News – Confirm Your UK Location under GB BPR

Date: 1 December 2021

To maintain access to the market in Great Britain (England, Scotland and Wales), as a GB BPR Authorisation holder or GB Article 95 supplier, biocides companies must:

  • be established in the UK (Great Britain or Northern Ireland)
  • confirm to the UK authorities (HSE), by the relevant deadline, that you are established in the UK

Deadlines
Companies must confirm HSE that they are established in the UK by:
31 December 2021 if they are existing UK authorisation holders (this includes Union authorisations and simplified authorisations and notifications)
31 December 2022 if they were included on the GB Article 95 List on 1 January 2021

SCC Legal, through its subsidiary SCC Legal UK Ltd, can act as your authorisation holder or GB Article 95 representative, if needed. Do not hesitate to contact This email address is being protected from spambots. You need JavaScript enabled to view it. for further information.


 

News – Downstream User Notification (DUIN): the deadline has been postponed

Date: 5 November 2021

The DUIN deadline expired on October 27, 2021. On HSE’s official website, downstream users are still encouraged to submit a notification, if eligible to do so. HSE has not specified a new deadline yet, but recommends to notify as soon as possible.
We will update you on further DUIN specifications as soon as available. In the meantime please feel free to contact us, if you have any questions.

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On August 8 2021, MAFF started a 30-day public comment period for the draft guidance on the literature review.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/)