Food and Food Supplements Regulatory Services in Japan

Food and Food Supplements
Regulatory Services in Japan


In Japan, health foods are regulated by the Ministry of Health, Labour and Welfare of Japan (MHLW) under the Food Sanitation Law. Japan is a major food importer, with a food self-sufficiency rate of about 40%. Foods are imported from various countries and to ensure the safety of import foods, the MHLW monitors and inspects them at the quarantine stations located at international airports and seaports.

The Food Sanitation Law treats health foods in the same manner as all other foods. Consequently, the import procedures for health foods are the same as for other foods, and importers must pay attention to the same provisions of the Law as for other foods, such as whether the food contains anything harmful or toxic, whether additives are used appropriately, etc.

Health foods in Japan are categorized into three types based on the guidelines laid down by MHLW namely:

  1. Foods with Nutrient Function Claims (FNFC)
  2. Foods for Specified Health Uses (FOSHU)
  3. Food for Special Dietary Uses (FOSDU).

Labeling in local language is a must on packaging of all domestic and imported products. Recognizing and targeting the domestic market is relatively difficult as the food preferences of Japanese consumers significantly vary from global preferences.


Freyr Expertise

  • Product Classification
  • Formula Review/Ingredients Assessment
  • Label and Claims Review
  • Compilation, gap analysis and Submission of Dossier to Health Authority
  • Claims consulting for FNFC, FOSHU, FOSDU
  • Legal Representation
  • Regulatory Intelligence
  • Local Language Labeling Support
  • Labeling Compliance and Translation
Freyr Advantages


Freyr Advantages


End-to-end food and food supplements Regulatory consultation for Japan


Food Product classification guidance for any complexities for Health Foods


Qualified team of experts with hands-on experience across all categories of foods like health supplements, dietary supplements, nutraceuticals, health functional foods, health functional beverages, foods for special dietary use, etc


Support for region-specific Regulatory activities


Extensive partner network across the globe


Strong relationship with different health authorities (MHLW for Japan)


Structured and cost-effective approach to ensure speed to market for the products