EU adopts regulations on biopesticides

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The European Union has announced, amended, and adopted the regulations regarding biopesticides on (EU) Nos. 546/2011 and 1107/2009 (Annex II). They lay out standardized principles and criteria for assessing and authorizing plant protection products and microorganism active substances. Regulation (EU) No. 283/2013 gives the information to be submitted for active substances and the specific data requirements for micro-organisms.  Regulation (EU) No 284/2013 gives the information to be submitted for plant protection products and the specific data requirements for plant protection products containing micro-organism origin.

The draft was proposed on 26 October 2021. From 26 October to 23rd November 2021 was the feedback period. Now, it has been adopted on 31August 2022.

Major points were segregated in those amendments.

The term microbial active substance has been replaced by ‘Microbial Pest Control Agent (MPCA)’.

The number of requirement of studies has been reduced. In this case mostly ‘the weight of evidence’-approach with justification shall be followed.

The amended version focuses on identifying, taxonomizing, and phylogeny of the microorganism, as well as its origin, occurrence, and history of use.

It also gives clarity about dossier submission which shall be done in accordance with Part A if the active substance is a chemical substance (including both semiochemicals and extracts from biological material), or a metabolite produced by a micro-organism.

To provide information on development of resistance, in case of provision of data is required, such data may be generated in experimental studies (either in laboratories or under field conditions) or retrieved from available scientific literature. Otherwise, information already submitted for the active substance under point 3.4 of Part B of the Annex to Regulation (EU) No 283/2013 are sufficient to permit an assessment to be performed.

The goal is to reflect the specificities and use of biological substances as compared to chemical substances.