ANIMALS Citation, commencement, extent and cessation 1 1 These Regulations may be cited as the Import and Export Restrictions (Foot-and-Mouth Disease) (Scotland) (No. 3) Regulations 2001 and shall come into force at 1.30 p.m. on 20th November 2001. 2 These Regulations extend to Scotland only. 3 These Regulations shall remain in force until midnight on 31st December 2001. Interpretation 2 1 In these Regulations, unless the context otherwise requires– “approved” means approved in accordance with regulation 3; “the Decision” means Commission Decision 2001/740/EC of 19th October 2001 (concerning certain protection measures with regard to foot-and-mouth disease in the United Kingdom and repealing Commission Decision 2001/356/EC ) as amended by Commission Decision 2001/763/EC and Commission Decision 2001/789/EC ; “dispatch” means dispatch from a place within the restricted area to a place outside the restricted area and includes consigning for dispatch; “export” means export outside the British Islands and includes consigning for export, and “exporting” and “exported” shall be construed accordingly; “inspector” means a person appointed to be an inspector for the purposes of these Regulations, the Products of Animal Origin (Import and Export) Regulations 1996 or the Animals and Animal Products (Import and Export) (Scotland) Regulations 2000 by the Scottish Ministers or a local authority, and when used in relation to a person so appointed by the Scottish Ministers, includes a veterinary inspector; “HACCP” means Hazard Analysis at Critical Control Points, which is a system in which the critical points of the manufacturing process have been identified, assessments have been made of the potential risks at those points, and necessary steps have been taken to minimise those risks; “local authority” means a council constituted under section 2 of the Local Government etc. (Scotland) Act 1994 ; “meat products” means meat products as defined in Article 2 of Council Directive 77/99/EEC (on health problems affecting the production and marketing of meat products and certain other products of animal origin) ; “milk” and “milk products” have the meaning given in Article 2 of Council Directive 92/46/EC (laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products) ; “official veterinary surgeon” means a person appointed as such under regulation 8 of the Fresh Meat (Hygiene and Inspection) Regulations 1995 , under regulation 8 of the Poultry Meat, Farmed Game Bird Meat and Rabbit Meat (Hygiene and Inspection) Regulations 1995 or under regulation 6 of the Wild Game Meat (Hygiene and Inspection) Regulations 1995 as the case may be. “port of import” means the ports of Cairnryan, Dover and Stranraer; “restricted area” means the British Islands other than Northern Ireland and the Isle of Man. “semen collection centre” means a semen collection centre authorised by the Scottish Ministers for the purposes of regulation 10(2)(c) for the dispatch of frozen bovine or porcine semen. 2 A reference in these Regulations to anything done in writing or produced in written form includes a reference to an electronic communication, as defined in the Electronic Communications Act 2000 , which has been recorded and is consequently capable of being reproduced. 3 Unless the context otherwise requires, any reference in these Regulations– a to a numbered regulation is a reference to the regulation so numbered in these Regulations; b to a numbered paragraph is a reference to the paragraph so numbered in the regulation in which it occurs; c to a numbered Schedule is a reference to the Schedule so numbered in these Regulations. 4 Unless the context otherwise requires, any reference in these Regulations (or in a certificate required by virtue of these Regulations) to Commission Decision 2001/172/EC or Commission Decision 2001/356/EC shall be construed as a reference to the Decision. Approvals 3 1 The Scottish Ministers may approve premises for the purposes of these Regulations if they are satisfied that the occupier of the premises will comply with– a the conditions specified in these Regulations; and b such additional conditions as the Scottish Ministers may impose. 2 Any approval shall be in writing and may be amended, suspended or revoked by notice in writing at any time if the Scottish Ministers are reasonably of the opinion that the conditions specified in these Regulations or any such additional conditions are not being complied with. 3 In relation to any premises which are in a part of the British Islands outside Scotland, any requirement for approval (so far as necessary for the purposes of these Regulations) shall be treated as fulfilled if such premises are approved by the relevant competent authority for the purposes of the Decision. Importation of live animals 4 1 No person shall import any live animal of species susceptible to foot-and-mouth disease into Scotland from another member State. 2 Paragraph (1) shall not apply– a in relation to animals brought into one of the areas in Scotland specified in Schedule 1 from Dover; or b in relation to animals brought into Scotland at Cairnryan or Stranraer for movement to one of the areas specified in Schedule 1, provided that the conditions specified at paragraph (3) are met. 3 The conditions referred to in paragraph (2) are– a the transport must be subject to authorisation by the competent authorities at the place from which the animals are sent; b the Scottish Ministers must be notified by those competent authorities, at least three days before arrival in Scotland, of the details of the consignment, the journey and the port of import; c before the animals are imported the importer must have obtained a specific movement licence under the Foot-and-Mouth Disease Order 1983 permitting movement from the port of import to the place of destination; d the animals must enter through a port of import; e when animals are brought in by road, each vehicle must contain only a single consignment; f the consignment must be taken directly to a single holding in an area specified in Schedule 1 which is the holding of destination in the specific movement licence referred to in sub-paragraph (c); g after unloading the animals, and before the vehicle departs from Great Britain, the empty vehicle must be moved under a licence issued by an officer of the local authority or the Scottish Ministers to cleansing and disinfection premises approved by the Scottish Ministers; h after cleansing and disinfection the Scottish Ministers shall issue a certificate in the form set out in Schedule 2; i the driver of the vehicle retains the certificate until the vehicle leaves Great Britain and produces it to an inspector on demand. Dispatch of live animals 5 1 No person shall dispatch any live animal of the bovine, ovine, caprine or porcine species or any other biungulate. 