Title, commencement and extent

1. These Regulations may be cited as the Bovines and Bovine Products (Trade) Regulations 1999, shall come into force on 1st May 1999 and shall extend to Great Britain.

Interpretation

2.-(1) In these Regulations, unless the context otherwise requires-�

• "additional mark"-�

  (a)

  in relation to any foreign origin export eligible goods (other than any goods in (c) or (d) below) means a mark conforming with Schedule 4 below;

  (b)

  in relation to any-�

  (i)

  DBES goods; or

  (ii)

  ECHS goods prepared in Great Britain,

  means a mark conforming with Schedule 5 below; or

  (c)

  in relation to any foreign origin export eligible goods which-�

  (i)

  consist of or are derived from fresh meat which has been deboned and from which all adherent tissues including obvious nervous and lymphatic tissues have been removed; and

  (ii)

  are mixed with any DBES goods or ECHS goods,

  means a mark conforming with Schedule 5 below or two marks, one conforming with Schedule 4 below and one conforming with Schedule 5 below;

  (d)

  in relation to any foreign origin export eligible goods which-�

  (i)

  consist of or are derived from fresh meat which has not been deboned or from which all adherent tissues, including obvious nervous and lymphatic tissues, have not been removed; and

  (ii)

  are mixed with any DBES goods or ECHS goods,

  means two marks, one conforming with Schedule 4 below and one conforming with Schedule 5 below; and

  (e)

  in relation to any type of ECHS goods which have not undergone any stage of preparation in Great Britain, means a mark conforming with the mark prescribed for goods of that type in the Northern Ireland Regulations;

• "bovine animal" includes buffalo of the species Bubalus bubalis and Bison bison;

• "bovine embryo" means an embryo of a bovine animal;

• "Community approved border inspection post" means any place in a member State which is specified in the Annex to Commission Decision 97/778/EC as amended(3) drawing up a list of border inspection posts agreed for veterinary checks on products and animals from third countries;

• "the Council Decision" means Council Decision 98/256/EC(4) concerning emergency measures to protect against bovine spongiform encephalopathy as amended by Commission Decision 98/564/EC(5) and Commission Decision 98/692/EC(6);

• "controlled bovine by-product" means-�

  (a)

  an amino acid;

  (b)

  a peptide;

  (c)

  tallow;

  (d)

  a tallow product not within (e) below; or

  (e)

  a product, derived by saponification, transesterification or hydrolysis from tallow,

  produced in the United Kingdom from any part of a bovine animal slaughtered in the United Kingdom which is liable to enter the human food or animal feed chain or is destined for use in cosmetics, medical or pharmaceutical products;

• "DBES" means the date based export scheme referred to in Annex III to the Council Decision;

• "DBES eligible animal" means a bovine animal which satisfies the conditions set out in paragraph 3 of Annex III to the Council Decision;

• "DBES goods" means any fresh meat, minced meat, meat preparation, meat product or food for domestic carnivores derived from DBES eligible animals;

• "the Department" means the Department of Agriculture for Northern Ireland;

• "despatch" includes carry;

• "ECHS goods" means any fresh meat, minced meat, meat preparation, meat product or food for domestic carnivores derived from bovine animals which-�

  (a)

  satisfy the conditions set out in paragraphs 6 and 7 of Annex II to the Council Decision; and

  (b)

  originated in a herd which satisfies the conditions set out in paragraphs 2 to 5 of Annex II to the Council Decision;

• "establishment" includes any premises;

• "export dedicated establishment" means an establishment approved as such under regulation 12 below;

• "export eligible goods" means-�

  (a)

  DBES goods, ECHS goods or foreign origin export eligible goods; or

  (b)

  any goods containing a mixture of one or more of those types of goods and which contain no ingredient, other than those type of goods, derived from a bovine animal;

• "foreign origin bovine by-product" means any of the following by-products derived from a bovine animal not slaughtered in the United Kingdom-�

  (a)

  gelatin, di-calcium phosphate, tallow or tallow product not in (b) below;

  (b)

  product derived from tallow by saponification, transesterification or hydrolysis; or

  (c)

  amino acid, peptide or collagen,

  which is liable to enter the human food or animal feed chain or is destined for use in cosmetics or medical or pharmaceutical products;

• "foreign origin export eligible goods" means-�

  (a)

  fresh meat;

  (b)

  any minced meat or meat preparation;

  (c)

  any meat product or other product of animal origin; or

  (d)

  food for domestic carnivores, derived from a bovine animal which was not slaughtered in the United Kingdom;

• "fresh meat" has the same meaning as in Council Directive 64/433/EEC(7);

• "inspector" means-�

  (a)

  a person appointed as such by the Minister, including a veterinary inspector; and

  (b)

  a person appointed as such by a local authority in relation to its enforcement responsibilities under these Regulations;

• "local authority" means-�

  (a)

  in England-�

  (i)

  as respects each local government area in respect of which there is a unitary authority established by an order under section 17 of the Local Government Act 1992(8), that authority;

  (ii)

  as respects each London borough, district or non-metropolitan county, the council of that borough, district or county;

  (iii)

  where there is a Port Health Authority, that authority in addition to the authority specified in paragraphs (i) or (ii) above;

  (iv)

  as respects the City of London, the Common Council; and

  (v)

  as respects the Isles of Scilly, the Council of the Isles of Scilly;

  (b)

  in Scotland, a council constituted under section 2 of the Local Government etc. (Scotland) Act 1994(9); and

  (c)

  in Wales-�

  (i)

  as respects each county or county borough the council of that county or county borough; and

  (ii)

  where there is a Port Health Authority, that authority in addition to the authority specified in paragraph (i) above;

• "meat product" and "other products of animal origin" have the same meaning as in Council Directive 77/99/EEC(10);

• "minced meat" and "meat preparation" have the same meaning as in Council Directive 94/65/EC(11);

• "the Minister" means, in relation to England, the Minister of Agriculture, Fisheries and Food and, in relation to Scotland or Wales, the Secretary of State;

• "the Northern Ireland Regulations" means the Bovines and Bovine Products (Trade) Regulations (Northern Ireland) 1999(12);

• "officer" means a person commissioned by the Commissioners of Customs and Excise;

• "official seal" means a seal of a kind described in Schedule 6 to these Regulations;

• "operator", in respect of an establishment for which an approval or registration is required under these Regulations, means the person carrying on or proposing to carry on a business there for which the approval or registration is required;

• "premises" includes any place, stall or moveable structure;

• "prepare" in relation to any export eligible goods (otherwise than when they are under official control) includes-�

  (a)

  manufacture;

  (b)

  production;

  (c)

  any form of processing or treatment;

  (d)

  packaging or re-packaging;

  (e)

  presenting, labelling, re-labelling, wrapping or re-wrapping;

  (f)

  storing at ambient or cold temperature, other than keeping in a sealed means of transport (or in any lockable chamber or lockable container for the purpose of being carried on a sealed means of transport) for any period when the goods are accompanied by an official certificate issued in accordance with the requirements of these Regulations in relation to the despatch of the goods from Great Britain;

  (g)

  handling; and

  (h)

  loading and unloading,

  and "preparation" shall be construed accordingly;

• "vertebral column" includes any part thereof; and

• "veterinary inspector" means a person appointed as a veterinary inspector by the Minister.

(2) Expressions in these Regulations which are not defined in paragraph (1) above and which appear in the Council Decision have the same meaning in these Regulations as in that Decision.

Trade in live bovine animals, bovine embryos, mammalian meat and bone meal and related products

3.-(1) Subject to paragraph (2) below, no person shall despatch from Great Britain to a member State or a third country, bring to any place in Great Britain for the purpose of such despatch or consign for the purpose of such despatch, any-�

(a)live bovine animal or bovine embryo;

(b)meat meal, bonemeal or meat and bonemeal derived from any mammal; or

(c)animal feed or fertiliser containing any meat meal, bonemeal or meat and bonemeal derived from any mammal.

(2) Nothing in paragraph (1) above shall prohibit the despatch, bringing or consignment of any food destined for domestic carnivores by reason only that such food contains meat meal, bonemeal or meat and bonemeal derived from any mammal, provided that those materials do not originate from the United Kingdom and each stage in the preparation of the food which took place in the United Kingdom took place at an establishment approved under regulation 12 below in accordance with the requirements of that approval.

Trade in meat, products, by-products and materials derived from bovine animals slaughtered in the United Kingdom

4.-(1) Subject to the following provisions of this regulation no person shall despatch from Great Britain to a member State or a third country, bring to any place in Great Britain for the purpose of such despatch or consign for the purpose of such despatch, any-�

(a)meat derived from a bovine animal slaughtered in the United Kingdom;

(b)product derived from a bovine animal slaughtered in the United Kingdom which is liable to enter the human food or animal feed chain; or

(c)material derived from a bovine animal slaughtered in the United Kingdom which is destined for use in cosmetics or medical or pharmaceutical products.

