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Recommendations for successful substantiation of new health claims in the European Union

Pravst, Igor, Hodgkins, Charo, Lähteenmäki, Liisa, Malcolm, Rosalind, Kušar, Anita, Kulikovskaja, Viktorija, Žmitek, Katja, Miklavec, Krista, Raats, Monique and Lavriša, Živa (2017) Recommendations for successful substantiation of new health claims in the European Union Trends in Food Science & Technology, 71. pp. 259-263.

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Background: While functional foods offer promise for public health and innovation in the food industry, the efficiency of such foods should be assured to protect consumers from misleading claims. Globally, many countries regulate the communication of the health effects of such foods to final consumers.

Scope and approach: In the European Union (EU), the use of health claims was harmonized in 2006. All claims need to be scientifically assessed by the European Food Safety Authority (EFSA) and pre-approved. Implementing the regulation has involved a steep learning curve for stakeholders, resulting in many health claims being rejected. The EU-funded REDICLAIM project used existing guidance documents, analyses of Scientific Opinions on new health claim applications, and a series of interviews with experts involved in such applications to identify key points in the process of authorizing new health claims.

Key findings and conclusions: Recommendations for the successful substantiation of new health claims in the EU were prepared. The substantiation of health claims is primarily based on human efficacy studies, and greater resources are required to authorize more innovative claims. The reported recommendations should be seen as a starting point for researchers in the area of nutrition and food technology, and for those dealing with functional foods, including the food industry.

Item Type: Article
Divisions : Faculty of Arts and Social Sciences > School of Law
Authors :
Pravst, Igor
Lähteenmäki, Liisa
Kušar, Anita
Kulikovskaja, Viktorija
Žmitek, Katja
Miklavec, Krista
Lavriša, Živa
Date : 31 October 2017
DOI : 10.1016/j.tifs.2017.10.015
Copyright Disclaimer : © 2017 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license (
Uncontrolled Keywords : Functional foods; Health claims; Food labelling; Substantiation; Regulation; European Union
Related URLs :
Depositing User : Clive Harris
Date Deposited : 31 Oct 2017 13:38
Last Modified : 16 Jan 2019 19:03

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