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

human intervention studies, randomised controlled studies, other randomised studies (non-controlled), controlled (non-randomised) studies, other intervention studies;

human observational studies, cohort studies, case-control studies, cross-sectional studies, other observational studies, such as case reports;

other human studies dealing with the mechanisms by which the food could be responsible for the claimed effect, including the studies on bioavailability.