PART 1 General provisions

Title, application, commencement and cessation

1.–(1) These Regulations–

(a) are entitled the Export and Movement Restrictions (Foot-and-Mouth Disease) (No.2) (Wales) Regulations 2007;

(b) apply in relation to Wales;

(c) come into force at 6.20 p.m. on 5 December 2007; and

(d) subject to paragraph (2), cease to have effect on 31 December 2007.

(2) Regulations 5 to 9 and 11 to 14 cease to have effect on 15 December 2007.

Interpretation

2. In these Regulations–

"approved" means approved for the purposes of these Regulations in accordance with regulation 17;

"the Decision" means Commission Decision 2007/554/EC concerning certain protection measures against foot–and-mouth disease in the United Kingdom(3);

"export" includes consigning for export;

"free area" means the areas in Great Britain not specified in Schedule 1;

"inspector" means a person appointed as an inspector or a veterinary inspector for the purposes of the Animal Health Act 1981(4) or the Animals and Animal Products (Import and Export) (Wales) Regulations 2006(5), or a person authorised by the Welsh Ministers, local authority or Food Standards Agency to be an authorised officer or official veterinary surgeon for the purposes of the Products of Animal Origin (Third Country Imports) (Wales) Regulations 2007(6) or the Products of Animal Origin (Import and Export) Regulations 1996(7);

"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 in relation to an area the council or county borough council for that area;

"official veterinarian" means a veterinarian who is qualified in accordance with Regulation (EC) No. 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption(8) to act in such a capacity and is appointed by the Food Standards Agency;

"premises" includes any land, building or other place;

"slaughter", in relation to an animal, means causing the death of the animal by bleeding; and

"veterinary inspector" means a veterinary inspector appointed by the Welsh Ministers for the purposes of the Animal Health Act 1981.

PART 2 Animal movement restrictions

Movement of live animals

3.–(1) No person may move any live animal of the bovine, ovine, caprine or porcine species or any other biungulate from an area specified in Schedule 1 to the free area or vice versa.

(2) The prohibition in paragraph (1) does not apply to live animals from the free area that are moved to premises in an area specified in Schedule 1 providing that the animals are moved under a licence issued in accordance with regulation 18.

(3) The prohibition in paragraph (1) does not apply to live animals from an area specified in Schedule 1 that are moved to the free area, providing that the animals–

(a) are moved under a licence issued in accordance with regulation 18; and

(b) show no clinical signs of foot-and-mouth disease immediately prior to loading.

(4) The prohibition in paragraph (1) does not apply to movements of live animals on main roads or railway lines without stops, other than stops required by traffic conditions–

(a) starting and ending in the free area via the areas specified in Schedule 1; or

(b) starting and ending in the areas specified in Schedule 1 via the free area,

under a licence issued in accordance with regulation 18.

PART 3 Export Restrictions

Export of live animals

4.–(1) No person may export any live animal of the bovine, ovine, caprine or porcine species or any other biungulate from Great Britain.

(2) By way of derogation from paragraph (1), a person may export animals originating outside Great Britain if–

(a) the animals were moved in direct transit on main roads or railway lines through Great Britain without stops, other than those required by traffic conditions; and

(b) the requirements in paragraph (3)(a) and (b) are complied with.

(3) No person may export any biungulate to another member State from Wales without the prior authorisation of the Welsh Ministers unless–

(a) at least three days before export the Welsh Ministers have notified that member State; and

(b) in the case of–

(i) bovine, ovine, caprine or porcine animals, the health certificate accompanying the animals bears the following words–

• "Animals conforming to Commission Decision 2007/554/EC of 9 August 2007 concerning certain protection measures against foot-and-mouth disease in the United Kingdom.";

(ii) other biungulates, the health certificate accompanying the animals bears the following words–

• "Live biungulates conforming to Commission Decision 2007/554/EC of 9 August 2007 concerning certain protection measures against foot-and-mouth disease in the United Kingdom.".

Export of fresh meat, minced meat, mechanically separated meat and meat preparations

5.–(1) No person may export meat from animals of the bovine, ovine, caprine or porcine species or other biungulates coming from, or obtained from animals originating in, an area specified in Schedule 1.

(2) In this regulation, "meat" includes fresh meat, minced meat, mechanically separated meat and meat preparations as defined in points 1.10, 1.13, 1.14 or 1.15 of Annex 1 to Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin(9).

