In the Nickel Institute’s opinion, effective chemicals management regulations need to recognise this principle of risk management. It puts the main responsibility on industry to ensure substances are used safely. This principle of ‘responsibility and care’ has, for example, been adopted by EU-REACH, where recommendations on risk management measures should be systematically conveyed through supply chains. This risk management can be furthered via a clear legislative framework that allows industry to take appropriate decisions.
Given a proper understanding of the properties and uses of a substance as well as the resulting exposure, industry can self-regulate (risk management). It can:
Decide which substance uses are appropriate and which are inappropriate
Decide which risk management measures should be applied during manufacturing and use to ensure safe handling.
Regulatory risk management measures that extend beyond the general legislative framework should be considered with care. The Nickel Institute believes that bans should be approached with particular caution.
Bans should be a last resort, when neither industry risk management nor other regulatory risk management measures prove sufficiently effective. Specifically, bans should not be considered for substances, but rather for inappropriate uses of those substances.
To ensure that regulatory risk management measures are only applied when necessary, and that the most effective risk management option available in a regulatory system is chosen, there needs to be a process for identifying the best regulatory route.
The Nickel Institute believes that each chemicals management system should provide for a process that allows the identification of the best regulatory route. It welcomes the decision of the EU authorities to establish a system – Risk Management Option Analysis (RMOA) – as an example of how to achieve this.
RPA conducted a study on behalf of the Nickel Institute, which examined how the most appropriate risk management option is selected in Australia, Canada, the EU (RMOAs), New Zealand and the United States. One of the Nickel Institute’s learnings from the study is that an integrated tool like the EU RMOA is particularly important to have where different pieces of chemicals management legislation overlap and need to be considered jointly to make the most effective use of the legislation and be proportionate in risk management. The study is available here.
RMOAs – an example
Three EU Member States (France, Germany and Hungary) carried out a Risk Management Option Analysis (RMOA) for nickel compounds. These RMOAs are representative for other nickel compounds. Nickel metal is not affected by this process as it has a lower hazard classification. As a result of this RMOA approach, the EU has prioritised setting 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 authorisation) are not foreseen for nickel compounds.