5. Claim Requirements

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Foods for Specified Health Uses (FOSHU)
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) allows 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 Labeling 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 FFC as “foods notified to the CAA as products whose labels bear function claims based on scientific evidence, under the responsibility of food business operators”, In order to market a food product as an FFC, completion of notification to the CAA is required.

5.1.2 List of Prohibited Claims

General Food

It is not allowed to make any health claim (including the FOSHU's 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.

Category

There is no specific prohibited claim under the FOSHU system, but FOSHU claims shall be within the maintenance and promotion of health.

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 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

A FOSHU product can bear nutrient content claims in addition to its FOSHU 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 allowed when the product fits into one of the following 3 categories of "Food with Health Claims":

Foods for Specified Health Uses (FOSHU): pre-market approval for a final product by the CAA is required.
Foods with Nutrient Function Claims (FNFC): no pre-market approval/submission is required, but a final product must meet the applicable requirements and bear prescribed FNFC claims.
Foods with Function Claims (FFC): a pre-market notification for a final product to the CAA is required.

Specific claim contents/wordings for FOSHU and FFC are determined by food business operators. The FNFC claims for each nutrient are prescribed by the CAA.

Category

Specific claim contents/wordings for FOSHU (FOSHU, Qualified FOSHU, Disease Risk Reduction FOSHU, and Reapproved FOSHU) are determined by food business operators.

The prescribed claims for the Standardized FOSHU are presented in Table 5.3.1-1 below [2].

There are prescribed claims for the Disease Risk Reduction FOSHU (Table 5.3.1-2 below) [3]. For those claims, reduced requirements for scientific evidence are applied.