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

Regulation (EC) No 470/2009 of the European Parliament and of the Council

of 6 May 2009

laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 37 and Article 152(4)(b) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee(1),

After consulting the Committee of the Regions,

Acting in accordance with the procedure referred to in Article 251 of the Treaty(2),

Whereas:

(1) As a result of scientific and technical progress it is possible to detect the presence of residues of veterinary medicinal products in foodstuffs at ever lower levels.

(2) In order to protect public health, maximum residue limits should be established in accordance with generally recognised principles of safety assessment, taking into account toxicological risks, environmental contamination, as well as the microbiological and pharmacological effects of residues. Account should also be taken of other scientific assessments of the safety of substances concerned which may have been undertaken by international organisations or scientific bodies established within the Community.

(3) This Regulation directly concerns public health and is relevant to the functioning of the internal market in products of animal origin included in Annex I to the Treaty. It is therefore necessary to establish maximum residue limits for pharmacologically active substances in respect of various foodstuffs of animal origin, including meat, fish, milk, eggs and honey.

(4) Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin(3) introduced Community procedures to evaluate the safety of residues of pharmacologically active substances in accordance with human food safety requirements. A pharmacologically active substance may be used in food-producing animals only if evaluated favourably. Maximum residue limits are established for such substances where they are considered necessary for the protection of human health.

(5) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to veterinary medicinal products(4) provides that veterinary medicinal products may be authorised or used in food-producing animals only if pharmacologically active substances contained therein have been assessed as safe according to Regulation (EEC) No 2377/90. Moreover that Directive contains rules concerning the documentation of use, re-designation (off label use), prescription and distribution of veterinary medicinal products intended for use in food-producing animals.

(6) In the light of the European Parliament’s resolution of 3 May 2001(5) on the availability of veterinary medicinal products, the Commission’s public consultation undertaken in 2004 and its assessment of the experience gained, it has proved necessary to modify the procedures for setting maximum residue limits while maintaining the overall system for setting such limits.

(7) Maximum residue limits are the points of reference for the establishment, in accordance with Directive 2001/82/EC, of withdrawal periods in marketing authorisations for veterinary medicinal products to be used in food-producing animals as well as for the control of residues in food of animal origin in the Member States and at border inspection posts.

(8) Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stock-farming of certain substances having a hormonal or thyrostatic action and of β-agonists(6) prohibits the use of certain substances for specific purposes in food-producing animals. This Regulation should apply without prejudice to any Community legislation prohibiting the use in food-producing animals of certain substances having a hormonal action.

(9) Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food(7) lays down specific rules for substances not resulting from intentional administration. Those substances should not be subject to legislation on maximum residue limits.

(10) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(8) lays down the framework for food legislation at Community level and provides for definitions in that area. It is appropriate that those definitions apply for the purposes of legislation on maximum residue limits.

(11) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules(9) lays down general rules for the control of food in the Community and provides for definitions in that area. It is appropriate that those rules and definitions apply for the purposes of legislation on maximum residue limits. Priority should be given to the detection of the illegal use of substances and part of the samples should be selected according to a risk-based approach.

(12) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency(10) entrusts the European Medicines Agency (the Agency) with the task of advising on the maximum residue limits for veterinary medicinal products which may be accepted in food of animal origin.

(13) Maximum residue limits should be set for pharmacologically active substances used or intended to be used in veterinary medicinal products placed on the market in the Community.

(14) It appears from the public consultation and from the fact that only a small number of veterinary medicinal products for food-producing animals have been authorised in recent years that Regulation (EEC) No 2377/90 has resulted in such medicinal products being less readily available.

(15) In order to ensure animal health and welfare, it is necessary that veterinary medicinal products are available to treat specific disease conditions. Furthermore, the lack of availability of appropriate veterinary medicinal products for a specific treatment for a specific species may contribute to the misuse or illegal use of substances.

(16) The system established by Regulation (EEC) No 2377/90 should therefore be modified with a view to increasing the availability of veterinary medicinal products for food-producing animals. In order to serve that objective, provision should be made for the systematic consideration by the Agency of the use of a maximum residue limit established for one species or foodstuff for another species or another foodstuff. In this respect, the adequacy of the safety factors already inherent in the system should be taken into account in order to ensure that food safety and animal welfare are not compromised.

