6 October 2017 EMA/CVMP/649018/2017 Committee for Medicinal Products for Veterinary Use

MRL summary opinion 1

Fluazuron In fin fish, in all ruminants except ovine, and in bovine milk

On 5 October 2017, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted an opinion 2 recommending the establishment of MRLs for fluazuron in fin fish. Furthermore, the Committee agreed to extrapolate the MRLs already established bovine tissues to tissues of all ruminants, except ovine species, and to milk of bovine species. Therefore, the Committee recommended the amendment of the entry for fluazuron in Table 1 (Allowed substances) of the Annex to Commission Regulation (EU) No 37/2010, in accordance with the following table: Pharmacologically active substance

Marker residue

Animal species

MRLs

Target tissues

Other provisions

Therapeutic classification

Fluazuron

Fluazuron

All ruminants except bovine and ovine

200 µg/kg 7000 µg/kg 500 µg/kg 500 µg/kg

Muscle Fat Liver Kidney

Not for animals from which milk is produced for human consumption.

Antiparasitic agents / Agents (acting) against ectoparasites

Bovine

200 µg/kg 7000 µg/kg 500 µg/kg 500 µg/kg 200 µg/kg

Muscle Fat Liver Kidney Milk

NO ENTRY

Fin fish

200 µg/kg

Muscle and skin in natural proportions

NO ENTRY

1

Summaries of opinion are published without prejudice to the Commission Decision. Applicants may request re-examination of any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to request such re-examination within 15 days of receipt of the opinion 2

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