Regulatory Systemsof Health foods in Japan October, 2010 Consumer Affairs Agency Food Labelling Division
Relationships among Japanese Agricultural Standards Law (JAS), Food SanitationAct, and Health Promotion Act [JAS法、食品衛生法及び健康増進法の関係性について] JAS: Food Sanitation Act Law ConcerningStandardization and Proper [食品衛生法]Labelling of Agricultural and Forestry Products For safety and security of food To help consumers for Statement of identity better food choice Expiration date Storage condition Ingredient lists Food allergens Genetically modified foods Origin of foods Manufacturer’s Food additives name and address Health Promotion Act (Nutrition Labelling and Health Claims System) [健康増進法 （栄養成分表示、特別用途食品）] For improvement of nutritional status and promotion of health 2
Health Foods：Category [健康食品：分類] Pharma- Foods ceuticals Food for Special Dietary [医薬品] Health Foods Uses (FOSDU) [健康食品] ● Prescribed [特別用途食品] drugs So-called Food for For patients ● Over-the -Counter drugs “Health Foods” Specified Health For pregnant and lactating women [いわゆる健康食品] Uses (FOSHU) For infants For dysphagia patients● Dietary supplements [特定保健用食品] ● Low protein food● Other health related products etc ● Dietary fibers ● Lactose-free food・Prohibited to indicate Health Claims ● Infant formula etc ● Oligosaccharides or Function Claims ● Isoflavones etc ・Allowed to indicate Food With ・Allowed to indicate Claims for Special Dietary Uses Claims for Specified Nutrient Function Claims Dietary Uses [栄養機能食品] ●Vitamins & Minerals ・Allowed to indicate Claims for Nutrient Function 3
Food With Nutrient Function Claims [栄養機能食品]12 Vitamins: Vitamin A, Vitamin D, Vitamin E, Vitamin C, Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B6, Folic acid, Vitamin B12, Biotin, and Panthothenic acid5 Minerals: Calcium, Magnesium, Iron, Zinc, and CopperVitamin B1 Vitamin B1 is a nutritional element that assists in the production of energy from carbohydrates and in maintaining the health of the skin and mucous membranes.Vitamin E Vitamin E is a nutritional element that has antioxidant effects that prevent oxidation of lipids in the body and helps maintain cellular health. Calcium Calcium is a nutritional element necessary for bone and tooth formation. Iron Iron is a nutritional element necessary for red blood cell formation. 4
Market share of Health Foods [健康食品の市場規模]≪Market Growth of Foods for ≪Market Growth of other Health Foods Specified Health Uses (FOSHU) Products ≫ (excluding FOSHU)≫(Billion Yen) (Billion Yen) 5
Procedure Flow for Foods for Specified Health Uses (FOSHU) [特定保健用食品の表示許可の手順] Applicant Consumer Affairs Agency Food Labelling DivisionConsumer Commission Reviews efficacy Assessment and Evaluation Group for Novel FoodFood Safety Commission Reviews safetyExpert Assessment Group for Novel FoodConsumer Commission Reviews efficacy and safety comprehensively Assessment Committee for Novel Food Checks whether the labelling violatesMinistry of Health, Labour and Welfare Pharmaceutical Affairs Act Consumer Affairs Agency Approval 6
Categories of Foods for Specified Health Uses (FOSHU)[特定保健用食品の類型]FOSHU[特定保健用食品] Requires detailed review process with scientific evidence for each application.Standardized FOSHU[規格基準型の特定保健用食品] No requirement of detailed review process for food products meeting the established standards and specifications. Must be accompanied by sufficient accumulation of scientific evidence. For efficiency: short cut process for products whose safety of use already approved.Reduction of disease risk FOSHU[疾病リスク低減表示の特定保健用食品] Requires detailed review process with scientific evidence for each application. Permitted for products whose ingredients clinically and nutritionally established to reduce a risk of certain disease (i.e., Calcium for Osteoporosis and Folic acid for neural tube defects).Qualified FOSHU[条件付き特定保健用食品] Requires detailed review process with scientific evidence for each application. Permitted for products with ingredients showing certain health effects but not reaching the established standards for FOSHU approval. Labelled as “Qualified Foods for Specified Health Uses.” 7
Approved Health Claims on FOSHU[特定保健用食品の既許可品] Number Food Ingredients approved Health uses Model Claim, statements (As of category (Example) 2010/08/23) ● Helps maintain good GI condition. GI function Table sugar Oligosaccharides ● Helps improve bowel movement. 350 PowderedCholesterol level Chitosan ● Helps lower cholesterol level. 141 soft drink Medium-chain Refined oil ● Helps resist body fat gain.Triacylglycerol ・ fatty acids Body fat 67 Oolong tea Polyphenol ● For those concerned about body fat. Instant powderBlood pressure Peptides ● For those with high blood pressure. 120 soup ， candy ● Promotes calcium absorption. Bone Soft drink Soy isoflavone ● Supports bone health. 53 Mixture of Xylitol, Calcium Chewing ● Helps maintain strong and Teeth gum Monohydrogen Phosphate healthy teeth 73 and Fukuronori extract Soft drink, Blood glucose ● For those concerned about level Instant miso Indigestible dextrin blood glucose level. 150 soup 8
Prohibition of False and Misleading Labelling with respect to Health maintenance and Promotional effects [健康の保持増進効果等に関する虚偽・誇大広告等の表示の禁止](Under Health Promotion Law, Articles 32-2 and 32-3) Effective 2003/08/29 No person shall sell or advertise any prepackaged product containing a label in a manner that (1)substantially differs from the declared content or (2) likely fall into confusion with respect to health maintenance or promotional effects Violation Advisory issued when the labelling may cause a significant negative impact on public health. Order issued upon failure to comply with Advisory. Enforcement action (Penalty, inspection, administrative detention, imprisonment, etc) imposed upon failure to comply with Order. 9
Roundtable on Health Claims [健康食品の表示に関する検討会] 20 09 20 10Time period: From November to July Areas of Discussion Review current systems of Health Foods and identify areas in need of improvement Labelling systems of Food for Specified Health Uses (FOSHU) and other foods under Health Promotion Law Enforcement for appropriate labelling of Health Foods 27 20 10 Final report released on August th,FOSHU ApprovalImprove approval process (e.g., speed, clarity, and transparency)Improve labelling presentation of information (e.g., clear, accurate, and understandable) Regulation of so-called “Health Foods”Develop Guidelines for tightening regulatory control on False and misleading labellingCollect scientific evidence on targeted nutritional components for further discussion about authorization Further issuesTransfer some responsibilities of Consumer Affairs Agency to Consumer Commission (e.g., Discussion on standards of suspension and expansion of regulation) 10
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