Commission Implementing Regulation (EU) No 406/2013 of 2 May 2013 amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance prednisolone  Text with EEA relevance
Date: 2013-05-02
Institutions: European Commission
Subjects: animal product, cattle, equidae, food safety, foodstuff, market approval, veterinary drug








L_2013121EN.01004201.xml










3.5.2013   


EN


Official Journal of the European Union


L 121/42








            COMMISSION IMPLEMENTING REGULATION (EU) No 406/2013
of 2 May 2013
         
amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance prednisolone
(Text with EEA relevance)


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 of 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 (‘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 should 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)


Prednisolone is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for bovine species, applicable to muscle, fat, liver, kidney and milk.












(4)


An application for the extension of the existing entry for prednisolone applicable to equidae has been submitted to the European Medicines Agency.












(5)


The Committee for Medicinal Products for Veterinary Use recommended the establishment of a MRL for prednisolone for equidae species, applicable to muscle, fat, liver and kidney.












(6)


The entry for prednisolone in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the MRL for equidae.












(7)


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.












(8)


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 3 July 2013.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 2 May 2013.


For the Commission


The President

José Manuel BARROSO
            





(1)  
            OJ L 152, 16.6.2009, p. 11.

(2)  
            OJ L 15, 20.1.2010, p. 1.




ANNEX
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry corresponding to prednisolone 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




‘Prednisolone


Prednisolone


Bovine


4  μg/kg


Muscle


NO ENTRY


Corticoids/Glucocorticoids’




4  μg/kg


Fat




10  μg/kg


Liver




10  μg/kg


Kidney




6  μg/kg


Milk





Equidae



4  μg/kg


Muscle




8  μg/kg


Fat




6  μg/kg


Liver




15  μg/kg


Kidney