Reach New EU chemicals policy

1
Reach - New EU chemicals policy

• Ir. Clarine Sieger
• Vogin
• Utrecht, 4 April 2006

2
Outline

• Brief introduction to REACH
• Why do we need it ?
• Main procedures
• REACH implementation

3
New EU chemicals policy why?

• -gt Drawbacks with implementation of current
  legislation
• Burden of proof with authorities
• There is a need for further information
• Inherent properties of substances
• Use of and exposure to substances
• Lack of incentives for innovation (new vs.
  existing substances)
• -gt Change of responsibility
• Today Authorities to identify risks
• Future Industry to demonstrate safety

4
Present situation for new and existing substances

• New substances
• - Pre-market control
• - 3000 substances (1981- )
• 300 additional per year
• - Notification gt10 kg gt
• Demanding data requirements
• Risk assessments
• - Low innovation rate
• High costs
• Long time-to-market
• Green new chemicals not promoted

• Existing substances
• - No pre-market control
• - gt100 106 substances on EINECS
• - Existing substances program (1993-2005)
• 141 HPV substances prioritised (2800 HPVs)
• 127 Risk assessments (39 final)
• No data requirements
• No Risk assessments
• - The burden of the past- Lack of data on
  Effects/Exposure/Risk

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New EU chemicals policy

• Mid/end 90ies Drawbacks with current policy
  identified
• White Paper published Feb 2001
• 29 October 2003 Commission adopts proposal for a
  REACH Regulation
• 17 November 2005 The European Parliament
  completes the first reading.(gt 5000 amendments)
• 13 December 2005 the Council adopts a political
  agreement. http//register.consilium.eu.int/pdf/en
  /05/st15/st15921.en05.pdf
• Autumn 2006? Final decision by the Parliament and
  the Council
• Spring 2007? REACH Regulation enters into force

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EU Co-decision procedure
2001
EU-Commission
DG Environment
DG Enterprise
Commission College
Council of the EU
European Parliament
Ad Hoc working group
Committees
COREPER
Plenary Session
Comp. Council
Envi. Council
2007
EU Regulation on REACH
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REACH

• Registration of manufactured/imported chemical
  substances gt 1 tonne/year (Industry)
• Evaluation of some registration dossiers (Member
  States)
• Authorisation for use of substances of very high
  concern (CMR, PBT, vPvB)
• Restriction Safety net (Can be initiated by
  Member states and the Commission)
• Chemicals

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The REACH-system Four parts
Registration, ca 30 000 substances
Evaluation, ca 5 000 substances -Test
proposals (gt100 ton) - Compliance check
-Substances with potential risks
Authorisation Substances of very high concern
e.g. CMR cat. 1,2 and PBTs ,vPvBs Restrictions,
when EU-wide measures are needed
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Registration - overview
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Simplified Reach process
Pre-registration
Production volume Uses Chemical safety reports
(for gt 10 tpa)
Consortia formation
gt 1 tpa
Registration
PBTs CMR cat.1 cat.2 vPvB
Down stream user
Dossier evaluation by competent authority
further test?
gt100 tpa
Evaluation
Restriction
Authorization/ or further information
Authorization PBTs CMR cat.1 cat.2 vPvB
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REACH Implementation Projects (RIPs)

• RIP 1 REACH Process Description
• RIP 2 REACH IT
• RIP 3 Technical Guidance and Tools for Industry
• RIP 4 Technical Guidance and Tools for
  Authorities
• RIP 5 Setting up the Pre-Agency
• RIP 6 Setting up the Agency
• RIP 7 Commission preparations for REACH

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RIP-1 REACH Process Description

• To achieve a better stakeholder understanding of
  the REACH procedures and to provide a basis for
  the detailed work in the other RIP projects.
• Flowcharts - REACH in detail of 04.04.2004
• Detailed Process Description of REACH of
  15.06.2004
• Questions and Answers on REACH Part II of
  22.11.2004

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RIP 2 REACH - IT

• REACHIT
• Workflow support system (Agency, Companies,
  Authorities)

• IUCLID 5
• Central Database (Agency, Companies, Authorities)

Uses OECD agreed data formats
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REACH IT.

