Regulation 7 Approval of establishments for the preparation of relevant goods
No person shall use any premises—
for any stage of preparation of any type of XAP relevant goods which are destined for despatch to another member State or a third country; or
for the production of any relevant goods of a type referred to in paragraph (e) of the definition of relevant goods in regulation 2(1) above (whether or not those goods are destined for despatch to another member State or a third country),
unless those premises are approved by the Minister under this regulation for the preparation of relevant goods of that type.
The Minister on an application made to him for the approval of an establishment under this regulation—
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
shall refuse to approve that establishment if he is not so satisfied.
The requirements for the approval of an establishment under this regulation are—
there is in operation at the establishment a system which ensures it is possible to identify the origin of the raw material contained in any relevant goods despatched from that establishment and to trace that raw material through each stage of preparation of the goods at the establishment;
there is in operation at the establishment a system for recording all amounts of incoming and outgoing materials, which ensures it is possible to cross-check consignments entering or leaving the establishment;
that all relevant goods are unloaded, processed or treated, stored, handled, loaded and transported separately, or at different times, from products which do not comply with the conditions set out in articles 9, 10, 11, 12 and 13 of the Council Decision;
in respect of the preparation at the establishment of any XAP relevant goods, that—
they are unloaded, stored, handled and loaded under official supervision;
the methods of operation comply with the requirements in Schedule 1 to these Regulations;
they 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 9, 10, 11, 12 and 13 of the Council Decision and are kept locked under the seal of a veterinary inspector when he is not present; and
they are transported in means of transport sealed by a veterinary inspector or a person acting under his responsibility;
in respect of the preparation at the establishment of any relevant goods other than relevant goods of a type referred to in paragraphs (d) or (e) of the definition of “relevant goods” in regulation 2(1) above, and subject to paragraph (f) below, that they are marked or labelled with the additional mark; and
that any relevant goods prepared at the establishment which are destined for placing on the market in the United Kingdom do not bear the additional mark or, if they do, that it is removed or cancelled in accordance with paragraph (11) below.
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.
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.
In approving an establishment under this regulation the Minister shall determine how the requirements set out in Schedule 1 to these Regulations are to apply to the establishment, as indicated in that Schedule.
The operator of an establishment approved under this regulation shall ensure that all relevant goods prepared there, other than—
relevant goods of a type referred to in paragraphs (d) and (e) of the definition of relevant goods in regulation 2(1) above; or
relevant goods destined for placing on the market in the United Kingdom,
are marked or labelled with the additional mark at the time they are prepared.
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.
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—
an instrument intended for the application of the additional mark;
any label or packaging bearing an additional mark; or
an official seal,
except in accordance with the instructions of an inspector.
An operator of an establishment approved under this regulation shall ensure that at the time any instrument, label, packaging or 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.
The operator of an establishment approved under this regulation shall ensure, in respect of any relevant 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—
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 in accordance with these Regulations; or
the time when the goods leave the establishment.
The operator of an establishment approved under this regulation shall ensure that—
any person employed by him, or any person invited to the establishment, complies with the requirements of this regulation relating to the approval of the establishment;
at each stage of the preparation of any type of relevant goods at the establishment the requirements of these Regulations relating to the preparation of relevant goods of that type at the establishment are complied with there; and
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.
The operator of an establishment approved under this regulation shall give the Minister written notice of, and shall obtain his agreement to, any material change he intends to make—
to any of the required methods of operation at the establishment in relation to which it has been approved; or
to any facilities or processes used at that establishment in the preparation of relevant goods,
before making any such change.
Where, in relation to any establishment approved under this regulation the Minister is satisfied that—
any requirement in relation to the approval of the establishment has not been complied with;
the operator of the establishment has failed to give notice to the Minister as required under paragraph (13) above; or
the preparation of relevant goods at the establishment in respect of which it was approved is no longer being carried on there,
the Minister 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.