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	Statutory Instruments made by the National Assembly for Wales
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"the Decision" means Commission Decision 2001/740/EC concerning certain protection measures with regard to foot-and-mouth disease in the United Kingdom and repealing Decision 2001/356/EC[3];

"dispatch" means dispatch from a place within the restricted area to a place outside the restricted area and includes consigning for dispatch;

"export" means export outside the British Islands and includes consigning for export;

"inspector" means a person appointed by the National Assembly, the Secretary of State or a local authority to be an inspector for the purposes of these Regulations or by the National Assembly, the Minister of Agriculture, Fisheries and Food or a local authority for the purposes of the Animals and Animal Products (Import and Export) (England and Wales) Regulations 2000 [4] or the Products of Animal Origin (Import and Export) Regulations 1996[5] and includes a veterinary inspector;

"HACCP" means Hazard Analysis at Critical Control Points, which is a system in which the critical points of the manufacturing process have been identified, assessments have been made of the potential risks at those points, and necessary steps have been taken to minimise those risks;

"local authority" means a county council or a county borough council in Wales;

"main roads" means motorways or trunk roads and in this context "trunk road" shall have the same meaning as in section 329(1) of the Highways Act 1980[6];

"meat products" means meat products as defined in Article 2 of Council Directive 77/99/EEC (on health problems affecting the production and marketing of meat products and certain other products of animal origin [7]);

"Minister" means the Minister of Agriculture, Fisheries and Food;

"milk" and "milk products" have the meaning given in Article 2 of Council Directive 92/46/EC (laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products [8]);

"National Assembly" means the National Assembly for Wales;

"official veterinary surgeon" means a person appointed as such under regulation 8 of the Fresh Meat (Hygiene and Inspection) Regulations 1995[9];

"restricted area" means the British Islands other than Northern Ireland and the Isle of Man; and

"veterinary inspector" means a veterinary surgeon appointed for export certification by the Secretary of State or the Minister.

    (2) Any reference in these Regulations to an instrument of the European Community is to that instrument as amended at the time these Regulations are made.

Approvals
     3.  - (1) The National Assembly or the Secretary of State shall approve premises for the purposes of these Regulations if satisfied that the occupier of the premises will comply with the provisions of these Regulations.

    (2) Any approval shall be in writing, may be made subject to conditions and may be amended, suspended or revoked by notice in writing at any time, and in particular may be suspended or revoked if the National Assembly or Secretary of State is reasonably of the opinion that the provisions of these Regulations are not being complied with.

    (3) Any requirement for approved premises shall be fulfilled if the premises are in a part of the British Islands outside Wales and are approved by the relevant authority for the purposes of the Decision.

Import and dispatch of live animals
     4.  - (1) No person shall dispatch any live animal of the bovine, ovine, caprine or porcine species or any other biungulate.

    (2) By way of derogation from the preceding paragraph, the National Assembly or the Secretary of State may by licence in writing authorise the dispatch of biungulate animals originating outside the restricted area if the animals travelled through that area in direct and uninterrupted transit on main roads or by rail or sea.

    (3) No person shall import any live animal of species susceptible to foot-and-mouth disease into Wales from another member State.

Dispatch of fresh meat, minced meat and meat preparations
     5.  - (1) No person shall dispatch any fresh meat of animals of the bovine, ovine, caprine or porcine species or other biungulate coming from the restricted area or obtained from animals originating in that area.

    (2) In paragraph (1), the reference to "fresh meat" includes minced meat and meat preparations to which Council Directive 94/65/EC (laying down the requirements for the production and placing on the market of minced meat and meat preparations [10]) applies.

    (3) The prohibition in paragraph (1) shall not apply in relation to - 

(a) fresh meat, minced meat or meat preparations obtained before 1st February 2001, provided that the meat, minced meat or meat preparation is clearly identified and since that date has been transported and stored separately from meat, minced meat or meat preparations which is not destined for dispatch; or

(b) fresh meat obtained from approved cutting plants under the following conditions - 


(i) the only meat processed in the establishment on the day of processing of meat destined for dispatch is fresh meat described in sub-paragraph (a), fresh meat from animals reared and slaughtered outside the restricted area, or fresh meat obtained from animals reared and slaughtered within the areas listed in the Schedule;

(ii) cleansing and disinfection must be carried out after processing any meat not meeting this requirement;