(3) The prohibition in paragraph (1) does not apply in relation to–

(a) meat obtained before 15 July 2007;

(b) meat derived from animals reared for at least the 90 days prior to slaughter (or since birth, if less than 90 days of age) and slaughtered outside Great Britain, or in the case of meat obtained from wild game of a species susceptible to foot-and-mouth disease, killed outside Great Britain;

(c) meat from bovine, ovine, caprine or porcine animals that complies with the conditions in Schedule 2, and is derived from animals that–

(i) were kept on premises situated within the areas specified in Schedule 1 in which premises there has been no outbreak of foot-and-mouth disease for at least the 90 days prior to slaughter (or since birth, if less than 90 days of age);

(ii) during the 21 days prior to transport to the approved slaughterhouse, remained under the supervision of the Welsh Ministers on premises complying with Schedule 3;

(iii) were transported to the approved slaughterhouse under the control of the Welsh Ministers in a means of transport that was cleansed and disinfected before loading at the premises described in sub–paragraph (c)(ii); and

(iv) were slaughtered less than 24 hours after arrival at the approved slaughterhouse separately from animals the meat of which is not eligible for export;

(d) meat from farmed game of a species susceptible to foot-and-mouth disease that complies with the conditions in Schedule 2, and is derived from animals–

(i) that were kept on premises situated within the areas specified in Schedule 1 in which premises there has been no outbreak of foot-and-mouth disease for at least the 90 days prior to slaughter (or since birth, if less than 90 days of age);

(ii) that, during the 21 days prior to on-farm slaughtering, remained under the supervision of the Welsh Ministers on premises complying with Schedule 3; and

(iii) any carcase of which was transported to the approved slaughterhouse under the control of the Welsh Ministers in a means of transport that was cleansed and disinfected before loading at the premises described in sub-paragraph (d)(ii);

(e) fresh meat obtained from bovine, ovine, caprine or porcine species or any other biungulates reared outside the areas specified in Schedule 1 and transported, under a licence issued pursuant to regulation 18, directly and under the control of the Welsh Minsiters to an approved slaughterhouse provided that–

(i) the slaughterhouse is situated in an area specified in Schedule 1;

(ii) the animals are slaughtered immediately, and in any event, within 24 hours of arrival at the slaughterhouse;

(iii) the slaughterhouse is operated under strict veterinary control; and

(iv) the fresh meat is clearly identified, and transported and stored separately from meat which is not eligible for export; or

(f) fresh meat obtained from an approved cutting plant situated in an area specified in Schedule 1 if–

(i) only fresh meat described in sub-paragraphs (a) to (e) is processed in the cutting plant in any one day;

(ii) cleansing and disinfection has been carried out after processing any meat not described in sub-paragraphs (a) to (e);

(iii) the cutting plant is operated under strict veterinary control; and

(iv) the fresh meat is clearly identified, and has been transported and stored separately from meat that is not eligible for export.

(4) Any person consigning an animal to a slaughterhouse to produce meat intended for export in accordance with sub-paragraph (c) or (d) of paragraph (3) must provide a written declaration that it complies with each of the conditions contained in that sub-paragraph and ensure that such declaration accompanies the animal consigned.

(5) Meat specified in paragraph (3) intended for export must bear a health mark in accordance with Chapter III of Section I of Annex I to Regulation (EC) No 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption(10).

(6) Meat exported to another member State from Wales must be accompanied by an official certificate which bears the following words–

• "Meat conforming to Commission Decision 2007/554/EC of 9 August 2007 concerning certain protection measures against foot-and-mouth disease in the United Kingdom.".

Marking meat not eligible for export

6. Meat not eligible for export to another member State must be marked in accordance with the second subparagraph of Article 4(1) of Council Directive 2002/99/EC laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption(11), or in accordance with Commission Decision 2001/304/EC on the marking and use of certain animal products(12).

Export of meat products

7.–(1) No person may export meat products, including treated stomachs, bladders and intestines, of animals of the bovine, ovine, caprine or porcine species or other biungulates coming from, or prepared using meat obtained from such animals originating in, an area specified in Schedule 1.

(2) The prohibition in paragraph (1) does not apply to meat products that have been transported and stored since the date of production separately from other meat products that are not eligible for export, provided that the meat products–

(a) are clearly identified;

(b) bear the health mark in accordance with Chapter III of Section I of Annex I to Regulation (EC) No 854/2004; and

(c) are made from meat–

(i) described in regulation 5(3); or

(ii) that has undergone at least one of the relevant treatments laid down for foot-and-mouth disease in Part 1 of Annex III to Directive 2002/99/EC.

(3) Meat products exported to another member State from Wales must be accompanied by an official certificate which bears the following words–

• "Meat products (including treated stomachs, bladders and intestines) conforming to Commission Decision 2007/554/EC of 9 August 2007 concerning certain protection measures against foot-and-mouth disease in the United Kingdom.".

(4) Paragraph (3) does not apply to meat products that comply with paragraph (2) and have been processed in an establishment operating HACCP and an auditable standard operating procedure that ensures that standards for treatment are met and recorded, if compliance with paragraph (2)(c)(ii) is stated in the commercial document accompanying the consignment, endorsed in accordance with regulation 14.

(5) Paragraph (3) does not apply to meat products heat treated in accordance with paragraph (2)(c)(ii) stored in hermetically sealed containers so as to ensure that they are shelf stable, if the heat treatment applied is stated in the commercial document accompanying the consignment.

Export of milk

8.–(1) No person may export milk produced or prepared in an area specified in Schedule 1.

