Commission Implementing Regulation (EU) 2015/152
of 30 January 2015
amending the Annex to Regulation (EU) No 37/2010, as regards the substance ‘tulathromycin’
(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.
Tulathromycin is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for bovine and porcine species, applicable to muscle, fat (skin and fat for porcine species), liver and kidney, excluding animals producing milk for human consumption. The provisional MRL for that substance set out for bovine and porcine species expires on 1 January 2015.
An application for the extension of the existing entry to ovine species applicable to muscle, fat, liver and kidney 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 extension of the MRL to ovine species and the extrapolation of the MRLs from ovine species to caprine species.
The entry for tulathromycin in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the MRL for ovine and caprine species.
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:
Article 1
The Annex to Regulation (EU) No 37/2010 is amended as set out in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 April 2015.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 30 January 2015.
For the Commission
The President
Jean-Claude Juncker
ANNEX
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance ‘tulathromycin’ is replaced by the following:
Pharmacologically active Substance
Marker residue
Animal Species
MRL
Target Tissues
Other Provisions (according to Article 14(7) of Regulation (EC) No 470/2009)
Therapeutic classification
‘Tulathromycin
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-ethyl-3,4,10,13-tetra-hydroxy-3,5,8,10,12,14-hexamethyl-11-[[3,4,6-trideoxy-3-(dimethy-lamino)-ß-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopent-decan-15-one expressed as tulathromycin equivalents
Ovine, caprine
450 μg/kg
Muscle
Not for use in animals from which milk is produced for human consumption
Anti-infectious agents/Antibiotics’
250 μg/kg
Fat
5 400 μg/kg
Liver
1 800 μg/kg
Kidney
Bovine
300 μg/kg
Muscle
Not for use in animals from which milk is produced for human consumption
Provisional MRLs expire on 1 January 2015
200 μg/kg
Fat
4 500 μg/kg
Liver
3 000 μg/kg
Kidney
Porcine
800 μg/kg
Muscle
Provisional MRLs expire on 1 January 2015
300 μg/kg
Skin and fat in natural proportions
4 000 μg/kg
Liver
8 000 μg/kg
Kidney