REACH at work

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REACH at work

• Selling in Europe? Be REACH Compliant.
• Hong Kong 2 April 2009
• Eva Sandberg
• International relations
• European Chemicals Agency

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REACH and ECHA

• REACH Regulation entered into force 1 June 2007
• ECHA was created in this regulation
• ECHA became operational 1 June 2008
• Building up phase till 2010
• Number of staff presently 300 will grow by end
  of 2010 to 430
• 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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European Chemicals Agency
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ECHA Mission

• Manage and carry out REACH tasks
• Ensure consistency at Community level
• Provide Member States EU institutions with
  advice on chemicals which fall under REACH
• Manage guidance, IT tools and data bases
• Support national helpdesks and provide advice to
  registrants
• Make info on chemicals publicly accessible

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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
• Registry of Intention incl. info on Annex XV
  dossier supplied
• Public consultations on the proposals for
  implementing REACH requirements (CL,
  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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What is ECHA?

• ECHA comprises (Art. 76)
• The Management Board
• The Committees
• a Committee for Risk Assessment
• a Committee for Socio-Economic Analysis
• a Member State Committee
• a Forum for Exchange of Information on
  Enforcement
• The Board of Appeal
• The Secretariat

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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 Agencys opinions for the Commission on
• Classification and Labelling proposals in
  accordance with the CLP Regulation 1272/2008
• Comparison of hazard data with the criteria
• Restriction proposals
• As to whether the suggested restrictions are
  appropriate in reducing risks
• Authorisation applications
• Risk assessment and assessment of appropriateness
  and effectiveness of the risk management measures
  described in the application, and if relevant
  assessment of risks of alternatives
• 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 Agencys opinions for the 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 socio-economic 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 socio-economic impact of possible
  legislative action on substances at the request
  of the Executive Director

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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
• ECHAs 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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The Forum

• Coordinates a network of Member States' competent
  authorities responsible for enforcement
• Tasks include
• Promotion of best practices tools
• 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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Board of Appeal

• To decide 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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REACH - Main Milestones

• Communication obligations from 1/6/2007
• Safety Data Sheets
• Pre-registration 1/6-1/12/2008
• Finished
• Registration
• Phase-in substances 2010/2013/2018
• Non-phase-in (new) substances from 1/6/2008
• Authorisation from 2012
• 1st candidate list and 28 Oct 2008
• information obligations
• Restrictions
• Annex XVII entry into force by 1/6/2009
• Notification of substances
• in articles from 2011

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REACH and Non-European Industry
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EU Legislation

• Applies to EU 27 Member States
• Austria
• Belgium
• Bulgaria
• Czech Republic
• Cyprus
• Denmark
• Estonia
• Portugal
• Finland
• France
• Germany
• Greece
• Hungary
• Ireland

• Italy
• Latvia
• Lithuania
• Luxembourg
• Malta
• The Netherlands
• Poland
• Portugal
• Romania
• Slovenia
• Slovakia
• Spain
• Sweden
• United Kingdom

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EU Legislation - REACH

• Applies to a legal entity within the EU
• Manufacturers and Down-stream users based in the
  EU
• Importers of chemicals or articles
• Only Representatives

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REACH for non-EU companies

• Non-EU companies are not directly impacted (i.e.
  do not have direct legal obligations)
• but imports to the 27 EU-Member States are under
  the scope of REACH
• EU-importers or Only Representatives (O.R.) must
  fulfill all REACH obligations for imported
  substances, preparations, articles, such as
• (pre-)registration, including data exchange
  (SIEF)
• notification of SVHC in articles if above 0,1
  SVHC in articles
• notification to ECHA (2011)
• info for downstream users (when introduced on the
  Candidate list)
• info to consumer on request (when introduced on
  the Candidate list)

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REACH for non-EU companies

• and
• EU-importers/O.R. rely on their suppliers in
  third countries for hazard data and safe use
  information that is required by REACH
• in practice, non-EU companies have to provide
  data of sufficient quality (e.g. OECD GLP
  certified labs) and in time to enable their
  importers/O.R.
• to participate in data-sharing and (joint)
  registration
• to fulfill their duties with regard to
  supply-chain information