(iii) all the meat must bear the health mark in accordance with Chapter XI of Annex I to Council Directive 64/433/EEC (on health problems affecting the production and marketing of meat products and certain other products of animal origin [11]) or, in the case of meat from biungulates to which that Directive does not apply, the health mark provided for in Chapter III of Annex I to Council Directive 91/495/EEC (concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat [12]);

(iv) the plant must be operated under strict veterinary control; and

(v) the meat must be clearly identified and transported and stored separately from meat, minced meat and meat preparations which is not destined for dispatch;



(c) minced meat and meat preparations obtained from establishments approved under the Minced Meat and Meat Preparations (Hygiene) Regulations 1995[13] and also approved under these Regulations under the following conditions - 



(i) the only meat processed in the establishment on the day of processing of meat destined for dispatch is fresh meat described in sub-paragraph (a), fresh meat from animals reared and slaughtered outside the restricted area or fresh meat obtained from animals reared and slaughtered within the areas listed in the Schedule;

(ii) cleansing and disinfection must be carried out after processing any meat not meeting this requirement;

(iii) all the minced meat and meat preparations must bear the health mark in accordance with Chapter VI of Annex I to Council Directive 94/65/EC;

(iv) the plant must be operated under strict veterinary control; and

(v) the minced meat and meat preparations must be clearly identified and transported and stored separately from meat, minced meat and meat preparations which are not destined for dispatch;



(d) fresh meat, minced meat or meat preparations obtained from porcine animals reared within the areas listed in the Schedule and conforming to the following conditions - 



(i) there has been no outbreak of foot-and-mouth disease in the group of counties listed in the Schedule during the 90 days prior to dispatch;

(ii) during the 30 days prior to transport to the slaughterhouse the animals have remained subject to the supervision of the National Assembly or the Department for Environment, Food and Rural Affairs on a single holding situated within the areas listed in Schedule in the centre of a circle around the holding of at least 10 km radius where there has been no outbreak of foot-and-mouth disease during at least the previous 30 days;

(iii) no animal of species susceptible to foot-and-mouth disease has been introduced into the holding referred to in sub-paragraph (d)(ii) during the past 30 days prior to loading, except in the case of pigs coming from a supplying holding which meets the requirements laid down in that sub-paragraph, in which case this period shall be 7 days;

(iv) the animals have been transported under licence in writing granted by an officer of the local authority where the holding is situated directly from the holding to an approved slaughterhouse situated in a county in Wales listed in the Schedule;

(v) the means of transport must be cleansed and disinfected before the animals are loaded;

(vi) before it leaves the holding, the means of transport must be sealed by a person authorized in writing by the National Assembly or the Secretary of State, and the number of the seal recorded on the movement licence;

(vii) the person consigning the animals to the slaughterhouse must give at least 72 hours written notice to the official veterinary surgeon at the slaughterhouse that pigs the meat of which is intended for dispatch under this paragraph will be sent to the slaughterhouse;

(viii) the official veterinary surgeon shall ensure that the seal is intact and correctly numbered when the means of transport arrives at the slaughterhouse;

(ix) the animals must be slaughtered within 24 hours of arrival at the slaughterhouse separately from animals whose meat is not eligible for dispatch;

(x) during inspection by the official veterinary surgeon at the slaughterhouse no evidence of clinical or post-mortem signs of foot-and-mouth disease were established;

(xi) the meat derived from such animals remained in the slaughterhouse for at least 24 hours after slaughter;

(xii) all fresh meat must bear the health mark in accordance with Chapter XI of Annex I to Council Directive 64/433/EEC;

(xiii) the slaughterhouse must be operated under strict veterinary control;

(xiv) in the case where foot-and-mouth disease has been diagnosed in the slaughterhouse, any further preparation of meat for dispatch shall only be authorized after the slaughter of all animals present, removal of all meat and dead animals and not earlier than 24 hours after the completion of the total cleaning and disinfection of the establishment under the control of a veterinary inspector;

(xv) the fresh meat must be clearly identified, and transported and stored separately from meat which is not eligible for dispatch;

(xvi) where the meat is subject to further processing this must be done in a plant approved under sub-paragraph (b) or (c) of this paragraph and in accordance with those sub-paragraphs.

    (4) Meat, minced meat or meat preparations consigned to another member State shall be accompanied by an official certificate prepared by the National Assembly, the Secretary of State or the Minister and signed by a person appointed as an officer of the kind specified in the certificate which bears the following words - 

" Meat conforming to Commission Decision 2001/172/EC of 1st March 2001 concerning certain protection measures with regard to foot-and-mouth disease in the United Kingdom".

