Implementation of REACH
in the EU
TAIEX Meeting
12 November 2009, Belgrade
Philippe BARRUEL
Administrator
European Chemicals Agency
http://echa.europa.eu
1
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
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Contents
Part III:
Registration
Part IV:
Authorisation /Restriction
http://echa.europa.eu
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Part I
ECHA: overview,
accomplishments and challenges
http://echa.europa.eu
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The European Chemical
Agency
http://echa.europa.eu
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Mission of ECHA
• Manage all REACH tasks by carrying out or cocoordinating 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
6
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
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http://echa.europa.eu
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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
http://echa.europa.eu
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Less known
Building
upRegulation
phase tillentered
2010 into force 1 June 2007
 REACH
Number
staff ~ in
300
will
grow by end
of 2010 to ~ 500

ECHA
wasofcreated
this
regulation
(Art.75.1)
26 nationalities.
 Role:
Implementation

 Implementation is the realization of an application, or
execution of a plan, idea, model, design or policy
2 other regulations:
 Purpose: one central Agency, instead of 27 MS Competent
 Regulation 1272/2008 on the classification, labelling
Authorities
and packaging of substances and mixtures
 From 2013: Biocides Regulation (currently still proposal in
codecision)
http://echa.europa.eu
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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
http://echa.europa.eu
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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)
http://echa.europa.eu
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REACH implementation figures
Pre-registrations received
> 2 750 000
Substances
> 143 000
Companies
> 65 000
The first 15 substances in the
Candidate list of Substances of Very High Concern
(SVHC)
(28 October 2008)
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
Preliminary
numbers for
the
Registration
procedure
First step for
the
Authorisation
procedure
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Part II
The role of Member State Competent
Authorities (MSCA) on ECHA’s work
http://echa.europa.eu
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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
http://echa.europa.eu
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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
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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
http://echa.europa.eu
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EU or not EU?
10%
8%
UK
DE
48%
Non EU
FR
50% of questions
from outside EU
6%
Other EU
28%
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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)
http://echa.europa.eu
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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
http://echa.europa.eu
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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;
http://echa.europa.eu
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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
http://echa.europa.eu
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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
http://echa.europa.eu
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RAC
http://echa.europa.eu
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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;
http://echa.europa.eu
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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.
http://echa.europa.eu
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SEAC
http://echa.europa.eu
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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;
http://echa.europa.eu
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Enforcement
&
Forum
http://echa.europa.eu
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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
http://echa.europa.eu
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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;
http://echa.europa.eu
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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
http://echa.europa.eu
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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 Network
Informal communication channel about national urgent
actions to protect human health and environment.
http://echa.europa.eu
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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
http://echa.europa.eu
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Part III
SIEF & Registration
http://echa.europa.eu
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REGISTRATION
Regulatory context
one
one
Joint
Submission
Substance
one
one
Lead
Registrant
SIEF
http://echa.europa.eu
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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 entities
1)
2)
3)
4)
Form SIEF (agreement on the same substance)
Start to organise and communicate
Select Lead Registrant
Share information/ data
http://echa.europa.eu
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Monster SIEFs : hypnotised
rabbits
55 000 substances
indicated by companies to be
registered by 2010
Awareness campaign:
“The clock is ticking form your SIEF now”
ECHA expects the number of substances
to be very close to the European
Commission’s
estimates (around 10.000)
Substance
Exchange Information
Forum (SIEF)
< 10%
have appointed the
Lead Registrant
80% of the
SIEFs
formed for those
55 000
substances
have between
10-99
companies/ importers
or
legal entities
ECHA launched multiple action to support
Lead registrants and SIEFs
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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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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
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
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SUBMISSION TO ECHA
Regulatory context
one
one
Joint
Submission
Substance
one
one
Lead
Registrant
SIEF
http://echa.europa.eu
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SUBMISSION TO ECHA
• How registrants register in practice?
Create the
Dossier in
IUCLID 5
Submit the
Dossier in
REACH-IT
INDUSTRY
Business
Rules
TCC and
Invoicing
Pass/Fail
Decision
ECHA
http://echa.europa.eu
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Tree view
area
Data area
46