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
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
200 µg/kg 7000 µg/kg 500 µg/kg 500 µg/kg 200 µg/kg
Muscle Fat Liver Kidney Milk
Muscle and skin in natural proportions
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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