ECHA updates recommendations to improve REACH registrations
The updated recommendations will help companies to comply with REACH requirements and ensure the safe use of chemicals. They focus on avoiding animal testing, specifically providing advice on read across. Statistics on the progress made on evaluating registered substances in 2022 have also been released.
Helsinki, 28 February 2023 – The recommendations for registrants are based on ECHA’s findings from registration dossier compliance checks and take recent changes to REACH information requirements into account. Companies should review the recommendations to make sure their dossiers comply with the law and ensure the safe use of their chemicals.
The recommendations focus on the rules for using adaptations to assess the safety of chemicals without animal testing. They provide advice on read across, which uses information from a source substance to predict the properties of a similar target substance. This advice covers considerations on structural similarity, defining substance groups, and predicting target substance properties.
Information is also available on adaptations that are based on exposure scenarios outlined in chemical safety reports. Further advice addresses the requirements for mutagenicity information and chronic aquatic toxicity studies for poorly soluble substances.
In 2022, ECHA conducted 330 compliance checks covering more than 2 300 registration dossiers and addressing 295 substances. 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.
Furthermore, ECHA adopted 252 compliance check decisions together with the Member States. These addressed data gaps remaining after draft decisions and dossier updates. The Agency also adopted 169 testing proposal decisions addressing 347 information requirements for which testing was originally proposed by industry.
From 2009 to 2022, ECHA conducted compliance checks for more than 2 740 registered substances. The full compliance checks accounted for approximately 14 000 registration dossiers, which represents more than 15 % of registered substances and 20 % of all submitted dossiers. ECHA checked the compliance of 27 % of high-tonnage substances registered in quantities of 100 tonnes or more per year.
To follow up information requests sent to companies, ECHA checks whether the information provided by companies complies with the REACH requirements. In 2022, this was concluded for 249 substances. In about 60 % of the cases, companies provided the requested information to the Agency. The remaining 40 % were notified to Member States for enforcement.
ECHA also adopted nine substance evaluation decisions, requesting further information to assess the safety of substances of potential concern.