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Health claims on functional foods: the Japanese regulations and an international comparison

Published online by Cambridge University Press:  14 December 2007

Toshio Shimizu*
Fresco Japan Ltd. Z-22-20-102, Akasaka, Minato-ku, Tokyo, Japan
Corresponding author: Dr Toshio Shimizu, fax +81 3 5549 4638, email
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The Japanese scientific academic community defined ‘functional food’ early in the 1980s. That is, functional foods are those that have three functions. The primary function is nutrition. The secondary function is a sensory function or sensory satisfaction. The third is the tertiary function, which is physiological. The Japanese Ministry of Health, Labour, and Welfare (MHLW) set up ‘Foods for Specified Health Use’ (FOSHU) in 1991 as a regulatory system to approve the statements made on food labels concerning the effect of the food on the human body. Food products applying for approval by FOSHU are scientifically evaluated in terms of their effectiveness and safety by the Council of Pharmaceutical Affairs and Food Hygiene under the MHLW. The regulatory range of FOSHU was broadened in 2001 to accept the forms of capsules and tablets in addition to those of conventional foods. FOSHU increased the total to about 330 items in January 2003. The MHLW enacted a new regulatory system, ‘Foods with Health Claims’, in April 2001, which consists of the existing FOSHU system and the newly established ‘Foods with Nutrient Function Claims’ (FNFC). Under the FNFC, twelve vitamins (vitamins A, B1, B2, B6, B12, C, E, D, biotin, pantothenic acid, folic acid, and niacin) and two minerals (Ca and Fe) are standardized. Examples of claims regarding these substances are as follows: ‘Calcium is a nutrient which is necessary to form bones and teeth’; ‘Vitamin D is a nutrient which promotes calcium absorption in the gut intestine and aids in the formation of bones.’ The upper and lower levels of the daily consumption of these nutrients are also determined. The labelling of functional foods should always be based on scientific evidence and be in harmony with international standards. The nutrient–function claim was adopted in the guidelines for nutrition claims by the Codex Alimentarius in 1997. The claims of the Japanese FNFC are equivalent to the nutrient function claims standardized by the Codex Alimentarius. The enhanced function claim and the disease risk-reduction claims were proposed by both the Codex Alimentarius and an Economic Union project in 1999. The structure function claim, which is similar to the enhanced function claim, was enacted by the Dietary Supplement Health and Education Act in the USA in 1994. Most of the statements of the Japanese FOSHU system are close to the category of structure/function claims in the USA or the enhanced function claims of the Codex Alimentarius.

