives

and those products should fall under either the former or the latter directive.

BELGIUM asked if the re-categorisation of products according the Medical Devices Directive was

possible.

COMM replied that it was possible to derogate from the classification enshrined in the MDD but

such derogation required a duly substantiated request from the Member States as it was required by

Art.13 of the MDD. He also asked the stakeholders of the Group to send their comments /concerns

in writing so those could be presented at the next MDD WG meeting.

ESF expressed also concern on the different classification of dual use products.

COMM thanked for the report and concluded the topic by asking all stakeholders to send their

comments in writing to the Commission so those could be submitted to the MDD WG meeting.

7. Update on New Approach revision


COMM (Ms Birgit Weidel from Unit C1 of DG Enterprise and Industry) gave an overview on the

current situation regarding the New Approach revision. The two proposals – a Regulation and a

Decision– adopted by the Commission on 14 February 2007 were in Council and in the European

Parliament for discussion. She mentioned that there was a strong political will from all parties to

finish the legislative procedure as soon as possible, preferably during first reading.

She also added that the European Parliament was scheduled to vote on the proposals on 27

November 2007 indicating that the legislative procedure was in an advanced phase.

AUSTRIA asked what did the Regulation say about the entry into circulation and entry into

operation? What was the preparation, did it include placing into operation?

He also added that the Regulation would exist in parallel to other Community legislation and they

might had contradictions.

COMM explained that the definition "placing on the market" became more general as "making

available on the market" which now included the putting into service as well.

She also added that definition of "putting into service" was not necessarily needed even if it was

only installed at the place of the end-users.

SPAIN said that there were two drafts document, a Decision and a Regulation – and both would

apply to new directives. He asked whether that would apply to old directives and whether their

national transpositions would have to be changed accordingly.

COMM responded that the Regulation would be directly applicable in the Member States. But it

would not affect existing legislation as in the Regulation there were only elements complementing

current legislation but not interfering with them.

She also added that the Decision was a “Tool box”, a self-addressed document to the legislator that

would not be directly applicable after its adoption. So in case there was a decision taken for revising

the PPE Directive then the common elements defined in the Decision could be taken into

consideration ( e.g. definitions).

COMM assured the members of the WG that future developments of the New Approach review

would be reported to the Group.

5. Scope of Directive -part 2

Helmet for children to protect against falling

BELGIUM was not sure of the exact purpose/function of the product. Nevertheless looking at it, it

seemed to give some limited protection for the head therefore it should be PPE and not a medical

device.

SWEDEN said that if it was a PPE then it would be a basked helmet. In case of the product in

question it seemed more like a Medical Device.

The UNITED KINGDOM reminded that a similar helmet was already discussed at previous WG

meetings and decision was already taken.

NORWAY stated the product could be used not only by children but also by adults.

FRANCE said that it should be considered as PPE as it provided protection against falling from a

standing position. As regards its categorization she added that it should not belong to the same

category as e.g. helmet for cyclist. It might be considered as light anti scalping helmet, category 1

PPE?

GERMANY agreed with FRANCE.

COMM summarised that no decision could be taken yet and invited the UNITED KINGDOM to

check for the similar case in the previous minutes.

Volley pads, nose plugs, ear plugs

BELGIUM presented the result of the discussion that already took place at the previous PPE

ADCO meeting concerning volley pads, nose plugs, ear plugs.


COMM concluded that the WG agreed with the outcome of the ADCO´s discussion and decided as

follows: Volley pads were category I PPE, while nose plugs and ear plugs were not PPE.

Dry gloves for divers

COMM describing the case in a nutshell said that the Commission was inquired on the

categorisation of "dry gloves". In line with the Categorisation Guide – according to the analogy that

dry suits were category 2 PPE– the Commission have indicated to the manufacturer that his product

was category 2. PPE that needed to undergo EC-type examination. The German manufacturer

concerned acted accordingly and received an EC-type examination certificate. Nevertheless in the

meantime he discovered there were similar products on the German market without any certificates

which he claimed to create unfair competition for him.

So the Commission contacted the German market surveillance authorities who requested to discuss

the issue at the PPE WG meeting in order to get the opinion of the WG.

GERMANY said that categorisation of the components caused problems -e.g. gloves as accessories

for diving suit, which category they should belong to?

COMM reaffirmed that according to the Commission's opinion it should be category 2 PPE and

needed EC type examination.

AUSTRIA expressed that the way accessories were attached to the suit could have an influence of

their categorisation.

GERMANY said that in this situation the users joined two products by themselves. The PPE

Directive did not cover situation when elements were not joined by the manufactures but user, so it

should not be PPE.

As the rest of the WG shared the opinion of the Commission COMM concluded that dry gloves for

divers were category 2. PPE.

8. Standardisation

Update of the formal objection

CEN-CENELEC presented the report. She highlighted the CEN strategy 2010 that also influenced

the PPE sector which probably would be restructured. She added –among others– that CEN

members agreed on a document which gave guidance on how to manage claims of defective

standards when those claims related to health and safety. She also mentioned that a new version of

the Guide on information to be supplied by the manufacturer was published on the CEN webpage.

COMM asked whether the new publication of their Guide meant that its reference in the PPE

Guidelines needed to be changed. CEN-CENELEC answered there was no need to change the

reference.

COMM also asked about the reasons/confusions behind the delay on revision EN795 Protection

against fall from a height –Anchor devices.

CEN-CENELEC Consultant said that this issue was discussed with the Commission and with the

manufacturers but there was no clear solution so far.

COMM recalled that the PPE WG´s opinion was clear on it (please see PPE/05/1/2) and asked CEN to

make steps – in line with the WG´s opinion.– in order to make the progress faster.

Report by CEN Consultant (doc. PPE/07/1/4)

The CEN-CENELEC Consultant presented the report highlighting his proposal to CEN TCs to

change the wording of the heading of Annex ZA in order to allow the standards users to know of

which BHSR were considered in the standard and which were not.

SPAIN and FESI found the idea very useful and were in favour of the project.

COMM thanked for the report and reminded that although harmonised standards were very useful

tools for manufactures it was known that such standards did not necessarily covered all applicable

BHSR and it was the responsibility of the manufacturer to make sure his product fulfilled all

applicable BHSR.


Update on the latest OJEU publication

COMM informed that the new list of references of the PPE standards would be published in the

OJEU no. C 281 on 23rd November 2007.

Q&A-31 Revision of harmonised standards (doc. PPE/07/1/6)

COMM introduced the document that attempted to consolidate the previous WG´s documents on

the matter.

AUSTRIA expressed his opinion that the next step should be the adoption of the document.

SPAIN pointed out that the transitional period provided by CEN was too short.

CEN-CENELEC agreed that in some cases that might be the case and also added the CEN TCs

had the possibility to give a transitional period up to 3 years.

HCNB said that it was not the task of the Notified Bodies to take the decision about whether there

were substantial changes in the new standard. He added that in his view that was for the

standardisation bodies as they were best qualified for taking the decision about the importance of

changes in standards.

The CEN-CENELEC Consultant mentioned the importance that manufacturers had to be

involved in the process and emphasized that an Annex to the standard should say why changes were

introduced. But he recalled that there were 12 CEN TCs working with PPE which might adopt

different resolution and not indicating such changes.

FESI expressed that the lack of information concerning modifications of standards might lead to

different interpretation.

COMM asked the participants to submit comments to the Commission within 6 weeks. The issue

would be re-tabled at the next meeting.

9. Updating of PPE Guide (doc. PPE/07/1/7, doc. PPE/07/1/12, doc. PPE/07/1/13)

COMM said that a large number of comments were received from SPAIN and the CEN-CENELEC

Consultant which were not to be discussed on the day due to lack of time. Nevertheless he asked

them to introduce their comments to the WG.

Stakeholders were requested to submit comments within 6 weeks. The Commission would probably

reinitiate the Drafting Group to consider comments. After that the updated document with track

changes was to be sent to the members of the WG for final look. And then the Guide would be

published on CIRCA and on the Commission’s website EUROPA.

10. Report on Coordination of Notified Bodies – recommendation for Use Sheets (Doc.

PPE/07/1/5)

COMM thanked Mr Noetel for the report and asked Member States to encourage their Notified

Bodies to participate at the next meeting of the Horizontal Committee of Notified Bodies that took

place on 13/14 December 2007.He also asked the stakeholders to send their comments on the

recommendation of use sheets to the Commission within 6 weeks. The Commission would transmit

those to HCNB for consideration.

11. ADCO – report by Chairperson

FINLAND presented summary or the PPE ADCO meeting that took place in Helsinki. The

following points among others were discussed:

- EmarS-project and the Rapid Advice Forum (PPE ADCO 16-03);


- Market surveillance projects in Member States - antivibration gloves;

- Medical Devices directive (MDD) and PPE Directive - letter to Director General Mr Zourek

concerning contradictions between these directives;

- Problem with fall arrest equipment;

- Anchor points – problem with standard EN 795 not interpreted in the same way in all MS;

- Breathing protective mask providing protection against microorganisms;

- Chemical protective clothing;

- Chairpersonship of the PPE ADCO Group.

12 Any other business

COMM said that mouthguards and ear protectors would be discussed at the next meeting.

13. Date of next meeting

COMM proposed the 3 and 4 June 2008 as the date for the next meeting and closed the meeting.


Summary of Action Points to be followed-up at the next meeting PPE WG meeting on 3-4

June 2008 Version 26/11/2007

No. Agenda

item

Subject Action

by

Action required Document

1 4 Scope of Directive (Questions) – Categorisation of diving equipment

All Provide comments PPE/05/1/5

2 4 Standardisation – Report on EN 353-1

IT IT to contribute with background information on similar cases.

3 4 Notified Bodies Uniform designation of Notified Bodies

All COMM

Provide comments on the table. After six weeks the table to be finalised by COMM. COMM to send official request to MS to re-notify their NBs according to the finalised table.

PPE/06/1/5bis PPE/06/1/5

4 4 Notified Bodies HCNB COMM

HCNB to submit documents on cancellation of EC-type examination certificates to COMM and MS. The document to be discussed at ADCO and the conclusions of that discussion to be shared at the WG

5 4 AOB - Addition to EC Certificate when product considerably changed

HCNB Provide documents to COMM which will then be distributed. Point to be raised at the next meeting.

6 5 Scope of Directive -Proposal for categorisation –reflective stickers

FR FR to check in previous minutes whether decision was already taken.

7 5 Scope Of Directive -Ice tools

FESI FESI to submit document on explaining the differences between ice-axes, ice pitons, ice tools.

8 5 Action point 3, moved from “Follow up of action points from meeting of 23 May 2006” -Categorisation of motor cycle gloves

COMM COMM to update point 6.13 of Categorisation guide as well as other points according to decisions reached on other categorisation issues.

9 5 Action point 3, moved from “Follow up of action points from meeting of 23 May 2006” -Categorisation of clothing providing UV protection

FI FI to provide further information on the subject.

10 5 Action point 3, moved from “Follow up of action points from meeting of 23 May 2006” -Categorisation for helmet for children to protect against falling

UK UK to find decision already taken on similar equipment in previous WG´s minutes.

PPE ADCO 15-18

11 6 Update on Directive 2007/47/EC -Amendment to the Medical Devices Directive (93/42/EEC)

All All to send comments/concerns to COMM regarding the amendment of the MDD as soon as possible. MDD meeting on 13 December so preferably before that date.

12 8 Update on possible formal objections

UK UK to keep the WG and COMM informed on progress made regarding the subject.

13 8 Q&A 31 Revision of harmonised standards

HCNB CEN

Submit comments to COMM within 6 weeks. COMM to finalise

PPE/07/1/6


CEN-Consultant ESF FESI All

the paper.

14 9 Updating of PPE Guide All COMM

Submit comments within 6 weeks on Guide. COMM probably to reinitiate the Drafting Group to consider comments. COMM to send out Guide with track changes for last look. Then put the revised Guide on CIRCA.

15 10 Recommendations for Use sheets All Provide comments to COMM within 6 weeks. COMM to transmit comments to HCNB for consideration. Put sheets on Europa.

PPE/07/1/5

16 12 AOB Gum shields, hearing protectors

FR To raise issue at next PPE WG.



MINUTES OF THE PPE WORKING GROUP MEETING HELD ON 12 JUNE 2008


meeting – 12 June 2008


Chairperson: Mr Előd Ajtony DUDÁS (EC ENTR/I4)

EC Participants: Mr Joaquin CALVO BASARAN, Ms Elzbieta PAPRZYCKA (ENTR/I4)

1. Welcome by the Chairperson



FESI asked to include under AOB their comments on table 12 page 104 of the PPE Guide.

CYPRUS would like to add an additional subject under AOB: "paintball– using PPE while playing

– how to use such equipment".

ESF would add a position paper regarding the follow up of Q&A 31.

The Chairperson agreed with the proposals.


3. Approval of the minutes of the meeting of 20 November (Doc. 2007 PPE//08/1/2

FESI mentioned that there was an error on page 6 stating that "ice pitons are the same as ice axes".

In fact ice axes were the same as Ice tools he explained.

“Ice tools” was a general term which included ice axes, ice pitons, and others.

He also insisted that while ice pitons were category 3 PPE according to 3.1 of the Categorisation

Guide; ice axes were excluded from the scope of the PPE directive – according to point 3.4 of the

said Guide – although they both served as anchor points. He added that “ice-axes” in the Guide

were the same as “ice-tools” according to EN 13089.

The Chairperson agreed to correct that in the minutes.

As there were no further comments raised the minutes was approved.

GERMANY mentioned that on page 3 point 8 regarding uniform designation of NB the minutes

mentioned that an official letters were to be sent out on requesting the MS to re-notify their NB. He


also mentioned that GERMANY did not receive that letter and was interested to know when he

could expect that. to arrive.

The Chairperson informed that it would be explained under point 3 of the follow up of action

points".

4. Follow-up of action points from meeting of 20 November 2007

1. Scope of Directive (Questions) –Categorisation of diving equipment

The Chairperson introduced the topic. The table presented originally came from an Italian

manufacturer which gave a good starting point for discussion. This table was presented at previous

WG meetings and till date only FESI, SPAIN and CEN-CENELEC had commented on it. He

recalled that many – if not the majority – of the equipment in the table were already categorised and

put into the Categorisation Guide. Therefore he suggested discarding this topic and to discuss

remaining diving equipments on a case-by-case bases should there be a need in the future.

2. Standardisation – Report on EN 353-1

The Chairperson said that no new information was received regarding this subject. He recalled

that at the previous meeting ITALY mentioned that they might have some related information. So

he asked ITALY whether he was in a position to share that information with the WG.

ITALY said that they did not have any additional information till date. Though they were looking

at files but it was a slow process that was coupled with technical delays in the legal procedures. He

said that relevant information if found would be sent.

FRANCE reminded that the last time this was discussed the WG asked the UNITED KINGDOM to

send additional information regarding the correspondent safeguard clause. The information supplied

by the UNITED KINGDOM so far mainly incorporated photos that might have shown that the

equipment against the fall was not used properly.

The Chairperson responding on the request from FRANCE asked the UK delegation to merge this

point with point 12 so that they could give an update on the current state of play. The UNITED

KINGDOM agreed with the proposal.

The UNITED KINGDOM did not recall this question was raised before but he answered to

FRANCE that the equipment in question was used properly as it was worn as to manufacturer’s

recommendation. He also added that if FRANCE and other MS wished to receive further

information that would be delivered.

Regarding the formal objection he mentioned that the UNITED KINGDOM was at the process of

analysing all available data on EN 353 but there was a slight delay in that as a peer review of their

research was taken place. He added that the UK authorities contacted users and manufacturers on

finding out whether there was an appropriate test method that could be used in the interim if the

formal objection was launched. Further he asked MS to inform the UNITED KINGDOM in case

they had information on the subject and also promised to report back if progress made in the

UNITED KINGDOM on this.

ITALY said that the provision (standard) as a whole did work but emphasis needed to be put on the

personal responsibility of how the equipment was used.

The Chairperson asked the UNITED KINGDOM to give an approximate date when the final result

could be given.

The UNITED KINGDOM responded that in a few weeks time they hoped to give some

information but there were many circumstances outside their competences that could hinder the

process.

The Chairperson concluded this point saying in case information was received that would be

distributed among the stakeholders.


3. Uniform designation of Notified Bodies

The Chairperson recalled the table on the competences of NBs that was circulated among all

stakeholders for comments. That table was finalised and was going to be sent out together with a

letter on requesting the MS to re-notify their NB according to that table as agreed at the previous

WG meeting. On responding to the question that DE raised at the beginning of the meeting he

added that this latter was to be signed very soon by the Director General of DG Enterprise Mr Heinz

Zourek.

He added that meant only days in term of timescale.

SPAIN was wondering if the final version of table would contain comments sent by ES on the

previous table.

ITALY asked if it was going to be published on CIRCA.

FRANCE asked if the NANDO database which did not match the table would be changed.

The UNITED KINGDOM said that the current situation in the NANDO system was very

confusing. The list e.g. was very extensive and sometimes categorisation had duplicates. She asked

if the letter was received by MS then did they have to notify their NB according to the new table?

The “old” and new categories would exist in the system side-by-side?

The Chairperson responded that:

- all comments received were taken into account as far as it was possible,

- an electronic copy of the signed letter was to be sent to the stakeholders via the CIRCA

system;

the originally signed letters would follow that via the official channels,

- the NANDO database would be modified accordingly. A transitional period though of 6

months applied. This meant that the new and “old” categories would appear in the system

side-by-side till the end of the year. After which only the new categories would remain in

the system and the old ones would be deleted. Therefore it was the interest of all MS to do

the re-notification asap.

The Chairperson concluded the discussion and encouraged the MS to re-notify their NB according

to the new table.

4. Notified Bodies

The Chairperson said that till date no document was received by COMM. He added that this topic

–in any case–was needed to be discussed in the ADCO group first and then the result of that

discussion could be presented to the WG.

5. AOB-Addition to EC Certificate when product considerably changed

The Chairperson said that till date no document was received by COMM. This issue would be

followed up at the next meeting.

The Chairperson suggested to move to point 11

11. Amendment to the Medical Devices Directive (93/42/EEC)

The Chairperson introduced the topic. He said that the amendment to the MDD brought up the

issue of the so called “dual use” products. In particular the question was on the relevant conformity

assessment procedures that had to be applied. On this issue COMM had received comments from

SPAIN, SWEDEN, the UNITED KINGDOM and ESF, and a letter on behalf of the ADCO group

co-signed by the UNITED KINGDOM and BELGIUM. In its response to that letter COMM

reassured the ADCO Group that the relevant services of the COMM were in close contacts in order

to find a common solution that suited all. He asked Mr Bischoff-Everding (COMM DG ENTR Unit

F3) dealing with the MDD to give the WG an update on the current state of play.


Mr Bischoff-Everding informed that the problem of so the called dual use products had been

identified. The revision of the MDD was going to be implemented by 31 March 2010, after which

for medical devices that served as PPE as well (dual use products) needed to fulfil the relevant

BHSR of the PPE Directive while the relevant CAP in the MDD needed to be followed. He

understood that this might create problem for the stakeholders of the PPE sector as some of the PPE

such as masks, corrective sunglasses etc. would now fall under the MDD´s CAP. And this in many

cases entailed the change from third party testing to self-declaration by the manufacturer.

He recalled that in order to better identify the scope of the problem in practice the first step would

be to create a list of concerned products that was as exhaustive as possible.

After that the COMM would have the possibility of choice on how to proceed by either

reclassifying some devices or device families under the MDD or to specify specific conformity

assessment procedure to be applied so providing derogation from the general rules under the MDD.

He recalled though that the solution had to be proportionate so that it did not become too

burdensome for the stakeholders. He also wondered whether under the current legal regime it was

possible achieving that for the BHSRs of the PPE Directive the intervention of an NB was

maintained while those of the MDD could –just as it was before- be subject to self-declaration by

the manufacturer.

He also raised a question to the WG whether under the PPE Directive it was possible for certain

products to be reconsidered.

On the current state of play he mentioned that this problem was briefly discussed with two groups:

The Compliance and Enforcement Working Group (competent authorities of MDD of MS) and also

with WG of MDD the latter that was asked to provide a list of dual use devices. COMM also

suggested to FR to include this issue in the agenda of the forthcoming so called Competent

Authorities meeting to be taken place in July.

He recalled the importance that in the MS the competent authorities should communicate with each

other facilitating the finding of a common solution.

FRANCE was not sure whether drawing up a list of dual use products was the right move. She

considered this issue to be a matter of principles rather than identifying individual products as this

might create problems for new product in the future e.g. due to innovation etc. Secondly she

questioned that if the two Directives were on the same level then how it was possible that an

amendment to the MDD could change the PPE Directive?

ITALY supported FRANCE.

Mr Bischoff-Everding responded that it was always good to have an overview on the current state

of play on which devices or device families a measure had to be taken. In addition he needed to

explore whether a decision (on an implementing measure) under the MDD was possible only for

individual products or “principles” could be used as well. He thought – when it came to

implementing measures– COMM needed to be specific rather than speaking in general terms. But

this was something needed to be found out.

He also recalled that there was no superiority between the PPE Directive and the MDD. But there

was also the so called principle of the posterior law derogates to the previous one. The MDD was

recently modified establishing the regime that for the so called dual use products the relevant BHSR

of the PPE Directive needed to be taken into consideration while the appropriate CAP of the MDD

needed to be followed. This regime was adopted by the MS in Council and by the European

Parliament so it was not possible the easily derogate from this unless a new legislative procedure

was started.

SPAIN agreed with FRANCE – and wondered if there was a problem of coordination between DGs

of the COMM. He also questioned how that was possible that one Directive regulates another

basically.

GERMANY agreed with SPAIN and expressed his opinion that this situation was a typical case for

European Court of Justice. He feared that some took a step into the wrong direction and now it was

left to the WG to try to find a solution that in any case could not be satisfactory. He also stated that

the scope of the MDD could not have any provisions on the PPE Directive.. This situation was not

legal.


The Chairperson stated that this amendment was adopted by the co-legislators and therefore it was

legal.

ESF agreed generally the comments made previously and hoped that solving the current problem

would prevent such events in the future. He understood that the MDD stakeholders were asked to

send a list of dual use products and asked about the deadline for the PPE stakeholders on sending

such list to the COMM.

Mr Bischoff-Everding responded that it was needed as soon as possible. He added nevertheless

that as the issue seemed more severe from the PPE viewpoint he expected more prompt reply from

the PPE stakeholders.

The Chairperson concluded this point and thanked Mr Bischoff-Everding for his contribution. He

asked all stakeholders to send their lists on dual use products to COMM and to contact those who

deal with the MDD in the MS to find a common solution.

6. Scope of Directive- Proposal for categorisation –reflective stickers

The Chairperson thanked FRANCE for checking the previous minutes for any decisions on the

issue. FR´s research discovered that in 2002 and 2003 this topic was discussed but there was never a

decision taken. Summarising the subject he recalled that this subject had been discussed for many

years without reaching an agreement and it was time to find a solution that could be applied

throughout the EU.

The situation was confusing as it was obvious that the scope of the PPE Directive determined the

range of equipment that fall under the Directive’s provisions but the fact could not be ignored that a

harmonised European standard EN 13356 – Visibility accessories for non-professional use - Test

methods and requirements was developed to give presumption of conformity to the corresponding BHSR of

the PPE Directive. The reference of this standard was being published in the OJEU since 21

December 2001 and so far no one has raised any objections against it. Since then manufacturers

used this standard to attest compliance with the PPE Directive and put the CE marking on their

products. During the years progress was not made therefore it was time to act.

He proposed to consider reflective stickers as category II. PPE if until 30 September 2008 no

objection is submitted against the aforementioned standard.

FRANCE said that it was possible to consider reflective stickers being not PPE without questioning

the aforementioned standard. EN 13356 dealt with high visibility accessories such as wrist bands

which were really PPE. She recalled that FR position had not changed and such reflective stickers

were not PPE.

The Chairperson recalled the position paper submitted by CEN TC162/WG7 with the reference

number

PPE/07/1/3ter. This document stated that reflective stickers “in EN13356 have to be classified as

Type 2 (removable accessories) or Type 3 (mounted accessories) depending on the intended use “

The CEN-CENELEC Consultant did not consider reflective labels as PPE. They could be if they

were put on something else The Directive applied to personal protective equipment and not to parts

of PPE. Standard EN 471 – high visibility clothing - applied to the whole clothing as a whole with

its reflective parts. So if reflective stickers were decided to be PPE then the same situation could

apply to reflective parts that one could attach to any clothing/garments. And although (EN 13356)

was a harmonised standard that did not mean that the product in question was a PPE.

The Chairperson recalled that no one had complained about the standard while it was being

developed and even after its publication. And that caused the confusion. It seemed that people were

buying such products because they saw the CE marking on them so they considered them to be safe

ones which satisfied the requirements of the Directive.

FRANCE said that no arguments were given why the equipment was decided to be PPE.

The Chairperson asked the participants to express their opinion on the issue now.

The UNITED KINGDOM said that they did not consider them as PPE in line what they had

expressed at the previous meeting, but to be sure they wanted to check for their previous position.

SWEDEN suggested to do the “roll call” in writing.


The UNITED KINGDOM supported SWEDEN.

GERMANY said that it was decided during the meeting in 2003 that this equipment was PPE

category 2.

The Chairperson asked GERMANY to give the reference of the document which stated that the

PPE WG decided on this issue.

GERMANY could not give the reference unfortunately. He said that we had the list that said what a

PPE was and what that needed to fulfil, the user needed to recognise if it was working as a PPE or

not but that was not the actual case here. If one decided that reflective stickers were PPE, then there

was no need to decide on its category as it was definitely category II PPE. In 2003 the Group did

not say it was category II PPE but agreed to work in that way. There were many such products on

the market with EC-type examination certificate.

The Chairperson responded that this was a crucial element of the situation. Because till date there

were products with and –also- without CE marking on the market. That was why a clarification was

needed.

NORWAY added that at the last meeting the WG reached a conclusion on this issue on the bases of

the summarising table (PPE/07/1/3) that COMM sent out for comments.

The Chairperson explained that the mentioned table contained several products with reflective

material but no conclusion was reached on reflective stickers.

SWEDEN quoted from page 4 of the minutes of the previous meeting (PPE/08/1/2): “The

conclusion of the said position paper from CEN/TC was that reflective stickers were category 2

PPE.”

The Chairperson answered that that conclusion was the CEN TC´s and not the PPE WG´s.

FRANCE suggested that as the standard was 7 years old then maybe there was no need to launch a

formal objection but a revision could be carried out in order to avoid confusion.

The Chairperson thanked FRANCE for the idea but expressed doubts whether amending a

standard was a faster process than launching the formal objection.

SPAIN said that they would be against raising an objection as the standard fulfilled the essential

safety requirements of the Directive. On could not raise an objection against the standard because of

the scope of that standard. That would imply that the equipment referred to in the standard did not

fulfil the essential health and safety requirements of the Directive. The standard could not be

objected on saying that some equipment was not covered by the Directive. One could though object

a standard on the bases that it did not fulfil the BHSR of the Directive. But for that there was a need

for launching a safeguard clause first.

The Chairperson summarised the statement made by ES according to which the way forward was

to modify the standard itself or at least the scope of the standard as the standard functioned well.

SPAIN agreed.

GERMANY wanted to clarify divisions of competences. Remind that New Approach Directives

were based on the fact that when the details of the fulfilment of the directive were established then

Standard Committees were setup, which had the competence to discuss these details and they

involved all the European standards organisations to bring them together to come up with the

consensus. The Standing Committee of the Directive did not have the competences to say whether

the standard should be changed. In case of reflective stickers the WG received a clear positions

from CEN TC 162 according to which the competent people considered them to be PPE. If however

the WG was on a different opinion then a formal objection was needed to come up with the decision

in the PPE WG to change the standard.

The CEN-CENELEC Consultant agreed with GERMANY that the Technical Committees were

the responsible ones for modifying the standards. But the standard on the reflective stickers did not

fulfil the BHSR of the Directive. BHSR 2.13 –PPE in the form of clothing capable of signalling the

user´s presence visually stated that “…clothing intended…”. Reflective stickers were not garments

or clothing. So they did not fulfil the BHRS of the PPE Directive. With regard to formal objections

he reminded that there were examples on standards that were published in the OJEU and although

no formal objection was launched against those, the Commission had established limits to their


application. For example EN 420 on the Chrome content and EN 795. So yes the COMM could

object to a standard if it felt that the standard did not fulfil the BHSR of the Directive.

The Chairperson responded that in case of both standards the decision was not taken by the

Commission but the 98/34/EC Committee consisting of representative of the Member States and the

Commission. That formed a part of a legal procedure on how to manage warnings to be published in

the OJEU or how to remove references of standards from there.

FESI asked that who had the competence of publishing the harmonised standards?

The Chairperson responded it was COMM who published the references of harmonised standards

(in the OJEU).

FESI tried to understand that if by the complication of the harmonised standards COMM verified

that it gave presumption of conformity to the BHSR of the Directive then could that not be a way to

say that COMM verified that the standard in question did not give presumption of conformity to the

BHSR of the Directive.

The Chairperson summarised the corresponding procedure according to which CEN sent the list of

references of harmonised standards to COMM for publication in the OJEU. If there was no

objection then COMM sent that for publication.

SWEDEN mentioned that this issue was something similar that had been discussed regarding

motorcycles´ equipment and thought that it was up to the manufacturer to decide to put the CE

marking or not on the product and he decided whether his product gave protection or not.

The Chairperson recalled that in case of the motorcycles gloves FR brought even samples where

the WG could see that –even though –the manufacturer did not claim that it gave protection to the

user, looking at it one could tell that it was intended to give protection to the wearer due to its built

in reinforced protective parts.

He concluded the discussion asking the participants to consult their experts and lawyers in order to

submit a solution to the problem. That could take many forms such as a formal objection against the

standard or parts of it or recommendations for a warning in the OJEU etc. by the end of September

2008.He also added that in case of lack of intervention by stakeholders by that time it was taken that

reflective stickers were category II PPE.

7. Scope Of Directive – Ice tools

The Chairperson proposed to merge point 5 of the agenda submitted by the UNITED KINGDOM

with this item but point 5 was cancelled on the suggestion of the UNITED KINGDOM.

As regards Ice tools he mentioned that on making some inquiries it seemed that this issue was

discussed before and even though a final decision was not taken the general understanding of the

matter was the following: Ice axes meant to help progressing (so called progressing aides) were not

considered as PPE while if those could be used as an anchorage point (being able to stop the fall of

the climber) then those were category 3 PPE. He was not though sure if there were Ice tools on the

market that could be used for both purposes.

The CEN-CENELEC Consultant said that the corresponding standard was evaluated by him

personally and the comment he made was that such equipment could not be considered as PPE

because in case those were used as an anchorage point in no case those would be able to guarantee

the protection of the user. He added that he had a video at his disposal showing how such devices

were used which supported his opinion.

FESI said that they also had a video at their disposal. He also explained that using an ice tool as an

anchor point the individual did not hold it but was attached to it. One held it when wanted to make

progress and then dig it to the snow when wanted to use as an anchor device. And this latter

situation made ice tools category 3 PPE. He expressed his interest to view the video that the CEN-

CENELEC Consultant had just referred to.

The Chairperson concluded that this issue would be followed up at the next meeting. Till that the

Commission would check the minutes of the previous minutes on whether this issue had been

already discussed. He also asked FESI to check whether the two videos were the same or not.


8. Categorisation of motor cycle gloves

The Chairperson considered this action to be fulfilled as the suggested modifications were put into

the PPE Guide. The additional comments submitted by FR would be discussed later on the day.

9. Categorisation of clothing providing UV protection

The Chairperson recalled the discussion from the previous meeting and asked FI if it had any

additional information on the matter.

FINLAND informed that this subject was raised by the Finnish Consumer Authorities and as no

new information had been received till date from them she asked the topic to be postponed until the

next meeting.


10. Categorisation for helmet for children to protect against falling

The Chairperson described the product which was a soft helmet with big holes on the upper part.

He reminded that the task of the WG was to decide whether this was a PPE or not. He wished to

thank the UNITED KINGDOM for checking the previous minutes on whether this issue had been

already discussed or not. The UNITED KINGDOM found that a decision was already taken in 2001

on a similar helmet but that looked differently and had more substantial design.

The UNITED KINGDOM said that the helmet which was discussed in 2001 in the PPE WG was a

more substantial design and was viewed as a category 2 PPE. She agreed with the Chairperson that

the helmet being discussed and the one from 2001 could not be compared to each other as the two

were different designs.

FRANCE said it was necessary to make a distinction between light helmets (such as the one on the

table) and hard helmets used during mountaineering or cycling. If the former was used then it might

protected against light risks –for example children when falling over a furniture - in which case it

could be considered as category 1 PPE.

GERMANY agreed with FRANCE that it might protect against minor impacts.

The Chairperson did not agree that the risks involved could be called as “minor risks”. He recalled

that the intended purpose of the helmet was to protect the child while falling on his head. And

looking at the helmet it did not seem to give adequate protection against such risk.

The CEN-CENELEC Consultant said that the question was not whether this helmet was a PPE or

not but rather helmets protecting children were PPE or not. And if so then they needed to fulfil the

BHSR of the Directive depending on the application. Otherwise every time the WG came across a

new helmet then a decision was needed. So the first question was to answer: should helmets for

children to be considered as PPE and if so what were the applicable BHSR for those helmets in line

with the risks involved.

The Chairperson wondered if the equipment could be called as a helmet at all with so many open

spaces.

The UNITED KINGDOM agreed with COMM, referring to the helmet discussed in 2001 which

had a softer outer coating material but it also had a harder shell within that coating without holes so

it could not be said that the two helmets offered the same degree of protection.

SWEDEN did not consider that the question was of being helmets for children or not as children

could use any helmets for riding or cycling etc. So the issue really was not to decide on the

requirements per age but to determine the kind of risks the helmet was supposed to protect from.

The Chairperson shared this opinion and asked to focus on the product in hand and not to broaden

up the discussion and make generalisations. He also understood the pros expressed by DE and FR

saying that the product might be a category 1 PPE but then the WG might conclude that it was a

non-compliant PPE.

He asked the WG whether it agreed to consider this product as a category 1 PPE against minor

impacts. As the WG agreed he went further asking whether it was a compliant PPE or not. The WG


agreed that considering its design it could not fulfil the relevant BHSR of the PPE Directive

therefore it was concluded that this soft helmet was considered to be a non-complying category 1

PPE.

Second part: after the lunch break

The Chairperson informed the WG that CYPRUS indicated it would provide a document for the

next meeting on the paintball issue so the subject would be dealt with then. He also added that the

point on the comments from the ADCO Chairperson would be discussed after finishing the follow

up of action points.

13 Q&A 31 Revision of harmonised standards

The Chairperson recalled that at the previous meeting COMM presented a new compromise paper

trying to offer a solution to the issue. At that meeting COMM asked in particular CEN-CENELEC,

HCNB, ESF and least but not last all stakeholders to comment on it. Comments were received from

HCNB, the CEN-CENELEC Consultant and ESF. He recalled the bottom line on which all agreed

that the overall responsibility stayed with the manufacturer. The manufacturer was responsible to

make sure that his product fulfilled the BHSR of the Directive. He added though that in this system

there were other players also, such as the standardisers creating the technical specifications to the

BHSR i.e. the standards and also the NBs who did the testing for category 2 and 3 PPE. From the

comments received one could tell that there was a need that CEN took more responsibility for the

amendments it prepared for standards.

The paper on Q&A 31 was not finalised on one hand because there was no agreement on the way

forward and on the other hand as this was a horizontal issue so it required a horizontal solution. He

said that the ATEX27 Committee was near finalising a solution to the issue and COMM therefore

suggested presenting a new consideration paper that took into account the papers produced in the

PPE WG and the ones in the ATEX Committee.

The CEN-CENELEC Consultant asked why CEN had more responsibility while a standard

changed as CEN worked according to the mandate given by the Commission.

The Chairperson answered that the reason was a generally felt sentiment saying the experts in the

TCs elaborating standards were the best placed in terms of technical knowledge to determine

whether a given modification to a standard was substantial or not.

The CEN-CENELEC Consultant agreed with COMM but highlighted that standards were not

revised because someone wanted them to be changed but because the verification processes or

technology had progressed or some of the BHSR were not taken into account in the previous

version. And that would mean that all the changes were substantial ones. Since almost a year now in

all revisions of standards that had been published had an annex with information on the changes so

manufacturers, Notified Bodies and market surveillance authorities knew about those changes.

The Chairperson reminded that apart from the revisions standards were amended from time to

time. This was the nature of the “beast” that standards evolved. Those amendments were in focus of

this discussion.

ESF draw the attention to a problem on certification of products based on old versions of standards.

He underlined that the problem was quite common and important because the same product could

be admissible in one country and be blocked in other which caused legal problems.

The Chairperson agreed and reminded that this topic was already discussed at previous meetings.

He recalled that a product did not become immediately non-compliant due to the fact that it was

certified according to a superseded standard. The important factor was the changes that the latest

27 Directive 94/9/EC of 23 March 1994 on the approximation of the laws of the Member States concerning equipment

and protective systems intended for use in potentially Explosive Atmospheres


edition of the standard brought, whether that was a substantial progress in terms of the state-of-art

that had important implications on the safety characteristics of the product or not.

The application of harmonised standard was one of the possibilities to attest the compliance of a

product to the requirements of the Directive. The manufacturer was free to choose any other

technical specifications he wished to use. The bottom line was that the product had to meet all the

relevant BHSR of the Directive in order to be placed on the market. He added though that the

manufacturer had in his best interest to use the latest version of a given harmonised standard in

order to benefit from the presumption of conformity.

ESF asked it to be underlined in the minutes that good practice was that the manufacturer complied

with the latest version of a standard but that was not legally binding.

14. Updating of PPE Guide PPE/01/1/11

The Chairperson wished to thank the members of the Editorial Group for their great work. As

agreed at the last meeting the Guide was presented today with “track changes” so all stakeholders

could see what the changes made were. The Chairperson also informed that additional comments

had been received from FR, ES, BG, and FESI which were to be discussed later on the day. The

Guide would be published after the discussion on the EUROPA website.

Doc PPE/08/1/7

1st Comment - article 5,6 a) - not discussed as the problem concerned the borderline between the

PPE Directive and MD Directive. As discussed earlier COMM with MS worked together to find a

common solution.–This point would be followed up.

2nd Comment - Article8,4 a) 3rd paragraph - agreed

3rd Comment - Article8,4 a) 6th paragraph - agreed

4th Comment – Article 10,5 2nd paragraph - not agreed. -text leaved unchanged.

The Chairperson reminded that this issue was discussed at previous meetings and when the new

Guide was written it was decided that the time limitation of EC type-examination certificate was

left on the contractual relationship made between the NB and its customer. He suggested therefore

leaving the Guide as it was.

SPAIN asked for clarification on why there was a need for such an agreement between the

manufacturer and the NB as the only way on time limiting certificates. She considered that an NB

could itself impose time limitations of it wanted. SPAIN did not remember for discussing this

before.

HCNB agreed with ES in the sense that the NB was allowed to put a time limit on the certificate,

even if an official agreement was not in place.

But in practice when a manufacturer made an application to an NB for an EC type examination

certificate, then that NB informed the manufacturer what it was going to contain. So there was a de

facto agreement with the manufacturer. In practise NB discussed this issue with the manufacturer.

Therefore she said that the text was OK for the NB.

ESF agreed with the NB that in fact there was a contractual agreement between the manufacturer

and the NB. And potential limitation could be a part of that. So if the manufacturer did not agree

with the terms then he could go to another NB. That was true the other way around as well. What

ESF would not wish to see was that if the text changed and the NB started to change the terms of

collaboration on existing certificates. So he suggested leaving the text as it was.

The Chairperson asked SPAIN if agreed to leave the text as it was. ES agreed so the proposal was

rejected.

5th Comment – Annex II 3.1.2.2 1st paragraph – not agreed -text leaved unchanged.


The Chairperson informed that there was a Commission Communication28 from 12.02.2000 which

stated that "The reference to European standards:

EN 1496 – Rescue equipment – rescue devices;

EN 1497 - Rescue equipment – rescue harnesses;

EN 1498 - Rescue equipment – rescue loops; will not be published it the Official Journal of the

European Communities pursuant to Directive 89/686/EEC. They do not therefore give rise to a

presumption of conformity to the provisions of that Directive.”

Taking this Communication into account he suggested to leave the “rescue systems “out of the

discussion and asked the stakeholders if they agreed to incorporate the other elements of the ES

comment into the Guide.

HCNB had some concerns on changing the text as she considered that the elements being discussed

were already in the text. As Chair of CEN TC 160 she did not have problems with the existing text

but feared to have one if it was changed.

The UNITED KINGDOM agreed with the NB. He wanted to make a distinction between

preventing falls and arresting falls. He added that preventing falls could only be a lanyard with a

waist-belt which might not require a full body harness while a fall arrest equipment is meant to

minimise the fall. He added it was worth looking at the Temporary work at height Directive29 that

made references to some of the issues under discussion.

GERMANY reminded that work positioning equipment was already decided as not PPE.

The CEN-CENELEC Consultant recalled that there was as a discussion on the equipment of

which DE was referring to but was not convinced that there was also a decision taken. With regards

to the ES comments and in particular the rescue equipments he stated that those could not be

regarded as PPE as they were excluded from the scope of the Directive.

FRANCE was confused as during the discussion the terms of “fall prevention systems” and “fall

arrest systems” were used as synonyms. She thought that the discussion was about “safeguard

systems or rescue systems”. She said that these equipment were not considered as PPE but could

not recall the exact grounds for that.

The Chairperson asked GERMANY to check the minutes for previously taken decision on work

positioning equipment and suggested this issue to be followed up at next WG meeting.

He also added that until the situation was clarified, the text would remain unchanged.

6th Comment – Appendix Table 2.6 and 2.8

Not discussed for the following reasons:

The Chairperson agreed with SPAIN to reconsider the exceptions but as the problem concerned

the borderline between the PPE Directive and MD Directive he suggested to wait for the outcome of

the discussion on the implications of the new modification to the MD Directive. Therefore this point

would not be discussed on the day but be followed up.

7th Comment – Appendix Table 3.2 – not agreed -text leaved unchanged.

The Chairperson agreed with SPAIN that it was a repetition but thought that it did not make any

harm. On the contrary the more it was emphasised the better it was. As no objection was raised the

text was left unchanged.

8th Comment – Appendix Table pg. 91- agreed

The Chairperson reminded that the Commission had published a Warning30 in the OJEU

concerning EN 795 saying that the following clauses of the standard did not give presumption of

conformity for anchor devices of category A, C, and D. The problem arose that the aforementioned

Warning was not interpreted the same way in all MS. The Warning implied that the excluded

categories were not PPE.

28 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2000:040:0009:0009:EN:PDF

29 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:195:0046:0049:EN:PDF

30 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2000:040:0007:0007:EN:PDF

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2000:040:0009:0009:EN:PDF

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:195:0046:0049:EN:PDF



He also added that the FR delegation also submitted comments on this very point but their approach

was different. While ES wanted to have the exact exclusion to be incorporated into the Guide the

FR proposed to refer to those that were PPE.

ESF suggested avoiding quoting the exact reference number of the standard. He also added that the

revision of EN 795 was in progress so referring to the exact reference number might entail of

revising the PPE Guide again once that standard’s revision was finished.

SPAIN thought that the problem was related to the different interpretation of the warning therefore

she insisted to put the exact reference number into the PPE Guide as that would prevent the

differences in the interpretation.

The Chairperson recalled that the PPE Guide was meant to be a living document therefore even if

the reference number of the standard was quoted in the PPE Guide that could be modified

accordingly at the time the revision of EN 795 was finished.

HCNB recalled that the Warning was about withdrawing the presumption of conformity from those

product categories that were referred to it. But, she added that it did not say whether those products

were in the scope of the Directive or not.

The Chairperson recalled that there was a reason why the PPE WG agreed on the Commission’s

Warning back in 2000 and also emphasised that in 2005 this WG also adopted an interpretation

document saying that all such equipment that were permanently fixed to a structure were outside the

scope of the PPE Directive. He added that looking at the categories referred to in the Commission’s

Warning those corresponded to those lines.

HCNB recalled that the problem was on defining the dividing line of what was PPE and what was

not. She added that this would be clarified in the new version of EN 795. She also added that a

solution could be what FR suggested but feared that quoting the exact reference number of the

standard went beyond the current state of discussion.

FESI supported the French wording.

The Chairperson understood the pros and cons but reminded that this general description could

lead to misinterpretation again that was in a need to be avoided. He suggested to insert the ES

comments into the PPE Guide and to look at this issue again when the revision of standard EN 795

was finished.

ESF asked if there was a procedure for revision of the Guide.

The Chairperson answered that there was no such a procedure. But as it was stated before it was a

living document so it could be updated anytime so the WG considered it necessary.

The Chairperson asked the WG if there was objection against the ES comments. As there was no

such objection the Chairperson concluded that the comments made by ES would be introduced into

the Guide.

9th Comment – Appendix Table 6.5 pg. 95 - agreed

The Chairperson had informed that according to experts on the field the effects of infective agents

were as severe as the ones of chemical agents but as Article 8) 4. of the PPE Directive did not refer

to infective agents such protecting clothing should be category 2.

As no objections were raised it was concluded that “clothing protecting against infective agents

used by other than the armed forces were category 2 PPE and would be as such incorporated into

the Guide.

10th Comment – Appendix – not decided

The Chairperson asked SPAIN to clarify their comment and present that at the next meeting.

Doc PPE/08/1/8

1st comment – page 14 – concerning the MD directive.

The Chairperson asked FRANCE to clarify their comment.

FRANCE said that the way the Guide was written might suggested that the links between the PPE

and MD Directives had been settled which was not the case here. So as this issue was still being

discussed that should be somehow reflected in the Guide.


The Chairperson explained that the intention of the text was to inform stakeholders that such

modification was taken place that would have an effect on "dual use products". He suggested

adding a sentence for better clarifying the situation as:” However please take note that this

amendment will become applicable as of 21 March 2010.”

He also added that in the meantime –just as it was mentioned during the morning session – all was

invited, in particular the MS and their colleagues working on the MDD field to find a common

solution that was acceptable for all stakeholders.

2nd comment – page 88 - agreed

3rd comment – pg. 91, point3.1 not agreed as solution already found during discussing the ES

comments.

4th comment – pg. 91, point 3.5 –discussion postponed till the next meeting and FR and FESI were

invited to give more information and bring photos on the product. This issue would be followed up

at the next meeting.

5th comment – pg. 95, point 6.1 – discussion postponed till the next meeting and FESI was invited

to give more information and bring photos on the product. This issue would be followed up at the

next meeting.

6th comment – pg. 96, point 6.13 - agreed

7th comment – pg. 105, point 13.3 – decision postponed –would be followed up at the next meeting.

FRANCE said this comment was submitted on explaining why the equipment mentioned there was

not PPE. (Because it required the user’s intervention to function) As it was the case with airbags in

the event of an avalanche. This was discussed approximately two years ago.

The CEN-CENELEC Consultant did not agree and said that the fact of whether the user had to

operate the equipment to function or not did not determine its classification. If this reasoning was

accepted then the WG would exclude for example all lifejackets from the scope of the Directive.

FRANCE explained that the decision on excluding such equipment was on the bases that such

protection was not automatic. In case the WG wanted to change that FR was not against it but it was

important to be coherent with the decisions made in the WG.

The Chairperson concluded by putting down an action point to COMM to check the previous

minutes whether there was a decision already taken on this issue. This will be followed up at the

next PPE WG meeting.

8th comment – pg. 106, point 14.4. –agreed.

Doc PPE/08/1/9 -agreed

Doc PPE/08/1/

FESI p.104 table 12

Point 12.3 – agreed Point 12.5 did not agree as Article 8) 3. referred to “gloves and light footwear.”

FESI 12.6 new - did not agree The Chairperson proposed to formulate a sentence together with FESI.

15 Recommendations for Use sheets

The Chairperson informed that the RfUs were circulated among the stakeholders. Only one

participant, the CEN-consultant sent his comments. Those were forwarded to the HCNB. In case the

HCNB sent the updated RfUs to COMM those would be published on the EUROPA website.

16 Gum shields, hearing protectors – done -issues placed on the agenda under point 7 and 8.

With this the follow up of action points from the meeting of 20 November 2007 was concluded.

The Chairperson asked to move to point 11 on the agenda.


11. PPE ADCO –comments from chairperson

The UNITED KINGDOM informed that during the last PPE ADCO meeting on 19 of November

2007 the UNITED KINGDOM and BELGIUM had volunteered to take the chairpersonship for the

ADCO Group 2008. But in the meantime due to unexpected circumstances that was no longer

viable. She emphasised the fact that the UNITED KINGDOM had undertaken this important task

already several times recently and only volunteered to do so again for the sake of continuation of

this cooperation. Nevertheless due to lack of resources they could not do it this time and in addition

the person in charge of the file at the BE authorities changed also position. Therefore she wanted to

raise this issue now in order to find a Chair for the ADCO Group.

The Chairperson thanked the UNITED KINGDOM for their efforts and underlined the importance

of ADCO Group. He raised the question to the MS if there was one MS willing to take this task.

GERMANY suggested that the rotation of chairpersonship should follow the Presidency order of

the Council.

FRANCE informed that they were willing to Chair the ADCO Group during the FR Presidency in

the Council in case the COMM could provide the necessary facilities. As this task was not foreseen

for them for 2008.

The Chairperson recalled that the ADCO Group already had a rule on who should take the next

chairpersonship of the ADCO Group. He also added that COMM would try to provide the room

with interpretation in November but that was also subject to a decision outside Unit I4´s

competences.

FRANCE agreed to be the chairperson for the ADCO Group upon the condition that COMM

provided the meeting room.

The Chairperson asked the MSs to try to sort out this continuous problem of being the next Chair

for the ADCO Group.

6. Update on New Approach revision

The Chairperson introduced the topic. He mentioned that the proposals were subject to the so

called co-decision procedure according to which the European Parliament and the Council acted as

co-legislators. The proposals were adapted by the Parliament on 21.02.2008 and were supposed to

be adapted by the Council on 23.07.2008. At the moment COMM was looking at the issue on

determining the appropriate way forward. That included on deciding on the possible need to amend

the sectoral directives including the PPE Directive. There were several options on the table

including carrying out modifications separately or together with other Directives, the latter that was

called “Omnibus” approach.

FRANCE said that there was a need to revise the Directive as in the NLF there were several

important elements that were in a need to be reflected in the PPE Directive, E.g. requirements for

the NB, definitions of economic operators and also the accreditation procedure etc. He understood

that Unit I4 of DG Enterprise was in charge of many New Approach Directives and therefore there

was a need for a common approach but reminded that this topic was lengthy discussed in the PPE

WG that had ended in a rather unsatisfactory way. He urged COMM to overcome any obstacles

against the revision of the Directive.

The Chairperson responded that he was aware of the previously ongoing then stopped Directive’s

revision process and emphasised that it was not the intention to sit and do nothing about this issue.

He said that COMM wanted to be perfectly prepared in case the revision process was re-initiated as

COMM wanted to avoid of jumping into the middle of that exercise without previously determining

the limits within that task could be carried out. So to say to avoid opening up Pandora’s Box and to

make sure that only those elements of the Directive were modified that were really in the need to do

so. Therefore he asked for a little more patience from the stakeholders and promised to provide

further information at the forthcoming meeting.


7. Mouthguards (Doc. PPE/08/1/3, Doc. PPE/08/1/3bis)

FRANCE informed that mouthguards were used during sports activities in order to protect the

wearer from risks by impact in the mouth or teeth. There were various types of mouthguards:

Standard ones ready to wear, involving high risks as those could be stuck in the airways. The

second type was adaptable ones, which either the user or a dentist could adapt and a third one that

was created after the dentist took a print. This latter considered to be the best.

The issue was that the corresponding draft standard prEN15712 at current stage did not offer the

adequate protection to the user. She emphasised that in case the standard was adopted without

changes then FRANCE would consider launching a formal objection against it.

The group that had looked at the draft contacted the French authorities to tell that they had received

a 4 year funding to do research onto the issue as that was quite a complex one. She added that this

was good news but in the meantime measures were needed to be taken as NB and the manufacturers

did not know how to certify such products. So she suggested that in the meantime the NB reach an

agreement on how to deal with this issue with a harmonised manner.

The Chairperson asked the HCNB whether that issue could be discussed at the forthcoming

HCNB meeting in October.

HCNB said it was possible bringing this issue up at their next meeting. The problem was

nevertheless that it was left to the NB to find a solution even though people said that it was done by

the standardisers. In case the standardisers were having a problem on finding a solution for this

issue and there was a need for a substantial research then she said it was not viable to expect the NB

to come up with a solution within 3 months time.

The Chairperson suggested to follow this issue up at the next PPE WG meeting and asked the NB

to report back on any possible outcome of their discussion made at their October meeting.

8. Hearing protectors (Doc. PPE/08/1/4, Doc. PPE/08/1/4bis)

FRANCE introduced the topic. Laboratory tests or the levels of reducing tests were largely

overestimated in comparison to real life situations. During tests the personnel using these equipment

were trained personnel while in real life that was not always the case. E.g. during work such

equipment moved and the user did not necessarily realise that to put them back in place or even if

they realised it they did not always can do that. Therefore there was a need to add correction factors

to reduce/adjust the reduction levels, to correct the difference and also to have a better look at the

standard to better reflect real-life situation. There were standards in the US and Australia for

example that better reflected the real life situation so it should not be a problem to change the

standards in question.

But in the meantime – as FRANCE already suggested it in about 2 years ago– correction factors

should be added for example 5 dB for headbands, 10 dB for earplugs and 7 dB for headbands

mounted on a helmet.

The Chairperson asked if these remarks were presented to CEN TC 159 dealing with hearing

protectors?

FRANCE did not have all the details of the standard so she could not respond surely but she

thought that this issue should have been discussed there –as Mr Alan Mayer (previous PPE CEN

Sector Forum rapporteur) was interested in this topic.

The CEN-CENELEC Consultant in principle agreed with FR. Hearing protectors were not used

by trained people, but people were trained to use them. The manufacturer had to indicate how the

equipment was to be used and the user had to be trained beforehand. He agreed with the proposal if

that was to be realised somehow in the legislations related to working conditions. But he

emphasised that standards were not a place to include correction points because it did not leave to


anything as there were many different situations to use/wear these equipment. Therefore real life

situation was not always possible to achieve in a test laboratory.

GERMANY informed that CEN TC 159 decided not to change the standard. Talking about trained

people, he recalled that the training –in the standard- had nothing to do with wearing these

equipment but of those people who was trained in audio sciences.

He recalled that the Use Directives had a role to play as it was the employers´ obligation to choose

the appropriate PPE for the employees.

FRANCE wanted to underline that the main concern was that the tests were carried out in

unrealistic situations and should be changed to reflect the reality. This was supported by various

scientific studies done recently on this field.

The Chairperson summarised the situation and asked FR to contact CEN TC 159 and to inform the

WG on any progress.

9 Standardisation

Report by CEN Secretariat

The CEN-CENELEC Consultant said that 56 standards were under development. In addition the

current PPE CEN Sector Forum rapporteur Mr Alain Mayer was retiring therefore a call had been

launched for finding the next rapporteur. Also guidance had been given to the medical devices TCs

in case of “dual use” products.

The Chairperson asked if there was a deadline on finding the substitute of Mr Mayer.

The CEN-CENELEC Consultant said that there was no deadline. In the past CEN provided the

PPE secretariat but CEN could not provide that in the future therefore CEN tried to find a national

body or other organisation who was willing to do that.

Report by CEN Consultant (Doc. PPE/08/1/6)

The CEN-CENELEC Consultant emphasised that a long standing problem still existed: One

could not tell whether a given standard covered all relevant BHSR of the PPE Directive or not.

Manufacturers did not know when using a harmonised standard if that meant to really meet all

requirements of the Directive or not.

Contexts of harmonised standards (Doc. PPE/08/1/5, Doc. PPE/08/1/5bis)

The Chairperson skipped this topic due to lack of time and introduced an action point to be taken

up at the forthcoming PPE WG meeting.

10. Report on Coordination of Notified Bodies

Recommendations for Use Sheets

The Chairperson said that RfUs were not received.

HCNB said that RfUs would arrive soon to COMM.

ESF underlined the need to have the vertical RfUs published on EUROPA web site as well.

The Chairperson summarised the situation and asked HCNB to send RfUs from previous meeting

to COMM for publication on EUROPA.

Update on latest OJEU publication Oral report – the issue was skipped due to lack of time.

12. Any other business – no issue was raised.



The Chairperson said that possible dates would be in November 2008. He added that more

detailed information would be circulated as soon as possible. By closing the meeting he wished to

thank the work of the participants as well as the interpreter’s and wished everybody a pleasant

journey home.


Summary of Action Points to be followed-up at the next meeting PPE WG meeting on

November 2008 Version 20/06/2008

No. Agenda

item

Subject Action

by


1 3 Approval of minutes of the meeting of 20 November 2007

FESI Provide corrections PPE/08/1/2

2 4 Notified Bodies HCNB

COMM

HCNB to submit documents on cancellation of EC-type examination certificates to COMM and MS. The document to be discussed at ADCO and the conclusions of that discussion to be shared at the WG

3 4 Standardisation – Report on EN 353-1

IT IT to contribute with background information on similar cases. Point to be raised at the next meeting.

4 4 AOB - Addition to EC Certificate when product considerably changed

HCNB Provide documents to COMM which will then be distributed. Point to be raised at the next meeting.

5 4 Scope of Directive - Proposal for categorisation – reflective stickers

ALL Send comments/ observations to COMM regarding the relevant standard (EN13356). If no objection/suggestion arrives till end of September 2008, then Reflective Stickers are considered PPE Cat. 2.

6 4 Scope Of Directive -Ice tools

FESI

COMM

To check video on how to use Ice-tools. To check minutes on possible decision made on the categorisation of Ice tools.

PPE/07/1/11 PPE/08/1/10 PPE/08/1/10bis

7 4 Categorisation of clothing providing UV protection

FI FI to provide further information on the subject.

8 4 Update on Directive 2007/47/EC -Amendment to the Medical Devices Directive (93/42/EEC)

All To send list of dual use products to COMM. List to be presented at next MD WG meeting on 4 July.

9 4 Update on possible formal objections including EN 353-1

UK To send additional information to COMM. COMM to distribute that among the WG members.

10 4 Q&A 31 Revision of harmonised standards

COMM

COMM

To prepare new discussion paper to be presented at next PPE WG. To annex email to the minutes made between COMM and ESF on modification of standards.

PPE/07/1/6 PPE/08/1/12 PPE/081/13

11 4 Updating of PPE Guide COMM To make the agreed changes in the Guide and then publish it on EUROPA asap.

12 4 Updating of PPE Guide FESI COMM

To formulate proposal to be sent to WG members on table 12 of Categorisation Guide. (Regarding equipment that is to enhance comfort, was not PPE.) Deadline for comments end of September.

13 4 Updating of PPE Guide FR FESI

To bring photos on specific type of equipment (harnesses) used by

PPE/08/1/8


paragliders. (Concerns page 91, point 3.5)

14 4 Updating of PPE Guide FESI To provide additional info/photos on clothing with “air bag for motorcyclists or horse riders”. (Concerns page 95, point 6.1)

PPE/08/1/8

15 4 Updating of PPE Guide DE To check if there was a decision already taken on work positioning equipment.

PPE/08/1/7

16 4 Updating of PPE Guide All Reconsider exceptions in Guide regarding PPE and MDD.

PPE/08/1/7 Ongoing

17 4 Updating of PPE Guide ES To clarify comment on categorisation based on “high temperature environments…” (Regarding Appendix)

PPE/08/1/7

18 4 Recommendations for use sheets HCNB To send RfUs from previous meeting to COMM for publication on EUROPA

19 7 Mouth guards HCNB

FR

To report on outcome of discussion made at HCNB To update the Group on progress

20 8 Hearing protectors FR To update the Group on progress

21 9 Contexts of harmonised standards COMM To put it on the next meeting’s agenda

PPE/08/1/5 PPE/08/15bis

22 12 AOB CY To send document on paint ball for discussion at next WG meeting








EC Participants: Mr Joaquin CALVO BASARAN, Mr Mario GABRIELLI COSSELLU

(ENTR/I4), Ms Maureen LOGGHE (ENTR I/2)



2. Approval of the draft agenda (Doc. PPE/08/2 /1)

The Chairperson explained that several items have been added to the agenda that were:

A formal objection from GERMANY regarding EN ISO 4869:4:2000 -ear muffs;

A formal objection from the UNITED KINGDOM regarding EN 353-1 - fall arresters;

Request from FRANCE on borderline cases between the Toys and the PPE Directive.

FESI asked to give its presentation on clothing for motorcycles riders with airbags in the morning

session.

FRANCE asked to add the topic of visibility aides on clothing. FRANCE also mentioned that they

had some samples with them to show.

The Chairperson explained that this issue was already preliminary discussed at the ADCO meeting

the day before, where it was agreed to put this item on the WG´s agenda in the AOB part. In case it

was not possible to discuss that on the day – due to time limitations – then this topic would be sent

out to the stakeholders for written consultation. He explained that details of that would be given

when the issue was discussed.


3.Approval of the minutes of the meeting of 12 June 2008 (/PPE/08/2/2)

The minutes was approved without modifications.


4. Update on New Approach revision (New legal framework for marketing products/NLF) –

implications (oral report)

The Chairperson introduced the topic highlighting the importance of the issue. The revision

process of NLF has been finalised with a result of a Decision31 and a Regulation32 that would have

an impact on the PPE field.

A Tentative time-table was shown to the stakeholders setting out the timeline for the revision of the

PPE Directive. The revision process started as of from now with the following explanation: The

essence of the revision included two main elements:

1) The alignment of the Directive with the above referred to Decision;

2) Examination – and possible amendment – of some of those elements of the Directive that were

not covered by the aforementioned Decision. The Commission’s intention was to keep this exercise

as simple as possible and to focus on those areas that were in the very need to be modified.

All Commission proposals needed to be accompanied by an impact assessment in order to assess

any possible impacts to the concerned field. The first step was therefore to have an impact

assessment study carried out to examine the social, environmental and economic impacts of the

proposal. (The economic part also covered any possible impacts on the small and medium sized

enterprises)

As the impact assessment study examined possible scenarios /options, The Chairperson asked the

stakeholders sending to COMM those areas where they saw problems in the Directive with an

explanation why there was a problem and possible solutions to solve that/those issue(s).

These draft options should contain three categories: (1) no change of certain elements, (2) urgent to

be modified in the Directive, (3) “wish list” –useful to change, but not urgent.

These draft options would be the basis determining on what the impact assessment study should

cover. In order to facilitate this work the COMM intention was to create an Editorial Group(EG) to

consider all the draft option sent by the stakeholders until end of January. This Group would be

selected by the COMM and be convened, possible at the end of March 2009. The COMM paid

careful attention that all stakeholders were represented in this Group. In any case the work of the

Group would be presented at the next PPE WG meeting in May/June 2009, where all other

stakeholder would have the possibility to have their voice heard.

In parallel to that work, and prior to the EG meeting the COMM would trace back on what

happened in the past in terms of revision of the PPE Directive and would have a deep look at the

latest documents produced during that process. That was coupled with the analysis of the Decision

of the NLF.

The UNITED KINGDOM said that the latest documents on the revision of the Directive

represented the common positions reached in the WG, after having discussed this topic many times.

Therefore she asked COMM to circulate those documents to the stakeholders in order to avoid

starting this process all over.

COMM responded that it was possible that not all elements were still adequate in those documents

but promised to go through them to check their content.

FESI supported the UNITED KINGDOM. They also raised a question regarding the composition

of the Editorial Group.

SPAIN asked whether there were any elements in the Directive that was not to be changed in the

Directive according to COMM. Such as the BHSR?

31 Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework

for the marketing of products, and repealing Council Decision 93/465/EEC

32 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the

requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation

(EEC) No 339/93


The Chairperson responding to FESI said that on the analogy of the editorial group for the PPE

Guide, COMM would invite experts from the WG to participate in the Editorial Group’s work, but

emphasised that COMM was paying attention to keep the balance between the representatives in the

WG.

COMM emphasised that the key element of this process was the consultation with stakeholders in

order to try to achieve consensus on every item regarding the matter.

The Chairperson answering ES said that as discussed in the ADCO Group the day before two

examples were given: 1) the question of the modules in the Directive, on which the Chairperson

said that the WG was on “safe grounds” as the Decision contained an updated modules decision.

Therefore choosing the most appropriate one for the Directive did not seem to be a complex task.

As for the BHSR of the Directive, as ES mentioned, COMM did not have the intention to amend it.

COMM did not want to open up the whole Directive for modification; the purpose of the exercise

was to modify some elements of the Directive where problems exist. As for the BHSR no problems

were raised till date.

AUSTRIA asked about the categories and in particular category 1 and 3 of the Directive. These

categories were too rigid, therefore the question was whether it was also an option to have the

possibility to make these more flexible and to be able to change them e.g. via comitology.

The Chairperson responded that the there was a reason why the Directive was created “rigid” on

this aspect which should be kept. Legal certainty required that those categories were not to be

changed frequently but only when it was justified.

ITALY supported the UNITED KINGDOM to use the previous documents produced as basis for

the revision exercise and emphasised to focus only those PPE elements that were important to

stakeholders.

COMM said that this was the purpose of the revision, to improve the Directive where it was

necessary and at the same time to align with the Decision in order to bring better regulation and

simplification. The impact assessment study was a step towards making sure that any changes

introduced during the revision process is carefully thought of.

CEN-CENELEC recalled that any changes could have major changes on the standardisation

system.

5. Update on amendment to the Medical Devices Directive (93/42/EEC)

The Chairperson said that this issue was discussed in June, where COMM asked the stakeholders

to send a list on possible “dual use” products in order to see the range of the issue. So far ESF and

POLAND have responded to this request. In addition, COMM asked the Member States to inform

their colleagues dealing with the Medical Devices Directive (MDD) about this topic. In July 2008,

there was a meeting of the Competent Authorities dealing with the said Directive, where two

Member States took the floor expressing opposite opinions. (One was in favour and the other was

against the modification in question.) He stressed the importance of Member States making contact

with their MDD colleague as the forthcoming Competent Authorities meeting was scheduled on 8-9

December 2008. This topic was tabled on the agenda of this meeting.

Under the MDD it was possible to derogate from the current classification of products. In order to

do that one Member State needed to submit a duly substantiated request. He added that that

Member State was already found but in order to reach any change, the other Member States needed

to support that.

Further he said that at the last meeting of the coordination of Notified Bodies he learnt the

misunderstanding that the new MDD could be applied voluntarily as of the middle of 2009. He

stressed that after having had this checked with the colleagues dealing with the said Directive it was

important to recall that there was no such a possibility and the Directive clearly stated that it needed

to be applied unanimously as of 2010.

FRANCE said that the authorities dealing with the PPE and MD Directives have sent a letter to

COMM on this issue and were still waiting for the answer.


In principle, the French authorities did not agree with the content of the COMM interpretative

document regarding the latest amendment to the Medical Devices Directive and in particular the

issue of dual use products. The FR authorities did not know on what elements the said interpretative

document was based upon. In addition it was the contrary of normal ways of proceeding: The Blue

Guide stated that in case a product fell under the scope of two directives then both CAPs were to be

applied. In the new text for the amendment to the MDD there was no provision stating that

otherwise. She emphasised that the COMM interpretative document was not an act from the

legislator which was significant from a legal point of view. In her opinion it was important for

COMM to decide on a solution that was legally viable in order to avoid risks for the safety and

health of users.

The Chairperson responded that the interpretative document on the EUROPA website was created

by COMM and in particular the colleagues dealing with the MDD in order to help stakeholders to

better understand the new provisions of the amendment to the MDD. COMM understood that this

caused a problem for the PPE field only as, so far there were no complaints received form the MDD

stakeholders. Therefore he asked again all stakeholders to contact the MDD experts they knew to let

them know about the problems. Unit I4 in the meantime was in close contact with the Unit dealing

with the MDD for looking at other possible solutions.

FRANCE said this issue was not only related to individual protective equipment.

This issue created a legal problem. Legally speaking there was no hierarchy between the PPE and

the Medical Devices Directive. What happened if in the near future the PPE WG decided to change

the PPE Directive saying that some products (that used to fall under the MDD) now go under the

PPE Directive? How was it possible that a Directive or its interpretation change the scope of

another Directive without going to the European Parliament and Council? This was a general legal

problem that was not only related to the PPE Directive. FRANCE did not want to see a precedent

created.

COMM replied that this issue was not new. For example there was already the border line case

between the Machinery Directive and the Low Voltage Directive. COMM said it took due note of

the comments and would pass them on to the colleagues dealing with the Medical Devices Directive

in the spirit of trying to find a common solution.

GREECE supported FRANCE. He also asked the COMM whether it was possible to get a copy of

the answer that COMM was going to send in response to the French letter.

COMM said that if FRANCE agreed then COMM would send a copy of its answer to other

stakeholders in the WG as well.

ITALY asked this issue to be recorded in the minutes.

The Chairperson concluded asking stakeholders to contact their MDD experts to let them know

about this issue, while a copy of any reply to the French letter would be circulated via the CIRCA

system. (The latter of course depended on the Unit of DG ENTR dealing with the MDD.)

6. Update of PPE Guidelines –minor changes

The Chairperson said that the relevant paper contained minor (mainly editorial) changes to the

PPE Guidelines and suggested to go to the next point of the agenda.

7. Follow up of action points from meeting of 12 June 2008

No 1. – Approval of minutes of the meeting of 20 November 2007 The Chairperson wished to thank FESI for their contribution. With that this point was fulfilled.

No.2. – Notified Bodies The Chairperson said that it was already agreed this issue was for the PPE ADCO Group and it

was needed to be discussed there first. The result of that could be presented in the WG. As the


relevant document was received late it was not possible to discuss it the day before therefore he

asked the can be presidency (FR) of the ADCO Group to schedule this topic for the next ADCO

Group meeting.

Action point –this issue to be discussed at ADCO and then in the WG.

No.3.– Standardisation – Report on EN 353-1 The Chairperson said that so far no information received from IT. Therefore he suggested deleting

this action point while asking IT to submit any relevant information to COMM when they had that.

AUSTRIA asked to discuss the relevant UK formal objection here.

The Chairperson suggested continuing with the action points as there was already a section

devoted to the formal objections.

No.4.– AOB – Addition to EC Certificate when product considerably changed The Chairperson said that the requested document was received from the HCNB and he asked

their representative to introduce the topic.

HCNB said the document was a summary of the topic and she suggested discussing it together with

another topic on the agenda, Q&A 31.


No.5.–Scope of Directive Proposal for categorisation – reflective stickers The Chairperson explained the topic. This issue had been discussed without making progress for

many years. Therefore at the last PPE WG meeting COMM asked the stakeholders to submit their

suggestions to COMM on the issue and in particular regarding the standard EN 13356 – that

incorporated such items – giving presumption of conformity to the Directive. He recalled that there

was also a COMM inquiry regarding this topic before where the majority of the stakeholders

responded considered reflective stickers as category 2 PPE. In the meantime COMM received two

additional comments from POLAND and SWEDEN also suggesting such stickers as being category

2 PPE. The Chairperson understood that not all stakeholders agreed with this opinion but he

emphasised that uniform application of the Directive was crucial. He also added that close to the

meeting room, one could go to the shops and buy reflective stickers with and without the CE

marking. Therefore he suggested closing this topic with the consideration that reflective stickers

were category 2 PPE. COMM would update the PPE Guide accordingly.

Action point: COMM to update the Categorisation Guide accordingly.

No.6. –Scope of Directive Ice tools

The Chairperson explained that COMM received a video form the CEN-CENELEC Consultant on

the application of ice tools, while FESI was also believed to have a video at its disposal on the same

issue. The Chairperson believed that the two videos were the same however. FESI asked for

postponing the discussion as their expert was not available on the day.

Action point: COMM to put this item on the next WG´s agenda and FESI to invite their expert at

the next PPE WG meeting.

No.7. Categorisation of clothing providing UV protection

The Chairperson said that this issue was originally raised by FINLAND. It was always said that

this issue needed to be addressed with caution in order not to end up categorising ordinary clothing

as PPE. And even though FINLAND suggested to drop this topic, in the meantime POLAND

submitted a presentation on UV protecting clothing.

POLAND explained their experience on testing textile fabrics protecting against UV radiation,

which can be found in document PPE/08/2/3. In his opinion a single t-shirt provided also protection

against the sun, but in some cases additional protection was needed of which clothing could be

considered as PPE.


The Chairperson said the purpose of this presentation was to show that products claiming

additional protection against UV radiation existed so at one point the WG should deal with them.

FRANCE wanted to know whether the standard EN 13758-1 referred to in the Polish presentation

was harmonised under the PPE Directive. Further she raised concern over the safety of such

clothing as many of these equipment contained nano particles / nano materials. Therefore she asked

POLAND how those nano particles were evaluated, whether POLAND was aware of any safety

issue attributed to nano particles in these clothing? In addition she understood that these garments

gave additional protection against UV radiation, therefore she would like to get more information

regarding that extra feature/protection of the garment. What did make such garments “special”

compared to ordinary clothing?

POLAND responded that the EN 13758-1 was not harmonised under the PPE Directive. He added

that usually textile fabrics provided protection against UV radiation but in there institute they were

developing new materials with extra protection against UV radiation by adding UV absorbers to the

fabrics. He added that the testing of this equipment was simple by using spectro-photometric

methods to calculate how much of UV radiation is transmitted to the skin.

The Chairperson said it appeared that such clothing had e.g. an additional layer inserted in order to

give additional protection against UV radiation.

POLAND answered that this textile gave additional protection.

The CEN-CENELEC Consultant said the UV protection was envisaged by WG 2 of CEN TC 162

dealing with protecting clothing. Regarding the standard that was mentioned in the PL presentation

he said it was a measuring standard for measuring the penetration of UV rays. This allowed to

determine the degree of protection the garment provided. It was not a problem including it into an

existing standard that took into account UV exposure risk but for the time being there was no

procedure for measuring this kind of protection. He said that sooner or later the standard needed to

be dealt with and probably to be harmonised with the Directive. Nevertheless to date the EN was

not harmonised.

BELGIUM said that she recently received a letter from an Organisation against cancer raising the

same question that the WG was discussing here. There were 4 brands that claim UV protection,

which were mainly websites on clothing for children, sailors, mountaineering and workers.

The Chairperson said it would be interested to see the range of this issue. That was why he asked

the stakeholders to check this issue and report on it at the next PPE WG.

SWEDEN said that swimming suits for children claiming UV protection were already on the

market.

FRANCE said that it was not the market that determined the scope of the Directive.

She emphasised the importance to proceed with due care in order not to mix ordinary clothing –

which also offered protection against sunlight– with such clothing that provided additional

protection against UV radiation.

The Chairperson agreed with FRANCE to proceed with caution as he did not wish either mixing

up ordinary clothing with protecting ones. He also shared the thought on the scope of the Directive

as it was evident that it was not the market determining the scope of the Directive. Nevertheless he

considered it useful – in order to better understand the topic – to check what was happening on the

market.

Action point: All to send information to COMM on protecting clothing for professional use.

(Within 6 weeks) No.8. Update on Directive 2007/47/EC – Amendment to the Medical Devices Directive (93/42/EEC)

The Chairperson explained that as this topic was already discussed this morning. He only wished

to thank ESF for its contribution of the list of dual use products that was sent to the Commission as

requested.

No.9. Update on possible formal objections including EN 353-1 The Chairperson recalled that this topic was going to be discussed under agenda point 10 –

Standardisation.


No.10 Q&A 31 -Revision of harmonised standards The Chairperson introduced the topic. The main issue was that what happened if a harmonised

standard was modified, and what were the implications of those changes? Who decided about the

gravity of those changes? I.e. whether those were substantial ones or not that changed the state of

art? This entailed the issue of what happened with the PPE that was manufactured according to an

“old”, superseded standard.

During the last meeting this issue was debated, the CEN-CENELEC Consultant indicated that CEN

attached an annex to the revised version of the standards indicating the changes the new standards

contained. This was a very welcome development but this did not solve the issue for standards not

being revised but modified for any reasons.

So the main issue remained on the question of responsibilities the different stakeholders bear. A

welcome development was that the members of the ATEX Committee had come to an agreement on

this issue, and the COMM desk officer for the ATEX Directive was going to present that

compromise to the WG.

COMM emphasised that this issue was a sensitive, horizontal one. At the end of their discussions

in the Committee they have agreed to slightly modify the ATEX Guidelines, point 10.3 related to

EC type-examination certificates and responsibilities of stakeholders33. The main issue was to better

clarify the responsibilities for the different stakeholders, while bearing in mind that the final and

overall responsibility for the compliance of the products stayed with the manufacturer. Nevertheless

there were other stakeholders in the field such as the standardisers, creating European standards and

Notified Bodies, testing and certifying products. In the Committee it was agreed that in case of the

revision of a standard superseding another old one shall indicate the substantiality of changes that it

contained. I.e. whether the changes in the new standard are significant with regard to change the

state of art or not. This of course had an implication on certificates issued according to the “old”

superseded standard. Therefore the Notified Bodies and the manufacturer should communicate to

one to another in case of a revised standard. COMM emphasised that even though only the

Directive was legally binding they wished to give strong guidance to the stakeholders on this issue,

which hopefully was to be followed by them. So to sum up on one hand there was the manufacturer,

placing products on the market and being responsible for those compliances, but on the other hand

there were the standardisers creating standards giving presumption of conformity and Notified

Bodies certifying products. All three play an important role in the system.

The Chairperson explained that the ATEX paper and the one elaborated by the PPE WG were very

similar. The only major difference was that in the document adopted by the ATEX Committee the

standardisers and in particular the Technical Committees of CEN were asked to indicate clearly

whether the changes in the new standard represented a change of the art or not.

The CEN-CENELEC Consultant recalled that at the last meeting it was already mentioned that

revised standards should have an annex on the changes. The only problem with regard to the ATEX

document was on what was meant by “significant” change? In CEN there were two procedures:

amending or revising a standard. In both cases, the amendments, whether it meant the change in the

conditions to satisfy he BHSR or whether it referred to the introduction of certain elements to

satisfy theses BHSR, that were not satisfied in the previous versions were significant.

Regarding Q&A 31, he reminded that CEN could not be given all responsibility as there were other

stakeholders in the field to play.

CEN supported the Consultant. The revised standards already contained an annex on the changes

the new standards contained; however it was not possible in all cases to envisage whether a change

was significant or not.

The Chairperson understood that it was a difficult task to carry out. He also emphasised that the

intention was not to push all responsibilities to CEN, but at the moment stakeholders were pointing

at each other and there were no clear indication on who should do what.

33 see http://ec.europa.eu/enterprise/atex/guide/chapten.htm

http://ec.europa.eu/enterprise/atex/guide/chapten.htm


It was also true that the CEN Technical Committees (TCs) consisting of independent technical

experts had the technical knowledge determining on the gravity of the changes.

FESI said that it was important to have a definition of "substantial change", which was the key to

resolve this issue.

COMM agreed with the CEN-CENELEC Consultant on saying that in case of a revised standard,

the changes were already indicated in the new version of the standard. But as the representative of

FESI has just explained the key was to determine, whether those changes were substantial ones or

not. In his opinion "substantial change" was a change that had a clear effect on the levels of safety

of the product; the levels that could guarantee the safety and protection of the user. And the

determination of such levels of safety is entrusted in the greatest experts participating in

standardisation, where the representatives of industry and Members States can take part also.

SPAIN wanted to recall that it was the manufactures’ responsibility to update their product in order

to make sure that it was and stayed in compliance with the Directive. The standardisers could give

some guidance in terms of issuance of a new standard but also the notified bodies had a role to play

by informing their client on such technical issues.

FRANCE Reminded that the authorities had also a role to play along with the manufacturers,

standardisers and Notified Bodies, in terms of market surveillance and of withdrawing non-

compliant products.

ESF underlined the amount of responsibilities for standardisers, and said that every change in

standards could be considered as relevant, but not necessarily with regard to safety. He said that the

main challenge was to make sure that all TCs in CEN applied in the same way of any related

decision of the WG, taking into consideration that a large number of TC's was involved in PPE

sector.

COMM responding to the French question said that the overall responsibility rest with the

manufacturer as it was defined in the Directive. He also agreed with the thought the Member States

had a responsibility here was well, as they had to carry out effective market surveillance activity.

GERMANY reminded to make sure that the provisions laid down in the ATEX paper were in

compliant with the NLF. He expressed the need for some general assurance on obligations, also for

market surveillance procedures.

COMM said that the document meant to guide stakeholders but did not create any obligations.

However he recalled that this interpretation did not contradict the New Approach, neither the NLF.

The Chairperson suggested not to take an immediate decision, but to give the opportunity to all

WG member to express their opinion in 6 weeks.

Action point: All to send comments within 6 weeks regarding this issue. No.11 Updating of PPE Guide

Done

No.12 Updating of PPE Guide

Done

No.13 Updating of PPE Guide -paragliders

The Chairperson invited FRANCE to introduce the topic as they have submitted documents on the

subject.

FRANCE said that the subject was to update the relevant section of the PPE Guide, which currently

said that paragliders´ harness was not PPE as it was not a fall arrester. They agreed with that but

there were on the market harnesses called “saddle” as well which were supposed to protect during

take-off and landing. They had reinforcements for absorbing shock energy. So FRANCE wanted to

have such harnesses to be PPE category 2. (This additional protection was also claimed by the

manufacturers as well)

The Chairperson recalled that the reasoning why parachutes or paragliding were not considered as

PPE was that they were not used to protect against falls from height instead they were used for


sports activity. Ha said there might be some similarities with the motorcycles clothing that was

discussed earlier on the day.

GERMANY said that products that required the intervention of the user in order to give protection

were decided not to be PPEs. However this was not the case with the motorcyclists´ garments as

their protection was triggered by the fall. It would be useful to know how the product worked

exactly.

FRANCE said there was certain harnesses equipment with foam all around it sufficient to absorb

the shock. But she could not give further information on triggering. She tended to agree with DE

that the protection needed to be “there” regardless of any action by the user. But that did not remove

the question on airbags that actively protected the user.

The Chairperson suggested creating an action point for FRANCE.

Action point: FRANCE to provide further information on this topic at the next PPE WG meeting.

The Chairperson said that from the last meeting there was one relevant action point overlooked. It

concerned the issue of whether PPE that automatically provided protection was only PPE or the

ones that needed the intervention of the user first as well. This issue was discussed several times in

200334 and 200435 without a decision reached; and even though it seemed that there was a general

agreement, a decision from this WG was needed. Therefore the error that has been in the meantime

introduced in the PPE Guidelines would be deleted. (It concerned point 13.4 of the Categorisation

Guide)

Action point: All to send opinions on what should be considered PPE? (Automatic vs. manually

activated products)

No.14 Updating of PPE Guide –clothing with airbag for motorcyclists or horse riders

FESI projected their presentation. The presentation focused on clothing for motorcyclist as they

were not able to gather information on clothing for horse riders. The structure of the presentation

was the following:

State of the art;

What products were available on the market;

o Airbag is incorporated in the helmets /or in the jackets.

Purpose of the products;

o To reduce the severity of the injuries caused by impact due to a motorcycle accident.

Functioning of the products –from a technical standpoint;

o The main components of the system consist of an airbag, a gas generator and an

activation system. The gas is pumped in the airbag to provide a “cushion” in case of an

accident. The gas generator is activated either mechanically or electronically.

Proposal for PPE classification.

o FESI proposed this equipment to be category 2 PPE.

The Chairperson thanked FESI for the presentation which gave an overview also on the products

available on the market. He also recalled that according to Annex I to the PPE Directive helmets

and visors intended for users of two or three wheeled motor vehicles were excluded from the scope

of the PPE Directive. Therefore he asked the participants to limit their interventions to the clothing

issue only.

FRANCE said that there were certain jackets for horse riders similar to the ones for the

motorcyclists. The principle was the same: The jacket was linked with a cord to the saddle and in

34 2003-06-10/11

35 2004-01-13/14 and 2004-09-29/30


case the rider fell of the horse, the cord activated the gas filling up the airbag in order to protect the

rider.

In addition there were some types of harnesses for (para)gliders that incorporate airbag also. In case

of landing the seat that contained the airbag activated. She proposed to categorise these seats as

category 2 PPE to be consistent.

The Chairperson considered useful to see again the products on the market and also invited FR to

bring further information to the next WG meeting regarding the above mentioned harnesses for

gliders. With this he asked the stakeholders to focus on the clothing issue and raised the question

whether the WG agreed that such clothing incorporating airbag was category 2 PPE.

ITALY agreed with the proposal but had another question for FESI: What was the category for the

helmets incorporating airbags?

The Chairperson responded that according to Annex 1 they were not PPE even if they incorporate

airbags.

GERMANY agreed with FESI´s proposal.

CZECH REPUBLIC considered such equipment prevented fatal consequences therefore it should

be category 3.

The Chairperson said that in the Directive there was an exclusive list for category 3 PPE and such

equipment was not among them. In addition, the WG already decided that motorcyclist’s garments

/clothing incorporating protectors were category 2 PPE. So for the above reasons category 3 was not

an option for this equipment. Therefore he asked the WG whether they agreed with the FESI´s

proposal, i.e. motorcyclist’s clothing incorporating airbags were category 2 PPE.

The WG concluded that motorcyclist’s clothing incorporating airbags were category 2 PPE.

Action point: COMM to modify the Categorisation Guide accordingly. No.15 Updating of PPE Guide –work positioning equipment

GERMANY said that at the last WG meeting the WG discussed an example of “pole climbers” and

some Member States were of the opinion that that was a PPE. (They served to climb electricity

pylons and helped to stay in position while the user did some work on the top of the pole.)

Nevertheless it was clearly stated on page 16 of the minutes of the meeting on 5-6 December 2002

that pole climbers were not PPE. The reasoning was that such products were designed to climb the

pole and to reach the top and not to prevent falling.

The Chairperson thanked GERMANY for finding this in the minutes and said this position would

be again recorded in the minutes.

No.16 Updating of PPE Guide –exceptions in the Guide regarding PPE and MDD

The Chairperson said that this issue was related to the topic on the relationship between the PPED

and the MDD which was why this issue would not be dealt with today, waiting on the outcome of

the former issue. No.17. Updating of PPE Guide – categorisation based on high temperature environments

The Chairperson asked SPAIN to send further explanation on the subject.

Action point: ES to send further explanation on the subject to COMM. No.18. Recommendation of use sheets

The Chairperson said that the publication of the latest RfUs were in progress. No. 19 Mouth-guards.

HCNB said that at their last horizontal meeting this issue could not be discussed as there was no

NB participating in the meeting certifying mouth guards. Therefore they had to contact individual

NB, but that was a slow process.

FRANCE said that at the moment there was no standard regarding such products. A standard was

being developed but this process would take a long time and a lot of research was needed. Therefore


FR said – at the last meeting where this issue was discussed – that it was desirable for NBs to come

to a common agreement on how to certify such products in the meantime.

HCNB it was also difficult for NBs to deal with this subject from scratch. They would consult their

relevant NBs to find out on how those bodies deal with this issue.

CEN-CENELEC said would check and report at next meeting on any progress made regarding the

subject.

Action point: HCNB to report to COMM on how relevant NBs deal with this issue.

Action point: CEN-CENELEC to report at next meeting on any progress made regarding the

subject No. 20 Hearing protectors

The Chairperson said that the issue of hearing protectors was already preliminary discussed earlier

on the day36 in relation to the German formal objection and invited FRANCE to further comment on

the subject.

FRANCE said that the hearing protectors´ issue went further than the German formal objection

because they under estimate protections afforded by these earmuffs. This issue was discussed at

several forums but it seemed that discussion at European level was stuck. Therefore in France the

French Authorities was organising consultations with industry so that workers should be aware of

the problem in order to put some pressure on standardisers to change the situation.

The Chairperson said that at the last meeting the WG was informed by CEN TC 159 that the

relevant French proposal was considered and then rejected.

The CEN-CENELEC Consultant responded that during the last two CEN TC 159 meeting there

was no representative from FR participating in the meeting.

CEN-CENELEC supported the Consultant and encouraged FRANCE to participate in the TC´s

work in order to present their proposal there.

The Chairperson encouraged FRANCE to participate in that work and concluded creating the

following action point:

Action point: FRANCE to report on any progress made regarding the subject at the next PPE WG. No. 21 Contexts of harmonised standards

Done

No. 22 AOB

Done

8. PPE for paintball

CYPRUS gave a presentation including categorisation of certain type of PPE. He emphasised that

the content of it was not a market surveillance exercise, but a topic that had recently emerged in

their labour department. Paint ball had become more and more popular in recent years and

CYPRUS had discovered that PPE was or was not used during this activity. Therefore CYPRUS

asked the WG whether the participants had also come across this issue; had any accidents in the

field and how they dealt with those.

GERMANY supported the classification suggested in CYPRUS´ presentation. Another problem

was what already CYPRUS mentioned that some simply did not wear protective clothing but that

could not be resolved here.

36 The DE formal objection was discussed before this item on the day, but in the minutes the items appear as indicated

on the agenda for better clarity.


AUSTRIA had a question regarding sport shoes. He said that sport shoes were excluded from the

scope of the Directive so that was a deviation from the PPE Guide.

CYPRUS responded that they had considered such shoes as belonging to point 8.6 of the

Categorisation Guide and therefore being category 1 PPE.

FESI raised the question regarding neck protectors categorised by CY as category 2 PPE. He said

that though point 6.1 of the Categorisation Guide dealt with protecting clothing used for sports

activity as being category 2 PPE, but there was also point 6.8 on clothing and accessories for sport

activities saying such equipment was category 1 PPE. So he was wondering whether neck

protectors shown in the CYPRUS presentation rather belonged to point 6.8. instead.

FRANCE raised the question whether the impact of a blow could be considered as superficial. In

her opinion the answer was no, which justified it to be category 2 PPE.

CYPRUS agreed with FRANCE. Such bullets travelled with a speed of 10 meter/second which

itself indicated the seriousness of its impact on the human neck.

FESI said he was not drawing conclusions but thinking aloud instead. Nevertheless he agreed with

the proposed categorisation class.

The Chairperson thanked CYPRUS for the presentation and closed the discussion.

9. Borderline between the PPE and the Toys Directive

The Chairperson asked FRANCE to introduce the subject.

FRANCE said this issue was discussed several times but there was no clear position reached so far.

