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The Testing Methods Process: From Current Legislation to REACH

This talk provides general information on testing methods, including why standardized methods are needed, the development process, and regulatory acceptance activities. It also discusses the role of testing methods in risk management, the free movement of goods, and harmonization efforts.

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The Testing Methods Process: From Current Legislation to REACH

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  1. The Testing Methods Process:From Current Legislation to REACH Juan Riego Sintes Steven Eisenreich Croatia – JRC-ECB InfoDays 11-13 December 2006 Zagreb, Croatia

  2. Objectives of this talk Give general information on: General on TMs - Why do we need standardized Testing Methods? - Which methods do we have, where are them? - How and by whom are they developed? Extract on Regulatory Acceptance Activities in the Interim period Testing Methods in REACH / RIP 3.3

  3. Why RISK MANAGEMENT FOR HUMANS AND THE ENVIRONMENT Protecting People and the Environment from Dangerous Chemicals RISK ASSESSMENT CLASSIFICATION AND LABELING HAZARD IDENTIFICATION AND ASSESSMENT DETERMINATION OF HAZARDOUS PROPERTIES OF CHEMICALS TESTING METHODS 1

  4. Why FREE MOVEMENT OF GOODS Both at EU and global level e.g. OECD Single Market and Free Trade based on MUTUAL ACCEPTANCE OF DATA relies on MAD agreement HARMONISATION OF TESTING METHODS for HAZARDOUS OR DANGEROUS CHEMICALS

  5. Where Current: ANNEX V Dir. 67/548/EEC* 88/302/EEC 92/69/EEC 93/21/EEC 96/54/EC 98/73/EC 2000/32/EC 2000/33/EC 2001/59/EC 2004/73/EC Testing Methods Annex V structure *These methods are legally binding Contains standardised Testing Methods to determine the properties of chemicals Part A. Methods for the determination of PHYSICO-CHEMICAL PROPERTIES Part B. Methods for the determination of TOXICITY Part C. Methods for the determination of ECOTOXICITY Future: Testing Methods regulation

  6. Where

  7. Overlapping regulations and actions Who EUROPEAN CHEMICALS BUREAU Carries out and co-ordinates scientific/technical work needed for the implementation of EU legislation in the area of chemicals control Current 67/548/EEC WA 1 Classification and labelling WA 2 New Substances WA 3 Testing Methods WA 4 Existing Substances WA 6 Biocides WA 5 Import/ Export Draft REACH proposal

  8. Who Duties of Testing Methods Work Area DEVELOPMENT INTRODUCTION of ADAPTATION TO TECHNICAL PROGRESS (ATP) TESTING METHODS (Annex V to Dir. 67/548/EEC CO-ORDINATE the

  9. Testing Methods Tasks Who and how - Co-ordinate COM and EU needs and inputinto OECD Test Guidelines Programme (National Co-ordinators Meeting). - Promote Testing Methods development for EU legislation (co-ordinated with OECD as far as possible). - Organise transfer of OECD accepted Test Guidelines into Annex V. - Co-operate with the European Centre for validation of Alternative Methods (ECVAM) to promote development and to accompany adoption of alternative Testing Methods within EU legislation and OECD TG programme. - Participate in relevant UN activities for global harmonisation. - Organise, support and evaluate ring tests or validation studies. - Organise and host expert meetings. - Develop review documents.

