The European Chemicals Agency

The European Chemicals
Agency
Chemical Safety Week - Ljubljana
24 May 2010
Pedro Roselló Vilarroig
ECHA – Guidance and Helpdesk Unit

Overview
• Mission
• Organisation
• Committees
• Enforcement
• CLP
• Website
• Main challenges
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REACH, CLP and ECHA
REACH Regulation entered into force on 1 June 2007
ECHA was created by this regulation
ECHA became operational on 1 June 2008
CLP regulation entered into force on 20 January 2009
ECHA - building up phase till 2010
Number of staff now ~ 390 will grow by the end of 2010 to ~ 490
ECHA is managing the implementation of the
REACH Regulation 1907/2006
Regulation 1272/2008 on the classification, labelling and packaging
of substances and mixtures
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ECHA – the coordinator of REACH
and CLP Implementation*
MISSION
ORGANISATION
Manage REACH and CLP tasks
Ensure a consistent implementation at
EU/EEA level
Provide the best possible scientific
advice on safety and socio-economic
aspects of the use of chemicals
Ensuring a credible decision-making
process, using the best possible
scientific, technical and regulatory
capacities
Manage guidance, IT tools and data
bases
Support national helpdesks and
provide advice to registrants
Make info on chemicals publicly
accessible
Management Board
Executive Director
Secretariat
Three Scientific Committees
Forum on Enforcement
Networks (HelpNet, RCN, SON)
Board of Appeal
* ECHA is not a policy maker
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ECHA: Mission
Providing ECHA Help desk and Guidance
Providing IT tools for use by industry and MSCA
Running multilingual ECHA Website
http://echa.europa.eu/home_en.asp
Guidance for industry and authorities on how to comply with REACH
requirements and how to use REACH-IT and IUCLID 5
Registry of Intention, info on submitted proposals Annexes XV (REACH)
and VI (CLP)
Public consultations on the proposals for implementing REACH
requirements (C&L, identification of substances of very high concern,
substances to be subject to authorisation, restrictions)
List of pre-registered substances
Guidance IT systems & work processes gradually operational starting
1 June 2008
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Core values of ECHA
Efficient in operations, transparent in procedures
Transparent (public documents)
Science-driven (expertise, Committees)
Independent (opinions to the Commission)
Balanced (equal treatment of all companies)
Trustworthy (data security)
Respecting deadlines (many are very short!)
Helpful (timely delivered clear relevant advice)
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ECHA: Organisation
Management Board
1 per Member State (+ observers EEA/EFTA), 2 by EP and 3 by COM
3 interested party observers nominated by COM
Secretariat lead by Executive Director
Currently around 390 employees
Committees
Committee for Risk Assessment
Committee for Socio-economic Analysis
Member State Committee
Forum for Exchange of Info on Enforcement
Several Networks: HelpNet, SON, RCN
Board of Appeal
independent from the Secretariat
http://echa.europa.eu
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ORGANISATION CHART OF ECHA – May 2010
MANAGEMENT BOARD
EXECUTIVE OFFICE
EXECUTIVE DIRECTOR
Geert Dancet
BOARD OF APPEAL
Chair: Mercedes Ortuño
Alain Lefebvre
REGISTRY OF
BOARD OF APPEAL
LEGAL AFFAIRS
SCIENTIFIC ADVICE : Derek Knight
Sari Haukka
Minna Heikkilä
INTERNAL AUDIT : Minna Strömberg
CO-OPERATION
ASSESSMENT
REGISTRATION & IT TOOLS
RESOURCES
Andreas Herdina
Jukka Malm
Christel Musset
Jef Maes
GUIDANCE & HELPDESK
EVALUATION I
SCIENTIFIC IT TOOLS
FINANCE
Pilar Rodríguez Iglesias
Wim de Coen
Hannu Hirvonen
Tuula Hakala
COMMITTEES &
INTERNATIONAL RELATIONS
RISK MANAGEMENT
SUBSTANCE IDENTITY &
DATA SHARING
HUMAN RESOURCES
Leena Ylä-Mononen
Jack de Bruijn
Anthony Wilson
Jens Debus
COMMUNICATIONS
CLASSIFICATION
REGISTRATION & DOSSIER
SUBMISSION
ICT
Lindsay Jackson
Jörg Lebsanft
Kevin Pollard
Thomas Bleser
EVALUATION II
CORPORATE SERVICES
Norbert Fedtke
Vivien Loxton
Directorate
Unit
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Member State Committee (MSC)
Consists of members appointed by the Member States
Tasks:
Seeks unanimous agreement on draft decisions concerning
evaluation
Dossier evaluations: testing proposals and compliance checks
Substance evaluations
Seeks unanimous agreement on identification of substances of very
high concern (SVHC)
Gives opinions on
ECHA’s draft recommendation for Annex XIV (authorisation list)
Community Rolling Action Plan established for substance evaluation
Safety of substances at the request of the Executive Director
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Committee for Risk Assessment
(RAC)
Consists of scientific experts nominated by Member States and
appointed by the Management Board
Tasks:
Prepares Agency’s opinions for the European Commission on
Classification and Labelling proposals in accordance with the CLP
Regulation 1272/2008
Restriction proposals
Authorisation applications
Provides opinions on any other questions relating to REACH and
risks to human health or the environment at the request of the
Executive Director
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Committee for Socio-economic
Analysis (SEAC)
Consists of scientific experts nominated by Member States and appointed
by the Management Board
Tasks:
Prepares Agency’s opinions for the European Commission on
