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Designing Human Intervention Studies for Scientific Substantiation of Health Claims – How EFSA Thinks

Steffen Jakobs, Andreas Hahn


According to Regulation (EC) 1924/2006, health claims made on foods need an authorisation and the effect must be ‘established by generally accepted scientific data’. The scientific assessment on applications for health claims is the responsibility of the European Food Safety Authority (EFSA). Thus, the Authority plays the crucial role in the scientific acceptance or rejection of health claims. In accordance with Regulation (EC) 353/2008, in order to substantiate a health claim, data from human studies are required to prove the relationship between the consumption of the food/food constituent and the claimed effect. In this context, EFSA considers double-blind randomised controlled trials in humans to be the gold standard. So far, the Authority has not published an exclusive guidance for reporting of human intervention studies in order to present transparent and consistent criteria for these studies. Thus, clear and concrete guidelines for adequately performing such studies are missing, which represents a general problem for applicants. Therefore, based on an evaluation of all scientific opinions on claims according to Article 13, this paper addresses key factors that EFSA requests to report on the design, conduct and statistical analysis of human intervention studies with foods or food constituents for scientific substantiation of health claims. It also shows that EFSA’s work often is neither transparent nor consistent.
Keywords: Health claims; EFSA; Food labelling; Human intervention studies; RCTs.

Dr Steffen Jakobs and Prof Dr Andreas Hahn, Leibniz University Hannover, Institute of Food Science and Human Nutrition, Am Kleinen Felde 30, D-30167 Hannover, Germany. For correspondence: <mailto:jakobs@nutrition.uni-hannover.de>; <mailto:hahn@nutrition.uni-hannover.de>.

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