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Implementation of REACH in the EU

Implementation of REACH in the EU. TAIEX Meeting 12 November 2009, Belgrade Philippe BARRUEL Administrator European Chemicals Agency. http://echa.europa.eu. Contents. Part I: ECHA: overview, accomplishments and challenges

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Implementation of REACH in the EU

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  1. Implementation of REACHin the EU TAIEX Meeting 12 November 2009, Belgrade Philippe BARRUEL Administrator European Chemicals Agency http://echa.europa.eu

  2. Contents Part I: ECHA: overview, accomplishments and challenges Part II: The role of Member State Competent Authorities on ECHA’s work http://echa.europa.eu

  3. Contents Part III: Registration Part IV: Authorisation /Restriction http://echa.europa.eu

  4. Part I ECHA: overview, accomplishments and challenges http://echa.europa.eu

  5. The European Chemical Agency http://echa.europa.eu

  6. Mission of ECHA Manage all REACH tasks by carrying out or co-coordinating the necessary activities Ensure a consistent implementation at Community level Provide Member States and the European institutions with the best possible scientific advice on questions related to the safety and the socio-economic aspects of the use of chemicals. http://echa.europa.eu

  7. What is ECHA structure? ECHA comprises The Management Board The Committees: Risk Assessment (RAC) and Socio-economic Analysis Committees (SEAC) The Member State Committee (MSC) The Forum for Exchange of Info on Enforcement The Secretariat (under the Executive Director, ED) The Board of Appeal (BOA, independent) http://echa.europa.eu

  8. http://echa.europa.eu

  9. Achievements so far (2007-2008) Building up operational capabilities Recruiting and training staff Committees & Forum Handover from European Chemicals Bureau(ECB) Working procedures and IT tools (REACH-IT) Information and Co-operation ECHA helpdesk Guidance Workshops, training for trainers, stakeholder contacts http://echa.europa.eu

  10. Less known Building up phase till 2010 Number of staff ~ 300 will grow by end of 2010 to ~ 500 26 nationalities. 2 other regulations: Regulation 1272/2008 on the classification, labelling and packaging of substances and mixtures From 2013: Biocides Regulation (currently still proposal in codecision) • REACH Regulation entered into force 1 June 2007 • ECHA was created in this regulation (Art.75.1) • Role: Implementation • Implementation is the realization of an application, or execution of a plan, idea, model, design or policy • Purpose: one central Agency, instead of 27 MS Competent Authorities http://echa.europa.eu

  11. ECHA’s agenda for 2009 (1/2) Ensure efficient decision-making(Annex XIV of the REACH Regulation) Establish and maintain the final list of substances before the first registration deadline in 2010 Consolidate IT tools needed for operations (REACH IT and CSR tool) Intensify the relationship with EU and non-EU partners in chemical risk assessment http://echa.europa.eu

  12. ECHA’s agenda for 2009 (2/2) Update ofguidance, addressing restrictions, authorisation and the new Classification, Labelling and Packing (CLP) Regulation Introduce efficient procedures forCLP Enhance ECHA’s interface with the general public and startdisseminationof data on substances (website) http://echa.europa.eu

  13. REACH implementation figures Pre-registrations received > 2 750 000 Preliminary numbers for the Registration procedure Substances >143 000 Companies >65 000 The first 15 substances in the Candidate list of Substances of Very High Concern (SVHC) (28 October 2008) First step for the Authorisation procedure The first recommendation of substances to be included in Annex XIV was submitted by ECHA to the Commission on 1 June 2009 (7 substances) http://echa.europa.eu

  14. Part II The role of Member State Competent Authorities (MSCA) on ECHA’s work http://echa.europa.eu

  15. Member States: main responsibilities Article 121 REACH and article 43 CLP Regulations Appointment of competent authorities responsible for: performing the tasks allotted to competent authorities under REACH Regulation for cooperating with the Commission and ECHA in the implementation of REACH. proposals for harmonised Classification and Labelling (C&L) and enforcement of the obligations Article 122 REACH and article 43 CLP Regulations The competent authorities shall cooperate with each other in the performance of their tasks under REACH and CLP Regulations and shall give the competent authorities of other Member States all the necessary and useful support to this end http://echa.europa.eu

