Information requirements under REACH Katinka van der Jagt DG ENTR

1. Information requirements under REACH Katinka van der Jagt DG ENTR / G1 - REACH Brussels, 23 October 2006

2. WHY REACH? Data gaps: 86% of HPVCs have less than base set data The process takes (too much) time Burden of proof on public authorities Administrative burden for new chemicals (low volume) prevents innovation

3. REACH Context Article 1.1: ..purpose of REACH is to ensure a high level of protection on HH and ENV as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation.. Article 25.1:.. Testing on vertebrate animals for the purpose of REACH shall be undertaken only as a last resort� necessary to take measures limiting duplication of other tests..

4. Information requirements under REACH General requirements Information requirements depending on tonnage NB Cumulative Flexible with adaptation possibilities Adequate justification and documentation needed

5. Information requirements under REACH Annex VI of REACH proposal Annex VII to X: Minimum information in Technical Dossier depends on volume: = 1 tonne/y: Annex VII (~20,000 subst) = 10 tonnes/y: Annex VIII = 100 tonnes/y: Annex IX = 1000 tonnes/y: Annex X (2,500 subst) Possibilities for waiving

6. Intrinsic properties of a chemical Phys-chem properties (e.g. solubility, vapour pressure) Toxicity properties (e.g. acute toxicity, irritation, mutagenicity, carcinogenicity) Fate properties (e.g. (bio)degradation, partition coefficients) Ecotoxicity properties (e.g. toxicity to aquatic or terrestrial organisms)

7. Information requirements under REACH Specific adaptations for individual endpoints column 2 General adaptations Annex XI(1): Testing is not scientifically necessary Annex XI(2): Testing is technically not possible Annex XI(3): Substance-tailored exposure-driven testing

8. Use of information on intrinsic properties of substances in a regulatory context For Chemical Safety Assessment For Classification and Labeling of chemicals (C&L) For the identification of Persistent, Bioaccumulative and Toxic (PBT) and very Persistent very Bioaccumulative (vPvB) substances

9. Key considerations Promotion of non-animal testing REACH article13.1, Guidance note of Annex VI, Annex VII-X, Annex XI Alternative information needs to be adequate for C&L and/or RA Standard information depends on tonnage but can be adapted

10. Annex XI: general rules for adaptation Testing not scientifically necessary Use of existing data (not GLP/ non standard tests) Historical Human data Weight of evidence (Q)SAR In vitro methods Grouping of substances and read-across approach

11. Annex XI: general rules for adaptation Testing is technically not possible Exposure-driven testing (only for tests in annex IX and X i.e. = 100 tons/year)

12. Different types of information Exposure information, consider Testing may be waived when exposure is controlled Experimental animal test COM Regulation on adopted test methods (replacing current Annex V to 67/548/EC) Other experimental methods (Annex XI) In vitro data Historical Human data

13. Different types of information (Quantitative) Structure Activity Relationships Read-across Category approaches

14. Process for obtaining information Collect and evaluate all available information Existing test data (in vivo, in vitro) on the substance Results of QSAR calculations Establishment of (membership of) chemical category and collection of existing test data and results of QSARs for members of category Read-across and application of weight-of-evidence approach Cf. Annex XI(1) NB! Registrant shall be in legitimate possession of or have permission to use information

15. Process for obtaining information Consider information needs All information that is relevant and available to the registrant Annex III options for 1-10 tpa substances Tonnage-based requirements incl. specific adaptation rules, cf. Annexes VII-X Substance-tailored exposure-driven testing (general adaptation rules) , cf. Annex XI(3) Identify information gaps Final check for existing information Evaluate whether testing is technically possible, cf. Annex XI(2)

16. Process for obtaining information Generate new data / propose testing strategy: Endpoints in Annexes VII and VIII Not requiring use of vertebrate animals, conduct test Requiring use of vertebrate animals, assess whether a suitable in vitro test method is available and, if possible, conduct in vitro test Requiring use of vertebrate animals but no suitable in vitro test method is available, conduct in vivo test

17. Process for obtaining information Generate new data / propose testing strategy: Endpoints in Annex IX and X Not requiring use of vertebrate animals, prepare testing proposal Requiring use of vertebrate animals, assess whether a suitable in vitro test method is available and, if possible, prepare testing proposal for in vitro test Requiring use of vertebrate animals but no suitable in vitro test method is available, prepare testing proposal for in vivo test

18. Testing proposal Annex VII � VIII, no Registrant should provide data, should consider whether a suitable in vitro test method is available, but can conduct in vivo test

19. Testing proposal Endpoints in Annex IX and X: Yes Not requiring use of vertebrate animals, ? testing proposal Requiring use of vertebrate animals, if a suitable in vitro test method is available ? testing proposal for in vitro test Requiring use of vertebrate animals but no suitable in vitro test method is available ? testing proposal for in vivo test

20. Testing does not appear scientifically necessary, cf. Annex XI(1) Non-testing methods, general provisions Scientific validation Results adequate for C&L and/or risk assessment Adequate and reliable documentation of method Grouping

21. Testing does not appear scientifically necessary, cf. Annex XI(1) Suitable in vitro test methods Fulfil pre-validation criteria (e.g. ECVAM criteria) No dangerous property, confirmatory testing required Dangerous property + risks not adequately controlled, iterative CSA incl. confirmatory testing as option Dangerous property + risks adequately controlled, no further testing

22. Testing does not appear scientifically necessary, cf. Annex XI(1) In vitro test methods Accepted in vitro test methods Scientifically validated, based on internationally agreed principles Results are adequate for C&L and/or risk assessment Adequate and reliable documentation of method

23. Substance-tailored exposure-driven testing, cf. Annex XI(3) General adaptation criteria (not endpoint specific) Adequate justification is required based on exposure assessment, cf. Annex I(5) � COM to adopt criteria on adequate justification within 18 after EiF Specific conditions of use must be communicated through the supply chain (SDS or article 32)

24. CONCLUSION  Legislative text (Annex XI in particular) + GUIDANCE should limit use of animals and prevent box-ticking A paradigm shift is needed from extensive animal testing to efficient, focussed animal testing Impetus to refine current in vivo methods, and further develop non-test and in vitro test methods to be used in a regulatory context. Further scientific work (2007 onwards) and regulatory implementation is needed.