Commission Implementing Regulation (EU) 2015/151
of 30 January 2015
amending the Annex to Regulation (EU) No 37/2010 as regards the substance ‘doxycycline’
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to the opinion of the European Medicines Agency formulated by the Committee for Medicinal Products for Veterinary Use,
Whereas:
The maximum residue limit (MRL) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry is to be established in accordance with Regulation (EC) No 470/2009.
Doxycycline is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for bovine, porcine and poultry species, applicable to muscle, liver and kidney in bovine species, excluding animals producing milk for human consumption, and to muscle, skin and fat, liver and kidney in porcine and poultry species, excluding animals producing eggs for human consumption.
An application for the extension of the existing entry for doxycycline to rabbits has been submitted to the European Medicines Agency.
In accordance with Article 5 of Regulation (EC) No 470/2009 the European Medicines Agency is to consider using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or MRLs established for a pharmacologically active substance in one or more species for other species. The Committee for Medicinal Products for Veterinary Use recommended the establishment of a MRL for doxycycline for rabbits, and the extrapolation of the MRLs for doxycycline from bovine, porcine, poultry and rabbit species to all food-producing species.
The entry for doxycycline in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the MRL for all food-producing species, applicable to muscle, fat, liver and kidney, excluding animals producing milk or eggs for human consumption.
It is appropriate to provide for a reasonable period of time for the stakeholders concerned to take measures that may be required to comply with the newly set MRL.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,
HAS ADOPTED THIS REGULATION: