Asia Personal Care & Cosmetics Market Guide 2016

Product Notification
Cosmetics products have to be notified via three venues:
Local Government (Prefecture)
Foreign Manufacturer Notification
For a quasi-drug registration, foreign manufacturer is required to be accredited by the Ministry of Health, Labour and Welfare.
For cosmetics, filing of notification with the name and address of foreign manfucturer and/or marketing entity will suffice.
Local Business Partner Requirements
Overseas manufacturers currently cannot sell in country directly without a local distributor. Two licenses are required for in-country business partner companies.
a. Local Marketing: Distributors "keshohin seizohanbaigyo kyoka" that take all the responsibilities on the market, on the commercial basis from the appropriate local government offices for each business office location.
1. General Marketing Business Controller “sokatsu seizoh hanbai sekininsha”.
(i) licensed pharmacist or (ii) a specialist who has completed university-level or (iii) equivalent pharmacology or chemistry courses.
2. Product Quality Manager “hinshitsu hoshoh sekininsha”
3. Safety Control Manager “anzen kanri sekininsha”
b. Local Manufacturing : Manufacturers “keshohin seizogyo kyoka,” that engage only in final packaging, Japanese labeling and storage, with one required for each manufacturing location.
Responsible Technical Manager “sekinin gijyutsusha”
(i) licensed pharmacist or (ii) a specialist who has completed university-level or (iii) equivalent pharmacology or chemistry courses.
Additional Resources
1. “Standards for Cosmetics, Notification No.331/2000”, amended April 2016. Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare (Japan).
http://www.mhlw.go.jp/file/06‐Seisakujouhou‐11120000‐Iyakushokuhinkyoku/0000032704.pdf
2. Japanese Version of the "List of Cosmetic Ingredient Label Names."
Compiled by the Japan Cosmetic Industry Association (JCIA) to be used in conjunction with the Pharmaceutical Affairs Act's PMD Act's requirement to list all ingredient names on the labeling. If a new label name needs to be devised, then a
request can be filed with the JCIA. Label names shall be, in principle, translated into Japanese from the International Nomenclature of Cosmetic Ingredients (INCI) published by the Personal Care Products Association (PCPC) of the United
The list of JCIA publication (Japanese version only) is available http://www.jcia.org/n/en/jcia/d/
The application procedure:
http://www.jcia.org/n/all_pdf/en/ApplicationProcedures_for_JapaneseLabelingName.pdf
3. Pharmaceuticals and Medical Devices Agency
https://www.pmda.go.jp/english/pnavi_e-07.html
4. Cosmetic Fair Trade Council Japan
http://www.cftc.jp/english/index.html
5. Yakuji Nippo Ltd. for English publications
http://yakuji-shop.jp/SHOP/547558/547972/list.html