The Animals and Animal Products (Examination for Residues and Maximum Residue Limits) Regulations 1997

PART I INTRODUCTORY

Title and commencement

1.  These Regulations may be cited as the Animals and Animal Products (Examination for Residues and Maximum Residue Limits) Regulations 1997 and shall come into force on 11th August 1997.

Interpretation

2.—(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;

“Annex IV substance” means a substance specified in Annex IV to the Council Regulation;

“appropriate Minister” means, as respects England, the Minister of Agriculture, Fisheries and Food and, as respects Scotland or Wales, the Secretary of State;

“approved laboratory” means—

(a)

a laboratory approved by the appropriate Minister for the purposes of Council Directive 96/23; or

(b)

any laboratory under the direction or control of a public analyst appointed in accordance with section 27 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—

(a)

the whole body of a slaughtered animal (other than an uneviscerated bird) after bleeding and dressing; or

(b)

the 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—

(a)

selling, possessing for sale and offering, exposing or advertising for sale;

(b)

consigning or delivering by way of sale;

(c)

storing or transporting for the purpose of sale;

(d)

slaughtering or deriving food from it for the purpose of sale or for purposes connected with sale; and

(e)

importing 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 replacing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC(1);

“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(2);

“the Council Regulation” means the Regulation specified in Schedule 1;

“enforcement authority”, subject to regulation 22(8) means, for the purposes of regulations 12, 20, 21, 22 and 23(1)(b), the Ministers and, except for the purposes of regulations 12, 20, 21 and 23(1)(b), means the Ministers and—

(a)

where enforcement is in relation to food or food sources, a food authority within its area; and

(b)

where 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—

(a)

where the official sample was taken at a farm, that farm;

(b)

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—

(a)

stilbenes and thyrostatic substances;

(b)

substances with oestrogenic, androgenic or gestagenic action;

“local authority” means—

(a)

in relation to England—

(i)

as respects the City of London (including the Temples) the Common Council;

(ii)

as respects the Inner Temple or the Middle Temple, the appropriate Treasurer;

(iii)

as respects the Isles of Scilly, the Council of the Isles of Scilly;

(iv)

as respects any part of England other than the City of London, the Inner Temple, the Middle Temple or the Isles of Scilly—

(aa)

where there is, within the meaning of the Local Government Changes for England Regulations 1994(3), a unitary authority for the local government area, that authority;

(bb)

where there is no such unitary authority, the council of each London borough, district or non-metropolitan county as appropriate;

(b)

in relation to Wales, the council of each county or county borough;

(c)

in relation to Scotland, each council constituted under section 2 of the Local Government etc. (Scotland) Act 1994(4);

“marketing authorisation” means a marketing authorisation within the meaning of the Marketing Authorisations Regulations or a product licence granted under the Medicines Act 1968(5);

“the Marketing Authorisations Regulations” means the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994(6);

“maximum residue limit” means, in relation to a concentration of a substance specified in the first column of Annex I or Annex III to the Council Regulation in the tissues or body fluids of an animal or in an animal product, the limit specified in the fourth column opposite the reference to that substance and the applicable animal species specified in the third column, where the substance is contained in the part of the animal specified opposite it in the fifth column or in an animal product derived from that part of the animal;

“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 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;

“sale” includes possess for sale, and offer, expose or advertise for sale, and “sale” and “sold” shall be construed accordingly;

“unauthorised substance” includes Annex IV substances, prohibited substances and unlicensed substances;

“unlicensed product” means a veterinary medicinal product, other than one which is or contains a beta-agonist or hormonal substance, in respect of which there is, in the United Kingdom, neither—

(a)

any current marketing authorisation authorising its sale or supply for administration to an animal or batch of animals; nor

(b)

any current animal test certificate, within the meaning of section 32 of the Medicines Act 1968, authorising its administration to an animal or batch of animals;

“unlicensed substance” means a substance, other than a hormonal substance, beta-agonist or Annex IV substance which, if transmitted to an animal product, would be likely to be harmful to human health and which has been administered or is intended for administration in the United Kingdom to an animal or batch of animals or, which has been administered to an animal in a member State of the European Community other than the United Kingdom and at the time of administration neither that substance, nor any product containing it, was authorised for use in that animal in that State;

“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 has been exceeded for the purposes of these Regulations, the presence of the drug or drug metabolite (or combination thereof) specified in the second column of Annex I or III to the Council Regulation opposite the reference to each substance specified in the first column of those Annexes shall 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, specified in the fifth column of such Annex I or III, opposite the reference to that substance and the maximum residue limit specified in the fourth column of such Annex I or III opposite the reference to that substance shall then 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 the Council Regulation 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 a numbered regulation or Schedule shall, unless the context otherwise requires, be construed as a reference to the regulation or Schedule so numbered in these Regulations.

(1)

OJ No. L125, 23.5.96, p.3.

(2)

OJ No. L125, 23.5.96, p.10.

(3)

S.I. 1994/867; to which there are amendments not relevant to these Regulations.

(4)

1994 c. 39.

(5)

1968 c. 67.

(6)

S.I. 1994/3142.