(2) The prohibitions in paragraph (1) above shall not apply in relation to any type of ECHS goods prepared in whole or in part in Northern Ireland in accordance with the requirements referred to in the Northern Ireland Regulations in respect of ECHS goods of that type if-�

(a)any stage of preparation of the goods in Great Britain took place in a slaughterhouse approved by the Minister under regulation 10 below, or in an establishment approved by the Minister under regulation 12 below, in accordance with those regulations and the requirements of regulations 11 and 13 below relating to that stage (including the requirement for supervision by a veterinary inspector);

(b)in the case of fresh meat no health marks applied to the meat for the purposes of Council Directive 64/433/EEC have been removed and the goods are accompanied by an official certificate, issued by a veterinary inspector in respect of any stage of preparation of the goods in Great Britain or by a veterinary surgeon appointed by the Department in respect of any stage of preparation of the goods in Northern Ireland, which-�

(i)states that the goods comply with the conditions referred to articles 6 and 7 and 9 to 13 of the Council Decision;

(ii)identifies the establishments in which they were prepared;

(iii)bears the words "produced in accordance with Council Decision 98/256/EC"; and

(iv)in the "identification of meat" section of the health certificate referred to in Annex IV to Council Directive 64/433/EEC, identifies all the labels affixed to the goods and the relevant numbers in the consignment ensuring traceability of each individual unit; and

(c)in the case of any minced meat, meat preparation, meat product or food for domestic carnivores, the goods are accompanied by an official certificate, issued by a veterinary inspector in respect of any stage of preparation of the goods in Great Britain or by a veterinary surgeon appointed by the Department in respect of any stage of preparation of the goods in Northern Ireland, which-�

(i)states that the goods comply with the conditions referred to in articles 6 and 7 and 9 to 13 of the Council Decision;

(ii)identifies the establishments in which they were prepared; and

(iii)identifies all the labels affixed to the goods and the relevant numbers in the consignment ensuring traceability of each individual unit.

(3) The prohibitions in paragraph (1) above shall not apply in relation to any controlled bovine by-product produced in an establishment registered under regulation 7 below if-�

(a)in the case of a controlled bovine by-product of a type referred to in paragraphs (a), (b) or (c) of the definition of controlled bovine by-products in regulation 2(1) above-�

(i)it is accompanied by an official certificate issued by a veterinary inspector specifying that it was produced in compliance with the conditions specified in Annex I to the Council Decision and attesting to the frequency of the official controls carried out; and

(ii)the Commission has set the date referred to in Article 4(6) of the Council Decision in respect of that type of controlled bovine by-product and that date has passed; or

(b)in the case of a controlled bovine by-product of a type referred to in paragraphs (d) and (e) of the definition of controlled bovine by-products in regulation 2(1) above, the Commission has set the date referred to in Article 4(6) of the Council Decision in respect of tallow and that date has passed; and

the implementation of official controls has been inspected for the purpose of article 4(5) of the Council Decision.

(4) The prohibitions in paragraph (1) above shall not apply in relation to any DBES goods if-�

(a)the DBES eligible animals from which the goods have been derived were slaughtered-�

(i)in a slaughterhouse in Great Britain approved under regulation 10 below; and

(ii)in accordance with that regulation and the requirements of regulation 11 below;

(b)each stage of the preparation of the goods which took place in Great Britain took place-�

(i)in a slaughterhouse approved by the Minister under regulation 10 below, or in an establishment approved by the Minister under regulation 12 below, and in accordance with those regulations and the requirements of regulations 11 and 13 below relating to that stage; and

(ii)under the supervision of a veterinary inspector;

(c)each stage of the preparation of the goods which took place in Northern Ireland took place-�

(i)in a slaughterhouse approved by the Department under the Northern Ireland Regulations, or in an establishment approved by the Department under the Northern Ireland Regulations, and in accordance with the requirements of those Regulations relating to that stage; and

(ii)under the supervision of a veterinary surgeon appointed by the Department;

(d)in the case of fresh meat it was obtained in accordance with article 6(2) of the Council Decision, no health marks applied to the meat for the purposes of Council Directive 64/433/EEC have been removed and the meat is accompanied by an official certificate issued by a veterinary inspector which-�

(i)states that the goods comply with the conditions referred to articles 6 and 7 and 9 to 13 of the Council Decision;

(ii)identifies the establishments in which they were prepared; and

(iii)bears the words "produced in accordance with Council Decision 98/256/EC" and, in the "identification of meat" section of the health certificate referred to in Annex IV to Council Directive 64/433/EEC, identifies all the labels affixed to the goods and the relevant numbers in the consignment ensuring traceability of each individual unit;

(e)in the case of any minced meat, meat preparation, meat product or food for domestic carnivores the goods were obtained in accordance with article 6(3) of the Council Decision and are accompanied by an official certificate issued by the veterinary surgeon who supervised their preparation which-�

(i)states that the goods comply with the conditions referred to in articles 6 and 7 and 9 to 13 of the Council Decision;

(ii)identifies the establishments in which they were prepared; and

(iii)identifies all the labels affixed to the goods and the relevant numbers in the consignment ensuring traceability of each individual unit;

(f)the Commission has carried out the inspections referred to in article 6(5) of the Council Decision, has set the date referred to in that article and that date has passed; and

(g)the goods are despatched in accordance with the relevant provisions of the Products of Animal Origin (Import and Export) Regulations 1996(13).

(5) The prohibitions in paragraph (1) above shall not apply in relation to any sample, derived from a bovine animal slaughtered in the United Kingdom and destined for use for the purpose of research into BSE and BSE diagnostic tests, despatched from the Veterinary Laboratory Agency Weybridge to an institute in a member State or third country approved by the competent authority of the member State or third country for the purpose of article 4(1)(c) of the Council Decision.

Trade in meat, products, by-products and materials derived from bovine animals not slaughtered in the United Kingdom

5.-(1) No person shall despatch from Great Britain to a member State or a third country, bring to any place in Great Britain for the purpose of such despatch or consign for the purpose of such despatch any foreign origin export eligible goods unless-�

(a)each stage of the preparation of those goods which took place in the United Kingdom took place-�

(i)in the case of a stage of preparation taking place in Great Britain, in an establishment approved by the Minister under regulation 12 below in accordance with that regulation and the requirements of regulation 13 below relating to that stage; or

(ii)in the case of a stage of preparation taking place in Northern Ireland, in an establishment approved by the Department under the Northern Ireland Regulations in accordance with the requirements of those Regulations relating to that stage;

(b)each stage of the preparation of those goods which took place in the United Kingdom took place under the supervision of a veterinary inspector or in the case of a stage of preparation taking place in Northern Ireland, by a veterinary surgeon appointed by the Department;

(c)the goods are accompanied by an official certificate issued by a veterinary inspector or, in the case of goods prepared in Northern Ireland, by a veterinary surgeon appointed by the Department-�

(i)stating, in the case of goods prepared in Great Britain, that they were prepared in accordance with regulation 12 below and the requirements of regulation 13 below in an establishment approved by the Minister under regulation 12 below or, in the case of goods prepared in Northern Ireland, that they were prepared in accordance with the requirements of the Northern Ireland Regulations in an establishment approved by the Department under those Regulations;

(ii)stating that the conditions referred to in articles 9, 10, 11, 12 and 13 of the Council Decision are met in respect of the goods, identifying all establishments approved under regulation 12 below where they were obtained, processed, handled or stored and identifying all labels and the relevant numbers in the consignment ensuring traceability of each individual unit; and

(iii)stating, in respect of any fresh meat, that the identity of all labels and the relevant numbers in the consignment ensuring traceability of each individual unit in respect of the meat has been stated in the "Identification of Meat" section of the certificate referred to in Annex IV to Council Directive 64/433/EEC in respect of the meat and that the words "produced in accordance with Council Decision 98/256/EC" have been added to that and any other certificate accompanying the meat;

(d)in respect of fresh meat no health marks applied to the meat for the purposes of Council Directive 64/433/EEC have been removed; and

(e)the goods are despatched in accordance with Part III of the Products of Animal Origin (Import and Export) Regulations 1996.

(2) No person shall despatch from Great Britain to a member State or a third country, bring to any place in Great Britain for the purpose of such despatch or consign for the purpose of such despatch any foreign origin bovine by-product unless-�

(a)the by-product comes from or has passed through an establishment in Great Britain approved by the Minister under regulation 12 below or, in the case of an establishment in Northern Ireland, comes from or has passed through an establishment approved by the Department under the Northern Ireland Regulations;

(b)in the case of a by-product referred to in paragraph (a) or (c) of the definition of foreign origin bovine by-products in regulation 2(1) above each stage of the preparation of the by-product took place under the supervision of a veterinary inspector or, in the case of a stage of preparation taking place in Northern Ireland, under the supervision of a veterinary surgeon appointed by the Department;

(c)in the case of a by-product referred to in paragraph (b) of the definition of foreign origin bovine by-products in regulation 2(1) above each stage of the preparation of the by-product took place under the supervision of an inspector or, in the case of a stage of preparation taking place in Northern Ireland, under the supervision of a person appointed as such by the Department; and

(d)there is a clear indication, either by means of a label affixed to the by-product or on its packaging-�

(i)of the identity of the establishment at which the goods were produced;

(ii)that the by-product was produced in accordance with the Council Decision; and

(iii)that the by-product is suitable for use in human food, animal feed, cosmetics or medical or pharmaceutical products.

Production of bovine by-products and consignment and placing on the market of bovine meat, products and certain by-products

6.-(1) No person shall produce any gelatin or collagen, derived from a bovine animal slaughtered in the United Kingdom, which is liable to enter the human food or animal feed chain or is destined for use in cosmetics or medical or pharmaceutical products.

(2) No person shall produce any gelatin or collagen derived from a bovine animal not slaughtered in the United Kingdom, which is liable to enter the human food or animal feed chain or is destined for use in cosmetics or medical or pharmaceutical products, except in accordance with regulation 12 below and the requirements of regulation 13 below relating to the production of foreign origin bovine by-products consisting of gelatin or collagen in an establishment approved by the Minister under regulation 12 below.

(3) No person shall consign or bring to an establishment registered under regulation 7 below material derived from a bovine animal which includes any part of the vertebral column of such an animal unless he ensures that-�

(a)any such material is contained in an impervious container which is clearly labelled to indicate that it contains bovine vertebral column; and

(b)any other material derived from a bovine animal carried in the same consignment is contained in a separate impervious container which is clearly labelled as not containing bovine vertebral column.

