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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 - PowerPoint PPT Presentation
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Implementation of REACHin the EU
TAIEX Meeting12 November 2009, Belgrade
Philippe BARRUELPhilippe BARRUELAdministrator
European Chemicals Agency
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Contents
Part I: ECHA: overview, accomplishments and challenges
Part II: The role of Member State Competent Authorities on ECHA’s work
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Contents
Part III: Registration
Part IV: Authorisation /Restriction
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Part I
ECHA: overview, accomplishments and challenges
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The European Chemical Agency
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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.
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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)
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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
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Less known
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
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)
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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
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ECHA’s agenda for 2009 (2/2)
• Update of guidance, addressing restrictions, authorisation and the new Classification, Labelling and Packing (CLP) Regulation
• Introduce efficient procedures for CLP
• Enhance ECHA’s interface with the general public and start dissemination of data on substances (website)
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REACH implementation figures
Pre-registrations received > 2 750 000
Companies > 65 000
The first 15 substances in the Candidate list of Substances of Very High Concern
(SVHC)(28 October 2008)
Substances > 143 000
Preliminary numbers for the Registration procedure
First step for the Authorisation procedureThe first recommendation of substances to be included
in Annex XIV was submitted by ECHA to the Commission on 1 June 2009 (7 substances)
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Part II
The role of Member State Competent Authorities (MSCA) on ECHA’s work
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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
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Member States on ECHA’s work
Management Board
ECHA
Forum
RAC SEAC MSC
REHCORN
Member State Competent Authorities
CARACAL
RCN
SON
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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
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EU or not EU?
50% of questions
from outside EU
10%
8%
6%
28%
48% Non EU
Other EU
UK
DE
FR
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REHCORN main principles (2/2)
Achieve consistent and harmonised advice to stakeholders within the whole EU by exchanging information
REACH Helpdesk Correspondent’s Network (REHCORN)
REACH Helpdesk Exchange Platform (RHEP)
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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
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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;
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MSC – tasks (1/2)
• Seek agreement when the examination of testing proposals by ECHA under dossier evaluation results in draft decisions to which amendments are proposed by Member States
• Seek agreement when compliance check 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
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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
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RACRAC
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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;
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RAC – tasks requiring MSCA input
• MSCA prepare Annex XV dossiers on Restriction proposals 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 prepare scientific opinions on other questions relating to safety of substances.
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SEACSEAC
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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;
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EnforcementEnforcement
&&
ForumForum
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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
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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;
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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
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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 NetworkRisk Communication Network
Informal communication channel about national urgent actions to protect human health and environment.
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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
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Part III
SIEF & Registration
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REGISTRATION
one
Joint Submission
one
SIEF
one
Substance
one
Lead Registrant
Regulatory context
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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 entities1) Form SIEF (agreement on the same substance)
2) Start to organise and communicate
3) Select Lead Registrant
4) Share information/ data
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Monster SIEFs : hypnotised rabbits
Substance Exchange Information
Forum (SIEF)
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
substanceshave between
10-99 companies/ importers
or legal entities
< 10% have appointed the
Lead Registrant
ECHA launched multiple action to support
Lead registrants and SIEFs
Awareness campaign: “The clock is ticking - form your SIEF now”
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Supporting Lead Registrants
• Webinars – 9 planned through to next spring• Online discussion platform ”LR Forum” –
available now• Targeted Helpdesk service
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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
OVERVIEW OF WEBINAR PLAN 2009/2010
WEBINAR DATE
General Principles of Dossier Preparation and Submission 4 November
Information Requirements I 30 November
Information Requirements II 10 December
Substance Identity To be confirmed
Technical Completeness Check (TCC Tool) To be confirmed
Chemical Safety Report (CSR) and CSA Part I To be confirmed
Chemical Safety Report (CSR) and CSA Part II To be confirmed
Business Rules To be confirmed
Classification and Labeling Notifications To be confirmed
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SUBMISSION TO ECHA
one
Joint Submission
one
SIEF
one
Substance
one
Lead Registrant
Regulatory context
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• How registrants register in practice?
Create the Dossier inIUCLID 5
Submit theDossier inREACH-IT
BusinessRules
TCC and
InvoicingPass/FailDecision
INDUSTRY ECHA
SUBMISSION TO ECHA
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Tree view Tree view areaarea
Data areaData area