The Foot-and-Mouth Disease (Export and Movement Restrictions) (Scotland) Regulations 2007

PART 1 General

Citation, commencement, cessation and extent

1.—(1) These Regulations may be cited as the Foot-and-Mouth Disease (Export and Movement Restrictions) (Scotland) Regulations 2007, and come into force at 1200 hours on 21st November 2007.

(2) These Regulations, subject to paragraph (3), cease to have effect on 31st December 2007.

(3) Regulations 7, 10 to 14, 16 to 18, and 20 to 22 cease to have effect on 15th December 2007.

(4) These Regulations extend to Scotland and, in so far as they extend beyond Scotland, do so only as a matter of Scots law.

Interpretation

2.  In these Regulations (unless the context requires otherwise)–

“ADNS” means the Animal Disease Notification System under Commission Decision 2005/176/EC of 1st March 2005 laying down the codified form and the codes for the notification of animal diseases pursuant to Council Directive 82/894/EEC(1);

“animal” means a live animal of the bovine, ovine, caprine or porcine species or other biungulate;

“approved” means approved in accordance with regulation 3;

“Decision 2001/304” means Commission Decision 2001/304/EC on the marking and use of certain animal products(2);

“the Decision” means Commission Decision 2007/554/EC concerning certain protection measures against foot-and-mouth disease in the United Kingdom and repealing Decision 2007/552/EC(3), as amended from time to time;

“disease” means foot-and-mouth disease;

“dispatch” means dispatch from Scotland, and includes consigning for dispatch, and export from Scotland;

“Directive 2002/99” means 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(4);

“export” includes consigning for export;

“farmed game” and “wild game” mean respectively a domestic or wild animal of a game species susceptible to disease;

“inspector” means a person appointed by the Scottish Ministers or a local authority to be an inspector for the purposes of–

(a)

these Regulations;

(b)

the Animal Health Act 1981(5);

(c)

the Products of Animal Origin (Import and Export) Regulations 1996(6);

(d)

the Products of Animal Origin (Third Country Imports) (Scotland) Regulations 2007(7); or

(e)

the Animals and Animal Products (Import and Export) (Scotland) Regulations 2007(8);

“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;

“official veterinarian” means a veterinarian who is qualified in accordance with Part A of Chapter IV of Section III of Annex I to Regulation 854/2004 to carry out the controls required of an official veterinarian under that Regulation;

“meat” means 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 853/2004;

“Regulation 1774/2002” means 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(9);

“Regulation 853/2004” means Regulation (EC) No. 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin(10);

“Regulation 854/2004” means Regulation (EC) No. 854/2004/EC 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(11);

“restricted area” means the areas specified in Schedule 1;

“susceptible animal” means an animal of a species susceptible to the disease; and

“veterinary inspector” means a veterinary inspector appointed by the Scottish Ministers for the purposes of the Animal Health Act 1981.

Approvals

3.—(1) The Scottish Ministers or a local authority may approve cutting plants, establishments, slaughterhouses , or holdings for the purposes of these Regulations.

(2) An approval under these Regulations must be in writing, may be made subject to conditions, and may be amended or suspended or revoked by notice in writing at any time.

(3) The Scottish Ministers or a local authority must, on granting or amending an approval, be satisfied that the occupier of the cutting plant or other premises will comply with these Regulations and with any condition of the approval.

Licences

4.—(1) A veterinary inspector may grant a licence for the purposes specified in regulations 8 and 10.

(2) A licence must be in writing, may be general or specific, and may be subject to such conditions as the veterinary inspector considers necessary to prevent the spread of disease.

(3) A licence may be amended, suspended or revoked in writing at any time.

(4) Any person carrying out an activity authorised by a licence must carry the licence (or a copy, in the case of a general licence) and produce the licence (or copy) to an inspector, veterinary inspector or official veterinarian on demand.

Approvals, licenses and activities in other parts of Great Britain

5.—(1) Where these Regulations require any approval to be issued or granted by the Scottish Ministers, an equivalent document issued in another part of Great Britain by a competent authority in that part is valid in Scotland.