(4) No person shall bring to any place in Great Britain or consign from any place in Great Britain, for the purpose of despatch from Great Britain to a member State or a third country, any export eligible goods unless these export eligible goods are transported in an officially sealed vehicle the seal of which has not been broken except for the purposes of an official inspection.

(5) No person shall bring to any place in Great Britain or consign from any place in Great Britain, for the purpose of despatch from Great Britain to a member State or a third country, any fresh meat which has been despatched from an establishment, or a Community approved border inspection post, in Northern Ireland or the territory of a member State unless-�

(a)it is accompanied by a veterinary certificate issued by an official veterinarian or a certificate issued by the competent authority in respect of any border inspection post; and

(b)it is transported in an officially sealed vehicle the seal of which has not been broken except for the purposes of an official inspection.

(6) No person shall bring to any establishment approved under regulation 12 below or consign from any place in Great Britain to such an establishment any product, by-product or material referred to in paragraph (7) below unless the establishment and member State where it was produced are clearly indicated, either by means of a label affixed to it or on its packaging or in a document accompanying it.

(7) The products, by-products and material referred to in paragraph (6) above are-�

(a)any gelatin, di-calcium phosphate, tallow, product derived from tallow by saponification, transesterification or hydrolysis, any other tallow product, or any amino acid, peptide or collagen, which is liable to enter the human food or animal feed chain or is destined for use in cosmetics or medical or pharmaceutical products; and

(b)any raw materials for use in the production of any such products,

derived from bovine animals which have not been slaughtered in the United Kingdom.

(8) No person shall store, sell or otherwise supply, or offer, expose or advertise for sale or supply, or consign or despatch to any other person, any product or by-product referred to in paragraph (9) below unless he ensures that-�

(a)the establishment at which that product or by-product was produced; and

(b)the unsuitability of that product or by-product for use in human food, animal feed, cosmetics or medical or pharmaceutical products,

is clearly indicated, either by means of a label affixed to the product or by-product or on its packaging or in a document accompanying it.

(9) The products and by-products referred to in paragraph (8) above are any gelatin, di-calcium phosphate, collagen, tallow, products derived from tallow by saponification, transesterification or hydrolysis or any other tallow products, produced, otherwise than for human food, animal feed, cosmetics or medical or pharmaceutical products, from raw materials derived from bovine animals slaughtered in the United Kingdom.

(10) No person shall place on the market in Great Britain any fresh meat, minced meat, meat preparation, meat product or other product of animal origin which bears an additional mark or the labelling or packaging of which bears an additional mark or which bears a mark equivalent to an additional mark, or the labelling or packaging of which bears a mark equivalent to an additional mark, prescribed by the Northern Ireland Regulations.

Registration of establishments for the production of controlled bovine by-products

7.-(1) No person shall use any premises for the production of any type of controlled bovine by-product unless those premises are registered by the Minister under this regulation for the production of that type of controlled bovine by-product and the premises are used in accordance with the conditions referred to in that registration.

(2) The Minister on an application made to him for the registration of an establishment under this regulation-�

(a)shall register the establishment to which the application relates-�

(i)for the production of controlled bovine by-products of the types referred to in paragraphs (a), (b) and (c) of the definition of controlled bovine by-products in regulation 2(1) above if, following an inspection of that establishment by a veterinary inspector, he is satisfied that the controlled bovine by-products of the type to be produced there will be produced in accordance with the appropriate conditions specified in Annex I to the Council Decision; or

(ii)for the production of controlled bovine by-products of the types referred to in paragraphs (d) and (e) of the definition of controlled bovine by-products in regulation 2(1) above if, following an inspection of that establishment by a veterinary inspector, he is satisfied that the controlled bovine by-products of those types to be produced there will be produced using tallow produced in establishments registered under this regulation,

and, in either such case, he is satisfied that no vertebral column derived from any bovine animal will be used there in the production of such by-products; or

(b)shall refuse so to register that establishment if he is not so satisfied.

(3) An application for registration of an establishment under this regulation shall be made in writing to the Minister by the operator of the establishment to which the application relates.

(4) The Minister shall notify the applicant in writing of his decision on the application; and, if he refuses to register an establishment, he shall notify the applicant in writing of his reasons for refusal.

(5) No person shall produce-�

(a)any controlled bovine by-product referred to in paragraphs (a), (b) or (c) of the definition of controlled bovine by-products in regulation 2(1) above-�

(i)except under the supervision of a veterinary inspector; and

(ii)otherwise than in an establishment registered under this regulation and operated for the production of the by-product in accordance with the applicable conditions in Annex I to the Council Decision;

(b)any controlled bovine by-product referred to in paragraphs (d) or (e) of the definition of controlled bovine by-products in regulation 2(1) above otherwise than from tallow produced in accordance with article 4 of the Council Decision.

(6) If in relation to any establishment registered under this regulation the Minister is satisfied that-�

(a)any requirement relating to the registration of the establishment has not been complied with;

(b)the operator of the establishment has failed to give notice to the Minister as required under regulation 8(3) below; or

(c)the production of controlled bovine by-products at the establishment in respect of which it was registered is no longer being carried on there,

he may withdraw the registration relating to that establishment and, where he does so, he shall give notice to the registered operator in writing that the registration is withdrawn and of the reason for withdrawing it.

Requirements imposed on the operator of a registered establishment

8.-(1) The operator of an establishment at which any controlled bovine by-product is produced shall ensure that the establishment, and the suitability of the controlled by-product for use in human food, animal feed, cosmetics or medical or pharmaceutical products, is clearly indicated, either by means of a label affixed to the by-product, or on its packaging or in a document accompanying the by-product.

(2) The operator of an establishment registered under regulation 7 shall ensure that-�

(a)any person employed by him, or any person invited to the establishment, complies with the provisions of these Regulations relating to the registration and operation of the establishment;

(b)at each stage of the production of each type of controlled bovine by-product at the establishment, the provisions of these Regulations relating to the production of controlled bovine by-products of that type at the establishment are complied with there; and

(c)any inspector, and any person acting under the responsibility of an inspector, is provided with adequate facilities so as to enable him to carry out his functions under these Regulations in relation to the establishment and that he is given such reasonable assistance and access to such records (including any records held in electronic form) as he may at any reasonable time require for that purpose.

(3) The operator of an establishment registered under regulation 7 above shall give the Minister written notice of any material change he intends to make-�

(a)of the suppliers of the materials used by him at that establishment in the manufacture of controlled bovine by-products; or

(b)of any facilities or processes used at that establishment in the manufacture of such by-products, before making any such change.

Use of controlled bovine by-products and other products

9.-(1) Subject to the following provisions of this regulation, no person shall use any-�

(a)controlled bovine by-product; or

(b)gelatin or collagen derived from a bovine animal (whether slaughtered in the United Kingdom or elsewhere) which has been produced in the United Kingdom, in the production of any product which is liable to enter the human food chain or animal feed chain or is destined for use as or in any cosmetics or medical or pharmaceutical product.

(2) The prohibition in paragraph (1)(a) above shall not apply to the use of a controlled bovine by-product produced in accordance with regulation 7 and the requirements of regulation 8 above or, in the case of a controlled bovine by-product produced in Northern Ireland, in accordance with the Northern Ireland Regulations.

(3) The prohibition in paragraph (1)(b) above shall not apply to the use of gelatin or collagen produced-�

(a)in an establishment approved under regulation 12 below and in accordance with that regulation and the requirements of regulation 13 below or, in the case of gelatin or collagen produced in Northern Ireland, in an establishment approved under the Northern Ireland Regulations and in accordance with the requirements of those Regulations; or

(b)before 1st May 1998 in an establishment which the Minister is satisfied would have complied with the conditions for approval under regulation 12 below at the time of production if those conditions had been in force at that time and which has subsequently been approved under that regulation or under regulation 7 of the Bovines and Bovine Products (Trade) Regulations 1998(14).

Approval of establishments for the slaughter of DBES eligible animals and preparation of DBES goods

10.-(1) No person shall use any premises for the slaughter of any DBES eligible animal from which any DBES goods will be derived unless-�

(a)the premises are an establishment approved by the Minister under this regulation for the slaughter of DBES eligible animals; and

(b)the date referred to in article 6(5) of the Council Decision for the despatch of DBES goods has been set by the Commission and has passed.

(2) The Minister on an application made to him for the approval of an establishment under this regulation-�

(a)shall approve the establishment to which the application relates if, following an inspection of that establishment by a veterinary inspector, he is satisfied that the establishment complies with the requirements of paragraph (3) below; or

(b)shall refuse to approve that establishment if he is not so satisfied.

(3) The requirements for the approval of an establishment for the slaughter of DBES eligible animals under this regulation are-�

(a)the establishment is licensed as a slaughterhouse under the Fresh Meat (Hygiene and Inspection) Regulations 1995(15);

(b)there is in operation in the OVS room at the establishment (as defined in regulation 2(1) of the Fresh Meat (Hygiene and Inspection) Regulations 1995) a computer facility sufficient to enable an inspector to carry out official checks in relation to an animal from which DBES goods may be derived for the purpose of determining whether the animal is a DBES eligible animal;

(c)that any bovine product not eligible for despatch abroad must have been removed from the establishment and-�

(i)all parts of the premises, and equipment on the premises, used for the production, processing, treatment, handling, storage, loading or unloading of any bovine product not eligible for despatch abroad have been thoroughly cleaned after the last such use; and

(ii)procedures must have been put in place to prevent entry on to the premises of bovine products which are not eligible for despatch abroad;

(d)that the methods of operation in respect of the slaughter of animals at the establishment comply with the requirements of the first column in Schedule 1 to these Regulations and the Minister has determined how those requirements are to apply to the establishment as indicated in the second and third columns of that Schedule; and

(e)in respect of the preparation at the establishment of any description of DBES goods, intended for despatch from Great Britain to a member State or a third country, derived from DBES eligible animals (whether or not slaughtered at the establishment)-�

(i)that the establishment is approved as an export dedicated establishment under regulation 12 below for the preparation of DBES goods of that description; and

(ii)the methods of operation in respect of the DBES goods comply with the requirements of the first column in Schedule 2 to these Regulations and the Minister has determined how those requirements are to apply to the establishment as indicated in the second and third columns of that Schedule.