(2) The prohibition in paragraph (1) does not apply to milk produced from animals kept in an area specified in Schedule 1 that has been subjected to at least a treatment in accordance with–

(a) Part A of Annex IX to Council Directive 2003/85/EC on Community measures for the control of foot-and-mouth disease(13), if the milk is intended for human consumption; or

(b) Part B of Annex IX to Directive 2003/85/EC, if the milk is not intended for human consumption.

(3) The prohibition in paragraph (1) does not apply to milk prepared in an approved establishment situated in an area specified in Schedule 1 under the following conditions–

(a) all milk used in the establishment has either–

(i) been treated in accordance with paragraph (2); or

(ii) has been obtained from animals reared and milked outside the areas specified in Schedule 1;

(b) the establishment must be operated under strict veterinary control;

(c) the milk is clearly identified and transported and stored separately from milk and dairy products not eligible for export; and

(d) transport of raw milk from premises situated outside the areas specified in Schedule 1 to the establishments in an area specified in Schedule 1 is carried out in vehicles that were cleansed and disinfected prior to operation and had no subsequent contact with premises in an area specified in Schedule 1 keeping animals of species susceptible to foot-and-mouth disease.

(4) Milk exported to another member State from Wales must be accompanied by an official certificate which bears the following words–

• "Milk conforming to Commission Decision 2007/554/EC of 9 August 2007 concerning certain protection measures against foot-and-mouth disease in the United Kingdom.".

(5) Paragraph (4) does not apply to milk that complies with the requirements of paragraph (2)(a) or (b) if such compliance is stated in the commercial document accompanying the consignment, endorsed in accordance with regulation 14, and 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) does not apply to milk that conforms with the requirements of paragraph (2)(a) or (b) and that has been heat treated in hermetically sealed containers so as to ensure that it is shelf stable provided that the commercial document accompanying the consignment states the heat treatment applied.

Export of dairy products

9.–(1) No person may export dairy products produced or prepared in an area specified in Schedule 1.

(2) The prohibition in paragraph (1) does not apply to dairy products–

(a) produced before 15 July 2007;

(b) prepared from milk complying with the provisions in regulation 8(2) or (3); or

(c) for export to a third country where import conditions permit such products to be subject to treatment other than laid down in regulation 8(2) which ensures the inactivation of the foot-and-mouth disease virus.

(3) The prohibition in paragraph (1) does not apply to dairy products intended for human consumption–

(a) that are finished products, the ingredients of which comply with the respective animal health conditions laid down in these Regulations;

(b) produced from milk of a controlled pH less than 7.0 and subject to a heat treatment at a temperature of at least 72°C for at least 15 seconds; or

(c) produced from raw milk of bovine, ovine or caprine animals (that have been resident for at least 30 days on a premises situated in Great Britain, and within 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 the date of production of the raw milk) and which has been subject to a maturation or ripening process of at least 90 days during with 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.

(4) The prohibition in paragraph (1) does not apply to–

(a) dairy products prepared in an approved establishment situated in an area specified in Schedule 1 if–

(i) all milk used in the establishment either conforms to the conditions of regulation 8(2) or is obtained from animals outside the areas specified in Schedule 1;

(ii) all dairy products used in the final product either conform to the conditions of paragraph (2)(a) or (b) or (3) of this regulation or are made from milk obtained from animals outside the areas specified in Schedule 1;

(iii) the establishment is operated under strict veterinary control; and

(iv) the dairy products are clearly identified and transported and stored separately from milk and dairy products that are not eligible for export; or

(b) dairy products prepared outside the areas specified in Schedule 1 using milk obtained before 15 July 2007 from Great Britain provided that the milk products are clearly identified and transported and stored separately from dairy products that are not eligible for export.

(5) Dairy products exported to another member State from Wales must be accompanied by an official certificate which bears the following words–

• "Dairy products conforming to Commission Decision 2007/554/EC of 9 August 2007 concerning certain protection measures against foot-and-mouth disease in the United Kingdom.".

(6) Paragraph (5) does not apply to milk products that comply with the requirements of paragraph (2)(a) or (b), (3) or (4) if such compliance is stated in the commercial document accompanying the consignment, endorsed in accordance with regulation 14, and the dairy 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.

(7) Paragraph (5) does not apply to dairy products that conform to the requirements of paragraph (2)(a) or (b), (3) or (4), which have been treated in hermetically sealed containers so as to ensure that they are shelf stable if the heat treatment applied is stated in the commercial document accompanying the consignment.

Export of semen, ova and embryos

10.–(1) No person may export semen, ova or embryos of animals of the bovine, ovine, caprine or porcine species or other biungulates produced in or brought into Great Britain.

