ECHA Updates Recommendations to Improve REACH Registrations
On February 28, 2023, the European Chemicals Agency (ECHA) announced that it updated its recommendations to improve Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) registrations. According to ECHA, the recommendations are based on ECHA’s findings from registration dossier compliance checks and take recent changes to REACH information requirements into account. The recommendations focus on the rules for using adaptations to assess the safety of chemicals without animal testing. ECHA states that they provide advice on read-across, covering considerations on structural similarity, defining substance groups, and predicting target substance properties. ECHA also provided information on adaptations based on exposure scenarios outlined in chemical safety reports. According to ECHA, further advice addresses the requirements for mutagenicity information and chronic aquatic toxicity studies for poorly soluble substances. ECHA recommends that companies review the recommendations to make sure their dossiers comply with REACH and ensure the safe use of their chemicals.
ECHA also released statistics on its progress evaluating registered substances. In 2022, ECHA conducted 330 compliance checks covering more than 2,300 registration dossiers and addressing 295 substances. According to ECHA, 302 checks were full compliance checks, addressing all relevant endpoints of substances of potential concern. They resulted in 277 draft decisions being sent to companies, requesting more data to clarify long-term effects on human health or the environment. ECHA adopted 252 compliance check decisions together with European Union (EU) member states. ECHA states that these decisions addressed data gaps remaining after draft decisions and dossier updates. ECHA also adopted 169 testing proposal decisions addressing 347 information requirements for which testing was originally proposed by industry.
ECHA follows up on information requests sent to companies to check whether the information provided by companies complies with REACH requirements. According to ECHA, in 2022, this was concluded for 249 substances. In about 60 percent of the cases, companies provided the requested information. ECHA notified the remaining 40 percent to EU member states for enforcement. ECHA notes that it also adopted nine substance evaluation decisions, requesting further information to assess the safety of substances of potential concern.