(2) A licence granted in another part of Great Britain for the same purpose as a licence granted under these Regulations shall, unless the Scottish Ministers direct otherwise, be valid for that purpose in Scotland, and any condition of that licence shall apply in Scotland is if it were in a licence granted under these Regulations.

(3) Where these Regulations require that any declaration is made, an equivalent document made in another part of Great Britain is valid in Scotland.

(4) Where these Regulations require anything to be done in an approved establishment, holding, slaughterhouse or cutting plant in Scotland, anything done in premises approved for the same purpose in another part of Great Britain shall be treated as if it had been approved in Scotland.

(5) Where these Regulations require that a thing is authorised by or done under the supervision or control of the Scottish Ministers, a thing authorised by or done under the supervision or control of the equivalent authority for the same purpose in another part of Great Britain shall be treated as if it had been authorised or done by the Scottish Ministers.

(6) A direction under paragraph (2) shall be in writing, and may be suspended or revoked in writing at any time.

Sharing of information

6.—(1) The Scottish Ministers and any local authority may exchange information for the purposes of these Regulations, and may disclose information to an enforcement authority in another part of the British Islands.

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

Endorsement of commercial documents

7.—(1) Where reference is made to a commercial document being endorsed in accordance with this regulation, the document must have attached to it a copy of the official certificate which–

(a) states that the production process has been audited and found to be–

(i) in compliance with the appropriate requirements in Community animal health legislation; and

(ii) suitable to destroy disease virus; or

(b) states that the product or products concerned have been produced from pre-processed materials which have been certified in accordance with paragraph (a), and that provisions are in place to avoid possible re-contamination with disease virus.

(2) The 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) 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 if sent from an approved establishment accompanied by a commercial document endorsed by the attachment of a copy of an official veterinary certificate which–

(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.

PART 2 Movement and export: animals, meat and meat products

Movement of animals

8.—(1) No person may move an animal from the restricted area to Scotland.

(2) The prohibition in paragraph (1) does not apply to a movement to an approved slaughterhouse that is–

(a) either direct or through no more than a single assembly centre; and

(b) authorised by a licence.

(3) The prohibition in paragraph (1) does not apply to a direct movement to premises–

(a) where the animal showed no clinical signs of disease on inspection immediately prior to loading, and–

(i) was subjected with negative results to a test for antibodies against disease virus carried out on a blood sample taken within 10 days prior to the date of transport from that area;

(ii) came from a holding that was subjected with negative results to serological survey pursuant to a sampling protocol suitable to detect 5% prevalence of disease with at least a 95% level of confidence; or

(iii) came from a holding situated in an area listed in columns 1 to 3 of Part 1 of Schedule 2, and meets the conditions set out in Part 2 of that Schedule; or

(iv) is a pig moving within the framework of a pyramid breeding structure from an approved holding situated in the centre of a circle round that holding of at least 10 km radius in which there has been no outbreak of disease during at least 30 days prior to the date of loading; and

(b) during which the animal does not come into contact with an animal of a lower disease health status; and

(c) authorised by a licence.

Dispatch, transit and export of animals

9.—(1) No person shall dispatch an animal from Scotland.

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

(a) animal has made a direct and uninterrupted transit through Scotland travelling only on main roads or railway lines; and

(b) the first and second conditions are met.

(3) The first condition is that at least three days before export the Scottish Ministers have notified the central and local veterinary authorities of the member State of the intended export.

(4) The second condition is that the animal is accompanied by a health certificate which bears in the case of–

(a) a bovine, porcine, ovine and caprine animal, the words–

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

(b) any other animal, the words–

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

Export of meat: general

10.—(1) No person shall export meat from an animal coming from the restricted area, or obtained from animals originating in that area.