(2) The prohibition in paragraph (1) does not apply in relation to–

(a) semen, ova or embryos produced before 15 July 2007;

(b) frozen bovine semen imported into the United Kingdom in accordance with the conditions laid down 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(14), which since introduction into the United Kingdom have been stored and transported separately from semen, ova or embryos not eligible for export;

(c) bovine embryos imported into the United Kingdom in accordance with the conditions laid down 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(15), which since introduction into the United Kingdom have been stored and transported separately from semen, ova or embryos not eligible for export;

(d) porcine semen imported into the United Kingdom in accordance with the conditions laid down 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(16), which since introduction into the United Kingdom have been stored and transported separately from semen, ova or embryos not eligible for export;

(e) frozen ovine or caprine semen or frozen ovine or caprine embryos imported into the United Kingdom in accordance with the conditions laid down in Council Directive 92/65/EEC laying down the animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules(17), which since introduction into the United Kingdom have been stored and transported separately from semen, ova or embryos not eligible for export; or

(f) frozen semen or embryos that–

(i) are from bovine, ovine, caprine or porcine animals kept for at least 90 days prior to the date of collection on premises within the free area or moved into the free area from areas not specified in Schedule 1 during the 90 days prior to the date of collection;

(ii) have been collected from donor animals kept in centres or on premises which comply with Part I of Schedule 4; and

(iii) have been stored in accordance with Part II of Schedule 4 for a minimum period of 30 days following collection during which the centre or premises where the semen or embryos were collected must have had no case of foot-and-mouth disease.

(3) The health certificate accompanying frozen bovine semen exported to another member State from Wales must bear the following words–

• "Frozen bovine semen conforming to Commission Decision 2007/554/EC of 9 August 2007 on certain protection measures against foot-and-mouth disease in the United Kingdom.".

(4) The health certificate accompanying bovine embryos exported to another member State from Wales must bear the following words–

• "Bovine embryos conforming to Commission Decision 2007/554/EC of 9 August 2007 on certain protection measures against foot-and-mouth disease in the United Kingdom.".

(5) The health certificate accompanying ovine or caprine semen exported to another member State from Wales must bear the following words–

• "Frozen ovine/caprine semen conforming to Commission Decision 2007/554/EC of 9 August 2007 concerning certain protection measures against foot-and-mouth disease in the United Kingdom.".

(6) The health certificate accompanying ovine or caprine embryos exported to another member State from Wales must bear the following words–

• "Frozen ovine/caprine embryos conforming to Commission Decision 2007/554/EC of 9 August 2007 concerning certain protection measures against foot-and-mouth disease in the United Kingdom.".

(7) The health certificate accompanying porcine semen exported to another member State from Wales must bear the following words–

• "Frozen porcine semen conforming to Commission Decision 2007/554/EC of 9 August 2007 on certain protection measures against foot-and-mouth disease in the United Kingdom.".

Export of hides and skins

11.–(1) No person may export hides or skins of animals of the bovine, ovine, caprine or porcine species or other biungulates produced in or brought into an area specified in Schedule 1.

(2) The prohibition in paragraph (1) does not apply in relation to hides or skins that–

(a) were produced in the United Kingdom before 15 July 2007;

(b) comply with the requirements of paragraph 2(c) or (d) of Part A of Chapter VI of Annex VIII to Regulation (EC) No 1774/2002 of the European Parliament and of the Council laying down health rules concerning animal by-products not intended for human consumption(18);

(c) were produced outside the areas specified in Schedule 1 in accordance with the conditions laid down in Regulation (EC) No 1774/2002 and since introduction into an area specified in Schedule 1 have been stored and transported separately from hides or skins not eligible for export; or

(d) were produced from animals slaughtered in a slaughterhouse, or in the case of farmed game, slaughtered on premises, or in the case of wild game, killed, for the production of meat in accordance with regulation 5(3),

provided that treated hides or skins are separated from untreated hides and skins.

(3) Hides or skins exported to another member State from Wales must be accompanied by an official certificate which bears the following words–

• "Hides and skins conforming to Commission Decision 2007/554/EC of 9 August 2007 on certain protection measures against foot-and-mouth disease in the United Kingdom.".

(4) Paragraph (3) does not apply to hides or skins which conform to the requirements of either–

(a) points (b) to (e) or paragraph 1 of Part A of Chapter VI of Annex VIII to Regulation (EC) No 1774/2002; or

(b) points (c) or (d) of paragraph 2 of Part A of Chapter VI of Annex VIII to Regulation (EC) No 1774/2002,

if compliance with those conditions is stated in the commercial document accompanying the consignment, endorsed (in the case of sub-paragraph (b)) in accordance with regulation 14.

Export of animal products

12.–(1) No person may export animal products of the bovine, ovine, caprine or porcine species or other biungulates not otherwise mentioned in these Regulations–

(a) produced after 15 July 2007 in an area specified in Schedule 1; or

(b) obtained from animals originating from an area specified in Schedule 1.

(2) No person may export dung or manure from animals of the bovine, ovine, caprine or porcine species or other biungulates from an area specified in Schedule 1.