(17) It is recognised that, in certain cases, scientific risk assessments alone cannot provide all the information on which risk management decisions should be based and that other factors relevant to the matter under consideration should legitimately be taken into account, including the technological aspects of food production and the feasibility of controls. The Agency should therefore provide an opinion consisting of a scientific risk assessment and risk management recommendations on residues of pharmacologically active substances.

(18) Detailed rules on the format and content of applications for the establishment of maximum residue limits and on methodological principles of risk assessment and of risk management recommendations are necessary for the smooth functioning of the whole framework of maximum residue limits.

(19) Besides veterinary medicinal products, other products which are not subject to specific legislation on residues, such as biocidal products, are used in animal husbandry. These biocidal products are defined in Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market(11). Furthermore, veterinary medicinal products not having a marketing authorisation in the Community may be authorised in countries outside the Community. That may be because in other regions different diseases or target species are more prevalent or because companies have chosen not to market a product in the Community. The fact that a product is not authorised in the Community does not necessarily indicate that its use is unsafe. For the pharmacologically active substances of such products, the Commission should be enabled to set a maximum residue limit for food, following an opinion by the Agency, in accordance with the principles set for pharmacologically active substances intended for use in veterinary medicinal products. It is also necessary to amend Regulation (EC) No 726/2004 to include, within the tasks of the Agency, advising on the maximum levels of residues of active substances in biocidal products.

(20) Under the system established by Directive 98/8/EC, operators having placed or seeking to place biocidal products on the market are obliged to pay charges for the evaluations carried out pursuant to different procedures associated with that Directive. This Regulation provides that the Agency is to carry out evaluations related to the establishment of the maximum residue limit for pharmacologically active substances intended to be used in biocidal products. As a consequence, this Regulation should clarify how those evaluations are financed, in order to take due account of fees already collected for evaluations carried out, or to be carried out, under that Directive.

(21) The Community contributes, in the context of the Codex Alimentarius, to the development of international standards on maximum residue limits, while ensuring that the high level of protection of human health maintained in the Community is not reduced. The Community should therefore take over without a further risk assessment those Codex Alimentarius maximum residue limits it has supported in the relevant Codex Alimentarius Commission meetings. Consistency between international standards and Community legislation on residue limits in food will thereby be further enhanced.

(22) Foodstuffs are subject to controls on residues of pharmacologically active substances in accordance with Regulation (EC) No 882/2004. Even if residue limits are not set for such substances pursuant to this Regulation, residues of such substances might occur due to environmental contamination or the occurrence of a natural metabolite in the animal. Laboratory methods are capable of finding such residues at ever lower levels. Such residues have caused different control practices in Member States.

(23) Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries(12) requires that each consignment imported from a third country is subject to veterinary controls, and Commission Decision 2005/34/EC(13) lays down harmonised standards for the testing for certain residues in products of animal origin imported from third countries. It is appropriate to extend the provisions of Decision 2005/34/EC to all products of animal origin placed on the Community market.

(24) A number of pharmacologically active substances are prohibited or currently not authorised under Regulation (EC) No 2377/90, Directive 96/22/EC or Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition(14). The residues of pharmacologically active substances in products of animal origin arising, in particular, from illegal use or from environmental contamination should be carefully controlled and monitored in accordance with Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products(15), regardless of the origin of the product.

(25) It is appropriate for the Community to provide for procedures to set reference points for action at concentrations of the residues for which laboratory analysis is technically feasible in order to facilitate intra-Community trade and imports, without undermining a high level of protection of human health in the Community. However, the setting of reference points for action should in no way serve as a pretext for condoning the illegal use of prohibited or non-authorised substances to treat food-producing animals. Therefore, any residues of those substances in food of animal origin should be considered undesirable.

(26) It is also appropriate for the Community to establish a harmonised approach for situations where Member States find evidence of a recurrent problem, since such a finding could suggest a pattern of misuse of a particular substance or a disregard for guarantees provided by third countries concerning the production of food intended for import into the Community. Member States should notify the Commission of recurring problems, and appropriate follow-up measures should be taken.