2 By way of derogation from paragraph (1), the Scottish Ministers may by licence in writing authorise the dispatch of biungulate animals originating outside the restricted area if the animals travelled through the United Kingdom in direct and uninterrupted transit on main roads or by rail or sea. Dispatch of fresh meat, minced meat and meat preparations 6 1 No person shall dispatch any fresh meat of animals of the bovine, ovine, caprine or porcine species or other biungulate coming from the restricted area or obtained from animals originating in that area. 2 The prohibition in paragraph (1) shall not apply in relation to– a fresh meat, minced meat or meat preparations obtained before 1st February 2001, provided that the meat, minced meat or meat preparations is clearly identified and since that date has been transported and stored separately from meat, minced meat or meat preparations which is not destined for dispatch; b fresh meat obtained from approved cutting plants under the following conditions:– i the only meat processed in the establishment at the time of processing meat destined for dispatch under these Regulations is– A fresh meat described in sub-paragraph (a) above; B fresh meat from animals reared and slaughtered outside the restricted area; or C fresh meat obtained from animals reared and slaughtered within one or more of the areas listed in Schedule 1 in accordance with the conditions in sub-paragraph (d) below; ii cleansing and disinfection must be carried out after processing any meat not meeting the requirements specified in sub-sub-paragraph (i) above; iii all the meat must bear the health mark in accordance with Chapter XI of Annex I to Council Directive 64/433/EEC (on health problems affecting the production and marketing of meat products and certain other products of animal origin) as amended or, in the case of meat from farmed game of species susceptible to foot-and-mouth disease, the health mark provided for in Chapter III of Annex I to Council Directive 91/495/EEC (concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat) as amended or in the case of wild game of species susceptible to foot-and-mouth disease, in accordance with the provisions of Chapter VII of Annex I of Council Directive 92/45/EEC as amended ; iv the plant is operated under strict veterinary control; and v the meat is clearly identified and transported and stored separately from meat which is not destined for dispatch; c minced meat and meat preparations obtained from establishments approved under the Minced Meat and Meat Preparations (Hygiene) Regulations 1995 and approved under these Regulations under the following conditions:– i the only meat processed in the establishment at the time of processing meat destined for dispatch under these Regulations is– A fresh meat described in sub-paragraph (a) above; B fresh meat from animals reared and slaughtered outside the restricted area; or C fresh meat obtained from animals reared and slaughtered within one or more of the areas listed in Schedule 1 in accordance with the conditions in sub-paragraph (d) below; ii cleansing and disinfection must be carried out after processing any meat not meeting the requirements specified in sub-sub-paragraph (i) above; iii all the minced meat and meat preparations must bear the health mark in accordance with Chapter VI of Annex 1 to Council Directive 94/65/EC (laying down the requirements for the production and placing on the market of minced meat and meat preparations); iv the plant is operated under strict veterinary control; and v the meat, minced meat and meat preparations are clearly identified and transported and stored separately from meat, minced meat and meat preparations which are not destined for dispatch; d fresh meat obtained from bovine, ovine, caprine or porcine animals or farmed game of species susceptible to foot-and-mouth disease and conforming to the following conditions:– i there has been no outbreak of foot-and-mouth disease in the same area listed in Schedule 1 during the period of 90 days prior to the date of dispatch; ii during the period of 30 days prior to the date of transport to a slaughterhouse, the animals were subject to the supervision of the relevant competent authority on a single holding situated within one of the areas listed in Schedule 1 in the centre of a circle around the holding of at least 10 km radius where there has been no outbreak of foot-and-mouth disease during the said period of 30 days; iii no animal of species susceptible to foot-and-mouth disease has been introduced into the holding referred to in sub-paragraph (d)(ii) above during the period of 30 days prior to the date of loading, or in the case of farmed game prior to on-farm slaughtering, except in the case of pigs coming from a supplying holding which meets the requirements laid down in that sub-paragraph, in which case the period concerned shall be 7 days; iv the animals, or in the case of farmed game slaughtered on the farm, the carcases, have been transported under licence in writing granted by the Scottish Ministers where the holding referred to in sub-paragraph (d)(ii) above is situated directly to an approved establishment situated in one of the areas listed in Schedule 1; v the licence must be endorsed by a person authorised in writing by the Scottish Ministers to confirm that they have checked farm movement records, inspected the vehicle for cleansing and disinfection and observed the loading of the consignment; vi the means of transport must