ANIMALS Title and commencement 1 This Order may be cited as the Specified Risk Material Order 1997 and shall come into force on 1st January 1998. Interpretation 2 1 In this Order— “approved premises” means premises approved for the purposes of article 10; “appropriate veterinary authority” means the central authority of a territory empowered to carry out veterinary checks, or any authority in that territory to which it has delegated such powers; “class I specified risk material” means— class I specified bovine material; and class I specified sheep or goat material, but does not include material derived from animals which— were slaughtered or died outside the United Kingdom before 1st January 1998; or were born, reared and slaughtered in Australia or New Zealand; “class II specified risk material” means— class II specified bovine material; class II specified sheep or goat material; any part of the animal remaining attached to class I or II specified bovine material or class I or II specified sheep or goat material after dissection of the carcase; any animal material which comes into contact with class I or II specified bovine material or class I or II specified sheep or goat material after it has been removed from the carcase; and specified solid waste; “feeding stuff” has the meaning given to it by section 66(1) of the Agriculture Act 1970 , save that it shall apply to products and substances for oral feeding to any creature except a human being, and section 66(2)(b) of that Act shall have effect for the purposes of this Order as it does for the purposes of that Act; “food” has the same meaning as in the Food Safety Act 1990 ; “intestines” means that part of the digestive tract of a bovine animal from the junction of the abomasum and the duodenum to (and including) the rectum and anal sphincter; “specified bovine material” has the meaning given in article 4; “specified risk material” means class I specified risk material and class II specified risk material; “specified sheep or goat material” has the meaning given in article 3; “specified solid waste” means any solid matter resulting from the slaughter of bovine animals, sheep or goats, or from the subsequent processing of their carcases, which is collected in any part of the drainage system draining any place where specified bovine or sheep or goat material is handled; and “ UK specified risk material” means specified risk material derived from an animal which has died or was slaughtered in the United Kingdom. 2 For the purposes of this Order the supply of specified risk material, feeding stuffs or cosmetic, pharmaceutical or medical products otherwise than by sale at, in or from any place where specified risk material, feeding stuffs or cosmetic, pharmaceutical or medical products are supplied in the course of a business, shall be deemed to be a sale, and “sell” includes have in possession for or offer or expose for sale. 3 For the purposes of this Order material shall be treated as a cosmetic, pharmaceutical or medical product whether it is used or intended for use as such by itself or as an ingredient or additive in something which is so used or intended for such use. 4 Unless the context otherwise requires, references in this Order to articles and Schedules are to articles of and Schedules to this Order. Specified sheep or goat material 3 1 In this Order “class I specified sheep or goat material” means— a in relation to material derived from a sheep or goat which at the time it was slaughtered or died either had one or more permanent incisor teeth erupted through the gum or was aged more than 12 months— i the skull, including the brain and eyes; ii the tonsils; and iii the spinal cord; and b the spleen of a sheep or goat. 2 In this Order “class II specified sheep or goat material” means the head of any sheep or goat which was slaughtered or died in the United Kingdom except— a any part of it which is class I specified sheep or goat material; b the horns, where they are removed from the head— i immediately after slaughter; ii before the head is removed from the carcase; and iii without breaking into the cranial cavity; and c the tongue, where it is removed from the head immediately after slaughter and before the head is stained in accordance with the Specified Risk Material Regulations 1997 . Specified bovine material 4 1 In this Order, “class I specified bovine material” means in relation to a bovine animal— a the skull, including the brain and eyes, tonsils and spinal cord, of an animal which was slaughtered or died outside the UK at an age greater than twelve months; and b the brains, spinal cord, thymus, tonsils, spleen and intestines of an animal which was slaughtered or died in the UK at an age greater than six months, and also the skull (including the eyes) of such an animal which was aged more than twelve months at the time of death. 2 In this Order “class II specified bovine material” means in relation to a bovine animal— a the head of an animal which was slaughtered or died in the United Kingdom at an age of six months or over, except— i any part of the head which is class I specified bovine material; and ii the tongue, where it is removed from the head immediately after slaughter and before the head is stained in accordance with the Specified Risk Material Regulations 1997; and b the thymus and intestines of an animal which— i died or was slaughtered in the United Kingdom at an age of two months or over but less than six months; or ii was slaughtered in the United Kingdom at an age of less than two months for human consumption. Approvals and licences 5 1 The appropriate Minister may, on application, approve any premises for the purpose of this Order if he is satisfied that such premises are properly equipped to carry out the functions to which the approval relates and comply with the requirements of this Order. 