FRANCE: Withdrawal of Adoxophyes orana granulovirus strain BV-0001, spiromesifen and Bacillus firmus I-1582-based products
23 October 2023
EUROPE : Update of Working Document on the Work-Sharing of the Southern Zone Member States
30 October 2023
The European Commission has published on 12 October 2023 an update of SANCO/6895/2009. This 3rd version updates version rev 2.2 of January 2018.
This revision includes new draft registration report (dRR) templates for plant protection products (PPP) containing active substances which are micro-organisms. This update aligns the dRR with the new requirements introduced by Regulation (EU) 2022/1440, as regards the information to be submitted for plant protection products and the specific data requirements for PPP containing micro-organisms, and Regulation (EU) 2022/1441, as regards specific uniform principles for evaluation and authorisation of PPP containing micro-organisms. These two regulations are applicable from 21 November 2022.
Furthermore, a dedicated section to the use of the weight-of-evidence approach in the risk assessment of micro-organisms has been introduced in the dRR, parts B.1, B.2 and B.4. In addition, the risk assessment of metabolites of concern has been included in the part of the dRR dealing with the risk assessment of micro-organisms.
The new dRR templates will come into force on 21 November 2024. Before this date, the former templates remain applicable for marketing authorisation submitted in accordance with Regulation (EU) No 284/2013 as it stood before being amended by Regulation (EU) 2022/1440. For marketing authorisation submitted in accordance with Reg (EU) No 284/2013 as amended by Reg (EU) 2022/1440, the new dRR templates are applicable.
To download:
See also our previous articles:
EUROPE: Update of GD SANCO/6895/2009 rev 2.2 – dRR format
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