The Feedingstuffs (Zootechnical Products) Regulations 1999

PART III APPROVAL OF ESTABLISHMENTS LOCATED IN THE UNITED KINGDOM

Applications for the approval of establishments

10.—(1) An eligible person may apply to the enforcement authority to approve an establishment as an establishment on which one or more of the following activities may be exercised—

(a) the manufacture of a zootechnical additive with a view to putting it into circulation;

(b) the manufacture of a zootechnical premixture with a view to putting it into circulation;

(c) the manufacture of a zootechnical compound feedingstuff with a view to putting it into circulation;

(d) the production of a zootechnical compound feedingstuff for the exclusive requirements of the applicant’s holding; and

(e) the manufacture of a zootechnical compound feedingstuff using a minimum proportion of 0.05% by weight of a premixture.

(2)  An application made under paragraph (1) shall be in writing, in the English langauge, (or, where the establishment in respect of which the application is made is situated wholly or partly in Wales, in either that language or the Welsh language) signed by or on behalf of the applicant, and shall contain the name (or business name) and address of the applicant, shall specify each activity in relation to which the application is made, and shall be accompanied by particulars which seek to demonstrate that the establishment meets the applicable minimum conditions laid down in the Annex to Directive 95/69/EC.

Approval of establishments

11.—(1) Where an application is made under regulation 10 or 12, the enforcement authority shall (subject to regulation 15)—

(a) check by means of an on the spot verification whether the establishment meets the applicable minimum conditions laid down in the Annex to Directive 95/69/EC, and

(b) process the application in accordance with the requirements of the second paragraph of Article 4.1 or the second paragraph of Article 4.2 of Directive 95/69/EC as applicable.

(2) Where the enforcement authority is satisfied that, in respect of the relevant establishment activity, the establishment meets the applicable minimum conditions laid down in the Annex to Directive 95/69/EC, it shall approve the establishment as an establishment on which the relevant establishment activity may be exercised, and register the establishment on the register of approved establishments in accordance with Article 5.1 of Directive 95/69/EC, as read with Articles 8 and 9 of, and the Annex to, Directive 98/51/EC, as being an approved establishment on which the relevant establishment activity may be exercised.

Amendment of approvals

12.—(1) An eligible person may apply to the enforcement authority to approve an approved establishment as an establishment on which a further establishment activity (“the new establishment activity”) may be exercised—

(a) in addition to an establishment activity in respect of which the establishment is already approved, or

(b) instead of that activity.

(2)  Where an application complying with regulation 10(2) is made under paragraph (1), the enforcement authority shall (subject to regulation 15) amend the approval relating to the establishment, and approve the establishment as an establishment on which the new establishment activity may be exercised, if, following the procedure in regulation 11(1), it is satisfied that, in respect of the new establishment activity, the establishment meets the applicable minimum conditions laid down in the Annex to Directive 95/69/EC.

(3) Where, pursuant to paragraph (2), the enforcement authority amends an approval relating to an approved establishment, it shall update the register of approved establishments to show all the establishment activities that may be exercised on the approved establishment.

Withdrawal of approvals

13.—(1) The enforcement authority shall withdraw an approval relating to the exercise of an establishment activity on an approved establishment if it is satisfied that the exercise of that activity on the establishment has ceased.

(2) The enforcement authority shall withdraw an approval relating to the exercise of an establishment activity on an approved establishment if, following the procedure in regulation 14, it is not satisfied that the person exercising the relevant activity on the establishment is complying with the duties imposed on him by regulations 34, 50, 62 or 64 as the case may be.

(3) Where, pursuant to paragraph (1) or (2), the enforcement authority withdraws an approval relating to the exercise of an establishment activity on an approved establishment, it shall update the register of approved establishments—

(a) to show any remaining establishment activity that may continue to be exercised on the approved establishment, or

(b) by removing the establishment from the register where, as a result of withdrawing the approval relating to the exercise of the relevant establishment activity, the establishment is no longer approved as an establishment on which an establishment activity of any sort may be exercised.