2 Any approval or licence granted under this Order shall be in writing and may be made subject to conditions and be amended, suspended or revoked at any time by notice in writing served on the person to whom it was granted if the appropriate Minister is satisfied that the conditions of this Order, or any additional conditions in the approval or licence, are not being complied with. Import of class I specified risk material 6 1 No person shall import into Great Britain, otherwise than from the British Islands— a any class I specified risk material, except where it is to be transported directly to approved premises; or b any food or feeding stuff listed in Schedule 1, except a food or feeding stuff which— i does not contain any class I specified risk material; and ii is accompanied by a certificate in the form set out in Schedule 2 issued by the appropriate veterinary authority of the place from which the food or feeding stuff was despatched. 2 Where class I specified risk material is imported under paragraph (1)(a) above the importer shall ensure that it is transported to approved premises without delay. 3 For the purposes of this article a food or feeding stuff shall be treated as containing class I specified risk material if it contains anything derived from it. 4 Contravention of, or failure to comply with, any provision of this article shall be an offence to which section 76(3) of the Animal Health Act 1981 applies. 5 It shall be a defence for any person charged with an offence under paragraph (1) above to prove— a where it is alleged that he imported a food or feeding stuff listed in Schedule 1 containing class I specified risk material, that he did not know or have any reason to believe that it contained any class I specified risk material; b where it is alleged that he imported a food or feeding stuff listed in Schedule 1 without the certificate referred to in paragraph (1)(b)(ii) above, that it was accompanied by a document purporting to be the certificate required by that paragraph, which he did not know or have any reason to believe to be false; and c where it is alleged that he imported a food or feeding stuff listed in Schedule 1 which contained class I specified risk material and was not accompanied by the certificate referred to in paragraph (1)(b)(ii) above, that he did not know or have reason to believe that the food or feeding stuff contained class I specified risk material nor that the document purporting to be the certificate was false. 6 It shall be a defence for any person charged with an offence under paragraph (2) above to prove that he took all reasonable steps to ensure that it was transported to approved premises as required by that paragraph. Specified risk material for use in cosmetic, pharmaceutical and medical products 7 1 No person shall sell any UK specified risk material for use in the preparation or manufacture of any cosmetic, pharmaceutical or medical product. 2 No person shall use any UK specified risk material in the preparation or manufacture of any ingredient to be sold for use in the preparation or manufacture of a cosmetic, pharmaceutical or medical product. 3 The prohibitions in paragraphs (1) and (2) above shall apply to anything derived from UK specified risk material as if it were UK specified risk material. 4 It shall be a defence for any person charged with an offence under paragraph (1) or (2) above to prove that he did not know or have any reason to believe that the material was, or was derived from, UK specified risk material. Specified risk material for consumption by any creature 8 1 No person shall sell any specified risk material for use in the preparation of any feeding stuff. 2 No person shall use any specified risk material in the preparation of any feeding stuff. 3 No person shall sell any specified risk material, or any feeding stuff containing specified risk material, for feeding to any creature. 4 No person shall feed to any creature— a any specified risk material; b any feeding stuff containing specified risk material; or c a whole carcase or any part of a sheep, goat or bovine animal from which specified risk material has not been removed in accordance with the Specified Risk Material Regulations 1997. 5 Paragraph (4) above shall not apply to the feeding to any creature of any specified risk material or feeding stuff for research purposes in a research establishment under the authority of a licence issued by a veterinary inspector of the Minister and in accordance with any conditions subject to which the licence is issued, and paragraph (2) above shall not apply to the use of any specified risk material in the preparation of any feeding stuff for such feeding. 6 For the purposes of this article— a “creature” does not include a human being; and b a feeding stuff shall be treated as containing specified risk material if it contains anything derived from it. 7 It shall be a defence for any person charged with an offence under any of paragraphs (1) to (4) above to prove that he did not know or have any reason to believe that the material was, or the feeding stuff contained, specified risk material. Prohibition on the removal of brain and eyes 9 No person shall remove the brain or eyes from the carcase of a bovine animal aged over six months, or from a carcase of a sheep or goat (of any age at death), except— a for the purposes of veterinary or scientific examination or research; and b in a part of the premises kept free at all times from food, feeding stuffs and any cosmetic, pharmaceutical or medical product. Approved premises not producing food, feeding stuffs or cosmetic, pharmaceutical or medical products 10 1 The appropriate Minister may approve premises as being suitable to process specified risk material for use in a manufacturing process which is not producing any food or feeding stuff or any cosmetic, pharmaceutical or medical product or anything intended or likely to come into direct contact with any of them. 2 The appropriate Minister shall approve premises for the purposes of paragraph (1) above where, following an inspection of those premises by a veterinary inspector, he is satisfied that— a the operator of those premises has in place a system for tracing through the manufacturing process all specified risk material delivered to him sufficient to demonstrate— i that all specified risk material delivered is either used in the manufacturing process or disposed of in accordance with such conditions as he may specify in the approval; and ii that no product manufactured in the process is used as, in connection with or in the production of any food or feeding stuff or any cosmetic, pharmaceutical or medical product; and b does not pose a risk to human or animal health. 