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3. The valid application, in line with the guidance referred to in Article 15(5), and any information supplied by the applicant shall be sent without delay to the Authority for a scientific assessment as well as to the Commission and the Member States for information. The Authority shall issue its opinion within a time limit of five months from the date of receipt of the request. Such time limit may be extended by up to one month if the Authority considers it necessary to seek supplementary information from the applicant. In such a case the applicant shall submit the requested information within 15 days from the date of receipt of the Authority's request. The procedure laid down in Article 16(3)(a) and (b), (5) and (6) shall apply mutatis mutandis.

4. Where the Authority, following scientific assessment, issues an opinion in favour of the inclusion of the claim in the list provided for in Article 13(3), the Commission shall take a decision on the application, taking into account the opinion of the Authority, any relevant provisions of Community law and other legitimate factors relevant to the matter under consideration, after having consulted the Member States and within two months of receiving the opinion of the Authority.

5. Where the Authority issues an opinion that does not support the inclusion of the claim in the list referred to in paragraph 4, a decision on the application designed to amend non-essential elements of this Regulation by supplementing it shall be taken in accordance with the regulatory procedure with scrutiny referred to in Article 25(3). However, where at the applicant's request for the protection of proprietary data the Commission proposes to restrict the use of the claim in favour of the applicant:

(a) a decision on the authorisation of the claim shall be taken in accordance with the regulatory procedure referred to in Article 25(2). In such case, the authorisation, if granted, shall expire after five years;

(b) before the expiry of the five-year period, if the claim still meets the conditions laid down in this Regulation, the Commission shall submit a draft of measures designed to amend non-essential elements of this Regulation by supplementing it for authorisation of the claim without restriction of use which shall be decided on in accordance with the regulatory procedure with scrutiny referred to in Article 25(3).

Claims referred to in Article 13(5) 1. A food business operator intending to use a health claim not included in the list provided for in Article 13(3) may apply for the inclusion of the claim in that list.

2. The application for this inclusion shall be submitted to the national competent authority of a Member State which shall acknowledge receipt of the application in writing within 14 days of its receipt. The acknowledgement shall state the date of receipt of the application. The application shall include the data provided for in Article 15(3) and the reasons for the request.