Definitions
Article 2
For the purposes of this Regulation, the definitions in Regulation (EU) 2017/625, Directive 2001/82/EC and Regulation (EC) No 470/2009 shall apply. The following definitions shall also apply: (a) ‘pharmacologically active substance’ means any substance or mixture of substances intended to be used in the manufacture of a veterinary medicinal product that, when used in its production, becomes an active ingredient of that product; (b) ‘unauthorised substances’ means pharmacologically active substances, which are not included in Table 1 of the Annex to Regulation (EU) No 37/2010 or substances that are not authorised as a feed additive under Regulation (EC) No 1831/2003, with the exception of substances essential for the treatment of equidae and substances bringing added clinical benefit compared to other treatment options available for equidae, as laid down in Regulation (EC) No 1950/2006. (c) ‘illegal treatment’ means the use in food producing animals of — prohibited or unauthorised substances or products, or — substances or veterinary medicinal products authorised under Union legislation for purposes or under conditions other than those laid down in the said legislation or, where appropriate, in national legislation. For the purpose of this Regulation for substances or veterinary medicinal products authorised under Union legislation, non-compliance with the withdrawal period or residues of pharmacologically active substances exceeding the maximum residue limit or maximum level shall not be considered as an illegal treatment, provided that all other conditions on the use of the substance or veterinary medicinal product, laid down in Union or national legislation, are complied with. (d) ‘residues of pharmacologically active substances exceeding the maximum residue limit’ means the presence of residues of authorised pharmacologically active substances in products of animal origin in a concentration, exceeding the maximum residue limits set under Union legislation; (e) ‘residues of pharmacologically active substances exceeding the maximum level’ means the presence of residues of pharmacologically active substances in products of animal origin, resulting from the unavoidable carry-over of these substances in non-target feed, in a concentration, exceeding the maximum levels set under Union legislation; (f) ‘batch of animals’ means a group of animals of the same species, in the same age range, reared on the same holding, at the same time and under the same conditions of rearing.