Commission Regulation (EC) No 353/2008 of 18 April 2008 establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council (Text with EEA relevance)

This Regulation establishes implementing rules for the following applications: (a) applications for authorisation, submitted in accordance with Article 15 of Regulation (EC) No 1924/2006; and (b) applications for the inclusion of a claim in the list provided for in Article 13(3) submitted in accordance with Article 18 of Regulation (EC) No 1924/2006.

Each application shall cover only one relationship between a nutrient or other substance, or food or category of food, and a single claimed effect.

The application shall specify which type of health claim is concerned among those listed in Articles 13 and 14 of Regulation (EC) No 1924/2006.

The indication of information which should be regarded as proprietary data and verifiable justification thereof, as referred to in Article 15(3)(d) of Regulation (EC) No 1924/2006, shall be included in a separate part of the application.

The studies and other material referred to Article 15(3)(c) and (e) of Regulation (EC) No 1924/2006: (a) shall consist primarily of studies in humans and, in the case of claims referring to children's development and health, from studies in children; (b) shall be presented according to a hierarchy of study designs, reflecting the relative strength of evidence which may be obtained from different types of studies.

In accordance with Article 15(3)(f) of Regulation (EC) No 1924/2006, and in addition to the proposal for the wording of the health claim, the conditions of use shall include: (a) the target population for the intended health claim; (b) the quantity of the nutrient or other substance, or food or category of food, and the pattern of consumption required to obtain the claimed beneficial effect; (c) where appropriate, a statement addressed to persons who should avoid using the nutrient or other substance, or food or category of food, for which the health claim is made; (d) a warning for the nutrient or other substance, or food or category of food, that is likely to present a health risk if consumed to excess; (e) any other restrictions of use and directions for preparation and/or use.

The application shall be prepared and presented in accordance with the technical rules as set out in the Annex.

This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.