Despite perceptions that biopesticides are inherently less dangerous, the EU regulates them as stringently as conventional, potentially highly hazardous, synthetic plant protection chemicals (Regulation [EC] No. 1107/2009). This has made approvals costly and slow. Recent regulatory revisions intended to redress this—to give EU farmers better and faster access to biological alternatives—may paradoxically increase the regulatory burden. Read on to learn what this may mean for registration or renewal of your biopesticide.
What are the drivers of EU regulatory revisions affecting biopesticides?
Underpinned by requests from the public to address pesticide risks, the EU aims to build sustainable food systems in line with the European Green Deal and its Farm to Fork Strategy. It intends to halve the use of hazardous chemical-based plant protection products (PPPs) by 2030, enhance integrated pest management, make chemical pesticides a last resort and convert more land to organic methods.
A prerequisite is a regulatory approach more specific to biopesticides. Here, the EU is catching up with the U.S., where bespoke biopesticide requirements contribute to faster, more numerous approvals: by 2016, the EU had approved 68 microbial active substances compared to 400 in the U.S., and in 2018, EU biopesticide approval time was 1369 days, almost double the approval time in the U.S.
The EU Commission believes recent revisions will ensure that biological solutions replacing chemical PPPs reach the market “significantly faster.” The big question is whether revisions will increase availability of biopesticide products and be capable of ensuring food safety and security at the same time as the EU reduces the number of conventional PPPs.
For microbial biopesticides, what is the focus of the 2022 revisions to EU regulation?
The EU does not recognize biopesticides as a regulatory category separate from other PPPs. However, revisions endorsed on February 8, 2022, and that entered into force in November 2022, have, have refined the regulatory approach to microorganisms, including viruses:
- Inclusion of scientific peer-reviewed literature data as an essential part of microbial dossiers(Point 3.5 of the revised Part B of Regulation (EU) No. 283/2013)
- Updated risk assessment regulations,amending Part B of Regulation (EU) No. 283/2013 and Regulation (EU) No. 284/2013 on pathogenicity and infectivity, production of metabolite(s) of concern and ability to transfer antimicrobial resistance (AMR) genes to other microorganisms
- Revised definition of “low risk” for a microorganism under Regulation (EC) No. 1107/2009, so it “shall be considered a low-risk active substance unless its susceptibility to at least two classes of antimicrobial agents has not been demonstrated.”
- Clear definitions in the revised Part B of Regulation (EU) No. 283/2013 for “antimicrobial resistance,” “antimicrobial agent,” “acquired antimicrobial resistance,” “intrinsic antimicrobial resistance” and “transferrable antimicrobial resistance genes”
Botanicals and semiochemicals fall under Part A of Regulation (EU) No. 283/2013 and Regulation (EU) No. 284/2013, but their regulation remains unchanged. You can read more about regulatory revisions in our e-book Regulatory Revolution in Biopesticides.
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What are the implications of the 2022 regulatory revisions for your registration or renewal application?
The EU Commission believes the changes “reflect the latest scientific developments and are based on the specific biological properties of microorganisms.” These properties are now central to risk assessments: much of the data required in the new legislation is conditional to the biology and ecology of the microorganism.
As the EU says, “More ‘fit for purpose’ and flexible requirements also imply streamlined application dossiers, more straightforward risk assessment, and shorter timelines to get access to the EU market.” In addition, the focus on relevant data also means less animal testing. However, data requirements may actually increase, as we discuss below, with implications for your timelines.
Furthermore, for some biopesticides, new data requirements may also make achieving “low-risk” classification under 1107/2009 harder, losing the benefits of 15-year authorization (instead of 10 years), 15-year data protection and use of “low risk” in advertising.
How does 2021 guidance on secondary metabolites and AMR impact data requirements for microbial biopesticides?
Microbial pesticides may be thought to be benign but can produce hazardous metabolites (in some cases, they are responsible for the mode of action) or have potential to transfer AMR genes into human/veterinary pathogens. New data requirements for these need to be factored in to avoid delay to market and unexpected costs.
Detection and assessment of secondary metabolites
Risk assessment of metabolites produced by microorganisms (SANCO/2020/12258) applies to all applications since November 2021. It is a “step-by-step” procedure, first determining whether a microorganism produces metabolites of potential concern and then requiring the same risk assessment for identified metabolites as for conventional active substances, including residue studies. This at least doubles the regulatory burden, with a separate data set for the microorganism and each metabolite of concern.
There is now provision to use data from literature searches on metabolites, but this is unlikely to address requirements fully. However, it may help you refine the testing strategy and predict whether you need to factor metabolite assessment into your study plan.
Assessment for drug resistance genes
Assessment for presence of resistance to the European Food Safety Authority’s list of antimicrobial drugs (SANTE/2020/12260) applies to all applications since May 2021. It uses a two-step approach: whole-genome sequencing to screen for known AMR genes, followed by phenotypic testing if genes are identified. Notably, microorganisms that test positive cannot be approved as a “low risk” under 1107/2009.
Implications for renewal applications
For renewals, you will have metabolite and resistance data gaps to fill. Testing takes time and depends on available capacity at experienced laboratories, so it’s essential to plan early for timely renewal.
How much will the EU regulatory landscape evolve in the short and long term?
In the short term, we expect revisions to the 2022 regulations as applicants and evaluators work through early implementation. Industry stakeholders have already noted that some of the conditional requirements leave a margin for interpretation, increasing potential for nonharmonized application by different member states (MSs). Collaboration between industry and regulators will be essential.
Longer-term evolution will be vital to support innovation in sustainable agricultural solutions. We anticipate developments in many areas, such as:
- Reforms to minimize differences in dossier requirements for the separate approval processes for new active substances and PPPs
- Fundamental reform of the product approval process, including much greater mutual recognition of authorizations by one MS in other MSs within a regulatory zone (if approval times are to come down and product availability is to improve)
- Guidance specific to more types of biopesticides, such as substances based on antibodies, peptides, dead cells, fermentation products or RNA interference techniques (recently developed guidance on semiochemicals and plant extracts shows this can be a successful way forward)
How can Labcorp’s teams help you navigate the evolving EU regulatory landscapes?
To optimize EU applications for your biopesticide, you will need in-depth interpretation of regulations. Let our global regulatory team provide this, with our extensive experience in biopesticide and synthetic active substance/PPP submissions in the EU, including discussions with competent authorities. We will keep you abreast of regulatory developments to smooth the journey for your new biopesticide authorizations and reapprovals.
Our microbiology experts understand the unique requirements for microbial biopesticides, for example, and we conduct a comprehensive range of studies in compliance with guidelines and test methods from the Organisation for Economic Co-operation and Development, the U.S., and Japanese Ministry of Agriculture, Forestry, and Fisheries, as well as the EU.
Learn more about our regulatory services for biopesticides and crop protection around the globe.