have been cleansed and disinfected before the animals are loaded; vii the person consigning the animals to the slaughterhouse must give at least 72 hours written notice to the official veterinary surgeon at the slaughterhouse that the animals (the meat of which is intended for dispatch under this paragraph) will be sent to that slaughterhouse; viii the animals are slaughtered– A within 24 hours of arrival at the slaughterhouse; and B separately from animals, the meat from which is not eligible for dispatch; ix during inspection by the official veterinary surgeon at the slaughterhouse, no evidence of clinical or post-mortem signs of foot-and-mouth disease emerges; x the meat derived from such animals remains in the slaughterhouse for at least 24 hours after slaughter; xi all such fresh meat must bear the health mark in accordance with Chapter XI of Annex I to Council Directive 64/433/EEC or in the case of farmed game the health mark provided for in Chapter III of Annex I of Council Directive 91/495/EEC ; xii the slaughterhouse is operated under strict veterinary control; xiii in a case where foot-and-mouth disease has been diagnosed in the slaughterhouse, any further preparation of meat for dispatch shall only be authorised– A after the slaughter of all animals present; B after removal of all meat and dead animals; and C at least 24 hours after the completion of the effective cleansing and disinfection of the establishment under the control of an official veterinary surgeon; xiv the fresh meat must be clearly identified, and transported and stored separately from meat which is not eligible for dispatch; xv the meat must be obtained from animals reared within the areas specified for the respective category of meat in the appropriate column in Schedule 1; e fresh meat obtained from wild game of species susceptible to foot-and-mouth disease and conforming to the following conditions:– i the meat must be obtained from wild game killed within the areas specified for the respective category of meat in the appropriate column in Schedule 1; ii there has been no outbreak of foot-and-mouth disease in the administrative area listed in Schedule 1 during the period of 90 days prior to the date of dispatch; iii the meat originates from animals killed at least 20 kilometres from any area not included in Schedule 1; iv the carcases were transported in a means of transport which had been cleansed and disinfected before loading directly to a wild game collection centre or to an approved processing house for chilling; v the wild game collection centre or the approved processing house must be located in an area listed in Schedule 1; vi during post-mortem inspection by the official veterinary surgeon the carcases were found free of lesions of foot-and-mouth disease; vii the meat derived from the animals remained in the establishment for at least 24 hours after the post-mortem inspection; viii at all stages of production the meat must have been handled in accordance with the requirements of Council Directive 92/45/EEC ; ix the meat must bear the health mark in accordance with Chapter VII of Annex I to Council Directive 92/45/EEC ; x the establishment must be operated under strict veterinary control; xi in the case where foot-and-mouth disease has been diagnosed in the slaughterhouse, any further preparation of meat for dispatch shall only be authorised– A after the slaughter of all animals present; B after removal of all meat and dead animals; and C at least 24 hours after the completion of the effective cleansing and disinfection of the establishment under the control of an official veterinary surgeon; xii the fresh meat must be clearly identified, and transported and stored separately from meat which is not eligible for dispatch; and f fresh meat destined for placing on the market in Great Britain and obtained from cutting plants situated in the British Islands outside the areas listed in Schedule 1 under the following conditions:– i the meat is derived from animals reared and slaughtered in the restricted area; ii the meat remained in the slaughterhouse for at least 24 hours after slaughter; iii the cutting plants processing the meat are approved by the competent authority exclusively for the production of fresh meat destined for dispatch only within the United Kingdom; iv all such meat shall be transported, stored and processed separately from meat eligible for dispatch and shall bear the health mark in accordance with Commission Decision 2001/304/EC (on marking and use of certain animal products in relation to Decision 2001/172/EC ); v all meat originating in the restricted area and processed in cutting plants referred to in sub-paragraph (f)(iii) shall only be placed on the market in the restricted area; vi the plants must be operated under strict veterinary control. 3 Meat, minced meat or meat preparations consigned to another member State shall be accompanied by an official certificate prepared on behalf of the Scottish Ministers which bears the following words:– Meat conforming to Commission Decision 2001/172/EC of 1st March 2001 concerning certain protection measures with regard to foot-and-mouth disease in the United Kingdom . 4 In paragraph (1), the reference to “fresh meat” includes minced meat and meat preparations to which Council Directive 94/65/EC applies. Dispatch of meat products 7 1 No person shall dispatch meat products of animals of the bovine, ovine, caprine, or porcine species or any other biungulate coming from the restricted area or prepared using meat obtained from animals originating in that area. 2 The prohibition in paragraph (1) shall not apply to meat products which have undergone one of the treatments laid down in Article 4(1) of Council Directive 80/215/EEC (on animal health problems affecting intra-Community trade in meat products) , or to meat products as defined in Council Directive 77/99/EEC which have been subjected during preparation uniformly throughout the substance to a pH value of less than 6. 