New bee risk assessment guidance for biocides

Up to press there has been no quantitative risk assessment methodology for the environmental risk assessment of bees when exposed to biocides. This is in contrast to the risk assessment for pesticides, where the assessment of bees is performed in accordance with SANCO (2002). In addition, extensive updates of the pesticide assessment have been proposed in the form of the updated bee guidance EFSA (2013) and EFSA (2023).

In 2019 the European Chemicals Agency (ECHA) was mandated by the European Commission (EC) to develop a guidance for assessing the risks to arthropod pollinators (including bees), and to specify the information required to enable a conclusion by any evaluating authority. The result of this is a new guidance on how to assess biocides risks to bees. Earlier this year ECHA hosted a webinar to introduce the guidance and provide a Q&A opportunity.

A honeybee feeding from a flower

Key take-home messages from the webinar

  • The Specific Protection Goal (SPG) for bees under the Biocidal Products Regulation (BPR) is: “Protection of pollination ecosystem service providers – bee colony/population strength”. As for Plant Protection Products (PPPs), this has been translated into a threshold of 10% maximum reduction in colony/population size for honey bees.
  • The threshold for bumblebees and solitary bees remains undefined – therefore there is no mandatory data/risk assessment requirements for bumblebees and solitary bees currently. However, data on bumble bees and solitary bees may be requested by the evaluating authority if considered relevant for the assessment.
  • Data requirements: if exposure of bees may occur (see emission scenarios below) then studies on honeybee acute oral/contact, chronic oral adult, and larvae (OECD 213, 214, 245, and 239) will need to be submitted for the active substance, and for formulations with ≥2 actives. Acute studies are required for formulations with 1 active, and chronic adult/larval studies may be required if toxicity of the formulation is not within a factor of 3 of the active substance endpoints. Metabolites must also be assessed where found in plant materials. A screening step of assuming 10x toxicity compared to the parent can be used.
  • The PNEC approach usually used for biocide risk assessment is not used for bees! Instead, the new biocide risk assessment is very similar to the EFSA (2023) guidance for pesticides. However, the exposure/emission scenarios have had to be considered specifically for biocides.
  • Current emission scenarios focus on PT 18 – insecticides, acaricides and products to control other arthropods – for the following uses:
    • Application to manure
    • Spraying walls/foundations of buildings
    • Irrigation of private gardens with treated water
    • Large-scale spraying of plants and water bodies.
  • Baits and applications to wasp/hornet nests are not currently assessed
  • Other PT types are not automatically exempt, and may be assessed in the future if concern for a chemical/use is raised.
  • Non-bee pollinators are not included in the assessment, but there is the intention to include these in an update to the risk assessment for non-target terrestrial arthropods in the future.

A graphic taken from ECHA webinar “Getting familiar with ECHA’s guidance to assess risks of biocides to bees” (5 March 2024) illustrating emission scenarios considered relevant to bee risk assessment

This is a big change to the bee risk assessment for biocides, introducing additional data requirements and a much higher level of complexity in the risk assessment for relevant chemicals and uses.

ECHA’s guidance can be found here. A recording of the webinar and copies of the presentation slides and Q&A can be found here.

What does this mean for you?

The new guidance will apply to active substance approvals and biocidal product authorisations for which applications are submitted on or after 1 February 2026. This is seemingly unlinked to the implementation date of EFSA (2023) for PPP risk assessments, which has yet to be decided (but is anticipated to be in 2025 based on current understanding).

If this applies to you, get in touch with CEA to discuss how the new guidance may impact your application.

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