# 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 3: The substantiation of health claims shall take into account the totality of the available scientific data and, by weighing the evidence, shall demonstrate the extent to which:

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

(a) the claimed effect of the food is beneficial for human health;
(b) a cause and effect relationship is established between consumption of the food and the claimed effect in humans (such as the strength, consistency, specificity, dose-response, and biological plausibility of the relationship);
(c) the quantity of the food and pattern of consumption required to obtain the claimed effect could reasonably be achieved as part of a balanced diet;
(d) the specific study group(s) in which the evidence was obtained is representative of the target population for which the claim is intended.

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Source: https://www.legislation.gov.uk/eur/2008/353/annex/division/2/division/3 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-353/annex/division-2/division-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.