3 The prohibition in paragraph (1) shall not apply to– a meat products prepared before 1st February 2001 provided that the meat products are clearly identified and since that date have been transported and stored separately from meat products which are not destined for dispatch; or b meat products prepared in approved establishments which at the time of processing of meat eligible for dispatch complies with the following conditions:– i all fresh meat used in the establishment must conform to the conditions in regulation 6(2); ii all meat products used in the final product must conform to the conditions in sub-paragraph (a) or be made from fresh meat obtained from animals reared and slaughtered outside the restricted area; iii all meat products must bear the health mark in accordance with Chapter VI of Annex B to Directive 77/99/EEC ; iv the establishment must be operated under strict veterinary control; and v the meat products must be clearly identified and transported and stored separately from meat and other meat products which are not destined for dispatch. c meat products prepared in parts of the United Kingdom outside the restricted area using meat obtained before 1st February 2001 from the restricted area provided that the meat and meat products are clearly identified and transported and stored separately from meat and meat products not destined for dispatch. 4 Meat products consigned to another member State shall be accompanied by an official certificate prepared on behalf of the Scottish Ministers which bears the following words:– Meat products conforming to Commission Decision 2001/172/EC of 1st March 2001 concerning certain protection measures with regard to foot-and-mouth disease in the United Kingdom . 5 Paragraph (4) shall not apply to meat products which conform to the requirements of paragraph (2) if such compliance is stated in the commercial document accompanying the consignment, endorsed in accordance with regulation 14, and the products have been processed in an establishment operating HACCP and an auditable standard operating procedure which ensures that standards for treatment are met and recorded. 6 Paragraph (4) shall not apply to meat products heat treated in hermetically sealed containers so as to ensure that they are shelf stable, if the meat products are accompanied by a commercial document stating the heat treatment applied. Dispatch of milk 8 1 No person shall dispatch milk. 2 The prohibition in paragraph (1) shall not apply to milk which has been subjected to at least– a an initial pasteurisation in accordance with the norms defined in paragraph 3(b) of Chapter 1 in Annex I to Council Directive 92/118/EEC (laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A(I) to Directive 1989/662/EEC and, as regards pathogens, to Directive 1990/425/EEC ) followed by a second heat treatment by high temperature pasteurisation, UHT, sterilisation so as to produce a negative reaction to the peroxidase test or by a drying process which includes a heat treatment with an equivalent effect to one of the above; or b an initial pasteurisation in accordance with the norms defined in paragraph 3(b) of Chapter 1 in Annex I to Council Directive 92/118/EEC , combined with the treatment by which the pH is lowered below 6 and held there for at least one hour. 3 The prohibition in paragraph (1) shall not apply in relation to milk prepared in approved establishments under the following conditions:– a all milk used in the establishment must either conform to the conditions of paragraph (2) or be obtained from animals outside the restricted area; b the establishment must be operated under strict veterinary control; c the milk must be clearly identified and transported and stored separately from milk and milk products which are not destined for dispatch; and d transport of raw milk from the restricted area to the establishment must be carried out in vehicles which were cleansed and disinfected prior to operation and had no subsequent contact with holdings in the restricted area keeping animals of species susceptible to foot-and-mouth disease. 4 Milk consigned to another member State shall be accompanied by an official certificate prepared on behalf of the Scottish Ministers which bears the following words:– Milk conforming to Commission Decision 2001/172/EC of 1st March 2001 concerning certain protection measures with regard to foot-and-mouth disease in the United Kingdom . 5 Paragraph (4) shall not apply to milk which conforms to the requirements of paragraph (2) if such compliance is stated in the commercial document accompanying the consignment, endorsed in accordance with regulation 14, and the milk has been processed in an establishment operating HACCP and an auditable standard operating procedure which ensures that standards for treatment are met and recorded. 6 Paragraph (4) shall not apply to milk which conforms to the requirements of paragraph (2) and has been heat treated in hermetically sealed containers so as to ensure that it is shelf stable, if the milk is accompanied by a commercial document stating the heat treatment applied. Dispatch of milk products 9 1 No person shall dispatch milk products. 2 The prohibition in paragraph (1) shall not apply in relation to– a milk products produced before 1st February 2001; b milk products prepared from milk which complies with paragraph (2) or (3) of regulation 8; c milk products intended for human consumption produced from milk of a pH less than 7.0 and subjected to heat treatment at a temperature of at least 72°C for at least 15 seconds or an equivalent treatment; d milk products destined for dispatch to a third country where import conditions permit such products to be subject to treatment other than laid down in these Regulations which ensures the inactivation of the foot-and-mouth disease virus; e milk products prepared in parts of the United Kingdom outside the restricted area using milk obtained before 1st February 2001 from the restricted area provided that the milk products are clearly identified and transported and stored separately from milk products not destined for dispatch. f milk products produced from raw milk of bovine, ovine or caprine animals which have been resident for at least 30 days on a holding situated, within the restricted area, in the centre of a circle of at least 10 km radius