Clarifying how aspects of the EU guidance for Bird and Mammal assessment are to be implemented in NI.
On 1 October 2025 new guidance entered into force in the EU on how to perform the bird and mammal risk assessment for pesticide active substances and PPPs. This guidance applies directly in NI.
From 1 October 2025, any application submitted for a new plant protection product authorisation in NI or the renewal of a plant protection product in NI, which relies on a new bird and mammal risk assessment, must take account of this guidance.
HSE has considered how applicants should approach certain aspects of this guidance for product authorisations and provides the following clarification:
Bench Mark Dose (BMD)
Until the BMD for the active substance has been derived as part of the approval or renewal of approval of the active substance, the “no-observed-adverse-effect level” (NO(A)EL) should be used (unless the agreed active substance endpoint is already a BMD value).
Time Weighted Average factor (TWA)
Until the approach on the use of TWA for the active substance has been agreed as part of the approval or renewal of approval of the active substance, the PPP risk assessments should be conducted and submitted to HSE using the TWA approach specified in the 2009 European Food Safety Authority (EFSA) guidance.
For PPP risk assessments only, if an EU Member State has decided that a TWA should be used for a PPP assessment according to the approach specified in the 2023 EFSA guidance, then HSE will accept that decision. The necessary supporting assessment should be provided to HSE to accept and evaluate the risk assessment using the same approach.
Find out more on our website about how HSE undertake pesticide bird and mammals risk assessments.
HSE is reviewing the 2023 EFSA guidance for use in Great Britain (GB) risk assessments and will seek stakeholder views on this issue. In the meantime, the previous 2009 EFSA guidance should be used for GB applications and assessments.
|
