New EU draft regulations on microbials for plant protection
At the end of October 2021, new draft regulations were published by the European Commission proposing clear definitions of the term "Microbial Active Substance as Manufactured" ("MASAM") and updates on Commission Regulations (EU) No 283/2013 and (EU) No 284/2013, as well as the definition of low risk for microorganisms in Regulation (EC) No 1107/2009.
We need more resilient food systems to secure food in the EU not only today but also in the future. In this sense, the EU Commission's "Farm to Fork Strategy" for a fair, healthy and environmentally friendly food system aims to reduce dependence on the use of chemical pesticides by 50%. This is to be facilitated by the marketing of biological agents such as microorganisms.
Since microorganisms are living organisms, scientific knowledge on their key characteristics is required for registration as plant protection products. These include their pathogenicity and infectivity, the possible production of metabolite(s) of concern and the ability to transfer antimicrobial resistance genes to other microorganisms. In this context, some long-awaited amendments to the EU regulations have been proposed and are open for commenting until Tuesday 23 November 2021. Notable changes include, for example, the addition of definitions of ‘antimicrobial resistance’ (AMR), ‘antimicrobial agent’, ‘acquired antimicrobial resistance’, ‘intrinsic antimicrobial resistance’ and ‘transferrable antimicrobial resistance genes’ to Part B of the Annex to the Commission Regulation (EU) No 283/2013.
This provides applicants with clearer guidance for the evaluation of these parameters, also with regards to the revised low risk definition of microbials in Regulation (EC) No 1107/2009, which now states that “an active substance that is a bacterium or a fungus shall be considered a low-risk active substance unless its susceptibility to at least two classes of antimicrobial agents has not been demonstrated.”
It is also worth highlighting point 3.5 of Part B of the Annex to Regulation (EU) No 283/2013, where scientific peer-reviewed literature data is now mentioned as an essential part of microbial dossiers. This underlines the EU Commission's aim to support manufacturers in bringing more microbial-based plant protection products (PPPs) to the market by 2030 to help farmers safeguard food production in the face of climate change.
Do you need support to place your biological products on the EU market? Our biocontrol team is at your side with the latest expert knowledge for all your questions on this dynamic and changing regulatory environment and will also be happy to accompany you in further steps. Get in touch with us or have a look at our Crop Protection services.