The update of the REACH annexes clarifies the information companies need to submit in their registrations and makes ECHA’s evaluation practices more transparent and predictable. The changes will start to apply from 14 October 2022. Companies should get familiar with the updated annexes and prepare to review their registration dossiers.
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…