3. Compositional Aspects
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3. Compositional Aspects
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Foods for Specified Health Uses (FOSHU)
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 FOSHU, 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. for this sub-food category (e.g. must comply with the compositional requirement of a soup or yogurt if the FOSHU is a soup or yogurt to begin with). 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 FOSHU except for the Standardized FOSHU. For all types of FOSHU, all raw materials 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 and shall be permitted for use in FOSHU.
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.
In addition to the above, Standardized FOSHU products shall contain a prescribed functional ingredient in order to bear a prescribed claim [2]. Currently, there are 9 prescribed ingredients, 3 of which are dietary fiber and 6 of which are oligosaccharides. They are presented in Table 5.3.1-1 together with the prescribed claims. There are compositional specifications that each of the 9 prescribed ingredients must conform to [2].
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 see Section 3.5 below.
Category
If the added nutrient is permitted for use in the food category to which the FOSHU product belongs (e.g., soft drink, supplement-form food) and permitted in FOSHU, it can be used for fortification of the FOSHU product.
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 FOSHU would be permitted.
The exact requirements can vary by food products, but the following parameters are generally required [3]:
- 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 Additives [4] and the List of Existing Food Additives [5]. Please also refer to the reference link on "Standards for Use" [6].
Category
Same as above.
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 [4], Essence list of 18 kinds [7], and List of Original Source Plants and Animals of Natural Flavoring Agents [8]. The permitted colors can be searched from the List of Designated Food Additives [4], the List of Existing Food Additives [5], and List of Substances Which Are Generally Provided for Eating or Drinking as Foods and Are Used as Food Additives [9]. For the permitted uses and use levels of colors, please also refer to the reference link on "Standards for Use" [6].
Category
Same as above.
Product
Same as above.
3.7 Permitted Processing Aids
General food
Same as above.
Category
Same as above.
Product
Processing aids are food additives in Japan. Please see “Product” in Section 3.5 on Permitted Additives 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. Appendix 3 of Notification by the Deputy Director General of the Consumer Affairs Agency (Shou-Shoku-Hyou No.259 of 30 October 2014)
3. 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)
4. List of Designated Food Additives
https://www.ffcr.or.jp/en/tenka/list-of-designated-additives/list-of-designated-additives.html
5. List of Existing Food Additives
https://www.ffcr.or.jp/en/tenka/list-of-existing-food-additives/list-of-existing-food-additives.html
6. Standards for Use
https://www.ffcr.or.jp/en/upload/StandardsforUseFeb32021.pdf
7. Essence list of 18 kinds
https://www.ffcr.or.jp/en/upload/5327644e6078f4442dfc6fa54238c7c7d23aeb77.xlsx
8. List of original source plants and animals of natural flavoring agents
9. List of Substances Which Are Generally Provided for Eating or Drinking as Foods and Are Used as Food Additives
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