Knowledge of properties and safe use of substances

Earlier generations of chemicals management regulation concentrated on new substances and certain existing substances such as nickel and nickel compounds. A number of other substances, which had been used by society for a long time, had not been well studied. Knowledge of their properties, and hence their safe use, was limited. This created a situation where regulatory attention primarily focused on those substances that were already well-studied, meaning there was no level playing field.

The European Union's REACH Regulation represents a new generation of chemicals management systems. It sets out to create a level playing field by requiring a standard information set for any substance imported or manufactured in the EU (registration requirement of REACH).

The registration requirements are commensurate with the annual tonnage registered by the individual manufacturer or importer. In the meantime, the Republic of Korea has put in place ARECS, a law inspired by EU-REACH. Although initially requiring only specifically-designated substances to be registered, a recent amendment has broadened the scope of ARECS registration requirements to resemble those of EU-REACH.

This is the foundation of a modern, successful chemicals management system: gathering existing high-quality information on substances and their uses and generating further information to bridge any gaps. 

In the Nickel Institute's opinion, the EU-REACH registration and evaluation chapters represent an excellent model for any jurisdiction that is aiming to establish a solid foundation for chemicals management regulation, which can be adapted for local circumstances.

The Nickel Institute's contributions

The Nickel Institute's science division, NiPERA Inc., has created a comprehensive repository of published and unpublished quality toxicity data on nickel and nickel compounds and has up-to-date hazard assessments for these substances. This forms the basis for the Nickel Institute's contribution to improving understanding of nickel and nickel compounds in different jurisdictions. Below, we provide two examples of the Nickel Institute's contributions.

EU-REACH: Nickel REACH Consortia

In the EU, the Nickel Institute acts as the Secretariat of the Nickel REACH Consortia. Here, the Nickel Institute helps companies manage their EU-REACH obligations. NiPERA provides hazard data and prepares the hazard assessment for the thirteen substances covered by the Consortia, while the Nickel Institute coordinates the gathering and analysis of information on how the substances are used. This way, it can prepare exposure scenarios and provide advice on appropriate risk management. The Nickel REACH Consortia follow the principle of continuous improvement: The REACH registration dossiers that NiPERA and the Nickel Institute prepare are updated annually to reflect new information and to adjust to regulatory developments (e.g. new guidance issued by European authorities).

ARECS: Nickel Institute shares data and advises on specificities of nickel

In the Republic of Korea, several nickel compounds were designated for registration by mid-2018. Their registration is managed by different consortia. The Nickel Institute has shared data on nickel compounds and the appropriate hazard assessment with these consortia. It has also provided advice on specificities of the nickel compounds. Under the revised ARECS, nickel metal will also be registered in the Republic of Korea; the Nickel Institute will follow a similar approach for this registration.

Based on its experiences in both jurisdictions, the Nickel Institute promotes cooperation between nickel compounds registrants.

Given the similarity in use and hazard profiles of the different groups of nickel compounds, cooperation between the different registrants of nickel compounds (and nickel metal) can bring greater efficiency and consistency. In the EU, this cooperation is facilitated through the joint Nickel REACH Consortium. The Nickel Institute recommends adopting this approach in other jurisdictions. Such consistency will also make it simpler for regulators when assessing the information provided on nickel and nickel compounds.

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