3. Compositional Aspects

Foods with Function Claims (FFC)
Japan

This section provides the compositional requirements for the food category and/or food products in scope and information on permitted nutrients, ingredients, and additives.

3.1 Composition Requirements

General food

None.

Category

There are no compositional parameters that are specifically required for FFC, but food products shall be compliant with the compositional requirements set out by the Food Sanitation Act (Act No. 233 of 1947) [1] and its subordinate regulatory texts. The exact requirements can vary depending on the type of product.

Product

Same as above.

3.2 Raw Material Requirements

General food

None.

Category

There are no items that are specifically required for raw materials used in FFC, but all raw materials shall be compliant with the Food Sanitation Act (Act No. 233 of 1947) [1] and its subordinate regulatory texts and shall be permitted for use in FFC.

In Japan, raw materials added to food products are divided into 2 categories: food ingredients and food additives.

Food ingredients are not regulated by a positive list, and their use is permitted when they conform to the requirements of the Food Sanitation Act and “The Specifications and Standards for Foods, Additives, etc.”. Specific requirements vary by type of products, but general requirements are: non-use of antibiotics unless it is approved, non-use of GM technology unless it is approved, non-use of unauthorized additives, compliance with the maximum residue limits (MRL) of agricultural chemicals, compliance with cesium limits and non-use of irradiation.

Food additives are regulated by a positive list system. For the list of permitted additives, please refer to Section 3.5 below.

Product

Same as above.

3.3 Fortification

General food

All added nutrients including vitamins, minerals and amino acids added as nutritional substances are food additives in Japan. Products can be fortified when the nutrient is permitted for use as a food additive. For the list of permitted additives, please refer to Section 3.5 - Permitted Additives - below. 

Category

If the added nutrient is permitted for use in FFC, it can be used for fortification of the FFC product. Vitamins and minerals are allowed to be added but cannot claim functional properties.

Product

Same as above.

3.4 Other Permitted Ingredients

General food

None.

Category

If the ingredient is a food ingredient (i.e., not an additive) and is compliant with the requirements set out by the Food Sanitation Act (Act No. 233 of 1947) [1] and its subordinate regulatory texts, its use in FFC would be permitted.

The exact requirements can vary by food products, but the following parameters are generally required [2]:

• Non-use of unauthorized food additives
• Non-use of GM technology unless it is permitted
• Conformity with the MRLs of agricultural chemicals
• Conformity with the cesium limit
• Non-use of irradiation
• Non-use of antibiotics unless it is approved
  

Product

Same as above.

3.5 Permitted Additives

General food

A product can contain food additives that are permitted for use in the food category of the product. The permitted additives can be searched from the List of Designated Food Additives [3] and the List of Existing Food Additives [4]. Please also refer to the reference link on "Standards for Use" [5].

Category

An FFC product can contain food additives that are permitted for use in FFC. The permitted additives can be searched from the Lists of Designated Food Additives [3] and the List of Existing Food Additives [4]. Please also refer to the reference link on "Standards for Use" [5].

Product

Same as above.

3.6 Permitted Flavors and Colors

General food

A product can contain flavors and colors (both are food additives) that are permitted for use in the food category of the product. The permitted flavors can be searched from the List of Designated Food Additives [3], Essence list of 18 kinds [6], and List of Original Source Plants and Animals of Natural Flavoring Agents [7]. The permitted colors can be searched from the List of Designated Food Additives [3], the List of Existing Food Additives [4], and List of Substances Which Are Generally Provided for Eating or Drinking as Foods and Are Used as Food Additives [8]. For the permitted uses and use levels of colors, please also refer to the reference link on "Standards for Use" [5].

Category

An FFC product can contain flavors and colors (both are food additives) that are permitted for use in FFC. The permitted flavors can be searched from the List of Designated Food Additives [3], Essence list of 18 kinds [6], List of Original Source Plants and Animals of Natural Flavoring Agents [7]. The permitted colors can be searched from the List of Designated Food Additives [3], the List of Existing Food Additives [4], and List of Substances Which Are Generally Provided for Eating or Drinking as Foods and Are Used as Food Additives [8]. For the permitted uses and use levels of colors, please also refer to the reference link on "Standards for Use" [5].

Product

Same as above.

3.7 Permitted Processing Aids 

General food

Processing aids are food additives in Japan. Please refer to “General food” in Section 3.5 - Permitted Additives - above.

Category

Same as above.

Product

Same as above.

3.8 Additional Notes 

None.

3.9 References

1. Food Sanitation Act (Act No. 233 of 1947)

https://www.japaneselawtranslation.go.jp/ja/laws/view/3687 (in English) 

2. Specification for General Foods in "the Specifications and Standards for Foods, Additives etc." (Ministry of Health and Welfare Public Notice No.370 of 1959)

https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/zanryu/591228-1.html (in Japanese) 

3. List of Designated Food Additives 

https://www.ffcr.or.jp/en/tenka/list-of-designated-additives/list-of-designated-additives.html

4. List of Existing Food Additives

https://www.ffcr.or.jp/en/tenka/list-of-existing-food-additives/list-of-existing-food-additives.html

5. Standards for Use

https://www.ffcr.or.jp/en/upload/StandardsforUseFeb32021.pdf

6. Essence list of 18 kinds

https://www.ffcr.or.jp/en/upload/5327644e6078f4442dfc6fa54238c7c7d23aeb77.xlsx

7. List of original source plants and animals of natural flavoring agents

https://www.ffcr.or.jp/en/upload/5327644e6078f4442dfc6fa54238c7c7d23aeb77.xlsx

8. List of Substances Which Are Generally Provided for Eating or Drinking as Foods and Are Used as Food Additives 

https://www.ffcr.or.jp/en/tenka/list-of-substances/list-of-substances-which-are-generally-provided-for-eating-or-drinking-as-foods-and-which-are-used-a.html