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October, 2010Consumer Affairs AgencyFood Labelling Division
Regulatory Systemsof Health foods in Japan
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]
2
JAS:Law Concerning
Standardization and ProperLabelling of Agricultural and
Forestry Products
Food Sanitation Act[食品衛生法]
Ingredient lists
Origin of foods
Food allergens
Food additives
Statement of identity
Genetically modified foods
Expiration date
Storage condition
To help consumers forbetter food choice
For safety andsecurity of food
Manufacturer’sname 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
Pharma-ceuticals[医薬品]
Health Foods:Category [健康食品:分類]
Foods
So-called“Health Foods”[いわゆる健康食品]
Food forSpecified HealthUses (FOSHU)
[特定保健用食品]
Food WithNutrient Function Claims
[栄養機能食品]
Food for Special DietaryUses (FOSDU)[特別用途食品]
3
● Prescribeddrugs
● Over-the-Counter drugs
● Low protein food● Lactose-free food● Infant formula etc
・Allowed to indicateClaims for SpecialDietary Uses
● Dietary fibers● Oligosaccharides● Isoflavones etc
・Allowed to indicateClaims for SpecifiedDietary Uses
●Vitamins & Minerals
・Allowed to indicateClaims for Nutrient Function
For patientsFor pregnant andlactating womenFor infantsFor dysphagia patients
● Dietary supplements● Other health related products etc
・Prohibited to indicate Health Claimsor Function Claims
Health Foods[健康食品]
Food With Nutrient Function Claims [栄養機能食品]
4
Calcium is a nutritional element necessary for bone and tooth formation.
Vitamin E is a nutritional element that has antioxidant effects that preventoxidation of lipids in the body and helps maintain cellular health.
Vitamin B1 is a nutritional element that assists in the production of energyfrom carbohydrates and in maintaining the health of the skin and mucousmembranes.
Vitamin B1
Vitamin E
Calcium
Iron is a nutritional element necessary for red blood cell formation.Iron
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 acid
5 Minerals: Calcium, Magnesium, Iron, Zinc, and Copper
Market share of Health Foods [健康食品の市場規模]≪Market Growth of Foods for
Specified Health Uses (FOSHU) Products ≫≪Market Growth of other Health Foods
(excluding FOSHU)≫
5
(Billion Yen) (Billion Yen)
Consumer Affairs Agency 6
Consumer CommissionAssessment Committee for Novel Food
Food Safety CommissionExpert Assessment Group for Novel Food
Ministry of Health, Labour and Welfare
Procedure Flow for Foods for Specified Health Uses (FOSHU)[特定保健用食品の表示許可の手順]
Reviews safety
Reviews efficacy and safety comprehensively
Checks whether the labelling violatesPharmaceutical Affairs Act
Approval
Applicant
Consumer Affairs Agency Food Labelling Division
Consumer CommissionAssessment and Evaluation Group for Novel Food
Reviews efficacy
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 andFolic 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.”
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.
Categories of Foods for Specified Health Uses (FOSHU)[特定保健用食品の類型]
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FOSHU[特定保健用食品] Requires detailed review process with scientific evidence for each application.
Approved Health Claims on FOSHU[特定保健用食品の既許可品]
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Health usesFood
categoryIngredients(Example)
Model Claim, statements
Numberapproved
(As of2010/08/23)
GI function Table sugar Oligosaccharides ● Helps maintain good GI condition.● Helps improve bowel movement. 350
Cholesterol levelPowderedsoft drink
Chitosan ● Helps lower cholesterol level. 141
Refined oilMedium-chain
fatty acids ● Helps resist body fat gain.
Oolong tea Polyphenol ● For those concerned about body fat.
Blood pressure
Instantpowdersoup,candy
Peptides ● For those with high blood pressure. 120
Bone Soft drink Soy isoflavone ● Promotes calcium absorption.● Supports bone health. 53
TeethChewing
gum
Mixture of Xylitol, CalciumMonohydrogen Phosphate
and Fukuronori extract
● Helps maintain strong andhealthy teeth 73
Blood glucoselevel
Soft drink,Instant miso
soupIndigestible dextrin ● For those concerned about
blood glucose level. 150
Triacylglycerol ・Body fat 67
Prohibition of False and Misleading Labellingwith 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]
9
Effective 2003/08/29
No person shall sell or advertise any prepackaged productcontaining 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
Advisoryissued when the labelling may cause a significant negative impact on public health.
Orderissued upon failure to comply with Advisory.
Enforcement action (Penalty, inspection, administrative detention, imprisonment, etc)imposed upon failure to comply with Order.
(Under Health Promotion Law, Articles 32-2 and 32-3)
ViolationViolation
Roundtable on Health Claims [健康食品の表示に関する検討会]
10
Time period: From November 20 09 to July 20 10
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
Final report released on August 27 th, 20 10
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)