where no outbreak of foot-and-mouth disease has occurred during the 30 days prior to producing the raw milk, and which are subject to a maturation or ripening process of at least 90 days during which the pH is lowered below 6.0 throughout the substance, and the rind of which has been treated with 0.2% citric acid immediately prior to wrapping or packaging; 3 The prohibitions in paragraph (1) shall not apply to milk products prepared in approved establishments under the following conditions:– a all milk used in the establishment will either conform to the conditions of regulation 8(2) or be obtained from animals outside the restricted area; b all milk products used in the final product will either conform to the conditions of paragraph (2)(a), (b) or (c) or be made from milk obtained from animals outside the restricted area; c the establishment shall be under strict veterinary control; and d the milk products must be clearly identified and transported and stored separately from milk and milk products which are not destined for dispatch. e the milk products are only intended for human consumption and all milk products used in the final product will either conform to the conditions of paragraphs (3)(a) and (b) above or meet the conditions of paragraph (2)(d) or (f) above. 4 Milk products consigned to another member State shall be accompanied by an official certificate prepared on behalf of the Scottish Ministers which bears the following words:– Milk products conforming to Commission Decision 2001/172/EC of 1st March 2001 concerning certain protection measures with regard to foot-and-mouth disease in the United Kingdom . 5 Paragraph (4) shall not apply to milk products which conform to the requirements of paragraph (2)(a), (b) or (c) if such compliance is stated in the commercial document accompanying the consignment, endorsed in accordance with regulation 14, and the milk products have been processed in an establishment operating HACCP and an auditable standard operating procedure which ensures that standards for treatment are met and recorded. 6 Paragraph (4) shall not apply to milk products which conform to the requirements of paragraph (2) and have been heat treated in hermetically sealed containers so as to ensure that they are shelf stable, if the milk products are accompanied by a commercial document stating the heat treatment applied. Dispatch of semen, etc. 10 1 No person shall dispatch semen, ova or embryos of animals of the bovine, ovine, caprine and porcine species and other biungulates. 2 The prohibition in paragraph (1) shall not apply in relation to– a frozen bovine and porcine semen produced before 1st February 2001; b frozen bovine and porcine semen and bovine embryos imported into the United Kingdom in accordance with the conditions laid down in Council Directives 88/407/EEC , 89/556/EEC , and 90/429/EEC (as amended) respectively, and which since introduction into the United Kingdom have been stored and transported separately from semen and embryos to which the prohibition in paragraph (1) applies; or c frozen bovine and porcine semen produced in accordance with the provisions of Council Directive 88/407/EEC or Council Directive 90/429/EEC after 30th September 2001 and also approved under these Regulations, subject to the following conditions– i the donor bull or boar showed no clinical sign of foot-and-mouth disease on the day of collection of the semen; ii the donor bull or boar was kept in the semen collection centre for at least three months (which may include the isolation period of at least 30 days in isolation accommodation attached to the semen collection centre) prior to the collection of the semen; iii no animal was introduced into the semen collection centre during the 30 days prior to the collection of the semen; iv the semen collection centre has been free from foot-and-mouth disease for at least three months and no case of foot-and-mouth disease occurred within a 10 kilometre radius around the semen collection centre for the 30 days before and after the collection of the semen; v no animal in the semen collection centre has been vaccinated against foot-and-mouth disease; vi the donor bull or boar showed a negative response to a test for antibodies against foot-and-mouth disease virus carried out at least 21 days after the collection of the last semen of the consignment and the negative test results were available before dispatch of the semen; vii prior to dispatch the frozen semen was stored for a period of at least 30 days immediately following collection and during the first 30 days of that storage period no animal in the semen collection centre where the donor bull or boar was kept showed any sign of foot-and-mouth disease; viii the semen was collected, processed and stored separately from semen which is not eligible for dispatch; and ix all semen collected, processed and frozen in the semen collection centre was dispatched from the semen collection centre in a way that avoids any risk of introducing foot-and-mouth disease into the centre. 3 The health certificate provided for in Council Directive 88/407/EEC (laying down the animal health requirements applicable to intra-Community trade in and imports of deep-frozen semen of domestic animals of the bovine species) accompanying frozen bovine semen consigned to another member State shall bear the following words:– Frozen bovine semen conforming to Commission Decision 2001/172/EC of 1st March 2001 concerning certain protection measures with regard to foot-and-mouth disease in the United Kingdom . 4 The health certificate provided for in Council Directive 89/556/EEC (on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species) accompanying bovine embryos consigned to another member State shall bear the following words:– Bovine embryos conforming to Commission Decision 2001/172/EC of 1st March 2001 concerning certain protection measures with regard to foot-and-mouth disease in the United Kingdom . 