Food Compliance
Intelligence & Solutions
Health Food Regulatory System in Japan
Jul 01, 2015
Rose Hong
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CONTENTS

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" in Japan. 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

Laws and Regulations

Responsible Organization

Coverage or Main Content

Food Sanitation Act

MHLW/CAA/Prefectural capital

All food and drink, and food-related products

Pharmaceutical Affairs Law

MHLW/Prefectural capital/Police

Health food shall not be claimed to have the efficacy of pharmaceutical products

Act against 

Unjustifiable 

Premiums and 

Misleading 

Representations

CAA/Prefectural capital

False and exaggerated advertisements

Health Promotion Act

CAA/Prefectural capital

False and exaggerated advertisements (Objects: including media and advertising agency’s improper promotion)

Food Labeling Act

CAA/Prefectural capital

Labeling requirements

2. Classification of health foods in Japan


In Japan, health foods generally refer to "foods with health claims", which are defined as foods that have characteristics between that of a drug and a conventional food and can improve people's physiological functions. The definition includes health functional food, which refers to Food with Function Claims (FFC), Food with Nutrient Function Claims (FNFC), and Food for Specified Health Uses (FOSHU).

Health foods other than health functional food are classified as health food in general sense (so-called health food), such as nutritional supplementary food, health supplement, nutrient controlling food, etc. In general, these health foods are included in conventional food.

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2.1 Food with Function Claims (FFC)

FFC refers to food that has been labeled with functionality based on scientific evidence. Enterprises need to be responsible for the function claims. The safety and functionality information is required to notify the Consumer Affairs Agency before sale. However, unlike FOSHU, the stakeholders do not need to get an individual license by CAA.

It is noteworthy that Japan attaches great importance to credit. If the notified information is found to have any safety problem, it will cause considerable losses to the enterprises.

2.1.1 Procedure for Notification

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2.1.2 Mandatory Statements on the Label

  1. "Food with Function Claims" with notification number;

  2. Function claims based on scientific evidences;

  3. Nutrient content (energy, protein, lipid, carbohydrate, sodium, and the mineral or vitamin claimed for function);

  4. Method of ingestion;

  5. Attention and warning;

  6. Dosage;

  7. "without national's functional and safety assessment";

  8. "not for the diagnosis, treatment, or prevention of any disease";

  9. "A balanced diet contains staple food, main course and side dishes".

2.2 Food with Nutrient Function Claims (FNFC)

FNFC refers to all food that is labeled with the nutrient function claims specified by MHLW. There are standards and specifications for the indication of nutritional function, covering 20 ingredients (1 fatty acid, 6 minerals, and 13 vitamins).

These foods can be manufactured and distributed without any permission from or notification to the national government as long as they meet the established standards and specifications.

  • 1 Fatty acid: n-3 fatty acid

  • 6 Minerals: Zinc, Kalium, Calcium, Iron, Copper, and Magnesium

  • 13 Vitamins: Niacin, pantothenic acid, Biotin, Vitamin A, Vitamin B1, Vitamin B2, Vitamin B6, Vitamin B12, Vitamin C, Vitamin D, Vitamin E, vitamin K, and Folic acid

2.2.1 Standards and Specifications

Nutritional Ingredient

Specified Range of Nutritional Ingredient’s Advisable Daily Intake

Function Claims

Warning Indication

n-3 fatty acid

0.6 g–2.0 g

Helps maintain skin health.

Increased intake of this product cannot help cure diseases or promote health. Please comply with the advisable daily intake.

Zinc

2.64 mg15 mg

A necessary nutrient to maintain normal taste and help to maintain healthy skin and mucous membranes.

It is involved in the metabolism of proteins and nucleic acids, which is helpful in maintaining health.

Increased intake of this product cannot help cure diseases or promote health. Be careful not to overdose zinc. Too much intake of zinc might inhibit the absorption of copper. Please comply with the advisable daily intake. Infants and young children should avoid use of zinc supplement product.

Potassium

840 mg–2,800 mg

Helps maintain proper blood pressure.

Increased intake of this product cannot help cure diseases or promote health. Please comply with the advisable daily intake. One with hepatic function damage should avoid use of this product.

Calcium

204 mg–600 mg

Necessary in the development of bone and teeth.

Increased intake of this product cannot help cure diseases or promote health. Please comply with the advisable daily intake.

Iron

2.04 mg–10 mg

Necessary in the red blood cell formation.

Copper

0.27 mg–6.0 mg

Helps form red blood cells, maintains the proper function of various body enzymes, and promotes the bone formation.

Increased intake of this product cannot help cure diseases or promote health. Please comply with the advisable daily intake. Infants and young children should avoid use of copper supplement product.

Magnesium

96 mg–300 mg

Helps develop bone and teeth, improves blood circulation, maintains proper function of various body enzymes, and helps energy generation.

Increased intake of this product cannot help cure diseases or promote health. Increased intake may cause diarrhea. Please comply with the advisable daily intake. Infants and young children should avoid use of magnesium supplement product.

Niacin

3.9 mg–60 mg

Helps maintain skin and mucosa health.

Increased intake of this product cannot help cure diseases or promote health. Please comply with the advisable daily intake.

Pantothenic acid

1.44 mg–30 mg

Biotin

15μg–500μg

Vitamin A

231μg–600μg

Helps improve night vision, and maintain skin and mucosa health.

