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:

the claimed effect of the food is beneficial for human health;

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);

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;

the specific study group(s) in which the evidence was obtained is representative of the target population for which the claim is intended.