Overview

In Japan, cosmetic products are regulated by the Ministry of Health, Labour, and Welfare (MHLW) under the Pharmaceutical and Medical Devices (PMD) Act. The MHLW reviews quasi-drug applications and Cosmetic Registrations in Japan (from foreign manufacturers and importers) and evaluates their adverse effect reports.

As one of the most affluent nations in Asia, Japan’s cosmetic market has been witnessing steady growth over the years despite economic fluctuations. Manufacturers/importers are required to complete their cosmetic Product Registrations in Japan and apply for marketing approvals, based on the type of product they seek to market.

The MHLW categorizes cosmetics in Japan into two (02) categories, which are:

General cosmetics: As per the Japanese cosmetics regulations, general cosmetics are further classified into five (05) categories, as listed below:

• Perfume and Eau de Cologne
• Makeup Products
• Skincare Products
• Haircare Products
• Special-purpose Cosmetics (including Sunscreens)

Quasi-Drugs: This category includes products that help prevent nausea, heat rash, and mosquito bites, and products that promote hair growth. Medicated cosmetics such as whitening products, anti-ageing products, and oily skin or acne treatment products, are also categorized under quasi-drugs.

In Japan, Cosmetic Product Registration is applicable to quasi-drugs, whereas for general cosmetics, a simple Notification is sufficient.

According to Japanese cosmetic labeling regulations, labeling in the local language on the primary cosmetic package is mandatory for all domestic and imported products. Erroneous labeling translations may lead to major reworks and thereby result in significant monetary loss.

The Japanese Cosmetic Registration process has proved to be challenging for manufacturers and importers. As a trusted Regulatory partner, Freyr provides cosmetics Regulatory services in Japan, including competent product compliance checks, comprising cosmetic product formulation review and cosmetic label and claims review. Moreover, Freyr can also help with Cosmetic Notification for the general category of cosmetics.