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 labelings may lead to major reworking and a significant monetary loss.
In Japan, health foods are generally referred to as “foods with health claims” and 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.
Food Supplement Registration in Japan - Freyr Expertise
- Product Classification.
- Product Testing/Inspection.
- Ingredient Check/Pre-consultation with the MHLW.
- Label Compliance and Claims Review.
- Regulatory Intelligence (RI).
- Japan Food Container/Package Requirements.
- Dossier Compilation, Gap Analysis, and Submission/Registration.
- Food supplement registration in the MHLW with strategic Regulatory consulting.
Food Supplement Registration in Japan - Freyr Advantages
- Expertise in decoding the classification of food products.
- Accurate translation services with regards to the Japanese language on primary food package labels.
- An extensive partnership network across the globe.
- Aims at first-time approval to firmly establish labeling compliance.
- Support in region-specific Regulatory activities.
- End-to-end food Regulatory consultation.