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The European Chemicals Agency (ECHA) carries out a completeness check on each incoming registration, as set out in Article 20(2) of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. In 2021 and 2022, the European Commission (EC) amended some of the information requirements for registering chemicals under REACH. In its January 23, 2023, press release, ECHA states that, beginning May 1, 2023, it will start checking both new registrations and updates to existing ones against the amended requirements, which will also take effect May 1, 2023, and will apply to both new registrations and updates of existing ones. ECHA states that registrants should prepare for the changes, as registrations submitted before may no longer pass the completeness check.
The new and amended checks concern:
- Substance identity: Ensuring correct and consistent identification of a substance’s boundary composition and its constituents and additives based on clarifications made to REACH Annex VI; and
- Standard information requirements based on REACH Annexes VII-XI: Supporting registrants in reporting information for endpoints concerning mutagenicity, degradation, and aquatic toxicity based on REACH Annex VII-XI information requirements. Registrants adding a new weight-of-evidence adaptation will be prompted to provide arguments for the approach in a more structured format.
According to ECHA, in parallel, it has made limited revisions to the completeness check in other areas, such as use information. ECHA notes that the IUCLID validation assistant will also be updated with the amended completeness check rules when the new version of IUCLID is released at the end of April 2023. ECHA encourages registrants to use the validation assistant to check their registrations before submitting them to ECHA.
ECHA held a webinar on February 8, 2023, for stakeholders to learn more about the changes. A recording is available.