Japan Requires Companies to Add Two Warnings on Instructions for Use of Hair Dyes Products

Japan recently announced that companies shall add two warnings on instructions for use of hair dyes products to ensure consumers will use the product safely.

1. People susceptible to hair dye associated scalp contact dermatitis and eye irritation should not use
2. Indication of potential risks caused by the hair dye

For products already in circulation modifications to labeled instructions shall be completed before the end of July in 2018.

Hair dye regulations

In Japan, hair dyes products are regulated as quasi drugs. Before marketing products, companies are required to apply for marketing approval with Ministry of Health, Labour and Welfare (MHLW). The instructions for use are necessary for submission when applying for marketing approval.

Furthermore, a GMP inspection will also be conducted to ascertain whether their manufacturing facilities and manufacturing and quality controls comply with standards such as the Good Manufacturing Practice (GMP), and whether the manufacturing sites have a system for manufacturing products of adequate quality.

There is an official positive list defining permitted active ingredients in hair dyes products. Companies are recommended to choose ingredients in the positive list. Otherwise, they have to submit documents of efficacy and safety to Ministry of Health, Labour and Welfare (MHLW) for approval.