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

(a) meat obtained before 15th July 2007;

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

(c) meat from a domestic ungulate or from farmed game that complies with regulation 11, and is derived from–

(i) a bovine, ovine, caprine or porcine animal that was–

(aa) kept on a holding where there has been no outbreak of disease for at least the 90 days prior to slaughter (or since birth if less than 90 days of age);

(bb) kept on a holding complying with regulation 12 during the 21 days prior to transport to an approved slaughterhouse;

(cc) was transported to the slaughterhouse under the control of the Scottish Ministers in a means of transport that was cleansed and disinfected before loading at the holding;

(dd) was slaughtered less that 24 hours after arrival at the slaughterhouse; and

(ee) was slaughtered separately from any animal from which meat is not eligible for export; or

(ii) farmed game that was–

(aa) kept on a holding in an area specified in Schedule 3 where there has been no outbreak of disease for at least the 90 days prior to slaughter; and

(bb) kept on a holding complying with regulation 12 during the 21 days prior to slaughter; and

(cc) transported after slaughter at an approved holding to an approved slaughterhouse or approved cutting plant in a means of transport that was cleansed and disinfected before loading at the holding; and

(d) fresh meat obtained from an animal reared outside the restricted area and transported under the authority of a licence direct to an approved slaughterhouse, provided that–

(i) the animal has no contact with any holding in the restricted area;

(ii) the slaughterhouse is–

(aa) in a part of the restricted area other than Surrey; and

(bb) operated under strict veterinary control;

(iii) the animal is slaughtered immediately on arrival at the slaughterhouse;

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

(e) fresh meat obtained from an approved cutting plant situated in the restricted area if–

(i) only fresh meat described in sub-paragraphs (a) to (d) 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 (d);

(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.

(3) Any person slaughtering, or consigning to slaughter, an animal to produce meat for export must in respect of–

(a) a bovine, ovine, caprine or porcine animal, make a written declaration to the Scottish Ministers that the conditions of sub-paragraphs (2)(c)(i) have been met, and ensure that the declaration accompanies the animal during the movement to the slaughterhouse; or

(b) farmed game, make a written declaration to the Scottish Ministers that the conditions of sub-paragraphs (2)(c)(ii) have been met.

(4) Meat intended for export to another member State 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(12).

(5) Meat intended for export to another member State must be accompanied by an official certificate which bears the 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”.

Export of meat: slaughter, handling and inspection

11.—(1) Meat from a domestic animal must, to comply with this paragraph, have been–

(a) obtained in an approved slaughterhouse situated in an area other than Surrey; and

(b) transported to that slaughterhouse without contact during transport with any holding in the restricted area.

(2) Meat must, to comply with this paragraph, be at all times clearly identified, handled, stored and transported separately from meat not eligible for export.

(3) Meat must, to comply with this paragraph, be derived from an animal subject to a post-mortem by an official veterinarian–

(a) in the slaughterhouse;

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

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

with no clinical signs or evidence of disease identified.

(4) Meat must, to comply with this paragraph, remain in the slaughterhouse, holding or establishment for at least 24 hours after the post-mortem inspection described in paragraph (3).

Export of meat: conditions applying to holdings

12.  A holding complying with this regulation–

(a) must be situated in the centre of a circle of at least 10 km radius in which there was no outbreak of disease during at least 30 days prior to the date of loading for transport to slaughter; and

(b) is one where no susceptible animal was introduced to the holding (“the first holding”) during the 21 days prior to the date of loading for transport to slaughter (except in the case of a pig, in which case the period of 21 days may be reduced to 7 days), unless–

(i) the animal–

(aa) complies with the condition in sub-paragraph (aa) of regulation 10(2)(c)(i) (if a cow, pig, sheep or goat), or of regulation 10(2)(c)(ii) (if farmed game); and

(bb) was under the supervision of the Scottish Ministers on a single holding complying with paragraph (a) during the 21 days prior to transport to the first holding (except in the case of a pig, in which case the 21 day period is reduced to 7 days);

(ii) the animal was subjected with negative results to a test for antibodies against disease virus carried out on a blood sample taken within 10 days prior to the date of transport to the holding; or

(iii) the animal comes from a holding that was subjected with negative results to a serological survey pursuant to a sampling protocol suitable to detect 5% prevalence of disease with at least a 95% level of confidence.