The French authorities was approached by a manufacturer that was planning to place a product on

the market that was a reversible vest, which on one side had high visibility stripes while the other

side was a toy. So the question arose whether a single product could fall under the scope of both

Directives. During an internal consultation within the French administration they had concluded

that was not possible for the following reasons:

PPE designed to protect people whereas Toys were planned to play. The product referred to above

was a classic high visibility vest, which if turned outside contained a gripping material with a

kangaroo pocket that contained darts that could be thrown at the vest which then would stick into

the gripping material. This however could not meet, both Directives requirements and in particular

PPE BHSR 1.2.1. Absence of risks and other “inherent” factors of nuisance effect. The foreseeable

condition of use was the key since the vest was reversible, if done was a Toy, when this protecting

function could be altered. The efficiency of protection depended on the vigilance of the wearer

which was against the spirit of the PPE Directive.

Further, since it was reversible, it encouraged the wearer and in particular the children to turn it

outside, even on public roads in order to play, which would endanger their safety.

As a conclusion three categories of products could be distinguished:

1) Toys which imitate PPE and which remained toys, e.g. imitations of firemen’s helmets

2) PPE sold with toys. Which case the two were clearly distinguished.

3) Products for children, even decorated in an infantile manner, which had a protection function

remained PPE.

FRANCE would like to reach an agreement on to only work with the above referred to three

categories when dealing with the borderline between the PPE and the Toys Directives.

The Chairperson recalled that this issue was already included in the PPE Guidelines, but the

French proposal went more into the details and seemed to be more specific on the mater.

COMM said that FRANCE rightly mentioned that this issue was discussed in the Toy WG in 2003

where similar categories were agreed. So COMM was willing to accept the categories proposed by

FRANCE.

The Chairperson recalled it was important to harmonise the approach between the two WGs in

order to echo the same message to all stakeholders involved.

As the PPE WG agreed on the French proposal, the Chairperson concluded including such

interpretation into the PPE Guidelines.


Action point: COMM to update the relevant part of the PPE Guidelines dealing with the borderline

between the PPE and the toys Directives.

10. Standardisation

Formal objections:

The Chairperson summarised the procedure for the formal objections.

UK formal objection on EN 353-1 – Guided type fall arresters including a rigid anchor line

The UNITED KINGDOM said their formal objection concerned primarily two areas:

1) Part 4.7 markings and instructions; the instructions for use requirements were inadequate,

because the devices could be used in circumstances that were dangerous.

2) Part 5 Test methods (reference EN 364:1992). Research had shown that the test method used did

not test for the essential performance aspects that would be encountered during foreseeable

condition of use. In particular problems with backwards falls: the vertical drop test described in the

standard did not take into consideration that a person fell backwards first and then downwards. In

addition to that the UK paper suggested the use of a dummy in different postures that would better

reflect real life situations.

Most recently following an accident, a product allegedly being to conform to EN 353-1 was tested

by the UK Authorities. This product failed to meet the testing requirements stipulated in EN 353-1

and the device had also failed to operate successfully during an additional backwards test. Further

information was available on the HSE website. This latter followed by a product safeguard clause

that was under review by the EU Commission.

As regards the inadequacies of the EN 353-1, this issue was raised in CEN TC 160 which had

developed the standard. WG 11 of CEN TC 160 acknowledged that the standard did not give the

sufficient evidence to provide for the conformity to the PPE Directive and advised notified bodies

to carry out further testes in addition those described in EN 353-1.

The revision of the standard was ongoing and was at consultation stage. However the deficiencies

described above were still not adequately addressed by the still draft standard.

The CEN-CENELEC Consultant agreed that EN 353-1 could not be used for certifying products.

At present no PPE standard alone could be used to certify a product. The reason for this was that

standardisers did not have the obligation to concern all the applicable BHSR. Nevertheless the

manufacturers had this obligation, regardless whether a standard covered all BHSR or not. And the

NB had the obligation to verify that all BHSR had been taken into account and correctly applied. As

the UNITED KINGDOM mentioned the standard EN 353-1 was being revised and the next meeting

on this issue in CEN was next week, where the UK representative would have the chance to express

his concerns over the standard.

CEN TC 160 said that this issue was not new to the TC which issue was being discussed at length.

As a result the TC decided to revise EN 353-1. The problem was that there were various designs of

products and therefore the test method that had been suggested by the UNITED KINGDOM had

been rejected so far because that would only cover a small amount of products/devices. So that

would favour some type of products while would reject others. Another issue regarding the

UNITED KINGDOM proposed test method was that it was not considered reproducible. As the

UNITED KINGDOM was referring to it there was a draft text sent out for inquiry and even though

its test content was not perfect the inquiry was necessary in order to broaden up the discussions.

Further this issue was also discussed in the relevant NB Vertical Group where everybody agreed

that more work had to be done in order to find a suitable solution for the problem.

As regards the concerns on markings, she has highlighted that this problem was mainly due to the

fact the present EN 353-1 made reference to the old EN 365 on information for use, whereas the EN


365 that was applicable since 2004 required more information from the manufacturer. So some of

the problems could be solved by replacing the old reference with the new one.

The Chairperson asked whether she could give an estimate when that above mentioned inquiry

would produce some results.

CEN TC 160 said the CEN inquiry was scheduled to end at the end of November 2008 and after

that normally there was a one year time-period to produce the final standard.

AUSTRIA asked that in case the formal objection was accepted then what test procedure the NB

would follow?

The Chairperson responded that in the UK paper there was already a proposal for testing also. And

even though the Chairperson of TC 160 said that could work for some equipment only, the NBs had

the technical knowledge to overcome this problem.

CEN TC 160 agreed with the Chairperson saying the NBs were aware of the problem and they took

issues into account when certifying products. Given the wide variety of products they had to adapt

to them in order to make sure those products were in conformity to the Directive, but she warned

that there was not one universal solution.

The Chairperson concluded this issue was in a need of further discussion.

Action point: Follow up this item at the next PPE WG. All participants are invited to send their

comments on this issue to COMM within 6 weeks.

DE formal objection on EN ISO 4869-4:2000 – Acoustics - Hearing protectors - Part 4:

Measurement of effective sound pressure levels for level-dependent sound-restoration ear-muffs

GERMANY said the problem was that there were the following two standards listed in the OJEU

for testing level-dependent sound-attenuating ear-muffs which overlap in scope and prescribed test

procedures that lead to divergent results:

EN 352-4:2001 Hearing protectors - Safety requirements and testing - Part 4: Level-

dependent ear-muffs

and EN ISO 4869-4:2000 Acoustics - Hearing protectors - Part 4: Measurement of effective

sound pressure levels for level-dependent sound-restoration ear-muffs that controlled

In addition regarding the EN ISO standard it was more like an expert report then a real standard.

Further, test results obtained according to that standard were neither representative of user exposure

nor sufficiently reproducible.

As a result of those findings the DE formal objection was aimed at deleting the reference of EN

ISO4869-4:2000 from the OJEU.

To better discuss the topic the DE delegation suggested inviting their expert for the next PPE WG

meeting in order to give a short presentation on the topic.

The CEN-CENELEC Consultant supported the DE approach to withdraw the reference of EN

ISO 4869-4:2000 from the OJEU.

FRANCE said this topic we already referred to 2 years ago. The main issue was the way the tests

were carried out for all kinds of hearing protectors. There was a tendency to overestimate the

protection. The level of protection should be in line with real life situation and not only with

theoretical levels. Therefore FRANCE was pleased that GERMANY brought this matter up again.

AUSTRIA was wondering that if GERMANY was right then why there was a need to follow any

formal procedure? Once the relevant CEN WG had given its opinion and said that a different

standard had to be applied, then CEN could take the initiative to withdraw that standards, could not

it?

The Chairperson said this was not possible as the reference of the standard was published in the

OJEU. Therefore the only way forward was to follow the appropriate procedure and present this

issue to the Committee created by Directive 98/34/EC.

CEN-CENELEC as this document was a late WG document the relevant CEN TC did not have

enough time to comment it. This would be presented at the next meeting.

The Chairperson concluded to further discuss this issue at the next WG.


Action point: GERMANY to invite their expert for the next PPE WG meeting. All participants to

send their comments within 6 weeks to COMM.

Context of harmonised standards

FRANCE said that some standards specified the context for PPE purposes and the distinction

between professional and non-professional use was not always relevant. And that created problems

for market surveillance. Motorcycles gloves with protection was an example: There was a standard

for professional use only. This created a problem on how to test the conformity of gloves declared

by the manufacturer for non-professional use. Another example concerned EN 567:1997

Mountaineering equipment - Rope clamps - Safety requirements and test methods. The question

arose: was it possible to use such clamps in the work context? Further there existed products with

similar functions which were covered by different standards.

In addition another worrying issue was the question of high visibility vests. Standard EN 471

covered high visibility clothing for professional use, while standard EN 1150 was for the same

clothing but for non-professional use. In comparison these two standards one could tell that they

covered the same BHSR nevertheless those were assessed at different levels in terms of

requirements. This was a big problem as e.g. somebody on the highway wearing a high visibility

vest had to be given the same protection as the ones for professional use because the associated

risks were the same. The existence of these two standards suggested the existence of sub standards.

One solution would be, as EN 471 was under revision to merge the two. Further FR prepared a list

of standards having the same issue.

The Chairperson suggested transmitting the list of standards collected by FR to CEN for further

distribution to the relevant CEN TCs for comment.

CEN-CENELEC said she would check the status of the revision of standard EN 471.

GERMANY supported FRANCE in general. He thought though that there would be no

fundamental clarification on this as e.g. there was the issue of oven gloves.

FRANCE agreed with GERMANY on the oven gloves, but emphasised that in case it was specified

it was for non-professional use then it was not a PPE. This was the only case here that was justified.

The ones listed by FRANCE on the hand covered PPE whether or not used in a professional, non-

professional context.

LUXEMBOURG agreed with GERMANY and FRANCE as well. He suggested deleting the

differences between professional and non-professional use.

FRANCE raised the question why PPE for the domestic use was excluded from the scope of

Directive. The people baking pizzas at home deserved the same level of protection as the ones in

restaurants.

SWEDEN supported FRANCE. He said that in Sweden there was a problem with mountaineering

equipment used in workplaces.

The Chairperson concluded the discussion by setting out the following action point:

Action point: CEN to check the revision of standard EN 471 and to consult the relevant TCs on the

list of standards collected by FRANCE. Report by CEN Secretariat

CEN-CENELEC gave the report. Among other things the followings were highlighted:

The replacement of the CEN rapporteur was in progress. As a consequence, the next meeting of the

PPE CEN Sector Forum depended on this process. Further CEN was preparing for any impacts on

standardisation regarding the latest modification to the Medical Devices Directive. In addition the

CEN Strategic Advisory Board for Occupational Health and Safety (SAB OHS) was created to

formally advise all involved technical committees on OHS and related aspects, and to coordinate all

relevant activities within CEN.

The Chairperson asked CEN if she could give a tentative deadline when the new rapporteur can be

chosen?


CEN replied that one remaining question was also to hand over the Sector Forum secretariat outside

CEN. As e.g. this could not be estimated by when it could be realised she could not give such a

timeline to the Group.

Report by the CEN Consultant

The CEN-CENELEC Consultant gave the report. Among other issues he emphasised that since

the last PPE WG meeting in June, 36 standards were drawn up out of which 4 were for enquiry, 14

for pre-formal vote assessment and 18 were for informal assessment. One last standing problem was

that standards did not cover all relevant BHSR of the Directive. However, it would be very easy to

avoid this situation: it would be only necessary to change the design of Annex ZA.

The Chairperson said that his suggestion would be good to achieve but as the ESOs were

independent organisations this WG could only encourage the CEN TCs to consider all relevant

BHSR when developing standards.

11. Report from the Coordination of Notified Bodies

HCNB gave the report. Among other things it was highlighted that the HCNB meeting was

organised on 16/17 October 2008, where alongside the NB, industry and the Commission were also

participating. During the meeting several issues of horizontal nature, such as the New Legislative

Framework was discussed. Another general issue was the Q&A 31. On this aspect the NB have

prepared a RfUs on time limiting the EC type-examination certificates for 5 years, which would

solve part of the problems raised during the discussions of Q&A 31 as it would remind NB and

manufacturers to review their certificates every 5 years. This brought us to the next relevant issue,

the status of RfUs. It was important that all sheets were publicly available, so that the information

was well disseminated. Therefore it was necessary to publish also the Vertical RfUs as well, which

was not followed by all NBs at the moment.

On today´s agenda there were two new RfUs tabled:

1) Regarding the time limitation of EC type-examination certificates;

2) Was a very technical one on Article 11B.

AUSTRIA asked why the time limitation of certificates was still being discussed in the WG.

The Chairperson responded that even though in the PPE Guidelines this issue was dealt with to

some certain extent as the Guide said this question was left to the contractual relationship between

the NB and the manufacturer. The reason behind this being tabled today was that the NB wanted to

have a horizontal agreement on their proposal so then everybody would follow it.

The Chairperson concluded the item by suggesting the following action point:

Action point:

Within 6 weeks All to send comments to COMM on the two RfUs. (Bearing the refs.:

CNB/P/00.135 and CNB/P/00.136.)

12. PPE ADCO –comments from the Chairperson

FRANCE gave the report.

Among other issues the following topics were discussed during the ADCO meeting:

1) Re-notification of NB;

2) Falsifications of EC type-examination certificates;

3) Two market surveillance actions, on buoyancy aids and another one on protective footwear;

4) Problem relating to certificates based on standards that no longer gave presumption of

conformity when the certificate was issued. The Group thought that certificates could not be

drawn up on such standards;


5) High visibility garments, which topic was not discussed at length due to lack of time. This topic

could be however discussed at the next PPE WG meeting;

6) BE accepted to represent the ADCO Group vis-à-vis the HCNB meeting;

7) One more remaining issue was to find the next Chairperson of the ADCO Group.

The Chairperson agreed to discuss the high visibility garments at the next WG meeting.

ESF asked about the two market surveillance actions and in particular on the one regarding safety

shoes: Did he understand correctly that 2/3 of products checked did not comply with the Directive?

FRANCE said the answer was yes. The result showed there was a very need for market

surveillance.

ESF said that in the past there used to be an open part of the ADCO meetings where other

stakeholders could take part in the meeting. He raised the question whether this habit would fade

away or it was still an intention to organise open parts again?

The Chairperson said that the intention was not to build a wall between the different stakeholders

as the system as whole worked better if all worked together. But at the moment the ADCO Group

was fulfilling its original purpose, meaning providing a forum to the Member States ´market

surveillance authorities to discuss issues on the ground. He reassured the participants that

everything else that was of competence of the WG was discussed here.

This issue was also linked to the chairpersonship of the ADCO group coupled with the lack of

resources from the Member States´ side on organising the meeting, meaning that in the past there

were two-day ADCO meetings which gave more possibility to devote some time to the open parts.

On the other hand with the recent one-day meetings this had become more and more difficult. It was

the Member State’s decision having the chairpersonship to decide on how to organise the ADCO

meeting.

FRANCE agreed with COMM.

Action point: COMM to table the issue of high visibility garments for the next PPE WG.

13. AOB

There was no further topic suggested.


The Chairperson said that the next meeting dates would be announced shortly after having verified

the availability of the meeting rooms.



MINUTES OF THE PPE WORKING GROUP MEETING HELD ON 25-26 MAY 2009


Meeting – 25/26 May 2009



EC Participants: Ms Alexandra JOUR-SCHRÖDER, Head of Unit I4, Mr Joaquin CALVO

BASARAN, Deputy Head of Unit I4, Mr Ian FRASER and Mr Mario

GABRIELLI COSSELLU (ENTR/I4)


COMM welcomed those present.


FRANCE asked to add the following two topics to the agenda which were discussed at the last PPE

ADCO meeting:

1) Clothing for motorcycles riders;

2) Certification procedures for custom-made PPE.

COMM agreed and said that the first point would be discussed under point 11 of the follow-up of

action points while the second issue would be taken up under point 10 of the Agenda, AOB.


3.Approval of the minutes of the meeting of 5 November 2008 (PPE/09/1/2)

The UNITED KINGDOM said that on page 14 in second paragraph it should read “VG 11”

instead of “WG 11”.

The minutes were approved with the modification above.

4. Revision of the PPE Directive – Progress on impact assessment

COMM introduced the topic highlighting the importance of the issue. She said that COMM had

prepared – with the help of the Editorial Group – a comprehensive table containing the elements of

the Directive that seemed to be candidates for the Impact assessment study.

The Chairperson explained the background of the exercise. On the 1-2 of April 2009 the

Commission organised an Editorial Group (EG) meeting with a group of selected experts in order to

discuss the comments received from various stakeholders on the revision of the Directive. He added

that in the meantime COMM also uploaded on CIRCA all the comments received in order to keep


this process as open as it was possible. He said that the Comprehensive table, prepared by the EG

was based on these comments. Further he wished to thank for the great work of the members of the

EG: AUSTRIA, FRANCE, GERMANY, the UNITED KINGDOM, FINLAND, SPAIN, FESI,

ESF, the CEN-CENELEC Consultant and HCNB. As explained at the last PPE WG meeting

COMM did not want to leave any stakeholder out of this process therefore the Comprehensive table

was tabled for discussion.

The reference of the document was PPE/09/13 and its structure was as follows:

1st column listed the candidate elements of the Directive;

2nd column set out the corresponding problem with the given element of the Directive;

3rd column described the goal of modifying that element of the Directive;

4th column set out the draft options / possible solutions for the given problem;

5th column listed the stakeholders commented on a given element of the Directive.

(Please note that only the elements of the table where additional information was given are listed

herewith):

Scope: The Chairperson said that there was a third draft option which was a so-called soft law.

This meant that the PPE Guidelines could be adopted by the PPE Committee giving more weight to

it.

Exclusions from scope: Ordinary clothing with reflective strips/material: The Chairperson said this issue would be discussed later on the day.

Inclusions in the scope

Custom made products

The Chairperson said that a third option could be the introduction of a note in one of the annexes

on how to apply EC type-examination for such products. RfUs could also be used as a basis for that.

Categories of PPE: COMM said that there was a need to introduce the Terms of Category 1,2 and

3 PPE into the Directive. And while this was fully shared by all stakeholders it did not require an

IAS; therefore this was not reflected in the table.

Deleting category 1 PPE: The Chairperson said that few stakeholders indicated their wish

deleting category 1 PPE. The reason was that many category 1 products – in their opinion– were

substandard ones and did not really give protection to the users. The EG did not consider this as a

viable option though understood that it was an area where the category for the equipment it covered

was not well applied. The EG believed that encouraging standardisation was the way forward here.

E.g. swimming goggles did not have their own standard though it was a wishful thing to have, while

on the other hand sunglasses, currently category 1 PPE then would be category 2 PPE, which was

not reasonable.

Sunglasses, PPE against sunlight in highly-reflecting environment: The Chairperson explained

that the European Sunglasses Association (ESA) was contacted for their opinion before deciding on

these two elements.

PPE Committee: The Chairperson said the intention was to create the PPE Committee. The only

remaining issue was whether this was necessary to be included in this exercise. (At a later stage it

had to be decided to what powers this Committee should be given)

Safeguard clause procedure: The Chairperson recalled that as one option was to align with the

NLF, the second option on defining exact deadlines for stakeholders in the process was not viable

because NLF alignment – if applied – took precedent.

Validity of EC type-examination certificates: The Chairperson said that with this issue the long

discussed Q&A 31 could be partly solved. In addition COMM thought of a third option which was

to use the example given in the new Machinery Directive37 on review of certificates in every five

years.

Market surveillance – obtaining documents from manufacturers: The Chairperson explained

that this issue was dealt with by the NLF Regulation and would therefore be deleted from this table.

37 Directive 2006/42/EC


The Chairperson explained that the main body of the Directive was discussed by the Editorial

Group. As for the Annexes it was COMM´s intention to discuss them on the day. Before doing that

though, COMM suggested taking one-by-one the elements already discussed by the Editorial

Group in order to give stakeholders the possibility to express their opinion directly on the matter.

He also highlighted that issues such as harmonisation of terms were not forgotten, but those did not

need an impact assessment, which was the reason for not including them in this table.

Taking the elements one-by one:

Scope

Definition of PPE

HUNGARY supported the clarification of the PPE definition because they have only considered

PPE legally when used at organised work. Therefore further clarifying the definition would help

their work.

As no other comments were expressed COMM concluded that the WG agreed on this point.

Exclusion from the scope – Anchorage point

The Chairperson said that the WG agreed on this point at the last PPE WG meeting by introducing

the elements of the warning of EN 795 into the Guidelines.

The UNITED KINGDOM said they have written to the Commission on EN 795 for clarification,

as they were not totally convinced that introducing the same wording as contained in the Guidelines

would be correct. They did not wish to discuss that on the day but would again contact the

Commission on this issue.

The Chairperson said that the first UK letter would be answered right after the meeting as the

answers were already there but due to the preparation for the WG meeting there was not enough

time to deal with it. In the meantime he invited the UNITED KINGDOM to send COMM any

further draft options on this one as those were always welcome at this stage of this exercise.


Toys

The Chairperson said that at the last PPE WG meeting the WG agreed to introduce further

clarification proposed by FRANCE on the matter.


Ordinary clothing with reflective strips/material

The Chairperson said this point was skipped as the issue was scheduled to be discussed under

point 6 of the Agenda.

Inclusions in the scope

Custom-made products

As no other comments were expressed the Chairperson concluded that the WG agreed on this

point.

Rescue equipment

FRANCE said that on the list of harmonised standards in the OJEU there were some standards

covering rescue equipment. That was why this matter needed clarification.

The Chairperson said that the list indeed needed to be checked as it seemed to be inconsistent.

Nevertheless he thought FR was referring to equipment used by rescuers to protect themselves. So

maybe there was a misunderstanding in terms of terminology.

Action Point 1: COMM to check the list of harmonised standards.


GERMANY – coming back to the previous topic – asked if they understood correctly that as

regards custom- made products there would be no change.

The Chairperson replied that the answer was no. The issue was included in the table with a

possible view to be part of the revision exercise. Future changes depended on the result of the

impact assessment study.

Creams and ointments

The Chairperson said that in the USE directives they were listed as PPE even though according to

the PPE Directive they were not PPE. This latter was also elaborated in the PPE Guidelines.

As this situation needed clarification COMM (DG ENTR Unit I4) would contact the colleagues in

DG EMPL.


point.

PPE for private use against heat

FRANCE suggested including such equipment into the scope of the Directive. Looking at the

current definition many similar products were in the scope. Not to mention the situation on the

market.

GERMANY said that looking at the definition (to be changed in both the Directive and the

Guidelines) then the “private” issue was not an issue anymore.

COMM said it was an issue because PPE for private use against heat was listed on the list of

exclusions.

BELGIUM supported FRANCE.

As no other comments were expressed the Chairperson concluded that the WG agreed this point to

be changed and the matter to be included in this exercise.

Dual use products – products covered by several Directives


point.

Definition/responsibilities of economic operators


point.

Categories of PPE

Deleting category 1 PPE

As no further comments were expressed the Chairperson concluded that the WG agreed on this

point on not to include this into the revision exercise.

Limited chemical protection (Art. 8.4)-current


point.

PPE protecting against cutting by hand-held chain saws


point.

PPE designed to prevent drowning

FESI said that as several types of products were available on the market it was important to

emphasize that the herewith referred to products were the ones preventing drowning.


SWEDEN also said it was important to clarify the products that were referred to here since not all

of those designed to prevent drowning could be Category 3 PPE.

The Chairperson said that this would be part of the Impact Assessment exercise, with the option to

include some drowning equipment into Category 3.

Therefore he suggested putting down a third option on including some of the equipment falling

under the umbrella preventing drowning into category 3 PPE so in this case it could be examined

what was viable to be included into this higher category.

FRANCE thought that the matter was related to definitions: e.g. buoyancy aids helping to learn

swimming should be category 2, while equipment preventing drowning was category 3.


point.

Bullet-resistant vests, knife stab-resistant vests and needle and spike stab resistance vests


point.

High-visibility clothing


point.

Ear plugs, ear muffs against noise


point.

Sunglasses and PPE against sunlight in highly-reflecting environment

ESA (European Sunglasses Association) said that they were waiting for replies from important

European manufacturers: these contributions would be forwarded to the Group. First comments

were oriented that sunglasses for general use should stay in category 1. Nevertheless discussion was

still under way regarding ski goggles and protective glasses for high-reflective environments. In the

next few days comments should be available for the Group.

FESI also analysed the question on sunglasses with the same results as ESA. But still some

discussions were ongoing regarding products to be Category 2.

The Chairperson said it seemed that sunglasses should stay category 1 PPE and therefore to be

excluded from this exercise. But there was still the remaining question whether there was a need to

distinguish between the different types of sunglasses.

POLAND said that the year before they had made a study on sunglasses and found non-

conformities so it was worthwhile considering putting them into Category 2. The main non-

conformities were: UV transmission, instructions for use and CE-marking.

ESA said that putting non-conform products to higher category was not the solution. It was up to

the market surveillance authorities to take action in such cases.

The Chairperson agreed with ESA.

Action Point 2: ESA and FESI to send report on the results of their consultation. Other delegations

to provide contributions also, if any. COMM then will decide on the next step in light of the

comments received.

Equipment protecting against high-pressure cutting


point.

Emergency equipment for use in high-temperature environments


point.


Emergency equipment for use in low-temperature environments


point.

PPE Committee


point.

Safeguard procedure


point.

Validity of EC type-examination certificates

The Chairperson recalled that as expressed above COMM thought of a third option which was to

use the example given in the new Machinery Directive38 on review of certificates in every five

years.


point.

Content of EC type-examination certificates


point.

European /central registry for certificates -Falsification

The Chairperson said that the EG considered the current practice, which was that authorities

contacted directly the NB concerned on certificates. Therefore considering – as a pre-impact

assessment – the costs/ benefits of such an option the EG rejected the idea of the creation of such a

database.

FRANCE said they suggested not creating a database on EC type-examination certificates as such

but for certificates that were falsified or withdrawn. It was true that authorities contacted regularly

the NB but it was not possible to do that in case of all falsified certificates.

ESF agreed that such a database could be a good idea but it would not have to be necessarily

included in the revision of the Directive. It could be a decision made by the Group outside this

exercise which would be beneficial not only for authorities but for distributors also. The CIRCA

system could be used for such a purpose for instance.

GERMANY supported FRANCE

COMM said that it would be indeed useful to verify certificates by consulting a database (for

example a “black list of certificates”), but the problem was that this would not work. Because if a

certificate was not on the list that did not prove it was a good /valid certificate as it might have been

falsified or withdrawn and the withdrawal has not been notified yet. He thought it was the

obligation of the NB to notify the authorities when they withdrew a certificate. So that information

should be available to the authorities. The idea to have such a database was nice but not workable.

The only sure method to verify a certificate was to turn to the NB concerned.

FRANCE partially agreed with COMM. It was true that in case of doubts on certificates the first

thing to do was to get in touch with the relevant NB. But there were certificates withdrawn by the

manufacturer and where was no doubt about the certificate, but the authorities still needed to know

whether the certificate was valid or not. And the authorities could not go to the NB for every and

each certificate.

38 Directive 2006/42/EC


The Chairperson said that COMM would examine the possibility to use the CIRCA system for

such purpose but as only COMM had the right to upload document for the CIRCA Group PPE WG,

it was not COMM´s intention to overburden its own colleagues with such task. So as for conclusion

this topic would not be included in the revision process but rather COMM would examine the

possibility if (at all) the CIRCA system could be used for that.

Action Point 3 COMM to examine the possibility of how to use the CIRCA system for

disseminating information of falsified certificates.

Conformity assessment (modules) (art 11A and 11B procedures)


point.

Notified Bodies


point.

Status of recommendation for use sheets


point.

Notifying Authorities


point.

Presumption of conformity and harmonised standards


point.

Formal objection


point.

CE marking


point.

AUSTRIA said regarding market surveillance: there was a problem in practice of getting hold of

the EC Declaration of conformities (DoC). Therefore he wished to make a suggestion creating an

obligation of providing the DoC with the product.

ESF agreed with AUSTRIA that the availability of such documents should be more accessible but

in terms of practicality of delivering EC Declaration of conformities with every single product did

not seem to be the right answer.

The Chairperson said that the relevant issue is elaborated in the PPE Guidelines but he raised the

question whether the WG felt the need to give more weight to the issue by introducing it into this

exercise.

SWEDEN said it was a good idea to have the DoC part of the instruction for use just as in the

Machinery Directive.

IRELAND and GERMANY supported SWEDEN.

COMM mentioned that the new Machinery Directive required a copy of the EC Declaration of

conformity to be included in the instructions.

The Chairperson closed the discussion noting an Action Point for AUSTRIA.


Action Point 4 AUSTRIA to provide a proposal to solve the question in light of the Impact

assessment study.

End of morning session

ANNEX I

PPE for private use against heat

The Chairperson said that as discussed during the morning session COMM would take over the

reasoning from the French paper why this should be part of the Impact assessment study.

PPE for self-defence

The Chairperson said that a proposal from FRANCE suggested deleting this from Annex 1.

He suggested leaving the example on the list but changing the “PPE” to equipment.

COMM pointed out that generally equipments that did not correspond to the definition were not in

the need to be explicitly excluded from the scope. In this case such equipment did not correspond to

the definition of PPE as it did not protect the user but could dissuade an attacker. But looking at

other New Approach directives this was not a standalone example where some items which did not

explicitly correspond to the definitions were excluded in order to avoid confusion. So he concluded

that the example might stay but replacing the “PPE” with “equipment” would create better clarity.

FRANCE responded saying that in that case the title of Annex 1 should also be changed as it was

“Exhaustive list of PPE…”

The Chairperson concluded that this seemed like a drafting exercise. Therefore as there were no

further comments he closed the discussion noting this would be taken up at a later stage of the

revisions of the Directive.

Dish washing gloves for private use

The Chairperson said that a proposal from FRANCE suggested deleting this from Annex 1.

FRANCE said their proposal was to remove the example from brackets as washing gloves were not

just protecting from water but also from the products that were used to do the washing-up /

housework. So washing gloves and household gloves should be covered by the PPE Directive.

Action Point 5: FRANCE to send proposal to COMM on exact problem with washing gloves being

outside of the scope of the Directive. COMM to include that into the table of IAS.

Helmets and visors for users of 2-3 wheeled motor vehicles

The Chairperson said there were two proposals on this issue. Both tried to avoid confusion on

helmets and visors for four-wheeled motor vehicles being PPE and the ones for two or three-

wheeled motor vehicles being outside the scope of the Directive, though the two were the same:

So the suggestions were:

1) To refer to the relevant “Geneva Agreement of 20 March 1958 on uniform adoption of approval

and mutual recognition of approval for motor vehicle equipment and parts”

2) Or to delete the reference to “two or three-wheeled” motor vehicles in the Directive.

FRANCE clarified that the Geneva Agreement said that helmets for users of two or-three wheeled

motor vehicles were also part of the Agreement. Helmets for users of four-wheeled vehicle fell

under the PPE Directive. Nevertheless helmets for motocross e.g. were not part of the Geneva

Agreement so those needed to be covered by the PPE Directive. Therefore FR suggested the

clarification on exclusion of helmets and visors for users of two or three-wheeled vehicles, for

vehicles that were covered by the Geneva agreement.

As no other comments were expressed the Chairperson concluded introducing the suggestions into

the table.

ANNEX II


Instructions for use (BHSR 1.4)

The Chairperson introduced the topic. Proposals from several stakeholders suggested setting a

minimum font size in the Directive. In addition they said requirements in standards were often to

include information that was not understandable for non-specialists.

He added nevertheless that this seems more an issue for standardisation.

ESF agreed that requirements in standards were a matter for standardisation. But he added that in

reality as the instructions for use was the only document available to the user standards required

much more information to be part of it to make sure that such information was available.

Nevertheless users in real life did not read such documents as they contained too much information.

(E.g. instructions for use contained information for the right selection and use of the equipment).

IRELAND supported ESF. She also highlighted that information requirements were too complex

for the user.

The Chairperson said that in 1.4. of Annex II there were enough requirements for information.

FESI agreed with COMM on the lack of need for requirements for more information.

COMM said that in the Machinery Directive there was a requirement on the instruction for use

saying that when the product was intended for non-professional use this fact should be taken into

consideration regarding the level of details given to the users. In his opinion this could be included

into the PPE Directive as well. As regards PPE for professional use, very often information required

by standards supporting Annex II of the PPE Directive was the information needed by the

employer. This information however was covered by the so-called Use Directives. Therefore these

two cases could be separated.

As no other comments were expressed the Chairperson concluded introducing draft options along

the lines that had just been expressed.

PPE bearing one or more identification or recognition marks directly or indirectly relating to health

and safety (BHSR 2.12)

The Chairperson said FRANCE suggested restructuring this point. It nevertheless raised the

question of impacting standardisation as in case the numbering of Annex II changed that would

have an effect on the corresponding Annex ZAs in standards.

CEN-CENELEC agreed with COMM saying such a case would have an impact on standardisation.

However she added that in case of changing other aspects in Annex II, this issue would not be a

major one.

The Chairperson said that strong arguments were needed to introduce elements into the table but

regarding this issue he felt the Group was on volatile grounds. He concluded that the topic would be

included in the table and asked FR to send arguments to COMM as to why it was necessary to do

so.

Protection against the harmful effects of noise (BHSR 3.5.)

The Chairperson said that according to proposals from stakeholders the “Comfort index“ (degree

of comfort) could not be measured. Therefore they suggested the deletion of requirement on the

comfort index.


point.

Mechanical vibrations (BHSR 3.1.3)

The Chairperson said this was a similar case than the previous issue.

He added that – according to stakeholders– products should give such protection that vibration

exposure above the limit values in the minimum Directives was not exceeded. The reason was that

this requirement was not reasonable as the exposure could vary within considerable limits and

products with different levels of protection might be selected depending on the actual situation.

Therefore stakeholders suggested the deletion of reference to “limit values is not exceeded..”.


FRANCE said they were hesitant about this deletion. Because the fact that there was a link between

the design of PPE and the directives which measured vibration/noise was a reasonable issue. It

might be challenging in practice. They would consult their expert in order to provide better

arguments.

SWEDEN said they had the same problem with the previous point.

The Chairperson concluded this issue with an

Action Point 6 for All to consult their experts and send their comments to COMM on both points.

(BHSR 3.5 and 3.1.3.) All to send their comments on what were the problems and any possible

draft options/solution to solve them.

He added that on the basis of the comments received COMM would decide on the next steps to be

taken.

Prevention of drowning (BHSR 3.4.)

The Chairperson said that comments on this requirements had been received.

FRANCE said that buoyancy aids (BHSR 3.4.1.) should not be a subcategory of prevention of

drowning but should be on an equal footing.

The Chairperson said that this was the issue COMM wished to avoid on the renumbering of

Annex II that would have an effect on standardisation. So far no problems had been raised with this

so he suggested leaving it as it was.

FRANCE said the issue raised the question of consistency when setting up a hierarchy between

these two BHSR. As discussed during the morning session some buoyancy aids would be category

3 PPE. And if the categorisation changed then the way in which the requirements were organised

would cause problems.

COMM said that for most equipment this was not a problem because most equipment covered by

BHSR 3.4.1. –Buoyancy aids prevented drowning, even though they did not completely prevented

drowning, but the aim was to prevent drowning. (E.g. equipment for kayaking or sailing. Here the

user was supposed to know how to swim). The problems with other buoyancy aids such as the ones

to learn to swim were that they had no drowning prevention at all. At the time of this discussion in

the PPE WG the decision was taken that they were PPE even though he (Mr Fraser) thought they

were not. He highlighted that this was the issue that had to be looked at. BHSR 3.4.1.covered life-

vests which were not life-jackets but which did have a certain degree of prevention of drowning.

The Chairperson concluded the discussion.

Action point 7 All participants to examine the relevant document uploaded on CIRCA regarding

this point for possible comments.

Innocuousness, ergonomics, ageing

The Chairperson introduced the topic. He said that this issue had been discussed for years now at

various forums as some stakeholders were of the opinion that the Directive lacked clear limit values

for certain chemicals. He nevertheless emphasised that the PPE Directive was a New Approach

Directive therefore this was more of a standardisation issue.

FRANCE agreed with COMM that this was a matter for standardisation.

ESF said that their intention was to clarify the issue.

The Chairperson proposed not to include this issue into this exercise.

IRELAND supported ESF on clarification regarding these requirements.

FRANCE mentioned that a Guide being developed on the new Machinery Directive and a relevant

section was devoted to ergonomics. That example could be followed to prepare something similar

on Annex II of the PPE Directive elaborating on what was meant regarding such requirements.

GERMANY supported COMM.

COMM added that the Guide was there to give general guidelines. But it was the job of

standardisers to deal with the issues of precise specifications that could be followed by


manufacturers. In addition there was a family of standards produced by CEN TC 122 on ergonomic

requirements for PPE, and there were several standards giving precise specifications and test

methods on verifying the comfort, usability and ergonomics of PPE. E.g. standards for respiratory

protective apparatus required the apparatus to be tested by a panel of people carrying out several

tests simulating work tasks where they have to report on the comfort and ergonomics. Similar case

was true for hearing protectors. Therefore it was necessary to make sure that the requirements were

general enough so that standardisers could develop the necessary technical specifications. To

legislate in a clumsy way was not a solution because that could result in requirements like the one

just being discussed on comfort index that could not be followed.

The Chairperson concluded that this issue would not be dealt with in the framework of the IAS.

But the relevant part of the Guide on the New Machinery Directive would be carefully examined

with a view of meriting ideas for the PPE Guidelines. He also highlighted that this was an issue of

standardisation mainly.

ANNEX III

The Chairperson said that FRANCE proposed that points 2) and 3) be provided for all PPE and

not only PPE covered by EC type-examination. In addition others suggested to align it with the

NLF Decision. So he raised the question whether there was a problem with the current system?

FRANCE said the problem was that manufacturers of category 1 PPE were reluctant to work

together with authorities when they were required to hand over documents on internal production

control, saying it was not obligatory for category 1 PPE. But it was important that manufacturers

could give such information.

The Chairperson said that the modules decision already provided what needed to be supplied with

the given product.

IRELAND supported FRANCE in relation to bringing clarity on this issue.

FRANCE added that they also had a drafting proposal of harmonising the terms. In the Machinery

Directive the documents was called Technical File while in the PPE Directive it was Technical

Documentation. It was reasonable to use the same term in both areas.

The Chairperson said that the second issue raised by FRANCE could be part of the drafting

exercise.

As no other comments were expressed the Chairperson concluded agreeing including the topic

into this exercise.

ANNEX VI

The Chairperson said it received proposals for clarification. He recalled that clarification already

existed in the PPE Guidelines. He emphasised that there was even a misprint in Annex VI referring

to the wrong category of PPE. This latter needed to be corrected.

ESF said they have suggested aligning Annex VI with the NLF Decision. In that case

manufacturers would use the same template that would help not only manufacturers but also

authorities who had to read such documents.

As no other comments were expressed the Chairperson concluded agreeing including the topic

into this exercise.

The Chairperson raised the question of whether there were any elements of the PPE Directive the

WG considered was forgotten and should be part of this exercise. He recalled the importance of it

because this table when finalised would give the framework for the WG within which the revision

exercise could be carried out.

FRANCE said that Annex V was not discussed on the day. She recalled the importance of the

requirement of availability of personnel. She was wondering whether it was worth specifying that

the NB should have its own staff and means to carry out its tasks in order to avoid subcontracting.

Because it happened that a NB that did not have the necessary resources fully subcontracted certain


tasks to laboratories that were not notified. And the current drafting of Annex V left the door open

for this type of behaviour.

The Chairperson responded that even though Annex V was not directly mentioned, the

requirements of Notified Bodies had been discussed on the day and that covered this topic as well.

As regards the general pictures of this exercise he added that there were two types of proposal

regarding the IAS. The first group included the elements of the Directive to be aligned with the

NLF Decision while the other group contained those parts of the directive that were separately in

the need for improvement. But as regards the first group COMM was not sure at the moment

whether that was also necessary to be included in this exercise since when the NLF Decision was

prepared an IAS was carried out. Therefore Unit I4 was seeking advice from other relevant services

of COMM to solve this puzzle.

As no other comments were expressed the Chairperson concluded this agenda point saying that

after the requested comments received, COMM would finalise the table and decide on the

appropriate steps to take in order to progress with the exercise as dynamically as possible. As a final

word he added it was still to be decided whether the IAS would be carried out by an external

contractor after having carried out the necessary tendering process or whether it would be carried

out internally by COMM.

FESI asked whether the revised table would be available to the WG? He also asked when the

decision on how to carry out the IAS could be expected?

The Chairperson replied the revised table would be uploaded on CIRCA. As regards the second

question COMM would take time to evaluate the pros and cons on how to proceed. But he

emphasised that whenever the decision was taken the WG would be informed.

5. Follow-up of action points from meeting of November 2008

No 1. – Notified Bodies – cancellation of EC type-examination certificates

The Chairperson introduced the topic saying that the PPE ADCO group could not come to a

common agreement on it. He recalled that the cancellation of certificates was not referred to in the

PPE Directive. This was a voluntary act of the manufacturer for example to change Notified Bodies.

In this case the NB did not have the obligation to report that to the authorities. (In 2006 the PPE

ADCO group – in an open session – agreed on this). It was important to emphasise that this was

only possible in case of compliant products of course.

Nevertheless some Member States raised question regarding traceability.

FRANCE said that this issue had been discussed at the last PPE ADCO meeting where the paper in

question was rejected. The text was difficult to understand and apply because the distinction

between the cancellation and withdrawal of a certificate did not seem relevant. The most important

thing was the situation of the product whether it was covered by a certificate in two forms? From a

market surveillance point of view it created a problem when the authority contacted a manufacturer

regarding the status of a product and the manufacturer in its reply said yes the certificate was valid

but the manufacturer asked for its withdrawal of which no one else knew about except the Notified

Body.

Nevertheless this situation would change with the NLF Decision, as Article R 28 stated: “ Information obligation on notified bodies

1. Notified bodies shall inform the notifying authority of the following:

(a) any refusal, restriction, suspension or withdrawal of a certificate;…” This seemed to cover all cases. So if this Decision was to be applied as of from next year, it seemed

that cancellation should not be treated differently form suspension or withdrawal, or other measures

taken by the Notified Body.

SPAIN commented on the cancellation of certificates: if a Notified Body reduced its activity and

for a certificate that it issued the manufacturer wanted an extension. But as the activity of the NB is


reduced the NB had to ask the manufacturer to cancel the relevant certificate and go to another NB

to issue a new one. This case should be included in the Article R28 of the Decision39.

The Chairperson replied that the modification of the Decision was not the task of the PPE WG. It

was already elaborated in the PPE Guidelines how an NB could extend a certificate. As for the

comments from FR, he added that he was not confident that the case of cancellation was covered by

the above quoted Article R28. Firstly the text of the Article did not seem to cover cancellation and

secondly the logic of the text did not suggest it either: the cases listed in the article were measures

taken by the NB itself, while cancellation was done by voluntarily by the manufacturer.

SPAIN said she was talking about a case where there was no other option for the manufacturer but

the cancellation of a certificate and not the extension of it.

HCNB explained that cancellation was not related to withdrawal or suspension and there was no

technical reason to do so. It was purely an administrative act in order to allow the manufacturer to

request a new certificate for various reasons.

She agreed with COMM that cancellation had nothing to do with withdrawal or suspension. She

raised the question what the Member States expected from the NB?

FRANCE said that Article R28 of the NLF Decision did not say the elements listed there were due

to technical reasons adding that in case of complying products the issue was just passing on

information to the authorities.

The Chairperson said that the discussion was ongoing on two parallel lines: 1) How to interpret

Article R 28 of the NLF Decision and 2) whether the Member States in the WG would like to

receive information on each case of certificate cancellation.

GERMANY supported FRANCE as he feared that at one point the act would be done by

cancellation and not withdrawal so the authorities would not be informed.

The Chairperson replied that two cases needed to be distinguished:

1) The manufacturer had a compliant product and asked for the cancellation of his certificate to go

to another NB.

2) The Notified Body withdrew a certificate in case it found that a product no longer was compliant

with the PPE Directive.

Action Point 8 All to examine the relevant document no. PPE ADCO 18-10 and send their

comments about it within 6 weeks. COMM to summarize the responses in a comprehensive table

and to circulate it via CIRCA.

ESF asked the ADCO paper to be available to all stakeholders.

The Chairperson replied it would be distributed via the CIRCA system. He then concluded this

agenda point.

No 2. –AOB - Addition to EC Certificate when product considerably changed

The Chairperson said that COMM decided to close this item. This issue was presented several

times in the WG with no success. At the last PPE WG meeting COMM even brought an example

from another field, i.e. the ATEX Directive but the PPE WG could not reach a compromise over the

topic. Therefore COMM decided to discuss related specific problems in the future while not seeking

for a general solution.

No 3. – Q&A 31 Revision of harmonised standards The Chairperson said the same applies to this topic as well. Item closed.

No 4. – Scope of Directive Proposal for categorisation –reflective stickers

The Chairperson said that the publication of the updated version of the PPE Guidelines was in the

pipeline.

39 Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework

for the marketing of products, and repealing Council Decision 93/465/EEC

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0082:0128:EN:PDF


No 5. – Scope of Directive - Ice tools

The Chairperson said that the experts from FESI would arrive the next day therefore this item was

postponed till the following day.

No 7. –Categorisation of clothing for professional use providing UV protection

The Chairperson said that comments were received from DE and CH.

As no other delegations took the floor and the comments received were not substantial therefore he

proposed to close this item.

No 8. – Update on amendment (Directive 2007/47/EC) to the Medical Devices Directive (93/42/EEC)

The Chairperson explained that COMM services were working together on a new version of the

disputed Guidance document. The latest version of the document was presented on the day. The

Chairperson recalled that it received the agreement of the Legal Service of the Commission so it

could be published on the EUROPA website even after the meeting. He added therefore that the

essence of the document could not be changed but said that stakeholders had the possibility to

comment for minor changes. This would be provided in parallel for the experts of the Medical

Devices Directive as well.

No 9. – Equipment (harnesses) used by paragliders (Concerns page 90, point 3.5 of PPE Guidelines)

FRANCE introduced the topic. The product itself composed of an airbag installed on a paraglider´s

seat (harness). The question was of how the airbag mechanism activated. According to an NB

certifying such products the airbag was already inflated and in case of fall the airbag would absorb

the shock. So there was no need for any activation.

The Chairperson reminded that the original question was whether such equipment was PPE or not.

In the past it was said that such equipment was outside the scope of the directive because they were

not manufactured to prevent falls from height.

FRANCE replied that a paraglider´s saddle was not a PPE. But once it was given features to

provide protection to the user it became one. It still did not give protection against falls from height

but provided protection against mechanical shock, therefore it was a category 2 PPE.

As stakeholders could not come to a common agreement on the categorisation of this equipment the

Chairperson concluded this point by setting out the following Action point:

Action point 9 All stakeholders to send COMM their comments whether they considered such

equipment as a PPE and if yes which category.

No 10. – Interpretation of the PPE (what should be considered PPE? (Automatic vs. manually activated products) The Chairperson said that this topic was discussed several times in the PPE WG. (For example in

2003 and 2004, but there was never a decision taken.) The issue was whether products that had to

be manually activated were also PPE or only the ones giving automatically protection counted as a

PPE. COMM received comments from: GERMANY, SWITZERLAND and DENMARK basically

all saying that further discussion was needed. The whole issue came to the surface again because

the question was raised whether a product – an anti-avalanche jacket with airbag that needed to be

activated in case of an avalanche – was PPE or not.

He recalled that in Article 1 of the Directive, the definition did not contain provisions on the means

of activation in terms of protection of the PPE. So one could understand that both were covered by

the Directive. Nevertheless the question could be still raised to what extent the intervention of the

user was needed? Because the equipment itself should have some intrinsic protection. He believed

that both were PPE.

FESI agreed with COMM that both should be considered a PPE. Nevertheless he was wondering

whether in case of any accident for example where the user became unconscious then what the

situation would be with an equipment that needed the intervention of the user.


The Chairperson said that FESI referred to an important issue. Taking the examples of lifejackets,

even the ones that needed the intervention of the user had some level of intrinsic protection that

kept the user afloat. Therefore it was important that the equipment itself had some level of

protection without the user’s actions.

FRANCE said that in the relevant document it was stated that the anti-avalanche jacket was not a

PPE because it required an intervention by the user. And on this analogy the general rule could be

established. She would not necessarily put the emphasis on whether it was automatic or not, but the

intrinsic protective function.

The Chairperson suggested to separate the two issues:

1) Whether anti-avalanche jackets were PPE or not?

2) Products that have to be manually activated were also PPE or only those giving automatically

protection counted as a PPE.

He also asked FRANCE to share the date of the decision when it was decided that anti-avalanche

jacket were not PPE.

FRANCE said that at a WG meeting in 2004 the topic was discussed at the request of FRANCE

and a strong rejection was expressed by the WG. And the reasoning was the same as COMM has

just expressed that it did not have any intrinsic protection.

The Chairperson said the COMM would check the relevant minutes for the decision.

GERMANY said that avalanche airbags had been discussed. However in the meantime in DE they

had tested these products. The avalanche airbags were subject to a Swiss study carried out by the

Swiss Avalanche Institute which suggested that such equipment had a personal protective function.

In Germany after having examined the PPE Directive they had concluded that there were not any

provisions in the Directive excluding the equipment with manual activation from its scope. In any

case according to the Swiss Avalanche Institute there is always time for the user to activate the

airbags in the jacket, which nevertheless increases the chances of survival. Therefore it was not

justified to decide on a case-by-case basis which manually activated equipment could be PPE or

not.

FESI asked the WG to have more time to study the issue in order to submit the WG a detailed

response.

FRANCE agreed with DE that there was a lack of consistency since a life-jacket with user

intervention could be a PPE while the anti-avalanche jacket could not. She highlighted that if a PPE

is worn the user is more likely to take more risks. In case of the anti-avalanche jacket no additional

risks should be taken in particular if the user is not capable of initiating the mechanism.

SWITZERLAND said the likelihood of taking more risks when wearing a PPE should not be a

driving principle because on this analogy many more PPE should be excluded from the scope of the

Directive. For example, the same would then be true for motorcycle clothing.

The Chairperson said that as the comments were widespread therefore a clear conclusion was not

possible to make. The decision (if) taken in 2004 remained valid according to which anti-avalanche

jackets were not PPE. He said this issue would be discussed again at the next PPE WG meeting,

hopefully the last time.

Action point 10: All to comment on document no. PPE/09/1/10. The topic to be re-discussed at the

next PPE WG meeting. No 11 – Clothing with airbag for motorcyclists

The Chairperson said that the updating of the PPE Guidelines was in the pipeline.

FRANCE introduced the additional topic that was adopted with the agenda during the morning

session. The French authorities had been requested by an importer about the rules that apply to

jackets and trousers for motorcyclists. There were parts of the jackets e.g. the elbows that had

protective functions and the CE marking while the jacket as a whole did not. The importer claimed

that the jacket as a whole was not a protective equipment as it did not correspond to the definition in

Article 1.2 of the PPE Directive. The French authorities thought that the whole equipment should be

a protective equipment. As the safety of the wearer depended on the clear complementarities


between the clothing and the protective device. She wished to hear the opinion of other stakeholders

and in case the French proposal was agreed to have the point 14.4 of the categorisation guide

updated accordingly.

The Chairperson said that when drafting the Guide it was concluded that such clothing – if for

private use – protecting against weather conditions was not a PPE, while any additional protective

devices on the clothing were PPE. Nevertheless it seemed that in the meantime there had been

developments. For example at one of the previous WG meetings FR brought samples of

motorcycles gloves where the protective device was “built” in the glove and the two could not be

separated. He thought that the key issue regarding the clothing was whether there should be some

interrelation between the clothing and the protective device so that in case of a fall the device

remained in place.

The Chairperson opened the floor for comments.

As neither objection nor further comments were expressed the Chairperson concluded that the WG

agreed with the French proposal which would be introduced in the PPE Guidelines.

No 12 – Updating of PPE Guide - Reconsider exceptions in Guide regarding PPE and MDD The Chairperson said that the updating of the PPE Guidelines was ongoing. The outcome of that

depended on the latest amendment (2007/47/EC) to the Medical Devices Directive and the modified

interpretative document on the relationship between the PPE and the MDD.

Action Point 11 COMM to examine the relevant examples (MDD-PPE) in the Guidelines.

No 13 – Updating of PPE Guide - To clarify comments on categorisation on “high-temperature environments

SPAIN said that replying to a call from COMM last year on updating the PPE Guidelines, SPAIN

suggested to update it regarding temperature risks. Since then SPAIN has sent new information. So

the intention of the Spanish paper was to clarify the point on how to determine categorisation

(category 2 or 3) of heat protection.

The Chairperson said that during the morning session this issue was touched upon when the draft

options for IAS were discussed. So in terms of future legislation the topic seemed to be covered.

Nevertheless he asked ES whether in their opinion there was room for further clarification in the

current PPE Guidelines.

SPAIN said that yes.

ESF said that info in the Spanish table was based on discussions in the NB VG 5 Group meeting.

He was wondering whether it was agreed by that Group. He added that there was an RfUs based on

the relevant old standard. So he raised the question whether that was still applicable, or was there

another one in preparation? Such paper would be a good start to further clarify this issue in the

Guide.

SPAIN replied saying that there was a proposal for a RfUs to be considered. But there were some

debated issues.

HCNB said that NB had some discussions on this issue but could not reach a general agreement.

This topic would be raised at the next HCNB meeting in 3 weeks time.

Action Point 12: SPAIN and HCNB to send proposal regarding this topic for further clarification in

the PPE Guidelines.

No 14 – Mouth-guards HCNB said that a few NB certified mouth-guards. One of them had already explained that they

were certifying mouth-guards against the Directive and used an old British document as a basis for

that.

The Chairperson asked whether that document was a British standard or just some sort of

technical document.

HCNB said that she was not sure about the status of the document but it had a reference no.: BS

DD253.


CEN-CENELEC said that she checked the status of prEN 15712 regarding mouth-guards. This had

received a negative assessment from the CEN-CENELEC Consultant. So now the issue was to

resolve that negative assessment. A new draft was to be expected shortly.

The Chairperson concluded the topic and said this action point (13) would stay on the list for the

next WG meeting. No 14bis – Hearing protectors FRANCE said the problem was that the protection offered by ear muffs was overestimated and

protection should be brought in line with real life situation. Nevertheless she had no time to deal

with this issue. She did not wish to leave the topic on the list.

The Chairperson concluded to delete this point from the list of action points and asked FR to

report at future meetings on this issue in case of new information would be available.

No 15 Borderline between the PPE and the Toys Directive

The Chairperson said that the updating of the PPE Guidelines was in the pipeline.

No 16 – UK Formal objections on EN 353-1 - Personal Fall Protection Equipment – Guided Type Fall Arresters The Chairperson said that comments were received from GERMANY, ITALY and the CEN-

CENELEC Consultant. This issue would be dealt with under agenda item 7 on formal objections. No 17 – DE Formal objection on EN ISO 4869-4 – Acoustics –Hearing protectors

The Chairperson said that DE was asked to invite their expert on presenting the topic.

This issue would be dealt with under agenda item 7 on formal objections.

No 18 – Context of harmonised standards The Chairperson introduced the topic. A document from FRANCE suggested that there were

different levels of requirements for equipments based on whether they were intended for private or

professional use. FR also sent a document listing relevant problematic standards.

CEN-CENELEC said it had contacted the relevant CEN TCs and received two categories of

replies:

1) Distinction was made to take into account specific risks. For example: EN 172 Personal eye

protection - Sunglare filters for industrial use where the specific risk existed in industrial

environment only.

2) Distinction was made when the standards were first published in order to enable the TCs to

proceed and achieve more rapidly a harmonised European standard. And for some cases of the

standards listed by FRANCE revision was under way and for many of these cases the distinction

was given up.

FRANCE said that they wanted the distinction to disappear except the cases where it was

appropriate. For example for high-visibility jackets there were two standards but their existence was

not justified.

Action point 14 CEN to send the comments of the TC to COMM on why there were different

levels of requirements for equipments based on whether they were intended for private or

professional use in their standards.

(In the light of that the WG could clearly see whether the practice was justified or not)

The Chairperson with this action point concluded the topic.

No 19 Recommendation for Use Sheets

The Chairperson said that the RfUs in question was circulated for comments after the previous

WG meeting and no comments were received. So according to the rules this RfUs should have been

deemed as agreed by the WG. But during the Editorial Group meeting on the revision of the

directive he learnt that there was a need to present this document again. So exceptionally it was


tabled on the day again to discuss the possibility of time limitation of RfUs. He added that a similar

solution was applied in the field of the Machinery Directive.

FESI supported the document in principle. But this should not ultimately open the door to

cumbersome and costly processes for manufacturers. He believed this was also agreed by the

Editorial Group.

ESF agreed with FESI. He added some sort of procedures, guarantees should be provided against

misuse of time limitation.

The Chairperson said he believed the NB consisted of decent people and they would not use this

possibility to create only more business for themselves. He pointed out that NB was independent

and it was not the task of this WG to regulate this aspect. Nevertheless he added that the points of

views were recorded in the minutes and assured stakeholders that malpractices could be brought

before the WG.

No 20 PPE ADCO –comments from the Chairperson

The Chairperson said that the issue of work clothing and other clothing with retro-reflexive strips

was put on the agenda under item 6.

End of day 1

Day 2

COMM welcomed the delegates on the second day.

6. Scope

Syriguard – needle stick prevention

BELGIUM introduced the topic. The product was designed to prevent injuries of personnel dealing

with needles. She said that in her opinion the product corresponded to the PPE definition.

Nevertheless responses to an earlier email sent out on the subject showed that stakeholders in the

WG were not on the same opinion.

The UNITED KINGDOM said that if the needle stayed in the holder then they would say it was

not PPE.

GERMANY said that the product was not PPE. It did not correspond to the PPE definition.

IRELAND agreed with the UNITED KINGDOM and GERMANY.

SWITZERLAND said it was a PPE. The main danger was that the medical personnel would stab

themselves with the needle so it gave protection against that risk and in addition it was held.

SPAIN and ITALY did not consider it as a PPE.

The Chairperson concluded that the product (Syriguard) was not a PPE.

Follow-up of action point from meeting on November 2008. No 5. – Scope of Directive - Ice tools

The Chairperson said that as agreed the day before FESI´s expert was present to give a

presentation on the topic.

FESI (Mark Held from European Outdoor Group) said he brought along two more experts: Alan

Hinkes, Britain’s leading high altitude climber and Antonio Codega, company owner.

The presentation was then given: In a nutshell, the first ice tools were manufactured in the late

1920s as a progression aid. In the 1970s the first ice axes appeared to be used also as an anchor

point, a protective device. It was emphasised that in many situations during climbing the climber’s

and his partner’s lives depended on it. Then a video on how to use the ice tool as an anchor point

and some samples were shown.

Mr Held, concluding on the point, emphasised:


Ice pitons were already classified as category 3 PPE,

There were often situations where there was no alternative solution than to use it as an

anchor,

Alpine snow slopes had no available rock features; an ice tool was therefore the sole

protection against falls from a height.

The ice tools responded to the definition of PPE in the directive.

Therefore ice tools should be recognised as category 3 PPE and standard EN13089 should be given

the status of harmonised European standard supporting the PPE Directive.

Mr Codega added that the relevant part in the Categorisation Guide did not use the appropriate

terms used by the climbing community. Therefore they proposed to modify the terminology.

FESI said that the European Outdoor Group was a member of FESI.

The Chairperson thanked for the presentation. He said that several issues were discussed:

1) Categorisation of ice tools;

2) The terminology used in the Categorisation Guide.

CEN-CENELEC said that CEN TC 136 agreed with the proposal to have ice tools classified as

PPE. In addition prEN 13089 had been put to vote but was delayed waiting for the outcome of this

discussion.

FRANCE said that it was an interesting presentation. She said that the argument put forward were

convincing that now ice tools were part of the technique and not only used for progression. But she

was wondering whether the debate was about the technique or a tool that would fall under the PPE

directive. As she understood not all ice tools could be used as an anchor point. So she raised the

question those then were not PPE? This would mean that there were two types of ice tools: so the

question arose how the market surveillance authorities could make a distinction between these two

types of ice tools then?

She also remarked that the samples of ice tools that were passed around the table had already CE

marking with the id number of a Notified Body. How that was possible, she raised the question if

the WG was about to decide on their status as regards the scope of the PPE Directive?

The Chairperson said that the last question was an interesting one, ice tools having the NB id

number 0123.

The UNITED KINGDOM said that the arguments were convincing so she agreed with the

proposal from FESI.

FESI responding to FRANCE´s question said that all ice tools could be used as an anchor point.

Even a banana shaped ice tool had the necessary surface area and strength for that purpose.

The Chairperson said that this was good to hear so then the market would not be disrupted in case

the WG decided that ice tools were PPE.

FRANCE asked whether prEN 13089 contained tests to test the reliability of these anchor points?

FESI said that the answer was yes.

The Chairperson added that before its publication the CEN-CENELEC Consultant had to also

evaluate the standard whether it really satisfied the requirements of the PPE Directive.

GERMANY said that he was surprised that CEN and the NB decided to CE-mark these ice tools

without coming to this WG for decision.

The Chairperson said that this did not concern CEN. The NB decided to certify a product or not,

over which CEN had no control. He nevertheless agreed with DE that the question was pertinent of

why an NB certified products regarding which the WG had not yet decided.

He added that the message had to be sent to the NB via both channels, the HCNB and the Member

State, responsible for that NB, that this was not acceptable.

Nevertheless he suggested to decide first on the original question whether ice tools were PPE or

not?

The WG agreed with FESI´s proposal therefore the Chairperson concluded that ice tools were

category 3 PPE.

FRANCE raised the question that what happened with the ice tools already being placed on the

market. Should they have the CE-marking too? Should then those be withdrawn from the market?

The Chairperson agreed this was an important question.


The UNITED KINGDOM said that according to the id number the Notified Body concerned was

TUV from Germany.

GERMANY said that they would get in touch with TUV on this issue.

HCNB asked what exactly COMM wanted from the Coordination to do? To contact TUV saying

that what they did was not right even though it was found ok by the PPE WG after all?

Notified Bodies got their notification according to their field of expertise. Very often they dealt with

innovative products where they had to take a decision on whether to certify it or not. And it was not

an appropriate way to them to tell the manufacturer that before being able to certify the product the

NB had to contact the PPE WG and wait at least 2 years for a decision. (Whether it was in the scope

of the Directive or not)

The Chairperson said the role of the HCNB was to make sure that the NB acted the same way.

Therefore the WG expected the HCNB to tell TUV about the appropriate way to proceed with such

issues.

As regards the second issue he understood that the tasks of the NB in many cases were not easy and

sometimes the decision of the WG took some time. But there were other possibilities to make the

decision-making faster, should any particular reason require that (e.g. written procedure). So in this

case it should have been signalled to the HCNB, which then should have passed that on to the WG

that there were already requests for CE-marking in the field therefore an early decision was needed.

But after all when it came to the interpretation of the scope of the Directive that was the task of the

PPE WG including all stakeholders. This was in particular true for a topic that had been discussed

several times in the WG as not all stakeholders agreed on it before.

FESI said on the question from FR that he believed that all ice tools placed on the market till date

were CE-marked. So if this was correct then the situation would be the same as for other PPE where

the relevant harmonised standard was under revision. And this was the case for the ice tools

standard.

The Chairperson said he understood that the standard on ice tools was just being developed and

not yet published.

FESI replied that the standard already existed but had not yet been given the status of European

harmonised standard.

CEN-CENELEC said that as referred to before the next revision of the standard was put on hold

awaiting the outcome of this discussion.

GERMANY said that the standard existed but had not yet been published in the OJEU and it did

not mean that the articles (that of the standard) were in conformity with the Directive.

FRANCE agreed with GERMANY. She also believed that most of the ice tools placed on the

market was CE-marked. But she disagreed with FESI and did not think this was a typical case for

the revision of a standard. He believed the work had to be started from the beginning. Now that ice

tools were PPE, all equipment needed to be checked again for the requirements.

The Chairperson asked the opinion of other authorities how they would now tackle with this issue.

ITALY agreed with the categorisation of ice tools. But he was also worried about its implication on

market surveillance. He emphasised it was important to decide when the CE-marking started.

The Chairperson agreed with ITALY. It was also important to say that this decision should not

have a retro-effective effect. Further he asked for the cooperation of the manufacturers to transmit

the message to manufacturers that they had to apply the Directive fully.

FESI agreed with FRANCE. He believed that though the standard was not listed in the OJEU but it

did satisfy the requirements of the Directive.

The Chairperson said he believed that legally speaking it was not possible to apply this decision

on products already placed on the market. But from now on ice tools could not be placed on the

market without fully complying with the PPE Directive.

Ha also understood that the market surveillance authorities worked according to yearly plans and it

was very difficult to introduce new items during the year. But he asked the Member States to check

the market on their territories in terms of ice tools. He added that at the next meeting COMM would

do a “roll call” asking for the relevant experience of Member States.


Action point 15 HCNB and GERMANY to get in touch with the NB certified ice tools prior to the

decision of the WG and tell them it was not appropriate to do so.

Action point 16 All to comment on the FESI paper regarding the terminology used in the relevant

part of the Categorisation Guide. Then COMM to update it accordingly.

Action point 17 Member States to check the situation in terms of ice tools in their territory.

The Chairperson with these action points concluded this agenda item.

6. Scope (continued)

Work clothing and other clothing with retro-reflexive strips

FRANCE said that at the last PPE WG meeting this topic was referred to by FR.

(case 1) On the market there was ordinary clothing with retro-reflexive strips around the leg, torso

or bottom of the arms. The question was whether such clothing was a PPE or not? In FR´s opinion

the answer was yes as the retro-reflexive strips did signal the person’s presence. But manufacturers

disagreed with the FR Authorities saying those were not manufactured according to standard EN

471 High-visibility warning clothing. The FR Authorities disagreed with that saying it was not the

standard that defined the scope of the Directive and on the other hand the fact that they were not

designed according to that standard did not mean they were not PPE. In Annex II of the Directive

under point BHSR 2.1.3 there was the requirement to signal the presence visually and for this

reason the FR authorities thought this clothing fell under the scope of the PPE Directive. They

suggested making a distinction by saying:

1) High-visibility jackets which were designed according to EN 471 those were visible by day and

night.

2) The clothing subject to the discussion was mainly visible by night when light reflected on the

strips.

So the FR authorities thought the latter were also PPE even without the application of EN 471.

Therefore the question was raised whether the WG agreed with this interpretation.

(case 2) Other type of equipment also appeared on the market (doc. PPE/09/1/4bis).

She said that before such clothing for hunters was camouflaged but due to accidents in the past now

the hunters wanted to be visible. So the question was again raised whether the clothing was PPE or

not? (It was an orange jacket made of fluorescent material.) The clothing was not visible during

night but given the fact that it was made of fluorescent material they were indeed visible during

daytime which was the reason why the jacket was worn.

(case 3) And a third case was a jacket, like a high-visibility jacket but it was purely fluorescent

yellow without the retro-reflexive strips.

So one could see that it was a broad market. This really led to confusion with the high-visibility

jackets. Therefore it was important to decide on the issue and then either create a standard or some

kind of classification within the existing one, not just for high-visibility clothing but for visibility

clothing which could cover all this clothing.

The Chairperson thanked for the introduction. He suggested separating the issues and discussing

them one-by-one.

So the first question regarded case 1. He wished to recall that ordinary work clothing was not PPE

as those did not give any protection but prevented the wearer from getting dirty. But in this case as

described above the issue was more than that. In his opinion the wearer of the clothing expected

additional protections due to its retro-reflexive strips and the manufacturer had also a reason why

those were on the clothing. He wished to recall though that the intention was not to categorise any

clothing having a small retro-reflexive stripe as a PPE.


ESF wanted to point out the issue that the Chairperson had just done. He raised the question where

the borderline was between products? There were lots of products on the market e.g. sport shoes

with small retro-reflective strips. Or another example was what if the clothing had only one strip?

The Chairperson said that the borderline cases were the difficult ones. That was why the WG was

created to sort such issues out.

FESI agreed with ESF and COMM. He added that in order not to open a Pandora box , it was better

to keep this clothing out of the scope of the Directive.

GERMANY agreed with ESF and FESI. In case the WG agreed these were PPE then the

authorities would face difficulties. For example school rucksacks with reflective strips could end up

being a PPE depending on the dimensions of the strips. It was important to think about the intention

of the manufacturer. So in his views these were category 2 PPE.

The Chairperson asked for clarification whether DE considered these PPE or not?

GERMANY clarified they did not consider them as PPE.

SPAIN said that for such clothing design as well as optical requirements were equally important to

make sure that visibility was guaranteed. On the equipment with limits for use, which was supposed

to protect and give visibility when lit up by lights during night. So it was difficult to set limits but

maybe there were situations where it was necessary to signal the presence of the user in night

conditions only. And fluorescent materials often had other problems, e.g. durability, transpiration,

etc. So in some cases it was maybe a good idea to have protective equipments only used for day or

night use.

ITALY thought there was confusion here. The trousers with reflective strips were PPE. But one

could place these with or without CE-marking on the market. A similar case was that of reflective

stickers and key-rings. There it was also said those had to provide a minimum amount of visibility.

He thought such clothing was PPE. On the single orange coloured jackets there was a problem. That

was less clear how those could be PPE.

The Chairperson said it was important to answer two related questions:

1) whether the products brought up by FR were PPE;

2) If yes, were they compliant to the Directive or not?

IRELAND said that according to the PPE definition any device designed to be worn for protection

was PPE. So the orange hunters´ jacket was designed for that while for the children’s jacket was

not. And as for the trousers with the retro-reflexive strips, they seemed to be designed for

protection.

The Chairperson asked the WG whether the trousers with retro-reflexive strips were PPE?

SWEDEN said that if the WG decided these were PPE then it would cause a problem. So in their

opinion these were not PPE.

The Chairperson invited SWEDEN to further elaborate why that would cause a problem.

SWEDEN responded that there were too many kinds of equipments with retro-reflexive strips and

that would create a big problem.

The Chairperson said that nevertheless looking at the clothing one could assume that it was bought

as users expected protection by wearing it.

SWITZERLAND said it depended on how it was marketed. If it was marketed as a PPE and its

main function was protection then the WG should consider it as a PPE. But if it was marketed as a

work-clothing which had the benefit of retro-reflexive strips then it should be considered as work-

clothing. In addition he raised the question on what IE referred to: what did “designed for” mean?

The Chairperson reminded that deciding on the scope of the Directive was the task of this WG and

no other market players.

FRANCE said the BHSR 2.13 of Annex II was very broad. This BHSR referred to foreseeable

conditions of use and looking at the hunters´ clothing for example one could see that the

manufacturer’s intention was to signal the presence of the user. This was also true for the clothing

with strips, the principle was the same. It was true that this might cause some problems but with the

revision of the New Approach framework market surveillance authorities would be given the means

to carry out their activities properly. So rather than being scared of the problem this should be


tackled by the authorities. So as a conclusion these were all PPE which had to comply with the

various requirements of the Directive.

In addition at the last WG meeting the decision was taken that reflective stickers and dangle tags

were category II PPE. Therefore consistency was needed here with that decision.

The UNITED KINGDOM agreed with IE and FR. The PPE definition and the requirement in

Annex II gave the answer: These were all category II PPE.

SWEDEN was wondering if these were decided to be category II PPE then what would happen

with ordinary clothing such as running shoes with retro-reflexive strips?

The Chairperson reminded that only clothing being discussed was subject to the discussion and

that was why he said that the purpose of the debate was neither to try to find new markets nor to try

to include sports clothing etc. into the scope of the Directive.

In addition as the UNITED KINGDOM and FRANCE rightly pointed out looking at the PPE

definition and BHSR 2.13 these should be category II PPE. He did not think that the manufacturer

put the retro-reflexive strips on the clothing for fashion purposes. It did not look like that anyway.

POLAND did not consider such clothing was a PPE. It was an ordinary working clothing with

strips.

GERMANY said it was not PPE.

FRANCE understood that this was a complex subject. There was a need to find a solution for the

broader question and draw a line somewhere on what was PPE.

Therefore she had two proposals:

1) Once a piece of clothing has retro-reflexive strips going around the arm, torso or the leg

then the purpose was to be seen. It was true that such strips were also used for fashion

purposes but those could be excluded.

2) In the review process of the Directive the WG could say visibility clothing were not PPE

because visibility was not really a protection. It did not protect the user from being crashed

for example. It was a type of indirect protection. Therefore a radical solution would be to get

rid of the relevant requirement from the Directive and exclude all high- visibility clothing

from the scope of the Directive which would solve the whole issue.

ESF said that in standard EN 471 there were requirements on how the strips needed to be placed

(circle around the torso etc.) and there were also limits on the maximum of how that could be

interrupted.

Action point 18 All to send comments on whether such work-clothing with retro reflexive strips

was PPE or not.

The Chairperson said the next question was about the hunters´ jacket.

FINLAND said that in FI under national regulation hunters were required to wear jackets in red or

orange colour. In FI so far the thinking was that the mere colour did not make the clothing/jacket

PPE, it was only the case if the clothing had fluorescent material also.

The Chairperson emphasised that this issue was a sensitive one care had to be taken because not

everything with bright colours was PPE.

ITALY said that there were also certain national requirements for hunters in IT as well. According

to these hunters had to wear high-visibility jackets, like the one according to standard EN 471.

GERMANY said they had also rules in this respect. In addition it was important to examine how it

was placed on the market. If it was put on the market to protect the wearer by making him/her more

visible, then it was a PPE.

The Chairperson asked FR for clarification: was the hunters´ jacket made of fluorescent material

or only the orange colour was there to signal the presence of the user?

FRANCE said that the jacket in question was made of fluorescent material but no retro-reflexive

element was used. In this case the manufacturer claimed that the jackets gave protection to hunters.

ESF said that in standard EN 471 the combination of daylight and night visibility was referred to.

This meant the application of fluorescent and retro-reflexive materials. In the standard there were

three colours defined as fluorescent colours. The retro-reflexive material only worked during night


when light is shone on it. In his opinion the jackets in question with fluorescent orange colour gave

more protection than a pair of trousers with one retro-reflexive strip on it (for example when

hunting with no light shining on the jackets.) It was important that the user was informed about the

correct application of such garments.

The Chairperson said that in his opinion the hunters´ jacket in question was a category 2 PPE.

FESI was concerned that this topic might bring some confusion on what was PPE or not.

GERMANY agreed with the Chairperson as to the jacket being category 2 PPE.

The Chairperson emphasised that the decision if taken would concern this particular jacket as it

seemed not possible to have a general solution. If needed then other equipments would have to be

discussed one-by-one by the WG.

IRELAND said that the jacket did not correspond to the requirements in Annex 2 BHSR 2.1340. So

it was not a PPE.

ESF said that he understood that fluorescent material emitted direct radiation, while the

“reflected…” bit in BHSR 2.13 was referring to the retro-reflexive material.

The Chairperson agreed with ESF as the jacket corresponded to BHSR 2.13. He also wished to re-

phrase the question: the question was whether hunters´ jacket made of fluorescent material and

claimed to give protection by the manufacturer was PPE or not?

POLAND considered it not being PPE.

PORTUGAL said that the jacket was PPE.

As the rest of the WG supported the proposal the Chairperson concluded that the hunters´ jacket in

question made of fluorescent material to signal the presence of the users was category 2 PPE.

FESI asked if both examples of hunters´ jackets were then considered as PPE.

The Chairperson replied yes. Both were considered PPE since they were made of similar materials

for the same purpose and also claimed by the manufacturer to give protection by signalling the

presence of the user.

Beekeeper veils

FRANCE introduced the topic. The question was whether or not such product worn by beekeepers

was PPE. FRANCE´s opinion was this was PPE category 2. The issue was discussed at the PPE

ADCO group meeting, where the Member States agreed it was PPE but they could not agree on the

category. The reason was that many considered the risk being minor but some said that people

could have allergy against bee-bites which then could have serious consequences.

HUNGARY said these were PPE category 2.

The UNITED KINGDOM agreed with FRANCE and HUNGARY.

GERMANY said it was a PPE but was not sure on the category. In any case they could accept

category 2.

FESI agreed it was a PPE. Nevertheless he considered it as category 1 rather than category 2. In his

opinion the product corresponded to the definition of category 1 where the user could in good time

identify the risk.

SWITZERLAND said it could only be a category 2 PPE because in the exclusive risks in Article 8

(3) for category 1 PPE one could not find the risk such product gave protection against.

The Chairperson raised question who disagreed with the categorisation of beekeeper veils being

category 2 PPE. As no further comments were expressed the Chairperson concluded that

beekeeper veils were category 2 PPE.

40 2.13. PPE in the form of clothing capable of signalling the user’s presence visually

PPE in the form of clothing intended for foreseeable conditions of use in which the user’s presence must be visibly and individually

signalled, must have one (or more) judiciously positioned means of or devices for emitting direct or reflected visible radiation of appropriate

luminous intensity and photometric and colorimetric properties.


7. Standardisation

Formal objections

The Chairperson recalled that the two formal objections on the agenda were preliminary discussed

at the last PPE WG meeting. So since then delegations had had time to get accustomed with the

issues.

UK formal objection against EN 353-1:2002 –Guided type fall arresters including a rigid anchor

line

The UNITED KINGDOM said that he did not intend to repeat the full presentation given at the

last PPE WG meeting but to give a summary of the case.

As a result of serious concerns the UNITED KINGDOM launched its formal objection against EN

353-1:2002. The system was built up like this: the user wears a harness and a lanyard attached to a

slider. The slider moves up and down with the user, sliding along a fixed rail/cable attached to a

ladder. If the user falls the slider should detect that and lock on thereby safely arresting the fall.

However there is significant risk that the product could fail due to the deficient test method

described in standard EN 353-1:2002 because there is no test for all reasonable foreseeable

conditions such as fall backwards and fall sideways. These fall conditions are fully foreseeable due

to the circumstances in which such devices are used. Currently standard EN 353-1:2002 describes a

vertical drop test only. The consequences of failure of such an equipment is likely to be a fatality or

serious injury. In summary EN 353-1 does not presently address fall arrest performance for

foreseeable fall scenarios such as falls backwards or sideways from a ladder. This was compounded

with inadequate instructions for use. CEN and VG 11 had also recognised the standard as deficient.

VG 11 had already advised NB to carry out further tests in addition the tests in EN 353-1.

Therefore the UNITED KINGDOM suggested withdrawing the presumption of conformity from

EN 353-1:2002.

The Chairperson said that as he understood the main concern was that the test method in the

standard did not take into consideration the so-called “fall back” effect.

In the meantime COMM received comments from DE and the CEN-consultant basically agreeing

on the UK findings.

GERMANY said they agreed with the UK formal objection nevertheless they came to a slightly

different conclusion and solution. The UNITED KINGDOM suggested that the standard EN 353-1

should be completely removed from the OJEU while GERMANY suggested to leave the standard in

the OJEU with a warning. GERMANY agreed that the standard did not cover all foreseeable

conditions of use. Indeed the side/back falls were not covered by the standard and the standard

needed to be improved in this respect. But in their view this should take place at standardisation

level. Nevertheless as far as a clean fall was concerned, the standard met the requirements of the

Directive. The big problem was though that there was no harmonised testing procedure for NB.

The Chairperson recalled the comments from the CEN-CENELEC Consultant saying that the

standard was deficient. Now the issue was the way forward.

CEN-CENELEC confirmed that the revision of the standard was underway. Nevertheless this

process was slow. A formal vote was expected on the (daft) prEN in October 2009.

The Chairperson asked about any possible time-line when after the above-referred to formal vote

the standard could be published.

CEN-CENELEC could not give any specific date. But she said that if all was according to

schedule then it could be published in the first quarter of 2010.

The Chairperson asked the UNITED KINGDOM whether the warning suggested by GERMANY

was acceptable for them.

The UNITED KINGDOM said that the way forward was a decision for the WG. However when it

came to the German suggestions in their opinion the warning had to be clearer and simpler. The


suggestion said that “additional testing may be required…”. Nevertheless in this case additional

testing was required.

GERMANY was not sure that the obligation of additional testing was the right way forward.

The Chairperson said that the reason to make it an obligation was that the standard was missing

those tests.

FRANCE said that given the arguments put forward by the UNITED KINGDOM and the

comments made by the CEN-CENELEC Consultant it was reasonable to request CEN to

completely review the standard instead of publishing a warning alongside the standard.

The UNITED KINGDOM recalled that their preference would be to withdraw the reference form

the OJEU.

SPAIN agreed with DE to leave the reference of the standard in the OJEU and give a warning to it.

ITALY said they sent a report on a serious incident. They would prefer a full revision of the

standard. Nevertheless in that case the manufacturers needed to be advised on how to deal with this

issue.

GERMANY asked about how to proceed as CEN just said that a new version of the standard might

be available as of next year. In his personal experience Commission’s decision on formal objections

took a long time so it was possible that a new revised standard would available before the decision

on the formal objection was made.

The Chairperson said that the colleagues organising the 98/34/EC Committee meetings had

already been notified of the issue. And as soon as the PPE WG managed to discuss this issue, the

98/34/EC Committee would take it up as well.

FRANCE said that GERMANY might be right saying the new revised standard would get there

first but she emphasised that the consequences of the two procedures (revision of the standard vs.

formal objection) were not the same. In case of review of the standard then products certified under

the old standard could remain on the market. Nevertheless if the formal objection deemed to be

justified then products on the market might need to be put in conformity.

GERMANY said that the German position was clear, they recognised the problems with the

standard but did not wish it to be completely removed from the OJEU but to further publish it with

a warning.

SPAIN agreed with GERMANY.

The Chairperson asked all delegates to express their opinions on the issue. Therefore he called for

a roll call:

AUSTRIA supported the DE proposal.

BULGARIA not present

BELGIUM supported the UK proposal.

CYPRUS supported the UK proposal.

CZECH REPUBLIC supported the UK proposal.

GERMANY supported the DE proposal.

DENMARK supported the UK proposal.

ESTONIA not present.

GREECE not present.

SPAIN supported the DE proposal.

FINLAND supported the UK proposal.

FRANCE supported the UK proposal.

HUNGARY supported the UK proposal.

IRELAND supported the UK proposal.

ITALY supported the UK proposal.

LITHUANIA supported the UK proposal.

LATVIA supported the UK proposal.

LUXEMBOURG not present.

MALTA not present.

The NETHERLANDS supported the UK proposal.

POLAND supported the DE proposal.


PORTUGAL supported the UK proposal.

ROMANIA not present.

SWEDEN supported the UK proposal.

SLOVAKIA not present.

SLOVENIA not present.

The UNITED KINGDOM supported the UK proposal.

The Chairperson said that other stakeholders should also be given the opportunity to express their

views:

SWITZERLAND supported the UK proposal.

NORWAY supported the UK proposal.

HCNB supported the DE proposal.

ESF preferred to abstain.

FESI preferred to abstain.

ESA preferred to abstain.

CEN-CEBELEC preferred to abstain.

The Chairperson concluded that the PPE WG decided to remove the reference of standard EN

353-1:2002 from the OJEU. He said that this message would be communicated to the chairperson of

the 98/34/EC Committee.

DE formal objection against EN ISO 4869-4:2000 - Acoustics - Hearing protectors - Part 4:

Measurement of effective sound pressure levels for level-dependent sound-restoration ear muffs

The Chairperson asked GERMANY to introduce the topic.

GERMANY introducing the formal objections said there were two standards on testing procedures

for testing level dependent ear muffs:

1. EN 352-4:2001 "Hearing protectors - Safety requirements and testing - Part 4: Level-

dependent ear-muffs"

2. EN ISO 4869-4:2000: "Acoustics - Hearing protectors - Part 4: Measurement of effective

sound pressure levels for level-dependent soundrestoration ear muffs"

The first standard was used for EC-type examination in Europe and it described a test procedure

whereby sound attenuation was measured using microphones in the human ear.

The EN ISO standard envisaged a test fixture using a head simulator. This was very different41 from

a human being.

The following problems emerged regarding the EN ISO standard:

1. According to its foreword, the document was a technical report and not a standard. (Though at

European level it had been recognised as a standard)

2. As the artificial head was not designed for this purpose, the measurement results obtained were

neither representative of the user’s exposure nor sufficiently reproducible.

3. The procedure led to an overestimation of the effectiveness of the hearing protector tested.

During the review of the EN ISO standard the DE expert committee unanimously recommended to

withdraw the standard. Further according to RfUs of NB no CNB/P/04.015 the test method

described in EN 352-4 should be used for testing such devices. In addition, looking at the standards

on testing hearing protectors all three basic standards described that human test subject had to be

used for the determination of the protection level of this type of PPE.

Therefore as a conclusion DE suggested the deletion of the reference of EN ISO 4869-4:2000 from

the list of harmonised standards pursuant to Directive 89/686/EEC for personal protective

equipment.

41 The acoustic test fixture reflected the sound produced by a loudspeaker. The sound was reflected by the flat surface

of the acoustic test fixture. And the reflected sound waves interfered with the incoming sound waves which produced

so-called standing waves. In such situations the measurement results depended on the location of the microphone. If the

microphone was moved a little bit that would give different results and this was different from a human ear canal where

that could not happen to such an extent.


The Chairperson raised the question of how the document became a harmonised European

standard since it was clearly said in its foreword that it was a technical report? He opened up the

floor for comments.

SWEDEN supported the DE formal objection.

CEN-CENELEC responding on the process of becoming a European standard said at that time

there was a wish to make reference to the test method on a higher level than a “TR” (technical

report) as at that time “TR” did not exist at CEN level. The standard was developed by an ISO TC

which would not meet till the end of the year; therefore the formal objection was not yet considered

by them. At CEN level, in CEN TC11 responsible for the issue, there was no related work item on

the revision of the standard registered either. But when the standard was under periodic review in

2007, it was maintained with large majority.

The Chairperson said he understood that if the reference of the standard EN ISO is removed, there

would still be the other standard so the withdrawal should not create problems.

CEN-CENELEC agreed with that.

The Chairperson raised the question of who disagreed with the DE formal objection. As no further

comments were expressed, the Chairperson concluded the PPE WG supported the DE formal

objection. He added this decision would be communicated to the Chairperson of the 98/34/EC

Committee.

EN 61331-3 on PPE to be used in medical X-ray environment

The Chairperson said that the relevant standard has never been published in the OJEU. Though it

was assessed by the previous and the current CEN-CENELEC Consultant as well. Both said that at

this stage the standard would not meet the requirements to become a harmonised European

standard. The reason for raising this issue was that COMM felt there would be a need to develop it

into a harmonised standard. This issue was discussed before in the PPE WG and even though from

the minutes it seemed there was an agreement on it a formal decision was never taken. In the

meantime COMM received questions from stakeholders on why this standard was not developed

into a harmonised one. So COMM said that CENELEC which developed the standard informed

COMM that in case there was a need they could take up the work again. Therefore COMM raised

the question whether delegates considered there would be a need to have this standard harmonised

under the PPE Directive. In case the answer was yes then COMM would mandate CENELEC to

carry out the work. He added that there had already been a mandate from COMM to CENELEC on

this but due to lack of time it was not possible to verify that till the WG meeting.

GERMANY said it would be necessary to develop a harmonised standard for such devices.

Nevertheless there were lead free equipments available which were not covered by the referred to

standard. A new standard was drawn up by DIN, the German Standards Institute which looked at

the aspects of these devices as well. The German authorities suggested DIN to turn to CEN to try to

make sure that the standard became a harmonised one.

FRANCE wished to clarify the issue. Did the standard cover equipment designed to protect against

X-ray radiations? Currently many products giving protection against ionising radiations were on the

market. In case there was no harmonised European standard then how were they certified?

The Chairperson replied that helping NB on certifying such equipment was one of the reasons

COMM raised this topic. According to the information available to the COMM the NB used the

DIN standard and the EN 61331-3 standard as a basis for their certification.

FRANCE said that the information would be transmitted to their specialised body INRS. In any

case it was about time to create a harmonised European standard in the field.

GERMANY recalled that for lead aprons there was no problem. For such devices the EN standard

should be developed into a harmonised one. Another issue was the question of lead free

equipment/aprons not covered by that standard recently appearing on the market. The correct way

forward would be to develop the German standard into a harmonised standard also.


The Chairperson concluded that the WG agreed developing such standard into a harmonised one.

He also asked GERMANY and FRANCE to get in touch with their experts to help this process.

In the meantime COMM would examine the original mandate sent to CENELEC and update it if

necessary.


The report was given on recent developments in the CEN PPE sector. This included the following

topics:

Nomination of the new rapporteur for PPE CEN Sector Forum;

Revision of PPE Directive;

Amended Medical Devices Directives (Directive 2007/47/EC);

Recent developments in the CEN OHS sector.

The Chairperson asked CEN to transmit the revised interpretative paper on the relationship

between the PPED and the MDD to the CEN TCs.

Report by the CEN consultant

Point skipped as the CEN-CENELEC Consultant sent his apologies in advance for not attending the

meeting.

8. Report from the Coordination of Notified Bodies

HCNB said that the next HCNB meeting would take place in June where topics discussed at the

WG would be taken up. Another important topic for the meeting was on how to proceed with the

updating with the RfUs and in particular with the vertical ones.

The Chairperson said that BE, nominated as representative of Member States in that meeting, and

COMM would also participate.

9. PPE ADCO –comments from the Chairperson

FRANCE said that the last PPE ADCO group meeting in Paris was a closed session for Member

States representatives only. Various different issues were discussed which could be grouped as:

Results of market surveillance campaigns;

o The UNITED KINGDOM – PPE for extreme sports, e.g. skiing and mountain biking;

o FRANCE – PPE against chemical risks.

o Non-conform products that had been withdrawn voluntarily or by means of a safeguard

clause;

o Quality of work of certain Notified Bodies in light of lack of expertise, subcontracting;

Directive’s interpretation and conformity of products,

o Motorcycles clothing;

o Retro-reflexive strips on clothing;

o Relation between the PPED and the MDD;

Implementation of NLF Regulation.

o Market surveillance – institutional and legal changes had taken place in MS to prepare

for the requirements of the new legal act. The problem of lack of resources had remained

so far which hindered the pro-active market surveillance activity.

FRANCE in addition informed that CZECH REPUBLIC took over the ADCO chairpersonship.

The Chairperson recalled that the NLF regulation had the purpose of reinforcing market

surveillance in Member States.

ESF asked about the FRANCE and UNITED KINGDOM campaigns on specific products. He was

interested of getting more information.


FRANCE responded that the campaigns had just started so giving details was premature. But

preparing a global/summary report was an option at a later stage.

The Chairperson said that sharing general information on such campaigns would be useful.

Further he congratulated CZECH REPUBLIC for taking over the ADCO chairpersonship.

10. AOB

The Chairperson asked FRANCE if it was acceptable to deal with the custom-made products

question at the next meeting?

FRANCE agreed with the proposal.

Action point 19: COMM to put the issue of custom-made products at next WG´s agenda.

GERMANY asked COMM to request its Legal Service on the issue of what was PPE. (manual vs.

automatic)

Action point 10bis: COMM to request its Legal Service on manual-automatic issue.


