Last updated 23 March 2018
In the context of the implementation of the REACH regulation, three EU Member States (France, Germany and Hungary) have carried out a Risk Management Option Analysis (RMOA) for nickel compounds. These RMOAs are representative for other nickel compounds. Nickel metal is not concerned by this process because it has a lower hazard classification. As a result of the RMOA process, the EU is prioritizing the setting of a binding Occupational Exposure Limit Value (binding OEL) as the most appropriate risk management measure for nickel compounds. Other regulatory risk management measures (e.g., Candidate Listing, restrictions or authorization) are not foreseen for nickel compounds.
French RMOA for nickel sulphate and nickel oxide
On 19 December 2016, ECHA published the French RMOA conclusions. The main finding is that a potential risk is limited to the workplace through exposure via inhalation. The setting of EU binding occupational exposure limits under existing workplace legislation is considered as the most adequate measure to control such risks. France has requested the European Commission to set a binding OEL under the Carcinogens and Mutagens Directive (Directive 2004/37/EC; CMD). France has also concluded that an inclusion of the nickel compounds in the REACH Candidate List is not appropriate.
France has included five further nickel compounds on the PACT, i.e., the list on which RMOA intentions are announced. While these RMOAs are not formally finalized, the Nickel Institute notes that in the RMOAs for nickel sulphate and nickel oxide, France has indicated that the conclusions also apply to the other nickel compounds.
The RMOA conclusions are available here:
Further details on the public consultation in 2014 are available here.
German and Hungarian RMOAs for nickel sulphide and nickel subsulphide
In August 2015, Germany and Hungary jointly started RMOAs for nickel sulphide and nickel subsulphide. Like nickel oxide, these two substances are used in the catalyst sector. Nickel oxide has other uses, whereas the German and Hungarian RMOAs focused entirely on the use in the catalyst sector. The German and Hungarian RMOAs concluded in 2017. They found that for this use of nickel sulphide and nickel subsulphide no further regulatory risk management measure was required. They do however support the setting of a binding OEL, which would also be applicable for nickel sulphide and nickel subsulphide.
The RMOA conclusions are available here:
The Nickel Institute actively supports the setting of an appropriate binding OEL for classified inorganic nickel compounds under the CMD with the recognition that nickel compounds are indirect carcinogens for which a practical threshold can be identified. The Nickel Institute encourages the early adoption of such a binding OEL and notes that the European Union has made good progress with setting binding OELs on a number of substances in the course of 2016.
On 8 March 2017, the European Commission mandated the ECHA's Risk Assessment Committee (RAC), instead of SCOEL (Scientific Committee on Occupational Exposure Limits) to make a scientific recommendation for occupational exposure limits for nickel and nickel compounds. The RAC's recommendation was due by 26 March 2018 and was published on 21 March 2018.
RAC recommended the following values (as 8-hour TWA (time weighted average)): 0.005 mg Ni/m³ as respirable fraction (nickel metal and inorganic nickel compounds) and 0.03 mg Ni/m³ as inhalable fraction (inorganic nickel compounds). A SEN notation for dermal sensitization was included, but no Biological Guidance Value or skin notation were recommended.
The recommendation is available here:
The RAC recommendation will feed into the EU regulatory process for establishing inding OEL values for classified nickel compounds under the Carcinogens and Mutagens Directive (CMD). It is expected that the topic will be debated by the Advisory Committee on Health and Safety at Work (ACSH) as early as June 2018. The current outlook is that nickel compounds will be covered by the 4th revision of the CMD, for which the European Commission is expected to issue a legislative proposal in 2019.
Importance of socio-economic and broader environmental considerations in an RMOA
The choice of workplace legislation and binding OELs as appropriate risk management measures will also ensure that nickel compounds will continue to make important contributions to green policy objectives such as achieving clean air, green transport, storing renewable energy. You will find information on the value chain and on important uses of nickel compounds here.
Nickel Institute supports a cross-industry initiative to strengthen the consistent application of the SVHC Roadmap
France's proposal for nickel compounds is a true application of the principles expressed by the Commission in the SVHC Roadmap: Member States should in RMOAs identify the best risk management option, be it within or outside of REACH. Under circumstances such as the ones applicable for nickel compounds, i.e., where the authorities have found that there is only a concern for the workplace, and not for consumers or the environment, specific workplace legislation is suited best to address these concerns. This principle should be applied consistently. The Nickel Institute has joined a cross-industry initiative (CII) to support this approach as a practical example of what could be achieved under the Commission's Better Regulation Agenda: Achieving regulatory objectives in the most effective and proportionate way. The initiative is open to examine ways to enable the swifter setting of binding OELs, in order to facilitate the effective use of workplace legislation further. You will find the position paper of the cross-industry initiative and further documents on the CII website.