5. Claim Requirements

Foods with Function Claims (FFC)
Japan

This section provides information on the definition of different types of claims and any restrictions or allowance of claims as well as claim registration processes.

5.1 Overview of Claims

5.1.1 Types & Definitions of Claims

Nutritional Claims

The Food Labeling Standards (Cabinet Ordinance No. 10 of 2015) allow nutrient content claims for specific nutrients as an optional labeling content [1]. When a food product meets the requirements set out by the Standards, it can bear a nutrient content claim without any submission or notification to the authority.

Health Claims

There is no legal definition for "health claims" in Japan. Article 9 (10) of the Food Labelling Standards (Cabinet Ordinance No. 10 of 2015) defines "Foods with Health Claims" as the collective term of the Foods for Specified Health Uses (FOSHU), Foods with Nutrient Function Claims (FNFC), and Foods with Function Claims (FFC) [1]. 

Additionally, "Foods with Health Claims" are generally defined as "foods that claim functions of foods according to the standards established by the Japanese government related to safety and functionality".   

The CAA gives a general definition of FOSHU as "foods containing a functional ingredient that has physiological effects and claiming that people can expect specific effects on their health by consuming the foods". In order to market a food product as a FOSHU, pre-market approval by the CAA is required.

The CAA gives a general definition of FNFC as "foods intended to supplement daily intake of the nutrients specified by the CAA and with claims that describe the well-established functions of the nutrients". The prescribed FNFC claims can be made when the product contains the required amount per daily serving of specific nutrients (currently 1 fatty acid, 6 minerals, and 13 vitamins) without any submission/approval. 

5.1.2 List of Prohibited Claims

General Food

It is not allowed to make any health claim (including the FFC claims) on foodstuff/general foods unless they fall into the categories of Foods for Specified Health Uses (FOSHU), Foods with Nutrient Function Claims (FNFC), or FFC by completing the necessary regulatory procedures [1]. 

Category [2]

FFC products are not allowed to bear any of the following claims:

• Claims that are associated with the cure, treatment, and prevention of diseases
• Claims that emphasize the nutrients contained in FFC products other than the functional ingredient (excluding the nutrient content claims described in "Nutritional Claims")
• Claims that could mislead consumers that the product has been evaluated and/or approved by the CAA
• Health/function claims of the nutrients for which a national dietary reference intake has been established 

 Examples of expression not allowed for FFC products are listed below:

• An expression that implies cure or prevention of diseases (e.g., “for people with diabetes”, “for people with hypertension”, etc.)
• An expression that intentionally claims to strengthen the body that exceeds maintenance and improvement of health (e.g., “reconstruction of the body (bodybuilding/muscle building)”, “hair restoration”, “skin-whitening”, etc.)
• Expression related to functionality that has not been explained based on scientific evidence (e.g., Expression in which the data of limited immunological indicators are exaggerated and wrongly imply that the product improves immunological function of the whole body; or expression based on the evidence that is confirmed through in vitro or in vivo experiments such as increased antibodies or immune cells, but not confirmed in the body for its functionality; etc.) 

If a food business operator wishes to make any function claim(s) for its final product under the FFC category, it will need to file a notification and receive a notification number from the CAA. Notification is required for each final product.

Product

Same as above.

5.2 Nutritional Claims

5.2.1 Permitted Claims

General Foods [1]

The following types of nutrient content claims are permitted for protein, dietary fiber, zinc, potassium, calcium, iron, copper, magnesium, niacin, pantothenic acid, biotin, vitamin A, B1, B2, B6, B12, C, D, E, and K, and folic acid:

• "High in" claims (e.g., "High in protein", "Plenty of Vitamin C")
• "Source of" claims (e.g., "Contain calcium", "Source of dietary fiber")
• "Fortified" claim (e.g., "Vitamin E 30% up", "Double calcium") 

The following types of nutrient content claims are permitted for calorie, fat, saturated fatty acids, cholesterol, sugars, and sodium:

• "Not-contained" claims (e.g. "Nonsugar", "Calorie zero")
• "Low in" claims (e.g. "Low cholesterol", "Calorie light")
• "Reduced" claims (e.g. "Calorie 30% cut", "Fat 10g off", "Calorie half")

Category [1]

An FFC product can bear nutrient content claims in addition to its FFC claim when it satisfies applicable requirements.

Product

Same as above.

5.2.2 Nutritional Claim Registration

N/A

5.3 Health Claims

5.3.1 Permitted Claims

General Foods

Health claims are not allowed on General Foods. Health claims are only allowed on one of the following 3 categories of "Food with Health Claims":

1. Foods for Specified Health Uses (FOSHU)
2. Foods with Nutrient Function Claims (FNFC)
3. Foods with Function Claims (FFC)

Category [2]

An FFC product cannot bear a “FOSHU claim" or FNFC claims along with its “FFC” claim. For FFC, a pre-market notification of the final product to the CAA is required. FFC claim content/wordings are determined by food business operators and shall be scientifically substantiated.

Possible claims for the purpose of health shall be within the expression that the product is helpful or suitable for individuals who are not in diseased conditions (expression related to disease risk reduction is prohibited) [2]:

• Helps to maintain or improve conditions of physiological functions, and functions of bodily tissues.
• Helps to maintain or improve physical conditions that are easily measured or can be recognized by individuals and to improve temporary changes of such conditions (not continuous or chronic).  

Product

Same as above.

5.3.2 Health Claim Registration

General Foods

N/A

Category

Unlike FOSHU, the government does not evaluate the safety and effectiveness of FFC. Food business operators make appropriate function claims based on scientific evidence for which they are responsible. The scientific evidence for function claims must be obtained from a clinical trial(s) or systematic literature review(s). The FFC claim is notified to the authorities as part of the FFC product notification (please refer to section 6).

Product

N/A

5.4 Other Notes or Requirements for Claims

N/A

5.5 References

1. Food Labelling Standards (Cabinet Ordinance No.10 of 2015)
https://elaws.e-gov.go.jp/document?lawid=427M60000002010 (in Japanese)

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 (in Japanese)