Research Article
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Akioka, H (2000) Effect on serum lipid of persons with mild high cholesterol levels. Journal of Nutritional Food 3, 3746.Google Scholar
Arai, S (1996) Studies on functional foods in Japan. Bioscience, Biotechnology and Biochemistry 60, 915.CrossRefGoogle ScholarPubMed
Arai, S (2002) Global view on functional foods: Asian perspectives. British Journal of Nutrition 88, Suppl. 2, S139–S143.CrossRefGoogle ScholarPubMed
Asaoka, T (1996) Effect of low molecular sodium alginate on serum cholesterol of healthy males. Nutrition – Evaluation and Therapy 13, 454459.Google Scholar
Asp, NG & Trossing, M (2001) The Swedish code on health-related claims in action – extended to product-specific physiological claims. Scandinavian Journal of Nutrition 45, 189192.Google Scholar
Codex Alimentarius Commission (1997) In Codex Guidelines for Use of Nutrition Claims. pp : CAC/GL 23–1997. http://www.codexalimentarius.netGoogle Scholar
Codex Alimentarius Commission (2002) In Proposed Draft Recommendations for the Use of Nutrient Health Claims. http://www.codexalimentarius.netGoogle Scholar
Codex Alimentarius Commission (2000) Proposed draft recommendations for the use of health claims, Comments from Japan, CX/FL00/9–CRD·33. http://www.codexalimentarius.netGoogle Scholar
Commission of the European Communities (2000) White Paper on Food Safety, Com (1999) 719 final of 12 January 2000. Brussels, Belgium. consumer/ library/pub/pub06_en.pdfGoogle Scholar
Diplock, AT, Aggett, PJ, Ashwell, M, Bornet, F, Fern, EB, Roberfroid, MB (1999) Scientific concepts of functional food science in Europe: consensus document.In British Journal of Nutrition 81, Suppl. 1, S1–S27.Google Scholar
Food Standards Australia New Zealand (2002) Media Releases & Publications. publications/publications/index.cfmGoogle Scholar
Fujita, H (2001) Human study of sardine peptides on blood pressure. In Nutrition Research 21,1149.CrossRefGoogle Scholar
Hata, Y, Yamamoto, M, Ohni, M, Nakajima, K, Nakamura, Y & Takano, T (1996) A placebo-controlled study of sour milk on blood pressure in hypertensive subjects. American Journal of Clinical Nutrition 64, 767771.CrossRefGoogle ScholarPubMed
Hieny, RP (1994) Effect of casein phospho-peptide on calcium absorption of postmenstrual women. Journal of Japan Bone Metabolism Association 12, 14.Google Scholar
Kagawa, K (1999) Effect of globin digest on blood lipids. Japanese Journal of Nutrition and Food 52, 7177.Google Scholar
Maezaki, Y (1993) Improvement of serum cholesterol by chitosan. Bioscience, Biotechnology and Biochemistry 57, 14391444.CrossRefGoogle Scholar
Morinaga, Y, Shimizu, T, Sueki, K & Hirahara, T (2000) In Health Claim on Functional Foods. Japan: International Life Scientific of Japan.Google Scholar
Nagao, T (2000) Effect of diacylglycerol on body fat metabolism. In Journal of Nutrition 130. 492.Google Scholar
Ookuma, T (2000) Effects of indigestible dextrin on blood sugar. Journal of Nutritional Food 3, 1927.Google Scholar
Reynolds, EC (1999) Advances in Enamel Remineralization: Casein Phosphopeptide-amorphous Calcium Phosphate. Journal of Clinical Dentistry 10, 8688.Google Scholar
Sakai, (2001) Improvement of blood sugar of healthy persons by L-alabinose. Journal of Nutritional Food 4, 14.Google Scholar
Sekiya, S, Kobayashi, Y & Kita, E (1992) Effect of hydrolyzed casein on hypertension and its adverse effect. Japanese Journal of Nutrition and Foods 45, 513517.Google Scholar
Shimizu, T (2002) Newly established regulation in Japan: Foods with health claims. Asia Pacific Journal of Clinical Nutrition 11, S94–S96.CrossRefGoogle ScholarPubMed
Shimizu, T, Morinaga, Y, Tokunaga, T, Seki, S, Sueki, K & Hirahara, T (2001) In Functional Foods Science in Japan. 213Japan: International Life Scientific of Japan.Google Scholar
Swedish Nutrition Foundation (1996) In Health Claims in the Labeling and Marketing of Food Products (Revised Programme): The Food Industry's Rules (Self-Regulatory Programme). Lund: Sweden: Swedish Nutrition Foundation.Google Scholar
Tabayashi, M, Matsuda, S, Shimizu, T & Huruya, H (1999) Effect of enzyme-hydrolyzed heme-iron on iron deficient anemia. Japanese Journal of Clinical Nutrition 21, 4854.Google Scholar
Tokunaga, T (1993) Effects of furacto-oligosaccharide on bacteria flora and movement of large intestine. Bifidus 6, 143150.Google Scholar
Tsukamoto, T (2000) Effect of Vitamin K2 by virtue of natto bacteria on osteocalcin. Journal of Health Science 46, 317321.CrossRefGoogle Scholar
UK Joint Health Claims Initiative (1998) Code of Practice on Health Claims on Foods. Leatherhead: UK: Joint Health Claims Initiative.Google Scholar
UK Joint Health Claims Initiative (2002) Code of practice on health claims on foods. Executive summary. http://www.jhci. Scholar
United States Food and Drug Administration (2000 a) Regulation on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body. Federal Register 65, 9991050.Google Scholar
United States Food and Drug Administration (2000 b) FDA Finalizes Rules for Claims on Dietary Supplements. Talk Paper T00-1.Google Scholar
United States Food and Drug Administration (2001) Claims that can be made for conventional foods and dietary supplements. Scholar
Voedingscentrum (1998) Code of Practice Assessing the Scientific Evidence for Health Benefits Stated in Health Claims on Food and Drink Products. The Hague, The Netherlands: Voedingscentrum.Google Scholar
Verschuren, PM (2002) Functional foods: scientific and global perspectives. British Journal of Nutrition 88, Suppl. 2, S125–S130.CrossRefGoogle ScholarPubMed
Yamamura, Y (2001) Effects of milk basic protein on bone mineral density and bone absorption maker. Bioscience, Biotechnology and Biochemistry 66, 702707.CrossRefGoogle Scholar
Yamatoya, K (1995) Effects of hydrolyzed guar gum on frequency and characteristics of evacuation. Journal of Japanese Society of Nutrition and Food Science 46, 199203.CrossRefGoogle Scholar
Zhao, YH (1999) Practical Procedure of Regulatory Control of Functional Food in China. Monthly Food Chemicals 10, 9295.Google Scholar