Nickel Risk Assessment

EU Environmental Nickel Risk Assessment and Ni Risk Reduction Strategy

Background

In the late 1990s, Nickel metal and four Nickel compounds (nickel sulphate, nickel chloride, nickel nitrate and nickel carbonate) were prioritised and selected for extensive hazard and risk review by the European Union under the now repealed EU Existing Substances Regulation ((EEC) 793/93). This review included a cradle to grave approach to evaluating the risks for workers, the environment, the general public and consumers from the production, use and recycling of Nickel and Nickel compounds.

Denmark acted as Rapporteur for the Nickel Risk Assessment (NiRA) for the EU. The whole process took more than eight years and included a hazard evaluation and classification (now manifest as the 1st ATP to the EU Classification, Labelling & Packaging Regulation (EC 1336/2008), a risk data set generation, a risk assessment (RA), and finally a risk reduction strategy (RRS). The occupational and related human health sections of the NiRA were closed in 2006; the environmental section however only got underway in 2005 and came to a close in April 2008.

Risk Assessment Conclusions

All EU risk assessments result in formal conclusions ranging from no identified risks to specific requests for data generation and risk reduction measures. These conclusions are legally binding for all nickel producers (and importers) in the EU as well as in EU Member States.

The Human Health Section

The Human Health aspects of the Nickel Risk Assessment are now dealt with via the REACH regulation. See more on our REACH pages.

The Environmental Section
  • Ni metal in massive form is not classified for environmental effects while fine powders are at the lowest aquatic hazard level
  • The risk assessment established "safe values" (PNECs) for soil and fresh water including full consideration of bioavailability. Taken together with Copper, this was the first time that a regulatory authority anywhere considered bioavailability to such a degree. The approach ensures a high level of protection and allows for the use of PNECs for setting environmental emission limits, in a more effective and cost-efficient way for industry.
  • Acceptance of a formal sediment testing proposal to allow industry to derive a reasonable environmental quality standard for nickel in sédiments. A major broad research program was initiated by NiPERA in  2008 to develop appropriate hazard and exposure information to assess the risks of Ni in sédiments. This process finalised with the publication by Denmark of the Summary report regarding risk management of nickel in relation to chronic toxicity to freshwater sediment organisms in December 2012. The report can be accessed here
  • Agreement on the risk characterisation (RC) including:
    • That the use of Nickel in general does not cause any widespread (regional) risk in the EU. Some soils in the UK and Spain are high in Ni and one sensitive water type was identified by the RC as requiring attention
    • That remaining local risks for Ni producers are related to historical contamination
    • User sites in general do not lead to a risk situation with exception of some sites. In the absence of specific data on exposure, generic default based user scenarios for sites lacking appropriate exposure information were generated. The plating sector was identified as being of particular concern.

Risk Reduction Strategy

The EU Risk Reduction Strategy (RRS) which followed the conclusions of the NiRA closed on April 29, 2009 with the agreement of EU Member States and the Commission on the RRS report.

The report concluded the following:

  • No need for any specific additional regulatory action beyond the application of existing EU environmental and consumer protection legilsation;
  • Member State competent authorities to review if the downstream user site permit conditions are in line with standard EU requirements (EU Integrated Pollution Prevention & Control (IPPC) guidance or BREF);
  • Need to set an EU-wide Ni water quality standard based on the NiRA and providing full recognition of the new bioavailability concept. Following this conclusion, the revision of the EU EQS Directive adopted in July 2013 set a freshwater Environmental Quality Standard for nickel (EQS) of 4µg bioavailable Ni/L. 

Some additional risk reduction action was requested from EU Member States with respect to transfers of nickel through the human food chain. This led to further recommendations to:

  • discourage the (inappropriate) use of Ni plated heating elements in water kettles
  • have Member States brief Ni hypersensitive consumers about which food materials have high nickel contents and the need to flush stagnant water from first water tap use (though this is not a Ni specific issue only).

The higher values of Ni in soil in Spain and the UK led to the recommendation of voluntary action by industry together with the respective national authorities to investigate the reasons for this. Industry and EU Member States were requested to adapt their environmental monitoring programs to include bioavailability parameters.

Nickel Industry Response to the Risk Assessment and Risk Reduction Strategy

The Nickel industry accepted the outcome of the Risk Assessment and Risk Reduction Strategy. The Nickel Institute and its colleagues at NiPERA have, since the conclusions were published by the European Commission, been actively addressing all of the conclusions and recommendations. Most of these have by now been addressed or are being finalised in the context of specific environmental standards reviews. The work to bring about closure of some of the conclusions (in particular with respect to the environment) has led to extensive new research on metal interaction with the environment being undertaken and published. Equally, the industry has pursued active product management in order to reduce the risk of impacts for sensitive consumer groups coming into contact with nickel. Finally, results of the risk assessment have been fed directly into the work of the Institute and the Nickel Consortia for the preparation of the Chemical Safety Reports (CSRs) for nickel metal and 11 other substances and intermediates under REACH.

Further information on the Nickel Risk Assessment can be found here.