  16. Member States on ECHA’s work Member State Competent Authorities Management Board CARACAL ECHA REHCORN RCN SON RAC SEAC MSC Forum http://echa.europa.eu

  17. National Helpdesks & REHCORN (1/2) Article 124 REACH and article 44 CLP Regulations The Member states shall establish National Helpdesks to provide advice on their respective responsibilities and obligations to: Manufacturers Importers Distributors Downstream users or Any other interested parties http://echa.europa.eu

  18. UK DE FR Non EU Other EU EU or not EU? • 50% of questions • from outside EU

  19. REHCORN main principles (2/2) http://echa.europa.eu

  20. Security Officers’ Network • Member State Competent Authorities and enforcers of REACH provisions need access to relevant REACH data • Confidential business information and ICT systems need to be protected • A network of Security Officers, coordinated by ECHA, prepares secure network connections and controlled access to REACH-IT • Experts are nominated for Security Officers’ Network (SON) to • Agree on REACH-IT standard security requirements • Define the security roles and responsibilities • Propose and agree on solutions to security issues related to REACH information • Give advice and comments

  21. MSC http://echa.europa.eu

  22. MSC – Responsibilities Article 76(1)(e): […] a Member State Committee, which shall be responsible for resolving potential divergences of opinions on draft decisions proposed by the Agency or the Member States and proposals for identification of substances of very high concern to be subjected to the authorisation procedure; http://echa.europa.eu

  23. MSC – tasks (1/2) Seek agreement when the examination of testing proposalsby ECHA under dossier evaluation results in draft decisions to which amendments are proposed by Member States Seek agreement when compliancecheck under dossier evaluation or substance evaluation results in draft decisions by ECHA where more information would be required but to which amendments are proposed by Member States Seek agreement on the identification of substances to be included on the candidate list for eventual inclusion in the authorisation list http://echa.europa.eu

  24. MSC – tasks (2/2) Provide an opinion for recommending priority substances to be included in the Annex XIV (authorisation list) Seek agreement in cases where two or more Member States have expressed an interest in evaluating the same substance Provide an opinion for establishing the Community rolling action plan for substances which could constitute a risk to human health or the environment Provide an opinion whether or not to add substances to the Community rolling action plan following proposals from any Member State http://echa.europa.eu

  25. RAC http://echa.europa.eu

  26. RAC – Responsibilities Article 76(1)(c): […] a Committee for Risk Assessment, which shall be responsible for preparing the opinion of the Agency on evaluations, applications for authorisation, proposals for restrictions and proposals for harmonised classification and labelling and any other questions that arise from the operation of this Regulation relating to risks to human health or the environment; http://echa.europa.eu

  27. RAC – tasks requiring MSCA input MSCA prepare Annex XV dossiers on Restrictionproposals and rapporteurs from other MS with MSCA support prepare Agency opinion on this proposal Rapporteurs from MS with MSCA support prepare the Agency opinion on industry applications for Authorisation; MSCA prepare Annex XV dossiers with draft proposals for harmonised classification and labelling under the CLP Regulation and rapporteurs from other MS with MSCA support prepare Agency opinion Rapporteurs from MS with MSCA support preparescientific opinions on other questions relating to safety of substances. http://echa.europa.eu

  28. SEAC http://echa.europa.eu

  29. SEAC – Responsibilities Article 76(1)(d): […] a Committee for Socio-economic Analysis, which shall be responsible for preparing the opinion of the Agency on applications for authorisation, proposals for restrictions, and any other questions that arise from the operation of this Regulation relating to the socio-economic impact of possible legislative action on substances; http://echa.europa.eu