5 The health certificate provided for in Council Directive 90/429/EEC (laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the porcine species) accompanying frozen porcine semen consigned to another member State shall bear the following words:– Frozen porcine semen conforming to Commission Decision 2001/740/EC of 19th October 2001 concerning certain protection measures with regard to foot-and-mouth disease in the United Kingdom . Dispatch of hides and skins 11 1 No person shall dispatch hides and skins of animals of the bovine, ovine, caprine and porcine species and other biungulates. 2 The prohibition in paragraph (1) shall not apply in relation to hides and skins which were produced before 1st February 2001 or which conform to the requirements of paragraph 1A indents 2 to 5 or paragraph 1B, indents 3 and 4 of Chapter 3 of Annex I to Directive 92/118/EEC if treated hides and skins are separated effectively from untreated hides and skins. 3 The hides and skins consigned to another member State must be accompanied by an official certificate prepared on behalf of the Scottish Ministers stating– Hides and skins conforming to Commission Decision 2001/172/EC of 1st March 2001 concerning certain protection measures with regard to foot-and-mouth disease in the United Kingdom . 4 Paragraph (3) shall not apply to hides and skins which conform to the requirements of either– a paragraph 1A indents 2 to 5 of Chapter 3 of Annex 1 to Council Directive 92/118/EEC ; or b paragraph 1B indents 3 and 4 of Chapter 3 of Annex I to Council Directive 92/118/EEC , if compliance with those conditions is stated in the commercial document accompanying the consignment, endorsed (in the case of sub-paragraph (b) above) in accordance with regulation 14. Dispatch of animal products 12 1 No person shall dispatch animal products of the bovine, ovine, caprine and porcine species and other biungulates not otherwise mentioned in these Regulations, produced after 1st February 2001. 2 No person shall dispatch dung or manure. 3 The prohibition in paragraph (1) shall not apply in relation to– a animal products which have been subject to– i heat treatment in a hermetically sealed container with a Fo value of 3.00 or more; or ii heat treatment in which the centre temperature is raised to at least 70°C; b blood and blood products as defined in Chapter 7 of Annex I to Council Directive 92/118/EEC which have been subjected to– i heat treatment at a temperature of 65°C for at least three hours followed by an effectiveness check; ii irradiation at 2.5 megarads or gamma rays followed by an effectiveness check; iii change of pH to pH5 or lower for at least two hours, followed by an effectiveness check; or iv a treatment provided for in Chapter 4 of Annex I to Directive 92/118/EEC ; c lard and rendered fats which have been subject to the heat treatment prescribed in paragraph 2(A) of Chapter 9 of Annex I to Council Directive 92/118/EEC ; d animal casings to which the provisions of paragraph B Chapter 2 of Annex I to Council Directive 92/118/EEC apply adapted as necessary to suit the case; e sheep wool, ruminant hair and pigs’ bristles which have undergone factory washing or have been obtained from tanning unprocessed sheep wool, ruminant hair and pigs’ bristles which are securely enclosed in packaging and dry; f semi-moist and dried petfood conforming to the requirements of paragraphs 2 and 3 respectively of Chapter 4 of Annex I to Council Directive 92/118/EEC ; g composite products which are not subject to further treatment containing products of animal origin on the understanding that the treatment was not necessary for finished products the ingredients of which comply with the respective animal health conditions laid down in these Regulations; h game trophies in accordance with paragraph 2(b) of Part B in Chapter 13 of Annex I to Council Directive 92/118/EEC ; i packed products intended for use as in-vitro diagnostic or laboratory reagents. 4 The animal products consigned to another member State must be accompanied by an official certificate prepared on behalf of the Scottish Ministers which bears the following words:– Animal products conforming to Commission Decision 2001/172/EC of 1st March 2001 concerning certain protection measures with regard to foot-and-mouth disease in the United Kingdom . 5 Paragraph (4) shall not apply to products specified in sub-paragraphs (b), (c) or (d) of paragraph (3) which have a commercial document required under the Products of Animal Origin (Import and Export) Regulations 1996 endorsed in accordance with regulation 14 of these Regulations. 6 Paragraph (4) shall not apply to products specified in sub-paragraph (e) of paragraph (3) which are accompanied by a commercial document stating either– a that the products have undergone factory washing or have been obtained from tanning; or b that the products comply with the conditions laid down in paragraphs (2) and (4) of Chapter 15 of Annex I to Council Directive 92/118/EEC . 7 Paragraph (4) shall not apply to products specified in sub-paragraph (g) of paragraph (3) which are consigned in hermetically sealed containers or have been processed in an establishment operating HACCP and an auditable standard operating procedure which ensures that standards for treatment are met and recorded if they have a commercial document required under the Products of Animal Origin (Import and Export) Regulations 1996 endorsed in accordance with regulation 14 of these Regulations. 8 Paragraph (4) shall not apply to products which conform to the requirements of paragraph (3)(i) above, if the products are accompanied by a commercial document stating that the products are for use as in-vitro diagnostic or laboratory reagents, provided that the products are clearly labelled “for in-vitro diagnostic use only” or “for laboratory use only”. Exemptions 13 The prohibitions in regulations 7, 8, 9 and 12 shall not apply in relation to– a products produced and packaged outside the United Kingdom if the packaging indicates the country of origin and they remain in their original packaging; or b products which are– i produced in an establishment approved by the Scottish Ministers from pre-processed products originating outside the restricted area which, since introduction into the United Kingdom have been transported, stored and processed separately from products not destined for dispatch; and ii accompanied by a commercial document or official certificate as required by these Regulations. Endorsement of commercial documents 14 1 Where reference is made to a commercial document being endorsed in accordance with this regulation, the document must have attached to it an official certificate prepared on behalf of the Scottish Ministers stating that the production process has been audited and found to be in accordance with these Regulations and suitable to destroy the foot-and-mouth disease virus or that the products concerned have been produced from pre-processed materials which have been certified accordingly and that provisions are in place to avoid possible re-contamination with the foot-and-mouth disease virus after treatment. 