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. (See our gap analysis below.)
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.
A harmonised EU definition of biocontrol
The Commission’s proposal is a promising starting point to agree on a future-proof and innovation-friendly of biocontrol substances.
Global competitiveness
However, these changes alone will not be enough to ensure that EU farmers can choose from a wide range of biocontrol products on a sustained basis. 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 of biocontrol solutions. A dedicated framework could ensure flexibility and address future technologies, through experimentation clauses (“sandboxes”) as tools for innovation and regulatory learning, with structured context for testing innovation, under supervision of a competent authority, and ensuring that appropriate safeguards are in place. In this light, we welcome the complementary proposals in the draft Biotech Act I also released on 16 December 2025.
Single market coherence, centralised evaluation, and pooling of expertise
As mentioned above, the proposals to treat the EU as a single zone for authorisation of biocontrol products and the reinforcement of mutual recognition are important and useful steps towards a single market. However it continues to rely on Member State authorities’ capacity to deliver the assessments.
The Commission also proposes a derogation for biocontrol substances whereby the European Food Safety Authority (EFSA) may “assume the duties of the rapporteur Member State.” This would reinforce the resources available to evaluate biocontrol substances by including EFSA resources; but it does not address the issue of divergent interpretations from a decentralised system.
Furthermore, these proposals do not address the duplication and additional delays that are inherent to a two-step registration/authorisation process.
We believe that the creation of panels specialised in specific biocontrol technologies and composed of experts from both Member States and EFSA would further strengthen the EU’s ability to evaluate biocontrol substances. These panels could be mobilised according to the nature of the applications received. Such panels would also provide an opportunity for peer-learning to further grow the pool of qualified experts for the various technologies.
Holistic evaluation of products, not isolated substances
The proposed amendments would not address one of the underlying mismatches between Reg (EC) 1107/2009 and the nature of biocontrol products. The regulation assumes that the fundamental safety and effectiveness of substances can be evaluated in isolation. However, in biocontrol products this is not necessarily the case. In some cases, multiple substances and/or microorganisms work together to provide biocontrol functions that would not exist if they were applied separately. For this reason, the two-step process of approving active ingredients and then authorising products is ill-adapted.
Enlarged concept of product effectiveness
The effectiveness of conventional crop protection products such as pesticides has been historically measured by yield compared to untreated crops and percentage of pests killed. In modern times, measurement has shifted to crop damage. But these measures cannot be applied in a copy-paste way to biocontrol products, nor do they capture some of the additional value offered by these products.
Described in more detail in our article “Time to rethink how to measure effectiveness of biocontrol products,” such added value includes fewer unwanted environmental impacts, short re-entry times after application, and heling to management pest resistance to other plant protections solutions.
Risk assessment based on problem formulations
Adapted data requirements, risk assessments and evaluation of product effectiveness should be based on problem formulation aligned with real-world conditions of use. A pragmatic approach can demonstrate safe uses while preventing unnecessary, costly and lengthy data generation without lowering safety standards.
Furthermore, we expect significant disruptions to how such evaluations are carried out and how companies prepare as artificial intelligence and other technologies are adopted. This is likely to have major repercussions for how innovations like biocontrol are developed and evaluated by regulators. These are likely to require significant rethinking of the procedures in the current regulatory framework.
A dedicated framework would also need to incorporate the outcomes of successful regulatory sandboxes (as proposed in the draft Biotech Act I also released on 16 December 2025) that had been conducted to test “alternative regulatory requirements and appraising their performance.”
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. However, by reducing resource constraints on competent authorities, the provisions in the Omnibus create the capacity to begin work on a truly fit-for-purpose stand-alone legislative framework. 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.
The need to have a separate framework for biocontrol was first recognised in 2007 by the REBECA project funded by the European Commission and has been reiterated since by the European Parliament, the Commission’s own Fit for Future platform Biosolutions report, OECD, FAO, and others. Across these various reports, recommendations have been to assess biocontrol products differently from chemical pesticides and to regulate biocontrol products in standalone legislation.
We want European farmers to have a wide choice of biocontrol solutions on an ongoing basis. To make this happen, we need to go beyond the excellent start in the Omnibus to build stand-alone legislation that meets the additional challenges outlined above.
Download the PDF version of this article for more details