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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.

For substance identification information, the following will change:

• new requirements 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.

You should make yourself familiar with these latest revisions and prepare to review and update your registration dossiers.

Please contact us if you need help with updating your dossier!