Updates on the Risk Assessment for Birds and Mammals Guidance
Updates on the Risk Assessment for Birds and Mammals Guidance
On Wednesday December 3rd, 2025, Kerona Scientific held its 6th Virtual Dublin Plant Protection Symposium. This annual event serves as a platform to delve into critical issues within the EU and GB/NI landscapes, drawing insights from key stakeholders in the plant protection industry. Among the various speakers, Mathilde Zorn (Ctgb, Netherlands) presented on the “Implementation of the new Birds and Mammals Guidance” from 2023, that has been mandatory since October 2025. Key updates included the expansion to 62 crop groups and 2,250 bird and 3,358 mammal scenarios, resulting in a significant increase in workload.
On endpoint selection, Mathilde highlighted that in line with Regulation 283/2013 and EFSA (2023), EL10/20 values are preferred, and the applicability of fTWA must be assessed. However, following the PAI meeting (September 2025), NO(A)ELs will remain in use until EU-level benchmark dose modelling (BMD values) is available for each active substance. The use of fTWA must be evaluated by a designated Member State in accordance with SANCO/10328/2004 rev. 10, noting that fTWA mainly concerns direct exposure and is not directly applicable to secondary poisoning assessments.
The Guidance also introduces the Terrestrial Area of Interest (TAI) to address off-field exposure, particularly for small mammals absent during early crop stages but still exposed via drift. TAI assessments must be conducted at Tier 1 for all crop growth stages.
Updates to seed treatment guidance are limited, with tubers and bulbs newly included. Expectations for DT50 refinements and residue studies are clarified, requiring applicants to provide study summaries containing essential information (location, timing, growth stage, rainfall, kinetic modelling, goodness-of-fit metrics). These details must be checked by the concerned Member State, and data pooling is acceptable when well justified.
The presentation also covered semi-field studies, emphasising the need for representative study sites across relevant regions, robust justification when extrapolating to other crops or application timings, and selection of realistic worst-case focal species. As extensive monitoring is often not feasible, refinements in PT and PD are used, and applicants must provide strong, well-documented justification when submitting higher-tier refinements.
If you missed the Dublin Plant Protection Symposium, please contact Kerona if you wish to obtain a copy of the presentations. For assistance with the Regulation of PPP in the EU and UK the Kerona Regulatory team can be contacted at info@kerona.ie