Regulation (EC) No 470/2009 of the European Parliament and of the CouncilShow full title

Article 14 U.K. Classification of pharmacologically active substances

[F1 1. The Secretary of State must classify pharmacologically active substances in accordance with this Article.]

2. The classification shall include a list of pharmacologically active substances and the therapeutic classes to which they belong. The classification shall also establish, in relation to each such substance, and, where appropriate, specific foodstuffs or species, one of the following:

(a) a maximum residue limit;

(b) a provisional maximum residue limit;

(c) the absence of the need to establish a maximum residue limit;

(d) a prohibition on the administration of a substance.

3. A maximum residue limit shall be laid down where it appears necessary for the protection of human health [F2 , and when laying down a limit regard may be had to any international decisions in respect of that substance.]

4. A provisional maximum residue limit may be established in cases where scientific data are incomplete, provided that there are no grounds for supposing that residues of that substance at the level proposed constitute a hazard to human health.

The provisional maximum residue limit shall apply for a defined period of time, which shall not exceed five years. That period may be extended once for a period not exceeding two years where it is demonstrated that such an extension would allow completion of scientific studies in progress.

5. No maximum residue limit shall be established where F3 ... it is not necessary for the protection of human health.

6. The administration of a substance to food-producing animals shall be prohibited F4 ... in either of the following circumstances:

(a) where any presence of a pharmacologically active substance or residues thereof in foods of animal origin may constitute a hazard to human health;

(b) where no final conclusion concerning the effect on human health of residues of a substance can be drawn.

7. Where it appears necessary for the protection of human health, the classification shall include conditions and restrictions for the use or application of a pharmacologically active substance used in veterinary medicinal products which is subject to a maximum residue limit, or for which no maximum residue limit has been set.

Textual Amendments

F1 Art. 14(1) substituted (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 18(5)(a) (as amended by S.I. 2020/1461, regs. 1(2)(a), 2(3); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 14(3) substituted (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 18(5)(b); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 14(5) omitted (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 18(5)(c); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Art. 14(6) omitted (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 18(5)(d); 2020 c. 1, Sch. 5 para. 1(1)