Dispatch of meat products
     6.  - (1) No person shall dispatch meat products of animals of the bovine, ovine, caprine or porcine species or any other biungulate coming from the restricted area or prepared using meat obtained from animals originating in that area.

    (2) The prohibition in paragraph (1) shall not apply to meat products which have undergone one of the treatments laid down in Article 4(1) of Council Directive 80/215/EEC (on animal health problems affecting intra-Community trade in meat products [14]), or to meat products as defined in Council Directive 77/99/EEC which have been subjected during preparation uniformly throughout the substance to a pH value of less than 6.

    (3) The prohibition in paragraph (1) shall not apply to - 

(a) meat products prepared before 1st February 2001, provided that the meat products are clearly identified and since that date have been transported and stored separately from meat products which are not destined for dispatch;

(b) meat products prepared in approved establishments under the following conditions - 


(i) all fresh meat used in the establishment must conform to the conditions in regulation 5(3);

(ii) all meat products used in the final product must conform to the conditions in sub-paragraph (a) or be made from fresh meat obtained from animals reared and slaughtered outside the restricted area;

(iii) all meat products must bear the health mark in accordance with Chapter VI of Annex B to Directive 77/99/EEC;

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

(v) the meat products must be clearly identified and transported and stored separately from meat and other meat products which are not destined for dispatch; or



(c) meat products prepared in parts of the United Kingdom outside the restricted area using meat obtained before 1 February 2001 from the restricted area provided that the meat and meat products are clearly identified and transported and stored separately from meat and meat products not destined for dispatch.

    (4) Meat products consigned to another member State shall be accompanied by an official certificate prepared by the National Assembly, the Secretary of State or the Minister and signed by a person appointed as an officer of the kind specified in the certificate which bears the following words - 

" Meat products conforming to Commission Decision 2001/172/EC of 1st March 2001 concerning certain protection measures with regard to foot-and-mouth disease in the United Kingdom".

    (5) Paragraph (4) shall not apply to meat products which conform to the requirements of paragraph (2) if such compliance is stated in the commercial document accompanying the consignment, endorsed in accordance with regulation 13, and the products have been processed in an establishment operating HACCP and an auditable standard operating procedure which ensures that standards for treatment are met and recorded.

    (6) Paragraph (4) shall not apply to meat products treated in hermetically sealed containers so as to ensure they are shelf stable if the heat treatment applied is stated in the commercial document accompanying the consignment.

Dispatch of milk
     7.  - (1) No person shall dispatch milk.

    (2) The prohibition in paragraph (1) shall not apply to milk which has been subjected to at least  - 

(a) an initial pasteurisation in accordance with the norms defined in paragraph 3(b) of Chapter 1 in Annex I to Council Directive 92/118/EEC (laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A(I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC[15]) followed by a second heat treatment by high temperature pasteurisation, UHT, sterilisation so as to produce a negative reaction to the peroxidase test or by a drying process which includes a heat treatment with an equivalent effect to one of the above; or

(b) an initial pasteurisation in accordance with the norms defined in paragraph 3(b) of Chapter 1 in Annex I to Council Directive 92/118/EEC, combined with treatment by which the pH is lowered below 6 and held there for at least one hour.

    (3) The prohibition in paragraph (1) shall not apply in relation to milk prepared in approved establishments under the following conditions - 

(a) all milk used in the establishment must either conform to the conditions of paragraph (2) or be obtained from animals reared and milked outside the restricted area;

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

(c) the milk must be clearly identified and transported and stored separately from milk and milk products which are not destined for dispatch; and

(d) transport of raw milk from outside the restricted area to the establishment must be carried out in vehicles which were cleansed and disinfected prior to operation and had no subsequent contact with holdings in the restricted area keeping animals of species susceptible to foot-and-mouth disease.

    (4) Milk consigned to another member State shall be accompanied by an official certificate prepared by the National Assembly, the Secretary of State or the Minister and signed by a person appointed as an officer of the kind specified in the certificate which bears the following words - 

" Milk conforming to Commission Decision 2001/172/EC of 1st March 2001 concerning certain protection measures with regard to foot-and-mouth disease in the United Kingdom".

    (5) Paragraph (4) shall not apply to milk which conforms to the requirements of paragraph (2) if such compliance is stated in the commercial document accompanying the consignment, endorsed in accordance with regulation 13, and the milk has been processed in an establishment operating HACCP and an auditable standard operating procedure which ensures that standards for treatment are met and recorded.

