Revised guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees)

Abstract

The European Commission asked EFSA to revise the risk assessment for honey bees, bumble bees and solitary bees. This guidance document describes how to perform risk assessment for bees from plant protection products, in accordance with Regulation (EU) 1107/2009. It is a review of EFSA's existing guidance document, which was published in 2013. The guidance document outlines a tiered approach for exposure estimation in different scenarios and tiers. It includes hazard characterisation and provides risk assessment methodology covering dietary and contact exposure. The document also provides recommendations for higher tier studies, risk from metabolites and plant protection products as mixture.

Roadmap for action on the environmental risk assessment of chemicals for insect pollinators (IPol‐ERA)

“…It is affected by consumption (oral exposure), related to the proportion of contaminated food in their diet and absorption, and the proportion of contaminated material penetrating their cuticle (contact exposure). Some quantitative estimates of adult and larval honey bee food consumption are used to calculate oral exposure from PPP use (EFSA et al, 2023). However, these estimates may introduce uncertainty and potential inaccuracy when there is little systematic data to base such estimates on, even for common bee species such as Bombus terrestris (EFSA et al, 2022c).…”

“…12 for IPol-ERA. Several additional key documents and initiatives have framed the work of IPol-ERA, e.g., the ERA guidance for bees (EFSA, 2013) and its revised version (EFSA et al, 2023), documents related to setting Specific Protection Goals (SPGs) for bees and non-target arthropods (EFSA, 2016(EFSA, , 2015EFSA et al, 2022a, and the EFSA scientific opinion on 'A systemsbased approach to the environmental risk assessment of multiple stressors in honey bees' (EFSA Scientific Committee et al, 2021), developed by the MUST-B working group. In developing and setting out a pathway for advancing ERA methodologies and encompassing holistic approaches for insect pollinators, it is acknowledged that detailing what a systems-based ERA will be is an on-going and iterative process of co-development involving multiple stakeholders/actors.…”

Breaking the cycle: Reforming pesticide regulation to protect pollinators

“…Pesticide toxicity is currently tested with a tiered approach that is intended to allow approval of only those chemicals at low risk of causing adverse impacts on the biotic environment (EPA 2014a , EFSA et al. 2023 ). The risks presented by pesticides to pollinators that encounter them have long been assessed using honey bees as a proxy for the thousands of insect species that contribute to plant pollination.…”

“…In Europe, various exposure models have been proposed depending on the pesticide application way (i.e., contact and dietary models), leading to various predictive exposure concentrations that result from the consideration of parameters such as the application rate, exposure factors, the body surface factor, or the food consumption (EFSA et al. 2023 ). These are then compared with LD 50 values under laboratory conditions.…”

“…Recently, the European Food Safety Authority (EFSA) reconsidered the hazard parameters in experimental studies and proposed to extract more information from the toxicological tests, considering the whole dose–response curves (from which other toxicological endpoints could be extrapolated—no observed effect concentration or LD x —calculating the existence of time-reinforced toxicity or integrating sublethal effects and mixture toxicity; EFSA et al. 2023 ). Such an approach with pollinators would increase test sensitivity and aid in addressing the disconnection between laboratory and field results where outcomes of exposure include a variety of sublethal effects at low concentrations.…”