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How Downstream Users REACH? Impacts and challenges of REACH

How Downstream Users REACH? Impacts and challenges of REACH for EU Cutlery, Flatware, Holloware, and Cookware Industries FEC General Assembly 20 November 2007 Françoise Duplat Orgalime secretariat. LU. BE. AT. CZ. 35 Member Associations 23 European Countries 130 000 Companies

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How Downstream Users REACH? Impacts and challenges of REACH

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  1. How Downstream Users REACH? Impacts and challenges of REACH for EU Cutlery, Flatware, Holloware, and Cookware Industries FEC General Assembly 20 November 2007 Françoise Duplat Orgalime secretariat

  2. LU BE AT CZ • 35 Member Associations • 23 European Countries • 130 000 Companies • €1779 Bn output 2006 (EU-27 estimates for the whole engineering industry) • 10.6 Mio employment FI NO SE LV DK LT IE UK PL NL DE FR CH SL HR ES BG PT IT

  3. Brief outline • Introduction • REACH priorities for DU • Communication in the supply chain • Substances in articles • Authorisation procedures • Conclusion

  4. Why « REACH »? • REACH: « Registration Evaluation Authorisation of Chemicals » • Before REACH – various legislation relating to chemicals : • Directive 67/548/EEC, Directive 1999/45/EC, Regulation (ECC) n° 793/93, Directive 76/769/EEC etc • BUTlack of harmonisation between so-called «new» and « existing» substances • Therefore elaboration of « REACH Regulation » • Publication of the COM Proposal on REACH: 29 Oct. 2003 • Negociation European Parliament and Council: end of 2003-Dec. 2006 • European Regulation n° 1907/2006 adopted 18 Dec. 2006 • Publication in EU Official Journal : 30 Dec. 2006 • Creation of European Chemicals Agency (ECHA)

  5. REACH Regulation n°1907/2006 • Entered into force on 1st June 2007 • Directly applicable and full harmonisation except enforcement • Strengthened industry responsibility toprovide and communicate safety information on substances and to properly manage the risk realted to their use. • Scope: All substances, on their own, in preparations, in articles • Exemption to scope: radioactive, non-isolated intermediates, waste, transport, transit or reexportation, interest of defence • Further exemptions to some parts of REACH, e.g. for R&D, acc. to use, nature of substance etc • All EU actors of supply chain concerned: from e.g. EU manufacturer/importer (M/I) of substances to downstream users (DU)/article producer or article importer • REACH obligations according to role in supply chain

  6. What focus for Orgalime? Substance manufacturer/ importer e.g. chemical industry Formulator of preparations (“1st level downstream users”) e.g. paint manufacturer Downstream users of substances/ preparations (“2d level downstream users”) Orgalime Industries FEC industries • Orgalime practical guide for downstream users, article producers and article importers to understanding Regulation N°1907/2006 on REACH (May 2007) • Available free of charge at www.publications.orgalime.org • Structure: • Introduction (definitions, acronyms etc.) • Overview important dates and deadlines • Orgalime quick screens • More detailed guidelines on selected issues • One page summary on timelines and obligations Article producers/ Article importers Orgalime Industries FEC industries

  7. ? REACH prioritiesfor Orgalime industries Check Orgalime quick screens 1,2,3,4

  8. Downstream user? Importer? (« only representative» nominated in the EU?) Article producer/importer? A company may play several roles! Takes time and ressources - early preparation is key ? First and foremost… Check Orgalime Guidelines 1,2,3,4 What is my role in the supply chain? 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 preparation, in the course of his industrial or professional activities (…) Establish inventories with key information according to role Article producer means…. “means any natural or legal person who makes or assembles an article within the Community” Check REACH scope/exemptions

  9. Registration procedurein a nutshell • Registration of substances on their own or in preparations, intentionallyreleasedfrom articles≥1 t/y per M/I • For “non phase-in substances” ≥ 1 t/y: asof 1/06/2008, before manufacturing/importing/putting on the market • For “phase-in” substances ≥ 1 t/y: transitional regime • ≥1000 t/y, CMR ≥1 t/y, aqu.tox. ≥100 t/y : 30 /11/2010 • 100 - 1000 t/y: 31/05/2013 • 1- 100 t/y : 31/05/2018 • To benefit from transitional regime: PRE-REGISTRATION required! • “No data - no market” • DU to communicate uses to allow manufacturer/importer (i.e. supplier) to complete registration dossier ·

  10. ? Communication in the supply chain (1) Check Orgalime guideline 5 ESSENTIAL to ensure that substances used will be pre-registered/registered by supplier • Pre-registration : between 1/06/2008 and 1/12/2008 (Art. 28) • DU not considered as potential registrant • List of pre-registered substances on the ECHA website by 1/1/2009 • Notification to Agency of interest for a non pre-registered substances • DU may be part to Substance Information Exchange Forum (SIEF) « No data - No market » Possible consequences on continuity of supply Time is running!

