1 EU Risk Assessment on Nickel Joint Meeting Birmingham, 4 th October 2007

1 What is the EU Risk Assessment ? An attempt to investigate and quantify the Human Health and Environmental impact of certain materials and to propose action to reduce these risks where necessary

1 A number of metals were selected for investigation on a priority basis CadmiumLeadMercuryCopperZincNickel

1 The EU selected the Danish Environmental Protection Agency as rapporteurs for the Nickel Risk Assessment programme Work commenced in 1996 It was divided into two separate categories Human HealthHuman Health Environmental AspectsEnvironmental Aspects

1 Five priority substances were selected for the Nickel Risk Assessment Nickel metal Nickel Sulphate Nickel Chloride Nickel Hydroxycarbonate Nickel Nitrate

6 10 Nickel Risk Assessment – Progress Chart HH ENV March 08 ENV Oct 08 HH ENV April 08

7 Current Situation Human Health Risk Assessment Report Finalised in December 2005

8 Current Situation Environment Risk Assessment Report September 2007 (Technical Committee on New and Existing Chemical Substances 3) Effects section almost closed Important methodological concepts agreed by Member States (bioavailability, ecoregion concepts) Exposure section in progress Risk characterization still to be covered at December and March 2008 meetings EC Committee (Scientific Committee on Health and Environment) will review later in 2008

9 Current Situation The complete and Final Risk Assessment Report Should be published around April 2008

10 Classification Issues The following points were agreed and adopted in February Nickel metal : Chronic toxicity classification(T; R48/23) will also apply to Ni powder

11 Classification Issues The following points were agreed and adopted in February NiSO 4, NiCl 2, NiCO 3, NiNO 3 will be classified as Carcinogen Class 1 (by inhalation), Reprotoxicant Class 2 (may cause harm to unborn children) Chronic toxicant (T; R48-23)

12 Classification Issues The following points were agreed and adopted in February Ni metal powder (particle size < 0.1 mm) will be classified as R52/53 (harmful to the aquatic environment)

13 Classification Issues Implementation : may be as early as June 2008 These changes will be in 30th Adaption to Technical Progress (ATP), due to be adopted in December 2007, and probably published in Official Journal early in 2008, for Implementation by Member States by June 2009

14 Classification Issues Implementation : may be as early as June 2008 The Commission has said that implementation will be automatic through an Annex to the Global Harmonisation System (GHS) to be implemented through an EU Regulation in June 2008.

15 Classification Issues INDUSTRY ACTION REQUIRED Prepare communication plan for workers, salesman, customers, etc. Refer - ENIA RA Communications workshop: September 2005

16 Classification issues Classification decisions expected during 2007 Read Across recommendation (vote of the 31st ATP in December 2007) Outcome of nickel inhalation carcinogenicity study (Autumn 2007: BUT no signs YET of carcinogenic tumors !!!)

17 What is READ ACROSS ? An attempt to classify 150 Ni compounds as: Carcinogen Category 1 Reprotoxicany Category 2 solely on the basis of solubility This may have a major perception and marketing impact on nickel metal and all other nickel compounds !!!

18 Read Across – The Nickel Industry Challenge Preparing the case Make a Legal Submission to EC Legal Services Obtain the Technical Committee for Classification & Labelling extensive summary report on Nickel Read Across recommendations Technical Committee for Classification & Labelling recommended Carcinogen Category 2 at it’s meeting during March 2006, HOWEVER EC decided to propose to Carcinogen Category 1 « for coherence » with the other already classified compounds Nickel Institue is protesting against this move

19 Read Across – The Nickel Industry Challenge Raising the political stake Nickel producer company’s CEOs have sent letters to European Commissioners and to national authorities UK and French authorities believe more more tests required. Nickel Institute has conducted a study to investigate similarities between NiSO 4, NiCO 3 and Ni(OH) 2. The results showed dissimilarities The Nickel Industry will therefore use this to oppose classification of NiCO 3 and Ni(OH) 2 as Carcinogens Category 1

20 Read Across – The Nickel Industry Challenge Raising the political stake Questions were lodged on the case at the European Parliament Very poor answers were given by the European Commission The case if being examined

21 Read Across – The Nickel Industry Challenge Ensuring Read Across methodology is adequate and coherent REACH IMPLEMENTATION PROJECT (testing alternatives) Reach Central Agency will decide whether or not to allow testing on vertebrates. It might well not allow the necessary testing for scientific justification Advocacy is proceeding at EC and OECD level

22 Read Across – The Nickel Industry Challenge CRITICAL TIME SCALE 30th ATP will vote on NiCO 3 December 2007 This was delayed due to remarks of WTO countries on NiCO 3 31st ATP will vote (Ni(OH) 2 and 150 other Ni compounds): December 2007

23 Risk Reduction Strategy Nickel Institute RRS Workshop took place in September 2006 Danish Environmental Protection Agency draft RRS report will be discussed at EU RRS meeting with active Ni Industry input Human Health Aspects in April 07 Environmental Aspects in April 08 All to be finalised and approved by EU before April 2008

24 Human Health DEPA draft Human Health Report Recommended RR actions set a Community binding OEL under the Carcinogens Directive Set a Community binding OEL for welding consider an exchange of information organized by the Commission to ensure proper guidance to severely nickel sensitized individuals through the Community Review the Nickel release standard for marketing Ni- containing materials in direct and prolonged contact with skin

PROGRAMME Completion of Environment Research Programme and Environmental Risk Assessment Report  Ensure correct read across methodology application  Advocacy for OECD review for Environmental Aspects  Assessment of Impact of UN Global Harmonised System of Classification for major classification endpoints  Ensure Risk Reduction Measures for Environmental Aspects are in line with Risk Assessment conclusions, and prepare stakeholders to carry out necessary local monitoring to assess actual HH and EH risks at specific sites (also to prepare for REACH)

26 ON-GOING NICKEL INSTITUTE PROGRAMME Communications programme Ni Risk Assessment Environmental Workshop, January 2008, in Belgium  One day to present outcome of RA for Environment  Half day to reach Industry position on proposed draft risk reduction measures, and Industry action This will be open to all Nickel user industries and companies