The Ctgb Biopesticides Evaluation Manual describes the Dutch evaluation of biopesticides in the EU framework under Regulation (EC) No 1107/2009 and is a supplementary guidance document to the main EU framework regarding the data requirements for microbial Plant Protection Products (PPP). The core interpretative guidance on microbial data requirements under EU Regulations 283/2013 and 284/2013 are the ‘Explanatory Notes’ published by the European Commission.
The Evaluation Manual for Biopesticides is divided in three parts:
The latest versions can be accessed in the following link:
Part 1 on Microorganisms has recently undergone substantial updates by the ‘Dutch Board for the Authorization of Plant Protection Products and Biocides’ (Ctgb). The 2024 revision (Version 3.0) reflects new scientific insights and aligns with both EU guidelines and specific Dutch regulatory needs. The Ctgb manual provides additional national criteria, enabling a more streamlined approach to evaluating microbial biopesticides in the Netherlands.
More specifically, the manual’s new format highlights the parts where Dutch assessments deviate from EU guidance, aiming to support efficient, accurate microbial evaluations. Significant revisions include clarifications in the assessment process for microbial active substances, focusing on microbial specificity, potential toxicological effects, environmental fate, and any potential health impacts on non-target organisms. It emphasises updated terminology and detailed specifications for metabolites, improving consistency in microbial assessments.
The manual is structured to keep the Ctgb’s guidelines aligned with both EU-level requirements and the flexibility to incorporate future scientific developments, facilitating smoother transitions for applicants and reviewers. This adaptation is also part of Ctgb’s approach to foster innovation while ensuring that regulatory standards for biopesticides remain practical and scientifically rigorous.
Kerona Scientific can help you with the EU registration of microbial active substances and products in The Netherlands and the rest of the EU. Contact our expert team at info@kerona.ie