Why targeted amendments to Regulation (EC) 1107/2009 are not enough for biocontrol?

September 2025

If we do a good job on targeted amendments to Reg (EC) 1107/2009, why do we need a dedicated framework to regulate biocontrol products? 

The European Commission’s Vision for Agriculture and Food—“Shaping together an attractive farming and agri-food sector for future generations1—sets out an ambitious plan to strengthen the competitiveness and resilience of Europe’s agri-food system. As part of this effort, the upcoming Food and Feed Safety Simplification Package, expected in Q4 2025, is likely to include measures to accelerate market access for biocontrol products. 

This is a welcome development. Targeted amendments to Regulation (EC) 1107/2009 could help streamline the approval process and bring more sustainable crop protection solutions to EU farmers. These amendments may include: 

  • Legal clarity through a harmonised definition: A consistent EU-wide definition of biocontrol products is foundational. It would eliminate ambiguity and provide a clear basis for regulation. 
  • Faster access through provisional authorisations: Due to the seasonality of agriculture, it takes a lot of time and resources to develop precise information about the conditions under which biocontrol products are most effective. Allowing label extensions and provisional approvals before full efficacy data is available would accelerate access to innovation. As more data is collected, product use can be refined and validated. 
  • Automatic mutual recognition: Making mutual recognition the default—unless a Member State raises a specific, justified concern—would move the EU closer to a true Single Market for biocontrol products. 

These steps would offer immediate relief, especially for overburdened national authorities. But they won’t solve deeper challenges, such as the mismatch between current regulatory requirements and the nature of biocontrol technologies. And the expected simplification package could be delayed or even fail due to more controversial topics it includes.

 

What a Dedicated Framework Could Achieve  

The Commission’s own Fit4Future panel on Biosolutions2 has highlighted the need for broader reform. A dedicated framework could address: 

  • Tailored evaluation procedures: Biocontrol products often work in combination or have low-risk profiles that don’t fit the hazard-based criteria designed for chemical pesticides. 
  • Streamlined processes: Inspired by models like seed treatments or the common catalogue of plant varieties, a new framework could reduce duplication and administrative burden. 
  • Adaptability to climate change: Shifting weather patterns mean that the agroclimatic zones used for authorisation and mutual recognition no longer reflect farmers’ reality. They need flexible access to products that suit rapidly changing conditions. 
  • Legal robustness: Guidance documents lack legal weight and cannot override ill-fitting provisions in Regulation (EC) 1107/2009. A new legal act could offer clearer, more precise rules. 

 

Legal Pathways Forward 

Concerns about reopening Regulation (EC) 1107/2009 are understandable. However, legal mechanisms such as recasting—which combines amended and unchanged provisions into a new act—offer a viable path forward. A dedicated legislative act would: 

  • Define its own purpose and scope; 
  • Establish harmonised procedures; 
  • Future-proof the framework for scientific and technological advances. 

The EU has already taken similar steps in other areas, including veterinary medicines, Advanced Therapy Medicinal Products, and New Genomic Techniques (NGTs). 

 

Next steps 

Developing future-proof legislation takes time. It requires stakeholder input, risk assessment, and thorough debate. That’s why we recommend the Commission begin the process in 2026, starting with an impact assessment to identify gaps left by the simplification package — inspired by the precedent of the Cosmetics Regulation, where immediate improvements through simplification have been paired with a long-term Better Regulation review.

By laying the groundwork now, the EU can ensure that biocontrol products are regulated in a way that supports innovation, sustainability, and farmer success—today and in the future. 

 

Source material 

 

Download the article in PDF format. 


< Back to latest articles