The Food and Feed Safety Omnibus: an important first step on the road to fit-for-purpose regulation for biocontrol

December 2025

The amendments to Reg (EC) 1107/2009 proposed by the European Commission in its Food and Feed Safety Simplification Omnibus, are important first steps in adapting EU regulation to give more choice of safe and effective biocontrol products in a timely manner. However, there are still fundamental issues that can only be addressed through a dedicated framework adapted to the characteristics of biocontrol products.

Positive developments in the Omnibus

The Biocontrol Coalition lauds the proposed definition of biocontrol substances, which is future-proof and innovation friendly. We acknowledge the need to refine the definition during interinstitutional negotiations to further strengthen the boundary with conventional plant protection products. In this context, we draw attention to our principles for defining biocontrol, particularly the additional criterion that products must decompose in the environment in a well-established and predictable manner or be environmentally inert to be categorised as biocontrol. Being derived from natural sources alone is not sufficient.

Recognising that competent authorities have not had the resources to cope with the excessive administration burden and duplication of the existing system for plant protection approvals, we welcome the Commission’s efforts to streamline processes by applying a one-zone approach for the authorisation of biocontrol products, improving mutual recognition with strict timelines, and focusing the obligation to undergo systematic renewal to the substances most likely to be of concern.

Bearing in mind that commercialising and using biocontrol products are business decisions that require a positive return on investment for manufacturers and farmers, we applaud how the proposed measures, including provisional authorisation, will improve the economic dynamics of bringing biocontrol products to the market in the EU by reducing administrative costs, aggregating markets, and allowing companies to begin recouping their investments earlier.

What is still missing to have a fit-for-purpose regulatory framework for biocontrol in the EU?

The sections below list key elements of a fit-for-purpose regulatory framework for biocontrol and indicates to what extent the proposed amendments in the Food and Feed Safety Omnibus would provide them.

• Global competitiveness: Even with the expected improvements, approval timelines will only drop from 8–10 years to around 4–5 years—still far from the 2–3 years achieved in other major agricultural markets.
• Regulatory flexibility with sandboxes: The proposed definition cannot cover all potential innovation. A dedicated framework could ensure flexibility and address future technologies through experimentation clauses (“sandboxes”).
• Single market coherence & centralized evaluation: The proposals to treat the EU as a single zone are useful but continue to rely on Member State authorities’ capacity. We believe that the creation of panels specialised in specific biocontrol technologies composed of experts from both Member States and EFSA would further strengthen the EU’s ability to evaluate biocontrol substances.
• Holistic evaluation of products: The regulation assumes safety and effectiveness of substances can be evaluated in isolation. However, in biocontrol products, multiple substances often work together. The two-step process of approving active ingredients and then authorising products is ill-adapted.

Omnibus Measures Are Not the End of the Journey

The measures proposed in the Omnibus are an excellent step in the right direction – but if we want to fully realise the potential of biocontrol on the EU market in the coming years we will need more. It is difficult to see how the gaps between the Omnibus and what is needed can be addressed within the constraints of Reg (EC) 1107/2009.

To ensure the EU can meet farmers’ needs for a wide range innovative biocontrol solutions as soon as possible, we believe that work on a dedicated framework should be launched no later than the 2027 Commission work programme.