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The impacts of EU Legislation REACH on Textile & Clothing Industries

The impacts of EU Legislation REACH on Textile & Clothing Industries. ITKIB Seminar – 28 October 2008, Istanbul Otto Linher – REACH unit. This presentation does not necessarily reflect the official opinion of the Commission. REACH.

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The impacts of EU Legislation REACH on Textile & Clothing Industries

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  1. The impacts of EU Legislation REACH on Textile & Clothing Industries ITKIBSeminar – 28 October 2008, Istanbul Otto Linher – REACH unit This presentation does not necessarily reflect the official opinion of the Commission

  2. REACH • One single and coherent system for new and existing chemicals • Shift of responsibilities: public authorities  industry • Core elements: • Registration of substances ≥ 1 tonne/yr (staggered deadlines) • Information in the supply chain • Evaluation of some substances by Member States • Authorisation only for substances of very high concern • Restrictions - the safety net • Agency to manage system • Focus on priorities: • high volumes (as a proxy for potential risk) • greatest concern (substances & uses with highest risk)

  3. Scope of the regulation • REACH applies to the manufacturing, import, placing on the market and use of substances • On their own, in preparations, in articles • However, there are exemptionsfor certain: • Substances • Uses of substances • Reduced obligations e.g. R&D, polymers and intermediates

  4. Manufacturers/Importers: Registration • Registration for substances ≥ 1 tonneper year • Chemical Safety Report (CSR) for all substances ≥ 10 t per year • In the absence of available information, tests may have to be conducted • Data sharing (in particular for vertebrate tests) • Substance Information Exchange Fora (SIEFs)

  5. Who has to register? Manufacturers of substances and producers of articles with intended release: Each legal entity must register separately May appoint Third Party Representative Importers Non-EU manufacturer may appoint Only Representative instead In such cases, Only Representatives is liable for registration and importer is considered as downstream user 9/18/2014 5

  6. When to register? Timeline REACH phase-in period (not in scale) Note that phase-in registration requires pre-registration! ≥ 1t/a 31 May 2018 Agency publishes List 1.1. 2009 Pre-registration 1 June 2008 – 1 Dec. 2008 Entry into force 1 June 2007 ≥1000 t/a CMR ≥1 t/a R50/53 ≥100 t/a 30 Nov. 2010 100 - 1000 t/a 31 May 2013 Registration of ‘new’ substances SIEF C&L notification (independent of tonnage)

  7. Substances in Articles (Article 7) • > 1 tonne / year per Manufacturer / Importer • Not registered for that use • Intended to be released(regardless of hazard) • Substance of Very High Concern (CMRs, PBTs and vPvBs, etc.) • Placed on candidate list for authorisation • Concentration of > 0.1 % weight-by-weight • Timeline in accordance with (phase-in) deadlines General obligation to register Pass on information in the supply chain • Immediately on request of consumers • At the earliest 1 June 2011 notify to ECHA Agency may require registration

  8. Evaluation • Dossier evaluation: Checking compliance of registration dossiers Checking of test proposals • Substance evaluation: Checking whether there is a need for further information on a substance

  9. Authorisation (1) • Only applies to Substances of Very High Concern, once included in Annex XIV • CMR (carcinogenic, mutagenic, toxic for reproduction) • PBT/vPvB (persistent, bioaccumulative, toxic) • substances of equivalent concern (endocrine disruptors, catch-all) • Identification of SVHC • Candidate list15 substances to be published very shortly • Priority list for inclusion into Annex XIV: June 2009 • Inclusion in Annex XIV (comitology decision)

  10. Identified as CMR • 4,4’-Methylene dianiline (C) • Bis(2-ethylhexyl)phthalate (R) • Dibutylphthalate (R) • Benzylbutylphthalate (R) • Cobalt dichloride (C) • Triethyl arsenate (C) • Lead hydrogen arsenate (CR) • Diarsenic trioxide (C) • Diarsenic pentaoxide (C) • Sodium dichromate (CMR)

  11. Identified as PBTs, vPvBs • Alkanes, C10-13, chloro- (SCCP) (PBT & vPvB) • Anthracene (PBT) • Bis(tributyltin)oxide (TBTO) (PBT) • Hexabromocyclododecane (HBCDD) (PBT)h • Musk xylene (vPvB)

  12. SVHC: Information Requirements Suppliers must provide sufficient information, available to the supplier, to clientsto allow the safe useof the article including, as a minimum, the name of that substance, if: They have been identified on the candidate list The substance is present > 0.1% w/w On request by consumers, suppliers must provide the consumers with the above information within 45 days Obligation starts immediatelyaftersubstance was put on the candidate list! 9/18/2014 12

  13. SVHC: Notification SVHC must be notified to the Agency after 1 June 2011, if They have been identified on the candidate listat least six months before They are present in articles quantities of 1 tonne / year or moreper Manufacturer / Importer, and The substance is present > 0.1% w/w The substance is not yet registeredfor that use The producer cannot exclude exposureto humans or the environment during normal or reasonably foreseeable conditions of use, including disposal. 9/18/2014 13

  14. Authorisation (2) • “Sunset date” after which manufacturing and use is only allowed when covered by an authorisation • Downstream users can: • Use substances for which an authorisation has been granted to a supplier up their chain, or • Apply for an autorisation themselves

  15. Restriction • Only minor changes compared to existing system (Directive 76/769/EEC) • In addition to “marketing & use”, now also manufacturing covered

  16. Textile supply chain Basic chemicals Textile Chemicals: Speciality Substances: Dyestuffs and Effect Giving Substances Textile Chemicals: Preparations Textile Auxiliaries and Dyestuff Preparations I M P O R T RECIPES Fibres, yarns, fabrics, garments Textile Finishing Finished fibre, yarn, fabric, garment (mostly articles) Users further Downstream (e.g. automotive industry) & Final Consumers

  17. What should non-EU textile companies do if they deal with substances/preparations1? • Non-EU companies cannot register substances under REACH • The “normal” way is that importers of substances (on their own, in preparations or in articles with intended release) have to register • However, non-EU companies can appoint Only Representatives (in this case the importer only has downstream user obligations) • Identify which information importers or Only Representatives need and assist them in fulfilling their obligations 1) also applies to substances in articles with intended release

  18. What should non-EU textile companies do if they deal with articles2? • Check ECHA website which substances are on the candidate list (or have been proposed for it) • Communicate in the supply chain to find out whether the substances are present in the article and in what concentration • Communicate their presence to clients (after substance was put on the candidate list) and make sure the importer or Only Representative notifies their presence to the Agency (not before June 2011)

  19. Where can industry turn for help? Check the legislation (available in all EU languages) http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2006:396:SOM:EN:HTML Check the Guidance websitehttp://echa.europa.eu Check the Frequently Asked Questions on the ECHA website (http://echa.europa.eu) Talk to colleagues, business associations, industry helpdesks Contact national helpdesk (addresses can be found on http://echa.europa.eu) 9/18/2014 19

  20. Further Information http://echa.europa.eu http://ec.europa.eu/enterprise/reach/index_en.htm http://ec.europa.eu/comm/environment/chemicals/reach.htm 9/18/2014 20

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