The EU President’s political guidelines highlight the need to “make business easier and deepen our Single Market to help innovative companies grow” while Draghi states that “innovative companies that want to scale up in Europe are hindered at every stage by inconsistent and restrictive regulations.”
Globally, biocontrol is the most rapidly growing segment of the global crop-protection industry, but Europe’s biocontrol industry is severely hindered by inconsistent and restrictive regulation. This is the primary reason European farmers have fewer biocontrol solutions available than farmers in other leading agricultural nations such as the USA and Brazil. It is also holding back an innovative sector of the European crop-protection industry with leading companies increasingly deciding to invest elsewhere.
How do we give European farmers more tools to produce food with nature-based solutions and ensure a future-proof crop protection industry in Europe?
The Strategic Dialogue report calls on the European Commission to ‘enable a robust legislative framework for biocontrol products and approaches’ by 2025, which should prioritize fast-track authorization processes for biological control. Mission letters for both Commissioners for Health and Agriculture and Food call for accelerating the authorization and use of biocontrol.
Farmers need biocontrol solutions as soon as possible both to continue their transition to sustainable resilient agriculture, to remain productive and ensure food security. Biocontrol has been shown to maintain and enhance biodiversity and provide on-farm climate mitigation solutions, thereby contributing to Europe’s sustainability leadership ambitions.
Biocontrol plant protection products (microbials, semiochemicals, and natural substances) are regulated under the EU Plant Protection Products (PPPs) Regulation (EC) No 1107/2009, together with chemical pesticides. This regulatory framework has been designed for chemical pesticides and is not well adapted to biological PPPs, leading to unnecessary delays and wasted resources.
The EU has the most complex framework in the world with the longest authorization timelines for biocontrol products – up to 10 years from submission to market – compared to 2 – 3 years in other global jurisdictions.
We need a combination of immediate solutions to address the most serious bottlenecks in the current system as well as a fundamental rethink of the regulatory system for biocontrol to ensure Europe can reclaim a position of global leadership.
Immediate Solutions
- Re-instatement of Article 30 to allow Provisional Authorization of biocontrol PPPs.
- Waiving the renewal process for biocontrol PPPs unless scientifically required.
- Facilitating label expansion for biocontrol PPPs.
Mid-Term Solutions
- Introducing a new regulatory framework enabling a one-step authorization process (1.5–2 years).
- Creating a shorter procedure for biocontrol PPPs based on active substances already on the EU market.
- Establishing an EU Biocontrol Agency to centralize the evaluation and approval processes.
- Moving away from the current zonal system to a single-zone market approach.
Biocontrol PPPs are nature-based solutions, and a robust regulatory process must ensure timely market access for farmers. The current 10-13 year re-registration process is bureaucratic and wasteful of resources, delaying much-needed innovations.
Footnotes:
- Political guidelines for the next European Commission 2024-2029
- The future of European competitiveness: Report by Mario Draghi
- Strategic Dialogue on the future of EU agriculture
- The agricultural transition: Building a sustainable future | McKinsey June 2023
- Commission Communication: Boosting Biotechnology and Biomanufacturing in the EU