What the GB 2023 Birds and Mammals Guidance Means for Your Submissions
What the GB 2023 Birds and Mammals Guidance Means for Your Submissions
As a plant protection product manufacturer, staying ahead of regulatory changes is essential for maintaining market access. The Health and Safety Executive (HSE) has reviewed the revised 2023 EFSA Guidance for birds and mammals ecotoxicology and confirmed its adoption in Great Britain under assimilated Regulation (EC) No 1107/2009. While the 2009 scheme currently remains active, the HSE’s formal roadmap introduces key operational deadlines that require immediate pipeline planning.
The transition offers a staged implementation timeline. From the 17th of August 2026, applicants can voluntarily submit dossiers built on the 2023 Guidance. From the 17th of February 2027, compliance becomes mandatory for any new active substance approval or product authorisation relying on a fresh birds and mammals risk assessment. Adopting these rules aligns GB requirements with the EU, enabling streamlined parallel submissions across both jurisdictions.
The EFSA 2023 update introduces refined residue values, updated crop groupings, and new dietary exposure calculations. Crucially, the HSE has adopted a pragmatic approach for product authorisations: active substance endpoints established during approval will remain fixed, preventing active substance re-evaluations during product-level reviews while applying the updated 2023 exposure models.
Applicants should review upcoming GB dossiers now to determine which fall after the February 2027 cutoff, ensuring exposure modeling and potential higher-tier refinements are prepared well in advance.
If you need support with your risk assessments for plant protection products including birds and mammals, please do not hesitate to contact the regulatory team at info@kerona.ie