Japan Puts Eyelash Beauty Liquid New Compliance Requirements

On Aug. 8, Japan Ministry of Health, Labour and Welfare (MHLW) issued a notice updating compliance obligations for the manufacturers and distributors of eyelash beauty liquid (excludes quasi-drug eyelash products), such as eyelash essence, eyelash serum and eyelash conditioner.

The new requirements are as follows:

1. Manufacturers and distributors of eyelash beauty liquid must add the warning information “Discontinue use and consult a doctor if adverse reactions such as redness, itching, swelling and pain occur due to irritation or allergy during or after use” to the instruction manuals.

(The usage precaution in Japanese)

Notably, for eyelash beauty liquid with a user instruction, the above information should be clearly conveyed on the manual; for eyelash cosmetics without a user instruction, the precautions for use should be written directly on the container or on the external packaging.

2. Manufacturers and distributors of eyelash beauty liquid should pay close attention to the health hazards caused using such products. If problems arise, they should submit adverse reaction reports to the MHLW in accordance with the 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.

3. Manufacturers and distributors of eyelash beauty liquid should recheck the safety of ingredients and products, recheck the compliance of cosmetics labels and advertisements, and make changes if necessary.