Procedure relating to the withdrawal of approvals

14.—(1) Where the enforcement authority proposes to withdraw an approval relating to the exercise of an establishment activity on an approved establishment because it is not satisfied that the person exercising the activity on the establishment is complying with the duties imposed on him by regulation 34, 50, 62 or 64, as the case may be, the enforcement authority shall not withdraw the approval unless—

(a) it serves a notice complying with the requirements of paragraph (2) on that person (“the recipient of the notice”), and

(b) it is not satisfied, after the time for compliance with the notice has expired, that the recipient of the notice has complied with the requirements specified in the notice.

(2) A notice served by the enforcement authority under paragraph (1) shall—

(a) state that it proposes to withdraw the approval of the establishment relating to the relevant establishment activity because it is not satisfied that the recipient of the notice is complying with the duties imposed on him by regulation 34, 50, 62 or 64 as the case may be;

(b) specify—

(i) the essential conditions that the enforcement authority is not satisfied that the recipient of the notice is complying with; and

(ii) the requirements that the recipient of the notice must comply with in order to satisfy the enforcement authority as to compliance with those essential conditions; and

(c) specify that, unless it is satisfied that the recipient of the notice has complied with the requirements specified in the notice within such reasonable time as is specified in the notice, the approval of the establishment insofar as it relates to the relevant establishment activity will be withdrawn.

Fees

15.—(1) In this regulation, “the relevant fee”, in relation to any application, means the fee specified opposite the application in question in Part II of Schedule 3, and (subject to paragraphs (5) to (11)) it shall be payable by a person who applies to the enforcement authority under regulation 10 or 12 to approve an establishment as an establishment on which an establishment activity may be exercised.

(2) Any fee payable under paragraph (1) shall be paid at the time the application is submitted to the enforcement authority.

(3) Any unpaid sum due by way of a fee payable under paragraph (1), or any part of such fee, shall be recoverable as a debt.

(4) Where any fee is payable under paragraph (1) in relation to any application, the enforcement authority need not process any application under regulation 10 or 12, unless the application is accompanied by that fee.

(5) Where an eligible person applies to the enforcement authority under regulation 10 for an establishment to be approved and in his application seeks approval to exercise more than one establishment activity, such person shall be liable to pay only one fee and, where the amount of the relevant fee differs according to establishment activity, the fee payable shall be the highest.

(6) Where an eligible person applies to the enforcement authority under regulation 10 for an establishment to be approved as an establishment on which an establishment activity may be exercised and, in relation to the same establishment, applies on the same date (evidenced by the date on the application forms) under regulation 3 of the MF Regulations to the relevant authority for approval of the establishment as premises on which medicated feedingstuffs may be manufactured, he shall be liable to pay only one fee under both these Regulations and the MF Regulations and, where the relevant fee differs in amount from the fee payable under the MF Regulations, the fee payable shall be the higher amount.

(7) An eligible person shall not be liable to pay the relevant fee where he applies to the enforcement authority under regulation 10 for an establishment to be approved as an establishment on which an establishment activity may be exercised and, in relation to the same establishment, has applied under regulation 3 of the MF Regulations for approval of the establishment as premises on which medicated feedingstuffs may be manufactured, if he applies under regulation 10 within twelve months of his application under regulation 3 of the MF Regulations and at the date of his application under regulation 10—

(a) an inspection by the relevant authority is pending in relation to his application under regulation 3 of the MF Regulations, or

(b) the relevant authority has conducted such inspection and has granted approval pursuant to regulation 4 of the MF Regulations which remains valid.

(8) Where an eligible person applies to the enforcement authority under regulation 12 for an establishment to be approved and in his application seeks approval to exercise more than one new establishment activity, such person shall be liable to pay only one fee and, where the amount of the relevant fee differs according to establishment activity, the fee payable shall be the highest.

(9) Subject to paragraph (10), an eligible person shall not be liable to pay the relevant fee where he applies to the enforcement authority under regulation 12 for an establishment to be approved as an establishment on which a new establishment activity may be exercised and, in relation to the same establishment, has applied under regulation 10(1)(a), (b) or (e), if he applies under regulation 12 within twelve months of his application under regulation 10 and at the date of his application under regulation 12—

(a) an on the spot verification by the enforcement authority is pending in relation to his application under regulation 10 at the date of his application under regulation 12, or

(b) the relevant authority has conducted an on the spot verification in relation to his application under regulation 10, and has granted approval pursuant to regulation 11 which has not been withdrawn.

