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1. When reference is made to this Article, an application for authorisation shall be submitted in accordance with the following paragraphs.

2. The application shall be sent to the national competent authority of a Member State.

(a) The national competent authority shall:

(i) acknowledge receipt of an application in writing within 14 days of its receipt. The acknowledgement shall state the date of receipt of the application;

(ii) inform without delay the Authority; and (iii) make the application and any supplementary information supplied by the applicant available to the Authority;

(b) The Authority shall:

(i) inform without delay the other Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them;

(ii) make the summary of the application referred to in paragraph 3(g) available to the public.

3. The application shall include the following:

(a) the name and address of the applicant;

(b) the nutrient or other substance, or the food or the category of food, in respect of which the health claim is to be made and its particular characteristics;

(c) a copy of the studies, including, where available, independent, peer-reviewed studies, which have been carried out with regard to the health claim and any other material which is available to demonstrate that the health claim complies with the criteria provided for in this Regulation;

(d) where appropriate, an indication of the information which should be regarded as proprietary accompanied by verifiable justification;

(e) a copy of other scientific studies which are relevant to that health claim;

(f) a proposal for the wording of the health claim for which authorisation is sought including, as the case may be, specific conditions for use;

(g) a summary of the application.

4. The Commission, having first consulted the Authority, shall establish in accordance with the procedure referred to in Article 25(2) implementing rules for the application of this Article, including rules concerning the preparation and presentation of the application.

5. The Commission, in close cooperation with the Authority, shall make available appropriate technical guidance and tools to assist food business operators, in particular SMEs, in the preparation and presentation of the application for scientific assessment.