CHAPTER III AUTHORISATION PROCEDURES FOR A NOVEL FOOD

SECTION II Specific rules for traditional foods from third countries

Article 17 Opinion of the Authority on a traditional food from a third country
1 The Authority shall adopt its opinion within six months from the date of receipt of a valid application.
2 In assessing the safety of a traditional food from a third country, the Authority shall consider the following matters:
(a) whether the history of safe food use in a third country is substantiated by reliable data submitted by the applicant in accordance with Articles 14 and 16;
(b) whether the composition of the food and the conditions of its use do not pose a safety risk to human health in the Union;
(c) where the traditional food from the third country is intended to replace another food, whether it 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, the Member States and the applicant.
4 In duly justified cases, where the Authority requests additional information from the applicant, the six-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 six-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 six-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 Member States.