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]

7

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]

8

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)