New dRR templates for PPP with microbial active substances
New dRR templates for PPP with microbial active substances
The new dRR (draft Registration Report) templates for plant protection products (PPP) containing micro-organisms are mandatory for all applications starting from November 21st, 2024. These changes align with updated EU regulations governing the authorisation and evaluation of such products. Specifically, these regulations aim to improve the evaluation process and to ensure the safety and effectiveness of PPPs containing micro-organisms.
The updated templates will help applicants present their product dossiers more clearly, covering aspects such as data evaluation, risk assessment, and confidentiality requirements. The revisions focus on three key parts of the dossier:
- Part A: Risk management (specific to national requirements)
- Part B: Data evaluation and risk assessment, split into core sections and national addenda
- Part C: Confidential information
These new requirements reflect the broader regulatory framework laid out by the EU under Regulation (EC) No. 1107/2009 and its amendments, particularly those introduced in 2022, which focus on microbial active substances in plant protection products. More specifically, Regulations (EU) 2022/1440 and 2022/1441 amend data requirements (Regulation (EU) No 284/2013) and Uniform Principles (Regulation (EU) No 546/2011) for the evaluation of these products. This new format should facilitate a smoother approval process by harmonising the presentation of microbial PPPs across the EU.
For more information, please find links to the corresponding regulations and the SANCO technical guidelines on the presentation and evaluation of plant protection product dossiers in the format of a (draft) Registration Report (SANCO/6895/2009 rev 3):
https://eur-lex.europa.eu/eli/reg/2022/1440/oj
https://eur-lex.europa.eu/eli/reg/2022/1441/oj
https://food.ec.europa.eu/document
Kerona Scientific can help you with the EU registration of microbial active substances and plant protection products. Please, feel free to contact our expert team at info@kerona.ie