European Nickel Industry Association
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About the European Nickel RA

 

  • EU Regulation 793/93 requires the evaluation and control of risks from the production and use of existing substances. More information from http://ecb.jrc.it/existing-chemicals/ >> 
  • The scope of a full EU risk assessment is very wide. Its purpose is to evaluate and control exposure to existing substances imported into the EU in volumes1 above 10 tonnes per year, in order to protect the general population, workers, consumers and each of the four environmental compartments; air, soil, water and sediments.
  • Existing substances enter into the full risk assessment procedure when they are nominated as priority-list substances. For each substance on a priority list, a Member State volunteers to act as Rapporteur2.
  • There are four overall stages in the Regulation for evaluating the risks:
    1. data reporting
    2. priority list setting
    3. risk evaluation
    4. risk management
  • The Regulation is a legal instrument, which imposes directly on manufacturers or importers precise requirements to provide information/data on substances. In certain cases, it is necessary to require manufacturers or importers to submit further data or to carry out further testing on the existing substances.
  • Commission Regulation (EC) 1488/94 (EC, 1994a) which is supported by a Technical Guidance Document-TGD (European Commission 1996, 1997a) sets out the methods for carrying out an EU risk assessment. The TGD was developed for use with man-made organic chemicals and there is concern about its suitability for assessing metals in terms of methodology and data interpretation. These concerns are shared by other metals industries. Zinc will be the first RAR (risk assessment report) to be completed and is expected to set important precedents.
  • EU Commission Director General - DG JRC- ECB3 acts as administrator of TC NES4 of Member States on the risk assessments. There are four TC NES meetings per year: in March, June, September and December. Observers from industry, consumer organisations, trade unions, environmental organisations and certain international organisations (e.g., OECD, WHO) are invited to attend.
  • The Rapporteur’s final-draft Risk Assessment Report agreed at TC NES is then peer-reviewed by the Scientific Committee on Toxicity, Ecotoxicity and the Environment (SCTEE) which gives its opinion to the European Commission on the quality of the risk assessment.
  • In the risk evaluation stage of the process the TC NES may come to three conclusions:
    • conclusion (i) need for further testing/information
    • conclusion (ii) no risks identified
    • conclusion (iii) risk identified, risk reduction/management measures required

The process as related to nickel

  • Five5 listed nickel priority substances are currently undergoing risk assessment in accordance with EU Regulation 793/93. In 1996 nickel and nickel sulphate were listed on the third priority list for risk evaluation. The basis of the listing appears to be concern expressed by the Danish Environmental Protection Agency (D-EPA)2. The substances are high production volume substances1 and known dermal sensitisers.
  • In 2000, three further high production volume nickel substances were listed on the 4th priority list5. The listing of further soluble nickel salts was on the basis that they are high production volume chemicals and that all soluble nickel salts have similar toxicity; therefore generic risk assessments of all soluble nickel salts may be made.
  • D-EPA (Denmark) is Rapporteur for the EU risk assessment report on nickel.
  • The Rapporteur and nickel industry representatives (ENIA)6 have worked closely together to develop draft risk assessment reports (RAR) (including the health and environment sections). These were first presented to the EU Member State TC NES4 experts in June, 2002.
  • D-EPA (Denmark) is also Rapporteur for nickel under the OECD HPV program. The Rapporteur will submit its draft EU risk assessment nickel report to OECD in Nov., 20037.
  • Discussions on nickel at TC NES level are ongoing and the aim of the Rapporteur and ECB3 was that consensus should be reached by TC NESIV/03 (December, 2003), but this was susequently postponed a further two years.  During the course of these discussions, the scientific interpretation of the underlying scientific information may change, more information may be included and the conclusions may change.
  • Conclusions of risk identified in the EU RAR have implications for much downstream EU legislation. Recommended risk reduction strategies are referred to the EU Commission who shall decide if measures (for example, in the framework of classification and labelling directive or the marketing restrictions and use of certain dangerous substances directive) are appropriate. A list of EU legislation that may be impacted by the nickel risk assessment has been developed. See the list >>
  • New or amended proposals to EU Regulations/Directives affecting the nickel substances under evaluation follow procedures set out in supplementary EU legislation. Conclusions on the risk evaluation at TC NES meetings may lead to discussions at other EU committees.
  • There is direct interaction between administrative technical committees and the political/policy EU committees.
  • Numerous EU Regulations and Directives may be impacted as a result of the risk evaluation process.

Footnotes

  1. High Production Volume substances greater than 1000 tonnes produced or imported into the EU in the period 1990-1994
  2. The Danish Environmental Protection Agency – DEPA (Denmark) is Rapporteur for nickel.
  3. EU Commission Director General - DG JRC- Joint Research Centre- Institute of health and consumer protection unit, toxicology and chemical substances – European Chemical Bureau (ECB). More on ECB >>
  4. Technical Committee for New and Existing Substances (TC NES) of Member States experts in risk assessment. (Formerly called TMs or Technical Meetings)
  5. Nickel metal, nickel sulphate -- 3rd priority list; nickel chloride, nickel nitrate, nickel carbonate -- 4th priority list.
  6. European Nickel Industry Association (ENIA) represents, at a European level, the interests of the European nickel supply industry and a portion of the European nickel-using industry.  More on ENIA  >>
  7. Cooperation between the OECD HPV chemicals program and the EU existing substances program Doc OECD ECB 4/01/02 revised 21 November, 2002.
Nickel
ENIA