News on dossier evaluation for Annex VII

Date: 23 August 2021

ECHA can now request a combined comet assay (OECD TG 498) and micronucleus test (OECD TG 474) as one study when a positive Ames test and an indication for chromosomal aberration are available and if there are no other adequate and appropriate in vivo genotoxicity data in the dossier.

This approach already applies to compliance checks and testing proposal examinations under REACH annexes VIII, IX and X since 1 July 2020. From now on, registrants can expect requests for a combination study also for Annex VII dossiers.

The proposed combined test is appropriate to investigate gene mutations and chromosome aberrations in vivo and will help to reduce animal testing if combined in one study.

Source: ECHA weekly, Dossier evaluation: request for a combination study at Annex VII, 23rd June 2021 (