(3) The prohibition in paragraph (1) does not apply in relation to–

(a) animal products that–

(i) have been subject to a heat treatment in a hermetically sealed container with a Fo value of 3,00 or more;

(ii) have been subject to a heat treatment in which the centre temperature is raised to at least 70oC;

(iii) were produced outside the areas specified in Schedule 1 in accordance with the conditions laid down in Regulation (EC) No 1774/2002, and which since introduction into an area specified in Schedule 1 have been stored and transported separately from animal products not eligible for export; or

(iv) were produced from animals slaughtered in a slaughterhouse, or in the case of farmed game slaughtered on premises, or in the case of wild game killed, for the production of meat in accordance with regulation 5(3), and comply with the requirements of Part A(1) of Chapter II of Annex VIII to Regulation (EC) No 1774/2002, and have been stored and transported separately from animal products not eligible for export;

(b) blood or blood products–

(i) as defined in points 4 and 5 of Annex I to Regulation (EC) No 1774/2002 which have been subjected to at least one of the treatments provided for in paragraph 3(a)(ii) of Part A of Chapter IV of Annex VIII to Regulation (EC) No 1774/2002, followed by an effectiveness check; or

(ii) that have been imported in accordance with Part A of Chapter IV of Annex VIII to Regulation (EC) No 1774/2002;

(c) lard or rendered fats which have been subjected to the heat treatment prescribed in point 2(d)(iv) of Part B of Chapter IV of Annex VII to Regulation (EC) No. 1774/2002;

(d) animal casings that comply with the conditions in Part A of Chapter 2 of Annex 1 to Directive 92/118/EC laying down animal health and public requirements governing trade in and imports into the Community of certain products(19), which have been cleaned, scraped and then either salted, bleached or dried, and where subsequently effective steps were taken to prevent the recontamination of the casings;

(e) sheep wool, ruminant hair or pigs' bristles, any of which has undergone factory washing or has been obtained from tanning;

(f) sheep wool, ruminant hair or pigs' bristles, any of which has been securely enclosed in packaging and is dry;

(g) petfood conforming to the requirements of points 2 to 4 of Part B of Chapter II of Annex VIII to Regulation (EC) No 1774/2002;

(h) composite products which are not subjected 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;

(i) game trophies in accordance with points 1, 3 or 4 of Part A of Chapter VII of Annex VIII to Regulation (EC) No 1774/2002;

(j) packed animal products intended for use as in-vitro diagnostic or laboratory reagents; or

(k) medicinal products as defined in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use(20), non-viable medical devices as defined in Article 1(5)(g) of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(21), veterinary medicinal products as defined in Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to veterinary medicinal products(22) and investigational medicinal products as defined in Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the conduct of clinical trials on medicinal products for human use(23).

(4) The animal products referred to in paragraph (3) for export to other member States from Wales must be accompanied by an official certificate which bears the following words–

• "Animal products conforming to Commission Decision 2007/554/EC of 9 August 2007 concerning certain protection measures against foot-and-mouth disease in the United Kingdom.".

(5) Paragraph (4) does not apply to products specified in paragraph (3)(a) to (d) or (g) that are accompanied by a commercial document stating that the products comply with the relevant requirements of paragraph 3(a) to (d) or (g) which is endorsed in accordance with regulation 14.

(6) Paragraph (4) does not apply to products specified in paragraph (3)(e) or (f) that are accompanied by a commercial document stating–

(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 points 1 and 4 of Part A of Chapter VIII of Annex VIII to Regulation (EC) No 1774/2002.

(7) Paragraph (4) does not apply to products specified in paragraph (3)(h) which have been produced in an establishment operating HACCP and an auditable standard operating procedure which ensures that pre-processed ingredients comply with the requirements of these Regulations and they have a commercial document endorsed in accordance with regulation 14.

(8) Paragraph (4) does not apply to products specified in paragraph (3)(j) or (k) if they are accompanied by a commercial document stating that the products are for use as in-vitro diagnostic or laboratory reagents or medical products or medical devices, provided that the products are clearly labelled "for in-vitro diagnostic use only" or "for laboratory use only" or as "medicinal products" or as "medical devices".

(9) Paragraph (4) does not apply to composite products that fulfil the conditions set out in Article 6(1) of Commission Decision 2007/275/EC concerning lists of animals and products to be subject to controls at border inspection posts(24) if they are accompanied by a commercial document which bears the following words–

• "These composite products are shelf stable at ambient temperatures or have clearly undergone in their manufacture a complete cooking or heat treatment process throughout their substance so that any raw material is de-natured.".

Exemptions

13. The prohibitions in regulations 7, 8, 9 and 12 do not apply in relation to–

(a) products not produced in the United Kingdom and which remain in their original packaging indicating the country of origin of the products; and

(b) products that are–

(i) produced in an approved establishment in Great Britain from pre-processed products originating outside Great Britain which, since introduction into the United Kingdom have been transported, stored and processed separately from products from Great Britain not eligible for export; 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 stating that–

(a) the products concerned have been produced–

(i) in a production process that has been audited and found to be in compliance with the appropriate requirements in Community animal health legislation and suitable to destroy the foot-and-mouth disease virus; or

(ii) from pre-processed materials that have been certified accordingly; and

(b) provisions are in place to avoid possible recontamination with the foot-and-mouth disease virus after treatment.

(2) The certificate must bear a reference to the Decision, is valid for 30 days, must state the expiry date and is renewable after inspection of the establishment.

(3) In the case of products for retail sale to the final consumer, a consolidated consignment of animal products, each of which is eligible for export in accordance with these Regulations, may be exported from an approved establishment accompanied by a commercial document endorsed by the attachment of a copy of an official veterinary certificate that–

(a) confirms that the establishment of export has in place a system to ensure that goods can only be exported if they are traceable to documentary evidence of compliance with these Regulations;

(b) confirms that this system has been audited and found satisfactory;

(c) refers to the Decision;

(d) is valid for 30 days;

(e) states the expiry date; and

(f) is renewable only after the establishment had been audited with satisfactory results.

Duties of slaughterhouses and other establishments

15.–(1) If foot-and-mouth disease is suspected in–

(a) a slaughterhouse;

(b) premises on which farmed game are slaughtered; or

(c) a game-handling establishment,

which handles meat controlled under these Regulations, the occupier must comply with paragraph (2).

(2) The occupier must, under the supervision of the Welsh Ministers, ensure that–

(a) all animals present are slaughtered;

(b) all meat and all dead animals are removed and disposed of in accordance with article 25(2) of the Foot-and-Mouth Disease (Wales) Order 2006(25);

(c) the establishment is cleansed and disinfected; and

(d) no meat is prepared for consigning outside the areas listed in Schedule 1 for 24 hours following the completion of the cleansing and disinfection required by sub-paragraph (c).

(3) If an animal susceptible to foot-and-mouth disease and from premises situated in an area specified in Schedule 1 is slaughtered in any of the establishments referred to in paragraph (1), the occupier must ensure that–

(a) all animals present are slaughtered;

(b) the establishment is cleansed and disinfected; and

(c) no meat is prepared for consigning outside an area specified in Schedule 1 until the completion of the cleansing and disinfection required by sub-paragraph (b).

Offers to dispatch or export

16. No person may offer to dispatch or export, or accept orders for the dispatch or export of, anything prohibited from being dispatched or exported by these Regulations, whether on the internet or otherwise.

PART 4 Administration and enforcement

Approvals

17.–(1) The Welsh Ministers or a local authority may approve establishments, slaughterhouses or cutting plants for the purposes of these Regulations if satisfied that the occupier will comply with the conditions of these Regulations.

(2) Any approval must be in writing, may be made subject to conditions and may be amended, suspended or revoked by notice at any time, and in particular may be suspended or revoked if the Welsh Ministers (or in the case of an approval granted by the local authority, that local authority) is reasonably of the opinion that the provisions of these Regulations or any conditions of approval are not being complied with.

Licences

18.–(1) A veterinary inspector, or inspector acting under the direction of a veterinary inspector, may–

(a) grant a licence; and

(b) amend, suspend or revoke a licence in writing at any time.

(2) The licence–

(a) must be in writing;

(b) may be general or specific; and

(c) may be made subject to such conditions as the veterinary inspector considers necessary to prevent the spread of foot-and-mouth disease.

(3) A person moving any animal under a specific licence granted under these Regulations must–

(a) keep the licence or a copy of it with them at all times during the licensed movement;

(b) on demand by an inspector or veterinary inspector–

(i) produce the licence, or copy;

(ii) allow a copy or extract of the licence to be taken; or

(iii) provide their name or address.

(4) A person moving any animal under a general licence granted under these Regulations must–

(a) keep with them at all times during the licensed movement, a consignment note that contains details of–

(i) the type, and numbers, of animals being moved;

(ii) the date of the movement;

(iii) the name of the consignor;

(iv) the address of the premises from which the movement started;

(v) the name of the consignee; and

(vi) the address of the premises of destination; and

(b) on demand by an inspector or veterinary inspector–

(i) produce the consignment note and allow a copy or extract to be taken; and

(ii) provide their name and address.

(5) Licences granted in England or Scotland for activities that can be licensed in Wales under these Regulations must have effect in Wales as if they were licences granted under these Regulations, but an inspector acting under the direction of the Welsh Ministers may serve a notice on any person moving any animal under such a licence, directing him or her to move it to or keep it on premises specified in the notice or move it out of Wales.

Notices

19.–(1) A veterinary inspector, or inspector, may serve any notice issued under the Regulations on–

(a) the owner or keeper of an animal; or

(b) the person in control of an animal, carcase or any part of an animal.

(2) The notice must–

(a) be in writing and may be amended or revoked, by further notice at any time; and

(b) specify how it must be complied with.

Powers of inspectors

20.–(1) An inspector may, at all reasonable hours enter any place, land, 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) Where an inspector enters any of the places specified in paragraph (1), that inspector must produce a duly authenticated document showing the inspector´s authority, if required to do so.

(3) An inspector may by notice, or as a condition of a licence, require the cleansing and disinfection of premises, vehicles, equipment, or any other thing that may spread foot-and-mouth disease.

