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 substancesOn 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 conductedData sharing (in particular for vertebrate tests)

Substance Information Exchange Fora (SIEFs)

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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?

100 - 1000 100 - 1000 t/at/a

31 May 31 May 20132013

Entry Entry

into forceinto force

1 June 20071 June 2007

Registration of Registration of ‘new’ substances‘new’ substances

≥ ≥ 1t/a1t/a

31 May 31 May

20182018

≥≥1000 t/a 1000 t/a

CMR ≥1 t/aCMR ≥1 t/a

R50/53 ≥100 t/aR50/53 ≥100 t/a

30 Nov. 30 Nov. 20102010

Pre-registrationPre-registration1 June 2008 1 June 2008 – – 1 Dec. 20081 Dec. 2008

Agency Agency publishes publishes

List List 1.1. 20091.1. 2009

C&L notification C&L notification (independent of tonnage)(independent of tonnage)

Timeline REACH phase-in period (not in scale)Timeline REACH phase-in period (not in scale)Note that phase-in registration requires Note that phase-in registration requires

pre-registration!pre-registration!

SIEFSIEF

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 registrationAgency 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 XIVCMR (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)

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SVHC: Information RequirementsSVHC: Information Requirements

• Suppliers must provide sufficient information, Suppliers must provide sufficient information, available to the supplier, available to the supplier, to clientsto clients to allow the to allow the safe usesafe use of the article including, as a minimum, of the article including, as a minimum, the name of that substance, if:the name of that substance, if:

They have been identified on the They have been identified on the candidate listcandidate list

The substance is present The substance is present > 0.1% w/w> 0.1% w/w

• On request by On request by consumersconsumers, suppliers must provide the , suppliers must provide the consumers with the above information within 45 daysconsumers with the above information within 45 days

Obligation Obligation starts immediatelystarts immediately afterafter substance was put on substance was put on the candidate list!the candidate list!

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SVHC: NotificationSVHC: Notification

• SVHC must be SVHC must be notified notified to the Agency to the Agency after after 1 June 20111 June 2011, if, if

They have been identified on the They have been identified on the candidate listcandidate list at least at least six months beforesix months before

They are present in articles quantities of They are present in articles quantities of 1 tonne / year 1 tonne / year or moreor more per Manufacturer / Importer, andper Manufacturer / Importer, and

The substance is present The substance is present > 0.1% w/w> 0.1% w/w

The substance is The substance is not yet registerednot yet registered for that usefor that use

The producer The producer cannot exclude exposurecannot exclude exposure to humans or to humans or the environment during normal or reasonably the environment during normal or reasonably foreseeable conditions of use, including disposal.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

IMPORT

Textile supply chainTextile supply chain

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

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 articles2?

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Where can industry turn for help?

1. Check the legislation (available in all EU languages)

http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2006:396:SOM:EN:HTML

2. Check the Guidance website http://echa.europa.eu

3. Check the Frequently Asked Questions on the ECHA website (http://echa.europa.eu )

4. Talk to colleagues, business associations, industry helpdesks

5. Contact national helpdesk (addresses can be found on http://echa.europa.eu )

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Further Information

http://echa.europa.eu

http://ec.europa.eu/enterprise/reach/index_en.htm

http://ec.europa.eu/comm/environment/chemicals/reach.htm