Regulation 6 Assessment of applications concerning new active substances
When the Ministers receive an application under regulation 5, they shall ensure that the dossiers submitted as part of that application satisfy the requirements of that regulation and, where those dossiers do so, the Ministers shall—
accept the dossiers; and
agree to the applicant forwarding a summary of the dossiers to the Commission and the member States.
Subject to paragraph (5) and subject to regulation 39(2), within the period of 12 months of the Ministers accepting the dossiers in accordance with paragraph (1)(a), the Ministers shall—
evaluate the dossiers submitted in accordance with regulation 5;
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
send a copy of their evaluation and recommendation to the Commission, the member States and the applicant.
Where necessary for the purpose of carrying out an evaluation required by paragraph (2)(a), the Ministers shall—
request in writing the applicant to provide such additional information relating to the new active substance as they may specify; and
at the same time inform the Commission and the member States of their request.
Where the Ministers request additional information under paragraph (3), the period of time between the date when the Ministers request the information and the date when the applicant responds to their satisfaction shall not be taken into account in calculating the period of 12 months referred to in paragraph (2).
After the Ministers have accepted the dossiers in accordance with paragraph (1)(a), they 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—
the Ministers shall not be under a duty to evalute those dossiers, unless and until there is a Commission decision to refuse their request; and
where there is such a Commission decision to refuse, the Ministers shall evaluate the dossiers within the period of 12 months of the date of that Commission decision.
Where there is a Commission decision that the Ministers 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 Ministers shall—
evaluate the dossiers;
make a recommendation as to whether the new active substance should, or should not, be included in Annex I, IA or IB; and
send a copy of their evaluation and recommendation to the Commission, the member States and the applicant.
Paragraphs (3) and (4) shall apply where the Ministers evaluate dossiers under paragraph (6)(a) as if the dossiers had been submitted under regulation 5.