1. Regulatory Systems
of Health foods in Japan
October, 2010
Consumer Affairs Agency
Food Labelling Division

2. Relationships among Japanese Agricultural Standards Law (JAS), Food Sanitation
Act, 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 Concerning
Standardization 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
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3. 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
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4. 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 acid
5 Minerals: Calcium, Magnesium, Iron, Zinc, and Copper
Vitamin 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.
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5. 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)
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6. 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 Division
Consumer Commission Reviews efficacy
Assessment and Evaluation Group for Novel Food
Food Safety Commission
Reviews safety
Expert Assessment Group for Novel Food
Consumer Commission
Reviews efficacy and safety comprehensively
Assessment Committee for Novel Food
Checks whether the labelling violates
Ministry of Health, Labour and Welfare Pharmaceutical Affairs Act
Consumer Affairs Agency Approval
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7. 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.”
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8. 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
Powdered
Cholesterol 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
powder
Blood 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
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9. 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

10. Roundtable on Health Claims [健康食品の表示に関する検討会]
20
09
20
10
Time 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
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20
10
Final report released on August th,
FOSHU Approval
Improve 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 labelling
Collect scientific evidence on targeted nutritional components for further discussion
about authorization
 Further issues
Transfer some responsibilities of Consumer Affairs Agency to Consumer Commission
(e.g., Discussion on standards of suspension and expansion of regulation)
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