Policy & Regulation

Sitting on the Fence on Omnibus can be Counter Productive

How the Omnibus can bring safe, effective biological tools to the farmers faster

By Karel Bolckmans, President, IBMA Executive Chair and Chair, Innovator Forum, GBA

Europe is at a critical point in crop protection as chemical active substances leave the market and farmers increasingly turn to biological solutions. However, regulatory processes are not keeping pace. Karel Bolckmans, President of IBMA, highlights the growing gap between the loss of existing solutions & the arrival of new biological alternatives.

For farmers, this is not simply a question of regulation. It is about having the right tools available when they need them. While the registration of new biological products can take six to ten years in Europe, other markets have demonstrated that significantly faster pathways are possible. Brazil, for example, has developed a much faster regulatory process for biologicals, with registration often taking 12 to 18 months.

OMNIBUS X: A PROMISE OF ACCELERATION

The European Commission’s original Omnibus X on Food and Feed Safety proposal offered a potential opportunity to change this equation. Among its proposals were a clearer definition of biologicals, additional EFSA resources and expertise, stronger support for member states, tacit mutual recognition, provisional authorisation for biocontrol products and a single European zone for biocontrol. The ambition was clear: simplify the system and substantially accelerate access to innovative solutions.

However, as negotiations have progressed, several mechanisms have faced resistance or been diluted. Mutual recognition and tacit approval, for example, are no longer part of the Council compromise in the form originally proposed. Provisional authorisation has also become more restricted, while acceleration is increasingly tied to products meeting the “low-risk” criteria. This raises the central question: if regulatory changes do not meaningfully accelerate access to biological solutions, what problem is the Omnibus solving?

WHEN “LOW RISK” BECOMES A BARRIER

One of the most significant concerns is the proposed reliance on the “low-risk” classification as a gateway to faster regulatory pathways. The problem is that some biological technologies may fail to qualify, not because they are not safe or unsuitable for agricultural use, but because existing regulatory criteria and testing methodologies were not necessarily designed around them.

Garlic extract is one example: its potential to cause skin irritation could affect its classification, even though protective measures can manage the risk. Similarly, some testing protocols do not suit substances such as pheromones. As a result, 58% of the 180 biological products on the European market may not qualify for the proposed fast-track system.

That figure raises a difficult question: Can Europe genuinely claim to be accelerating biological innovation if more than half of the technologies assessed could still be left outside the fast-track pathway?

REGULATING YESTERDAY’S TECHNOLOGY

The regulatory challenge becomes even more complicated because biological technology itself is changing rapidly. Microbial strains, metabolites, peptides, RNAi, semiochemicals, formulations and combinations are becoming increasingly sophisticated, with companies developing solutions designed to improve efficacy, stability and usability.

Yet regulation can take many years to catch up. A product may spend six to ten years moving through registration while the science and technology behind it continue to advance. Products that reach the market today are already yesterday’s technology. More advanced biocontrol technologies will currently only reach the market in 6 to 10 years.

The danger is not simply slow regulation. It is applying old regulatory assumptions to new generations of technology.

BRAZIL: A MARKET THAT IS MOVING

Brazil provides an important contrast. Biologicals are already being used across millions of hectares, and the scale of adoption demonstrates that biological crop protection is no longer simply an emerging concept. According to Bolckmans, the market has pushed companies to develop solutions that deliver on the fundamentals that farmers care about: efficacy, cost-effectiveness and ease of use.

The Brazilian experience demonstrates that accelerating regulatory access does not necessarily mean lowering standards. Instead, it can create the conditions for technologies to reach farmers, generate market experience and continue evolving through real-world application.

BEYOND BIOLOGICALS VS. CHEMICALS

Perhaps equally important is the need to move beyond the idea that biologicals and chemical crop protection represent opposing sides of the agricultural debate.

Farmers need integrated crop protection, and the future toolbox will likely include biological and chemical solutions working together. As chemical modes of action decline, biologicals can contribute to resistance management through combination and rotation strategies. The issue, therefore, is not about replacing one category with another. It is about ensuring that farmers have enough effective tools to choose from.

FROM DEBATE TO ACTION

The conversation ultimately moves beyond criticism of the regulatory process and towards what needs to happen next. The biocontrol industry is calling for a system that maintains safety and scientific rigour while recognising the specific characteristics of biological technologies.

That could mean strengthening the proposed mechanisms, providing regulators with the expertise and resources, developing appropriate assessment methods and creating a differentiated pathway for biological crop protection. But farmers also have a role. If the regulatory debate is about their toolbox, their voices need to be heard more strongly. Farmers and their representative organisations have a direct stake in whether new technologies reach their fields fast enough.

THE COST OF MISSING THE BUS

The metaphor behind the discussion is more than a catchy title. It captures the cost of delay.

If the current opportunity to improve the regulatory pathway is missed, Europe could be waiting years for another chance. And because regulatory reform itself can take many years, the consequences could extend well beyond the biological industry, to farmers, crop production, food security and ultimately consumers.

The Omnibus debate is therefore about much more than a piece of legislation. It is about whether Europe can create a regulatory environment capable of keeping pace with agricultural innovation.

The technology is moving. The need is growing. The farmers are waiting. The question now is whether Europe will accelerate the journey or miss the bus.

BioAg World Digest | Summer 2026