Maximum Residue Limits
This article was originally published in SRA
Executive Summary
Amendments to MRLs for morantel, carprofen and ivermectin in the EU
Amendments to MRLs for morantel, carprofen and ivermectin in the EU
The Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMEA) has revised the maximum residue limit (MRL) of morantel permitted in milk1. The MRL for morantel was extrapolated to cover all species by the CVMP in February 2005 and a MRL value of 100 μg/kg for milk was set. This value has now been corrected to 50 μg/kg, in line with the milk MRL previously established for bovine and ovine species2.
Two further MRLs have been amended, with effect from 8 August 20053. Carprofen was included in Annex I to Regulation (EEC) No 2377/90 as a marker residue for bovine and Equidae muscle, fat, liver and kidney, except in cases where bovine milk was produced for human consumption. It has now been replaced by the sum of carprofen and carprofen glucuronide conjugate as a marker residue. Carprofen itself should be included in Annex II only.
The MRLs set for ivermectin in Annex I have been extended to all mammalian food-producing species excluding animals from which milk is produced for human consumption. The MRLs previously only applied to bovine, porcine, ovine and Equidae for liver and fat and for deer, including reindeer, for liver, fat, muscle and kidney.
References
1. CVMP press release, 16 June 2005, www.emea.eu.int
2. The Regulatory Affairs Journal - Pharma, 16(1), 45
3. Commission Regulation (EC) No 869/2005 of 8 June 2005 amending Annexes I and II to Council Regulation (EEC) No 2377/90 Laying Down a Community Procedure for the Establishment of Maximum Residue Limits of Veterinary Medicinal Products in Food Stuffs of Animal Origin as Regards Ivermectin and Carprofen, OJ, 2005, L145, 19-20