Belgrade – May 31, 2012 – Guido Bottini – Technology & Environment Area Manager Workshop on REACH and EU Biocidal Product Legislation in practice Impact.

Belgrade – May 31, 2012 – Guido Bottini – Technology & Environment Area Manager

Workshop on REACH and EU Biocidal Product Legislation in practice

Impact of REACH on Serbian exporters of Textiles and Clothing

SERBIA

Textile manufacturing (spinning, weaving, knitting, fabric production)

Garment production

Serbian Textile Industry imports dyes and chemicals, fabrics

Raw materials from clients

Exports: about 55% textiles, 45% final products


Whatever you manufacture

is an ARTICLE

REACH definition: an article is “an object which during production is given a special shape, surface or design which determines its function to a greater degreethan its chemical composition”.

For example, the design of a textile may be determined bythe twist of fibres in the yarn, the weave of threads in a fabric and the treatment of the surface of the textile.


Any company carrying out:

-Textile manufacturing (spinning, weaving, knitting, fabric production)

-Garment production

is a producer of articles

using substances, mixtures or articles for its production.




CURRENT SITUATIONSerbian (Extra-EU) exporter vs EU importer of articles

Four potential obligations for an EU importer of articles if specific conditions are met:

1. Registration of substances in articles intended to be released

2. Notification of SVHC substances in articles not intended to be released

3. Communication in the supply chain (Art. 33)

4. Compliance with restrictions of use (Annex XVII)


SUBSTANCES IN ARTICLES

The application of REACH provisions for substances in articles is a serious challenge for EU importers of yarns, fibres and grey fabrics as well as finished articles

WHY?

Lack of information on the production process and the corresponding chemicals input


COMPLIANCE withRESTRICTIONS ON USE OF SUBSTANCES

(Annex XVII)

-the use or content of substances in articles, imported included, can be restricted or banned

-EU importers of articles have to follow the conditions outlined in Annex XVII of REACH from the 1 June 2009


ANNEX XVIIRESTRICTIONS ON USE OF SUBSTANCES


ANNEX XVII(following)
































Duty to Communicate Information on SVHC substances in Articles according to Article 33

Mandatory downstream provision for professional users

Information has to be also provided to consumers upon request within 45 days

It concerns SVHC present in the article in concentration above 0.1% (w/w)

The obligation cannot be exempted via article 7(3) (exclusion of exposure)

the obligation cannot be exempted via article 7(6) (already registered for that use)


Duty to Communicate Information on Substances in Articles according to Article 33

IMPORTANT

• There is no tonnage trigger for this obligation

• The obligation applies from the date the SVHC has been included on the candidate list for authorisation

• The obligation apply also to articles which were imported before the substance was included in the candidate list and are supplied after the inclusion in the list



WHAT INFORMATION MUST BE PROVIDED

“Any supplier …. shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.”

Level of detail – not specified (normal or reasonably foreseeable conditions of use)

Format – not specified, professional user/consumer (instruction for use/label –

electronic/paper)

SVHC substances of interest for textiles & clothing

SVHC substances with notifications of use in articles (ECHA 05/03/2012)

- Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins) – fireproofing agents leather

- Benzyl butyl phthalate (BBP) – plasticizer for PVC coated textile products and packaging materials

- Bis (2ehtyl(hexyl)phthalate) (DEHP) – plasticizer for PVC coated textile

products- Boric Acid – flame retardant

- Diarsenic pentaoxide – preserving agent natural textile fibres

- Dibutyl phthalate (DBP) – plasticizer for PVC coated textile products

- Diisobutyl phthalate (DIBP) fabrics, textiles, apparel, leather

- Hexabromocyclododecane (HBCDD) – flame retardant



SVHC substances with information of use in articles in registration dossier but without notifications (ECHA 05/03/2012)

- 4-4’ Diaminodiphenylmethane (MDA) – aromatic amine, from azo-dyes textile products and leather

- Bis(tributyltin)oxide – preserving agent for plastic polimers

- Diarsenic trioxide – preserving agent natural textile fibres

- Lead hydrogen arsenate – preserving agent natural textile products

- Potassium Dichromate – wool dyes

- Sodium dichromate – Chromium based dyes animal textile fibres - Triethyl arsenate – preserving agent natural textile products




SVHC substances without information of use in articles in registration dossier and without notifications

- 2-Ethoxyethyl acetate (2-EEA) – industrial textiles and dyes

- 2-Methoxyaniline – intermediate in manufacturing azo-dyes, pigments and fragrances

- Musk Xylene – fragrances

- Arsenic acid – desiccant for cotton

- Bis(2-methoxyethyl)ether – used in sealants and adhesives, paintsand water-based dyes

- Cobalt Chloride - production of pigments

- Dichromium tris(chromate) – catalyst in the mordanting of yarns

- Disodium tetraborate – flame retardant

- N,N-dimethylacetamide (DMAC) – used in coatings formulations

13 New potential SVHC substances (27/02/2012)


Calculation of 0,1% threshold

If no component of a complex article contains above 0.1% (w/w) of a SVHC on the Candidate List, also the entire article does not contain it above 0.1% (w/w).

If one or more components of a complex article contain above 0.1% (w/w) of a SVHC on the Candidate List, the producer/importer of the article needs to:

1. find out the concentration of the SVHC in each component and the mass of each component containing the SVHC [whether above 0.1% (w/w) or below]

2. calculate the mass of the SVHC in each of these n components

3. calculate the average concentration of the SVHC in the article and check if it is above 0.1% (w/w)


Calculation of 1t/a threshold

If three different types of articles containing an SVHC substance are imported (A1, A2 and A3), the importer of the article needs to:

1.calculate the average concentration of the SVHC in each article and check if it is above 0.1% (w/w)

2.exclude the one(s) with SVHC < 0,1% [A1 = 0,02%, A2 = 0,5%, A3 = 1%]

3.calculate the total SVHC volume per year on the basis of the imported quantities of each articles involved (i.e. A2 and A3)

4.sum up the total volumes of SVHC and check if it is > 1t/a


Chemical analysis of substances in articles

Substances contained in articles can be identified and their concentrations quantified by applying analytical methods;

It may be an option to obtain information on the composition of articles (ok if an article consists of a homogenous material, but also for complex, small articles, shredding and testing of a sample might be a feasible approach);

For certain articles (e.g. toys, shoes, textiles) it is even common practice to perform chemical analyses of materials used in the production or of final products. Such analyses performed routinely for checking of compliance with other legislation or product quality control can also serve to obtain information needed for compliance with REACH;

Anyway, they may yield ambiguous results and/or be very costly and are thus not recommended as the preferred instrument for obtaining information


Difficulties related to chemical analysis

Articles may be very complex and composed of different parts and materials. It is therefore difficult to create a sample for the analysis that represents the whole article;

Substances that are included in the article matrix may have to be extracted from it (e.g. chemical reactions could “create” substances which do not exist in the article; extraction may not be exhaustive, the full content of substances in the matrix may not be obtainable);

Various analytical methods are available to screen for the existence and identification of different substances in a sample [measurements in most cases will identify the chemical constituents in the sample but not necessarily “the substance” originally used to produce the article; some methods may show the existence of certain elements (e.g. halogens) rather than the existence of substances; etc.].


Steps to be considered, when planning chemical analyses:

-consult experts or sector information sources to narrow down which substances to look for (e.g. for many articles it can be excluded that gaseous substances are contained therein);

-Develop a strategy for testing as a tiered process, i.e. broad screenings, narrow screenings and identification by e.g. semi-quantitative methods.

-Identify which part(s) of the article to analyse: liquids, gases or powders contained in the article, extracts from the article matrix, article parts likely to contain a particular SVHC, etc.

-Perform the chemical analysis for the identification of substances.


Information on SVHC substances:

• this could be done “top down”:- by certifying that SVHC are not used- collecting information from your suppliers- remaining under certain concentration range in articles

• the “bottom up” approach consist of EU importer including criteria in supply contracts

• narrow down the range of SVHC in the candidate list by using the “exclusion” approach

• consider 0.1% (trace amounts would normally not exceed the threshold)

• consider when relevant the 1t/a threshold

• only as last resort conduct targeted analysis


Determining whether the article contains SVHC

Be aware of the possibility to accumulate SVHC throughout the whole production process

If the exact concentration in the article is not known, a first screening may be performed on the basis of the maximum amount or concentration in the article. If it shows a concentration > 0.1% a more precise determination of the SVHC amount or concentration should be made