(4) An application for approval of an establishment under this regulation shall be made in writing to the Minister by the operator of the establishment to which the application relates.

(5) The Minister shall notify the applicant in writing of his decision on the application; and, if he refuses to approve the establishment, he shall notify the applicant in writing of his reasons for refusal.

(6) If in relation to any establishment approved under this regulation the Minister is satisfied that-�

(a)any requirement in relation to any of the requirements of regulation 11 below are not being complied with;

(b)the operator of the establishment has failed to give notice to the Minister as required under regulation 11(11) below; or

(c)DBES eligible animals are no longer being slaughtered there,

he may withdraw the approval relating to that establishment and, where he does so, he shall give notice to the operator in writing that the approval is withdrawn and of the reason for withdrawing it.

Requirements imposed on the operator of an establishment approved under regulation 10

11.-(1) The operator of an establishment approved under regulation 10 above shall ensure that-�

(a)any person employed by him, and any person invited to the establishment, complies with the requirements of these Regulations relating to the approval of the establishment;

(b)each stage of the slaughter of any bovine animal at the slaughterhouse-�

(i)takes place under official supervision; and

(ii)complies with the requirements for the methods of operation of the first column in Schedule 1 to these Regulations in accordance with the determination made by the Minister under regulation 10(3)(d) above as to the application of those requirements to the slaughterhouse;

(c)each stage of the preparation of any DBES goods at the slaughterhouse complies with the requirements for the methods of operation for the preparation of DBES goods of the first column in Schedule 2 to these Regulations in accordance with the determination made by the Minister under regulation 10(3)(e)(ii) above as to the application of those requirements to the slaughterhouse;

(d)he takes all reasonable measures to enable the computer facility referred to in regulation 10(3)(b) above to be operated at any reasonable time by an inspector to carry out official checks in relation to an animal from which DBES goods may be derived for the purpose of determining whether the animal is a DBES eligible animal; and

(e)any inspector, and any person acting under the responsibility of an inspector, is provided with adequate facilities so as to enable him to carry out his functions under these Regulations in relation to the establishment and that he is given such reasonable assistance and access to such records (including any records held in electronic form) as he may at any reasonable time require for that purpose.

(2) The operator of an establishment approved under regulation 10 above shall ensure that all DBES goods prepared there, other than DBES goods destined for placing on the market in the United Kingdom or food for domestic carnivores (whether or not destined for placing on the market in the United Kingdom), are marked or labelled with an additional mark-�

(a)in the case of fresh meat derived from an animal slaughtered at the establishment, immediately after the meat has been passed fit for human consumption following post mortem inspection under the Fresh Meat (Hygiene and Inspection) Regulations 1995; and

(b)in the case of any other such DBES goods, before a relevant despatch of the goods from the establishment.

(3) In paragraph (2)(b) above a "relevant despatch" of goods is-�

(a)a despatch of the goods from the establishment for the purpose of a despatch of the goods from Great Britain to a member State or a third country;

(b)a despatch of the goods from the establishment to any establishment approved under these Regulations for the purpose of a despatch of the goods from that establishment, or subsequently from any other such establishment, from Great Britain to a member State or a third country; or

(c)a despatch of the goods from the establishment to any export dedicated establishment whether or not for the purpose of despatch from that establishment, or subsequently from any other such establishment, from Great Britain to a member State or a third country.

(4) The operator of an establishment approved under regulation 10 above shall not mark any goods with an additional mark other than those required to be so marked under paragraph (2) above.

(5) The additional mark shall be applied by persons acting under the responsibility of a veterinary inspector; and no other persons shall apply the additional mark or possess or use the instruments or labels intended for applying or bearing the additional mark.

(6) No person shall produce, modify, store, sell or otherwise supply, or offer, expose or advertise for sale or supply, or consign or despatch to any other person-�

(a)an instrument intended for the application of the additional mark;

(b)any label or packaging bearing an additional mark; or

(c)an official seal,

except in accordance with the instructions of a veterinary inspector.

(7) An operator of an establishment approved under regulation 10 above shall ensure that at or before the time any instrument intended for the application of the additional mark, or any label or packaging bearing an additional mark, or any official seal, is delivered to him or to the establishment, or otherwise to his order, he notifies an inspector for the purpose of enabling any inspector or person acting under the responsibility of an inspector to put the instrument, label, packaging or official seal into a store at the establishment (maintained under the responsibility of an inspector) or (in the case of an instrument, label or packaging) to give instructions for the use of the instrument, label or packaging at the establishment.

(8) The operator of an establishment approved under regulation 10 above shall ensure, in respect of any DBES goods prepared there which are destined for placing on the market in the United Kingdom and which bear the additional mark, that the mark is removed or cancelled at whichever of the following times is the first to occur-�

(a)the time when, for any reason other than the removal of the additional mark, the goods cease to be eligible for despatch from Great Britain to a member State or a third country in accordance with these Regulations; or

(b)the time when the goods leave the establishment.

(9) If a bovine animal is slaughtered at an establishment in contravention of any of the requirements of these Regulations and the operator of the establishment becomes aware of the contravention before the carcase of the animal, or any meat or product derived from the carcase at the establishment, has been consigned from the establishment for the purpose of despatch abroad, the operator shall ensure that the carcase, meat or product is not so consigned.

(10) If a bovine animal is slaughtered at an establishment in contravention of any of the requirements of these Regulations and the carcase of the animal or any meat or product derived from the carcase at the establishment has already been consigned from the establishment by the time the operator of the establishment becomes aware of the contravention, the operator, immediately after he has become aware of the contravention, shall-�

(a)notify an inspector; and

(b)take such further action as the inspector may require-�

(i)for the purpose of preventing the despatch abroad of the carcase of any such meat or product; or

(ii)where the carcase or any such meat or product has already been despatched abroad, for the purpose of enabling the competent authority of the place of destination to take the measures referred to in paragraph 4 of Annex III to the Council Decision.

(11) The operator of an establishment approved under regulation 10 above shall give the Minister written notice of, and shall obtain his agreement to, any material change he intends to make to-�

(a)the computer facility referred to in regulation 10(3)(b) above in operation at the establishment and in relation to which it has been approved; or

(b)any facilities, processes or methods of operation used at that establishment in relation to the slaughter of DBES eligible animals,

before making any such change.

Approval of establishments for the preparation or despatch of foreign origin export eligible goods, DBES and ECHS goods and foreign origin bovine by-products

12.-(1) No person shall use any premises-�

(a)for any stage of preparation of any foreign origin export eligible goods, DBES goods or ECHS goods destined for despatch from Great Britain to a member State or a third country; or

(b)for the production of any foreign original bovine by-products (whether or not those goods are destined for despatch to a member State or a third country),

unless those premises are an establishment approved by the Minister under this regulation for the preparation respectively of foreign origin export eligible goods, DBES goods or ECHS goods or foreign origin bovine by-products.

(2) On an application made to him for the approval of an establishment under this regulation, and following an inspection of that establishment by a veterinary inspector, the Minister-�

(a)shall approve the establishment to which the application relates-�

(i)as an export dedicated establishment if he is satisfied that the establishment complies with the requirements of paragraph (3) below relating to export dedicated establishments; or

(ii)as an establishment which is not an export dedicated establishment if he is satisfied that the establishment complies with the requirements of paragraph (3) below relating to such establishments; or

(b)shall refuse to approve that establishment if he is not so satisfied.

(3) The requirements for the approval of an establishment under this regulation are-�

(a)in respect of an export dedicated establishment, that the establishment is not used for the preparation of any goods derived from bovine animals, other than export eligible goods;

(b)in respect of an establishment which is not an export dedicated establishment, that it is not intended to be used for the preparation (other than cold storage) of any DBES goods or ECHS goods destined for despatch from Great Britain to a member State or a third country;

(c)in respect of an export dedicated establishment-�

(i)that any bovine product not eligible for despatch abroad must have been removed from the establishment; and

(ii)all parts of the premises, and equipment on the premises, used for the production, processing, treatment, handling, storage, loading or unloading of any bovine product not eligible for despatch abroad have been thoroughly cleaned after the last such use and procedures must have been put in place to prevent entry onto the premises of bovine products which are not eligible for despatch abroad;

(d)in respect of an export dedicated establishment that the methods of operation for the preparation of export eligible goods comply with the requirements of the first column in Schedule 2 to these Regulations and the Minister has determined how those requirements are to apply to the establishment as indicated in the second and third columns of that Schedule;

(e)in respect of an establishment which is not an export dedicated establishment the methods of operation for the preparation of foreign origin export eligible goods comply with the requirements of the first column in Schedule 3 to these Regulations and the Minister has determined how those requirements are to apply to the establishment as indicated in the second and third columns of that Schedule; and

(f)that there is in operation at the establishment a system which ensures it is possible-�

(i)to identify the origin of the raw material contained in any export eligible goods or foreign origin bovine by-products despatched from that establishment and to trace that raw material through each stage of preparation of the goods at the establishment; and

(ii)to record all amounts of incoming and outgoing materials and cross-check consignments entering or leaving the establishment.

(4) An application for approval of an establishment under this regulation shall be made in writing to the Minister by the operator of the establishment to which the application relates and shall state whether it is an application for approval of an export dedicated establishment or an application for approval of an establishment which is not an export dedicated establishment.