(27) The current legislation on maximum residue limits should be simplified by placing together in one single Commission regulation all decisions classifying pharmacologically active substances as regards residues.

(28) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(16).

(29) In particular, the Commission should be empowered to adopt methodological principles for the risk assessment and risk management recommendations regarding the establishment of maximum residue limits, rules on the conditions for extrapolation, measures setting reference points for action, including measures reviewing those reference points, as well as methodological principles and scientific methods for the establishment of reference points for action. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(30) When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of measures setting reference points for action and measures reviewing those reference points.

(31) Since the objectives of this Regulation, namely the protection of human and animal health and ensuring the availability of appropriate veterinary medicinal products, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of this Regulation, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

(32) In the interests of clarity, it is therefore necessary to replace Regulation (EEC) No 2377/90 with a new regulation.

(33) A transitional period should be provided for in order to allow the Commission to prepare and adopt a regulation incorporating the pharmacologically active substances and their classification regarding maximum residue limits as laid down in Annexes I to IV to Regulation (EEC) No 2377/90, as well as certain implementing provisions for that new regulation,

HAVE ADOPTED THIS REGULATION:

TITLE I U.K. GENERAL PROVISIONS

Article 1 U.K. Subject matter and scope

1. For the purposes of ensuring food safety, this Regulation lays down rules and procedures in order to establish:

(a) the maximum concentration of a residue of a pharmacologically active substance which may be permitted in food of animal origin (maximum residue limit);

(b) the level of a residue of a pharmacologically active substance established for control reasons in the case of certain substances for which a maximum residue limit has not been laid down in accordance with this Regulation (reference point for action).

2. This Regulation shall not apply:

(a) to active principles of biological origin intended to produce active or passive immunity or to diagnose a state of immunity, used in immunological veterinary medicinal products;

(b) to substances falling within the scope of Regulation (EEC) No 315/93.

3. This Regulation shall apply without prejudice to F1 ... legislation prohibiting the use in food-producing animals of certain substances having a hormonal or thyrostatic action and of beta-agonists, as provided for by [F2 the retained EU law which transposed] Directive 96/22/EC.

Textual Amendments

F1 Word in Art. 1(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(2)(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 1(3) inserted (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(2)(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 2 U.K. Definitions

In addition to the definitions laid down in Article 1 of Directive 2001/82/EC, Article 2 of Regulation (EC) No 882/2004 and Articles 2 and 3 of Regulation (EC) No 178/2002, the following definitions shall apply for the purposes of this Regulation:

(a)

‘residues of pharmacologically active substances’ means all pharmacologically active substances, expressed in mg/kg or μg/kg on a fresh weight basis, whether active substances, excipients or degradation products, and their metabolites which remain in food obtained from animals;

(b)

‘food-producing animals’ means animals bred, raised, kept, slaughtered or harvested for the purposes of producing food.

TITLE II U.K. MAXIMUM RESIDUE LIMITS

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. [F3 Scope]

[F4 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.]

F5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F3 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)

F4 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)

F5 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. [F6 Assessment report]

[F7 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. [F8 The assessment report must take account of any relevant findings of internationally recognised scientific bodies.]

Textual Amendments

F6 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)

F7 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)

F8 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 [F9 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

F9 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 F10 ....

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

F10 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.

[F11 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

F11 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

[F12 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

F12 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

[F13 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 [F14 Secretary of State] shall classify the pharmacologically active substances referred to in [F15 paragraphs 1 and 1A] in accordance with Article 14 [F16 , 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))]. F17 ...

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 [F18 Article 19(7) of Regulation (EU) No 528/2012].

F19 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F13 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)

F14 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)

F15 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)

F16 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)

F17 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)

F18 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)

F19 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

[F20 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

F20 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 [F21 Secretary of State must publish the assessment report referred to in Article 4] after deleting any information of a commercially confidential nature.

Textual Amendments

F21 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)

F22 Article 13 U.K. Implementing measures

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

Textual Amendments

F22 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)

CHAPTER II U.K. Classification

Article 14 U.K. Classification of pharmacologically active substances

[F23 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 [F24 , 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 F25 ... it is not necessary for the protection of human health.