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Only Representatives

• REACH text Article 8

1. A manufacturer established outside the
Community who manufactures a substance on its
own, in preparations or in articles, formulates a
preparation or produces an article that is
imported into the Community may by mutual
agreement appoint a natural or legal person
established in the Community to fulfill, as his
only representative, the obligations on importers
under this requirement.
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Only Representatives

• REACH text Article 8

2. The representative shall also comply with all
other obligations of importers under this
Regulation. To this end, he shall have a
sufficient background in the practical handling
of substances and the information related to them
and, without prejudice to Article 35 (obligation
to keep information) shall keep available and
up-to-date information on quantities imported and
customers sold to, as well as information on the
supply of the latest update of the safety data
sheet referred to in Article 31.
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Focus on Only Representatives

• The EU O.R. shall
• comply with all obligations of an EU-importer,
  e.g.
• (pre-)registration including data sharing (SIEF)
• information in the supply chain
• have a sufficient background in handling
  substances
• keep available up to date info on imported
  volumes and customers (importers, treated as down
  stream users)
• have and distribute the latest version of SDS (to
  importers)
• notify (2011) SVHC gt0.1 to ECHA
• inform DU and consumer (upon request) of presence
  of gt0.1 SVHC in articles

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Focus on Only Representatives

• The non-EU manufacturer shall
• inform the importers within the same supply chain
  of the appointment
• provide the O.R. with all necessary information
• Hazard data, incl. test data
• Information on all importers and their subsequent
  supply chains (exposure scenarios)
• Presence of SVHC at gt0.1 in articles
• All information needed for preparing/updating a
  SDS
• Without good and complete data from the Exporter,
  the importer or O.R. cannot function!

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Information sources on ECHA Website

• ECHA Helpdesk questions via web form
• Basic REACH 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
• Guidance Fact Sheets
• Glossary
• Guidance feedback form
• Formats, templates (e.g. CSR)

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ECHA Website
Support Websites
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ECHA contact
ECHA contact For additional information
Questions to ECHA Helpdesk - Only via web-form,
no direct e-mails, no phone calls!!

• For additional information

Please choose the right option
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ECHA Helpdesk

• Operational since 1 June 2007
• Coordination of REACH national helpdesks in each
  Member State 1st point of contact for EU
  industry (list on ECHA website)
• Service to registrants and MSCAs
• 1st point of contact for non-EU industry
• ECHA chairs and has Secretariat of the REACH
  HelpNet, represented by the REACH helpdesk
  correspondents network (REHCORN)
• Aim of the network achieve consistent and
  harmonised advice to stakeholders across EU

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Who are the customers?

• Industry in the EU
• Industry outside the EU
• Consultancy companies
• Users of IUCLID
• National REACH Helpdesks
• Anyone that posts a question

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Questions from non-EU countries
Shows Jan-March 2009 496/1916 questions from Non
EU-countries
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Guidance Documents published for industry and
authorities

• Work started before REACH 2004-2007
• Most Guidance documents already published on ECHA
  web-site (incl. translation where possible)
• Initiatives for new guidance/updates under
  discussion
• Ongoing improvement of guidance IT tools (e.g.
  navigator, keyword search, CSA/CSR tool)

http//echa.europa.eu
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Guidance Website
Guidance Website
Guidance fact sheets available
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Guidance Documents

• Registration (incl. Polymers, PPORD,
  Intermediates)
• Substance Identity
• Data Sharing (including pre-registration)
• Information Requirements and Chemical Safety
  Assessment
• Downstream User Requirements
• Classification and Labelling (expected 2009)
• Substances in Articles
• Socio-economic assessment
• Process for inclusion in Annex XIV
  (authorization)
• Priority setting for evaluation (dossier, test
  proposals, substances)
• Annex XV Dossiers proposals for CL, candidate
  substances for authorization, restrictions

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ECHA Welcomes All To Its 2nd Stakeholders Day

• WHEN 27 May 2009,
• WHERE Helsinki Exhibition and Convention
  Centre, Finland Up to 500
• WHO participants worldwide from industry,
  national authorities and interest groups
• COST Free of charge.
• REMOTE Can be followed over the Internet via
• ACCESS web streaming
• PRECEEDS The Helsinki Chemical Forum on 28 and
  29 May 2009
• INFO http//echa.europa.eu/home_en.asp

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http//echa.europa.eu
ECHA website For any information about REACH and
ECHA

• Follow the news on our home page

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• Thank You for Your attention!
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