EU Risk Assessment on Nickel

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EU Risk Assessment on Nickel
Joint Meeting Birmingham, 4th October 2007
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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
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A number of metals were selected for
investigation on a priority basis
Cadmium Lead Mercury Copper Zinc Nickel
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The EU selected theDanish Environmental
Protection Agency as rapporteurs for the Nickel
Risk Assessment programme

• Work commenced in 1996
• It was divided into two separate categories
• Human Health
• Environmental Aspects

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Five priority substances were selected for the
Nickel Risk Assessment
Nickel metal Nickel Sulphate Nickel
Chloride Nickel Hydroxycarbonate Nickel Nitrate
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Nickel Risk Assessment Progress Chart
HH ?
ENV Oct 08
HH ?
ENV March 08
HH ?
ENV April 08
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Current Situation

• Human Health Risk Assessment Report
• Finalised in December
  2005

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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

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Current Situation

• The complete and Final Risk Assessment
  Report
• Should be
  published around
• 
  April 2008

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Classification Issues

• The following points were agreed and adopted
  in February 2007.
• Nickel metal
• Chronic toxicity classification(T R48/23) will
  also apply to Ni powder

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Classification Issues

• The following points were agreed and adopted
  in February 2007.
• NiSO4, NiCl2, NiCO3, NiNO3 will be classified
  as
• Carcinogen Class 1 (by inhalation),
• Reprotoxicant Class 2
• (may cause harm to unborn children)
• Chronic toxicant (T R48-23)

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Classification Issues

• The following points were agreed and adopted
  in February 2007.
• Ni metal powder (particle size lt 0.1 mm)
  
• will be classified as
• R52/53 (harmful to the aquatic environment)

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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

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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.

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Classification Issues

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

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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 !!!)

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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 !!!

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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
  its 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

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Read Across The Nickel Industry Challenge

• Raising the political stake
• Nickel producer companys 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 NiSO4, NiCO3 and
  Ni(OH)2.
• The results showed dissimilarities
• The Nickel Industry will therefore use this to
  oppose classification of NiCO3 and Ni(OH)2 as
  Carcinogens Category 1

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Read Across The Nickel Industry Challenge

• Raising the political stake
• Questions were lodged on the case at the
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  European Parliament
• Very poor answers were given by the European
  Commission
• The case if being examined

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Read Across The Nickel Industry Challenge

• Ensuring Read Across methodology is adequate and
  coherent
• REACH IMPLEMENTATION PROJECT 3.3.2 (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

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Read Across The Nickel Industry Challenge

• CRITICAL TIME SCALE
• 30th ATP will vote on NiCO3
• December 2007
• This was delayed due to remarks of WTO countries
  on NiCO3
• 31st ATP will vote (Ni(OH)2 and 150 other Ni
  compounds) December
  2007

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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

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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

Accepted
Rejected
Rejected
Accepted
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2007 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)

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ON-GOING NICKEL INSTITUTE PROGRAMME

• Communications programme
• Ni Risk Assessment Environmental Workshop,
• 24-25 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