By Lynn L. Bergeson
The EC updated the European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation on March 25, 2022, to clarify the information required by registrants of substances. Major changes include:
- Requirements and specific rules for adaptation of:
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- 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 (OR) 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 fulfill information requirements under REACH Annexes VII-X;
- 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 (UVCB); and
- Clarified requirements for reporting constituents, impurities, and additives, as well as for analytical information.
The changes will begin to apply from October 14, 2022. Registrants should review the updated legislation and prepare to update their dossiers.