(5) The Minister shall notify the applicant in writing of his decision on the application; and, if he refuses the application, he shall notify the applicant in writing of his reasons for refusal.

(6) If in relation to any establishment approved under this regulation the Minister is satisfied that-�

(a)any of the requirements of paragraph (3) above are not being complied with;

(b)the operator of the establishment has failed to give notice to the Minister as required under regulation 13(14) or (15) below; or

(c)the preparation of foreign origin export eligible goods, DBES goods or ECHS goods at the establishment in respect of which it was approved is no longer being carried on there,

he may withdraw the approval relating to that establishment and, where he does so, he shall give notice to the operator in writing that the approval is withdrawn and of the reason for withdrawing it.

Requirements imposed on the operator of an establishment approved under regulation 12

13.-(1) The operator of an establishment approved under regulation 12 above shall ensure that-�

(a)any person employed by him, or any person invited to the establishment, complies with the requirements of these Regulations relating to the approval of the establishment; and

(b)any inspector, and any person acting under the responsibility of an inspector, is provided with adequate facilities so as to enable him to carry out his functions under these Regulations in relation to the establishment and that he is given such reasonable assistance and access to such records (including any records held in electronic form) as he may at any reasonable time require for that purpose.

(2) In respect of the preparation at the establishment of any export eligible goods, that-�

(a)each stage of their preparation takes place under official supervision;

(b)where the establishment is approved as an export dedicated establishment the methods of operation for the preparation of export eligible goods comply with the requirements of the first column in Schedule 2 to these Regulations in accordance with the determination made by the Minister under regulation 12(3)(d) above as to the application of those requirements to the establishment; and

(c)where the establishment is approved as an establishment other than an export dedicated establishment the methods of operation for the preparation of foreign origin export eligible goods comply with the requirements of the first column in Schedule 3 to these Regulations in accordance with the determination made by the Minister under regulation 12(3)(e) above as to the application of those requirements to the establishment.

(3) The operator of an establishment approved under regulation 12 above shall ensure that all export eligible goods prepared there, other than-�

(a)foreign origin export eligible goods, DBES goods or ECHS goods destined for placing on the market in the United Kingdom; or

(b)food for domestic carnivores (whether or not destined for placing on the market in the United Kingdom),

are marked or labelled with an additional mark before a relevant despatch of the goods from the establishment.

(4) In paragraph (3) above a "relevant despatch" of goods is-�

(a)a despatch of the goods from the establishment for the purpose of a despatch of the goods from Great Britain to a member State or a third country;

(b)a despatch of the goods from the establishment to any establishment approved under these Regulations for the purpose of a despatch of the goods from that establishment, or subsequently from any other such establishment, from Great Britain to a member State or a third country; or

(c)a despatch of the goods from the establishment to any export dedicated establishment whether or not for the purpose of despatch from that establishment, or subsequently from any other such establishment, from Great Britain to a member State or a third country.

(5) The operator of an establishment approved under regulation 12 above shall not mark any goods with an additional mark other than those required to be so marked under paragraph (3) above.

(6) The operator of an establishment approved under regulation 12 above shall ensure that no products of animal origin derived from DBES and ECHS meat, other than export eligible goods, are produced in the establishment.

(7) The operator of an establishment approved under regulation 12 above shall ensure that all export eligible goods-�

(a)are stored in cold stores in chambers which are not used at the same time for storing any bovine products, by-products or materials which do not comply with the conditions set out in articles 6 and 7 and 9 to 13 of the Council Decision and are kept locked, under the seal of a veterinary inspector or a person acting on his authority, when any veterinary inspector or any person acting on the authority of a veterinary inspector is not present; and

(b)are despatched from the establishment in means of transport, or in a lockable chamber or lockable container for the purpose of being carried on any means of transport, sealed by a veterinary inspector or a person acting under his responsibility.

(8) The operator of an establishment approved under regulation 12 above shall ensure that all foreign origin export eligible goods or foreign origin bovine by-products are unloaded, processed or treated, stored, handled, loaded and transported separately, or at different times, from bovine products which do not comply with the conditions set out in articles 6 and 7 and 9 to 13 of the Council Decision.

(9) The operator of an establishment at which any foreign origin bovine by-products are produced shall ensure that the establishment, and the suitability of the by-products for use in human food, animal feed, cosmetics or medical or pharmaceutical products, is clearly indicated, either by means of a label affixed to the by-product, or on its packaging or in a document accompanying the by-product.

(10) The additional mark shall be applied by persons acting under the responsibility of a veterinary inspector; and no other persons shall apply the additional mark or possess or use the instruments or labels intended for applying or bearing an additional mark.

(11) No person shall produce, modify, store, sell or otherwise supply, or offer, expose or advertise for sale or supply, or consign or despatch to any other person-�

(a)an instrument intended for the application of an additional mark;

(b)any label or packaging bearing an additional mark; or

(c)an official seal,

except in accordance with the instructions of a veterinary inspector.

(12) An operator of an establishment approved under regulation 12 above shall ensure that at or before the time any instrument intended for the application of an additional mark, or any label or packaging bearing an additional mark, or any official seal, is delivered to him or to the establishment, or otherwise to his order, he notifies an inspector for the purpose of enabling any inspector or person acting under the responsibility of an inspector to put the instrument, label, packaging or official seal into a store at the establishment (maintained under the responsibility of an inspector) or (in the case of an instrument, label or packaging) to give instructions for the use of the instrument, label or packaging at the establishment.

(13) The operator of an establishment approved under regulation 12 above shall ensure, in respect of any export eligible goods prepared there which are destined for placing on the market in the United Kingdom and which bear the additional mark, that the mark is removed or cancelled at whichever of the following times is the first to occur-�

(a)the time when, for any reason other than the removal of the additional mark, the goods cease to be eligible for despatch from Great Britain to a member State or a third country in accordance with these Regulations; or

(b)the time when the goods leave the establishment.

(14) The operator of an establishment approved under regulation 12 above shall give the Minister written notice of, and shall obtain his agreement to, any material change he intends to make to any of the facilities or processes used at that establishment in the preparation of foreign origin export eligible goods, DBES goods or ECHS goods before making any such change.

(15) The operator of an establishment approved under regulation 12 above shall give the Minister written notice of any material change he intends to make-�

(a)of the suppliers of the materials used by him at the establishment in the manufacture of foreign origin bovine by-products; or

(b)of any facilities, processes or methods of operation used at that establishment in the production of any foreign origin bovine by-products,

before making any such change.

Fees

14.-(1) The Minister may charge an operator reasonable fees in respect of costs reasonably incurred by him or on his behalf in connection with-�

(a)the issue of any certificate under these Regulations, any application of an additional mark or official seal by or on behalf of an inspector appointed by him or any purchase of labels by or on behalf of such an inspector for the purpose of applying an additional mark or an official seal;

(b)the registration of an establishment under regulation 7 above;

(c)the approval of an establishment under regulation 10 or 12 above;

(d)the inspection or supervision of establishments registered or approved for the purposes of these Regulations; or

(e)carrying out official checks in relation to the eligibility of bovine animals for the purposes of the DBES.

(2) Where the Minister has notified the operator of any establishment of a fee charged for the purposes of these Regulations in respect of the establishment the operator shall pay to the Minister the amount of the fee so charged.

(3) A fee charged to an operator for the purposes of these Regulations shall be recoverable on demand by the Minister as a debt from the operator.

Powers to stop and search vehicles and vessels and detain goods

15.-(1) At any time while a vehicle or vessel is-�

(a)within the limits of or entering or leaving a port or any land adjacent to a port and occupied wholly or mainly for the purposes of activities carried on at the port;

(b)at, entering or leaving an aerodrome; or

(c)at, entering or leaving an approved wharf, transit shed, customs warehouse or free zone,

an officer or an inspector may, for the purposes of the enforcement of these Regulations, stop and search the vehicle or vessel and may inspect any commercial documents or certificate accompanying any goods carried on the vehicle or vessel.

(2) Where at any place (including any place which is referred to in paragraph (1) above) an officer or an inspector has reasonable grounds to suspect that any vehicle or vessel is or may be carrying a consignment of any goods which are-�

(a)of a kind described in regulation 3(1), 4(1) or 6(1), (4), (7) or (9) above;

(b)foreign origin export eligible goods, DBES goods or ECHS goods;

(c)controlled bovine by-products or foreign origin bovine by-products; or

(d)any part of the vertebral column of a bovine animal,

and which he reasonably suspects may be illegal, he may search that vehicle or vessel and may inspect any commercial documents or certificate accompanying any goods carried on the vehicle or vessel.

(3) Where an officer or an inspector has stopped and searched a vehicle or vessel under paragraph (1) above or has searched a vehicle or a vessel under paragraph (2) above, he may detain for not more than three working days any goods which he reasonably suspects may be illegal.

(4) Any goods detained under this regulation shall be dealt with during the period of their detention in such manner as the officer or inspector detaining the goods may direct, at the expense of the person who is or appears to be in control of the consignment.

