Regulation (EC) No 470/2009 of the European Parliament and of the CouncilDangos y teitl llawn

CHAPTER I U.K. Risk assessment and risk management

Section 1 U.K. Pharmacologically active substances intended for use in veterinary medicinal products in the Community

Article 3 U.K. [F1 Scope]

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

F3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 Art. 3 heading substituted (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 6(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 3 substituted (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 6(4)(b) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(4)(b)); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 3 omitted (31.12.2020) by virtue of The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 6(4)(c); 2020 c. 1, Sch. 5 para. 1(1)

Article 4 U.K. [F4 Assessment report]

[F5 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 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.]

2. The scientific risk assessment and the risk management recommendations shall aim to ensure a high level of human health protection, whilst also ensuring that human health, animal health and animal welfare are not negatively affected by the lack of availability of appropriate veterinary medicinal products. [F6 The assessment report must take account of any relevant findings of internationally recognised scientific bodies.]

Textual Amendments

F4 Art. 4 heading substituted (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 6(5)(a); 2020 c. 1, Sch. 5 para. 1(1)

F5 Art. 4(1) substituted (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 6(5)(b) (as amended) by S.I. 2020/1461 regs. 1(2)(a), 3(4)(c)(i)); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in Art. 4(2) substituted (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 6(5)(c); 2020 c. 1, Sch. 5 para. 1(1)

Article 5 U.K. Extrapolation

With a view to ensuring the availability of authorised veterinary medicinal products for conditions affecting food-producing animals [F7 whilst ensuring a high level of protection of human health, the 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]

Textual Amendments

F7 Words in Art. 5 substituted (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 6(6) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(4)(d)); 2020 c. 1, Sch. 5 para. 1(1)

Article 6 U.K. Scientific risk assessment

1. The scientific risk assessment shall consider the metabolism and depletion of pharmacologically active substances in relevant animal species, the type of residues and the amount thereof, that may be ingested by human beings over a lifetime without an appreciable health risk F8 ....

2. The scientific risk assessment shall concern the following:

(a) the type and amount of residue considered not to present a safety concern for human health;

(b) the risk of toxicological, pharmacological or microbiological effects in human beings;

(c) residues that occur in food of plant origin or that come from the environment.

3. If the metabolism and depletion of the substance cannot be assessed, the scientific risk assessment may take into account monitoring data or exposure data.

Textual Amendments

F8 Words in Art. 6(1) omitted (31.12.2020) by virtue of The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 6(7); 2020 c. 1, Sch. 5 para. 1(1)

Article 7 U.K. Risk management recommendations

The risk management recommendations shall be based on the scientific risk assessment performed in accordance with Article 6 and shall consist of an assessment of the following:

(a)

the availability of alternative substances for the treatment of the relevant species or the necessity of the substance evaluated in order to avoid unnecessary suffering for animals or to ensure the safety of those treating them;

(b)

other legitimate factors, such as the technological aspects of food and feed production, the feasibility of controls, conditions of use and application of the substances in veterinary medicinal products, good practice in the use of veterinary medicinal and biocidal products and the likelihood of misuse or illegal use;

(c)

whether or not a maximum residue limit or a provisional maximum residue limit should be established for a pharmacologically active substance in veterinary medicinal products, the level of that maximum residue limit and, where appropriate, any conditions or restrictions for the use of the substance concerned;

(d)

whether the data provided are not sufficient to allow a safe limit to be identified, or whether a final conclusion concerning human health with regard to residues of a substance cannot be established given the lack of scientific information. In either case, no maximum residue limit may be recommended.

[F9 Article 8 U.K. Application for a maximum residue limit

1. An application under these Regulations for a new or amended maximum residue limit for a substance intended for use in a veterinary medicinal product must be made to the Secretary of State.

2. An application must include all necessary administrative information, and all scientific documentation necessary for demonstrating the safety of the substance.

3. The applicant must pay to the Secretary of State the application fee, which is—

(a) for a new maximum residue limit in respect of a substance, £62,300;

(b) for an amended maximum residue limit in respect of a substance, £18,850.

4. The Secretary of State must ensure that where a valid application is received, the substance is classified under Article 14 within 210 days.

5. For the purposes of paragraph 4 an application is valid when both the requirements in paragraphs 2 and 3 have been complied with.

6. As soon as practicable after the substance is classified under Article 14, the Secretary of State must publish—

(a) a notice setting out the classification;

(b) the assessment report that has been prepared, with any commercially confidential or personal information deleted.

