Commission Implementing Regulation (EU) No 1191/2012 of 12 December 2012 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 sodium salicylate Text with EEA relevance
Date: 2012-12-12
Institutions: European Commission
Subjects: animal product, food safety, foodstuff, market approval, veterinary drug








L_2012340EN.01003501.xml










13.12.2012   


EN


Official Journal of the European Union


L 340/35








            COMMISSION IMPLEMENTING REGULATION (EU) No 1191/2012
of 12 December 2012
         
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 sodium salicylate
(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 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (2).












(3)


Sodium salicylate is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance for bovine and porcine species, excluding animals producing milk for human consumption, for all food-producing species except fin fish species, for topical use only, and for turkey, applicable to muscle, skin and fat, liver and kidney, excluding animals producing eggs for human consumption. The provisional MRL for that substance set out for turkey expires on 1 July 2015.












(4)


Additional data were provided and assessed leading the Committee for Medicinal Products for Veterinary Use to recommend that the provisional MRLs for sodium salicylate for turkey should be set as definitive.












(5)


The entry for sodium salicylate in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended accordingly.












(6)


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.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 12 December 2012.


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
The entry corresponding to sodium salicylate in Table 1 of the Annex to Regulation (EU) No 37/2010 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




‘Sodium salicylate


NOT APPLICABLE


Bovine, porcine


No MRL required


NOT APPLICABLE


For oral use.
Not for use in animals from which milk is produced for human consumption.


NO ENTRY




All food-producing species except fin fish


No MRL required


NOT APPLICABLE


For topical use only.




Salicylic acid


Turkey


400  μg/kg


Muscle


Not for use in animals producing eggs for human consumption.


Anti-inflammatory agents/Non-steroidal anti-inflammatory agents’




2 500  μg/kg


Skin and fat in natural proportions




200  μg/kg


Liver




150  μg/kg


Kidney