Marking of meat not eligible for export

13.  Meat not eligible for export to another member State must be marked in accordance with the second subparagraph of Article 4(1) of Directive 2002/99/EC, or in accordance with Decision 2001/304.

Export of meat products

14.—(1) No person shall export meat products of an animal coming from the restricted area, or prepared using meat obtained from an animal originating in that area.

(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 not eligible for export, provided that the first mentioned meat products–

(a) are clearly identified;

(b) bear the health mark in accordance with Chapter III of Annex I to Regulation 854/2004; and

(c) are–

(i) made from meat described in regulation 10(2); or

(ii) products that have 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.

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

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

(4) Paragraph (3) does not apply to meat products which–

(a) comply with paragraph (2);

(b) have been processed in an establishment operating HACCP and an auditable standard operating procedure that ensures that standards for treatment are met and recorded; and

(c) are on export accompanied by a commercial document endorsed in accordance with regulation 4, which states that the product has been treated in accordance with sub paragraph (2)(c)(ii).

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

(6) In this regulation, references to meat products includes treated stomachs, bladders and intestines.

Cleansing and disinfection

15.—(1) Any person in charge of a vehicle used to transport any live animal shall cleanse and disinfect that vehicle after the transport of the animal is completed.

(2) That person shall ensure that a record is kept of the date and place of the cleansing and disinfection, in accordance with Article 12(2)(d) of Council Directive 64/432/EEC on animal health problems affecting intra-Community trade in bovine animals and swine(13).

Occupiers of slaughterhouses and other premises

16.—(1) If the disease is identified in premises the occupier must ensure that–

(a) all animals present are slaughtered;

(b) all meat and dead animals are removed;

(c) the establishment is cleansed and disinfected under the supervision of the Scottish Ministers; and

(d) no meat is prepared for consigning outside the areas listed in Schedule 2 for 24 hours following the completion of the cleansing and disinfection required by sub-paragraph (c).

(2) If an animal from the restricted area is slaughtered in premises the occupier must ensure that–

(a) all animals present are slaughtered; and

(b) the establishment is cleansed and disinfected under the supervision of the Scottish Ministers; and

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

(3) In this regulation, “premises” means a slaughterhouse, an approved holding on which farmed game is slaughtered, or a game-handling establishment which handles meat controlled under these Regulations.

PART 3 Export: products of animal origin and animal products

Export of milk

17.—(1) No person shall export milk produced or prepared in the restricted area.

(2) The prohibition in paragraph (1) does not apply to milk produced in the restricted area which has been subjected to 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(14) (milk 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 or is intended for feeding to susceptible animals.

(3) The prohibition in paragraph (1) does not apply to milk prepared in an approved establishment in the restricted area if–

(a) all milk used in the establishment has been treated in accordance with paragraph (2), or has been obtained from animals reared and milked outside the restricted area;

(b) the establishment is operated under strict veterinary control;

(c) the milk is clearly identified;

(d) the milk is transported and stored separately from milk and dairy products which are not eligible for export; and

(e) raw milk from outside the restricted area is carried to the establishment in vehicles which–

(i) are cleansed and disinfected prior to carriage; and

(ii) have no contact during carriage with any holding in the restricted area on which a susceptible animal is kept.

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

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

(5) Paragraph (4) does not apply to milk which–

(a) complies with paragraph (2);

(b) has been processed in an establishment operating HACCP and an auditable standard operating procedure that ensures that standards for treatment are met and recorded; and

(c) is on export accompanied by a commercial document endorsed in accordance with regulation 7 which states that the milk has been treated in accordance with paragraph (2).

(6) Paragraph (4) does not apply to milk treated in accordance with paragraph (2) and stored in hermetically sealed containers in such manner as to ensure that they are shelf stable, if the treatment applied is stated in the commercial document accompanying the export of such milk.

Export of dairy products

18.—(1) No person shall export a dairy product produced or prepared in the restricted area.