The Chairperson said that the next meeting would probably take place in November 2009. This

however depended on the availability of meeting rooms.


ANNEX

Summary of Action Points to be followed-up at the next meeting PPE WG meeting on

November 2009

Version 31/8/2009

No. Agenda

no/

item

Subject Action

by


1 4 Revisions of PPE Directive

– Rescue equipment

COMM COMM to check consistency of the EN list in the OJEU.


– Sunglasses and PPE against sunlight in highly-reflecting environment

ESA

FESI

ALL

ESA and FESI to send report on the results of their consultation. Other delegations to provide contributions also, if any. COMM then will decide on the next step in light of the comment received.


– European /central registry for certificates

-Falsification

COMM COMM to examine the possibility of how to use the CIRCA system for disseminating information of falsified certificates.


CE marking

AT AT to provide a proposal to solve the question in light of the Impact assessment study.


- Dish-washing gloves for private use

FR

COMM

FR to send proposal to COMM on exact problem with washing gloves being outside of the scope of the Directive. COMM to include that into the table of IAS.


-Annex II

Protection against the harmful effects of noise (BHSR 3.5)

Mechanical vibrations (BHSR 3.1.3)

All All to send their comments on what were the problems and any possible draft options/solution to solve them.

COMM to decide on next step in light of comments.


-Annex II

Prevention of drowning (BHSR 3.4.)

All All participants to examine the relevant document uploaded on CIRCA regarding this point for possible comments.

COMM to decide on next step in light of comments.

8 5 Follow up of action points

Notified Bodies – cancellation of EC type-examination certificates

All

COMM

All to examine the relevant document no. PPE ADCO 18-10 and send their comments about it within 6 weeks. COMM to summarize the responses in a comprehensive table and to circulate via CIRCA.

9 5 Follow-up of action points

Equipment (harnesses) used by paragliders

All All stakeholders to send COMM their comments whether they considered such equipment as a PPE and if yes which category.


10 5 Follow- up of action points

Interpretation of the PPE (what

should be considered PPE? (Automatic vs. manually activated products)

All All to comment on document no. PPE/09/1/10. The topic to be re-discussed at the next PPE WG meeting

10bis 5 Follow-up of action points

Interpretation of the PPE (what

should be considered PPE? (Automatic vs. manually activated products)

COMM COMM to request its LS on the issue of what was PPE. (manual vs. automatic )


Reconsider exceptions in Guide regarding PPE and MDD

COMM COMM to examine the relevant examples (MDD-PPE) in the Guidelines


Updating of PPE Guide - To clarify comments on categorisation on “high-temperature environments”

ES

HCNB

ES and HCNB to send proposal to COMM regarding this topic for further clarification in the PPE Guidelines


Mouth-guards

HCNB

CEN

Check with relevant NBs how the certification of such equipment is done.

To report on any possible progress made to the relevant PrEN. (PrEN 15712)


Context of harmonised standards

CEN CEN to send the comments of the TCs to COMM on why there were different levels of requirements for equipment based on whether they were intended for private or professional use in their standards.


Ice tools

HCNB

DE

To get in touch with the NB certified ice tools prior to the decision of the WG and tell them it was not appropriate to do so.


Ice tools

All

COMM

All to comment on the FESI paper regarding the terminology used in the relevant part of the Categorisation Guide. Then COMM to update it accordingly.


Ice tools

Member States

Member States to check the situation in terms of ice tools in their territory.

18 6 Scope

Work clothing and other clothing with retro-reflexive strips

All All to send comments on whether such work-clothing with retro-reflexive strips was PPE or not.

19 10 AOB COMM To put the issue of certification procedures for custom-made PPE at next WG´s agenda.


EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Chemicals, metals, mechanical, electrical and construction industries; Raw materials Mechanical, Electrical and Telecom Equipment

MINUTES OF THE PPE WORKING GROUP MEETING HELD ON 29 APRIL 2010

Subject: Personal Protective Equipment (PPE) Directive 89/686/EEC Working Group Meeting – 29 April 2010


Chairperson: Ms Alexandra JOUR-SCHRÖDER, Head of Unit I4

EC Participants: Mr Joaquin CALVO BASARAN, Deputy Head of Unit I4, Mr Előd Ajtony DUDÁS, Mr Ian FRASER and Mr Mario GABRIELLI COSSELLU (ENTR/I4)

Item 1. Welcome

COMM welcomed those present.

Item 2. Approval of the draft agenda (PPE/10/1/1)

COMM informed the participants that Ms Jour-Schröder would join the group for the afternoon session. Further the following items would be discussed after the lunch break:

Item 4 (Revision of the PPE Directive) as well as the issue of Motorcyclists´ garments.

The UNITED KINGDOM asked that item 7 be moved forward on the agenda.

COMM replied that the item would be discussed definitely before the UK delegation had to leave.

Item 3. Approval of the minutes of the meeting 29 April 2010 (PPE/10/1/2)

The minutes were approved without modifications.

Item 5. Follow-up action points from meeting 29 April 2010 (PPE/10/1/1 – Annex)

Action point 1: COMM apologised saying that due to other engagements, such as the revision process this item had not yet been dealt with by COMM.

FESI (Federation of the European Sporting Goods Industry) asked about the status of the Editorial Group which was convened a few times for assisting COMM regarding the revision process. Did this group achieve its purpose?

COMM asked the participants to limit their intervention to the topic in hand as there was a time pressure due to the heavy agenda. Regarding the Editorial Group, he

http://www.fesi-sport.org/


said that the group helped COMM very much elaborating on the candidate elements of the PPE Directive for the Impact Assessment Study. Now as the Study was ongoing it could be said that the group achieved its purpose. Of course – as already expressed before – COMM appreciated the assistance of those experts having participated in that work.

Action point 2: COMM introduced the topic. The responds to COMM´s inquiry showed that the majority of stakeholders did not support the idea of categorising sunglasses into different PPE category.

ESA (European Sunglass Association) supported COMM. He recalled that in 2002 ESA had already sent a technical document setting out their reasoning behind this.

FESI said that after inquiring their members they were also on the opinion to not to change the categorisation of sunglasses.

Action point 3: COMM said that this issue had been discussed since the action point was created. The outcomes of those discussions were showing to the directions that using CIRCA for such purposes (uploading (allegedly) falsified EC type-examination certificates into the CIRCA system) did not seem the right step in this respect. He recalled that some Notified Bodies had already databases where one could see the valid certificates issued by those bodies. Another element in the discussion was that general practice showed that market surveillance authorities usually went to the source directly in case they had a suspicion over a certificate, i.e. they contacted the Notified Bodies (NBs) directly. Further element of the discussion was how to ensure that the information uploaded was correct. In any case COMM had preliminary contacts with the CIRCA administrators and access rights were an issue to be further discussed with them in the first place. He said that he would keep continue follow this issue up.

Action point 4: Done.

Action point 5:

Done. COMM further explained that after the lunch break the version of the table on the candidate elements of the Directive for the revision would be presented. This version was sent to the contractor carrying out the Impact Assessment Study (IAS).

Action point 6:

COMM said that there seemed to bit a degree of confusion regarding BHSR 3.5 and 3.1.3 as many understood that it was proposed to delete these requirements from the Directive. COMM clarified that only some references from these requirements were proposed for deletion. After having received the comments from stakeholders the relevant proposals were included in the table.

Action point 7:

Done.

Action point 8:

COMM introduced the topic. It was commonly know that NBs were required to notify their notifying authorities in case they withdrew a certificate. Nevertheless the issue here was when the manufacturer voluntarily requested to cancel certificates and in particular if this action needed to be notified by the NB to their authorities? He explained that this latter action was not required by the PPE Directive nor it seemed to be the case in the NLF Decision42 in its Article R28. Therefore he suggested

42DECISION No 768/2008/EC – OJEU L 218/82, 13.8.2008


agreeing with the proposal put forward by the Coordination of the Notified Bodies (HCNB).

Action point 9:

COMM said that there was a low number of responds to this action point that was quite discouraging. The issue was nevertheless very important as once the Working Group decided on it, all stakeholders had to follow suit. Therefore he proposed exceptionally to give some more time to those stakeholders who did not comment but wished to do so to express their opinion on the categorisation of harnesses to paragliders.

FRANCE wished to recall that this issue was being discussed during the last two PPE WG meetings, therefore it did not seem logical to further delay taking any decisions as many stakeholders waited for that decision. She reminded that paragliders´ harnesses as such were not PPE. However on the market there were harnesses that had foam reinforcement or airbags that during take-off and landing served as cushion the impacts. Therefore FR said that this latter category of harnesses could be considered as category 2 PPE.

COMM agreed with FRANCE that a quick decision was needed. Therefore he said that all who wished to comment would have 3 weeks to do so. After this period considering the previously and newly received comments COMM would make a decision.

Action point 1: All to comment on the categorisation of harnesses to paragliders. After that COMM to conclude on the result of the inquiry.

Action point 10:

COMM said that two question were raised:

1) The categorisation of avalanche airbags;

2) Could there be made any distinction between equipment that automatically provide protection and the ones that required the intervention of the user? He recalled the comment made by the CEN-CENELEC Consultant at the previous PPE WG meeting, where he said that in case it was decided that only equipment giving automatic protection was considered as PPE then a wide range of lifejackets would also be automatically ruled out of the scope of the Directive. Given the fact that in its scope the PPE Directive did not make such a distinction, therefore the Legal Service of the Commission was not consulted on this one. He considered that it should be understood that both kind of protective equipment fell under the scope of the Directive.

GERMANY agreed with COMM. Only the automatic ones could be considered as PPE.

FESI said that PPE should be protective as such. PPE needed to be protective even if the user was unconscious and could not activate some protection function of the equipment. This was FESI´s opinion expressed in May 2009.

FRANCE agreed with FESI. She said that many examples could be listed, such as the avalanche jackets. She would consider only the automatic equipment as PPE, with a possible exception as regards lifejackets as those were already in the scope. She also recalled that people wearing PPE tended to take more risks as they thought they were protected. In danger where the user might not be able to activate the protective function of the equipment for any reasons it was important that the equipment provided protection.


COMM said that this issue went back to the original discussion when it was said that the equipment needed some degree of intrinsic protection in order to qualify for being a PPE. He did not wish to further discuss the topic as the issue was already broadly discussed and the group would only be running in circles. He concluded that COMM would still consult the Legal Service of the Commission (LS).

FESI suggested providing a background paper to the LS in order to better reflect the opinion of the PPE stakeholders.

COMM agreed that such a document was needed to facilitate the decision of the LS.

Action point 2: COMM to contact LS on the question regarding automatic vs. manually activated products.

Action point 10bis: DONE.

Action point 11: DONE.

Action point 12:

HCNB: NBs received a document from ES (Spain) that was discussed in VG543. The issue in hand was a complex one. So he reassured that the NBs were working on the topics and the HCNB would put forward a relevant proposal as soon as it was possible.

Action point 3: Changing action point 12 of November 2009: HCNB to submit proposal to COMM on the issue of categorisation of “high temperature environments”.

SPAIN agreed with this proposal.

Action point 13:

COMM said that custom made products were being discussed on and off in the PPE WG. This issue also appeared to be a very complex one. He recalled that when organising a meeting with Matrix on the Impact Assessment Study, Matrix raised the question what was meant under the term “custom made”. He said that he was not able to give that answer and after verifying a wide range of documents – both for the PPE WG and for other field related ones – there was no such a clear definition that was once agreed upon.

He reminded that the issue in hand was on how e.g. NB certified custom made products, for example mouth-guards? He recalled the in the lack of a clear definition it was unfair to expect from NBs to give the answer that would fit all cases, but he hoped to expect an indication on the approach the NBs were taking in response to this matter.

He emphasised that there was also a standard in preparation (prEN 15712 - Mouthguards for use in sports - Safety requirements and test methods) that was helping this process hopefully in the near future.

CEN-CENELEC said that the relevant TC (Technical Committee) of CEN developed its final draft of prEN 15712). It was sent out for inquiry and the CEN-consultant gave a negative assessment on it. This delayed the process and as the delay was

43 VG 5 of NB – Protective clothing , hand and arm protection


too long the work item was deleted automatically. Therefore it was up to the TC to decide on creating a new work item on this issue or not.

HCNB said that this was the problem the NBs were facing. In the absence of a harmonised standard NBs were looking for non-harmonised standards, e.g. some NBs used an old British standard.

FRANCE feared that in the course of the discussion two issues were mixed up:

1) Specific problem with the standard itself and there the difficulties of defining mouth guards;

2) Custom made products in general. And here the point was that a product was made only one at a time for a particular user and there the standard would not change much. (Whether that product was a mouth guard or an orthopaedic shoe.)

The problem was how to deal with destructive testing for such products.

COMM agreed that it was difficult to economically justify the destruction of several products to produce only one. He understood that this issue was not an easy one which was also included in the table for candidate elements of the Directive for the Impact Assessment Study. He thought it was important to make distinctions between different custom made products as there were such ones that could even be subject to destructive testing.

Further he encouraged CEN to transmit the message to the relevant TC on continuing the work on the standard regarding mouth guards as there was a clear need for a common, harmonised approach in the field.

FRANCE said that another example for custom made products could be sunglasses with corrective lenses. Perhaps ESA could shed some light on how such products were certified.

Action point 4: (Mouth-guards) HCNB to check with relevant NBs how the certification of such equipment is done – Report back to COMM within 6 weeks.

MS to check how the certification of such equipment is done – Report back to COMM within 6 weeks. CEN is encouraged to re-open the discussion on relevant prEN.

Action point 5: ESA/FESI to check how sunglasses with corrective lenses were tested and certified.

ESA said that this issue rather concerned the lenses industry as they (ESA) did not produce lenses. ESA though had contacts with the lenses industry so they would try to get the required information.

ITALY said regarding sunglasses with corrective lenses that it was the final assembler who had to certify the product.

COMM that the discussion showed this topic needed further clarification He would contact the colleagues at COMM dealing with the Medical Devices Directive on how they saw this issue.

FESI said that they would also try to get some relevant information.

COMM concluded to follow this item up at the next PPE WG meeting.

Action point 14:


COMM introduced the topic, which was about standards containing different level of requirements which nevertheless were having the same scope but were distinguished for either professional or private use.

CEN-CENELEC said that the relevant TCs were contacted. The reasoning behind this practice was incorporated into the report from CEN (PPE/10/1/7).

In general, in some cases the distinction was introduced because it was felt to be easier for TCs to develop standards separately but in many cases these distinctions were – or were planned to be – given up. The distinction maintained for different requirements for professional or non-professional use was explained by the existence of different risks for these two areas.

COMM said that stakeholders were invited to comment on the relevant part of the CEN report after the meeting as well.


COMM recalled the role of the PPE WG was to discuss and to decide on issues regarding the implementation of the PPE Directive. This also included the issue of which equipment fell under the scope of the Directive. Therefore he hoped that the NB – certifying products according to the Directive before the WG decided on that particular product had been transmitted the message – that all stakeholders should act diligently according to their role in the European system as a whole.


Action point 17:

COMM said that only 3 Member States (CYPRUS, HUNGARY and FRANCE) replied to this action point on checking ice tools on their territory.

He reminded that this issue was raised 1 year earlier, therefore Member States had the time to check this.

BELGIUM said that they had also checked the Belgian market according to which they found 7 brands of ice tools and the main problem was that the instructions for use was never available in Dutch.

Action point 18:

COMM said that the question was on where to draw the fine line on what clothing with retro-reflexive strips belonged to the PPE Directive. He stressed the importance that the purpose of the discussion was not to create “new markets” for the PPE stakeholders but to make sure that equipment fulfilling the definition of the PPE was rightly understood by stakeholders and the relevant requirements were fulfilled.

This issue would be further discussed under agenda item 6.

Action point 19

COMM said that FRANCE agreed to drop this action point as the issue was now part of the Impact Assessment Study.

Item 6. High Visibility PPE


COMM said that this topic was being discussed for a long time and it seemed that at one of the recent PPE WG meetings44 the group managed to put an end to it. The issue in brief was to decide whether visibility accessories that were in the scope of standard EN 13356:2001 Visibility accessories for non-professional use - Test methods and requirements were PPE or not. It was not an acceptable situation that Member States followed different interpretations. At the meeting above it was decided that such accessories were in the scope of the PPE Directive. He recalled that that decision was also in line with the opinion of CEN TC 162 responsible for the elaboration of the above standard (PPE/07/1/3ter).

He reminded that it was always possible to remedy mistakes of the past. He added though that in order to reopen a discussion the group needed substantial grounds in order to preserve legal certainty.

One of the reasons to reopen the discussion was that following the relevant decision at the PPE ADCO Group meeting Member States brought practical examples to demonstrate how difficult it was to follow the above decision which created a real problem for the authorities.

FRANCE said that Member States´ market surveillance authorities were responsible for a very wide range of products and the authorities had the obligation to take decisions on those products. Therefore it was not possible to come to the PPE WG every time with individual products. Therefore FR would like to establish the border line between clothing containing retro-reflexive material which would not be PPE and clothing which increased the visibility of the wearer and would be considered as PPE.

Therefore FRANCE proposed that clothing having retro reflexive bands that encircled a part of the body, e.g. the arm, the chest or the leg would become PPE. So that the wearer could be visible in all cases and that would comply with the requirements of the Directive. In BHSR45 2.3. of Annex 2 to the Directive referred to clothing and it did not mention accessories. This approach would help stakeholders on how to draw the fine line referred to above. For example in case of a pair of gloves: were those considered as clothing or if those had retro-reflexive parts, then were those considered an accessory?

The same question might arise for shoes and so on.

In her opinion retro-reflexive stickers and dangling tags were not PPE and should go under the General Product Safety Directive46 (GPSD). So in that case such products would still be subject to legal provisions under that Directive.

COMM said that Mr Stig A. Schibbye, expert on high visibility products was invited by the Swedish Authorities to help to group better understanding the topic.

SWITZERLAND agreed with FRANCE. He proposed to withdraw the standard EN 13356:2001 as the PPE Directive only referred to clothing and not accessories. So he believed that it was time to correct the mistake made in the past. He recalled that the original version of the Directive was in French, which clearly referred to “vêtement” and that was not to be mixed up with accessories.

44 Personal Protective Equipment (PPE) Directive 89/686/EEC Working Group meeting 5 November 2008

45 Basic Health and Safety Requirements

46 Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (Text with EEA relevance)


COMM acknowledged that the French version was there first and that several mistranslations existed in the English version of the Directive. He nevertheless would not consider translating the French “vêtement”” into “clothing” in English a mistranslation. Even though the word clothing in English did not seem to be that strict in the sense of the word as its French “counterpart”.

Mr Schibbye said that categorisation of visibility products was always a problematic area. He recalled that according to the FR proposal all the clothing with reflective or fluorescent material encircling a body part should be PPE. In response to that he showed several examples where PPE (clothing) had retro-reflexive part but did not encircle any parts of the human body. He showed further examples according to which if the FR proposal, if followed; PPE should not be a PPE anymore. In addition, other examples where projected that showed how complex this issue was.

He recalled that the positive effect of the FR proposal would be that it was very easy to classify products.

Nevertheless the negative effects included the products that the end users perceived as PPE would not be classified as PPE by the authorities and then those would not need any type-examination. This was true the other way around as well.

Regarding the CH proposal to withdraw the relevant standard: He raised the question: that was not the purpose of the group to make sure that the users got good products in order to protect themselves, instead of finding out why something happened in the past?

He further emphasised that it might have the effect to generate more products on the market as there would be no control left over those. This included that as the control went down the quality of the products would follow that also. Therefore there was a need for third party examination to make sure that it was not happening.

Both FR and CH argued that the Directive referred to clothing. If the product attached to the clothing, then it was not part of the clothing? He raised questions about the validity of this discussion. Was the reason to get rid of some products as the group did not see their use?

In the Nordic countries there was a long tradition for using small but high performance reflectors.

In the late 1990ies lot of products came mostly from China. The fact of requiring EC type-examination for such products reduced the impact of this import. Meaning that this managed to keep most of the products on the market which were really effective. Statistical figures showed that between 8%-92% of population in Norway used reflectors depending on several factors. In Finland some products wear obligatory to wear for pedestrians. It was also important to emphasize that not all products provided safety during day time or night time.

Further there was a big difference geographically in terms of application of such products: i.e. Nordic countries used them a lot, while the southern ones did not.

During night time a dangle tag was much more effective because it was flashing as it moved.

As a conclusion he proposed:

To reject the French proposal. He nevertheless agreed that this was a problem area. So in case there was a consensus in the group to make more strict rules to categorising garments, not high visibility products then further analysis were needed;


As response to the Swiss proposal: to change the wording of the Directive to “clothing/accessories”;

To instruct the relevant CEN TC to make a more strict standard for such products. (As for this latter he added that the relevant TC was already working on a proposal as they also agreed that a reflective key ring was not a PPE.

COMM agreed that this issue was a complex matter and one of the reasons for the discussion was that it caused many problems for market surveillance authorities. Apparently the attempt to try to find a solution to the matter did not succeed fully as this topic was raised from time-to-time by different stakeholders.

He could not agree with stating that in case such products were not PPE then the quality of those would plunge and bad quality products from third countries would flood the European market.

He recalled that FRANCE proposed these products to fall under the scope of the GPSD. This would not mean that such products would stay without any control. They would then belong to that Directive’s legal requirements.

It seemed that the group would not be able to conclude on the day.

Further he proposed to set up an Ad-hoc group to further discuss this topic in detail with a limited number experts and then to put forward a proposal to the PPE WG. In addition he proposed to call upon the Machinery Committee47 for voting on the relevant future decision reached at this WG.

FRANCE said that she did not agree with the proposal put forward by the expert above on saying all accessories should stay PPE. That would not be admissible according to the PPE Directive. It was not about the percentage of a population using some products that determined the scope of a Directive. Nor was valid the argument that legal obligation of wearing some products made a products a PPE. (An example could be seatbelts in cars etc.)

Further she agreed with COMM that if these products were not PPE then they would come under the GPSD with harmonised standards. They would still be checked by market surveillance authorities. In conclusion it did not seem that the group was closer to solve this issue.

FESI supported the French proposal. He recalled that in their position paper the same proposal was elaborated referred to by FRANCE. There was a need for clear rules distinguishing what was PPE and what was not.

He did not hear any concrete proposal that would make him thinking of changing his proposal.

Action point 6: COMM to organise an Ad-hoc group meeting to discuss this issue more in detail. All stakeholders wishing to contribute to this process send their comments to COMM.

47 Article 6 (2) of the PPE Directive reads: The Commission shall be assisted by the Standing Committee, set up by Article 6(2) of Directive 98/37/EC (1), hereinafter referred to as ‘the Committee’. Please note that Directive 98/37/EC has been since replaced by Directive 2006/42/EC.


Session after the lunch break


Item 4 Revision of the PPE Directive – Progress on impact assessment study

The Chairperson explained that COMM was committed to carry out the revision process with full cooperation of all stakeholders. The PPE Directive – though- was not so new anymore still functioned well. However during the last 20 years, since the Directive became applicable, new developments (such as the revision of the NLF48), and the experience gained, justified the fine tuning of the Directive. Therefore COMM intended to put forward a proposal that was generally accepted by the stakeholders. But before arriving there, there was a need to identify of what should be done.

For that end COMM contracted an external contractor to carry out a study on this process. She recalled that COMM sent a letter to stakeholders asking for their cooperation with the contractor (MATRIX Knowledge Group), which was a crucial element in conducting the study successfully.

Matrix said that he was pleased to present the findings of the Study. He recalled that this was work in progress and therefore did not represent the final findings of the Study. Matrix was an international company that was present in the US, Europe and India. They had a great experience on conducting impact assessment studies to the Commission. As for the Study:

The purpose of the Study was to:

1. Assist the Commission services to carry out an impact assessment entitled "Legislative amendment of the Directive 89/686/EEC on personal protective equipment (PPE Directive)"

2. Collect additional market data on personal protective equipment to develop a comprehensive picture of the market for the production and use of PPE and the competitiveness of the PPE industry

The output of the study would feed directly into the Commission’s impact assessment and would be geared to respect the relevant impact assessment guidelines.

It should be noted that impacts of amendments of the PPE Directive needed to be assessed in terms of their impact on

• simplifying the existing regulatory regime

• reducing associated burdens for businesses (particularly SMEs) and Member States

• reducing the number/severity of accidents for users of PPE that are caused by i.e. quality problems in the production of PPE

In terms of time-scale the project was running till the end of January 2011. During the coming months Matrix would start involving stakeholders into the process.

48 Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC and Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93.


The Chairperson added that the study and the involvement of the stakeholders were not only to help COMM to do its work (impact assessment). Because as it was explained by Matrix the scope of the study was broader then just to look into particular issues of the legal text but also to have more understanding on the situation that the sector was facing in Europe and in the world.

SPAIN said that in the beginning regarding the revision of the Directive COMM only wanted to adapt the Directive to the New Legislative Framework. Now it seemed that COMM was prepared to go much further than that to carry out a complete revision of the Directive. Was this the case?

COMM replied that in 2008 when COMM announced the re-starting of the revision process, COMM stated that there were two problem areas in terms of the revision:

1) Adaptation to the Decision49 of the NLF;

2) PPE specific issues; as during the last 20 years experience had gained that there was space to fine tuning the Directive. That was the reason why this group worked on a table summarizing elements of the Directive in order to assess whether those elements were really in the need for modification. Therefore the answer to that question was yes.

The Chairperson thanked for the presentation and as no further questions were raised closed this agenda item.

Item 6. High visibility classification – Work clothing and other clothing with retro-reflexive strips

COMM introduced the topic recalling that before the lunch break the group had already touched upon on this issue when it was discussing the high visibility PPE agenda item.

There, COMM concluded that an Ad-hoc group meeting was needed to better reflect on the complexity of this topic. Therefore the purpose of opening this item was not to re-start the discussion taking place during the morning session but to allow Mr Wolfgang Quednau, an expert representing ETSA (European Textile Services Association) to give his presentation (PPE/10/1/16) on the topic to help the PPE WG members to better understand this topic.

ETSA in his introduction added that he was also the convenor of WG 7 of CEN TC 162 dealing with high visibility garments. Further WG 7 was responsible for 3 harmonised standards:

1. EN 471 High-visibility warning clothing for professional use - Test methods and requirements, which was under revision;

2. EN 1150 Protective clothing - Visibility clothing for non-professional use - Test methods and requirements

3. En 13356 Visibility accessories for non-professional use - Test methods and requirements

The distinction between EN 471 and EN 1150 was occupational related, whether it was for professional use or not. Now WG 7 was heading toward taking into account a risk related distinction and the occupational aspect would disappear. WG 7 was already preparing for the revision of the other two standards as well.

49 DECISION No 768/2008/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC


The risk depended on a combination of the likelihood and the severity of the event.

(Further ETSA gave his presentation that can be found in document PPE/10/1/16.)

COMM asked whether he understood right that standard EN 471 would cease to exist? So these two standards EN 471 and 1150 would be merged?

ETSA replied that standard EN 471 was the most important standard in the high-visibility area, therefore there were no intentions of deleting that. There was the revision process ongoing on ISO level and they were very close to finalising a proposal.

FRANCE wanted to get some clarification on the revision of standard EN 471. She understood that there was a draft proposal at ISO level: Would this draft ISO standard lead to the merger of standard EN 471 and EN 1150 or would that leave these two standards apart?

ETSA replied that the revision of standard EN 471 was a joint revision with ISO. For the moment the reference of the standard was EN 471 while in the future it would be ISO 20471. It did concern neither EN 1150 nor EN 13356. In the new standard the link related to “non”·/or “professional” use would be eliminated as that link would be a risk related one.

FRANCE said that the risk related principle was encouraging. However the existence of three separate standards in the field (En 1150, EN 471 and ISO20471) was an area of concern.

ETSA replied that when the ISO revision was finalised then the EN 471 would cease to exist and the new EN ISO 20471 would prevail.

COMM wished to thank for the presentation and with that he closed the discussion.

Item 6. Motorcyclists´ garments

The Chairperson introduced the topic. She said that this issue would definitely come up when the revision of the Directive would take place but reminded that at the moment the group was discussion issues within the framework of the current PPE Directive.

FRANCE asked to discuss clothing providing protection against climatic conditions for professional use and within this in particular garments for motorcyclists´ garments. She said that clothing that provided protection against the weather and they chose the example of clothing for motorcyclists´. She wished to remind the group for the general rule, according to which clothing for motorcyclists was not PPE as it was ordinary clothing. It only became a PPE if it offered additional protection against mechanical impacts. And in that case the entire item became category 2 PPE.

In Annex 1 to the PPE Directive there was an exclusion stating that PPE for private use against climatic conditions was not PPE. In the Categorisation Guide it stated that clothing that provided protection against weather conditions for private use was not PPE. However as soon as that clothing used in a professional context it became category 1 PPE.

This meant that one piece of clothing could became a PPE if it used by a worker/professional, whereas the same clothing was not PPE if it was used by an individual. This distinction caused the market surveillance authorities problems.

She raised the question whether ordinary rain constituted a risk? If so what risks?

Moreover this distinction did not seem relevant.

Therefore FR proposed that climatic condition would not be regarded as a risk. As a consequence clothing for providing protection against climatic conditions even if it was used by a professional would not be PPE. (An example otherwise could be that if somebody operated a motorcycle taxi, then the driver acting in his professional capacity

http://www.iso.org/iso/home.html




wearing clothing against the weather would be PPE while the same jacket worn by the passenger would not be)

Among the consequences would also be the update of the PPE Guidelines accordingly.

COMM said that this issue appeared to be a problem. The same could be said on the issue of gloves against heat for professional or domestic use. He nevertheless recalled that at the moment the group had to accept the text of the Directive and could not go beyond that.

He recalled that the Impact Assessment Study was ongoing on making sure that the future COMM proposal would contain all elements of the Directive that was in the need of modification. However adding new elements to the currently assembled table on those elements – on which this WG working for more than a year – would be very difficult at this stage. One of the reasons would be that when establishing a legal relationship with the contractor (Matrix) on carrying out the IAS, COMM presented the tasks to be carried out. So adding new elements to those tasks would be problematic therefore this seemed too late to be flagged out at this stage.

SPAIN did not understand COMM as he thought the revision process would be carried out in cooperation with stakeholders. That included the consideration of concerns of those stakeholders. He feared that in the absence of that the COMM proposal would receive strong headwinds.

IRELAND supported SPAIN.

GERMANY said that in GERMANY the employer had to bear the costs of the employees’ equipment. Looking at the French proposal, if adopted would entail that the workers themselves would need to cover those costs. That would be quite burdensome on the workers.

The Chairperson clarified that there was a need to make a distinction between the procedure and the substance. In substance it appeared that FRANCE and some other delegations had further issues with the Directive, while other stakeholders though seemed to be satisfied with the Directive as it was. Therefore it was not easy saying whether this issue was completely wrong or right.

She wished to re-ensure that COMM would look into every issues raised next to the ones concerning the NLF alignment. Therefore COMM would look into all issues. The end of that process however there would be a need to take a decision on what aspects of the Directive were in the need for modification. That might not suit all, but COMM intended to go for a direction that pleased the majority of the stakeholders and represented the real needs of the sector.

With this clarification the Chairperson closed the discussion.

Item 6. Respiratory protection against carbon-monoxide

FRANCE introduced the topic. Carbon monoxide (CO) was a very dangerous gas as it was odourless, therefore without a detector it was not possible to realise its presence in the air. Even a very small concentration in the air was fatal.

In terms of respiratory protective devices on one hand there was a harmonised standard EN 40350 which allowed to design masks which provided protection against carbon

50 EN 403:2004 Respiratory protective devices for self- rescue - Filtering devices with hood for escape from fire - Requirements, testing, marking


monoxide that were exclusively intended for purposes of evacuation. In other words once the presence of this gas was detected the individual put on the EN 403 mask that would be working for the period of evacuation. That mask could not be used while working. In parallel there were two other standards; EN 40551 and EN 1438752 which allowed designing protective respiratory devices that provided protection against various gasses and used different colours to let the user know against which gases the given mask provided protection against. Nevertheless these standards explicitly excluded carbon monoxide. So masks designed according to these two standards should not have a “CO” marking indicating that those provided protection against carbon monoxide as well. However there were masks on the market – designed according to these two standards (EN 405 and EN 14387) – that claimed to give protection against “CO” as well. So the question arose how those masks had been assessed and certified? What reference was used for the conformity assessment? And could the “CO” reference maintained on those products given the fact that these two standards in question excluded it.

Therefore FR proposed to provide explicit clear reference to the user that those masks did not provide protection against “CO”.

HCNB could not give immediate information on how these masks were tested. He wished to confirm what FR had just said that masks designed according to EN 403 provided protection against “CO” for a short period of time.

COMM said that in any case it was not acceptable that a person had to work in the presence of “CO”. As it was always quoted PPE should be the last resort, therefore there was the obligation to take organisational and other technical measures first to make sure that this very dangerous gas was not present in the workplace.

As for raising awareness on what gases certain masks provided protection against he said that, manufacturers had a role to play. Also CEN should be invited to check whether there was the possibility to improve the above standards in this respect.

The CEN-CENELEC Consultant said that the problem raised by FR had nothing to do with standards as those were perfectly clear, that one could not use the filters against “CO”. The problem was –if those filters existed on the market- who certified them and which manufacturers placed them on the market. Either a NB certified the product wrongly or the manufacturer falsified the certificate but this was not related to the standards in question.

COMM said even though the standards above excluded “CO” still NBs might had other technical specifications / knowledge on how to certify such products. The same applied to manufacturers, therefore he suggested taking a firm but cautious approach on trying to verify what was going on before starting blaming anybody on doing something deliberately wrong.

He asked the HCNB to check how NBs certified such masks.

HCNB agreed that the lack of a harmonised standard in the field was a problem. There was a DIN standard that was the basis for NBs in GERMANY. He added he was ready to check what was going on in other Member States but again the problem was the absence of a harmonised standard.

51 EN 405:2001+A1:2009 Respiratory protective devices - Valved filtering half masks to protect against gases or gases and particles - Requirements, testing, marking

52 EN 14387:2004+A1:2008 Respiratory protective devices - Gas filter(s) and combined filter(s) - Requirements, testing, marking


POLAND said that the certification of such masks should not be a problem as such filters could be classified as special use gas filters intended for use against gases recommended by manufacturers. The filtering of “CO” was not different (from filtering other dangerous gases) and they had a large experience of doing that.

The CEN-CENELEC Consultant said that it was not his intention to state that NBs were not doing their work properly. However as he understood the FR intervention; the filters on the market were certified according to EN 405 in which case those should not be certified as giving protection against “CO”. Those might be certified according to other standards but those could not be certified according to standard EN 405.

COMM agreed with the CEN-CENELEC Consultant saying that if only the standard was used for designing the product that excluded explicitly “CO” then it was not legally possible to claim the other way around.

FRANCE could not fully agree with POLAND. The two corresponding standards (EN 405 and EN 14387) explicitly excluded “CO”. So it was not possible to exclude “CO” and at the same time claim that such filters were part of some special gas filters.

Therefore the main question that arose was whether market surveillance authorities could prohibit masks that claimed to have been manufactured according to these two standards while at the same time claiming to cover “CO” as well.

COMM agreed that in this case by misleading the user could have very serious consequences. So market surveillance authorities had to take action.

ESF said that he sent out an inquiry to their members on this issue, but due to the short notice between the WG meeting and the dissemination of the corresponding document had not given any results yet. He agreed that in this case there was the possibility of misleading users, which needed to be looked at.

COMM closed this item by setting out the following Action point:

Action Point 7 HCNB to check with relevant NBs how the certification of such equipment is done. ESF to check how manufacturers produce these kinds of masks.

Item 6. Categorisation of type 6 protective clothing against liquid Chemicals

BELGIUM introduced the item. It seemed that there were different interpretations about the categorisation of the protecting clothing in subject. These PPE were considered by some stakeholders as category III but others considered them as category II PPE.

Looking at the PPE-Directive, PPE providing only limited protection against chemical attack or against ionizing radiation were category III PPE (art. 8, point 4a). As explained in the PPE Guidelines this limitation needed to be understood as the protection was limited in time. This meant that the reduction of the potential risk for direct skin contact could only be used for defined time periods as intended by the manufacturer and prescribed in the instructions for safe use.

The introduction and scope of the harmonized standard EN 13034 ‘Protective clothing against liquid chemicals - Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB [6] equipment)’ read: “Type 6 and PB [6] are intended to be used in cases where risk has been assessed as low and a full liquid permeation barrier is not necessary i.e. when wearers are able to take timely adequate action when their clothing is contaminated. Type 6 and PB [6] protective clothing form the lowest level of chemical protection and are intended to protect from a potential exposure to small quantities of spray or accidental low volume splashes”.


However, if a closer look was taken at the test method required in EN 13034, toxic chemicals like, for example H2SO4 and NaOH were used to determine liquid penetration and repellence.

There was no clear and straightforward argument for categorizing these PPE in either category II or III.

FRANCE said that after consulting a French NB, they confirmed that they dealt with type 6 protecting clothing as category 2 PPE. The reason for that was that in the Directive Article 8(4) was rather ambiguous on this referring to “limited chemical protection” which they did not really know what word limited meant. It was considered that this limitation referred to time as the chemical products were so aggressive that the protection was always limited in time.

In the field of application of the relevant standard for type 6 overalls, the limited term was used as well but there the meaning of “limited” was that it provided superficial protection. Comparing the tests to be carried out on type 6 and type 3 and 4 protecting clothing one could see there was no permeation test for the former which suggested that the protection was very superficial. So in fact type 6 clothing was intended in conditions were there was no accidental projection of chemical products foreseen, but if exceptionally such splashes occurred then the type 6 protecting clothing would provide sufficient protection to allow the user to clean himself/herself and get rid of the chemical agent. And this was the reasoning followed by France deciding that type 6 protecting clothing was category 2 PPE.

HCNB said that there was a RfUs 33 (CNB/P/00.033) dealing with gloves against chemical protection, where category 3 PPE was supported. The sheet stated that such gloves were category 3 PPE. Also VG 5 (No. 0513) adopted a vertical use sheet on the issue which said that these gloves should be category 3 PPE. These sheets were adopted and available on the EU website. These provided a clear direction that the PPE in question was category 3 PPE.

FRANCE raised the question whether that sheet on gloves applied to type 6 protecting clothing as well? So could the WG extrapolate that if gloves were category 3 PPE then type 6 protecting clothing was as well?

ESF recalled that there was a vertical use sheet from VG5 dealing with garments including type 6 coveralls. That sheet stated such garments were category 3 PPE. So he always understood this issue the same way and was surprised to see that some Member States had diverging opinions. Further he recalled that, this issue was not unique as other products such as welder’s clothing or protective equipment against cold had different category interpretation in different Member States.

COMM recalled that uniform application of the Directive was important. From the Commission side the answer was clear. As laid down in the PPE Guidelines on Article 8

(4) third intend such limitation was referring to limitation in time53! So in this term it did not matter how long the clothing gave protection against certain chemicals, 2 minutes or 2 hours because the protection had to be full for that period of time prescribed. Therefore the above mentioned Article of the Directive had to be understood that all such PPE were category 3 PPE.

53 PPE Guidelines (version 12 April 2010, page 23): PPE providing only limited protection against chemical attack or against ionizing radiation needs to be understood that the protection is limited in time. This means that this type of PPE that reduce the potential risk for direct skin contact can only be used for defined time periods as intended by the manufacturer and prescribed in the instructions for safe use.


Item 6. Lifejackets / buoyancy aids

IRELAND explained the background of the topic.

In 2006 / 2007 a number of standards were withdrawn in relation to lifejackets / buoyancy aids. But till date some manufacturers were still using the “old” standards for manufacturing and certifying such products. In order to clarify the situation Ireland wished to raise the following questions:

1. Withdrawn EN standards could not be used to show presumption of conformity to the basic health and safety requirements of the PPE Directive. Is this correct?

2. Withdrawn EN standards could be used to show conformity to the basic health and safety requirements of the PPE Directive. Was this correct?

3. Therefore if a withdrawn EN standard is still being used by the manufacturer, they are only able to CE-mark their lifejackets and show no marking on the label of the withdrawn standard. Was this correct?

4. If withdrawn standards could be used to show conformity then a new Declaration of Conformity is required. Was this correct?

COMM said that he did not wish to open the floor for discussion on these basic principles so he wanted to answer the questions as he did the day before at the PPE ADCO Group meeting:

For question 1: The answer was no. If the reference of the standard was withdrawn from the OJEU then that given standard no longer benefited from the presumption of conformity.

For question 2: The answer was it depended. It depended on what the changes meant in the new edition of standard.

When a revised standard became available, this did not entail that a product designed to the previous version of the standard could no longer be considered to comply with BHSRs and could no longer be placed on the market.

However, this would be true in the following cases:

- if the revised standard remedied a deficiency in the previous version of the standard (see, for example, the case of the standards for dust masks subject to a formal objection),

- if the revised standard marked a significant improvement in the level of protection that could be attained. In such a case, products designed to the superseded version of the standard could no longer be considered as reaching the "highest level of protection possible" required by section 1.1.2.1 of Annex II to the PPE Directive.

For question 3: The answer was no, meaning that the manufacturer could put the reference of the technical specification it used on the label of the product to meet the requirements of the Directive.

For question 4: The answer to this question was no. If the new standard did not improved the safety characteristics of the product then there was no need for change in this respect.

IE raised further questions:

1. If the latest version of a harmonised standard represented higher level of safety then were the manufacturers obliged to use that standard?

2. If the answer to that question was yes, then how that could be enforced? Who was responsible to enforce manufacturer to use the latest standard?


COMM recalled what he explained before according to which if the new version of the standard significantly improved the level of protection of a PPE then manufacturers – if they chose to use standards- had to use that latest version of the standard.

As regards the question on who was responsible for enforcement, the answer was that the Member States´ market surveillance authorities had the obligation according to Article 2 of the PPE Directive to make sure that only compliant products placed on the market. Enforcement was their responsibility.

COMM further explained that the reason for this topic being placed on the agenda was that in case of lifejackets the series of standards EN 39x were replaced in the OJEU by EN ISO 12402-X series in 2007 and it appeared that for some reasons manufacturers of lifejackets were reluctant to use the new EN ISO standards. This might have serious implications on the free movement of goods. That was why this issue was discussed at this WG meeting with the representative of EBI (European Boating Industry) to try to help understanding this phenomenon.

He added that as COMM had been addressed with this issue by several stakeholders COMM was also conducting its own inquiry to see why this was happening. But as the COMM inquiry was still ongoing he could not go into details.

EBI said that they also debated this issue within the industry as there were diverging interpretations of the issue. She was pleased to hear the answers provided to the questions raised by Ireland.

She added that on the question about responsibility of enforcement, they had their own recommendation that said that manufacturers were recommended to contact their Notified Body to see with them what had changed in the new standard and whether any further, additional steps in the conformity assessment procedure was needed to be taken.

She wanted to now explain why standards that were elaborated with the participation of manufacturers were not used by themselves, which seemed rather perplex.

One of the reasons was that during the revision of standards EN 39X new countries, mainly non-European ones pushed for more stringent testing limits and more difficult testing procedures also that were reflected in the EN ISO 12402-x standards now. This meant a real problem to the (European) boating industry as that lead to a more expensive conformity assessment procedure. So new lifejackets produced according to these new standards cost 20% more than the one manufactured according to the “old” series of standards. This placed a significant economic burden on the European manufacturers. This was mainly for example the case as the delegation that was pushing for the most for these tests was the US delegation who would use the new standards as of from 2011 due to some internal procedures where ISO standards had to be validated by the US Coastguards.

This also had a negative effect on European companies exporting products. So that was the reason why manufacturers for products that was marketed before the adoption of the new standards decided manufacturing and certifying them according to the old standards. Nevertheless the common understanding within the industry was that new products should be developed and manufactured according to the new standards.

There were two specific situations in two Member States, which were Spain and Italy.

In Italy last year (18 March 2009) a decree was adopted making reference to the new ISO standards and therefore it made obligatory to work with the new standards for manufacturers wishing to place products on the Italian market.

So she raised the question whether that move from Italy was legally compatible with European law in a sense that the Italian decree in question imposed the obligatory


application of a harmonised standard that by nature was of voluntarily applicable. So did this not raise any technical barriers to trade?

As for Spain, Spain decided that until the end of 2010 the installation onboard of lifejackets that were CE marked according to the “old” standard would be acceptable only if two conditions were met:

- If the lifejackets were at the distributor facilities before 28 February 2010;

or

- Lifejackets were ordered before 20 November 2009.

After the 31 December 2010 lifejackets manufactured according to the old standards would not be allowed for sale but only the lifejackets manufactured according to the new ones.

EBI was surprised about such decision and wish to hear the opinion of the WG on this one.

The reason why these questions were raised was, because on one hand the PPE Directive was not revised so far and on the other hand there was no evidence that the lifejackets manufactured according to the old standards provided a significant failure on achieving the BHSR of the Directive. So they did not see the old standards being potentially dangerous for the user. In addition she was informed that a series of amendments to correct the too strict elements of the new standards were proposed and being voted for so by the year end the new standards should be amended hopefully in a way that lead to lower testing costs. In 2011 these standards were also due to automatic review. Therefore this issue would definitely evolve in the next two years and that was the reason she was pleading for some degree of tolerance until the situation was fully set.

ITALY said he understood the conflict in the issue as the new standard cost more.

He added that standards EN 39X series ceased to give presumption of conformity on 31 March 2007. So they felt it was advisable to take action and require that the products needed to meet the requirements of the new standard.

He said that there were manufactures in Member States who kept continue producing lifejacket according to the old standard even though the old standard did not benefit from the presumption of conformity as of March 2007.

ITALY always said that if the certified product manufactured according to the old standard had already been sold then it could be sold up until the end of the lifecycle of the product. But manufacturers could not produce new stocks on the basis of the old standards, which he believed was the common agreement of this WG.

SPAIN said that this issue was debated yesterday in the PPE ADCO Group meeting in more detail and now this issue was only discussed in brief. He thought that the place of such discussions was at this PPE WG meeting.

Further on the issue itself, he said that harmonised standards applied in general in any community legislation so the same principle applied in every case. He thought that the PPE WG was deferring from the general principle, by taking another approach that was not logical. When a market surveillance authority, could not apply different criteria for different products. The approach was very simple: a standard that had been revised or had been cancelled for another standard then the old standard no longer provided presumption of conformity. And this applied for any product. Now, the IT colleague said that the old standard could be applied for a whole series of products, the Directive applied to individual products when those were placed on the market. Two identical products could be placed on the market in different time, and it was the time when the product was placed on the


market that determined the form of the Directive or standard to be applied. So the standard which was in force at the time of the placing the product on the market applied, otherwise the presumption of conformity did not exist and the product had to be placed on the market under the new standard.

Looking at the market in Spain, regardless of the Directive, products that had been put on the market in accordance with standards that had been withdrawn were not in compliance anymore. They might be in compliance administratively because the administrative requirements had not been changed but that it was an administrative infringement in a sense that it referred to a standard that had been withdrawn. So it was the new standard that gave conformity. If the manufacturer wanted to use the old standard he could do that but he could not use it as a harmonised standard giving presumption of conformity. This was to do with technical specifications. If the market surveillance authority were to look at the product to verify it complied with the standard then the authority also needed to verify whether the old standard met the requirements of the Directive.

ITALY said that he agreed with ES on saying that once a standard was withdrawn then it could not be used for products as the presumption of conformity was given by the new standard.

FRANCE addressed the question to CEN on asking why part 1 and 7 of the standard series of EN ISO 12402 on lifejackets had never been published in the OJEU?

COMM said that before giving the floor to CEN it was important to clarify some basic principles:

The presumption of conformity was a legal status given to a standard of which reference was published in the OJEU. This meant that in case the manufacturer chose to apply such standard, and the standard covered all the relevant BHSRs, then the manufacturer did not need to show in any other way that his product complied with the requirements of the Directive.

The manufacturer could use any other technical specifications he wished to use to manufacture his product. But the bottom line was that his product had to comply with the requirements with the Directive. And as explained above the existence of a new standard did not mean automatically that products manufactured according to the ´old´ standard(s) became automatically unsafe and could not be placed on the market anymore. That always depended on a thorough analysis determining what the new features of the new standard meant in terms of the safety characteristics of the given product.

The PPE Directive was a New Approach Directive, meaning that harmonisation was limited to basic health and safety requirements (BHSR) and the technical specifications of how to meet those requirements were set out in voluntary harmonised standard. The standards represented the state of art at a given time. Therefore referring to what EBI said before he emphasized that even though the Directive had not been revised so far that did not mean that the state of art could not change.

So as for the case in hand in case the new EN ISO 12402 series of standard changed the state of art then there was a problem with manufacturers who still used the old standards EN 39X. He pointed out that the issue was not new as the new EN ISO standards were in the OJEU since three years. So in case there was a safety reason then the industry had to stop using the old standards and use the new ones.

He also understood the concern from the Member States as they were confronted with this issue on the ground. So in case of a market surveillance check there might be the case that in a shop hanging next to each other there might be two lifejackets, one manufactured according to the old standards while the other one was produced according to the new


one. So there was a justified question to be raised on what was going on, why this was happening. And this WG had to know the answer for this question.

Also ES mentioned that there could not be different principles for different Directives. He agreed with ES saying that of course not. The base line was that manufacturers could use any technical specifications as long as they met the requirements of the Directive(s).

He stressed again that careful analysis had to be made on the changes what the new standards brought referring to the decision of EBI to use the old standards for old productions and the new standards for new products.

He said that the Commission was carrying out an inquiry on this issue to see behind the reasoning of the changes in the new standards as legal certainty was needed.

The CEN-CENELEC Consultant said that the group talked about a standard while a group of 10 standards should be discussed. As regards the question from FRANCE (on the missing parts of the EN ISO standards) he replied that Part 1(EN ISO 12402-1) did not affect PPE as that part dealt with lifejackets used on boats which were covered by the Geneva convention and therefore it fell outside of the scope of the Directive. Part 7 (EN ISO 12402-7) was not published which dealt with how the manufacturer chose materials to manufacture lifejackets. So this did not fall under the scope of the Directive either. And that was why those two were not published in the OJEU.

Further he thought that the question from IT and ES referred to the Part 1 of the standard that covered lifejackets that were going to be used on boards of ships and were therefore not covered by the PPE Directive but the above referred to Geneva Convention. In those cases each country could decide that those lifejackets had to meet specific standards.

EBI said as regards Part 7 that it was a critical element for manufacturers in the decision of shifting production to the new standards. In effect, the new EN ISO standards require that some of the materials be tested and certified - a requirement which did not apply to materials used under the old standard. So part of the cost issue but also availability of certified raw materials are linked to the additional testing and certification of materials under the new EN ISO standard, and required by Part 7 which was not yet officially published.

COMM said it was clear that there were diverging opinions on this issue that needed to be looked at in more detail. He recalled that as the CEN-consultant highlighted the whole series of standards needed to be discussed. He emphasised that COMM was conducting an inquiry and its result(s) would be shared with the WG.

IRELAND said that due to lack of time it would be useful to send out in writing the following question to the WG: Question 3 regarding BHSR 3.4 of Annex 2 of the PPE Directive in document PPE/10/1/6.

Another question was that what happened if a harmonised standard did not cover all relevant basic health and safety requirements?

What happened when a manufacturer took a product to the NB and there were BHSR not covered by the applied standard then who was responsible that apart from using the standard other means were used to meet all the relevant requirements?

She thought that the best solution would be if the CEN TCs were developed standards that covered all the relevant BSHRs. But in case that not possible then the Annex ZAs should specify what BHSR was not addressed by that standard. This would make it easier for both the manufacturer and the NB.

COMM said that it was desirable that standards covered all relevant BHSR. Unfortunately this was not the case today. In any case the overall responsibility rested with the manufacturer who was responsible for products compliance. Further if a NB was involved


in the conformity assessment process then of course the NB had also a role to play to make sure that only products that met the requirements of the Directive got certified.

HCNB said that COMM actually replied the question on saying that if a standard did not cover all BHSR then the NB used other technical specification (for the missing BHSR) to make sure that only products complying to the Directive got their certificate. So the NB worked together with the manufacturer to ensure that all BHSR were covered. In case there was a specific problem then it was discussed in the relevant Vertical Group in order to come up with a harmonised solution that could be used throughout Europe. That was why NB´s coordination was important.

EBI asked what the WG thought about the practice of SPAIN and ITALY, whether that lead to violation of EU law and created technical barriers to trade?

COMM said that this was an important issue as the uniform application of the Directive was paramount. But he said that the question could not be answered on the day as more information was needed which was why the COMM was conducting its inquiry.

EBI asked that then this issue would be addressed and answered in the inquiry results to be published at the end of May (2010)?

COMM answered: no. Hopefully the inquiry would provide substantial background for the answer /consequences which then could be drawn from the data. He could not give though an exact time-frame when that could be expected as lot was still to be done in this respect. He concluded the topic as the diverging opinions were noted, the COMM was conducting its own inquiry with a broad range of stakeholders to see what was going on. He also invited the participants to send their comments to the COMM on the issue. And then COMM would try to propose a solution that would be circulated to the WG.

SPAIN said that she feared that the WG was mixing up two fields of legislations, as Part 1 of the standard dealt with lifejackets that did not fell in the scope of the PPE Directive.

COMM thanked for this clarification and closed the item.

Action Point 8 COMM to share results of inquiry on lifejackets with the WG.

Item 7 standardisation

Information on formal objections

COMM informed the WG that following a positive opinion from the 98/34/EC Committee

the COMM adopted its decisions54 on removing the references of the following standards from the OJEU:

EN 353-1:2002 -Guided type fall arresters including a rigid anchor line;

EN ISO 4869-4:2000 -Acoustics - Hearing protectors, ear muffs.

He emphasised that removing those references from the OJEU was only the start of the process as now the important question arose on what to do following those decisions. COMM was looking into this follow-up exercise and in the framework of that sent out inquiries to different stakeholders to see what was going on in the field.

54 Commission Decision of 19 March 2010 withdrawing the reference of standard EN 353-1:2002 Personal protective equipment against falls from a height — Part 1: Guided type fall arresters including a rigid anchor line’ in accordance with Council Directive 89/686/EEC – OJEU L75 of 23.3.2010; Commission Decision of 18 March 2010 withdrawing the reference of standard EN ISO 4869-4: 2000 ‘Acoustics — Hearing protectors — Part 4: Measurement of effective sound pressure levels for level-dependent sound-restoration ear- muffs (ISO/TR 4869-4: 1998)’ in accordance with Council Directive 89/686/EEC – OJEU L69 of 19.3.2010


There were the following issues to be considered in particular:

1) Member States were obliged by Article 2 of Directive PPE to ensure that only compliant equipment is placed on the market. The corresponding decisions of the COMM compelled them to check that in their territory.

2) Meanwhile, the Notified Bodies had to, on the one hand, harmonise their approach for the new products, and on the other hand, re-examine the certificates already granted to the existing equipments to check that the essential requirements were really taken into account, in the light of the Commission Decisions.

3) A mandate of the Commission would be given to the CEN-CENELEC to develop a harmonised standard on fall arresters.

In addition he recalled that the UNITED KINGDOM worked out an interim solution that was to be shared with the WG.

The UNITED KINGDOM said that they have already drafted a relevant short document, which after some fine tuning would be uploaded to CIRCA.

Since the launch of the UK formal objection, it had been recognised that once the standard (EN 353-1) gave no longer presumption of conformity, there was a clear need for an interim solution. Therefore an interim meeting with relevant stakeholders was held by the UK authorities. The measure to be presented would take effect immediately in the UNITED KINGDOM as there was no other harmonised solution that existed till date.

In detail the question was what NBs might do with existing and new 353-1 products.

It was a two course action:

1) Setting out how to handle the situation;

2) Agreeing on what test method NBs could use.

This included that NB would cease to issue conformity certificates based solely on standard EN 353-1. In addition, they would also review all existing certificates given to products already placed on the market. Where suitable additional testing had been carried out, NB would take no further action. But where no addition testing took place the NB would withdraw the certificates with a 3 month notice that would allow the manufacturer to carry out further testing. In case such products fail those testing or no tests would be carried out then the corresponding certificates would be withdrawn.

The UK market surveillance authorities would follow this process up closely.

As regards the test method: the UNITED KINGDOM proposed to use a test dummy of 100 Kg, which allowed testing sideway-falls, fallbacks etc. These tests had to be carried out in addition to the procedure described in standard EN 353-1.

COMM recalled that the problem with standard EN 353-1 was that the test method in the standard did not consider all foreseeable conditions of use. Among others it did not take into account the fall-backs and sideway-falls. That was the reason why the UNITED KINGDOM required additional testing to the method currently described in the said standard.

FRANCE asked the question whether this proposal was discussed by the relevant NBs in order to achieve harmonised action on the field?

POLAND asked what the UNITED KINGDOM proposed to use in terms of the rest of the standard, an old standard or was there a new one?


The UNITED KINGDOM replied that the proposal was elaborated in agreement with all the

UK NBs. The UK NBs would send this proposal to VG1155 for their comment.

As regards the question to the UNITED KINGDOM:

EN 353-1 would be still used but the additional testing above had to be use as well.

HCNB said that the UK proposal was already discussed among NBs in the VG but their proposal deviated from that slightly. All NBs agreed that a proposal was needed though. At standards level this issue had been also debated and as no solution was found yet the topic was discussed at the VG level. Nevertheless the VG did not manage to agree on a solution. So he was not sure that forcing through a proposal that was nor agreed at standardisation level neither at VG level was the right way forward. A solution was indeed needed, but a harmonised one that everyone accepted.

The UNITED KINGDOM understood the need for a common solution but the problem was the degree of urgency to this situation, therefore immediate action was needed.

The CEN-CENELEC Consultant said that one of the reasons of withdrawing the reference of standard EN 353-1 was that this standard did not meet all the BHSR of the Directive. So he raised the question that once the UK proposal was followed then would the product fulfil all the relevant BHSR?

The UNITED KINGDOM recalled that it was up to the NBs to judge that but the UNITED KINGDOM thought that was the way to help then doing that.

COMM asked the HCNB whether they could give a time-line within which the NBs could come up with a harmonised solution?

HCNB said that at the last VG 11 meeting the NBs worked out a procedure that the UK NBs could not endorse. It was important that this group met again to discuss the UK proposal which also required readiness for compromise from the UK representatives as well.

The UNITED KINGDOM said that the test specification proposed by the UNITED KINGDOM was different that might have been discussed at the VG 11 meeting. He suggested sending the relevant document to the VG, which he believed helped to avoid misunderstanding.

COMM suggested uploading the document to CIRCA. He recalled the importance of a common solution.

This topic would be followed up at the next PPE WG meeting.

HCNB said that the next VG 11 meeting was in November (2010). He added that he would try to move the meeting forward in order to achieve the common solution before.

Action Point 9 HCNB to report to the WG whether common test method regarding EN 353-1 has found.

Report by the CEN Secretariat

CEN-CENELEC said that the major pieces of the report were already shared throughout the day. In addition 352 standards were currently published and 67 revisions were ongoing. CEN was waiting for the mandate from COMM on EN 353-1.

Other topics included in the report were:

CEN PPE Forum;

55 Vertical Group 11 of NBs – Protection against falls from a height


CEN Strategic Advisory Board Occupational Health and Safety (SAB OH&S);

prEN 13089 ‘Mountaineering equipment - Ice-tools - Safety requirements and test methods’;

prEN 15712 ‘Mouthguards for use in sports - Safety requirements and test methods’;

Appeal EN 341 ‘Personal fall protection equipment - Descender devices for rescue’.

COMM recalled that CEN made an important progress following the PPE WG decision on ice tools last year. It was important that the corresponding standard was recognised as a harmonised one as soon as possible in order to help stakeholders to comply with the PPE Directive.

He added that the new list of references of harmonised standards was in progress of publication.

Report by the CEN Consultant

The CEN-CENELEC Consultant said that since the last PPE WG meeting 35 standards had been assessed. Out of which 5 got a negative assessment and 1 was considered not falling within the scope of the PPE Directive.

Two issues that effected certification and the scope of the Directive could be highlighted:

Whether all BHRS were covered by standards;

Whether a product was accepted as PPE or not.

As regards the first bullet point: In standards there were the Annex Zas that showed the relationship between the standard and the Directive. Nevertheless that did not give information on whether all the relevant BHSR were covered by the given standard or not.

As regards the second bullet point: Deciding on what was PPE or not, was not always consistent. There were examples that showed this. (Such as motorcyclists´ garment for professional use vs. private use.) So there was a need to find a way to be consistent when making decisions in the PPE WG.

COMM responded agreeing the need for consistent decisions. It was important in order to keep legal certainty. In case the CEN-CENELEC Consultant had examples of not having a consistent decision then please send those to COMM so if needed those could be rectified.

FRANCE said that such issues should be dealt with in the framework should be dealt with.

COMM replied that as the Chairperson agreed to it before such issues (e.g. clothing against weather conditions) would be looked at in the course of the revision process).

SPAIN recalled the issue of Annex Z as in the standards. The problem was not whether the standard covered all the BHSR but rather knowing which BHSR were covered by the standard and which were not? So who should take a decision to correct this?

COMM believed that there was a CEN resolution regarding this topic, which required that once a standard was revised then it had to be referred to which BHSRs were covered and which were not.

CEN-CENELEC replied that CEN in co-operation with COMM developed a template on Za. Nevertheless with this being said the TCs enjoyed a certain degree of freedom. She was nevertheless pleased to take back any recommendation regarding Annex Za.


COMM understood the CEN-CENELEC was an independent entity but he was wondering whether there was a way to further encourage the TCs to provide the information mentioned by the CEN-CENELEC Consultant and SPAIN.

Rapporteur of CEN Sector Forum: He said that the Forum was also ready to take this issue up.

Action Point 10 CEN-CENELEC Consultant to send COMM the list of PPE with controversial categorisation.

Item 8 Report from the Coordination of Notified Bodies

HCNB said that from the written report he wanted to highlight the issue of review of certificates as it was closely looked at by stakeholders. This procedure had now been developed so the NBs could follow a uniform procedure. Fears that were expressed that the NBs would carry out a re-certification every five years were expelled.

Another issue was on how to make the RfUs (Recommendation for Use sheet) more binding. One of the solutions was to further encourage self-commitment as legally imposing that would create problems.

As for the accreditation of NBs: there was a degree of divergence between Member States in this respect that should be looked at.

COMM said that the progress made on the issue of time-limitation of certificates was reassuring. This topic was discussed before and stakeholders and in particular the representatives of in industry expressed their need to get insurances that the review process would not give an occasion the NBs to increase their revenue without real needs for retesting products.

As for accreditation he recalled the Regulation56 adopted in the framework of the NLF that was created to solve that issue.

FESI he was pleased that HCNB took into consideration their concern. However he had two additional concerns:

1) The HCNB requested that renewals be applied for a minimum of 6 months before their end. The Committee agreed to accept this condition on the basis that once a certificate was applied for (minimum 6 months before expiry) that it triggered an automatic renewal beyond the 5 year limit for the same amount of time that it took for the notified body to return its results. As an example if a result took 3 months to be received from a notified body then the original certificate was valid for a total period of 5 years and 3 months.

2) Finally, it was noted that the HCNB had proposed a procedure to the Commission whereby certificates would remain valid even if a standard had been amended or superseded if there was a relatively small amount of time remaining before the expiry of the 5 year validity of the certificate of the product concerned, however it was not clear whether this period was 12 or 24 months before expiry.

ESF was concerned about the 5 years limitation procedure. It was seen as a possible distortion of the market in case not everybody followed it as set out. Another issue that had to be verified was this: what happened if within that 5 year period a NB stopped operating?

56 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93.


HCNB said that these were complex issues and was happy to receive them in writing.

As for the first part the NBs undertook to respect the 6 months period. The voluntary commitment sent out a signal to Member States. All those who signed up for that would be listed on the Internet.

As for the NB that stopped working there were clear rules on how to deal with such situation.

COMM asked stakeholders to comment on the RfUs within six weeks following the meeting.

Action Point 11 Stakeholders to comment on the RfUs within six weeks following the meeting.

FRANCE had a question of the RfUs regarding the procedure reviewing certificates. She thought this should had been discussed on the day. The WG needed time to discuss this issue. So was this considered to be adopted by the WG now?

COMM replied that the answer was of course not. That was the reason why he had just asked the stakeholders to comment on the sheets within six weeks following this meeting. In case there were diverging opinions on them then those sheets would be taken up at the next PPE WG meeting.

Item 9 Any other business

No item was raised.

Item 10 Date of next meeting and close

COMM said that the next PPE WG meeting was planned for November 2010.

He thanked the participants for their contribution and the interpreters for their work. He then closed the meeting.







Chairperson: Mr Elöd Ajtony DUDÁS (EC ENTR/I4)

EC Participants: Ms Alexandra JOUR-SCHRÖDER (Head of Unit I4), Mr Joaquin CALVO

BASARAN (Deputy Head of Unit I4), Mr Ian FRASER and Ms Catherine

KOECKX (ENTR/I4)

1. Welcome



COMM pointed out that information would be given about the Judgment of the Court of Justice

from 31/10/2010 on anchor devices before starting the follow-up of action points.

FRANCE asked to include two additional points:

(3) Status of PPE used for rescue actions: were they covered by the Directive?

(4) UV clothing. The WG never ruled on this and the issue was against raised in FR.

COMM proposed to discuss these points in the “Any other business” section.

3. Approval of the minutes of the meeting of 29 April 2010 (Doc. PPE/10/1/2)

The UNITED KINGDOM flagged out some typos in the text.

COMM informed that the minutes of former PPE WG meetings (from 2002 to 2010) would be put

on the COMM website in order to increase transparency, and asked for comments.

As there were no comments on this and on no other points of the minutes the latter were approved.


4. Scope

Lifejackets – Commission’s inquiry (Doc. PPE/10/2/3)

The Chairperson summarised Doc. PPE/10/2/3, which explains the background of this issue and

presents the outcome of the inquiry conducted by the Commission among stakeholders. Further the

document also contains the Commission’s proposal on the subject.

EBI (European Boating Industry) was happy with this paper. There were lots of discussions among

manufacturers because ITALY and SPAIN required switching to the EN ISO standards, which led

to chaos. In case of IT a decree was published in the IT Official Journal requiring that.

Further the Italian association has asked to take part in the revision of the Directive. In any case the

members of EBI agreed to use the EN ISO standards for new models of lifejackets.

COMM asked EBI to send a written contribution for the revision of the Directive.

FRANCE agreed with most of the COMM paper. The new standards were not established as a

remedy to a deficiency confirmed by a formal objection but in their opinion it was necessary to use

to EN ISO standards instead of the old (superseded EN 393 etc.) standards due to their improved

characteristics.

GERMANY said there was a lack of precision regarding the content of the standard. The new

standard included more stringent test specifications. And yet, as regards the problem raised, the

question was whether the tests assured a better quality of products.

COMM said that prudency in the language of documents was needed in this respect. The revised

standard included an improved revised test method. New tests did not prove that old products could

not pass the new tests. They just have not been tested that way. This was a fairly common situation.

In most cases in the past, this was solved by market itself. Market pressure went toward the

application of the new standard. Further COMM agreed to make its paper more precise on the part

of “results of inquiry”.

IRELAND agreed with FRANCE. As regards Part 7 of EN ISO 12402, she said that it was not

available but it was published.

Regarding new models IRELAND asked what was meant by new model. New models should then

be tested to EN ISO 12402. IRELAND added that the tests specified in the new standard would give

more protection to the user. It therefore recommended to EBI that manufacturers produce lifejackets

according to the new standards series.

SPAIN agreed with IRELAND and added that the Commission proposal takes into account the

main aspects of the issue.

When negotiating about a standard, it was up to industry to indicate the problems. ES, therefore, did

not understand what the problem was since industry took part in establishing the standard. They did

not understand why it was now said that these standards were not ok. The new standards were the

only ones that gave presumption of conformity. As regards the products manufactured beforehand,

they could still be placed on the market because there was no formal objection. Standards have just

simply been revised. If they were implemented, this has to be done with all consequences.

SPAIN said that the COMM proposal takes over all essential aspects. They added that he did not

have knowledge of any restrictive measures taken by the competent Spanish authorities against

lifejackets on the grounds that those were manufactured according to the EN 393 etc., series of

standards. In his opinion consumer organisations were suggesting to consumers to buy lifejackets


manufactured according to the new EN ISO series of standards. Anybody who had information to

the contrary was welcome to make contact with him to manage the problem as soon as it was

possible.

COMM thanked for all comments and explanations. The purpose of raising this point on the agenda

was not to question the new standards but to examine the state-of-play of its implementation.

The Chairperson welcomed the decision of EBI that new models of lifejackets will be designed

according to the new EN ISO standards.

IRELAND said that as the person in charge of market surveillance he spoke on behalf of

consumers. He reserved his opinion because this issue requested deeper examination. He disagreed

with many points. Did COMM consult DG SANCO? When a new standard entered into force,

products should be withdrawn even though the products manufactured before were in conformity

with the new standards. What was the relevance of a standard which has been withdrawn? How

then could consumers know whether a product was in conformity or not?

COMM said this raised a general issue of market surveillance which was wider than the problem of

these particular standards and which was to know whether product manufacturing according to a

new standard improved the safety of products. If it represents a new level of safety, then products

which did not reach that level of safety, even if they were in conformity with the former standard,

should be modified. We have not been given clear evidence that products manufactured according

to former standards were not sufficiently safe. To give an example to the contrary he mentioned the

application of crotch scraps, which was not required till date by the relevant standards.

EBI said that the issue of crotch scraps was not addressed by the relevant (EN ISO) standards.

COMM concluding this point said the document would be modified according to this discussion

and uploaded again. He added that COMM would investigate the publication of the alleged Italian

Decree above.

Buoyancy aids

IRELAND reported on its market surveillance activity regarding arm bands and wanted to seek

advice from participants. A study on the level of compliance of products had been conducted and

the results showed that out of 49 products 3 passed, 30 failed (24 with high risk and 6 with low risk)

and 16 were inconclusive. IRELAND asked whether it was a substantial risk if there was no name

of manufacturer and/or no CE-marking.

COMM referred this topic to the ADCO Group and asked for conclusions in writing.

Categorisation of footwear incorporating toecaps (Doc. PPE/10/2/6)

FRANCE introduced the topic: It was about footwear which could be considered as fashion

footwear but had a protective toecap to have a military, commando-style look, and could be

confused with safety footwear. Should these be considered as PPE because of the toecap?

In their opinion, the answer was yes if that was a real toecap. If the manufacturer of this city

footwear wanted a security footwear look, he could put a toecap. But the people who bought such

footwear could believe that they were protected, so protection should be provided. If this footwear

was not considered PPE, how then could market surveillance authorities keep an order on the

market in terms of what was PPE, non-compliant PPE and those which were not PPE?

The Footwear industry considered that fashion footwear was not in the scope of the Directive if

the manufacturer did not highlight the security elements. There was nothing preventing a


manufacturer from incorporating resistant material as long as he did not draw the attention to

protection characteristics. Such footwear was not PPE.

The UNITED KINGDOM agreed with FRANCE. This issue had been discussed over the years. If

the product gave an impression of protection, then the UNITED KINGDOM thought it should be

considered as PPE.

SPAIN agreed with the UNITED KINGDOM and FRANCE. If the manufacturer decided to

incorporate a protective element, it was then a PPE even if the manufacturer said the contrary.

COMM said this issue had already been discussed. The conclusion had been to follow the point of

view of the footwear industry, which was not to consider this footwear as PPE. There were always

shoes with toecaps but they were not considered as conferring protection. Therefore consumers did

not consider them as such. There was a residual risk that somebody would buy such footwear and

consider himself/herself as protected. He suggested therefore to leave the market regulate this.

FRANCE said they understand this position but if a protective element was incorporated, rules

were to be applied in all cases. It has always been said that decisive importance would be given to

the declarations of the manufacturer. This left the door open to abuse. There was no particular

reason to exclude them from the Directive.

LUXEMBOURG agreed with the Footwear industry and COMM. He gave the example of the toys

which looked like PPE and for which the manufacturer has to warn that it was not a PPE. A solution

might be to have a warning indicated on the packaging for the products which did not have the

function corresponding to their aspect.

ESA said they also have products with different functions and therefore the most careful

manufacturers would inform about those. But all products must comply with the GPSD.

COMM said that a toecap was not necessarily a protection toecap and one cannot prevent the

fashion industry to place toecaps on shoes.

FRANCE asked whether COMM has the last word in this respect.

COMM said the last word was for the Court of Justice. COMM could only give advice. COMM

would draft another discussion paper and would come back to this issue.

Categorisation of type 6 protective clothing against liquid chemicals (Doc. PPE/10/2/5)

FRANCE reported that some considered this clothing as category 3 PPE and others as category 2.

Art. 8.4 a points out that this type of cat. 3 PPE were PPE providing only limited protection in time

against chemical attack. However the notion of time was absent from the English version. The

original Directive was written in French. What made things more complicated was that the

European standard dealing with that type 6 clothing seemed to have been written in an imprecise

way. Did the limited protection refer to protection in time, or to a lower protection? Considering the

not very strict tests required by this standard, it seemed therefore that the protection provided was a

low protection like for instance for a laboratory coat. On the other hand at the last working group

meeting the European Coordination of NB mentioned a NB coordination use sheet, which stipulated

that this product should be considered as category 3 PPE.

Considering what has been said, FRANCE was of the opinion that this clothing cannot be

considered as cat. 3 but as cat. 1.

The CEN-CENELEC Consultant considered this product as cat. 3 and insisted that FR should

contribute to a new version of the standard.


COMM said that FRANCE was right because the wording of the article had to be understood in

light of the basic health and safety requirements for chemicals, but this type of clothing could be

used for risks where this type of clothing was not appropriate. Cat. 3 was not a quality level, it was

only a procedure.

COMM said to check that all versions of the Directive would be the same. With no further

comments, he noted a general agreement on considering type 6 protective clothing against liquid

chemicals as category 3 PPE.

Diving gloves (Doc. PPE/10/2/8)

COMM reminded the participants that the decision was that these products were cat. 2 PPE as the

PPE WG concluded on its meeting held 20 November 2007.

Possible contradictions or disagreements with the Directive 89/686/EEC in PPE categorisation

(Doc. PPE/10/2/10)

The Chairperson wished to flag out some issues from the document presented by the CEN-

CENELEC Consultant:

– Point 3.2 EN 795: this point was to be discussed at the AdCo meeting as well. COMM

referred to the ruling of the Court of Justice57. Two competitors manufacturing anchor

devices for protection against falls from a height went to the Court in the Netherlands

(Rechtbank ’s-Gravenhage), on the interpretation of the applicability of the PPE Directive,

standard EN 79558 and the Construction Product Directive59. The Duct national Court

requested for preliminary ruling by the Court of Justice under Article 234 EC. The case was

about that one product was manufactured according to EN 795 bearing the CE marking and

another one manufactured by the second competitor did not refer to this standard neither

bore the CE marking. It was ruled that the devices were outside the scope of the Directive.

This confirmed the position of the PPE Working Group. COMM asked that this message to

be spread among stakeholders, who would help to put an end to this long debate. The

consequences from the point of view of market surveillance were to be discussed at the

AdCo meeting on the day after (11 November).

– Point 8: COMM had checked the 2005 and 2006 minutes. There were no rugby shoes with

toecaps to be found. (At least on the Internet)

FESI agreed with the CEN-CENELEC Consultant. They agreed that rugby shoes should

not be cat. 1 PPE.

The Chairperson asked for comments to be sent to COMM.

FRANCE asked whether studs for football shoes were included.

COMM said that both rugby and football shoes have become lighter and lighter and less

protective. Technology had changed. and shoes did no longer have toecaps. Some shoes

had studs. As football shoes were not considered PPE, COMM suggested not making any

57 Judgment of the Court (Third Chamber) of 21 October 2010 in case C-185/08

58 EN 795 ‘Protection against falls from a height – Anchor devices – Requirements and testing’

59 Council Directive 89/106/EEC


distinction with rugby shoes. Both should be considered as not in the scope of the PPE

Directive.

5. Revision of the PPE Directive – Progress on impact assessment study

The Chairperson recalled that before every legal text was proposed by the Commission it was

obliged to carry out an Impact Assessment. In the framework of this process the Commission was

already running – by an external contractor – an Impact Assessment Study. The main purpose of

this study was to assist the Commission services to carry out the above impact assessment. He also

recalled that a number of the stakeholders would be contacted by the contractor for their

contribution.

The tasks for the Study included the collection and evaluation of economic data in the field of PPE

in order to get a clear picture of the sector and its competitiveness as well as the assessment of the

identified policy options proposed for certain elements of the Directive set out in Annex 1. (This

Annex was elaborated with the PPE WG members)

These serve the purpose of not only to simplify the current Directive where it was possible

including the reduction of burdens, for example administrative ones on economic operators and

Member States but also to be beneficial for the users of PPE by reducing the number of accidents

caused by inhomogeneous production, i.e. quality problems.

The next step was to organise a Public Consultation. The objective of the consultation was to obtain

the views of the European public, as well as concerned European stakeholders, on the adequacy and

the scope of possible EU measures in the field. All citizens and organisations were welcome to

contribute to this consultation. Contributions were particularly sought from PPE stakeholders,

including public authorities, industry, standardisers and Notified Bodies. The consultation was

scheduled for the first half of 2011. The Chairperson asked all stakeholders to inform all their

contacts about its existence once the Consultation was on-line.

6. Standardisation

Follow-up of formal objection against standard EN 353-1 – fall arresters (Doc. PPE/10/2/4,

PPE/10/2/7, PPE/10/2/11)

The Chairperson asked the Notified Bodies about the state of play in finding a common test

method for fall arresters.

HCNB said that there was a major decision on a new measure regarding tests. It was indicated that

certificates could no longer be issued according to standard EN 353.

As regards the former certificates, according to NB, there was no real problem. In some countries

there was a transitional period, in some not. Otherwise they were ready to go on testing on the basis

of presented documents.

The UNITED KINGDOM asked what was the impact of this sheet for CEN. The UNITED

KINGDOM wanted to be sure that CEN would continue their work.

CEN-CENELEC responded that since they have just received the mandate from COMM, their

work would not stop.


The Chairperson asked whether the technical solution mentioned represented the agreement of the

different committees (vertical, horizontal and standing).

HCNB answered yes and COMM replied this was encouraging.

FRANCE agreed with the document.

HCNB said that the vertical group concerned had proposed this solution which should be accepted

by the horizontal committee in May 2011.

The Chairperson feared that things would go too quickly. He thought that the horizontal

committee should have accepted the document before the PPE WG had discussed it.

HCNB said the official way has to be followed, meaning the three committees. But for this

particular document the vertical group had to propose a solution in order to have a test procedure.

They said they were going to transfer the document to the horizontal committee with a request for

adoption. Such documents had never been rejected by the horizontal committee.

The Chairperson said the WG should contribute anyway. He asked for comments.

GERMANY had a question: the decision published on 23 March in the Official Journal as regards

the withdrawal of the standard should have as a consequence that the Notified Bodies which had

issued those certificates should withdraw them. The decision came into force on the publication

date. Therefore, certificates should be withdrawn.

The Chairperson said that it was indicated that if there was a deficiency in the standard, then yes.

HCNB said that they got in touch with companies asking information about their equipments. It had

also been checked – considering the new procedure – whether certificates had to been withdrawn or

not. There was a transitional period of 3 months. It had to be made sure that such equipment

complied with the Directive. But differences in practice on this were noted among Member States.

Withdrawing a certificate had as a consequence that new tests have to be made, etc. That was why a

transitional period has been foreseen.

BELGIUM asked, whether PPE which were manufactured in compliance with the withdrawn

standard, were still in conformity?

COMM said it should be checked that the product was not defective. There could not be a single

scenario but in any case products should be checked. The FR document was interesting. FR

proposed a correct way to approach the situation.

In the French text, it was said that conformity had to be revaluated (art. 10.2.11).

As soon as the decision was published in the Official Journal, the Notified Body wrote registered

letters to each manufacturer inviting them to have the products they place on the market revaluated

in the light of the standard failure. If the manufacturer did not reply, the Notified Body withdrew

the EC type-examination certificates, which had the consequence that the concerned products could

no longer be placed on the EU market. In case of a successful re-valuation, the conformity

certificate was updated.

FRANCE agreed with COMM who said that a standard failure did not necessarily imply the failure

of the product. There were many existing products which remain in conformity after they were re-

valuated.


COMM said that not responding to such a letter would mean a failure to the approved quality

assurance system. In this case, the Notified Body that delivered such a system should do something.

ESF agreed with the approval of the document by the vertical committee, which they considered a

good start. ESF noticed that FR had addressed a large part of the question. He wondered whether

this was a way to have a harmonised approach or whether the Member States took such an

initiative.

The Chairperson noticed that approaches were very similar.

The UNITED KINGDOM asked about the exact status of the sheet, whether all had to wait until

May 2011 for approval by the horizontal committee?

HCNB said that the approval by the horizontal committee is only a formality.

FRANCE asked about the status of the document.

COMM underlined what COMM meant by saying the document itself may not have a particular

status. The Group was talking about guidance on how to apply obligations that exist as regards

market surveillance. These obligations exist and guidance was needed. This document was simply

drawing attention on obligations which were part of market surveillance obligations.

The Chairperson concluded that the Commission would work on a paper recommending an

approach and see which form it could take. COMM added that the WG should not wait for the

document to take action.

Report by CEN-CENELEC

FRANCE had questions about mouth guards: Why was a standard not going to be established?

Why were we going towards a technical recommendation? Why did the committee dealing with

clothes also deal with the standard about mouth guards?

About EN 341, FRANCE asked for more information about the current situation.

CEN-CENELEC said there was an internal decision in CEN to appoint CEN TC 162 for the job.

She recalled that there were lots of unsolved issues.

The Chairperson asked whether there were any results about the enquiry related to equestrian

helmets and CEN replied negatively.

Report by the CEN-CENELEC Consultant

The CEN-CENELEC Consultant presented his report (Doc. PPE/10/2/9)

FRANCE commented on the last part of the report. Some standards did not satisfy all essential

requirements covered by the standard. FRANCE asked whether it could be possible to have the list

of requirements which were not covered by the standard. How was it that these requirements were

not covered by standards?

SPAIN agreed with FRANCE.

The CEN-CENELEC Consultant said he always raised this issue. The manufacturer should take

his responsibilities. He insisted on this. He asked whether COMM would take things in hand.


Did COMM already know about the transition periods before the application of the new standard? It

was not like that before. For this Directive it often arose that at the date of publication of a new

standard, the new standard become implementable on the day after. A period of 6 months should be

envisaged.

IRELAND agreed with FRANCE and SPAIN. This has already been asked at several meetings. A

document should be sent to CEN TC asking to adjust Annex ZA. Employers had to know about the

essential requirements covered by the standard. (And those that were not covered)

COMM said the relation between a standard and essential requirements was a problem which was

related to the New Approach. As regards PPE, the situation was exemplary. Most PPE have an

Annex ZA with all requirements covered. However, information about non-covered essential

requirements was missing. The only solution would be the clause about the scope where covered

and non-covered requirements could be mentioned. We could check whether COMM might have an

agreement with CEN on this. The question of Annex Z was also raised in the sector of medical

devices.

CEN-CENELEC said that Annex ZA was a hot issue. Discussions were ongoing. If there were

recommendations which could be implemented, if things could be improved, CEN could try to

ensure this, but it would be useful that ENTR/G4 should give its support. However, this should be

done within the current limits of the agreement between CEN and COMM.

Regarding the ES comments on a 6 months period during which the former and new standard could

co-exist in theory, CEN added that this had to be decided on by each technical committee for each

individual standard.

7. Horizontal Coordination of Notified Bodies

HCNB said that the adopted decisions were not always transposed in the same way by all Member

States. They asked that decisions be transposed in a similar way. As regards the vertical group, the

next meeting was scheduled on 3 and 4 February 2011.They would make comments on COMM’s

comments on RfUs after the meeting. NB agree that type 6 PPE were cat. 3 PPE.

Reply to RfUs on time-limitation of certificates (Docs. PPE/10/2/13, PPE/10/2/14, PPE/10/2/15,

PPE/10/2/16)

A draft document had been drawn up by the European Coordination of Notified Bodies (HNBC),

which described the revision procedure for EC type-examination certificates. This document was

presented as an annex to sheet 136 and recommends a validity of 5 years maximum for type-

examination certificates.

ESF presented a joint paper co-signed with ETSA and FESI. The problem was a lack of

harmonisation within the EU regarding the application of the PPE Directive. The three associations

concluded that after 20 years of PPE Directive was in force, there was more and more dis-

harmonisation.

FESI underlined that we should all work for the competitiveness of industry. The key message was

to seek for support and harmonisation.

The Chairperson said we all knew there were issues regarding market surveillance. An issue was

that everybody should apply the same rules.


FESI recalled their position paper of June 2010 (Doc. PPE/10/2/15). After having consulted their

members they concluded to oppose to any limitations to EC type-examination certificates because

this would create difficulties to manufacturers. They did not see how time limitations could improve

safety (see 4th and last indents). In addition they needed more guarantee by the NB that this

possibility (time limit of certificates) would not be exploited by the NB.

ESF said that both papers were similar but wanted to add that their members felt that this limitation

was an attempt to solve a problem of market surveillance. They did not see how those problems

could be solved, but it would enlarge the gap between not complying manufacturers and complying

ones. We should pay attention not to overburden them and at the same time not solving these

problems.

The Chairperson said that the reason of this time-limitation was not only to solve a market

surveillance problem. It also had to do with the revision process. He added that when this issue was

raised, industry agreed with the idea, but was interested in some details before giving its agreement.

HCNB said that sheet 136 was discussed in the horizontal committee with FESI and ESF. The

document was accepted even though there were many arguments against it.

Previously there was a limitation of validity because after 5 years, a product could have undergone

many changes. Clear procedures had been established for NBs. The purpose was not to introduce

constraints, but to protect both consumers and users. Unfortunately, transposition was not the same

in all Member States and all NBs did not proceed the same way. Decision regarding sheet 136

should be harmonised.

The Chairperson said that asking automatically for technical documentation and information

represents a significant burden and should not be compulsory if not necessary. He thought that

industry would agree with the time-limitation of certificates if conditions were fulfilled.

ESF said there could possibly be an added value but the main problem was that there was a

recommendation sheet and they noticed that not everybody fulfilled these recommendations, which

gave rise to difficulties for manufacturers. It was needless to say that there was no harmonisation.

FESI agreed with ESF. If they could be reassured about harmonisation they could definitely be

constructive.

The Chairperson asked the Member States to cooperate in order to ensure that the Notified Bodies

would respect recommendations. COMM was pleased to hear that industry wants to be pro-active

and constructive. This issue would be addressed again in the framework of the revision of the

Directive.

FRANCE recalled they had always said that they agreed on the principle but it was still necessary

to think about the implementation. They often noticed that the controlled products did no longer

correspond to the certificates of EC type-examination which were transmitted to them. They

thought that there was a lack of knowledge of the Directive. Products had often been modified and

therefore when controlled, performance levels were no longer the same. The products were no

longer the same to those which had been subject to the NB examination. Products manufactured

according to former standards were still placed on the market while new products should respect

new standards which were more restrictive. This gave rise to unfair competition between products.

FRANCE highlighted that: the sheet was incomplete on several points:

– Fiche 136 should be merged with the annex in order to improve its legibility;

– Foresee cases where the manufacturer did not ask the renewal of the certificate;


– Present several scenarios, e.g. if there were modifications in the standard or not;

No evolution of the standard during the period of validity;

If the standard had been modified following a revision during the validity period of the

certificate;

If a standard had been approved but not yet published in the OJEU, a prolongation of the

validity period by 12 months could be accepted until the publication of the new reference;

If a manufacturer wants to change body, the renewal has to be considered as a new request.

HCNB replied that this would be discussed at the next meeting in three months time. She added

they would take into account all comments received.

SPAIN thought that FRANCE had raised very important issues. SPAIN disagreed on many aspects

of the fiche. From the point of view of the administration, this position could not be made

restrictive. Otherwise this left the decision and harmonisation to notified bodies.

COMM said that some things still had to be clarified. The application of standards was not

compulsory. If the product still complied with the Directive, there was no need for a new certificate.

If for any reason – a modification of standard, a modification of the product, etc. – a product did not

comply with the Directive, then the product had to be withdrawn.

The Chairperson proposed the NB to take these elements into account to try to fine-tune their

document by the next PPE Working Group, and come with a compromise solution. For the time

being sheet 136 would remain unchanged on the COMM website.

ESF would welcome any clarification. They pointed out that the last comments were a clear

example of the differences of interpretation. They asked COMM to be clear on this.

The Chairperson said the issue was not to always come up with a new interpretation. The "Blue

Guide" existed and needed to be read by all to speak the same language. This problem was also

described in the NLF. He recommended the application of such a RfUs and stressed again the need

of a cooperation of Member States.

8. Any other business

FRANCE:

– About UV clothing. FRANCE would like to submit this question to the WG’s reflection in order

to have a reply for the next meeting. They have been approached by a lawyers’ office.

– PPE which are used for rescue operations had not been subject to harmonisation. Could such

products which were worn after an accident occurred be considered as PPE or should they be

excluded?

The Chairperson said that at the previous meeting the WG concluded that we would have to look

into this subject again since it kept coming back.

The CEN-CENELEC Consultant pointed out that there was an EN standard to measure radiation

from external sources in the technical committee of textile, which was not in support of the PPE

Directive.


Regarding clothing for rescue operations, the standard reference should be withdrawn from the

OJEU.

COMM said that due to lack of time this could not be discussed further but would be raised at the

next PPE WG meeting.

The next meeting was scheduled in May 2011.

End of meeting.



PPE 89/686/EEC WORKING GROUP

MINUTES OF THE MEETING HELD IN BRUSSELS, 4 OCTOBER 2011

Subject: Personal Protective Equipment (PPE) Directive 89/686/EEC Working

Group

Place: Albert Borschette Conference Centre (CCAB), Brussels

Chairperson: Mr Luis Filipe GIRÃO (COMM ENTR/G4)

COMM Participants: Ms Birgit WEIDEL, Mr Mario GABRIELLI COSSELLU, Ms Catherine

KOECKX (ENTR/G4)

1. Welcome

The Chairperson welcomed those present and introduced himself, Mr Girão, as the new Head of

Unit G4 "Mechanical, Electrical and Telecom Equipment" in charge also of the Personal Protective

Equipment (PPE) sector. He also introduced the other European Commission (COMM) participants

and announced that Mr Dudás, the former Desk Officer managing the PPE Directive 89/686/EEC,

had left the Commission services at the end of September 2011.

COMM introduced Ms Weidel as the new Deputy Head of Unit G4 "Mechanical, Electrical and

Telecom Equipment".


The Chairperson introduced the draft agenda.

The draft agenda was approved.

