Addressing substances of concern
Building on the experience gained during the first years of implementing REACH and the CLP Regulation, ECHA has developed an integrated regulatory strategy that brings together the various regulatory processes. The strategy provides a clear and coherent basis for achieving the aims of the regulations and contributing to the goals set by the United Nations Sustainable Development Goals concerning chemicals.
- To efficiently select substances or groups of substances that raise potential concern. The information needed to assess their safety is generated so that any remaining concerns can be addressed through the most suitable regulatory risk management measures.
- To ensure appropriate and timely intervention by all actors – ECHA, Member States, the European Commission and industry
- To provide confidence among stakeholders that registrants meet REACH information requirements, promoting improved communication on safe use in the supply chain.
Implemented since 2016, the strategy has continued the work started under the SVHC Roadmap.
How are the processes integrated?
The infographic below provides an overview of the different processes and how they relate to each other. A substance may enter a regulatory process at any point in time without following the flow shown in the diagram.
Addressing substances of concern
Screening helps to identify groups of structurally similar substances that should be prioritised for regulatory action, as well as those that are of low priority for further work. Grouping these substances ensures that a bigger share of all registered substances are addressed over a shorter period of time. If further information is needed to confirm the hazard properties of a substance, the substance proceeds to either substance evaluation or compliance check. Identifying and setting aside groups of low priority substances authorities can focus their resources on substances that matter.
Carrying out a regulatory management option analysis (RMOA) helps authorities decide the most appropriate way to address the identified concern. Outcome of this analysis could be to either to confirm the hazard properties via harmonised classification and labelling (CLH) or identification of a substance of very high concerns (SVHC), or move the substance to further regulatory risk management processes (e.g. restriction).
Once the concern is confirmed via either harmonised classification (CLH) or identification as a substance of very high concern (SVHC identification), authorities may decide if further regulatory risk management action is required:
- Harmonised classification and labelling: A substance is normally subject to harmonised classification and labelling if it meets the criteria for carcinogenicity, mutagenicity, reproductive toxicity (CMR) or respiratory sensitisation.
- Identification as a SVHC: A substance may be identified as a SVHC if it meets the criteria for a CMR substance, a PBT/vPvB substance, or a substance that gives rise to an equivalent level of concern as such substances. The substance is then placed on the Candidate List.
- Recommendation for the Authorisation List: ECHA prioritises and regularly recommends substances from the Candidate List for inclusion in the Authorisation List.
- Application for Authorisation: If a substance is on the Authorisation List, it cannot be placed on the market or use after the sunset date unless an authorisation has been granted for a particular use. Companies need to submit their applications for authorisation to ECHA.
- Restriction: A restriction limits or bans the manufacture, placing on the market or use of a substance that poses an unacceptable risk to human health or to the environment.
Stakeholders are informed about a substance entering regulatory risk management via the Registry of intentions until outcome and the public activities coordination tool (PACT).
Screening helps identify substances on which data needs to be generated or further assessed. The main tools for generating missing hazard information are compliance check and substance evaluation. The data is then assessed to determine whether it confirms the concern.
Dedicated expert groups have been established to provide support to Member States in defining testing strategies, carrying out assessments, and making conclusions in relation to PBT/vPvB or endrocine-disrupting properties of substances.
Member States consult the expert groups before a substance enters the formal substance evaluation or SVHC identification decision-making process.