  30. Enforcement & Forum http://echa.europa.eu

  31. Enforcement of REACH and CLP Regulations (tasks of MS) Article 76(1)(f) REACH and article 46 (3) CLP regulation a Forum for Exchange of Information on Enforcement (“ the Forum”) which shall coordinate a network of Member States authorities responsible for enforcement of these Regulations Article 125 REACH and article 46 CLP Regulations MS shall take all necessary measures, including maintaining a system of official controls Article 126 REACH and article 47 CLP Regulations MS shall introduce penalties for non-compliance of these regulations and shall take all measures necessary to ensure they are implemented http://echa.europa.eu

  32. Forum MS- Tasks (1/2) Article 77 (4) REACH and Article 46 (3) CLP regulations (a) spreading good practice and highlighting problems at Community level; (b) proposing, coordinating and evaluating harmonised enforcement projects and joint inspections; (c) coordinating exchange of inspectors; (d) identifying enforcement strategies, as well as best practice in enforcement; (e) developing working methods and tools of use to local inspectors; http://echa.europa.eu

  33. Forum MS- Tasks (2/2) (f) developing an electronic information exchange procedure; (g) liaising with industry, taking particular account of the specific needs of SMEs, and other stakeholders, including relevant international organizations, as necessary; (h) examining proposals for restrictions with a view to advising on enforceability. (Only for REACH Regulation) Plus agreement on common issues to be covered in the reports sent to the EC every 5 years http://echa.europa.eu

  34. Risk Communication Network (RCN) Article 123 of REACH: “Communication to the public of information on risks of substances” The competent authorities of the Member States shall inform the general public about the risks arising from substances where this is considered necessary for the protection of human health or the environment. Risk Communication Network Informal communication channel about national urgent actions to protect human health and environment. http://echa.europa.eu

  35. CARACAL CARACAL is an expert group of the Competent Authorities for the REACH and CLP Regulations Aim: Advice on policy issues to the European Commission and ECHA on the implementation and the functioning of the REACH and CLP Regulations in their respective areas of responsibility http://echa.europa.eu

  36. Part III SIEF & Registration http://echa.europa.eu

  37. REGISTRATION one Substance one Joint Submission one SIEF one Lead Registrant Regulatory context http://echa.europa.eu 39

  38. Substance Information Exchange Forum (SIEF) Aim Help registrants on the same substance to share information and avoid duplication of testing ECHA Very limited obligations under REACH regulation Companies/ Importers or legal entities Form SIEF (agreement on the same substance) Start to organise and communicate Select Lead Registrant Share information/ data http://echa.europa.eu

  39. Monster SIEFs : hypnotised rabbits Awareness campaign: “The clock is ticking - form your SIEF now” < 10% have appointed the Lead Registrant 55 000 substances indicated by companies to be registered by 2010 ECHA expects the number of substances to be very close to the European Commission’s estimates (around 10.000) 80% of the SIEFs formed for those 55 000 substances have between 10-99 companies/ importers or legal entities Substance Exchange Information Forum (SIEF) ECHA launched multiple action to support Lead registrants and SIEFs

  40. Supporting Lead Registrants • Webinars – 9 planned through to next spring • Online discussion platform ”LR Forum” – available now • Targeted Helpdesk service

  41. OVERVIEW OF WEBINAR PLAN 2009/2010 Further information on Lead Registrant webinars can be found in the webinar section of the ECHA website at: http://www.echa.europa.eu/news/webinars_en.asp http://echa.europa.eu

  42. SUBMISSION TO ECHA one Substance one Joint Submission one SIEF one Lead Registrant Regulatory context http://echa.europa.eu 44

  43. How registrants register in practice? INDUSTRY ECHA SUBMISSION TO ECHA Create the Dossier in IUCLID 5 Submit the Dossier in REACH-IT Business Rules TCC and Invoicing Pass/Fail Decision http://echa.europa.eu 45

  44. Tree view area Data area

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