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Changes to EFSA’s Guidance on Bee Risk Assessments
Bee Risk Assessment
In 2013, EFSA initially published a guidance document indicating how risk assessments should be conducted for honeybees, bumble bees, and solitary bees in accordance with Regulation (EU) 1107/2009. A public consultation on the 2019 revision of this original document completed in September 2022.
EFSA’s final guidance documents on bee risk assessments are now expected in Spring 2023 So, who does this affect and what impact could this have?
Background on Bee Risk Assessment Changes
This guidance relates specifically to agrochemicals and aims to establish the Environmental Risk Assessment framework for pollinators requested during the active substances and plant protection product approval process in the EU.
EFSA’s guidance proposed that in addition to a bee risk assessment based on acute toxicity data, chronic toxicity test data from adult bees and larvae would need to be addressed by default. Furthermore, where risk is detected, additional (semi-) field studies might be required to clarify the risk.
Further Revision Required
With a lack of agreement and support among Member States, the 2013 guidance document was never fully implemented in the regulatory approval process. Due to the delay in implementation and the need to escalate pollinator protection, the European Commission requested that EFSA revise the original document in 2019 and should:
- Consider the feedback from Member States and stakeholders
- Provide evidence on bee background mortality (both beekeeping management and natural background mortality)
- Review the list of bee-attractive crops
- Revise the requirements for field studies
- Review the bee risk assessment guidance based on the specific protection goals (SPGs) agreed by the Commission
Key Take-aways
Charles River regulatory experts are reviewing the new proposal and have highlighted a few key points raised.
An important step in the outline of the review is the updating and implementation of specific protection goals (SPG) for bees. These specific protection goals were extensively debated and agreed within the risk managers from the Member States based on scientific information. Agreement was reached about the maximum permittable effect on honeybees following pesticide exposure in the entire EU: this should not be larger than a 10% reduction in colony size. Due to lack of data, no consensus was achieved in establishing SPG for bumble bees and solitary bees. However, risk managers agreed that higher-tier data should be generated within approval of the active substances.
Bee Risk Assessments and Specific Protection Goals
The SPG sets the tone for the rest of the guidance review, where effects should now coherently address the agreed SPG in all tiers. In practice this means that effects need to be extrapolated from individual levels to higher levels of biological organization (i.e., colony or population). Also, the concept of time-reinforced toxicity (known as “accumulative toxicity” in the previous guideline version) was re-discussed and a different proposal is presented.
One of the main points of divergence in the previous guidance on bee risk assessments has been withdrawn for now in the new proposal: the contaminated water scenario (exposure through guttation, surface water, and puddle water). This is due to the lack of sufficient data to quantify the water consumption, frequency, and magnitude of water collection by bees.
In addition to the above-mentioned points, the new bee risk assessment scheme proposal incorporates different data analysis and interpretation approaches, which on initial review, seems to put the risk assessment scheme in an upper level of complexity. In fact, the consequences for the future agrochemical registrations will still be uncertain after the conclusion of the public call.
Our regulatory experts are available if you’d like to discuss your pollinator study requirements or how these upcoming changes may affect your bee risk assessments.