The Animals and Animal Products (Examination for Residues and Maximum Residue Limits)(England and Scotland) Regulations 2015

Made: 18th March 2015

Laid before Parliament: 20th March 2015

Coming into force: 1st July 2015

The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of, and paragraph 1A of Schedule 2[^f00008] to, the 1972 Act, and by sections 16(1)(a), (b) and (f) and (3), 17(1) and (2), 26(1) and 48(1) of, and paragraph 7 of Schedule 1 to, the Food Safety Act 1990[^f00009], and section 14A of the Interpretation Act 1978[^f00010] and now vested in the Secretary of State[^f00011].

PART 1 — INTRODUCTORY

Title, commencement and application

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• (1) These Regulations may be cited as the Animals and Animal Products (Examination for Residues and Maximum Residue Limits)(England and Scotland) Regulations 2015 and come into force on 1st July 2015.

• (2) These Regulations apply in relation to England and Scotland only.

Interpretation

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• (1) In these Regulations, unless the context otherwise requires—

• “the Act” means the Food Safety Act 1990;

• “analysis” includes any technique for establishing the composition of an official sample;

• “analyst” means the person having the management or control of an approved laboratory;

• “animal” includes aquaculture animals;

• “animal product” includes meat, meat products, processed products derived from animals, milk, honey and eggs;

• “appropriate Minister” means, as respects England, the Secretary of State and, as respects Scotland, the Scottish Ministers;

• “approved laboratory” means—a laboratory approved by the appropriate Minister for the purposes of Council Directive 96/23; orany laboratory under the direction or control of a public analyst appointed in accordance with section 27[^f00012] of the Act;

• “authorised officer” means any person (whether or not an officer of an enforcement authority) who is authorised in writing by that authority, either generally or specially, to act in matters arising under these Regulations;

• “carcase” means—the whole body of a slaughtered animal (other than an uneviscerated bird) after bleeding and dressing; orthe whole body of a slaughtered uneviscerated bird after bleeding;

• “commercial operation”, in relation to an animal or batch of animals, means any of the following, namely—selling, possessing for sale and offering, exposing or advertising for sale;consigning or delivering by way of sale;storing or transporting for the purpose of sale;slaughtering or deriving food from it for the purpose of sale or for purposes connected with sale; andimporting and exporting;

• “Council Directive 96/22” means Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/ECC;

• “Council Directive 96/23” means Council Directive 96/23/EC on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC;

• “enforcement authority” , subject to regulation 22(8), means, for the purposes of regulations 12, 20, 21, 22 and 23(1)(b), the appropriate Minister and, except for the purposes of regulations 12, 20, 21, 22 and 23(1)(b), means the appropriate Minister and—where enforcement is in relation to food or food sources, a food authority within its area; andwhere enforcement is other than in relation to food or food sources, a local authority within its area;

• “examination” includes a physical examination of an animal or animal product or other article or substance and the taking, and any analysis of, an official sample;

• “farm of origin”, in relation to an official sample taken from any animal or animal product means—where the official sample was taken at a farm, that farm;where the official sample was taken at any other place, the last farm on which the animal from which the sample was taken or derived was kept before being taken to that place;

• “hormonal substance” means any substance within either of the following categories—stilbenes and thyrostatic substances;substances with oestrogenic, androgenic or gestagenic action;

• “list A substance” means a substance named in List A of Annex II to Council Directive 96/22;

• “list B substance” means a substance named in List B of Annex II to Council Directive 96/22;

• “local authority” means—in relation to England—as respects the City of London (including the Temples), the Common Council;as respects the Inner Temple or the Middle Temple, the appropriate Treasurer;as respects the Isles of Scilly, the Council of the Isles of Scilly;as respects any part of England other than the City of London, the Inner Temple, the Middle Temple or the Isles of Scilly—where there is, within the meaning of the Local Government Changes for England Regulations 1994[^f00013], a unitary authority for the local government area, that authority;where there is no such unitary authority, the council of each London borough, district or non-metropolitan county as appropriate;in relation to Scotland, a council constituted under section 2 of the Local Government etc. (Scotland) Act 1994[^f00014];

• “marketing authorisation” has the same meaning as it bears in Article 5 of Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products[^f00015];

• “maximum residue limit” means the maximum concentration of residue, or residues, resulting from the use of a veterinary medicinal product (expressed in µg/kg or µg/L on a fresh weight basis) that the Secretary of State has established in relation to a substance classified under Article 14 of Regulation 470/2009 as being necessary or appropriate for the protection of human health;