3. Approval of the minutes of the meeting of 10 November 2010 (Doc. PPE/11/1/2)

The Chairperson introduced the draft minutes of the latest PPE WG meeting held in Brussels on

10 November 2010. Due to the late submission to CIRCA, he asked those participants to send their

written contributions, comments or suggestions by e-mail to the PPE functional mailbox

[email protected], until mid-November 2011, before considering the minutes as approved.

He pointed out that at page 4, under "Categorisation of footwear incorporating toecaps", third

paragraph, the intervention of the Footwear industry should be corrected, by removing "agreed with

FR. He" and leaving it as "The Footwear industry considered that…".


BELGIUM remarked that references to CENTEXBEL at pages 5 and 12 were not accurate: those

interventions had been made as invited CEN expert, not in the name of the laboratory. Also, at page

5, for "considered this product as cat 1", should be corrected as "considered this product as cat. 3".

With those remarks, the draft minutes remained pending of approval until mid-November 2011.

4. Revision of the PPE Directive – Public consultation in the framework of the impact

assessment – Results (Doc. PPE/11/1/3)

The Chairperson recalled that the Commission had conducted a Public Consultation in the

framework of the revision of the PPE Directive in order to give all stakeholders the possibility to

contribute to this process. The consultation had been open for 9 weeks, from 13 April to 16 June

2011. The results, presented in the paper, appeared to be in the same direction of discussions of the

Working Group and the findings of the PPE Impact Assessment Study conducted for the

Commission, and showed that the Commission with the PPE Working Group were on the right

track with the revision exercise. Now, the Commission was drafting the Impact Assessment Report

for the revised directive, necessary for any new legislative act. In absence of any problem, the

revised text should be prepared in the second quarter of 2012, in the best scenario, to be adopted by

the Commission. The Commission would keep informed the Committee about the developments.

5. Scope

Traceability between DoC and EC-type examination certificate (Docs. PPE/11/1/5,

PPE/11/1/5bis)

SWEDEN introduced the paper. As market surveillance authority, they had found Declarations of

Conformity referred to EC-Type Examination Certificates issued to different companies and

products. They proposed three questions to the PPE WG to clarify the issue.

FRANCE said that indeed the Directive did not establish a clear link between Declaration of

Conformity and EC-Type Examination Certificate, but it would be quite obvious: without such a

direct link, DoC would have no meaning.

The Chairperson said that traceability was a major issue also in the New Legislative Framework,

and he agreed with FRANCE on the obviousness of a link between Declaration of Conformity and

EC-Type Examination Certificate. All Member States should have the same understanding in this

sense, on what to do in similar cases, even not specifically legislated, but by an implementation

point of view.

Instructions for use (Doc. PPE/11/1/6)

SWEDEN introduced the paper, underlining the need to have more precise written instructions for

use for PPE and not just in general terms, in particular in the example of eye/facial protective

equipment.

FESI asked SWEDEN to be more specific on the type of product they referred to, having many

different one in the mentioned category.

SWEDEN specified that the question concerned equipment for protection against particles,

chemicals and similar. The same instructions were used for different kind of eye protectors.


FRANCE supported what SWEDEN said: such a situation would not be acceptable, according to

the basic health and safety requirements of the Directive (Annex II, 1.4). It would be the

responsibility of market surveillance authorities not to allow placing such products on the market,

and to check what Notified Bodies did. This equipment should be stopped until manufacturers

change this kind of general instructions, even if it could be easier for them to have the same

instructions for different products.

The Chairperson recognised the common agreement on the need to have clear instructions for use

PPE products, as that also contributed to the safe use of PPE. If not, Member States competent

authorities should intervene with the relevant market surveillance actions. This point could be

discussed also at the next PPE Administrative Cooperation Group meeting, if necessary.

Categorisation of diving suits and clothing for any kind of water sports (Doc. PPE/11/1/7)

CEN-CENELEC introduced the paper, from German members of CEN, DIN.

The CEN-CENELEC Consultant explained the situation and characteristics of diving suits and

other clothing for water sports, with regard to their categorisation. Dry gloves and other similar

equipment "offshore" were considered as Category II since long time, when for "onshore"

equipment as wet suits, they even could not be considered PPE, or at most as Category I.

The Chairperson noted no comment on the paper, so he confirmed that diving suits were Category

II, as indicated in the Categorisation Guide, point 6.1.

Dry suits (Doc. PPE/11/1/8)

FINLAND introduced the paper, asking whether dry suits were to be considered as PPE, and of

which Category.

The CEN-CENELEC Consultant said that this case was similar to the previous point, as this

equipment was designed to prevent the user from the shock in the first contact with water. So, it

should be considered as Category II PPE.

FESI suggested that more information could be asked to the manufacturers of this kind of products,

additional material to take a clear decision on the issue, making reference to members of FESI.

The Chairperson said that any information would be welcome, but from the perspective of COMM

the issue appeared to be quite clear, as addressed in the Categorisation Guide. This kind of product

was usually considered as Category II PPE, as in the previous case. In any case, the intended

approach should be based on general consensus.

The NETHERLANDS expressed the need to have more information to take a decision.

FRANCE agreed with COMM. This kind of product for protection could not be covered by the

exclusions in Annex I, as this would give serious consequences to national authorities; and not

being Category I or III, it should be considered as Category II PPE.

The Chairperson said that further information would be considered, but it was also true that there

were manufacturers already CE-marking these products, considering them as PPE.

FINLAND clarified that it was an American manufacturer, not CE-marking the product.

NORWAY mentioned some problems in Norway with CE marking of dry suits, according to their

experience as market surveillance authorities and to the characteristics of the products, the lack of


CE marking, etc. The conclusion was to consider the product as Category II PPE. They would like

to know more from other market surveillance authorities and from manufacturers of those products.

The Chairperson recognised a general consensus on confirming the decision to consider dry suits

as Category II PPE, apart from NETHERLAND asking for more information. This was in line with

the Categorisation Guide and to practice of most manufacturers CE-marking those products,

assuming them as PPE. At the next PPE meetings (AdCo, WG) it would be possible to further

discuss the issue by the point of view of market surveillance operations.

Protective gloves against micro-organisms (Doc. PPE/11/1/15)

FINLAND introduced the paper, asking for categorisation of protective gloves against micro-

organism, making reference to harmonised standards EN 374-1:199460 and EN 388:199461

involving also chemicals. According to the description and instructions for use, could they be

considered as Category II PPE?

FRANCE asked for more clarification on the question, in particular on the link between the aspects

covered by the two standards mentioned.

FINLAND explained that the gloves fulfilled the requirements against one chemical and also

against micro-organisms: the manufacturer claimed for those protections in their instructions for

use. The question was whether Category II could be correct or not, or even Category III: there were

different opinions from experts.

SPAIN said that the standard 374-1 made reference to micro-organisms in the production process,

but there were not specific tests on that. Making some parallelism with similar cases, the product

could be considered Category II, but the mention of chemical protection could be misleading for

users. As indicated, gloves would provide protection against mechanical risks and a barrier against

micro-organisms but it was not so clear about chemicals. In this sense it would be necessary to be

very careful with the information provided to users.

The Chairperson agreed on the difficulty to take a decision on categorisation, as the question

involved possible protection against chemicals for the reference to the standard; but in the product

description it was suggested that gloves were not to be used against chemicals. Indications from the

manufacturers should be followed.

The CEN-CENELEC Consultant observed that in principle the manufacturer indicated in

instructions for use the protection against one chemical and against penetration and abrasion, in

humid conditions, and not against chemicals, preventing from improper use of gloves. Taking into

consideration the information provided, and with the need to have proper instructions for use, the

product could be considered as Category II PPE.

The Chairperson, with no further comments, noted the agreement on Category II PPE for the

product.

UV protecting clothing (Doc. PPE/11/1/9)

60 Superseded as by 6.10.2005 by EN 374-1:2003 Protective gloves against chemicals and micro-organisms - Part 1:

Terminology and performance requirements

61 Superseded as by 6.10.2005 by EN 388:2003 Protective gloves against mechanical risks


The Chairperson introduced the paper on an issue coming up from time to time, according to

request received regarding the status of UV protecting clothing. The documents included the draft

answers to the main questions raised. He asked for comments, underlining the need to be careful,

not to consider PPE any kind of clothing, as they provided protection against sunlight as well.

FESI thought that what COMM has put forward was a serious issue; but, as the document had been

proposed only a week before the meeting, he had no time to extensively consult with his

association's members. He asked the Committee to leave some more time to take a proper decision-

making process.

FRANCE said that indeed the document was late, but it was not a new issue: it had been already

discussed at WG and AdCo meetings with the participation of several Member States, COMM and

international lawyers. It would be possible to take a position making reference to Article 8.3 of the

PPE Directive: it talked about sunglasses and it could be possible to extend this, looking at essential

requirements in Annex II, point 3.9 dealing with protection against radiation and 3.9.1 on non-

ionizing radiation, including UV. The text covered only eye protection, excluding clothes. This was

the first point; on the second point, any clothes protected against UV, so it could lead to include all

clothes under the PPE Directive: need to be careful. There were other standards on this with

different aspects involved and kind of protection, and also in FRANCE there were different

questions with protective clothing, being indeed a quite complicate matter.

LUXEMBOURG completely supported FRANCE. Certain manufacturers put markings on

clothing for special UV protection, but it would be quite strange, as for example with Australian

standards. European standards were stricter in this sense, but it would be necessary to carefully

check the consistency of categorisation for UV clothing, sunglasses, etc.

The CEN-CENELEC Consultant said that he had been the secretary of the standardisation

working group that had developed the standards 13758 parts 1 and 262, to clarify that these

standards concerned specific methods and classification for protection against UV radiation, but not

in general, and not for PPE. There was not a mandate under the PPE Directive or the GPSD, but as

textile committee. He concluded that if garments protecting against UV were considered, all

garments should be included. In most cases, clothing just covered the skin and it could be sufficient

to provide protection, in particular when very performing material was used; but they could also

leave parts of the body not covered and not protected.

The Chairperson recognised that it would be difficult to get a solution; but the question could be

further looked into in the ongoing revision exercise of the Directive, taking into consideration also

the GPSD. For the time being, it would be necessary to comply with the requirements stated by the

manufacturer in the clothing, and to understand what kind of requirements could be imposed in the

framework of the PPE Directive.

FRANCE considered that if a manufacturer claimed additional protection, national authorities

should be able to check it, on the basis of clear criteria regarding special protection, in particular

materials and techniques to get such extra protection (as for example nanomaterials, chemicals,

etc.), also to take into consideration any possible additional risk. In fact, they mentioned one of the

basic requirements regarding "absence of risk of harmful nature" from unusual materials.

The Chairperson agreed on products should be checked as well as the related certification, also

taking into consideration possible new risks. Research would be open in this sense.

62 EN 13758-1:2001+A1:2006 Textiles - Solar UV protective properties - Part 1: Method of test for apparel fabrics; EN

13758-2:2003+A1:2006 Textiles - Solar UV protective properties - Part 2: Classification and marking of apparel


ESF remarked differences between sunglasses and protective garments. He basically agreed on the

need to prove the level of protection as claimed by manufacturers, also in terms of chemicals and

other potentially dangerous products.

The Chairperson confirmed that they were not at the point to decide whether manufacturers'

claims would make their products to be considered into the scope of the PPE Directive. The

question was at stake now, without an agreement at the moment, but all the Committee members

were invited to think about it, to come back on the issue at the next meetings.

The CEN-CENELEC Consultant said that the first point of the discussion should be the question

whether these protective clothing were PPE or not, and then, how to consider them, with the

different products for private use – not under the Directive – and for industrial/professional use.

FINLAND recalled that the question on protective clothing had been introduced at the AdCo

meeting held by them in 2007, with different technical solutions. They agreed with FRANCE on the

importance of different technologies used there.

LUXEMBOURG disagreed with the consideration of protective clothing for private use as not

PPE: there was not such a distinction personal/professional in the PPE Directive, as for example for

sunglasses.

GERMANY made reference to the Categorisation Guide, point 6.11, where clothing for private use

was considered "not PPE".

The Chairperson summarised reaffirming the need to have a look to all those questions, in order to

reach a consensus at the next meeting, with a particular attention to protective clothing in working

environments, in the framework of the PPE Directive and its revision, and the related guidance

documents.

6. Standardisation

Normative change VS conformity assessment (Doc. PPE/11/1/4)

FRANCE introduced a paper on the consequences of normative changes for assessing the

compliance of PPE, with the specific case of life jackets. It concerned the question of new

harmonised standards replacing previous versions, and the related practices and responsibilities for

certificates, with products placed on the market making reference to "old" standards, etc.

The Chairperson underlined that it was not a technical issue, but a legal one: it would not be

possible to have two standards providing presumption of conformity at the same time, but only one,

irrespective of any technical issue involved. The legal framework in force established that

manufacturers had to comply with the standard presently harmonised under the directive, to obtain

presumption of conformity with the requirements of the directive. The "old" standard, no longer in

force, could not provide such presumption of conformity. The related responsibilities regarded

Notified Bodies for issuing certificates, and market surveillance authorities of Member States.

UCINA made reference to the case of life jackets to express UCINAs position on the question.

There are still a number of manufacturers producing according to the "old" standard, and Notified

Bodies accepting that. This, however, is not compatible with the PPE Directive. According to

section 1.1.2.1 of Annex II to the PPE Directive, PPE should be designed in a way to ensure the

“highest level of protection possible.” The PPE guidelines explain that the level of protection of

PPE must be highest possible according to the current state of the art. The notion of “state of the

art” is explained in the Guide to application of the Machinery Directive 2006/42/EC. That Guide


explains that since harmonised standards are developed and adopted on the basis of a consensus

between the interested parties, their specifications provide a good indication of the state of the art at

the time they are adopted. The evolution of the state of the art is thus reflected in later amendments

or revisions of harmonised standards. This is certainly the case as regards the currently applicable

harmonised standards for lifejackets, which contain a number of more stringent requirements than

the previously applicable harmonised standards, in particular as regards certain testing

specifications. UCINA circulated a copy of the report prepared by Rina (an Italian Notified Body)

that highlights the differences between the EN 39x Standards and ISO 12402-X standards. The

majority of European manufacturers already produce with the current harmonised standards, not

only to get presumption of conformity with the basic essential requirements, but also to ensure the

highest levels of safety, as required by the PPE Directive. In this respect, UCINA supported the

French document.

CEN-CENELEC also supported the French document as well as the position of UCINA. The

Commission should provide clear recommendations on the issue. With manufacturers still using

"old" standards, it could be risky for safety.

The Chairperson stressed on the need to follow the legal requirements of the PPE Directive, as for

all the New Approach/New Legislative Framework directives. Standards were not mandatory, but

as harmonised standards they would give presumption of conformity; when a harmonised standard

superseded a previous one, it would be the one that could give presumption of conformity, and not

the "old" one, no longer. There would not be any "coexistence" of two harmonised standards, apart

of a reasonable transition period. In the case of life jackets, only the new standards from the EN ISO

12402 series63 were the harmonised standards in force, with their references published on the

Official Journal of the European Union. This was the situation, and the market surveillance

authorities of Member States had the power to check that and to take action when products would

not comply with the basic health and safety requirements of the Directive. There was the need to

have a common perspective and understanding on that.

LUXEMBOURG entirely agreed with COMM. He just remarked that, according to the mentioned

1.1.2.1 of Annex II, the optimum level of protection should be considered in the design phase, and it

was different from manufacturing. Maybe the question could be further discussed in the revision of

the Directive.

The CEN-CENELEC Consultant partially agreed with LUXEMBOURG, but recalled that the

PPE Directive had been drafted under the Article 95 of the Treaty, aiming for the highest level of

safety. He agreed with COMM, as it was clear that, for the highest level of protection possible, the

newest harmonised standard in force should be used. When new products were placed on the

market, the standard in force should be applied, if manufacturers wanted to use a harmonised

standard for presumption of conformity.

SPAIN said that, since the legal principles were fixed, the question would be up to the market

surveillance authorities. This would include the documentation that they should obtain by

63 EN ISO 12402-2:2006 Personal flotation devices - Part 2: Lifejackets, performance level 275 - Safety requirements

(ISO 12402-2:2006), published on the OJEU on 21.12.2006, superseded EN 399:1993 as by 31.3.2007; EN ISO

12402-3:2006 Personal flotation devices - Part 3: Lifejackets, performance level 150 - Safety requirements (ISO

12402-3:2006), published on the OJEU on 21.12.2006, superseded EN 396:1993 as by 31.3.2007; EN ISO 12402-

4:2006 Personal flotation devices - Part 4: Lifejackets, performance level 100 - Safety requirements (ISO 12402-

4:2006), published on the OJEU on 21.12.2006, superseded EN 395:1993 as by 31.3.2007; EN ISO 12402-5:2006

Personal flotation devices - Part 5: Buoyancy aids (level 50) - Safety requirements (ISO 12402-5:2006), published

on the OJEU on 21.12.2006, superseded EN 393:1993 as by 31.3.2007; EN ISO 12402-8:2006 Personal flotation

devices - Part 8: Accessories - Safety requirements and test methods (ISO 12402-9:2006), published on the OJEU

on 2.8.2006, superseded EN 394:1993 as by 31.8.2006.


manufacturers, as Declarations of Conformity and Certificates stating which standards had been

used. The same for the technical file: if an "old" standard was used, this should be updated with the

relevant standard in force, keeping coherency in the whole documentation with regard to

harmonised standards. This would be the point of view of Member States, but manufacturers had a

different opinion based in economic considerations: but legislation in force should be applied.

LUXEMBOURG agreed in principle with SPAIN, but how it could be implemented? It should

involve also Notified Bodies in their role for certificates, and also standardisers with regard to the

time lag in publication of new standards.

The Chairperson clarified that there was a transition period between the old and the new

superseding standard, taking into consideration the technical characteristics and the needs of

interested parties. But the case under discussion concerned a standard that did not provide

presumption of conformity since 2007!

ESF said that such a debate was going on since 2007 at least, with different approaches in Member

States, and that was an unacceptable situation: it should be clarified for all the interested parties in

all the countries. They also asked COMM to take a clear position on the legal issue: there was no

discussion about the need to use new harmonised standards when available for newly developed

products, but if a product remained unchanged, there would not be any legal basis to withdraw

products. After the paper issued by COMM in April 2011, there was the need of a clear statement.

UCINA added that a mechanism should be envisaged to determine to what extent manufacturers

and Notified Bodies could rely on "old" standards. UCINA considered quite reasonable the proposal

made by FRANCE.

The Chairperson said that the aim of the discussion was to reach a clear agreement on the

implementation of legislation in the same way in all the Member States. The legal requirements

were very clear, despite any other document produced – and in any case, only the European Court

of Justice would have the last word on interpretation. Only the new harmonised standard could give

presumption of conformity; on the contrary, the issue on EC-Type Examination Certificates

(duration of certificates, modalities of revision, etc.) would be more complicated. This was a

horizontal problem, to be raised in deep for all the New Approach/New Legislative Framework

directives, from a legal and implementation point of view. The Commission would take the point

and any contribution in this area would be welcome.

SWEDEN remarked the difficulties for market surveillance activities to deal with certificates in

such a situation.

FESI wanted to understand the size of the problem under discussion: how many manufacturers

were using "old" standards, etc., in order to have a picture of the real debate mixing validity of

harmonised standards and validity of certificates, being in fact different questions.

The Chairperson recalled that the discussion was on the paper circulated by FRANCE, and that the

questions concerning harmonised standards and certificates were related. It would be difficult to

have a clear picture of the size of the problem, how many manufacturers involved etc.

FRANCE answered to FESI: indeed there were two different questions, but with a link between

them, especially with certificates with no limit of validity: the legislation did not fix a duration,

even with the evolution in the state of technology. In fact, there were no-time limited certificates

referred to very old standards, of two or three version before the current one. Such practices would

lead to the end of the system.


FESI thought that it would be better to have bilateral contact to clarify specific situations. A priori

limitation of validity of certificates could have the risk not to follow the evolution of technology. In

any case, manufacturers should not be allowed to use very old versions of standards, otherwise they

should be brought to courts.

The Chairperson said that those would be quite limit situations. It was responsibility of market

surveillance authorities to invite manufacturers to comply with the applicable requirements. He

invited the Member States to provide their contributions by the point of view of market surveillance

authorities, with information on the situation and the practices of implementation of legislation and

related requirements.

FRANCE considered very interesting to know more on those practices, but also information from

manufacturers would be needed.

The Chairperson agreed, to verify that everybody had the same understanding of the legal

framework. All the information would be needed on this very important question.

ESF said that there were different visions, but it would be necessary to keep working with standards

and all the related questions, taking into consideration all the possible consequences: also on the

customers' side, as they would be very interested in buying products according to the newest

standards available, or on procurements, working with public administrations.

EN 341:199264 Personal protective equipment against falls from a height - Descender devices

(Doc. PPE/11/1/4ter)

FRANCE introduced a paper on the standard EN 341:1992 on descender devices, based on a

question raised by Notified Bodies in France. The standard was still in the list of harmonised

standard and a new version had been published in 2011, but this kind of products had been

recognised to be out of the scope of the PPE Directive. In their opinion, the EC-Type Examination

Certificates issued on the basis of the 1992 version of the standard should be withdrawn.

COMM confirmed that in the PPE Guidelines there was a clear statement on the status of this

product as not PPE, so the new version of the standard would not be submitted for publication, even

if the old version was still listed as harmonised standard. He asked CEN to inform on the situation

of the standard.

CEN-CENELEC said that the standard EN 341:1992 would be withdrawn by CEN from the list of

standards to be harmonised under the PPE Directive. She also confirmed that the 2011 version of

the standard had no reference to the Machinery Directive.

COMM noted no further comments on the French document and the agreement on proceeding as

suggested.

Follow-up of formal objection against standard EN 353-165 – fall arresters state of play on

finding a common test method

COMM recalled that, following the Commission Decision on 23 March 2010 regarding

withdrawing the reference of standard EN 353-1:2002 from the list of harmonised standards, a

64 EN 341:1992 Personal Protective equipment against falls from a height - Descender devices




mandate had been issued by the Commission to CEN to revise the standard, and Notified Bodies

had been requested to find a common test method while the standard was being revised. He asked

the Notified Bodies and CEN for the state of the play.

CEN-CENELEC reported on the ongoing progress on the revision of the standard, with a number

of meetings already held by the relevant working group, even if a draft revised standard was not

completed yet. A new meeting on that was planned at the end of the year 2011 towards a definitive

new version.

HCNB reported on discussions at the appropriate NB vertical group on test procedures, to reach an

agreement on additional tests to be carried out by manufacturers, with clear rules to withdraw

products not compliant with those tests. In the framework of the ongoing revision of standard EN

353-1, through CEN, a uniform clearly established test procedure would be available very soon.

FRANCE asked for information on the technical references to be taken into consideration by

manufacturers and Notified Bodies in order to fill the gap between the old withdrawn standard, and

the new one in progress.

HCNB answered that in the process of revising the standard, slight changes could be made with

regard to technical references; but it would be defined in the final result, working together with

CEN. She mentioned the preparatory work at the relevant CEN TC 160 for the revision of the

standard and the discussions on the procedures and their extent to fill the gap with regard to the

withdrawn standard. The relevant working group kept contact with Notified Bodies to share

information taking over the available Recommendation for Use Sheets, for the necessary changes.

COMM welcomed this interchange of information between CEN and NBs and confirmed that the

issue would be followed up at the next PPE WG meeting, to check for progresses.

Formal objection against standards EN 138466 and EN 1457267 on helmets for equestrian

activities

COMM recalled the background on the question, coming from two petitions from the European

Parliament regarding protective helmets for equestrian activities, following a fatal accident

involving the son of a MEP. A first petition in 1996 had claimed that the harmonised standard EN

1384:1996 (reference published on the OJEU since 14.6.1997) did not meet the requirements of the

PPE Directive, so the Commission had given a mandate to CEN to revise the standard to improve

the level of protection provided by these helmets. In response, CEN had developed a new standard

EN 14572:2005, harmonised since 6.10.2005. But a second petition in 2008, it had been stated that

the specification of this latest standard were impossible to meet with existing technology, so no

helmets designed according to EN 14572 had been placed on the market, leaving unsolved the issue

raised by the first petition; and EN 1384 was still used to get presumption of conformity. The

Commission had sought technical assistance on the question from an external text laboratory, and

taking into account the results of the study, COMM decided to launch formal objections against the

two standards EN 1384 and EN 14572, in order to remove their references from the list of

harmonised standards and to withdraw the presumption of conformity. Relevant documents would

be drafted in coming weeks.

CEN-CENELEC informed that the relevant TC 158 had held a meeting in May 2011: work was in

progress to deal with the issue, and they have decided to withdraw the standard EN 14572,

66 EN 1384:1996 Helmets for equestrian activities + A1:2001

67 EN 14572:2005 High Performance Helmets for Equestrian Activities


removing it from their database for publication. A new meeting of TC 158 would be held at the end

of October 2011, with new proposals received from different national delegations to find the best

way to progress, to draft a new standard and also to revise EN 1384. They would report back on the

situation.

FRANCE asked for more details on the formal objections against the standards, and on the nature

of the problems encountered by COMM and the study.

COMM confirmed that in principle the formal objection would cover both standards, to remove

their references from the list of harmonised standards on the OJEU according to the applicable

procedure. In any case it would be defined in the relevant documents, with the different technical

aspects involved.

CEN-CENELEC thought that it would not a good idea to remove both references from the list, as

it would be better to keep at least one standard, EN 1384, than nothing for manufacturers, also

considering that the revision of this standard was under way.

The CEN-CENELEC Consultant considered the case of withdrawing the standards for not being

safe or for not actually covering essential requirements, with different legal aspects and

consequences in each case.

COMM clarified that the launch of the formal objections would have a result depending on the

technical consideration provided, and it would possible to withdrawn both references of the

standards, or to limit presumption of conformity with a warning.

FRANCE made reference to Article 6 of the PPE Directive concerning harmonised standards not

completely satisfying the relevant basic requirements. The situation should be clarified.

CEN-CENELEC Consultant underlined that standards as such had not to cover all the

requirements of the directive, but on the contrary products should comply with.

COMM recalled that the basic safety requirements covered by a harmonised standard should be

specified in Annex ZA.

SPAIN agreed on the situation of harmonised standards, safety requirements and Annex ZA. In

practice there could be some confusion for manufacturers, but the responsibility of Notified Bodies

was to very compliance of the product with the requirements of the Directive.

The Chairperson recalled that, in fact, EC-Type Examination Certificates were issued by Notified

Bodies only when all the BHSRs were complied with by the product, and not on compliance of a

harmonised standard which provided presumption of conformity only with regard to the

requirements addressed in the standard itself, as specified in Annex ZA. This was an important

issue needed a clear common understanding.


CEN-CENELEC reported on the latest developments in CEN-CENELEC Management Centre and

re-allocation of responsibilities. She also mentioned the question of lists of harmonised standards on

the OJEU, asking for more regular publication, having the latest one in July 2011 and a new

sending in next days.

Report by CEN Consultants (Doc. PPE/11/1/14)

The CEN-CENELEC Consultants introduced Mr Foubert as the new CEN Consultant, taking

over the responsibility of the work with a number of Technical Committees from the beginning of


2011. He referred to the report from the other CEN-CENELEC Consultant, but he had sent his

contribution – as a second part of such report – only one day before the meeting, not available for

distribution: so, he presented an oral report on the activities during his first 9 months, including

assessment of standards, meetings attended, etc. All the details on that was included in their written

report.

7. Report from the Coordination of Notified Bodies (Doc. PPE/11/1/16)

HCNB introduced the report of the European Coordination of Notified Bodies for PPE. It included

information on the last meeting of the Horizontal Committee on May 2011 in Brussels, the situation

of Recommendation for Use Sheets and their application, considerations on requirements for

notification, etc. There was a number of RfUs still waiting for their publication on the Commission

website. The next HC meeting would be held on March 2012.

Recommendations for Use Sheets (RfUs) - Horizontal RfUs - Vertical Use sheets VG1, VG2,

VG3, VG7 (Docs. PPE/11/1/10, 11/1/11, 11/1/12, 11/1/13)

FRANCE asked for more information on the sheet 00.136, dealing with time-limit of certificates of

5 years: this sheet was not yet approved and they reaffirmed some reservations on the content,

applicable only to new certificates. In this sense, FRANCE was against this sheet, because this

would create unfair competition among manufacturers, for new products.

HCNB answered that the previous version of the sheet 00.136 had been already confirmed in May

2009, and it was a new Annex to be submitted now. But the main content remained the same, and

the application of 5 year limit to new certificates would not be a problem; on the contrary, it would

be more problematic to apply that to old certificates, with very large number of tests to be carried

out again, and it would not be feasible for Notified Bodies and manufacturers. If in the revision of

the PPE Directive, a time-limit for all certificates would be included, an appropriate transitional

period should be established.

FRANCE recognised the difficulties but suggested that the revision of certificates should start from

the oldest ones. For new certificates, at the end of 5 years of validity, maybe the new directive

would be already applicable and the situation could change.

The Chairperson said that indeed a number of questions dealt with by those Horizontal

Recommendations for Use Sheets would be discussed in the revision exercise, regarding the time-

limit of certificates and the minimum content or common template for EC-Type Examination

Certificates. In any case, he invited those presents to express their comments and point of view on

the RfUs, by forwarding them to the Commission and to the Coordination of Notified Bodies for

PPE, not being in position at this meeting to take a decision on them, due to their technical nature.

GERMANY went back on the sheet 00.136, saying that, in the case of certificates which

contractual base was signed before application of sheet 00.136, a retroactive "obligatory"

application of the five years period of validity of certificates could not be done by Notified Bodies.

This would be a change of the contractual agreements with manufacturers, and would go beyond

their legal possibilities.

COMM agreed on the need to properly update the lists of Recommendations for Use Sheets in the

Commission website68, with some new Horizontal RfUs. He announced that new updated lists

68 Personal Protective Equipment - Notified Bodies


would be available with the status in September 2011, but he recalled that the use of RfUs by

Notified Bodies did not need the approbation of the Committee and the publication on the

Commission website. In any case, he invited the European Coordination of Notified Bodies for PPE

to have bilateral contact to check the situation and clarify the status of RfUs still under discussion or

waiting for approbation; to be reported at the next PPE WG meeting.


No any other business proposed.


The Chairperson said that the next PPE Working Group meeting would take place in 2012; the

exact date had not been fixed yet, but it would be communicated in due time.

End of the meeting

http://ec.europa.eu/enterprise/sectors/mechanical/documents/legislation/personal-protective-equipment/notified-

bodies/index_en.htm

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EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Resources Based, Manufacturing and Consumer Goods Industries Engineering Industries


MINUTES OF THE MEETING HELD IN BRUSSELS, 7 JUNE 2012


Group


Chairperson: Mr Luis Filipe GIRÃO (COMM ENTR/G4)

COMM Participants: Ms Birgit WEIDEL, Mr Mario GABRIELLI COSSELLU,

Mr Michael THIERBACH, Ms Nathalie BOUTTEFEUX (ENTR/G4)

1. Welcome

The Chairperson welcomed those present and announced that a new Desk Officer managing the

PPE Directive 89/686/EEC is working in his unit.

COMM introduced Mr Thierbach as the new Desk Officer and expressed his wishes for a good

working relationship with the PPE Community.




The Chairperson explained the foreseen adaption of Commission's Committees and Working

Groups to the provisions of the Treaty on the Functioning of the European Union. In future the

Commission will have committees where is a need from legislation to establish implemented acts.

In addition to committees there will be Expert Groups. The PPE Working Group will be

transformed into an Expert Group. The PPE Expert Group will be added to the publicly available

register of expert groups. Representatives of the Member States will be members of the Expert

Group, representatives of other states as well as representatives of industrial associations are

considered as observers. There will be no change in the work practice for this group. The

information concerning the expert group as well as agendas, working documents and minutes of the

meetings will be made publicly available in the expert register of the European Commission.

3. Approval of the minutes of the meeting of 4 October 2011 (Doc. PPE/12/1/2)


The Chairperson introduced the draft minutes of the latest PPE WG meeting held in Brussels on 4

October 2011. He pointed out that a few comments were received that led to slight changes in

points 5, 6, and 7.

FRANCE asks for an additional correction. At page 5 under "UV protective clothing", third

paragraph, the term "high protection" should be corrected as "eye protection".

No further comments were made.

With these changes the minutes were approved.

4. Follow-up (Doc. PPE/12/1/3)

4.1 Diving suits (Doc. PPE/12/1/4)

The Chairperson recalled that today all diving suits are category II PPE. Last meeting there was a

suggestion to consider the possibility to split between category I and II in line with a paper

presented by the European boating industry but no decision was made. He asked for further

opinions.

EBI (European Boating Industry) introduced the document PPE/12/1/4. They propose a distinction

between wet and dry suits and relating accessories used in water sport activities. Products relating to

diving should remain category II whereas products used for on the surface water sports should be

considered as category I because they do not protect against cold but are used mainly in water

temperature above 30 degrees and protect user from possible sun burn, scrape and scratches or wind

and are used for fashion.

The CEN-CENELEC Consultant agreed with the expressed opinion of European Boating

Industry. He pointed out that the products for usage for on the surface water sports are not covered

by the scope of the standard EN 14225-1 mentioned in the document.

FRANCE pointed out that the question is what risks the products protect against whether there is a

standard available or not.

The Chairperson concluded that the question whether the on the surface water sport products are

PPE or not is not solved yet. He invited the group to send their opinions by the next meeting in

order to decide whether this kind of equipment should be considered as PPE or not. If they are

considered as PPE we will decide on the categorisation.

4.2 Dry suits

The Chairperson reminded that at the last meeting more information was asked from the

manufacturers of these products. As there was no further input and new information available he

invited the group to present their comments on the issue until 15 July 2012. If no further opinions

are received objecting to the proposed categorisation this kind of dry suits will be considered as

PPE category II.

After the meeting only opinions were received that support the Finish proposal. It is the

consensual approach of the PPE WG to consider dry suits as presented in document PPE/11/1/8

as PPE category II.

4.3 High visibility PPE


The Chairperson recalled the discussion at the meeting 2010 with the decision to establish an ad-

hoc group of volunteers to discuss the issue in more detail. Until now the ad-hoc group has not met.

He invited to participate in the group and asked if there is a Member States willing to lead this

group.

ESF, ETSA, FESI, the UNITED KINGDOM, BELGIUM and FRANCE expressed their interest

to participate in the ad-hoc group.

BELGIUM additionally informed about a currently on-going joint action from PROSAFE on high

visibility clothing and accessories with 6 Member States participating (BELGIUM, PORTUGAL,

CZECH REPUBLIC, SLOVAKIA, LATVIA and LITHUANIA). BELGIUM will give an update

on the exercise at the next meeting.

The Chairperson recognised that there is wide interest. He encouraged the members of the

Working Group to inform the Commission if there are more volunteers to participate. He stressed

again that a Member State should lead the group.

4.4 UV protective clothing (Doc. PPE/12/1/5)

The Chairperson reintroduced the topic. It was discussed whether products, in particular clothing,

that claim to protect against solar radiation should be considered as PPE subject to the Directive. He

asked for opinions of the members of the Working Group.

POLAND expressed the opinion that UV protective clothing should be category I if it is intended to

use by professionals. There are many workplaces where employees are exposed not only to solar

radiation but also artificial UV radiation.

The CEN-CENELEC Consultant pointed out that PPE against artificial UV radiation has to be

considered as category II.

FRANCE agreed with FESI position paper that only clothing to protect professional users against

solar radiation is considered as PPE. FRANCE asked for the legal ground for Netherland's support

for category II. According to the French opinion solar radiation comes under article 8(3) –

atmospheric conditions neither exceptional nor extreme what would follow to category I.

The Chairperson concluded that clothing for daily live, intended for private use, that claims to

have UV protective function should not be considered as PPE. These products should be discussed

in the framework of the textile legislation or the GPSD.

BELGIUM supported the logic of France and asked about PPE against industrial UV radiation.

These products should be considered as category II. There should be a clear distinction between

atmospheric condition and industrial environment.

The Chairperson explained that PPE against industrial UV radiation is considered as category II.

ESF could follow the arguments of France. Nevertheless he would like to discuss the matter with

members of ESF in particular on the distinction between solar and non-solar radiation.

The CEN-CENELEC Consultant expressed his opinion that PPE against solar radiation for

professionals should not always considered as category I. He questioned whether solar UV radiation

could be considered as neither exceptional nor extreme. In some cases it could be of the same value

as industrial exposure.

POLAND supported the opinion of the CEN-CENELEC Consultant.


The Chairperson summarised that the open question is the categorisation of PPE for professional

use against solar radiation. He invited the group to send written comments in order to be able to find

a consensus at the next meeting.

4.5 Automatic vs. non-automatic protective function

The Chairperson introduced the topic. The discussion concerns the question whether products for

which the protective function has to be manually activated can be considered as PPE or not.

FESI recalled the FESI position paper from 2009 on this question. PPE has to be protective per se

and should not require a volunteer action in order to protect. FESI is of the opinion that a volunteer

action requires an element of conscious by the user what should not be presumed.

FRANCE fully agreed with FESI's position. For France it is a very important concept that there

should be an intrinsic protection independent on the action or the will of the user. She recalled the

discussion on anti-avalanche equipment and the decision that this kind of equipment is not subject

to the PPE Directive because they need an action to protect the user.

GERMANY explained that at that time it was in favour of the position expressed by France. In the

meantime Switzerland carried out detailed investigation on the effectiveness of this kind of

equipment that has convinced Germany of the opposite. Now it is the opinion of Germany that

protective equipment what is not intrinsically active should also be considered as PPE.

CZECH REPUBLIC and POLAND supported the view that manual activation should not be a

reason for exclusion. Only the protection offered by products should be taken into account, the way

of working is not so important. There is already equipment covered by the Directive with manual

activation, for example respiratory protection devices or welding shields.

The CEN-CENELEC Consultant explained is opinion that the only way to decide if equipment is

PPE or not is to follow the Directive. The legal text does not contain any reference that the

equipment has to be automatically. In the Directive the only reference that is made to automatic

activation is in the requirement for lifejackets69 however this is not a requirement but an option. He

pointed out the consequence of the exclusion of non-automatic activated equipment: We would

subsequently exclude many products from the Directive that are covered in the means that there are

many explicit requirements for this kind of equipment. He mentioned again the example of

respiratory protection devices for diving that in most cases are manually activated by the diver.

According to FRANCE two cases must be distinguished, the intervention of the user before the risk

arises (e.g. lifejacket) and the requested quick activation of the PPE at the time when the risk arises

(e.g. avalanche airbag).

LUXEMBOURG added another example for non-automatic PPE. On a welder’s helmet the eye

protection can be lifted up by the user. The protection is not permanent it is up to the will of the

user.

BELGIUM supported France on the difference of the two cases. A product should only be

considered as PPE when the activation is done before the risk arises. Even then non-automatic

equipment can be PPE. The example given by Luxembourg is this kind of PPE.

The Chairperson concluded that the current legislation does not make a distinction between

automatically and manually activated equipment. Regardless of the fact whether a product is

69 BHSR 3.4 Prevention of drowning (lifejackets, armbands and lifesaving suits), 2nd paragraph


activated automatically or manually it has to comply with the requirements of the Directive. He

believes an exclusion of manually activated product would bring us to a grey zone where some of

the existing PPE products would be challenged whether they should be considered as PPE products

or not. The debate shows we are not yet close to a consensual agreement. The Chairperson invites

the group, in particular France and FESI, to take a look into the issue from the perspective, what

would we lose if manually activated products would be considered as PPE.

5. Revision of the Directive – State of play (Doc. PPE/12/1/26)

COMM presented the state of play of the revision process for the PPE Directive. He explained the

current draft of the Commission proposal for the revised Directive. All in all there will be only

marginal technical changes. Apart from this the Directive will also be aligned to the New

Legislative Framework (NLF). He informed that the Commission thinks to publish the new

legislative text as a Regulation rather than a Directive.

LUXEMBOURG pointed out that a reference to the limit values in the directive on vibration in

BHSR 3.1.3 (mechanical vibration) would be useful; it should not be deleted. At least there should

be a reference to that directive what will be useful information.

COMM explained that it is not practicable to request a reduction of mechanical vibration below

limit values for each PPE. In consequence that PPE might be no longer be usable for the intended

work. Nevertheless it could be considered to include a note in the text to inform about the directive

2002/44/EC on vibration.

POLAND asked for the reason to change the classification for hearing protection to category III

and asked for further details concerning the proposed requirement on technical documentation for

category I PPE.

COMM pointed out that noise protection equipment fits to the definition of category III. The main

criterion to consider this product as category III PPE is related to the fact that the user is not able to

evaluate immediately the risk. Concerning the technical documentation it is proposed that all

requirements of annex III should be applied to all categories, not only to categories II and III as it is

the case u to now.

The UNITED KINGDOM wanted to know whether there would still be a transitional period if the

legal text will be published as a regulation.

The Chairperson answered that the Commission will take into account a reasonable transitional

period.

FRANCE proposed to change the term Basic Health and Safety Requirements into Essential Health

and Safety Requirements in order to be in line with the other directives. She also mentioned that

with the transposition of the PPE Directive into French law France has added additional provisions.

Is it possible to keep these provisions if the legislation will become a regulation?

The Chairperson explained that the term Essential will be used. Concerning the second question

he replied that it depends on the particular provision if it could be kept. Obligations for importers

for instance will be handled within the alignment to the NLF.

FESI asked whether there will be a special non-costly procedure for the renewal of the EC type-

examination certificate for the case that there were no substantial changes of the product as well as

for the relevant standard. He expressed reservations on the obligation that every PPE should be

accompanied by the Declaration of Conformity (DoC). Apart from the technical documentation this


would be a second document for the same purpose: to support the market surveillance authorities.

Adding the DoC will not bring any added value in terms of safety for the user but higher costs for

the manufacturer. He mentioned the fact that a DoC can also be counterfeited easily.

COMM explained that it is the aim to provide for a "light" process in case of a renewal of the

certificate without major changes of the product and the standard. COMM also replied that all PPE

should be accompanied by the DoC which can be easily integrated in the user instruction. We do

not see a major impact here. The DoC has to be clearly distinguished from the technical

documentation which is an essential part of each conformity assessment procedure. The

manufacture has to demonstrate and explain how his product meets the requirements and how it has

been demonstrated. It is based on a risk assessment of the product. The manufacturer explains

which technical solutions he has adopted to meet the requirements of the Directive. The

documentation remains with the manufacturer who has to provide it on request of the authorities.

GERMANY came back to the reference to limit values for mechanical vibrations. In BHSR 3.5

there is a comparable reference to limit values for noise. Both references should be treated in the

same way. If we decide to cancel the reference both of the references should be cancelled. The

arguments used for the mechanical vibration can be applied to noise too. If we refer to limit values

we have to be sure that the PPE enables these limits to be respected.

The CEN-CENELEC Consultant recalled that the PPE Directive is applicable to all PPE

regardless if the equipment is used in private of professional context. But the references to other

directives in case of PPE against mechanical vibration and noise refer to workplace related

legislation only. He has doubts if the Directive is able to make these references from a legal point of

view.

The Chairperson responded that both comments will be considered.

POLAND reminded that the Directive contains requirements for eye protection against harmful UV

radiation and asked to consider an integration of comparable requirements for skin protection too.

LUXEMBOURG compares sunglasses with hearing protection. The same argument should be

followed. For sunglasses the user also is not able to evaluate the risk. He asked for a classification

of sunglasses in a higher category (currently category I).

EBI (European Boating Industry) asked about the way of translation of the legislative text in the

case of a regulation.

The Chairperson explained that before any legislation is published all the text is checked in great

detail by Commission's and Council's translation services that includes lawyer linguists.

ESF pointed out to be careful with the proposal to exclude clothing against adverse weather

conditions for professionals from the scope of the Directive. In principle ESF agrees with the fact

that if there is a protection for the same risk there is no reason to have a difference between

professional and private use. It is the ESF opinion that in the case of weather clothing there is not

the same risk. As a private user you have the choice to be in the bad weather or not; or you can keep

it for a short period. Professional users (e.g. road construction workers) do not have that choice;

they have to work in the rain for 8 hours or longer. If these persons are not protected properly

against these adverse weather conditions there will be a lot of health problems.

The Chairperson summarised that all issues raised in the discussion will be considered during the

revision process. He thanked the Members of the WG for their cooperation with respect to the

drafting of the revised Directive.


6. Scope

6.1 Categorisation of dry suits providing complete insulation from the atmosphere (Doc.

PPE/12/1/6)

CZECH REPUBLIC asked if a dry suit as described in the document and used together with other

equipment (e.g. dry gloves, diving helmet) providing complete insulation of the body and the

respiratory tract from the atmosphere can be considered as category III according to point 6.6 of the

categorisation table, although it is independent of protection of the respiratory tract. Czech Republic

raised the question whether this interpretation could be correct. Czech Republic does not think so

and considers it as category II because this dry suit does not represent a facepiece of the respiratory

protection device. He proposed adjustment for point 6.6 of the categorisation table for accurate

understanding.

Czech Republic informed about its additional proposal which is described in the document. Because

of serious dangers in case of damage or dysfunction (primarily drowning, death or irreversible harm

of health caused by decompression sickness) all dry suits for diving should be classified as category

III. With regard to the opinion and findings of Czech experts, the Czech Republic considers

prospective change of classification of dry suits for diving (EN 14225-2:2005), including dry gloves

for mounting with the dry suit, to the category III as appropriate with these real hazards. A similar

case regards some PPE designed to prevent drowning or for use as buoyancy aids - buoyancy

compensators, life jackets and abandonment suits (EN ISO 15027-2:2002), which should be, in its

opinion, included in category III as well.

FRANCE expressed the opinion that the guide could be improved but that needs a risk based

approach. One has to differentiate between full insulation from the atmosphere in case of chemical

risks and in case of diving. For the chemical risk the full insulation is due to the pollution of the

surrounding air whereas in case of the dry suits for diving the insulation is to protect the wearer

against hypothermia. Having this in mind she is the opinion of that dry suits for diving should

remain in category II; the respiratory apparatus for diving should be category III.

The Chairperson concluded that we can follow the suggestion to check the guidelines in order to

clarify that point.

6.2 Categorisation of knee protectors for cycling purposes (Doc. PPE/12/1/7)

COMM explained the two different types of protectors and the Commission proposal for

categorisation according to the definition and common use of categories.

The UNITED KINGDOM and BELGIUM supported the Commission proposal.

THE NETHERLANDS asked for the definition of minor or higher impact.

GERMANY reminded on earlier discussion on this question and recalled the consensus that the

definition can be found in article 8(3), 5th intend of the directive: Minor impacts do not affect vital

areas of the body and cannot cause irreversible lesions.

The Chairperson summarised that the proposal is approved by the PPE WG.

6.3 Hat "helmet" for cycling – PPE Cat I or Cat II? (Doc. PPE/12/1/8)

FINLAND explained the product and raised the question whether the classification in category I, as

done by the manufacturer, is correct. The product does not fulfil the requirements of the harmonised


standard for bicycling helmets EN 1078. The manufacturer has told he does not sell helmets; he

sells caps/beanies with additional protection function. Finland is of the opinion that this product

should be category II as it is intended to protect during cycling that includes falls and collisions

with a car. According to the guidelines all helmets including sports helmets are PPE category II.

The CEN-CENELEC Consultant pointed out that independently of the question on categorisation

the product has to fulfil the BHSR of the directive.

GERMANY explained the decision of the German Working Committee Market Surveillance. It

was concluded that the manufacturer can sell the product as PPE category I but he must not

advertise or sell his product as an alternative to a helmet. Germany pointed out that other

manufacturers of this kind of head protection refer to EN 812 "Industrial bump caps" for caps with

an inner scalp guard. For the product presented by Finland the manufacturer has done false claims

in his user instructions that do not reflect the properties of his product. This has to be criticised.

LUXEMBOURG agreed with GERMANY. These anti-bump hats are not helmets but scalp

protecting hats. The information provided by the manufacturer is wrong. After correcting the

information the product could be classified as category I.

FRANCE cannot agree with GERMANY and LUXEMBOURG. Products in the scope of EN 812

protect against bumps against sharp objects. But a cyclist is not subject to that sort if risk. The

problem here is that the product is described as an alternative to a normal helmet without providing

the same level of protection. That could mislead consumers. There is not the same protection

provided in the case of falling or a collision with a car.

IRELAND supported the position of FRANCE.

BULGARIA pointed out that more information is needed on the properties of this product.

The Chairperson summarised the current situation. The product is presented in a misleading way

to the consumer. It claims to provide protection that it does not provide. This may lead to dangerous

situations. The market surveillance authorities should use the usual procedures: Communicate with

the manufacturer in order to either describe the product in line with its actual properties or, if this

product should replace helmets, bring it in compliance with the applicable requirements for helmets.

He asked the authorities to inform the Commission about any action in order to circulate this

information to the other Member States.

6.4 Bullet-proof vests (Doc. PPE/12/1/9)

FINLAND introduced the situation that bullet-proof vests are sold without CE-marking and

without relevant documentation. The distributer took the protective panels out of the vests. The

vests are sold as collection items but not as PPE. The actual manufacturer does not advertise the

vests for any particular user group but describes these products as bullet-proof vests. FINLAND

raised the question: If bullet-proof vests are sold without protective part are they still considered as

PPE?

LUXEMBOURG replied that he would consider this product as PPE and would ban it from the

market.

The Chairperson did not see any objections to this opinion. He concluded that this case should

also be dealt with by the market surveillance authorities.

6.5 Instructions for use for hearing protectors (Doc. PPE/12/1/14)


SWEDEN raised a question on the way how user information is presented. Is it sufficient to have

only abbreviations of the attenuation values without any further explanations printed in the user

instruction?

GERMANY explained that for the layman most of the properties of hearing protection are totally

incomprehensible. There are even standards available to explain how the user has to deal with these

values (EN 45870). Which means it is not possible to explain each individual value to the end user.

There is real expertise needed to understand it at all.

The CEN-CENELEC Consultant mentioned that the Directive requires in Annex II 1.4 g) that

marking should be explained. Additional he informed of the on-going revision of EN 458. One aim

is to make it better understandable to the non-expert.

FRANCE added that BHSR 1.4 should be applied together with 2.12 which clearly states that

marks that relate to health and safety must be explained. She is the opinion of that only the letters is

not satisfying. It would be better to put the full phrase in the instruction as a minimum. This might

not be clearer but at least one knows the phrase and is able to search for more information.

The Chairperson summarised that we have to decide whether we will systematically replace the

letter with the full phrase because it would be easier to gain more information and to understand

what is involved. He asked the PPE WG for written opinions in order to reach a conclusion.

6.6 Minimum font size for information supplied by the manufacturer (Doc. PPE/12/1/15)

GERMANY explained the great importance of the user instructions for the safety of the users. The

user information is of great importance for the effectiveness of the PPE and for the knowledge

about additional risks due to the use of that PPE. Unfortunately some manufacturers try to put as

many as possible language versions on a small piece of paper. Formally the manufacturer fulfils the

requirement on presenting the information but it is not in a usable form. That means the user does

not read such instructions in practice what presents a great risk. He informed about the decision that

was taken by the German market surveillance authorities last year that in Germany all products with

user information which does not respect EN 6207971 are withdrawn from the market. This standard

requires a font size of 9 points. On the other hand there is a Commission guidance document on the

European Directive on medicinal products72 that recommend a minimum font size and a minimum

line separation. GERMANY proposed to integrate these recommendations into the PPE Guidelines.

He added that German manufacturers support that proposal.

FESI acknowledges the concern of GERMANY. Nevertheless he pointed out that in consequence

some user instructions will be bigger than the product itself. One should also think about other ways

of communicating information to the user such as pictograms or using the internet.

ESF mentioned that manufacturer in principle agree on a guidance for the size of user instructions.

Additional he wants to broaden the discussion to the content of the user instructions to the question,

what is really needed within the instructions. Often there is too much and too complex information

on it. He reminded the discussion on instruction for hearing protectors in the agenda point before:

70 EN 458 "Hearing protectors – Recommendations for selection, use, care and maintenance – Guidance document"

71 EN 62079 "Preparation of instructions - Structuring, content and presentation"

72 Guideline on the readability of the labelling and package leaflet of medicinal products for human use

(http://ec.europa.eu/health/files/eudralex/vol-2/c/2009_01_12_readability_guideline_final_en.pdf)

http://ec.europa.eu/health/files/eudralex/vol-2/c/2009_01_12_readability_guideline_final_en.pdf


one has to be an expert in order to understand the information. This would be one way to reduce the

size of the user instructions.

BELGIUM added that in the harmonised standard EN 115073 on protective clothing it is required

that the marking shall not use characters smaller than 2 mm. She reminded that an agreement should

not be contradictory to requirements already in place.

The Chairperson pointed out that we have to differentiate between user instructions supplied with

the PPE and labels marked on the PPE itself. He added that the question on font size is a horizontal

issue. So we have to search other legislation and standards providing solutions and try to find a

horizontal way. He pointed out that the requirement on the correct language version is out of the

question. This is a clear request by the Member States.

6.7 A new information system for Market Surveillance in Greece (Doc. PPE/12/1/17)

GREECE briefly explained their newly introduced system for market surveillance. The tool is

made to assist authorities working in the field of all New Approach Directives. It is possible to

interact with ICSMS, RAPEX and other systems. He asked the group for their experiences in

gaining technical information in order to be able to prove the compliance with the Directive for a

product of category I where no EC type-examination is required.

LUXEMBOURG described that unfortunately there is almost nothing available. Therefore he

asked for an additional requirement in the revised Directive that the Declaration of Conformity has

to accompany each product. There is a lot of information on the Declaration of Conformity which

can be checked without carrying out detailed tests on the product.

The Chairperson reminded that such a requirement is discussed in the framework of the revision

of the Directive. Additional to that, already currently market surveillance authorities can ask for a

technical file.

6.8 Market surveillance campaign on PPE for motorcyclists (Doc. PPE/12/1/18)

FRANCE introduced the issue: A French market surveillance campaign on PPE for motorcyclists

identified a number of problems with protective clothing containing protective shells. There is no

certification for motorcyclist's clothing as a whole. Only the protective shells are certified. On the

basis of Article 1(2) of the Directive in addition with the categorisation guide point 14 that deals

with motorcyclists' equipment FRANCE is the opinion of that the whole item of clothing should be

certified. If equipment should be effective it is not enough to have sufficient shell elements but it

must be ensured that the protective shells remain in place all over the usage in particular during an

accident. Clothing also provides protection against abrasion but that is not certified. Additional a

certain number of products were not certified because the Notified Bodies considered that there was

no suitable standard for them. But the absence of a standard should be not a reason not to certify a

PPE. FRANCE asked the PPE WG to restate that items of clothing that include protectors the item

of clothing as a whole should be considered as PPE and should be examined as a whole and that it is

not enough simply to evaluate the protective elements.

The Chairperson asked the PPE WG for written opinions on the French proposal that if you have

items of clothing for motorcyclists which contains impact protectors than it should be the whole

item of clothing that should meet the requirements of the Directive not simply the protective

elements. He mentioned that the other point on examination of a product in absence of a

73 EN 1150 "Protective clothing – Visibility clothing for non-professional use – Test methods and requirements"


harmonised standard should be self-evident. The conformity of the product shall be examined using

other technical solutions. This is the philosophy of the New Approach.

7. Standardisation

7.1 Report by CEN Secretariat

Not discussed due to lack of time

7.2 Report by CEN Consultants


7.3 Draft programming mandate on protective textiles and personal protective equipment

(Doc. PPE/12/1/10)

COMM presented the background and content of the programming mandate. She explained that the

concept of protective textiles is closely linked to PPE but encompassing a wider range of products

and uses than the definition given in the PPE Directive. The mandate is only a first step in the

direction to develop standards, a programming mandate. It will not have standards as immediate

result but asks CEN to investigate the field and to develop a plan for future standardisation work.

FRANCE asked whether the drafting of this mandate means that the already existing mandates in

the PPE field are insufficient.

COMM clarified that the programming mandate is complementary to already existing mandates.

The Commission requests CEN to identify clearly whether there is a need to revise existing or to

develop new harmonised standards. In that case those standards would be developed under the

mandates that already exist.

The Chairperson added that results of this mandate could also be plans for standards that are not

linked to safety issues but to other technical proposals.

This programming mandate M/509 was sent to the European Standardisation Organisations on

24 September 2012.

7.4 EN 13138-1 "Buoyant aids for swimming instruction" – Small parts


7.5 EN 20345 "Safety shoes" (Doc. PPE/12/1/12, PPE/12/1/22, PPE/12/1/23)

FRANCE introduced the topic on safety shoes including an anti-puncture sole. In the past it was

demonstrated that the relevant standard (EN ISO 20345:2004) was not sufficient to guarantee that

these soles really provide protection. With the new version of the standard (EN ISO 20345:2011)

that safety problem is solved. It contains new requirements and a new test concerning the anti-

puncture sole. In the list of harmonised standards in the Official Journal of the European Union (OJ)

a transitional period is given during that both the new and the old version of the standard provide

for presumption of conformity with the requirements of the PPE Directive. Nevertheless we are

back to the often discussed question what happens to products manufactured according the old

version of the standard. She asked for a statement for a precise time table to ensure that all models

on the market will be in compliance with the new version of the standard.


ESF explained the statement. In general there is no disagreement that the new standard offers a

solution to a problem. Due to huge amount of protective footwear sold every year including many

different types there will be a problem with the workload for redesign and for the necessary tests

including EC type-examination by Notified Bodies. ESF asks for a common agreement for the

timing to make sure that it is in practice possible to introduce products based on these new

requirements.

CEN-CENELEC reminded of the possibility to propose for a longer transitional period already

during the standardisation process. This was not done in this case.

HCNB and FESI supported the arguments of ESF. There will be a practical problem to be in

compliance with the standard for the manufacturer. All the necessary changes cannot be done

within a short period of time.

FRANCE pointed out that French authorities do not agree with ESF position. In consequence of the

proposed time table there would be shoes on the market that are not in conformity with the

Directive until end of 2014.

The Chairperson summarised that we are discussing the proposal that market surveillance

authorities should accept that shoes are produced and placed on the market according to the old

standard for an extended period of time. This cannot be decided by our group. In order to be in line

with the legislation we have to enlarge the transitional period in the OJ. It is his understanding that

we have to answer two questions. In order to enable the manufacturers to produce shoes for an

extended time according to the old standard firstly we have to change the transitional period in the

OJ to be in line with the legal principles. Secondly we have to decide on the period of time that

products legally manufactured according to the old standard are allowed to stay in the distribution

chain (selling stocks). He asked for opinions of the manufacturers for a reasonable time for the

transitional period in the OJ. We will ask the Member States and decide on the date. He also

stressed to use the standardisation process in order think earlier about such problems and possible

longer transitional periods. The mentioned allowed period for selling stocks is another question.

The manufacturers and associations are also asked for comments and suggestions for that. The

Commission together with the Member States will discuss this issue in a later step.

After the meeting it was decided to change the date of cessation of presumption of conformity of

EN ISO 20345:2004 to 30 June 2013. A corrigendum to the original publication was published in

the Official Journal on 4 July 2012.

7.6 EN 795 "Anchor devices"


8. Notified Bodies

8.1 Report from the Coordination of Notified Bodies


8.2 Recommendations for Use Sheets (RfUs) (Doc. PPE/12/1/19)

COMM explained the written procedure in order to handle the huge number of RfUs to be endorsed

by the PPE WG. All RfUs already approved by the Horizontal Committee of Notified Bodies

(HCNB) were placed on CIRCA open for comments (189 sheets in total). We received comments

for 15 RfUs. For the sheets of VG10 we received a general comment by the CEN-CENELEC


consultant that some of these RfUs are obsolete with regard to the standards that are already

covering these issues. The recommendations without any comment should be considered as

endorsed and could be published on the EUROPA webpage. For the recommendations which have

received comments we would like to invite the HCNB and the members of WG who expressed the

comments to have a bilateral discussion to try to reach an agreement on the specific RfUs. The

solution should be presented at the next WG meeting in order to endorse this RfUs.

As no other opinions were raised the Chairperson concluded that the RfUs without comments are

endorsed by the PPE WG. For the other recommendations the procedure explained above will be

followed.


9.1 Clarification if Snow- and Ice-spikes are PPE (Doc. PPE/12/1/25)



The Chairperson said that the next PPE Working Group meeting is scheduled for 24 October

2012; as usual this date is subject to confirmation.

End of the meeting






Group


Chairperson: Ms Birgit WEIDEL (COMM ENTR/F5)

COMM Participants: Mr Mario GABRIELLI COSSELLU, Mr Michael THIERBACH, Ms

Nathalie BOUTTEFEUX (ENTR/F5)

1. Welcome


2. Approval of the draft agenda (Doc. PPE-12-2-1)



3. Approval of the minutes of the meeting of 7 June 2012 (Doc. PPE-12-2-2)

The Chairperson introduced the draft minutes of the latest PPE WG meeting held in Brussels on 7

June 2012. Due to the late circulation of the minutes she asked the participants to send their written

contributions, comments or suggestions 5th December 2012, before considering the minutes as

approved.

FESI asked for a change of his contribution on page 10 from "FESI appreciates" into "FESI

acknowledges".

With those remarks, the draft minutes remained pending of approval until 5th December 2012.

4. Items not discussed at the last meeting

4.1 Report by CEN Secretariat (Doc. PPE-12-2-12, PPE-12-1-21)


CEN-CENELEC reported on the latest developments in CEN and CENELEC. She gave

information on the published standards in the field of PPE, on the last meeting of the PPE Sector

forum as well as on details of the work on some particular standards.

FESI wondered whether it would be possible for sporting goods industry to take part in the work on

the programming mandate on protective textiles (M/509). Concerning the standardisation on horse

riding helmets he asked whether the experts in the CEN/TC 15874 meeting came from industry too

or whether mainly experts from Member States were present. CEN-CENELEC explained that the

future BT Working Group on the mandate is open for everyone. But the mandate has to be approved

by CEN and CENELEC first. After this step a call for experts will be circulated and who is

interested will be very much welcomed in this group. Regarding the experts attending the CEN/TC

158 meeting on horse riding helmets, the representative of SWEDEN replied that in fact there were

more manufacturers represented than authorities.

COMM was interested in the timeframe for the work on EN 138475, in particular when the final

draft is expected. Furthermore he expected a typing error in document PPE-12-2-12 that speaks

about a “Formal Objection” connected with EN 13138-176. CEN-CENLEC agreed that it is a

typing error. There is no formal objection against that standard. For EN 1384 a first draft is

expected earliest for summer 2013.

4.2 Report by CEN Consultants (Doc. PPE-12-1-16, PPE-12-1-24)

The CEN-CENELEC Consultant presented his activities during the last months, including

assessment of standards, meetings attended, etc. He pointed out that negative assessments had to be

given to two standards under the Vienna agreement on sunglasses. In these standards certain

mandatory requirements of the PPE Directive were presented as options – what cannot be accepted

for European harmonised standards. There are requirements that are different in Europe and other

parts of the world. After discussion with the convenor a solution was found. The final drafts of

these standards are expected soon. Furthermore, negative assessments had to be delivered to prEN

1227077 and prEN 1227678 due to poor quality of Annex ZA. Mr Foubert emphasised the

importance of the Annex ZA of harmonised standards as being the link between legal provisions of

the Directive and the technical provisions of the standard.

FRANCE used these examples to stress the importance of the work done by the CEN-CENELEC

Consultants being a control instance for the quality of future harmonised standards. In practice the

authorities cannot monitor standardisation work in such a detail what makes the consultant's work

so essential.

4.3 EN 13138-1 "Buoyant aids for swimming instruction" – Small parts (Doc. PPE-12-1-11)

COMM introduced the document on questions about the interpretation of requirements on small

part in the standard EN 13138-1. It is connected with a safeguard clause notification. Apart from the

74 CEN/TC 158 “Head Protection”

75 EN 1384 “Helmets for equestrian activities”

76 EN 13138-1 "Buoyant aids for swimming instruction - Part 1: Safety requirements and test methods for buoyant

aids to be worn"

77 prEN 12270 “Mountaineering equipment - Chocks - Safety requirements and test methods”

78 prEN 12276: "Mountaineering equipment - Frictional anchors - Safety requirements and test methods"


question whether the standard's text is unambiguous or not it is asked whether the provision of the

standard fulfils the relevant requirement of the Directive.

FESI asked whether there is a statement of the manufacturer.

COMM explained the problematic circumstances of this issue. During the EC type-examination

ordered by the manufacturer the test on small parts was not performed. The interpretation was that

the product does not have any attached small parts. After the safeguard notification the test was

performed by the manufacturer; no small parts were generated. On the other hand, the test

performed by the notifying Member State has generated small parts.

FRANCE expressed its principle opinion that the test should be carried out on the whole item. This

particular PPE is designed for young children so any test should be carried out on all parts of the

equipment which might become detached even though the standard is not clear in this respect.

Additional France argued that there could be several reasons for different results of the tests (e.g.

different procedures, different batches of the product).

CEN-CENELEC informed that both points the unclear wording and the unclear test method were

raised during the public inquiry which ended in August this year. CEN has to deal with these

remarks. During that enquiry also the CEN-CENELEC Consultant mentioned that the relevant

clause could be improved in both points.

The Chairperson thanked CEN that the item is taken up by standardisation. The Commission will

follow the issue with the abovementioned safeguard clause notification.

4.4 EN 79579 "Anchor devices" (Doc. PPE-12-2-3, PPE-12-2-10)

FRANCE introduced its formal objection against EN 795:2012 on the basis of the circulated

document. France is the opinion of that the standard covers both equipment that is subject to the

PPE Directive (mobile anchor points, i.e. transportable and temporary) and equipment that is not

seen as PPE (fixed anchor points that are permanently secured to a structure). France recalled the

decision of the European Court of Justice80 has confirmed that only type/class B and E anchor

devices are PPE. France proposed that the standard should be changed in a way that it only covers

anchor devices subject to the PPE Directive (i. e. type/class B and E).

The Chairperson of CEN/TC 160 explained the viewpoint of the standardisation group on EN

795:2012. She pointed out the fact that the market of anchor devices is huge and many different

types are available on the market.

CEN had to admit that the 1996 version of the standard mixes both kinds of anchor devices; those

that are permanently fixed to the structure and so become integral to it and those that are not

permanently fixed to the structure (only fixed to the structure for the time of the work and can be

removed from the structure at any time). The anchor devices that are permanently fixed to the

structure cannot be considered as PPE. So CEN realised that in the revision it must be made clear

what is part of the structure and was is not. Technically it is not as simple as the warning for EN

795:1996 in the OJEU appears. The warning only states classes A, C, and D are permanently fixed

and therefore cannot be considered as PPE. Under those classes in EN 795:1996 there were also

some types which are removable from the structure. With the new standard CEN tried to make that

79 EN 795:2012 "Personal fall protection equipment - Anchor devices"

80 Case C-185/08, judgement of 21 October 2010


distinction clear and excluded from the standard all anchor devices which are permanently fixed to

the structure.

CEN is the opinion of that the anchor devices which are removable from the structure are in fact

PPE. These types fit the definition in Article 1(3) of the PPE Directive on connection systems to

external devices. The real PPE is the harness that the worker is using and this had to be connected

somewhere. This connection can be the lanyard, the connectors, and it does have to include the

anchor device which is not part of the structure. Otherwise this part would never be tested in any

way. The scope of the 2012 version of EN 795 excludes those anchor devices that are permanently

fixed to the structure. The relevant Working Group and the CEN/TC are convinced that EN

795:2012 only covers PPE. It was important for CEN to cover all these different types of devices in

one standard because they all follow the same design and test principles and splitting into different

standards would have caused a lot of problems and confusion.

CEN-CENELEC added that the draft of EN 795:2012 was voted positively by a large majority of

CEN members (86%). This is taken as a sign of a good improvement of the standard. It is CEN’s

opinion that it would be a mistake not to harmonise that standard under the PPE Directive.

GERMANY could follow the French position at first glance. However, after a closer look at the

issue and after a detailed discussion with national experts, it came to the conclusion that CEN has

done a good work with the 2012 version. The old classes of anchor devices were restructured taking

into account the European Court of Justice decision. Germany is of the opinion that the scope of EN

795:2012 is clearly described. Additionally, and this is confirmed by the French document, the

standard is technically correct and constitutes a clear improvement. Germany is in favour of a

harmonisation of standard EN 795:2012 under the PPE Directive.

FRANCE pointed out that there is agreement that anchor devices that are permanently fixed to a

structure are not PPE. France does not agree, however, with the concept that anchor devices that are

fixed to the structure by not permanently, i.e. movable, anchor devices should be PPE. France does

not recognise an anchor device that can be detached from a structure as the same as a mobile anchor

device. The question is, when the anchor device is used, is it fixed to the structure or is it not? It is

understandable that manufacturers try to solve an issue of confusion but a standard cannot be used

to define the scope of a directive. France emphasised that it is a legal issue but it is also a safety

issue. It is the opinion of France that conformity of anchor devices that are fixed to the structure

during use, even if they are detachable, cannot be assessed pursuant to the PPE Directive; they can

only be assessed pursuant to the construction products legislation.

The Chairperson summarised that the problem cannot be solved today and invites the members to

present written contributions within 2 months.

4.5 Report from the Coordination of Notified Bodies (Doc. PPE-12-1-27)

HCNB based the report on the document and focused on the problems related to accreditation and

notification of notified bodies by the Member States. It seems that the relevant procedures are not

really harmonised. HCNB asked the Member States to work on these in order give the NBs the

same basis for work and a level playing field.

FRANCE pointed out that accreditation is compulsory in France. However, the procedures of

accreditation can be different. The French accreditation body could not define a standard rule for

those procedures. France asked for guide what rules or standards should be used for accreditation.

The Chairperson recalled that in the course of the revision of the PPE Directive there will be

alignment to the New Legislative Framework (NLF). This will lead to substantial changes relating

to accreditation and notification practises. There will be much more precise notification criteria.


There is also a document elaborated that shows the link between the different criteria and the

relevant standards. However, the Commission cannot fix the standards because the usage of

standards is voluntary, also in this context. On the other hand, accreditation is not obligatory. But

the procedures for notification are much more complicated if accreditation is not used. For example,

the other Member States will have the possibility to assess the notification on the basis of the

relating documents that must be provided by the notifying Member State if accreditation is not used.

It is also possible to object to a notification.

4.6 Clarification whether Snow- and Ice-spikes are PPE or not (Doc. PPE-12-1-25)

COMM introduced the document. The German committee of notified bodies for PPE asked for the

position of the PPE WG whether the described equipment is PPE and if so of which category. The

Commission notes that this equipment fits the description of point 8.1 in the categorisation guide:

“equipment and/or accessories ... manufactured … to provide anti-slip protection”. With that it

would be recognised as PPE category II.

The UNITED KINGDOM and FESI agreed with the Commission opinion. A fall or slip on ice is

certainly not classified as minor impact and that excludes category I.

COMM concluded that the Commission will provide an answer declaring that this type of products

is PPE category II. Furthermore it will be added as an example in the categorisation guide.

5. Follow-up (Doc. PPE-12-2-9, PPE-12-2-8)

5 (4.1) Diving suits

COMM recalled the question, whether suits used for on the surface water sports are PPE or not and

where is the borderline to the suits used for in the water activities. That borderline could be used to

differentiate between the categories. The Netherlands, the European Boating Industry, Finland and

Sweden have provided comments. Even if Finland and the European Boating Industry suggested

water temperature of 30 degrees for the borderline Sweden noted that the water temperature is not

sufficient to distinct between the categories. One has also to take into account the air temperature

and the wind. As there was no common opinion presented the Commission asked for written

contributions by the members of the working group until the end of the year.

5 (4.2) Dry suits

COMM summarised the collected opinions on the question whether dry suits for the use on water

or on ice is PPE of category II. Only supporting comments were received. This item is closed with

the following decision that will be reflected in the categorisation guide.

It is the consensual approach of the PPE WG to consider dry suits as presented in document

PPE/11/1/8 as PPE category II.

5 (4.3) High visibility PPE

COMM recalled that there are many open questions relating to high visibility PPE. An ad-hoc

group should be established to discuss the topic and present draft solutions to the PPE WG. The

Commission asked the Member States to volunteer to lead that group and to start the work.

The UNITED KINGDOM admitted that there are outstanding questions concerning high visibility

PPE in the UNITED KINGDOM too. It is necessary that the group starts its work as soon as

possible. So the UNITED KINGDOM did volunteer being the Chairperson of the HiViz ad-hoc-


group but stressed that it will need the assistance of the other members of the PPE WG that are

active in this field.

The Chairperson expressed her gratitude to the UNITED KINGDOM and reassured that the

members that already committed to participate in the group will support the work.

5 (4.4) UV protective clothing

COMM reintroduced the topic whether clothing providing protection against solar UV radiation is

PPE. The comments given last meeting and received in written form do not present a common

opinion of the PPE WG; the topic is still open. He recalled that there is consensus that equipment

intended to protect against artificial UV radiation is PPE, at least of category II. In order to collect

more opinions he asked the members of the WG for written comments until the end of the year.

5 (4.5) Automatic vs. non-automatic protective function

COMM presented the comments that were received after the last meeting. All comments make

clear that there is no legal basis for excluding equipment that needs intervention by the user in order

to provide protection. The Commission proposed to conclude that equipment with non-automatic

protective function is considered as PPE subject to the PPE Directive.

FRANCE remarked that this will have a major effect to some types of products. All the anti-

avalanche products for example must be taken as PPE. The contrary advice was often given in the

past. France proposed to enforce this change only with the revised legislation.

The Chairperson explained that this conclusion does not constitute a change in legislation. It is a

clarification. Therefore it is not linked with the revision process.

As no further comments were raised the conclusion was taken as proposed by the Commission.

5 (6.1) Categorization of dry suits providing complete insulation from the atmosphere

COMM proposed to circulate additional explanation to this question provided by Czech Republic

that raised this issue and to ask the Working Group for written comment. As there were no

objections raised item was not discussed in this meeting.

5 (6.3) Hat "helmet" for cycling – PPE Cat I or Cat II?

FINLAND recalled the discussion about the product “helt-pro” intended to be used for cycling. The

manufacturer claims that his product is PPE of category I. In particular the values for impact

protection provided by the harmonised European standard for bicycling helmets are not fulfilled by

the product. At the last meeting the PPE WG came to the consensus that the product is not an

alternative to a bicycle helmet because it does not comply with the requirements of the relevant

harmonised standard. At that meeting the Chairperson summarised that the product is presented in a

misleading way to the consumer and that manufacturer either has to describe the product in line

with its actual properties or, if this product should replace helmets, bring it in compliance with the

applicable requirements for helmets. Finland reported that the product was discussed again at the

last PPE AdCo meeting. The AdCo members concluded that “helt pro” cannot be considered as

category I PPE, it is of category II.

GERMANY explained that no German representative was present at the AdCo meeting to

communicate the German opinion. Germany repeated its opinion explained at the last PPE WG

meeting. The product should not be seen as a replacement for a helmet, and it should be possible to

place it on the market as PPE category I providing that it is accompanied with correct user

information.


SWEDEN and FRANCE pointed out the problems that could be raised by a decision in favour of

category I. It should not be possible to downgrade the category if the product does not fulfil the

relevant harmonised standard. In most cases it is not possible for the consumer to decide on the

safety level provided by the product. The product must cover all risks for its foreseeable intended

use. The “helt pro” product should be considered as PPE category II.

The UNITED KINGDOM, LUXEMBOURG, DENMARK, BELGIUM and SPAIN agreed with

categorisation as PPE category II.

The Chairperson summarised that the majority of the PPE WG made a clear statement.

It was decided that the product in question is to be considered as PPE category II.

5 (6.5) Instructions for use for hearing protectors

COMM reintroduced the topic. The open question after the last meeting was whether only the

abbreviations of the required parameters are sufficient or whether the full phrases shall also be

provided in order to enable the users to search for additional explanations. After the last meeting

ESF were the opinion that there is no real add-on for the untrained user if the full phrases are

provided. Finland and Sweden were in favour of the addition.

GERMANY reminded that there is a harmonised standard (EN 45881) available where the user can

find detailed explanations of the parameters.

ESF supported by FESI added to the abovementioned ESF position that a more general discussion

about the content and the format of the user instruction should be started. In particular it should be

discussed whether parts of the user instruction could be provided using an electronic format.

COMM commented that the latter remark is indeed another topic. However, the Commission’s

opinion did not change. The user instruction required by the PPE Directive shall be provided in

printed format. The requirements by the standards that constitute an addition to the Directive’s

provisions should be discussed in the relevant standardisation groups. He acknowledged the

information provided by EN 458. However, in order to better assist the user the Commission

proposed that both abbreviation and full phrase of the required parameters shall be used in the user

instructions supplied with the hearing protectors.

As no further comments were raised the decision was taken as proposed by the Commission.

5 (6.6) Minimum font size for information supplied by the manufacturer

COMM explained the proposal raised by Germany at the last meeting. In the PPE guidelines should

be introduced explanations to enhance the readability of the user instructions (used font, font size,

and size of space between the lines). The Commission proposed to formulate a draft on the basis of

the German proposal that will be circulated through the PPE WG with the next update of the PPE

guidelines.

As no further comments were raised the Commission will proceed as proposed.

5 (6.8) Market surveillance campaign on PPE for motorcyclists

81 EN 458:2004 “Hearing protectors - Recommendations for selection, use, care and maintenance - Guidance

document”


COMM explained that all 5 comments that were received agree with the French proposal that

motorcyclists clothing that incorporate protectors should be considered as PPE. The whole garment

has to undergo the EC type-examination procedure. The Commission proposes to close this item

with the following decision:

A protective garment for motorcyclists incorporating protectors has to be considered

as PPE as a whole. Consequently the product is subject to the relevant conformity

assessment procedure for PPE category II (categorisation guide point 14.4).

The Swedish comment draws attention to the fact that it would be necessary to have a protocol

available for the Notified Bodies as a first step. The Commission would appreciate if France could

make available to all relevant Notified Bodies the test protocol mentioned in the presentation at the

last meeting. The Commission emphasises that the final aim should be a harmonised standard that

could be used for this kind of PPE in particular for the motorcyclists garments used by non-

professionals.

FRANCE clarified the nature of the mentioned test protocol. During market surveillance

observations France noted that only elbow, shoulder and knee protectors had been subject to

conformity assessment, however the garment as a whole did not bear the CE marking; only the

protective parts bore CE marking. For France it is crucial to check the whole garment as a PPE in

order to ensure that the protectors are situated at the right point in the garment and that the garment

would not rip and afford the sufficient protection. For this check there is no specific protocol

available but one could use the general requirements for the garment. The mentioned French

protocol, however, was drafted as a first step to revise the existing harmonised standard for

professional motorcyclists garments (EN 13595 series82). The aim of that revision is to have no

further distinction between professional and non-professional garments as well as to ensure that this

new standard would cover garments which are lighter and in materials other than leather thus

ensuring that such garments do nonetheless afford protection. This draft has been circulated

amongst Notified Bodies.

As no further comments were raised the decision was taken as proposed by the Commission.

Please note: After the meeting concerns about the interpretation of that decision were raised.

This item will be discussed again in the PPE WG.

5 (7.5) EN 20345 "Safety shoes"(Doc. PPE-12-2-9)

COMM recalled the decision taken after the last meeting to change the date of cessation of

presumption of conformity of EN ISO 20345:2004 to 30 June 2013. A corrigendum to the original

publication was published in the Official Journal on 4 July 2012. That means that one additional

year was given to the relevant stakeholders to ensure that the products comply with the new version

of the standard. The Commission explained its position that from 1 July 2013 footwear covered by

EC type-examination certificates based on the superseded standard can only continue to be placed

on the market if the EC type-examination certificate has been reviewed. The notified body must

check whether the footwear can still be considered to comply with the applicable BHSRs of the PPE

Directive in the light of the new version of the standard or whether further examination or testing is

required. In light of the outcome of this review, the EC type-examination certificate shall be

updated or withdrawn as appropriate. The Commission emphasised that all products placed on the

market before that date are to be considered as placed on the market in line with the legislation.

82 EN 13595 series of standards “Protective clothing for professional motorcycle riders - Jackets, trousers and one-

piece or divided suits”


This includes products that are still in the distribution chain (e.g. distributers, end-user shops) after

1 July 2013 but placed on the market before that date. The relevant stakeholders, including

manufacturers and market surveillance authorities, should respect that legal framework accordingly.

The Chairperson explained, on request by ESF and UK, that the abovementioned position will be

circulated to the PPE WG in writing. However, she emphasised that these rules are well described

in the guidelines to the new approach legislation, e.g. the Blue Guide.

On 20 December 2012 the Commission Services circulated a document to the PPE WG that

explains the procedure on the basis of the legal background.

6. Revision of the PPE Directive – State of play (Doc. PPE-12-2-6)

The Chairperson gave a short overview on the state of play of the revision process. The

Commission services have been working on the impact assessment report. After finalising that

report the Commission’s internal Impact Assessment Board has to approve the assessment. This

step will be followed by an inter-service consultation of the draft proposal throughout all the other

DGs of the Commission. Finally the Commission has to approve the proposal. With that the

Commission proposal will be publicly available and will be submitted to the European Parliament

and Council for discussion.

POLAND introduced their proposal for a change of the categorisation of antistatic PPE designed

for the use in potentially explosive atmospheres. Considering the consequences of accidents due to

non-working antistatic PPE as well as the circumstance that the user cannot easily foresee effect of

the related risk Poland is the opinion of that it fits the definition of category III. Experience from

tests, in particular of antistatic safety footwear, show irregularities in the production and support the

proposal to have mandatory regular checks of the production quality by Notified Bodies. Most of

the problems are found with footwear but not with clothing or gloves. Furthermore Poland proposed

to introduce basic health and safety requirements for protection of the skin against UV radiation. As

described in the document long term studies have shown that UV radiation from sun is dangerous

for persons working in open air. Additionally there are many workplaces where the employees are

exposed to artificial UV radiation but no effective PPE against UV radiation is used. Poland

proposed to include protective clothing and gloves against UV radiation in category I PPE.

The Chairperson pointed out that the process of revision of the PPE Directive is already quite

advanced. It is practically no longer possible to introduce changes that require an extensive

assessment of the possible impacts. In particular for the proposals to change the categorisation of

some other types of PPE intensive studies have been carried out. Insofar the proposal concerning

the antistatic PPE cannot be taken up by the Commission. However, the revised legislation will

provide for a procedure to adopt changes in categorisation that will not require undergoing the

whole revision process, i.e. a more flexible and faster way. The Commission will propose a

delegated act for changing the relevant part of the PPE legislation. Concerning the proposal on UV

protective clothing the Chairperson referred to the discussions at the last and today’s meeting that

have shown a large majority supporting the opinion that such products are not considered as PPE.

COMM presented a compilation of proposed changes to the PPE Directive. These proposals have

been collected during the past consultation processes. The PPE WG was asked to comment in order

to collect most recent opinions but not to reopen general discussion:

exclude from the scope clothing for adverse atmospheric conditions for professional use:


A number of members of the WG expressed disagreement with that proposal. There is a

difference of the risk compared to the already excluded same type of clothing intended for

private use. Employees cannot decide whether they stay outside under poor weather conditions.

There is a need for high quality products that provide protection against the related risks.

Compliance with the requirements of the PPE Directive ensures such a high quality. France

pointed out that it was one of the Member States that have been in favour of that proposal. This

was seen as a simplification and a way to avoid problems for market surveillance work.

However, France can follow the arguments and sees the advantages of keeping this kind of PPE

in the scope.

include to the scope oven and dishwashing gloves for private use:

no objections were raised

addition of certain types of PPE to the list of category III:

o life jackets:


o PPE against noise:

The Commission explained the opinion that PPE against noise fit the definition of category III.

It is an established fact that damage to hearing is irreversible. The actual damage may not be

perceived as an irreversible development because the effect of the damage will be perceptible

only in the medium or long term. Poland pointed out that it is not aware of any problems with

these products. France described that not only ear plugs but also technically more sophisticated

products are covered by this class of PPE (e.g. ear muffs that only filter out certain

frequencies) what might be one reason for difficulties with its categorisation.

o Bullet-resistant, knife stab-resistant PPE:

The CEN-CENELEC Consultant asked to reconsider the wording. Stabbing might not only be

a result of a knife as well as this type of PPE might also provide protection against explosions

and not only against bullets.

o PPE against cutting by hand-held chainsaws:


o PPE against high pressure cutting:


limit validity of EC type-examination certificates to 5 years in maximum:

FESI supported by ESF and Luxembourg repeated the request for a light procedure to review

the certificate after the 5 years validity. The CEN-CENELEC Consultant asked how the old and

maybe unlimited certificates will be dealt with. The Commission’s proposal will provide for a

review procedure as well as transitional provisions for the old certificates issued based on

89/686/EEC.

require full technical file for category I:



require minimum content of EC type-examination certificates:

Poland proposed to require a picture of the PPE in the certificate. Even if this was supported at

first glance it was discussed which quality/dimensions the picture should have. The Chairperson

asked the PPE WG to comment on that new proposal within 6 weeks after the meeting.

require Declaration of Conformity (DoC) to be supplied with the PPE:

Some members pointed out that this new requirement will only generate costs without any effect

on the safety of the user. ESF asked for a compromise if the supporters of that requirement will

stick on it. It should be sufficient if a light DoC is supplied with the PPE. The Commission

replied that the proposal will include a so-called simplified DoC that could be supplied with the

PPE. On this simplified DoC the manufacturer declares that the PPE is in compliance with the

PPE legislation. An internet address shall follow where the normal DoC can be obtained. This

would result in both support of the market surveillance work and minimisation of the additional

burden for the manufacturer.

Directive or Regulation?

France and Germany expressed their experiences that even a Regulation requires action at

national level. They do not see real advantage if a Regulation is proposed. Both are in favour of

a Directive.

7. Scope

7.1 Tick bite prevention garments (Doc. PPE-12-2-4)

COMM introduced the question raised by a German association whether workwear garment

providing protection against tick bites has to be considered as PPE. During the written procedure

the responses mainly supported the proposed answer by the Commission that it is PPE category II.

It was added that it applies only if the manufacturer claims especially for this protection in his

publicity. Furthermore it was pointed out that an appropriate test procedure must be available.

AUSTRIA explained its position. These insects can cause serious harm to human’s health.

Therefore Austria is in favour of classifying tick bite prevention garment in category III. However,

if this is not possible due to legal reasons, Austria would agree to the consensus that this garment is

considered as PPE category II. He stressed the fact that a procedure must be available how the

manufacturer can meet the applicable BHRS as well as how Notified Bodies can test the PPE

accordingly. Either a harmonised standard should be adopted or a recommendation for use should

be formulated. Additional the decision on this issue should be inserted in the categorisation guide.

COMM summarised the consensus that garments providing for additional protection against tick

bites is considered as PPE category II (independently of whether intended for professional or

private use). For the next steps it was agreed to inform the questioner on the decision and request a

communication with the relevant standardisation group in order to discuss the possibility to develop

a standard for this kind of PPE. It is important that the relevant vertical group of the Notified Bodies

will be involved in order to ensure that all NBs carry out the test in a harmonised manner – it might

be appropriate to develop a RfU as first step valid until a standard will be available.

It is the consensual approach of the PPE WG to consider garments that provide additional

protection against tick bites as PPE category II.

7.2 Instructions for use (Doc. PPE-12-2-5)


FINLAND introduced the issue that can be reduced to the general questions who is responsible for

supplying the information for use; is it necessary to supply that information with the PPE to the

end-user; and in which form this must be done. Finland reported on the result of the discussion of

this issue in the AdCo group. Based on the current legislation the AdCo group clearly sees the

obligations with the manufacturer. The instructions must be supplied with each PPE in paper form.

In particular this obligation must not be transferred to distributers.

FESI supported by ESF suggested starting to think about other possibilities to inform the user

about the instructions. It should be possible, at some point in time, to adjust the relevant

requirements to the modern means of communication including the internet.

FRANCE stressed the importance of the user information. The internet could be used to inform the

user about the PPE but only as a complementary measure. The current obligations laid down in the

Directive must be followed. Moreover with the alignment of the Directive to the new legislative

framework there will be the obligation of the distributer to verify that the PPE is accompanied with

the user information. However, the manufacturer is obliged to ensure that the PPE is supplied with

that information.

COMM closed the item with the statement that based on the current legislation the manufacturer

has the obligation to deliver the information for use in paper form with each PPE placed on the

market. It is not allowed to transfer that obligation to the distributer.

8. Standardisation

8.1 PPE against falls from a height used in potentially explosive atmospheres

(Doc. PPE-12-2-7)

FRANCE explained the question raised concerning the marking of PPE against falls from a height

if the manufacturer also wants to add protection against static electricity, so that it is able to use the

product in potentially explosive atmosphere. PPE standards that cover the antistatic properties of

clothing require the use of the “lightning bolt”-pictogram to show that this clothing has antistatic

properties. The PPE in question is not clothing. What pictogram could be fixed to PPE other than

clothing/garment? France pointed out that products that have been evaluated for protection against

electrostatic risk would benefit from having a pictogram differentiating them from other products

that have not been assessed. France also recalled that PPE covered by 89/686/EEC is excluded from

the scope of the ATEX Directive 94/9/EC. The ATEX Directive requires the EX-pictogram;

consequently that EX-pictogram must not be affixed on a PPE subject to the PPE Directive. France

proposed to add a section to relevant PPE standards (other than the clothing standard) in order to

take account of the relevant BHSR 2.6 Annex II PPE Directive and requiring the marking of the

products that have antistatic properties with the “lightning bolt”-pictogram.

LUXEMBOURG believed that reason should prevail on legislation. It should be able to affix the

necessary marking EX and the “lightning bolt”-marking since there are both relevant and known

symbols. There are PPE that can be very dangerous if used in potential explosive atmosphere.

Therefore it should fall under the scope of ATEX Directive. But currently PPE is excluded from

ATEX Directive. We should think of changing this point when the ATEX Directive is technically

revised – PPE should be included within the scope of the ATEX Directive.

The UNITED KINGDOM supported the clear argumentation in the French document. It makes

sense that it should be possible to mark also non-clothing PPE with “lightning bolt”-marking.


ESF reported on experience with the “lightning bolt”-pictogram on gloves. The users were

confused and took this marking as a sign for protection against electrical risks. There were accidents

reported. The standardisation has reacted in changing the standard in a way that the “lightning

bolt”-pictogram is not allowed to be used in gloves. We should be careful putting this pictogram on

non-clothing PPE.

FRANCE acknowledged Luxembourg’s proposal but it is a proposal for the future, at least a

medium term perspective. The problem in using the “lightning bolt”-pictogram reported by ESF

could perhaps be solved only by an information campaign of the end-users. Nevertheless if the

user’s safety should be protected the indispensable information about the fact that the PPE is safe in

potentially explosive atmospheres should be given and the meaning of the pictogram should be

explained through the information leaflet.

