The New EFSA Guidance for Birds and Mammals
On November 21st, during the 2023 Dublin Plant Protection Symposium, Dr Gabe Weyman, an independent consultant with a vast experience in regulatory ecotoxicology, talked about the new EFSA guidance for Birds and Mammals.
Ecotoxicological guidance is being continually updated with increasing requirements making them more extensive and complex and the new EFSA guidance for Birds and Mammals is no different.
Although the principles of the goals and methods are the same as the current guidance, the new guidance brings some points that will increase its complexity. The much higher number of crop-species scenarios at Tier 1 (>5000) for spray applications, the new secondary poisoning scenario for birds and mammals eating benthic invertebrates and the off-field assessment for small mammals at early growth stages are some of the examples.
In addition to requiring more work, some assessments will also be more subjective and will require careful consideration. This includes the preference to use the Benchmark dose 10% (BMD10) instead of the NOEC for the chronic risk assessment, the use of the fTWA which will be decided based on the assessment of the toxicological data or the need to consider the migratory birds which can be triggered based on neurotoxicological effects in mammals studies.
On the other hand, not everything will be more difficult. The screening tier is simpler, the selection of the GAP scenarios is clearer and there are more residue data sets and lower RUD values than before. Additionally, applicants can use the new EFSA online calculator that can be found at https://r4eu.efsa.europa.eu/app/birds-mammals
The exact date of the implementation of the new guidance is not yet known however all signs point to spring 2024, followed by a long implementation period.
In conclusion, the ecotoxicologist specialists will need to put in a lot of work to implement this new guidance, but it is a positive step toward increasing the protection of birds and mammals from PPP use.
The new guidance can be found at Risk assessment for Birds and Mammals – – 2023 – EFSA Journal – Wiley Online Library
If you missed the PPP Symposium, a copy of all the presentations is available on the publications section of the Kerona website at https://kerona.ie/product-category/publications/
If you need assistance with the registration of plant protection products in the EU, please do not hesitate to contact the experts at Kerona firstname.lastname@example.org