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

(a) produced before 15th July 2007;

(b) prepared from milk complying with the provisions in regulation 17(2) or (3); or

(c) for export to a third country where import conditions permit a product to be subject to treatment, other than as laid down in regulation 17(2), that ensures the inactivation of disease virus.

(3) The prohibition in paragraph (1) does not apply to a dairy product intended for human consumption produced from–

(a) 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, on the understanding that such treatment is not necessary for a finished product the ingredients of which comply with the respective animal health conditions laid down in these Regulations; or

(b) raw milk–

(i) of a bovine, ovine or caprine animal which has been resident for at least 30 days on a holding within the restricted area and situated in the centre of a circle of at least 10 km radius in which no outbreak of disease has occurred during the 30 days prior to the date of production of the raw milk; and

(ii) subjected 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 product–

(a) prepared in an approved establishment in the restricted area if–

(i) all milk used in the establishment conforms to the conditions of regulation 17(2) or is obtained from animals outside the restricted area;

(ii) all dairy products used in the final product conform to the conditions of paragraph (2)(a) or (b) or (3) or are made from milk obtained from animals situated outside the restricted area;

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

(iv) the product is clearly identified; and

(v) the product is transported and stored separately from milk and dairy products which are not eligible for export;

(b) prepared in a part of the United Kingdom outside the restricted area using milk obtained before 15th July 2007 from the restricted area if the product is–

(i) clearly identified; and

(ii) transported stored separately from milk products not eligible for export.

(5) A dairy product exported to another member State must be accompanied by an official certificate which bears the words–

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

(6) Paragraph (5) does not apply to dairy products which–

(a) comply with paragraphs (2)(a) or (b), (3) or (4);

(b) have been processed in an establishment operating HACCP and an auditable standard operating procedure that ensures that standards for treatment are met and recorded; and

(c) are on dispatch accompanied by a commercial document endorsed in accordance with regulation 7 which states that the product complies with the requirements of paragraphs (2)(a) or (b), (3) or (4).

(7) Paragraph (5) does not apply to dairy products treated in accordance with paragraphs (2)(a) or (b), (3) or (4) and stored in hermetically sealed containers in such manner as to ensure that they are shelf stable, if the heat treatment applied is stated in the commercial document accompanying the dispatch of such products.

Export of semen, ova and embryos

19.—(1) No person shall export semen, ova or embryos of an animal produced in or coming from Great Britain.

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

(a) Semen, ova and embryos produced before 15th July 2007;

(b) frozen semen of a bovine, ovine, caprine or porcine species, or frozen embryos of a bovine, ovine or caprine species, imported into the United Kingdom in accordance with the conditions in–

(i) 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(15);

(ii) 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(16);

(iii) 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(17); or

(iv) 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(18),

and which since introduction into the United Kingdom have been stored and transported separately from semen, ova and embryos from the restricted area not eligible for export; or

(c) frozen semen or embryos–

(i) from a bovine, ovine, caprine or porcine animal–

(aa) kept at for at least 90 days prior to the date of and during collection on a holding outwith the restricted area; or

(bb) moved to premises outwith the restricted area from premises outwith that area during the 90 days prior the date of collection;

(ii) that have been collected from donor animals kept in centres or on holdings which comply with Part I of Schedule 3; and

(iii) that have been stored in accordance with Part II of Schedule 3 for a minimum period of 30 days following collection during which the centre or holding described in sub-paragraph (c)(ii) must have had no case of foot-and-mouth disease.

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

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

(4) The health certificate accompanying frozen porcine semen exported to another member State must bear the words–

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

(5) The health certificate accompanying frozen ovine or caprine semen exported to other member States must bear the words–

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

(6) The health certificate accompanying frozen ovine or caprine embryos exported to other member States must bear the words–

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

(7) Frozen bovine embryos exported to another member State must be accompanied by a health certificate bearing the words–

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

Export of hides and skins

20.—(1) No person shall export the hide or skin of an animal produced in or coming from the restricted area.

