Prsentation PowerPoint

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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
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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)

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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. RD, polymers and
  intermediates

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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)

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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

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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
100 - 1000 t/a 31 May 2013
1000 t/a CMR 1 t/a R50/53 100 t/a 30 Nov.
2010
Registration of new substances
SIEF
CL notification (independent of tonnage)
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Substances in Articles (Article 7)

• gt 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 gt 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
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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

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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)

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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)

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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 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
• They have been identified on the candidate list
• The substance is present gt 0.1 w/w
• On 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!

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SVHC Notification

• SVHC 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 gt 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.

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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

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Restriction

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

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Textile supply chain
Basic chemicals
Textile Chemicals Speciality Substances Dyestuff
s 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
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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

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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)

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Where can industry turn for help?

• Check the legislation (available in all EU
  languages)
• http//eur-lex.europa.eu/JOHtml.do?uriOJL20
  06396SOMENHTML
• Check the Guidance website http//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 )

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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/rea
  ch.htm

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