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THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and the Council (1), and in particular Article 14 in conjunction with Article 17 thereof,
Having regard to the opinion of the European Medicines Agency formulated by the Committee for Medicinal Products for Veterinary Use,
Whereas:
(1)
The maximum residue limit (hereinafter ‘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.
(2)
Pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin are set out in the Annex to Commission Regulation (EU) No 37/2010 (2).
(3)
Rafoxanide is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for bovine and ovine species, applicable to muscle, fat, liver and kidney, excluding animals producing milk for human consumption.
(4)
A request for an opinion on the extrapolation of the existing entry for rafoxanide applicable to bovine milk has been submitted to the European Medicines Agency.
(5)
The Committee for Medicinal Products for Veterinary Use has recommended the establishment of a provisional MRL for rafoxanide for bovine and ovine milk and the removal of the prohibition to use that substance in animals from which milk is produced for human consumption.
(6)
The entry for rafoxanide in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the recommended provisional MRL for bovine and ovine milk and to remove the prohibition to use that substance from animals from which milk is produced for human consumption.
(7)
The provisional MRL for rafoxanide set out in that Table should expire on 31 December 2015.
(8)
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.
(9)
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 third day following that of its publication in the Official Journal of the European Union.
It shall apply from 19 August 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 20 June 2014.
For the Commission
The President
José Manuel BARROSO
ANNEX
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance ‘rafoxanide’ 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 |
|
‘Rafoxanide |
Rafoxanide |
Bovine |
30 μg/kg |
Muscle |
NO ENTRY |
Antiparasitic agents/Agents against endoparasites’ |
|
30 μg/kg |
Fat |
|||||
|
10 μg/kg |
Liver |
|||||
|
40 μg/kg |
Kidney |
|||||
|
Ovine |
100 μg/kg |
Muscle |
||||
|
250 μg/kg |
Fat |
|||||
|
150 μg/kg |
Liver |
|||||
|
150 μg/kg |
Kidney |
|||||
|
Bovine, ovine |
10 μg/kg |
Milk |
Provisional MRL shall expire on 31 December 2015 |
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