Implementation of REACH in the EU

1http://echa.europa.eu

Implementation of REACHin the EU

TAIEX Meeting12 November 2009, Belgrade

Philippe BARRUELPhilippe BARRUELAdministrator

European Chemicals Agency


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/sief_en.asp


Contents

Part III: Registration

Part IV: Authorisation /Restriction



Part I

ECHA: overview, accomplishments and challenges



The European Chemical Agency


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)





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



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)


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



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)



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)



Part II

The role of Member State Competent Authorities (MSCA) on ECHA’s work



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



Member States on ECHA’s work

Management Board

ECHA

Forum

RAC SEAC MSC

REHCORN

Member State Competent Authorities

CARACAL

RCN

SON



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


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



MSCMSC



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;



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


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


RACRAC


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;


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.


SEACSEAC


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;


EnforcementEnforcement

&&

ForumForum


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


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;


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


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.


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


Part III

SIEF & Registration

39http://echa.europa.eu 39

REGISTRATION

one

Joint Submission

one

SIEF

one

Substance

one

Lead Registrant

Regulatory context


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


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


SUBMISSION TO ECHA

one

Joint Submission

one

SIEF

one

Substance

one

Lead Registrant

Regulatory context


• 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

Implementation of REACH in the EU

Documents

echa structure

implementation implementation

substances website

recommendation of substances

packaging of substances

candidate list of substances

final list of substances

biocides regulation