4. Labeling Requirements

Foods with Function Claims (FFC)
Japan

This section provides information on labeling requirements and the label approval process.

4.1 Mandatory Labeling Parameters

General Food [1,2]

A) Processed foods shall bear the following labeling items and shall be presented in the same table in the following order according to Article 8 and Appended Form 1 of the Food Labeling Standards:

1. Product generic name
2. List of ingredients (in decreasing order of weight)
3. List of additives (in a decreasing order of weight including processing aids unless exempted)
4. Net quantity
5. Expiry date (use-by date or best-before date)
6. Storage conditions
7. Country of origin (applicable for imported products)
8. Name of food business operator (manufacturer, processor, distributor, or importer)
9. Nutrition declaration table (per 100 g, 100 ml, serving, etc.)
10. Other labeling items are required on a case-by-case basis by the Food Labeling Standards 

The nutrition declaration table shall be prepared according to Article 8 and Appended Form 2 of the Standards. The nutrition declaration shall include the following mandatory information:

1. Unit (100 g, 100 ml, serving, etc.)
2. Energy (kcal)
   
3. Protein (g)
4. Fat (g)
5. Carbohydrates (g)
6. Salt equivalent (g)

The 5 macronutrients are mandatory for all processed foods, with some exemptions (e.g., the surface area for label indication is 30 cm² or smaller, alcoholic beverages, foods of which nutritional contribution is very limited such as coffee beans and their extract, herbs, and its extracts).

Note: The % of RDI is mandatory for FNFC, but not required for the other foods including general foods and FFC/FOSHU.

Declaration of other nutrients described below is optional but when doing so, there is a specific way required by the regulation.

The contents of the following nutrients can be included in the above table (Article 8 and Appended Form 3). When doing so, cholesterol shall be presented after fat and before carbohydrates. Saturated fatty acid, n-3 fatty acid, and n-6 fatty acid shall be presented as a breakdown of fat. The trans fatty acid can be declared after n-6 fatty acid. Similarly, sugar and dietary fiber shall be presented as a breakdown of carbohydrates. Mono- and di-saccharides shall be presented as a breakdown of sugar. The other ‘optional’ nutrients (i.e., vitamins and minerals) shall be presented after the salt equivalent.

• Unit (100 g, 100 ml, serving, etc.)
• Energy (kcal)
• Protein (g)
• Fat (g)
  • Saturated fatty acid (g)
  • n-3 fatty acid (g)
  • n-6 fatty acid (g)
  • Trans fatty acid (g)
• Cholesterol (mg)
• Carbohydrates (g)
  • Sugar (g)
  • Mono- and di-saccharides (g)
  • Dietary fiber (g)
• Salt equivalent (g)
• (vitamins and minerals (mg or µg))

The contents of any other food constituents that are not specified in the Food Labeling Standards (e.g., polyphenol, catechin, beta carotene, DHA) can be declared, but they shall be presented for example outside of the nutritional declaration table so that consumers can easily understand that they are not the nutrients specified by the Standards. 

B) Fresh foods (agricultural products, meat products, and seafood) shall bear the following labeling items:

1. Product generic name
2. Place of origin
3. Other labeling items required on a case-by-case basis by the Food Labeling Standards 

 Category

In addition to the mandatory items listed in "Foodstuff/General Food", the following items are required for FFC products (the words and sentences in brackets are the precise statements that FFC products must bear on their package):

1. Food classification
2. Notified health claim
3. Nutritional declaration table (per recommended daily serving)
4. Quantity of functional substance per unit of recommended daily intake
5. Recommended daily intake
6. Directions for use
7. Warnings for use
8. Notification number
9. The contact number of the food business operator (notifier)
10. Warnings that this product is not evaluated by the CAA
11. Notes for healthy eating
12. Instructions for storage and/or cooking method (if applicable)
13. Warnings that this product is not a drug
14. Warnings related to the intended population
15. Warnings for diseased people
16. Warnings related to health problems after consuming the product

Product

Same as above.

4.2 Languages

Japanese

4.3 Mandatory Information on Stickers

It is acceptable to capture mandatory labeling information on an additional sticker if such a sticker is used to present labeling information required by the Japanese regulations in the Japanese language.

4.4 Product Legal Name

Category

機能性表示食品 (meaning "Food with Function Claim")

4.5 Product-specific Labeling Statements

Category

Please see the "List of all the mandatory labeling parameters".

Product

Same as above.

4.6 Authority Approval of Product Label

General Food

Authority approval is not required for general foods (non-FFC products)

Category

Authority approval is not required. However, a product label sample must be included in the notification document and will be subject to the CAA's administrative check. The notification number issued by CAA shall be reflected on the label after approval.

The CAA will conduct an administrative check of the submitted notification document including the product label sample.

There are no governmental fees required for the FFC notification.

Product

Same as above.

4.7 Additional Notes on Labeling

None.

4.8 References

1. Food Labelling Standards (Cabinet Ordinance No.10 of 2015) 

https://elaws.e-gov.go.jp/document?lawid=427M60000002010

2. Guideline for the Notification Procedures of Foods with Function Claim https://www.caa.go.jp/policies/policy/food_labeling/foods_with_function_claims/assets/foods_with_function_claims_220401_0002.pdf