Hartford Steam Boiler UK Limited Crosby Court 28 George Street Birmingham, B3 1QG United Kingdom Notified Body Number 2561 Registered Address: Baker Tilly Marlborough House Victoria Road South Chelmsford Essex CM1 1LN England Registration Number: 02708264 HSB Global Standards Technical Service Bulletin New Legal Framework Pressure Equipment Directive (PED 2014/68/EU) Synopsis August 2015
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Hartford Steam Boiler UK Limited
Crosby Court 28 George Street Birmingham, B3 1QG United Kingdom Notified Body Number 2561
Registered Address: Baker Tilly Marlborough House Victoria Road South Chelmsford Essex CM1 1LN England Registration Number: 02708264
HSB Global Standards
Technical Service Bulletin
New Legal Framework Pressure Equipment Directive
(PED 2014/68/EU) Synopsis
August 2015
HSB Global Standards Pressure Equipment Directive
(PED 2014/68/EU) Synopsis
Hartford Steam Boiler UK Limited
Crosby Court 28 George Street Birmingham, B3 1QG United Kingdom Notified Body Number 2561
Registered Address: Baker Tilly Marlborough House Victoria Road South Chelmsford Essex CM1 1LN England Registration Number: 02708264
Foreword
2014/68/EU was published on June 27, 2014 in the European Union (EU) Official Journal approved by
the European Parliament and of the Council of May 15, 2014 as a part of a larger initiative by the EU to
bring nine European Commission (EC) “New Approach” Directives, such as 97/23/EC, into alignment
with the “New Legal Framework” (NLF) which was adopted in 2008. The prime objective of the NLF
Pressure Equipment Directive 2014/68/EU is alignment, to ensure a pattern of consistency is followed
that is evident between this and all other directives. The essential safety requirements remain virtually
unchanged with the exception of the addition of risk analysis which will be discussed in the synopsis.
In an effort to avoid confusion between the two Pressure Equipment Directives, this synopsis will refer to
the outgoing “New Approach” PED 97/23/EC as 97/23/EC and the “New Legal Framework” Pressure
Equipment Directive 2014/68/EU as 2014/68/EU.
Compared to 97/23/EC, the 2014/68/EU has grown in size by almost 60% to 96 pages, it now has seven
Chapters containing 52 Articles and a further six Annexes. Although there are extensive additions, a
number of deletions and changes to the document, the impact on manufacturers is less than might be
imagined. The majority of the additions concern the Notification of Conformity Assessment Bodies and
EU legal aspects. This document will assist manufacturers in identifying the areas that need to be
addressed for future compliance. There were several editorial changes made between the two directives
that will not be covered within this document, but all significant changes applicable for the manufacturer
will be addressed.
2014/68/EU will be implemented in two parts. The first part became mandatory on June 1, 2015, and is
in relation to Article 13, Classification of pressure equipment. The second part, the replacement of the
97/23/EC becomes effective July 19, 2016. This implementation is discussed in detail below.
Obligations of Economic Operators (Chapter 2)
97/23/EC only identified manufacturers, and manufacturer’s representatives, as being the entities to
place equipment on the market, and bear the associated responsibilities of the Directive. 2014/68/EU
expands greatly on this and now includes defined obligations of importers and distributers. These are
described as being responsible for ensuring that the pressure equipment manufacturer has drawn up the
necessary technical documentation, that the equipment bears the CE marking and is accompanied by
the appropriate operating instructions.
HSB Global Standards Pressure Equipment Directive
(PED 2014/68/EU) Synopsis
Hartford Steam Boiler UK Limited
Crosby Court 28 George Street Birmingham, B3 1QG United Kingdom Notified Body Number 2561
Registered Address: Baker Tilly Marlborough House Victoria Road South Chelmsford Essex CM1 1LN England Registration Number: 02708264
Importers and distributers have defined responsibilities when they have reason to believe the equipment
is not in conformity to the Directive. This includes informing the market surveillance authorities where
this presents a safety risk.
Article 10, NLF PED contains important information for importers and distributers. It states when they
place the equipment on the market under their own name or trademark that they shall be considered as
a manufacturer (and thus bear the associated responsibilities of the manufacturer, as described in the
Directive). This requirement is not intended to apply to such organizations who place the equipment on
the market under the original manufacturers name, for example valve stockists who hold catalogues of
valves where the manufacturer is clearly identified.