    (6) Paragraph (4) shall not apply to milk which conforms with the requirements of paragraph (2)(a) or (b) and which has been treated in hermetically sealed containers so as to ensure they are shelf stable if the heat treatment applied is stated in the commercial document accompanying the consignment.

Dispatch of milk products
     8.  - (1) No person shall dispatch milk products.

    (2) The prohibition in paragraph (1) shall not apply in relation to  - 

(a) milk products produced before 1st February 2001;

(b) milk products prepared from milk which complies with paragraphs (2) or (3) of regulation 7;

(c) milk products destined for dispatch to a third country where import conditions permit such products to be subject to treatment other than laid down in these Regulations which ensures the inactivation of the foot-and-mouth disease virus;

(d) milk products intended for human consumption produced from milk of a pH less than 7.0 and subjected to heat treatment at a temperature of at least 72^oC for at least 15 seconds or an equivalent treatment;

(e) milk products intended for human consumption produced from raw milk of bovine, ovine or caprine animals which have been resident for at least 30 days on a holding situated, within the restricted area, in the centre of a circle of at least 10 km radius where no outbreak of foot-and-mouth disease has occurred during the 30 days prior to producing the raw milk, and which are subject to a maturation or ripening process of at least 90 days during which the pH is lowered below 6.0 throughout the substance, and the rind of which has been treated with 0.2% citric acid immediately prior to wrapping or packaging.

    (3) The prohibitions described in paragraph (1) shall not apply to - 

(a) milk products prepared in approved establishments under the following conditions - 


(i) all milk used in the establishment must either conform to the conditions of regulation 7(2) or be obtained from animals outside the restricted area;

(ii) all milk products used in the final product must either conform to the conditions of paragraph (2)(a) or (b) of this regulation or be made from milk obtained from animals outside the restricted area;

(iii) the milk products must only be intended for human consumption and all milk products used in the final product will either conform to the conditions of paragraphs 3(a) (i) and (ii) above or meet the conditions of paragraph (2)(d)or (2)(e) of this regulation;

(iv) the establishment shall be under strict veterinary control; and

(v) the milk products must be clearly identified and transported and stored separately from milk and milk products which are not destined for dispatch; or



(b) milk products prepared in parts of the United Kingdom outside the restricted area using milk obtained before 1st February 2001 from the restricted area provided that the milk products are clearly identified and transported and stored separately from milk products not destined for dispatch.

    (4) Milk products consigned to another member State shall be accompanied by an official certificate prepared by the National Assembly, the Secretary of State or the Minister and signed by a person appointed as an officer of the kind specified in the certificate which bears the following words  - 

" Milk products conforming to Commission Decision 2001/172/EC of 1st March 2001 concerning certain protection measures with regard to foot-and-mouth disease in the United Kingdom".

    (5) Paragraph (4) shall not apply to milk products which conform to the requirements of paragraph (2)(a), (b), (d) or (e) if such compliance is stated in the commercial document accompanying the consignment, endorsed in accordance with regulation 13, and the milk products have been processed in an establishment operating HACCP and an auditable standard operating procedure which ensures that standards for treatment are met and recorded.

    (6) Paragraph (4) shall not apply to milk products which conform to the requirements of paragraph (2)(a), (b), (d) or (e) and which have been treated in hermetically sealed containers so as to ensure they are shelf stable if the heat treatment applied is stated in the commercial document accompanying the consignment.

Dispatch of semen, etc.
     9.  - (1) No person shall dispatch semen, ova or embryos of animals of the bovine, ovine, caprine and porcine species and other biungulates.

    (2) The prohibition in paragraph (1) shall not apply in relation to  - 

(a) frozen bovine and porcine semen produced before 1st February 2001; or

(b) frozen bovine and porcine semen and bovine embryos imported into the United Kingdom in accordance with the conditions laid down 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 [16]);

(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[17]); and

(iii) Council Directive 90/429/EEC (laying down the animal health requirements applicable to intra-Community trade in and and imports of semen of domestic animals of the porcine species[18]);



and which since introduction into the United Kingdom have been stored and transported separately from semen and embryos to which the prohibition in paragraph (1) applies;

(c) frozen bovine and porcine semen produced in accordance with the provisions of Council Directive 88/407/EEC or Council Directive 90/429/EEC after 30th September 2001 and also approved under these Regulations, subject to the following conditions  - 



(i) the donor bull or boar showed no clinical sign of foot-and-mouth disease on the day of collection of the semen;

