Health Food Regulatory System in Japan

1. Introduction

1.1 Definition of “health food” in Japan

Foods that are sold or used as items useful for maintenance and improvement of health are generally referred to as “health foods”. From the legal perspective, however, there is no explicit definition for the term, except from “foods with health claims” that is defined under Health Promotion Law.

1.2 Relevant laws and regulations

  • Food Sanitation Act
  • Food Safety Basic Law
  • Japanese Agricultural Standards Law
  • Health Promotion Law
  • Pharmaceutical Affairs Law

1.3 Classification

“Foods with health claims (FHC)” are defined as foods which alter physiological functions and have characteristics between that of a drug and a conventional food. The definition includes so-called functional foods, and can be divided into two subcategories based on differences in purpose and function: “foods with nutrient function claims (FNFC)” and “foods for specified health uses (FOSHU)”. The former refers to the foods that are labeled with the functions of nutritional ingredients (vitamins and minerals), and the latter refers to the foods officially approved to claim a physiological effect on the human body. FNFC is the standard regulation system, consisting of 12 vitamins and 5 minerals, while FOSHU is an individual approval system, including four subcategories under it: ordinary FOSHU, standardized FOSHU, health claims for the reduction of disease risk, and qualified FOSHU.

Classification of Foods with Health Claims

Medicine

Foods with Health Claims (FHC)

Other foods (may include so-called functional foods)

Food with Nutrient Function Claims (FNFC)

(Standard regulation system)

Foods for Specified Health Uses (FOSHU)

(Individual approval system)

Ordinary FOSHU

Standardized

Reduction of disease risk

Qualified

1.3.1 Food with Nutrient Function Claims (FNFC)

FNFC refers to all food that is labeled with the nutrient function claims specified by the MHLW. The standards and specifications for indication of nutritional function have been established for 17 ingredients (12 vitamins and 5 minerals).
These foods may be freely manufactured and distributed without any permission from or notification to the national government, provided that it meets the established standards and specifications.

12 vitamins: Niacin, Pantothenic acid, Biotin, Vitamin A, Vitamin B1, Vitamin B2, Vitamin B6, Vitamin B12, Vitamin C, Vitamin D, Vitamin E, and Folic acid

5 minerals: Zinc, Calcium, Iron, Copper, and Magnesium

Standards and specifications

Nutritional Ingredient Specified Range of nutritional ingredient of the advisable daily intake Function Claims Warning Indication
Niacin 3.3 ~ 60 mg Helps to maintain skin and mucosa healthy Increased intake of this product will not result in curing diseases or promoting health.   Please comply with the advisable daily intake.
Pantothenic acid 1.65 ~ 30 mg Helps to maintain skin and mucosa healthy
Biotin 14 ~ 500 μg helps to maintain skin and mucosa healthy
Vitamin A 135 ~ 600 μg Helps to maintain vision in the dark, and helps to maintain skin and mucosa healthy Increased intake of this product will not result in curing diseases or promoting health.   Please comply with the advisable daily intake. Women within third months of pregnancy or women considering to be pregnant should be careful of over consumption.
Vitamin B1 0.30 ~ 25 mg Helps to produce energy from carbohydrate and  to maintain skin and mucosa healthy Increased intake of this product will not result in curing diseases or promoting health.   Please comply with the advisable daily intake.
Vitamin B2 0.33 ~ 12 mg Helps to maintain skin and mucosa healthy
Vitamin B6 0.3 ~ 25 mg Helps to produce energy from protein and to maintain skin and mucosa healthy
Vitamin B12 0.60 ~ 60 μg Aids in the red blood cell formation
Vitamin C 24 ~ 1000 mg Helps to maintain skin and mucosa healthy and has anti-oxidizing effect
Vitamin D 1.5 ~ 5.0 μg Promotes to absorb calcium in gut intestine and aids in the growth of bone
Vitamin E 2.4 ~ 150 mg Helps to protect fat in the body from being oxidized and to maintain the cell health
Folic acid 60 ~ 200 μg Aids in the red blood cell formation, and contributes the normal growth of the fetus Increased intake of this product will not result in curing diseases or promoting health.   Please comply with the advisable daily intake.  This product helps normal development of fetus, but increased intake of this product will not result in better development of fetus.
Zinc 2.1 ~ 25 mg Necessary nutrient to maintain normal taste and helps to maintain healthy skin and mucous membranes. It is involved in the metabolism of protein and nucleic acids and is helpful in maintaining health Increased intake of this product will not result in curing diseases or promoting health.   Too much intake of zinc might inhibit absorption of copper.  Please comply with the advisable daily intake.  Infants and young children should avoid use of this product.
Calcium 210 ~ 600 mg Necessary in the development of bone and teeth Increased intake of this product will not result in curing diseases or promoting health.   Please comply with the advisable daily intake.
Iron 2.25 ~ 10 mg Necessary in the red blood cell formation
Copper 0.18 ~ 6 mg Helps to form red blood cells and helps proper function of many body enzymes and bone formation Increased intake of this product will not result in curing diseases or promoting health.   Please comply with the advisable daily intake. Infants and young children should avoid use of this product.
Magnesium 75 ~ 300 mg Necessary in the development of bone and teeth, maintain proper blood circulation, and helps proper function of many body enzymes and energy generation Increased intake of this product will not result in curing diseases or promoting health.   Increased intake might cause diarrhea.  Please comply with the advisable daily intake.  Infants and young children should avoid use of this product.

