News – Japan’s MAFF intends to introduce a new requirement within the PP re-evaluation programme

Date: 30 August 2021

The Ministry of Agriculture, Forestry and Fisheries (MAFF) is going to introduce a new requirement for the review of the published literature within the framework of the re-evaluation program of plant protection products.

On August 8 2021, MAFF started a 30-day public comment period for the draft guidance on the literature review. Opinions can be submitted at the eGov website. Following the requirements set out by the European Food Safety Authority (EFSA), the new guidance will request the review of peer-reviewed literature on toxicity, residues, metabolisms and ecotoxicity.

For more information on the upcoming changes, please contact our Regulatory Science expert at SCC Japan – Hidetoshi Goto (This email address is being protected from spambots. You need JavaScript enabled to view it.).

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 (https://echa.europa.eu/)