Increased intake of this product cannot help cure diseases or promote health. Please comply with the advisable daily intake. Female within three months of pregnancy or during pre-pregnancy should be careful of over consumption.

Vitamin B1

0.36 mg–25 mg

Helps produce energy from carbohydrate and maintain skin and mucosa health.

Increased intake of this product cannot help cure diseases or promote health. Please comply with the advisable daily intake.

 

 

 

 

 

 

 

Vitamin B2

0.42 mg–12 mg

Helps maintain skin and mucosa health.

Vitamin B6

0.39 mg–10 mg

Helps produce energy from protein and maintain skin and mucosa health.

Vitamin B12

0.72μg–60μg

Aids in red blood cell formation.

Vitamin C

30 mg–1,000 mg

Helps maintain skin and mucosa health and has anti-oxidizing effect.

Vitamin D

1.65μg–5.0μg

Promotes the absorption of calcium in gut intestine and aids in the growth of bone.

Vitamin E

1.98 mg–150 mg

Helps protect fat in the body from being oxidized and  maintain the cell health.

Vitamin K

45μg–150μg

Helps maintain proper blood coagulability.

Increased intake of this product cannot help cure diseases or promote health. Please comply with the advisable daily intake. One who is taking anticoagulant should avoid using  this product.

Folic acid

72μg–200μg

Aids in the red blood cell formation, and contributes the normal growth of the fetus.

Increased intake of this product cannot help cure diseases or promote health. Please comply with the advisable daily intake. This product helps the normal development of fetus, but an excessive intake cannot lead to better development of fetus.

2.2.2 Mandatory Statements on the Label

  1. "Food with Function Claims" with nutritional ingredient;

  2. Nutrient function claims;

  3. Nutrient content (energy, protein, lipid, carbohydrate, sodium, and the mineral or vitamin claimed for function);

  4. Method of ingestion;

  5. Attention and warning;

  6. Dosage;

  7. Percentage of the nutrient's daily consumption to the recommended dietary allowance;

  8. "Unlike food for specified health uses, this product has not undergone individual evaluation by Consumer Affairs Agency";

  9. "A balanced diet contains staple food, main course and side dishes".

2.3 Foods for Specified Health Uses (FOSHU)

Foods for specific health uses are foods that include functional health ingredients with physiological functions and can improve the biological activity of human body. FOSHU claims expect changes in physiological functions from intaking the food.

When foods are sold as FOSHU, a screening by the national government must be conducted concerning the product’s safety and efficacy of improving individual physiological functions and specified health functions, and an approval must be obtained before sale.

2.3.1 Different Types of FOSHU 

Mark

Food for Specified Health Uses







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  • Ordinary FOSHU:

A detailed review with scientific evidence is required for each application.

 

  • FOSHU to reduce disease risk:

FOSHU to reduce disease risk are products whose ingredients are clinically and nutritional-based to reduce the risk of certain diseases. (i.e., Calcium for Osteoporosis and Folic acid for neural tube defects). A detailed review with scientific evidence is required for each application.

 

  • Standardized FOSHU:

Standardized FOSHU refers to FOSHU with established standards and specifications for their ingredients, supported by sufficient scientific evidence. These FOSHUs are not required to conduct a detailed review for the ingredients have already met the established standards and specifications.


  • Re-permitted FOSHU:

The food has been approved but now applies for a slight change on the product name and flavor.

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  • Qualified FOSHU:

Qualified FOSHU refers to products with ingredients showing certain health effects but not reaching the established standards for FOSHU approval. A detailed review with scientific evidence is required for each application.

2.3.2 Flow Chart of FOSHU Approval

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  • Step 4 can be started before the completion of step 3. In other words, after applying, the applicant can send product samples to the National Institutes of Biomedical Innovation, Health and Nutrition (the National Institutes) or a registered inspection institute for analysis.

  • A detailed review is not required if the food products meet the established standards and specifications. FOSHU for reducing disease risk and re-permitting FOSHU is unnecessary to conduct a food health assessment; the applicant may omit the examination during step 2 and 3.

  • The practical period required for FOSHU approval process is approximately 2-5 years. 

2.3.3 Allowed Health Claims of FOSHU

  • Gastrointestinal health

  • Cholesterol moderation

  • Hypertension moderation

  • Lipid metabolism moderation

  • Sugar absorption moderation

  • Mineral absorption

  • Bone health

  • Tooth health

  • Iron supplement

  • Skin moisture maintenance

2.3.4 Mandatory Statements on the Label

  1. "Food for Specified Health Use";

  2. Nutrient content;

  3. Energy, protein, lipid, carbohydrate, sodium, and the ingredient claimed for function;

  4. Approved structure/function health claims or enhanced health claims ;

  5. Dosage;

  6. Method of ingestion;

  7. Percentage of the nutrient's daily consumption to the recommended dietary allowance if any nutrient is covered in FNFC's standard;

  8. Attention and warning;

  9. "A balanced diet contains staple food, main course and side dishes".

3. Comparison



Health food in general sense

Food with Function Claims

(FFC)

Food with Nutrient Function Claims

(FNFC)

Food for Specified Health Uses

(FOSHU)

Inspection

×

× 

(Corporate responsibility)

×

 (CAA)

Procedure

×

Notification

Standards compliance only

Registration

Labeling Requirements for Health Function claims

No health function claims

Labeling required for health function claims

Labeling required for the nutritional function claims indicated in the standard

Labeling required for approved health function claims

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