REACH: Chemical Safety Report (RIP 3.2) WERCS 2007 US User group Albany

1. REACH: Chemical Safety Report (RIP 3.2) WERCS 2007 US User group Albany 27/06/2007 Dr. Erwin Annys Sr. Advisor Product & Innovation Policy

2. Annex I • A chemical safety assessment consists of • Evaluation human health hazard • Evaluation physicochemical hazard impact on human health • Evaluation environmental hazard • PBT en vPvB evaluation Event – Erwin Annys

3. Annex I • If this ends up in a classification according to directive 67/548/EEG or 1999/45/EG or as PBT or vPvB • Exposure assessment • Risk characterisation Event – Erwin Annys

4. Human health hazard assessment • Objectives • Classification and labelling according to 67/548/EEC • Determine the levels not to be exceeded upon exposure by man • Derived no effect level DNEL • « Treshold concentration » Event – Erwin Annys

5. Human health hazard assessment • Following effects are evaluated • Toxicocinetics, metabolism and distribution • Acute effects (toxicity, irritation and corrosion) • Sensibilisation • Toxicity repetitive administration • CMR-effects Event – Erwin Annys

6. Human health hazard assessment • The evaluation consists of four steps • Step 1: Evaluation of other information than on man • Step 2: Evaluation of information on man • Step 3: Classification and labelling • Step 4: Derive DNEL and treshold concentration Event – Erwin Annys

7. Human health hazard assessment • Step 1: Evaluation of other information than on man • Identification of hazard based on all available non human information • Determine quantitative relationship between dose (concentration) and respons (effect) Event – Erwin Annys

8. Human health hazard assessment • If not possible then semi quantitative or qualitative • Describe all information (preferentially tabular) (LD50, NO(A)EL, LO(A)EL) • If different studies available, use the one raising the highest concern Event – Erwin Annys

9. Registration Event – Erwin Annys

10. Registration Event – Erwin Annys

11. Human health hazard assessment • Step 2: Evaluation of information on man • If nothing available, mention this explicitky Event – Erwin Annys

12. Human health hazard assessment • Step 3: Classification and labelling • Directive 67/548/EEC, a comparison with the criteria of CMR substances category 1 or 2 must be evaluated • If not sufficient information to determine the endpoint, the registrant has to motivate this Event – Erwin Annys

13. Human health hazard assessment • Step 4: Derive DNEL and treshold concentration • Based • On results in step 1 - 3 • Expected exposure routes • Time, frequency • More than one value may be necessary • Take care of relevant human populations • Workers • Consumers • Indirect exposure via environment Event – Erwin Annys

14. Human health hazard assessment • Upon determination of DNEL – treshold concentration consider following factors: • The uncertainty, result of variability experiments and interspecies variations • The nature and severity of the effect • The sensitivity of the human population consideredde Event – Erwin Annys

15. Physicochemical hazard assessment • Objectives • Classification and labelling according to 67/548/EEC • Potential effects to human • Explosivity • Flammability • Oxydising potential Event – Erwin Annys

16. Registration Event – Erwin Annys

17. Environmental hazard assessment • Objectives • Classification and labelling according to 67/548/EEC • Determine predicted no-effect concentration - PNEC Event – Erwin Annys

18. Registration Event – Erwin Annys

19. Registration Event – Erwin Annys

20. Environmental hazard assessment • Consider potential effects on the environment • Aquatic compartment (including sediment) • Terrestrial compartiment • Atmospheric compartiments • Possible effects via food chain accumulation • Potential effects on microbiological activity of sewage treatment Event – Erwin Annys

21. Environmental hazard assessment • The hazard assessment comprises three steps: • Step 1: Evaluation of information • Step 2: Classification and labelling • Step 3: Derivation Predicted No-Effect Concentration (PNEC) Event – Erwin Annys

22. Environmental hazard assessment • Step 1: Evaluation of information • The avaluation shall comprise: • Hazard identification based on all available information • Determine quantitative relationship between dose (concentration) and respons (effect) • If not possible then semi quantitative or qualitative Event – Erwin Annys

23. Environmental hazard assessment • All information shall be briefly commented, if possible in table form mentioning relevant test results (LC50 or NOEC) and test conditions (test duration, route of administration) • If different studies available, use the one raising the highest concern Event – Erwin Annys

