5 October 2017 EMA/CVMP/616458/2017 Committee for Medicinal Products for Veterinary Use
Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits Procedure no: EMEA/V/MRL/003471/EXTN/0002 Name of the substance: Fluazuron (INN) Basis for the opinion Pursuant to Article 3 of Regulation (EC) No 470/2009 of 6 May 2009, Farmacologia en Aquacultura Veterinaria FAV S.A. submitted to the European Medicines Agency on 20 April 2017 an application for the extension of maximum residue limits for fluazuron to fin fish.
Recommendation The Committee, having considered the application, recommends by the majority of 26 out of 28 votes the extension of maximum residue limits for fluazuron to fin fish. Furthermore, and with reference to Article 5 of Regulation (EC) No 470/2009, the Committee agreed to extrapolate the maximum residue limits established in bovine tissues to tissues of all ruminants except ovine species and to milk of bovine species in accordance with the following table: Pharmacologically active substance
All ruminants except bovine and ovine
µg/kg µg/kg µg/kg µg/kg
Muscle Fat Liver Kidney
Not for use in animals from which milk is produced for human consumption
Antiparasitic agents / Agents (acting) against ectoparasites
200 7000 500 500
500 µg/kg 200 µg/kg
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The Norwegian CVMP member agrees with the above-mentioned recommendation of the Committee. The scientific conclusions of the Committee are presented in the European public MRL assessment report (EPMAR), provided in Annex I of this opinion. The divergent position is presented in Annex II of this opinion. The analytical method for monitoring of residues is appended to this opinion. The present opinion is forwarded to the European Commission and to the applicant together with its appendices.
Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits EMA/CVMP/616458/2017
Annex I European public MRL assessment report (EPMAR)
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