xmlns:atom="http://www.w3.org/2005/Atom"

Part IIActive Substances

Assessment of applications concerning new active substances

6.—(1) Where the Executive receives an application under regulation 5, it shall ensure that the dossiers submitted as part of that application satisfy the requirements of that regulation and, where those dossiers do so, the Executive shall—

(a)accept the dossiers; and

(b)agree to the applicant forwarding a summary of the dossiers to the Commission and the member States.

(2) Subject to paragraph (5) and subject to regulation 39(2), within the period of 12 months of the Executive accepting the dossiers in accordance with paragraph (1)(a), the Executive shall—

(a)evaluate the dossiers submitted in accordance with regulation 5;

(b)make a recommendation as to whether the new active substance in question should, or should not, be included in Annex I, IA or IB; and

(c)send a copy of its evaluation and recommendation to the Commission, the member States and the applicant.

(3) Where necessary for the purpose of carrying out an evaluation required by paragraph (2)(a), the Executive shall—

(a)request in writing the applicant to provide such additional information relating to the new active substance as it may specify; and

(b)at the same time inform the Commission and the member States of its request.

(4) Where the Executive requests additional information under paragraph (3), the period of time between the date when the Executive requests the information and the date when the applicant responds to its satisfaction shall not be taken into account in calculating the period of 12 months referred to in paragraph (2).

(5) After the Executive has accepted the dossiers in accordance with paragraph (1)(a), it may make a request to the Commission for the evaluation of the dossiers to be carried out by a competent authority, and, in such a case—

(a)the Executive shall not be under a duty to evaluate those dossiers, unless and until there is a Commission decision to refuse its request; and

(b)where there is such a Commission decision to refuse, the Executive shall evaluate the dossiers within the period of 12 months of the date of that Commission decision.

(6) Where there is a Commission decision that the Executive shall evaluate the dossiers submitted to a competent authority in support of an application for the inclusion of a new active substance in Annex I, IA or IB, subject to regulation 39(2), within the period of 12 months of receiving the dossiers, the Executive shall—

(a)evaluate the dossiers;

(b)make a recommendation as to whether the new active substance should, or should not, be included in Annex I, IA or IB; and

(c)send a copy of its evaluation and recommendation to the Commission, the member States and the applicant.

(7) Paragraphs (3) and (4) shall apply where the Executive evaluates dossiers under paragraph (6)(a) as if the dossiers had been submitted under regulation 5.