3.

The application shall include the following: the name and address of the applicant; 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; 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; where appropriate, an indication of the information which should be regarded as proprietary accompanied by verifiable justification; a copy of other scientific studies which are relevant to that health claim; a proposal for the wording of the health claim for which authorisation is sought including, as the case may be, specific conditions for use; a summary of the application.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-08 · Text as adopted (Official Journal); later amendments are not incorporated in this text.