Asia Personal Care & Cosmetics Market Guide 2016

Language Requirement Yes Must be labeled in Japanese
Product Function Yes As necessary, specify if Soap
Formula: Quantitative, Qualitative or Both Yes Use Japanese version of INCI (International Nomenclature for Cosmetics Ingredients). A full incredient listing in descending order of content.
Fragrances Yes Allowed to list as "Fragrances"
Percentage of Ingredients Claimed No
Alcohol Content
No
Information on Product Use Yes Allows for labeling on container, packaging and/or inserts.
Warning Statements Yes If DMDM hydantoin and Imidazolidinyl urea are mixed for shampoos and soaps. For aerosols and products deemed hazardous: High Pressure Gas Safety Act and the Fire
Service Act define label.
Manufacturer Name and Address
No
Importer Name and Address
Yes
Date of Durabilty / Period after Opening No
Storage Conditions
No
Expiration Date Yes Include, if less than 3 years.
Claims Yes Industry uses Standards for fair advertisement practices of drugs, quasi-drugs, cosmetics, and medical devices under Article No.66 of PMD Act, Codes of fair competition for
representation of Cosmetics, Cosmetics Soaps, and Premium Offers in the Cosmetic Industry, under certification, by the Premium and Representations Law.
Environmental Labeling Yes Act on the Promotion of Effective Utilization of Resources
Certificate of Free Sale
By Product
No
Post Market Monitoring
Consumer Hot Line Yes Importers must have a system to provide and retain information in response to customer inquiries.
Notification of Local Authorities Yes Information must be provided to both local and national authorities
Recall Yes Importers should have procedures for registration and tracking of product delivery, processing and withdrawal of defective products, per GVP standards.
Government Fee to Notify/Register No No charge for cosmetic notification
Time to Process 1 Day One day for cosmetic notification
Product Classification
MHLW reviews notification to ensure that the product is a cosmetics and not a quasi drug or drug, based on : the formulation of a product and the level of active ingredients, as well as application method, dosage and product appearance. The
definition of a quasi-drug is as follows:
A quasi-drug is defined as:(1) Preventing nausea and other discomfort. (2) Preventing heat rash, soreness, etc. (3) Encouraging hair growth or removing hair, or (4) Exterminating and preventing mice, flies, mosquitoes, fleas, etc. Among the
quasi-drugs are sunscreens, deodorants, depilatories, hair growth treatments, hair dyes, perm and straightening products, as well as medicated cosmetics, such as whitening products, anti-aging products and oily skin or acne treatment
products. Besides, the item shall have mild effects on the human body, shall not be a utensil or device, and shall be designated by the MHLW based on these characteristics.