Changes to certain REACH information requirements will start applying from 14.10.2022
The proposed amendments to the REACH annexes under Commission Regulation (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R0477) aim at providing clarifications of certain information requirements that companies need to submit in their REACH registration dossiers and at increasing the legal certainty of the evaluation practices applied by ECHA. The European Commission has revised certain REACH information requirements and the changes related to this revision will begin to apply in October 2022.
Implications for REACH Registrants
ECHA advices companies to start getting familiar with the updated annexes as they might trigger an update to their REACH registration dossiers. To help registrants understand the information requirements ECHA is working on updating its guidance materials and is planning to publish key information for REACH registrants during the second half of 2022.
According to ECHA’s website the main changes concern:
- Requirements and specific rules for adaptation of:
- in vitro and in vivo mutagenicity studies, specifying when further studies are needed based on mutagenicity concerns;
- reproductive toxicity studies, specifying the preferred animal species and administration routes, and clarifying the conditions triggering the need for further studies based on concerns;
- aquatic toxicity studies, clarifying when long-term studies must be performed instead of short-term studies or in addition to them;
- toxicity studies on terrestrial and sediment organisms, specifying when long-term studies are needed instead of short-term studies and clarifying that long-term testing must investigate both degradation and transformation products; and
- degradation and bioaccumulation studies, specifying when further testing is needed, including investigation of both degradation and transformation products.
- The obligation for only representatives to provide details on the non-EU manufacturer they represent.
- Substance identification information including:
- the requirement to describe the compositions, nanoform or set of similar nanoforms related to information submitted to fulfil information requirements under Annex VII-X of REACH;
- new requirements for reporting a crystal structure and for reporting compositions for substances with unknown or variable composition, complex reaction products or of biological materials (UVCBs); and
- clarified requirements for reporting constituents, impurities, and additives as well as for analytical information.
More information can be found here: