1.

Articles 11 and 12 are replaced by the following: ‘Article 11 Receipt of and access to the draft assessment report 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 to the rapporteur Member State receipt of that report. 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 two months. 2. The EFSA shall without delay communicate the draft assessment report to the Commission, the other Member States and the notifiers setting a time period of no more than two months for the submission of comments by those Member States and the notifiers. It shall collate the comments it receives, including available comments from the EFSA, and forward them to the Commission, Member States and the notifiers. 3. The EFSA shall make available at specific request or keep available for consultation by any person the following: (a) the draft assessment report except the elements thereof which have been accepted as confidential in accordance with Article 14 of Directive 91/414/EEC; (b) the list of any data required for the evaluation in view of the possible inclusion of the active substance in Annex I to that Directive as finalised by the EFSA where it has finalised such a list. Article 11a Examination of the draft assessment report The Commission shall, without delay, examine the draft assessment report and the recommendation by the rapporteur Member State and the comments received from other Member States, the EFSA and from the notifiers in accordance with Article 11(2). Article 11b Active substance with clear indications that they do not have any harmful effects If there are clear indications that it may be expected that the active substance does not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, as set out in Annex V, Article 12(1)(a) and (2)(a) shall apply. Article 11c Consultation of the EFSA 1. Where Article 11b does not apply, the Commission may, at any time during the evaluation, ask the EFSA to carry out a peer review of the full draft assessment report or to focus on specific points including points related to criteria set out in Annex VI. The EFSA shall organise a consultation of Member States experts including the rapporteur Member State. Where the Commission requests the EFSA to carry out a full peer review, the EFSA shall deliver its conclusion at the latest six months after the request. Where the Commission does not request a full peer review, but only a conclusion on specific points, the period shall be reduced to three months. The submission of the conclusions shall in any event be no later than 30 September 2008. 2. If during the peer review there are clear indications that an active substance is expected to have harmful effects on human or animal health or on groundwater as set out in Annex VI, the EFSA shall inform the Commission. The Commission may take a Decision as referred to in Article 11f. 3. The Commission and the EFSA shall agree on a schedule for the delivery of the conclusions in order to facilitate the planning of the work. The Commission and the EFSA shall agree on the format in which the conclusions of the EFSA are submitted. Article 11d Submission of additional information after the draft assessment report has been submitted to the EFSA 1. Without prejudice to Article 7 of Directive 91/414/EEC, submission of new studies shall not be accepted. 2. Where the EFSA considers that additional information from the notifier is necessary to comply with a request made by the Commission under Article 11c, the rapporteur Member State shall request that information. Such requests shall be made explicitly and in writing, setting a time period for submission of one month. They shall not concern the submission of new studies. The rapporteur Member State shall inform the Commission and the EFSA of such requests in writing. The rapporteur Member State shall, within one month after the receipt of such information, evaluate the information received and send its evaluation to the EFSA. 3. Information submitted by the notifier but which has not been requested, or which has not been submitted before the end of the time period referred to in paragraph 2, shall not be taken into account unless this information has been submitted in accordance with Article 7 of Directive 91/414/EEC. Where the rapporteur Member State, pursuant to paragraph 1 or to the first subparagraph of this paragraph, refuses to take into account studies or information received from the notifier, it shall inform the Commission and the EFSA and indicate the reasons for such refusal. Article 11e Withdrawal by notifier Where Article 11b does not apply, the notifier may withdraw his support of the inclusion of the active substance in Annex I to Directive 91/414/EEC within two months from receipt of the draft assessment report referred to in Article 11(2). Article 11f Active substance for which there are clear indications of harmful effects If there are clear indications that it may be expected that the active substance has harmful effects on human or animal health or on groundwater as set out in Annex VI, the Commission shall take a Decision on the non-inclusion of the active substance in Annex I to Directive 91/414/EEC, in accordance with Article 12(1)(a) and (2)(b) of this Regulation. Article 12 Presentation of a draft directive or draft decision 1. The Commission shall submit to the Committee a draft review report at the latest six months after: (a) receipt of the draft assessment report where Article 11b or Article 11f applies; (b) receipt of the conclusion established by the EFSA where Article 11c applies; (c) receipt of a written withdrawal of the notifier’s support where Article 11e applies. 2. Together with the draft review report the Commission shall submit to the Committee: (a) a draft directive including the active substance in Annex I to Directive 91/414/EEC, setting out where appropriate the conditions, including the time limit, for such inclusion; or (b) a draft decision addressed to the Member States requiring them to withdraw, within six months, the authorisations of plant protection products containing the active substance, pursuant to the fourth subparagraph of Article 8(2) of Directive 91/414/EEC, whereby that active substance is not included in Annex I to that Directive, mentioning the reasons for the non-inclusion. The Directive or Decision shall be adopted in accordance with the procedure referred to in Article 19(2) of Directive 91/414/EEC. 3. By way of derogation from paragraph 2(b), the latest date for Member States to withdraw authorisations shall be 31 December 2010 in the case referred to in paragraph 1(c) unless the Commission has concluded that the substance meets the criteria of Annex VI, if appropriate after having consulted the EFSA. Article 12a View by the EFSA Where an active substance is included in Annex I to Directive 91/414/EEC pursuant to Article 11b of this Regulation, the Commission shall request the EFSA to deliver its view on the draft review report by 31 December 2010 at the latest. Member States and notifiers shall cooperate with the EFSA and the Commission. In order to facilitate the planning of the work, the Commission and the EFSA shall agree on a schedule for the delivery of the view of the EFSA on the draft review report and on the format in which that view is submitted.’