  11. ? Communication in the supply chain (2) Check Orgalime guideline 5 • Supplier (M/I) to compile registration dossier • Technical dossier: starting at 1 t/y • Chemical safety report (CSR): starting at 10 t/y • CSR to include exposure scenario (ES) if substance is dangerous, PBT or vPvB • ES to cover manufacture of sub. and DU identified uses • DU «identified use» covered ? DU has the right to make his use known to supplier (« brief description of use ») • DU to provide sufficient information to allow supplier to prepare exposure scenario/use and exposure category (ES/UEC) for his use • ES annexed to safety data sheet (SDS)

  12. ? Communication in the supply chain (3) Check Orgalime guideline 5 • Possible uses advised against, but only for reasons of protection of human health or the environment • If no SDS but risks management measures (RMMs): Article 32 • DU to identify, apply and where suitable recommend RMMs ( listed in SDS or Article 32) • 12 Months to comply with Art. 37 after receiving registration number in SDS • Further DU communication duties Important to BE PRO-ACTIVE and inquire early enough on supplier’s policy towards substance/preparation used

  13. ? DU own chemical safety report Check Orgalime guideline 6 • Specific cases : DU to perform own chemical safety report (CSR) and report to ECHA (Art. 37.4, 38 and Annex XII) for: • Use outside conditions described ES/UEC of supplier • Use advised against (protection of health and the environment) • DU to identify, apply and where suitable recommend RMMs of his own CSR • Information to be kept available and up to date • Exemptions foreseen! Requires specific chemical knowledge Time consuming and expensive Make sure supplier’s ES covers DU uses

  14. ? Substances in articles Check Orgalime Guidelines 7,8,9 • What is an « article »? “an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition” (Art. 3.3) E.g.: electrical and electronic equipment, a screw, a bolt, a motor, cutlery, cookware, etc.

  15. ? Check Orgalime guideline 7 Registration of substancesintentionally released from articles Article producer,article importer/«only representative» to REGISTER any substance in articles if   • Intentional release under normal or reasonably foreseeable conditions of use AND • Total amount of substance present in articles over 1 tonne per producer/importer per year (Art. 7.1) Same timeline to register as for any other substances (2010-2013-2018) - Registration fees NOregistration ofsubstance in article if substance hasalready been registered for that use (Art. 7.6)

  16. ? Notification of substances present in articles Check Orgalime guideline 8 Article producer,article importer/«only representative» to NOTIFY substances in articles if the substance • Has been identified as of very high concern (Art.57) i.e.CMR 1 & 2, PBT/ vPvB and any other substance of equivalent concernAND • Is present in articles in quantities over 1 t/y AND • Has been included in the candidate list (Art.59) AND • Is present in the article above a concentration of 0.1% w/w (Art. 7.2) FROM 1/06/2011, 6 months after inclusion in candidate list Notification of substance in article NOT required • If substance has already been registered for that use (Art. 7.6) • If exposure to human health and the environment, including disposal, can be excluded (appropriate instructions to recipient) (Art. 7.3)

  17. Further points to consider…. • ECHA to possibly require registration for substances present in articles under certain conditions (Art. 7.5) • Concentration calculation « 0.1% w/w » at the level of the article • Consequences on smooth running of supply chain and just in time delivery of articles

  18. ? Communication requirements on substances in articles Check Orgalime guideline 9 • Supplier of an article to provide sufficient information available to him, as a minimum name of substance, to recipient of article to allow safe use if the substance • Is identified as of very high concern AND • Is included in the candidate list for inclusion in Annex XIV AND • Is present in the article in concentration above 0.1% w/w • Extended to consumers upon request (within 45 days free of charge)

  19. ? Authorisation procedure (1) Check Orgalime guideline 10 • Concerns substances of very high concern on their own/in preparations/ incorporated in articles during process phase • « Progressive» procedure: • Sub. incorporated in the candidate list • Priority list from ECHA no later than 01/06/09 • Further inclusion of sub. in Annex XIV • Application for authorisation (by M/I/DU - analysis of alternatives - fees!) • COM to decide on granting/reviewing authorisation • NO tonnage threshold • DU may use a substance listed in Annex XIV if authorisation granted for that use up the supply chain • Notification to ECHA within 3 months of first supply! • Exemption certain uses and categories of uses • Further exemptions foreseen! • Two routes foreseen

  20. ? Authorisation procedure (2) Check Orgalime guideline 10 • An authorisation for the use of a substance listed in Annex XIV will be granted only if : • Risks adequately controlled, OR • Adequate control cannot be demonstrated but it is shown that socio-economic benefits outweigh the riskto human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies.

  21. Possible consequences of authorisation procedures • Substance withdrawal from the market • Disruption in the supply chain • Technology changes • Costly and time consuming procedures (analysis of alternatives and where such alternative exists – substitution plan) DU to make sure that the substance used is authorised for his use up the supply chain

  22. To know more…. Orgalime REACH guide ? Guide available free of charge atwww.publications.orgalime.org

  23. Conclusion • REACH : complex legislation • New duties for inter alia downstream users, article producers and article importers • Important to prepare NOW • Orgalime practical guide to understanding REACH Regulation 1907/2006 http://publications.orgalime.org/

  24. Thank you for your attention! Orgalime Diamant building 5th floor 80 Boulevard Reyers 1030 Brussels Secretariat@orgalime.org Tel.:0032.(0)2.706.82.35 Fax.:0032.(0)2.706.82.50 www.orgalime.org

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