Article 10 also details firm rules when an importer or distributer modifies the equipment in such a way
that compliance with the Directive may be affected. If they make such modifications before placing on
the market then they are to be considered a manufacturer.
Generally the responsibilities of the manufacturer, or authorized representatives, remain the same in
2014/68/EU.
Fluid Classification Change (Article 13)
The Dangerous Substances Directive (Directive 67/548/EEC) has been repealed as of June 1, 2015 and
replaced by the European Regulation (EC) No 1272/2008 on classification, labeling and packaging of
substances and mixtures. It is known by its abbreviated form, ‘the CLP Regulation’ or just plain ‘CLP’.
The CLP Regulation adopts the United Nations’ Globally Harmonised System on the classification and
labeling of chemicals (GHS) across all European Union countries.
The CLP re-classifies certain substances from the Dangerous Substances Directive. The European
Commission conducted an assessment regarding the effects of the re-classifications and concluded that
only a small number of substances/mixtures would be affected and that the impact on manufacturers
would be minimal.
Article 9 of 97/23/EC outlines the provisions for dangerous fluids (substances) and classifies them in
Group 1, all other fluids not referenced were placed in Group 2. Article 13 of 2014/68/EU classifies
substances and mixtures as hazardous and places them in Group 1, all other substances and mixtures
fall into Group 2. The hazardous substances and mixtures are now broken down into 17 different
physical and health classes in accordance with Parts 2 and 3 of Annex I in the CLP Regulation.
HSB Global Standards Pressure Equipment Directive
(PED 2014/68/EU) Synopsis
Hartford Steam Boiler UK Limited
Crosby Court 28 George Street Birmingham, B3 1QG United Kingdom Notified Body Number 2561
Registered Address: Baker Tilly Marlborough House Victoria Road South Chelmsford Essex CM1 1LN England Registration Number: 02708264
What this means for manufacturers is that all equipment CE marked after June 1, 2015 must have its
fluid group determined by the new regulation. This applies even to existing designs already certified on a
B (EC-Type Examination), B1 (EC Design Examination) certificate and those also approved under the
module H1 design examination certificates. All pressure equipment manufacturers are encouraged to
review the fluid groups based on the equipment’s contents. Should the fluid group change from Group 2
to Group 1 when performing this against the CLP Regulation, then the category of the equipment should
also be re-checked. If this results in a change in the category of the equipment, then this will require
revision or possible invalidation of the certificate if it results in a higher category than the module may be
applied to. Manufacturers are encouraged to contact the Notified Body should this occur. As mentioned
before – the EC has stated that these will affect only a very small number of substances, but it is
essential the check is performed.
The labels associated with the substances and mixtures have also been changed to coincide with the
CLP, manufacturers are also encouraged to review these.
Hazard and Risk Analysis (Annex I)
Annex I, paragraph 3 was revised. In 97/23/EC this paragraph stated that the manufacturer was
responsible for performing a hazard analysis in order to identify those which apply to the equipment on
account of pressure, and then take these into account in the design of the equipment. The revision has
introduced only two words – “and risks”. 2014/68/EU now requires the manufacturer to analyze the
hazards and risks as they apply to the equipment. Although a minimal amount of text has been added,
the impact of these two words, and how the manufacturer is to address this adequately, is still being
discussed in the Conformity Assessment Body forums.
Whilst a hazard analysis considers such common and less common factors as overpressure, fatigue,
brittle fracture, wind, earthquake, fire, explosion and so on, it’s implied that a risk analysis would take this
a step further, most likely considering the probability and the magnitude of a failure. It’s understandable
that this presents a problem for the majority of manufacturers, such finite details regarding the location
and nature of the installation is usually unknown and often the final user will not readily release such
information.
