Regulatory Forum

Why Europe needs a Definition of Biocontrol Now

Low-Risk was a great ideal but fail to deliver on its good intentions

By Dr. José Carvalho, Director, Regulatory Affairs, Biotrop Europe and Chair, Regulatory Forum, GBA

A lot has been written on the EU Omnibus, with some people still insisting on exploring a pathway that did not deliver on its targeted intentions: the low-risk concept. It was a good intention but ill-implemented and functionally dysfunctional from the beginning as a legislative tool.

When Regulation (EC) No 1107/2009 was adopted, the “low-risk” category looked like a sensible incentive. Active substances and products with a better safety profile would get longer approvals, faster product authorisation and, implicitly, a competitive advantage over what we usually call “conventional chemistry”, aiming to accelerate the development of less impactful pesticides. (Note: I will use the term conventional chemistry for all small organic molecules produced by organic synthesis). More than fifteen years on, the biocontrol industry, and the International Biocontrol Manufacturers Association (IBMA) as its main voice, has largely concluded that the low-risk promise was not delivered, and that the category itself may be part of the problem rather than a solution for the agricultural transition. So why do we keep insisting on the low-risk categorization if it did not deliver on its goal to accelerate new approvals and safer products on the ground?

WHAT THE FRAMEWORK SAYS

Article 22 and point 5 of Annex II set the criteria for low-risk active substances. Simply, a substance qualifies if it is not classified as carcinogenic, mutagenic, toxic for reproduction, sensitising, very toxic or toxic, explosive or corrosive, and is not an endocrine disruptor, neurotoxic, or immunotoxic. It must also not be persistent (soil half-life under 60 days) and must not bioaccumulate beyond a set threshold. Micro-organisms are treated separately by nature, and I’ll address this later.

Article 47 then extends the concept to products. A plant protection product can be authorised as low-risk only if its active substance is low-risk, it contains no substance of concern, and it is sufficiently effective, among other conditions. The intended pay-off was a shorter authorisation timeline, and approval periods of up to 15 years for the substances themselves.

WHERE THE LOW-RISK DESIGN FAILS BIOCONTROL

a) Low-risk is a hazard-and-fate label, not a description of what biocontrol is. The criteria were built around toxicology and environmental persistence the logic used for chemical active substances. Biocontrol is defined by its origin and mode of action: macro-organisms, micro-organisms, natural substances, and semiochemicals. The two categories overlap only partly for different reasons, and many biocontrol agents ended up not formally low-risk, mostly due to procedural issues or the absence of adapted testing methodologies. A regime that uses “low-risk” as a proxy for “biocontrol” is aiming at the wrong target, and the sector has been forced to fit into a box that was not designed for it. Examples include classifying micro-organisms as toxic to aquatic organisms due to wrong testing methodologies, natural substances being readily biodegradable making it impossible to test them for certain studies, etc. It is not that they are not low-risk; it is the Precautionary Principle being (inappropriately) applied because certain testing cannot be performed in the lab/fields due to the nature of biocontrol technologies.

b) The incentive is weak in practice. The promised fast track exists on paper but rarely on the real-world calendar of EU submissions. Evaluation of the underlying active substance is still slow, the number of substances approved as low-risk remains small, and at product level Member States apply the low-risk provisions unevenly. The zonal system, with the zonal rapporteur Member State evaluating and others deciding, means a company can get a low-risk classification in one zone and face doubts about it in another. In reality, a category meant to speed things up has added a further point of dispute and another layer of complexity in the EU authorisation system. This hinders Single Market principles and creates divergence between Member States and in growers’ access to the products. It is in the end a competitiveness issue for growers that must be addressed by the EU Commission.

c) Qualifying is itself a source of delay. To claim low-risk status, an applicant must generate and defend additional arguments on each criterion, including persistence and data on co-formulants which belong to different business operators and are covered by trade secrets, as they constitute vital know-how to the companies producing them. Authorities must then assess all these additional data and navigate discussions among 27 Member States to reach an agreement. For small and medium-sized biocontrol companies, which dominate the sector, this is a heavy burden with an uncertain reward at the end of the process. In some cases, applicants weigh whether pursuing low-risk status is worth the risk of slowing the dossier down, or even decide not to advance in the EU with certain products as the return on investment is not there. Unfortunately, these are exactly the products the EU is looking for: the more targeted and niche biocontrol products (with fewer non-target effects) that cannot make it through the system of high costs and lengthy timelines.

d) Conventional data requirements still shape the process. Even with the updated data requirements for micro-organisms and the guidance developed since, dossiers for other biocontrol technologies (e.g. botanicals, fermentation mixtures, etc.) are frequently judged by expectations designed for synthetic chemistry. Low-risk status does not cure that. What biocontrol needs is a framework in which the type of substance triggers adapted requirements, timelines and evaluation practices from the outset. This is only possible with a definition for Biocontrol in Regulation 1107/2009, which then will allow further implementing regulations to be implemented. This has been proven successful for micro-organisms, whose definition in Reg. 1107/2009 allowed the development of tailor-made data requirements and generated a number of applications for approvals on micro-organisms. We are not seeing this move happening for the other technologies, and the lack of a definition for Biocontrol is the main blockage.

e) The low-risk category creates uncertainty rather than clarity. Because low-risk status depends on detailed criteria for chemicals, biological-based products generate long exchanges between applicants, rapporteurs and EFSA. Where a substance narrowly fails a single criterion, it loses the whole category, even if its overall profile is clearly favourable compared with existing substances on the market. And this is not because a biological substance is not, for example, easily biodegradable; it is just that some substances cannot run through the testing systems designed for chemical substances.

