Article 11
Evaluation by the EFSA 1. After receiving the updated summary dossier and the draft assessment report referred to in Article 10(1), the EFSA shall, within 30 days, acknowledge receipt of the report to the rapporteur Member State. In exceptional cases where the draft assessment report clearly does not fulfil the requirements concerning the format recommended by the Commission, the Commission shall agree with the EFSA and the rapporteur Member State on a period for resubmission of an amended report. This period shall not exceed four months. 2. The EFSA shall circulate the rapporteur's draft assessment report to the Member States and may organise a consultation of experts including from the rapporteur Member State. The EFSA may consult some or all of the notifiers of active substances specified in Annex I on the report or parts of the report on the relevant active substance. Without prejudice to Article 7 of Directive 91/414/EEC, submission of new studies shall not be accepted except for the studies as referred to in Article 10(4) of Regulation (EC) No 451/2000. The rapporteur Member State, with the agreement of the EFSA, may request the notifiers to submit within specified periods further data considered by the rapporteur Member State or EFSA necessary to clarify the dossier. 3. The EFSA shall make available at specific request or keep available for consultation by any person the following: (a) the information referred to in the last subparagraph of Article 10(1), except the elements thereof which have been accepted as confidential in accordance with Article 14 of Directive 91/414/EEC; (b) the name of the active substance; (c) the content of the pure active substance in the manufactured material; (d) the list of any data required for consideration of the possible inclusion of the active substance into Annex I to Directive 91/414/EEC, first as contained in the rapporteur's report and secondly as finalised by the EFSA; (e) the draft assessment report, except the elements thereof which have been accepted as confidential in accordance with Article 14 of Directive 91/414/EEC. 4. The EFSA shall evaluate the rapporteur's draft assessment report and deliver its opinion on whether the active substance can be expected to meet the safety requirements of Directive 91/414/EEC to the Commission at the latest one year after receipt of the rapporteur Member State draft assessment report. Where appropriate, the EFSA shall give its opinion on the available options claimed to meet the safety requirements. The Commission and the EFSA shall agree on a schedule for the delivery of the opinions in order to facilitate the planning of the work. The Commission and the EFSA shall agree on the format in which the opinion of the EFSA is submitted.