Evaluation of the renewal assessment report
Article 16
1. The Commission shall, without delay, examine the renewal assessment report and the comments received in accordance with Article 15(1). 2. The Commission may consult the Authority asking it for a conclusion on the entire risk assessment or on specific points thereof. Such consultation may include a request to organise a consultation of experts. The Authority shall use the guidance documents available at the time of the entry into force of this Regulation. The Authority shall deliver its conclusion at the latest 6 months after receipt of the request. Where paragraph 3 applies, that period shall be extended by the periods referred to in the first and the second subparagraph of that paragraph. 3. Where the Authority considers that additional information or data from the applicant is necessary to comply with a request made by the Commission pursuant to paragraph 2, it shall in consultation with the rapporteur Member State, set a period of maximum 1 month for the applicant to supply it. It shall at the same time inform the Commission and the Member States. The applicant shall communicate the requested information to the Authority, the rapporteur Member State and the co-rapporteur Member State. The rapporteur Member State shall, within 2 months of receipt, evaluate the information received and send its evaluation to the Authority. 4. Information submitted by the applicant without having been requested, or after expiry of the period set for its submission in accordance with the first subparagraph of paragraph 3, shall not be taken into account, unless submitted in accordance with Article 7 of Directive 91/414/EEC.