ES workshop intro

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Preparing for REACH implementation The RIP
process Dimosthenis A. Sarigiannis,
PhD Institute for Health and Consumer
Protection DG Joint Research Centre
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Preparation for REACH Commission Interim Strategy

• Refocus Activities under current legislation
• REACH Implementation Projects (RIPs)
• RIP 1 Process descriptions
• RIP 2 Development of IT systems (REACH-IT)
• RIP 3 Guidance Documents and tools for industry
• RIP 4 Guidance Documents and tools for
  authorities
• RIP 5/6 Setting up the (pre-)Agency
• Strategic partnerships (test out elements of
  REACH)

AIM In close collaboration with all stakeholders
develop guidance to help fulfil the obligations
under REACH
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3.1 Preparing the registration dossier
3.10 Guidance on substance ID
3.2 Preparing the CSR
3.4 Guidance on data-sharing
3.3 Information requirements
RIP-3 Guidance 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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4.1 Guidance on dossier evaluation
4.2 Guidance on substance evaluation
4.5 Priority setting for evaluation
RIP-4 Guidance for Authorities
4.3 Inclusion of substances in Annex XIII
4.4 Preparation of Annex XIV dossiers
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(No Transcript)
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Structure of Guidance package
Links to relevant formats and IT tools
Web based navigation tool
General Introduction (RIP-1 Extended)
Harmonised CL and SVHC ID
Registration

• Requirements in the regulation
• Main tasks of the actors
• The workflows
• The time limits

Authorisation
CL notification
Restrictions
DU requirements
Evaluation
Articles
Chemical Safety/ Risk assessment
Priority setting
Substance ID
CL under GHS
SEA / risk reduction options
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Organisational Diagram
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Main implementation challenges ahead

1. Focus on exposure/risk management
2. Intelligent testing strategies (ITS)
3. Downstream User communication

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Main implementation challenges ahead

• Focus on exposure/risk management
• Intelligent testing strategies (ITS)
• Downstream User communication

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Today
Future
Extended Safety Data Sheets
Regulation Agreements ..
I Industry
A Authorities
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Core tools under REACH

• The Chemical Safety Assessment (CSA) is the tool
  used to determine
• The Chemicals Safety Report (CSR) is the tool
  used to record/document
• The Safety Data Sheet (SDS) is the tool used to
  communicate
• Conditions for use (for sufficiently protecting
  human health and the environment)
• risk management measures
• operational conditions

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Main implementation challenges ahead

• Focus on exposure/risk management
• Intelligent testing strategies (ITS)
• Downstream User communication

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REACH and the use of test animals

• Testing on vertebrate animals shall be undertaken
  only as a last resort (art. 23)
• Information may be generated by other means than
  tests, in particular through (Q)SARs and
  read-across (art 12)
• Testing may be waived on the basis of exposure
  considerations
• ? Legislative text guidance should limit use of
  animals and prevent box-ticking

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Intelligent Testing Strategies (ITS)
Read Across
(Q)SARs
In-vitro
Endpoint information
Exposure Scenarios (Annex VII/VIII)
Existing information
?
TESTING
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Main implementation challenges ahead

• Focus on exposure/risk management
• Intelligent testing strategies (ITS)
• Downstream User communication

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The Downstream User

• Must
• Implement Risk Management Measures 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 (and
  for his downstream uses if he is a supplier)
• Implement necessary RMM from own safety
  assessment
• Report to the Agency
• Communicate further down the supply chain if he
  is supplier

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Supply chain communication
SDS including Exposure Scenarios (Recommended
Risk Management Measures)
Safety Data Sheet
Identify use
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Concluding remarksTrends paradigm shifts

1. Burden of proof from public authorities to
   industry
2. From focus on Risk Assessment to Risk Management
   Measures
3. From effects-oriented to exposure-driven
4. From full testing to selective testing (ITS)
5. Attitude from reactive to pro-active
6. Implementation of REACH has just started!

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Further information on RIPs

• http//ecb.jrc.it/REACH/
• E-mail dimosthenis.sarigiannis_at_ec.europa.eu