COMM invited the members to assess the French proposal and the expressed opinions and to

provide written comments until end of the year.

9. Notified Bodies

9.1 Recommendations for Use Sheets (RfUs)

COMM reported on the actual status of the RfUs. The endorsed RfUs were published at the Europa

website mid of 2012. A number of recommendations, in particular from vertical group 10 (foot and

leg protection), are still under discussion after observations by Member States and the CEN-

CENELEC Consultant.

HCNB explained that the relevant groups are in bilateral discussions with the persons who raised

the comments. Results are awaited for end of 2012. The sheets will be adapted or changed

accordingly and presented again to the PPE WG.


10.1 Visual signalling PPE for motorcyclists (Doc. PPE-12-2-11)

FRANCE introduced the issue on visual signalling PPE intended for motorcyclists riding at night.

Some models of clothing incorporate retroreflective bands on the arms only or on the arms and

torso and therefore does not fully correspond to the products covered in the relevant harmonised

standards (EN 47183, EN 115084, EN 1335685). In particular EN 13356, on accessories that are

intended to signal the wearer's presence at night only (or in "low light levels"), includes items

manufactured to be permanently affixed (type 3 accessories) but states in its scope that it is not

applicable to garments. France raises the question, how can clothing to which the manufacturer has

irremovably affixed retroreflective arm bands be assessed? France pointed out the problematic

scenario: an arm band that complies with EN 13356 may be worn on top of a jacket, but when an

identical arm band is incorporated into the jacket by design, the jacket in question becomes non-

83 EN 471: “High-visibility warning clothing for professional use”

84 EN 1150: “Visibility clothing for non-professional use”

85 EN 13365: “Visibility accessories for non-professional use”


compliant PPE (non-compliant with relevant standards EN 1150 or EN 471) even though the two

methods produce an identical level of safety.

SWEDEN did not agreed with the French conclusion that such clothing with incorporated

retroreflective arm bands has to be considered as non-compliant PPE. Sweden argued that one

cannot directly apply EN 1150 because such clothing is not covered by that standard – it is not high-

visibility clothing, it is motorcyclist’s garment that does not have to fulfil high-visibility

requirements.

COMM recalled the decision taken earlier today that the ad-hoc group on high-visibility PPE will

start to work soon. The French issue is a problem that fit exactly the scope of that group. He

concluded to take this issue to the work program of the ad-hoc group on high-visibility PPE.


The Chairperson informed that for 2013 two PPE Working Group meetings are scheduled for

April and October. The precise dates will be circulated as soon as possible. As usual these dates are

subject to confirmation.

End of the meeting



PPE 89/686/EEC EXPERTS WORKING GROUP

MINUTES OF THE MEETING HELD IN BRUSSELS, 25 APRIL 2013

Subject: Personal Protective Equipment (PPE) Directive 89/686/EEC Experts

Working Group



COMM Participants: Mr Michael THIERBACH, Mr Mario GABRIELLI COSSELLU, Ms

Nathalie BOUTTEFEUX (ENTR/F5).

1. Welcome





3. Minutes of the meeting of 24 October 2012

The Chairperson explained that the Commission Services have not been able to distribute the draft

minutes of the last meeting held on 24 October 2012, due to the high workload with the on-going

revision process of the PPE Directive. The minutes will be circulated as soon as possible for

approval by the PPE WG.

Regarding the draft minutes of the previous meeting held on 7 June 2012, they were approved after

some minor changes due to additional comments (from the CZECH REPUBLIC and from FESI).

They will be uploaded on the relevant folder on CIRCABC and distributed within the next days.

4. Follow-up

4.1 EN 13138-1 “Buoyant aids for swimming instruction” – Small parts

COMM recalled the issue concerning the quality of the relevant requirements of the standard EN

13138-1. The members of the PPE WG expressed their opinions. However, in order to decide on the


associated safeguard clause, COMM needed to seek for external expertise: a call for tender was to

be launched within the next weeks. COMM will report on progress. With that information, this item

can be considered closed.

4.2 EN 795 “Anchor devices” (Docs. PPE-13-1-8, PPE-13-1-9, PPE-13-1-10, PPE-12-2-3,

PPE-12-2-10)

COMM recalled the question making reference to Doc. PPE-13-1-10, summarising the different

positions expressed by Member States and Industry after the last PPE WG meeting.

FRANCE introduced Doc. PPE-13-1-8, providing additional argument to support the “formal

objection” against EN 795, in particular describing the problems still pending to be solved in the

2012 version of the standard. Not all types of anchor devices in the scope of the standard are PPE in

fact, and it is not in line with the ruling by the European Court of Justice of 21 October 2010 (case

C-1 85/08).

ESF introduced Doc. PPE-13-1-9, expressing a negative opinion on the formal objection raised by

FRANCE against EN 795:2012, for a matter of legal certainty.

COMM recognised that it was not an easy problem, being necessary to ensure safety of the

complete system, but borderline issues were involved due to the interface between different

legislations (PPE and Construction Products). In order to make substantial progresses, he proposed

to create a small group to analyse and solve the question, with the participation of the most directly

involved parties from Member States and Industry. The results will be presented in written form or

at the next meeting as appropriate.

4.3 Diving suits (Doc. PPE-13-1-11)

COMM recalled the need to decide on categorisation of wet suits and clothing for on the surface

water sports, through Doc. PPE-12-1-11 with the comments expressed by Member States and

industry at the last and to the present meeting. Discussion and comments had shown that there were

no strong criterion to decide on different categories, so the Commission concluded for products that

claim protection against risks (whereas the related main risks were water/air temperature and

mechanical risks) that they can be considered all Category II PPE, until a clearer way to distinguish

could be proposed and made available, based on criteria both practicable and testable. If it would be

the case, they could be submitted back to the PPE WG.

GERMANY agreed on the decision to classify this equipment as Category II PPE, and asked

whether it would be necessary to update the Categorisation Guide.

COMM answered that a draft of an updated version of the PPE Guide would be circulated within

this year. He noted the general agreement on the COMM proposal so the item was closed on the

reached conclusion.

4.4 UV-protective clothing (Doc. PPE-13-1-12)

COMM made reference to Doc. PPE-12-1-12 with the comments expressed by Member States and

industry at the last and to the present meeting, to decide on whether UV-protective clothing were to

be considered PPE or not. He proposed a conclusion on the following terms:

1) Protection against artificial UV radiation is undoubtedly Category II PPE, including all products

for working places and private ones as e.g. eye protection used in sunbeds;

2) Comments showed that a majority saw UV-protective clothing for private use as excluded via

Annex I (exclusion of PPE designed and manufactured for private use against adverse atmospheric

conditions);


3) Comments showed that a majority saw UV-protective clothing designed and manufactured for

professional use as Category I PPE, whereas it is necessary that the manufacturer claims this

protective function. COMM agreed on this but:

- there must be a special protective function added to this clothing that ensures this UV-protection

and that is not found in ordinary working clothing (that is not seen as PPE, even if normal cotton

provides some protection),

- this special (additional) protective function against solar UV radiation must be described by the

manufacturer in the technical file,

- it would be recommendable that the relevant market surveillance authorities may check/investigate

some of such products to examine how the special (additional) protection is made and assessed by

the manufacturer, and

- of course it would be very convenient to have a harmonised standard for this, providing clear

requirements and test methods. All the interested parties are encouraged to get in contact with CEN

on this issue.

FRANCE did not oppose on the COMM proposal, but still had some doubts on identification and

classification of such equipment, in particular regarding professional clothing, shoes etc., how to

know that they could provide this kind of protection. They agreed on the position expressed by the

CZECH REPUBLIC; it would be necessary to have clarity on the issue.

The CEN-CENELEC Consultant said that it would be necessary to clarify the scope of existing

standards, in particular EN 13758-2 as mentioned in the comment by the CZECH REPUBLIC.

The Chairperson suggested that COMM could draft a paper, as a proposal to see these items for

professional use as Category I PPE, but there must be a special protective function compared to

ordinary clothing; also, it would be necessary to delimit the various UV-protective clothing. Such

COMM proposal would be drafted in cooperation with CEN and the other interested parties, and it

would be submitted to the next PPE WG meeting.

LUXEMBOURG welcomed such proposal, as it would be a clear message for protection to

manufacturers, employers and workers.

4.5 Categorisation of dry suits providing complete insulation from the atmosphere (Docs.

PPE-13-1-13, PPE-12-1-6)

COMM said that the item described in the document from the CZECH REPUBLIC was not

finalised yet. The first part of Doc. PPE-12-1-6, with the additional explanation in Doc. PPE-13-1-

13, concerned point 6.6 of the Categorisation Guide: they proposed that dry suits for diving which

did not represent a facepiece of the respiratory protection device should be Category II, as such

products would not provide complete insulation from the atmosphere. But, whereas dry suits for

diving which did represent a facepiece of the respiratory protection device, they should be Category

III, when products did provide complete insulation from the atmosphere. On this basis, CZ proposes

change of text of point 6.6 of the Categorization Guide as follows: “Clothing and/or accessories

(whether or not detachable) designed and manufactured to provide complete insulation of the

respiratory tract from the atmosphere - Cat. III - Equivalent to 3.3.2.”. The issue was still open, so

on this first part, COMM asked to provide comments to the CZ proposal in written form in order to

decide or to discuss it at the next meeting.

In the second part of the document, the CZECH REPUBLIC proposed to reconsider the

categorisation of all dry suits for diving: they should fall under Category III (“serious danger in case

of damage or dysfunction of diving dry suits – drowning, decompression sickness”). The revised

PPE Directive would list “risk of drowning” in Category III (up to now only seen for life jackets),

but it would not possible to cover also these products at the current stage of the process. This could

be taken into consideration for future changes of the category lists, through a possible delegated act


to change the Category list under the revised Directive will provide for delegated act in order to

change the category lists). With no further comments, the issue relate to this second part could be

closed.

4.6 PPE against falls from a height used in potentially explosive atmospheres (Doc. PPE-13-

1-14)

COMM gave a short report on comments collected in Doc. PPE-13-1-14. The “epsilon-x” x

pictogram defined by the ATEX Directive 94/9/EC must not be used for PPE, but the “shield” /

“lightning bolt” pictogram could be used for non-clothing PPE too. According to that, it would be

up to standardisation to change standards, but it would necessary to think of an appropriate

explanation of the possible confusion of this marking with the meaning of protection against

electrical risk. This this might be a task for the European associations through an information

campaign, etc. Interested parties, in particular FRANCE who raised the question, could especially

stimulate and take part in standardisation work. Also, CEN was requested to include information on

this issue in their report for the next meeting.

5. Revision of the PPE Directive – State of play

The Chairperson explained the latest status of the revision process of the PPE Directive, as an

information point. The Commission Proposal should be completed by the end of the third quarter of

2013; then, the ordinary legislative procedure should start at the European Parliament and the

Council. A timeframe for approval would be quite difficult to describe now, taking into

consideration the recess period for the European elections in 2014, so a positive outcome would not

take place before the end of 2015. Afterwards, a transitional period would be fixed before the new

legislative text become applicable, at least in 2016-2017. Further updated information would be

provided in due time.

6. Scope

6.1 Report of the ad-hoc group on High visibility equipment (Docs. PPE-13-1-2, PPE-13-1-3)

The UNITED KINGDOM and BELGIUM introduced the draft meeting note of the Ad-hoc group

on high visibility equipment, with Docs. PPE-13-1-2 and PPE-13-1-3, explaining the main results,

including a proposal of “decision tree” for assessing a product in respect of the high visibility

criteria and the scope of the PPE Directive.

COMM recalled that the issue on visual signalling PPE for motorcyclists raised by FRANCE in the

last meeting should be part of the work of this group. Action points and next steps would be

followed up at the next PPE WG meeting.

7. Standardisation

7.1 Report by CEN Secretariat (Doc. PPE-13-1-15)

CEN-CENELEC presented the written report, including specific information on the activities of

PPE Technical Committees and the ongoing work with standards.

7.2 Report by CEN Consultants (Docs. PPE-13-1-4, PPE-13-1-5)


The CEN-CENELEC Consultants presented their written reports on the activities carried out

from the last PPE WG meeting in October 2012.

7.3 EN 1384 “Helmets for equestrian activities” (Doc. PPE-13-1-6)

COMM reported on the issue, with the evolution from the first stage of information and collection

of opinions, making reference also to the documents presented. The question was quite complicated,

with the formal objection raised against EN 1384:1996, now having listed in the Official Journal the

2012 version, not differing technically from the previous version. A decision should be taken

regarding the status of this last standard that superseded the previous one, for a possible new formal

objection against the presumption of conformity.

IRELAND, as secretary of CEN/TC 158 WG 4 in charge of the revision of the standard, reported

on progresses made, with meetings of representatives of six countries and excellent experts

participating in the process. Some problems were still to be solved.

The Chairperson expressed thanks for such efforts and asked for comments on the initiative of

COMM regarding a new formal objection.

SWEDEN announced some written comments on the issue.

The Chairperson agreed on a 3 months period to comment, inviting all the members to make their

positions heard, to be taken into consideration within this very important process.

7.4 EN 1621-4 “Motorcyclists’ inflatable protectors” (Doc. PPE-13-1-7)

FRANCE introduced Doc. PPE-13-1-7 with a summary of the shortcomings raised by French

standardisation experts on the European standard EN 1621-4:2013 concerning motorcyclists’

inflatable protectors, recently published by CEN. According to them, technical shortcomings in this

standard did not allow its harmonization under the PPE directive. French authorities had been

informed of this issue and presented it to the PPE WG to seek the opinion and comments of the

members.

The CEN-CENELEC Consultant said the arguments developed had been discussed in the

relevant WG, with counter-arguments putting in evidence other aspects to be considered.

FRANCE replied that their remarks had not been kept.

The Chairperson confirmed that the standard had been submitted by CEN for harmonisation by

the publication in the Official Journal, but it was not listed yet. The situation should be cleared as

soon as possible.

FESI said that they had not enough time to discuss with their experts, and asked for a deadline for

comments.

The Chairperson proposed a 4-weeks time to react to the French paper and to provide inputs as

soon as possible. For the time being, the standard would not be published on the OJEU.

8. Notified Bodies



HCNB reported on the latest activities of the European Coordination of PPE Notified Bodies. The

next meeting would be held in November 2013.


COMM reported on the actual status of the RfUs. The latest endorsed RfUs had been published on

the EUROPA website in March 2013.

HCNB would report on bilateral discussions for RfUs where comments had been received, as soon

as possible.


Nothing to discuss.


The Chairperson recalled that the next meeting is scheduled for 16 October 2013 in Brussels. As

usual, the date would be subject to confirmation; to be communicated in due time.

End of meeting




MINUTES OF THE MEETING HELD IN BRUSSELS, 11 NOVEMBER 2013


Group


Chairperson: Mr Luis Filipe GIRÃO (COMM ENTR/F5)

COMM Participants: Mr Michael THIERBACH, Mr Mario GABRIELLI COSSELLU, Ms

Nathalie BOUTTEFEUX (ENTR/F5)

1. Welcome





3. Approval of the minutes (Doc. PPE-13-2-6)

The Chairperson explained that, due to high workload (in particular with the on-going revision of

the PPE Directive), the Commission services (COMM) were not able to draft the minutes of the last

meeting held on 25 April 2013. They will be presented as soon as possible; nevertheless, all the

relevant points are considered in the follow-up points.

Doc. PPE-13-2-6 contains the draft minutes of the meeting held on 24 October 2012, that were not

presented at the last meeting; they had been uploaded on CIRCABC three weeks ago, and they are

submitted now to the approval of the Working Group.

With no comments from the Working Group Members, the draft minutes of the meeting held on

24 October 2012 were approved.

3. Action point: COMM, to make available the draft minutes of PPE WG meeting on 25

April 2013, as soon as possible.


4. Follow-up

4.1 EN 795 “Anchor devices” (Docs. PPE-13-2-7, PPE-13-2-10, PPE-12-2-3, PPE-12-2-10, PPE-

13-1-10)

COMM recalled the question regarding the standard EN 79586, on the basis of the formal objection

raised by FRANCE. The problem appeared not solved yet, as not all types of anchor devices in the

scope of EN 795:2012 are PPE; the standard is not in line with the ruling by the European Court of

Justice on 201087. For the time being, some Member States were in favour of the formal objection,

others not; at the last meeting, it was decided to meet in a small ad-hoc group, but no result was

reached, as all the participants had defended their opinion. It is indeed necessary to come to an end,

by reaching a final and clear position on the issue. He made reference to the tabled documents, to

the “old” ones (PPE-12-2-3: FR original formal objection; PPE-12-2-10: CEN response to FR; PPE-

13-1-10: all comments on the formal objection) and to the “new” ones, with the latest comments

sent by ESF (PPE-13-2-7), with a specific proposal to finally get a solution for the long-term

discussion on anchor devices, and by the CEN-CENELEC Consultant (PPE-13-2-10), proposing to

develop a two-part standard.

The Chairperson proposed to carry out a tour de table among all those presents, to have their

opinion: in favour of the FR formal objection, or against, on the basis of the ESF proposal.

BELGIUM supported the ESF proposal, as well as the proposal from the CEN-CENELEC

Consultant, to split the standard in two parts, to prevent confusion.

CZECH REPUBLIC agreed on the ESF proposal and on the opinion of the CEN-CENELEC

Consultant as well.

DENMARK supported the ESF proposal, on the same ground of BELGIUM.

GERMANY supported the FR objection, as the content of the standard need to be clarified, as it

covered elements not under the PPE Directive.

IRELAND supported the ESF proposal.

CEN-CENELEC agreed with the document but asked COMM to express a position on whether

anchor devices are PPE or not, it is correct or not to have them in the standard.

The Chairperson replied that it was not a question of interpretation of the Directive, but it is

necessary to follow the formal procedure regarding an objection on a harmonised standard,

searching for the opinion of the Working Group and then to be submitted to the Standardisation

Committee.

CYPRUS supported the ESF proposal.

FRANCE recalled the main elements of their formal objection. They considered that the documents

submitted are interesting, and the conclusion can be supported. If the formal objection is accepted,

CEN should take action to revise the standard and to clarify the situation.

86 EN 795:1996 Protection against falls from a height - Anchor devices - Requirements and testing, plus EN

795:1996/A1:2000. Reference published on the OJEU with a warning; new version EN 795:2012 Personal fall

protection equipment - Anchor devices, issued in July 2012, reference not published on the OJEU yet

87 Case C-185/08: Judgment of the Court (Third Chamber) of 21 October 2010, OJ C 346, 18.12.2010, p. 3-4.




GREECE reserved their vote.

POLAND supported the ESF proposal as it is.

AUSTRIA supported the French position.

The NETHERLANDS also supported the French position, sharing the need for more clarity. There

are still questions to be answered in the standard, even in the definitions. The document from the

CEN-CENELEC Consultant was very interesting.

ASEM had no comment.

SWITZERLAND supported the French position, also considering very important to gain clarity.

LUXEMBOURG also supported the French position.

ESF had no comment.

The UNITED KINGDOM supported the ESF document and reaffirmed their position, in favour to

consider the formal objection justified, and to the need to revise the standard.

SWEDEN supported the ESF proposal.

FINLAND also supported the ESF proposal.

NORWAY also supported the ESF proposal.

SLOVENIA also supported the ESF proposal.

HCNB Notified Bodies expressed strong support for the ESF position.

TURKEY supported the FR objection, as the standard needs more clarification; but it would be

preferable to investigate more deeply the question, so they reserved their opinion.

The Chairperson summarised the result of the consultation of the PPE WG Members, with a

majority against the FR formal objection, and 5 in favour (DE, AT, NL, CH, LUX). He said that

COMM will report these opinions as expressed. He also shared the view that it is necessary to

clarify the standard, through a revision process.

CEN-CENELEC welcomed the decision, underlining the need to clarify the definition of “anchor

devices” as such.

The Chairperson replied that these details are precisely those to be analysed in depth, in view to

reach a common understanding on the definition of “anchor devices”, and not just a general one, but

also in “borderline” situations.


COMM made reference to Doc. PPE-13-2-11 with the comments expressed by the CEN Consultant

after the last meeting. COMM proposed to see these items for professional use as PPE Category I,

but there must be a special protective function compared to ordinary clothing. The question is how

to distinguish between different products: COMM will provide a proposal on how to delimit the

various UV-protective clothing.

The NETHERLANDS remarked the need to have clear guidance for clothing for professional use,

to differentiate them from the non-professional, according to their intended use.


The Chairperson confirmed that this would be the subject of the document that COMM wants to

prepare, to solve the issue, taking a position on a case-by-case basis, between “foreseen use” and

“intended use”.

EPSA recalled that, some years ago, a work was carried out in standardisation, regarding distinction

between professional and non-professional use of UV-protective clothing.

The Chairperson said that they were different issues, standardisation and legislation.

SWEDEN asked whether protection available for children, currently available on the market, can

be considered within the scope of the PPE Directive or not. They do not support the differentiation

between professional and non-professional use.

The CEN-CENELEC Consultant mentioned the use of the product under the sun as “private”

users.

The Chairperson considered that such interesting question should be addressed in the future. For

the time being, COMM is preparing a document for discussion at the next WG meeting, to try to

find a common approach on the issue, also with the co-operation of CEN-CENELEC. All

contributions from the Members are very welcome, by e-mail, CIRCABC, etc.

4.2 Action point: COMM and CEN, to draft a proposal on how to delimit the various UV-

protective clothing, to be presented at the next PPE WG meeting.

4.3 Categorisation of dry suits providing complete insulation from the atmosphere (Doc. PPE-13-

2-12)

COMM made reference to Doc. PPE-13-2-12 summarising the comments received after the last

meeting, on the proposal made by the CZECH REPUBLIC, to change point 6.6. of the

Categorisation Guide, in order to clarify the interpretation: “Clothing and/or accessories (whether

or not detachable) designed and manufactured to provide complete insulation of the respiratory

tract from the atmosphere - Cat. III - Equivalent to 3.3.2.”.

GERMANY expressed their disagreement on the CZ proposal, considering that it would be

misleading: an amendment should only cover diving suits.

The Chairperson proposed to ask CZECH REPUBLIC and GERMANY to submit a new draft text

for point 6.6. of the categorisation table, following a written procedure with the aim to add the new

text, when agreed, to the Guide.

4.3 Action point: CZ and DE, to provide proposal for text for point 6.6 of the

categorisation table based on Doc. PPE-13-2-12. Deadline: 31 January 2014.

4.4 EN 1384 “Helmets for equestrian activities” (Docs. PPE-13-2-13, PPE-13-2-14)

COMM reported on the issue, recalling that COMM raised a formal objection against the

harmonised standard EN 1384:199688, but in the meantime a new 2012 version was listed in the

OJEU, whereas the criticised elements of the previous version did not change (except of marking

the helmet with its weight); COMM will update the formal objection against EN 1384:2012. As

indicated at the last PPE WG meeting, and the comments received, the majority of Member States

are in favour of the formal objection; only BSIF submitted an opinion against. According to that,

88 EN 1384:1996; EN 1384:1996/A1:2001; EN 1384:2012 Helmets for equestrian activities


COMM would draft a decision on the formal objection in line with the opinion of the majority of

the PPE WG.

CEN-CENELEC reported on the status of the revision process of the standard, with the prEN 1384

rev under development.

The UNITED KINGDOM commented the BSIF paper, supporting the idea to study particular

types of injuries and to send contributions to the standardisation technical committee working with

the improvement of the standard.

IRELAND, as secretary of CEN/TC 158 WG 4 in charge of the revision of the standard, reported

on the process. It appears to be very difficult to make progresses, taking into consideration different

inputs from the European Parliament (Petitions), other standards, manufacturers very reluctant to

change and to invest in equipment and technology, etc. Horse riders should have access to helmets

providing the highest levels of protection, preventing serious internal problems and according to the

state of the art. The situation is quite disappointing; the TC is trying to comply with the mandate

and to address the current deficiencies of the standard. He asked the Member States to assist as

much as possible this process.

The Chairperson expressed thanks for such efforts, understanding the difficulties. He asked the

Member States to contribute to the work by assisting the relevant CEN TC WG with experts, in

particular with biomechanical background, in order to move forward on the revision of the standard,

recalling that it is a very sensitive issue, involving different actors, after a fatal accident. Contact via

Ms Poidevin (CEN-CENELEC): [email protected].

4.4 Action point: Member States, to assist the relevant CEN TC WG with experts, in

particular with biomechanical background, as soon as possible.

4.5 EN 1621-4 “Motorcyclists’ inflatable protectors” (Docs. PPE-13-2-1, PPE-13-2-5, PPE-13-2-

22)

COMM recalled that FRANCE raised a formal objection against the standard EN 1621-489, not

published yet on the OJEU, due to an inadequate test method, not covering possible additional risks.

The CEN-CENELEC Consultant explained his comments as summarised in Doc. PPE-13-2-15,

answering to the arguments put forward by FRANCE in its objection. He expressed disagreement to

the formal objection but there is room for improvement of the standard; in fact, CEN has already

decided accordingly.

FRANCE welcomed the contribution from the CEN Consultant but they had not enough time to

deeply study it. In any case they remarked a lack of formal content in the discussion, confusion and

uncertainty in the work. They made reference to their Doc. PPE-13-2-1 with the reasons for the

formal objection, essentially related to the test method used, including the pressure measurements

on the airbag, its characteristics, etc.

The CEN-CENELEC Consultant said that, for the moment, no alternative test method was

presented to the CEN TC 162 WG 9 dealing with the standard. The members consider that the test

method is adequate, but in any case it can be improved, also according to the comments of the

convener of the WG (Doc. PPE-12-22).

89 EN 1621-4:2013 Motorcyclists’ protective clothing against mechanical impact - Part 4: Motorcyclists’ inflatable

protectors - Requirements and test methods


The Chairperson proposed to develop further contacts between CEN and FRANCE to find a

solution for this formal objection, asking to bring their conclusions to the next PPE WG meeting.

COMM will explore the possibility to publish the reference of the standard on the OJEU, but urging

a fast revision.

4.5 Action point: CEN and FR, to develop bilateral contacts, to try to solve open issues, in

particular to investigate test methods. They will report the results at the next PPE WG

meeting.

5. Revision of the PPE Directive – State of play

The Chairperson gave a short update of timeline of the revision process. COMM will submit a

Proposal for a Regulation on PPE, to replace the current Directive; it should be ready by December

2013, to be discussed by the Council in 2014 under the Greek Presidency.

AUSTRIA expressed surprise for the change to a Regulation, and asked COMM to explain the

reasons behind such move as well as the legal background, taking into consideration that the

legislative texts in the NLF alignment package are still directives.

The Chairperson clarified that it was already announced and discussed before, also in other

sectors. It is due to an effort for simplification, with the aim of better regulation of the internal

market; the Proposal for a PPE Regulation will be presented in a package with other two

Regulations, on Cableways and on Gas Appliances. Legislation in terms of Regulations instead of

Directives would give a clear benefit in terms of direct applicability (no need for national

transposition), having the same text everywhere in Europe for manufacturers and other interested

parties. Apart of the legislative format, all the rest will remain the same. It will not prevent Member

States to develop their own implementation measures, where necessary, as in other sectors.

FRANCE agreed on that it was not a surprise, but they considered that opinions and contributions

from Member States had not been attended. The use of a Regulation can be justified in terms of

simplification, but it could lead to possible problems of interpretation for manufacturers.

The UNITED KINGDOM also objected on the idea of a Regulation.

GERMANY supported FRANCE and the UNITED KINGDOM; they would have preferred a

Directive.

The Chairperson said that in any case, the Commission Proposal will be discussed in the

Parliament and in the Council, within the ordinary legislative procedure (“co-decision”). It is not

possible now to provide further details on the text of the Proposal, as it is under the approval

procedure by the Commission; but it would include the alignment to the NLF provisions, with the

Decision 768/2008/EC.

6. Scope

6.1 Beekeeper equipment (Doc. PPE-13-2-3)

GERMANY introduced a question on beekeeper equipment, asking whether it can be considered

PPE and, if yes, what category.


The CEN-CENELEC Consultant said that this should be considered PPE Category II. He recalled

a decision in this sense taken in a meeting in 2009.

FRANCE agreed with the CEN-CENELEC Consultant, taking into consideration the risks

involved. They recalled another analogue case discussed at the meeting in October 2012. Regarding

the smoker, it is not considerable as personal protection: according to its use and characteristics, it is

rather a collective protection, not PPE.

AUSTRIA also agreed on PPE Category II as GERMANY and FRANCE. Regarding bee smokers,

it would be necessary to be very careful on their use and effect. It could be necessary to have more

reference and guidance on this equipment, a standard or a Recommendation for Use etc.

GREECE also agreed on PPE Category II and asked for statistics or reports on possible problems

related to equipment currently used, malfunctions, etc.

The Chairperson proposed, in order to reach a common answer to the question, to ask to all the

PPE WG Members, to provide written comments on the German proposal, in addition to the

positions already expressed, in particular concerning smokers.

6.1 Action point: ALL, to provide comments on the DE proposal. Deadline: 23 December

2013.

6.2 Bump caps EN 812 (Doc. PPE-13-2-4)

GERMANY introduced a question on bump caps related to the harmonised standard EN 81290,

asking for the right categorisation of these products, as some manufacturers declared them as

Category I, others II. They proposed a categorisation of bump caps according to the protection

offered, in particular the additional one against cold temperatures or electricity.

FRANCE thought that, regarding penetration-protection, it would be better to have Category II.

They agreed on Category II for temperature and Category III for electricity.

The CEN-CENELEC Consultant agreed with FRANCE regarding penetration-protection, making

reference also to the applicable standard.

CZECH REPUBLIC also considered that penetration-protection should be Category II, according

to their experts: the risks are comparable to those for gloves.



positions already expressed, regarding categorisation for this kind of additional protections for

bump caps.


2013.

6.3 Categorisation of PPE for motorcyclists (Docs. PPE-13-2-16, PPE 13-2-20)

COMM recalled the PPE WG decision taken in October 2012: protective garments for

motorcyclists incorporating protectors have to be considered as PPE as a whole, subject to the

relevant conformity assessment procedure for Category II. There is still a need to clarify the

90 EN 812 EN 812:2012 Industrial bump caps


interpretation of such decision, taking into consideration the products on the market and what the

tests should verify regarding the placement and use of protectors and its action in an accident. For

the time being, there are no standards or a Recommendation for Use available for these products;

standards are still in development. Problems arisen regarding the use in France by the national

Notified Bodies of specific protocols for test methods not used by other Notified Bodies; currently

there is a non-harmonised implementation of the requirements of the Directive regarding these

products.

FRANCE introduced their Doc. PPE-13-2-16 on the state of play in France concerning garments

with protectors. They reaffirmed their position: protective garments should be considered PPE as a

whole, explaining that they also protect against abrasion.

ACEM introduced their Doc. PPE-13-2-20 explaining their point of view on the problem and on the

need of adequate harmonised standards under development. They considered that FRANCE should

cease enforcement action until the revised standards are completed and harmonised, plus a

transitional period of 3 years.

The CEN-CENELEC Consultant underlined the difficulties related to professional and non-

professional use of protective garments for motorcyclists, not fully covered by existing standards:

the series EN 1359591 deals with “Protective clothing for professional motorcycle riders”.

SWEDEN agreed with the CEN-CENELEC Consultant.

The Chairperson considered necessary to come back to the discussion, to look into the related

risks, by keeping bilateral contacts between COMM and FRANCE regarding “national” protocols

for test methods. The question will be reported at the next PPE WG meeting, to try to reach a

conclusion and to close the point.

6.3 Action point: COMM and FR, to keep bilateral contacts on national protocols. ALL,

to provide comments. The results will be presented at the next PPE WG meeting.

6.4 Validity of EC type examination certificates based on a previous version of a harmonised

standard (Doc. PPE-13-2-9)

ESF introduced Doc. PPE-13-2-9 bringing up the urgent problem to find a clear position on the

procedure connected with the harmonisation of a revised standard: how to deal with EC type

examination certificates. He remarked that it is a recurrent question and urged a clear position by

COMM, by a legal point of view, making reference in particular to the harmonised standard EN

ISO 20471:201392 as well as to the draft new “Blue Guide”.

The CEN-CENELEC Consultant recalled discussion during many years on the question,

involving the Directive, its essential requirements and harmonised standards. Products have to

comply with the requirements when put on the market, according to the state of the art.

FRANCE agreed with the CEN-CENELEC Consultant.

91 EN 13595:2002 Protective clothing for professional motorcycle riders - Jackets, trousers and one piece or divided

suits - Part 1: General requirements; Part 2: Test method for determination of impact abrasion resistance; Part 3:

Test method for determination of burst strength; Part 4: Test method for determination of impact cut resistance

92 EN ISO 20471:2013 High visibility clothing - Test methods and requirements (ISO 20471:2013, Corrected version

2013-06-01) – superseding EN 471:2003+A1:2007 as by 30/09/2013


SWEDEN mentioned also the question of Notified Bodies and test certificates, that should be

remain valid until is not withdrawn by the Notified Body.

The Chairperson said that in the New Legislative Framework (NLF) package, some clarification is

provided regarding the obligations of economic operators and of Notified Bodies, to check the

certificates when there is a revision of a harmonised standard. It is not possible to have two

standards at the same time providing presumption of conformity, beyond the date of cessation of

presumption of conformity of the superseded standard. The question would be about safety issues or

not, when the change is a formal or substantial one: it is difficult to find a legal solution to all these

kind of questions, apart of the general principle that only one harmonised standard can provide

presumption of conformity when the transitional period is over. There is not the final text of the

new “Blue Guide” yet, but for the time being it is advisable to approach the question consciously.

To minimize costs for manufacturers it would be necessary to analyse the nature of changes. A

solution should be checked also with CEN.

The CEN-CENELEC Consultant considered that it would be about a case-by-case approach.

Possibly the Notified Bodies also can make an analysis between the old and the new standard; a

Recommendation for Use could be drafted to clarify the question.

HCNB said that standardisation should clearly identify why the revision is necessary, stating when

changes are related to safety or not. The possibility of such statement should be considered when

revising a standard.

The CEN-CENELEC Consultant confirmed that in revised standards there is already included a

list of mayor technical changes. It could be useful to have some kind of common understanding

between CEN and NBs.

The Chairperson welcomed such an agreement for a practical solution, also involving Member

States, industry and other interested parties, to reach an easy and minimum cost procedure to deal

with changes in standards and certificates. He invited all to provide proposals on the question.

6.4 Action point: ALL, to provide proposals for an easy and minimum cost procedure to

change the certificates. Deadline: 15 March 2014.

6.5 Knee protectors EN 14404 (Doc. PPE-13-2-8)

GERMANY introduced a question on knee protectors (knee pads) for work in the kneeling

position. They asked to consider whether the product is PPE or not, and which categorisation; they

proposed to connect the category with the fact whether the product is intended to be used in private

or professional framework, considering that “professional” means more time under risk.

FRANCE considered that knee protectors are PPE Category II, with no distinction between

professional and non-professional use. It is a similar logic as the protection for motorcyclists.

GREECE and the NETHERLAND agreed with the French opinion.

The CEN-CENELEC Consultant also agreed. On the question professional / non-professional

use, in the standard EN 1440493 there is reference only to protectors as such, there is no distinction.

In this case, it is PPE Category II.

POLAND fully supported the CEN-CENELEC Consultant and the previous opinions.

93 EN 14404:2004+A1:2010 Personal protective equipment - Knee protectors for work in the kneeling position




positions already expressed.


2013.

6.6. Report of the ad-hoc group on High visibility equipment

The Chairperson noted that the expert from the UNITED KINGDOM responsible of the ad-hoc

group was not present at the meeting. The point will be reported to the next PPE WG meeting.

6.6 Action point: UK, to provide a written report on the state of play. Deadline: 23

December 2013.

6.7 Protective glasses for phototherapy on babies (Doc. PPE-13-2-17

FRANCE introduced a paper asking for confirmation on categorisation, PPE Category II.

DENMARK agreed with FRANCE, underlining that it is a delicate matter, concerning new born

babies.

The NETHERLANDS and GREECE also agreed with FRANCE.

The Chairperson noted the general agreement on considering the product as PPE Category II: it

should be clear, not comparable with sunglasses.

7. Standardisation

COMM said that the latest publication on the OJEU of the list of harmonised standards under the

PPE Directive took place on 28 June 2013. The next one is pending but it should be done in

December 2013.



PPE Technical Committees and the on-going work with standards: statistics, highlights, formal

objections, etc.

7.2 Report by CEN Consultants (Docs. PPE-13-2-5, PPE 13-2-21)

The CEN-CENELEC Consultants presented their written reports on the activities carried out

from the last PPE WG meeting in April 2013.

8. Notified Bodies


HCNB reported on the latest activities of the European Coordination of PPE Notified Bodies, in

particular regarding the Vertical Groups, Recommendations for Use, and specific questions about

differences in notification procedures in different Member States, the problem of responsibilities


when standards are revised (as discussed before), etc. The next meeting of the Horizontal

Coordination will take place on 21-22 November 2013.


COMM reported on the actual status of the RfUs. No new endorsed RfUs had been published on

the EUROPA website since March 2013.

HCNB would report on bilateral discussions for RfUs where comments had been received, as soon

as possible.


9.1 Interpretation of the PPE Directive - Descender devices (Doc. PPE-13-2-18)

NORWAY introduced a paper on the interpretation of the PPE Directive and appropriate measures

when a Notified Body refuses to assess conformity of a PPE Category III, specifically referred to

descender devices. They asked for an opinion on considering the product as PPE Category III.

The Chairperson invited all the delegations present to provide their comments and opinions. On

this basis, it would be possible to discuss on the situation when a Notified Body refuse to proceed

with the due applicable assessment. There are different aspects and tasks to take into consideration.

The CEN-CENELEC Consultant clarified that the referred standard EN 34194 on descender

devices was assessed but not published as harmonised standard, as it is not under the scope of the

PPE Directive.

FRANCE considered that it is difficult to consider such equipment as PPE: it is rather similar to a

stair, to be used in emergency situations. For the time being, they reserved their opinion on the

issue, even if it is rather negative.

NORWAY provided some further clarifications and said that they are very concerned about the

question, as the product is sold as PPE.

DENMARK said that, according to their experts, their opinion supported NORWAY; but the

French arguments against are interesting and understandable. They will consult back their experts

and will report on that.

IRELAND said that descender devices are used also in wind turbines.

LUXEMBOURG understood the Norwegian position, comparable with devices for climbing, in

this case to go down with a “controlled speed”, for professionals. They did not agree with

FRANCE, they saw it as a protection device.

GERMANY basically sympathised with the points of view expressed by NORWAY and

LUXEMBOURG. Their arguments can be perfectly valid to compare descender devices with

devices for climbing, as PPE.

94 EN 341:2011 Personal fall protection equipment - Descender devices for rescue


The NETHERLANDS agreed with FRANCE. It is different from climbing mountains; however

the question is not clear.

The Chairperson recognised that it is not an easy question. It is necessary more time for analysis

and discussion: he invited all the Members to provide comments on the question raised by

NORWAY, in view of the next PPE WG meeting, to develop a common approach on that.

Regarding the question on Notified Bodies, it is also dealt with in the New Legislative Framework.

It is responsibility of National Administrations, according to the requirements of the Directive. In

case of problems, they should be informed, as well as COMM, taking contact with the relevant

competent authorities. National authorities have the power and faculties to take the necessary

action, based on the applicable legal provisions.

9.1 Action point: ALL, to provide comments on the NO question, whether this product is

subject to the PPE Directive. Deadline: 28 February 2014.


The Chairperson said that the next meetings of the PPE Working Group in 2014 are scheduled for

8 April and 18 September, in Brussels. As usual, these dates are subject to confirmation; 6-8 weeks

in advance, to be communicated in due time.

End of the meeting






Group


Chairperson: Mr Luis Filipe GIRÃO (COMM ENTR/F5)

COMM Participants: Ms Birgit WEIDEL, Mr Mario GABRIELLI COSSELLU, Ms Isabel

Maria LOPES GUERRA, Ms Felicia STOICA, Ms Elzbieta

PAPRZYCKA, Ms Eva LEFEBVRE-FOLTYNOVA, Ms Nathalie

BOUTTEFEUX (ENTR/F5)


The Chairperson welcomed those present and introduced the COMM participants, explaining

some recent changes in the organisation and announcing that a new Policy Officer for the PPE

sector would join the team as by 1st May 2014.

2. Approval of the draft agenda (Doc. PPE-14-1-1 v. 3)



3. Approval of the minutes of the latest meetings: 25 April 2013, 11 November 2013 (Docs.

PPE-14-1-2, PPE-14-1-3)

The Chairperson presented the draft minutes of the two latest PPE WG meetings: 25 April 2013

and 11 November 2013. The first one had not been presented at the previous meeting due to the

high workload with current issues (in particular, the legislative revision process).

IRELAND, regarding the draft minutes of 11 November 2013, asked to have included the word

"wind" before "turbines" in his comment on point 9.1 (page 12) and to delete, at page 12, the second

part of their statement, from “The question…”.

FRANCE also asked to remove the last sentence of their statement regarding point 6.7, from “It is

not…”.


The Chairperson agreed. The minutes of 11 November 2013 would be changed accordingly. The

minutes as approved would be added to the consolidated document published on the PPE website

“Minutes of the PPE Working Group”95.

With the changes based on the two comments expressed, the minutes of the latest PPE WG

meetings held on 25 April 2013 and 11 November 2013 were approved.

Action point: COMM to add the approved minutes to the consolidated document

published on the PPE website.

4. Revision of the PPE Directive - State of play: Proposal for a Regulation of the European

Parliament and of the Council on personal protective equipment (Doc. 14-1-23)

COMM made reference to the Commission Proposal for a Regulation on Personal Protective

Equipment issued on 27 March 2014 and published on the PPE website on EUROPA, with the

Articles, the Annexes, the Impact Assessment Report and its Executive Summary. She explained

the main changes with regard to the current PPE Directive, starting with the change to a Regulation,

within the simplification process carried out by the Commission, in line with the policy outlined in

the Communication on Internal Market. In this sense, it would be better to have the same text in all

the EU Member States, rather than 28 national transposition instruments, providing more legal

certainty to operators and users. In the text, there were two type of changes: firstly, the alignment to

the New Legislative Framework, including definitions, obligations of economic operators,

rewording of conformity assessment procedures, etc.; then, some more substantial changes, in the

scope regarding PPE for private use, clarification on made-to-measure PPE, relocation of existing

exclusions, improved risk categorisation, etc. Also, in the Regulation there would be the possibility

to adopt implementing acts, by establishing a PPE Committee, to react more quickly when

necessary, for example modifying categorisation of PPE.

Regarding further process, she described the ordinary legislative procedure in the European

Parliament and the Council, with the related discussion, negotiations etc. This should start already

in April 2014 under the Greek presidency, then taking some time due to the European elections in

June, and to continue under the Italian presidency, etc. After the final approval, a transitional period

of probably 2 year would be established before the new PPE Regulation would become applicable.

LUXEMBOURG asked for more information on the difference between “adapted” and “made-to-

measure” PPE.

The Chairperson said that it would not be useful to discuss the content of the Proposal for

Regulation in the Working Group, as the work on the text would be done in the Parliament and

currently in the Council, according to the calendar established by the Greek and Italian presidencies.

5. Follow-up issues on scope and interpretation of the PPE Directive

5.1 EN 795 “Anchor devices” (Docs. PPE-13-2-24, PPE-12-2-3, PPE-12-2-10, PPE-13-1-10,

PPE-13-2-7, PPE-13-2-10)

95 http://ec.europa.eu/enterprise/sectors/mechanical/personal-protective-equipment/directive-management/index_en.htm

http://ec.europa.eu/enterprise/sectors/mechanical/personal-protective-equipment/directive-management/index_en.htm


The Chairperson reported on the most recent developments in view of clarifying the situation

regarding the standard EN 79596 and the formal objection raised by FRANCE. After the discussion

held in previous meetings, it would be necessary to process the formal objection, through the

Standardisation Committee, also on the basis of Court opinion97. Contacts had been held with the

French authorities to explore the possibility to move forward the publication of the standard;

COMM sent a letter to CEN asking for the revision of the standard, in line with the option to split

the standard into two parts, indicating those elements would be under the PPE Directive and those

under the Construction Products Regulation (CPR). A written procedure could be used to draft a

warning to be added to the standard EN 795:2012 to publish its reference on the OJEU.

CEN-CENELEC reported on the ongoing revision work in the CEN Technical Committee, in view

of the last developments. She regretted for not publishing the standard and for the need to wait for a

formal decision.

The Chairperson said that such process would be quite normal in cases like this, with different

opinions and possible interpretations of a standard and the related legislation. With a formal

objection, the reference of the standard could not be published on the OJEU without the formal

procedure and the decision of the Standardisation Committee. In any case it would be always

possible to reach a consensual approach to straightforward the process. For the time being, COMM

proposed to publish the standard with a warning, to clarify the scope and to address the problems

raised by the formal objection.

FRANCE agreed on the proposed approach with COMM and CEN. With that, they would be

available to withdraw the formal approach.

The Chairperson confirmed that the issue would continue to be followed up for the next meeting.

Action point: COMM to manage the formal objection, preparing a warning for the

publication of the standard on the OJEU; CEN, to report on progress on revision.

5.2 UV-protective clothing (Docs. PPE-13-2-11, PPE-14-1-12)

CZECH REPUBLIC informed on their comments supporting the CEN-CENELEC Consultant

opinion, to consider PPE only for professional use, as Category I against sunlight and Category II

against artificial UV radiation.

The Chairperson recalled the compromise taken at the last meeting, to draft a proposal in co-

operation with CEN on how to delimit the various UV-protective clothing, for discussion at the next

PPE WG meeting, to find a common approach on the issue.

Action point: COMM and CEN, to draft a proposal on how to delimit the various UV-

protective clothing, to be presented at the next PPE WG meeting; PL, to prepare more

detailed description of their position on UV-protective clothing.

5.3 Categorisation of dry suits providing complete insulation from the atmosphere (Docs. PPE-

13-2-12, PPE-14-1-19)

96 EN 795:1996 Protection against falls from a height - Anchor devices - Requirements and testing, plus EN

795:1996/A1:2000. Reference published on the OJEU with a warning; new version EN 795:2012 Personal fall

protection equipment - Anchor devices, issued in July 2012, reference not published on the OJEU yet

97 Case C-185/08: Judgment of the Court (Third Chamber) of 21 October 2010, OJ C 346, 18.12.2010, p. 3-4.




The Chairperson noted that the related action point from the last meeting had not been developed

yet by the CZECH REPUBLIC and GERMANY. This would be reported to the next meeting: to

submit a new draft text for point 6.6 of the categorisation table, based on Doc. PPE-13-12. This

would be followed by a written procedure with the aim to add the new text, when agreed, to the

PPE Guide.

CZECH REPUBLIC said that they had discussed with GERMANY on how to come to a

conclusion on a text for point 6.6. of the categorisation guide. It would be necessary to get more

contributions from experts to draft something more clear and precise, for the next meeting.

EBI (European Boating Industry) introduced a paper on a different aspect of the question, as

comments on the categorisation of dry suits, used in the atmosphere. They proposed a number of

questions to the European Commission and the Member States, regarding the designation of “dry

suits” for specific products and how to deal with them.

The NETHERLANDS made some considerations on categorisation II or III for dry suits according

to their properties: water repellence as PPE or only clothing, not PPE. It would be the manufacturer

to declare what it is placed on the market.

The Chairperson confirmed that categorisation should be in accordance to the practice and the use

of the equipment: it would be necessary to ensure so throughout the whole EU. He asked those

present their agreement on a conclusion as a common approach, to be included in the minutes of the

next meeting: for dry suits providing complete insulation of the respiratory tract, Category III; those

providing isolation, Category II; other just clothing, not PPE. Such decision was already in the

categorisation table; at the next PPE WG meeting this would be confirmed in the minutes, to ensure

that the same approach would be followed everywhere.

Action point: CZ and DE, to provide proposal to change point 6.6 of the categorisation

table based on Doc. PPE-13-2-12; COMM, to confirm decision on categorisation in the

minutes of the meeting.

5.4 EN 1384 “Helmets for equestrian activities” (Docs. PPE-13-2-13, PPE-13-2-14, PPE-14-1-

22)

The Chairperson recalled the main elements of the question from the last PPE WG meeting and

confirmed that COMM updated the formal objection to withdraw from the OJEU the reference of

the harmonised standard EN 1384:201298.

BSIF presented a document with the position of its association on consequences and timings of the

EN 1384 withdrawal from the OJEU. They proposed a specific transitional period for certificates

issued on the basis of the standard, to give time to develop and apply the new requirements and test

methods.

FRANCE agreed on the need of a transitional period, but noted that the standardisation work was

not progressing satisfactorily. The relevant CEN TC group and all the interested parties should be

more active, to get a good standard covering the requirements of the directive, after a transitional

period that should not be too large.

CEN-CENELEC said that the group was very active, but the work was progressing slowly due to

long lasting work and difficulties for lack of specific knowledge and studies, also waiting for

98 EN 1384:2012 Helmets for equestrian activities


expertise from Member States. Some progress had been made on field of vision; more difficulties

for shock absorption, etc. A new meeting would be held in October 2014 in Stockholm.

The Chairperson said that there was not yet a confirmed date for withdrawal of the standard, being

necessary to go through the Standardisation Committee; it would be probably in the next two

months. No transitional period would be foreseen in the decision to be submitted to the Committee:

it would be difficult as this was based on complaints from citizens after a fatal accident. When the

reference of the standard would be withdrawn from the OJEU, no presumption of conformity will

be possible for products complying with the withdrawn standard; but, for products already on the

market, the situation should be examined by the Member States authorities in charge of market

surveillance (in the Administrative Co-operation group) on the basis of the reasons for withdrawal.

The current standard did not ensure adequate coverage of fatal risks, so specific decisions should be

taken regarding those helmets already on the market.

Action point: COMM to manage the formal objection, to withdraw the reference of the

standard from the OJEU; CEN and Member States, to report on progress on revision, and

to assist the relevant CEN TC WG with experts.

5.5 EN 1621-4 “Motorcyclists’ inflatable protectors” (Docs. PPE-13-2-1, PPE-13-2-5, PPE-13-2-

22, PPE-14-1-18)

The Chairperson recalled that question on the formal objection raised against the standard EN

1621-499, not published yet on the OJEU, due to an inadequate test method, not covering possible

additional risks. Contacts with the French authorities and standardisers had been held.

FRANCE introduced a paper answering to the comments of the convener of CEN TC 162 - WG 9.

They were still waiting for progress in the standardisation work to revise the standard.

CEN-CENELEC said that the next step of standardisation work would be a meeting on 15 May in

Paris, with experts from Member States, to discuss on the French formal objection and to move

forward to a solution.

The Chairperson confirmed that the point would remain open to follow-up further developments at

the next PPE WG meeting, continuing with bilateral contacts between FRANCE and CEN.

Action point: CEN and FR, to continue developing bilateral contacts to solve open issues,

in particular on test methods.

5.6. Beekeeper equipment (Docs. PPE-13-2-3, PPE-14-1-4, PPE-14-1-8, PPE-14-1-9, PPE-14-1-

10, PPE-14-1-12, PPE-14-1-13, PPE-14-1-21)

The Chairperson reported on the comments received on the German paper on beekeeper

equipment. He noted a general agreement on considering all beekeeper equipment as PPE Category

II, as proposed by GERMANY, with the exception of “bee smokers”, not to be considered PPE.

POLAND agreed but pointing out serious technical problems related to the lack of harmonised

standards to certify equipment and carry out tests. They asked CEN to develop specific standards

for this kind of equipment.

99 EN 1621-4:2013 Motorcyclists’ protective clothing against mechanical impact - Part 4: Motorcyclists’ inflatable

protectors - Requirements and test methods


The UNITED KINGDOM said that similar questions had been discussed already in the past.

Manufacturers should be already aware of categorisation II for this equipment.

POLAND confirmed that this was already discussed in the past but recall the practical problems

faced by manufacturers and Notified Bodies.

FRANCE said that discussion in 2009 considered only beekeeper helmets; but now the question

was different, on the whole equipment. Manufacturer would need to adapt to the applicable

requirements, based on categorisation II of this equipment.

The Chairperson underlined that, with a common agreement on categorisation, equipment should

comply with the applicable requirements in the legislation, not being the lack of harmonised

standards an obstacle to such compliance. Harmonised standards were not mandatory in the EU;

other technical solution could be used.

With the general agreement on categorisation, the point was closed.

5.7 Bump caps EN 812 (Doc. PPE-13-2-4, PPE-14-1-6 PPE-14-1-8, PPE-14-1-9, PPE-14-1-10,

PPE-14-1-13)

The Chairperson reported on the comments received on the German paper on bump caps and the

harmonised standard EN 812100. He noted different positions on categorisation of bump caps with

only impact- and penetration-protection (I or II), with additional protection against cold

temperatures (I, II or III) and with additional protection against electricity (general agreement on

III).

The NETHERLANDS supported FRANCE and BELGIUM on considering bump caps with only

impact- and penetration-protection as PPE Category II.

FINLAND said that, according to the characteristic of the product as it is, it would be rather

Category I.

GERMANY considered important to make a distinction between different types of impacts for the

bump cap wore by an individual.

The Chairperson suggested re-arranging the definition according to the risk, having Category I for

impact and Category II for penetration? This should be further checked. Further checks would be

necessary also for categorisation of bump caps with additional protection against cold temperatures,

where the three options remained open; when a general agreement seemed to have been reached on

bump caps with additional protection against electricity, on Category III.

GERMANY agreed on Category III for protection against electricity, and on the need of further

clarification for the other types of bump caps, that should be better defined and distinguished

according to their use and protection offered. This would not be a “black or white” issue.

The Chairperson asked GERMANY to rework the document to better clarify categorisation for

different kinds of protection of bump caps, taking into consideration the comments provided. The

issue would be further discussed at the next PPE WG meeting.

Action point: DE, to rework the document to better clarify categorisation for different

kinds of protection, taking into consideration comments provided.

100 EN 812:2012 Industrial bump caps


5.8 Categorisation of PPE for motorcyclists (Docs. PPE-13-2-16, PPE 13-2-20, PPE-14-1-13)

The Chairperson reported on current developments and the dialogue with FRANCE about the

question of “national test protocols” and the concerns raised by ACEM. He asked CEN on the latest

news on standards for non-professional motorcyclists.

CEN-CENELEC said that there was no new information available.

HUNGARY asked for clarification on the general issue on categorisation of products and possible

change: how to deal with it, with any “transitional period” for manufacturers, responsibilities, etc.

The Chairperson explained that it would not the real issue for motorcyclists’ garments, but about

“national test protocols” used in France, when standards for non-professional users were still under

development. Products could be categorised as I, II or III and they should comply with the

requirements of the law, regardless the existence or not of harmonised standards, but based on

technical analysis of the product and the related risks. Indeed, in case of changes from one system

to another, it would be useful to make things easier as possible, taking into consideration the

specific situations and questions raised. For motorcyclists’ garments, when clothing protecting

combination should be tested, there were different methods, including abrasion tests, not all of them

accurate by a technical point of view. It could be considered the possibility for manufacturers to

offer their garments indicating that the full combination was not tested, even offering some kind of

combination, in order to have some “transitional” condition until a specific standard would be ready

in the medium term.

ITALY described the current situation as particularly difficult for market surveillance authorities

and their activities against products, not having specific harmonised standards but other methods or

technical standards, at national level but not agreed and published at European level. There could be

different possibilities, for CE-marked products, by indicating whether a test had been carried out,

but in any case it would appear quite problematic.

The Chairperson said that the problem would be mainly for manufacturers, with French Notified

Bodies following a specific protocol, even not “imposed” as such by French authorities. In any case,

as confirmed by the PPE WG decision, protective garments for motorcyclists incorporating

protectors have to be considered as PPE as a whole, subject to the relevant conformity assessment

procedure for Category II: so, manufacturers should be able to demonstrate that their products

comply with the PPE Directive, as Category II, with EC-Type Examination Certificate, as such

recognised everywhere in the EU. There were no “mandatory national standard”. This would be

valid irrespective of availability of a specific harmonised standard, according to the applicable EU

legal framework, preventing any possible barriers to circulation.

ITALY considered that there was a factual restriction in the market due to technical standards used

in practice in a Member State, and no formally made public. The PPE Working Group agreed on

EC-Type Certification as Category II, but if such certificate would use a non-communicated test

procedure, this would go against Art. 38 of TFUE, so it could not be accepted. This is a problem of

circulation of these products, manufactured in the EU but also with respect to products from third

countries.

FRANCE said that, according to the directive and the categorisation of the product, the French

coordination of Notified Bodies had agreed conditions for specific requirements to carry out the

relevant conformity assessment: when a new harmonised standard would be available, the question

would be clear, but for the time being it is more complicated.

HUNGARY remarked that the use of laboratory tests from professional standards extended to a

leisure product resulted extremely severe. A new standard for non-professional users should be


introduced, avoiding “national protocols” that could cause lower performance levels, open to

possible legal challenge.

The Chairperson reaffirmed that there were no “French standard” in this area, just French Notified

Bodies issuing certificated following “their” protocol. If there were cases of prohibition of products

in France from other countries, the Commission should be informed, through the appropriate

procedure (Safeguard Clause, etc.): this is not the case for the moment. Waiting for specific

harmonised standards for non-professional use, possible solution to deal with practical problems

could be considered, on the basis of proposals from Member States, Notified Bodies,

manufacturers’ organisations, etc.

Action point: COMM and FR, to continue developing bilateral contacts on “national”

protocols; CEN, to develop standards for non-professional users.

5.9 Validity of EC type examination certificates based on a previous version of a harmonised

standard (Docs. PPE-13-2-9, PPE-14-1-13, PPE-14-1-20)

The Chairperson made reference to the Proposal for a new PPE Regulation, introducing a

maximum of 5 years for validity of EU-Type Examination Certificates; as well as to the new “Blue

Guide on the implementation of EU product rules”101, § 4.1.2.6, on revision of harmonised

standards and validity of certificates issued by Notified Bodies.

HCNB presented a paper with the position of Notified Bodies on the consequences of the revision

of harmonised standards and validity of certificates.

ESF said that the HCNB position paper was very much in line with the feeling of the members of

his organisation. The point should be further checked and discussed.

FRANCE mentioned the experience from the transition to the new Machinery Directive in 2008-

2009, regarding new standards and validity of certificates, and different questions with

manufacturers. It would be better not to withdraw certificates without substantial changes in the

standards, for technical and legal reasons. With the proposal for the new PPE Regulation, the way

to deal with the question could continue as it is, making reference only to substantial changes to

consider the possibility to withdraw certificates; if not, they should remain valid.

ITALY recalled horizontal decision from the standardisation unit of the Commission, considering

different situations when the products would be already on the market or not, at the time of

modifications in standards. It should be the responsibility of the manufacturer to reconsider the

product and to revise the certificate when necessary, according to the extent of the modification.

This should be applicable also within the normal revision process of harmonised standards, each 5

years.

The Chairperson said that this question would be checked more in deep in the discussion on the

Proposal of Regulation in the European Parliament and the Council, to be better clarified also in the

guidance documents.

5.10 Knee protectors EN 14404 (Docs. PPE-13-2-8, PPE-14-1-5, PPE-14-1-8, PPE-14-1-9, PPE-

14-1-10, PPE-14-1-12, PPE-14-1-13, PPE-14-1-21)

101 http://ec.europa.eu/DocsRoom/documents/4942/attachments/1/translations/en/renditions/pdf

http://ec.europa.eu/DocsRoom/documents/4942/attachments/1/translations/en/renditions/pdf


The Chairperson reported on the comments received on the German paper on knee protectors and

the standard EN 14404102. He noted a general agreement not to consider PPE those used for

preventing pollution only; on the contrary, some Member States considered knee protectors as PPE

Category II irrespective of professional or non-professional use, when others defend PPE Category I

for non-professional use. Finally, other Member States proposed an alternative classification based

on risk, rather than use.

FRANCE considered that distinction between professional and non-professional use would not be

pertinent and would cause problems. According to the basic requirements of the PPE Directive, it

should be necessary to analyse the level of risks, considering the whole equipment as Category II,

as described in the paper provided (doc. PPE-14-1-21).

The Chairperson proposed to ask the members for further comments on the German proposal and

in particular to the French paper, to consider changing the method of classification, based on the

risk rather than the use. Such comments should be sent within the next two months, to make

COMM able to prepare a synthesis document to be submitted at the next PPE WG meeting, and to

reach a satisfactory agreement.

ITALY expressed their support to the French position.

AUSTRIA mentioned some recent developments related to employees protection law in Austria,

covering different products including knee protectors. The employers had to assess the level of risk

and to inform users on that, choosing the appropriate equipment according to such assessment. They

agreed with FRANCE, but it would be necessary to check the question also with manufacturers

beforehand, to take into due consideration also the use of the product and to prevent possible

problems with different approaches in the EU.

The Chairperson noted the general agreement on providing comments on German and French

documents in two months.

Action point: ALL, to provide further comments on the DE proposal and on other

proposals, in particular from FR; COMM, to draft a synthesis document.

5.11. Report of the ad-hoc group on High visibility equipment

The UNITED KINGDOM, as responsible of the Ad-hoc group on High visibility equipment,

reported on the last developments on the issue. On December 2012 a meeting had been held, to deal

with the problems related to categorisation of high visibility products. Since then, more

contributions had been received but the work was not continuing for the moment, due to other

priorities for the members, as well as for ongoing discussion on the new Regulation.

The Chairperson explained that the intention of the Ad-hoc group was to address doubtful and

borderline cases for this kind of PPE; but this would not challenge the current definitions already in

force, as high visibility equipment for professionals, excluding “fashion garments” etc.

FESI considered that it was an important issue: they would come back in incoming months with

some new proposals to improve the situation and to clarify borderline cases.

5.12 Descender devices (Docs. PPE-13-2-18, PPE-14-1-7, PPE-14-1-9, PPE-14-1-11, PPE-14-1-

14, PPE-14-1-15, PPE-14-1-16, PPE-14-1-17)

102 EN 14404:2004+A1:2010 Personal protective equipment - Knee protectors for work in the kneeling position


NORWAY introduced a new document to clarify the paper presented at the last PPE WG meeting

on descender devices, with a comparison of different types of equipment. They noted a number of

comments from Member States supporting their position on considering these products as PPE

Category III. Discussion was still open, regarding the different aspects related to possible action by

national authorities, certification, etc. They asked the PPE WG members to reach a common

position on the issue.

LUXEMBOURG disagreed on point 2 of the paper (“Rope with harness/belt for use in rescue

operations”): it would be necessary to distinguish whether the manufacturer had foreseen for rescue

operations in building fronts, so, to carefully check the conception of the product and how it could

be used.

The Chairperson considered that the situation of specific descender devices should need more

clarification and further comments.

BELGIUM said that they were not in favour to consider these products as PPE, but with the new

Norwegian document, they could support it.

ESF agreed with BELGIUM. The Norwegian document was very useful, also to introduce more

elements into the PPE categorisation guide. They could support it but they should need more time to

consult with their association members.

FRANCE reserved their opinion on the question but they also could join the Norwegian position; in

any case they also need more time for more in-depth analysis of the document, also taking into

consideration the comments from LUXEMBOURG.

The Chairperson agreed on asking for more comments on the Norwegian document until mid-June

2014, to bring this point into a consensual approach at the next PPE WG meeting.

Action point: ALL, to provide further comments on the NO question.

6. Standardisation

6.1 Harmonised standards on the OJEU

COMM said that the latest publication on the OJEU of the list of harmonised standards under the

PPE Directive took place on 13 December 2013. The next one had been sent to publication in

March 2014 and should be issued this month of April.



PPE Technical Committees and the on-going work with standards: statistics, highlights, formal

objections, etc. She also stressed on the situation of CEN-CENELEC New Approach consultants,

with their work suspended since beginning of this year 2014 due to lack of agreement between

CEN-CENELEC and COMM: this would have negative effects on the whole standardisation work

and on successful sectorial co-operation.

The Chairperson had no specific details on the situation of consultants, being the problems related

to financial regulations and modalities for financial support from COMM to CEN-CENELEC.

Discussions were ongoing and hopefully a solution should be found soon.

6.2 Report by CEN Consultants


No report was offered (due to the current situation with CEN-CENELEC Consultants, as

above).

7. Notified Bodies

7.1 Report from the Horizontal Coordination of Notified Bodies

HCNB reported on the latest activities of the European Coordination of PPE Notified Bodies,

making reference in particular to Recommendations for Use (RfUs) drafted by Vertical Groups, the

operation in the NANDO system, re-notification issues under the new Regulation, etc. The next

meeting of the Horizontal Coordination would take place in November 2014.


COMM said that the latest publication on EUROPA took place in March 2013; no new RfU had

been proposed, and no written procedure for endorsement was currently open. A number of RfUs

were still under the oral procedure; no further information on that was available.

7.3 Lists of Notified Bodies in NANDO and in CIRCABC)

COMM informed that COMM would carry out checks on correspondence between the

official/public NANDO database and at least one representative in the relevant interest group on

CIRCABC. The results would be presented at the next PPE WG meeting.


GREECE, as the current Chair of the PPE Administrative Co-operation Group (AdCo), introduced

the main issues to be discussed at the meeting to be held the day after (9 April 2014), in particular

regarding point 8 of the Agenda: RAPEX, ICSMS and DRPI - Directive Related Product

Information, based on the informative note sent by the standardisation unit of COMM to the AdCo

chairpersons on 13 February 2014.


The Chairperson said that the next meeting of the PPE Working Group was scheduled for 18

September 2014, in Brussels. This should be confirmed 6-8 weeks in advance and communicated in

due time.

End of the meeting


EUROPEAN COMMISSION Directorate General for Internal Market, Industry, Entrepreneurship and SMEs Resources Based, Manufacturing and Consumer Goods Industries Engineering Industries


MINUTES OF THE MEETING HELD IN BRUSSELS, 18 SEPTEMBER 2014


Group



COMM Participants: Mr Niccolò COSTANTINI , Mr Mario GABRIELLI COSSELLU, Ms

Isabel Maria LOPES GUERRA (ENTR/F5), Mr Lutz KOEPPEN

(ENTR/B1)


The Chairperson welcomed those present and introduced the COMM participants, including the

new Policy Officer for the PPE sector who joined the team on 1st May 2014. She also informed

participants on the new Commissioner-designate for DG Enterprise and on the new transparency

rules applicable to the Working Group.

2. Approval of the draft agenda (Doc. PPE-14-2-1 v. 2)


The draft agenda was approved; point 8.4 was anticipated due to logistic reasons and

point 6.3 was split as it covers two separate issues.

3. Approval of the minutes of the latest meeting: 8th April 2014 (Doc. PPE-14-2-2)

The Chairperson presented the draft minutes of the latest PPE WG meeting held on 8 April 2014

and asked for further comments.

FINLAND asked the first sentence of his comment on point 5.7 "bump caps" to be deleted.

IRELAND asked clarification on the latest comment of the Chairperson in point 5.4 "equestrian

helmets".

CZECH REPUBLIC asked to remove the last sentence of his comment on point 5.2 "UV-

protective clothing". CZECH REPUBLIC also asked to change in the point 5.2 "CZECH

REPUBLIC" to "POLAND".


The Chairperson agreed. The minutes of 8 April 2014 would be changed accordingly and a revised

version will be circulated to the members of the PPE WG. An additional period for comments will

be given in order to approve the minutes via written procedure Once the minutes are approved they

will be added to the consolidated document published on the PPE website “Minutes of the PPE

Working Group”103.

Action point: COMM, to amend the minutes and circulate them to PPE WG members.

ALL, to provide their comments to the amended version. COMM to add the approved

minutes to the consolidated document published on the PPE website.

4. Report from ADCO meeting of 17th September

COMM reported on the ADCO meeting held on 17th September due to the absence of the ADCO

chair. A market surveillance campaign and proposed guidelines on market surveillance were

mentioned, together with some product-specific issues such as dry suits, safety shoes and high-

visibility equipment.

5. New PPE proposed legislation - State of play

The Chairperson gave a brief overview of the negotiation at the Council and stressed that good

progress was made in many aspects. The more controversial issues which are still open were also

mentioned: the concepts of made-to-measure and individually adapted PPE; the need to have a

declaration of conformity (or a simplified one) accompanying each product and the categorisation

of some risks. Negotiations at the Parliament still have to start, however a Rapporteur has been

designated.

LUXEMBOURG asked for more information on the difference between “adapted” and “made-to-

measure” PPE.

The Chairperson said that it would not be useful to discuss the content of the Proposal for

Regulation in the Working Group, as the work on the text would be done in the Parliament and

currently in the Council, according to the calendar established by the Greek and Italian presidencies.


6.1 EN 795 “Anchor devices” (Docs. PPE-14-2-3, PPE-14-2-4, PPE-14-2-5, PPE-14-2-18)

The Chairperson reported on the most recent developments and reminded that a proposed warning

to be published in the OJEU was circulated among PPE WG members.

COMM referred to document PPE-14-2-18 and summarised the rationale behind the proposed

warning.

The NETHERLANDS and FRANCE supported the Commission position.

103http://ec.europa.eu/enterprise/sectors/mechanical/personal-protective-equipment/directive-

management/index_en.htm




IRELAND supported the Commission position but suggested a slight amendment to the warning.

CEN-CENELEC stated the position against the warning. They also reported on a meeting with

chairmen of TC 160, of TC 128 (construction sector) and with CEN consultant. A proposal was

prepared to prepare three different standards: one covering purely PPE, one covering purely

construction products and one covering equipment which has elements of both types of products

and therefore should be in conformity with both legislation.

ITALY stated that the problem is the lack of a clear definition in the standard of what "permanent"

means. Moreover, the Construction Products Regulation (CPR) stipulates that the system "in its

entirety" has to be considered construction material.

The UNITED KINGDOM asked for the opinion of the European Commission services dealing

with CPR, i.e. if such anchor devices can be considered construction products. It was also asked

whether some equipment can fall within the scope of both legislations.

The Chairperson clarified that anchorage points are not to be discussed in the PPE WG. The CEN

proposal has been noted with interest and can be a possible solution for the future. In the current

situation, it is considered appropriate to proceed with the warning. The proposal from Ireland will

be considered and, if the text of the warning is revised, it will be circulated.

COMM explained that there are clear definitions of construction products. Discussions are ongoing

on whether products excluded from the scope of PPE Directive are to be considered construction

products.

Action point: COMM, to bring forward the formal objection to the Standardisation

Committee, after assessing the proposed amendment from Ireland; CEN, to prepare a

written proposal on the splitting of the standard.

6.2 UV-protective clothing (Docs. PPE-14-2-16, PPE-14-2-17)

The Chairperson informed the participants of the document received by Poland and circulated

before the meeting.

COMM referred to document PPE-14-2-16 where a proposed delimitation of different UV-

protective clothing is presented.

POLAND presented document PPE-14-2-17 and the proposal to add new health and safety

requirements in the proposed new Regulation.

The Chairperson reminded that the proposed new Regulation is currently being discussed in the

Council WP.

SWEDEN stated that neither the sun nor its radiation can be considered part of the atmosphere and

they would therefore not fall under "atmospheric conditions". According to this interpretation,

which is backed by the Nordic countries, all products offering protection from natural UV-radiation,

both for private and for professional use, are to be considered PPE category I. Equipment offering

protection from artificial UV-radiation are PPE category II.

FESI underlined the risk of having a great number of textile items which would fall under PPE

category I, even if the main purpose of such items is not to protect the wearer against UV-radiation.

This would mean very high costs on the industry. The proposal from the European Commission is

preferable.


POLAND proposed to include in category I special garments used to protect from solar UV-

radiation during sport activities or other activities where the risk from UV-radiation is higher, but

not all types of clothing.

FRANCE supported the proposal from the European Commission.

The NETHERLANDS supported the Commission position with the exception of sunglasses, as the

degradation of the eyes is a slow and irreversible process and sunglasses are often used by

professional drivers. Sunglasses should fall under PPE category II.

The Chairperson reminded that what is currently discussed is the current situation under the

existing Directive, where sunglasses are clearly indicated as PPE category I.

SWEDEN supported the position of Poland, and only clothes with specific properties for UV-

protection should be considered PPE. The table presented by the Commission should be much

shorter.

FESI highlighted that the crucial points are the primary purpose of the product and the claims of the

manufacturer.

The Chairperson clarified that leisure clothing would be considered PPE only if there is a claim

from the manufacturer that the garment provides additional UV-protection compared to a standard

garment. The comments provided will be taken into account and the proposal document will be

amended accordingly.

Action point: COMM, to amend the proposal on how to delimit the various UV-protective

clothing; ALL, to provide contribution in writing.

6.3 (a) Categorisation of dry suits providing complete insulation from the atmosphere (Doc. PPE-

14-2-6)

The Chairperson reminded that the Czech Republic has asked to split the discussion in two parts,

starting from the suits providing complete insulation from the atmosphere.

COMM) briefed on a proposal to amend the PPE guidelines, more precisely point 6.6 of the

categorisation guide, in order provide clarification on this matter and to include a direct reference to

insulation of the respiratory tract, making the guide more consistent with the legal provisions of

PPE Directive.

CZECH REPUBLIC and GERMANY supported the Commission proposal.

The NETHERLANDS asked whether dry suits that incorporate a respiratory system are PPE

category III or not.

COMM replied that it depends on whether such dry suits are integrated with the respiratory

protection equipment, i.e. whether a damage in the dry suit would affect the insulation of the

respiratory tract or not.

The Chairperson summarised that a consensus has been reached on this issue and informed that

the PPE guidelines will be amended accordingly.

Action point: COMM, to amend the PPE guidelines in line with the proposal made.

6.3 (b) Dry suits providing only thermal protection and not insulation of the respiratory tract


COMM presented a proposal to consider dry suits providing thermal protection as PPE category II,

except in cases where the temperatures would be comparable with an air temperature of > 100 °C or

< -50 °C, in which case they would be category III.

FINLAND asked whether the proposal refers to diving suits or to dry suits providing thermal

protection, such as those protecting from hypothermia.

FRANCE asked to have a COMM document summarising the proposals and highlighting the

different scenarios for the different types of dry suits.

FESI proposed to provide an additional insight on the different types of dry suits which are

currently on the market.

The Chairperson thanked FESI and highlighted that written contribution also on this issue are

welcome.

Action point: COMM, to prepare and circulate a summary document; FESI, to give

additional information on the types of dry suits on the market.

6.4 EN 1384 “Helmets for equestrian activities”

The Chairperson informed that COMM has launched the procedure for withdrawal of the standard.

The final text will be submitted to the Standardisation Committee for a formal vote.

CEN informed that a revised draft of the standard is expected to be circulated for public enquiry in

the coming weeks.

6.5 EN 1621-4 “Motorcyclists’ inflatable protectors”

The Chairperson reminded the status of the issue. The concern from France on the current version

of the draft standard was recalled.

CEN gave an update on the activities of the working group in charge. At the last meeting in May

2014 an agreement on some aspects was considered within reach and these parts could be included

in the next revision of the standard. For other aspects further studies and considerations are needed

before making a decision, but there are also some parts which have been rejected by the working

group (especially the pressure measurement method). A possible solution would be to develop two

separate standards because the "French approach" is too different from the current version of the

standard.

FRANCE acknowledged and expressed its satisfaction for the progress in the working group

revising the standard, according to the information provided by CEN. An intermediate solution

could be possible, on the basis of considerations expressed in the formal objection and contributions

from experts, in view to reach an acceptable compromise.

The Chairperson confirmed that the point would remain open to follow-up further developments at


Action point: CEN and FR, to report on the progress at the next PPE WG meeting.

6.6 Bump caps EN 812 (Docs. PPE-13-2-4, PPE-14-2-7, PPE-14-2-25)

The Chairperson summarised the status of the issue.

COMM presented the proposal contained in PPE-14-2-25 to categorize such products.


GERMANY supported the interpretation proposed by the Commission.

ESF agreed in principle but requested more clarification on extreme temperatures as indicated in

points 4.2 and 4.3 of the categorisation table.

POLAND stated that the new wording, changing "helmets" with "head protectors", may cause

confusion as there are respiratory protective devices which also protect the head, e.g. hoods, and

could be considered Category II.

FRANCE pointed out that the equipment described in point 4.5 should be Category II and not

Category I as indicated.

CZECH REPUBLIC reminded the discussion on the "helt-pro" products for cycling which took

place in previous PPE WG meetings, where an agreement was reached that such products are

Category II.

COMM highlighted that point 4.5 was already present in the current PPE guidelines and the

addition is mostly taken from the text of the PPE Directive.

FRANCE stated that bump caps should be PPE Category II and therefore reference to such

products in point 4.5 should be repealed. Bump caps should be under point 4.1, i.e. PPE Category

II.

The NETHERLANDS supported the position of France.

The Chairperson took note of the comments and of the lack of consensus on the issue. The

Commission proposal will be revised accordingly for discussion in the next meetings.

Action point: COMM, to revise its proposal taking into account the comments provided.

6.7 Categorisation of PPE for motorcyclists

The Chairperson recalled the issue and the extensive discussions carried out on this issue in

previous PPE WG meetings. No further contributions were received from Member States.

CEN-CENELEC informed that standard EN 13595 is being revised and reorganised at the

moment. A draft may be available for enquiry in spring/summer 2015.

FRANCE said that they have been monitoring the revision of EN 13595. Making a distinction of

protection against impact and against abrasion may prove problematic. The adequacy of the

categories provided in the standard will need to be assessed.

ACEM gave some background information on the reasoning for the different categories being

developed in the standard, which is to give more choice to the consumers.

FRANCE reminded that the purpose of PPE is to provide protection.

The Chairperson stated that the issue will be discussed again after further development in the

standardisation process. The Commission will keep developing bilateral contacts with the different

parties involved.

6.8 Knee protectors EN 14404 (Doc PPE-14-2-8)

COMM presented the proposal contained in PPE-14-2-8 for a risk-based classification of knee

protectors.


SWEDEN commented that the table should be amended as the differentiation between personal and

professional use is not appropriate in this case. A better categorisation of sport activities is also

deemed necessary, as well as a differentiation between protection against abrasion and penetration.

POLAND stated that the "repeated and prolonged" concept may cause interpretation issues and

problems for market surveillance authorities. The classification should be based on the risk

assessment and on the hazards against which the equipment provides protection.

The NETHERLANDS supported the Commission proposal but reminded that the PPE Directive

does not differentiate between private and professional use.

FRANCE supported the Commission proposal but is ready to consider improvements to it.

FINLAND asked which hockey is intended in the categorisation table, as different types of hockey

may have different risks.

LITHUANIA said the categorisation should be based on hazards and not on activities.

The Chairperson summarised that a better wording and more risk-based categorisation will be

inserted in an amended proposal. Written comments and proposals are welcome.

Action point: ALL, to provide further comments; COMM, to revise its proposal taking

into account the comments received

6.9 Descender devices (Docs. PPE-14-1-11, PPE-14-2-9)

COMM summarised the different opinions received which are tabled on PPE-14-2-9. A possible

interpretation is that such equipment provides protection against fall from a height and therefore

should be considered PPE, but the debate is still open on that.

BELGIUM supported the Norwegian position, but said that this is not correctly reflected in the

tabled positions.

FRANCE highlighted the importance of conditions of use, as not all potential users may be able to

use such device within a short time, which is a critical factor during evacuation situations.

The Chairperson reminded that the classification of a PPE and its conditions of use are two

separate issues.

FRANCE clarified its concern that the product may not be suitable for all users in emergency

situations, and it may even cause additional hazards for non-trained users.

The Chairperson stated that this issue will be discussed further in the next meetings and written

contributions are welcome.

Action point: ALL, to provide further comments; COMM, to draft a synthesis document.

7. New issues on scope and interpretation of the PPE Directive

7.1 Free fall devices (Doc. PPE-14-2-10)

COMM introduced the topic which was triggered by a request for clarification received by the

Commission. Different interpretations are possible on whether these products are to be considered

PPE or not.


LITHUANIA pointed the attention to article 8.4 of PPE Directive, especially on the part "the

immediate effects of which the designer assumes the user cannot identify in sufficient time", as in

this specific case the fall is sought on purpose and the user can identify the risk.

AUSTRIA stated that such devices can be found on road access works in places like pillars, trees

etc. and therefore the use can be also for professional activities. Leisure activities where such

devices are used include team-building activities and during school trips. Products exist in the

Austrian market which do not bear any CE-marking. Austrian authorities consider such products as

PPE Category III. At least part of the device has to be worn or held. The braking device works

independently without any action from the user. These devices should be considered in the same

way as descender devices discussed under point 6.9.

FRANCE stated that the function of this equipment is different from descender devices since it is

not meant to provide protection against fall, but to make users fall. The users of these devices

voluntarily want to fall for leisure purposes. Additionally, the device is permanently fixed to the

structure. Therefore, such products should be excluded from the scope of PPE Directive.

POLAND highlighted that such devices are designed to provide fun and not protection, and

therefore do not fulfil the requirements to be classified as PPE.

The Chairperson observed that several products currently considered PPE protect against risks

arising from activities sought after by the users, e.g. PPE for sport activities.

IRELAND reminded that the BHSR indicated in point 3.1.2.2 of Annex II to the PPE Directive

reads: "[…] falls from a height or their effects […]". These devices protect against the effect of a

fall and should therefore be considered PPE.

CEN-CENELEC stated that this case should be dealt with consistently with the issue of anchor

devices discussed under point 6.1. The principles of these two categories of products are similar as

they both are devices attached to a structure.

The Chairperson summarised that due to the lack of consensus this topic will be discussed at the

next meeting, and invited all delegations to submit their comments and observations.

Action point: ALL, to provide comments and observations.

7.2 Nose filters (Doc. PPE-14-2-11)

FINLAND explained the issue and gave some background information. Some products are on the

market with the CE-marking indicating they are PPE category III. The interpretation from Finland

is that such products are not PPE.

FRANCE, CZECH REPUBLIC and the NETHERLANDS supported the position of Finland

that such products are not PPE.

ESF mentioned that a question regarding similar products was raised in 2012, and the common

opinion was that such products are not PPE.

LITHUANIA agreed that such products are not PPE, at least when used alone.

POLAND shared the opinions of the other Member States. The certificate already issued by a

Notified Body for such products should be withdrawn.

The Chairperson summarised that a consistent view has emerged and such products should not be

considered PPE.


Action point: to confirm that such products are not PPE with the approval of these

minutes.

8. Standardisation

8.1 Harmonised standards on the OJEU

COMM recalled the latest publication of reference to harmonised standards, which took place in

April 2014, shortly after the last PPE WG meeting. The new publication will take place probably

towards the end of the year.


CEN-CENELEC presented the written report and gave an overview of the ongoing activities in the

work programme.

8.3 Reports by CEN Consultants (Docs. PPE-14-2-22, PPE-14-2-23)

The CEN consultant highlighted that the consultants could resume their work only on 1st August

due to contractual reasons. He presented his report (PPE-14-2-22) and drew the attention that,

during the assessment of standards, it is increasingly found that the items are at the crossroad of

several technologies and legislations. He gave the example of electronically-activated avalanche

airbags and also referred to EN 795 (see point 6.1 above).

8.4 Formal objection by Germany against EN ISO 20344:2011 (Test methods for footwear)

(Docs. PPE-14-2-12, PPE-14-2-13, PPE-14-2-14, PPE-14-2-15, PPE-14-2-19, PPE-14-2-24,

PPE-14-2-27) (this point was discussed after point 5)

GERMANY presented their position and the reasons for presenting the formal objection. Safety

shoes with textile insoles were involved in workplace related accidents even if they complied with

the standards and the text method. Nails with smaller diameters can penetrate the textile insole.

Therefore, the standard should be revised and tests should be carried out also with nails with

smaller diameters.

HSDL (Federation of German footwear industry) referred to document PPE-14-2-19 which was

presented by the federation and presented its content in detail.

SPAIN pointed out that, while tests do not cover thinner nails, there are data showing that footwear

with textile insoles increase safety in some situations. Metallic insoles are not appropriate for some

situations. Additional information should be provided to consumers indicating the suitable uses of

different footwear.

AUSTRIA considered that the current situation is not ideal and safety should be further improved.

Use sheets are almost unreadable since the font size is too small, however this is a common problem

for many PPE and not just for safety shoes. He then quoted document PPE-14-2-25, a position

paper from CEN, not agreeing with the proposal to define two classes of penetration resistance in

the standards. There should be information on the footwear indicating the suitable uses.

The CEN TC 161 convener pointed out that the standard was revised in 2011 and the test methods

are now different for textile and metallic insoles. Products which were available on the market in

2010 were either withdrawn or revised. Textile insoles are needed for different reasons and have

many advantages. He highlighted the need to have two levels of penetration resistance, as indicated

in PPE-14-2-25.


FESI backed CEN TC 161 convener and asked which communication has taken place on this issue

with footwear association.

GERMANY replied that the incident statistics are coming from manufacturers, not only from those

which are members of the associations. Regarding the tests, it was stated that investigations carried

out using the 2011 version of the standard lead to similar results. Users may still be using products

produced following the previous version of the standard and not be aware that they are not safe.

ITALY highlighted that the problem is associated with improper housekeeping at the workplace.

These products are meant for professional users at the workplace, thus consumers should have an

increased awareness on the problems they may face. The standard should be reassessed, but it is

important to focus on the right issues.

FRANCE clarified that trials were carried out using the newer version of the standard and gave

similar results to those presented by Germany. France supports Germany on the formal objection,

but attention should be paid to problems which may be caused to Notified Bodies and

manufacturers. The penetration test should be revised.

ESF stated that risk assessment of the activities at the workplace is central in ensuring selection of

the right PPE, and a formal objection would not help in solving the identified issue.

The Chairperson thanked for the contributions and asked to submit the observations in writing.

The Commission will then consolidate the positions in a single document.

Action point: ALL, to provide contributions in writing; COMM, to draft a consolidated

document.

8.5 Formal objection by Sweden against EN ISO 12402:2006 parts 2, 3 and 4 (inflatable life

jackets) (Doc. PPE-14-2-20) (this point was discussed after point 6.5)

SWEDEN introduced the issue and the rationale behind the formal objection, which was triggered

by a work accident with nearly fatal consequences. The accident is considered to be due to a

shortcoming of the standard.

CEN-CENELEC stated that, according to a first investigation of the formal objection by the

relevant TC, it seems more a problem of safety at workplace and of correct maintenance of PPE

(Directive 89/391/EEC). The standard will be revised as part of the regular revision cycle and the

draft for enquiry will be circulated after October.

SWEDEN added that the instructions for use where followed in the work accident mentioned, and

the user has no possibility to check whether the PPE is still fit for purpose.

CEN-CENELEC proposed to circulate a more detailed document by the TC convener.

SWEDEN stated that a police investigation is ongoing in the case, and therefore not all details can

be circulated at this stage.

The Chairperson summarised that the issue will be discussed at the next meeting, when more

information will be available.

9. Notified Bodies



HCNB reported that the contract for technical secretariat expired in April 2014 and the new

contract was signed in July. Some Recommendations for Use (RfUs) are expected to be approved

by the Horizontal Committee in the near future. He stated the importance of keeping record of

obsolete versions of RfUs. The next meeting of the Horizontal Coordination is scheduled for

November 2014. A position paper on the problems generated by the revision of standards was

circulated and discussed at the last meeting of the Horizontal Committee. He proposed that the

position paper is discussed in the PPE WG.

ESF agreed on the need to have the position paper discussed in the PPE WG in the near future.


The situation was already explained while discussing point 9.1 of the agenda.

9.3 Lists of Notified Bodies in NANDO and in CIRCABC

There were no interventions on this topic.


No other business has been discussed.


The Chairperson said that the next meeting of the PPE Working Group is expected to take place in

spring 2015. The provisional dates will be circulated as soon as they are available, and they are

usually confirmed 6-8 weeks in advance.

End of the meeting


EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR INTERNAL MARKET, INDUSTRY, ENTREPRENEURSHIP AND SMEs Industrial Transformation and Advanced Value Chains Advanced Engineering and Manufacturing Systems




Group


Chairperson: Mr Luis Filipe GIRÃO (COMM GROW/C3)

COMM Participants: Mr Niccolò COSTANTINI, Mr Mario GABRIELLI COSSELLU

(GROW/C3)



2. Approval of the draft agenda (Doc. PPE-15-1-1 rev. 2)



3. Approval of the minutes of the latest meeting: 18th September 2014 (Doc. PPE-15-1-2)

The Chairperson presented the draft minutes of the latest PPE WG meeting held on 18 September

2014 and asked for further comments.

With no comments from the Working Group Members, the draft minutes of the meeting

held on 18 September 2014 were approved.

4. Report from ADCO meeting of 20th April

The ADCO Chairperson reported on the ADCO meeting held on 20th April. One of the main

points of discussion was market surveillance activities, with the aim of harmonising such activities

and of identifying common products to be subject to information exchange. Discussions were also

held on current open issues such as equestrian helmets.



The Chairperson gave a brief overview of the inter-institutional discussions. The Council adopted

a common position in December 2014, while the Internal Market and Consumer Protection (IMCO)

Committee of the European Parliament will vote the proposal for amendments on Thursday 23rd

April. The next step is the "trilogue", the negotiations between the three institutions in order to find

an agreement which can be approved by the co-legislators.


6.1 EN 795 “Anchor devices”

COMM summarised the discussion and explained that no comments were received on the latest

proposal circulated by the Commission. Therefore, such proposal is considered as endorsed by the

working group and it is now being reviewed by the other services of the Commission before being

submitted to the Standardisation Committee. Publication in the OJEU is expected before the next

PPE WG meeting.


The Chairperson reminded that a proposal was circulated and asked for the opinion of the WG.

COMM summarised the discussion at the last WG and recalled that the main controversial point is

whether natural UV-radiation should be considered as "atmospheric conditions" or as "sunlight", as

this would affect the inclusion on the scope of some products for private use.

FESI supported the view of considering radiation as "atmospheric conditions". Some users of

sportswear may want a partial exposure to sun radiation. The garment should be considered PPE

only if the manufacturer claims full protection against sun radiation.

FRANCE expressed its reservation about using the criterion of "manufacturers' claims" for

classification of a product as PPE or not.

LITHUANIA supported the view that natural UV-radiation should be considered "atmospheric

conditions".

SWEDEN expressed the preference for considering UV-radiation as "sunlight".

The NETHERLANDS supported the position of Sweden and cited the example of sunglasses.

FESI referred to Annex I of PPE Directive, where "seasonal clothing" for private use is excluded

from the scope.

The Chairperson reminded that not all delegations agree with the view that the products concerned

are seasonal clothing.

POLAND recalled that there are no BHSR covering protection of the skin against sunlight.

GERMANY expressed its support for the interpretation as "atmospheric conditions", as this

interpretation is more in line with the spirit of PPE Directive.

The Chairperson concluded that a conclusion cannot be reached due to diverging opinions from

different delegations. He invited members of the WG to send the Commission any additional


technical elements in order to further investigate the issue. He reminded that, if a protection is

claimed for some equipment, such protection should be based on technical criteria.

