Food Supplements Regulatory Support in Japan

Overview

In Japan, food products are regulated by the Ministry of Health, Labor, and Welfare (MHLW) and the Consumer Affairs Agency (CAA), under the Food Sanitation Act, Food Labelling Act, and the Health Promotion Law. The MHLW reviews the notification and performs an inspection to monitor the food products.

Food Classification

In Japan, health foods are generally referred to as "foods with health claims" and are classified into Food with Function Claims (FFC), Food with Nutrient Function Claims (FNFC), and Food for Specified Health Uses (FOSHU).

Food Registration

According to the food labeling standards in Japan, labeling in the Japanese language on the primary food packages is mandatory for all domestic and imported products. Erroneous labeling translations may lead to major reworks and a significant monetary loss.

To ensure the safety of imported foods and other related products, the Food Sanitation Act obliges importers and manufacturers to submit the import notification. The Food Sanitation Act states that "Those who wish to import food, food additives, apparatuses, or containers and packages for sale or for use in business, shall notify the Minister of Health, Labour, and Welfare (MHLW) on each occasion as prescribed by the Ministerial Ordinance." The imported foods and related products must not be used for sale without an import notification.

Important Validities

The validity of the Registration Certificate and other important certifications is for a period of one (01) year, and renewals must be done every year.

Freyr Expertise

  • Formulation Review or Ingredients assessment
  • Safety Assessment and Toxicology Services
  • Labeling Review
  • Claims Review
  • Claims Consultation and Substantiation
  • Research and Development Solutions
  • Dossier Compilation
  • Regulatory Intelligence
  • Region-specific Requirements Compliance/Consulting
  • Go-to-market Regulatory Support
  • Product Notification or Registration Support

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