How to exclude exposure for substances in articles

Exposure can be excluded in the following situations:

no release occur

there is a release but the article is embedded during use and the substance will not escape to the environment or get into contact with humans during use and disposal

include arguments based on:

knowledge of the article and its service life

knowledge on the substance properties

quantification based on exposure models demonstrating no exposure during the life cycle and disposal

measurements proving that no emission from the article take place including the phase of its disposal


Substances in Annex XIV (Authorization)of interest for textiles & clothing





Information on Substances in Articles to be supplied to EU Importers

for notification according to article 7(2)

Only when all conditions are met:the substances is included in the candidate list for authorisation [article 59(1)], i.e. it is a SVHC substanceis present in all articles in amount totalling over 1t/ais present in the articles above 0.1% (w/w) [threshold is applied to an article as imported and not to its homogeneous parts (but remember the Authority dispute on this issue)]

Notification is not requested if one of the following conditions is met:exposure is excluded (we advise against it)the substances has already been registered for the specific use


Information on Substances in Articles to be supplied to EU Importers

for registration according to article 7(1)

Two conditions must be met:

intended release and

total amount exceeds 1 t/a

For calculations:

1.the total amount of the substances in all articles is taken into account2.if more than one type of articles with intended release of that substance, the quantities in all articles have to be summed up3.the substance does not have to be registered if already registered by an actor in the supply chain


To be considered for a release of substances from articles: accessory function (to be differentiated from the main function according to section 2.1) which is deliberately planned and would not be achieved if the substance were not released. E.g. scented clothes (children products)

Normal conditions of use means the conditions associated with the main function of an article

Reasonably foreseeable conditions of use mean conditions of use that can be anticipated as likely to occur because of the function and appearance of the article (even though they are not normal conditions of use).

Example: in the case of a panty hose with lotion, the main function is to provide clothing. This main function is clearly unrelated to the lotion. The function of the lotion (skincare) is an accessory function, which would not be achieved if the lotion were not released. As a consequence, the panty hose with lotion should be regarded as an article with an intended release.



http://eur-lex.europa.eu/RECH_menu.do?ihmlang=en

Search by document number Consolidated text

Packaging and containers

-Importers of packaged articles have to fulfil the same requirements as for any other article, be it a carton or a plastic wrapping or other material.

-In general no intended release from packaging materials is foreseen but they may be unintended release.

-The packaging does not belong to the substance, mixture or article being packaged and is therefore to be considered as a separate article under REACH.

-Packaging with different functions needs to be considered separately (e.g. if an article is directly wrapped in plastic and then packed in a cardboard box, the plastic and the cardboard box should be considered as separate articles).


NON-EU Exporters can play a fundamental role in facilitating the import process and reducing the work load

-preparing/colleting information to be supplied to your EU Customers

-document the results of their compliance checking with the requirements of substances in articles and information to consumers

-if you have a quality management systems, you could incorporate REACH conformity as a criterion with a clear indication of how conformity will be secured and documented

-you may establish “good practice code” with supporting documents including letters to importers, certificates, results of analysis etc.


Serbian Textile Industry

imports dyes and chemicals, fabrics

and

receives raw materials from clients

Information received/collected along your entire supply chain on the presence of SVHC substances is of fundamental importance in order not to face problems when exporting to the EU



FUTURE POTENTIAL SITUATIONSerbian company = EU company

producer of an article: means any natural or legal person who makes or assembles an article within the Community;

importer: means any natural or legal person established within the Community who is responsible for import;

downstream user: means any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities.


FUTURE POTENTIAL SITUATION(following)

actors in the supply chain: means all manufacturers and/or importers and/or downstream users in a supply chain;

supplier of an article: means any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market (e.g. third party company, packaging/label supplier, retailer);

recipient of an article: means an industrial or professional user, or a distributor, being supplied with an article but does not include consumers (e.g. any company receiving an article to be worked out);


Obligations according to Article 7 and Title VII

Registration of substances if articles contain substances intended to be released (art. 7.1)

Notification of substances if articles contain SVHC substances not intended to be released (art. 7.2)

Authorization (Annex XIV)


Obligations in the supply chain (Title IV)

Article 33Obligation of information on SVHC substances

Article 34Obligation of communication of new information upstream for substances and mixtures

