2. Product Categories

Foods with Function Claims (FFC)
Japan

This section provides the regulatory definition of the food category in scope, or the appropriate food category for the product in scope. Additionally, it provides the food products that belong to this food category along with the definition and specific information on each of these types of food products.

2.1 Category Name & Definition

Context

In Japan, food that is allowed to be labeled with certain nutritional or health function claims is of 3 types:

1) Foods for Specified Health Uses (FOSHU) 

FOSHU are scientifically recognized as helpful for maintaining and promoting health and are permitted to bear claims such as "Slows cholesterol absorption." FOSHU requires pre-approval by the Consumer Affairs Agency (CAA) which evaluates the claimed effects and safety of the product. 

2) Foods with Function Claims (FFC) 

FFC can be labeled with function claims under the food business operator's own responsibility. Evidence supporting the safety and effectiveness of the product must be submitted to the Consumer Affairs Agency before the product is marketed. However, unlike FOSHU, the product is not individually pre-approved. 

3) Foods with Nutrient Function Claims (FNFC) 

FNFC can be used to supplement or complement the daily requirement of nutrients (vitamins, minerals, etc.) which tend to be insufficient in everyday diet. FNFC contains certain amounts of nutrients whose function has already been substantiated by scientific evidence, it can bear a nutrient function claim prescribed by the Standards (currently 1 fatty acid, 6 minerals, and 13 vitamins) without submitting a notification to the government. 

Category Name

Foods with Function Claims (FFC) 

Definition

FFCs are pre-packaged food products that satisfy the following four criteria [1]:

1. The target users of FFC are healthy adults (18 years of age or older) who are not affected by any diseases. Children, expectant mothers (including those who are planning to become pregnant), and lactating mothers are excluded from the target users.

2. FFC is a food product that bears a function claim on its product package. The function claim indicates the fact that the particular FCC can contribute to a specific health purpose (which must be in the range of maintenance and promotion of health), and the claim must be based on scientific evidence. 

3. General foods are eligible for FFC, but the following items are excluded: Food for Special Dietary Uses (FSDU) including Food for Specified Health Uses (FOSHU) and Food with Nutrient Function Claims (FNFC), alcoholic beverages, and products that could lead to excessive consumption of lipids, saturated fatty acids, cholesterol, sodium, and sugars (restricted to monosaccharides and disaccharides but not sugar alcohol). 

4. Information that is included on the label of FFC products, name of food business operators and their contact information, evidence of safety and function claim, manufacturing process and quality control, post-market data collection system for adverse events, and other necessary information shall be notified to Secretary General of the CAA 60 days prior to the introduction of the product in the market. 

It is important to note that nutrients for which a national dietary reference intake has been established (e.g., vitamins and minerals) are excluded from the functional ingredients of FFC.

2.2 Product & Definition [1]

1) Supplement-Form Processed Foods 

Definition

Processed foods that:

• are in the form of tablets, capsules, powder, or liquid; and
• contain extracts of natural origin whose composition has been changed by separation/purification/chemical reactions etc., or synthetic chemicals as ingredients.

Specifications/Target Age

No specification is defined for this category of foods. FFC is intended for healthy adults (18 years of age or older). Children, expectant mothers (including those who are planning to become pregnant), and lactating mothers are excluded from the target users.

Additional Information

None.

2) Non-Supplement-Form Processed Foods

Definition

Processed foods that are not supplement-form processed foods. 

Tablets, powder, and liquid-form processed foods can be included in this category if there is a reasonable explanation that such foods do not result in excessive consumption and any health damages.

Specifications/Target Age

No specification is defined for this category of foods. FFC is intended for healthy adults (18 years of age or older). Children, expectant mothers (including those who are planning to become pregnant), and lactating mothers are excluded from the target users

Additional Information

Notifier needs to provide the rationale as to why their products can be considered conventional foods even in tablet/powder/liquid forms with no risk of overdose.

3) Fresh Foods

Definition

The definition is not provided.

Specifications/Target Age

No specification is defined for this category of foods. FFC is intended for healthy adults (18 years of age or older). Children, expectant mothers (including those who are planning to become pregnant), and lactating mothers are excluded from the target users.

Additional Information

None.

2.3 References

1. 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)