Restriction proposals based on
consideration of socio-economic factors of the proposal and
evaluation of the socio-economic impact
assessment of comments of interested parties concerning socioeconomic
impact
Authorisation applications based on
assessment of socio-economic factors and the availability, suitability
and technical feasibility of alternatives
Provides opinions on any other questions relating to REACH and socioeconomic
impact of possible legislative action on substances at the request
of the Executive Director
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Board of Appeal
Decides on appeals against decisions taken by Agency
Independent and impartial
No other duties inside the Agency
Not against all ECHA decisions
Appeal fee – which may be refunded
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ECHA Helpdesk
Operational since 1 June 2007
Coordination of REACH and CLP national helpdesks in each
Member State which are the 1 st point of contact for EU industry
Service to registrants and MSCAs
1 st point of contact for non-EU industry
ECHA chairs and has secretariat of the REACH and CLP
Helpdesk Network, represented by the REACH and CLP
helpdesk correspondents
Aim of the network: achieve consistent and harmonised advice to
stakeholders across EU
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National Helpdesks
• Established in 27 EU Member States in 2007 and in
Norway and Iceland
– In most cases operated by national REACH Authorities
• Provide
– Advice to companies and other stakeholders on their REACH
obligations
– Wide ranging information on the provisions of REACH
• National helpdesks = 1 st point of contact for industry
• List of national REACH and CLP helpdesks available on
ECHA website:
http://echa.europa.eu/help/nationalhelp_contact_en.asp
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Enforcement
Enforcement and penalties are the responsibility of the
Member states
Member States are obliged to establish the necessary
arrangements for the implementation of REACH
Some legal instrument is required at national level
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The Forum for Information
Exchange on Enforcement
Coordinates a network of Member States' competent
authorities responsible for enforcement
Tasks include:
Promotion of best practices & tools (Minimum criteria for
inspections adopted)
Development of electronic info exchange procedures
Identification of enforcement strategies
Coordination and evaluation of harmonised enforcement projects
Liaison with industry
Advising on enforceability of restriction proposals
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ECHA’s tasks under CLP
Managing proposals for harmonised C&L
Developing and managing the C&L inventory
Providing guidance to industry
Providing guidance and support to MS-CAs
Co-ordinate enforcement activities via Forum
Receiving reports from MSs on control & enforcement
Carrying out a study on communication on safe use of
substances and mixtures
Handling requests for use of alternative names
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Harmonised C&L
Proposals may be submitted by
MSCAs
Industry (Manufacturers/Importers, Downstream
Users)
Which types of substances
Carcinogenic, Mutagenic, Reprotoxic, Respiratory
sensitizers
Pesticidal & biocidal active substances
Others case-by-case
How many?
Estimated 90 proposals per year
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CL Harmonisation
No detailed procedures in the CLP Regulation
on how to handle proposals for harmonised C&L
ECHA has established procedures on
Notification of intention
Check of accordance with requirements (informal)
Process for consultation of parties concerned
Process for developing opinion
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Information on ECHA Website
ECHA Helpdesk – questions via web form
Basic REACH and CLP information for non-EU inquirers
Question related to REACH IT, IUCLID and other ECHA tools
Questions related to REACH requirements (non EU inquirers)
Frequently asked questions, FAQ
Guidance website
Navigator
Guidance Documents related to the REACH processes and
CLP
Guidance Fact Sheets
Glossary
Guidance feedback form
Formats, templates (e.g. CSR)
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Dissemination of information
According to REACH legislation, ECHA will provide
public access to (non-confidential) information on
registered substances
Accessible and useful also to countries outside the EU
Dissemination website - free public access to
information on registered substances:
http://apps.echa.europa.eu/registered/registeredsub.aspx
Other ECHA initiative: hosting the OECD Global Portal
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Main challenges for 2010
First REACH registration deadline 30 November 2010
Handling test proposals and compliance checks within
legal deadlines
Major scientific task for ECHA (target for 2010: 600 evaluations
started (compliance checks and testing proposals) & 70
decisions taken
Stringent deadlines for decisions (testing proposals - by 1 Dec
2012, if received by 1 Dec 2010; >1000 tonnes p/a)
Classification and labelling notifications – CLP deadline
3 January 2011
Update candidate list & new recommendations for
authorisation list
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Thank you for your attention!
http://echa.europa.eu
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