Action point: ALL, to provide contributions in writing.

6.3 Categorisation of dry suits not providing insulation of the respiratory tract (Docs. PPE-15-1-

4, PPE-15-1-9)

COMM introduced the subject and reminded that this discussion is a follow-up from previous

meetings. He explained that two main categories of such products exist: one providing thermal

protection, keeping the user warm and not just dry, and one which does not provide thermal

protection but only comfort to the user by ensuring he/she remains dry.

EBI presented document PPE-15-1-9 and clarified that such suits are meant to be used on the

surface of the water, not for diving, and the contact of the water would happen only after a fall into

the water She reminded that "dry-suits" is the commercial name for both types of products, and it

may be difficult for user to distinguish between the two different categories.

FINLAND expressed support for the Commission paper and stated that the proposed categorisation

for immersion suit and for rainwear can be endorsed. However, the issue is not about immersion

suits or rain suits but about garments, such as overalls and two-piece suits, made by Gore-Tex or

similar material and meant to keep the user dry and warm when falling into the water by accident.

Therefore, such garments do not protect only against splashes of water. In 2012, the PPE WG voted

and decided that dry suits made of Gore-Tex, and which are not immersion or rain suits, are PPE

category II. The Commission's paper covers only products which have a harmonised standard.

The NETHERLANDS supported the position of the Commission as per PPE-15-1-4.

GREECE expressed his concern about the consequences of relying, for products which are not

PPE, on a recommendation or a warning to be issued by manufacturers, as indicated in EBI paper

PPE-15-1-9.

FRANCE expressed his support to Greece's concerns. Regarding the Commission paper, he stated

that the products covered by paragraph 6.7 on clothing for non-extreme weather conditions do not

appear to be the same as those discussed, e.g. those used for canoeing. The similarity between this

issue and the one discussed in point 6.2 on UV-protective clothing was also highlighted. Finally, a

distinction between professional and non-professional use is considered difficult to ascertain.

The Chairperson reminded that a distinction between personal and professional use is foreseen in

the legislation, and it cannot be modified by the working group. He stressed that in the

Commission's paper paragraph 6.7 does not change, i.e. the wording remains the same of the current

guidelines. Regarding the notion of atmospheric conditions, he reminded that this issue has been

discussed extensively also with the European Council and the Parliament and invited all members

of the PPE working group to look for a better notion and propose it to the rest of the group.

ITALY reminded that the conditions of use of a PPE need to determine whether the equipment is

for personal or professional use.

EBI stressed that the goal of manufacturers is to respect the Directive with their products, regarding

the categorisation of different products and the differentiation between private and professional use.

Some doubts were expressed in the creation of a third group covering accidental fall into the water,

as this may further complicate the proper categorisation of products.

SWEDEN agreed with Finland and reminded that in 2012 a decision was already taken that dry

suits are PPE category II.


The Chairperson asked Finland and Sweden which changes would be required in the Commission

paper, and in the guidelines, in order to cover the products they are referring to. He also asked to

verify whether harmonised standards currently exist for such products, as otherwise there will be

the need to take some actions in order to have new, appropriate standards developed. He stressed

that there are suits currently on the market which are not PPE but may potentially be confused with

PPE, and underlined that a decision needs to be taken on how to deal with these products.

FRANCE expressed its general support for the Commission proposal, but would like to see

additional clarity on products providing against water splashes such as those used for canoeing.

IRELAND highlighted the need to have clarity on the definition of PPE and on the criteria to be

used in order to decide whether a product is a PPE or not, especially when there is no claim by the

manufacturer that the product is not providing protection.

The Chairperson explained that this is a very broad issue and reminded that the authorities have

the right to verify whether the product falls or not within the scope of the applicable legislation,

regardless of the claims made by the manufacturer. What prevails is the safety of consumers and

market surveillance authorities have the right to take their decisions on the products regardless of

the claims. When there are doubts, the working group is the forum where to discuss and reach a

common approach across the EU. He concluded that the Commission will contact Finnish

authorities asking which changes would be needed in the Commission document and in the PPE

guidelines in order to satisfy its requests, and will amend the proposal accordingly. He reminded

that the issue of suits providing protection only against water splashes remains open and it needs to

be agreed how to consider such products.

Action point: COMM, to contact Finland in order to verify which changes are needed in

its proposal; COMM, to circulate the amended proposal to other members of the PPE

WG; ALL, to provide ideas and opinions on how to consider suits against water splashes

which do not provide thermal protection.

6.4 EN 1384 “Helmets for equestrian activities” (Doc. PPE-15-1-24)

The Chairperson reminded the status of the issue and the withdrawal of the presumption of

conformity for standard EN 1384.

HCNB highlighted that this is a long-standing issue and that the withdrawal of the standard

represents a gap for notified bodies. A consistent approach is needed on the matter, to this purpose

the relevant vertical group has prepared a recommendation for use which has been approved by the

horizontal group.

CEN-CENELEC informed that CEN TC 180 is revising the standard, taking into account the

elements which led to the formal objection. The new version should be ready in 2016.

GERMANY welcomed the initiative taken by HCNB, but expressed reservations on the proposed

transition period in the recommendation for use.

FRANCE also expressed reservations on the proposed transition period. He asked how products

which were tested and certified according to the withdrawn standard should be dealt with,

depending on whether they were placed on the market before or after the standard was withdrawn.

The NETHERLANDS supported Germany in the opposition against the transition period. He also

suggested that the drop height proposed in the recommendation for use should be reassessed.

The UNITED KINGDOM proposed a practical solution for products that were on the market

before withdrawal of the standard, for which manufacturers should check with the notified bodies


whether such products conform to the basic health and safety requirements. She also supported

Germany on the objections to the transition period in the recommendation for use.

The Chairperson highlighted that, due to the sensitivity of the issue, a common approach should

be sought for products placed on the market before the standard was withdrawn. He supported the

position by Germany et al. that a transition period is possible only if it is foreseen in the legal act.

The UNITED KINGDOM expressed the opinion that products placed on the marked before the

cut-off date should be checked for conformity to the basic health and safety requirements in order to

be allowed to remain on the market.

ITALY reminded that the WG already discussed transition periods for withdrawn standard. There

should be no automatic withdrawal of products placed on the market before withdrawal of the

standard.

The Chairperson clarified that there is a potential fatal risk associated with the products

manufactured according to the withdrawn standard, and this potential risk needs to be assessed.

The UNITED KINGDOM reiterated that products on the market need to comply with the basic

requirements at all times.

AUSTRIA stated that, for PPE used in the workplace, it is up to the employer to assess whether the

products can still be used after the presumption of conformity has been withdrawn.

FRANCE mentioned that there are two main categories of helmets: one of high-quality, high-price

products, where the performance levels are already above those indicated in the standard and for

which no problems are foreseen; another of lower-price products which will require a certain

amount of time in order to be brought in compliance with the new situation after withdrawal of the

standard. Manufacturers of the second category of products stated that there will be a shortage of

products on the market. Placing products on the market and making available products to

consumers are two different issues, the second one not being relevant for this discussion. Each

product should be examined individually and there should be no blanket withdrawal of products

from the market.

ITALY agreed with Austria and France and stated that the zero risk is not feasible, as this is the

case for other helmets such as motorcycle helmets and mining helmets. The risk should be

minimised if it cannot be avoided in its entirety.

The Chairperson recalled that UK proposal does not involve automatic withdrawal of products but

requests, as a temporary measure, manufacturers to contact notified bodies in order to re-assess the

products which were placed on the market on the basis of the withdrawn standard.

SWEDEN agreed with the concerns of France regarding the consequences for users and the

availability of products on the market.

The UNITED KINGDOM clarified that its proposal does not call for an automatic withdrawal of

products but requests an assessment of whether such products meet the basic health and safety

requirements.

DENMARK shared the concerns of Sweden related to lack of available helmets.

IRELAND highlighted that one of the reasons for withdrawal of the standard is that it did not

reflect the state-of-the-art. Several alternatives exist on the market.


CEN suggested that the draft of the standard could be used in the transition phase, as it addresses

the shortcomings that led to withdrawal of the standard.

IRELAND stated its support for CEN proposal.

FRANCE expressed disagreement with CEN and Ireland as the draft version is not yet ready to be

used and the way forward towards adoption of the standard seems still difficult.

The Chairperson reminded that the proposed standard is going to be sent for public enquiry in

May and that standards are never mandatory. He summarised that the discussion has shown that

alternative products are available on the market even after withdrawal of the standard. A common

agreement has also emerged that no transition period is foreseen, i.e. the standard does not give

presumption of conformity since the Decision entered into force. The course of action suggested by

UK was apparently already implemented in Ireland; he invited other delegations to consider UK

proposal as a consistent approach on the issue to be implemented.

FRANCE highlighted that products can be placed on the market by other economic operators than

the manufacturers, and stressed the importance of consulting the bodies responsible for making the

products available on the market.

The UNITED KINGDOM proposed that economic operators which place products on the market

should refer to manufacturers for such products.

FESI stated that there might be a shortage of affordable products and this may lead users to use

older, less safe helmets.

The Chairperson summarised that it will be requested to UK authorities to circulate a document

proposing a course of action on the issue. A consensus has been reached on products placed on the

market after the cut-off date, while work is still needed on products which were placed on the

market before the cut-off date.

Action point: UK, to circulate its proposal on the issue; ALL, to provide comments on UK

proposal.


The Chairperson reminded the status of the issue. He recalled that the expected contributions and

progress reports were not received and therefore discussion was not possible. He stated that the

point would remain open to follow-up further developments at the next PPE WG meeting, and the

action point remains the same of the previous meeting.

Action point: CEN and FR, to report on the progress at the next PPE WG meeting.


COMM summarised the status of the issue and introduced the document, which is based on a

previous document, PPE-14-2-25, revised taking into account the comments received during last

meeting.

FRANCE stated that "bump caps" should be brought back in the categorisation guide.

POLAND asked why the wording "light headgear" is used in proposed point 4.5 of the

categorisation guide, while in the other entries the wording "head protection equipment" is used. He

reminded that in standard EN 812 the term "bump caps" are used.


The Chairperson reminded that "light headgear" is already present in the current version of the

guidelines, previously endorsed by the working group.

IRELAND questioned whether thermal protection is appropriate and necessary for head protection

equipment.

COMM clarified that there is a distinction between the need for head protectors to maintain their

performance levels under all foreseeable conditions (including extreme temperatures) and the

possibility for some head protectors to provide also thermal protection for extreme temperatures. In

the latter case, the head protector should be considered PPE category III and not category II like

"standard" head protectors. He also recalled that the term "bump caps" was removed since in the

previous meeting there were diverging opinions on whether such products should be PPE category I

or II. As indicated in the approved minutes of last meeting (PPE 15-1-2), France stated that such

products should be category II. However, the harmonised standard EN 812 explicitly stipulates that

those products provide protection against "laceration or other superficial injuries". Therefore, the

proposed compromise solution is to use more general terms, based on the text of PPE Directive.

FRANCE stated that the problem may be due to different language versions of the harmonised

standard.

The Chairperson took note of the comments and of the lack of consensus on the issue. The

Commission proposal will be revised accordingly and circulated for agreement via written

procedure.

Action point: COMM, to revise and circulate its proposal taking into account the

comments provided.

6.7 Categorisation of PPE for motorcyclists (Doc. PPE-15-1-10)

ACEM presented its proposal contained in the position paper. "Modular PPE" are being developed

in this area but the legal framework is not yet clear. Such equipment may be useful especially for

urban commuters, which have different needs compared to sport riders. Example of such modular

PPEs are garments that can be worn under normal clothing, such as gilet and shoulders' protectors.

FRANCE highlighted that, while riding a moped or a motorbike, any accident can be fatal

regardless of the route travelled. The gravity of an accident, and whether protection against impacts,

abrasions or both is needed, cannot be predicted in advance. It was also stated the level of detail

proposed appears to be more appropriate in the performance of a standard rather than in the

guidelines. Another difficult point is the use of claims by manufacturers in distinguishing whether a

product is PPE or not.

ACEM stressed that the goal is to improve the current situation and to encourage riders who

currently do not wear any PPE to use some so as to have some protection.

The NETHERLANDS stated that the position paper is confusing in some parts and expressed

some doubts that the document is in line with PPE Directive.

LITHUANIA asked in which situations protection only against abrasion or impact is appropriate.

The UNITED KINGDOM expressed the opinion that any move that encourages the use of PPE is

a step in the right direction, as long as the consumer is clearly aware of the protection provided by

the equipment purchased.


ITALY encouraged ACEM to improve its position paper and reminded that a PPE should protect

against all foreseeable risks during the intended activity. The safety of the equipment is

responsibility of the manufacturer and it should not be shifted to the user.

GERMANY agreed with UK that any steps promoting use of PPE is a step in the right direction.

He supported the distinction between equipment providing protection against abrasion or against

impact. The wording of the position paper may be improved.

ACEM highlighted that there are situations when protection only against one of the risks is

appropriate, and expressed the willingness to improve the wording of the position paper in order to

provide additional clarity.

FRANCE stressed the importance to check equipment against BHSR of PPE Directive, especially

"ergonomics" (1.1.1), and "levels and classes of protection" (1.1.2). Levels of performance should

be established by the standardisers, and PPE for motorcyclists should protect both against abrasion

and impact.

ACEM stated that, if only garments providing the highest level of protection would be available,

such garments would be purchased only by a very small minority of people.

The Chairperson summarised that two different views emerged from the discussion: one

sustaining that protective clothing for motorcyclists can be placed on the market only if they cover

both risks of abrasion and impact, and another one affirming that such protective clothing can be

placed on the market also if they provide protection against only one of the two risks. The views in

written form from delegations on whether, under the current Directive, the marketing of equipment

providing only limited protections is allowed are necessary in order to ensure a consistent approach.

Action point: ALL, to provide their views in writing about the legal interpretation of the

Directive on this matter.


COMM presented the proposal contained in PPE-15-1-6, where the risk-based classification of

knee protectors has been fine-tuned taking into account the comments received during the previous

meeting.

FESI supported the proposal, however pointed out that the differentiation between controlled and

uncontrolled falling may sometimes be difficult to assess. Examples in this area would be helpful,

e.g. indicating volleyball as a sport as an activity where controlled falling may occur and mountain

climbing for uncontrolled falling.

SWEDEN pointed out that for kneeling position the risk may derive not only from penetration but

also from uneven surfaces and from the load associated with the kneeling position, and all risks

should be considered category II. It was reminded that a harmonised standard, EN 14404, exist for

knee protectors for work in the kneeling position.

The Chairperson clarified that the list included in the document is not an exclusive list and that

products not mentioned are not automatically excluded. Since more examples would be beneficial

and provide additional clarity, he invited the delegations to submit such examples so they can be

incorporated in the document.

FRANCE stated that more examples are needed and expressed its support for the inclusion of a

reference to work carried out while kneeling, as in the previous version of the document (ref. PPE-

14-2-8). Some knee protectors which do not provide protection nor claim any capacity to prevent

injuries but simply keep the knee joints in the right position may in some cases be considered


medical devices under Directive 93/42/EEC, and the table may be useful to clarify that such

products are outside the scope of PPE Directive.

AUSTRIA asserted that the examples' list should not be excessively long as it may cause problems

to market surveillance authorities when assessing the intended use and distinguishing between PPE

category I and II.

The Chairperson explained that guidelines are not a legislative text and can be changed when the

need arise. The document will be amended taking into account the comments expressed and will

then be circulated for a written consultation among members of the PPE WG.

Action point: COMM, to amend its proposal and circulate it for written consultation

6.9 Descender devices (Doc. PPE-15-1-7)

COMM presented the proposed categorisation and the main changes compared to the previous

document, ref. PPE 14-2-26. Such products should be considered PPE category III.

DENMARK supported the position of the Commission.

FRANCE stated that the position of the Commission could be accepted, but would like to know

which standards should be used for this equipment.

The Chairperson reminded that standards are not mandatory. In case harmonised standards are not

present, a mandate can be issued to CEN for drafting of such a standard.

The NETHERLANDS supported the position of the Commission.

The Chairperson concluded that the WG agrees with the document. In case no further comment is

received in writing within the following three weeks, i.e. by mid-May, the document will be

considered endorsed and incorporated in the PPE guidelines.

Action point: COMM, to incorporate the document in the PPE guidelines.

6.10 Free fall devices

The Chairperson explained that no contribution has been received on this open point since the last

meeting and restated the request for contribution in order to allow preparation of a synthesis

document.

Action point: ALL, to provide their contribution on the issue.

6.11 New PPE guidelines (Doc. PPE-15-1-11)

The Chairperson explained that the updated version which was circulated (ref. PPE-15-1-11)

incorporated decision endorsed by the working group since the last version was released. Comments

and proposals are welcome in written form before the next working group. Once the new PPE

Regulation is approved, probably before the end of the year, new guidelines will need to be

prepared and endorsed by the working group. A small group of volunteers may be created for the

preparation of the guidelines of the new Regulation.

FRANCE expressed its willingness to participate in the preparation of the new guidelines and

asked whether manufacturers can also participate.


The Chairperson clarified that EU-wide associations are welcome, while participation of national

associations or single manufacturers may be complicated and make the whole group very large and

difficult to manage.

ESF reminded its involvement in the preparation of the previous guidelines and expressed its

willingness to be part of the drafting group.

6.12 PPE offering protection against phytopharmaceutical products (Docs. PPE-15-1-25, PPE-

15-1-26)

FRANCE presented the documents submitted to the working group. Clarity is needed on the

classification of such equipment and its approval procedure. Comfort and wearability of this

equipment may greatly affect its use. According to the analysis carried out by French authorities,

such equipment is PPE category III and a harmonised standard is needed, which is currently lacking

at European level.

The Chairperson clarified that two different issues need to be clarified: 1) the classification of

such garments, whether they are PPE category II or III and 2) which technical solutions can be used

to comply with the basic health and safety requirements. With regards to the latter point, it is

important to keep in mind that a specific technical solution cannot be imposed on manufacturers.

Since the working documents were circulated very close to the meeting, the discussion will need to

continue. Written comments are greatly appreciated as they facilitate the discussion and the finding

of a solution.

The NETHERLANDS expressed sympathy to the initiative of the French authorities aimed at

ensuring safe working conditions for users of such products. Nevertheless, reservation was

expressed on the conclusion in PPE-15-1-25 that "Member States could be legally liable and the

health and safety of users of PPP cannot be guaranteed". Member States cannot be legally liable.

Phytopharmaceutical products, when used for plant protection, classify as biocides and therefore

fall under Regulation 528/2012, which states that carcinogenic, mutagenic or toxic to reproduction

(CMR) substances of category 1A and 1B cannot be used as biocides unless under very specific and

strict conditions. Additionally, Directive 89/391 on health and safety of workers at work stipulates

that employers have to ensure a healthy work environment for users. Therefore, Member States

cannot be liable for an obligation of employers. The Netherlands cannot support the French paper.

FRANCE maintained that such equipment is PPE category III as it protects against chemicals. A

test protocol was notified by French authorities and all Member States are invited to respond with

their views. The protocol is inspired by the future standard and does not impose a technical solution.

The Chairperson invited delegations to submit written comments on the documents submitted by

the French authorities before mid-June.

Action point: ALL, to submit their written comments on the issue.

6.13 Ear plugs for sleeping and ear plugs for flying (Doc. PPE-15-1-20)

FINLAND presented its document and asked the opinion of delegations on whether such products

are PPE or not.

The NETHERLANDS stated that aircrafts must be designed to prevent harmful noise in the cabin.

Ear plugs for sleeping are more comfort items. Therefore, both products should not be considered

PPE. In some specific circumstances ear plugs would be needed for medical reasons, however in

this case they should be considered medical devices.


FRANCE differentiated the two different types of ear plugs. Products exist on the market that

provide protection against noise and against pressure on a plane; the status of such products should

be assessed, whether they fall under PPE Directive or other legislation. Ear plugs for sleeping could

be seen as PPE since they could be used in the workplace, at concerts etc. to protect against harmful

noise. Standard for individual protection against noise considers ear plugs to be PPE.

The Chairperson clarified that it needs to be assessed whether such products are within the scope

of PPE Directive according to the text of the Directive itself. Standards do not interpret or define the

scope of the Directive. Delegations are invited to submit their view by the end of May, in order to

come to a conclusion and a common understanding on the issue.

GERMANY expressed the view that neither of those ear plugs are PPE since the level of noise

experienced in both situations is lower than the one in the scope of PPE Directive.

FRANCE asserted that protection against pain caused by pressure on a plane should also be taken

into account in the assessment.

Action point: ALL, to submit their written comments on the issue.

6.14 High-visibility products (Doc. PPE-15-1-28)

ESF presented the document and stated that good progress was made on an ad-hoc working group

in 2012, but afterwards the work of this group has stopped. Some problems still remain on this

issue, especially regarding whether products with a limited amount of reflective material should be

considered PPE or not. A decision by the working group on the matter would be welcomed.

DENMARK suggested that an indicative list may be prepared in order to decide on high-visibility

products on a case-by-case basis; such list would be similar to the one available for lifting

equipment in machinery.

The Chairperson stated that, as the document was circulated very recently, more time is needed

and a written document needs to be prepared as a basis for discussion. The item will be discussed

more in detail in the next meeting.

6.15 Inflatable wristband/watch (Doc. PPE-15-1-23)

HCNB explained that Notified Bodies receive by manufacturers on a regular basis the request to

certify as PPE innovative products; often it is not clear whether such products are PPE or not.

Vertical group 8 "lifejackets" asked whether inflatable wristbands/watches are in the scope of PPE

Directive. The decision on whether an item is a PPE or not has to be taken by the working group.

FRANCE expressed the opinion that such products, as they are used only in one arm, may make

the user less stable in the water instead of helping him/her. Therefore, the product is not a PPE.

The NETHERLANDS supported French position that the product is not a PPE.

The Chairperson stated that, according to the analysis carried out, such products do not appear to

be PPE. On the other hand, such products may create risks to consumers and may need to be

assessed under other Community legislation. Written comments are welcome, preferably before the

end of May.

6.16 Cooling vests (Doc. PPE-15-1-30)


The Chairperson explained that the document recently distributed will not be discussed during this

meeting. Received written comments, preferably by the end of June, will be taken into account and

incorporated into a synthesis document.

7. Standardisation


CEN-CENELEC presented the written report and gave an overview of the ongoing activities in the

work programme. An update was given on the status of CEN-CENELEC Consultants, explaining

that currently they are not operational and their activities are expected to restart around the summer.


(Docs. PPE-15-8, PPE-15-1-18, PPE-15-1-27) (this point was discussed after point 5.7)

The Chairperson recalled that this is an open issue from last meeting.

CEN asserted the disagreement to this formal objection and reminded that the approval of the

standard was unanimous.

CEC (European Confederation of the Footwear Industry) explained that some work aimed at

clarifying the situation was carried out after the formal objection was issued. A study of the issue

from a technical, economical and standardisation point of view was carried out. The situation is

deemed to be under control and no increased accident rate at the workplace has been registered. A

new test method was developed and a new standard to assess the non-metallic insert is expected to

be released around the end of the year.

ESF expressed the support to the positions of CEN and CEC. Some statistics show that, since the

introduction of non-metallic inserts, penetration accidents and incidents have decreased. A risk

assessment is the correct tool to ensure that the proper safety shoes are used.

GERMANY reminded that the reasons why a formal objection was raised were presented

extensively at the last PPE working group meeting. He welcomed the progress in standardisation,

stating that this is a sign that the standard needs improvements in some parts. The formal objection

criticises the current test method and work should continue on the management of such objection.

FRANCE stated that, at the previous meeting, he supported the German formal objection as the

standard is insufficient. It is important to find a right compromise between protection and comfort

for such equipment. The ongoing work on the revision of the standard should be considered with a

view to reaching a new version of this standard.

CEC underlined the two points in the formal objection: 1) the information for users and 2) the test

method. On 1), a recommendation for use (RfU) which redefines the information to be provided

with such shoes has been approved by the relevant vertical group of notified bodies (VG10) and by

the horizontal group. Progress is ongoing on 2) and finalization of a new test method for non-

metallic inserts is expected by the end of 2015.

PORTUGAL stated that, given the circumstances and the data available, the situation is deemed

under control and therefore the formal objection cannot be supported.

HCNB pointed out that the already mentioned RfU has been approved by the horizontal group the

day before the meeting, and it will be circulated to the member of the working group in the next

days.


The Chairperson summarised the outcome of the discussion and reminded the procedure to follow

when dealing with a formal objection. The RfU needs to be assessed by the working group and,

when agreed, endorsed. The two possible courses of action are 1) to proceed with the formal

objection or 2) to assess in the next months the progress made on the points raised in the formal

objection.

GERMANY acknowledged the work done on the RfU and on the revision of the standard, however

given the shortcomings of the current harmonised standard it appears necessary to move forward

with the formal objection.

ITALY stressed that this is mainly an issue of workplace management. It has not been proved that

shoes with metallic inserts are of higher quality than shoes with non-metallic inserts, especially in

relation to BHSRs 1.1.1 "ergonomics" and 1.3 "comfort and efficiency".

The Chairperson clarified that the formal objection will remain open in any case, the timing is

what is under discussion now. An opinion of the working group is needed on the matter.

DENMARK asserted that there is no proof that accidents are decreasing, therefore the formal

objection is supported.

GERMANY stated that, without the certainty that progress will be achieved before the next

meeting, the formal objection should be dealt with already in the next months.

ITALY highlighted that there is no consensus on this issue within the working group.

The Chairperson clarified that a formal objection needs to be treated even when it is supported by

only one Member States. The Standardisation committee then decides by voting on the formal

objection. An e-mail with the content of the objection will be sent via CIRCABC, giving some

weeks to Member States to express their opinion on the formal objection.

Action point: COMM, to circulate a message requesting the opinion of Member States on

the formal objection; ALL, to provide their opinion.


jackets) (Doc. PPE-14-2-20)

SWEDEN recapped the issue and explained that the current standard does not include requirements

and test methods covering the risk of detachment of the gas cartridge. Solutions and test methods

already exist, therefore they may be included in the standard.

The Chairperson informed that no comment on this issue was received by delegations. Additional

information on the matter will be gathered from Sweden and circulated among members of the

working group.

8. Notified Bodies

8.1 Report from the Horizontal Coordination of Notified Bodies (Doc. PPE-15-1-21)

HCNB presented the report and reminded the importance of participation of Notified Bodies to the

coordination work.

8.2 Recommendations for Use Sheets (RfUs) (Docs. PPE-15-1-12, PPE-15-1-13, PPE-15-1-14,

PPE-15-1-15, PPE 15-1-16, PPE-15-1-17, PPE-15-1-19, PPE-15-1-22)


The Chairperson reminded the RfU's which were circulated after last meeting. The following

RfU's are considered endorsed by the working group: 1) 5 RfU's of vertical group (VG) 4 "hearing

protection", listed in PPE-15-15, circulated in November 2014 and for which no comments were

received; 2) 8 RfU's of VG 11 "protection against falls from a height", listed in PPE-15-1-17,

circulated in November 2014 and for which no comments were received; 3) 5 RfU's of VG 9

"protective clothing for motorcycle riders", circulated in December 2014. All the RfU's listed in

PPE-15-1-16 are considered approved except for RfU 09.005, as a comment was received and it

therefore needs to be analysed separately. Regarding the 25 RfU's of VG 1 "head protection", listed

in PPE-15-1-13 and circulated in January 2015, a comment has been received on RfU 01.020. With

this exception, the other RfU's of this VG will be considered approved if no further comments have

been received by the end of May. With respect to the RfU's of VG 2 "respiratory protection" and of

the horizontal group, comments are requested before the end of September as they were circulated

more recently. If no comments are received, they will be considered endorsed by written procedure.






The Chairperson said that the next meeting of the PPE Working Group is expected to take place

on 17th November 2015. The date of the meeting will be confirmed 6-8 weeks in advance.

End of the meeting






Group



COMM Participants: Mr Niccolò COSTANTINI, Mr Mario GABRIELLI COSSELLU

(GROW/C3)


The Chairperson welcomed those present and explained that, since the meeting could start only in

the afternoon, some points of the agenda may not be covered as planned.




3. Approval of the minutes of the latest meeting: 21st April 2015 (Doc. PPE-15-2-2)

The Chairperson presented the draft minutes of the latest PPE WG meeting held on 21 April 2015

and asked for further comments.

FRANCE stated that its position on point 6.8 on knee protectors is not fully reflected in the

minutes. It also expressed some comments on the new version of PPE guidelines.

The Chairperson explained that it is not possible during the meeting to review the guidelines due

to lack of time. He reminded that the guidelines are to be considered a living document and the goal

is to have a consensus on its content, in order to ensure a consistent implementation of the

Directive. Comments in writing on the guidelines are welcome. He also invited France to submit the

comments on the minutes from previous meeting in writing. Once the minutes have been amended,

they will be circulated for approval by written procedure.

Action point: FRANCE, to send in writing the comments to the minutes; COMM, to

circulate the amended minutes for approval by written procedure.


4. Report from ADCO meeting of 16-17th November

A representative of the ADCO Chair reported on the ADCO meeting held on 16th and 17th

November. Several market surveillance actions were presented during the meeting, together with

the structures of the authorities in charge of market surveillance in different Member States. The

lack of harmonised standards for some products was also discussed.


The Chairperson informed that the text of the Regulation has been approved by COREPER in the

Council and by the internal market and consumer protection (IMCO) Committee in the European

Parliament. The text is being reviewed by lawyer-linguists from all Institutions, with the presence of

representatives of the Member States. The text is expected to be approved in the beginning of 2016.

The NETHERLANDS requested more time to review the translation of the text and asked for an

extension of the deadline.

The Chairperson clarified that the lead in the process is taken by the Legal Service of the

European Council and such requests should be directed to them.


6.1 EN 795 “Anchor devices”

COMM recalled that a consensus on the matter was achieved in the previous WG meeting and, on

this basis, reference to the standard will be published in the Official Journal with a warning,

clarifying that only some of the anchor devices included in the standard are to be considered PPE.

Anchor devices which are not PPE may be covered by a new standard for construction products.

The UNITED KINGDOM stated that there are some anchor devices which may not be considered

PPE or constructions products, e.g. those used in ships. For such anchor devices, uncertainty will

remain.

ESF informed that a meeting on this topic is organised for beginning of December with the major

manufacturers of such products in order to make an analysis of the situation. After the meeting,

extra information and possibly proposals will be provided.

The Chairperson clarified that the discussion is about a harmonised standard for PPE; if some

information is available about anchor devices which are PPE and not covered by the existing

harmonised standard, such information can be circulated among members of the WG in order to

discuss the issue at the next meeting.

CEN-CENELEC explained that the standard, which includes products that are outside the scope of

PPE Directive, remains valid from a technical point of view.

The Chairperson explained that the revision of the standard for the products which are not PPE is

outside the scope of this WG.



COMM summarised the key points of the document submitted.

The Chairperson concluded that, since no objections were raised, the document can be considered

endorsed and the point closed.

Action point: With the adoption of these minutes, document PPE-15-2-3 is considered

endorsed and the point is closed.

6.3 Categorisation of dry suits not providing insulation of the respiratory tract (Docs. PPE-15-2-

4)

COMM introduced the subject and presented the updated categorisation proposal.

LATVIA requested clarification on which parts of the guidelines will be modified with the

endorsement of the document.

COMM clarified that the changes will affect only the dry-suits related parts of the guidelines.

The Chairperson concluded that a consensus was found and that the guidelines will be updated

accordingly.

Action point: With the adoption of these minutes, document PPE-15-2-4 is considered

endorsed and the point is closed. COMM will update the guidelines

6.4 EN 1384 “Helmets for equestrian activities”

The Chairperson informed that a revision of the standard is currently ongoing. A consensus could

not be found on the actions to be taken for products which have already been placed on the market.

IRELAND, who is also responsible for the relevant CEN WG, informed that the standard has been

revised and performance requirements have been improved; the standard is expected to be approved

in the beginning of 2016.

COMM clarified that discussion took place in the ADCO meeting regarding the approach to take

towards product manufactured according to an out-of-date standard.

FESI stated that a position paper on this matter was submitted in May, where it is supported the

view that helmets placed on the market before the standard was withdrawn should remain on the

market, unless the relevant safeguard procedure is applied.

ITALY expressed the opinion that any decision on the withdrawal could potentially be problematic,

especially in cases of widely-used products.

The Chairperson reminded that the peculiarity of this case is due to a life-threat potentially

associated with products manufactured in accordance with the withdrawn standard. He also

expressed his appreciation for the complex work carried out by members of the relevant CEN WG.

Action point: The point is closed.


This point was not discussed due to lack of time. On the day of the meeting the assessment of the

standard by CEN-CENELEC Consultant was sent to COMM. This assessment will be circulated

to members of the PPE WG for discussion at the next meeting.



COMM summarised the status of the issue and introduced the document, which is based on a

previous document, PPE-15-1-25, revised taking into account the comments received during last

meeting.

CEN-CENELEC remarked that the second sentence in point 4.1 of the categorisation table is a

general remark and should be clear that it refers to all types of head protectors.

COMM reminded that this sentence was added following discussions during previous meetings.

The Chairperson suggested to move this sentence to the heading of the table in order to clarify that

it applies to the full table.

Action point: The point is closed. The document, with the shifting of the sentence

mentioned above, is approved by the working group.

6.7 Categorisation of PPE for motorcyclists

This point was not discussed due to lack of time.


COMM presented the proposal contained in PPE-15-2-6, which was amended in order to reflect

comments received since the last meeting of the working group.

FRANCE stated that, as commented on the minutes from previous meeting, it is important not to

merge two potential categories of products: kneepads not providing protection nor claiming it and

kneepads to be considered Medical devices.

The Chairperson agreed that these are two different products but reminded that both of them are

not PPE. It is outside the scope of the working group to investigate whether such products are in the

scope of other Community legislation.

POLAND expressed the opinion that, out of the knee protectors used during professional (non-

sport) activities, only those providing protection against penetration should be considered as PPE

category II. All other types of knee protectors for workers should be category I.

SWEDEN supports the categorisation as in the Commission's document.

FRANCE supports the position of Sweden. Users should be protected also against long-term

damages.

The Chairperson explained that equipment protecting against severe impacts, i.e. not minor ones,

is clearly not PPE category I.

FESI expressed the agreement with the proposal of the Commission.

GERMANY expressed that knee protectors against chronic illnesses should be PPE category II.

The Chairperson clarified that knee protectors used for short periods of time are already covered.

Action point: COMM, to amend its proposal and circulate it for written consultation

6.9 Free fall devices



6.10 PPE offering protection against phytopharmaceutical products (Docs. PPE-15-1-25, PPE-

15-1-26)


6.11 Ear plugs for sleeping and ear plugs for flying (Doc. PPE-15-2-8)

COMM recapped the status of the discussion and presented PPE-15-2-8. An almost unanimous

opinion is that such products are not PPE, as they are designed to provide comfort and not to protect

against hazards. Misuse of products is always possible but this is not a reason to improperly classify

them.

FRANCE stated that there are health concerns associated with the prolonged use of these ear plugs.

Noise is a known stress factor even at very low levels. Comfort cannot also be a discriminating

factor as some products providing comfort also significantly attenuate noise. A marked level of

noise attenuation implies that the product is reducing a risk. Such products can also be used for

professional purposes, and currently such products are PPE category II or even category III.

The Chairperson clarified that products providing protection to the ears are PPE and therefore

have to comply with PPE Directive. However, the products currently discussed are not protecting

against any hazards. Such products are very specific and are used when flying or sleeping, i.e. in

situations where the noise level is lower than the levels against which PPE protect. Ear plugs such

as those distributed by airlines during the flight are a good example of the products being discussed;

considering such products as PPE does not appear to be correct.

GERMANY expressed agreement with the proposal of the Commission.

FRANCE expressed doubts on the use of the term "comfort".

The Chairperson suggested removing the reference to "comfort" in the document. He clarified that

for some users such products actually provide comfort. Such products are not meant to be used for

professional purposes.

NORWAY gave examples of when such products can be used for comfort and supported the

Commission's proposal.

The Chairperson explained that it should be avoided to have all ear plugs classified as PPE.

GERMANY reminded that it is another Directive, on use of PPE at the workplace, which regulates

selection of appropriate PPE and employers' responsibilities to provide them when necessary. If ear

plugs for flying are to be considered PPE, employers may have provide them to their employees

flying for business reasons, and this does not appear to be sensible. The case of ear plugs for

swimming was recalled, where the WG decided that they are not PPE.

FRANCE expressed openness to a newly formulated document where the term "comfort" is

removed. It stated that ear plugs indicating a noise reduction level on the package should be

considered PPE.

The Chairperson clarified that such products need to be assessed on a case-by-case basis. Clearly,

a protection claimed and indicated has to be actually provided by the product and this protection

should be tested and proven. The document will be amended reflecting the discussion and circulated

to the members of the WG for approval by written procedure.

Action point: COMM, to amend its proposal and circulate it for written consultation.


6.12 High-visibility products (Doc. PPE-15-1-28)


6.13 Cooling vests (Docs. PPE-15-1-30, PPE 15-2-9)

COMM briefly described the products subject of analysis and summarised the status of the

discussion, the main point being under which PPE category such products should fall.

SWEDEN expressed the opinion that garments should be considered PPE only if they offer a

minimal level of protection. If such products are to be considered PPE, they should be category I.

The UNITED KINGDOM supported the position of Sweden that such products, when worn by

professionals working in excessive heat and at risk of heat stroke, should be considered PPE

category I.

POLAND expressed the opinion that such products should not be considered PPE. Categorisation

of PPE products should be risk-based.

CEN-CENELEC explained that such garments are usually worn in combination with other

protective clothing. They are mostly used in environments, such as steel plants and nuclear reactors,

where the risks require category II or even category III PPE. They are used as an extra layer of

protection and therefore should be considered PPE.

The Chairperson requested other participants to the PPE WG to express their views. The point will

remain open for discussion at the next meeting.

Action point: All, to provide their opinion on the matter.

6.14 Impact protection helmets for young children (Doc. PPE-15-2-18)


7. Standardisation

7.1 Harmonised standards in the OJEU

COMM explained that a new publication of standards is expected by end of 2015.


CEN-CENELEC presented the report and gave an overview of the ongoing activities. Regarding

new approach consultants, a new contractual agreement, which will last until end of 2017, is in

place.

7.3 Formal objection by Germany against EN ISO 20344:2011 (Test methods for footwear) (this

point was discussed after point 5)

The Chairperson recalled that this is an open issue from last meeting, with some delegations in

favour of the formal objection and others against it.

CEN-CENELEC stated that the accident rate in Europe is marginal and has further decreased since

the latest standard was introduced. The relevant technical committee has been informed of the

concerns at the basis of the formal objection and is considering them.


The Chairperson concluded that the meeting will remain open for the next meeting, when experts

of the German authorities are expected to be present.


jackets) (Doc. PPE-15-2-11)

The Chairperson informed that, as agreed with Swedish delegation, this point will be discussed in


7.5 Draft standardisation mandate on garments for protection against heat and flame (Doc. PPE-

15-2-7)

COMM representative from textile unit presented the ongoing work on garments integrating smart

textiles and non-textiles elements providing protection against heat and flame. Users and informers

have to be informed on ongoing activities, and this is the purpose of the presentation. The mandate,

as currently designed, requests European Standards Organizations (CEN, CENELEC and ETSI) to

prepare standards to measure the properties and overall performance of garments, as well as on

selection, use, maintenance and care of them. A wide variety of stakeholders were consulted,

receiving mostly positive feedback.

8. Notified Bodies

8.1 Report from the Horizontal Coordination of Notified Bodies (Doc. PPE-15-2-20)

HCNB presented the report and summarised the results of the last meeting of the horizontal

committee. An overview of the status of RfUs was also given

8.2 Recommendations for Use Sheets (RfUs) (Docs. PPE-15-2-12, PPE-15-2-13, PPE-15-2-14,

PPE-15-2-15, PPE 15-2-16, PPE-15-2-17, PPE-15-1-22)

This point was already covered by the presentation under point 8.1.







on 27th April 2016. The date of the meeting will be confirmed 6-8 weeks in advance. As some

points could not be discussed due to lack of time, he invited members of the working group to send

written comments before next meeting.

End of the meeting






Group


Chairperson: Ms Birgit WEIDEL (COMM GROW/C3)

COMM Participants: Mr Niccolò COSTANTINI , Mr Mario GABRIELLI COSSELLU

(GROW/C3)


The Chairperson welcomed those present and thanked for the additional efforts needed to reach

Brussels due to the security situation. As many delegations could not be present, this meeting will

advance discussions on some open points, but no decision will be taken.


The Chairperson introduced the draft agenda, clarifying that it may not be possible to cover all

points. A point originally foreseen under AOB, linked to document PPE-16-1-18 submitted by

Poland, will be treated after point 3.

The draft agenda was approved with the change indicated above.

3. Approval of the minutes of the latest meeting: 21st April 2015 (Doc. PPE-16-1-2)

The Chairperson presented the draft minutes of the latest PPE WG meeting held on 18 November

2015 and asked for further comments.

CEN-CENELEC requested its comments on point 7.3 to be slightly modified.

FRANCE referred to document PPE 16-1-20, where some modifications to the latest version of the

PPE guidelines are proposed.

The Chairperson stated that such modifications will be assessed, taking into account that the

change in the legal framework brought in by new PPE Regulation. As document PPE-16-1-20 was

circulated only the day before the meeting, it is not possible to discuss it with such a short notice.

The document can be discussed in the next meeting.


Action point: COMM, to modify CEN comment and to circulate the amended minutes for

approval by written procedure.

4. The new PPE Regulation

The Chairperson informed the new PPE Regulation has been published in the Official Journal on

31st March 2016; it is Regulation (EU) 2016/425. It will enter into force on 21st April 2016 and

become applicable two years later, i.e. 21st April 2018; Member States can notify Notified Bodies to

the Commission as of 21st October 2016. Among the preparatory work required before the new

Regulation becomes applicable, some institutional arrangements may be needed, as well as

reflecting the changes in the Regulation in the next guidelines, with the aim of publishing a revised

version before April 2018. A specific workshop on the implementation of the new Regulation may

also be organised before the end of the year (NOTE: the workshop will take place on 16th

November 2016 in Brussels).

ESF stated that member organisations are already asking many questions on the new Regulation,

with rumours and uncertainty spreading among stakeholders. Especially the transitional provisions

are raising doubts. A consolidated list of questions received by the industry will be sent to the

Commission. It may be useful to set up a restricted group working on a FAQ document, to be

submitted to the working group after being drafted.

The Chairperson stated an editorial group composed by volunteers reviewing the guidelines will

be set up. Interest in participating in this group should be indicated to Mr Costantini.

GERMANY mentioned that the transition period is actually shorter than two years, as preparatory

work (from design of new products to testing) is time-consuming and needs to start before the

Regulation becomes applicable.

The Chairperson invited to send to the Commission any questions, which will be included in the

agenda of the workshop.


5.1 EN 1621-4 “Motorcyclists’ inflatable protectors”(Docs. PPE-16-1-3, PPE 13-1-2)

The Chairperson recalled the issue and reminded that the two documents circulated present the

formal objection by France and the related comments by CEN-CENELEC Consultant.

CEN-CENELEC expressed the importance of having a decision on the listing of the standard to be

taken soon. The relevant CEN TC (162) has discussed the issue and came to the conclusion that the

concerns raised by France are not valid to justify the formal objection. It is not possible to say at

this stage whether the revision of the standard will address the issues raised in the formal objection.

It is also the opinion of the CEN-CENELEC Consultant that the concerns are not sufficient.

The Chairperson requested delegations to provide their opinion on the matter in order to reach a

conclusion in one of the next meetings.

FRANCE stated that the standard was published by CEN despite a number of significant objections

and gaps identified during the work of the TC. Disagreement with CEN-CENELEC Consultant's

comments was also expressed. The publication of the reference to this standard is still strongly

opposed by France.


The Chairperson stated that, since the issue has been in the agenda for many years, a request for

written contribution will be sent to the delegations. Delegations which do not send their position

within the set deadline will be considering as opposing the formal objection and supporting

publication of the reference to the standard in the Official Journal.

CEN-CENELEC underlined that the lack of reaction from other Member States is an indicator that

the issue is not relevant for the vast majority of them.

The Chairperson reminded the importance of close cooperation between CEN and Member States

authorities, besides and beyond the formal procedure for treating formal objection.

Action point: COMM: to send a request to written comments to Member States

authorities. MEMBER STATES: to send their written comments. Delegations who do not

express their opinion will be considered as rejecting the formal objection and endorsing

publication of reference to the standard in the Official Journal.


This point was not discussed as the WG member who submitted the document could not be

present.


COMM presented the proposal contained in PPE-16-1-7, which reflects the comments received by

delegations on the previous version of the document, PPE-15-2-6.

SWEDEN suggested removing the reference to "progressive lower limb disorder", as products

providing such protection should be considered medical devices instead.

COMM clarified that such insertion was requested after consulting native English speakers and the

situation indicated refers to an actual risk associated with repeated activities.

The UNITED KINGDOM stated that there are millions of "housemaid/carpet fitters knee" coming

from repetitive kneeling activities. This is the meaning of "progressive".

GERMANY compared the products with hearing protectors, therefore should be clearly considered

PPE. It suggested to remove the part starting with "including those protecting" in the first box, as it

may be misleading.

COMM mentioned an industry association expressed a concern that goes in the opposite direction,

i.e. to keep this part. Manufacturers do not see it as misleading. The document can be further

modified if necessary, however it is already the result of long discussions and comments; most of

the suggested changes were already included and taken away in previous versions of the documents

as they were not supported by the WG.

GERMANY stated that even in case of controlled falls a higher level of protection may be needed.

LITHUANIA supports the position of Germany as severe lesions could happen also in cases of

voluntary falls.

COMM mentioned that this clarification was included at the explicit request of some delegations,

and a much greater level of detail was requested in previous meetings. A balance needs to be found

between delegations who prefer a higher level of detail and those who prefer to have the market

surveillance authorities play a bigger role. It is also important to reflect in the guidelines the

products currently on the market.


FRANCE stated that "controlled fall" is a concept not apt for protective equipment, in a similar

fashion to the discussion on free fall devices.

CYPRUS expressed support for German position.

COMM expressed the need to ensure consistency between the level of detail provided for different

categories, i.e. a change in the first line will probably require a change in the second line too.

The Chairperson concluded that the point will be discussed at the next meeting.

Action point: COMM, to redraft and circulate a new version of the document.


The Chairperson reminded that the vast majority of delegations have not yet expressed their

opinion on the matter.

COMM summarised document PPE-15-2-10, which reflects the two different positions on the

matter.

The Chairperson stated that there is an increasing number of consumers engaging in high-risk

sport activities and it is important to keep pace with the market development and to ensure that the

products provide the necessary protection.

The UNITED KINGDOM stated that such products provide protection from hitting the ground

after a free fall, therefore they should be considered PPE.

LITHUANIA stated that it is not clear which is the hazard against which the equipment is

providing protection.

POLAND expressed that the equipment is not PPE as it is not protecting against any hazard. People

are seeking these risks.

COMM clarified that, if the equipment does not work properly, there can be very serious damages

to the user and therefore a hazard exists. It was also mentioned that there is a variety of products

protecting against searched-for risks and where the protection will be needed, e.g. diving suits.

FRANCE questioned that such products would not comply with the relevant basic requirements.

GERMANY stated that it is difficult to claim that such products are not PPE. Falling from a height

without such equipment would certainly result in very serious injuries. Products such as knee

protectors also provide protection against sought-after risks.

DENMARK stated that it should also be considered which legislation may cover such products in

case it is deemed not to be PPE.

FRANCE reminded that the General Product Safety legislation applies to products which are not

covered by specific legislation, therefore there should be no issue on this aspect.

The UNITED KINGDOM stated that some protection is needed while performing such activities,

and this equipment is providing that protection.

The Chairperson clarified that in such devices there is clearly a protective element, which may

need to be better defined, and stated that it is common to have PPE covering against sought-after

risks.


Action point: COMM, to develop the document taking into account today's discussion.

5.5 High-visibility products (Doc. PPE-15-1-28).

The Chairperson recalled that this is a long-standing issue.

ESF presented the document PPE-15-1-28 and stressed the importance of moving forward on this

matter, possibly building on the work already carried out by the ad-hoc group established a few

years ago and then discontinued.

The UNITED KINGDOM stated that it won't be able to take the lead on this issue as in the past.

FRANCE expressed the willingness to take the lead and organise meetings in France on this matter.

DENMARK stated that a Danish expert on this matter is not currently available but may be in the

near future.

SWEDEN expressed the likely interest of the Swedish consumer agency.

ESF expressed the appreciation for the interest shown by Member States and stated the interest of

the organisation in participating and, if necessary, to help with the logistics.

The Chairperson requested that delegations interested in taking the lead inform the Commission

shortly. (NOTE: a first meeting on this matter was organised in Paris in July).

Action point: MEMBER STATES, inform the Commission if they are interested in taking

the lead on this issue.

5.6 Cooling vests (Docs. PPE-15-1-30, PPE-15-2-9)

COMM recapped the issue and the products under discussion. Diverging opinions exist on whether

such products should be considered PPE category I or II.

SWEDEN supported the position that such products should be category I.

POLAND expressed the view that special categorisation for such equipment is not needed, as the

performance of the clothes should be the determining factor in deciding their category.

SWEDEN stated that such products may also have medical use and in this case should not be

considered PPE.

The Chairperson clarified that some products may be considered both PPE and medical devices. In

this case, the assessment performed shows that the protection provided is against environmental

conditions, falling in the scope of PPE Directive. Delegations were invited to send comments and

observations.

Action point: MEMBER STATES, send their comments and observations to the

Commission

5.7 Impact protection helmets for young children (Docs. PPE-15-2-18, PPE-16-1-10)

This point was not discussed as one of the WG members who submitted the document could not

be present.

5.8 Anti-slip footwear (Doc. PPE-16-1-5)


COMM informed the Working Group that this, the previous and the next point will be moved to the

next meeting as the Finnish delegation, which prepared the documents, could not be present at the

meeting.

The UNITED KINGDOM expressed the view that, if such products are an aid for outdoor walking

ensuring a good grip and/or stability, they should not be considered PPE. On the other hand, if the

manufacturer claims anti-slip properties such products should be considered PPE; however, the

outdoor activities should be some specific ones and not simply walking on the snow.

CYPRUS supports the UNITED KINGDOM position.

POLAND agrees with the position expressed by Finland as presented in the submitted document.

COMM reminded that the claims of the manufacturer are not a deciding factor on deciding whether

the product is a PPE or not.

FRANCE expressed support for the Commission's statement.

The UNITED KINGDOM stressed that it is important to see and understand which are the

intentions of the manufacturer when placing a product on the market. It is not clear which outdoor

activities are referred to in the document submitted by Finland.

5.9 Ropes to exit water after a fall through ice (Doc. PPE-16-1-6)

This point was not discussed, see above.

6. Standardisation


COMM expressed the intention of publishing the next list of harmonised standard in the Official

Journal before next meeting. (NOTE: the list was published in OJ C 332 of 09/09/2016).

The Chairperson informed that, in preparation for the Regulation, a new request for

standardisation will be prepared and circulated. In the Regulation there are, among others changes

in the scope and in the categorisation, which will need to be reflects in the request.


CEN-CENELEC presented the written report, circulated shortly before the meeting.

FRANCE stated the French interest to progress on the smart PPE area and asked which is CEN's

vision for the future in this sector.

CEN-CENELEC informed that a number of consultations were carried out among CEN and

CENELEC members. A market need is acknowledged, however currently the available technical

expertise is not sufficient to make meaningful progress in this area. This is a complex emerging

issue also at the international level, i.e. ISO and IEC.


CEN informed that the process of reviewing the standard has started and gave an overview of the

activities performed, also taking into account the work carried out at international level. The


standard is already at an advanced preparation stage. It was recalled that appropriate users'

instructions are an integral part of the PPE.

GERMANY welcomed the progress made in the revision of the standard but does not see the

possibility to withdraw the formal objection at this stage.

FRANCE expressed the position that the standard needs to be improved in some aspects and

welcomed the developments as outlined by CEN. Footwear with non-metallic inserts are requested

by the market for some activities.

CZECH REPUBLIC expressed disagreement to the formal objection.

DENMARK supports the formal objection.

UK supports addressing the concerns raised via the revision of the standard rather than a formal

objection.

POLAND expressed opposition to the formal objection, mainly on the basis that no accidents have

been reported due to the use of products tested according to the standard.

The Chairperson invited the delegations to express their position before next meeting. It was

recalled that a formal objection requires a significant amount of administrative work and a revision

of the standard may be the fastest way to address the concerns raised.

Action point: All, send their position to the Commission


jackets) (Docs. PPE-16-1-8, PPE-16-1-11, PPE-16-1-12, PPE-16-1-13, PPE-16-1-14, PPE-16-1-

5, PPE-16-1-16, PPE-16-1-17)

SWEDEN presented the background of the case, which was triggered by an accident on the

workplace and the subsequent investigation. A man fell into the water and the life jacket he was

wearing did not inflate. The gas cartridge loosened due to use of the jacket (body movements etc.)

and during the investigation it was found that several jackets had the cartridge loosened as well. It is

often the case that it is not possible to check the status of the gas cartridge during the use of the

jacket. There is no requirement in the standard to have the gas cartridge secured and to ensure that

the gas cartridge will fulfil its function during the use of the jacket. Technical solutions exist to

solve this issue but they are not included in the standard.

FRANCE stated that it is not clear whether the issue is related only to a certain product by a

specific manufacturer or a more general problem.

The NETHERLANDS agreed with FRANCE that is appears to be rather a design issue than a

standardisation one.

CEN-CENELEC informed that the documents received have been forwarded to the relevant

Technical Committee (TC), 162. As some of them were received very recently, it was not possible

to discuss them yet.

SWEDEN stated that the problem identified is common to several products on the market, not just

a particular one. Corrective actions to secure the gas cartridge were required to the Swedish

manufacturer involved in the specific case that triggered the formal objection. A warning also was

issued together with the Swedish consumers' agency.


The Chairperson clarified that this issue is relevant for this working group as it relates to the

design of protective equipment, however more information is needed on whether such issue affects

only a certain manufacturer or a whole category of products.

GERMANY stated that this aspect is covered by the obsolescence basic requirement, and therefore

it should be integrated in the standard.

DENMARK stated that market surveillance authorities should take actions against non-compliant

products, which do not function as intended.

The UNITED KINGDOM expressed the position that user's instruction would not solve the issue

as it would not guarantee safety of users.

The Chairperson asked delegations to submit their written comments on the issue before next

meeting, and clarified that it may also be discussed in the ADCO framework.

Action point: All, send their position to the Commission.

7. Notified Bodies


HCNB informed that there was no meeting of the HCNB since last meeting of the PPE WG. The

notified bodies will focus in the near future on how to prepare for the PPE Regulation, which will

involve several aspects, from notification according to the new Regulation to review of RfUs.


COMM reminded that there are several RfUs in the written procedure from VG3 and VG10.

(NOTE: the RfUs were endorsed by written procedure and published in the Europa website in

August).




8.1 Laboratory tests carried out as part of an EC quality control system (PPE-16-1-18) (this point

was discussed after point 3)

POLAND presented document PPE-16-1-18 and expressed concerns that the approach of some

Notified Bodies may make difficult for some companies, especially SMEs, to cope with the

associated burden.

GERMANY expressed support for the approach of Notified Bodies.

SWEDEN stated that a consistent approach needs to be put forward by Notified Bodies.

The Chairperson confirmed that a common position needs to be reached by the coordination of

Notified Bodies. It is important that all Notified Bodies act in a consistent manner.


HCNB expressed support for the Commission's stance.

The Chairperson concluded that the issue will be further discussed in the WG once a position by

HCNB is submitted.

8.2 Subcontracting and use of manufacturers' testing facilities (PPE-16-1-9)

CZECH REPUBLIC presented the document submitted and expressed reservations on the content

of RfU 00.123 in its current form. It is important to ensure a consistent approach among Member

States, as well as to guarantee independence in the activities of Notified Bodies.

HCNB stressed that accredited laboratory have to prove their independence.

FRANCE welcomed the points raised by Czech Republic and mentioned that practical guidelines

by the European Commission would be welcome in order to ensure consistency.

GERMANY informed that national guidelines exist on subcontracting, which differentiate between

"main" and "auxiliary" testing and which specify the requirements for the Notified Bodies in the

different situations.

The Chairperson reminded that the responsibility for notification lies with the Member States'

notifying authorities and a certain verification of the sub-contracted activities has to be in place. It

was also clarified that this is a general issue, not specific to the PPE sector. Delegations were

invited to submit their opinion on the issue. The point will remain open for next meeting.

Action point: All, send their opinion and available information to the Commission.



on 15th November 2016. The date of the meeting will be confirmed 6-8 weeks in advance.

End of the meeting



PPE 89/686/EEC AND (EU) 2016/425 WORKING GROUP



Group



COMM Participants: Mr Niccolò COSTANTINI (GROW/C3)


The Chairperson welcomed those present. He recalled the need for private stakeholders to register

in the transparency register in order to be allowed to participate in the working group. A new

member of the WG was introduced: a representative of ETUI, the European Trade Union Institute.


The Chairperson introduced the draft agenda and asked whether additional issues had to be

discussed.


3. Approval of the minutes of the latest meeting: 5th April 2016 (Doc. PPE-16-2-2)

The Chairperson presented the draft minutes of the latest PPE WG meeting held on 5th April 2016,

which were circulated shortly before the meeting.

The NETHERLANDS highlighted that points 5.2 and 5.7 were not discussed, and requested to

have it reflected in the minutes.

FRANCE reminded of having already expressed the position on Motorcyclists’ inflatable

protectors (point 5.1 of the agenda), and asked whether a note requesting written comments was

circulated.

COMM confirmed that such note was not circulated yet.

The UNITED KINGDOM requested a typing mistake in point 8.2 to be corrected.


Action point: COMM, to modify and to circulate the amended minutes for approval by

written procedure.

4. Preparation for the new PPE Regulation

The Chairperson reminded that a workshop was foreseen for the following day, 16th November

2016. The workshop will follow the chapter structure of the Regulation. He also informed that a

guidance document will be prepared by the Commission services and will be circulated to the

working group. The guidelines will also follow the structure of the Regulation and potential

controversial points will be discussed in the WG.

GERMANY requested whether a drafting group will be set up.

LITHUANIA asked whether the draft guidelines will be submitted to the working group or the PPE

Committee.

FESI expressed the same request of Germany on the possibility of having a drafting group.

The Chairperson clarified that the first draft will be prepared internally by the Commission

services and will be submitted to the working group. Smaller drafting groups can be later created on

an ad-hoc basis if the needs arise.



The Chairperson recalled the issue and reminded that the discussion has been ongoing for several

meetings, but an agreement could not be reached. In order to come to a conclusion, a note will be

sent to Member States asking for their positions. He stated that the Commission, after carefully

studying the issue and the different argumentations, is in favour of citing the standard in the OJEU.

He reminded that one of CEN PPE consultants has submitted a paper commenting the formal

objection raised by France; this document was circulated with number PPE-16-1-3. In the note

which will be circulated a proposal will be made to proceed with citation of the standard. A

deadline will be indicated in the note, and Member States who do not express their position will be

considered as supporting citation of the standard.

CEN reminded that the standard was submitted for citation back in 2013 and requested to come to a

final decision on the issue.

The Chairperson clarified it is necessary to know the positions of Member States before coming to

a conclusion, and this is not the case yet. He also explained that it is a right for Member States to

launch a formal objection, which then needs to be handled as required. Until the procedure is

closed, the standard will not be published. The importance to follow and abide by the law was also

reminded.

FRANCE reminded that reservations on the standard were expressed during its drafting, which

were not taken into account in the final version of the standard.

Action point: COMM: to send a note requesting written comments to Member States



express their opinion will be considered as rejecting the formal objection and endorsing

publication of reference to the standard in the Official Journal.


The WG participant who submitted the document could not be present.

The Chairperson recalled the issue and mentioned that it may become obsolete once the new PPE

Regulation becomes applicable.

FRANCE expressed that motorcyclists are exposed to a combination of risks, including abrasion

and shock/impact. All potential risks that may arise in a specific context or in the course of a

specific activity should be covered by a PPE.

The Chairperson clarified that the questions raised in the document are different and that points

related to the new Regulation should be discussed separately.

This point is closed.


The Chairperson explained that, after long and extensive discussions and after several compromise

documents prepared by the Commission, it was not possible to reach a consensus. Therefore, this

issue will be made dormant until new elements arise that may pave the way for a consensus.

Currently, there aren't the conditions to reach a consensus.

This point is momentarily closed and will not be in the agenda of the next meeting.


The Chairperson explained that the situation here is the same as for knee protectors, see point 5.3.


5.5 Cooling vests (Doc. PPE-15-2-9).

The Chairperson explained that the situation here is the same as for knee protectors and free fall

devices, see points 5.3 and 5.4. At this point in time, for all three issues the positions of Member

States are too distant to reach to a compromise solution that can be endorsed by all.


5.6 Impact protection helmets for young children (Docs. PPE-15-2-18, PPE-16-1-10, PPE-16-2-

8)

FINLAND introduced the issue and presented document PPE-15-2-18.

FESI summarised the position of the organisation as described in document PPE-16-1-10.

SWEDEN presented document PPE-16-2-8 where its position is reflected.

The NETHERLANDS reminded that the manufacturer should take into account, when carrying out

a risk analysis, not only the intended use but also the foreseeable use of the product. It was also

highlighted that statements such as "the product does not pose any danger to the consumer" (PPE-

16-1-10) can be quite misleading as such products should protect the users from hazards, not just

avoiding the insurgence of additional hazards. Some accidents happen also to children elder than 7


years old. The responsibility of manufacturing products in compliance with the BHSR of PPE

Directive remains with the manufacturer.

The UNITED KINGDOM stated that the scope of standard EN 1080 needs to be clarified.

The NETHERLANDS clarified that what is not clear is how to verify the compliance of Play

Helmets with the BHSR of the Directive. The horizontal coordination of Notified Bodies (HCNB)

may be the right format to clarify the issue.

The Chairperson invited other participants to express their opinion; on the basis of the feedback

received, it will be assessed whether to continue the discussion on the issue in the working group.

Action point: MEMBER STATES, send their comments and observations to the

Commission.


FINLAND presented the case as summarised in PPE-16-1-5, giving some concrete examples.

POLAND expressed the position that such detachable accessories should be considered PPE

category II.

FRANCE highlighted that BHSR 3.1.2.1 "prevention of falls due to slipping" explicitly refers to

"added elements", and therefore such accessories should be regarded as PPE.

SWEDEN stated that "better grip" and "prevention of falls" are two separate issues, and shoes

simply ensuring better grip should not be considered PPE. A case-by-case analysis, also taking into

account the use of the shoes, may be necessary.

AUSTRIA reminded a previous similar request related to products to be inserted into shoes to

prevent falling and slipping in icy and snowy surfaces. At the time the decision was that such

products are PPE category II. [NOTE: see point 4.6 of the minutes of the 24 October 2012 meeting

on snow- and ice-spikes]

The Chairperson invited other participants to express their opinion.


authorities. MEMBER STATES: to send their written comments.

5.8 Ropes to exit water after a fall through ice (Doc. PPE-16-1-6)

FINLAND introduced the issue by presenting document PPE-16-1-6. It is asked whether such

ropes should be considered PPE or rescue equipment, which is the opinion of Finland.

The NETHERLANDS agrees with Finland that such products should be considered rescue

equipment.

GERMANY supports Finland and the Netherlands.

IRELAND stated that similar situations exist during kayaking activities, all year round. Such

products should be categorised as rescue equipment.

POLAND agreed with the other delegations who expressed their opinion.

The UNITED KINGDOM too expressed the agreement.


FRANCE stated that it should be investigated why a 1998 Q&A document listed ropes […] used to

get out of the water after falling through ice as PPE category II. A possible reason is that such ropes

were considered to be secured to an anchorage point.

The Chairperson stated that the ropes indicated in PPE-16-1-6 should be considered as rescue

equipment and not PPE.



express their opinion will be considered as supporting the interpretation that such ropes

are not PPE.

5.9 Laboratory tests carried out as part of an EC quality control system (Doc. PPE-16-1-18)

POLAND recalled the issue as presented in PPE-16-1-8. The number of parameters to be tested and

the frequency of such tests would have significant financial implications.

The NETHERLANDS invited the HCNB to give their opinion on the issue, in order to be assessed

by the WG.

HCNB stated that PPE-16-1-8 was discussed in the advisory panel and the positions expressed in

the document can be supported by HCNB.

GERMANY stated that individual aspects cannot just be removed as such from the evaluation of

conformity.

The UNITED KINGDOM supported the position of Germany.

POLAND expressed the opinion that Notified Bodies have the possibility to decide which aspects

have to be checked.

The Chairperson clarified that Notified Bodies are responsible to carry out their activities as

required, and authorities have the responsibility to ensure that only compliant and safe products are

made available on the market. This issue could be subject of a RfU, which can then be assessed by

the working group. The HCNB was invited to discuss this issue and present a proposal to the

working group.

5.10 Subcontracting and use of manufacturers' testing facilities (Docs. PPE-16-1-9, RfU-

00.123/7)

The CZECH REPUBLIC introduced the questions raised in PPE-16-1-19.

The Chairperson clarified that, in case of subcontracting, the obligations of the subcontracting

entity are the same of the Notified Body, including the obligation of independence. Subcontracting

tests to a manufacturer's laboratory would not be in compliance with the independence criterion.

Subcontracting activities need to be closely looked at from Notifying Authorities in order to ensure

the obligations are respected.

The UNITED KINGDOM asked whether using the laboratories of another manufacturer would

also imply a non-compliance with the independence criterion.

HCNB highlighted that accredited laboratories has independence as a pre-requisite, therefore

accredited laboratories are independent by definition.


ITALY stated that, in case of subcontracting, the Notified Body maintains responsibility for all the

activities and operations of the subcontracting body. The issue should be investigated in greater

detail.

POLAND agreed that the Notified Body should have a supervising and control role when

subcontracting activities.

The NETHERLANDS reminded that subcontracting is part of the accreditation standard; when a

Notified Body is accredited, it has to take provisions for subcontracting. Article 26 of the new PPE

Regulation 2016/425 also regulates subcontracting. The combined provisions of the standard and of

the Regulation set the conditions for subcontracting activities while respecting independence.

The Chairperson reminded that notification and control of the activities of Notified Bodies are

responsibility of Member States notifying authority. It is not considered necessary to continue the

discussion on this matter.

This point is closed.

5.12 PPE Directive guidelines – beekeepers (Docs. PPE-16-1-20, PPE-16-2-9)

FRANCE introduced the point, related to a request for corrections in the PPE guidelines. The

request stems from a market surveillance issue.

The NETHERLANDS asked which are the relevant BHSR/EHSR for beekeepers equipment. The

garments protect beekeepers against biological agents, which according to the new PPE Regulation

would make them PPE category III.

FRANCE expressed the position that the protection is against the stings (a physical hazard) and not

against biological agents. Beekeepers equipment should be PPE category II according to the

Regulation.

The UNITED KINGDOM stated that such garments are advertised as offering protection from bee

stings, i.e. there is a claim for protection; therefore, they are marketed as PPE. Also the foreseeable

uses should be taken into account: are they used to be protected from bee stings or to avoid getting

dirty? In case such garments are PPE, they should be category II.

IRELAND reminded that very serious consequences can arise from bee stings, such as anaphylactic

shock. It should be assessed whether such garments are to be classified as category II or III.

GERMANY recalled that the guidelines should be modified to reflect the consensus reached back

in 2014, i.e. that all beekeepers garments have to be considered PPE.

AUSTRIA supported France and Germany.

The Chairperson concluded that the guidelines will be amended as proposed by France.

FRANCE reminded that there are two other points raised in the document submitted.



express their opinion will be considered as supporting the changes in the PPE guidelines

proposed in PPE-16-1-20.

5.13 Smart PPE for firefighters (Doc. PPE-16-2-6)


GERMANY introduced the outcome of a workshop on smart PPE for firefighters which took place

in June 2016. He also recalled the recent standardisation request on "smart garments" for protection

against heat and flame issued by the European Commission. Simplicity and user-friendliness, as

well as clear information on the limitations of smart PPE, are indicated as crucial elements in

ensuring uptake and acceptance of such products, as well as appropriate use which actually increase

safety.

The Chairperson thanked Germany for the presentation and stated that many questions arise from

this topic, which will need to be tackled separately.

CEN sector forum representative informed that the standardisation request has been received.

[NOTE: the mandate was adopted on 06/01/2017]

FRANCE stated that this subject should be discussed more in detail, possibly in a dedicated follow-

up group.

The NETHERLANDS mentioned that firefighters' garments need to be washed after use; this is an

obligation in The Netherlands. With smart PPE, potentially including electronic components, this

aspect should also be taken into account.

The Chairperson concluded that a dedicated discussion will take place in one of next WG

meetings. Contribution from members of the WG is welcome. He reminded the importance of

keeping a safety-centred perspective in the discussion, as these products are PPE and should

provide increased safety compared to a "standard" PPE. In perspective, smart PPE are expected to

expand their scope beyond firefighters' protection and beyond garment products.

6. Standardisation


The Chairperson reminded that the last publication of harmonised standards in the Official Journal

took place in September 2016.


CEN gave an update on the latest standardisation activities in the PPE sector. An overview of the

organisation and its internal structure (technical committees, working groups etc.) was also

provided. An analysis of the standards which need to be amended to reflect the changes of the new

PPE Regulation is currently ongoing, and the draft standardisation request is being reviewed by

affected sectors.

The UNITED KINGDOM requested the status of the revision of standard EN 1384 on equestrian

helmets, and reminded that the EN 1384:2012 was withdrawn from the Official Journal in 2014.

The option of renumbering the new standard (versus just changing the year) should also be

investigate, in order to avoid confusion among economic operators and users.

The Chairperson invited CEN to take note of the requests and proposals from the UK.

CEN claimed that it is the relevant technical committee which decides on whether to change the

number of a standard. Keeping the same number and changing the year is a long-standing practice.

The new version of the standard is already at an advanced preparation stage and therefore changes,

albeit limited, may not be possible without delaying the process.


IRELAND reminded that there have been previous cases in the PPE sector where the standard was

withdrawn from the Official Journal, and where the updated version of the standard kept the

original numbering. Information and communication to stakeholders should be the right strategy.

6.3 Formal objection by Germany against EN ISO 20344:2011 (Doc. PPE-16-2-5)

CEN informed that work is ongoing on the revision of the standard, which has now reached the

final stages (public enquiry). The amended standard is expected to address the concerns raised by

Germany in the formal objection.

GERMANY welcomed the progress made in the revision of the standard but does not see the

possibility to withdraw the formal objection at this stage, as some shortcomings still appear to

remain in the revised standard.

The Chairperson reminded that the opinion of the WG, in particular from Member States, is

required before submitting the file to the Committee on Standardisation. Delegations were invited to

express their position before next meeting. Written comments on remaining shortcomings in the

revised standard are also very welcome, in order to avoid the risk of having a formal objection also

on the revised standard.

DENMARK reminded that some Member States already expressed their position, and Denmark is

in favour of the formal objection.

The UNITED KINGDOM asked if the revised draft standard can be made accessible to Member

States.

CEN expressed disagreement that the voting on the existing formal objection is somehow linked to

the revision of the standard.

The Chairperson clarified that one of the reasons why the formal objection is still being discussed

is that the revised standard is still being considered as having some shortcomings. If such

shortcomings are not addressed before the standard is published, the risk of another formal

objection is quite significant. The current discussion's goal is to find a solution via a cooperative

approach. It was reminded that the Commission has always been ready to cooperate with ESOs

(CEN/CENELEC/ETSI) from an early stage in the standard preparation, in order to address and

when possible solve potential conflicting issues.



express their opinion will be considered as not supporting the formal objection.


jackets) (Docs. PPE-16-1-8, PPE-16-1-16, PPE-16-2-3, PPE-16-2-4, PPE-16-2-7)

SWEDEN summarised the background of the case, which was triggered by an accident on the

workplace and the subsequent investigation. The consumers' perspective on the issue, as described

in PPE-16-2-7, was also presented.

CEN stated that all BHSRs that form the basis for the formal objection are either already covered

by the current standard or not relevant. The clauses on instructions are a central part of this

standard. Revision of the standard is currently ongoing. Concrete proposals on how to address the

shortcomings were not submitted to the relevant technical committee.

NORWAY expressed support for the formal objection. In 2016, a market surveillance action took

place in Norway on inflatable life jacket; a negative outcome identified was the high frequency of


detachment of the gas cylinder during rotating shock tests. In several cases, the gas cylinder came

completely loose.

DENMARK expressed support for the formal objection.

FRANCE stated that this is not a standard-related issue, rather of market surveillance and safeguard

clauses. It was reminded that no such products were so far withdrawn from the market.

SWEDEN explained that voluntary corrective actions were taken by Swedish manufacturers in

order to avoid detachment of the cartridge.

IRELAND highlighted that these are complex PPE initially reserved for workplace uses, which are

now increasingly used by consumers lacking the necessary knowledge.

CEN invited participants to familiarise with PPE-16-2-4, where the position of CEN is explained.

The Chairperson asked delegations to submit their written comments on the issue before next

meeting. It was reminded that the rationale of the formal objection is described in PPE-16-1-8.



express their opinion will be considered as supporting the formal objection.

7. Notified Bodies


HCNB expressed that the transition period to the new PPE Regulation is currently a very important

topic for Notified Bodies. It was also reminded that a significant work is needed to update RfUs to

make them suitable to the new legal framework.

The Chairperson reminded the importance of re-notify Notify Bodies, which is possible since

October 2016. This will facilitate the transition to the Regulation, especially in the recertification of

products.

7.2 Recommendations for Use Sheets (RfUs) (Docs. RfU 00.148/0, RfU 00.149/0)

There were no interventions on this topic. As the RfUs were circulated too close to the meeting,

they will be submitted to written consultation.




The Chairperson informed participants that this is going to be the last working group before

retirement, and thanked all the members of the working group for their cooperation throughout

these years.




on 14th March 2017. The date of the meeting will be confirmed 6-8 weeks in advance.

End of the meeting




MINUTES OF THE MEETING HELD IN BRUSSELS, 14 MARCH 2017


Group


Chairperson: Ms Birgit WEIDEL (COMM GROW/C3)

COMM Participants: Mr Niccolò COSTANTINI (GROW/C3)



2. Approval of the draft Agenda (Doc. PPE-17-1-1)

The Chairperson introduced the draft Agenda and asked whether additional issues had to be

discussed.

FRANCE asked to introduce a point on high-visibility jackets.

The draft Agenda was approved with the changes suggested.

3. Approval of the minutes of the latest meeting: 15th November 2016 (Doc. PPE-17-1-2)

The Chairperson informed that, as it was not possible to circulate the minutes before the meeting,

they will be circulated for approval via written procedure. [NOTE: the minutes were circulated on

4th of April and were approved by written procedure]

Action point: COMM, to modify and to circulate the amended minutes for approval by

written procedure.

4. Preparation for the new PPE Regulation (EU) 2016/425

COMM recalled the main phases of the process and of the transition between Directive

89/686/EEC and Regulation (EU) 2016/425.


The Chairperson reminded that some provisions of the Regulation are already applicable, namely

those on the Committee procedure and on the notification of conformity assessment bodies. It was

also clarified that notified bodies can already start to issue certificates under the Regulation.

FESI requested information on the timing of the guidance documents and on the publication of

harmonised standards providing presumption of conformity with the requirements of the

Regulation.

The Chairperson stated that the target is to have a list of harmonised standards before the

Regulation becomes fully applicable. The requirement to have a new standardisation request was

also recalled. The point will be discussed more in detail under point 6 of the agenda. [NOTE: the

FAQ document was published on EUROPA website on 20/03/2017] It was also clarified that the

transition foreseen in article 47 (2) of Regulation (EU) 2016/425 refers only to certificates and

approval decisions. As from 21 April 2019, every single PPE which is placed on the market has to

be in compliance with the requirements of the Regulation. An analysis of whether the products are

in compliance with the requirements of the Regulation should therefore be undertaken by the

relevant economic operators.

ESF informed that they are preparing their own guidance (flowchart) for internal purposes and this

document will be shared with the members of the WG.

COMM reminded of some possible indicators which may indicate the need to prioritize the analysis

of the product to check its compliance with the requirements of the Regulation, such as the change

of category of the product or an old EC certificate (e.g. referring to an outdated version of the

standard).

SME-safety stressed that for the vast majority of products the changes would be only in the

documentation and requested an approach which is not too burdensome for companies, especially

SMEs. A single Declaration of Conformity (DoC) allowing reference to both the Directive and

Regulation would be a possible solution.

The Chairperson reminded that this solution was used in the past for changes in the legislation

when no transition period was foreseen.

FRANCE requested how this would apply to EC and EU certificates.

The Chairperson clarified that the point was on the Declaration of Conformity, which is a separate

issue from EC and EU certificates. It is important to keep these two issues separated.


5.1 EN 1621-4 “Motorcyclists’ inflatable protectors” (Doc. PPE-17-1-3)

COMM recalled the issue. A formal objection against the standard was raised in 2013 against this

standard and, given the diverging opinions on the issue, the standard has not yet been published. A

message was sent by the Commission asking the Member States to express their positions on the

matter, which are reflected in Doc. PPE-17-1-3.

FRANCE recalled the rationale behind the formal objection.

CCMC reminded that the standard has been proposed in 2013 and more than 3 years have passed

without a decision. Listing the standard would also help different actors to gain knowledge on the

standard and potential room for improvement.


The Chairperson concluded that an extensive discussion already took place and it will not be

restarted during the meeting. The Commission will prepare a proposal to publish the reference of

the standard on the OJEU, and submit it to the Standardisation Committee.

Action point: COMM, to prepare a proposal to publish the reference of the standard on

the OJEU, and submit it to the Standardisation Committee.

5.2 Impact protection helmets for young children (Docs. PPE-15-2-18, PPE-16-1-10, PPE-16-2-

8)

The Chairperson recalled the issue, which is related to a special kind of helmet and the

applicability of the harmonised standard EN 1080:2013.

COMM highlighted that a consensus is still not within reach and therefore a common interpretation

cannot be put forward. A message requesting Member States to send their opinion will be sent

before next meeting, treating the issue in a similar manner to previous point.

Action point: COMM, to send a note requesting written positions to Member States

authorities. MEMBER STATES, to send their written positions.


The Chairperson reminded the main point of the discussion, which is whether such products fall

under the scope of PPE Directive. A document was circulated (ref. PPE-16-1-5) but no comments

were received.

Action point: COMM, to send a note requesting written positions to Member States

authorities. MEMBER STATES, to send their written positions.

5.4 Ropes to exit water after a fall through ice - Conclusions (Doc. PPE-17-1-4)

COMM presented the results of the discussions and consultations as reported in Doc. PPE-17-1-4.

A consistent view is that these products are not PPE. An entry in the PPE Guidelines is suggested to

reflect the consensus on this matter.

Action point: COMM, to amend the PPE Guidelines as indicated in Doc. PPE-17-1-4.

5.5 PPE Directive Guidelines - Conclusions (Docs. PPE-17-1-5, PPE-17-1-6)

The Chairperson explained that three requests were tabled to make some changes in the PPE

Guidelines regarding the following products: protective garments for motorcyclists incorporating

protectors, anti-avalanche airbags and beekeeper garments.

On protective garments for motorcyclists incorporating protectors, diverging opinions exist.

ACEM expressed its position that the Guidelines should not be modified. Manufacturers of

garments and manufacturers of removable protectors are often different.

FRANCE reminded the background of the case, as presented in Doc. PPE-16-1-20. The case was

already discussed in the WG in 2012. The Guidelines could incorporate some provisions on this

matter which are present in the text of Regulation (EU) 2016/425.

SWEDEN expressed concerns that making this insertion in the Guidelines without any further

clarification may cause confusion among economic operators.


COMM summarised that a different wording may help reducing the confusion.

FRANCE expressed openness to modify its proposal and to submit it to the WG, and reminded that

the goal is to avoid having the protectors marked as PPE inserted in garments which are not

considered PPE.

SWEDEN shared the concerns raised by FRANCE and expressed supports for the goal aimed at.

The Chairperson suggested that FRANCE and SWEDEN coordinate bilaterally on an alternative

wording. The Commission is ready to provide support when needed.

Action point: FRANCE and SWEDEN: to present a modified proposal.

On anti-avalanche airbags, the proposal suggested to insert explicitly these products as PPE

category II.

COMM presented the result of the consultation with Member States; it appears that a consensus

exist that such products are indeed PPE category II and therefore it is proposed to amend the

Guidelines as suggested.

The Chairperson concluded that the point can be closed and the Guidelines modified accordingly.

Action point: COMM, to amend the PPE Guidelines as indicated in Doc. PPE-17-1-5.

On beekeeper garments, the main contentious point is how to differentiate between protective

beekeepers garments and garments which are only "protecting" against dirt (e.g. trousers).

Protective garments should be considered PPE, at the same time normal clothes are excluded from

the scope of PPE Directive.

COMM presented the results of the consultation with Member States and put forward a proposed

compromise solution, presented in Doc. PPE-17-1-5.

FRANCE referred to Doc. PPE-16-1-20 and to the minutes of the PPE WG of 08/04/2014, where it

is stated that all beekeeper equipment should be considered PPE. Garments not providing protection

against bee stings should not be called nor considered beekeeper garments, and the suggested

compromise solution may cause confusion.

COMM reminded that a document (ref. PPE-16-2-9) was circulated, where real-life examples of

beekeeper garments not providing protection from stings were listed. From the consultation, it

appears clear that there is no consensus on the original proposal. It was also reminded that the value

of the Guidelines is based mainly on a common understanding by the experts' community, as they

are not a legal text.

UNITED KINGDOM highlighted that beekeeper garments such as overalls are always white as

bees are not attracted by that colour. They will be beekeeper-specific and not providing specific

protection.

FRANCE stated that a decision on the matter was already been taken in 2014. The choice of white

colour also has a protective feature.

COMM highlighted that also alternative formulations have to be accepted by all Member States,

and the vast majority of them supports the compromise solution presented by the Commission in

Doc. PPE-17-1-5.

The Chairperson concluded that a solution cannot be found and the point will remain open.


Action point: COMM, to prepare an alternative proposal and submit it to the WG.

5.6 Formal objection by Germany against EN ISO 20344:2011 (Test methods for footwear) -

Conclusions (Doc. PPE-17-1-7)

COMM introduced the issue and recalled that discussions have been ongoing for some time. A

message was sent by the Commission asking the Member States to express their positions on the

matter, which are reflected in Doc. PPE-17-1-7.

FRANCE explained that, while they are abstaining, they support a number of comments made by

Germany on how the standard may be improved.

COMM clarified that the two aspects, the formal objection and the revision of the standard, are

related.

CCMC gave an update on the ongoing revision work.

COMM summarised that, given a vast majority of Member States opposing the formal objection, it

will prepare a proposal along these lines, to maintain the reference of the standard on the OJEU, and

submit it to the Standardisation Committee.

Action point: COMM, to prepare a proposal to maintain the reference of the standard on

the OJEU, and submit it to the Standardisation Committee.

5.7 Formal objection by Sweden against EN ISO 12402:2006 parts 2 ,3 and 4 (inflatable life

jackets) - Conclusions (Doc. PPE-17-1-8)

COMM presented the case, related to accidents involving a detachment of the cartridge from the

jacket. A message was sent by the Commission asking the Member States to express their positions

on the matter, which are reflected in Doc. PPE-17-1-8.

ITALY expressed the opinion that it would be disproportionate and counterproductive to withdraw

the standard. The problems identified are more related with a misuse of the product rather than with

shortcomings in the design and construction of the product.

NORWAY informed that a market surveillance initiative was conducted in 2016 and summarised

the main results of the initiative.

FRANCE expressed the view that the formal objection would not be helpful at this stage as

significant improvements are present in the new version of the standard.

SWEDEN expressed appreciation for the progress made at standardisation level. However, the

process to have a new version of the standard published in the OJEU could still take several months

or even years, and in this period the existing standard would continue to give presumption of

conformity to jackets which may present a fatal risk to users. The current version of the standard

has some serious deficiencies and should therefore be withdrawn from the OJEU.

UNITED KINGDOM stated that it needs more time in order to take a final position on the issue.

GERMANY also expressed the view that more information is needed in order to have a complete

picture.

IRELAND questioned whether the full standard should be withdrawn or only some clauses.


The Chairperson highlighted two important aspects: whether the failing products were

manufactured in accordance to the harmonised standard, and the fact that possible consequences of

a malfunctioning of the jacket could be fatal.

CEN-CENELEC expressed the opposition to the formal objection and to the rationale behind it.

COMM highlighted that some Member States expressed the need to have more time to reflect on

the issue.

NORWAY expressed that, in the current situation, when accidents happen it is possible to take

action against the employer but not against the manufacturer of the products.

The Chairperson reminded that it is always possible to take market surveillance actions against

products not in compliance with the basic requirements.

SWEDEN pointed out that the accident that triggered happened on a nearly new jacket, with an

inflating device manufactured by a leading company and used in several different jackets from

different major jacket brands.

HCNB informed that the notified bodies are preparing a RfU on the matter.

The Chairperson concluded that more time will be given to Member States to analyse the case and

express their opinion

Action point: MEMBER STATES, to express their opinion.

5.8 Ergo- and Exo-Skeletons (Docs. PPE-17-1-9, PPE-17-1-13)

COMM introduced the point and explained that it is a new issue, discussed for the first time in the

WG. The point was included in the agenda upon request from manufacturers producing such

products, who would like to know whether such products are PPE or not.

ESF stated that such products are very wide in function and therefore a general conclusion for every

product marketed is difficult to draw. In principle, ESF is in favour of considering the products

described in Doc. PPE-17-1-9 as PPE.

GERMANY expressed the opinion that such products are not PPE. In one of the products described

there is an indicator of a hazard, similarly to what an air monitoring/gas detector device could give

(such products are not PPE), but the product itself does not provide any prevention or protection

against the hazard. Additionally, the force acting in the human body is lowered and shifted by the

device but it is not reduced, and this shifting may cause damage to other parts of the body.

FRANCE agreed with Germany and said the terminology used is confusing. The terms used cover

a very broad range of products and a case-by-case analysis is needed. The product described

relocates the effort but does not provide protection and therefore should not be considered PPE.

POLAND is the opinion that the product described in Doc. PPE-17-1-9 is a PPE.

NETHERLANDS supported the position of FRANCE and GERMANY: the product should not be

considered PPE as it can increase the burden on other parts of the body.

CZECH REPUBLIC agreed on the position of FRANCE, GERMANY and NETHERLANDS.

SPAIN informed that it had consulted manufacturers and came to the conclusion that such products

are not PPE.


IRELAND observed that transferring the load from a part of the body (e.g. the spine) to other,

stronger parts (e.g. the legs) does offer some protection and therefore an equipment ensuring this

load transfer could be considered PPE.

COMM summarised the discussion and concluded that diverging opinions exist. It proposed to

circulate a document and request Member States to express their opinion.

Action point: COMM, to send a note requesting written comments to Member States

authorities. MEMBER STATES, to send their written comments.

5.9 Air Buddy (Doc. PPE-17-1-10)

COMM introduced the issue, raised by an Australian manufacturer which asked if the product

described has to be considered PPE.

GERMANY stated that a discussion on similar products took place at national level among market

surveillance authorities and the conclusion was that such products are PPE.

POLAND informed that it consulted two groups of stakeholders: divers and testers of diving

equipment, receiving contrasting opinions. The Polish assessment is that only some parts of the

product are to be considered PPE.

NORWAY expressed the position that the product is not PPE since it is not worn nor held by the

user and extra equipment is required in order to use it.

DENMARK stated it needs more time to provide its assessment.

COMM observed that a consistent opinion appears to emerge towards considering such products as

not being PPE, however additional time to reflect and comment seems necessary.

The Chairperson concluded that a note will be circulated, similarly to previous points. The

complexity of the equipment described, where other legislation may also be applicable (e.g.

Pressure Equipment Directive 2014/68/EU, Marine Equipment Directive 2014/90/EU), was also

highlighted.

Action point: COMM, to send a note requesting written comments to Member States

authorities. MEMBER STATES, to send their written comments.

6. Standardisation


COMM reminded that the last publication of harmonised standards in the Official Journal took

place at the end of 2016 and a new publication is expected in the next few weeks. [NOTE: the list

of standard was published in the OJEU on 12/04/2017] The assessment of standards is still made

under the Directive standard and against its basic health and safety requirements.

6.2 Report by CEN Secretariat (Docs. PPE-17-1-11, PPE-17-1-12)

CEN-CENELEC gave an update on the latest standardisation developments in the PPE sector. An

overview of the main CEN/TC involved in the preparation of standards in the PPE sector was

presented. The transformation of the sector forum as CEN-CENELEC PPE Sector Forum was

introduced and explained. The current and expected PPE-related standardisation mandates were


listed, and the updated approval procedure (enquiry and formal vote) for new or revised standards

was also presented.

NETHERLANDS requested clarification on standards for high visibility clothing.

CEN requested the question in writing in order to provide an adequate answer.

COMM updated on the standardisation request and informed that, due to recent court judgments,

some elements of the request may need to be changed. It was reminded that constant ongoing

communication is going on with CCMC and ESOs and that the essential health and safety

requirements of Regulation (EU) 2016/425 are already well-known by all stakeholders.

7. Notified bodies


COMM introduced the point by informing that a set of RfUs were recently approved via written

procedure and the related list of RfUs was updated on EUROPA website.

HCNB informed that some RfUs are still open for comments. The preparation for the application of

the new Regulation is being carried out by notified bodies and by the Coordination. Among other

aspects, a new layout for RfUs was put forward.

The Chairperson reminded the importance of re-notify notify bodies, which is possible since

October 2016. This will facilitate the transition to the Regulation, especially in the recertification of

products.

7.2 Recommendations for Use Sheets (RfUs) (Doc. PPE-17-1-14 (HCNB))

This point was covered by HCNB intervention under 7.1.

7.3 Lists of notified bodies in NANDO and in CIRCABC

HCNB informed that a number of requests from notified bodies to receive notification under

Regulation (EU) 2016/425 were submitted, however the number of notified bodies already certified

under Regulation (EU) 2016/425 is still very limited.


COMM introduced the request by FRANCE to have a discussion on high-visibility jackets.

FRANCE stated that it was decided to have an ad-hoc group on such products and requested the

Commission to launch a call for candidates.

COMM reminded that an ad-hoc group on this topic was already established and was discontinued.

When the plan to re-activate such group was suggested, the Commission expressed the opinion that

such group would be more efficient and effective if it is chaired by an authority from a Member

State. The group would need to be based on voluntary contributions. When the group was first

established, it was created as a sub-group of the PPE WG.