(ii) the donor bull or boar was kept in the semen collection centre for at least three months (which may include the isolation period of at least 30 days in isolation accommodation attached to the semen collection centre) prior to the collection of the semen;

(iii) no animal was introduced into the semen collection centre during the 30 days prior to the collection of the semen;

(iv) the semen collection centre has been free from foot-and-mouth disease for at least three months and no case of foot-and-mouth disease occurred within a 10 kilometre radius around the semen collection centre for the 30 days before and after the collection of the semen;

(v) no animal in the semen collection centre has been vaccinated against foot-and-mouth disease;

(vi) the donor bull or boar showed a negative response to a test for antibodies against foot-and-mouth disease virus carried out at least 21 days after the collection of the last semen of the consignment and the negative test results were available before dispatch of the semen;

(vii) the frozen semen was stored for a period of at least 30 days between collection and dispatch and during this period no animal in the semen collection centre showed any sign of foot-and-mouth disease;

(viii) the semen was collected, processed and stored separately from semen which is not eligible for dispatch; and

(ix) all semen collected, processed and frozen in the semen collection centre was dispatched from the semen collection centre in a way that avoids any risk of introducing foot-and-mouth disease into the centre.

    (3) The health certificate provided for in Council Directive 88/407/EEC accompanying frozen bovine semen consigned to another member State shall bear the following words - 

" Frozen bovine semen conforming to Commission Decision 2001/172/EC of 1st March 2001 concerning certain protection measures with regard to foot-and-mouth disease in the United Kingdom".

    (4) The health certificate provided for in Council Directive 89/556/EEC accompanying bovine embryos consigned to another member State shall bear the following words - 

" Bovine embryos conforming to Commission Decision 2001/172/EC of 1st March 2001 concerning certain protection measures with regard to foot-and-mouth disease in the United Kingdom".

    (5) The health certificate provided for in Council Directive 90/429/EC accompanying frozen porcine semen to other member States shall bear the following words - 

" Frozen porcine semen conforming to Commission Decision 2001/740/EC of 19 October 2001 on certain protective measures with regard to foot-and-mouth disease in the United Kingdom".

Dispatch of hides and skins
     10.  - (1) No person shall dispatch hides and skins of animals of the bovine, ovine, caprine and porcine species and other biungulates.

    (2) The prohibition in paragraph (1) shall not apply in relation to hides and skins which were produced before 1st February 2001 or which conform to the requirements of paragraph 1(A) indents 2 to 5 or paragraph 1(B), indents 3 and 4 of Chapter 3 of Annex I to Directive 92/118/EEC if treated hides and skins are separated effectively from untreated hides and skins.

    (3) Hides and skins consigned to another member State must be accompanied by an official certificate prepared by the National Assembly, the Secretary of State or the Minister and signed by a person appointed as an officer of the kind specified in the certificate stating - 

" Hides and skins conforming to Commission Decision 2001/172/EC of 1st March 2001 concerning certain protection measures with regard to foot-and-mouth disease in the United Kingdom".

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

(a) paragraph 1(A) indents 2 to 5 of Chapter 3 of Annex I to Council Directive 92/118/EEC; or

(b) paragraph 1(B) indents 3 and 4 of Chapter 3 to Annex I to Council Directive 92/118/EEC

if compliance with those conditions is stated in the commercial document accompanying the consignment, endorsed (in the case of sub-paragraph (b)) in accordance with regulation 13.

Dispatch of animal products
     11.  - (1) No person shall dispatch animal products of the bovine, ovine, caprine and porcine species and other biungulates not otherwise mentioned in these Regulations produced after 1st February 2001.

    (2) No person shall dispatch dung or manure.

    (3) The prohibition in paragraph (1) shall not apply in relation to - 

(a) animal products which have been subjected to - 


(i) heat treatment in a hermetically sealed container with a Fo value of 3.00 or more; or

(ii) heat treatment in which the centre temperature is raised to at least 70^oC;



(b) blood and blood products as defined in Chapter 7 of Annex I to Council Directive 92/118/EEC which have been subjected to  - 



(i) heat treatment at a temperature of 65^oC for at least three hours followed by an effectiveness check;

(ii) irradiation at 2.5 megarads or gamma rays followed by an effectiveness check;

(iii) change of pH to pH5 or lower for at least two hours, followed by an effectiveness check; or

(iv) a treatment as provided for in Chapter 4 of Annex I to Council Directive 92/118/EEC;



(c) lard and rendered fats which have been subjected to the heat treatment prescribed in paragraph 2(A) of chapter 9 of Annex I to Council Directive 92/118/EEC;

