Japanese Regulatory Overview

The nutrition market in Japan is the second largest in the world. As a significant part in global nutrition industry, it is important to have an understanding of current trends in this market. In this feature, I will provide a brief overview of some of the regulations that impact dietary supplements and foods.

There are several regulations focusing on the registration and sales of supplements and functional foods. The regulatory body overseeing these regulations is the Japan Ministry of Health, Labor and Welfare (MHLW). Important regulations include:

Regulation and Description(s)

Medicine Act
This regulation classifies whether each material/ingredient is considered a “drug” or “food”.
- A material/ingredient on the "drug list" cannot be used for supplements.
- A material/ingredient on the “food list” can be used in a supplement.
- Any material/ingredient which is not on either list needs to submit an application to the authority as a new material/ingredient. (Safety data, experience of oral consumption in foreign countries and other data are necessary for the application.)

Food Sanitation Law
This regulates food additives.
This regulates labels of products such as a product name, additives used, storage conditions, shelf life, manufacturer name, place of manufacturing, potential allergens and whether it is a genetically-modified product.

FOSHU Registrations
Foods by Specified Health Uses (FOSHU).
This allows a product to be registered and make a claim independently from a category of products. A manufacturer needs to submit safety and clinical data to receive an approval related to the claim.

Source: Tokyo Metropolitan Government, Global Nutrition Group

Products marketed as general foods (excludes registered FOSHU products) are prevented from making claims. There is a category of 12 vitamins and 5 minerals where individual product claim approval is not required and an approved functional claim is allowed. These include common vitamins such as vitamin C and minerals such as calcium.

When evaluating whether your products can be imported into Japan, companies must first review its finished product or ingredient to ensure that the ingredients included in the product are approved as a food additive(s) under Japanese law. If the ingredients included are on the listing of approved food additives in Japan, an importation assessment should be conducted with the MHLW where the specifications, certificate of analysis and manufacturing methods need to be submitted. When importing a product, importers must submit an “Import Notification” to the MHLW quarantine station at the time of import. The importer will then receive a “Certificate of Notification”. Without this certificate, the product cannot be marketed in Japan. To this “Import Notification”, the importer must attach an ingredient list and describe the manufacturing method using a flowchart.

As discussed previously, Japan is an important market and one that any company involved in the nutrition industry needs to understand both in terms in regulations as well as new product development opportunities.

We want to hear your ideas, stories and comments. If you have items of interest to NPIAsia, please contact us by e-mail at [email protected].

Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.