24. Environmental hazard assessment • Step 2: Classification and labelling • Directive 67/548/EEC • If not sufficient information to determine the endpoint, the registrant has to motivate this Event – Erwin Annys

25. Environmental hazard assessment • Step 3: Derivation Predicted No-Effect Concentration (PNEC) • Based on the available informationthe PNEC for each environmental sphere shall be established. de PNEC voor elk milieucompartiment bepaald. The PNEC may be calculated by applying an appropriate assessment factor to the effect values (such as LC50 or NOEC). • If it is not possible to derive the PNEC, then this shall be clearly stated and fully justified Event – Erwin Annys

26. PBT and vPvB assessment • The PBT and vPvB assessment is based on all information entered in the technical dossier. If the dossier only contains information on the endpoints requested for annex V and VI, then the registrant has to consider whether additional information has to be generated to make the PBT vPvB assessment possible Event – Erwin Annys

27. PBT and vPvB assessment • The PBT and vPvB assessment comprises two steps : • Step 1: Comparison with the criteria • Step 2: Emission characterisation Event – Erwin Annys

28. PBT and vPvB assessment • Step 1: Comparison with the criteria • Compare with the criteria described in annex XII Event – Erwin Annys

29. PBT and vPvB assessment Event – Erwin Annys

30. PBT and vPvB assessment Event – Erwin Annys

31. PBT and vPvB assessment Event – Erwin Annys

32. PBT and vPvB assessment • Step 2: Emission characterisation • If the substance fulfils the an emission characterisation shall be conducted comprising the relevant parts of the exposure assessment as described in Section 5. In particular it shall contain an estimation of the quantities of the substance released to the different environmental compartments during all activities carried out by the M/I and all identified uses, and an identification of the likely routes by which the humans and the environment are exposed to the substance Event – Erwin Annys

33. Exposure assessment • Objective • Quantitative or qualitative estimation of dose/concentration of substance to which humans and environment are or may be exposed. The assessment has two steps • Step 1: generation of exposure scenarios • Step 2: exposure estimation Event – Erwin Annys

34. Exposure assessment • Step 1: generation of exposure scenarios • Iterative • For each identified use • An exposure scenario gives the operating conditions and the risk management measures for production and use of the substance in all parts of the chain and covering the whole life cycle Event – Erwin Annys

35. Exposure assessment • Production processes • The processes for the identified uses of the substances • The applied risk management measures by the producer • The risk management measures to reduce or avoid exposure of humans and environment to the substance during use, waste, disposal and recycling Event – Erwin Annys

36. Exposure assessment • Step 2: exposure estimation • The exposure is estimated for each exposure scenario and contains three : • Estimation of the emission • Assessment of chemical fate and pathways • Estimation of exposure levels Event – Erwin Annys

37. Exposure assessment • Emission in all relevant phases of the life cycle are estimated taking into consideration the risk management measures • The characterisation of of possible transformation, degradation or reaction products and an estimation of the distribution and fate shall be done • An estimation of the exposure levels for all populations • Workers, consumers, indirect exposure • By each relevant exposure route • Inhalation, oral, dermal and combinations • Considering • Frequencies, duration Event – Erwin Annys

38. Risk characterisation • The risk characterisation will be done for each exposure scenario • Looking at the risks for all human populations and the environmental compartments Event – Erwin Annys

39. Risk characterisation • The risk characterisation consists of • A comparison of the exposure of each human population known to be likely to be exposed with the appropriate DNEL and treshold conc • A comparison of the predicted environmental concentrations in each environmental sphere with the PNECs • An estimation of the likelihood and severity of an event occurring due to the physicochemical properties of the substance Event – Erwin Annys

40. Risk characterisation • For any exposure scenario the risk to humans and the environment can be considered to be adequately controlled, throughout the lifecycle of the substance that results from manufacture or identified uses if • The exposure levels do not exceed the appropriate DNEL, treshold concentration and PNEC • The likelihood and severity of an event occurring due to the physicochemical properties of the substance is negligible Event – Erwin Annys

41. Thanks for your attention Event – Erwin Annys