Upcoming Changes to REACH Information Requirements - Lisam

20 April 2022

Upcoming Changes to REACH Information Requirements

ECHA announces that, from October 2022 onwards, the information requirements for registering chemicals under REACH will change based on Commission Regulation (EU) 2022/477 of 24 March 2022. The Agency confirms more advice will be published on these requirements before they come into effect.

The REACH annexes have been updated to make the information that companies must present in their registrations clearer and more predictable, as well as to make ECHA’s review methods more transparent and predictable. The modifications will take effect on October 14, 2022. ECHA therefore urges companies to evaluate their registration dossiers and get acquainted with the updated annexes.

The most significant changes concern:

§  Requirements and specific rules for adaptation of:

–         in vitro and in vivo mutagenicity studies;

–         reproductive toxicity studies;

–         aquatic toxicity studies;

–         toxicity studies on terrestrial and sediment organisms; and

–         degradation and bioaccumulation studies.

§  Only representatives are required to disclose information on the non-EU manufacturer they represent.

§  Substance identification information, including:

–        obligation to describe compositions, nanoform or collection of similar nanoforms related to information submitted to fulfil information requirements pursuant according to the REACH’s Annex VII-X information requirements;

–        new reporting requirements for crystal structures and compositions for chemicals with unknown or variable compositions, complex reaction products, and biological materials (UVCBs);

–         clarified requirements for identification and quantification of its constituents and, where appropriate, its impurities and additives.

Updated guidance material and advice will be made available by ECHA in the second half of 2022.

IUCLID will be affected by the modifications as well. Data can already be reported in the new REACH annexes using the current IUCLID 6 format. Some improvements will be made in the next major IUCLID release in April 2023, including changes to the Validation assistant. ECHA’s completeness check will be also harmonized with the updated information requirements.

More information on these changes can be found here: https://echa.europa.eu/fr/-/upcoming-changes-to-reach-information-requirements-1