ECHA Updates Recommendations To Improve REACH … – Mondaq News Alerts
23 March 2023
Bergeson & Campbell
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On February 28, 2023, the European Chemicals Agency (ECHA) announced that it updated its recommendationsto improve Registration, Evaluation, Authorisation and Restrictionof Chemicals (REACH) registrations. According to ECHA, therecommendations are based on ECHA's findings from registrationdossier compliance checks and take recent changes to REACHinformation requirements into account. The recommendations focus onthe rules for using adaptations to assess the safety of chemicalswithout animal testing. ECHA states that they provide advice onread-across, covering considerations on structural similarity,defining substance groups, and predicting target substanceproperties. ECHA also provided information on adaptations based onexposure scenarios outlined in chemical safety reports. Accordingto ECHA, further advice addresses the requirements for mutagenicityinformation and chronic aquatic toxicity studies for poorly solublesubstances. ECHA recommends that companies review therecommendations to make sure their dossiers comply with REACH andensure the safe use of their chemicals.
ECHA also released statistics on its progress evaluatingregistered substances. In 2022, ECHA conducted 330 compliancechecks covering more than 2,300 registration dossiers andaddressing 295 substances. According to ECHA, 302 checks were fullcompliance checks, addressing all relevant endpoints of substancesof potential concern. They resulted in 277 draft decisions beingsent to companies, requesting more data to clarify long-termeffects on human health or the environment. ECHA adopted 252compliance check decisions together with European Union (EU) memberstates. ECHA states that these decisions addressed data gapsremaining after draft decisions and dossier updates. ECHA alsoadopted 169 testing proposal decisions addressing 347 informationrequirements for which testing was originally proposed byindustry.
ECHA follows up on information requests sent to companies tocheck whether the information provided by companies complies withREACH requirements. According to ECHA, in 2022, this was concludedfor 249 substances. In about 60 percent of the cases, companiesprovided the requested information. ECHA notified the remaining 40percent to EU member states for enforcement. ECHA notes that italso adopted nine substance evaluation decisions, requestingfurther information to assess the safety of substances of potentialconcern.
The content of this article is intended to provide a generalguide to the subject matter. Specialist advice should be soughtabout your specific circumstances.
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