Overview on Regulatory Issues with relevance for nickel International Nickel Study Group Environment and Economic Committee Meeting Lisbon April 12, 2011 Nickel : one of the strongest documented metal Risk assessment completed in 2008 (Ni + 4 Ni compounds) and associated Risk assessment completed in 2008 (Ni + 4 Ni compounds) and associated Risk Management Measures implemented Registration dossiers on Ni metal and 12 Ni compounds completed in time by Ni consortia Update of the registration dossiers already initiated! Continuous research programme
REACH Consortia activities 2011 2013 Nickel metal, Ni sulphate, Ni dinitrate, Ni chloride, Ni sulphide, Ni hydroxycarbonate, Ni subsulphide, Ni acetate, Ni sulphamate, Ni dihydroxide, Ni oxide, Ni matte, Ni Ash Voluntary Updates of Registration dossiers: The Registration i dossiers of Nickel and nickel compounds will be updated d on a yearly basis 2011 Updates: Nickel metal and Nickel sulphate updates already submitted successfully Updates for other dossiers are ready and will be submitted Q2 2011 after update of REACH IT FeNi specific CSR waiting for final guidance 2012? Standard method for metals in alloys: handle alloys as a Special preparation p : Register the individual component substances including a CSR and an Exposure Scenario for the alloy AND Voluntarily demonstrate different properties of the alloy through testing Challenges: Guidance on Special Preparation assessment (SPA): Time to validate the SPA on a science point of view Time to validate the SPA on a political point of view 3 3 REACH Consortia activities 2011 2013 Nickel metal, Ni sulphate, Ni dinitrate, Ni chloride, Ni sulphide, Ni hydroxycarbonate, Ni subsulphide, Nickel sulphamate, Ni acetate, Ni dihydroxide, Ni oxide, Ni matte, Ni Ash Legal obligations Main challenge: uncertainties regarding timing and prioritization in Evaluation of dossier and Evaluation of substance 4 4
REACH Authorization Update On the basis of new CMR status after 1 st ATP to CLP circa 100 nickel compounds could end up in the authorisation ti process However, nickel and 36 nickel containing substances have been registered by December 2010 including several multi constituents substances. Only nickel and 21 nickel compounds are listed in the 1 st ATP. Current status of the Candidate list : 76 % of substances are CMR, only 11 % are PBT/vPvB and 50 % are metals compounds. No Nickel compounds on: «Candidate List» Annex XIV! 5 Listing of Nickel substances: French consultation 15 February 2011: French consultation on 24 substances in preparation of Annex XV submission in August 2011 Four nickel compounds are included: Nickel sulphate Ni carbonate Ni chloride Ni dinitrate Aim of consultation: gather data to complement existing CSR and mainly information on substitution Deadline for consultation: 15 March 2011 First advice from the ad hoc French Commission: Nickel compounds would not be listed in August 2011 more information on the compounds is needed The Nickel Industry welcomed the French initiative and would like to encourage other Member States to consult with industry at an early stage on the best Risk Management Options (Authorisation, Restriction ). 6
Ni compounds classifications Legal case in process December 2008 Case on NiCO3 April 2009 Case on read across Ni compounds lodged by NI at UK Court for a reference at ECJ January 2010 UK Court links both cases and sends a reference for preliminary ruling to European Court of Justice (ECJ) May 2010 All Parties send their comments to ECJ (NI, UK, with interventions from EC, Austria, Denmark and Germany) January 2011 Hearing, intermingled with the borates case March 2011 Opinion of Advocate General By Autumn 11 Judgement 7 Advocate General s Opinion AG s opinion is not binding for the Court and should not be interpreted as pre empting p the Court s ruling Does not look at the specific classification criteria in the DSD Declares that the case was admissible because, contrary to the claims of the Commission, the 30th and 31st ATP were still in force and should have been specifically repealed 8
Downstream legislative impacts for Nickel Classifications 3rd Revision of SEVESO Directive major accident hazards Named Substances scope Five named nickel compounds currently included d in SEVESO Draft Commission paper suggested enlargement of scope to all nickel compounds on the 1 st ATP, without rationale After a dialogue with NI, the suggestion was removed. Classification endpoint scope : more Ni compounds under Seveso Acute inhalation or oral toxicity NiCl2 Aquatic acute toxicity 1 or 2 NiCl2, Ni(OH)2, NiCO3, NiNO3, Ni3S2, NiSO4 NiS, Ni sulphamate, Ni2S, Ni acetate Chronic toxicity* Ni metal and all Ni compounds * From 1 Dec. 2010 until implementation of new Seveso Directive 9 Nickel Metal Classification: Current status Germany: review of C Cat 3 classification since end of 2008. Nickel inhalation study on rats reviewed. Negative outcome for C appreciated. Decision on classification expected in 2011 or later. Japan Japanese authorities removed R classification in August 2010. Will be published in MSDS guidance International: International Agency on the Research of Cancer (IARC) reviewed nickel compounds classification in 2009 a review of Ni metal in the future was indicated No developments in 2009 and 2010, unclear if review will be announced in 2011 10
Nickel Metal Classification: Nickel Institute activities Germany / EU Support for efforts on classification discussion at EU level to prevent stigmatization of nickel metal and nickel metal containing products International: Important to ensure that global approaches to metals hazard assessment is balanced and based on robust science Important also to ensure that regulatory policies and instruments to protect workers, consumers and the environment are based on assessment of actual risk not hazard Critical issue for all governments with relevant nickel production and relevant nickel markets Unjustified nickel metal classification with respect to carcinogenicity does impact production and use of nickel in materials and products 11 EU Occupational Exposure Limits The EU SCOEL Committee released in January 2011 a revised proposal for nickel OELs: indicative inhalable size OEL of 0.01 mg Ni/m 3 all nickel compounds (excluding Ni metal) indirect genotoxic carcinogens with threshold no great concern regarding respiratory sensitisation no carcinogen concern for nickel metal based on epidemiological cancer data indicative respirable size OEL of 0.005 mg Ni/m 3 nickel metal and all nickel compounds takes particle size into account based on animal respiratory toxicity data biological guidance value (BGV) for nickel in urine of 3 µg Ni/liter (no binding limit value). not based on adverse health effects not a biological limit value (BLV) Socioeconomic factors are not be considered at this stage 12
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