The Commission shall present to the Committee referred to in Article 79(1) of Regulation (EC) No 1107/2009 a draft renewal report and a draft Regulation within six months from the date of receipt of the conclusion of the Authority or in cases where there is no such conclusion of the Authority, from the expiry of the period referred to in Article 12(3) of this Regulation.

The draft renewal report and the draft Regulation shall take into account the draft renewal assessment report, the comments referred to in Article 12(3) of this Regulation and the conclusion of the Authority, where such a conclusion has been submitted, and the opinion of the Committee for Risk Assessment, if any, referred to in Article 37(4) of Regulation (EC) No 1272/2008.

The applicant shall be given the possibility to submit comments on the draft renewal report within a period of 14 days.

On the basis of the renewal report and taking into account comments submitted by the applicant within the period referred to in the third subparagraph of paragraph 1 of this Article as well as other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 are relevant, the Commission shall adopt a Regulation in accordance with Article 20(1) of Regulation (EC) No 1107/2009.