Designing human intervention studies for scientific substantiation of health claims - how EFSA thinks

authored by

S. Jakobs, A. Hahn

Abstract

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 aremissing, 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.

Organisation(s)

Institute of Food Science and Human Nutrition
Nutrition Physiology and Human Nutrition Section

Type

Article

Journal

European Food and Feed Law Review

Volume

14

Pages

412-429

No. of pages

18

Publication date

2019

Publication status

Published

ASJC Scopus subject areas

Food Science, Law

Sustainable Development Goals

SDG 3 - Good Health and Well-being