Approval of Microbial Active Substances
At Kerona’s 2021 Dublin PPP Symposium, Agata Jakubowska of Applied Insect Science (APIS) gave a helpful overview of new developments in the approval of microbial active substances under the PPP Regulation.
Microorganisms are one of several categories of biopesticides, along with natural substances, semiochemicals and beneficial organisms.
The presentation began with a discussion of the European Transparency Regulation (EU) 2019/1381 before moving on to the IUCLID dossier software and various issues relating to microorganism data. This was followed by an examination of the proposed new data requirements for microorganisms.
As part of the EU’s “farm to fork” strategy, which includes enabling biological alternatives to chemical PPPs, the current data requirements will be updated to accommodate the properties of microorganisms. While the symposium was underway, draft proposals were being discussed at the latest ScoPAFF (Standing Committee on Plants, Animals, Food and Feed) meeting. The proposals include a new definition of a microorganism active ingredient to include combinations of strains as well as metabolites.
The remainder of the presentation looked at two new guidance documents of relevance to microbial active substances. SANCO/2020/12258, “Guidance on the risk assessment of metabolites produced by microorganisms used as plant protection active substances”, entered into force on 1st November 2021. This guidance provides some much-needed definitions regarding metabolites of microorganisms that distinguish them from metabolites of chemicals. It also provides a stepwise procedure for the risk assessment for metabolites.
SANTE/2020/12260, “Guidance on the approval and low-risk criteria linked to “antimicrobial resistance” applicable to microorganisms used for plant protection in accordance with Regulation (EC) 1107/2009”, came into force on 1st May 2021. The guidance explains how to assess the antimicrobial resistance of a microorganism, as well as the risk of increasing the spread of antimicrobial resistance of human and veterinary concern.
Kerona Scientific can help you with the EU registration of microbial active substances and products. Contact our expert team at email@example.com