Abstract

The Japanese Ministry of Health, Labour and Welfare (MHLW) established the “Foods for Specified Health Uses (FOSHU)” designation in 1991 as a regulatory system for the approval of health claims on labels that refer to the physiological effects of foods or food components on the human body. This labeling system has been revised twice, most recently in 2005. Thus, “Food with Health Claims” (FHC) in Japan consists of two categories. One is “Foods with Nutrient Function Claims” (FNFC), for which health claims on labels can be freely used if the product satisfies the standard for the minimum and maximum levels per daily portion of consumption; the other is FOSHU. FOSHU are foods that contain beneficial dietary ingredients that maintain or promote human health, or that improve risk factors for lifestyle-related diseases. In the present system, FOSHU health claims are individually reviewed and approved on the basis of scientific evidence. In addition to the existing FOSHU, three new types of classifications were established in February 2005: the new regulatory standards of “Standardized FOSHU” and “Qualified FOSHU” and the new health claim “Reduction of disease risk”.

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