Statutory Instruments 1999 No.

Statutory Instruments 1999 No.
The Bovine and Bovine Products (Trade) Regulations 1999 - continued

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-

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-

(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[

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[

(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)-

    (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-

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-

(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-

(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-

(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-

(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-

    (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.

Notes:

[14] S.I. 1998/1135.back

[15] S.I. 1995/539, to which there are amendments not relevant to these Regulations.back



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