1. EU Nickel Risk Assessment under EU Regulation 793/93 Human Health Classification a review by Dr. Tony Hart – Nickel Institute Consultant Given to the Nickel Risk Assessment Symposium Birmingham, 16 th March 2006

2. EU Risk Assessment where are we ?  Human Health final draft report available (December 2005)  Decisions on nickel salts classification were taken during 2005  Final decision on nickel metal classification will not be made until 2007  A report has gone to Member States (TC NES meeting) and the Commission  First consideration of risk reduction measures are to be proposed by DEPA (2006?)  OECD review in Autumn 2006

3. EU Nickel Risk Assessment Can be considered in two separate categories Nickel Metal Nickel Salts

4. EU Nickel Risk Assessment Nickel Salts

5. Priority Substances !! 4 ‘Soluble’ Nickel Salts were selected as ‘Priority Substances’ for Assessment Sulphate SulphateChloride Nitrate Hydroxycarbonate All have major implications for the plating industry !!!! for the plating industry !!!!

6. Possible conclusions from the Risk Assessment– Human Health report For each type of exposure, one of three conclusions is admissible: n 1: More data is required n 2: Risks are being managed n 3: Additional risk-management measures are needed

7. Soluble Nickel Conclusions from the RA – Health report The GOOD News The report finds that for consumer issues: The report finds that for consumer issues: Conclusion 2 applies Conclusion 2 applies risks are being adequately managed risks are being adequately managed (However, further risk reduction measures may be needed for dermatitis)

8. Soluble Nickel Conclusions from the RA – Health report The BAD news The report finds that for Workplace Issues: Conclusion 3 applies Conclusion 3 applies Additional risk reduction measures are required (specifically related to inhalation) Additional risk reduction measures are required (specifically related to inhalation)

9. Classification of Nickel Salts – the major areas of concern  Carcinogenicity  Reprotoxicity  Mutagenicity

10. Soluble Nickel Salts – The New Classifications Ni sulphate Ni nitrate Ni chloride Ni carbonate Cancer Cat 1 Reprotox Cat 2 Mutagen Cat 3

11. What about other Nickel Compounds Initial DEPA intention READ ACROSS !!!! Initial DEPA intention READ ACROSS !!!! n to classify approximately 300 Ni containing substances, by ‘reading across’ to already classified Ni compounds on the sole basis of similar solubility

12. Reaction to‘READ ACROSS’ proposal Nickel Industry representatives have challenged this approach on two counts:- Nickel Industry representatives have challenged this approach on two counts:- u In the interim period before REACH, classification must concentrate on the priority substances listed for Risk Assessment u Even in case of similar solubility, substances display a different toxicity

13. What will happen to Occupational Exposure Levels (OELs) ? These are being reviewed in the light of these new hazard classifications These are being reviewed in the light of these new hazard classifications

14. Occupational Exposure Levels (OELs) The starting point will be a science- based review The starting point will be a science- based review (to be carried out by SCOEL = Scientific Committee on Occupational Exposure Limits )

15. Occupational Exposure Levels (OELs) However, final OELs will be based on a However, final OELs will be based on a Political Compromise Political Compromise

16. The Political Compromise This will take account of:- This will take account of:- n Socio-economic factors n Technical feasibility This evaluation will be undertaken by a new Ad- Hoc committee under EU DG Employment This evaluation will be undertaken by a new Ad- Hoc committee under EU DG Employment

17. EU Nickel Risk Assessment EU Nickel Risk Assessment - Human Health Nickel Metal

18. Nickel Metal Classification Largely unchanged at present Largely unchanged at present n Carcinogenicity : Remains Category 3 n Repro-toxicity: Not classified n Respiratory sensitiser: Not classified n Skin sensitisation: Positive classification

19. Review of Hazard Classification Nickel Metal: The future Nickel Metal: The future n Carcinogenicity n Mutagenicity These will be re-assessed when the animal inhalation study is complete – expected 2007

20. Future Decision Deadlines ???? 2006 What deadlines are there in 06 ?? What deadlines are there in 06 ??2007 Nickel metal (review Carcinogenicity & Mutagenicity) Nickel metal (review Carcinogenicity & Mutagenicity)

21. Do you need further information ? n For further information on the Classification and Labeling of Nickel Metal and Soluble Compounds, please visit the website http://www.nickelforum-eura.org