(10) Where an eligible person applies to the enforcement authority under regulation 12 for an establishment to be approved as an establishment on which a new establishment activity may be exercised and, in relation to the same establishment, applies on the same date (evidenced by the date on the application forms) under regulation 3 of the MF Regulations to the relevant authority for approval of the establishment as premises on which medicated feedingstuffs may be manufactured, he shall be liable to pay only one fee under both these Regulations and the MF Regulations and, where the relevant fee differs in amount from the fee payable under the MF Regulations, the fee payable shall be the higher amount.

(11) An eligible person shall not be liable to pay the relevant fee where he applies to the enforcement authority under regulation 12 for an establishment to be approved as an establishment on which a new establishment activity may be exercised and, in relation to the same establishment and establishment activity, has applied under regulation 3 of the MF Regulations for approval of the establishment as premises on which medicated feedingstuffs may be manufactured, if he applies under regulation 12 within twelve months of his application under regulation 3 of the MF Regulations and at the date of his application under regulation 12—

(a) an inspection by the relevant authority is pending in relation to his application under regulation 3 of the MF Regulations, or

(b) the relevant authority has conducted such inspection and has granted approval pursuant to regulation 4 of the MF Regulations which remains valid.

(12) A fee payable under combined regulations as described in paragraphs (6) and (10) shall, as well as a fee payable by reference to paragraph (5) or (8), be treated for the purposes of paragraphs (2) to (4) as included among fees payable under paragraph (1).

Publication of the national list of approved establishments

16.  The enforcement authority shall provide the Minister in writing, on demand being made by him, such information as is available to it and which will assist the Minister to comply with the requirements of Article 6.1 of Directive 95/69/EC relating to the publication of the national list of approved establishments, as read with Article 13.3 and 13.4 of Directive 70/524/EEC as amended by Directive 96/51/EC.

Interpretation of Part III

17.  In this Part—

• “the applicable minimum conditions laid down in the Annex to Directive 95/69/EC” means the minimum conditions laid down in—

  (a)

  Chapter I.1(b) of the Annex to Directive 95/69/EC in the case of an application to approve an establishment, other than an Article 12 establishment, as an establishment on which the activity specified in regulation 10(1)(a) may be exercised;

  (b)

  points 4, 5, 6.2 and 7 of Chapter I.1(b) of the Annex to Directive 95/69/EC in the case of an application to approve an Article 12 establishment as an establishment on which the activity specified in regulation 10(1)(a) may be exercised;

  (c)

  Chapter I.2(b) of the Annex to Directive 95/69/EC in the case of an application to approve an establishment as an establishment on which the activity specified in regulation 10(1)(b) or (e) may be exercised;

  (d)

  Chapter I.3(b) of the Annex to Directive 95/69/EC in the case of an application to approve an establishment as an establishment on which the activity specified in regulation 10(1)(c) may be exercised; and

  (e)

  with the exception of the requirements set out in point 7, Chapter I.3(b) of the Annex to Directive 95/69/EC, in the case of an application to approve an establishment as an establishment on which the activity specified in regulation 10(1)(d) may be exercised;

• “approved establishment” means an establishment approved by the enforcement authority as an establishment on which an establishment activity may be exercised;

• “eligible person” means a person who is entitled to apply to the enforcement authority in accordance with the first paragraph of Article 4.1 of Directive 95/69/EC or the first paragraph of Article 4.2 of that Directive for an establishment to be approved as an establishment on which an establishment activity may be exercised;

• “essential conditions” means the essential conditions in—

  (a)

  Chapter I.1(b) of the Annex to Directive 95/69/EC in the case of the exercise of the establishment activity specified in regulation 10(1)(a);

  (b)

  Chapter I.2(b) of the Annex to Directive 95/69/EC in the case of the exercise of the establishment activity specified in regulation 10(1)(b) or (e);

  (c)

  Chapter I.3(b) of the Annex to Directive 95/69/EC in the case of the exercise of the establishment activity specified in regulation 10(1)(c);

  (d)

  with the exception of the requirements set out in point 7, Chapter I.3(b) of the Annex to Directive 95/69/EC in the case of the exercise of the establishment activity specified in regulation 10(1)(d); and

• “establishment activity” means an activity specified in sub-paragraph (a), (b), (c), (d) or (e) of regulation 10(1).