Art. 10

32015R2283 → 02015R2283-20210327

Article 10 Procedure for authorising the placing on the market within the Union of a novel food and updating the Union list 1. The procedure for authorising the placing on the market within the Union of a novel food and updating of the Union list provided for in Article 9 of this Regulation shall start either on the Commission's initiative or following an application to the Commission by an applicant. applicant, in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002. The Commission shall make the application available to the Member States without delay. The Commission shall make the a summary of the application, based on the information referred to in points (a), (b) and (e) of paragraph 2 of this Article, publicly available. 2. The application for an authorisation shall include: (a) the name and address of the applicant; (b) the name and description of the novel food; (c) the description of the production process(es); (d) the detailed composition of the novel food; (e) scientific evidence demonstrating that the novel food does not pose a safety risk to human health; (f) where appropriate, the analysis method(s); (g) a proposal for the conditions of intended use and for specific labelling requirements which do not mislead the consumer or a verifiable justification why those elements are not necessary. 3. Upon request by Where the Commission, Commission requests an opinion from the European Food Safety Authority (the Authority) Authority), the Authority shall make public the application in accordance with Article 23 and shall give its opinion as to whether the update is liable to have an effect on human health. 4. When test methods are applied to engineered nanomaterials as referred to in points (a) (viii) and (ix) of Article 3(2), an explanation shall be provided by the applicants of their scientific appropriateness for nanomaterials and, where applicable, of the technical adaptations or adjustments that have been made in order to respond to the specific characteristics of those materials. 5. The procedure for authorising the placing on the market within the Union of a novel food and updating the Union list as provided for in Article 9 shall end with the adoption of an implementing act in accordance with Article 12. 6. By way of derogation from paragraph 5, the Commission may terminate the procedure at any stage, and decide not to proceed with an update, where it considers that such an update is not justified. In such cases, where applicable, the Commission shall take account of the views of Member States, the Authority's opinion and any other legitimate factors relevant to the update under consideration. The Commission shall inform the applicant and all Member States directly of the reasons for not considering the update to be justified. The Commission shall make the list of such applications publicly available. 7. The applicant may withdraw its application at any time, thereby terminating the procedure.