Japan Implements New Compliance Requirements for Depilatories

On Dec. 19, 2019, Japan Ministry of Health, Labour and Welfare (MHLW) issued a notice updating compliance obligations for the stakeholders of quasi-drugs with depilation efficacy, in response to Japan National Consumer Affairs Center’s (NCAC) safety warning on the use of hair removal agents ^[1].

The specific requirements are as follows:

1. Manufacturers and distributors of depilatories shall mark the product usage precautions directly on the container, except for those products that already have relevant statements.

Also, when applying for the manufacture and sale of depilatories, the following items should be indicated as the precautions for use in the remarks column of the application form. If any other items need to be added, it shall also be indicated.

• Apply a small amount of this product to the area where you want to remove hair in advance. Do not use if you have a rash, itching, or redness. Discontinue use and consult a doctor if any of these abnormalities are observed during or after use.

• Do not use on face, skin lesions, or other areas that cause inflammation such as swelling, eczema, erosion. And avoid using before and after menstruation, before and after childbirth, during illness and convalescence.

• Do not rub this product directly on the skin.

2. Manufacturers and distributors of depilatories should pay close attention to the health hazards caused by using such products. If problems arise, they should submit adverse reaction reports to the MHLW in accordance with Item 1, Article 68 -10 of Act on Securing Quality, Efficacy, and Safety of Products Including Pharmaceuticals and Medical Devices.

The enforcement rules of the reporting system on adverse effects coupled with the specific framework, content, and format of the reports shall refer to the provisions specified in Post-Market Safety Management Standards for Pharmaceuticals, Quasi Drugs, Cosmetics, and Medical Devices: Report on Side Effects of Quasi-Drugs and Cosmetics.