Registration of microbial biopesticides as low risk products in the European Union

The paper entitled “Registration of microbial biopesticides as low risk products in the European Union”, given by Núria Banyuls, Project Manager and APIS regulation expert (Applied Insect Science SL), is framed in Block I of Microbiome, dedicated to Legislation.

Dra. Núria Banyuls i Ferrando

Dr. Núria Banyuls is a biologist, with a background in terrestrial ecology and agricultural sciences, and specializes in integrated crop protection. Before becoming involved in regulatory affairs in 2015, he focused his activities on protein biochemistry and microbiological research for the biological control of insect pests.

Núria is a project manager and expert in regulation specialized in efficiency and evaluation of residues of biological and conventional substances and products.

Biopesticides: green agricultural solutions

Biopesticides, including micro-organisms, plant extracts (botanical products) and semiochemicals (pheromones) are becoming increasingly important in the phytosanitary product market. This high demand is due in part to the reduction in the number of available chemical active substances and the greater interest in green agricultural solutions.

Biocontrol products generally have little or no effect on human health, non-target organisms and the environment. However, the registration of bio-protection products continues to face particular problems.

Since 2011, active substances and products for use in agriculture are evaluated in accordance with Regulation 1107/2009. The data requirements are the same for active substances and chemical and microbial products, which often cause obstacles when registering biopesticides. Some data requirements that can be easily covered for synthetic chemicals can not be met for microbial products and their assets for technical reasons.

Information on the taxonomy

On the other hand, the main advantage of many biological control products is that their active ingredients are well known scientifically, and humans are familiar with them, either by direct use or environmental exposure for a long time. The information on the precise taxonomy is the key to determine what experimental data is needed. Many active microbial substances can potentially be considered as low risk substances, a slightly different process that gives some advantages compared to conventional assets, such as longer data protection periods or reduced data packets for efficacy as indicated in the new EPPO directive PP1 / 296 (1).

APIS, Contract Research Center dedicated to biopesticides

Based on extensive experience within the biopesticide industry, Applied Insect Science is a company specializing in regulatory testing for microbial pesticides. Its catalog of services covers batch analysis and detection of microbial pesticides.

Its catalog of services ranges from batch analysis and contaminant detection to storage stability and terrestrial ecotoxicology. His bioanalytical capability also allows him to carry out evaluations of dose validation, infectivity and elimination of toxicology studies.