ECHA/NR/22/09 April, 12
On March 24 2022, the European Commission published amendments to Annexes VI – X of the REACH Regulation (COMMISSION REGULATION (EU) 2022/477).
The update of the annexes includes revised requirements for the registration of chemical substances in the European Union under REACH. The changes mainly concern:
- determining when further in vivo and in vitro tests on the mutagenic potential of the substance are needed;
- identification of the preferred animal species and administration routes in reproductive toxicity studies;
- clarification of when long-term studies should be performed instead of short-term aquatic toxicity studies and terrestrial organisms studies;
- identify the need for a degradation and bioaccumulation study.
In addition, the registration dossier for substances should include the description of nanoforms, identify crystal structures and UVCB substances, clarify information on impurities and additives, as well as analytical information.
In the second half of 2022, ECHA will publish an updated guide to registration requirements. Companies should start preparing to update their substance registration dossiers as the changes will apply in October 2022.
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