(5) Goods for "illegal" for the purposes of this regulation if-�

(a)they are falsely described on their packaging, wrapping, label or any container in which they are placed, or in any certificate or a document accompanying them;

(b)in the case of any goods of a kind described in-�

(i)regulation 3(1), 4(1), 6(4) or (7) above, they are being brought or consigned in contravention of regulation 3(1), 4(1), 6(4) or (6) above respectively, as the case may be;

(ii)regulation 6(1) above, they have been produced in contravention of that provision;

(iii)regulation 6(9) above, there has been a contravention of regulation 6(8) above in relation to any of them;

(c)in the case of DBES goods, or ECHS goods which have undergone a stage of preparation in Great Britain, the goods-�

(i)have been prepared in contravention of any provision of these Regulations relating to the goods; or

(ii)are being or have been brought, despatched or consigned otherwise than in accordance with regulation 4(2) above (in the case of ECHS goods) or regulation 4(4) above (in the case of DBES goods);

(d)in the case of ECHS goods which have not undergone a stage of preparation in Great Britain-�

(i)they have been prepared in contravention of any provision of the Northern Ireland Regulations relating to the goods; or

(ii)they are being or have been brought, despatched or consigned in contravention of any provision of the Northern Ireland Regulations relating to the goods;

(e)in the case of foreign origin export eligible goods-�

(i)they have been prepared in contravention of any provision of these Regulations relating to the goods; or

(ii)they are being or have been brought, despatched or consigned in contravention of regulation 5(1) or 6(5) above;

(f)in the case of controlled bovine by-products, they were produced in contravention of regulation 7 above;

(g)in the case of foreign origin bovine by-products-�

(i)they have been produced in contravention of any provision of these Regulations relating to such by-products; or

(ii)they are being or have been brought, despatched or consigned in contravention of regulation 5(2) above; or

(h)in the case of vertebral column of a bovine animal, the goods are not in an impervious container clearly labelled in accordance with regulation 6(3) above.

(6) For the purposes of paragraph (1) above a "port", an "aerodrome", an "approved wharf", "transit shed", "customs warehouse" and "free zone" have the same meanings as they respectively have in the Customs and Excise Management Act 1979(16).

Powers of entry

16.-(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 premises (excluding premises used only as a dwelling) for the purpose of ascertaining whether-�

(a)there is or has been on the premises any contravention of any provisions of these Regulations; or

(b)there is on the premises any evidence of any contravention of any provisions of these Regulations.

(2) If a justice of the peace, on sworn information in writing is satisfied that there is reasonable ground for entry into any premises (excluding premises used only as a dwelling) for any such purpose as is mentioned in paragraph (1) above and that either-�

(a)admission to the premises has been refused, or a refusal is apprehended, and that notice of the intention to apply for a warrant has been given to the occupier; or

(b)an application for admission, or the giving of such a notice, would defeat the object of the entry, or that the case is one of urgency, or that the premises are unoccupied or the occupier temporarily absent,

the justice may by warrant signed by him authorise an inspector to enter the premises, if need be by reasonable force.

(3) In the application of this regulation to Scotland any reference to a justice of the peace includes a reference to the sheriff and to a magistrate.

Seizure of illegal goods

17.-(1) Where an inspector has a reasonable suspicion that a consignment of any-�

(a)goods of a kind described in regulation 3(1), 4(1), 6(1), (4), (7) or (9) above;

(b)foreign origin export eligible goods, DBES goods or ECHS goods;

(c)controlled bovine by-products or foreign origin bovine by-products; or

(d)any part of the vertebral column of a bovine animal,

is illegal, he may require the person in control of any commercial documentation or certificate accompanying the consignment to deliver that documentation or certificate and any copies to him on demand.

(2) Where an inspector exercises the power conferred by paragraph (1) above or where, otherwise than in relation to the exercise of that power he has such a suspicion in respect of any such consignment, he may, in respect of the consignment or any part of it-�

(a)give notice that, until the notice is withdrawn, it may not be removed or may not be removed except to some place specified in the notice;

(b)give notice that it must be removed at the expense of the person who is or appears to be in control of the consignment to some place specified in the notice and kept there at that person's expense until the notice is withdrawn or an order is made under paragraphs (6) or (7) below; or

(c)seize it and remove it in order to have it dealt with by a justice of the peace.

(3) Where an inspector exercises the power conferred by paragraph (2) above, he shall as soon as is reasonably practicable, and in any event within the period of 21 days beginning on the day on which he exercises that power, determine whether he is satisfied that the consignment is not illegal.

(4) Where the inspector is satisfied that the consignment is not illegal, he shall-�

(a)return any certificate or commercial documentation which has been delivered to him;

(b)withdraw any notice given pursuant to paragraph (2)(a) or (b) above relating to the consignment; and

(c)return anything which he has seized and which, in the case of food, is not unfit for human consumption.

(5) Where the inspector is satisfied that the consignment is illegal, he shall inform the person in charge of the consignment of his intention to have it dealt with by a justice of the peace and-�

(a)any person who may be liable for prosecution in respect of the consignment shall, if he attends 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 any offence in relation to the consignment.

(6) If it appears to a justice of the peace, on the basis of such evidence as he considers to be appropriate in the circumstances, that a consignment is illegal, he shall, unless he is satisfied that there is no relevant risk in respect of the consignment (or any part of it) if it is returned to the owner, order-�

(a)the consignment to be destroyed or otherwise disposed of so as to prevent it from being despatched to a member State or a third country; and

(b)any expenses reasonably incurred in connection with such destruction or disposal and (where the consignment was seized pursuant to paragraph (2)(c) above) in connection with storage prior to destruction, to be defrayed by the owner of the consignment.

(7) Where the justice of the peace is satisfied that there is no relevant risk in respect of the consignment if it is returned to the owner, he shall order the consignment to be returned to the owner.

(8) For the purposes of paragraphs (6) and (7) above, the "relevant risk" in respect of a consignment is the risk that-�

(a)in the case of a consignment of any goods of a kind described in-�

(i)regulation 3(1), 4(1), 6(4) or (7) above, the owner will despatch some or all of those goods to a member State or a third country;

(ii)regulation 6(1) above, the owner will produce goods in contravention of that provision;

(iii)regulation 6(9) above, the owner will contravene regulation 6(8) above in relation to any of them;

(b)in the case of a consignment of foreign origin export eligible goods, DBES goods or ECHS goods or foreign origin bovine by-products, the owner will despatch some or all of those goods to a member State or a third country;

(c)in the case of a consignment of controlled bovine by-products, the owner will use some or all of those by-products in any product liable to enter the human food chain or animal feed chain or in any cosmetics or medical or pharmaceutical product; or

(d)in the case of vertebral column of a bovine animal, the owner will consign some or all of that material in contravention of regulation 6(3) above.

(9) A consignment is "illegal" for the purposes of this regulation if-�

(a)it is falsely described on its packaging, wrapping, label or any container in which it is placed, or in any certificate or commercial documentation accompanying it;

(b)in the case of a consignment of any goods of a kind described in-�

(i)regulation 3(1), 4(1), 6(4) or (7) above, they are being brought or consigned in contravention of regulation 3(1), 4(1), 6(4) or (6) above respectively, as the case may be;

(ii)regulation 6(1) above, they have been produced in contravention of that provision;

(iii)regulation 6(9) above, there has been a contravention of regulation 6(8) above in relation to any of them;

(c)in the case of a consignment of DBES goods, or a consignment of ECHS goods which have undergone a stage of preparation in Great Britain, the goods-�

(i)have been prepared in contravention of any provision of these Regulations relating to the goods; or

(ii)are being or have been brought, despatched or consigned in contravention of regulation 4(2) above (in the case of ECHS goods) or regulation 4(4) above (in the case of DBES goods);

(d)in the case of a consignment of ECHS goods which have not undergone a stage of preparation in Great Britain-�

(i)they have been prepared in contravention of any provision of the Northern Ireland Regulations relating to the goods; or

(ii)they are being or have been brought, despatched or consigned in contravention of any provision of the Northern Ireland Regulations relating to the goods;

(e)in the case of a consignment of foreign origin export eligible goods-�

(i)it contains goods prepared in contravention of any provision of these Regulations relating to the goods; or

(ii)it contains goods which are being or have been brought, despatched or consigned in contravention of regulation 5(1) or 6(5) above;

(f)in the case of a consignment of controlled bovine by-products, it contains goods produced in contravention of regulation 7 above;

(g)in the case of a consignment of foreign origin bovine by-products-�

(i)it contains by-products prepared in contravention of any provision of these Regulations relating to such by-products; or

(ii)it contains by-products which are being or have been brought, despatched or consigned in contravention of regulation 5(2) above; or

(h)in the case of a consignment of vertebral column of a bovine animal, the goods are not in an impervious container clearly labelled in accordance with regulation 6(3) above.

(10) In the application of this regulation to Scotland-�

(a)any reference to a justice of the peace includes a reference to the sheriff and to a magistrate;

(b)paragraph (5)(b) above shall not apply; and

(c)any order made under paragraph (6) above shall be sufficient evidence in any proceedings in relation to these Regulations of the fact that the consignment in question was falsely described.

Sampling and other checks and examinations

18.-(1) An inspector shall have power to carry out all checks and examinations necessary for the enforcement of these Regulations.

(2) An inspector may-�

(a)take samples (and, if necessary, send the samples for laboratory testing) from any goods, product, by-product or material;

(b)examine any record (including any record held in electronic form) which he believes to be relevant to any checks and examinations under these Regulations;

(c)seize, detain and require the production of any such record which he has reason to believe may be required as evidence in proceedings under any of the provisions of these Regulations;

(d)take with him such other person as he considers necessary to carry out any checks and examinations under these Regulations;

(e)require any person who is or appears to be in control of any goods of a kind described in regulation 3(1) or 4(1) above, or any foreign origin export eligible goods, DBES goods or ECHS goods, controlled bovine by-products, foreign origin bovine by-products, or any goods, products, by-products or material of a kind described in regulation 6 above, to arrange, at his own expense, for those goods, products, by-products or material to be removed from any store, vehicle, vessel, container, packing or wrapping;

(f)inspect any process or operation carried out under these Regulations and anything used for the marking and identification of products and materials; and

(g)take with him a representative of the Commission acting for the purposes of the Commission.

Powers of customs officers to detain vehicles and vessels

19.-(1) An officer may, for the purpose of facilitating the exercise by any inspector of the powers conferred on the inspector by these Regulations, detain any vehicle or vessel for such period as may reasonably be necessary for that purpose.