2 That certificate shall bear a reference to the Decision, shall be valid for 30 days, shall state the expiry date and shall be renewable after inspection of the establishment. 3 Notwithstanding paragraph (1), in the case of a consolidated load of products (unless the products are fresh meat, minced meat and meat preparations) which individually are eligible for dispatch in accordance with these Regulations and intended for sale to a final consumer, reference to a commercial document endorsed in accordance with this regulation includes a commercial document accompanying that load endorsed by attachment of a copy of an official veterinary certificate prepared on behalf of the Scottish Ministers and signed by a person appointed as an officer of the kind specified in the certificate, in the form specified in paragraph (4). 4 A certificate under paragraph (3), shall– a confirm that the premises of dispatch have been audited and have in place a satisfactory system to ensure that goods can only be dispatched from those premises if they are traceable to documentary evidence of compliance with these Regulations; and b also comply with paragraph (2). Third country certificates 15 No person shall dispatch anything to which these Regulations apply to a third country unless the consignment is accompanied by an official certificate prepared on behalf of the Scottish Ministers and signed by an inspector certifying compliance with these Regulations. Export of Equidae 16 1 Any person dispatching equidae shall ensure that they are accompanied by an Animal Health Certificate in accordance with the model in Annex C of Directive 90/426/EEC on animal health conditions governing the movement and import from third countries of equidae . 2 A veterinary inspector shall only issue a certificate referred to in paragraph (1) if– a satisfied that the animal has not come from a holding in relation to which a notice in Form A or Form D is in effect in accordance with the Foot and Mouth Disease Order 1983; b satisfied following inspection of the animal that it has been groomed to remove as far as practicable visible faeces, dirt and debris and that its hooves have been cleaned and disinfected; and c the owner of the animal or the owner’s representative has given a written declaration to the veterinary inspector stating that the equine animal will remain on the holding until sent to the place of destination stated in the health certificate, without stopping at any holding in relation to which a notice in Form A or Form D is in effect in accordance with that Order. 3 The health certificate accompanying equidae exported to another member State in accordance with the provisions of this article shall bear the following words:– Equidae conforming to Commission Decision 2001/356/EC of 4th May 2001 concerning certain protection measures with regard to foot-and-mouth disease in the United Kingdom. 4 Paragraph (1) shall not apply to equidae in transit from outside the United Kingdom which are accompanied by a valid health certificate in accordance with the model in Annex C of Directive 90/426/EEC on animal health conditions governing the movement and import of equidae from third countries. Offers to dispatch or export 17 No person shall offer to dispatch or export, or accept orders for the dispatch or export of, anything prohibited from being dispatched or exported by these Regulations. Powers of inspectors 18 1 An inspector shall, on producing, if required to do so, some duly authenticated document showing the authority of that inspector, have the right at all reasonable hours to enter any land or premises for the purposes of ascertaining whether there is or has been on the premises any contravention of these Regulations and in this regulation “premises” includes any place, installation, vehicle (including any container, trailer, semi-trailer, caravan or other thing which is designed or adapted to be towed by another vehicle), train, ship, vessel, boat, craft, hovercraft or aircraft. 2 An inspector shall have powers to carry out all checks and examinations necessary for the enforcement of the Decision, and in particular may– a carry out inspections of any processes used for the marking and identification of animals, any premises and any installation; b examine documentary or data processing material relevant to the checks carried out under these Regulations; and c be accompanied by a representative of the European Commission acting for the purposes of the Decision. Power of detention 19 The Scottish Ministers may detain any vehicle, vessel, container or anything which they reasonably suspect to contain animals or products regulated by these Regulations, but only for as long as is reasonably necessary to enable an inspector to exercise a power under these Regulations. Illegal consignments 20 1 Where an inspector knows or suspects that animals or animal products are intended for dispatch and do not comply with the requirements of these Regulations, that inspector may serve a notice on the person in charge of the consignment prohibiting the export of the animals or products in the consignment until the inspector is satisfied that the animals or products comply with the Regulations. 