(d) animal casings to which the provisions of paragraph B Chapter 2 of Annex I to Council Directive 92/118/EEC apply adapted as necessary to suit the case;

(e) sheep wool, ruminant hair and pigs' bristles which have undergone factory washing or have been obtained from tanning and unprocessed sheep wool, ruminant hair and pigs' bristles which are securely enclosed in packaging and dry;

(f) semi-moist and dried petfood conforming to the requirements of paragraphs 2 and 3 respectively of Chapter 4 of Annex I to Council Directive 92/118/EEC;

(g) composite products which are not 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;

(h) game trophies in accordance with paragraph 2(b) of Part B of Chapter 13 to Annex I to Council Directive 92/118/EEC; or

(i) packed products intended for use as in-vitro diagnostic or laboratory reagents.

    (4) The animal products must be accompanied by an official certificate prepared by the National Assembly, the Secretary of State or the Minister and signed by a person appointed as an officer of the kind specified in the certificate stating - 

" Animal products conforming to Commission Decision 2001/172/EC of 1st March 2001 concerning certain protection measures with regard to foot-and-mouth disease in the United Kingdom".

    (5) Paragraph (4) shall not apply to .products specified in sub-paragraphs (b), (c) or (d) of paragraph (3) which have a commercial document required under the Products of Animal Origin (Import and Export) Regulations 1996[19] endorsed in accordance with regulation 13 of these Regulations.

    (6) Paragraph (4) shall not apply to products specified in sub-paragraphs (e) of paragraph (3) which are accompanied by a commercial document stating either  - 

(a) that the products have undergone factory washing or have been obtained from tanning; or

(b) that the products comply with the conditions laid down in paragraphs (2) and (4) of Chapter 15 of Annex I to Council Directive 92/118/EEC.

    (7) Paragraph (4) shall not apply to products specified in sub-paragraph (g) of paragraph (3) which 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 13.

    (8) Paragraph (4) shall not apply to products specified in sub-paragraph (i) of paragraph (3) if they are accompanied be a commercial document stating that the products are for use as in-vitro diagnostic or laboratory reagents, provided that the products are clearly labelled "for in-vitro diagnostic use only" or "for laboratory use only".

Exemptions
     12.  - (1) The prohibitions in regulations 6, 7, 8 and 11 shall not apply in relation to - 

(a) products produced and packaged outside the United Kingdom if the packaging indicates the country of origin and they remain in their original packaging; or

(b) products which are - 


(i) produced in an establishment in the restricted area approved by the National Assembly, the Secretary of State or the Minister from pre-processed products originating outside that area which, since introduction into the United Kingdom have been transported, stored and processed separately from products not destined for dispatch; and

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

Endorsement of commercial documents
     13.  - (1) Where reference is made to a commercial document being endorsed in accordance with this regulation, the document must have attached to it an official certificate prepared by the National Assembly, the Secretary of State or the Minister and signed by a person appointed as an officer of the kind specified in the certificate stating that the production process has been audited and found to be in accordance with these Regulations and suitable to destroy the foot-and-mouth disease virus or that the products concerned have been produced from pre-processed materials which have been certified accordingly and that provisions are in place to avoid possible re-contamination with the foot-and-mouth disease virus after treatment.

    (2) 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 case of products for retail sale to the final consumer, a consolidated load of products other than fresh meat, minced meat and meat preparations, each of which is eligible for dispatch in accordance with these Regulations, may be dispatched from approved premises accompanied by a commercial document endorsed by the attachment of a copy of an official veterinary certificate prepared by the National Assembly, the Secretary of State or the Minister and signed by a person appointed as an officer of the kind specified in the certificate which - 

(a) confirms that the premises of dispatch has in place a system to ensure that goods can only be dispatched 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 this 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.

Third country certificates
     14.  - (1) No person shall dispatch anything to which these Regulations apply to a third country unless the consignment is accompanied by an official certificate prepared by the National Assembly, the Secretary of State or the Minister and signed by a person appointed as an officer of the kind specified in the certificate certifying compliance with the Regulations.

Export of equidae
     15.  - (1) Any person dispatching equidae shall ensure that they are accompanied by a health certificate in accordance with the model in Annex C of Directive 90/426/EEC on animal health conditions governing the movement and import from third countries of equidae [20].