6. The administration of a substance to food-producing animals shall be prohibited F26 ... 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

F23 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)

F24 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)

F25 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)

F26 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)

[F27 Article 14A U.K. MRL register

1. The Secretary of State must maintain a register (“the MRL register”) in accordance with this Article.

2. The MRL register must contain—

(a) a list of substances which have been classified under Article 14;

(b) in respect of each such substance—

(i) any maximum residue limit or other matter established under paragraph 2 of Article 14;

(ii) any conditions or restrictions included in the classification pursuant to paragraph 7 of Article 14.

3. The MRL register must be kept up to date.

4. The MRL register must contain a search facility.

5. The Secretary of State must make the MRL register available for inspection by the public on a website maintained by the Secretary of State.]

Textual Amendments

F27 Art. 14A inserted (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. 4 (as amended by S.I. 2020/1461, regs. 1(2)(a), 2(5)(d)(ii)) 2020 c. 1, Sch. 5 para. 1(1)

F28 Article 15 U.K. Accelerated procedure for an opinion of the Agency

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

Textual Amendments

F28 Art. 15 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(11); 2020 c. 1, Sch. 5 para. 1(1)

Article 16 U.K. Administration of substances to food-producing animals

1. Only pharmacologically active substances which are classified in accordance with Article 14(2)(a), (b) or (c) may be administered to food-producing animals F29 ....

[F30 2. Paragraph 1 does not apply in the case of clinical trials which are authorised under an Animal Test Certificate.]

Textual Amendments

F29 Words in Art. 16(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(12)(a); 2020 c. 1, Sch. 5 para. 1(1)

F30 Art. 16(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(12)(b); 2020 c. 1, Sch. 5 para. 1(1)

F31 Article 17 U.K. Procedure

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

Textual Amendments

F31 Art. 17 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(13); 2020 c. 1, Sch. 5 para. 1(1)

TITLE III U.K. REFERENCE POINTS FOR ACTION

Article 18 U.K. Establishment and review

When it is deemed necessary in order to ensure the functioning of controls of food of animal origin imported or placed on the market in accordance with Regulation (EC) No 882/2004, the [F32 Secretary of State] may establish reference points for action for residues from pharmacologically active substances which are not subject to a classification in accordance with Article 14(2)(a), (b) or (c).

The reference points for action shall be reviewed regularly in the light of new scientific data relating to food safety, the outcome of the investigations and analytical tests referred to in [F33 relevant international decisions] and technological progress.

F34 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F32 Words in Art. 18 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(14)(a) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(4)(g)); 2020 c. 1, Sch. 5 para. 1(1)

F33 Words in Art. 18 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(14)(b); 2020 c. 1, Sch. 5 para. 1(1)

F34 Words in Art. 18 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(14)(c); 2020 c. 1, Sch. 5 para. 1(1)

Article 19 U.K. Methods for establishing reference points for action

[F35 1. 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.]

F36 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F37 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F35 Art. 19(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(15)(a); 2020 c. 1, Sch. 5 para. 1(1)

F36 Art. 19(2) 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(15)(b); 2020 c. 1, Sch. 5 para. 1(1)

F37 Art. 19(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(15)(b); 2020 c. 1, Sch. 5 para. 1(1)

F38 Article 20 U.K. Community contribution to the support measures for reference points for action

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

Textual Amendments

F38 Art. 20 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(16); 2020 c. 1, Sch. 5 para. 1(1)

TITLE IV U.K. MISCELLANEOUS PROVISIONS

[F39 Article 21 U.K. Analytical methods

The 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.]

Textual Amendments

F39 Art. 21 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(17) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(4)(h)); 2020 c. 1, Sch. 5 para. 1(1)

F40 Article 22 U.K. Circulation of foodstuffs

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

Textual Amendments

F40 Art. 22 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(18); 2020 c. 1, Sch. 5 para. 1(1)

Article 23 U.K. Placing on the market

Food of animal origin containing residues of a pharmacologically active substance:

(a)

classified in accordance with Article 14(2)(a), (b) or (c) at a level exceeding the maximum residue limit established pursuant to this Regulation; or

(b)

not classified in accordance with Article 14(2)(a), (b) or (c), except where a reference point for action has been set for that substance pursuant to this Regulation and the level of residues does not equal or exceed that reference point for action;

shall be considered not to comply with [F41 retained EU law].

