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

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.