Changes to REACH requirements

The European Commission has revised certain information requirements for registering chemicals under REACH. It advised companies to start preparing as the changes will start to apply in October. Further advice will be issued in 2H and changes will be made accordingly in Iuclid.

The main changes concern requirements and specific rules for the adaptation of:

* In vitro and in vivo studies, 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

* 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

* Degradation and bioaccumulation studies, specifying when further testing is needed, including investigation of both degradation and transformation products

There are also additional substance identification information requirements, including:

* Describing the compositions, nanoform or set of similar nanoforms related to information submitted to fulfil information requirements under Annexes VII-X

* Reporting a crystal structure and for reporting compositions for substances with unknown or variable composition, complex reaction products or of biological materials

* Clarified requirements for reporting constituents, impurities, additives and analytical information