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THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Councilnote, and in particular Article 14, in conjunction with Article 17, thereof,Whereas:
(1)In accordance with Regulation (EC) No 470/2009, the Commission is to establish, by way of a Regulation, maximum residue limits (‘MRLs’) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry.
(2)Commission Regulation (EU) No 37/2010note sets out the pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin.
(3)The substance fluralaner is included in that Regulation as an allowed substance for poultry.
(4)On 24 April 2024, Farmacologia En Aquacultura Veterinaria FAV S.A. submitted an application to the European Medicines Agency (‘the Agency’) in accordance with Article 3 of Regulation (EC) No 470/2009 for the establishment of the maximum residue limits of the substance fluralaner in Salmonidae and other fin fish.
(5)In accordance with Article 5 of Regulation (EC) No 470/2009, the Agency is to consider using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or MRLs established for a pharmacologically active substance in one or more species for other species.
(6)On 12 February 2025note, the Agency, based on the opinion of the Committee for Veterinary Medicinal Products, recommended the establishment of MRLs for fluralaner use in Salmonidae, applicable to muscle and skin in natural proportions. The Agency concluded that the extension by extrapolation of the MRLs for fluralaner to all fin fish is appropriate.
(7)In view of the opinion of the Agency, the Commission considers it appropriate to establish the recommended MRLs for fluralaner in all fin fish.
(8)Regulation (EU) No 37/2010 should therefore be amended accordingly.
(9)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,
HAS ADOPTED THIS REGULATION:
Article 1#
The Annex to Regulation (EU) No 37/2010 is amended as set out in the Annex to this Regulation.
Article 2#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance ‘fluralaner’ is replaced by the following:
Pharmacologically active substance | Marker residue | Animal species | MRL | Target tissues | Other provisions(according to Article 14(7) of Regulation (EC) No 470/2009) | Therapeutic classificationFluralaner | Fluralaner | Poultry | 65 μg/kg650 μg/kg650 μg/kg420 μg/kg1300 μg/kg | MuscleSkin and fat in natural proportionsLiverKidneyEggs | NO ENTRY | Antiparasitic agents/Agents against ectoparasitesFluralaner | Fin fish | 65 μg/kg | Muscle and skin in natural proportions
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