30. The owner of an establishment of initial processing of animal products shall, in respect of each animal or animal product brought into that establishment, ensure that—
(a)it does not contain—
(i)a residue level which exceeds the maximum permitted limit;
(ii)any unauthorised substance or unlicensed product; and
(b)any appropriate withdrawal period has been observed.
31. It is hereby declared that a person shall not be entitled to rely on the defence provided by Article 20(1), (5) and (6) of the Order, as applied by regulation 34, in any proceedings alleging a contravention of regulation 8 or 10 if he has contravened regulation 30.
32.—(1) A person engaged by way of business in the rearing, production or treatment of animals intended for human consumption, or in a business in the course of which any commercial operation is carried out with respect to animals intended for human consumption, shall kept a record of particulars relating to the administration of any authorised veterinary medicinal product to such animals or batch of animals which record shall be made as soon as practicable after administration and shall include the following information—
(a)date of administration;
(b)identity and quantity of the authorised veterinary medicinal product;
(c)name and address of the supplier of the authorised veterinary medicinal product; and
(d)identification of the animal or batch of animals to which the authorised veterinary medicinal product was administered.
(2) The owner of an establishment of initial processing of animal products shall keep such records as are sufficient, either alone or in combination with records or information held by some other person, to enable the animals from which those animal products were derived, and the farm of origin or departure of those animals, to be identified.
(3) The persons referred to in paragraph (1)(b) and sub-paragraphs (a) and (b) of paragraph (2) of regulation 4 shall, in relation to hormonal substances and beta-agonists, keep a record in chronological order of—
(a)quantities produced;
(b)quantities purchased or otherwise acquired and from whom each quantity was purchased or acquired;
(c)quantities sold and to whom each quantity was sold; and
(d)quantities used in the production of pharmaceutical or authorised veterinary medicinal products.
(4) Any person required to keep a record by paragraph (1), (2) or (3) shall keep that record in a permanent and legible form and shall retain that record for a period of three years from the end of the calendar year to which such record relates save in the case of a prescription intended to show that withdrawal periods have been observed which shall be retained for a period of five years from the date of the commencement of the withdrawal period to which it relates.
(5) Subject to paragraph (6) if an authorised officer directs a person to produce for inspection a record which paragraph (1), (2) or (3) requires him to keep, he shall comply with the direction.
(6) An authorised officer shall not give a direction under paragraph (5) in relation to a record after the end of the appropriate period mentioned in paragraph (4).
(7) The requirement in paragraph (4) to keep records in a permanent and legible form shall not prevent their being kept by means of computer.
(8) Where a record is so kept, the duty under paragraph (5) to produce it for inspection, is a duty to produce it in a form in which it can be taken away.
33. The powers of suspension or revocation of a manufacturer’s licence given by section 28 of the Medicines Act 1968(1) shall additionally be exercisable by the licensing authority within the meaning of section 6 of that Act in accordance with Article 25 of Council Directive 96/23 in circumstances where the holder of the licence is in possession of, uses or manufactures, unauthorised substances or unlicensed products, and the relevant provisions of Schedule 2 to that Act shall apply accordingly.
34.—(1) The following provisions of the Order shall apply for the purposes of these Regulations and any reference in them to the Order shall be construed for the purposes of these Regulations as a reference to these Regulations—
(a)Article 2 (extended meaning of “sale” etc.);
(b)Article 4 (presumption that food is intended for human consumption);
(c)Article 19 (offences due to fault of another person);
(d)Article 20(1), (5) and (6) (defence of due diligence);
(e)Article 21 (defence of publication in the course of business);
(f)Article 34 (obstruction etc. of officers);
(g)Article 36 (punishment of offences) in so far as it relates to offences under Article 34(1) and (2); and
(h)Article 43 (protection of public analyst acting in good faith).
(2) Article 8 of the Order (inspection and seizure of suspected food) shall, subject to paragraph (3), apply for the purposes of these Regulations as if an animal product which it is an offence to sell under these Regulations were food which failed to comply with food safety requirements.
(3) Article 8 of the Order shall apply for the purposes of these Regulations subject to the modification that the reference in paragraph (5)(a) thereof to Articles 6 and 7 of the Order shall be construed as a reference to these Regulations.
(4) Article 29 of the Order (procurement of samples) shall apply for the purposes of these Regulations subject to the modification that for the words “Article 33” in paragraph (b)(ii) thereof shall be substituted “Article 33 as applied by this regulation”.
(5) Articles 30 and 31 of the Order (analysis etc. of samples) shall apply for the purposes of these Regulations subject to the modification that in each case after the words “Article 29” there shall be inserted the words “, other than an official sample,”.
(6) Article 33 of the Order (powers of entry) shall apply for the purposes of these Regulations with the omission of the word “food” in paragraph (6) thereof and the references to “regulations” in paragraph (1) thereof shall be construed as including a reference to Articles 5 and 14 of the Council Regulation.
35.—(1) In the Food Safety (Sampling and Qualifications) Regulations (Northern Ireland) 1991(2) in Schedule 1 (provisions to which these Regulations do not apply) the title of the Animals, Meat and Meat Products (Examination for Residues and Maximum Residue Limits) Regulations (Northern Ireland) 1992 in the left hand column and their reference in the right hand column shall be deleted and at the end of that Schedule there shall be added in the left hand column the title of these Regulations and against it in the right hand column their reference.
(2) In the Dairy Products (Hygiene) Regulations (Northern Ireland) 1995(3) in paragraph 1(e) of Part I (Animal health standards) of Schedule 3 (requirements for raw milk) for the words “Council Directive 81/602/EEC, as amended, concerning the prohibition of certain substances having a hormonal action and of any substances having a thyrostatic action and Council Directive 88/146/EEC prohibiting the use in livestock farming of certain substances having a hormonal action” there shall be substituted the words “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/EEC”.
(3) In the Poultry Meat, Farmed Game Bird Meat and Rabbit Meat (Hygiene and Inspection) Regulations (Northern Ireland) 1995(4) in paragraph 5 of Part I (general requirements) of Schedule 9 (post-mortem health inspection) for the words “Group A III and Group B I(a) and (c) and II(a) of Annex I to Directive 86/469/EEC, as amended by Decision 89/187/EEC” there shall be substituted the words “Group A (1), (2), (3), (4), (5) and (6) and Group B (1), (2)(a), (b), (c) and (e) and (3)(a), (c) and (d) of Annex I to 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”.
(4) In the Meat (Hygiene, Inspection and Examination for Residues) (Charges) Regulations (Northern Ireland) 1995(5) in paragraph (2) of regulation 2 (interpretation) for the definition of “the Residues Regulations” there shall be substituted the following—
““the Residues Regulations” means the Animals and Animal Products (Examination for Residues and Maximum Residue Limits) Regulations (Northern Ireland) 1998;”.
(5) In the Fresh Meat (Hygiene and Inspection) Regulations (Northern Ireland) 1997(6) in paragraphs (n) and (p) of paragraph 1(1) of Schedule 9 (slaughter and dressing practices — requirements applicable in slaughterhouses and farmed game processing facilities) for the words “the Animals, Meat and Meat Products (Examination for Residues and Maximum Residue Limits) Regulations (Northern Ireland) 1992” there shall be substituted “the Animals and Animal Products (Examination for Residues and Maximum Residue Limits) Regulations (Northern Ireland) 1998”.
36. The Regulations specified in Schedule 2 are hereby revoked.
S.R. 1991 No. 198; the relevant amending Regulations are S.R. 1992 No. 39 and S.R. 1995 No. 107
S.R. 1995 No. 201; to which there are amendments not relevant to these Regulations