Importing and selling cosmetics

【 Importing and selling cosmetics 】

There are the people who misunderstand that importing cosmetics to Japan from overseas and sell them in the Japanese market is more or less the same as importing and selling general merchandise so it can be done by anyone.
However, cosmetics are strictly ordained under "the Pharmaceutical Affairs Law (the PA law hereinafter)" and relative laws same as medicines and medical devices, and it is prohibited to import and sell them without following the full procedure prescribed in the PA law even if the product is authorized and sold in foreign countries.

It is not just the matter of product quality but also the legality including WHO will do the designated procedures correctly.
The biggest difference between importing and selling general merchandise and cosmetics is the workflow.

General merchandise : "foreign manufacturer" → ("Importer") → "selling agency (and importer)",
Cosmetics: "foreign manufacturer" → (" Japanese cosmetics manufacturing license holder (factory)" ) → "Japanese cosmetics manufacturing and sales license holder（company *There are the companies which have both manufacturing license and manufacturing and sales license）

In addition, in the process from importing to selling cosmetics, preparing application materials including registration of products at concerned governmental office are needed and most of them should be done by aforementioned Japanese licensed holder.

１．The business flow when importing and selling foreign-made cosmetics in Japanese market

A) Overseas manufacturer (original brand holder) + B) Japanese cosmetics manufacturing license holder + C) Japanese cosmetics manufacturing and sales license holder + D) Selling agency
*If the Japanese company holds licenses of both B＆C, the company can act concurrently.

２．Permitting and notification system in Japan

1. As for above B), cosmetics manufacturing license (Keshouhin Seizougyou Kyoka)* is required.
Q. Where to apply? A. Apply to the governor of prefectural government in Japan where the company (factory) registered

2. As for above C), cosmetics manufacturing and sales license (Keshouhin Seizouhanbaigyou Kyoka)* is required.
Q. Where to apply? A. Apply to the governor of prefectural government in Japan where the company (factory) registered

3. As for above A), application for Accreditation of Overseas Manufacturer (Gaikoku Seizougyou (seizouhanbaigyou) kyoka) is required.
Q. Where to apply? A. Apply to Pharmaceuticals and Medical Devices Agency (PMDA), an Independent Administrative Legal Entity of Japan

4. Registration of cosmetics to be sold in Japan (1 item each)
Q. Where to apply? A. Apply to the governor of prefectural government in Japan where the company (factory) registered

5. Registration of importing cosmetics for manufacturing*and selling in Japan *Preparation process such as Japanese labeling, inspection, etc. is considered as “manufacturing” process in Japan. (1 item each but it could be listed on one document at once)
Q. Where to apply? A. Apply to the Department of Human Services of the region where the company (factory) of above mentioned C) registered

After go through the above explanation, some people (not only foreigners but also Japanese) may give up to import and sell overseas cosmetics in Japan. How about you? Do you feel it is too troublesome to handle all procedures by yourself？

Roughly speaking, there are 3 major difficulties as follows:

1．”Language barrier (all documentations and registrations are required to be written in Japanese)”
2. “Legal requirement (i.e. license) and knowledge – especially Japanese Pharmaceutical Law
Not only product formulation but also all documents including product labels
3. “Preparation of application forms, documentations and materials including product information, product manual, training materials and promotion tools which meets Japanese legal requirement as well as business custom.”

NOTE: Basically, legal documents are required to be prepared by above C), Japanese cosmetics manufacturing and sales license holder. However, Japanese qualified administrative scrivener can act for it in case the license holder’s ability is insufficient (e.g. just got the license so not fully accustomed yet). Besides, generally say, most of Japanese companies/factories’ communication skills in English are not so good and they do not have English website. We can assist foreign clients not only to look for the Japanese license holder but also act as communicator between two or more parties when necessary in addition to translation works in cooperation with FRE&COS LLC, a professional cosmetics translation firm (Osaka city). Here are the examples of what we can do:

Q1.“Can we use the contents of product explanation or advertisement just by translating them in Japanese?”
→ A1 “No. You cannot use the contents you are using abroad just by translating them. All contents must meet the requirement of Japanese Pharmaceutical Law and relative laws. We can support you for legal check and translation while modifying the contents to be legal in Japan.

Q2.“Can we import and sell the overseas cosmetics as they are in Japan?”
→ A2 “May be not. There are negative list and limitation of particular ingredients in Japan. Besides, if the formulation contains an ingredient new in Japan, firstly, you must register it with new Japanese ingredient name as per the requirement of Japanese law. On the contrary, when exporting Japanese cosmetics to overseas market, if there is an ingredient which has no INCI name yet, to apply it is required beforehand. Please consult with us for more details.”

Q3.“Japanese labels, product information, promotion tools and even website contents must meet the requirement of Japanese laws* sounds too difficult for non-professional. *If the government officials find any illegal contents, there is a risk of withdrawal from market and penalty charges.
Can you provide the service to prepare such information for us as well?”
→ A3 “Yes, we can assist it. If you just translate the original label in Japanese, it won’t meet the Japanese legal requirement. On the contrary, if you want to export Japanese cosmetics to overseas market, we can also provide necessary services such as translating product information from Japanese to English.