Scientific substantiation of functional food health claims in China.

This article provides an overview of the procedures involved in scientific substantiation of functional food health claims in China. The definition of a functional food is discussed, in addition to the factors that led to its modification in 2005. The framework of administration includes the regulation of functional foods, steps involved in submission of dossiers, the safety control system for raw materials and products, and technical procedures for testing and evaluation. Scientific evidence required for a claim includes evidence from product tests in addition to evidence resulting from complete scientific literature searches relative to the food material or component in question. Currently, the 4 main rules for functional food assessment in China include 1) functional assessment procedures; 2) standard toxicological assessment; 3) regulations on nutrient supplements; and 4) standard analytical methods for functional components. The current situation for functional foods in China is analyzed, including a discussion of the distribution of the 27 currently allowed functional food health claims. The effectiveness of functional foods and health claims for improving health relies largely on the motivation and education of the public to be able to make good choices.