Member States Breakfast: How much progress does Omnibus X offer biocontrol?
March 2026
Organised by the Biocontrol Coalition
Purpose
The breakfast meeting gathered representatives from Member States, industry, and stakeholders to discuss the extent to which the forthcoming Food and Feed Safety Simplification Omnibus (“Omnibus X”) could address current regulatory bottlenecks affecting biocontrol. The discussion aimed to assess short-term improvements offered by the proposal while also reflecting on the need for a longer-term fit-for-purpose framework to accelerate innovation and farmer access to biocontrol solutions.
Key themes and discussions
- Elements of the Omnibus proposal relevant to biocontrol
• The Omnibus introduces several improvements relevant to biocontrol, including an innovation-friendly definition of biocontrol substances, a one-zone approach for product authorisation, strengthened mutual recognition timelines, and measures aimed at reducing administrative burdens and duplication for competent authorities.
• Participants welcomed that under the Commission’s proposal, facilitated market access mechanisms for biocontrol remain conditional on the outcome of the risk assessment and subject to the discretion of Member States, as it reinforces that each product still undergoes a thorough scientific evaluation.
• At the same time, some elements of the definition may still require refinement or clarification, particularly regarding concepts such as functional identity and structural similarity with natural counterparts.
• It was noted that the Commission’s proposal maintains a clear distinction between the frameworks for biocontrol and organic agriculture, which evolve independently and serve different objectives. This should not be changed during the amendment process.
- Remaining regulatory gaps and structural challenges
• Despite improvements proposed in the Omnibus, significant barriers gaps remain compared to an ideal regulatory system for biocontrol products.
• Even in a best-case scenario, the Commission’s proposals would still result in a approval timelines for innovative products that is still twice as long as competing major agricultural markets. This creates difficulties for EU farmers who will still be at least one generation of innovation behind while facing rapidly evolving pest and disease pressures linked to climate change.
• Regulatory processes designed for synthetic chemistry are not adapted to biological products, whose mechanisms of action often involve complex natural processes that cannot be characterised in the same way as synthetic substances.
• Participants also noted that the current “low-risk” classification framework may not be fully appropriate for biocontrol products and that dedicated categorisation approaches may be needed.
- Market dynamics, innovation, and the risk of losing EU competitiveness
• Regulatory delays were identified as a major factor shaping investment decisions in the sector, highlighting the importance of building a regulatory framework that remains robust while enabling faster access to safe solutions. One participant pushed back against the argument that the slow process in the EU is required to ensure safety: “it is not because it is slow that it is safe”.
• Smaller innovators and start-ups may struggle to survive long development timelines, potentially limiting the diversity of actors in the marketplace. The EU regulatory framework should support a broader ecosystem of innovators rather than favouring only large companies able to absorb regulatory risk.
• Participants pointed out that substantial EU funding supports research on biocontrol technologies in Europe, yet regulatory barriers may result in these innovations being commercialised first in non-EU markets and inadvertently “subsidizing competitors”.
- Mutual recognition and administrative capacity
• Fragmentation across Member States remains a key barrier to timely access to new solutions.
• Some Member States apply mutual recognition more systematically due to limited national administrative capacity, while others rely primarily on their own assessments.
• Participants discussed possible ways to streamline assessments, including stronger reliance on mutual recognition mechanisms or the potential creation of a panel of European experts able to conduct a single assessment at EU level while integrating diverse scientific expertise and geographical perspectives.
- Farmer adoption, trust, and implementation realities
• Not only time-to-market but also time-to-farm: participants highlighted that bringing products to market is only part of the challenge; farmers also need time and support to integrate new tools into their crop protection strategies.
- Political timing and the opportunity to advance a dedicated framework
• If negotiations progress smoothly, the Omnibus proposal could be adopted as early as late 2026 or during the first half of 2027.
• Participants emphasised that the 2027 Commission Work Programme may represent the last realistic opportunity in the current institutional cycle to initiate work on a dedicated regulatory framework for biocontrol before the 2029 European elections. Missing this window could postpone additional regulatory improvements until the next decade, potentially delaying innovation and market access for many years
• Participants also stressed the importance of considering the “cost of non-action” for farmers and agricultural resilience. Maintaining the status quo is not a neutral option: it means delaying the opportunity to equip farmers to better meet the challenges of increasingly volatile growing conditions and to reduce unwanted impacts of protecting their crops.
Conclusions
The discussion highlighted that the Omnibus proposal represents an important step toward improving the regulatory environment for biocontrol, particularly by reducing administrative burdens and clarifying elements of the framework. At the same time, participants stressed that these improvements alone will not fully address the structural challenges facing the sector. Building momentum toward a dedicated, fit-for-purpose regulatory framework will therefore be essential to ensure that innovative biocontrol solutions reach European farmers in a timely and predictable manner.
