1. Authorities

Infant, Follow-up, Young Child, and Maternal Milk Formula
Japan

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

Consumer Affairs Agency (CAA) [1]

A competent authority in the external bureau of the Cabinet Office responsible for consumer policy, including the establishment and enforcement of rules relating to specifications and standards as well as labeling and advertisement in relation to food safety and hygiene. Related to FOSDU, this authority evaluates submitted applications and authorizes the sales of products as FOSDU. 

Ministry of Health, Labor and Welfare (MHLW) [2]

Responsibility for policies and services on public health including food safety and hygiene, labor, and welfare. Related to FOSDU, this authority offers advice and opinions to the CAA in the authorization of new FOSDU products.

National Institute of Biomedical Innovation, Health and Nutrition (NIBIOHN) [3]

A national research institute under the MHLW that conducts research and survey for the purpose of improving the public health. Related to FOSDU, this institute conducts an analysis to confirm conformity with the requirements of the applicable FOSDU. A certificate of analysis issued by the NIBIOHN or a Registered Testing Laboratory* will be sent to the CAA for their evaluation.

*Refers to testing laboratories that are registered by the Prime Minister according to the Health Promotion Act (Act No. 103 of 2002) [4]. Related to FOSDU, similar to the NIBIOHN, the laboratories conduct analysis to confirm conformity with the requirements of the applicable FOSDU. 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 [5].

1.1 References 

1. Consumer Affairs Agency (CAA) (in English)

https://www.caa.go.jp/en/ 

2. Ministry of Health, Labour and Welfare (MHLW) (in English)

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

3. National Institutes of Biomedical Innovation, Health and Nutrition (NIBIOHN) (in English)

https://www.nibiohn.go.jp/en/ 

4. Health Promotion Act (Act No. 103 of 2002) (in English)

https://www.japaneselawtranslation.go.jp/ja/laws/view/3727/je 

5. List of Registered Testing Laboratories (in Japanese)

https://www.caa.go.jp/policies/policy/food_labeling/foods_for_special_dietary_uses/registered_testing_institution/