(4) An inspector may–

(a) require the detention or isolation in a specified place of any animal by serving a notice requiring such action on the occupier of the premises where it is present, or its keeper; and

(b) mark, or cause to be marked, for identification purposes any animal, carcase or thing.

(5) A veterinary inspector may inspect, or take samples from, any animal, carcase or thing.

(6) An inspector may carry out all checks and examinations necessary for the enforcement of these Regulations, and in particular may–

(a) by notice on the person they consider to be appropriate, detain any vehicle, vessel, container or anything which they reasonably suspect to contain animals or products controlled by these Regulations and intended for export for as long as is reasonably necessary to determine whether the consignment complies with the conditions for export;

(b) search any premises;

(c) carry out inspections of any processes used for the marking of any animal, carcase or thing;

(d) examine documentary or data-processing material relevant to the checks carried out under these Regulations, including any import or export manifest; and

(e) take with them a representative of the European Commission acting for the purposes of the Decision.

(7) If any person fails to comply with a requirement in these Regulations, or a notice, approval or licence issued or granted under these Regulations, an inspector may take such steps as they consider necessary to ensure the requirement is met at the expense of that person, including the power to require, by notice, any person to take or refrain from a specified action in respect of any place, animal, vehicle or other thing.

Powers of officers of Revenue and Customs

21. An Officer of Revenue and Customs may detain any vehicle, vessel, container or anything which the officer reasonably suspects to contain animals or products controlled by these Regulations for as long as is reasonably necessary to enable an inspector to exercise a power under these Regulations.

Illegal consignments of products

22.–(1) This regulation has effect when an inspector, on reasonable grounds, suspects that anything other than live animals is intended to be exported in contravention of these Regulations.

(2) The inspector may seize it and remove it in order to have it dealt with by a justice of the peace.

(3) If anything other than live animals is seized under this regulation, the inspector must inform the person appearing to the inspector to be in charge of the consignment of the inspector´s intention to have it dealt with by a justice of the peace, and–

(a) any person who might be liable for prosecution under these Regulations in relation to the export must, if they attend before the justice of the peace by whom the matter falls to be dealt with, be entitled to be heard and to call witnesses; and

(b) the justice of the peace may, but need not, be a member of the court before which any person is charged with an offence under these Regulations in relation to that consignment.

(4) If it appears to a justice of the peace that there was an intention to export the consignment in contravention of these Regulations the justice of the peace must, unless satisfied that the consignment can be returned to the owner without risk of a further attempt to export it in contravention of these Regulations, order that the consignment be destroyed or otherwise disposed of so as to prevent it from being despatched.

(5) When under the preceding paragraph a justice of the peace is satisfied that there was an intention to export a consignment in breach of these Regulations, the owner, the consignor and the consignee are jointly and severally liable for the costs reasonably incurred in its removal to storage, its storage and its destruction or disposal.

Obstruction

23. No person must–

(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 his or her functions under these Regulations;

(c) furnish to any person acting in the execution of these Regulations any information which they know to be false or misleading; or

(d) deface, obliterate or remove any mark made by an inspector under these Regulations.

Offences by bodies corporate

24.–(1) Where a body corporate is guilty of an offence under these Regulations, and that offence is proved to have been committed with the consent or connivance of, or to have been attributable to any neglect on the part of–

(a) any director, manager, secretary or other similar officer of the body corporate, or

(b) any person who was purporting to act in any such capacity,

that person as well as the body corporate, is guilty of the offence and is liable to be proceeded against and punished accordingly.

(2) For the purposes of this regulation, "director" in relation to a body corporate whose affairs are managed by its members, means a member of the body corporate.

Penalties

25.–(1) A person contravening any provision of these Regulations, or any conditions of an approval or licence granted, or a notice served, under these Regulations, is guilty of an offence and liable–

(a) on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment not exceeding three months or to both; or

(b) on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or to both.

Authorisations, certificates, etc. issued in another part of the United Kingdom

26.–(1) Where these Regulations require any authorisation, certificate or approval to be issued or granted by the Welsh Ministers, a veterinary inspector or inspector, an equivalent document issued in another part of the United Kingdom by the relevant competent authority is valid.

(2) Where these Regulations require anything to be done in approved establishments or cutting plants in Wales, anything done in premises approved for those purposes in another part of the United Kingdom must be treated as if it had been processed in approved premises in Wales.

Sharing information

27.–(1) The Welsh Ministers, the Commissioners and any local authority may exchange information for the purposes of these Regulations, and may divulge information to the enforcement authorities in another part of the British Islands.

(2) Paragraph (1) is without prejudice to any other power of the Welsh Ministers, the Commissioners or any local authority to disclose information.

(3) No person, including a servant of the Crown, may disclose any information received from the Commissioners under paragraph (1) if–

(a) the information relates to a person whose identity–

(i) is specified in the disclosure; or

(ii) can be deduced from the disclosure;

(b) the disclosure is for a purpose other than the purposes of these Regulations; and

(c) the Commissioners have not given their prior consent to the disclosure.