  10. Who and how Member States Competent Authorities Scientific Community Testing Methods Development (II) European Chemicals Bureau National Co-ordinator TM C&L New Substances Existing Substances Biocides Other Commission Services National Co-ordinators Meeting or written procedure advice on work plan priorities preferred approach OECD TG Programme Commission Services Consultants Experts Development by ECB Development by MS NC’s Meeting or written procedure Working Groups Task Forces Experts’ Meetings Workshops Decide to introduce in Annex V

  11. Who and how Testing Methods Development (III) Draft Method Meeting of NC’s or written procedure Approval to introduce into Annex V DG ENV Preparation of proposal for ATP Interservice Consultations Proposal to Member States ATP CommitteePublication in OJ Formatting Draft Testing Method in Annex V format Final translated versions of TM Meeting(s) of NC’s or Experts Commenting Round(s) Checking by NCs Correction of translated versions Introduce Corrections and/or Guidance Translation in all official languages Meeting or written procedure Approval by NC’s Final version of Testing Method

  12. REGULATORY ACCEPTANCEof TMs(extract)

  13. ROLESIN THE EU (current)* (regarding to TMs acceptance) MEMBER STATES: Give opinion and advice Vote Commission’s proposal Review, endorse, implement, enforce EUROPEAN COMMISSION: Coordinates and prepares proposals Has legislative initiative Review, endorse, implement DG Environment: “Chef de file” Policy responsible Competent Authorities: Policy responsible ECB: Technical matters and delegated duties National Coordinators: Technical matters and delegated duties *In future similar for TMs, where Agency?

  14. HARMONISATION Aims to allow Single market, free trade, free movement of goods at EU and global level EU Annex V OECD TG Ensure acceptance at EU level (within and among authorities, 25+2+1) Harmonized methods at EU level Legally binding: You must use these Ensure acceptance of data at OECD level (among authorities, 30+3) Harmonized guidelines at OECD level MAD* agreement: If you use these, I will accept Important to keep harmonization between both sets *MAD: Mutual Acceptance of data

  15. INTERIMfrom Annex V to the new Testing Methods Regulation and REACH

  16. Testing Methods (Interim) Objective: Coordinate the development, introduction and adaptation to technical progress of Testing Methods of Annex V to Dir 67/548 and contribute to relevant REACH Implementation Projects (RIP). Current priorities: • Maintain functioning current system and prepare for new (at COM, EU and OECD levels): • Methods needed for the base set. • Alternative or in vitro methods. • Methods for EU specific needs. • Contribute to RIP projects, in particular developing new “Intelligent” Testing Strategies (ITS) (e.g. RIP 3.3) • Identify and prioritize new or updated methods needed for REACH implementation. • Cooperate with the leading DG(s) in order to finalise the new Regulation on Testing Methods How: • Collaboration with EU MS National Coordinators and other stakeholders. • Collaboration with OECD • Collaboration with ECVAM and other COM Units

  17. REACH and Test Methods General political objectives of REACH RIPs RP 3.3 motivation Information integration: ITS Testing requirements Adaptations and waiving Overview of RIP 3.3 Objectives Deliverables Management Status

  18. (some) REACH Political objectivesHow are they reflected in the Testing Strategies? • Protection of human health and the environment • Maintenance and enhancement of the competitiveness • Prevent fragmentation of internal market • Increased transparency • Integration with international efforts • Promotion of non-animal testing (= avoid testing in animals) • Conformity with EU obligations under WTO

  19. REACH objectives (II) • Protecting health and environment • Gathering and generating the information required to prepare a Chemical Safety Report and eventually manage the risks. • Priority evaluation of substances of particular concern (CMR, PBT, vPvB,…) or when an aggregate tonnage trigger has been reached. This may involve generating new data

  20. REACH objectives (III) • Maintaining and enhancing competitiveness • Exhaustive use of existing information (existing test results, human evidence, in vitro,…) • Use of non-test based information (QSAR, grouping,…) • No testing for very low production volumes (below 1 T) (and limited between 1-10 T) • No requirements for polymers and intermediates (with limited exposure potential) • Exposure driven tailored testing (exposure scenarios) • R&D exemption (up to 10 y) • Sharing of data

  21. REACH objectives (III) • Promoting non-animal testing Same as previous and, in addition: • Allow non (not yet)-validated in vitro methods in some circumstances • Evaluation of proposals for substance-tailored testing involving animals (in particular required under annexes IX and X) • Limited testing inanimals below10 Tonnes