The Chairperson clarified that the term "experts' group" should be used with caution as

establishing such group implies a series of administrative requirements, including involving the

general public.



on 8 November 2017. The date of the meeting will be confirmed 6-8 weeks in advance.

End of the meeting





Subject: Working Group under the Personal Protective Equipment (PPE) Directive

89/686/EEC and Regulation (EU) 2016/425


Chairperson: Ms Birgit WEIDEL (COM GROW/C3)

COM participants: Mr Mario GABRIELLI COSSELLU, Ms Isabel Maria LOPES GUERRA,

Ms Elzbieta PAPRZYCKA-JUNG, Ms Ann Sofie LINDGREN KERO, Ms

Magdalena MODER (GROW/C3)

1. Welcome by the Chairperson and information on the current sectorial issues

The Chairperson welcomed those present and explained the circumstances of the meeting, with the

specific difficulties to find a suitable date and the usual interpretation services. Finally, despite all

the efforts made by the COM sectoral services, the only opportunity to hold the second meeting of

the PPE Working Group in the last quarter of the year was on 6 November but with no

interpretation services. COM apologised for that and reconfirmed the compromise to provide for the

best conditions possible to ensure the wider participation of all the members. At that respect,

FRANCE sent a note regretting the lack of interpretation services in French, which made

impossible for the French delegation to attend the meeting.

The Chairperson also informed on the current sectoral issues in COM: the former Policy Officer in

charge of PPE, Mr Costantini, temporally left the Commission services and was replaced by Mr

Gabrielli Cossellu, with the legal and administrative support of Ms Lopes Guerra and Ms

Paprzycka-Jung; also, Ms Lindgren Kero, as "National Expert in Professional Training" from

Sweden, joined the team during five months, from October 2017 until March 2018, to contribute to

the work on the sectoral files.

2. Approval of the draft Agenda (Doc. PPE-17-2-1 rev.3)

The Chairperson introduced the draft Agenda of the meeting, with a specific item devoted to the

transition to the new PPE Regulation.

FESI asked to take into account the question on reflective garments within the point on the new

PPE Guidelines, to reach uniform interpretation of the provisions of the new Regulation.

With no further comments, the draft Agenda was approved.


3. Approval of the draft Minutes of the last meeting held on 14 March 2017 (Doc. PPE-17-2-2

rev.1)

The Chairperson introduced the draft Minutes of the latest meeting of the PPE WG held on 14

March 2017, in a revised version after some corrections and improvements from the first version

circulated right after the meeting. When approved, the minutes will be inserted into the consolidated

document in the sectoral website.

Action point: COM, to insert the approved minutes into the consolidated "Minutes of the

PPE Working Group meetings from 2002 onwards" in the Commission's sectoral website.

4. Transition to the new PPE Regulation (EU) 2016/425:

4.1. Implementation of Article 47 on transitional provisions (Doc. PPE-17-2-9)

The Chairperson introduced the draft proposal from COM for implementation of Article 47 of the

PPE Regulation on transitional provisions. After some preliminary considerations on the new

legislation to become applicable on 21 April 2018 and the transitional provisions laid down in

Article 47, the general rule on validity of EC type-examination certificates and approval decisions

issued under the PPE Directive until 21 April 2023 is confirmed, but this would not be applicable in

some specific cases: changes in essential requirements, in the product or in the state of the art

reflected by harmonised European standards. This approach would allow the use of EC type-

certificates to support compliance with the PPE Regulation with some conditions, to prevent

potential health and safety issues related to the mentioned changes.

NETHERLANDS and LITHUANIA asked for clarification on the possibility to issue EC type-

examination certificates after 21 April 2018, as the Directive would be then derogated, and on the

"general rule" as expressed in the last part of the document.

The Chairperson explained that these transitional provisions, allowing placing on the market of

products under the PPE Directive until 20 April 2019, had been established to facilitate the

implementation of the new regime for Member States and economic operators. In this sense, there is

no legal impediment for a notified body to certify products according to the PPE Directive until

2019. The PPE Regulation will be the only applicable legislation from 21 April 2019.

CZECH REPUBLIC thought on possible ways to ensure the activities of notified bodies under the

PPE Directive until the end of the transitional period, taking into consideration the notification in

NANDO and the question of repeal of national transposition provisions in the Member States after

21 April 2018. Then, concerning compliance of PPE with the new Regulation in paragraph II.2,

they proposed to add a reference to test reports and other reports and documents issued by notified

bodies. For the rest of the document, they agree on the proposed approach in paragraph II.3.

NETHERLANDS agreed on the implementation problems mentioned by CZECH REPUBLIC, in

particular the potential legal problems related to validity of notification of notified bodies under the

PPE Directive.

The Chairperson said that they were separate questions: on one hand, on validity of certificates,

and the other one, until when notified bodies could continue to issue certificates under the PPE

Directive. The proposed document was focused on the first question, as laid down in Article 47 of

the PPE Regulation. On the other hand, COM will look to clarify the legal uncertainties regarding

the activities of the notified bodies during the transitional period, as mentioned by CZECH

REPUBLIC and NETHERLANDS.


SWEDEN considered that the proposal was good and fully in line with what the Member States

discussed in previous meetings, so they expressed their support.

UNITED KINGDOM also supported the proposed document, underlining the need to consider

Articles 46 and 47 together with respect to the repeal of the PPE Directive and the transitional

provisions for the PPE Regulation.

SPAIN expressed doubts on notified bodies issuing certificates under the PPE Directive valid until

2023: this could be unfair with respect of certificates with an expiry date. The questions on

standards related to the state of the art, and on instructions for use, were also important, in particular

when substantial changes take place and PPE could be on the market without all the information

required in the Regulation.

The Chairperson reaffirmed that all PPE placed on the market from 21 April 2019 must have

instructions according the Regulation. The proposed document had to face the situation during the

transitional period established in the Regulation: this could lead to "unfair" situations but it was

made to have something manageable for the economic operators from the old legislation to the new

one. It could be possible to intervene in a proportionate manner and on a case-by-case basis, in

particular when there are changes in standards that can be used to comply with the essential

requirements. With respect to the questions raised on notified bodies and the possibility to continue

to issue certificates after April 2018, it would be better to remove the references to that in the

document, to keep them separate from the topic on validity of certificates.

ESF fully supported the proposed document on Article 47, being the most urgent question, when

those on notified bodies should be kept apart. In any case, it would not be usual to have

manufacturers asking for EC type-examination certificates after April 2018. Concerning the point

on standards, the words in brackets should be clarified, to take into account significant changes in

protection levels with concrete changes in the state of the art.

FESI agreed on ESF comments. The COM proposal was in the right direction, even if clarification

on notified bodies would be necessary, as well as on listing in NANDO.

EURATEX also welcomed the document from COM and fully supported it.

SME Safety supported the proposal, being useful in particular for SMEs which asked several

questions on the transitional provision of the PPE Regulation. They also agree on holding separate

discussion on notified bodies and the related problems on notification, certificates, etc.

The Chairperson noted the general agreement and concluded saying that COM will revise the

document with a clean version by removing the references to notified bodies and EC type-

examination certificates, focusing only on validity of certificates. The revised version will be

circulated during a 2-weeks period, for editorial comments only, to consider the document as a

common approach on the implementation of Article 47 of the PPE Regulation, to be published in

the Commission's sectoral website.

Action point: COM, to revise the document to remove the references to notified bodies and

to focus it on validity of certificates, and to recirculate it during a 2-weeks period in

November 2017, for editorial comments only, to formally approve it and to make it available

in the Commission's sectoral website.

4.2. Lifetime of EU type-examination certificates issued before 21 April 2018 (Doc. PPE-17-2-10)

The Chairperson introduced the draft proposal from COM on the lifetime of EU type-examination

certificates issued before the date of applicability of the PPE Regulation, taking into account the


five years limitation of validity as established in point 6.1 of Annex V, and the possibility for

notified bodies to carry out conformity assessments according to Article 32 (1) which was already

applicable since October 2016. In any case, the effective period of validity of such certificates

should start from 21 April 2018, the date of applicability of the PPE Regulation: in this sense, it is

proposed, for certificates issued before that date of applicability, to indicate not only the date of

issue, but also the date when the certificate starts to be valid, which cannot be anterior to 21 April

2018, until the date of expiry up to 21 April 2023.

NETHERLANDS thought that it would be better to keep the five years limitation from the date of

issue of the certificate, also in line with other EU legislation under the New Legislative Framework.

SWEDEN made reference to possible problems with respect to changes in the state of the art, from

the date of issue before April 2018 until the maximum in April 2023, when a period longer than five

years from the issue of certificate would be allowed for re-examination. In this sense, they tend to

agree with NETHERLANDS.

BELGIUM said that the question was discussed in the AdCo Group, making reference to the Gas

Appliances sector under the new Regulation (EU) 2016/426, where it was agreed to keep the date of

issue as reference for the five years limitation of validity. The same approach should be kept also

for PPE.

The Chairperson explained that by the legal point of view, it is not possible to place products on

the market in compliance with the new PPE Regulation before 21 April 2018, so any EU type-

examination certificate issued before that date cannot be used until then. The applicability of the

provisions on notified bodies since already October 2016 was intended to facilitate the work of

notifying authorities and notified bodies themselves, to be adequately prepared in advance. The

possibility of having a longer period for re-examination would rather depend on the notified body,

taking its responsibility when issuing the certificate. It would be preferable not to consider the date

of issue as the reference for the five years limitation, but the date of effective usability of the

certificate, which is the date of applicability of the new PPE Regulation. This should be the same

logic in PPE as in Gas Appliances.

LITHUANIA recalled the guidance given in the "FAQ document" on the transition published in the

Commission's sectoral website, on the possibility for a notified body to issue certificates according

to the new PPE Regulation before 21 April 2018.

UNITED KINGDOM remarked that the date of issue as mentioned in point 6.2. of Annex V is not

indicated to be the same as the date of applicability. The same kind of problem could arise also for

the renewal of certificates, with the possible differences between the dates of issue (as the

applications for renewal are submitted well before the expiry date) and of the effective applicability

of the certificates.

The Chairperson agreed on the fact that this is not clearly set in the Regulation with respect to the

limit of validity, so it would be useful to look for the most reasonable solution. It is a more general

debate on what notified bodies should indicate in the certificates, when issued for the first time

under the new PPE Regulation and when they need to be renewed. It would be necessary to better

formulate some practical guidance in these cases.

NETHERLANDS proposed to indicate the same dates of issue and applicability, for the first time

from 2018 until 2023 at latest, and for renewal.

HCNB said that, according to the current practices of notified bodies, they can support the COM

proposal, even if they would need to look more in depth at the questions raised by the members, in

particular with respect to renewal of certificates.


UNITED KINGDOM underlined the need to make reference to the Gas Appliances sector and the

solution reached there, in order to ensure coherence with the implementation of the PPE Regulation.

The Chairperson concluded that it would be necessary to cross-check the proposed solution with

the situation in the Gas Appliances sector as well as at horizontal level with the other NLF

legislation, to define a common approach to the question and provide appropriate guidance. COM

will revise the document accordingly, to submit it to approval by written procedure.

Action point: COM, to cross-check the proposed solution with the Gas Appliances

Regulation (EU) 2016/426 as well as at horizontal level, to define a common approach to

the question, and to revise the document accordingly, to submit it to approval by written

procedure.

4.3. New PPE Guidelines and Ad-hoc Group (Doc. PPE-17-2-15)

COM made reference to the paper circulated to explain the idea to develop the new PPE Guidelines

for the PPE Regulation by the Commission with the support of an Ad-hoc Group to deal with

specific issues. Such group should be integrated by a restricted number of members of the PPE WG

(around 10), as representatives of the key sectoral players (Member States, standardisers, notified

bodies, industry...), to provide their expert contributions and to be able to provide the new PPE

Guidelines in time for the applicability of the new Regulation. The editorial work of the Ad-hoc

Group should be developed by e-mail, interchanging texts and comments, but also through informal

meetings, when possible. A first list of specific issues has been identified, mainly related to the

changes from the Directive, and some basic draft texts for discussion will be circulated among the

members of the group right after its constitution. In this sense, all the members of the PPE WG are

invited to communicate their availability to participate. The results of the work, as the final draft of

the new PPE Guidelines, will be submitted to the PPE WG at the first meeting in 2018 for general

discussion and approval.

ESF, EURATEX and FESI confirmed their intention to participate with their representatives.

SPAIN, POLAND and DENMARK also expressed their interest.

The Chairperson invited all the members to manifest in written their availability to join the Ad-

hoc Group, in two weeks time (until 20 November 2017). On this basis, COM will configure the

editorial group on the basis of representativity and effectivity, and will send confirmation to the

members, to start the work with the basic draft texts by the end of November 2017.

Action point: ALL, to communicate their availability to participate in the Ad-hoc Group to

help COM to draft the new PPE Guidelines on specific issues, within two weeks from the

meeting, until 20 November 2017. COM, to configure an Ad-hoc Group of about 10 experts

from the different members of the PPE WG and to organise its activities mainly by e-mail,

providing the basic draft texts for the specific issues to discuss by the end of November

2017.

4.4. New standardisation request ("mandate")

The Chairperson introduced the ongoing work to draft the new standardisation request

("mandate") to make harmonised European standards available under the new PPE Regulation.

COM explained that such mandate was still under discussion internally in the Commission (in

particular with the Legal Service) because it needed to take into account the related legislation in


force (Regulation (EU) No 1025/2012 on European standardisation104) as well as some recent rules

of the European Court of Justice on standardisation (in particular the "James Elliott Construction"

case105). On the other hand, due to the fact that the extent of changes in the health and safety

requirements from the Directive to the Regulation is quite limited, most of the current standards

would remain valid. Co-operation with CEN-CENELEC was also very important, to complete the

procedures for the new mandate, until the formal adoption by the Standardisation Committee. If this

would not be possible before the date of applicability of the PPE Regulation, a first list under the

new legislation, with most of the same standards under the Directive, could be published by

adopting a pragmatic approach.

CEN-CENELEC confirmed the good co-operation and dialogue with COM to reach the objective

to have the first list of harmonised standards for the PPE Regulation in due time. In any case it

would be better to ensure the legal certainty of the formal standardisation request as soon as

possible.

The Chairperson confirmed that it would be difficult to have the standardisation request adopted

before April 2018, as it was still under discussion and then to be submitted to the Standardisation

Committee; but, even if such procedures are not complete, it would be possible to take a pragmatic

approach to be able to publish a first list of harmonised standards for the PPE Regulation in time for

its applicability.

Action point: COM and CEN-CENELEC, to continue their co-operation to complete the

procedures for the new standardisation request for harmonised standards under the PPE

Regulation (EU) 2016/425 as soon as possible.

4.5. List of notified bodies in NANDO

COM recalled that the provisions of the PPE Regulation on notified bodies, including those on

notification, were already applicable since 21 October 2016: so, a new space in the NANDO

database was created, to list the bodies already notified by the relevant national authorities under the

new legislation. So far, there were 35 notified bodies from 7 Member States; more communications

on the procedures for notification, and the related notifications, were expected, to have a complete

list as most as possible before 21 April 2018.

The Chairperson said that, beside the new list of notified bodies for the PPE Regulation, the

current list of notified bodies for the PPE Directive will remain available during all the transition

period, until April 2019. It would be very important to speed up the related communications of

procedures for notification.

Action point: Member States, to continue communicating their procedures for notification

of conformity assessment bodies under the PPE Regulation (EU) 2016/425, and to carry

out the related notifications as soon as possible.

4.6. Clarification on the new EHSR 1.3.4. on Protective clothing containing removable protectors

(Docs. PPE-17-2-11, PPE-17-2-12)

104 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European

standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC,

95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European

Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the

European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).

105 C-613/14 - James Elliott Construction. Judgment of the Court (Third Chamber) of 27 October 2016.


The Chairperson proposed that the item on protective clothing containing removable protectors

would be discussed with item 5.5. on protective garments for motorcyclists incorporating

protectors, already under discussion from previous meetings.

4.7. Report from the PPE AdCo Group - Categorization of swimming aid and apron for butcher

(Docs. PPE-17-2-17, PPE-17-2-17_1)

SWEDEN, as the current Chair of the PPE Administrative Co-operation (AdCo) Group, reported

on the activities of the Group, in particular from the last meeting held in Malmö (Sweden) on 19-20

October 2017. Among them, it was agreed to submit to the PPE WG two questions for discussion

on categorization of swimming aid and apron for butchers, as reported in the papers with some

preliminary opinions of the members.

NETHERLANDS confirmed their opinion on considering swimming armbands as category II, and

PPE for butchers as category II, according to their purpose.

UNITED KINGDOM informed on their Internet research on butcher’s clothing, where different

kinds of products are offered for sale, some claiming compliance with EN ISO 13998:2003106,

which could lead to consider some butcher’s clothing as category III. Further checks and

investigations should be made, also with manufacturers, to reach a clear understanding of risks

involved whether these fit into description of category III risks.

CEN-CENELEC considered that swimming aids should be category II, as they are intended for

training, rather than for life.

The Chairperson underlined the need to adapt the approach for determination of classification of

PPE according to the provisions of the new Regulation on risks. This should be carefully revised

also for the new PPE Guidelines and its Categorisation Guide.

ESF expressed their idea on PPE for butchers as category II, as shown in the paper, on the basis of

reasoning for type of risk, to protect against non-intentional stabbing. But this should be better

clarified.

BELGIUM agreed on considering swimming armbands as PPE category II, when for PPE for

butchers, they would provide protection against cutting; stabbing would be something additional,

not normal use.

POLAND identified two types of hazards for butchers and two types of equipment for aprons

should be considered. The question seemed to be more complicated between category II or III and it

should be further analysed.

The Chairperson asked all the members to provide further comments and opinions on

categorisation of swimming aids and aprons for butchers, to be discussed at the next PPE WG

meeting to reach a common approach, to be included in the new PPE Guidelines.

Action point: ALL, to provide further comments and opinions on the categorisation of the

presented products under the PPE Regulation (EU) 2016/425, to reach a common

agreement at the next PPE WG meeting and to include it in the new PPE Guidelines.

106 EN ISO 13998:2003 Protective clothing - Aprons, trousers and vests protecting against cuts and stabs by hand

knives (ISO 13998:2003)


5. Follow-up issues on scope and interpretation of the PPE Directive:

5.1. EN 1621-4 on motorcyclists' inflatable protectors: COM Implementing Decision to publish

the reference on the OJEU

COM confirmed that, after the conclusion reached at the previous PPE WG meeting, the procedure

to draft and submit the Implementing Decision to the Standardisation Committee, to publish the

reference of the standard EN 1621-4107 on the OJEU, will be completed as soon as possible. More

specific information will be provided in due time.

Action point: COM, to complete the procedure to submit the Implementing Decision to the

Standardisation Committee as soon as possible.

5.2. Impact protection helmets for young children: positions and comments (Docs. PPE-15-2-18,

PPE-16-2-8, PPE-16-1-10, PPE-17-2-3)

COM recalled the issue and the results of the latest PPE WG meeting, asking for the written

positions of the Member States on the questions raised by FINLAND on the applicability of the

harmonised standard EN 1080108 and its possible revision for a specific type of helmets. Only an

abstention from SPAIN was received, so it would be necessary to check whether a common answer

can be reached, or further information would be needed.

NETHERLANDS considered that an opinion on the scope of a standard would not be the task of

the Working Group.

FESI thought that there were more appropriate standards to cover those products, taking into

account the possibility of multiple impacts, as mentioned in their document as well as in the

Swedish one. Questions referred to products still on the market, for which it would be necessary to

collect more information.

The Chairperson agreed on the need to collect more information on such cases. In any case, it

appeared that those products were no longer manufactured, so for the time being, the point could be

closed, unless new specific information on market surveillance activities or risks related to products

on the market is reported.

Action point: COM, to close the point, unless new specific information on market

surveillance activities or risks related to these products is reported.

5.3. Anti-slip footwear: positions and comments (Docs. PPE-16-1-5, PPE-17-2-4)

COM recalled the issue and the results of the latest PPE WG meeting, asking for the written

positions of the Member States on the questions raised by FINLAND on considering these products

as PPE or not. A couple of comments have been received but the questions seemed not to be clear

yet.

NETHERLANDS considered that these products were not PPE.

FESI also considered that they were not PPE, according to the characteristics of the "protection"

given.

107 EN 1621-4:2013 Motorcyclists' protective clothing against mechanical impact - Part 4: Motorcyclists' inflatable

protectors - Requirements and test methods.

108 EN 1080:2013 Impact protection helmets for young children.


POLAND said a similar discussion was held in the past and it was concluded that these products

were PPE category II.

The Chairperson made reference to the "Categorisation guide" in the PPE Guidelines, point 8.1,

whether this kind of products could be considered as PPE providing anti-slip protection, as category

II. It seemed that this should be further discussed for the revision of the guide. The point would be

kept in the Agenda for the next PPE WG meeting, asking the members to provide further comments

and opinions, to reach a common agreement on the issue.

Action point: ALL, to provide further comments and opinions on the consideration of the

presented products as PPE and of which category, to reach a common agreement at the

next PPE WG meeting within the revision of the "Categorisation guide" in the PPE

Guidelines.

5.5. Protective garments for motorcyclists incorporating protectors: modified FR and SE

proposal (Docs. PPE-16-1-20_1, PPE-16-1-20 rev.1)

The Chairperson recalled the question on protective garments for motorcyclists incorporating

protectors from the previous meeting, on the basis of the papers drafted by FRANCE and

SWEDEN, and also with the latest contributions from CEN and ACEM on the new requirement

1.3.4. of the PPE Regulation on protective clothing containing removable protectors (see item 4.6.),

as well as the definition in Article 3(1)(b).

SWEDEN confirmed that clarification was still needed, to modify the text in the PPE Guidelines.

The formulation proposed was in principle agreed with FRANCE.

NETHERLANDS made reference to the French comments, for the need of testing garments for CE

marking.

ITALY agreed on the text, but then, they pointed out at the definition in Article 3(1)(b) for the

consideration of removable protectors as "interchangeable components" as PPE, with the need to

clarify the difference and not to have contradictions with the requirement 1.3.4. in the Annex.

The Chairperson explained that it would be necessary to test the combination and not just the

removable components: it would not be a contradiction.

AUSTRIA supported the idea of the combination as PPE, only valid for the whole product.

CEN WG 9 said that a new set of standards would be developed for the requirements in the

Regulation. In this case, consumers would know which protection should go in the jacket as

removable parts.

The Chairperson considered that this would be very useful, to go to the point and in the right

direction, to clarify the related section of the PPE Guidelines as a positive outcome of a quite long

debate.

UNITED KINGDOM supported the Swedish proposal on interchangeable components, for the

removable protections to be certified on their own.

CEN-CENELEC made reference to the methods to ensure compatibility between the garment and

the removable protectors, being necessary to carry out the related assessment on the basis of the

general principles as agreed but also on a case-by-case basis.

The Chairperson confirmed that the removable protectors were PPE on their own, and the

protective garments including them were also PPE, to be certified as a combination: individual


removable plus jacket with the removable protectors, according to the new requirement 1.3.4. of the

PPE Regulation. The latest version of the text proposed by SWEDEN and accepted by FRANCE, as

well as the latest contributions received and the agreement reached at the PPE WG meeting, will be

considered by COM to draft the appropriate guidance in the new PPE Guidelines.

Action point: COM, to take into account the latest version of the text proposed by

SWEDEN and accepted by FRANCE, as well as the latest contributions received and the

agreement reached at the PPE WG meeting, to draft the appropriate guidance for the new

essential requirement of the PPE Regulation (EU) 2016/425 in the new PPE Guidelines.

5.6. Beekeeper garments: revised COM proposal (Doc. PPE-17-1-5 rev.1)

COM presented the revised version of the proposal for point 6.1 of the "Categorisation guide" in

the PPE Guidelines, to take into account the latest inputs received.

NETHERLANDS said that stings could be deadly, so maybe the protection should be category III,

also considering the new PPE Regulation on "protection against harmful biological agents".

DENMARK agreed on the revised proposal.

The Chairperson noted the general agreement on the proposal, so it will be included into the PPE

Guidelines. On categorisation II or III, for life risk, this could be further considered within the

revision of the "Categorisation guide".

Action point: COM, to include the approved proposal into the PPE Guidelines; further

considerations on categorisation could be taken into account within the revision of the

"Categorisation guide".

5.7. EN ISO 20344 on test methods for footwear: COM Implementing Decision to keep the

reference on the OJEU

COM confirmed that, after the conclusion reached at the previous PPE WG meeting, the procedure

to draft and submit the Implementing Decision to the Standardisation Committee, to confirm the

publication of the reference of the standard EN ISO 20344109 on the OJEU, will be completed as

soon as possible. More specific information will be provided in due time.

Action point: COM, to complete the procedure to submit the Implementing Decision to the

Standardisation Committee as soon as possible.

5.8. Formal objection by Sweden against EN ISO 12402:2006 parts 2, 3 and 4 on inflatable life

jackets: MS positions and conclusions (Docs. PPE-17-1-8 rev.1, PPE-17-2-16)

COM recalled the question from the previous meeting, making reference to the paper collecting the

positions expressed by the Member States on the formal objection raised by SWEDEN against the

standards EN ISO 12402:2006 parts 2, 3 and 4110, the conclusions and the proposed way forward.

There was not a clear majority on the support of the formal objection, so it would be convenient to

further analyse and discuss the question.

109 EN ISO 20344:2011 Personal protective equipment - Test methods for footwear (ISO 20344:2011).

110 EN ISO 12402-2:2006 Personal flotation devices - Part 2: Lifejackets, performance level 275 - Safety requirements

(ISO 12402-2:2006) and EN ISO 12402-2:2006/A1:2010; EN ISO 12402-3:2006 Personal flotation devices - Part 3:

Lifejackets, performance level 150 - Safety requirements (ISO 12402-3:2006) and EN ISO 12402-3:2006/A1:2010;

EN ISO 12402-4:2006 Personal flotation devices - Part 4: Lifejackets, performance level 100 - Safety requirements

(ISO 12402-4:2006) and EN ISO 12402-4:2006/A1:2010.


CEN-CENELEC presented their position and of the related Technical Committees, explaining the

background of the standard series, the way it addressed the contents of the formal objection - in

particular considering that the accident taken as reference was not due to deficiency in standards -

and rejecting the withdrawal of the presumption of conformity. They asked for a clear position of

the Member State to take a decision on the formal objection.

The Chairperson recalled the rules for vote in the Standardisation Committee, when the

Commission Implementing Decision would be submitted there; but for the time being, positions

expressed in the PPE WG would be just an orientation for COM, not bounding for its final decision

but very interesting for taking it.

SWEDEN summarised their position with the reasons for the formal objection against the standard

series. It was a safety issues with gas cylinders, which could put life at risk: this should be taken

into account when taking a final position. The amendments put forward by CEN were still

insufficient to solve the problem and to attain the necessary level of protection. Inflatable life

jackets are consumer products and it would not be acceptable to rely on instructions. In this sense,

they considered that the product was not safe, due to mistakes in design, and the standard did not

make the product safe.

DENMARK recalled that, according to the indications provided by COM, Member States who

abstained in the written consultation had been considered as supporting the formal objection. But it

would be better to explicitly express a position, being a matter of life for users.

EBI remarked that the question concerned products already on the market and the removal of

presumption of conformity of the standard series could lead to negative consequences.

AUSTRIA confirmed their support to the formal objection, considering that the current standard

was not good enough for safety.

POLAND thought that the situation was not as dramatic as presented by SWEDEN. The problems

detected would be very limited to a small number of users, and it would not be possible to simulate

all kind of possible hazards.

ITALY and CZECH REPUBLIC supported the CEN position and confirmed their opposition to

the formal objection.

NORWAY reported on their contacts with fishfarming which use this kind of safety equipment on

a daily basis, and they did not consider them sufficient and reliable. They confirmed their support

for the formal objection.

IRELAND did not express a position in the written consultation but they should be rather

considered as neutral, because they were not completely in favour of the formal objection. They

would need to consult experts.

LITHUANIA did not support CEN. They considered that mistakes in designing and manufacturing

the product should not allowed by the standard to be passed to users.

The Chairperson clarified that discussion was on the substance of the question, to determine

whether there was some kind of gap in the standards, to consider them safe enough to confer

presumption of conformity with the requirements of the Directive. This should not necessarily lead

to take a formal position in the PPE WG, nor a vote: the debate was useful to clarify ideas, but then,

formal votes should be expressed by the members of the Standardisation Committee, on the basis of

the information and indications provided to them. For the time being, there were arguments for and

against the formal objection, as already quite exhaustively discussion. COM must proceed on the


formal objection to take a formal decision to be submitted to the Standardisation Committee.

Information on that would be provided as soon as possible.

Action point: COM, to proceed on the formal objection taking into account the opinions

expressed by the PPE WG members, and to draft the Implementing Decision to be

submitted to the Standardisation Committee as soon as possible.

5.9. Ergo- and exo-skeletons (Docs. PPE-17-1-9, PPE-17-1-13, PPE-17-2-5)

COM recalled the questions raised on ergo- and exo-skeletons, as summarised in the last paper. A

couple of comments have been received, from the Nordic countries (DENMARK, FINLAND,

ICELAND, NORWAY and SWEDEN) and from SPAIN, expressing the opinion that those

products were not PPE.

NETHERLANDS also agreed on not considering them as PPE.

ESF asked to be careful when calling these products as "smart PPE", because they should not be

considered as PPE. But maybe there were other kind of products in the market that could be PPE.

The Chairperson noted the agreement on not considering the described products as PPE, to be

reflected in the minutes of the meeting.

Action point: COM, to close the point, reflecting in the minutes of the meeting the common

agreement on not considering the described products as PPE.

5.10. AirBuddy (Docs. PPE-17-1-10, PPE-17-1-13, PPE-17-2-6)

COM recalled the questions raised on the product called "Air Buddy", as summarised in the last

paper. A couple of comments have been received, from the Nordic countries (DENMARK,

FINLAND, ICELAND, NORWAY and SWEDEN) and from SPAIN, expressing the opinion that

those products were not PPE.

NETHERLANDS also agreed on not considering them as PPE.

The Chairperson noted the agreement on not considering the described product as PPE, to be

reflected in the minutes of the meeting.

Action point: COM, to close the point, reflecting in the minutes of the meeting the common

agreement on not considering the described product as PPE.

5.11. High visibility clothing

COM recalled the question raised by FRANCE on clarification on high visibility clothing as PPE,

asking for new contributions after a first intent to have an ad-hoc group on the issue and the most

recent discussion held in the PPE AdCo Group.

FESI announced a paper on the notion of "reflective elements for reason of design", to be provided

at the next PPE WG meeting.

DENMARK said that no new document was made available. It would be possible to recover the

documents produced in the "task force" active in the past. For the new PPE Regulation, with respect

to work clothing and reflective clothing, it would be necessary to define what could be considered

PPE and what not. This should be made on a case-by-case basis.


The Chairperson agreed on the importance of the question, to establish a division line as clear as

possible.

UNITED KINGDOM considered that the criteria should be based on the situation of users with

respect to others who would be able to see them, involving different aspects on protection,

identification and visibility. The ad-hoc group worked to reach some conclusions for the PPE

Directive and the task was almost complete: it would be useful to recover the documents and send

them to COM and the members of the PPE WG for further discussion.

The Chairperson confirmed that the question would be followed up at the next meeting of the PPE

WG. She asked the members to provide new information and contributions, also from the previous

ad-hoc group, for discussion also with respect to the new PPE Regulation.

Action point: ALL, to provide new information and contributions on the issue, taking also

into account the documents already produced in the PPE AdCo Group and in the specific

task force / ad-hoc group. FESI, to provide a paper on the notion of "reflective elements for

reason of design" for the next PPE WG meeting. COM, to follow up the issue, also taking

into account the new references in the PPE Regulation (EU) 2016/425.

5.12. Declaration of lower levels of protection to those achieved during the EC/EU type

examination (Doc. PPE-17-2-13)

SPAIN introduced a paper for discussion on different opinions between some manufacturers and

notified bodies on the possibility to declare lower levels of protection to those achieved during the

type-examination assessment procedure, due to specific market strategies.

ESF thought that this was a complicated situation with this kind of difference between the results of

conformity assessment and the declaration for products placed on the market. This should be related

also to changes in levels of protection and uncertainties in measurements.

The Chairperson said it would be necessary to know why this kind of practices are used, and

whether this could be an infringement of the Directive.

SPAIN further explained the question, pointing out to the problems related to "overprotection" in

some kind of PPE, as for example for thermic protection.

CROATIA also mentioned some cases of higher and lower results for textile PPE as for gloves, or

others with cotton fibres with imperfections: this could be the reason for declaring lower levels of

protection. But it would be also possible to have unfair business practices; this should be

investigated.

The Chairperson thought that this could be related to the aim to "play safe", to prevent problems

by declaring lower levels of protection. Maybe it would not be easy to prohibit such products. It

would be necessary to collect more information on similar experiences in other Member States.

CZECH REPUBLIC asked for more time to analyse and discuss the question. They could mention

some similar problems at national level for firemen gloves. This should be related also to the

expectations of users of PPE.

The Chairperson agreed on asking the members to provide comments and opinions on the issue,

and in particular for notified bodies to check the current practices at that respect, for further

discussion at the next PPE WG meeting.

Action point: ALL, to provide comments and opinions on the issues raised by SPAIN, for

the next PPE WG meeting. HCNB, to consider the question for their next meeting in


November-December 2017, to collect information on the current practices and the notified

bodies' opinions.

5.13. Categorization protective clothing for wildland firefighters (EN 15614) (Doc. PPE-17-2-14)

SPAIN introduced a paper for discussion on the categorisation of protective clothing for wildland

firefighters, certified on the basis of the harmonised standard EN 15614111, as category II or III. By

making reference to point 9.3 of the "Categorisation guide" of the PPE Guidelines, this could be

category III.

NETHERLANDS considered that it would be necessary to take into account the Directive

89/656/EEC on use of personal protective equipment, to decide what equipment must be provided

by employees for use: it would be the responsibility of national labour authorities to check this,

rather than market surveillance authorities.

SPAIN agreed with NETHERLANDS, but the question they raised would be rather related to

placing on the market of this kind of PPE, and its categorisation.

DENMARK said that, according to the opinion on their experts making reference to the standard

EN 15614, this kind of clothing were used only by firefighters, for protection against high

temperatures, with fire resistance and comfort features. They are provided with specific instructions

for users, in particular to avoid being too close to fire. In this sense the product could be considered

as PPE category II, and its use should follow the PPE user Directive, to be checked by the relevant

national authorities.

ESF considered that this clothing should be PPE category III, but the intended use, and relevant

training and instructions for users, are essential.

The Chairperson recognised that the different aspects related to the PPE "product" and "use"

Directives needed to be taken into account for these products, to clarify the question on which kind

of equipment would be suitable for the intended use. To understand better the situation for garments

for specific temperatures and conditions of use, she asked all the members to provide comments and

opinions, for further discussion and a common decision at the next PPE WG meeting.

Action point: ALL, in particular Member States, to provide comments and opinions on the

issues raised by SPAIN, to reach a common decision at the next PPE WG meeting.

6. Standardisation:

6.1. Lists of references of European harmonised standards in the OJEU under Directive

89/686/EEC

COM recalled the two latest publications of references of harmonised European standards in the

Official Journal of the European Union (OJEU), on 12 April and 13 October 2017. A new

publication should take place as soon as possible, on the basis of the most recent sending by CEN

and CENELEC in October-November 2017.

111 EN 15614:2007 Protective clothing for firefighters - Laboratory test methods and performance requirements for

wildland clothing.


Action point: COM, to prepare the new list of references of European harmonised

standards under the PPE Directive 89/686/EEC, to be published on the OJEU as soon as

possible, according to the last sending by CEN-CENELEC in October-November 2017.

6.2. Availability of European harmonised standards for Regulation (EU) 2016/425: state of play

COM said that CEN-CENELEC accepted to provide the first list of references of standards under

the new PPE Regulation by the end of December 2017. COM will carefully analyse such list to

confirm the suitability to provide presumption of conformity with the requirements of the new

legislation, and will publish it in the OJEU before the date of applicability in April 2018.

Action point: CEN-CENELEC, to provide the first list of references of European

harmonised standards under the PPE Regulation (EU) 2016/425 by the end of December

2017. COM, to publish such list in the OJEU before April 2018.

6.3. Report by CEN Secretariat

CEN-CENELEC reported on their activities in the PPE sector, in particular about the state of play

of the adaptation of standards to the new PPE Regulation, as already mentioned at the last PPE WG

meeting. Almost 300 references were currently published in the OJEU under Directive 89/686/EEC:

most of them would be proposed for the Regulation too, taking into account the modest changes in

the requirements, when on the contrary, about 80 standards on test methods are not going to be

listed anymore. About 27 standards need to be aligned to the new legislation due to changes, by a

revision or amendment process: those 27 standards are not going to be ready soon, but they

confirmed that the first list of standards under the PPE Regulation would be offered to COM by the

end of December 2017, on the basis of the relevant technical reports. In any case, CEN-CENELEC

expected to have the new mandate adopted as soon as possible.

FESI asked for more information about the mentioned 27 standards to be revised or amended to

align them to the changes in the new PPE Regulation.

CEN-CENELEC said that the list of those 27 standards impacted by changes would be provided as

soon as possible upon the inputs from the concerned Technical Committees. This should take into

account the relevant technical reports also with respect to the established deadlines in the

standardisation requests, under PPE as well as for "smart textiles". It would be necessary

cooperation between different experts.

ESF added that the questions on the ongoing standardisation work for PPE and textiles were also

under discussion at the PPE Sectorial Forum, in particular on the deliverables related to the

standardisation mandates.

7. Notified bodies:

7.1. Report from the Horizontal Coordination of Notified Bodies (HCNB) (Doc. PPE-17-2-8)

HCNB presented the written report on the activities of the Horizontal Coordination of Notified

Bodies under the PPE Directive and Regulation.

7.2. Recommendations for Use sheets (RfUs)

HCNB informed that they had been working on the adaptation of Recommendations for Use sheets

(RfUs) to the new Regulation, and they sent to COM the new list of RfUs for endorsement by the

PPE WG, preferably before the date of applicability in April 2018.


The Chairperson confirmed that COM received the list and the RfUs adapted to the new PPE

Regulation will be submitted to the written procedure for endorsement via CIRCABC as soon as

possible.

Action point: COM, to launch the written procedure for endorsement by the PPE WG of

the RfUs adapted to the PPE Regulation (EU) 2016/425, as soon as possible, to complete it

before April 2018.

7.3. Lists of notified bodies in NANDO and in CIRCABC

The point was already discussed in item 4.5.


No other business was discussed.


The Chairperson said that the next meeting of the PPE Working Group is expected to take place in

the first quarter of 2018, in principle on 21 February. The exact date will be confirmed 6-8 weeks in

advance.

Action point: COM, to confirm the exact date of the next PPE WG meeting, in principle

planned on 21 February 2018. [NOTE: lately, the date was fixed on 12 March 2018]

End of the meeting





Subject: Working Group under the Personal Protective Equipment (PPE) Directive

89/686/EEC and Regulation (EU) 2016/425


Chairperson: Ms Barbara BONVISSUTO (COM GROW/C3)

COM participants: Mr Mario GABRIELLI COSSELLU, Ms Isabel Maria LOPES GUERRA,

Ms Magdalena MODER (GROW/C3); Ms Ann Sofie LINDGREN KERO

(former COM NEPT)


The Chairperson welcomed those present and introduced the COM representatives, referring to the

latest changes in the Unit and the team managing the PPE sector. Among the most relevant ongoing

issues, the COM proposals on "Goods package" for two new Regulations on the mutual recognition

of goods and on compliance and enforcement, have been submitted in December 2017112.

COM made a presentation on the "Goods package", in particular on the proposal for a Regulation

on compliance and enforcement of EU product legislation, explaining the scope, the problems to

address, the relationship with the "Product safety and market surveillance package" submitted in

2013, and the tools to improve enforcement and coordination, including the "EU product

compliance network". The proposals will be discussed in the European Parliament and the Council,

with the aim to be approved and published by the end of the current legislature in 2019. The

presentation will be circulated in CIRCABC.

Action point: COM, to circulate the presentation on compliance and enforcement in

CIRCABC.


The Chairperson introduced the draft Agenda of the meeting.

NETHERLANDS expressed doubts on the convenience to discuss the item 5.9. as it concerned

specific standardisation issues.

COM explained that it was proposed by the CZECH REPUBLIC and it was intended as

information, then to be discussed at standardisation level.

FESI asked for the possibility to mention the question on UV material protection.

The Chairperson answered that this could be done within the item on the new PPE Guidelines.

With no further comments, the draft Agenda was approved.

112 Press release: http://europa.eu/rapid/press-release_IP-17-5301_en.htm.

http://europa.eu/rapid/press-release_IP-17-5301_en.htm


3. Approval of the draft Minutes of the last meeting held on 6 November 2017 (Doc. PPE-18-

1-2)

The Chairperson introduced the draft Minutes of the latest meeting of the PPE WG held on &

November 2017. A comment was received by UNITED KINGDOM, on item 4.7., to better specify

their statement on butcher's aprons: it will be integrated into the text. When approved, the Minutes

will be inserted into the consolidated document in the COM sectoral website.

CZECH REPUBLIC remarked, at page 3, first paragraph, that their intervention on the problems

related to the transition to the new PPE Regulation should be clarified.

The Chairperson asked CZECH REPUBLIC to send their comments in writing.

With the changes pointed out, the draft Minutes were approved.

Action point: CZ, to send their written comments on the point on the transition to the new

PPE Regulation. COM, to insert the approved minutes, with the changes pointed out, into the

consolidated "Minutes of the PPE Working Group meetings from 2002 onwards" in the

Commission's sectoral website.

4. Transition to the new PPE Regulation (EU) 2016/425:

4.1. New PPE Guidelines: Final Draft February 2018 (Doc. PPE-18-1-4)

COM introduced the final draft of the new PPE Regulation Guidelines, circulated in CIRCABC in

February 2018, as the result of the work carried out by COM with the support of an ad-hoc editorial

group, in particular for the elements related to changes in the new legislation, as well as for the

transitional issues, as indicated in the accompanying e-mail message sent to all the members on 19

February 2018. The document is proposed for discussion and approval to be made public in the

COM website before the date of applicability of the new PPE Regulation (21 April 2018); other

issues still potentially to be improved or clarified will be further analysed and discussed later on, as

the Guidelines, as usual, will remain a living document to include the agreements reached in the

PPE Working Group.

The former COM NEPT, as the co-ordinator of the ad-hoc group, explained more in detail the

contents of the new PPE Regulation Guidelines, referring in particular to the changes related to

Articles 2 ("Scope"), 3 ("Definitions"), 19 ("Conformity assessment procedures"), 35 and 36

("Exchange of experiences between notifying authorities and coordination of notified bodies") and

47 ("Transitional provisions"); to Annexes I ("Risk categories of PPE"), II ("Essential health and

safety requirements": 1.3.4., 3.1.3., 3.4.1., 3.6.1., 3.8.2., 3.10.), III ("Technical documentation for

PPE"), V ("EU type-examination"); and to the "Categorisation guide".

FRANCE asked for more information on the specific points which have revised in the new PPE

Guidelines with respect to the previous version for the Directive. They remarked some errors in the

"Categorisation guide", as for example missing text in point 10.2 on "Life-buoys and life-jackets to

prevent drowning", or in point 16 on "Protection against UV radiation", why had the entry on

sunglasses been deleted? Then, they would make some more comments on Article 47 (pages 78-

80), and on Article 2(2)(b) and (c) (pages 24-25), where it would be necessary to include more

considerations on some kind of gloves used for kitchens, as the question of the modifications to the

exclusions from the scope is not very clear yet: this should be discussed and agreed to be reflected

into the Guidelines as well. Furthermore, there is the case to clarify in the "Categorisation guide"

for some type of equipment for hearing protection (point 1): it should be aligned to the results of

discussions already carried out in November 2015 (Doc. PPE-15-2-8), not to create further issues on

this topic.


The Chairperson asked FRANCE, as well as all the members, to send their comments and

suggestions (mainly editorial) on the new PPE Regulation Guidelines in writing, during a 4-weeks

period until 10 April 2018, to allow the COM services to take them into due consideration to

publish the Guidelines before the date of applicability. On Article 47 and the transition provisions,

more discussions have to be held, to align the contents of the guidance documents proposed by

COM to a commonly agreed approach, to be integrated into the Guidelines.

SPAIN also expressed their comments on some contents of the new PPE Guidelines, in particular

on Article 45 on "Penalties" (page 45, the world "transposing" should not be used) and on some

points of the "Categorisation guide", as in 9.14 Protective gloves against micro-organisms" should

be category III under the new PPE Regulation; in 3. on "Equipment for protection against falls from

a height", about anchor devices; and in 11. on "Equipment for protection against electrical risks", to

be adapted. They will send their comments and suggestions in writing within the indicated deadline.

The Chairperson took the opportunity to recall to the Member States representatives the obligation

to notify their provisions on penalties to COM, according to Article 45(1), by 21 March 2018.

NETHERLANDS noted the paragraph in the comments to Article 8, on compliance to "type font

size" for the manufacturer's instructions and information (page 39), considering that such detailed

information would be rather covered in standards; they asked to better check or even to delete it.

The former COM NEPT said that such indication came from an AdCo guide, as a general

reference.

FESI expressed concerns on point 16.4 of the "Categorisation guide" about the indication "a UPF

of more than 40+", at it could give wrong information to consumers: the threshold seemed to be too

low and it should be checked to the relevant standards. They recommended to have it at 60+. They

will also send written comments.

The former COM NEPT said that such indication was based on contributions of members of the

ad-hoc editorial group, modifying the previous level at 60+. This would be further checked.

UNITED KINGDOM also expressed some comments, to be sent in written. They agreed with

NETHERLANDS on the "type font size", which is a horizontal issue and could be mentioned just

as a recommendation. Then, they asked for more clarification on guidance on Article 8(3) about

keeping the EU declaration of conformity during 10 years after the placing on the market of the

product, rather than "after the last single unit PPE has been manufactured" (page 43); also there, the

expression "high quality information" could be misleading; and, in Article 2, considerations on

exclusions from the scope, with examples, should be better inserted in the Annex.

ESF considered the proposed PPE Guidelines as a good document, still with some room for

improvement. They have already sent a written comment about point 1.4. of Annex II on

"Manufacturer' instructions and information" with respect to printed format, as they would be rather

in favour of opening the door to more flexible electronic formats, according to the state of the art.

The Chairperson recalled that the preference for paper format for instructions and other safety-

related documents is a horizontal issue, which could be further discussed.

FRANCE inquired on the possibility of translating the new PPE Guidelines into other languages, as

made in other sectoral guidance documents.

The Chairperson answered that it would depend on the availability of resources, but COM could

make an effort to have the Guidelines translated into at least the three working languages: English,

French and German.

NETHERLANDS added comments on point 16.4 of the "Categorisation guide" concerning "Skin

protection against natural UV radiation", referring to safety standards boundaries. Then, on user

documents, they underlined the importance of having them in written format, as for example an

internet connection is not always available.


POLAND referred to the risk categories of PPE as in Annex I and the consideration of chemical

hazards, non-toxic industrial dusts, and others. They will send written comments on the

categorisation to better clarify the question.

FESI, coming back to the question of UV radiation and "a UPF of more than 40+" in point 16.4 of

the "Categorisation guide", explained that it would be necessary to have due diligence in using

standards for products claiming for UV protection, at least of 60+ UPF, to ensure compliance with

the requirements and significance of the CE marking.

POLAND considered that the reference to the UPF for garments could be removed, to better focus

on the risk and to avoid confusion.

FESI supported POLAND, considering it would go in the right direction, to provide non-

misleading information to consumers and more legal certainty, with a harmonised interpretation

about PPE for UV protection.

FRANCE also underlined the need for more clarity on point 16.4, as well as on point 16.3

concerning artificial UV radiation. Claims of the manufacturer could not be the only element to

consider the product as PPE or not. This would be related also to horizontal recurrent subjects as

market surveillance, legitimate expectations of consumers, etc.

The Chairperson agreed on the need to revise some contents of point 16. on "Protection against

UV radiation" of the "Categorisation guide", as for 16.4 possibly coming back to a similar wording

as it was before, without a specific reference to a value but with a statement on UPF.

BULGARIA said that they were still analysing the text of the new PPE Guidelines. Concerning the

transitional provisions, would the guidance documents drafted by COM (as on Article 47 etc.) be

incorporated into the Guidelines or would they remain as separate documents?

COM said that such guidance documents would be in principle incorporated into the Guidelines,

even if some of them have been already published on the COM's sectoral website.

The Chairperson summarised the discussion confirming that all the members are asked to send

their written comments and suggestions (mainly of editorial nature) to COM until 10 April 2018.

The editorial corrections will be integrated in a final version which will be distributed among the

members in CIRCABC as soon as possible during a week more, in view of making the new

Guidelines available on the COM's sectoral website before the date of applicability of the new PPE

Regulation (21 April 2018). With respect to other questions, they will be collected in separated

papers to be further discussed in the next meetings of the PPE WG.

Action point: All, to send their written comments and suggestions (mainly editorial) on the

new PPE Regulation Guidelines, until 10 April 2018. COM, to integrate the editorial

corrections into the Guidelines, to distribute a final version among the members in CIRCABC

during a week more, and then to make it available on the sectoral website before the date of

applicability of the new PPE Regulation (21 April 2018).

4.2. Validity of an EC type-examination certificate and revision of harmonised standards (Docs.

PPE-18-1-5, PPE-18-1-9)

COM presented the draft proposal on the validity of an EC type-examination certificate and the

revision of harmonised standards. This was a horizontal question referred to section 4.1.2.6. of the

“Blue Guide”113 about “Revision of harmonised standards”, and it was raised in particular

concerning standards for gloves (for instance EN 388114). The conclusion proposed in the COM

paper reaffirmed the general principle and underlined the need to carry out a case-by-case

113 The 'Blue Guide' on the implementation of EU product rules: http://ec.europa.eu/DocsRoom/documents/18027.

114 EN 388:2016 Protective gloves against mechanical risks.

http://ec.europa.eu/DocsRoom/documents/18027


assessment to ensure compliance with the applicable health and safety requirements and the state of

the art.

ESF asked for more clarification on the expression “such certificates could continue to be

considered valid until their expiry date”, to improve the wording there.

BSIF thought that certificates should normally considered valid as a default position.

FRANCE referred to the note they sent on the issue, in particular on the need to better clarify the

“Blue Guide”, to avoid to have different practical approaches in different sectors, and in particular

in the transition from the PPE Directive to the PPE Regulation. They proposed that manufacturers

should carry out a specific assessment with respect to changes in the harmonised standards they

have used. In the COM document, things appeared to be even more complicated; the paragraph

starting with “Where a revision of a harmonised standard…” should be deleted.

SPAIN considered that the paper seemed to be correct, on the basis of the analysis of market

surveillance authorities on the documents issued by the notified body, as included into the technical

file.

GERMANY agreed in principle on the COM proposal, but the documentation of the assessment

carried out by the manufacturer and the notified body should be added to the technical file, so

supporting the position of SPAIN.

The Chairperson noted that it would be possible to reach an agreement on the need to have a case-

by-case assessment, in line with the general principle stated in the “Blue Guide”: the changes in the

standards need to be assessed but not necessarily to issue a new certificate, as it could be

disproportionate. Therefore, the COM proposal could be integrated by adding a reference to the

need to include the results of the assessment into the technical file. The revised paper will be re-

circulated in CIRCABC for written approval.

Action point: COM, to revise the proposal by adding a reference to the need to include the

results of the assessment to be carried out by the manufacturer and the notified body on the

changes to the standard, into the technical file. The revised paper will be re-circulated in

CIRCABC for written approval and publication on the COM’s sectorial website.

4.3. Approval decisions under the PPE Regulation based on EC type-examination certificates

(Doc. PPE-18-1-6)

COM presented the draft proposal on the validity of approval decisions linked to EC type-

examination certificates. This included considerations on different possible cases of the application

of the transitional provisions of Article 47 of the PPE Regulation, according to the applicable

conformity assessment procedures. Two main situations are discusses, when approval decisions are

issued before the applicability of the new legislation, or after, during the transition period.

NETHERLANDS recognised that the issue was quite complicated. According to Article 47, EC

type-examination certificates and approval decision remain valid until 21 April 2023, but how to

deal with such documents issued under the PPE Directive until 20 April 2019, when it is repealed

from 21 April 2018 according to Article 46? Should conformity assessment bodies still be notified

under the Directive during the transition period? This should not be in line with the provision on

repeal, as it would take away the legal basis for the activities of notified bodies under the Directive.

It would be necessary to reach a common agreement on this, to prevent disputed situations.

The Chairperson said that different interpretation could be given on the basis of Article 47 and the

relationship with Article 46, but in principle notified bodies under the Directive should be able to

continue their activities during the transition period, until 20 April 2019.

GERMANY, taking into account that there are Member States who will continue to notify during

the transition period and other not, proposed a pragmatic approach: to add at the end of the paper a

note as “The notified body must have the notification to act like that”.


NETHERLANDS pointed out that there were not equal opportunities of all notified bodies after 20

April 2018, for the different national approaches, as in some cases not even national legislation on

notification would be available.

COM explained that, as Article 47(1) allow to place on the market products in conformity with the

PPE Directive until 20 April 2019, this would need also of the activities of notified bodies under the

Directive, to issue the relevant certificates and approval decisions. In this sense, in the NANDO

system, the two lists of notified bodies, under the Directive and under the Regulation, will be kept

during the transition period.

GERMANY agreed with NETHERLANDS. There will be no conformity assessment body notified

under the PPE Directive in Germany from 21 April 2018. They asked to add to the paper a sentence

stating that bodies need to be notified still under the Directive to apply the referred provisions. In

any case, the notified bodies would remain liable for the products legally placed on the market

before 21 April 2018, and in principle all the German bodies will be notified under the Regulation

too.

SPAIN supported the COM point of view, and considered that the transitional provisions of Article

47 prevail on the derogatory ones of Article 46.

POLAND also supported the COM proposal.

NETHERLANDS agreed with GERMANY but not on the sentence to add. The problem is the

legal basis for the notification of conformity assessment bodies when the PPE Directive is repealed

by the PPE Regulation: in this sense, with the lack of the legal basis, it would not be possible to

continue with the notification.

The Chairperson underlined that the interpretation should be coherent with the possibility of still

allowing placing products on the market under the Directive.

FESI appreciated the pragmatic approach proposed by COM, with a fully applicable transition

period and the principle of proportionality. It is necessary to apply the same provisions through the

EU, taking into account also category I products, without the intervention of notified bodies.

GERMANY recalled that discussions on Article 47 were ongoing since two years, and it would be

necessary to take some pragmatic solution, but trying to avoid to have two separate and overlapping

legal frameworks. In this sense, as a practical solution, they could accept the COM proposal.

The Chairperson agreed on the need to reach a practical solution, “for the real world”. Could it

possible to agree on the COM document, or would it be necessary to consult the Legal Service for

an opinion on the transitional provisions? The paper could be adopted as guiding principle, for

coordination and uniform application in all the Member States.

NETHERLANDS said that, if the COM paper is adopter, they want the minutes of the meeting to

reflect that NETHERLANDS did not support it.

FRANCE said that they had been also working on de-notification of bodies under the Directive and

notification under the Regulation. They considered that a legal assessment on the interpretation of

Article 47 would be convenient and useful.

The Chairperson concluded that, due to the questions and reservations raised by some Member

States, it would not be possible to adopt the document to ensure its uniform application, as it would

be necessary a legal review. It would kept on hold and forwarded to the Legal Service of COM, to

get an answer as soon as possible on the interpretation of Article 47 of the PPE Regulation on

transitional provisions, but without a specific commitment on timing.

Action point: COM, to keep on hold the proposal on certificates and approval decision, and

to ask the Legal Service for interpretation of Article 47 of the PPE Regulation on transitional

provisions.


4.4. New standardisation request ("mandate") and availability of European harmonised

standards for Regulation (EU) 2016/425

COM informed that the structure and contents of the draft new Standardisation Request

(“mandate”) for the PPE Regulation have been agreed with the Legal Service, to duly take into

account the applicable legislative and jurisprudential references (Regulation (EU) No 1025/2012 on

European standardisation115 and rulings of the European Court of Justice116). The procedure for the

formal approval and issue of the mandate is going to be launched, by submitting it to the

Standardisation Committee, likely in May 2018. When issued and accepted by the European

Standardisation Organisations (CEN and CENELEC), the new Standardisation Request will provide

the adequate legal basis for PPE standardisation under the Regulation.

Action point: COM, to submit the draft Standardisation Request for the PPE Regulation to

the Standardisation Committee.

4.5. List of notified bodies in NANDO and CIRCABC

COM informed that, for the time being, in the NANDO list there were 67 notified bodies under the

PPE Regulation, from 14 Member States and 1 MRA Country, when those notified under the PPE

Directive were 116 from 22 Member States, 1 MRA Country and 1 Custom Union Country. The

process to provide the most complete list as possible is still ongoing and should be achieved in due

time. At the same time, the match between the lists in NANDO and in the CIRCABC Interest

Group for notified bodies is going to be checked, to ensure the correct participation in the activities

of the European Coordination.

Action point: Member States, to continue communicating their procedures and notifications

for conformity assessment bodies under the PPE Regulation as soon as possible. COM, to

continue publishing the notifications in NANDO and to check the match with the list of

representatives in the relevant CIRCABC Interest Group.

5. Scope and implementation of the PPE Directive and Regulation:

5.1. Protective clothing containing removable protectors: clarification and proposal for the PPE

Guidelines (Doc. PPE-18-1-3)

COM recalled the question from the last meeting, where it was concluded that removable protectors

are PPE on their own (according to Article 3(1)(b) of the Regulation) and protective garments

which include them are also PPE to be assessed as a combination (according to Annex II, 1.3.4).

This would be reflected in Doc. PPE-18-1-3 as comments to the new requirement 1.3.4. in the PPE

Guidelines.

GERMANY suggested to add to the last sentence, “In case removable protectors are placed on the

market…”, to better clarify the comment.

NETHERLANDS, UNITED KINGDOM and ESF supported the German proposal.

COM noted the general agreement on the paper, with the addition proposed by GERMANY. The

text as approved will be inserted into the new PPE Guidelines.

115 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European

standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC,

95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament

and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European

Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).

116 In particular, cases C-613/14 - James Elliott Construction. Judgment of the Court (Third Chamber) of 27 October

2016; T-474/15 - GGP Italy. Judgment of the General Court (Second Chamber) of 26 January 2017.


Action point: COM, to insert into the new PPE Guidelines the approved text, with the

addition proposed by DE.

Questions related to Annex II 1.3.4. of the PPE Regulation (Doc. PPE-18-1-12)

COM presented Doc. PPE-18-1-12 with two questions from FINLAND and ESF on the possible

application of the requirement 1.3.4. on “Protective clothing containing removable protectors” to

ordinary work trousers with knee pockets and to knee protectors.

NETHERLANDS thought that they should be also tested as a whole.

FRANCE also thought that similar provisions as for motorcyclists’ garments should be applied in

this case, for adequate protection. The question of placing on the market the elements together or

separated, and to be CE-marked or not, should be further analysed.

UNITED KINGDOM said that, according to the circumstances, the characteristics of the product

and conditions of use, it would be necessary to ensure that this would work adequately for the

intended protection. This should also involve the responsibility of the employer/user.

POLAND considered that there is no need for special tests for the combination in this case, by

taking a pragmatic approach.

FRANCE reaffirmed that it would be necessary to check whether the work trousers with the knee

pockets for protectors are adequate for the intended level of protection.

NETHERLANDS agreed with FRANCE.

ETSA said that, according to today’s practice, the combination are certified; but this could be

clarified in standardisation, by defining the pockets and the protectors, and the different possible

combinations.

ESF supported ETSA.

FRANCE also agreed that possibly the best way to deal with this kind of questions would be

standardisation, for a common understanding on how to proceed, on the basis of the definition of

PPE and the intended protection.

The Chairperson noted a general agreement on the convenience to better analyse the question by

the point of view of standardisation. Therefore, for the time being, if no further comments are

provided, this point can be closed.

5.2. Categorization of swimming aid and apron for butcher: positions and comments (Docs. PPE-

17-2-17, PPE-17-2-17_1, PPE-18-1-14)

COM recalled the question from the last meeting, to reach a conclusion on the categorisation of

swimming aids and aprons for butcher, on the basis of the description of the products and the

comments received so far: swimming aids (armbands) could be considered PPE category II (as

buoyancy aids, not to prevent drowning) and aprons for butchers could be considered PPE category

II (being protection against cutting rather than stabbing).

FESI agreed on both conclusions.

GERMANY agreed on category II for aprons for butchers, as it would be different from protection

against unintended stabbing which would be high risk; but in this case, it is protection for

professionals with adequate user information and standardised knifes, so without so high risk of

accidents.

FRANCE also agree on category II for swimming aids, but with some doubts on aprons, which in

some circumstances could be considered as category III under the Regulation. Maybe it would be

necessary to further clarify the question.


NORWAY asked for clarification on the different levels of protection for intentional and

unintentional stabbing, referring to the position of the Nordic Countries who are rather oriented to

consider those aprons for butchers as PPE category III.

UNITED KINGDOM supported FRANCE and NORWAY on the need for further clarification on

protection against intentional or unintentional stabbing, with the differences in assessment for those

products.

POLAND mentioned some fatal accidents of butchers, having different products on the market.

They would rather prefer to consider those aprons as PPE category II.

COM noted the general agreement on considering swimming aids as PPE category II, and this

would be added to the “Categorisation guide” of the new PPE Guidelines; when for aprons for

butcher, the positions are not very clear between category II or III. This could be further followed

up at the next PPE WG meeting, asking for more comments to be able to reach a conclusion.

Action point: COM, to add the reference of swimming aids as PPE category II to the

“Categorisation guide” of the new PPE Guidelines. All, to provide further comments and

opinions on the categorisation of aprons for butchers under the PPE Regulation, to reach a

conclusion at the next PPE WG meeting.

5.3. Anti-slip footwear: positions and comments (Docs. PPE-16-1-5, PPE-17-2-4, PPE-18-1-14)

COM recalled the question from the last meeting, to reach a conclusion on the consideration of the

proposed anti-slip footwear as PPE or not, taking into account the comments received so far: those

products in principle are not PPE, unless the manufacturer claims for specific anti-slip protection as

PPE category II in the sense of point 8.1 of the “Categorisation guide”.

FESI and NETHERLANDS supported the conclusion suggested by COM.

FRANCE also agreed on not considering those products as PPE, even if for the first ones (“anti-slip

shoe heel patch”) it is not so evident.

COM noted the general agreement on not considering the proposed products as PPE, and closed the

point.

5.4. High visibility clothing: Re-activation of the Ad-hoc group (Docs. PPE-13-1-2, PPE-13-1-3),

Active lighting signalling the user’s presence (Doc. PPE-18-1-14), Are these products high

visibility PPE? (Doc. PPE-18-1-7), Infographic about reflective elements (Doc. PPE-18-1-8)

COM introduced the point on high-visibility clothing, regrouping some specific issues related to

the question, starting from the to re-activate the Ad-hoc group which was active some time ago and

produced some basic documents, as the tabled PPE-13-1-2 and PPE-13-1-3: a note after a meeting

held in December 2012, and a proposal for a “decision tree” to assess whether a product can be

considered high-visibility clothing in the sense of the PPE Directive. These documents, and other

than can recovered, could be the basis to retake this work, to reach common understanding and

agreements to provide guidance for the new PPE Regulation Guidelines.

DENMARK referred to their Doc. PPE-18-1-7 to decide whether some specific kind of garments

“GripGrab” are PPE or not, as an example of the practical questions from the market with respect to

high-visibility protection. An ad-hoc group or task force on high-visibility clothing should take a

general approach, focusing on claims for safety to ensure that such products would be effectively

able to provide safety.

ESF agreed with DENMARK. It would be necessary to reach some general conclusions on the

scope and exceptions of the PPE Regulation with respect to those products: a specific task force

would be useful for such difficult work.

FESI referred to their Doc. PPE-18-1-8 about reflective elements, proposing a text to be included

into the PPE Guidelines to clarify the status of clothing intended for private use with reflective or

fluorescent elements included for reason of design and decoration. They also provided some


examples on the difference between design and protective elements, and suggested to add some

kind of disclaimer or pictograms to adequately inform consumers, about the intentions of the

manufacturer and the possible use of those products. They also agreed with DENMARK on the

need to have a general approach for the work of a specific ad-hoc group on high-visibility clothing.

SPAIN supported the Danish position and proposals. They offered their availability to participate in

a new ad-hoc group, with the relevant documents, covering the different issues on design and

manufacturing as well as on use.

FRANCE referred to the comments to Article 2 of the new PPE Guidelines (pages 23-24), to

further develop guidance in the ad-hoc group on general principles for high-visibility clothing. To

re-activate it, it would be necessary to take the leadership from UNITED KINGDOM, to organise

technical meetings, to translate the relevant documents, etc.

NETHERLANDS, ETSA, DENMARK and POLAND also supported the idea of re-activating the

ad-hoc group, and proposed their participation, taking into account the different issues related to

scope and changes in legislation, market surveillance, accidents to pedestrians, etc.

The Chairperson noted the general agreement to re-activate the ad-hoc group on high-visibility

clothing, even if it could be difficult to COM to actively contribute to it, by participating or

providing translations etc. Maybe this could be done within the activities of the PPE AdCo Group,

to discuss and to reach conclusions to be taken into account for the PPE Guidelines. This could be

an acceptable way forward.

Action point: COM, to forward the basic information to re-activate the ad-hoc group on

high-visibility clothing to the PPE AdCo Group, for their discussions to reach conclusions for

the PPE Guidelines. All, to express their willing to participate to the ad-hoc group and to

provide contributions and proposals through the PPE AdCo Group.


examination: positions and comments (Docs. PPE-17-2-13, PPE-18-1-14)

COM recalled the question proposed by SPAIN at the last meeting and said that comments have

been received by the Nordic Countries only, considering that the levels of protection declared on the

product should be the same as in the EC/EU type-examination certificate.

GERMANY agreed on the position of SPAIN.

FRANCE stressed on the need to prevent any possible confusion for users.

SPAIN asked the representatives of manufacturers’ associations and of notified bodies, whether

they can provide information on the extent and the reason of such practices.

HCNB said that it could be a general practice in the PPE sector, that some products are certified

against different levels of protection. However, the question should be addressed to manufacturers

rather than to notified bodies.

ESF said that they could collect information from manufacturers, based on the Spanish document.

COM recognised the need to collect more information on the question, in particular from

manufacturers, to be able to further discuss and to reach a decision at the next PPE WG meeting.

Action point: All, in particular manufacturers’ associations, to provide information on the

extent and the reason of the practices described in the Spanish document, for further

discussion and to take a decision at the next PPE WG meeting.

5.6. Categorization protective clothing for wildland firefighters (EN 15614): positions and

comments (Docs. PPE-17-2-14, PPE-18-1-14)


COM recalled the question proposed by SPAIN at the last meeting, on the categorisation of

protective clothing for wildland firefighters referring to standard EN 15614117. Comments have

been received by the Nordic Countries only, in favour of considering that the described products as

PPE category II.

ESF remarked that differences in practice could be possible, as well as testing on the same levels

with different results. Those garments could be better considered as category III.

NETHERLANDS though that, according to their characteristics and the intended protection for

users, this clothing should be considered as category III.

SPAIN agreed that, by the point of view of firefighting, the level of risk would correspond to

category III.

FRANCE also agreed on categorisation III.

The Chairperson noted the general agreement on concluding that the described protective clothing

for wildland fighters is to be considered PPE category III. This would be added to the

“Categorisation guide” of the new PPE Guidelines.

Action point: COM, to add the reference of protective clothing for wildland fighters as PPE

category III to the “Categorisation guide” of the new PPE Guidelines.

5.7. prEN ISO 21420: how innocuous must protective gloves be?

KAN made a presentation on protective gloves referring to the general requirement 1.2. of the PPE

Regulation on “Innocuousness of PPE” and to the standard prEN ISO 21420118 currently under

development. He developed different considerations on the limit values of the standard and the

relationships with the REACH regulations, calling for the need to establish clearer criteria on

innocuousness, as well as some guidance, to be agreed also at PPE WG level.

NETHERLANDS commented on the production and washing processes for gloves.

POLAND asked for more information on the chemical components used in manufacturing gloves

and their level of potential danger for users.

KAN answered to NETHERLANDS and POLAND providing more detailed information.

COM said that the presentation from KAN would be circulated in CIRCABC for information and

possible comments from the members, for follow-up at the next PPE WG meeting.

Action point: COM, to circulate the presentation made by KAN in CIRCABC, for follow-up

at the next PPE WG meeting.

5.8. Categorisation of protective gloves against heat for private use (Docs. PPE-18-1-11, PPE-18-

1-15)

COM introduced the document submitted by the Vertical Group 5 of the European Coordination of

Notified Bodies on Personal Protective Equipment (VG5 PPE-NB) on categorisation of protective

gloves against heat for private use, asking for opinions and support. SWEDEN has submitted

another paper in answer, agreeing on considering gloves for cooking as PPE category II.

FINLAND explained the situation in their country with those products, and also considered them as

PPE category II.

POLAND would rather considered those gloves as PPE category I, as the related risks for users are

low.

117 EN 15614:2007 Protective clothing for firefighters - Laboratory test methods and performance requirements for

wildland clothing.

118 prEN ISO 21420 (January 2018) Protective clothing including hand and arm protection and lifejackets.


NETHERLANDS and UNITED KINGDOM agreed with FINLAND on categorisation II.

FRANCE took into consideration the different possibilities for categorisation, according to the

temperatures, and concluded that category II seemed the most reasonable option.

SPAIN also agreed on categorisation II.

ESF referred to the second question raised in the VG5 paper, on considering some items as PPE for

private use against heat, or not.

FRANCE considered that, on the basis of the pictures provided and the described characteristics

and use, it would not be easy to take a decision, also because the meaning of terms as “traditional”

in opposition to “industrial” was not very clear.

SWEDEN also expressed doubts on the second question.

The Chairperson noted the general agreement on concluding that protective gloves against heat for

private use are to be considered PPE category II. This would be added to the “Categorisation guide”

of the new PPE Guidelines. On the second question, on the other items proposed, it would be

necessary to ask for more comments and contributions, to follow up it at the next PPE WG meeting.

Action point: COM, to add the reference of protective gloves against heat for private use as

PPE category II to the “Categorisation guide” of the new PPE Guidelines. All, to provide

comments and contributions on the other items proposed, to follow-up the question at the next

PPE WG meeting.

5.9. Certification of industrial safety helmet for work in height by applying a combination of the

requirements of EN 397+A1:2012 and EN 12492:2012 (Doc. PPE-18-1-13)

CZECH REPUBLIC introduced their paper, on a notified body’s input. They asked for the views

of the PPE WG on possibly contradictory requirements on industrial safety helmets from the

standards EN 397119 and EN 12492120, on the basis of assessment according to the use.

COM confirmed that the point was presented for information only, and it will be forwarded to

CEN-CENELEC for due consideration in the standardisation work.

Action point: COM, to forward the CZ paper to CEN-CENELEC for due consideration.

6. Standardisation:

6.1. Lists of references of European harmonised standards in the OJEU

COM informed that the latest lists of references of harmonised European standards under the PPE

Directive have been published on the Official Journal of the European Union (OJEU) on 15

December 2017, with 285 references (278 from CEN and 7 from CENELEC). After good

cooperation with the European Standardisation Organisation, it will be possible to publish on in the

OJEU the last list under the PPE Directive and the first list under the PPE Regulation, together on

27 March 2018. The last list under the PPE Directive will contain 288 references (281 from CEN

and 7 from CENELEC) and will be applicable until 20 April 2019; the first list under the PPE

Regulation will contain 172 references (all from CEN) and will be applicable from 21 April 2018.

Those lists will include specific notes to explain their contents and validity.

Action point: COM, to publish the next lists of references under the PPE Directive (the last

one) and under the PPE Regulation (the first one) in the OJEU on 27 March 2018.

6.2. Report by CEN-CENELEC (Doc. PPE-18-1-16)

119 EN 397:2012+A1:2012 Industrial safety helmets.

120 EN 12492:2012 Mountaineering equipment - Helmets for mountaineers - Safety requirements and test methods.


CEN-CENELEC made a presentation on the standardisation activities in the PPE sector, referring

to the relevant Technical Committees (CEN/TCs and CLC/TCs), the PPE Sector Forum, the PPE

standards published and under development, and the upcoming Standardisation Request for PPE, in

the framework of the transition from the Directive to the Regulation, and also of the new regime for

the “HAS” (former “NAC”) Consultants. They also mentioned to the Standardisation Request on

“Smart textiles”, issued by the COM services in charge of the Textile sector, but also involving

PPE.

7. Notified bodies:

7.1. Report from the Horizontal Coordination of Notified Bodies (HCNB)

HCNB reported on the most recent activities of the Horizontal Coordination of Notified Bodies

under the PPE Directive and Regulation. The last meeting was held in Brussels on 30 November - 1

December 2017, discussing several issues related to the legislative transition, the Recommendation

for Use sheets (RfUs), and other on the practical implementation of legislation and standards. The

next meeting is planned at the end of May 2018. HCNB also welcomed the proposals made by

COM with guidance on the transition, in particular concerning validity of EC type-examination

certificates and approval decisions until 21 April 2023 according to Article 47(2) of the Regulation.

A written report will be provided later on.

Action point: HCNB, to provide a written report on their most recent activities.

7.2. Horizontal and vertical Recommendations for Use sheets (RfUs) (Doc. PPE-18-1-10)

COM presented the results of the written procedure for endorsement of horizontal RfUs produced

by HCNB under the new PPE Regulation, launched in CIRCABC for comments until 23 January

2018. Out of 57 RfUs proposed, 34 received comments from Member States and other members of

the PPE Working Group, as well as from COM. In this sense, the 23 RfUs for which no comments

had been produced can be considered as endorsed and will be published on the COM’s sectoral

website, alongside the list of the RfUs under the PPE Directive, before the date of applicability of

the PPE Regulation (21 April 2018); for the others, they remained pending of endorsement, and the

relevant parties are invited to bilaterally discuss and clarify the issues raised in the comments, in

order to reach an agreement on the way forward: modification of the concerned RfU, withdrawal of

the comment or withdrawal of the RfU.

Action point: COM, to publish on the PPE sectoral website the 23 RfUs under the PPE

Regulation considered as endorsed, before the date of applicability of the Regulation (21

April 2018). PPE WG members and HCNB, to bilaterally discuss and clarify the issues

raised in the comments produced on the other 34 RfUs.

8. Report on the activities of the PPE Administrative Co-operation (AdCo) Group

SWEDEN, as the current Chair of the PPE Administrative Co-operation (AdCo) Group, said that

there were no specific issue to inform about since the latest meeting held in Malmö (Sweden) on

19-20 October 2017. The next meeting of the PPE AdCo Group is planned on 19-20 May 2018,

again in Malmö, to continue discussing and following up a set of questions related to market

surveillance activities, implementation of legislation and the transition from the Directive to the

Regulation.

9. Report on the activities under the OSH Directive 89/656/EEC on use of personal protective

equipment


COM reported on the latest news on the evaluation of the 24 Occupational Safety and Health

Directives, including the use of personal protective equipment (89/656/EEC). The main findings are

presented in the COM SWD(2017)10, available on the EUR-Lex service121. In light of the results of

this evaluation, the COM services in charge (the Directorate-General for Employment, Social

Affairs and Inclusion) are working on the program launched with the Commission Communication

“Safer and Healthier Work for All - Modernisation of the EU Occupational Safety and Health

Legislation and Policy” (COM(2017)12) for removing or updating outdated provisions of a number

of OSH Directives. Among them, six Directives have been identified in a first step, including the

personal protective equipment. The work is being carried out in close cooperation with the tripartite

Advisory Committee for Safety and Health at Work and with the support of experts from Member

States raising issues of more technical nature. After the most recent meetings held in February and

March 2018, the relevant working group should be able to adopt a draft opinion on the revision of

Directive 89/656/EEC in May: the COM services in charge of the PPE Directive and Regulation

will continue to follow up the exercise, in particular to ensure coherence in aspects of common

interest, as for instance the definitions of personal protective equipment, the adequate terminology,

the interplay between design, manufacturing and use of PPE, etc., and will report to the PPE WG in

due time.


No other business was discussed.


The Chairperson said that the next meeting of the PPE Working Group is provisionally planned on

19 November 2018, to be confirmed 6-8 weeks in advance.

Action point: COM, to confirm the exact date of the next PPE WG meeting, provisionally

planned on 19 November 2018.

End of the meeting

121 http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1496925284215&uri=CELEX:52017SC0010.

http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1496925284215&uri=CELEX:52017SC0010



PPE REGULATION (EU) 2016/425 WORKING GROUP


Subject: Working Group under the Personal Protective Equipment (PPE) Regulation

(EU) 2016/425

Place: Conference room Building L-130, Brussels


COM participants: Mr Mario GABRIELLI COSSELLU, Mr Rostislav VARBANOV

(GROW/C3)


The Chairperson welcomed those present and introduced the COM representatives.



With no comments, the draft Agenda was approved.

3. Approval of the draft Minutes of the last meeting held on 12 March 2018 (Doc. PPE-18-2-

02)

The Chairperson introduced the draft Minutes of the latest meeting of the PPE WG held on 12

March 2018.

FESI pointed out that on pages 3 and 4, the references in their interventions to the UPF level should

mention their recommendation to have it at least at 60+.

COM agreed to revise the draft Minutes accordingly.

With the changes pointed out, the draft Minutes were approved.

Action point: COM, to insert the remark from FESI on the “UPF level” recommended at

60+. The approved minutes with this change will be included into the consolidated “Minutes

of the PPE Working Group meetings from 2002 onwards” in the COM sectoral website.

4. Transition to the new PPE Regulation:

4.1. New PPE Regulation Guidelines: editorial group for continuous improvement

COM recalled that the new PPE Regulation Guidelines - 1st Edition - April 2018 were published on

the COM sectoral website in May 2018, including mostly editorial comments from the PPE WG

members after the last meeting. In order to deal with some still pending issues to be further clarified

and improved (as listed in the Agenda of the PPE WG meeting, and others when necessary), an


“editorial group” could be set up to assist the Commission services, in a similar way as made during

the drafting of the new Guidelines.

The Chairperson clarified that the setting up of such an “editorial group” should be discussed in

the context of the conversion of the current Working Group to an Expert Group, according to the

applicable EU rules. This should be done within the next months: COM will inform through

CIRCABC about the formal steps to be taken, as soon as possible.

4.2. Validity of an EC type-examination certificate and revision of harmonised standards (Doc.

PPE-18-1-05 rev.1)

COM presented the revised version of the paper on the draft proposal on the validity of an EC type-

examination certificate and the revision of harmonised standards, taking into account the comments

provided at the last PPE WG meeting, in particular on the need for documentation of the assessment

carried out.

GERMANY referred to the changes listed in the standards, for which not all the products would be

concerned. They proposed to add a sentence in this sense, as “Such given information is not

automatically useful for all products” or “may not affect all the products”, not to be misleading

about the applicable procedure.

The Chairperson explained that the paper aimed to reaffirm the general principles and then, when

asking for information on changes, this would specifically apply to the concerned products.

SPAIN proposed to move the added sentence “The necessary information should be included in the

revised standard…” just below the first paragraph in point III, to improve the readability of the text.

FRANCE could agree on the document, also with the German comments. They asked for the

possibility to have it translated in French.

The Chairperson said that the question of changes in standards and the practical consequences on

specific products, should be assessed on a case-by-case basis, while complying with the general

principles. The document will be revised by integrating the suggested changes: for that, she asked

the members, in particular GERMANY and SPAIN, to send their comments in writing. The new

version of the document will be circulated in CIRCABC for written approval and then published in

the PPE website. For translation, it should be possible, considered that the document is a short one.

Action point: DE and ES, to send written drafting comments as expressed at the meeting.

COM, to include such comments into a revised version of the document, to be circulated in

CIRCABC for written approval. The approved document will be published in the COM

sectoral website and then included into the next edition of the PPE Regulation Guidelines.

4.3. Approval decisions under the PPE Regulation based on EC type-examination certificates

(Doc. PPE-18-1-06 rev.1)

COM presented the revised version of the paper on the validity of approval decisions linked to EC

type-examination certificates, taking into account the comments provided at the last PPE WG

meeting and the opinion of the Legal Service of the Commission on the interpretation of Article

47(1) of the PPE Regulation.

FRANCE supported the document, just asking to correct the date “21 April 2019” into “20 April

2019” in the second paragraph of section I and the last paragraph of section III.

The Chairperson agreed on checking and correcting the dates. She noted the general agreement on

the document, which was then considered as approved by the PPE WG: it will be published in the

PPE website.

Action point: COM, to correct the dates in the document as indicated by FR, and to publish

the approved document in the COM sectoral website, then to be included into the next edition

of the PPE Regulation Guidelines.

4.4. Placing on the market and products in stocks (Docs. PPE-18-2-08, PPE-18-2-09)


COM presented the question on the basis of two papers proposed by FINLAND and ESF.

FINLAND introduced their doc. PPE-18-2-08. It proposed two kind of questions: the first ones

were related to delivery of products with group/corporate/subsidiary companies and their placing on

the market; the second one was about the possibility of selling products in warehouses, compliant

with the PPE Directive, as from 21 April 2019.

ESF introduced their doc. PPE-18-2-09. It deals more specifically with placing on the market of

products in stocks/warehouses, making reference to the applicable sections 2.2.and 2.3. of the “Blue

Guide”122 and proposing some practical examples.

FRANCE said that the definitions of “Making available on the market” and “Placing on the

market” as in the “Blue Guide” should be applied to answer the questions raised by FINLAND. In

particular, for stocks, the date to be taken into consideration is when the product is distributed for

use.

NETHERLANDS reported on ongoing discussions on these issues. They drafted a scheme to

clarify the different steps on placing on the market of products: this will be circulated among all the

members.

GERMANY said that these questions were not really PPE-specific, but also interesting at

horizontal level. On the questions raised by FINLAND, they thought that it would not possible to

place products on the market within the same single entity, but it would be necessary to have

separate entities, otherwise it would be only distribution. On the ESF document, they considered it

as a good one, but they disagreed on some of the examples provided. The important thing is the

physical exchange of the product for effective placing on the market. Some other remarks can be

made; in any case it was a quite complicated issue, to be further discussed and clarified.

The Chairperson recognised that the proposed papers were valuable inputs, for further discussions.

She asked the members to provide written comments, in particular NETHERLANDS and

GERMANY, by the end of the year 2018, to make COM able to draft a consolidated document with

the different inputs received. The document will be circulated in CIRCABC for written approval.

Action point: All, in particular NL and DE as expressed at the meeting, to provide written

comments on the submitted documents, by the end of the year 2018. COM, to draft a

consolidated document with the different inputs received, to be circulated in CIRCABC for

written approval. The approved document will be published in the COM sectoral website and

then included into the next edition of the PPE Regulation Guidelines.

5. Scope and implementation of the PPE Regulation:

5.1. Categorization of apron for butcher: positions and comments (Docs. PPE-17-2-17 ext., PPE-

17-2-17_1 ext., PPE-18-1-14 ext., PPE-18-2-04, PPE-18-2-19)

COM recalled the still open question, whether aprons for butchers should be considered PPE

category II (protection against cutting rather than stubbing) or III (serious damages from intentional

or unintentional stubbing). An expert was invited to provide more information: his presentation will

be circulated to all the members in CIRCABC after the meeting.

BGN-DGUV Expert gave a presentation as in doc. PPE-18-2-19. Taking into account the legal

requirements and the risk categorisation in the PPE Regulation, the characteristics of the products

on the market and the related available standards, the accidents and injuries, and the safety levels to

guarantee, he concluded that the most appropriate categorisation for butcher’s PPE would be

category II.

122 The ‘Blue Guide’ on the implementation of EU product rules: http://ec.europa.eu/DocsRoom/documents/18027.



GERMANY said that it was not clear which types of knifes had been used in tests with aprons, as it

would be necessary to be very specific on that. The PPE Regulation should be interpreted and

implemented to cover the cases of both intentional and accidental stabs, and category III would be

more appropriate for these aprons.

NETHERLANDS referred to their doc. PPE-18-2-04, where they concluded that the correct

categorisation would be category III, due to the consequences of bullet wounds and stabbing.

FRANCE considered that no clear answer was provided yet on categorisation II or III. There are

different kinds of risks related to the tasks a butcher can perform. The arguments put forwards so far

are understandable, but FRANCE would prefer to have category III for these products according to

the risk categorisation in the Regulation. In their opinion, there was no legal doubt in applying the

case of Annex I - Category III (l). In any case, they mentioned the possibility offered by Article 42

of the Regulation on the reclassification of risks in Annex I from one category to another, according

to the technical progress and knowledge.

POLAND supported the comments from FRANCE and GERMANY. However, an appropriate risk

assessment is needed to determine the category, and on this basis, it could be category III, but also

II depending on the specific risk.

The Chairperson briefly summarised the different information and positions expressed so far. It

seemed that it would be necessary to have more discussions with experts, taking into account the

safety levels, the costs implied and the consequences on the effective use of these protections.

LITHUANIA agreed on the need to base categorisation on risk assessment, involving also the

responsibility of the employers. Stating that aprons for butchers are PPE category III could lead to

serious consequences, as employers should have to pay more for these protections and would not

provide them to the workers, and also the aprons could be less comfortable for use. The French

opinion on considering the product as category III based on the Regulation would be correct, but in

reality it would be necessary to take into account the specific risk assessment in the workplace, to

choose the adequate apron of category II or III.

FRANCE clarified that they agreed on the need of risk assessment, but this would open similar

issues also for other products. They understand the potential problems related to costs and usability,

and the need to distinguish between intentional or unintentional stabbing; but it is necessary to take

a common line and to be coherent.

The Chairperson recognised the validity of the legal coherence: if there is some “marge of

manoeuvre” for these products, the same should be also for others. This could be checked with the

lawyers, but for the time being, it seemed that the most appropriate option is to consider aprons for

butchers as PPE category III, according to the classification in Annex I to the Regulation.

GERMANY agreed on the need to deal with the question internally. They supported FRANCE: the

same approach would be taken not only for aprons but also for other products, as those currently

under discussion in other topics in the Agenda. The legal text must be followed to ensure a common

approach. If necessary, categorisation could be reworked, by using the possibility given by Article

42.

IRELAND wondered on the real meaning of “stabbing”, when for this kind of aprons, it would be

rather an accident, not intentional stabbing.

UNITED KINGDOM considered that the intention of the legislation on that point is confusing,

putting in the same point “bullet wounds” and “knife stabs”. Some sort of assessment should be

made to clarify the meaning.

The Chairperson concluded that there was a general issue of legal nature to be taken into account.

Concerning the specific question on aprons for butchers, it would be necessary to gather more

evidence on the level of risks and its assessment in the different cases: therefore she asked all the


members to provide written contributions, also from workers’ and employees’ associations. The

point was reported to the next PPE WG meeting to try to reach a consensus.

Action point: COM, to circulate in CIRCABC the presentation given at the meeting. All, to

provide written contributions and evidence on the risks related to the product, to reach a

consensus on categorisation at the next PPE WG meeting.

5.2. High visibility clothing: updates from AdCo Group and “High Visibility Information

Network”

SWEDEN, as the current Chair of the PPE AdCo Group, informed on the latest activities, making

reference to the “High Visibility Information Network” (HiViz) created in CIRCABC for the AdCo

members as a common platform for discussion and common work. A wiki-space was built up to

move forward on separate discussions: on specific items and categorisation of products; and for a

general approach on high visibility clothes. The results of such discussion would be presented at the

next meetings of the PPE AdCo Group and then forwarded to the PPE WG.

The Chairperson appreciated the initiative as a good tool to exchange ideas and practices, for

possible horizontal and vertical guidance.

FRANCE agreed on the need to reach common approaches and agreements, in particular with

respect to manufacturers’ practices and users’ expectations.

ESF also appreciated the initiative, and agreed with FRANCE on the need to take into due account

current practices and expectations. They asked whether the HiViz platform would be accessible for

Member States only.

SWEDEN answered that it was accessible for AdCo members only but it would be possible to

invite also outside members.

FESI expressed thanks for the preliminary work done and supported continuing it. They echoed the

French comments, to improve the comments at pages 24-25 of the PPE Regulation Guidelines. On

this point, they were working on the idea of a “warning”, as some kind of pictogram or similar, to

adequately inform users: they will share these ideas with the PPE WG for further discussion.

DENMARK mentioned the situation on the market of working clothing, with huge amount of

reflective elements claiming for protection or not. It is necessary to clarify how to deal with them.

SPAIN recalled a “decision tree” which was elaborated in 2013 on high visibility clothing and the

different related aspects, including users’ expectations, as well as the appearance of the product and

the effective protection provided. They will recover and re-circulate that document.

SWEDEN also recalled that point, produced by some experts. It would be useful for the ongoing

work too.

The Chairperson said that the point would continue to be followed up, also taking into account the

input of the HiViz platform and the related discussions and documents, as well as that of the

editorial group on the PPE Regulation Guidelines.


examination: positions and comments (Docs. PPE-17-2-13, PPE-18-1-14 ext., PPE-18-2-05)

COM recalled the question proposed by SPAIN. New comments have been received from

NETHERLANDS.

NETHERLANDS explained their position as expressed in doc. PPE-18-2-05.

GERMANY expressed doubts on the last sentence of the Dutch paper, which could be better

rephrased by an editorial point of view.

The Chairperson reaffirmed that the results of the EU type-examination conformity assessment

procedure should be reflected in the EU declaration of conformity.


ESF said that they asked their associates to inform on the question. As a result, they all agree on the

need for certificates to correspond to the results of the procedure, even if in some cases, declaration

of lower levels could happen in the market, probably related to different levels in ergonomics or

similar issues. Concerning the Dutch paper, it should be considered that there are different standards

products should comply with, and this could cause confusion when declaring the levels of

protection.

FRANCE reconsidered the Spanish document and they agreed on that. Commercial reasons could

lead to declare lower levels, but in any case the certification requirements should be respected.

The Chairperson concluded noting a broad consensus on the need to indicate levels of protection

according to the certification process, to prevent any possible confusion or even incompatibility

with the legal requirements of the PPE Regulation. Then, the point can be closed.

5.4. prEN ISO 21420: How innocuous must protective gloves be? (Doc. PPE-18-1-17)

COM recalled the presentation given by KAN at the last PPE WG meeting on protective gloves,

then circulated in CIRCABC. No reaction was received so far; then, with no further comments, the

point can be closed.

