Biosolutions and sustainable agriculture: overcoming regulatory challenges in Europe
The future of agriculture relies on innovative and environmentally friendly solutions. Yet, despite their potential, biosolutions face regulatory hurdles that hinder their adoption. How can we accelerate their integration into agricultural practices?
Among these solutions, biosolutions such as biocontrol products and biostimulants play a crucial role.
Recently, during a meeting organized in Brussels by Wagralim and Awex, several Walloon companies, including FytoFend, had the opportunity to present their innovations and regulatory challenges in the field of agricultural biosolutions to European commission representatives.
Why does regulation hinder the growth of Agricultural Biosolutions?
While biosolutions provide a relevant response to contemporary agricultural challenges, their deployment within the European Union is hampered by regulatory barriers.
The Current Paradox:
- Biocontrol products, despite being classified as “low risk,” undergo a long and complex approval process, often similar to that of conventional plant protection products.
- The lack of regulatory harmonization among Member States complicates and slows down market authorization.
- Other regions, such as the USA or Brazil, are progressing much faster in integrating biocontrol solutions, threatening Europe’s competitiveness.
Approval of biosolutions in Europe: Disparities that slow down the market
The approval of biosolutions in Europe is marked by varying timelines and a lack of predictability among Member States. Mutual recognition between countries is slow, and some products must go through multiple evaluation steps:
- First Submission: After evaluation by a reference Member State (zRMS), an average period of 4 months is expected for review of a low risk PPP.
- Evaluation by Other Member States (cMSs): This phase can take between 3 and 4 months, but in practice, it often extends well beyond that.
- Final Recognition and Market Entry: Each country may have its own requirements, prolonging the process to several years.
- Concrete Example: The FytoSol dossier, developed by FytoFend, is based on the COS-OGA molecule, which has been approved since 2015. Despite this prior recognition, it required multiple submissions between 2019 and 2024, with varying delays and decisions depending on the country. Some nations approved it quickly, while others took several years to reach a decision, and in some cases, even rejected it despite an identical submission dossier.
This administrative sluggishness hinders the adoption of biosolutions and negatively impacts the competitiveness of European agriculture.
Proposals for a more adapted regulatory framework
FytoFend advocates for a more pragmatic approach to biosolutions regulation in Europe. Here are key actions that could facilitate the adoption of biocontrol and biostimulants:
- Clearly define the biocontrol framework within European regulations. To this day, Biocontrol has no official EU definition, putting all products of this kind within a grey zone.
- Accelerate Mutual Recognition of Biocontrol Products
- Simplify and harmonize approval procedures among Member States.
- Establish a priority pathway for biosourced solutions.
- Adapt Legislation to Encourage Innovation
- Introduce a provisional authorization for biocontrol solutions, enabling faster market access.
- Remove burdensome and redundant periodic re-registrations.
- An Evolving Regulatory Approach
- Strengthen coordination with scientific bodies to ensure a well-adapted and dynamic regulatory follow-up.
A joint commitment for a greener agriculture
The adoption of biosolutions is not just about innovation; it is also a necessity to ensure a more sustainable and competitive agriculture in Europe. Farmers, the biocontrol industry, consumers, and regulators must work together to lift these regulatory barriers and promote a more environmentally friendly agricultural model.
FytoFend continues to play an active role in this transformation and remains convinced that regulatory advancements will accelerate the expansion of biosolutions in the European market.
