In 2019, the European Chemicals Agency (ECHA) moved from a substance-by-substance approach to an approach addressing structurally similar chemicals in groups. The aim was to speed up the identification of hazardous substances and control the risks more quickly.
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The ECHA’s second report on the Integrated Regulatory Strategy offers an overview of addressing substances of concern and in the ‘mapping of the chemical universe.’ This includes recommendations to authorities and the cosmetic industry on managing chemical risks.
Mapping the chemical universe and assigning substances for further action is a key part of the Integrated Regulatory Strategy. The aim is to have full clarity for all registered substances by 2027.
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Overall, the chemical universe of more than 21,000 registered substances in both high-volume and low-volume substances includes approximately 330 substances whose regulatory risk management are under consideration; 1,550 substances that are under data generation; 390 substances that have ongoing regulatory risk management; and 700 substances where no further actions have currently been proposed after authority reviews.
Together with the Member States, the agency reviewed around 220 substances registered at more than 100 tonnes per year and allocated them to different pools of the chemical universe for regulatory action. Fifty-six percent of substances needed more data to clarify the need for further risk management. For 22% of the substances, no further action was proposed and 7% of substances were considered a high priority for EU regulatory risk management.
“We aim for more clarity on all chemicals registered at more than 100 tonnes by the end of 2020.”
The number of substances registered above 100 tonnes that have not yet been assigned to a pool in the chemical universe has been reduced to around 2,400 substances. The grouping approach enabled the ECHA to scrutinize more than 300 low-production volume substances in 2019.
“The progress we have made with the Integrated Regulatory Strategy is a step toward better protecting Europe’s citizens,” said Jack de Bruijn, ECHA’s director of prioritization and integration. “To gain the most impact, we have focused the work on high-volume substances and we aim for more clarity on all chemicals registered above 100 tonnes by the end of 2020. Grouping similar substances help to speed up and make regulatory actions more consistent. It also helps national authorities step up their efforts to manage chemical risks under REACH and other pieces of legislation.”
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The ECHA’s Integrated Regulatory Strategy report covers an overview of the pre-regulatory steps, the evaluation processes and the regulatory risk management activities under REACH and CLP.
The report offers the following recommendations:
- Screening groups of substances, data generation and assessment should be further optimized to ensure substances are progressed to regulatory risk management without delay.
- Harmonized classification and labeling should become a priority, as it has a direct impact on company-level risk management and is often the step before the restriction, authorization or other measures under other pieces of legislation are taken.
- The priority and appropriateness of previously identified but still pending. Follow-up actions should be reviewed and those substances that need further regulatory risk management should be progressed without delay.
- The compliance of registration information needs to be improved, in particular for substances with a high potential for exposure that are currently lacking appropriate hazard data.
- Compliance of dossiers, their systematic review and updates of registrations based on new information remains the industry’s responsibility. ECHA welcomes the initiative of industry associations to develop review programs to help registrants review chemical safety data.
- Further enhancement of cooperation and coordination between authorities.