Food Supplements

Food Supplement Registration In Japan - Overview

In Japan, food products are regulated by the Ministry of Health, Labour, and Welfare (MHLW) and the Consumer Affairs Agency (CAA) under the Food Sanitation Act, Food Labeling Act, and the Health Promotion Law. The MHLW reviews the notifications and performs inspections to monitor food products.

The process for food supplement registration in the MHLW in Japan involves several key steps. For Food supplement manufacturers looking to register their products with the MHLW must first conduct rigorous safety and efficacy testing, ensuring that the supplements comply with relevant regulations and standards.

Japan Food Import Regulations

The Food Sanitation Act obliges importers and manufacturers to submit import notifications to ensure the safety of imported foods and other related products. As the Food Sanitation Act states, “Those who wish to import food, food additives, apparatuses, or containers and packages for sale or use in business shall notify the MHLW on each occasion as prescribed by the Ministerial Ordinance.” Imported foods and related products should not be used for sale without proper import notifications.

Japan Food Labeling Regulations

According to food labeling standards in Japan, labeling in the Japanese language on the primary food package is mandatory for all domestic and imported products. Moreover, any kind of erroneous translation of the labeling may lead to major reworking and a significant monetary loss.

In Japan, “foods with health claims” are classified into the following three (03) categories:

• Food with Function Claims (FFC).
• Food with Nutrient Function Claims (FNFC).
• Food for Specified Health Uses (FOSHU).

As the largest global Regulatory solutions and services provider, Freyr provides food Regulatory services in Japan and supports market entrants in complying with Japanese food regulations and assisting with each step required for food supplement registration in the MHLW.