3. Compositional Aspects

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General Foods
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

None.

3.2 Raw Material Requirements

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 (Act No. 70 of 2013) [1] and Public Notice No. 370 [1]. Specific requirements vary by type of product, but general requirements include:

Non-use of antibiotics unless it is approved
Non-use of GM technology unless it is approved
Non-use of unauthorized additives (described in more detail in Sections 3.3, 3.5 to 3.7 below)
Compliance with the maximum residue limits (MRL) of agricultural chemicals (described in more detail in Sections 8.3 and 8.4 of this guidebook)
Compliance with cesium limits (described in more detail in Section 8.2)
Non-use of irradiation

3.3 Fortification

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 see Section 3.5 - Permitted Additives - below.

3.4 Other Permitted Ingredients

None.

3.5 Permitted Additives

Imported products that are sold in Japan must be compliant with the Japanese requirements regardless of their country of production. 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 Additives [2] and the List of Existing Food Additives [3]. The permitted food categories and use levels can be seen in the "Standards for Use of Food Additives" [4].

In the permitted additives lists, there are 2 types of permitted additives:

Additives permitted with no restriction for use (can be used according to GMP)
Additives permitted with restrictions for use

For additives with restrictions for use, the use of the additive must conform to the use standards (whether their product is included in the permitted food categories and their use is within the permitted upper use level).

3.6 Permitted Flavors and Colors

Flavors and colors are considered as food additives in Japan. Therefore, the same approach applies, 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 [2], Essence list of 18 kinds [5], and List of Original Source Plants and Animals of Natural Flavoring Agents [6].

The permitted colors can be searched from the List of Designated Food Additives [2], the List of Existing Food Additives [3], and the List of Substances Which Are Generally Provided for Eating or Drinking as Foods and Are Used as Food Additives [7]. For the permitted uses and use levels of colors, please also refer to the reference link on "Standards for Use of Food Additives" [4].