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European public MRL assessment report (EPMAR)
Publication date: 22-02-2012On 1 February 2012 the European Commission adopted a Regulation establishing maximum residue limits for phenoxymethylpenicillin in eggs, valid throughout the European Union. These maximum residue limits were based on the favourable opinion and the assessment report adopted by the Committee for Medicinal Products for Veterinary Use.
Phenoxymethylpenicillin is intended for use in poultry for the treatment and control of clostridium enteritis and administered via the drinking water.
Phenoxymethylpenicillin had maximum residue limits already established for pigs and poultry.
Dopharma Research B.V. submitted the application for the extension of maximum residue limits to the European Medicines Agency, on 28 September 2010.
Based on the original and complementary data in the dossier, the Committee for Medicinal Products for Veterinary Use recommended on 14 July 2011 the establishment of maximum residue limits for phenoxymethylpenicillin in eggs. Subsequently the Commission recommended on 1 December 2011 that maximum residue limits in eggs are established. This recommendation was confirmed on 22 December 2011 by the Standing Committee on Veterinary Medicinal Products and adopted by the European Commission on 1 February 2012.
With this MRL adopted we soon expect the full EU registration for Phenoxypen for use in poultry.
Download the full report or visit our Phenoxypen website for more information.
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