F42 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F41 Words in Art. 23 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(19)(a); 2020 c. 1, Sch. 5 para. 1(1)

F42 Words in Art. 23 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(19)(b); 2020 c. 1, Sch. 5 para. 1(1)

F43 Article 24 U.K. Action in case of confirmed presence of a prohibited or non-authorised substance

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

Textual Amendments

F43 Arts. 24-28 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(20); 2020 c. 1, Sch. 5 para. 1(1)

TITLE V U.K. FINAL PROVISIONS

F43 Article 25 U.K. Standing Committee on Veterinary Medicinal Products

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

Textual Amendments

F43 Arts. 24-28 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(20); 2020 c. 1, Sch. 5 para. 1(1)

F43 Article 26 U.K. Standing Committee on the Food Chain and Animal Health

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

Textual Amendments

F43 Arts. 24-28 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(20); 2020 c. 1, Sch. 5 para. 1(1)

F43 Article 27 U.K. Classification of pharmacologically active substances under Regulation (EEC) No 2377/90

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

Textual Amendments

F43 Arts. 24-28 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(20); 2020 c. 1, Sch. 5 para. 1(1)

F43 Article 28 U.K. Reporting

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

Textual Amendments

F43 Arts. 24-28 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(20); 2020 c. 1, Sch. 5 para. 1(1)

Article 29 U.K. Repeal

F44 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F44 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

References to the repealed Regulation shall be construed as references to this Regulation or, as appropriate, to the regulation referred to in Article 27(1) of this Regulation.

Textual Amendments

F44 Words in Art. 29 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(21); 2020 c. 1, Sch. 5 para. 1(1)

F45 Article 30 U.K. Amendments to Directive 2001/82/EC

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

Textual Amendments

F45 Arts. 30-32 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(22); 2020 c. 1, Sch. 5 para. 1(1)

F45 Article 31 U.K. Amendment to Regulation (EC) No 726/2004

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

Textual Amendments

F45 Arts. 30-32 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(22); 2020 c. 1, Sch. 5 para. 1(1)

F45 Article 32 U.K. Entry into force

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

Textual Amendments

F45 Arts. 30-32 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(22); 2020 c. 1, Sch. 5 para. 1(1)

F46 ...

Done at Strasbourg, 6 May 2009.

For the European Parliament

The President

H.-G. Pöttering

For the Council

The President

J. Kohout

Textual Amendments

F46 Words in Signature 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(23); 2020 c. 1, Sch. 5 para. 1(1)

(1)

OJ C 10, 15.1.2008, p. 51.

(2)

Opinion of the European Parliament of 17 June 2008 (not yet published in the Official Journal), Council Common Position of 18 December 2008 (OJ C 33 E, 10.2.2009, p. 30) and Position of the European Parliament of 2 April 2009 (not yet published in the Official Journal).

(3)

OJ L 224, 18.8.1990, p. 1.

(4)

OJ L 311, 28.11.2001, p. 1.

(5)

OJ C 27 E, 31.1.2002, p. 80.

(6)

OJ L 125, 23.5.1996, p. 3.

(7)

OJ L 37, 13.2.1993, p. 1.

(8)

OJ L 31, 1.2.2002, p. 1.

(9)

OJ L 165, 30.4.2004, p. 1;. corrected by OJ L 191, 28.5.2004, p. 1.

(10)

OJ L 136, 30.4.2004, p. 1.

(11)

OJ L 123, 24.4.1998, p. 1.

(12)

OJ L 24, 30.1.1998, p. 9.

(13)

OJ L 16, 20.1.2005, p. 61.

(14)

OJ L 268, 18.10.2003, p. 29.

(15)

OJ L 125, 23.5.1996, p. 10.

(16)

OJ L 184, 17.7.1999, p. 23.