Information requirements under REACH

1
European Commission
Enterprise and Industry Directorate-General

• 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)

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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
  (CL)
• 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
  CL and/or RA
• Standard information depends on tonnage but can
  be adapted

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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)

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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 CL 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 CL and/or risk
  assessment
• Adequate and reliable documentation of method

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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)

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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.