# 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), Division: FOOD CHARACTERISTICS

Extent: E+W+S+N.I.

The following information shall be given with regard to the food constituent, the food or the food category for which the health claim is made.
1.. For a food constituent:
(a) the source and specifications, such as physical and chemical properties, composition; and
(b) where applicable, the microbiological constituents of the food constituent.
2.. For a food or category of food:
(a) the description of the food or food category, including characterisation of the food matrix and the overall composition including the nutrient content of the food;
(b) the source and specifications of the food or food category and, in particular, the content of the constituent(s) related to the health claim.
3.. In all cases:
(a) where applicable, the variability from batch to batch;
(b) analytical methods applied;
(c) where applicable, a summary of the studies undertaken on production conditions, batch-to-batch variability, analytical procedures, and of the results and conclusions of the stability studies, and the conclusions with respect to storage conditions and shelf-life;
(d) where applicable, the relevant data and rationale that the constituent for which the health claim is made is in a form that is available to be used by the human body;
(e) if absorption is not necessary to produce the claimed effect, such as for plant sterols, fibres, lactic acid bacteria, the relevant data and rationale that the constituent reaches the target site;
(f) all available data on factors that could affect the absorption or utilisation in the body of the constituent for which the health claim is made.

---
Source: https://www.legislation.gov.uk/eur/2008/353/annex/division/3 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-353/annex/division-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.