5.5. Categorisation of protective gloves against heat for private use (Docs. PPE-18-1-11, PPE-18-

1-15, PPE-18-2-06, PPE-18-2-17)

COM recalled that protective gloves against heat for private use have been considered PPE

category II at the last PPE WG meeting, and included as such at point 9.15 of the “Categorisation

guide” in the PPE Regulation Guidelines. On the other items proposed in doc. PPE-18-1-11, new

comments have been received by NETHERLANDS and FINLAND.

NETHERLANDS referred to their doc. PPE-18-2-06, concluding that none of those products

should be considered as PPE.

FINLAND referred to their doc. PPE-18-2-17 and concluded that potholders and similar products

should be considered as PPE.

SWEDEN agreed on the Dutch position, taking into consideration the definition of PPE “to be

worn or held”.

GERMANY supported the Finnish opinion. On the basis of the legal text, potholders and similar

products provide protection against specific risks and they should be considered as PPE.

DENMARK agreed with FINLAND and GERMANY, and recalled the huge amount of injuries in

private spaces.

SPAIN and UNITED KINGDOM also agreed with FINLAND and GERMANY.

FRANCE referred back to the scope and definitions of the PPE Regulation, to recognise that those

products are covered, putting into evidence the protection they provide, rather than their

morphology. They just have some reservation on the grey product in the top left of the third page of

the doc. PPE-18-1-11.

AUSTRIA also agreed that those products were PPE, to include them into the “Categorisation

guide” of the PPE Regulation Guidelines, as proposed by the European Coordination of Notified

Bodies.

The Chairperson concluded noting the general agreement on considering potholders and similar

products used for the same purpose as oven gloves and mittens, as PPE category II, with some

exceptions as mentioned by FRANCE. This will be included in the next edition of the PPE

Regulation Guidelines.

Action point: COM, to include into the next edition of the PPE Regulation Guidelines the

point on categorisation of potholders and similar products used for the same purpose as oven

gloves and mittens, as PPE category II, according to the terms agreed at the meeting.


5.6. Categorisation of welder’s clothing and gloves for welders (Doc. PPE-18-2-10)

COM introduced a paper drafted on a point raised by ESF, proposing to clarify the categorisation of

welder’s clothing and gloves for welders and to remove a potential contradiction in the

“Categorisation guide” of the PPE Regulation Guidelines with respect to other guidance documents.

SPAIN expressed doubts on the basis for categorisation of those products, noting some confusion in

particular for gloves.

FRANCE noted the issue and would need more time to analyse it more in depth. They will send a

written position on that.

GERMANY agreed with the proposed changes, to make things clearer.

ESF said that the changes could affect categorisation for gloves for welders, among categories II or

III, so it would be necessary to revise the concerned documents based on evidence. There were

different cases to consider and occupation health and safety authorities could help.

The Chairperson recalled that those gloves for welders are PPE category III as indicated in point

9.3 of the “Categorisation guide”. The proposal would be rather for an editorial change, not to re-

open a discussion on categorisation, unless new evidence is provided. It seemed that more time was

necessary to analyse the question: therefore, she invited all the members to provide written

comments and contributions by the end of the year 2018, for further discussion at the next PPE WG

meeting.

Action point: All, to provide written comments and contributions on the submitted document,

by the end of the year 2018. COM, to revise the document according to the inputs received,

for further discussion at the next PPE WG meeting.

5.7. PPE produced as a single unit to fit an individual user and PPE produced in series which

need to be adapted to individual users (Doc. PPE-18-2-11)

COM introduced a paper drafted on a point raised by GERMANY and others, asking for specific

proposals to improve the contents of the related section of the PPE Regulation Guidelines (page 55

on Article 19 - Conformity assessment procedures).

SPAIN in principle agreed on the need to clarify the examples there, but the point raised by

GERMANY was not clear, concerning products addressed to a specific person.

GERMANY explained the problem with protective glasses with corrective lenses, with respect to

the conformity procedure which would destroy the product for testing. The categorisation should be

clarified there.

FRANCE agreed on the need to be more precise on the question. There are different possible cases,

as for example with sunglasses, considered PPE category I, but with corrective lenses they are

medical devices, with specific conformity assessment procedures.

GERMANY said that unclear or incorrect categorisation could be a problem for manufacturers as

well as for notified bodies when applying the relevant conformity assessment procedure. The

example of protective corrective glasses should be shifted to the paragraph on custom-made

orthopaedic footwear.

SPAIN did not agree with GERMANY. This could be a problem also for custom-moulded

earplugs; they did not see the difference.

The Chairperson asked for comments and suggestions on the issue, in particular examples, by the

end of the year 2018, for further discussion at the next PPE WG meeting.

Action point: All, to provide written comments and contributions on the issues raised in the

submitted document, by the end of the year 2018. COM, to draft a consolidated proposal for

improving the concerned text in the PPE Regulation Guidelines, for discussion at the next

PPE WG meeting.


5.8. Risk category III (a) - Industrial dusts and classification of substances and mixtures (Doc.

PPE-18-2-12)

COM introduced a paper drafted on a point raised by POLAND, to improve the PPE Regulation

Guidelines in section 10.3 (page 83).

FRANCE saw no problem at all with the proposal.

SPAIN said that experts already used to include industrial dusts and nanoparticles in solids, so in

principle any additional explanation would not be necessary: it could be redundant but not wrong.

On the reference to the Regulation, the footnote would be enough.

The Chairperson noted a general agreement on the proposal. The modified text will be included

into the next edition of the PPE Regulation Guidelines.

Action point: COM, to include the modified text as approved into the next edition of the PPE

Regulation Guidelines.

5.9. Protection against cleaning materials of weak action or prolonged contact with water (Doc.

PPE-18-2-13)

FINLAND introduced their doc. PPE-18-2-13 to improve the “Categorisation guide” of the PPE

Regulation Guidelines on equipment for hand and arm protection. They would remove the

specification “for professional use” in order to have more safety also for private use.

GERMANY had some doubts in particular on the exception for private use. They tend to agree on

the Finnish proposal to delete that specification.

FRANCE though that the distinction based on the exclusion of Article 2(2)(c)(ii) should be kept.

The Chairperson underlined the need to find the correct wording when identifying the risks and

the products.

SWEDEN said that “dishwashing” would include the whole operation, also cleaning. It was not

that obvious, it would be necessary to analyse the question and come back with written comments.

FRANCE agreed on considering this a sensitive issue, concerning gloves, detergents and other

substances strong enough to affect the skin. It would be necessary to reflect to ensure coherence in

the practical use, by using a pragmatic approach.

The Chairperson recognised the need to have more time to express positions, in favour or against

the Finnish proposal. She asked all the members for comments and suggestions by the end of the

year 2018, for further discussion at the next PPE WG meeting.

Action point: All, to provide written comments on the FI proposal, especially those

disagreeing on it, by the end of the year 2018, for further discussion at the next PPE WG

meeting.

5.10. Skin protection UV radiation (Doc. PPE-18-2-18)

COM introduced a paper drafted on a point raised by SPAIN, on a possible inconsistency in the

PPE Regulation Guidelines with respect to skin protection against natural UV radiation for private

use.

FESI recognised the existence of the problem, but disagreed on the solution proposed. They were

working on a paper, to be sent as written contribution to solve the issue.

SWEDEN recalled old discussions on that, and wondered on the need to reopen the discussion,

with more comments.

FRANCE said that it would be necessary to analyse more in detail the specific properties of the

protection. More information and expertise are needed on the point raised by SPAIN as well as on

the categorisation.


The Chairperson asked FESI to provide their proposal, to circulate it among all the members, so

that they can provide written comments for further discussion at the next PPE WG meeting.

Action point: FESI, to provide a proposal to solve the issue raised by ES. COM, to circulate

the FESI document, and All, to provide written comments, for further discussion at the next

PPE WG meeting.

5.11. PPE for hairdressers

COM informed on the requests of the social partners in the field of hairdressing, to improve health

and safety of protective equipment against specific risks, as far as guidance documents,

standardisation and market surveillance are concerned. They announced the attendance of the social

partners to the next PPE WG meeting, in order to provide clarification on their concerns and the

possible ways forward.

6. Standardisation:

6.1. New standardisation request for PPE: state of play (Doc. PPE-18-2-15)

The Chairperson informed on the latest developments with the new Standardisation Request in the

field of PPE. The latest draft, as tabled as doc. PPE-18-2-15, was submitted to the meeting of the

Standardisation Committee on 15 October 2018: some comments had been provided by Member

States. A revised version of the draft is currently under preparation to take into account such

comments, to the extent possible, and should be re-submitted for approval at the next meeting of the

Standardisation Committee in 2019.

FRANCE confirmed that they provided some comments on the draft, taking into consideration that

the new Standardisation Request for PPE would be a reference for other future requests in other

fields.

The Chairperson added that the Commission was going to adopt a Communication on the Single

Market and also a Communication on Standardisation: this would include a reference to the

procedures and contents of Standardisation Requests. Further information will be provided as soon

as possible.

[the Commission Communications “The Single Market in a changing world - A unique asset in

need of renewed political commitment”123 and “Harmonised standards: Enhancing transparency and

legal certainty for a full functioning Single Market”124 have been issued on 22 November 2018]

6.2. Update on the procedure on the formal objection against standards on inflatable lifejackets

(Doc. PPE-18-2-16)

COM informed on ongoing development concerning the formal objection lodged by SWEDEN

against standards EN 1SO 12402:2006 parts 2, 3 and 4 on inflatable lifejackets. On the basis of the

presentation given at the last meeting of the Standardisation Committee on 15 October 2018 and

tabled as doc. PPE-18-2-16, COM was oriented to consider the formal objection justified, and to

remove the presumption of conformity of the concerned clauses of the standards only.

CEN reaffirmed their position against the formal objection, and referred to the ongoing work in

CEN/TC 162 to revise the standards, even if they considered that a locking device as requested by

SWEDEN would not be possible as a technical solution in a product standard.

123 Press release and link to the Communication and other documents: http://europa.eu/rapid/press-release_IP-18-

6490_en.htm.

124 Press release and link to the Communication and other documents: http://europa.eu/rapid/press-release_IP-18-

6491_en.htm.






FRANCE reported on their investigations on the market, and on this basis they shared most of the

conclusions of SWEDEN. They supported the option proposed by COM.

SWEDEN said that the Swedish manufacturer has taken voluntary measures and installed a

construction to keep the cylinder in place. Most of the brands of inflatable lifejackets have an

inflation device with a similar construction as the Swedish brand, but they have not installed any

construction to keep the cylinder in place. There is no requirement in the standard yet covering the

risk of the gas cylinder becoming loose during use. It is an urgent issue to introduce requirement

and test method in the standards EN ISO 12402.

FINLAND also expressed support to the COM proposal.

The Chairperson confirmed that COM would draft an Implementing Decision under the PPE

Directive to add a warning limiting the presumption of conformity of the concerned standards; this

would be submitted for approval at the next meeting of the Standardisation Committee in 2019. In

the meantime, the relevant CEN/TC should take into account the concerns expressed to improve the

standards.

6.3. Lists of references of European harmonised European standards in the OJEU

COM informed that the latest lists of references of harmonised European standards under the PPE

Regulation have been published on the Official Journal of the European Union (OJEU) on 15 June

2018 (with a Corrigendum on 26 June), with 173 references (172 from CEN and 1 from

CENELEC). New lists should be published according to the implementation of a new procedure.

6.4. Report by CEN-CENELEC (Doc. PPE-18-2-20)

CEN-CENELEC gave a presentation on the standardisation activities in the PPE sector, referring

to the relevant Technical Committees (CEN/TCs and CLC/TCs), the PPE Sector Forum, the PPE

standards published and under development, and the upcoming Standardisation Request for PPE.

They also made reference to the ongoing Standardisation Request on “Smart garments”, to the

operation of the HAS Consultant system, and to other open issues on non-citation of standards, in

particular those on equestrian helmets and on inflatable lifejackets.

COM said that the presentation would be circulated in CIRCABC.

The Chairperson referred in particular to the HAS Consultants systems, in place as from April

2018, aimed to make the assessment process of standards more effective; and to the still open

issues, remarking the active participation of the COM services and the positive co-operation with

CEN-CENELEC to find suitable solutions as soon as possible.

Action point: COM, to circulate in CIRCABC the presentation given at the meeting.

6.5. Report by HAS Consultants (Doc. PPE-18-2-22)

HAS Consultant reported on the activities carried out in the PPE field, with the results of

assessments of draft standards under development in 7 CEN Technical Committees.

COM said that the written report prepared by the HAS Consultant will be circulated in CIRCABC.

Action point: COM, to circulate in CIRCABC the written report presented at the meeting.

7. Notified bodies:

7.1. Lists of notified bodies in NANDO and CIRCABC

COM informed that at the moment in NANDO there are 103 notified bodies under the PPE

Regulation, from 21 Member States and 1 MRA Country: this is almost the same number as in the

previous PPE Directive, which is a good result.



HCNB reported on the most recent activities of the Horizontal Coordination of Notified Bodies

under the PPE Regulation. The last meeting was held in Brussels on 29-30 May 2018 and the next

one should take place at beginning of 2019, with a new Technical Secretariat.

Action point: COM, to circulate in CIRCABC the written report presented at the meeting.

7.3. Horizontal and vertical Recommendations for Use sheets (RfUs) (Docs. PPE-18-1-10 rev.1,

PPE-18-2-03, PPE-18-2-07)

COM presented the results of the most recent written procedures for endorsement of horizontal and

vertical RfUs produced by HCNB under the PPE Directive and the PPE Regulation, making

reference to the documents with the comments provided by the PPE WG members. The endorsed

RfUs would be published on the PPE website; for the other RfUs, COM and the Technical

Secretariat of HCNB will consolidate the list in the oral procedure, to promote bilateral dialogue

between the concerned parties, to reach agreements and to reduce as most as possible the number of

pending items.

Action point: COM, to publish on the COM sectoral website the RfUs recently endorsed.

COM and HCNB-TS, to consolidate the list of RfUs in the oral procedure, to promote

bilateral dialogue for solutions between the concerned parties about the comments received.

8. Report on the activities of the PPE Administrative Co-operation (AdCo) Group) (Doc. PPE-

18-2-14)

SWEDEN, as the current Chair of the PPE Administrative Co-operation (AdCo) Group, presented a

written report as summary of the activities carried out in 2018, including the last meeting held in

Malmö (Sweden) on 19-20 April 2018. For the next year 2019, a new Chair should be chosen.

FRANCE informed, concerning the point on diving equipment, that they were currently developing

a specific project. When available, they could provide the French version.

Then, they proposed to recover the meetings of the PPE AdCo Group in Brussels, as the availability

in other Member States could be a problem.

The Chairperson explained that this should be decided by the members of the AdCo Group

themselves, with the Administrative Secretariat, for the best possible solution.

IRELAND inquired on the question of validity of EC/EU type-examination certificates after the

“Brexit”, making reference to the position of COM as expressed in the “Note to the stakeholders”

published in the sectoral websites, and to the contents of the “Blue Guide” when bodies are no

longer notified, which seemed to be contradictory.

The Chairperson said that it was a very sensitive issue, to be discussed with the specific “Task

force”125. More information will be provided as soon as it is made available.

9. Update on the activities under the OSH Directive 89/656/EEC on use of personal protective

equipment

COM said that there were no new information available.


The Chairperson informed on notification of Member States’ rules on penalties, according to

Article 45 of the PPE Regulation. The deadline was set on 21 March 2018 but some Member States

125 Brexit negotiations: https://ec.europa.eu/commission/brexit-negotiations_en.

https://ec.europa.eu/commission/brexit-negotiations_en


did not notify their rules yet; a new reminder would be sent. If no answer were received, the next

step would be an infringement procedure.

TURKEY mentioned a question on categorisation of goalkeeper gloves, and the tests used for

certification, which considered a working conditions time much longer (8 hours) than the usual one

during matches (2 hours). They asked whether such gloves could be excluded from these tests.

FRANCE answered that those gloves could be considered as PPE category I or II, according to the

specific risks, applying the relevant tests.

The Chairperson encouraged TURKEY and FRANCE to have bilateral exchanges on this point,

and if necessary, this could be reported to the next PPE WG meeting.


The Chairperson said that the next meeting of the PPE Working Group is scheduled on 26 March

2019, to be confirmed about 8 weeks in advance.

Action point: COM, to confirm the date of the next PPE WG meeting, scheduled on 26

March 2019.

End of the meeting






(EU) 2016/425

Place: Conference Centre Albert Borschette (CCAB), Brussels

Chairperson: Ms Felicia STOICA (COM GROW/C3)

COM participants: Mr Mario GABRIELLI COSSELLU, Mr Rostislav VARBANOV, Ms

Laurence DEDOBBELEER, Ms Sandra VERKAMMEN (GROW/C3)


The Chairperson welcomed those present and introduced the COM representatives.



With no comments, the draft Agenda was approved.

3. Approval of the draft Minutes of the last meeting held on 19 November 2018 (Doc. PPE-19-

1-02 rev.1)

COM introduced the draft Minutes of the last meeting of the PPE WG held on 10 November 2018.

Comments received by SWEDEN and LITHUANIA on the first version circulated in CIRCABC

had been included into the revised version in “track changes”.

With no further comments, the revised version of the draft Minutes was approved.

Action point: COM, to include the approved Minutes into the consolidated “Minutes of the

PPE Working Group meetings from 2002 onwards” in the COM sectoral website.

4. Transition to the new PPE Regulation:

4.1. Validity of an EC type-examination certificate and revision of harmonised standards (Doc.

PPE-18-1-05 rev.2)

COM explained that the referred document was revised adding the comments provided by

GERMANY and SPAIN at the last PPE WG meeting, and circulated in CIRCABC for written

approval from 4 to 22 March 2019. No additional comments have been received, therefore the paper

was considered as approved by the PPE WG and published on the COM sectoral website on 25

March 2019, as guidance document “Validity of an EC-type examination certificate and revision of

harmonised standards” https://ec.europa.eu/docsroom/documents/34601.

https://ec.europa.eu/docsroom/documents/34601


FRANCE inquired on the possibility to have this guidance document translated into French and

other languages.

The Chairperson replied that COM is not in the position to translate guidance documents, due to

limitations in resources, but it could be directly done by Member States or other interested parties.

4.2. Placing on the market and products in stocks (Docs. PPE-18-2-08, PPE-18-2-09, PPE-19-1-

03, PPE-19-1-05, PPE-19-1-07, PPE-19-1-08, PPE-19-1-13, PPE-19-1-16)

COM recalled the question and informed that the COM paper (PPE-19-1-13) proposed for approval

includes the elements presented by FINLAND and ESF at the last PPE WG meeting, as well as the

subsequent comments made by NETHERLANDS, Nordic countries, FRANCE and again

FINLAND. The paper is also referring to the relevant contents of the “Blue Guide”126.

FRANCE agreed on the substance of the document, in particular on the need for economic

operators to provide concrete evidences on the date of placing on the market of products. However,

they pointed out that some dates should be checked and corrected at pages 1 and 4, to indicate “20

April” instead of “21 April”.

SPAIN observed that the main contents of the draft guidance document are the same as in the “Blue

Guide”. This could create problems to market surveillance authorities at the external borders for

products coming from non-UE countries.

GERMANY agreed with SPAIN, considering that the “Blue Guide” is applicable to legislation in

general but not necessarily to transition of legislation.

The Chairperson explained that the document cannot further interpret what is stated in the “Blue

Guide” in particular with respect to the concept of “placing on the market” and the related offer,

agreement, hand-over of the product, etc. These are horizontal issues, which will then be applied to

the different situations of sectorial legislation, including transition. In any case, for practical

implementation, a case-by-case analysis is necessary.

UNITED KINGDOM pointed out that in the diagram at page 2, the indications on “withdrawal”

are not really relevant for the case; it would be better to remove them.

The Chairperson agreed on the editorial corrections suggested by FRANCE and UNITED

KINGDOM, to be inserted into the document. With no further comments, she noted a general

agreement on the guidance document as proposed by COM: therefore, it can be considered as

approved by the PPE WG and it will published on the COM sectoral website.

Action point: COM, to publish the approved guidance document, with the editorial

corrections suggested by FR and UK, in the COM sectoral website.


5.1. Categorisation of apron for butcher: positions and comments (Docs. PPE-17-2-17 ext., PPE-

17-2-17_1 ext., PPE-18-1-14 ext., PPE-18-2-04, PPE-18-2-19, PPE-19-1-07, PPE-19-1-12, PPE-

19-1-16)

COM recalled the question on categorisation of aprons for butchers, referring to the contributions

and documents provided by Member States and other stakeholders. As requested at the last meeting

of the PPE WG, COM analysed the question by a legal point of view, concerning the interpretation

of point (l) on “bullet wound or knife stabs” of the list for category III in Annex I to the PPE

Regulation. Where the only criteria to be taken into consideration for the categorisation is the risk

related to knife stabs, and not the “intention” nor the “likelihood” of stabbing, it appears that the

correct classification for aprons for butcher would be PPE category III.

126 The ‘Blue Guide’ on the implementation of EU product rules: http://ec.europa.eu/DocsRoom/documents/18027.



UNITED KINGDOM thought that the question remained difficult to resolve. Point (l) of category

III seems to cover particular situations, for knife stabs as for bullet wounds, related also to the force

involved and the harm caused to the butcher. If category III is confirmed, this would impose stricter

conformity assessment procedures, but this would not make these products safer. It would be better

to classify them as category II, as the related risk is not strictly listed as category III.

POLAND agreed with UNITED KINGDOM. Instead of a more restrictive conformity assessment

procedure, it would be better to take a case-by-case approach, to avoid unnecessary higher costs.

Aprons for butcher could be classified as category II or III depending on specific cases.

FRANCE shared the COM point of view, to consider these products as PPE category III on the

basis of the risk of harm. This would be better in particular for industrial butchers, regularly using

those products. Problems raised by POLAND are understandable in some situations, but it would be

difficult to define different categorisations. More clarification is needed, to further investigate

whether there is room for interpretation.

AUSTRIA also shared the COM position in favour of category III. This is not protective equipment

to be used at home, it can be quite dangerous for operators.

The Chairperson noted the different positions expressed so far. It is necessary to reach a common

agreement for the uniform application of the legislation, based on the legal text as well as taking

into account the intention of the legislators. As further clarification is needed, COM will provide a

more comprehensive legal analysis on the categorisation of aprons for butcher in written. At the

same time all the members are requested to provide more written contributions and opinions on the

question, for further discussion at the next PPE WG meeting.

Action point: COM, to provide written legal analysis on the categorisation of aprons for

butcher. All, to provide more written contributions and opinions on the question, for further

discussion at the next PPE WG meeting.

5.2. High visibility clothing: updates from AdCo Group and “High Visibility Information

Network” (Doc. PPE-19-1-07)

SWEDEN said that no meetings of the PPE AdCo Group took place in the last months, so there is

no new information on the “High Visibility Information Network” (HiViz).

FRANCE presented some considerations laid down in Doc. PPE-19-1-07. They welcomed the

opportunity to exchange information and proposals in the PPE AdCo Group to make progresses on

the question; but it would be necessary to carefully manage the proposed database of products to

prevent possible different interpretations on specific cases. The idea of a “decision tree” needs to be

based on the legal provisions of the PPE Regulation, in particular Article 5 and point 2.13 of Annex

II on the essential health and safety requirements on “PPE capable of signalling the user’s presence

visually”; and not only on the claims of manufacturers.

FESI agreed that claims only from manufacturers would not be sufficient to ensure adequate

protection to users. They referred to Recital (10) of the PPE Regulation to try to clarify whether a

product is in the scope of the legislation or not, by distinguishing protective features from design or

decorative purposes only. It is necessary to explain why a product is PPE or not, to increase legal

predictability and to eliminate possible “grey areas”.

The Chairperson confirmed that discussion should continue within the PPE AdCo Group, for

efficiency, and then, results and conclusions would be brought to the PPE WG for common

agreement and approval.

5.3. Categorisation of welder’s clothing and gloves for welders (Docs. PPE-18-2-10, PPE-19-1-

05, PPE-18-2-10 - Comments, PPE-19-1-08, PPE-19-1-16)

COM recalled the question by referring to the contributions provided so far, including the proposals

to improve the related points in the “Categorisation guide” of the PPE Regulation Guidelines. The

COM paper reflects a compromise position.


ESF identified some problems in the categorisation of products for heat and flame protection. It is

necessary to agree on the interpretation of point (e) on “high-temperature environments, the effect

of which are comparable to those of an air temperature of at least 100 °C” of the list for category III

in Annex I to the PPE Regulation, taking into account the current practices in the sector as well as

data from real working situations, to have coherent discussion and results.

The Chairperson agreed on the need to receive more evidences on heat and flame protection

categorisation, to justify the possible options to take and to explain the changes in the guidance text.

GERMANY agreed with COM and though that the key point to consider is the risk from which

protection is required. The transition from the Directive to the Regulation is an opportunity to

clarify this.

FRANCE could accept the changes as proposed by COM, but the related potential problems should

be considered as well. Otherwise, the situation could remain as it is now.

The Chairperson said that the point remains open for further discussion at the next PPE WG

meeting. All members are asked to provide more written comments and contributions on the

question on categorisation and in particular the ESF on heat and flame protection categorisation.

Action point: All, to provide more written comments and contributions on the question, in

particular ESF on heat and flame protection categorisation, for further discussion at the next

PPE WG meeting.


need to be adapted to individual users (Docs. PPE-18-2-11, PPE-18-2-11 - Comments, PPE-19-1-

16)

COM recalled the question and referred to the written comments provided by SPAIN and

NETHERLANDS. In particular, SPAIN suggested to involve the different Vertical Groups of the

Horizontal Coordination of Notified Bodies (HCNB) for PPE, dealing with eye protection with

corrective lenses, custom moulded earplugs and orthopaedic footwear. Also, the Recommendation

for Use sheet PPE-R/00.022 rev.2, currently under written procedure for endorsement until 22 April

2019, can be relevant for the question, as it deals with “variants”. Some written comments had been

produced on rev.1 under a previous written procedure for endorsement (see Doc. PPE-19-1-09).

GERMANY said that, after consultation with experts, they modified their position and now rather

agree with SPAIN, considering that the concerned text in the PPE Regulation Guidelines is correct.

FRANCE also said that, beside possible comments and improvements, the example provided can

be considered as adequate.

The Chairperson asked for more written comments and contributions to further clarify the

question and possibly improve the PPE Regulation Guidelines. Comments are sought in particular

from the concerned Vertical Groups of Notified Bodies. The point will continue to be discussed at


Action point: All, to provide more written comments and contributions on the question, in

particular HCNB from the concerned VGs, for further discussion at the next PPE WG

meeting.

5.5. Protection against cleaning materials of weak action or prolonged contact with water (Docs.

PPE-18-2-13, PPE-19-1-04, PPE-19-1-07, PPE-18-2-13 - Comments, PPE-19-1-16)

COM recalled the question raised by FINLAND to improve the “Categorisation guide” of the PPE

Regulation Guidelines on equipment for hand and arm protection, with comments received from

SWEDEN, FRANCE, SPAIN and NETHERLANDS, showing their different positions.

SWEDEN considered that the need for clarification of the concerned point 9.6. was not very clear,

but they proposed an alternative wording.


FRANCE disagreed on the Finnish proposal, due to some specific problems and taking into

account the contents of the PPE Regulation, in particular Article 2.2.(c)(ii) and point (b) of

Category I in Annex I. The proposed changes could cause confusion for the operators.

The Chairperson noted that the Finnish proposal did not receive support from the other members.

With no further comments, the point can be put apart for the moment, unless further clarification is

requested.

5.6. Skin protection UV radiation (Docs. PPE-18-2-18, PPE-19-1-06, PPE-19-1-07, PPE-19-1-

11, PPE-19-1-16)

COM recalled the question raised by SPAIN with respect to skin protection against natural UV

radiation for private use. Different positions have been expressed by FRANCE, SWEDEN and

NETHERLANDS, referring in particular to point 16.6 of the “Categorisation guide” and to point (e)

of Category I in Annex I to the PPE Regulation.

FESI gave a presentation on the technical paper they provided on UV protective clothing, including

considerations on the notions of “atmospheric conditions”, “extreme nature” and “minimal risks”.

They proposed to amend the relevant points in the PPE Regulation Guidelines accordingly,

considering skin protection for private use against natural UV radiation as “not PPE”, and garments

claiming for UV protection of UPF 60 or more, as PPE category II.

SPAIN understood the concerns of manufacturers, but the point on private use is not clear, as for

UV radiation there is the risk that the related damages are not perceived by the user. Establishing

category II for all skin protection against natural UV radiation could be problematic, but when

additional protection is claimed for specific garments, it is necessary to take into account also other

factors, as for example activities with higher levels of exposure. These garments for private use

should not be excluded from the scope of the PPE Regulation as proposed by FESI, taking into

account the legal text: all garments claiming for specific protection should be considered PPE

category II.

FRANCE though that the term “specific protection” in point 16.6 should be clarified. Nevertheless,

the current categorisation should not be changed. Concerning the concept of “extreme nature”,

operational conditions could represent a risk even not being “extreme”.

GERMANY said that the PPE Regulation does not give the possibility to categorise these products

as category I as in the “Categorisation guide” now. The only legal possibility is to consider them as

category II.

UNITED KINGDOM agreed with GERMANY by a legal point of view, as it would not possible

to stretch interpretation of point (e) of Category I in Annex I.

SWEDEN also agreed on category II as the best way forward to deal with the question of UV

radiation and atmospheric conditions, also taking into consideration the essential health and safety

requirement 3.9.1.

LITHUANIA agreed with GERMANY and UNITED KINGDOM. According to the PPE

Regulation, these PPE should be category II, with the exception of sunglasses, PPE category I.

FESI reaffirmed that the change in categorisation would be problematic and not really providing

added value, as the costs for manufacturers to go through a certification process would be

significant.

The Chairperson recalled that it is the responsibility of manufacturers to identify the risks and

protection levels related to their products. Having regard to different members’ positions, there is no

support to modify the PPE Regulation Guidelines about “atmospheric conditions”, but to modify

point 16.6 of the “Categorisation guide” by changing category I to category II for products

providing skin protection against natural UV radiation. She asked the members for confirmation.


FRANCE and GERMANY said that it would be convenient to have more time to re-assess the

point.

SPAIN pointed out the problems potentially caused by further postposing a decision on the issue,

considering that in the legal text there is no option to maintain category I.

The Chairperson agreed on the need to respect the legal text of the PPE Regulation. It would be

convenient to give some more time for further analysis as requested by some members, to clearly

distinguish which products should be considered PPE category I or category II. In this sense, the

members are requested to provide more written comments on the question, in particular on the

products concerned and the possible impact from redefinition of categorisation, in 4 weeks time –

until 26 April 2019 – to reach a conclusion at the next PPE WG meeting.

Action point: All, to provide written comments on the question, in particular on the products

concerned and the impact from redefinition of categorisation, in 4 weeks time until 26 April

2019, to reach a conclusion at the next PPE WG meeting.

5.7. PPE for hairdressers (Doc. PPE-19-1-15)

The Social Partners in the field of hairdressing presented the main contents of the document on the

“state of play on hairdressers gloves”. The presentation made reference to the “ErgoHair project”

which identified standards as a key tool to improve the working conditions of hairdressers, in

particular concerning protective gloves against specific risks related to their activity. They also

mentioned other two aspects to be considered: the proposal to include a chapter on hairdressers

gloves into the PPE Regulation Guidelines, and the call to market surveillance authorities to

enhance their activities.

SPAIN asked for more information on the need for new standards while considering the existing

ones for products already on the market, as well as on the questions related to gloves for single use

and the risks for skin.

The Social Partners explained that the existing standards do not cover enough the relevant risks, in

particular the risks deriving from the use of chemical substances. It this sense, they seized the

necessity to develop new standards and improve existing ones. They will engage and provide their

contribution in standardisation activities.

The Chairperson said that the questions related to standardisation should be shared with CEN, and

those on market surveillance with the members of the PPE AdCo Group. Concerning the possible

additions to the PPE Regulation Guidelines, she asked for written comments and proposals, for

follow-up at the next PPE WG meeting.

FRANCE said that it would not be necessary a new “chapter” in the PPE Regulation Guidelines,

but just some lines on protective equipment against the relevant risks, and the adequate

categorisation.

Action point: All, and in particular the Social Partners, to provide written comments and

proposals on possible additions to the PPE Regulation Guidelines, for follow-up at the next

PPE WG meeting.

5.8. Implementation of point 7 of Annex V: Review of the EU type-examination certificate (Doc.

PPE-19-1-10)

FRANCE presented a paper on the interpretation and implementation of point 7 of Annex V to the

PPE Regulation concerning review of the EU type-examination certificate, also referring to the

Recommendation for Use PPE-R/00.059 rev.1 submitted to the written procedure for endorsement

until 22 April 2019. They proposed to make some clarifications in different practical cases.

The Chairperson invited the members to express their written comments on the questions raised

by FRANCE, also within the written procedure for endorsement of the referred RfU. The point will

be followed up at the next meeting of the PPE WG.


Action point: All, to provide written comments on the question, also within the written

procedure for endorsement of the RfU PPE-R/00.059-1 open until 22 April 2019.

6. Standardisation:

6.1. Standardisation request for PPE: update

The Chairperson reported on the still ongoing process to adopt the new Standardisation Request

under the PPE Regulation. After further discussions and contributions received from some Member

States, the final text of the Standardisation Request was presented at the meeting of the Committee

on Standards under the Standardisation Regulation (EU) No 1025/2012, held on 5 March 2019.

This revised version clarified some points and added an informative note in respect to the procedure

of amending the Standardisation Request, and to the relationship with the work programme to be

adopted by CEN and Cenelec. With that, no further changes are possible, due to the legal

boundaries established in particular by the Standardisation Regulation. As the last version of such

document has been circulated only short time before the meeting, it has not been submitted to vote,

but it will be the object of a written procedure for approval. The approval and adoption of the new

Standardisation Request is the necessary legal basis for new publications of references of

harmonised European standards under the PPE Regulation.

6.2. Update on the formal objection against standards on inflatable lifejackets

COM informed on the ongoing procedure to adopt the Commission Implementing Decision on the

formal objection against standards EN 1SO 12402:2006 parts 2, 3 and 4 on inflatable lifejackets.

Some issues are to be clarified with respect to the legal basis to issue the restriction of presumption

of conformity for the concerned clauses of the standards, taking into account that the standards were

cited in the OJEU under the PPE Directive and this will no longer be applicable after 20 April 2019.

In the meantime, cooperation is already in place between the experts of SWEDEN and the relevant

CEN/TC 162, in view of the meeting held on 25 March 2019, to adequately revise the standards for

a new 2019 version under the PPE Regulation.

6.3. Lists of references of European harmonised European standards in the OJEU

The Chairperson informed that new lists of references of harmonised European standards in

support of the PPE Regulation would be published in the OJEU right after the adoption of the new

Standardisation Request. The publication will follow a new procedure, through a Commission

Implementing Decision in the “L” series of the OJEU, instead of a Commission Communication in

the “C” series, and structured in a set of recitals and annexes, listing the references published for the

first time and those withdrawn. This will be similar as done for standards under the Machinery

Directive 2006/42/EC, published with the new procedure on 19 March 2019.

6.4. Report from CEN-Cenelec (Doc. PPE-19-1-17)

CEN-Cenelec presented the latest report on standardisation in the PPE sector. It included

information and considerations on the PPE standards, the relevant Technical Committees, the Sector

Forum, the upcoming Standardisation Request, the operation of the HAS Consultants system, and

some open issues on non-citation of standards.

The Chairperson underlined that the operation of the HAS Consultants system is ruled by the

specific contract between the Commission and EY, with defined procedures. Any related question

should be clarified with the appropriate interlocutors.

6.5. Report from the HAS Consultants (Doc. PPE-19-1-18)

The HAS Consultants reported on the most recent activities carried out in the PPE field, with the

results of assessments of draft standards under development.

7. Notified bodies:



COM informed that at the moment in NANDO there are 105 notified bodies under the PPE

Regulation, from 22 Member States and 1 MRA Country. After the conclusion of the transition

period on 20 April 2019, the list of notified bodies under the PPE Directive will be removed by the

COM sectoral website.

AUSTRIA and FRANCE considered useful to keep some information on notified bodies under the

PPE Directive, for possible checks on certificates issued before 21 April 2019 and potentially valid

until 21 April 2023.

COM ensured that such information will remain available on NANDO, through the appropriate

section.


HCNB Technical Secretariat presented a written report on the activities of the Horizontal

Coordination of Notified Bodies under the PPE Regulation. The next meeting is planned on 28-29

March 2019, covering different topics for discussion. She also mentioned the questionnaire

circulated by DG GROW concerning conformity assessment activities performed by notified

bodies.

7.3. Horizontal and vertical Recommendations for Use sheets (RfUs) (Doc. PPE-19-1-09)

COM presented the documents with the updated results of the most recent written procedures for

endorsement of horizontal and vertical RfUs produced by HCNB under the PPE Regulation. He

recalled the importance of bilateral dialogue between the concerned parties to solve the questions

raised, so to reduce the number of RfUs still pending for endorsement in the oral procedure. In the

meantime, a written procedure is ongoing until 22 April 2019, for 34 horizontal RfUs, 13 vertical

RfUs from VG 9 and 30 vertical RfUs from VG 11.

ESF asked for more clarity and transparency in new versions of RfUs, by using the “track changes”

mode.

UNITED KINGDOM inquired on the timeframes to circulate RfUs and to publish them in the

COM sectoral website when endorsed.

COM answered that this is usually done at the shortest possible delay. In particular, those endorsed

on 22 April 2019 will be published straightforwardly.

8. Report from the PPE Administrative Co-operation (AdCo) Group)

SWEDEN confirmed that no meetings of the PPE AdCo Group took place in the last months, and it

is still necessary to designate the new Chair, as they have already completed a period of two years

in the position. He called for volunteers, to retake the usual activities and meetings as soon as

possible.

The Chairperson underlined the importance of the activities of the PPE AdCo Group and

supported the call for volunteers for the new Chair, which would continue to receive the support of

COM in particular through the funding of the Administrative Secretariat. She suggested that further

information about AdCo Chair responsibilities can be sought from SWEDEN as the former Chair,

as well as from BELGIUM which has chaired other AdCo Group.


ESF raised a question on exoskeletons, which are not considered as PPE for the time being, and

asked whether new information is available, taking into account new products on the market which

can be at the borderline with the Machinery Directive. In this respect, COM clarified that powered


exoskeletons should not be considered within the scope of PPE as they are covered by the

Machinery Directive.

COM provided updated information on notification of Member States’ rules on penalties, according

to Article 45 of the PPE Regulation. Reactions from Member States have been received on still

pending notifications; in other cases, an infringement procedure should be launched.


The Chairperson said that the next meeting of the PPE WG is scheduled on 21 October 2019; date

to confirmed about 8 weeks in advance.

Action point: COM, to confirm the date of the next PPE WG meeting, scheduled on 21

October 2019.

End of the meeting


EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR INTERNAL MARKET, INDUSTRY, ENTREPRENEURSHIP AND

SMEs

Industrial Transformation and Advanced Value Chains

Advanced Engineering and Manufacturing Systems




(EU) 2016/425

Place: Conference Centre Albert Borschette (CCAB), Brussels


COM participants: Mr Mario GABRIELLI COSSELLU, Mr Rostislav VARBANOV, Mr Iván

ARIAS ROLDÁN, Ms Laurence DEDOBBELEER (GROW/C3)


The Chairperson welcomed those present and introduced the COM representatives. She reminded

the participants about the process to replace the existing working group with the new Commission

Expert Group on Personal Protective Equipment (E03678). In the “Register of Commission Expert

Groups and other similar entities”, the “Terms of Reference” and the “Continuously open call for

applications for the selection of members”, for specific “type C” members, have been published: the

concerned stakeholders are invited to submit their applications, while national authorities, European

standardisation organisations and the European coordination of notified bodies will receive a direct

invitation by COM. The call is open and there is no specific deadline, but the first applications to be

assessed will be those received by the end of December 2019, in order to be able to configure the

expert group in time for the first meeting in 2020. At that meeting, the Rules of Procedure of the

expert group will be presented and approved. More detailed information will be sent in writing, in

particular about practical arrangements related to the continuously open call for “type C” members.

Action point: COM, to send written information on the new Commission Expert Group on

Personal Protective Equipment, in particular about practical arrangements related to the

continuously open call for “type C” members.



ESF asked to add a point to “Any other business”, on subcontracting and accreditation of notified

bodies, and acceptance of test reports, as it seems that there are different approaches in some

countries.

With no other comments, the draft Agenda was approved.

3. Approval of the draft Minutes of the last meeting held on 26 March 2019 (Doc. PPE-19-2-

02)

COM introduced the draft Minutes of the last meeting of the PPE WG held on 26 March 2019.


ESF, on point 5.5. of the draft Minutes, considered that there is still some confusion amongst

manufacturers on the status of dishwashing gloves, in particular when they are not PPE and when

they are PPE category I. They offered to provide some complementary wording for the PPE

Regulation Guidelines, on categorisation and exclusion from the scope, in order to give more clarity

on different types of gloves available on the market.

The Chairperson said that further contributions could be considered as long as they do not put into

question the conclusions already reached in the last meeting. For the time being, as possible new

wording would be related to Guidelines, the draft Minutes of the last meeting remain unchanged.





COM introduced the points on follow-up issues and new questions submitted, mostly for

clarification and improvement of the PPE Regulation Guidelines. The first edition was issued in

April 2018 and COM is working on a second edition, to include the results and agreements from the

most recent meetings held in 2018 and 2019. In the meantime, these agreements can be found in the

consolidated minutes of the meetings, which are publicly available on the COM website in its

commitment for transparency and help the stakeholders’ community.

4.1. Categorization of apron for butcher: positions and comments (Docs. PPE-17-2-17 ext., PPE-

17-2-17_1 ext., PPE-18-1-14 ext., PPE-18-2-04, PPE-18-2-19, PPE-19-1-07, PPE-19-1-12, PPE-

19-1-16, PPE-19-2-03, PPE-19-2-08)

The Chairperson informed that, after previous discussion and several contributions, COM

prepared a paper on the categorisation of apron for butcher from a legal perspective.

COM introduced the legal analysis, considering that the correct categorisation should be based

solely on the criterion of the existence of the risk and not on other criteria like the likelihood that

the risk would occur, or the force of the stabbing or the intention of the act. Taking this into

account, apron for butcher should be PPE category III, and should therefore be included in point

6.8 of the “Categorization guide”.

NETHERLANDS supported COM conclusions. They mentioned two fatalities happened in the

Netherlands involving aprons for butcher.

IRELAND expressed preference for category II, considering the criterion of intention and arguing

that a higher categorisation would be problematic and excessive in terms of proportionality.

The Chairperson clarified that bullet wounds and knife stabs are equally addressed as category III

risks in Annex I to the Regulation. The intention cannot be considered as a valid criterion according

to the analysis of the legal text.

SWEDEN and FRANCE also supported COM for category III. FRANCE also referred to a serious

accident related to the subject.

The Chairperson concluded the discussion noting a majority agreement on considering apron for

butcher as PPE category III. This will be inserted into the next edition of the PPE Regulation

Guidelines, in point 6.8 of the “Categorisation guide” as in the COM paper.

Action point: COM, to insert the agreed categorisation of apron for butcher, as PPE

category III, into the next edition of the PPE Regulation Guidelines, in point 6.8 of the

“Categorisation guide” as in the COM paper.

4.2. Categorisation of welder’s clothing and gloves for welders (Docs. PPE-18-2-10, PPE-19-1-

05, PPE-18-2-10 - Comments, PPE-19-1-08, PPE-19-1-16, PPE-19-2-08, PPE-19-2-15)


COM recalled the question, making reference to the papers already presented, and to new

contributions received.

ESF introduced a new paper on categorisation of gloves and clothing for welders, proposing to keep

them as PPE category II as in the previous Directive; when other risks are also covered, they could

be category III. They made reference to documents available from HCNB as well as to the current

situation on the market, where no serious problems have been detected in the majority of welder’s

clothing.

NETHERLANDS thought that it is necessary to consider the welding process where the risk is

above 100 ºC: welder’s clothing providing protection against such high temperatures should be

classified as PPE category III. If the risk would be only UV radiation, then welder’s clothing would

be category II, but welders have always to face the risk to be exposed to liquid metal above 100 °C,

therefore all welder's clothing should be category III.

ESF said that considering welder’s clothing as PPE category III would have a huge impact on the

market. In any case they agreed with NETHERLANDS on the fact that welders are not only

exposed to the risk of UV radiation, but to other risks too, therefore all welder’s clothing should be

PPE category III and not only gloves.

The Chairperson remarked the need to have more technical information and data on accidents, to

provide clarification on welder’s clothing and gloves and the risks related to the welding process.

The question is whether it should be always category III or not, considering that the related

temperatures are above 100 ºC. She proposed that COM draft a paper with the different options for

categorisation II or III, to be circulated in view of the next meeting in 2020, to reach a conclusion.

Action point: COM, to draft a paper with the different options for categorisation II or III of

welder’s clothing and gloves for welders, to reach a conclusion at the next meeting in 2020.


need to be adapted to individual users (Docs. PPE-18-2-11, PPE-18-2-11 - Comments, PPE-19-1-

16)

COM recalled the question. Comments have been requested on the possibility of improving the

contents of the relevant section of the PPE Regulation Guidelines. After those from SPAIN and

NETEHRLANDS, no further comments have been received; therefore, for the time being the text of

the Guidelines can be kept as it is.

ESF agreed with the proposal but remarked that for some custom-made products, different

approaches are taken by some notified bodies, especially for those which are covered by the PPE

Regulation and also by other EU legislation, as for example on medical devices. They proposed to

provide a non-exhaustive list of products in such a situation, to be taken into consideration for

future revision of the PPE Regulation Guidelines.

The Chairperson said that such a list would be very useful for possible future improvements. For

the time being, as there is no opposition against the COM proposal, the text of the PPE Regulation

Guidelines remain as it is.

Action point: ESF, to provide a non-exhaustive list of concerned products with borderlines

with other possibly applicable EU legislation, for consideration at the next meeting in 2020.

4.4. Skin protection UV radiation (Docs. PPE-2-18, PPE-19-1-07, PPE-19-1-11, PPE-19-1-16,

PPE-19-2-05, PPE-19-1-06 rev.1, PPE-19-2-07, PPE-19-2-14)

COM recalled the question, referring to the new contributions received from SPAIN, FESI (revised

paper), UK and FESI again with other associations. There still were different positions on the

proposal to remove an inconsistency in the PPE Regulation Guidelines and the “Categorisation

guide”.


SPAIN presented their paper summarising the situation and indicating two possible options to solve

the problem: either to follow the PPE Regulation and consider skin protection against natural UV

radiation as PPE category II, for private and professional use independently of the protection factor

offered by the material; or to use Article 42 of the PPE Regulation empowering COM to modify

Annex I through a delegated act, to include damage to the skin due to exposure to sunlight for

private use, therefore having PPE against natural UV radiation for private use in category I and PPE

against natural UV radiation for professional use in category II.

FESI introduced their papers, proposing to modify the PPE Regulation Guidelines to consider

natural UV radiation (sunlight) also as an atmospheric condition, and then, in the “Categorisation

guide”, to distinguish two cases: on one hand, UV protective clothing for skin protection against

natural UV radiation, not providing high levels of UV protection, should be considered as PPE

category I for professional use, and not PPE if designed for private use; on the other hand, garments

claiming a high level of protection against natural UV radiation (UPF ≥ 60), or where the

manufacturer claims a protective function against exceptional/severe atmospheric conditions,

should be considered as PPE category II. In any case, if the current situation would be changed, it

would be necessary to carry out an impact assessment.

NETHERLANDS supported the position expressed by SWEDEN in their paper, to have PPE for

skin protection against sun radiation in category II, according to the categorisation of Annex I to the

PPE Regulation. Economic arguments should not prevail over legal boundaries and health and

safety aspects.

The Chairperson agreed on the need to preserve health and safety, but we should also be aware of

the costs and benefits implications.

SPAIN pointed out that it would be necessary to consider as well the impact on users and not only

the economic arguments. The simpler way of solving the question would be that UV radiation is not

an atmospheric condition and therefore keep these PPE in category II.

FRANCE agreed with NETHERLANDS, to duly consider both legal and technical aspects. The

possibility to modify Annex I should be considered, to include skin protection against natural UV

radiation in risk category I, to provide more clarity in the legal text and not only in guidance.

The Chairperson said that modification of the text of the PPE Regulation should be better kept as a

side option. For the time being, it would be better to consider only the possibility of sound legal

interpretation, trying to accommodate the preferred technical outcome in the PPE Regulation

Guidelines and the “Categorisation guide”.

EUROM remarked the different approaches taken by the legislator concerning eyes protection and

skin protection. Skin does not always have a protective barrier and can be worse damaged.

FESI, answering to NETHERLANDS, considered necessary to assess the economic impact related

to categorisation, even if it is not the only aspect to take into account: consumers’ protection is to be

considered as well. The risk depends on a number of factors and an impact assessment on possible

changes should be made.

SPAIN said that if there is no possibility of modifying the PPE Regulation then the category should

be II for both professional and private use.

NETHERLANDS agreed with SPAIN and recalled that the important thing is what manufacturers

claim for protection.

The Chairperson suggested narrowing down the options in a way that they would be legally sound

and not requiring a change in the legal text of Annex I. Such options can be expressed as follows:

1) If natural UV radiation (sunlight) is considered as not constituting an “atmospheric condition”,

then PPE for skin protection against natural UV radiation should be re-classified as PPE category II,

both for professional and private use;


2) If natural UV radiation (sunlight) is considered to constitute an “atmospheric condition”:

- if PPE is intended to protect against non-extreme conditions, skin protection against natural UV

radiation for private use should not be considered as PPE, while PPE for skin protection against

natural UV radiation for professional use should be classified as PPE category I;

- if PPE is intended to protect against extreme conditions, PPE for skin protection against natural

UV radiation should be classified as category II, both for professional and private use.

These options would be better clarified in a paper to be drafted by COM and circulated to the

Member States by the end of October 2019, to ask for their positions and comments by the end of

December 2019. On that basis, a conclusion should be reached at the next meeting in 2020.

Action point: COM, to draft a paper with the different options for categorisation of PPE for

skin protection against UV radiation, to circulate it to MSs by the end of October 2019.

MSs, to express their position and comments on the options as presented by COM, by the end

of December 2019.

4.5. PPE for hairdressers (Docs. PPE-19-1-15, PPE-19-2-06, PPE-19-2-17_1, 2, 3, 4, 5, 6)

The Chairperson recalled the point from the previous meeting, with three lines of action on PPE

for hairdressers: inclusion of specific contents into the PPE Regulation Guidelines, development at

standardisation level for CEN-Cenelec, and raising awareness on market surveillance for the PPE

AdCo Group.

SSPP and COIFFURE EU presented their papers with proposals for the PPE Regulation

Guidelines concerning gloves for hairdressers, at pages 87 (risk assessment), 93 (adaptation to the

user morphology), 108-109 (multi-risk PPE), 124-125 and 157 (cutaneous contact and the related

categorisation). They also provided a background document on the specific risks hairdressers are

exposed to.

The Chairperson remarked that the papers had been circulated just before the meeting, therefore

with not enough time for the members to check them. Questions and comments could be expressed

later on.

NETHERLANDS appreciated the initiative, for continuous improvement of the PPE Regulation

Guidelines. Nevertheless, most of the issues raised by the SSPP concern the use of PPE and would

rather belong to the PPE “workplace” Directive 89/656/EEC.

The Chairperson agreed on the need to rework some of the proposals, to make them more

adequate as guidance for the PPE Regulation, in terms of design and manufacturing, and not for the

use of PPE. On the other hand, other proposals are examples that increase the visibility on the

sector, exactly as it has been done for other sectors.

LITHUANIA agreed with NETHERLANDS, and also on the explanations given by COM. They

asked for more clarification on the proposal to consider “single use gloves for hairdressers” as PPE

category III in point 9.5 of the “Categorisation guide”.

AUSTRIA supported LITHUANIA on the need to have more information on the proposals,

including figures and experiences, to discuss and decide, in particular on categorisation.

SSPP and COIFFURE EU made reference to the background document provided, as well as to

other sources, to explain their proposals. Some aspects were indeed more related to usability of

those PPE, while adequate categorisation would address the main problems faced by hairdressers,

as skin diseases, allergies, irreversible dermatitis etc. due to working conditions and exposure to

harmful substances. More supporting documents would be distributed for including hairdressing

gloves in category III.

SPAIN agreed that proposals for the usability of PPE do not fit in the guidelines but examples do

fit. With regards to the categorisation of gloves for hairdressers, the PPE Regulation does not permit


for exposure to chemical risk other category different from III, regardless of the working

environment.

NETHERLANDS agreed with SPAIN on including gloves for hairdressers in category III. In any

case, they highlighted that the PPE Regulation concerns the manufacturer and not the working

place, which is the object of other legislation. PPE placed on the market are controlled by market

surveillance authorities and not by labour inspectors.

SSPP and COIFFURE EU expressed their availability for further discussion on the feedback they

will receive on their proposals.

SPAIN said that the example on gloves should be included with the proper wording, clarifying the

risks involved, in particular for chemical substances used in hairdressing.

SSPP and COIFFURE EU indicated that protection against chemical substances would be the

main problem, even if the question of contact with hot water should be considered too. It would be a

matter of finding the best place and the proper wording for the examples.

AUSTRIA asked whether exposure to chemical risk should be considered not only for the workers

in the hairdressing sector but also for users in general when dealing with these kind of cosmetic

products.

The Chairperson invited all the members to a pragmatic approach in discussion about the

suitability of the examples in the PPE Regulation Guidelines. Considering that risk is by definition

a combination of probability and severity, the level of risk for consumers is not the same as the one

for workers; more information on specific questions would be provided by the SSPP.

The Chairperson noted the general agreement on introducing possible changes in the PPE

Regulation Guidelines. COM and the SSPP would bilaterally discuss to clarify and improve the

proposals for further discussion at the next meeting in 2020. At the same time, the PPE AdCo

Group is requested to add a point on market surveillance for PPE for hairdressers to the Agenda of

their next meeting in 2020.

Action point: COM and SSPP, to bilaterally discuss to clarify and improve the proposals for

new contents in the PPE Regulation Guidelines, and to draft a revised paper to be circulated

among all the members, for further discussion at the next meeting in 2020.

PPE AdCo Group, to add a point on market surveillance for PPE for hairdressers to the

Agenda of their next meeting in 2020.

4.6. Implementation of point 7 of Annex V: Review of the EU type-examination certificate (Docs.

PPE-19-1-10, PPE-19-2-08)

COM recalled the point proposed by FRANCE and informed that UNITED KINGDOM provided a

written comment supporting the French position.

NETHERLANDS indicated its support to the French position as well.

The Chairperson, with no further comments, noted the general agreement on the French proposal.

The agreed clarification text would be inserted into the next edition of the PPE Regulation

Guidelines.

Action point: COM, to insert the agreed clarification text as proposed by FR, into the next

edition of the PPE Regulation Guidelines.

4.7. Baby neck buoys as “not PPE” (Docs. PPE-19-2-10, PPE-19-2-19_1, 2, 3)

FRANCE presented a paper, to consider baby neck buoys under the General Product Safety

Directive 2001/95/EC and not under the PPE Regulation, as presupposed by CEN/TC 162/WG 10.

NETHERLANDS supported the French proposal.


BELGIUM said that these products were considered as PPE category II in order not to let them

enter the EU market without type-examination. Most of baby neck buoys are placed on the market

as toys, but studies from the USA and Australia evidenced the risks related to these products, as

their objective is to keep the baby’s head above the water and safe, not for playing. Hence, they

cannot be considered as a toy but as PPE category II.

The Chairperson indicated that, being a new item proposed, it would be necessary more time for

the PPE WG members to analyse it, as well as to check the legal references with other COM

services potentially concerned, as those for toys or general product safety.

HAS Consultant asked not to delay the decision as the referred WG 10 would meet in Berlin in the

following week to discuss about this product. In any case CEN would develop a standard, but it

would be convenient to clarify the situation as soon as possible.

The Chairperson explained that a decision could not be taken in such short time. Comments and

positions on the French paper on baby neck buoys should be expressed by the end of the year 2019,

to follow up the question at the next meeting in 2020.

Action point: COM, to consult other COM services potentially concerned by the products.

All, to express their position and comments on the FR paper, by the end of December 2019,

for further discussion at the next meeting in 2020.

4.8. Conditions for “not PPE” status for products considered as toys or similar to PPE (Doc.

PPE-19-2-11)

FRANCE presented a paper on the conditions for considering a product as “not PPE” and the

related information in specific cases, concerning in particular a possible contradiction in the PPE

Regulation Guidelines, and the responsibility of manufacturers.

NETHERLANDS said that it is not always clear what manufacturers claim as protection, and the

product could provide misleading information to users. They supported the French position.

SPAIN also supported FRANCE on the proposed changes in the PPE Regulation Guidelines.

The Chairperson asked the members to express their position and comments on the French paper,

by the end of December 2019, for further discussion at the next meeting in 2020.

Action point: All, to express their position and comments on the FR paper, by the end of

December 2019, for further discussion at the next meeting in 2020.

4.9. Exoskeletons: new information about the legal status (Docs. PPE-19-2-12_1, 2, PPE-19-2-

13)

ESF introduced two papers on the characteristics and the legal status of exoskeletons (this last one

on behalf of FEES and ESF), after a first consideration of those products as not covered by the PPE

Regulation. It would be necessary to collect more information and examples on products on the

market, to take into due account all the relevant elements related to the current situation and

potential developments..

The Chairperson said that, in view of the possible revision of the Machinery Directive,

exoskeletons would be considered too, in particular at standardisation level in CEN-Cenelec. When

more information would be available, it would be distributed to the members of the group and

shared with other COM services in charge of potentially concerned sectorial legislation. All the

interested parties are invited to contribute and participate.

FRANCE considered that exoskeletons are not PPE, as they are not addressed to protect against an

external risk. The question could be further clarified in the PPE Regulation Guidelines.

NETHERLANDS agreed with FRANCE. They informed on a recent meeting of the relevant ISO

Committee, remarking the negative side of exoskeletons in terms of injuries potentially caused


depending on rotation, movements etc. It would be necessary to be very careful when considering

the status of those products by the point of view of health and safety.

GERMANY said that a German document referred to in the bibliography would be published soon

in English, providing for interesting information on the issue.

The Chairperson confirmed that more information on the subject is needed, to be distributed for

possible further consideration.

4.10 Classification of face masks with integrated snorkel (Doc. PPE-19-2-16)

The HCNB Technical Secretariat presented a paper from VG8 asking for the categorisation of

face masks with integrated snorkel.

SPAIN said that they have already dealt with these products as PPE category I, referring to the

standard EN 16805 on diving masks. The snorkel as such is not a PPE, being covered by the

General Product Safety Directive, but the whole mask with integrated breathing tube is PPE

category I.

FRANCE agreed with SPAIN, as their approach is the same.

The Chairperson also agreed on the considerations exposed. Noting the general agreement on that,

categorisation of face masks with integrated snorkel as PPE category I will be inserted into the next

edition of the PPE Regulation Guidelines, in point 2.5 of the “Categorisation guide”.

Action point: COM, to insert the agreed categorisation I into the next edition of the PPE

Regulation Guidelines, in point 2.5 of the “Categorisation guide”.

5. Standardisation

5.1. Standardisation Request for PPE: updates

The Chairperson reported that the draft Standardisation Request for PPE should be submitted to

the vote of the Committee on Standards at the next meeting, possibly in November 2019, according

to the effective availability of premises and interpretation. Other Standardisation Requests were

following the same model of PPE and had already received a positive vote. The approval by the

Committee on Standards, the adoption by the Commission and the acceptance by CEN-Cenelec of

the PPE Standardisation Request would be necessary to publish in the OJEU the references of

standards, in particular when they cover essential health and safety requirements which have been

modified from the previous Directive to the current Regulation.

5.2. Lists of references of harmonised European standards in the OJEU

The Chairperson reported that no new list of standards had been published since June 2018. CEN-

Cenelec proposed about 20 new standards, to be assessed by COM taking into account the situation

of the PPE Standardisation Request as mentioned.

5.3. Report by CEN-Cenelec (PPE-19-2-20)

CEN-Cenelec presented the latest report on standardisation in the PPE sector. It included

information and considerations on the PPE standards, the relevant Technical Committees, the Sector

Forum, the upcoming Standardisation Request, the operation of the HAS Consultants system, and

some open issues on inflatable jackets, equestrian helmets and baby neck buoys. On the revision of

the standard on equestrian helmets, CEN-Cenelec called the Member States authorities to work

together with their national SBS to encourage and increase experts’ participation within the

concerned Technical Committee.

The Chairperson confirmed that CEN-Cenelec inputs would be integrated into the list of work

items annexed to the PPE Standardisation Request. With respect to equestrian helmets, she joined

the call to the experts to participate on the discussions: there was no concrete progress on this topic


and if such situation persists, COM would consider alternative means to adopt technical

specifications to face the lack of an adequate standard.

5.4. Report by HAS Consultants (Docs. PPE-19-2-18, PPE-19-2-21)

The HAS Consultants reported on the activities carried out in the PPE field, with the results of

assessments of draft standards under development in CEN-Cenelec Technical Committees. They

mentioned some problems that led to negative assessments, related to undated references and

technical issues.

AUSTRIA expressed concerns on the significant rate on non-compliant standards, which would

lead to a low number of new references of harmonised standards in the next OJEU publication.

The Chairperson explained that it increased the level of scrutiny following some case laws in the

ECJ, with a new system of consultants and way of publication, and still some time would be

necessary for the smooth implementation of those changes. Despite some extent of non-compliance,

several other standards received positive assessments, and COM may be in the position to publish

new references soon.

SPAIN asked whether undated normative references in harmonised standards would make

reference to the latest version of the standard, and if so, what would happen when the latest version

of the referenced standards change, in order to ensure the necessary coherence and legal certainty.

The Chairperson said that undated normative references should not be used in harmonised

standards, as they cause legal uncertainty; only some justified cases could be accepted. In that cases,

the date for undated references should be understood as being the version of the standard applicable

at the time when the harmonised standard were published. Indeed, if there are changes in those

referenced standards, it would become difficult for operators to know which version applies, and

that is why undated references are not allowed as a general rule.

6. Notified Bodies


COM informed that in NANDO there were 109 notified bodies under the PPE Regulation from 22

Member States, 1 from Switzerland (MRA) and 1 from Turkey 5CU): practically the same as under

the PPE Directive. All NBs should have at least one representative in the relevant CIRCABC

Interest Group, to ensure that NBs are duly informed on the state of the art and can apply the

Recommendations for Use issued by the European Coordination (HCNB).


The HCNB Technical Secretariat presented the written report on the ongoing activities of the

HCNB. In particular, she made reference to some topics under discussion, as the concept of “state

of the art” related to harmonised standards and presumption of conformity; determination of

uncertainty in measurements; application of different legislative acts to the same product and the

need for intervention of different notified bodies; subcontracting and acceptance on testing reports;

etc.

6.3. Horizontal and vertical Recommendations for Use sheets (RfUs) (Doc. PPE-19-1-09 rev.1)

COM informed on the ongoing written and oral procedures for endorsement of Horizontal and

Vertical RfUs under the PPE Regulation. A written procedure was currently ongoing until 29

November 2019, while the ongoing oral procedure concerned the RfUs listed in the document

circulated, including those after the latest written procedure closed on 22 April 2019.

The Chairperson invited the concerned parties to solve the still pending issues, through bilateral

discussion, to come to a conclusion as soon as possible. If consensus is not reached, the related

RfUs should be withdrawn.


Action point: HCNB, VGs and MSs, to bilaterally discuss and clarify the pending comments

and issues on RfUs still in the oral procedure for endorsement, to come to a conclusion as

soon as possible.

7. Report on the activities of the PPE Administrative Co-operation (AdCo) Group

COM highlighted the importance of the activities of the PPE AdCo Group in support of market

surveillance to ensure that only compliant and safe products are placed on the EU market. During

the year 2019, no PPE AdCo meetings had been held, as no new Chairpersonship succeeded to

SWEDEN; NETHERLANDS has volunteered for the next two-year period 2020-2021. COM will

continue supporting the activities of the PPE AdCo Group by funding the administrative secretariat.

NETHERLANDS confirmed their availability and noted the general support by all the members.

The date of the first meeting in 2020 was not established yet, but it would be communicated as soon

as possible.

The Chairperson informed on the adoption of the two “Goods Package” Regulations: (EU)

2019/515 on mutual recognition (OJ L 91, 29.3.2019, p. 1) and (EU) 2019/1020 on market

surveillance and compliance of products (OJ L 169, 25.6.2019, p. 1). This latter one in particular

provides for an improved legal framework for market surveillance, creates the “Union Product

Compliance Network” and includes specific financial provisions in support of activities.

Action point: AdCo Group, to inform on the date of their next meeting in 2020 as soon as

possible.

8. Report on the revision of the PPE “workplace” Directive 89/656/EEC (Doc. PPE-19-2-04)

COM informed on the exercise to revise the PPE “workplace” Directive 89/656/EEC, managed by

DG EMPL. The COM services in charge of the PPE Regulation participated to ensure coherence in

aspects of common interest, as for instance the definitions of personal protective equipment, the

adequate terminology, the interplay between design, manufacturing and use of PPE, etc. Specific

suggestions and contributions were provided, in particular to clarify some of the risks in relation to

the body parts to be protected by PPE (Annex I) as well as to improve the non-exhaustive lists of

types of PPE with regard to the risk they provide protection against (Annex II) and of activities and

sectors which may require the provision of PPE (Annex III). The scrutiny of the Commission

Directive and its Annex at the European Parliament and the Council should be finalised by mid-

October 2019; then, the adopted act will be published in the OJEU.

NETHERLANDS and IRELAND expressed concerns about the different interpretation of what a

PPE is in the PPE “workplace” Directive and the PPE “product” Regulation, as in the case of barrier

creams.

COM said that a footnote has been inserted in order to inform that barrier creams are not PPE from

the point of view of the PPE Regulation. It is not an ideal situation but a contribution for

clarification; further work with DG EMPL would be done in order to ensure a smooth

implementation.

The Chairperson indicated that COM will forward these comments and will continue working on

the best alignment of the two legal frameworks.


ESF informed that there were discussions on the different interpretations in different countries

about subcontracting and accreditation for notified bodies. There is an RfU already endorsed on the

issue but certain countries are not consistently applying it. They offered to draft a paper on the

question, for discussion at the next meeting in 2020.


The Chairperson said that question was not only related to PPE, being a more horizontal issue

with broader consequences. She asked to provide specific examples in order to submit the question

to the COM services dealing with horizontal aspects of internal market, including those related to

notified bodies.

Action point: ESF, to draft a paper on subcontracting and accreditation for notified bodies,

for discussion at the next meeting in 2020.

The Chairperson informed as well that the current Policy Officer for the PPE sector would move

to another COM service from mid-November 2019.


The Chairperson said that the next meeting, in the format of PPE Expert Group, should take place

in the first quarter of 2020. The exact date would be confirmed as soon as possible.

Action point: COM, to confirm the date of the meeting of the PPE Expert Group in 2020, as

soon as possible.

End of the meeting


EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR INTERNAL MARKET, INDUSTRY, ENTREPRENEURSHIP AND SMES Ecosytems III: Construction & Machinery H2. Machinery & Equipment




(EU) 2016/425

Place: Webex

Chairperson: Ms Barbara BONVISSUTO (COM GROW/H2)

COM participants: Mr Rostislav VARBANOV, Ms Annalisa TESSAROLO, Mr Iván ARIAS

ROLDÁN


The Chairperson welcomed the attendees, informed about the virtual meeting rules and introduced

the PPE team. She highlighted the extremely busy period of the preceding months due to the

COVID crisis and particularly to the shortages of PPE, and thanked the members that were actively

supportive. She pointed out the importance of exchanging information, and expressed the intention

to include in the group discussions other important topics like production capacity, supply, demand,

etc. She also informed that the following meeting would be in the format of expert group.

FR remarked that according to Regulation 1 of April 1958 the meeting must be held in the

languages of the Member States, that translation was provided in the AdCo meeting, and asked the

COM to find a solution to provide translation in case virtual meetings continue in time.

The Chairperson clarified that all the expert groups’ virtual meetings have been held in English

only, however indicated that if the situation continues the option of providing interpretation will be

explored.

2. Approval of the draft Agenda (doc. PPE-20-1-01 v2(COM))


SBS asked to discuss the point on sustainability aspects of PPE earlier in the agenda.

With no other comments, the draft Agenda was approved.

3. Approval of the draft Minutes of the last meeting held on 7 October 2020 (doc. PPE-20-1-

02(COM))

The Chairperson introduced the draft Minutes of the last meeting of the PPE WG held on 7

October 2020. The Chairperson confirmed that the comment from FEES indicating that the paper

on the legal status of the exoskeletons was presented by ESF on behalf of ESF and FEES has been

introduced.





4. COVID-19 related issues

4.1. State of play of PPE supply chains (docs. PPE-20-1-3(COM), PPE-20-1-

13(ESF&MEDTECH EUROPE))

COM presented the actions undertaken during the last months by the Clearing House, which

focused mainly on the bottlenecks in the supply chain and the matchmaking of supply and demand

of medical equipment in the EU, highlighting the limitation of the lack of reliable quantitative data.

After the end of the mandate of the Clearing House the tasks were taken over by DG GROW, DG

SANTE and Secretariat General according to their remit of competences.

EDANA provided the status of the industry of meltblown nonwoven, which is the raw material for

surgical and FFP masks. EDANA informed about the surge of new players in the EU and warned

about the risk of overcapacity next year should imports of masks continue at the current volume;

raised their concern about the commercial viability of this new players in the future; and

discouraged non validated reprocessing of single use surgical or FFP masks.

The Chairperson reemphasized that the Clearing House has been dissolved and its tasks have been

taken over by the respective Commission services. Any further exchanges on these tasks with

stakeholders will need to go through the Commission Services directly. The Chairperson also

reiterated the difficulty of having reliable market data on the sector and encouraged the members to

inform on the available data and to find a way to put these data together. She also asked about the

usefulness of the matchmaking tool.

ESF gave an update of the situation of the PPE sector in the EU. He informed about an increase

again in the presence of K95 masks and the critical situation of availability of gloves. He pointed

out the confusion on the concept of protective equipment vs medical devices, the need to consider

the industry as essential for the distribution of PPE, and the need of PPE demand data. He expressed

his concerns on the compliance and the expiry date of products in stockpiles, on the logistic

problems caused by closing internal borders, on the future commercial viability of the new players

in the market, and on the proper use of the PPE. He asked for coherence in public procurement

considering the incentives to local production. He suggested revising the requirements for importers

and distributors due to the surge of new ones without knowledge of the PPE Regulation, and

creating a European online tool where to verify the certificates of the notified bodies.

The Chairperson thanked ESF for the information provided, insisted on the importance of having

data also from the Member States in order to be able to react properly, and asked the Member States

to share their views and experiences.

Action point: Member States, to provide information in writing to the possible extent on

lessons learned, data on COVID-related PPE production capacity and needs, etc. to have a

clearer picture of the situation.

SE thanked ESF for the assessment of the situation, and recognised many of the concerns. SE

informed that the supply of CE marked PPE was greater than in March 2020, but that they still have

big volumes of non-CE marked PPE in stock that need to be distributed to the health care sector in

line with Commission Recommendation (EU) 2020/403.

The Chairperson informed that this would be discussed in point 4.3 of the agenda.

4.2. Report from the PPE Administrative Co-operation (AdCo) Group - Market surveillance

during COVID

The AdCo chair informed about the last meeting held on October 2020, which was focused on the

COVID crisis, and indicated that NO, FI, ES, FR have stopped applying Recommendation (EU)

2020/403 at the end of last year and NL would do it from 1 April 2021.

ESF asked to be invited to AdCo meetings. He expressed his concerns about the confusion and lack

of efficiency of having different market surveillance authorities dealing with PPE, medical devices

and community face coverings; about the basis of the testing protocols put in place and the


competences of the personnel in charge; and about the uneven use of RAPEX among the Member

States; and remarked the effectiveness of this tool.

The Chairperson added that Commissioner Reynders wrote a letter to the national authorities to

bring the attention about the uneven use of RAPEX, and highlighted its usefulness and the

transparency it brings.

The AdCo Chair informed that NL would feed RAPEX after solving one issue with the test

reports, and confirmed that although it was not the case of the last meeting there will be meetings

open to other stakeholders.

4.3. Emergency measures in the COVID context: Recommendation (EU) 2020/403

The Chairperson invited the Member States to express their views on the status of the application

of the Recommendation and whether it should be kept or phased out.

SE informed that they have non-CE marked PPE based on the Recommendation; that according to

the Swedish accreditation body, Swedac, conformity assessment bodies do not show interest to be

notified against PPE Regulation for COVID-related PPE; and that they have issued a decision with

temporary permits for PPE following the Recommendation which is valid until 30 June 2021, with

the possibility of an extension depending on the situation. Therefore SE asked to phase out the

Recommendation on 30 June 2021 at the very earliest.

COM clarified that the Recommendation does not have an expiration date, highlighted the

discretional nature of the act with respect to its application by the Member States and asked for a

coordinated approach on its use or its phase-out. He also clarified that the users who may benefit

from the Recommendation are mainly essential healthcare workers (point 8), but also a wider

population as soon as the conformity assessment procedures of these equipment are ongoing (point

7).

BE informed that although, as highlighted in the PPE AdCo meeting, many Member States do not

longer experience problems in the supply of CE marked products, BE has not been able to obtain

the data on the needs from the hospitals yet, due to their current critical situation. She also informed

that BE still receives some requests for PPE from independent healthcare workers and that local

producers are experiencing delays in the conformity assessment procedures performed by the

notified bodies. She asked the MS to share their best experiences to get more access to local

manufacturing.

The Chairperson remarked that the purpose of having this point is to share the experience and the

state of play of the MS.

SE informed that their temporary decisions referred mainly to point 8 of the Recommendation and

very few to point 7, and that they will need to apply the Recommendation for a longer period.

ESF pointed out the risks of having non-CE marked products in the normal supply chain for the

health and safety of the users and for the operation of the internal market, and asked for a common

approach on the use and the phase-out of the Recommendation.

ES informed about the difficulties in the beginning with a lot of fake products entering the market,

and the confusion with the documentation provided by the manufacturer, and that currently all

products are CE marked. She complained about the lack of consensus in the approval of simplified

conformity assessment procedures (RfUs) that would have eased the work of notified bodies.

MT informed about the difficulties experienced with the masks entering their market, rejecting 70%

of the masks due to different issues: CE-marked counterfeit products, quality, problems with the

declaration of conformity, with the standards, etc. She also pointed-out the confusion with

mandatory documentation, asking for common harmonised templates.

NL informed that they are investigating false FFP masks certificates.


The Chairperson suggested to the MS to inform in writing on the situation and use of the

Recommendation in their markets by the end of the year.

Action point: Member States to provide information in writing about the situation and use

of the Recommendation by the end of the year.

4.4. Emergency measures in the COVID context: RfUs on essential COVID-related PPE

products

COM informed that RfU 02.075_02 on facemasks and RfU 03.031_01 on faceshields which were

circulated on July 2020 for written procedure were not endorsed yet, and invited the MS to share

their position

DE indicated that they have some technical concerns.

SE raised a point on the need of an RfU for polyethylene protective aprons, which do not fit the

standards because of their different mechanical properties in the longitudinal and transversal

directions, and the basic hygiene rules.

FR complained that the RfU for faceshields was not validated by the vertical group.

ESF alerted that the marking indicated in the RfUs stating “for COVID protection” could lead the

users to use the PPE in other situations that they consider less dangerous.

BE agreed with the DE’s comments on the RfUs, indicated that there are still some questions in the

case of faceshields, and expressed their interest in an RfU for polyethylene aprons.

The Chairperson questioned the current need of the RfUs on facemasks and faceshields,

considering that the objective of having a timely simplified procedure for COVID related PPE has

not been achieved, and that there is no consensus.

COM informed that will follow-up with HCNB the question on the RfU for polyethylene aprons

and the need to respect internal procedures.

Action point: COM to contact HCNB on the RfU for polyethylene aprons and internal

validation procedures.

The Chairperson asked stakeholders to share in writing the need of keeping or not these RfUs.

Action point: Member States to send their position on the need of keeping RfUs 02.075_02

and RfU 03.031_01

4.5. Emergency measures in the COVID context: list of essential COVID-related PPE products

and survey on capacity and availability of notified bodies (docs. PPE-20-1-4 (COM), PPE-20-1-5

(COM))

COM presented the list of essential COVID-related PPE, which was consulted with stakeholder by

written procedure, and a survey on the capacity and availability of notified bodies for PPE, which

was communicated to economic operators. Both documents were distributed on early summer 2020.

Both documents are also available on circabc.

4.6. Difficulties of doing on-site visits required in Annex VIII during COVID crisis

FR expressed its concern on the feasibility of performing the visits to manufacturer’s premises

required in Annex VIII of the PPE Regulation, considering the current travel restrictions.

The Chairperson indicated that this is a horizontal problem and the colleagues dealing with

horizontal EU product rules sent a clarification on this respect.

COM informed it is necessary to perform an assessment on a case by case basis and that it is

allowed to perform remote assessments as soon as this procedure does not put in risk the safety

properties of the products.


Action point: COM to re-distribute the clarification already sent by the horizontal unit on

this regard.

4.7. Categorisation of face shields and other protective eyewear (cat. II or cat. III) (docs. PPE-

20-1-6 (COM), PPE-20-1-12 (FR))

COM introduced its paper on the categorization of face shields and proposed classification in

category II, based on the discussions of the national market surveillance authorities, the respective

legal framework, the relevant provisions of the guidelines, and harmonised standard EN 166:2001

on personal eye protection.

FR claimed that it is not possible to treat differently two products that protect against the same risk,

meaning COVID-19, and that according to the document issued by COM on 27 March 2020 that

masks and other equipment used in the context of COVID-19 pandemic should be considered

category III.

DE, BE, ESF, SE, DK, LV, ES, CZ, CH, NO, LU, IE and PO agreed that face shields should be

category II.

IT indicated that face shields could be category II or III in function of the specific risk resulting

from the normal and foreseeable use.

BE questioned the classification of FFP1 masks as category III.

COM clarified that for the categorization of PPE it is necessary to consider the risks against which

PPE have been conceived to protect by design, and not the level of efficiency to achieve this

objective. COM added that in this line face shields are not capable to provide protection from

harmful biological agents because, unlike FFP masks, they are not conceived as leak tight by

design.

The Chairperson indicated that, as the position paper was recent, COM will wait for other possible

reactions in writing in order to confirm the classification of face shields, which will most probably

be category II.

4.8. Community face coverings

COM clarified that the purpose of community face coverings is to minimize the projection of user's

respiratory droplets in the community and not to protect the wearer, therefore they do not fall under

the PPE Regulation, but under the General Product Safety Directive 2001/95/EC. At the beginning

of the pandemic COM reached out to CEN to invite them to consider the adoption of a technical

specification, which they issued on 17 June 2020. This specification states the requirement of

clearly informing the users that these masks are not PPE.

CEN informed that community face coverings are in the remit of the technical committee for

textiles and would ask the colleague in charge to inform in case of updates or further steps forward.

The Chairperson thanked CEN for having reacted so quickly on this request.

ESF and FESI asked the market surveillance authorities to look into these products, which in many

occasions are wrongly advertised as protective equipment.

SE expressed their concerns that consumers use these masks in many occasions as personal

protection, and informed that they have taken measures against many companies placing in the

market community face coverings that were not properly marked.

The Chairperson indicated that it is indeed necessary to make an effort in terms of market

surveillance and consumer awareness.

4.9. Dual use products under the PPER and MDD (doc. PPE-20-1-14 (ESF))

ESF informed about the confusion that exists in the market around products that are both PPE and

medical devices, providing some examples like glasses with corrective lenses or orthopaedic


protective footwear. ESF also proposed to create standards that combine both PPE and MD

legislation, following the logic of the use of the product instead of the legislative framework.

The Chairperson asked ESF to come with a proposal and address it to the relevant fora, which in

the case of the guidelines fall in the remit of the PPE working group.

Action point: ESF to propose step forward.

4.10. Reflexions on the sustainability aspects of the PPE supply chains/reusability/circular

economy aspects (docs. PPE-20-1-10 (ESF), PPE-20-1-7 (SBS & ECOS))

The Chairperson invited ESF, SBS and ECOS to introduce their presentation on the subject.

ESF introduced the policy background (green public procurement, green deal, circular economy,

Europe fit for the digital age), and proposed to delete in the PPE guidelines the obligation of

supplying instructions in paper format with PPE, in favour of the electronic format.

SBS pointed out the need to reinforce local production in the EU and to focus on reusable masks

following standards EN 140 and EN 143. SBS also claimed the need to increase reusability,

reparability and longevity of PPE and to update the standards in this line.

ECOS reminded the need to include sustainability aspects in procurement practices especially

through GPP principles, and summarized the different actions to be considered within the PPE

sector in terms of sustainability.

The Chairperson pointed out that it is necessary to differentiate between the means through which

these actions can be implemented: PPE Regulation, standardisation, MS (public procurement), or

horizontal legislation (circular economy action plan, product rules, which may include product life

cycle assessment).

FR remarked that it is necessary to provide PPE safety instructions in paper format in order to

guarantee the access to them to all the sectors of the population, and that other proposals such as

reparability would need a thorough analysis. FR agreed on the need of an horizontal approach for

some cases.

The Chairperson informed that the question of instructions in electronic format is a highly debated

topic that affects different sectors and it would be necessary to come to a compromise on which is

the level of information to be provided on paper and what can be left for the digital support.

NL shared some concerns about the reusability of PPE: collection and transport, import from third

countries with other risks, etc. NL informed that they are investigating on the circularity of PPE.

FESI agreed with the need to find a more sustainable and modern way to provide information to

consumers beyond paper format, and added that 70% of the persons get rid of this information. He

also agreed on the approach of digitalising part of the information.

IT informed about the reconversion of some Italian companies to produce different categories of

PPE, and agreed on the supply of information on electronic format.

EDANA reflected on the safety purpose of the PPE and the need to take into account the use of the

products, especially in the health care sector. He added that in some cases it is better to think of

recyclability rather than reusability.

The Chairperson suggested circumscribing the discussions within the limits of the different

frameworks: PPE Regulation, standardisation, horizontal product rules, etc.. She also added the

importance of taking into account health protocols and other possible obstacles when thinking about

reusability.

ESF informed that the CEN-CENELEC sector forum is organising a workshop on sustainability of

PPE in the first quarter of 2021.

5. Scope and implementation of the PPE Regulation


The Chairperson informed that, due to the workload originated by the crisis, the guidelines would

not be updated most probably before end 2021.

5.1. Categorisation of welder’s clothing and gloves for welders (doc. PPE-20-1-8 (COM))

COM presented its paper on the categorisation of welders’s clothing and gloves, where it proposed

to classify them as category III taking into account that ‘high-temperature environments the effects

of which are comparable to those of an air temperature of at least 100°C’ is a risk inherent to

welder’s work and these kind of PPE shall always protect against it.

DE asked to specify in the document that it refers to metal welding and not ultrasound welding.

ESF warned that this decision could have an impact on PPE that protect against heat and flame

which currently can be classified both as category II and category III.

FR and SE agreed with the classification in category III.

The Chairperson asked the MS to send their position by 31 December 2020.

Action point: Member States to send their position on the categorisation of welder’s clothing

and gloves for welders by 31 December 2020.

5.2. Skin protection UV radiation (doc. PPE-19-2-22 (COM))

COM recalled the two possible options of classification as indicated in its paper. Option 1, which

states that natural UV radiation is not an atmospheric condition and therefore the PPE should be

classified as category II. And option 2, which states that natural UV radiation is an atmospheric

condition and considers three possible classifications: not PPE (in case of equipment for private use

that protects against not-extreme atmospheric conditions), category I (in case of professional use

and not-extreme atmospheric conditions) or category II (for private or professional use against

atmospheric conditions of extreme nature). COM informed that the opinions were equally divided

between both options.

FESI indicated that there is link between natural UV radiation and weather conditions, and

questioned if considering this PPE as category II in every case would be proportionate.

The Chairperson encouraged those MS that have not expressed their opinion or would like to

revisit their positon to express themselves by the end of the year.

5.3. Baby neck buoys as “not PPE” (PPE-19-2-10 (FR), PPE-19-2-19_1, 2, 3 (CEN))

COM introduced the subject on the consideration or not of baby neck buoys as PPE, and informed

that again the opinions received so far were equally divided between the two options.

SE reminded that the purpose of baby neck buoys is to keep the baby’s head above the water

surface and to prevent liquid entering their airways, and thus protect the baby against the risk of

drowning. Therefore, SE supported the classification of baby neck buoys under category II or III.

The Chairperson encouraged again those MS that have not expressed their opinion or would like

to revisit their positon to express themselves by the end of the year.

NL and PL indicated their support to the classification of baby neck buoys as “not PPE”.

Action point: Member States to send their position on the categorisation of baby neck buoys

as “not PPE” by 31 December 2020.

5.4. Conditions for “not PPE” status for products considered as toys or similar to PPE (doc.

PPE-19-2-11 (FR))

COM introduced the point raised by FR in the past, which disputed the text of page 25 of the PPE

guidelines regarding clothing with reflective parts as “not PPE”, and which suggested to put it in

line with the wording of page 49 on toys as “not PPE”, in order to avoid the exemption of the

manufacturer from his responsibilities with regards to safety.


FESI and SE agreed with the revision of the text in page 25, but highlighted that a statement is

important to inform the consumer about the protection provided.

ESF indicated that manufacturer’s claims should not be misleading.

The Chairperson indicated that COM will make a proposal of a new wording in page 25 and

submitted to the group for its approval.

Action point: COM to propose a new wording for the text in page 25 of the PPE guidelines

regarding clothing with reflective parts as “not PPE”.

5.5. Surface wetsuits (doc. PPE-20-1-9 (FESI))

FESI presented its paper that explains the difference between diving and surface suits and the

difference on the risks applying to both kind of wetsuits, e.g. hypothermia or compression,

concluding that they should not be considered as PPE unlike diving suits that are PPE category II.

NL indicated that if the manufacturer claims for protection it has to be PPE, so in the case of

protection against cold, it should be category II or even category III.

SE indicated that most of wetsuits have always been considered as PPE category II regardless that

the equipment is for diving or other activities, and that there are many wetsuits in the market that do

not fulfil the requirements of PPE Regulation. He believed that surface wetsuits shall not only

provide comfort but protection against cold as sometimes users can find themselves far from the

shore and hypothermia is a risk factor for sports like windsurfing or far distance swimming.

FESI clarified that the purpose of the surface wetsuits is to provide thermal comfort and not

protection against hypothermia.

The Chairperson invited the participants to provide their positions before the next meeting of the

working group.

Action point: Member States to send their position on the categorisation of surface wetsuits

before the next meeting of the working group.

5.6. Respiratory protective equipment for children – Conformity with EN149 (doc. PPE-20-1-11

(ES))

ES presented its paper on the respiratory protective equipment for children, indicating that as

agreed in RfU PPE-R/2-049 manufacturers cannot use EN 149 for the design of protective masks

for children but other technical solutions, and added that EN 149 should not give presumption of

conformity for FFP masks in the case of children.

ESF agreed that EN 149 is not meant for children, added that precision should be made on the age

of the children, and that there is the same discussion in hearing protection for children. ESF

remarked that the differences in question for children are the fitting and the breathing resistance of

the masks. He asked if this is work for standardisation or for the vertical group of notified bodies.

The Chairperson indicated that the COM would transmit the paper from ES to the technical

committee in charge of standard EN 149 and discuss with them the possible adaptation of this

standard for children.

Action point: COM to address the question on respiratory protective equipment for children

to CEN’s technical committee in charge of EN 149.

5.7. PPE for hairdressers (docs. PPE-20-1-17 (UNI), PPE-20-1-18 (UNI))

COM informed that they met the SSPP on 23 October 2020 to clarify and improve the proposed

inputs for the PPE Regulation guidelines, and that the SSPP prepared a revised proposal, which

includes the categorization of gloves for hairdressers as category III, which has been distributed in

the working group on 12 November 2020. COM asked MS to share their views on this proposal

before the next working group meeting.


ESF informed that the work in the relevant technical committee for standardisation of gloves is

progressing and they are very close to a first draft that they would submit for inquiry maybe before

the end of the year.

Action point: Member States to send their position on the proposed adaptation of the PPE

guidelines to include PPE for hairdressers including the categorization of gloves for

hairdressers.

6. Standardisation

6.1. Standardisation Request for PPE: updates

COM informed that the CoS has delivered a positive opinion on the new standardisation request

and that its adoption would be in a matter of days. After that it will submitted to CEN for its

acceptance.

6.2. Lists of references of harmonised European standards in the OJEU

COM informed that new references of harmonised standards have been published on 18 May 2020,

making a total of 178 references (177 CEN, 1 CENELEC) under the PPE Regulation, and that

CEN-CENELEC has proposed 19 new standards for publication.

ESF asked when will be the next publication

COM indicated that it will be done as soon as possible taking into account the current pandemic

situation.

6.3. Report from CEN-Cenelec

CEN-CENELEC informed about the latest activities on standardisation of PPE; agreed on the

technical feasibility of the new standardisation request with the exception of the date of availability

of EN 1384 ‘Helmets for equestrian activites’, for which they asked for an extension; and expressed

its concerns on the flexibility to adapt the work programme of the standardisation request to the

market needs, and on the timeframe for the publication of 50 EN ISO standards.

7. Notified bodies

7.1. Report from the Horizontal Coordination of Notified Bodies (HCNB)

HCNB introduced the new technical secretary and informed about some issues discussed in the last

meeting from 22-23 September 2020: HCNB asked to be involved in any future decisions like

Recommendation 2020/403 that affect their activity; requested to update the product categories in

Nando; asked how to deal with PPE for multiple risks where different NBs are involved but only

one should be responsible for the certificate, and informed that they are working on a lessons

learned document from COVID.

The Chairperson informed that CZ had also the same concerns on the handling of the Nando

database and that COM would liaise with the horizontal unit to see how to approach it.

Action point: COM to liaise with the horizontal unit to revise the PPE product categories in

Nando.

7.2. Horizontal and vertical Recommendations for Use sheets (RfUs)

COM informed that the comments received for the two packages of RfUs under written procedure

were submitted to the HCNB for their consideration. HCNB will come back to the COM on these

and the ones under oral procedure.

Action point: HCNB to revise the comments received for the two packages in written

procedure and provide the status on those in oral procedure. .


No other business was proposed for discussion.



The Chairperson informed that the next meeting would be most probably in May in the form of

expert group

End of the meeting

Minutes of the PPE Working Group meetings from 2002 onwards

Documents