The new EFSA Guidance Document (GD) ‘Risk assessment for bird and mammals’ was issued on the 6th of February 2023 and details updates on how to perform risk assessments for birds and mammals for plant protection products (PPP), containing active substances, in accordance with Regulation (EU) 1107/2009

This risk assessment guidance is an update of EFSA’s existing guidance document entitled ‘Risk assessment for Birds and Mammals’ which was published in 2009 (EFSA Journal 2009; 7(12):1438). It outlines a tiered risk assessment scheme covering dietary exposure, exposure via secondary poisoning and exposure via intake of contaminated water. Substantial parts of the risk assessment methodologies have been clarified, updated and/or complemented. An associated calculator tool has been developed to implement the screening, Tier 1, Tier 2 and Tier 3 exposure and risk assessments and is available online in the EFSA Platform, R4EU, at the following web address: https://r4eu.efsa.europa.eu/app/birds-mammals.

New information and data used in the guidance includes updates to the model species used, new residue data for bird and mammal food items and an update of various risk assessment methodologies.

With the revised assumptions, the lower tier oral exposure assessment for bat species is assumed to be covered by the Exposure Assessment Screening tier and Exposure Assessment Tier 1 calculations for other insectivorous mammals. The WG recommends developing dermal and inhalation exposure models for all terrestrial non-target organisms including bats at a later date.

The following areas are refined in the new guidance:

• For the indicator model species and generic model species in the screening and tier 1 exposure assessments – relevant feeding guilds (herbivorous, insectivorous, granivorous and omnivorous) for the various scenarios, range of body weights for model species and the different proportions of food items in the diet for each generic model species.
• For small mammals, direct effects caused by exposure outside of the treated area should be considered.
• Guidelines for the use of the time-weighted average approach in the reproductive exposure assessment have been developed.
• Options for Tier 2 effects assessment have been provided, noting that the WG discourages the performance of additional vertebrate testing. Toxicokinetic–toxicodynamic (TKTD) models included as a potential useful tool for the Tier 2 effect refinement, however these models may require more development for their use in regulatory ERA of birds and mammals.
• Tier 2 options for exposure assessment for spray applications include refined residue values and refinement considering substance-specific dissipation data, and further guidance is provided on evaluating such data.
• Tier 3 options for exposure assessment include field studies for the selection of focal species and studies for refining ecological data used in the exposure estimates, i.e. the proportion of food obtained in the treated area (PT) and the different proportions of dietary items obtained in the treated area (PD) for the identified focal species.
• Higher tier integrated exposure and effect assessments for spray applications and seed treatments, and based on focal species, include effect field studies and population models which are considered to integrate effect and exposure. In the absence of technical guidance, the regulatory use of these approaches will be based on a case-by-case expert judgement.
• A Tier 1 risk assessment for benthic invertebrate-eating birds and mammals has been included, in addition to the one related to piscivorous and vermivorous birds and mammals.
• Formulation risk assessment and how to perform a risk assessment for formulations which contain more than one active substance have also been updated in line with the latest developments and methods.

The risk assessment results obtained from the use of EFSA Journal 2009; 7(12):1438 were already critical for a high number of PPP active substances and their representative products. It is expected that this new guidance will also be critical for a high number of PPP active substances and the updated guidance may also lead to new areas of concern.

The implementation timeline for this updated EFSA risk assessment for birds and mammals is not yet known. We would expect a transition period before dossiers need to be submitted using the updated guidance however, the length of such a transition period for active substances with EFSA or PPPs at the concerned member state level has not yet been confirmed.

Full citation

EFSA (European Food Safety Authority), Aagaard A, Berny P, Chaton PF, Antia
AL, McVey E, Arena M, Fait G, Ippolito A, Linguadoca A, Sharp R, Theobald A and Brock T, 2023.
Guidance on the risk assessment for Birds and Mammals. EFSA Journal 2023;21(2):7790, 300 pp.
Full details are provided at the next link: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2023.7790

Article contributor: Josie Tomlinson (Principal Ecotoxicology Consultant – Staphyt Regulatory Affairs)