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): –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 3.1: Preparing the registration 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: Requirements for articles 3.8: Requirements for articles 3.6: Guidance on C&L under GHS 3.6: Guidance on C&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-3 Guidance 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 setting for evaluation 4.5: Priority setting for evaluation RIP-4 Guidance for Authorities

Structure of Guidance package General Introduction (RIP-1 ‘Extended’) Registration DU requirements Articles Evaluation Harmonised C&L and SVHC ID Restrictions Substance ID Chemical Safety/ Risk assessment C&L under GHS Priority setting SEA / 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 based navigation tool

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

TodayFuture What were the assumptions ?? ? Industry to implement I I = Industry A = 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 implement I Output: Exposure Scenarios = Recipe for Risk Management Risk Assessment A Extended Safety Data 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 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) Endpoint information (Q)SARs Read Across In-vitro Exposure Scenarios (Annex VII/VIII) Existing information 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 use Safety Data Sheet SDS including Exposure Scenarios (Recommended Risk Management Measures)

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