Assessment by the rapporteur Member State
Article 8
1. Within twelve months of the date of the application provided for in Article 3(1), the rapporteur Member State shall prepare and submit to the Commission with a copy to the Authority a report (hereinafter draft assessment report) assessing whether the active substance can be expected to meet the requirements of Article 5 of Directive 91/414/EEC. It shall at the same time inform the applicant that the draft assessment report has been submitted and request him to forward the updated dossier to the Authority, the Member States and the Commission immediately. 2. The rapporteur Member State may consult the Authority. 3. Where the rapporteur Member State needs additional information, it shall set a time period for the applicant to supply it. In that case, the twelve-month period shall be extended by the additional time period granted by the rapporteur Member State. The additional time period shall be no more than six months and shall cease at the moment when the additional information is received by the rapporteur Member State. It shall inform the Commission and the Authority. In its assessment the rapporteur Member State shall only take into account information submitted within the time period granted. 4. Where at the end of the period referred to in paragraph 3, the applicant has not submitted the missing elements, the rapporteur Member State shall inform the applicant, the Commission and the other Member States. If, after giving the applicant an opportunity to comment, the Commission determines that the applicant has failed to submit missing elements which are necessary to decide on whether the substance meets the requirements of Article 5 of Directive 91/414/EEC, it shall adopt a decision providing that the active substance in question is not to be included in Annex I to that Directive and ending the assessment of that active substance under this Regulation. 5. A new application for the same substance may be submitted at any time.