Commission Implementing Regulation (EU) 2025/1908 of 24 September 2025 amending Regulation (EU) No 37/2010 regarding the classification of the substance fluralaner and its maximum residue limits in food of animal origin
On September 24, 2025, the European Commission adopted Implementing Regulation (EU) 2025/1908, amending Regulation (EU) No. 37/2010 with regard to the classification of the substance fluralaner and its maximum residue limit (MRL) in food of animal origin. This regulation was adopted pursuant to Regulation (EC) No. 470/2009, laying down Community procedures for the establishment of MRLs for pharmacologically active substances used in veterinary medicinal products, in order to ensure food safety and protect public health.
The amendment mainly concerns the extension of the use of fluralaner, already authorized for poultry, to finfish, in particular salmonids. The European Medicines Agency evaluated the data provided by the applicant and recommended the establishment of MRLs for fluralaner in fish muscle and skin, extrapolating these limits to all finfish. The MRLs set ensure that the consumption of these foods of animal origin remains safe for consumers.
The regulation also specifies the therapeutic classification of the substance as an antiparasitic agent/medicine acting on ectoparasites and defines the marker residues and target commodities for the application of the MRLs. The measure was adopted in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products and is directly applicable in all Member States. The regulation was published in the Official Journal of the European Union on September 25, 2025, and enters into force 20 days after its publication.