2. Product Categories
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2. Product Categories
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Foods for Specified Health Uses (FOSHU)
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
Category Name
Foods for Specific Health Uses (FOSHU)
Definition [1]
FOSHU are generally defined as pre-packaged food products that satisfy the following criteria:
- Products that bear a claim that consumers can expect the specified health benefit by consuming the product.
- Products that are evaluated by the government for their safety and effectiveness and are approved by the CAA. Depending on the type of governmental evaluation, FOSHU is divided into the 5 categories presented in Table 2.1-1 below.
Table 2.1-1 Categories of FOSHU | |
Category name | Definition |
FOSHU | Food products that bear a claim that consumers can expect the specified health benefit by consuming the products. Food products in this category are subject to a full evaluation. |
Qualified FOSHU | Food products that bear a claim that consumers may expect the specified health benefit by consuming the products. Food products in this category are subject to a full evaluation. |
Standardized FOSHU | Food products that bear prescribed claim and are approved by satisfying the specifications and standards established by the CAA Food products in this category are subject to a simplified evaluation. |
Disease Risk Reduction FOSHU | Food products that bear a claim related to disease risk reduction. There are 2 prescribed claims and claims that can be determined by an applicant. Food products in this category are subject to a full evaluation. |
Reapproved FOSHU | Food products are prepared by adding minor changes (e.g., changes in FBO, product name, and flavor) to already-approved FOSHU. Food products in this category are subject to a simplified evaluation. |
2.2 Product & Definition
FOSHU are foods that are consumed daily and are not alcoholic beverages or foods that lead to excessive intake of sodium, sugar, etc. [2]
Standardized FOSHU, is the only type of FOSHU that contains defined food categories. Below is the list of food categories per functional ingredient type [3].
1) Products Containing Dietary Fiber
Definition
The product form is tea (tea bags), biscuits (crackers and cookies), rice crackers, Western-style (non-Japanese) cakes, ham, sausages, flavored fish cakes, instant miso soup, rice porridge, soft drinks, lactic drinks, or powdered drinks (fruits, vegetables, cocoa).
Specifications/Target Age
No specification is defined for this category. While no target age is legally defined, FOSHU is generally interpreted as intended for healthy adults (18 years of age or older).
Additional Information
None.
2) Products Containing Oligosaccharides
Definition
The product form is table sugar, bun, biscuits (crackers and cookies), candies, chocolates, tablet confectionery, packed soybean curd, fermented milk, lactic fermented milk drinks, instant miso soup, brewed vinegar, soft drinks, or powdered drinks (fruits, cocoa, coffee).
Specifications/Target Age
No specification is defined for this category. While no target age is legally defined, FOSHU is generally interpreted as intended for healthy adults (18 years of age or older).
Additional Information
None.
3) Products Containing Indigestible Dextrin (with FOSHU claim related to blood glucose)
Definition
The product form is tea (tea bags), buckwheat dried vermicelli (noodles), bread, dried rice porridge, rice crackers, soybean curd, fermented milk, instant miso soup, dried soup, packed (microwavable/sealed pouch) steamed white rice, soft drinks, or powdered drinks (vegetables, tea, coffee).
Specifications/Target Age
No specification is defined for this category. While no target age is legally defined, FOSHU is generally interpreted as intended for healthy adults (18 years of age or older).
Additional Information
None.
4) Products Containing Indigestible Dextrin (with FOSHU claim related to triglyceride)
Definition
The product form shall be soft drinks.
Specifications/Target Age
No specification is defined for this category. While no target age is legally defined, FOSHU is generally interpreted as intended for healthy adults (18 years of age or older).
Additional Information
None.
2.3 References
1. Overview of the FOSHU system
2. Appendix 1 of Notification by the Deputy Director General of the Consumer Affairs Agency (Shou-Shoku-Hyou No.259 of 30 October 2014)
3. Appendix 3 of Notification by the Deputy Director General of the Consumer Affairs Agency (Shou-Shoku-Hyou No.259 of 30 October 2014)
https://www.caa.go.jp/policies/policy/food_labeling/foods_for_specified_health_uses/notice/assets/food_labeling_cms201_220831_04.pdf
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