Preparing for the New Biocide Bee Guidance: What You Need to Know.

Why has this guidance emerged? 

Biocides, including PT18 insecticides and acaricides, were often assumed to pose limited risk to bees. That assumption is no longer considered valid. Evidence of pollinator exposure from a wider range of chemical uses, combined with increased political and societal pressure to strengthen pollinator protection, has driven the European Commission to extend the requirements for bee risk assessments to the biocides framework. 

ECHA’s 2024 guidance adapts EFSA’s sophisticated bee risk assessment paradigm to particular exposure scenarios of biocidal products. 

 

Timeline and transition 

The new requirements will apply to all applications for biocidal active substance approval or product authorisation submitted on or after 1 February 2026. 

• Until then: dossiers may still be prepared under the existing framework. 

• From that date: applicants must include a bee risk assessment consistent with the new guidance, where exposure is plausible. Or indicate why it is not considered necessary. 

• Ongoing evaluations: submissions lodged before 1 February 2026 will generally continue under the old approach, unless regulators specifically request updated information. 

This transition period gives companies a short window, but dossiers take months to prepare. Waiting until the deadline to act will leave applicants with limited flexibility if studies or modelling are required. 

 

Scope: who is affected? 

The guidance primarily focuses on PT18 products: insecticides, acaricides, and other arthropod control products. These are, unsurprisingly, the product types most likely to affect bees. 

Some important clarifications: 

• Baits and direct nest applications are excluded from the scope, since exposure to bees is minimal or absent. 

• Honey bees remain the regulatory reference species, with a protection goal aligned with EFSA’s approach, while bumble bees and solitary bees are acknowledged but not yet subject to binding data requirements.  

• Other biocidal product types (e.g. PT8 wood preservatives, PT21 antifouling) are not formally in scope at present, but may come under scrutiny in the future if relevant exposure pathways are identified. 

For now, companies operating in PT18 should treat this as a firm regulatory obligation. However, a bee risk assessment may also be required for other biocidal Product Types resulting in a potential exposure to bees and containing an active substance with an insecticidal mode of action. 

 

What is changing compared to PPP guidance? 

ECHA has not simply copied the EFSA 2023 guidance across. The framework is similar (tiered risk assessment, clear protection goals, focus on colony/population level endpoints) but it has been adapted to biocide use scenarios: 

• Exposure assessment: Instead of agricultural spray drift or systemic residues in flowering crops, biocides must consider surfaces, treated articles, residual deposits, or indoor uses. Exposure estimates are tailored accordingly. 

• Protection goals: For honey bees, the Specific Protection Goal (SPG) is aligned with EFSA’s: a maximum 10% reduction in colony strength/population size. For other bee groups, expectations remain case-by-case. 

• Data requirements: Applicants must provide acute oral and contact toxicity data (OECD 213/214), chronic adult and larval toxicity, and additional studies where exposure cannot be excluded. Formulations with multiple actives may trigger further testing. 

• Metabolites: These must be considered if residues in bee-relevant matrices are plausible, often applying conservative assumptions (e.g. 10× toxicity multipliers in absence of data). 

• Risk characterisation: The traditional biocides “PEC vs PNEC” approach does not apply. Instead, EFSA-style exposure–effect ratios and colony-level modelling are considered. 

 

Implications for applicants 

For companies developing or maintaining products, this change has practical consequences: 

• Earlier data planning: Chronic studies and larval toxicity tests are not trivial. Timelines are long and study capacity is limited. Starting now avoids bottlenecks later. 

• Different modelling requirements: Exposure estimation will no longer be a simple worst-case assumption, but it requires tailored scenarios reflecting real-world use. Many applicants will need specialist modelling support. 

• Strategic dossier preparation: Submitting a dossier close to the 1 February 2026 cut-off risks being trapped between old and new systems. Applicants should assess whether to accelerate or delay depending on their data package readiness. 

• Heightened regulatory scrutiny: Regulators are likely to expect applicants to demonstrate not only compliance but also a clearer justification of assumptions, uncertainties and any proposed risk mitigation. 

 

Where Enviresearch comes in 

At Enviresearch, we are already helping clients navigate this transition. Our team combines technical ecotoxicology expertise with regulatory strategy, ensuring clients are not only compliant but positioned advantageously. 

• Study design and commissioning: We advise on which bee studies are genuinely required, avoiding unnecessary cost while ensuring robustness. 

• Exposure modelling: Our specialists adapt the EFSA bee calculator and biocide-specific models to reflect realistic emission scenarios. 

• Dossier preparation: We integrate bee risk assessments seamlessly into active substance and product authorisation submissions. 

• Regulatory strategy: We help clients decide whether to accelerate applications under the current framework or prepare for the 2026 requirements. 

Most importantly, we ensure that assessments withstand the rigorous scrutiny of Member State authorities and the European Commission. 

 

Looking beyond 2026 

It is clear that this guidance will continue to evolve. Pressure to extend binding protection goals to bumble bees and solitary bees is likely to increase, and additional biocidal product types may be drawn into scope as evidence of pollinator exposure grows. As EFSA 2023 becomes embedded in plant protection regulation, the biocides framework will evolve in parallel. Staying aligned with both systems will be essential for companies operating across both regulatory regimes. 

 

Act now 

The message is simple: with February 2026 almost here, the time to act is now. 

• Review your portfolio: which products fall within scope? 

• Check your data: do you have the necessary acute, chronic, and larval studies? 

• Consider modelling: can realistic exposure scenarios be defined? 

• Develop your strategy: accelerate, delay, or build transitional flexibility? 

At Enviresearch, we are already supporting clients through these questions. Our role is to translate complex guidance into clear, defensible regulatory strategies that save time, reduce cost, and secure successful outcomes. 

Final thoughts 

Pollinator protection is a political, scientific, and societal priority. The new biocide bee guidance ensures that biocides, like pesticides, are subject to rigorous scrutiny. For applicants, the challenge is real, but so is the opportunity to demonstrate responsible stewardship and regulatory readiness. 

Enviresearch stands ready to support you. With our blend of technical expertise, regulatory insight, and hands-on dossier experience, we are uniquely positioned to guide you through this transition. 

If you would like to discuss how the new requirements affect your products, or to explore your dossier strategy, please get in touch with the Enviresearch team today.