Preparing for REACH implementation: The RIP process Dimosthenis A. Sarigiannis, PhD Institute for Health and Consumer Pr

1. Preparing for REACH implementation: The RIP process Dimosthenis A. Sarigiannis, PhD Institute for Health and Consumer Protection DG Joint Research Centre

2. 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. 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 C&L under GHS

4. 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

6. 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 Registration • Requirements in the regulation • Main tasks of the actors • The workflows • The time limits Authorisation C&L notification Restrictions DU requirements Evaluation Articles Chemical Safety/ Risk assessment Priority setting C&L under GHS SEA / risk reduction options Substance ID

7. Member States and Observers Commission ENV and ENTR Commission Working Group Level 1 Practical Aspects of REACH Comment Technical Committee NES Technical Committee C&L Combined LWG and RRSM Level 2 JRC Comment Specific Questions Cleen Stakeholder Expert Group JRC Level 3 Scientific Technical Input – “Consensus” Drafting Contractor Organisational Diagram

8. Main implementation challenges ahead • Focus on exposure/risk management • Intelligent testing strategies (ITS) • Downstream User communication

9. Main implementation challenges ahead • Focus on exposure/risk management • Intelligent testing strategies (ITS) • Downstream User communication

10. Iterative CSA until exposure scenarios show that risks are controlled (risk management integrated!) I A Risk Assessment Output: Is there a risk? (Yes/No) ? What were the assumptions ?? Output: Exposure Scenarios = Recipe for Risk Management A Need / Options for Risk Management Output: Risk Reduction Strategy Industry to implement I (A) • (Authorities still have the option to intervene, e.g. via a restriction proposal) Industry to implement I Today Future Extended Safety Data Sheets Regulation Agreements …….. I = Industry A = Authorities

11. Exposure Scenario 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

12. Main implementation challenges ahead • Focus on exposure/risk management • Intelligent testing strategies (ITS) • Downstream User communication

13. 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

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

15. Main implementation challenges ahead • Focus on exposure/risk management • Intelligent testing strategies (ITS) • Downstream User communication

16. 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

17. Supplier Downstream user(s) Supply chain communication SDS including Exposure Scenarios (Recommended Risk Management Measures) Safety Data Sheet Identify use

18. Concluding remarks:Trends & paradigm shifts • Burden of proof: from public authorities to industry • From focus on Risk Assessment to Risk Management Measures • From effects-oriented to exposure-driven • From full testing to selective testing (ITS) • Attitude: from reactive to pro-active • Implementation of REACH has just started!

19. Further information on RIPs http://ecb.jrc.it/REACH/ E-mail: dimosthenis.sarigiannis@ec.europa.eu