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Commission Delegated Regulation (EU) 2019/2090 of 19 June 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and Council regarding cases of suspected or established non-compliance with Union rules applicable to the use or residues of pharmacologically active substances authorised in veterinary medicinal products or as feed additives or with Union rules applicable to the use or residues of prohibited or unauthorised pharmacologically active substances (Text with EEA relevance)
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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:
‘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;
‘unauthorised substances’ means pharmacologically active substances, [F1the administration of which have been prohibited under Article 14(2)(d) of Regulation (EC) No 470/2009] 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.
‘illegal treatment’ means the use in food producing animals of
prohibited or unauthorised substances or products, or
substances or veterinary medicinal products authorised under F2... legislation for purposes or under conditions other than those laid down in the said legislation F3....
For the purpose of this Regulation for substances or veterinary medicinal products authorised under F4... 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 F5... legislation, are complied with.
‘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 F6... legislation;
‘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 F7... legislation;
‘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.
Textual Amendments
F1Words in Art. 2(b) substituted (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 8(3)(a)
F2Word in Art. 2(c) omitted (31.12.2020) by virtue of The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 8(3)(b)(i)(aa)
F3Words in Art. 2(c) omitted (31.12.2020) by virtue of The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 8(3)(b)(i)(bb)
F4Word in Art. 2(c) omitted (31.12.2020) by virtue of The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 8(3)(b)(ii)(aa)
F5Words in Art. 2(c) omitted (31.12.2020) by virtue of The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 8(3)(b)(ii)(bb)
F6Word in Art. 2(d) omitted (31.12.2020) by virtue of The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 8(3)(c)
F7Word in Art. 2(e) omitted (31.12.2020) by virtue of The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 8(3)(d)
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