2 No person shall dispatch anything subject to a notice served under this regulation unless it has been revoked. A notice under this section shall be in writing, may be subject to conditions and may be amended or revoked by further notice in writing at any time. Animals imported in contravention of these Regulations shall be dealt with as provided for in regulation 13 of the Animals and Animal Products (Import and Export) (Scotland) Regulations 2000 . Recovery of Costs 21 1 The Scottish Ministers may charge the occupier of any holding or premises at which supervision or inspection (including supervision or inspection by the Food Standards Agency) is carried out for the purposes of establishing the eligibility for dispatch of products under these Regulations for the costs reasonably incurred in that respect. 2 Any charge made by the Scottish Ministers under paragraph (1) in respect of supervision or inspection by the Food Standards Agency shall be payable to the Scottish Ministers by the occupier and shall be recoverable on demand by the Scottish Ministers, or by the Food Standards Agency acting on their behalf, as a debt from such occupier. Obstruction 22 1 No person shall– a intentionally obstruct any person acting in the execution of these Regulations; b without reasonable cause, fail to give to any person acting in the execution of these Regulations any assistance or information which that person may reasonably require for the purposes of the functions of that person under these Regulations; or c furnish to any person acting in the execution of these Regulations any information which is known to be false or misleading in a material particular. 2 Nothing in paragraph (1)(b) shall be construed as requiring any person to answer any question or give any information if to do so might incriminate that person. Penalties 23 1 A person contravening any provision of these Regulations shall be guilty of an offence. 2 A person guilty of an offence under regulation 22(1)(a) or (b) shall be liable on summary conviction to a fine not exceeding level 5 on the standard scale or to imprisonment for a term not exceeding three months or to both. 3 A person guilty of any other offence under these Regulations shall be liable– a on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment not exceeding three months or to both; b on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or to both. Offences by bodies corporate 24 1 Where an offence under these Regulations committed by a body corporate or a partnership is proved to have been committed with the consent or connivance of, or to have been attributable to any neglect on the part of, any director, manager, secretary or similar officer of the body corporate, or any person who was purporting to act in any such capacity (or in the case of a partnership, a partner or a person who was purporting to act as such), that person as well as the body corporate or the partnership, as the case may be, shall be guilty of that offence and shall be liable to be proceeded against and punished accordingly. 2 Where the affairs of a body corporate are managed by its members, the provisions of paragraph (1) shall apply in relation to the acts and defaults of a member in connection with the members’ functions of management as if the member were a director of the body corporate. Effect of certificates, etc. issued in another part of the British Islands 25 1 For the purposes of these Regulations, any certificate, licence or approval issued or granted by the Secretary of State in England or the National Assembly for Wales or the Department of Rural Development (in Northern Ireland) of an equivalent nature to a certificate, licence or approval issued by the Scottish Ministers under these Regulations shall have effect in or as regards Scotland as if issued or granted by the Scottish Ministers. 2 Where these Regulations require anything to be processed in approved premises in Scotland, anything processed in premises approved for those purposes by the Secretary of State in England or the National Assembly for Wales or the Department of Rural Development (in Northern Ireland) shall be treated as if it had been processed in approved premises in Scotland. Enforcement 26 These Regulations shall be enforced by the Scottish Ministers or the local authority. Consequential amendments to the Meat Products (Hygiene) Regulations 1994 27 1 The Meat Products (Hygiene) Regulations 1994 are amended in accordance with this regulation. 2 For paragraph 3A(2) of Part VI of the Schedule there is substituted– 2 Paragraph 3A(1) shall not apply to meat products which have been heat-treated in accordance with regulation 7(2) of the Import and Export Restrictions (Foot-and-Mouth Disease) (Scotland) (No. 3) Regulations 2001 (“the 2001 Regulations”), but if they are dispatched from Great Britain this must be done in accordance with these Regulations and regulation 7(4), (5) and (6) of the 2001 Regulations. . Consequential amendments to the Fresh Meat (Hygiene and Inspection) Regulations 1995 28 1 The Fresh Meat (Hygiene and Inspection) Regulations 1995 are amended in accordance with this regulation. 2 In sub-paragraph (1) of paragraph 9 of Schedule 12, for “and processed” there shall be substituted “ or meat from such species or other biungulates processed in Great Britain ” . 3 In sub-paragraph (3) of paragraph 9 of Schedule 12 for “regulation 4(2) of the Import and Export Restrictions (Foot-and-Mouth Disease) (Scotland) (No. 2) Regulations 2001” there shall be substituted “ regulation 6(2) of the Import and Export Restrictions (Foot-and-Mouth Disease) (Scotland) (No. 3) Regulations 2001. ” . Consequential amendments to the Minced Meat and Meat Preparations (Hygiene) Regulations 1995 29 1 The Minced Meat and Meat Preparations (Hygiene) Regulations 1995 are amended in accordance with this regulation. 2 In regulation 7(6) and 8(7) for “regulation 4(2) of the Import and Export Restrictions (Foot-and-Mouth Disease) (Scotland) (No. 2) Regulations 2001” there shall be substituted “ regulation 6(2) of the Import and Export Restrictions (Foot-and-Mouth Disease) (Scotland) (No. 3) Regulations 2001. ” . Revocations 30 The Regulations listed in Schedule 3 are revoked to the extent specified in column (3) in Schedule 3. DAVID R DICKSON A member of the staff of the Scottish Ministers Pentland House, Edinburgh 20th November 2001