EBB European Biodiesel Board DATA GAP ANALYSIS Biodiesel

EBB European Biodiesel Board DATA GAP ANALYSIS (Biodiesel Substances) Mark BLAINEY EBB Biodiesel Consortium REACH Expert EBB Consortium Technical Committee Conference Call Brussels, May 28 th, 2009 EBB BIODIESEL REACH CONSORTIUM EBB Biodiesel REACH Consortium Technical Committee Conference Call May 28 th, 2009 Moderator: Raffaello Garofalo, EBB REACH Consortium President

EBB European Biodiesel Board REACH Information Requirements Registrant shall submit: Ø Ø all relevant and available physicochemical, toxicological and ecotoxicological information. as a minimum, the information specified in Annexes VII-X taking into account the specific rules for adaptation of the standard testing regimes (Column 2 of Annexes VI-X/Annex XI). GAP analysis: − − Identify and collect all relevant and available physicochemical, toxicological and ecotoxicological information: in vivo or in vitro test data, data generated by non-testing methods (e. g. from ( Q)SARs, grouping, read-across, weight of evidence), epidemiological data etc. Collect information on exposure, use and risk management measures. Identify the relevant information requirements according to tonnage manufactured/imported, adapted in accordance with column 2 or Annex XI. Compare the identified information needs with the available information. When a data gap has been identified: − − Information requirement in Annex VII or VIII: the registrant may need to conduct a test. Information requirement in Annex IX or X: the registrant will need to develop a testing proposal. EBB Biodiesel REACH Consortium Technical Committee Conference Call May 28 th, 2009 Moderator: Raffaello Garofalo, EBB REACH Consortium President 2

EBB European Biodiesel Board Physicochemical Properties Annex VII/VIII 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. State of the substance at 20 o. C and 101, 3 k. Pa Melting/freezing point Boiling point Relative density Vapour pressure Surface tension Water solubility Partition coefficient n-octanol/water Flash-point Flammability Explosive properties Self-ignition temperature Oxidising properties Granulometry EBB Biodiesel REACH Consortium Technical Committee Conference Call May 28 th, 2009 Moderator: Raffaello Garofalo, EBB REACH Consortium President 3

EBB European Biodiesel Board Health Annex VII/VIII 1. 2. 3. 4. 5. 6. 7. Skin and eye irritation or skin corrosion. Skin sensitisation Mutagenicity − In vitro gene mutation study in bacteria − In vitro cytogenicity study in mammalian cells or in vitro micronucleus study § § if a negative result an in vitro gene mutation study in mammalian cells is required if there is a positive result a second in vivo somatic cell test may be necessary Acute toxicity – By oral route – By dermal route Repeated dose toxicity* – Short-term repeated dose toxicity study (28 days) via most appropriate route of administration Reproductive toxicity* An initial assessment to take into consideration all available toxicological information. Concerns: – None -reproduction /developmental toxicity screening test (OECD 421) – Serious - pre-natal developmental toxicity study. Toxicokinetic assessment * Test can be waived if relevant human exposure can be excluded in accordance with Annex XI section 3 EBB Biodiesel REACH Consortium Technical Committee Conference Call May 28 th, 2009 Moderator: Raffaello Garofalo, EBB REACH Consortium President 4

EBB European Biodiesel Board Environment Annex VII/VIII 1. Aquatic toxicity – Short-term toxicity testing on invertebrates (preferred species Daphnia) – – § § 2. 3. 4. The registrant may consider long-term toxicity testing instead of short-term Growth inhibition study aquatic plants (algae preferred) Short-term toxicity testing on fish: The registrant may consider long-term toxicity testing instead of short-term. Long-term aquatic toxicity study on fish shall be considered if the substance is poorly water soluble – Activated sludge respiration inhibition testing Biotic degradation – Ready biodegradability Abiotic degradation – Hydrolysis as a function of p. H. Fate and behavior in the environment – Adsorption/desorption screening EBB Biodiesel REACH Consortium Technical Committee Conference Call May 28 th, 2009 Moderator: Raffaello Garofalo, EBB REACH Consortium President 5

EBB European Biodiesel Board Example: Fatty acids, C 14 -18 and C 16 -18 -unsatd. , Me Esters SDA Substance Name: C 14 -C 18 and C 16 -C 18 unsaturated alkyl carboxylic acid methyl ester. • Physicochemical information − Granulometry not required. − Information probably available for read-across • Health information – Information generally available for read-across – 28 day sub-acute toxicity study and reproductive toxicity screening available for Fatty acids, rape-oil, Me esters (needs assessment if read-across possible) Ø Use information needed to assess if tests necessary – Toxicokinetic assessment necessary • Environmental information − Information generally available for read-across. EBB Biodiesel REACH Consortium Technical Committee Conference Call May 28 th, 2009 Moderator: Raffaello Garofalo, EBB REACH Consortium President 6

EBB European Biodiesel Board Gap Analysis Progress EBB REACH Consortium Literature Review − Comprehensive literature review of Biodiesel and other substances carried out by Dr. Luca Segato § Studies identified for a number of substances and endpoints Information on uses requested from members of the EBB Consortium Relevant information requirements identified – Adaptations in accordance with column 2 or Annex XI awaited EBB Biodiesel REACH Consortium Technical Committee Conference Call May 28 th, 2009 Moderator: Raffaello Garofalo, EBB REACH Consortium President 7

EBB European Biodiesel Board Next Steps Ø Use consolidated substances to finalise ‘gap analysis’ Ø Complete assessment of read-across opportunities Ø Assess waiving for 28 day sub-acute toxicity study and reproductive toxicity screening Ø Assess other available information sources e. g. Fatty acids Ø Determine testing needs (if any) EBB Biodiesel REACH Consortium Technical Committee Conference Call May 28 th, 2009 Moderator: Raffaello Garofalo, EBB REACH Consortium President 8