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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):
–
–
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–
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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 the
registration dossier
3.10: Guidance on
substance ID
3.2: Preparing
the CSR
3.4: Guidance on
data-sharing
3.3: Information
requirements
3.5: Guidance for
downstream users
RIP-3
Guidance for
Industry
3.8: Requirements
for articles
3.7: Guidance on
applications for
authorisation
3.9: Guidance
on SEA
3.6: Guidance on
C&L under GHS
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
RIP-4
Guidance for
Authorities
4.4: Preparation of
Annex XIV dossiers
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
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Timelines for RIP 3 and 4 projects
Structure of Guidance package
Links to relevant
formats and IT tools
Web based
navigation tool
General Introduction
(RIP-1 ‘Extended’)
Harmonised C&L
and SVHC ID
•Requirements in the regulation
•Main tasks of the actors
•The workflows
•The time limits
Registration
Authorisation
C&L notification
Restrictions
DU requirements
Articles
Substance ID
Chemical Safety/
Risk assessment
Evaluation
C&L under GHS
Priority setting
SEA / risk
reduction options
Organisational Diagram
Member States and Observers
Commission
Level 1
Level 2
ENV
and
ENTR
JRC
Commission Working Group
Practical Aspects of REACH
Comment
Comment
Technical
Committee
NES
Technical
Committee
C&L
Combined
LWG and
RRSM
Specific
Questions
Level 3
JRC
Scientific Technical
Input – “Consensus”
Drafting
Contractor
Stakeholder
Expert Group
Cleen
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
I
Risk Assessment
A
Output:
?
What were the
assumptions ??
Is there a risk?
(Yes/No)
Need / Options for Risk A
Management
Output:
Risk Reduction
Strategy
Regulation
Agreements
……..
Industry to implement
A = Authorities
I
Iterative CSA until exposure
scenarios show that risks are
controlled (risk management
integrated!)
Output:
Extended
Safety
Data
Sheets
I
Exposure Scenarios
= Recipe for Risk
Management
Industry to implement
(A) (Authorities still have the
option to intervene, e.g. via
a restriction proposal)
I = Industry
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
Scenario
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)
Read Across
(Q)SARs
In-vitro
Endpoint
information
Exposure
Scenarios
(Annex VII/VIII)
?
TESTING
Existing
information
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
SDS including
Exposure Scenarios
(Recommended Risk
Management
Measures)
Safety
Data
Sheet
Downstream user(s)
Identify use
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!
Further information on RIPs
http://ecb.jrc.it/REACH/
E-mail: [email protected]