7. If the Secretary of State classifies a substance under Article 14(2)(b) or (d), the Secretary of State must notify the applicant accordingly, and the applicant may appeal to the Veterinary Products Committee under regulation 29 of the Veterinary Medicines Regulations 2013.]

Textual Amendments

F9 Art. 8 substituted (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), reg. 1(2), Sch. 9 Pt. 1 (as amended by S.I. 2020/1461, regs. 1(2)(a), 2(5)(a)); 2020 c. 1, Sch. 5 para. 1(1)

Section 2 U.K. Other pharmacologically active substances for which an opinion of the Agency may be requested

[F10 Article 9 U.K. Further power for appropriate authority to classify substances

1. The Secretary of State may classify a substance intended for use in a veterinary medicinal product which is to be administered to food-producing animals under Article 14 without an application having been made under these Regulations.

2. The power in paragraph 1 includes power to classify a substance which has previously been classified under Article 14.]

Textual Amendments

F10 Art. 9 substituted (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), reg. 1(2), Sch. 9 Pt. 2 (as amended by S.I. 2020/1461, regs. 1(2)(a), 2(5)(b)); 2020 c. 1, Sch. 5 para. 1(1)

Article 10 U.K. Pharmacologically active substances contained in biocidal products used in animal husbandry

[F11 1. An application for the classification of a pharmacologically active substance intended to be used in a biocidal product used in animal husbandry pursuant to Article 19(7) of Regulation (EU) 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products must be made under Article 8, notwithstanding that it is not a substance intended for use in a veterinary medicinal product to be administered to food-producing animals.

1A. The power to classify a substance under Article 9 may be exercised in respect of a pharmacologically active substance intended to be used in a biocidal product used in animal husbandry, notwithstanding that it is not a substance intended for use in a veterinary medicinal product to be administered to food-producing animals, where the Secretary of State considers it appropriate to do so for the purposes of Article 19(1)(e) of Regulation (EU) 528/2012.

1B. Where proposals are made for the classification of a substance under Article 9 in the circumstances described in paragraph 1A by a devolved authority, the Secretary of State must have regard to such proposals when exercising functions under that paragraph.

1C. In this Article, “devolved authority” means the Scottish Ministers or the Welsh Ministers.]

2. The [F12 Secretary of State] shall classify the pharmacologically active substances referred to in [F13 paragraphs 1 and 1A] in accordance with Article 14 [F14 , subject to the consent requirement in Article 83B of Regulation (EU) 528/2012 (treating this Article as a provision of that Regulation for the purposes of construing Article 83B(1))]. F15 ...

However, any specific provisions relating to the conditions of use of the substances classified in accordance with the first subparagraph of this paragraph shall be laid down pursuant to [F16 Article 19(7) of Regulation (EU) No 528/2012].

F17 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F11 Art. 10(1)-(1C) substituted for Art. 10(1) (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), reg. 1(2), Sch. 9 Pt. 3 (as amended by S.I. 2020/1461, regs. 1(2)(a), 2(5)(c); 2020 c. 1, Sch. 5 para. 1(1)

F12 Words in Art. 10(2) 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(4)(b)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F13 Words in Art. 10(2) 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(4)(b)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)

F14 Words in Art. 10(2) inserted (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(4)(b)(i)(cc); 2020 c. 1, Sch. 5 para. 1(1)

F15 Words in Art. 10(2) omitted (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 18(4)(b)(i)(dd); 2020 c. 1, Sch. 5 para. 1(1)

F16 Words in Art. 10(2) 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(4)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F17 Art. 10(3) omitted (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 18(4)(c); 2020 c. 1, Sch. 5 para. 1(1)

Section 3 U.K. Common provisions

[F18 Article 11 U.K. Review of maximum residue limit

Where the 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 Secretary of State, together with any recommendations.]

Textual Amendments

F18 Art. 11 substituted (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 6(8) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(4)(e)); 2020 c. 1, Sch. 5 para. 1(1)

Article 12 U.K. Publication of opinions

The [F19 Secretary of State must publish the assessment report referred to in Article 4] after deleting any information of a commercially confidential nature.

Textual Amendments

F19 Words in Art. 12 substituted (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 6(9) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(4)(f)); 2020 c. 1, Sch. 5 para. 1(1)

F20 Article 13 U.K. Implementing measures

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F20 Art. 13 omitted (31.12.2020) by virtue of The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 6(10); 2020 c. 1, Sch. 5 para. 1(1)