The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019

Regulation (EC) 470/2009 of the European Parliament and of the Council U.K.

6.—(1) Regulation (EC) 470/2009 of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin is amended as follows.

(2) In Article 1(3)—

(a) omit “Community”;

(b) after “for by” insert “ the retained EU law which transposed ”.

F1 (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) In Article 3—

(a) for the heading substitute “ Scope ”;

(b) for the first paragraph substitute—

“This Regulation applies to any pharmacologically active substance intended for use in [F2 Great Britain] in veterinary medicinal products which are to be administered to food producing animals.”;

(c) omit the second paragraph.

(5) In Article 4—

(a) for the heading substitute “ Assessment report ”;

(b) for paragraph 1 substitute—

“1.   Where an application for a new or amended maximum residue limit for a substance intended for use in a veterinary medicinal product is made under Article 8, the [F3 Secretary of State] must produce an assessment report which includes a scientific risk assessment and risk management recommendations for the purposes of establishing maximum residue limits for the substance in question.”;

(c) in paragraph 2, for the second sentence substitute—

“The assessment report must take account of any relevant findings of internationally recognised scientific bodies.”;

F4 (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6) In Article 5, for the words from “, the Agency” to the end substitute—

“whilst ensuring a high level of protection of human health, the [F5 Secretary of State] must consider extrapolating maximum residue limits from one species to another or from one foodstuff to another when drafting risk management recommendations”.

(7) In Article 6(1), omit the words from “expressed in terms” to the end.

(8) For Article 11 substitute—

“Article 11 U.K. Review of maximum residue limit

Where the [F6 Secretary of State] considers that a review of the maximum residue limit for a substance is necessary in order to protect human or public health and issues a notice to that effect to the Veterinary Products Committee, that Committee must review the substance in question and report its findings to the [F6 Secretary of State] , together with any recommendations.”.

(9) In Article 12, for the words from “Agency” to “11” substitute “ [F7 Secretary of State] must publish the assessment report referred to in Article 4 ”.

(10) Omit Article 13.

(11) Omit Article 15.

(12) In Article 16—

(a) in paragraph 1, omit the words from “within the” to the end;

(b) for paragraph 2 substitute—

“2.   Paragraph 1 does not apply in the case of clinical trials which are authorised under an Animal Test Certificate.”.

(13) Omit Article 17.

(14) In Article 18—

(a) in the first paragraph, for “Commission” substitute “ [F8 Secretary of State] ”;

(b) in the second paragraph, for “Article 24” substitute “ relevant international decisions ”;

(c) omit the third paragraph.

(15) In Article 19—

(a) for paragraph 1 substitute—

“The reference point for action must be set having taken into account the lowest residue concentration which can be quantified with an analytical method validated in accordance with the Annex to Commission Decision 2002/657/EC. The relevant national reference laboratory must advise the appropriate authority on the performance of analytical methods.”;

(b) omit paragraphs 2 and 3.

(16) Omit Article 20.

(17) For Article 21 substitute—

“Article 21 U.K. Analytical methods

The [F9 Secretary of State] must consult relevant national reference laboratories on appropriate analytical methods for detecting residues of pharmacologically active substances for which maximum residue limits have been determined in accordance with Article 14.”.

(18) Omit Article 22.

(19) In Article 23—

(a) in the first paragraph, in the words after point (b), for “Community legislation” substitute “ retained EU law ”;

(b) omit the second paragraph.

(20) Omit Articles 24 to 28.

(21) In Article 29, omit the first two paragraphs.

(22) Omit Articles 30 to 32.

(23) After Article 32, omit the words from “This Regulation” to “Member States”.

Textual Amendments

F1 Reg. 6(3) omitted (31.12.2020 immediately before IP completion day) by virtue of The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(a), 3(4)(a)

F2 Words in reg. 6(4)(b) substituted (31.12.2020 immediately before IP completion day) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(a), 3(4)(b)

F3 Words in reg. 6(5)(b) substituted (31.12.2020 immediately before IP completion day) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(a), 3(4)(c)(i)

F4 Reg. 6(5)(d) omitted (31.12.2020 immediately before IP completion day) by virtue of The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(a), 3(4)(c)(ii)

F5 Words in reg. 6(6) substituted (31.12.2020 immediately before IP completion day) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(a), 3(4)(d)

F6 Words in reg. 6(8) substituted (31.12.2020 immediately before IP completion day) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(a), 3(4)(e)

F7 Words in reg. 6(9) substituted (31.12.2020 immediately before IP completion day) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(a), 3(4)(f)

F8 Words in reg. 6(14)(a) substituted (31.12.2020 immediately before IP completion day) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(a), 3(4)(g)

F9 Words in reg. 6(17) substituted (31.12.2020 immediately before IP completion day) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(a), 3(4)(h)

Commencement Information

I1 Reg. 6 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)(b)