(2) The prohibition in paragraph (1) does not apply to hides and skins which–

(a) were produced before 15th July 2007;

(b) conform to the requirements of point (c) or (d) of paragraph 2 of Part A of Chapter VI of Annex VIII to Regulation 1774/2002;

(c) were produced outside the restricted area in accordance with the conditions laid down in Regulation 1774/2002, and since introduction into the restricted area have been transported and stored separately from hides and skins not eligible for export; or

(d) were produced from an animal slaughtered in a slaughterhouse, or in the case of farmed game slaughtered on premises, or in the case of wild game killed for meat,

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

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

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

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

(a) Points (b) to (e) of paragraph 1 of Part A of Chapter VI of Annex VIII to Regulation 1774/2002; or

(b) Points (c) or (d) of paragraph 2 of Part A of Chapter VI of Annex VIII to Regulation 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 7.

Export of other animal products

21.—(1) No person shall export an animal product not otherwise mentioned in these Regulations–

(a) produced after 15th July 2007 in the restricted area; or

(b) obtained from an animal originating in that area.

(2) No person shall export any dung or manure from an animal.

(3) The prohibition in paragraph (1) does not apply 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 of the product is raised to at least 70°C;

(iii) were produced outside the restricted area in accordance with the conditions laid down in Regulation 1774/2002, and which since introduction into the restricted area have been stored and transported separately from animal products not eligible for dispatch; or

(iv) were produced from animals slaughtered in a slaughterhouse, or in the case of farmed game slaughtered in premises, or in the case of wild game killed for meat, and which comply with the requirements of Part A(1) of Chapter II of Annex VIII to Regulation 1774/2002, and which have been stored and transported separately from animal products not eligible for export;

(b) blood and blood products as defined in paragraphs 4 and 5 of Annex I to Regulation 1774/2002–

(i) which have been subjected to one of the treatments provided for in paragraph 3(a)(ii) of Part A of Chapter IV of Annex VIII to that Regulation, followed by an effectiveness check; and

(ii) that have been imported in accordance with Part A of Chapter IV of Annex VIII to Regulation 1774/2002;

(c) lard and 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 1774/2002;

(d) animal casings that comply with the conditions in Part A of Chapter 2 of Annex I to Directive 92/118/EC laying down animal health and public requirements governing trade in and imports into the Community of certain products(19), and which are cleaned and scraped and then–

(i) salted, bleached or dried; and

(ii) subject to effective steps taken to prevent recontamination of the casings;

(e) sheep wool, ruminant hair and pig bristles which have undergone factory washing or have been obtained from tanning;

(f) unprocessed sheep wool, ruminant hair and pig bristles which are securely enclosed in packaging and in a dry state;

(g) pet food conforming to the requirements of paragraphs 2 to 4 of Part B of Chapter II of Annex VIII to Regulation 1774/2002;

(h) composite products containing products of animal origin not subjected to further treatment provided 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 paragraphs 1, 3 or 4 of Part A of Chapter VII of Annex VIII to Regulation 1774/2002;

(j) any packed product intended for use as an in-vitro diagnostic or laboratory reagent; or

(k) medicinal products as defined in Directive 2001/83/EC of the European Parliament and of the Council of 6th 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 14th 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 6th 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 4th 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) A product specified in paragraph (3) exported to another member State must be accompanied by an official certificate which bears the words–

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

(5) Paragraph (4) does not apply to a product specified in sub-paragraphs (a) to (d) and (g) of paragraph (3) accompanied by a commercial document endorsed in accordance with regulation 7.

(6) Paragraph (4) does not apply to a product specified in sub-paragraph (e) or (f) of paragraph (3) accompanied by a commercial document stating that the product–

(a) has undergone factory washing or have been obtained from tanning; or

(b) complies with the conditions laid down in paragraphs 1 and 4 of Chapter VIII of Annex VIII to Regulation 1774/2002.

(7) Paragraph (4) does not apply to a product specified in sub-paragraph (h) of paragraph (3) 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 accompanied by a commercial document endorsed in accordance with regulation 7.

