Export to Japan
In Japan, cosmetics are regulated under Pharmaceutical and Medical Devices Law (PMDL), formerly known as the Pharmaceutical Affairs Law. The Ministry of Health, Labour and Welfare (MHLW) serves as the competent authority overseeing these regulations. Japan classifies cosmetics into two main categories: Cosmetics and Quasi Drugs.
Difference between Cosmetics and Quasi Drugs (Article 2.3 of the Pharmaceuticals Affairs Law):
Cosmetics
“The term “cosmetic” used in this law refers to articles with
mild action on the human body which are intended to be
applied through rubbing, sprinkling or other similar methods,
and are used to clean, beautify and increase attractiveness,
alter the appearance or to keep the skin or hair in good
condition. Proviso: these articles shall exclude quasi-drugs
and those intended concurrently for the uses specified in
Paragraph 1, Item 2 or Item 3.”
The comprehensive Licensing Standards of Cosmetics by
Category (released in 1999) indicated 11 distinct categories of
cosmetic products.
Quasi-Drugs
“Products with mild action on the human body, they are
considered as cosmetics with mild pharmacological action.”
Quasi-drug categories have been specified in Announcement
No. 25 of the Ministry of Health from February 6, 2009. There
are currently 27 quasi-drug categories.
The following products are included in the quasi-drug
category: anti-dandruff, whitening, anti-acne, anti-chapping,
anti-dryness, deodorants, antiperspirants, hair-growth, hair
dying, hair perming, toothpastes, bath salts, mouth washes,
breath products, etc.
Cosmetic Notification in Japan Cosmetics and Quasi-drug Notification in Japan – Personal and Home Care Products – CIRS Group(cirs- group.com)
1. Licensing Requirements
- Importers must obtain two licenses: a cosmetics manufacturing and
sales license (化粧品製造販売許可) and a cosmetic manufacturer’s
license (化粧品製造許可).
- These licenses are necessary for importing and distributing cosmetics.
3. Documentation Requirements
- The notifications should be accompanied by either:
- An ingredient list from the importer’s supplier or manufacturer.
- If an ingredient list cannot be obtained, a record of testing and
inspection results confirming that the product does not contain
any prohibited ingredient combinations.
2. Notification Process
- After obtaining the licenses, importers must submit three notifications
to the relevant administrative agency before importing the products:- Manufacture and Sales of Cosmetics Notification
- Cosmetics Import Notification for Manufacture and Sales
- Manufacturer’s or importer’s brand name
4. Safety Responsibility
Importers bear the responsibility for ensuring the safety of the imported
cosmetics.
WHO SHALL REGISTER?
Cosmetics manufacturer or distributors who export cosmetics to Japan
Importers/primary distributor of cosmetics in Japan
Our services includes
Japan Cosmetics and Quasi-drug Notification
- Formula and label review
- Testing required for the notification
- Dossier preparation for notification