(1)

The maximum residue limit for pharmacologically active substances intended for use in the European 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 maximum residue limits 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 for oral use only, excluding animals from which milk is produced for human consumption, and for all food producing species except fish, for topical use only.

(4)

An application for the extension of the existing entry for sodium salicylate, which is restricted to oral use, to include turkeys has been submitted to the European Medicines Agency.

(5)

The Committee for Medicinal Products for Veterinary Use (hereinafter ‘CVMP’) has established an acceptable daily intake (ADI) for salicylic acid, the marker residue for sodium salicylate, at 0,38 mg/person or 0,0063 mg/kg bodyweight by using and adjusting data available for the related substance acetyl salicylate.

(6)

Based on residue depletion within 24 hours of sodium salicylate in turkeys treated with the substance, the CVMP recommends in its opinion of 13 January 2010 provisional MRLs for muscle, skin, fat, liver and kidney of turkeys. Those provisional MRLs represent 96 % of the maximum daily intake of residues contained in food obtained from turkey.

(7)

Since the relevant data on depletion of sodium salicylate in eggs are not available, the CVMP could not evaluate the safety of substance in eggs. Sodium salicylate should therefore not be used in animals producing eggs for human consumption.

(8)

The entry for sodium salicylate in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the recommended provisional MRLs for sodium salicylate for turkey while excluding the use of the substance in animals producing eggs for human consumption. The provisional MRL set out in that Table for sodium salicylate should expire on 1 January 2015.

(9)

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.

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,