The Feedingstuffs (Zootechnical Products) Regulations 1999

Preliminary ordinary applications

6.—(1) A person who, in the specified circumstances, wishes the Minister to act in accordance with the following provisions of this regulation in connection with an application for the Community authorisation of a zootechnical additive may submit an application for the Community authorisation of the additive and a dossier relating to the additive to the Minister.

(2) Where documentation is submitted to the Minister pursuant to paragraph (1), he shall—

(a) forward it to the Commission, and

(b) forward a copy of it to each Member State,

if he is satisfied as specified in paragraph (3) and has received the appropriate fee in accordance with paragraph (4).

(3) The Minister is satisfied in accordance with this paragraph if he is satisfied that—

(a) the dossier submitted pursuant to paragraph (1) has been compiled in accordance with the applicable provisions of Directive 87/153/EEC, and

(b) the zootechnical additive to which the dossier relates meets the conditions laid down in Article 3a of Directive 70/524/EEC as amended by Directive 96/51/EC.

(4) If the Minister is satisfied in accordance with paragraph (3), the Minister shall notify the person who has submitted the documentation pursuant to paragraph (1) of the Minister’s intention, subject to receipt of the appropriate fee, to forward the dossier to the Commission and the other Member States in accordance with paragraph (2), and upon receipt of such notice such person shall pay the appropriate fee to the Minister and any unpaid sum shall be recoverable as a debt.

(5) If, in relation to a dossier submitted pursuant to paragraph (1), the Minister is not satisfied about both of the matters specified in paragraph (3), he shall reject the documentation or postpone taking the action specified in paragraph (2) in relation to the documentation, until such time as he is satisfied about both of those matters.

(6) Where the Minister rejects the documentation submitted to him pursuant to paragraph (1), or postpones taking the action specified in paragraph (2) in relation to it, he shall inform the person who has submitted the application pursuant to paragraph (1), the Commission and each Member State of the rejection or postponement, and shall notify them of the reasons for the rejection or postponement.

(7) If requested to do so by the Commission, the Minister shall forward a copy of all or part of a dossier relating to a zootechnical additive for which an application has been submitted to him pursuant to paragraph (1) to each member of the Scientific Committee for Animal Nutrition.

(8) For the purposes of this regulation—

(a) the “specified circumstances” apply where—

(i) the person in question is, at the time these Regulations come into force, putting the additive in question into circulation,

(ii) he is not an eligible person under regulation 5 in relation to that additive,

(iii) he wishes to be able to continue putting the additive into circulation lawfully on or after 1st October 1999, and

(iv) he submits the documentation required pursuant to paragraph (1) to the Minister and this is received by the Minister before 1st October 1999; and

(b) “the appropriate fee” means the fee specified in relation to an application under regulation 6(1) in Part I of Schedule 3.

(9) The Minister shall, subject to paragraph (10), treat any documentation submitted to him in anticipation of paragraph (1) as submitted pursuant thereto, and accordingly references in this regulation to anything submitted pursuant to that paragraph shall be taken to include anything required by this paragraph to be so treated.

(10) Paragraph (9) shall only apply where the person who has submitted the documentation in question has, following the coming into force of that paragraph, notified the Minister that he wishes the documentation to be treated as specified in that paragraph.