Adoption of the EFSA-Guidance Document on Risk Assessment for Birds and Mammals

With effect from 1 July 2010, the "Guidance Document on Risk Assessment for Birds and Mammals" (SANCO/4145/2000) was replaced by a new Guidance Document by the European Food Safety Authority (EFSA). Based on this new Guidance Document, the BVL has set the generic parameters for refined risk assessments in notification BVL 10/02/14 of 1 June 2014, published in the Federal Gazette.

This notification is replaced by notification BVL 16/02/08 of 12 September 2016, because the overall consideration of a reduced PT factor of 0.3 for the acute exposure scenario is no longer justified.

Thus, when assessing the risks for products for seed treatment in cases where no other data is available for a refined risk assessment, a PT factor of 0.3 will only be considered to assess the long-term risk for small granivorous mammals. For the acute exposure scenario, however, the standard PT factor of 1.0 will be considered.

This notification will be repealed as of 31 December 2022. For marketing authorisation applications submitted on or after 1 January 2023, the risk assessment with regard to effects on wild birds and mammals will be carried out without generic national refinement (see technical information of 1 July 2022, only in German).