(2) Any vehicle or vessel detained by an officer under this regulation shall be dealt with during the period of its detention in such manner as the officer may direct.

Suspension notices and orders

20.-(1) If an inspector is satisfied that the despatch risk is fulfilled with respect to a consignment on business premises of any goods, products, by-products or material of a kind described in regulation 3(1), 4(1) or 6 above, any controlled bovine by-products or foreign origin bovine by-products, or any foreign origin export eligible goods, DBES goods or ECHS goods, he may, by a notice served on the proprietor of the business (a "suspension notice"), impose a suspension of the use of the premises for-�

(a)the despatch of those goods, products, by-products or material for any purpose in relation to the despatch risk; and

(b)the receipt or despatch for any such purpose of any other goods, products, by-products or material of a similar kind.

(2) If a magistrates' court or, in Scotland, the sheriff is satisfied, on the application of an inspector, that the despatch risk is fulfilled with respect to a consignment on business premises of any such goods, products, by-products or material of a kind referred to in paragraph (1) above, the court or sheriff shall, by an order (a "suspension order"), impose a suspension of the use of the premises for-�

(a)the despatch of those goods, products, by-products or material; and

(b)the receipt or despatch of any other goods, products, by-products or material of a similar kind.

(3) An inspector shall not apply for a suspension order unless, at least one day before the date of the application, he has served notice on the proprietor of the business of his intention to apply for the order.

(4) As soon as practicable after the service of a suspension notice, an inspector shall affix a copy of the notice in a conspicuous position on such premises used for the purpose of the business as the inspector considers appropriate.

(5) As soon as reasonably practicable after the making of a suspension order, an inspector shall-�

(a)serve a copy of the order on the proprietor of the business; and

(b)affix a copy of the order in a conspicuous position on such premises used for the purpose of that business as the inspector considers appropriate.

(6) A suspension notice shall cease to have effect-�

(a)if no application for a suspension order is made within the period of three days beginning with the service of the notice, at the end of that period; and

(b)if such an application is so made, on the determination or abandonment of the application.

(7) A suspension notice or suspension order shall cease to have effect on the issue by the Minister of a certificate to the effect that he is satisfied that the proprietor has taken sufficient measures to secure that the despatch risk is no longer fulfilled with respect to the use of the premises for the receipt and despatch of goods, products, by-products or material.

(8) The Minister shall issue a certificate under paragraph (7) above within three days of his being satisfied as mentioned in that paragraph; and on an application by a proprietor for such a certificate, the Minister shall-�

(a)determine, as soon as is reasonably practicable and in any event within the period of 14 days beginning on the day on which the proprietor makes that application, whether or not he is so satisfied; and

(b)if he determines that he is not so satisfied, give notice to the proprietor of the business of the reasons for that determination.

(9) Where a suspension notice is served on the proprietor of a business, the Minister shall compensate him in respect of any loss suffered by reason of his complying with the notice unless-�

(a)an application for a suspension order is made within the period of three days beginning with the service of the notice; and

(b)the court declares itself satisfied, on the hearing of the application, that the despatch risk was fulfilled with respect to the business at the time when the notice was served;

and any disputed question as to the right to or the amount of any compensation payable under this paragraph shall be determined by arbitration or, in Scotland, by a single arbiter appointed, failing agreement between the parties, by the sheriff.

(10) For the purposes of this regulation, the "despatch risk" in respect of a consignment of goods, products, by-products or material is the risk that some or all of those goods, products, by-products or material will be despatched to a member State or a third country.

Obstruction

21.-(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 of him for the purpose of carrying out 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.

Offences and penalties

22.-(1) No person shall slaughter a bovine animal, for the purpose of deriving from the animal any DBES goods, otherwise than in an establishment approved for the slaughter of DBES eligible animals under regulation 10 above.

(2) No person shall slaughter a bovine animal, for the purpose of deriving from the animal any DBES goods, unless the animal is a DBES eligible animal at the time of slaughter.

(3) A person contravening or failing to comply with paragraph (1) or (2) above, or with any other provision of these Regulations, shall be guilty of an offence and shall be liable-�

(a)on summary conviction to a fine not exceeding the statutory maximum or to imprisonment for a term 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.

(4) 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 person of the body corporate, or

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

he, as well as the body corporate, shall be guilty of the offence and shall be liable to be proceeded against and punished accordingly.

(5) 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.

(6) Where an offence under these Regulations which has been committed by a Scottish partnership is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of, a partner, he as well as the partnership shall be guilty of the offence and shall be liable to be proceeded against and punished accordingly.

Offences due to fault of another person and defence of due diligence

23.-(1) Where the commission by any person of an offence under any of the provisions of these Regulations is due to the act or default of some other person, that other person shall be guilty of the offence; and a person may be charged with and convicted of the offence by virtue of this paragraph of this regulation whether or not proceedings are taken against the first-mentioned person.

(2) In any proceedings for an offence under any of the provisions of these Regulations, it shall, subject to paragraph (3) below, be a defence for the person charged to prove that he took all reasonable precautions and exercised all due diligence to avoid the commission of the offence by himself or by a person under his control.

(3) If in any case the defence provided by paragraph (2) above involves the allegation that the commission of the offence was due to an act or default of another person, or to reliance on information supplied by another person, the person charged shall not, without leave of the court, be entitled to rely on that defence unless-�

(a)at least seven clear days before the hearing; and

(b)where he has previously appeared before a court in connection with the alleged offence, within one month of his first such appearance,

he has served on the prosecutor a notice in writing giving such information identifying or assisting in the identification of that other person as was then in his possession.

(4) In paragraph (3) above any reference to appearing before a court shall be construed as including a reference to being brought before a court.

Enforcement

24.-(1) Except as provided in paragraph (2) below, these Regulations shall be enforced and executed by the Minister and the local authority.

(2) The Minister may direct, in relation to cases of a particular description or any particular case, that the duty imposed on a local authority under this regulation shall be discharged by the Minister and not by the local authority.

Service of notices and other documents

25.-(1) Any notice or other document to be given or served on any person under these Regulations may be given or served either-�

(a)by delivering it to that person;

(b)in the case of an incorporated body, by delivering it to their secretary or clerk at their registered or principal office, or by sending it by post to him at that office; or

(c)in the case of any other person, by leaving it, or sending it by post to him, at his usual or last known address.

(2) Where a notice or other document is to be given or served on the owner, proprietor, operator or occupier of any premises and it is not practicable after reasonable enquiry to ascertain the name and address of the person to or on whom it should be given or served, or the premises are unoccupied, the document may be given or served by addressing it to the person concerned by the description of "owner", "proprietor", "operator" or "occupier" of the premises (naming them) and-�

(a)by delivering it to some person on the premises; or

(b)if there is no person on the premises to whom it can be delivered, by affixing it, or a copy of it, to some conspicuous part of the premises.

Revocation of the Bovines and Bovine Products (Trade) Regulations 1998 and savings provisions

26.-(1) The Bovines and Bovine Products (Trade) Regulations 1998 are hereby revoked.

(2) Any registration or approval of premises under the Bovines and Bovine Products (Trade) Regulations 1998 which is in force immediately before the commencement of these Regulations shall have effect from the commencement of these Regulations as if granted under these Regulations.

(3) Any appointment of an inspector or veterinary inspector under the Bovines and Bovine Products (Trade) Regulations 1998 which is in force immediately before the commencement of these Regulations shall have effect from the commencement of these Regulations as if made under these Regulations.

Regulation 10(3)(d)

SCHEDULE 1Required methods of operation for DBES slaughterhouses

Regulations 10(3)(e)(ii) and 12(3)(d)

SCHEDULE 2Required methods of operation for the preparation of export eligible goods in export dedicated establishments

Regulation 12(3)(e)

SCHEDULE 3Required methods of operation for the preparation of foreign origin export eligible goods in establishments which are not export dedicated establishments

Regulations 2(1) and 13(3), (4), (5), (10), (11), (12) and (13)

SCHEDULE 4Additional Mark for foreign origin export eligible goods

1. The additional mark for application to meat using a marking instrument shall consist of an elongated hexagonal mark, with two parallel straight sides of 4.5 cm length, 4.5 cm apart and joined by two shorter sides of equal length to form a point at each end, so that the mark is 8.5 cm long from point to point; bearing on the upper part the initials XAP and in the lower part the approval number of the establishment at which the mark is applied, e.g. 31/1, the letters and figures being at least 1.0 centimetre high and, together with the hexagonal mark, legible and indelible.

An example follows:

2.-(1) The additional mark to be borne on labels to be applied to packaging, other than the additional marks described in paragraphs 3 and 4 below, shall consist of a mark in the form described in paragraph 1 of this Schedule together with the following statement "the contents of this package/box were produced in accordance with Council Decision 98/256/EC"; and each such label shall have a unique sequential serial number.

(2) Labels bearing the additional mark must be applied in such a way that they are destroyed when the package is opened or the packaging must be constructed so that it may not be re-used once opened.

3.-(1) The additional mark to be borne on labels to be applied to the wrapper of an individually wrapped product, or the packaging of an individually wrapped and packaged product, intended for supply direct to the final consumer shall, subject to the following provisions of this paragraph, consist of a mark in the form described in paragraph 1 of this Schedule; and each such label shall have a unique sequential serial number.

(2) The dimensional requirements relating to size described in paragraph 1 above shall not apply and the statement "the contents of this package/box were produced in accordance with Council Decision 98/256/EC" is not required.

(3) Labels bearing the additional mark must be applied in such a way that it is destroyed when the package is opened or the packaging must be constructed so that it may not be re-used once opened.

