(1)

Regulation (EC) No 1924/2006 establishes rules for the use of claims in the labelling, presentation and advertising of foods.

(2)

Applications for authorisation of health claims should adequately and sufficiently demonstrate that the health claim is based on and substantiated by generally accepted scientific evidence, by taking into account the totality of the available scientific data and by weighing the evidence.

(3)

As provided by Article 15(4) of Regulation (EC) No 1924/2006, it is necessary to establish implementing rules concerning health claims applications submitted in accordance with that Regulation, including rules for the preparation and presentation of applications.

(4)

The implementing rules should ensure that the application dossier is compiled in a way which defines and classifies the scientific data needed with a view to assessment of the applications by the European Food Safety Authority.

(5)

The implementing rules are intended primarily as a general guide, and, depending on the nature of the claim, the nature and extent of the studies necessary to evaluate its scientific merit may vary.

(6)

Applications for health claims should take account of the requirements laid down in Regulation (EC) No 1924/2006, particularly the general principles and conditions set out in Articles 3 and 5 thereof. Separate applications should be made for individual health claims and characterise the type of claim.

(7)

Particulars and documents to be provided in accordance with this Regulation should be without prejudice to any supplementary information that the European Food Safety Authority (the Authority) may request where appropriate, as laid down in Article 16(2) of Regulation (EC) No 1924/2006.

(8)

At the request of the Commission, the Authority has issued an opinion on scientific and technical guidance on the preparation and the presentation of applications concerning health claims (2). Applications should follow the Authority guidance in conjunction with the implementing rules to ensure the harmonised submission of applications to the Authority.

(9)

In order to benefit from data protection, as laid down in Article 21 of Regulation (EC) No 1924/2006, requests for protection of proprietary data must be justified and all data kept in a separate part of the application.

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

(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.

(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.

(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.