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 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)

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 exemptions for certain:  Substances  Uses of substances Reduced obligations e.g. R&D, polymers and intermediates

Manufacturers/Importers: Registration Registration for substances ≥ 1 tonne per 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)

5/16/20155 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

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

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

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

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 list 15 substances to be published very shortly  Priority list for inclusion into Annex XIV: June 2009  Inclusion in Annex XIV (comitology decision)

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)

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)

5/16/ SVHC: Information Requirements Suppliers must provide sufficient information, available to the supplier, to clients to allow the safe use of the article including, as a minimum, the name of that substance, if:Suppliers must provide sufficient information, available to the supplier, to clients to allow the safe use of 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 daysOn request by consumers, suppliers must provide the consumers with the above information within 45 days  Obligation starts immediately after substance was put on the candidate list!

5/16/ SVHC: Notification SVHC must be notified to the Agency after 1 June 2011, ifSVHC must be notified to the Agency after 1 June 2011, if  They have been identified on the candidate list at least six months before  They are present in articles quantities of 1 tonne / year or more per Manufacturer / Importer, and  The substance is present > 0.1% w/w  The substance is not yet registered for that use  The producer cannot exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use, including disposal.

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

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

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

What should non-EU textile companies do if they deal with substances/preparations 1 ?  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

 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) What should non-EU textile companies do if they deal with articles 2 ?

5/16/ Where can industry turn for help? 1.Check the legislation (available in all EU languages) 2.Check the Guidance website 3.Check the Frequently Asked Questions on the ECHA website ( ) 4.Talk to colleagues, business associations, industry helpdesks 5.Contact national helpdesk (addresses can be found on )

5/16/ Further Information