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

Steffen Jakobs, Andreas Hahn

European Food and Feed Law Review, Volume 14 (2019), Issue 5, Page 412 - 429

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.

Case Report: The Water-Claim Proceedings: Statement of Claim journal article

Tobias Teufer, Moritz Hagenmeyer, Andreas Hahn

European Food and Feed Law Review, Volume 7 (2012), Issue 1, Page 28 - 52

Four years ago the second and the third authors submitted an application for authorisation of a health claim (in the shape of a disease risk reduction claim) via the German Federal Office for Consumer Protection and Food Safety. Their application was recently refused in a Commission Regulation relying on a negative opinion of the European Food Safety Authority. As a means of last resort the applicants have decided to challenge this Regulation and have asked the first author to represent them before the General Court of the European Union. As a measure of transparency, in order to assist the current debate of issues caused by the Nutrition and Health Claims Regulation and to give interested parties an opportunity to participate, the authors make a swift convenience translation of the statement of claim dated 13/1/2012 available to the public with this article. The General Court received the pleadings on 16/01/2012 and allocated the case number T-17/12.

Surprisingly “cheap” Health Claims for Food Supplements – By Courtesy of EFSA journal article

Moritz Hagenmeyer, Andreas Hahn

European Food and Feed Law Review, Volume 5 (2010), Issue 6, Page 325 - 340

Many producers of food supplements deplore the strict assessment practice of EFSA. They fear that soon they will not be able to market their products any longer. If, however, one looks at the current draft of a first Regulation on the authorisation of certain health claims, it will be possible to make lots of “cheap” claims without great effort. This is because the pertaining EFSA opinions suggest recipes which open up unimagined perspectives for food advertising. The authors of this article reveal the secrets of these recipes and show how they can be used for marketing food supplements. First they sketch the regulatory background and the general problems (I.); then they present the draft Regulation together with the pertaining scientific opinions (II.). Thereafter, they propose several model recipes which allow the use of “cheap” health claims (III.). In some critical comments they show practical consequences of the envisaged authorisations (IV.) before concluding with a brief assessment (V). The authors suspect that neither legislators nor EFSA have asked for the partly absurd results to which the instant analysis must lead. However, the strange consequences of the current authorisation practice have to be accepted until better and more sensible rules as well as an adequate scientific assessment procedure are available.

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