Our Design Check List template (DCL, form QP10.3-F.002) has always addressed risk evaluation at a
fundamental level and was compiled following the results of discussions at the EU Conformity
Assessment Body Forum in Brussels at the onset of the 97/23/EC. We know from these discussions that
HSB Global Standards Pressure Equipment Directive
(PED 2014/68/EU) Synopsis
Hartford Steam Boiler UK Limited
Crosby Court 28 George Street Birmingham, B3 1QG United Kingdom Notified Body Number 2561
Registered Address: Baker Tilly Marlborough House Victoria Road South Chelmsford Essex CM1 1LN England Registration Number: 02708264
there was always an underlying belief that the hazard analysis should include the consideration of risk
otherwise the use of Annex I 1.2 bullet points could not be technically justified. We continue to be
involved in CABF meetings at national and European level that include discussions regarding the
resulting expectations from the addition of “and risks” and hope that the outcome will be no more
onerous in the future than it is now for our manufacturers completing our DCL.
Crosby Court 28 George Street Birmingham, B3 1QG United Kingdom Notified Body Number 2561
Registered Address: Baker Tilly Marlborough House Victoria Road South Chelmsford Essex CM1 1LN England Registration Number: 02708264
Correlation Table
Following is a correlation table, which is in Annex VI of 2014/68/EU, along with the newly introduced
Chapters, general comments giving descriptions on the contents of new or amended Articles and
Annexes.
CORRELATION TABLE
Directive 97/23/EC
Directive 2014/68/EU Comments
~~~ Chapter 1 General provisions, Articles 1 to 5
~~~ Chapter 2 Obligations of economic operators, Articles 6 to 11
~~~ Chapter 3 Conformity and classification of pressure equipment and assemblies, Articles 12 to 19
~~~ Chapter 4 Notification of conformity assessment bodies, Articles 20 to 38
~~~ Chapter 5 Union market surveillance, control of pressure equipment and assemblies entering the Union market, and Union safeguard procedure, Articles 39 to 43
~~~ Chapter 6 Committee procedure and delegated acts, Articles 43 to 46
~~~ Chapter 7 Transition and final provisions, Articles 46 to 52
Article 1(1) Article 1(1) Definitions have been moved to Article 2. The Article has been revised editorially, but there is no technical change in the scope of the new PED.
Article 1(2) Article 2(1) to (14) Includes all the definitions from the old PED, and expands this list significantly. New definitions are in sections (17) through (32) and include definitions for putting into service, economic operators etc…
Article 1(3) Article 1(2) See Article 1 above
~~~ Article 2(15) to (32) See Article 2 above
Article 2 Article 3 Title changed from Market Surveillance to Making Available on the Market and Putting Into Service. Editorially revised also.
Article 3 Article 4 Numbering and editorial revision only.
Article 4(1) Article 5(1) Added a paragraph on free movement for equipment assessed by user inspectorate.
Article 4(2) Article 5(3) See Article 5 above.
~~~ Article 6 New Article. It correlates several major responsibilities of the manufacturer that were previously found scattered throughout the old PED, and lists these obligations in one article.
~~~ Article 7 New Article. Gives the responsibilities of authorized representatives, when one is appointed by a manufacturer.
~~~ Article 8 New Article. Gives the responsibilities for importers.
~~~ Article 9 New Article. Gives the responsibilities for distributers.
~~~ Article 10 New Article. Important Article highlighting that when importers or distributers place equipment on the market under their own name or trademark, or modify equipment already on the market, that they shall be considered as a manufacturer for the purpose of the Directive.