    (2) A veterinary inspector shall only issue a certificate referred to in paragraph (1) if - 

(a) he or she is satisfied that the animal has not come from a holding in relation to which a notice in Form A or Form D is in effect in accordance with the Foot-and-Mouth Disease Order 1983 [21];

(b) he or she has inspected the animal and is satisfied that it has been groomed to remove as far as practicable visible faeces, dirt and debris and that its hooves have been cleaned and disinfected to his or her satisfaction; and

(c) the owner of the animal or the owner's representative has given a written declaration to the veterinary inspector stating that the equine animal will remain on the holding until sent to the place of destination stated in the health certificate, without stopping at any holding in relation to which a notice in Form A or Form D is in effect in accordance with the Foot-and-Mouth Disease Order 1983.

    (3) The health certificate accompanying equidae exported to another member State in accordance with the provisions of this article shall bear the following words - 

" Equidae conforming to Commission Decision 2001/356/EC of 4th May 2001, concerning certain protection measures with regard to foot-and-mouth disease in the United Kingdom."

    (4) Paragraph (1) shall not apply to equidae in transit from outside the United Kingdom which are accompanied by a valid health certificate in accordance with the model in Annex C of Directive 90/426/EEC.

Offers to dispatch or export
     16. 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 inspectors
     17.  - (1) An inspector shall, on producing, if required to do so, some duly authenticated document showing his authority, have the right at all reasonable hours to enter any land or premises for the purposes of ascertaining whether there is or has been on the premises any contravention of these Regulations; and in this regulation "premises" includes any place, installation, vehicle (including any container, trailer, semi-trailer, caravan or other thing which is designed or adapted to be towed by another vehicle), train, ship, vessel, boat, craft, hovercraft or aircraft.

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

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

(b) examine documentary or data processing material relevant to the checks carried out under these Regulations; and

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

Powers of customs officers
     18. A customs officer may detain any vehicle, vessel, container or anything which he or she 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
     19.  - (1) An inspector who knows or suspects that animals or animal products are intended for dispatch and do not comply with the requirements of these Regulations may serve a notice on the person in charge of the consignment prohibiting the dispatch of the animals or products in the consignment until the inspector is satisfied that the animals or products comply with the Regulations.

    (2) No person shall dispatch anything subject to a notice served under this regulation unless it has been revoked.

    (3) A notice under this section shall be in writing, may be subject to conditions and may be amended or revoked by further notice in writing at any time.

    (4) Animals imported in contravention of these Regulations shall be dealt with as specified in regulation 13 of the Animals and Animal Products (Import and Export) (England and Wales) Regulations 2000[22].

Obstruction
     20.  - (1) No person shall - 

(a) intentionally obstruct any person acting in the execution of these Regulations;

(b) without reasonable cause, fail to give to any person acting in the execution of these Regulations any assistance or information which that person may reasonably require for the purposes of his functions under these Regulations, or

(c) furnish to any person acting in the execution of these Regulations any information which he knows to be false or misleading.

    (2) Nothing in paragraph (1)(b) above shall be construed as requiring any person to answer any question or give any information if to do so might incriminate him.

Furnishing false information
     21. No person shall furnish to any person acting in the execution of these Regulations any information which he or she knows to be false or misleading.

Offences by bodies corporate
     22.  - (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,

he or she 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 paragraph (1) above, "director" in relation to a body corporate whose affairs are managed by its members, means a member of the body corporate.

Penalties
     23.  - (1) A person contravening any provision of these Regulations shall be guilty of an offence.

    (2) A person guilty of an offence under regulation 16 or regulation 20(1)(a) or (b) shall be liable on summary conviction to a fine not exceeding level 5 on the standard scale or to imprisonment for a term not exceeding three months or to both.

    (3) A person guilty of any other offence under these Regulations shall be liable - 

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

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

Certificates, approvals, etc. issued in another part of the British Islands
     24.  - (1) Where these Regulations require any certificate, licence or approval to be issued or granted by the National Assembly, the Secretary of State or the Minister in Wales, an equivalent certificate, licence or approval issued in another part of the British Islands by the relevant competent authority is valid.

    (2) Where these Regulations require anything to be processed in approved premises in Wales, anything processed in premises approved for those purposes in another part of the British Islands shall be treated as if it had been processed in approved premises in Wales.

Enforcement
     25. These Regulations shall be enforced by the Secretary of State or the local authority.

Consequential amendment to the Fresh Meat (Hygiene and Inspection) Regulations 1995
     26. In so far as they apply to Wales, the Fresh Meat (Hygiene and Inspection) Regulations 1995[23] are amended by substituting for sub-paragraph (3) of paragraph 9 of Schedule 12 the following - 

    " (3) Sub-paragraph (1) does not apply to fresh meat handled in accordance with regulation 5(3) of the Import and Export Restrictions (Foot-And-Mouth Disease) (Wales) (No. 10) Regulations 2001.".

