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

• Published in: Trends in food science & technology 2018-01, Vol.71, p.259-263
• Main Authors: Pravst, Igor, Kušar, Anita, Žmitek, Katja, Miklavec, Krista, Lavriša, Živa, Lähteenmäki, Liisa, Kulikovskaja, Viktorija, Malcolm, Rosalind N., Hodgkins, Charo, Raats, Monique M.
• Format: Article
• Language: English
• Subjects: Consumer protection; Consumers; European Union; Food industry; Food labelling; Food processing industry; Food safety; Food technology; Functional foods; Functional foods & nutraceuticals; Health claims; Innovations; Nutrition; Public health; Regulation; Studies; Substantiation
• ISSN: 0924-2244; 1879-3053
• DOI: 10.1016/j.tifs.2017.10.015

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. 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. 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. •Key recommendations are identified using guidance, evaluations and interviews.•Food safety is not assessed during the evaluation of health claims.•Substantiation is primarily based on human efficacy studies.•Increased resources are required to authorize more innovative health claims.