In addition to these nutrients, vitamin K, potassium and omega-3 fatty acids are newly incorporated into this self-certification system.

1.3.2 Foods for Specified Health Uses (FOSHU)

Foods for specific health uses are foods that include functional health ingredients with physiological functions and biological activity on the body bearing claims relating to the expected changes in physiological functions that can be expected from intake of the food with the intention of achieving a specific health function.

When foods are sold as foods for specified health uses, a screening by the national government must be conducted concerning the efficacy of the individual physiological functions and specified health functions as well as safety, etc. and approval must be obtained.
 
Ordinary FOSHU: requires detailed review process with scientific evidence for each application

Standardized FOSHU:

  • 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 has already be assessed and approved

Reduction of disease risk FOSHU:

  • 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:

  • 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
  • Labeled as “Qualified Food for Specified Health Uses”

1.3.3 FOSHU health claims allowed

  • Gastrointestinal health
  • Cholesterol moderation
  • Hypertension moderation
  • Lipid metabolism moderation
  • Sugar absorption moderation
  • Mineral absorption
  • Bone health
  • Tooth health

2. FOSHU approval

2.1 General procedure for approval of FOSHU

Those who wish to apply their products for FOSHU labeling are required to submit the following documentation:

Sample of the entire package with labels and health claims
Documentation that demonstrates clinical and nutritional proof for the product and/or its functional component for the maintenance of health
Documentation that demonstrates clinical and nutritional proof of the intake amount of the product and/or its functional component
Documentation concerning the safety of the product and its functional component, including additional human studies about the eating experience
Documentation concerning the stability of the product and its functional component
Documentation of the physical and biological characteristics of the product and the functional component
Methods of qualitative/quantitative analytical determination of its functional component, and analytical assay results of the component in the product
Report on the analysis of the designated nutrient constituents and energy content of the product
Statement of the production method, list of factory equipment, and an explanation of the quality control system

Mandated FOSHU documentation can be summarized into 3 essential requirements for FOSHU approval: 1) its effectiveness based on scientific evidence including clinical studies; 2) its safety as assessed from historical consumption pattern data and additional safety studies conducted in humans; and 3) analytical determination of the functional component responsible for the beneficial physiological action.

2.2 Flow chart of FOSHU approval

FOSHU was enacted under the Nutrition Improvement Law. This law lists five categories of “food for special dietary uses”: (1) milk powder for pregnant and lactating women; (2) formulated milk powder for infants; (3) foods for elderly individuals with difficulty in masticating or swallowing; (4) medical foods for the ill; (5) FOSHU
 
FOSHU applications are accepted every three months. The practical minimum period required for the approval process is approximately 1 year.

3. Labeling requirements

3.1 Mandatory statements on the label of “food with health claims” in Japan

Foods with nutrient function claims Foods for specified health uses
1. “Food with Health Claim (Food with Nutrient Function Claim)”
2. Nutrient content
Energy, protein, lipid, carbohydrate, sodium, and the mineral or vitamin claimed for function
3. Nutrient function claim
4. Dosage and administration
5. Method of consumption
6. Percentage of the daily portion of consumption to the recommended dietary allowance
7. Attention and warning
8. “Unlike food with specified health uses, this product has not undergone individual evaluation by the Ministry of Health, Labor and Welfare.”
1. “Food with Health Claim (Food for Specified Health Use)”
2. Nutrient content
Energy, protein, lipid, carbohydrate, sodium, and the ingredient claimed for function
3. Structure/function health claim or enhanced health claim approved
4. Dosage and administration
5. Method of consumption
6. Percentage of the daily portion of consumption to the recommended dietary allowance, if RDA is available for the ingredient
7. Attention and warning

3.2 Nutrient content claims

(1) Possible expression for high in XX, etc.

a) High: "high", "many", "rich in", and other similar expressions

b) Contain: "source of", "provides", "contains", "in", "used", "added", and other similar expressions

c) Enhanced:  Used when a nutrient is enhanced compared to other similar food

In order to display the statements above, the amounts of nutrients must be equal or greater than the standard value.

(2) Possible expression for low XX, etc.

a) Not contained: "none", "zero", "non-", and other similar expressions

b) Low: "low", "less", "a little", "light", and other similar expressions

c) Reduced: Used when nutrients are reduced compared to other similar food.

In order to display the statements above, the amount of nutrients must be equal or lesser than the standard value.