preparing for reach implementation: the rip process dimosthenis a. sarigiannis, phd
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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. Preparation for REACH: Commission Interim Strategy. Refocus Activities under current legislation REACH Implementation Projects (RIPs): - PowerPoint PPT PresentationTRANSCRIPT
Preparing for REACH implementation:
The RIP process
Dimosthenis A. Sarigiannis, PhD
Institute for Health and Consumer ProtectionDG Joint Research Centre
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
3.1: Preparing theregistration dossier
3.1: Preparing theregistration dossier
3.2: Preparing the CSR
3.2: Preparing the CSR
3.3: Information requirements
3.3: Information requirements
3.10: Guidance on substance ID
3.10: Guidance on substance ID
3.5: Guidance for downstream users
3.5: Guidance for downstream users
3.8: Requirementsfor articles
3.8: Requirementsfor articles
3.6: Guidance onC&L under GHS
3.6: Guidance onC&L under GHS
3.7: Guidance on applications for authorisation
3.7: Guidance on applications for authorisation
3.9: Guidance on SEA
3.9: Guidance on SEA
3.4: Guidance on data-sharing
3.4: Guidance on data-sharing
RIP-3Guidance for
Industry
4.1: Guidance on dossier evaluation
4.1: Guidance on dossier evaluation
4.2: Guidance on substance evaluation
4.2: Guidance on substance evaluation
4.3: Inclusion of substances in
Annex XIII
4.3: Inclusion of substances in
Annex XIII
4.4: Preparation of Annex XIV dossiers
4.4: Preparation of Annex XIV dossiers
4.5: Priority settingfor evaluation
4.5: Priority settingfor evaluation
RIP-4Guidance for
Authorities
Timelines for RIP 3 and 4 projects
RIP-3: TGD for Indystry
RIP-3.1: TGD on the Registration dossier
RIP-3.2-1A: TGD on the CSR (Scoping)
RIP-3.2-1B: TGD on the CSR (Draft CSA)
RIP-3.2-2 TGD on the CSR (Final Guidance)
RIP-3.3-1: TGD on Info requirements (Scoping)
RIP-3.3-2: TGD on Info requirements (Final Guidance)
RIP-3.4: TGD on data sharing
RIP-3.5-1: TGD on DU requirements (Scoping)
RIP-3.5-2: TGD on DU requirements (Final Guidance)
RIP-3.6: Guidance on C&L under GHS
RIP-3.7: TGD on applying for Authorisation
RIP-3.8: Guidance on requirements for articles
RIP-3.9-1: Guidance on SEA (Scoping)
RIP-3.9-2: Guidance on SEA (Final Guidance)
RIP-3.10: Guidance on substance ID
RIP-4: Technical Guidance Documents and Tools for Authorities
RIP-4.1: Guidance on dossier evaluation
RIP-4.2: Guidance on substance evaluation
RIP-4.3: Guidance on selection for Annex XIII
RIP-4.4: Guidance on Annex XIV dossiers
RIP-4.5: Guidance on priority setting for evaluation
Structure of Guidance packageGeneral Introduction(RIP-1 ‘Extended’)
Registration
DU requirements
Articles Evaluation
Harmonised C&Land SVHC ID
Restrictions
Substance IDChemical Safety/Risk assessment
C&L under GHS Priority settingSEA / risk
reduction options
C&L notification Authorisation
•Requirements in the regulation•Main tasks of the actors •The workflows •The time limits
Links to relevant formats and IT tools
Web basednavigation tool
Organisational DiagramCommission
Level 1
Level 2
Level 3
ENV and
ENTR
JRC
JRC
Commission Working GroupPractical Aspects of REACH
TechnicalCommittee
NES
CleenStakeholder Expert Group
Member States and Observers
Contractor
Specific Questions
Scientific Technical Input – “Consensus”
Comment
Comment
Drafting
TechnicalCommittee
C&L
Combined LWG and
RRSM
Main implementation challenges ahead
1. Focus on exposure/risk management
2. Intelligent testing strategies (ITS)
3. Downstream User communication
Main implementation challenges ahead
1. Focus on exposure/risk management
2. Intelligent testing strategies (ITS)
3. Downstream User communication
Today Future
What were the assumptions ??
?
Industry to implement I
I = IndustryA = Authorities
Iterative CSA until exposure scenarios show that risks are controlled (risk management
integrated!)
I
(Authorities still have the option to intervene, e.g. via a restriction proposal)
(A)
Industry to implementI
Output:
Exposure Scenarios = Recipe for Risk
Management
Risk Assessment A
Extended SafetyData
Sheets
Regulation Agreements
……..
Need / Options for Risk Management
A
Output:
Is there a risk? (Yes/No)
Output:
Risk Reduction Strategy
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
Exposure Exposure ScenarioScenario
Main implementation challenges ahead
1. Focus on exposure/risk management
2. Intelligent testing strategies (ITS)
3. Downstream User communication
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
Intelligent Testing Strategies (ITS)
Endpointinformation
(Q)SARs
Read Across
In-vitro
ExposureScenarios
(Annex VII/VIII)
Existinginformation
TESTING
?
Main implementation challenges ahead
1. Focus on exposure/risk management
2. Intelligent testing strategies (ITS)
3. Downstream User communication
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
Supply chain communication
Supplier
Downstream user(s)
Identify useSafetyDataSheet
SDS includingExposure Scenarios
(Recommended RiskManagementMeasures)
Concluding remarks:Trends & 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!
