# 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 2: Human data shall be classified according to a hierarchy of study design in the following order:

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

(a) human intervention studies, randomised controlled studies, other randomised studies (non-controlled), controlled (non-randomised) studies, other intervention studies;
(b) human observational studies, cohort studies, case-control studies, cross-sectional studies, other observational studies, such as case reports;
(c) other human studies dealing with the mechanisms by which the food could be responsible for the claimed effect, including the studies on bioavailability.

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Source: https://www.legislation.gov.uk/eur/2008/353/annex/division/4/division/2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-353/annex/division-4/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.