Article 11U.K.Opinion of the Authority
1.Where the Commission requests an opinion from the Authority, it shall forward the valid application to the Authority without delay, and not later than one month after having verified its validity. The Authority shall adopt its opinion within nine months from the date of receipt of a valid application.
2.In assessing the safety of novel foods, the Authority shall, where appropriate, consider whether:
(a)the novel food concerned is as safe as food from a comparable food category already placed on the market within the Union;
(b)the composition of the novel food and the conditions of its use do not pose a safety risk to human health in the Union;
(c)a novel food, which is intended to replace another food, does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.
3.The Authority shall forward its opinion to the Commission, to the Member States and, where applicable, to the applicant.
4.In duly justified cases, where the Authority requests additional information from the applicant, the nine-month period provided for in paragraph 1 may be extended.
After consulting the applicant, the Authority shall specify a period within which that additional information is to be provided and shall inform the Commission thereof.
Where the Commission does not object to the extension within eight working days of being informed by the Authority, the nine-month period provided for in paragraph 1 shall be automatically extended by that additional period. The Commission shall inform the Member States of that extension.
5.Where the additional information referred to in paragraph 4 is not provided to the Authority within the additional period referred to in that paragraph, the Authority shall draw up its opinion on the basis of the available information.
6.Where an applicant submits additional information on its own initiative, it shall send that information to the Authority.
In such cases, the Authority shall give its opinion within the nine-month period provided for in paragraph 1.
7.The Authority shall make the additional information provided in accordance with paragraphs 4 and 6 available to the Commission and to the Member States.