(4) In this regulation, "the Commissioners" means the Commissioners for Her Majesty´s Revenue and Customs.

Enforcement

28. These Regulations must be enforced by the Welsh Ministers or the local authority.

Revocations

29. The Export and Movement Restrictions (Foot-And-Mouth Disease) (Wales) Regulations 2007(26) are revoked.

Regulation 3

SCHEDULE 1 Areas subject to export restrictions

Regulation 5

SCHEDULE 2 Additional requirements for meat

1. The meat must at all times be clearly identified, handled, stored and transported separately from meat not eligible for export.

2. The meat must be inspected, along with the animal from which it derived, post-mortem by an official veterinarian–

(a) in the slaughterhouse;

(b) in the case of on-farm slaughtering of farmed game, on the premises; or

(c) in the case of wild game, at the game-handling establishment,

with no clinical signs or evidence of foot-and-mouth disease identified.

3. The meat must remain in the slaughterhouse, premises or game-handling establishment for at least 24 hours after the post-mortem inspection described in paragraph 3.

Regulation 5

SCHEDULE 3 Premises from which an animal may be transported for slaughter

1. The premises must be situated in the centre of a circle of at least 10 km radius in which there was no outbreak of foot-and-mouth disease during at least the 30 days prior to transport.

2. The premises must have had no animal of a species susceptible to foot-and-mouth disease introduced into it during the 21 days prior to transport to slaughter of any animal in the premises susceptible to foot-and-mouth disease (except in the case of pigs, in which case the period of 21 days is reduced to 7 days), unless–

(a) such animal complies with the conditions in regulation 5(3)(c)(i) or 5(3)(d)(i) and was under the supervision of the Welsh Ministers on a single premises–

(i) complying with paragraph 1 during the 21 days prior to its transport; and

(ii) into which no animal of a species susceptible to foot-and-mouth disease was introduced during the 21 days prior to the transport of the animal (except in the case of a pig, in which case the period of 21 days is reduced to 7 days);

(b) a test for antibodies against the foot-and-mouth disease virus was carried out on a blood sample taken from the animal at least 10 days prior to the date of transport to the premises and produced a negative result; or

(c) the animal comes from a premises on which a serological survey pursuant to a sampling protocol suitable to detect 5% prevalence of foot-and-mouth disease with at least 95% level of confidence was conducted and produced negative results.

Regulation 10

SCHEDULE 4 Semen and Embryos

PART 1 Centres or premises from which semen or embryos may be collected

1. The centre or premises must have been free from foot-and mouth disease for at least three months prior to the date of collection of the semen or embryos.

2. It must be situated in the centre of an area of 10 km radius in which there has been no case of foot-and-mouth disease for at least the 30 days prior to the date of collection.

PART 2 Storage conditions for frozen semen and embryos

1. Frozen bovine embryos must have been stored in accordance with the Bovine Embryo (Collection, Production and Transfer) Regulations 1995(28).

2. Frozen porcine semen must have been stored in accordance with Chapters I and II of Annex A of 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(29).

3. Frozen porcine embryos must have been stored in accordance with Chapter III of Annex D of Council Directive 92/65/EEC.

4. Frozen ovine or caprine semen must have been stored in accordance with Chapters I and III of Annex D of Council Directive 92/65/EEC.

5. Frozen ovine or caprine embryos must have been stored in accordance with Chapter III of Annex D of Council Directive 92/65/EEC.

Explanatory Note

(This note is not part of the Regulations)

These Regulations revoke and remake The Export and Movement Restrictions (Foot-and-Mouth Disease) (Wales) Regulations 2007. They implement Commission Decision 2007/554/EC as last amended by the Commission Decision of 5 December 2007 amending Decision 2007/554/EC concerning certain protection measures against foot-and-mouth disease in the United Kingdom (not yet published in the Official Journal). The Commission Decision of 5 December extends the categories of products derived from animals which may be exported, and extends the areas from which such export may take place.

They regulate–

(a) the movement and export of live animals (regulations 3 and 5);

(b) the export of meat from bovine, ovine, caprine and porcine animals and other biungulates, (regulation 5);

(c) the marking of meat not eligible for export (regulation 6);

(d) the export of meat products, milk and dairy products (regulations 7, 8 and 9); and

(e) the export of semen, ova or embryos of animals of the bovine, ovine, caprine or porcine species or other biungulates (regulation 10), hides and skins (regulation 11) and various animal products (regulation 12).

They create an offence of offering to export anything which it is prohibited to export under the Regulations (regulation 16).

They provide powers for enforcement, and powers for officers of Revenue and Customs (regulations 20 to 22) and create an offence of obstruction (regulation 23).

Breach of the Regulations is an offence, punishable with up to two years' imprisonment.

The Regulations are enforced by the Welsh Ministers or the local authority (regulation 28).

A regulatory impact assessment has not been prepared for these Regulations.