• “offal” means meat other than that of the carcase whether or not naturally connected to the carcase;

• “official sample” means a sample taken by an authorised officer for analysis for the purpose of these Regulations which bears a reference to the type, the amount or quantity concerned and the method of collection and, in the case of an animal or animal product, the species and, where appropriate, particulars identifying the sex and farm of origin of the animal;

• “owner” includes, in relation to any animal, batch of animals or premises, the person in charge of such animal, batch of animals or premises, and in relation to any animal product the person in possession of such product;

• “possession” in relation to any farm animal or aquaculture animal does not include possession under official control;

• “primary analysis” means an analysis of an official sample carried out by an approved laboratory;

• “primary analysis certificate” means an analyst’s certificate specifying the finding of a primary analysis;

• “prohibited substance” means any beta-agonist or hormonal substance administered to an animal contrary to the prohibition in regulation 5;

• “reference analysis” means an analysis carried out by an approved laboratory to check the finding of a primary analysis;

• “reference analysis certificate” means an analyst’s certificate specifying the finding of a reference analysis;

• “Regulation 470/2009” means Regulation (EC) No 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, 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[^f00016];

• ...

• “sell” includes possess for sale, and offer, expose or advertise for sale, and “sale” and “sold” are to be construed accordingly;

• “Table 1 substance” means a substance classified under Article 14(2)(a), (b) or (c) of Regulation 470/2009;

• “Table 2 substance” means a substance classified under Article 14(2)(d) of Regulation 470/2009;

• “unauthorised substance” means a Table 2 substance, a prohibited substance and any other substance or product the administration of which to animals is prohibited by or under assimilated law;

• “unlicensed substance” means a substance—for which a maximum residue limit has been established under Regulation 470/2009, andwhich has been—administered (or is intended for administration) in the United Kingdom to an animal or a batch of animals, oradministered to an animal outside the United Kingdom,where at the time of administration neither that substance, nor any product containing it, was authorised for use in that animal in that country of administration;

• “veterinary surgeon” means a person registered in the register of veterinary surgeons or in the supplementary veterinary register;

• “withdrawal period”, in relation to a veterinary medicinal product administered to an animal or batch of animals, means the period, specified in a current veterinary medicinal product licence or marketing authorisation relating to the product or (in the absence of any such specification) specified in a prescription given by a veterinary surgeon in respect of the administration of the product, which is required to elapse from the cessation of the medication of the animal or batch of animals with the product to the slaughter of the animal or batch of animals for human consumption or to the taking of animal products derived from the animal or batch of animals for human consumption.

• (2) For the purpose of ascertaining whether the maximum residue limit established for a pharmacologically active substance has been exceeded for the purposes of these Regulations—

• (a) the presence of the drug or drug metabolite (or combination thereof) as specified in the marker residue for that pharmacologically active substance is to be taken to indicate the presence of that substance in that part of an animal or batch of animals, or in any animal product derived from that part of an animal or batch of animals, as specified in the target tissues for that substance;

• (b) the maximum residue limit (if any) corresponding to that substance is to apply in respect of the presence in such part of an animal or batch of animals, or in any animal product derived from such part of an animal or batch of animals, of any such drug or drug metabolite (or combination thereof) as if it were that substance.

• (3) Other expressions used in these Regulations and in Council Directive 96/22, Council Directive 96/23 or Regulation 470/2009 have, in so far as the context admits, the same meaning as they bear in those Directives or that Regulation, as appropriate.

• (4) Any reference in these Regulations to an Annex to Council Directive 96/22 or Council Directive 96/23 ... is a reference to that Annex as amended from time to time.

PART 2 — Prohibitions and Exceptions

Prohibition on the sale of list A and list B substances

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• (1) Subject to paragraph (2), no person may sell for administration to any animal any product which is, or which contains, a list A substance or a list B substance, if the animal or any product of that animal is intended for human consumption.

• (2) Paragraph (1) does not apply to the sale of a product that complies with the requirements of regulation 25 and which is for administration in accordance with regulation 27.

• (3) Any product sold which is, or which contains, a list A substance or a list B substance is to be presumed, unless the contrary is proven, to have been sold for administration to an animal which is, or any product of which is, intended for human consumption.

