The Feeding Stuffs (Scotland) Regulations 2000

Applications for Community authorisation of additives and of new uses for additives

11.—(1) Any person resident, or having a place of business in Scotland who wishes the United Kingdom to act as the rapporteur in connection with–

(a) an application for the Community authorisation of an additive which is not a zootechnical additive; or

(b) an application for the Community authorisation of a new use of an already authorised additive which is not a zootechnical additive,

may submit to the Agency an application for the Community authorisation of the additive or the new use of the additive, as the case may be, and a dossier relating to the additive, or the new use, as the case may be.

(2) Where documentation is submitted to the Agency pursuant to paragraph (1) above, it shall–

(a) forward it to the Commission; and

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

in accordance with Article 4.3 of the Additives Directive, if it is satisfied as specified in paragraph (3) below.

(3) The Agency is satisfied in accordance with this paragraph if it is satisfied that–

(a) the dossier submitted pursuant to paragraph (1) above has been compiled in accordance with the applicable provisions of the Dossiers Directive; and

(b) the additive to which the dossier relates, or the new use to which it relates, as the case may be, appears to meet the conditions laid down in Article 3a of the Additives Directive.

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

(5) Where the Agency rejects documentation submitted to it pursuant to paragraph (1) above, or postpones taking the action specified in paragraph (2) above in relation to it, it shall inform the Commission, the applicant and each member State of the rejection or postponement, and shall notify them of the reasons for the rejection or postponement.

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