(8) Paragraph (4) does not apply to a product specified in sub-paragraph (j) or (k) of paragraph (3) accompanied by a commercial document stating that the product is for use as in-vitro diagnostic or laboratory reagent or medical products or medical devices, provided that the product is clearly labelled “for in-vitro diagnostic use only”, or “for laboratory use only”, or as “medicinal products” or “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 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

22.  The prohibitions in regulations 14, 17, 18 or 21 do not apply to a product–

(a) not produced in the United Kingdom and which remains in the original packaging indicating country of origin; or

(b) which is–

(i) produced in the restricted area in an approved establishment from pre-processed products originating outside that area which, since introduction into the United Kingdom, were transported, stored and processed separately from products not intended for export; and

(ii) accompanied by a commercial document or official certificate as required by these Regulations.

PART 4 Enforcement and revocation

Personal exports

23.  No person travelling out of Scotland to a place outside the restricted area shall take with them in any personal luggage or on any other non-commercial basis anything prohibited from being dispatched or exported by these Regulations.

Offers to dispatch or export

24.  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, whether on the internet or otherwise.

Powers of an inspector

25.—(1) An inspector shall, on producing, if required to do so, some duly authenticated document showing his authority, have the right to enter any land or premises at all reasonable hours for the purpose of ascertaining whether there is or has been on the land or premises any contravention of these Regulations.

(2) An inspector may by notice in writing required the occupier, or any person in charge, of premises or equipment to cleanse and disinfect in accordance with that notice.

(3) An inspector shall have powers to carry out all checks and examinations necessary for the enforcement of these Regulations, and in particular may–

(a) detain any vehicle, vessel, container or anything which the inspector reasonably suspects to contain animals or products controlled by these Regulations and intended for dispatch or export for as long as is reasonably necessary to determine whether the consignment complies with the conditions for dispatch or export;

(b) search any premises;

(c) carry out inspections of any processes used for the marking and identification of animals, any premises and any installation;

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

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

(4) 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.

Illegal export of products

26.—(1) An inspector who has reasonable grounds to suspect that any product other than an animal is intended to be exported in contravention of these Regulations may seize and remove the product.

(2) An inspector who has seized and removed a product shall forthwith–

(a) apply to the sheriff for an order under paragraph (3); and

(b) intimate that application to any person appearing to the inspector to be in charge of the product.

(3) The sheriff, if satisfied that it was intended to export the product in contravention of these Regulations, shall–

(a) if satisfied that the product can be returned to the owner without a significant risk of a further attempt to export it in contravention of these Regulations, order that it is so returned; or

(b) if not satisfied that the product can be returned in accordance with sub-paragraph (a), order that is to be put into storage (if practicable) or destroyed.

(4) The owner and any person in charge of a product destroyed or disposed in accordance with an order under paragraph (3) shall be jointly and severally liable for the costs incurred in the return to the owner, removal to storage, storage, or destruction or other disposal.

(5) An inspector may apply to the sheriff for the destruction of a product stored in accordance with an order under paragraph (3), and the sheriff shall order that it is to be destroyed if satisfied that the owner cannot–

(a) be found; or

(b) pay the costs associated with storage of the product.

Obstruction

27.  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 their functions under these Regulations.

False information

28.  No person shall provide to any person acting in the execution of these Regulations any information which the first mentioned person knows to be false or misleading.

Offences by bodies corporate

29.—(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 officer or person as well as the body corporate, shall be guilty of the offence and be 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 or partner of the body corporate.

Penalties

30.  A person contravening any provision of 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;

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

Enforcement

31.  These Regulations shall be enforced by the Scottish Ministers or the local authority.

Revocation

32.  The Import and Export Restrictions (Foot-and-Mouth Disease) (Scotland) (No. 6) Regulations 2007(25) are revoked.

NEIL RITCHIE

A member of the staff of the Scottish Ministers

Pentland House,

Edinburgh

21st November 2007