Information about the new EFSA bee guidance

The new EFSA Guidance Document (GD) ‘Revised guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees)‘ was issued on the 11th of May 2023 and describes how to perform the risk assessments for bees for plant protection products (PPP) and their active substances under Regulation (EC) No 1107/2009.

The new GD is a review of EFSA’s existing guidance document (EFSA Journal 2013;11(7):3295), which was originally published in 2013. Substantial parts of the risk assessment methodologies have been updated in the reviewed GD.

The focus of this GD is to assess the risk to bees which may be exposed to chemical active substances. The GD does not cover the risk assessment for microorganism active substances for semiochemicals (including natural-identical synthesised molecules) for which specific considerations are needed.

For honey bees, as the maximum permitted level of colony size reduction (i.e., the Specific Protection Goal, SPG) a value of 10% is accepted in the new GD.
For bumble bees and solitary bees, the GD does not define a quantitative magnitude of acceptable effects due to the lack of data.

The risk assessment to bees, which are exposed to plant protection products (PPPs) in agricultural areas, follows a tiered approach for the exposure estimation and the effects assessment

The emission of the PPP in the environment and the way it can become a source of exposure for bees are determined by the type of use (i.e., crop-growing system) and the application method of the PPP under assessment. The categories defined by EFSA (2014a,b) and EPPO Global Database for the type of uses: i) Closed spaces (indoor/permanent greenhouses), ii) Semi-open structures (e.g., walk-tunnels), and iii) Open field (outdoor uses) are considered in the new GD. It has to be borne in mind that semi-open structures are assessed as outdoor uses. The most frequently used application methods that may lead to bee exposure are spraying of a liquid (emulsions, suspensions or solutions), seed treatments and distribution of granules. The reviewed GD focuses mainly on these methods of applications. However, bee exposure to PPPs applied with other methods of application cannot be excluded, so a proper characterisation of the exposure in line with the principles of the GD must be provided.

The reviewed GD considers four risk cases based on the routes of exposure (contact and dietary), the different timescales of effects (acute and chronic) and the life stages of bees (adults and larvae): 1) Acute-contact; 2) Acute-dietary; 3) Chronic-dietary; 4) Larvae-dietary. For the lower tier risk assessment, a combined approach integrating the different risk cases is proposed.

Information about the new EFSA bee guidance

Bees may come into direct contact with the PPP as well as be exposed via diet when bees consume contaminated pollen and nectar in different exposure scenarios, including intentionally treated areas and contaminated surrounding areas. Mathematical models to estimate the exposure (Predicted Exposure quantity, PEQ) in the different Tiers (screening, Tier 1 & 2) have been revised and re-parameterized, including reviews for the key parameters related, e.g., to a better estimation of food consumption and the crop-specific sugar content in nectar. Guidance has been developed for appropriate refinement options for many of the parameters.

The effect assessment proposed in the reviewed GD for the lower Tier relies on full Dose–Response Curve (DRC) from standard laboratory tests, rather than single effect point estimates (e.g., NOED, LD50). Therefore, the effect endpoints are the combination of the chosen dose–response model and the values of its parameters. Four of the models included by BMD guidance document (EFSA, 2022) for quantal effects are regarded as acceptable in the new GD.

As part of the effect-tier assessment of the PPPs, the guidance document suggests addressing two additional aspects for honey bees: 1) The phenomenon called ‘accumulative toxicity’– the potential for the compound under evaluation for showing increasing toxic effects due to long-term exposure to low doses (time reinforced toxicity assessment (TRT)), and 2) Potential concerns due to sublethal effects.

No SPGs for bumble bees and solitary bees has been defined in the reviewed GD, so the lower tier risk assessment scheme and the combined approach are not recommended to be applied until having defined thresholds of acceptable effects. Higher tier studies should generally be produced, allowing a better understanding and protection of these bee groups.

Risk assessment schemes for metabolites and mixtures and considerations of possible risk mitigation measures are also provided in the renewed GD.

EFSA Journal 2013;11(7):3295 was never endorsed unanimously by Member State representatives on the European Commission’s Standing Committee for Plants, Animals, Food and Feed (the ScoPAFF). In principle, the endorsement by Member States would be needed for the use of new guidance(s) during the scientific assessments performed for the approval or the renewal of the active substances and the registration of the PPPs at zonal level. It is interesting to note that Authorities have often used EFSA Journal 2013;11(7):3295 during the approval/renewal process of active substances (see recommendations mentioned in EFSA Supporting publication 2015:EN-924) and for the national registrations of the PPPs in some Member States of the Center and the South of the EU. The risk assessment for bees became a critical point for a high number of active substances and PPPs, not only for insecticides as a priori was expected.

It is reasonable to assume that the reviewed GD will also have a significant impact on authorizations of the active substances and the PPPs. This GD may also lead to new areas of concern.

Full citation:
EFSA (European Food Safety Authority), Adriaanse P, Arce A, Focks A, Ingels B, Jölli D, Lambin S, Rundlöf M, Süßenbach D, Del Aguila M, Ercolano V, Ferilli F, Ippolito A, Szentes Cs,Neri FM, Padovani L, Rortais A, Wassenberg J and Auteri D, 2023. Revised guidance on the riskassessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees). EFSAJournal 2023;21(5):7989, 133 pp.

Full details are provided at the next link: https://www.efsa.europa.eu/en/efsajournal/pub/7989