The changes to the guidance include (but are not limited to) indicator model species, generic model species, residues per unit dose, deposition factors, benthic invertebrate-eating species, and consideration of exposure outside treated areas.
Two interconnected and critical areas in the revised guidance are the restricted use of the time-weighted average factor (fTWA) and the introduction of benchmark dose modelling (BMD). The default fTWA of 0.53, previously used for long-term exposure estimation, is now restricted. Additionally, the introduction of BMD at the 10 percent level (BMD10) is considered more appropriate than the no-observed-adverse-effect-level (NOAEL) approach for setting long-term endpoints.
These changes will result in fewer compounds passing Tier 1 assessments, necessitating higher tier risk assessments and potentially the need for higher tier data. This could impact the registrability of plant protection products (PPPs) and require early planning and preparation, especially for field trials subject to seasonal variations.
To navigate these changes, we recommend that companies conduct systematic reviews of their PPPs and available data. The available online tools developed by EFSA, such as the birds and mammals risk assessment calculator and BMD EFSA Tools, should be applied to support these assessments.
TSG offers streamlined preliminary assessments, detailed compound analysis, and expert advice to navigate the revised EFSA guidance. Contact us at [email protected].
Adapting to EFSA's revised guidance is essential for continued compliance and market authorisation. Proactive steps and expert support can help manage these regulatory changes effectively.
Discover more about the impact of EFSA’s revised birds and mammals guidance
Further details about the revised guidance are presented in TSG’s latest Insight: Navigating the impact of EFSA’s revised birds and mammals guidance.