  22. Preparing for REACH: RIPs REACH Implementation Projects (RIPs) • RIP 1: REACH Process Description; • RIP 2: REACH – IT; • RIP 3: Technical Guidance and Tools for Industry; • RIP 4: Technical Guidance and Tools for Authorities; • RIP 5: Setting up the Pre-Agency • RIP 6: Setting up the Agency • RIP 7: Commission preparations for REACH

  23. Guidance for Industry on how to fulfil Information Requirements (RIP 3.3)Information Integration before Testing RIP 3.3 Intelligently Integrating Information The 3 I’s Read Across (Q)SARs In-vitro Endpoint information Exposure Scenarios (Annex IX/X) Existing information ? TESTING

  24. RIP 3.3 background (I) Testing Annexes (Info requirements) • Annex VI: Guidance on testing annexes plus basic information requirements • Annex VII: Information requirements for >1T • Annex VIII: Additional Information requirements for >10T • Annex IX: Additional Information requirements for >100T • Annex X: Additional Information requirements for >1000T • Annex XI: General Guidance and rules for Adaptation of the standard test regime Testing Methods Regulation But always hand in hand with Annex I (CSR)!!

  25. RIP 3.3 background (II) General guidance in Annexes VI and XI of draft REACH (1) 1 Gather + shareexisting information on • Properties: test results, QSAR estimates, human data,… • Uses: current and foreseen • Exposure • Risk Management Measures: implemented or proposed 2 Identify precise information needs on the basis of • Tonnage • Use • Exposure • Risk Management Measures

  26. RIP 3.3 background (III) General guidance in Annexes IV and IX of draft REACH (2) 3 Identify information gapsand consider how missing information can be generated Consider (Annex IX): • Testing not scientifically necessary • Quality GLP and Annex X quality data exists • Adequate non-GLP or non-Annex X data exists • human data • weight of evidence • QSAR • grouping or read across • in vitro data • Testing is technically not possible • Substance-tailored exposure-driven testing (consider exposure scenarios) 4 Generatenew information or propose testing strategy According to Annexes VII to X and using theTesting Methods of the New Regulation

  27. RIP 3.3 Development of Guidance for Industry on how to fulfil Information requirements(RIP 3.3) Overview • Introduction (Objectives, Deliverables, Organisation) • Tasks (specific deliverables, status)

  28. Objectives of RIP 3.3 • Guidance for industry on how to fulfill the information requirements on intrinsic properties (Annex VI to XI) and how to use all information and testing in an optimal way for decision-making under REACH This should allow for: • Carrying out Chemical Safety Assessment (CSA) • includes whether substance is PBT or vPvB • Classification and labelling (C&L) • includes assessment whether a substances is CMR

  29. RIP 3.3 Deliverables • Guidance onstrategies for generationof information on relevant inherent properties; should explain and illustrate: • How tofind and use existing information (including human data, non GLP studies and other information obtained with non-standard test methods); • How toimplement the rules for adaptation as provided in the different annexes, especially for substances manufactured/imported in higher tonnages; • The guidance shall provide the rationale for adaptation (waiving) from the test requirements specified in column 2 of Annexes VIII-X.

  30. RIP 3.3 Partners and Organisation (I) • RIP 3.3. Consortium: • CEFIC(lead) • Concawe • ECETOC • Environment Agency (UK) • DK EPA • Eurométaux • INERIS (F) • KEMI (S) • OECD • RIVM (NL) • TNO (NL) All are members of Project Management Group (PMG) plus DG ENTR and DG JRC ECVAM/ECB • Ad hoc working groups • Endpoint Working Groups (EWG)

  31. RIP 3.3 Tasks • Task 1 : General structure / cross-cutting issues • Task 2 : Specific Endpoint Guidance • Task 3 : Chemical Categories / Read Across guidance • Task 4 : Preparation of draft TGD