3 Any person delivering specified risk material to premises approved under this article shall state in writing to the operator of those premises the place from which that specified risk material was collected for delivery to those premises. 4 The operator of approved premises shall record on arrival of specified risk material— a the weight of the specified risk material delivered; b the date of delivery; and c the place from which it was collected for delivery to those premises, and shall keep such records for two years from the date of arrival. 5 No person shall process specified risk material at premises approved under this article except in accordance with any conditions specified in the approval. Transport 11 1 The person in control of a vehicle transporting specified risk material shall ensure that it is conveyed either in an impervious container which contains nothing but specified risk material or in a part of the vehicle which is impervious and contains nothing but specified risk material and which in either case is kept covered at all times except when necessary for loading or unloading or examination by an inspector. 2 Any person transporting specified risk material shall ensure that the part of the vehicle in which specified risk material has been conveyed is thoroughly washed and disinfected before any food, feeding stuff or other animal material or any cosmetic, pharmaceutical or medical product is placed in that part of the vehicle. 3 In this article the expression “vehicle” means, in any case in which specified risk material is conveyed in a bulk container, that container. Storage 12 1 Subject to paragraph (2) below, no person shall store specified risk material in the same room as any food, feeding stuff or any cosmetic, pharmaceutical or medical product. 2 The requirement in paragraph (1) above shall not apply where an inspector has approved the storage of specified risk material in the same room as any food, feeding stuff or any cosmetic, pharmaceutical or medical product, on being satisfied that the arrangements for storage will ensure the adequate separation of the specified risk material from the food, feeding stuff or product. Samples 13 Where an inspector has reasonable grounds for supposing that the provisions of this Order are not being complied with, he may take from any carcase, material, food, feeding stuff, or from any cosmetic, pharmaceutical or medical product, such samples as he considers necessary to establish whether or not an offence has been committed. Recall, seizure and destruction of foods and feeding stuffs 14 1 An inspector may serve on any person in whose possession is found any feeding stuff containing specified risk material (except a feeding stuff prepared for use in accordance with article 8(5) above), a notice requiring that person to dispose of the material, and any other material with which it has come into contact, in such manner and within such period as may be specified in the notice. 2 An inspector may serve on any person who has sold or supplied any feeding stuff containing specified risk material a notice requiring that person to collect at his own expense that product from the person to whom he supplied or sold it, or from such other person to whom it may have subsequently been supplied or sold, and to transport it to such place and within such time as may be specified in the notice. 3 It shall be a defence for any person charged with an offence under paragraph (1) or (2) above to show that he took all reasonable steps necessary to comply with the notice. 4 If any person on whom a notice is served under paragraph (1) or (2) above fails to comply with the requirements of the notice, an inspector may, without prejudice to any proceedings arising out of such default, carry out or cause to be carried out the requirements of the notice. 5 The amount of any expenses reasonably incurred by or on behalf of an inspector acting pursuant to paragraph (4) above shall be recoverable as a debt by him or by any person under whose authority he is acting from the person who was in default of the notice, unless he took all reasonable steps to comply with the notice. Seizure and destruction of imports 15 1 Where an inspector has reasonable grounds for suspecting that any class I specified risk material or any food or feeding stuff has been imported in contravention of article 6, he may at any time seize or cause to be seized that material, food or feeding stuff, or anything into which it has subsequently been incorporated. 2 A veterinary inspector may destroy anything seized pursuant to paragraph (1) above without compensation. Consignment 16 No person shall consign from Great Britain to another member State UK specified risk material, or protein or tallow derived from UK specified risk material, except in accordance with a licence granted by the Minister. Enforcement 17 The provisions of this Order shall be executed and enforced by the local authority. Amendment and revocation 18 1 In the Schedule to the Zoonoses Order 1988 there shall be inserted after the reference to section 8 the following reference:— Section 10 Importation Section 32 Slaughter in other diseases . 2 The Specified Bovine Material Order 1997 and the Heads of Sheep and Goats Order 1996 are hereby revoked. Jack Cunningham Minister of Agriculture, Fisheries and Food 16th December 1997 Sewel Parliamentary Under Secretary of State, Scottish Office 11th December 1997 Signed by authority of the Secretary of State for Wales Win Griffiths Parliamentary Under Secretary of State, Welsh Office 12th December 1997