• Central IT system of European Chemicals Agency
  that will support the implementation of the REACH
  legislation
• web portal for submission and consultation of
  information by industry
• workflow system for full control of all tasks
  triggered by REACH
• (REACH-IT database) identification and status of
  dossiers,
• dissemination system for publishing
  non-confidential data on the Agency website

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IUCLID 5

• In Industry
• The tool for capturing data on chemicals,
  preparing and submitting dossiers
• In the Agency in the Member states competent
  authorities
• The central data repository for all dossiers
  submitted
• The basis for dossier compliance check and
  substance evaluation

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3.1 Preparing the registration dossier
3.10 Guidance on checking substance ID
3.2 Preparing the CSR
3.4 Guidance on data-sharing
3.3 Information requirements
RIP 3 - Technical Guidance and Tools for Industry
3.7 Guidance on applications for authorisation
3.5 Guidance for downstream users
3.8 Requirements for articles
3.9 Guidance on SEA
3.6 Guidance on CL under GHS
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RIP 4 - Tech. Guidance and Tools for Authorities
4.1 Guidance on dossier evaluation
4.2 Guidance on substance evaluation
4.5 Priority setting for evaluation
4.3 Inclusion of substances in Annex XIII
4.4 Preparation of Annex XIV dossiers
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REACH does NOT include RULES for CL

• It refers to
• -gt Substance classification Directive 67/548/EEC
• -gtPreparation classification Directive
  1999/45/EC
• -gt Safety Data Sheets REACH Annex I a

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..but REACH links to CL e. g.

• -gt Registration
• - Information requirements for registration
  Art. 9, Annex IV
• - CSA/CSR Art. 13, Annex I
• -gt Information in the supply chain
• - SDS provisions Art. 29, Annex Ia
• - Authorisation and restrictions of CMRs -
  Article 54, 65
• -gt CL Inventory Title X Article 109-113
• - Notification aim to reach agreement on CL
  Art. 110 (industry)
• - Community harmonised CL for CMR, respiratory
  sensitisers, other endpoints on a case-by-case
  basis
• Art. 112 (authorities)

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Aim GHS (Global Harmonized system) entry into
force as close as possible to REACH

• Technical consultation with stakeholders
• Studies
• - GHS Implementation Study differences between
  EU and GHS system
• http//europa.eu.int/comm/enterprise/reach/ghs_en
  .htm
• - Analysis of the impact of the adoption of the
  GHS, final report expected end of March
• - Assessment on possible effects on downstream
  legislation about to be finalised
• Technical support
• - Preparation of technical Annexes
• Public internet consultation planned for May/June
  2006 with specific questions

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Chemical Safety Report (CSR)

• Part of registration dossier (gt10 tonne/year)
• The manufacturer/importer must
• Conduct a Chemical Safety Assessment (CSA)
  showing that the chemical can be used safely for
  all identified uses throughout the chemical life
  cycle
• The chemical life cycle covers all uses of the
  substance on its own, in preparations and in
  articles/products

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Chemical Safety Report (CSR)

• The manufacturer/importer must also
• Declare that Risk Management Measures (RMM) are
  implemented for own manufacturing and use
• Declare that RMM are communicated to downstream
  users for downstream identified uses
• RMM are process and emission control, personal
  protective equipment, good hygiene, etc.

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Exposure Scenarios

• Exposure scenarios are the crosscutting tools in
  the process for preparing the CSA, CSR, and SDSs.
  An exposure scenario sets out the conditions
  (risk management measures and the related
  operational conditions) under which a substance
  can be used.
• An exposure scenario contains the information
  and/or assumptions that enables the risk assessor
  to estimate the exposure
• Characteristics of the substance physical state,
  vapour pressure etc.
• Technical description of use and control
• Process description
• Tasks of operator (description, duration,
  frequency of exposure, etc.)
• Risk management measures

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The Downstream User

• Must
• Implement RMM communicated to him via the
  exposure scenarios in the SDS Annex
• If he uses the chemical outside the conditions
  described in the exposure scenario(s)
• Inform his supplier of this use to make it an
  identified use
• Alternatively
• Conduct a safety assessment for his own use
• Implement RMM for safe use
• Submit a postcard registration
• Communicate safe use further down the supply
  chain if he is supplier

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Communication
SDS including Exposure Scenarios (Recommended
Risk Management Measures)
Safety Data Sheet
Specific use
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All information available on

• http//ecb.jrc.it/REACH
• CLEEN, Chemicals Legislation European Enforcement
  Network
• http//www.cleen-eu.net
• DG Enterprise REACH
• http//europa.eu.int/comm/enterprise/reach
• DG Environment REACH
• http//europa.eu.int/comm/environment/chemicals
  /reach.htm