The European Chemicals Agency (ECHA) has published a report that argues for grouping chemicals to speed up regulatory action to better manage their risks.
ECHA’s second Annual Report on Integrated Regulatory Strategy, published in May 2020, provides an overview of progress made in addressing substances of concern and in mapping all registered substances or ‘mapping the chemical universe.’ It includes recommendations for consideration by authorities and industry on managing chemical risks.
In 2019, ECHA moved from a substance-by-substance approach to addressing structurally similar chemicals in groups in an effort to accelerate the identification of hazardous substances and manage their risks. That same year, the Agency, together with national authorities, reviewed around 220 high-volume substances registered above 100 tonnes per year and allocated them to different pools of the chemical universe for regulatory action. 56% required more hazard data to clarify the need for further risk management, 22% required no further action, and 7% were considered high priority for EU regulatory risk management.
Overall, the chemical universe of over 21,000 registered substances included, as of August 2019, around: 330 substances with regulatory risk management under consideration; 1,550 substances under data generation; 390 substances with ongoing regulatory risk management; and 700 substances with no further actions proposed following reviews by authorities. The aim is to have full clarity for all registered substances by 2027.
The report overviews pre-regulatory steps, evaluation processes, and regulatory risk management activities under the EU's REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) and the Classification, Labeling and Packaging (CLP) regulation. ECHA has an interim goal of generating a sufficient understanding of all substances registered above 100 tonnes by 2020 and assigning each substance to one of the following work streams: high priority for risk management; high priority for data generation; or currently of low priority for further regulatory action.
The report recommends:
- further optimizing screening groups of substances, data generation and assessment to ensure substances are subject to regulatory risk management;
- prioritizing harmonized classification and labeling;
- reviewing the priority and appropriateness of previously identified, but still pending, follow-up actions and advancing those substances that need further regulatory risk management without delay;
- improving the compliance of registration information, particularly for substances with a high potential for exposure and lacking appropriate hazard data; and
- further enhancing cooperation and coordination between authorities.
The report also underscores that industry is responsible for compliance of dossiers, their systematic review and updates of registrations based on new information. It states that ECHA welcomes the initiative of industry associations to develop review programmes to help registrants review chemical safety data. [ECHA Press Release]