EU-risk assessment programme and reports

The background and the procedures in relation to the EU-risk assessment programme on existing substances carried out under Regulation 793/93 is described at the EU-website where the finalised risk assessment reports also can be found and downloaded.

In this programme the Danish EPA has in close collaboration with the international nickel industry elaborated environmental and human health risk assessment reports on five nickel substances: metallic nickel, nickel carbonate, nickel chloride, nickel nitrate and nickel sulfate.

The following final and agreed draft versions has recently been sent to the EU-website for inclusion in the EU-database:

Human health risk assessments reports

(all documents are in pdf)

Metallic nickel
Nickel carbonate
Nickel chloride
Nickel nitrate
Nickel sulfate

Furthermore a nickel background has been elaborated in order to get an overview on the human health toxicity data on the various nickel compounds and to establish the basis for using the read-across approach on the data from the various substances.

Nickel background report

A risk assessment report has also been elaborated on humans indirectly exposed via environment i.e. assessments in relation to Nickel exposure from various media such as air, drinking water and food.

Environmental risk assessments reports

(all documents are in pdf)

Section 3.1 Environmental Exposure Assessment
Section 3.2 Effects Assessment
Section 3.3 Risk Characterization
Appendix G: Ancillary information for Section 3.2.1 (Aquatic Effects)
Section 6 References

Please note, that there are tracked changes in the documents, to show which changes have been made after the OECD procedure.

The environmental risk assessment report and annexes include a detailed risk assessment of the five high production volume nickel substances.

The effects assessment part contains an evaluation the nickel ion which is the responsible species for the effects observed for all of the five nickel substances. It is noted that the final version of the assessment reports include an annex G8 based on concern expressed by Canada during the adoption process in the OECD HPVC (SIDS) Programme. This annex has thus been added after adoption of the report in the EU Existing Chemicals Programme.

Finally it is noted that the environmental risk assessment reports do not contain a section concerning assessment of the risk to sediment organisms and to the function of microorganisms in biological waste water treatment plants. Work is currently ongoing in a collaboration between nickel Industry and the Danish EPA to complete the environmental risk assessment in this regard.

The EU risk assessment reports on the selected nickel substances have also been discussed and with minor revisions been adopted in the OECD Programme on Investigation of High Production Volume Chemicals. In the OECD programme the following summaries focussing on hazard profiles, i.e. Screening Initial Assessment Profiles (SIAPs)  have been adopted.