Consequential amendments to the Minced Meat and Meat Preparations (Hygiene) Regulations 1995
     27.  - (1) In so far as they apply to Wales, the Minced Meat and Meat Preparations (Hygiene) Regulations 1995[24] are amended in accordance with this regulation.

    (2) For paragraph (1B) of regulation 7 there is substituted - 

    " (1B) Paragraph (1A) does not apply to minced meat processed in accordance with regulation 5(3) of the Import and Export Restrictions (Foot-And-Mouth Disease) (Wales) (No. 10) Regulations 2001.".

    (3) For paragraph (6) of regulation 7 there is substituted - 

    " (6) The health mark may be affixed to minced meat which satisfies the requirements of paragraph (1) of this regulation and regulation 5(3) of the Import and Export Restrictions (Foot-And-Mouth Disease) (Wales) (No. 10) Regulations 2001.".

    (4) For paragraph (4B) of regulation 8 there is substituted - 

    " (4B) Paragraph (4A) does not apply to meat preparations made in accordance with regulation 5(3) of the Import and Export Restrictions (Foot-And-Mouth Disease) (Wales) (No. 10) Regulations 2001.".

    (5) For paragraph (7) of regulation 8 there is substituted - 

    " (7) The health mark may be affixed to any meat preparation which satisfies the requirements of paragraph (1) of this regulation and regulation 5(3) of the Import and Export Restrictions (Foot-And-Mouth Disease) (Wales) (No. 10) Regulations 2001.".

Revocations
     28. The Import and Export Restrictions (Foot-and-Mouth Disease) (Wales) (No. 9) Regulations 2001 [25], the Import and Export Restrictions (Foot-and-Mouth Disease) (Wales) (No. 9) (Amendment) Regulations 2001[26] and the Import and Export Restrictions (Foot-and-Mouth Disease) (Wales) (No. 9) (Amendment) (No. 2 ) Regulations 2001 [27] are revoked.



Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998 [28]


D. Elis Thomas
Presiding Officer

22nd October 2001

[2] 1972 c. 68.back

[3] OJ No. L277, 20.10.2001, p. 30.back

[4] S.I. 2000/1673.back

[5] S.I. 1996/3124.back

[6] 1980 c.66.back

[7] OJ No. L26, 31.1.1977, p. 85 as last amended by Directive 92/45/EEC (OJ No. L268, 14.9.1992, p. 35).back

[8] OJ No. L268, 14.9.92, p.1 as last amended by Council Directive 94/71/EC (OJ No. L368, 31.12.94, p. 33).back

[9] S. I. 1995/539 as amended.back

[10] OJ No. L368, 31.12.94, p. 10.back

[11] OJ No. 121, 27.9.1964, p.2012/64; Directive updated by Directive 91/497/EEC (OJ No L268, 24.9.1991, p. 69) as last amended by Directive 95/23/EC (OJ No. L243, 11.10.1995, p. 7).back

[12] OJ No. L 268, 24.09.1991 p. 41 as last amended by Council Directive 1994/65/EC (OJ No. L 368 , 31.12.1994 p. 10).back

[13] S.I. 1995/3205.back

[14] OJ No. L47, 21.2.1980, p. 4.back

[15] OJ No. L62, 15.3.1993, p. 49.back

[16] OJ No. L194, 22.7.1988, p. 10 as last amended by Council Directive 93/60/EEC, OJ No. L 186, 28.7.1993, p. 28.back

[17] OJ No. L302, 19.10.1989, p.11 as last amended by Council Directive 94/113/EC, OJ No. L53, 24.2.1994, p. 23.back

[18] OJ No. L224, 18.8.1990, p. 62 as last amended by Council Directive 2000/39/EC, OJ No. L13, 19.1.2000, p. 21.back

[19] 1996/3124.back

[20] OJ No. L224, 18.8.90, p. 42.back

[21] S.I. 1983/1950, as amended.back

[22] S.I.2000/1673.back

[23] S. I. 1995/539 as amended.back

[24] S. I. 1995/3205 as amended.back

[25] S. I. 2001/2529 (W.207).back

[26] S. I. 2001/2628 (W.217).back

[27] S. I. 2001/3283 (W.272).back

[28] 1998 c.38.back

  Prepared 29 October 2001