EU Discussions for Moving Biological Products to Market Faster in 2025—Will It Happen?
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By Geoffroy Moulin
According to the International Biocontrol Manufacturers Association (IBMA), biocontrol technologies originate from nature – directly or identical to nature if synthesized.
IBMA includes four categories of biocontrol products:
| 1. Chemical mediators which are substances emitted by plants, animals and other organisms, used for intra-species and/or inter- species communication. They have a specific mode of action to the target and are not toxic (pheronomes, kairomones, etc.). |
| 2. Microorganisms which includes bacteria, fungi, protozoa, viruses, viroids, mycoplasma, and may include whole microorganisms, living and dead cells, any associated microbial metabolites, fermentation materials and cell fragments. |
| 3. Natural substances that consist of one or more components from nature, including plants, algae/microalgae, animals, minerals, bacteria, fungi, peptides, protozoa, viruses, viroids, and mycoplasma. They can be of natural origin or identical to nature if they are synthesized. |
| 4. Macroorganisms that are natural pests such as insect species, mites and nematodes, which control pest populations through predation or parasitism. |
In France, biocontrol is defined as the “set of preventive and curative plant protection methods against crop pests that are based on the natural processes at work in ecosystems” (Végéphyl). While for the Rural Code and Marine Fisheries (L. 253-6), biocontrol products are “agents and products using natural mechanisms in the framework for integrated management of crop pests.”
However, as IBMA points out in its communication of 30 March 2022 (IBMA, 2022), no specific European legislation exists for the approval of biocontrol substances and the registration of products. Thus, the Marketing Authorisation (MA) of these products follows the common approval process for all active substances in Europe. The first step is the approval of the active substance at European level, and the second step is the MA of the product at national level, once the substance has been approved at European level.
In its communication, the IBMA also underlines the urgency of giving a legal European definition to biocontrol as well as an adapted European legislative framework as it may already exist across the Atlantic. But these difficulties do not prevent the expansion of these alternative crop treatment methods thanks to fruitful discussions between applicants and both national and European authorities.
Five Top Points for Next Year’s Biocontrol Discussions
When it comes to discussing biocontrol, a lot is expected in the near future as you can see. If we summarize what is expected, or hoped, for 2025 we can highlight the five points:
- We are getting closer to a definition of biocontrol with the inclusion of biocontrol in the strategic dialogue on the future of EU agriculture,
- Proposals of amendments of the regulations EU No.546/2011, No.283/2013 and No. 264/2013 are already in discussion between EU commission and Member States to add specificities of biological and natural origin substances. These exchanges should be pursued next year.
- A new format of labeling is in discussion for implementation in 2026 and the coming exchange may have an impact on biologicals,
- More and more countries are settling their plan for pesticide use reduction with, among other objectives, to reinforce the development of biological alternatives,
- European and Mediterranean Plant Protection Organization (EPPO) has worked for the last two years on validating a guidance on how to use digital technologies in efficacy experimentation. The outcome of this work should be visible in the fields coming 2025.
Finding alternatives is great, bringing them up to the market is better.
There is a current shift on the market of plant protection solutions. More and more substances are not renewed due to not passing the cut-off criteria of acceptability. This brings uncertainty to growers that are seeing their usual tools removed from them.
In the meantime, alternatives are identified and designed, first as potential replacement for the withdrawn substances but most importantly, to a larger extent, as tools to define new crop production models.
A concern arises when the budget and timelines for the deployment of these solutions are up to the growers.
a substance can take less than three years between conclusions of the evaluation from EFSA and the last date of authorized use. On the contrary, when it comes to regulated biocontrol products, it takes seven to 10 years to get the registration and without mentioning the time needed to get the innovation accepted by the end users.
Most of the innovations are supported by small companies which struggle to finance the – at least – 1 million € worth-registration dossier without turnover for a decade.
To develop a biocontrol product, the budget for the required studies can be significantly reduced if data can be extrapolated from the “substance” data. Thus, the main share will go to efficacy trials as well as ecotoxicological studies (effects on bees and non-target arthropods). Toxicology and residue trials are generally limited or non-existent when considering a low-risk substance with very limited effects on humans. Finally, the physico-chemical characterization of the product, as well as the cost of writing and risk assessments, represent an intermediate cost.
A shift in the inertia of European registration is hoped by a large part of the industry in order to avoid seeing Europe let down compared to the other continents booming currently on biologicals. •
Geoffroy Moulin is a Key Account Manager for Staphyt. Staphyt is a service provider supporting its clients in the study of biopesticides and biostimulants, with a BioTeam made up of agronomists, scientists, and regulatory experts specializing in these products.
Photo Credits: Geoffroy Moulin, Staphyt