13.2.2013 Official Journal of the European Union L 42/1 II (Non-legislative acts) REGULATIONS COMMISSION REGULATION (EU) No 122/2013 of 12 February 2013 amending Regulation (EC) No 1950/2006 establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European modes of actions, different pharmacokinetic or phar- macodynamic profiles, different lengths of treatment or different routes of administration. Union, (4)  Substances listed in the Annex to Commission Regu- Having regard to Directive 2001/82/EC of the European lation (EU) No 37/2010 of 22 December 2009 on phar- Parliament and of the Council of 6 November 2001 on the macologically active substances and their classification Community code relating to veterinary medicinal products (*), regarding ‘maximum residue  limits in foodstuffs of and in particular Article 10(3) thereof, animal origin (*) should not appear on the list of essential substances and substances bringing added clinical benefit. Therefore, it is necessary to amend the Whereas: list in the Annex to Regulation (EC) No 1950/2006 to remove from that list any substances listed in Regulation (EU) No 37/2010. (1)  Commission Regulation (EC) No 1950/2006 (%) estab- lished a list of substances essential for the treatment of equidae which, by way of derogation from Article 11 of . . L Directi - . (5) It is also appropriate to remove from the list in the irective 2001/82/EC, may be administered to equidae . . : ; Annex to Regulation (EC) No 1950/2006 several intended for slaughter for human consumption subject to b dentified I . he sub a withdrawal period of not less than six months substances identified as alternatives to the substances : listed, which are not available for the treatment of horses because they are not listed as ‘essential substances’ ()  Regulation (EC) No 470/2009 of the European or ‘substances bringing added clinical benefit' under Parliament and of the Council of 6 May 2009 laying Regulation. (EC) No 1950/2006 nor listed in the Annex down Community procedures for the establishment of to Regulation (EU) No 37/2010. residue limits of pharmacologically active substances in foodstuffs of animal origin (}) amended Article 10(3) of Directive 2001/82/EC in order to include in the list of (6)  Due to changes in Union legislation since the adoption substances reff-:rr.ed to in.that Article substances which of Regulation (EC) No 1950/2006, the references in that bring added clinical benefit compared to other treatment Regulation to the relevant legislation on control mech- options available for equidae, hereinafter ‘substances anisms for equidae and on maximum residue limits bringing added clinical benefit’, in addition to essential should be updated. substances. (3) A substance should only be included in the list as a (7)  The amended list set out in the Annex to this Regulation ‘substance bringing added clinical benefit where it has been subject to a scientific evaluation carried out by provides a Clinically relevant advantage based on the Committee for Veterinary Medicinal Products Of the improved efficacy or safety or a major contribution to European Medicines Agency established by Regulation treatment. This may be the result, inter alia, of different (EC) No 726/2004 of the European Parliament and of the Council (%). () OJ L 311, 28.11.2001, p. 1. () O] L 367, 22.12.2006, p. 33. () OJ L 15, 20.1.2010, p. 1. () O] L 152, 16.6.2009, p. 11. () O] L 136, 30.4.2004, p. 1.