4.-(1) The additional mark to be applied by pre-printing, ink stamping or branding to the wrapper of an individually wrapped product, or the packaging of an individually wrapped and packaged product, intended for supply direct to the final consumer, shall, subject to the following provision of this paragraph, consist of a mark in the form described in paragraph 1 of this Schedule.

(2) The dimensional requirements relating to size described in paragraph 1 of this Schedule shall not apply, the statement "the contents of this package/box were produced in accordance with Council Decision 98/256/EC" and the sequential serial numbering referred to in paragraphs 2(1) and 3(1) of this Schedule are not required; but the mark must be applied in such a way that it is destroyed when the wrapper or package is opened or the wrapper or packaging must be constructed so that it may not be re-used once opened.

Regulations 2(1), 11(2), (3), (4), (5), (6), (7) and (8) and 13(3), (4), (5), (10), (11), (12) and (13)

SCHEDULE 5Additional Mark for DBES goods, ECHS goods prepared in Great Britain, goods containing any DBES goods or ECHS goods (whether or not prepared in Great Britain), or foreign origin export eligible goods consisting of, or derived from, fresh meat which has been deboned and from which all adherent tissues, including obvious nervous and lymphatic tissues, have been removed

1.-(1) The additional mark for application to meat using a marking instrument shall consist of an elongated hexagonal mark, with two parallel straight sides of 4.5 cm length, 4.5 cm apart and joined by two shorter sides of equal length to form a point at each end, so that the mark is 8.5 cm long from point to point; bearing on the upper part the initials XEL and in the lower part the approval number of the establishment at which the mark is applied, e.g. 31/1, the letters and figures being at least 1.0 centimetre high and, together with the hexagonal mark, legible and indelible. An example follows:

(2) The additional mark to be applied to carcases shall consist of a mark in the form described in paragraph 1(1) of this Schedule applied by means of ink or hot brand to each half of the carcase on the external surface of the thigh and the shoulder.

2.-(1) The additional mark to be borne on labels to be applied to packaging, other than the additional marks described in paragraphs 3 and 4 below, shall consist of a mark in the form described in paragraph 1(1) of this Schedule together with the following statement "the contents of this package/box were produced in accordance with Council Decision 98/256/EC"; and each such label shall have a unique sequential serial number.

(2) Labels bearing the additional mark must be applied in such a way that they are destroyed when the package is opened or the packaging must be constructed so that it may not be re-used once opened.

3.-(1) The additional mark to be borne on labels to be applied to the wrapper of an individually wrapped product, or the packaging of an individually wrapped and packaged product, intended for supply direct to the final consumer shall, subject to the following provisions of this paragraph, consist of a mark in the form described in paragraph 1 of this Schedule; and each such label shall have a unique sequential serial number.

(2) The dimensional requirements relating to size described in paragraph 1(1) above shall not apply and the statement "the contents of this package/box were produced in accordance with Council Decision 98/256/EC" is not required.

(3) Labels bearing the additional mark must be applied in such a way that it is destroyed when the package is opened or the packaging must be constructed so that it may not be re-used once opened.

4.-(1) The additional mark to be applied by pre-printing, ink stamping or branding to the wrapper of an individually wrapped product, or the packaging of an individually wrapped and packaged product, intended for supply direct to the final consumer, shall, subject to the following provision of this paragraph, consist of a mark in the form described in paragraph 1 of this Schedule.

(2) The dimensional requirements relating to size described in paragraph 1(1) of this Schedule shall not apply, the statement "the contents of this package/box were produced in accordance with Council Decision 98/256/EC" and the sequential serial numbering referred to in paragraphs 2(1) and 3(1) of this Schedule are not required; but the mark must be applied in such a way that it is destroyed when the wrapper or package is opened or the wrapper or packaging must be constructed so that it may not be re-used once opened.

Regulations 2(1), 6(4) and (5)(b), 11(6) and (7) and 13(11) and (12)

SCHEDULE 6Official seal

1. An official seal for purposes of official control under these Regulations shall-�

(a)be manufactured from a material which ensures that means of transport and cold store chambers can be locked and sealed so that products cannot be added or removed without breaking the seal;

(b)be tamperproof; and

(c)bear the capital letters-�

(i)XAP (in respect of an official seal for an establishment other than an export dedicated establishment); or

(ii)XAPD (in respect of an official seal for an export dedicated establishment)

followed by the approval number of the establishment at which or in relation to which the seal will be applied, followed by a unique serial number.

2. The letters and numbers required by paragraph 1(c) above shall be embossed on an official seal, or indelibly applied to it, at the time when the seal is manufactured.

Explanatory Note

(This note is not part of the Regulations)

These Regulations replace the Bovines and Bovine Products (Trade) Regulations 1998 (S.I. 1998 No. 1135). They give effect in Great Britain to Commission Decisions 98/692/EC (OJ No. L328, 4.12.98, p. 28) and 98/564/EC (OJ No. L273, 9.10.98, p. 37) which amended Council Decision 98/256/EC (OJ No. L113, 15.4.98, p. 32) concerning emergency measures to protect against bovine spongiform encephalopathy in relation to the despatch to third countries and member States of bovine animals and embryos and meat and other products and by-products derived from bovine animals.

Together with equivalent Regulations in Northern Ireland, the Regulations make new provision for derogations from the despatch abroad prohibitions contained in the Council Decision in respect of the United Kingdom meat and products eligible for the Date Based Export Scheme (DBES). The Regulations also continue with the equivalent Northern Ireland Regulations to make provision for the preparation and despatch abroad of meat and products eligible for the Export Certified Herds Scheme (ECHS) and the despatch abroad of meat, products and by-products produced in Great Britain from imported beef. The Regulations continue the existing controls on products and by-products produced from UK-slaughtered bovine animals.

Regulation 2 contains definitions and these include a definition of "additional mark" which has to be applied to goods for despatch abroad. Regulation 3 makes provision in relation to trade in live bovine animals, bovine embryos, mammalian meat and bone meal and related products. Regulation 4 makes provision in relation to trade in meat, products, by-products and materials derived from bovine animals slaughtered in the United Kingdom. Regulation 5 makes provision in relation to trade in meat, products, by-products and materials derived from bovine animals not slaughtered in the United Kingdom.

Regulation 6 makes provision in relation to the production of gelatin and collagen, the consignment of material containing bovine vertebral column to establishments registered under regulation 7, the despatch abroad and consignment and movement for that purpose of imported fresh meat, the consignment of export eligible goods in officially sealed vehicles and the consignment and movement of the imported products and by-products referred to in articles 5 and 8(e) of the Council Decision. Regulation 6(10) prohibits the placing on the market in Great Britain of fresh meat, minced meat, meat preparations, meat products or other products of animal origin which bear, or are labelled or packaged with, an additional mark.

Regulation 7 makes provision for the registration of establishments for the production of controlled bovine by-products and regulation 8 imposes requirements on the operators of these establishments. Regulation 9 makes provision in relation to the use of controlled bovine by-products and other products in the production of products liable to enter the human food or animal feed chains or destined for use in cosmetics, medical or pharmaceutical products.

Regulation 10 provides for the approval of establishments for the slaughter of DBES eligible animals and regulation 11 imposes requirements on the operators of establishments approved under regulation 10. Regulation 12 makes provision for the approval of establishments used for the production of foreign origin export eligible goods, DBES goods and ECHS goods and foreign origin bovine by-products. Regulation 13 imposes requirements on the operators of establishments approved under regulation 12.

Regulation 14 makes provision for the Minister to charge reasonable fees in respect of costs reasonably incurred by him or on his behalf in connection with the issue of certificates, the application of the additional mark and official seals, the registration and approval of establishments, the inspection or supervision of establishments registered or approved under the Regulations and the carrying out of official checks in relation to the eligibility of bovine animals for the purposes of the DBES.

Regulation 15 makes provision in relation to powers of search and powers of stop and search. Regulation 16 provides powers of entry to premises. Regulation 17 provides power to seize goods. It also makes provision for the destruction of a consignment of goods where there is a risk of them being dealt with illegally. Regulation 18 provides for sampling and other checks and examinations. Regulation 19 confers power on customs officers to detain vehicles and vessels. Regulation 20 makes provision for suspension notices and orders, suspending the use of business premises for the receipt or despatch of the goods and by-products referred to in regulation 20(1).

Regulation 21 provides offences of obstruction. Regulation 22 provides for offences and penalties. Regulation 23 makes provision for offences due to the fault of another person and the defence of due diligence. Regulation 24 provides that the Regulations are enforced by the Minister and local authorities, as defined in regulation 2(1), and regulation 25 makes provision for the service of notices and other documents. Regulation 26 revokes the Bovines and Bovine Products (Trade) Regulations 1998 and makes savings provisions.

Schedule 1 sets out the required methods of operation for DBES slaughterhouses. Schedule 2 sets out the required methods of operation for the preparation of export eligible goods in export dedicated establishments. Schedule 3 sets out the required methods of operation for the preparation of foreign origin export eligible goods in establishments which are not export dedicated establishments. Schedule 4 makes provision for the additional mark for foreign origin export eligible goods and Schedule 5 makes provision for the additional mark for DBES goods, ECHS goods prepared in Great Britain, goods containing any DBES goods or ECHS goods (whether or not prepared in Great Britain), or foreign origin export eligible goods consisting of, or derived from, fresh meat which has been deboned and from which all adherent tissues, including obvious nervous and lymphatic tissues, have been removed. Schedule 6 makes provision for official seals.

A Regulatory Impact Assessment has been prepared and placed in the library of each House of Parliament. Copies can be obtained from the International Trade Unit of the Animal Health (BSE) Division of the Ministry of Agriculture, Fisheries and Food, Government Buildings, Hook Rise South, Tolworth, Surbiton, Surrey KT6 7NF.