Regulation of bacteriophages as Plant Protection Products
Regulation of bacteriophages as Plant Protection Products
In late June Fera Science held a webinar entitled: “From Research to Regulation: A deep dive into bacteriophage applications and challenges”. As the name suggests, the webinar focused on bacteriophages (viruses that devour bacteria) as a form of biocontrol against microbial pathogens. The webinar featured five guest speakers who discussed academic research, regulation and commercial applications of bacteriophages.
Dr. Ana Bejarano from Knoell, Spain delivered a presentation: “Regulation of Plant Protection Products” which gave an overview of the guidelines for the registration of microbial active substances in Europe. There are no bacteriophages currently approved in the EU but there are registrations in North America. EFSA conducted a comprehensive review of bacteriophages which showed them to be non-toxic, safe for users and target-specific leading to them being possibly used in precision driven plant protection products (PPPs) in the near future. The main talking points were around Regulation (EC) No 1107/2009 (placing of PPPs on the market) and the data requirements for active substances [(EU) 2022/1439] and PPPs [(EU) 2022/1140], respectively. In 2013, two Commission Regulations were published setting out the data requirements for active substances and PPPs, for the first time there was a part of the dossier (Part B) dedicated exclusively for microorganisms and their microbial PPPs. It is important to note that these regulations do not explicitly refer to bacteriophages but to microorganisms in general. While in October 2023, the Commission published explanatory notes for the implementation of the data requirements on microorganisms and PPPs containing them in the framework of Regulation (EC) No 1107/2009.
There are cut off criteria for the authorisation of microbial PPPs under Reg (EU) 2022/1441 which amended (EU) 546/2011. No authorisation will occur if the microorganism is pathogenic to humans or terrestrial vertebrates, if it has effects on other non-target organisms and if it has toxicological effects on humans, animal health and the environment.
Dr. Bejarano discussed in depth the required sections for Part B of this microbial dossier regarding active substance approval [Regulation (EU) 283/2013 and Commission Regulation (EU) 2022/1439] and formulated product authorisation [Regulation (EU) 284/2013 and Commission Regulation (EU) 2022/1440]. For an active substance (MPCA) 8 sections must be filled, while for a formulated product (MPCP) an additional 2 sections (10 in total) must be completed. For the submitted dossier, the microbial can be a single strain or can be a qualitatively defined combination of strains (consortium). Currently no guidance is available on the risk assessment for microbial consortia for plant protection purpose. The relevance of data requirements for specific consorts or for the full consortium (active substance) will depend on the characteristics of the consortium and on the proposed use.
Information such as that delivered by Dr. Bejarano is invaluable, as microbial active substances are becoming a viable PPP and the need to understand regulatory frameworks as they come on stream in Europe is paramount.
If you need any support with the registration of microbial products in Europe, please do not hesitate in contacting one of our regulatory consultants at info@kerona.ie