~~~ Article 11 New Article. Economic operators responsibilities regarding requests from Market Surveillance Authorities
Article 5 ~~~ Deleted, included in Article 12, see below
HSB Global Standards Pressure Equipment Directive
(PED 2014/68/EU) Synopsis
Hartford Steam Boiler UK Limited
Crosby Court 28 George Street Birmingham, B3 1QG United Kingdom Notified Body Number 2561
Registered Address: Baker Tilly Marlborough House Victoria Road South Chelmsford Essex CM1 1LN England Registration Number: 02708264
Article 6 ~~~ Deleted, now obsolete
~~~ Article 12(1) New Article. Presumption of Conformity, includes intent of Article 5 97/23/EC
Article 7(1) Article 45 Part of Chapter 6. Committee procedure and delegated acts Delegated power, expands on empowerment of the Commission to take actions for safety reasons
Article 7(2) Article 44(1) Part of Chapter 6. Requirements for the Committee on Pressure Equipment according to the addressed Regulation
Article 7(3) ~~~ Deleted, now obsolete
Article 7(4) Article 44(5), second subparagraph
Part of Chapter 6. Change of wording, same intent, addressed Regulation number
Article 8 ~~~ Deleted, requirements expanded, see Chapter 5, Articles 39 to 43 below
Article 9(1) Article 13(1), introductory sentence
Identical
Article 9(2) point 1
~~~ Deleted, obsolete
~~~ Article 13(1)(a) Group 1 substances and mixtures, references CLP Regulation
Article 9(2) point 2
Article 13(1)(b) Group 2 substances and mixtures
Article 9(3) Article 13(2) Identical
Article 10 Article 14 Editorial changes, deletion of paragraph 1.1, text references the module changes
Article 11(1) Article 15(1) Identical
Article 11(2) Article 15(2) Editorial changes only
Article 11(3) Article 15(3) Editorial changes only
Article 11(4) Article 12(2) Identical
~~~ Article 15(4) New paragraph, Commission shall publish approval of EAM that meet Annex in the OJ
Article 11(5) Article 15(5) Identical
~~~ Article 15(6) New paragraph, withdrawal of EAM from the OJ
Article 12 ~~~ Revised and included under Article 24
Article 13 ~~~ Revised and included under Article 24
Article 14(1) Article 16(1) Identical
Article 14(2) Article 5(2) Editorial changes only
Article 14(3) to (8)
Article 16(2) to (7) Editorial changes only
Article 14(9) and (10)
~~~ Intent included in Article 32
~~~ Article 17 New Article References DOC requirements
~~~ Article 18 References the Regulation regarding the principles of CE Marking
Article 15(1) ~~~ Deleted, obsolete, information contained in Article 18
Article 15(2) Article 19(1) Editorial changes only
Article 15(3) Article 19(2) Editorial changes only
Article 15(4) and (5)
~~~ Deleted
~~~ Article 19(3) to (6) New paragraphs regarding CE Marking, Reinforcement of requirements previously in modules or not addressed
HSB Global Standards Pressure Equipment Directive
(PED 2014/68/EU) Synopsis
Hartford Steam Boiler UK Limited
Crosby Court 28 George Street Birmingham, B3 1QG United Kingdom Notified Body Number 2561
Registered Address: Baker Tilly Marlborough House Victoria Road South Chelmsford Essex CM1 1LN England Registration Number: 02708264
~~~ Article 20 Chapter 4 of the Directive. Notification of Conformity Assessment Bodies New Articles. Rules and requirements for Notification Authorities and Conformity Assessment Bodies. Includes information from parts of previous PED
~~~ Article 21
~~~ Article 22
~~~ Article 23
~~~ Article 24
~~~ Article 25
~~~ Article 26
~~~ Article 27
~~~ Article 28
~~~ Article 29
~~~ Article 30
~~~ Article 31
~~~ Article 32
~~~ Article 33
~~~ Article 34
~~~ Article 35
~~~ Article 36
~~~ Article 37
~~~ Article 38
Article 16 ~~~ Deleted, the intent is included in Chapter 5, see below
Article 17 ~~~ Deleted
Article 18 ~~~ Deleted, the intent is included in Chapter 5, see below
~~~ Article 39 Chapter 5, Union market surveillance, control of pressure equipment and assemblies entering the Union market, and Union safeguard procedure. New Articles address non-complying equipment, including reference to new Regulations
~~~ Article 40
~~~ Article 41
~~~ Article 42
~~~ Article 43
~~~ Article 44(2) to (4) New paragraphs, addresses the Committee on Pressure Equipment applicable Regulations ~~~ Article 44(5), first
subparagraph
~~~ Article 46 New Article under Chapter 6. Addresses the Commissions power to adopt delegated acts for a set period and further extensions
~~~ Article 47 Part of Chapter 7. Transitional and final provisions New Article, Penalties, addresses penalties on economic operators regarding infringements of national laws (the Directive)
Article 19 ~~~ Deleted, obsolete
Article 20(1) to (2)
~~~ Deleted, obsolete
Article 20(3) Article 48(1) Editorial changes
~~~ Article 48(2) and (3) New paragraphs address equipment put into service prior to 1 June 2015 and validity of certificates and decisions made under 97/23/EC
~~~ Article 49 Part of Chapter 7 New Article, Transposition. Adoption in Law and the effective date of implementation
HSB Global Standards Pressure Equipment Directive
(PED 2014/68/EU) Synopsis
Hartford Steam Boiler UK Limited
Crosby Court 28 George Street Birmingham, B3 1QG United Kingdom Notified Body Number 2561
Registered Address: Baker Tilly Marlborough House Victoria Road South Chelmsford Essex CM1 1LN England Registration Number: 02708264
~~~ Article 50 Part of Chapter 7 New Article, Repeal. Deletion of Article 9 from 97/23/EC from 1 June 2015, repeal of 97/23/EC from 19 July 2016
~~~ Article 51 Part of Chapter 7 New Article, Entry into force and application of 2014/68/EU from 19 July 2016
Article 21 Article 52 Editorial changes only
Annex I Annex I Essential Safety Requirements. Generally minor editorial changes only. Preliminary observation 3 was revised to add in the word “risk”, when describing the manufacturers’ responsibilities with regards to performing a hazard and risk analysis.
