Assessment by the rapporteur Member State and the co-rapporteur Member State
Article 14
1. Within 11 months of informing the applicant that the supplementary dossiers are considered to be complete in accordance with Article 11(2), the rapporteur Member State shall, after consulting the co-rapporteur Member State, prepare and submit to the Commission, with a copy to the Authority, a report assessing whether the active substance can be expected to continue to meet the requirements for inclusion, as provided for in Article 5(1) and (2) of Directive 91/414/EEC, hereinafter ‘the renewal assessment report’. The renewal assessment report shall also include the following: (a) a recommendation with regard to the renewal of the inclusion; (b) where relevant, a suggestion for maximum residue levels to be set; (c) a conclusion on which of the new studies included in the supplementary dossiers are relevant for the assessment; (d) a recommendation as to the parts of the report on which a consultation of experts is to be organised in accordance with Article 16(2); (e) the points on which the co-rapporteur Member State did not agree with the assessment by the rapporteur Member State, where relevant. 2. For the assessment, the rapporteur Member State shall take into account the supplementary dossiers, any information submitted by a third party, comments on such information received from the applicant and, where appropriate, the original dossiers. 3. Where the rapporteur Member State needs additional information, it shall set a period for the applicant to supply that information. That period shall not lead to an extension of the period of 11 months provided for in paragraph 1. 4. The rapporteur Member State may consult the Authority and request additional technical or scientific information from other Member States. Such consultations and requests shall not lead to an extension of the period of 11 months provided for in paragraph 1. 5. 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. 6. When submitting the renewal assessment report to the Commission, the rapporteur Member State shall request the applicant to submit the supplementary summary dossier, updated to include the additional information requested by the rapporteur Member State in accordance with paragraph 3 or submitted in accordance with Article 7 of Directive 91/414/EEC, to the Authority, the other Member States and, on request, to the Commission.