,"The European Commission has adopted Implementing Regulation (EU) 2025/1908, amending Regulation (EU) No 37/2010 to expand the permitted use of the veterinary drug fluralaner. Previously authorized for poultry, fluralaner is now approved for use in all fin fish, including Salmonidae, with clearly defined maximum residue limits (MRLs).
Key Changes Introduced
1. New Classification for Fluralaner:
Species Added: All fin fish (including Salmonidae)
Target Tissues: Muscle and skin in natural proportions
New MRL: 65 μg/kg
2. Existing MRLs for Poultry (unchanged):
Muscle: 65 μg/kg
Skin and fat: 650 μg/kg
Liver: 650 μg/kg
Kidney: 420 μg/kg
Eggs: 1,300 μg/kg
Scientific Basis and Approval
The update follows a formal request by Farmacologia En Aquacultura Veterinaria FAV S.A., and a scientific opinion issued by the European Medicines Agency (EMA). The EMA’s Committee for Veterinary Medicinal Products concluded that extrapolating fluralaner’s safety profile from poultry to fin fish is scientifically justified.
Regulatory Impact
The regulation enters into force 20 days after publication in the Official Journal of the European Union.
It is directly applicable in all EU Member States.
The change supports broader use of fluralaner in aquaculture, particularly for treating parasitic infestations, while maintaining strict consumer safety standards."
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