Annex II Annex II Changes to the Module names. A1 is now A2, C1 is now C2, B1 is now B (design type). The conformity assessment tables themselves remain unchanged.
Annex III, introductory wording
Annex III, introductory wording
Identical
Annex III, point 1, Module A
Annex III, point 1, Module A
Editorial changes only. Added paragraph on CE Marking and the Declaration of Conformity by the manufacturer. Added paragraph on Authorised Representative responsibilities, when used (these paragraphs have been added to all modules).
Annex III, point 2, Module A1
Annex III, point 2, Module A2
Changed Module from A1 to A2 and module name changed. The text has been expanded for clarification in places, and also revised to remove the need for several cross references to other modules when describing requirements.
Annex III, Module B
Annex III, point 3.1, Module B, EU-type examination - Production type
Changed Module name EU-Type examination – production type. Other minor editorial changes.
Annex III, Module B1
Annex III, point 3.2, Module B, EU-type examination - design type
Changed Module name EU-Type examination – design type. Other minor editorial changes.
Annex III, Module C1
Annex III, point 4, Module C2
Changed Module from C1 to C2 and module name change. The text has been expanded for clarification
Annex III, Module D
Annex III, point 5, Module D
Changed Module name. Other minor editorial changes
Annex III, Module D1
Annex III, point 6, Module D1
Changed Module name. Other minor editorial changes
Annex III, Module E
Annex III, point 7, Module E
Changed Module name. Other minor editorial changes
Annex III, Module E1
Annex III, point 8, Module E1
Changed Module name. Other minor editorial changes
Annex III, Module F
Annex III, point 9, Module F
Changed Module name. Other minor editorial changes
Annex III, Module G
Annex III, point 10, Module G
Changed Module name. Other minor editorial changes
Annex III, Module H
Annex III, point 11, Module H
Changed Module name. Other minor editorial changes
Annex III, Module H1
Annex III, point 12, Module H1
Changed Module name. Other minor editorial changes and text expanded instead of cross references
HSB Global Standards Pressure Equipment Directive
(PED 2014/68/EU) Synopsis
Hartford Steam Boiler UK Limited
Crosby Court 28 George Street Birmingham, B3 1QG United Kingdom Notified Body Number 2561
Registered Address: Baker Tilly Marlborough House Victoria Road South Chelmsford Essex CM1 1LN England Registration Number: 02708264
Annex IV ~~~ Deleted. Information contained within chapter 4 now
Annex VII ~~~ Deleted. Information contained within chapter 4 now
Annex VII ~~~ Deleted
Annex VII Annex IV EC Declaration of Conformity has been renamed to EU Declaration of Conformity. There have been small changes to the options for content of the declaration, as well adding a format for particulars of the signatory authorized to sign, where appropriate.
~~~ Annex V Gives the formal repeal of directive 97/23/EC
~~~ Annex VI Correlation table. Follows the format of this table and gives the correlation between Articles and Annexes
For more information pertaining to the new Directive please see the following links:
New Pressure Equipment Directive (PED) Website
Archived Pressure Equipment Directive (PED): Overview – European Commission Website
PED EC 2014/68/EU – Full text Regulation (EC) No 1272/2008 – Full Text
Classification and Labeling (CLP/GHS)
EU Blue Guide
This Synopsis was prepared by the HSB Global Standards Notified Body Staff to provide insights into the intent of these changes, and their potential impact on PED users.
We hope you find this information helpful. Any questions or comments on this document may be directed to: