Updates in the Bees Risk Assessment for Biocides
Updates in the Bees Risk Assessment for Biocides
As of February 2026, the assessment of environmental risks of biocidal products to bees has changed significantly. The European Chemicals Agency (ECHA) has issued new guidance on evaluating bee risks for biocides, aligning the biocidal framework with the EFSA 2023 Guidance for plant protection products.
Current emission scenarios mainly focus on product type (PT) 18, however, for other PTs, a bee risk assessment may also be required where there is potential exposure to bees, particularly for active substances with an insecticidal mode of action. Where exposure is likely, applicants will need to submit acute oral and contact toxicity studies, as well as chronic and larval studies on honeybees, for both single active substances and for products containing two or more active substances.
The new requirements will apply to all applications for biocidal active substance approval or product authorisation submitted after the 1st of February 2026. Dossiers submitted before this date will generally continue to be assessed under previous rules, although regulators may request additional or updated information during ongoing evaluations. Applicants submitting after the 1st of February 2026 must include a bee risk assessment in line with the new Guidance where exposure is plausible or provide a justification if such an assessment is not considered necessary.
This represents a substantial shift for many biocidal products, moving from minimal or, in many cases, no dedicated assessment for bees to a formal, quantitative risk assessment framework. Under the new approach, data requirements are broadly comparable to those applied under plant protection product legislation. While there is currently no mandatory requirement to generate bumblebee or solitary bee data due to the absence of specific protection goals (SPGs), authorities may still request such information where it is considered relevant to the substance or use pattern. In addition, the traditional PNEC-based ecotoxicological approach used in biocides is not applied to bees; instead, the assessment methodology follows the EFSA (2023) Guidance for PPPs placing greater emphasis on exposure–effect relationships.
On the 27th of April 2026, the HSE adopted ECHA’s Guidance for assessing the risks to bees from using biocides in Great Britain. This Guidance will apply to applications submitted to the HSE after the 1st of February 2027. However, for Northern Ireland, the Guidance is already in effect and applies for all applications.
At Kerona, we support applicants in navigating these evolving requirements, from early gap analysis to full dossier preparation and regulatory strategy. With the shortened transition window, early planning is key to avoiding delays and ensuring submissions remain fully compliant under the new system.
For assistance with the regulation of biocides in the EU and the UK the Kerona Regulatory team can be contacted at info@kerona.ie