THE PARTICULAR CASE FOR MICRO-ORGANISMS

The number of micro-organisms approved or renewed as not being low-risk in the EU shows the flaws of the system. Even though they complied with the low-risk criteria (e.g. Bacillus thuringiensis strains), the EU failed to approve them as low-risk. Such decisions show how inappropriately the low-risk criteria are implemented and how unpredictable the decisions are at the end of the process, even when the micro-organisms fulfil the criteria for low risk. Member States’ decisions on low-risk status for micro-organisms in the past years show how low-risk cannot be a pathway for the safer and sustainable use of our land, soil and environmental protection. The low-risk mechanism has been there; it did not work. We need to move on and find a way.

It is difficult to understand what is happening in Europe: approvals take years while farmers lose tools and policy documents keep asking for more biologicals. We have the products. Political ambition to reduce pesticide use has not been matched by an approval system that lets biocontrol products reach growers, hindering IPM implementation. It is a policy decision by Brussels and Member State capitals to change course; the Omnibus is the remaining chance for the EU to correct course and return to the innovation path.

WHY A BIOCONTROL DEFINITION IS MORE USEFUL

A definition of biocontrol would actually do what low-risk could not deliver:

• It supports differentiated rules. Once biocontrol is defined in law, data requirements, evaluation timelines, fees and post-approval procedures can be tailored to it, instead of being retrofitted through complex guidance documents.
• It gives legal certainty. Applicants, Member States and courts would work from a shared understanding of what qualifies, reducing case-by-case arguments.
• It can coexist with risk assessment. A definition does not remove the need for safety evaluation. It just changes where the process starts and how fast it moves. Biocontrol products would still have to show they are safe and effective, and they would still be excluded from approvals where risks are identified and cannot be addressed. However, they will not be excluded because the approval time is 10 years and companies either go bankrupt or they don’t even move the products through the system. This is where the change will happen. And low-risk can still be granted at the end, i.e., after the assessment, if the products qualify for it and applicants wish to apply.
• It aligns with wider policy. Priorities such as the EU sustainability ambitions, biodiversity preservation, integrated pest management and recent simplification proposals all depend on a workable path for biological products. Recent Commission proposals to introduce biocontrol-specific provisions (the Omnibus proposal) are moving in this direction and must be embraced, because they signal to business operators that Europe can actually improve its legislative process and deliver on the policy goals which the EU is pitching to the rest of the world.

CONCLUSION

The low-risk concept was a well-intentioned attempt to reward safer chemistry, but it was not built for biocontrol, and it has not delivered the speed or certainty the sector needs. Interestingly, low-risk did not deliver for chemical substances either, and none has been approved as low-risk to date. So why keep insisting on an incentive that did not work to deliver safer chemicals and is failing the uptake of new biological technologies?

Continuing to bang our heads against this wall ignores a serious structural problem in an already crumbling approval system, which already takes years to get something to the market. If Member States really want biological solutions on farms, they should define biocontrol in the legislative text and build the lanes around that definition. Low-risk status can remain as a secondary marker, but it should no longer carry the weight of the EU’s biocontrol ambitions. Low-risk requires an assessment, and this can be done at the end of the process, as it is done today; but we need functional incentives in practice to allow existing technologies to reach the hands of EU farmers. And low-risk qualification has proven not to be such a mechanism.

TECHNICAL NOTE ON LOW-RISK MICRO-ORGANISMS

The EU has recognised that micro-organisms require specific data requirements and assessment principles because their characteristics and potential risks differ fundamentally from those of single chemical substances. Specific criteria were established and further developed by Regulation (EU) 2022/1438.

The current approval criteria for micro-organisms focus on demonstrating the absence of pathogenicity, infectivity, effects on non-target organisms, and toxicity, and showing antimicrobial susceptibility at the relevant strain level. And because the safety criteria are already established at the approval level-to consider that the micro-organism is safe for use and therefore can be approved-the only criterion introduced for low-risk is that the micro-organism should be sensitive to at least two classes of antimicrobial compounds. This is because there is scientifically nothing else needed to consider that all micro-organisms that fulfil the approval criteria should indeed be considered as low-risk.

However, this low-risk criterion is poorly applied by some agencies, and in practice any point can be raised and transformed into a last-minute concern to prevent granting low-risk status to a micro-organism, against the legislation’s intention. This is frequently done by Member States and the Commission, without providing sound justifications for such decisions, not granting low-risk status in the approval or renewal regulations for micro-organisms.

BioAg World Digest | Summer 2026