Prohibition on possession of beta-agonists

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No person, other than a veterinary surgeon, may possess on a farm any veterinary medicinal product containing a beta-agonist which is authorised to be used for induction purposes in the treatment of tocolysis.

Prohibition on administration of beta-agonists or hormonal substances

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• (1) Subject to paragraph (2), no person may administer or knowingly cause or permit to be administered to any animal any product which is, or which contains, a substance listed in Annex II or III to Council Directive 96/22.

• (2) The prohibition in paragraph (1) does not apply to the administration of a compliant veterinary medicinal product—

• (a) containing testosterone, progesterone or a derivative of these substances which readily yields the parent compound on hydrolysis after absorption at the site of application, if the administration is in accordance with regulation 26;

• (b) containing allyl trenbolone or a beta-agonist, if the administration is in accordance with regulation 27; or

• (c) having oestrogenic action (but not containing oestradiol 17b or its ester-like derivatives), androgenic action or gestagenic action, if the administration is in accordance with regulation 28.

• (3) In paragraph (2), “compliant veterinary medicinal product” means a veterinary medicinal product which complies with the requirements of regulation 25.

Prohibition of administration to animals of unlicensed substances or products

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• (1) Subject to paragraph (2), no person may administer or knowingly cause or permit to be administered to an animal any unlicensed substance.

• (2) Nothing in paragraph (1) prohibits the administration of any veterinary medicinal product in accordance with an exemption specified in paragraphs 1, 5 and 9 of Schedule 4 to the Veterinary Medicines Regulations 2013[^f00017].

Prohibition of administration of Table 2 substances

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It is an offence to contravene Article 14(6) of Regulation 470/2009 (prohibition on administration of substances to food-producing animals in certain circumstances).

Prohibition of possession or slaughter of animals and of processing

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• (1) No person may slaughter or otherwise be in possession on a farm of an animal intended for use for human consumption to which there has been administered, which contains, or in which the presence has been established of, any substance listed in Annex II or Annex III to Council Directive 96/22.

• (2) No person may process the meat of an animal intended for human consumption where—

• (a) that animal contains, or

• (b) the presence in has been established of, or

• (c) to which there has been administered,

any substance listed in Annex II or Annex III to Council Directive 96/22.

• (3) Any animal slaughtered or in the possession of a person on a farm which is commonly slaughtered or possessed for use for human consumption is presumed, until the contrary is proven, to have been slaughtered or possessed for such use and an animal commonly used for human consumption from which meat is processed is presumed, until the contrary is proven, to be an animal for such use.

Prohibition on the sale of animals

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• (1) Subject to paragraph (2), no person may sell or supply, for slaughter for human consumption, any animal—

• (a) which contains or to which there has been administered an unauthorised substance;

• (b) to which there has been administered a substance in contravention of regulation 5;

• (c) that is an aquaculture animal to which a substance listed in Annex II or III of Council Directive 96/22 has been administered;

• (d) to which a list A substance or a substance listed in Annex III of Council Directive 96/22 has been administered;

• (e) which contains a Table 1 substance at a concentration exceeding the maximum residue limit; or

• (f) to which a medicinal product has been administered if the withdrawal period for that product has not expired.

• (2) Nothing in paragraph (1)(f) prohibits the sale before the end of the withdrawal period of any high-value horse to which has been administered allyl trenbolone or a beta-agonist in accordance with regulation 5, provided that the type and date of treatment was entered on the horse’s passport by the veterinary surgeon directly responsible for the treatment.

Prohibition of the sale of animal products

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• (1) No person may sell for human consumption any animal product derived from an animal the sale or supply for slaughter of which is prohibited under regulation 9.

• (2) No person may sell for human consumption any animal product which contains—

• (a) an unauthorised substance; or

• (b) an authorised substance at a concentration exceeding the relevant maximum residue limit.

Prohibition of disposal of slaughtered animal or batch of animals

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Where an animal or batch of animals has been slaughtered further to a notice referred to in regulation 22(3), no person may dispose of the carcase or offal of that animal or of any animal of that batch of animals, or any part of such carcase or offal, for human or animal consumption.

Exception to prohibition on slaughter

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• (1) Notwithstanding the prohibition on slaughter of an animal or batch of animals by notice given in accordance with regulation 22(4), that animal or batch of animals may be slaughtered before the withdrawal of such notice if the owner of that animal or batch of animals complies with the following paragraphs of this regulation.