1. Authorities

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Foods for Specified Health Uses (FOSHU)
Japan

This section provides an overview of the Authorities involved in setting regulations and in managing compliance with the food product in scope.

Consumer Affairs Agency (CAA) [1]

Established in 2009, this competent authority holds the responsibility for consumer policy including food labeling and advertising.

Related to FOSHU, the authority also carries out an administrative check of the submitted dossier and makes an overall decision as to whether approval can be granted by taking into account the evaluation results by the Consumer Commission and the Food Safety Commission (FSC).

Food Safety Commission (FSC) [2]

A risk assessment organization related to food safety from an independent science-based point of view. Related to FOSHU, this authority evaluates the safety of submitted FOSHU products.

Consumer Commission [3]

Established in 2009, this governmental body is formed by experts in consumer affairs and makes proposals related to consumer issues and consumer policies as an organization independent of the government. Related to FOSHU, this authority evaluates the safety and effectiveness of submitted FOSHU products.

Ministry of Health, Labour and Welfare (MHLW) [4]

Responsibility for policies and services on public health including food safety and hygiene, labor, and welfare. Related to FOSHU, this authority conducts regulatory checks to see whether submitted FOSHU products are in conflict with the Act on Securing Quality, Efficacy, and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960).

National Institutes of Biomedical Innovation, Health and Nutrition (NIBIOHN) [5]

A national research institute under the MHLW that conducts research and surveys for the purpose of improving public health. Related to FOSHU, this institute conducts an analysis to qualify and quantify the amount of the functional ingredient in submitted FOSHU products. A certificate of analysis issued by the NIBIOHN or a Registered Testing Laboratory will be sent to the CAA for their evaluation.

Registered Testing Laboratories

Testing laboratories that are registered by the Prime Minister according to the Health Promotion Act (Act No. 103 of 2002) [6]. Related to FOSHU, similar to the NIBIOHN, the laboratories conduct analysis to qualify and quantify the amount of the functional ingredient in submitted FOSHU products. A certificate of analysis issued by the NIBIOHN or a Registered Testing Laboratory will be sent to the CAA for their evaluation. Currently, 5 testing laboratories have been registered [7].

1.1 References

1. Consumer Affairs Agency (CAA)

https://www.caa.go.jp/en/

2. Food Safety Commission (FSC)

https://www.fsc.go.jp/english/index.html

3. Consumer Commission

https://www.cao.go.jp/consumer/en/e-index.html

4. Ministry of Health, Labour and Welfare (MHLW)

https://www.mhlw.go.jp/stf/english/index.html

5. National Institutes of Biomedical Innovation, Health and Nutrition (NIBIOHN)

https://www.nibiohn.go.jp/en/

6. Health Promotion Act (Act No. 103 of 2002)