  32. Task 1: General structure / cross-cutting issues

  33. Task 1 • ToRs ,Templates (HH and Env) and source documents for EWGs • Harmonisation of horizontal issues and 1 General introduction to REACH 2 General Decision Making Framework 2.1 Introduction 2.2 General Decision Making Framework 3. Information requirements 3.1 Information sources/searching 3.2 REACH Annexes VI-X interpretation 4 Evaluation of available data 4.1 Adequacy 4.2 Reliability 4.3 Relevance 4.4 Fit for purpose 5 Considerations affecting information requirements and testing strategies 5.1 Use of existing data 5.2 WoE 5.3 QSAR 5.4 In vitro 5.5 Grouping & Read across 5.6 Testing is technically not possible 5.7 Substance tailored exposure driven testing 5.8 Toxicokinetics 5.9 Non standard Substances 8 Conclusions on Hazard assessment 8.1 Concluding C&L 8.2 Concluding DNEL 8.3 Info not adequate either for C&L and/or DNEL 8.4 Remaining uncertainties 9 Glossary STATUS: 2nd draft available in December

  34. RIP 3.2 6 Dose response relationship 6.1 Derivation of NOAEL, starting point, assessment factors 6.2 Modification of NOAEL or LOAEL 6.3 Different routes of exposure and bioavailability 6.4 Deriving adequate starting point 7 ITS 7.1 Phys-chem &adsoption desorption 7.2 Skin&Eye Irritation/corrosion & respiratory irritation 7.3 Skin & respiratory sensitisation 7.4 Acute toxicity 7.5 Repeated dose 7.6 Reproductive & Developm. Toxicity 7.7 Muta and Carcinogenicity 7.8 Aquatic Toxicity; long term tox to sediment 7.9 Degradation/Biodegradation 7.10 Bioconcentration & Bioaccumulation/ long term birds 7.11 Effects on Terrestrial Organisms Task 2

  35. PURPOSE OF REACH Balance between ensuring high level of Human Health and Environmental protection - limitation of EU industry administrative burdens/costs in order to maintain competitiveness and innovative capacity (Council document 7524/06 AD1) MEANS Providing adequate information for C&L and for carrying out CSA HOW - Providing integrated testing strategies. - Minimizing animal testing THEREFORE - Integrated testing strategy: move from old to new strategy; tiered approach - Guidance which is accessible and understandable for non-expert - Scientifically robust but practical Task 2: Development of Guidance & ITS for Specific Endpoints (general)

  36. Task 2: Development of Guidance & ITS for Specific Endpoints DELIVERABLES: • Guidance on identifying information sources and how to ensure the reliability of the used information (generic aspects part of Task 1); • A testing strategy to help registrants provide adequate and relevant information for registration sufficient for • Carry out Chemical Safety Assessment (CSA) • Classification and labelling • Guidance on when and how to use alternative information (instead of (animal) testing) including guidance on what is “adequate and reliable documentation”; HOW: by specific Endpoint Working Groups (EWG) STATUS: variable depending on EWG, drafts to be sent to SEG in December

  37. Task 3: Guidance on Chemical Categories / Grouping of Substances • Develop non-prescriptive guidance: • explanation of key concepts: SARs, read-across and categories (including sub-categories) • how to perform qualitative and quantitative read-across • how to build a category (including special cases) • how to justify and report the “adequacy” of a read-across or category proposal  appropriate reporting formats Results being Merged in Task 1 STATUS: 6 consensus chapters + >10 individual appendices Submission to SEG on December. Being integrated in Task 1

  38. Task 4 – Preparation of draft TGD • Specific objective: To combine all the input from the Working Groups into the overall Technical Guidance Document • Deliverables: • final draft of the Technical Guidance for RIP 3.3 • Status: Task 1 Drafting Group is already engaged in defining the structure and generic content of the overall TGD Information Requirements, liaising with RIP 3.2 to ensure compatibility. To be developed mainly in 2007. All package expected to be delivered by April 2007

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