Article 35Information to workers for substances and mixtures

Article 36Obligation of keeping documents for 10 years after last manufacture, import, supply or use of a substance/mixture


T/C Company importing articles(e.g. yarn/textile/button/finished suit)

Registration of substances (art. 7.1):- NO, if there is no intended release of a substance- NO, if there is intended release of one or more substances but

qty of each substance is < 1t/a- YES, if there is intended release of one or more substances,

qty of each is > 1t/a and substance not registered for the same use

- NO, if there is intended release of one or more substances, qty of each is > 1t/a and substance(s) have been already registered for the same use

FEW EXAMPLES



Notification of substances (art. 7.2)- NO, if article does not contain any SVHC substances- NO, if article contains one or more of SVHC substances but

each one in concentration < 0,1% p/p- NO, if article contains one or more of SVHC substances,

each one in concentration > 0,1% p/p, but total qty of each is < 1 t/a

- YES, if article contains one or more of SVHC substances,each one in concentration > 0,1% p/p, total qty of each is > 1 t/a and not registered for the same use

- NO, if article contains one or more of SVHC substances,each one in concentration > 0,1% p/p, total qty of each is > 1 t/a and already registered for the same use



Restrictions – no differences with the current situation

Authorizations – must comply with provisions of Annex XIV

Information according to Art. 33 – SVHC substances- NO, if article does not contain or contains SVHC substances

but in concentration < 0,1 % p/p- YES, if article contains SVHC substances in concentration

> 0,1 % p/p- if YES, mandatory communication to

professional users without waiting for their request- if YES, mandatory communication to

consumers within 45 days but only upon their request


T/C Company manufacturing articles(e.g. yarn/textile/dyeing/printing/garment)

and downstream user (e.g. third party manufaturer)

Registration of substances (art. 7.1):- NO, if there is no intended release of a substance- NO, if there is intended release of one or more substances but

qty of each substance is < 1t/a- YES, if there is intended release of one or more substances,

qty of each is > 1t/a and substance not registered for the same use

- NO, if there is intended release of one or more substances, qty of each is > 1t/a and substance(s) have been already registered for the same use




Notification of substances (art. 7.2)- NO, if article does not contain any SVHC substances- NO, if article contains one or more of SVHC substances but each one in concentration < 0,1% p/p- NO, if article contains one or more of SVHC substances,each one in concentration > 0,1% p/p, but total qty of

each is < 1 t/a- YES, if article contains one or more of SVHC substances,each one in concentration > 0,1% p/p, total qty of

each is > 1 t/a and not registered for the same use- NO, if article contains one or more of SVHC substances,each one in concentration > 0,1% p/p, total qty of

each is > 1 t/a and already registered for the same use




Information according to Art. 33 – SVHC substances- NO (neither to receive nor to give) if article does not contain or

contains SVHC substances but in concentration < 0,1 % p/p

- YES (both to receive and to give) if article contains SVHC substances in concentration > 0,1 % p/p

- if YES, mandatory communication to professional users without waiting for their request

- if YES, mandatory communication to consumers within 45 days but only upon their request




Restrictions – no differences with the current situation

Authorizations – must comply with provisions of Annex XIV

Obligation to communicate upstream new information on substances and mixtures - Article 34

Information to workers on substances and mixtures - Article 35

Obligation of keeping documents for 10 years after last manufacture, import, supply or use of a substance/mixture - Articolo 36

Biocides – Treated Articles

Planned replacement of Directive 98/8/EC with new Biocidal Products Regulation (Jan 2013?)

Treated articles, including imported ones, may only contain EU-approved active substances and have to be labelled

Examples: sleeping bags, sofas, smell-free socks, treated bed linen

Question marks to be clarified: definition of “primary function”; “relevant use”; “a claim is made”, etc.

A Concept paper for treated articles is under discussion


Guido Bottini

[email protected]

Tel. +39 02 64 11 92 44 / 17

THANK YOU FOR YOUR ATTENTION


Belgrade – May 31, 2012 – Guido Bottini – Technology & Environment Area Manager Workshop on REACH and EU Biocidal Product Legislation in practice Impact.

Documents

following belgrade

clothing slide

list belgrade

use of substances belgrade

use of substances annex

final products belgrade

restrictions of use

producer of articles