Importation of Cosmetics to Japan
Would you like to import cosmetics to Japan? Let's start with a little background information.
Importation of cosmetics is subject to the provision of the Pharmaceutical Affairs Act（薬事法）. Additionally, aerosol products are subject to the provisions of the High Pressure Gas Safety Act.
Definition of cosmetics (Pharmaceutical Affairs Act):
Articles with mild action on the human body, which are intended to be applied to the human body through rubbing, sprinkling or other methods, aiming to clean, beautify and increase the attractiveness, alter the appearance or to keep the skin or hair in good condition.
Requirements for Importation of Cosmetics:
1) Manufacturing & Distributor License For Cosmetics (化粧品製造販売業許可) & Manufacturer's License for Cosmetics (粧品製造業許可) (Pharmaceutical Affairs Act, hereinafter referred to as "Act")
Importers will need the Manufacturing & Distributor License For Cosmetics to import and sell cosmetics. This can be applied for at the Prefectural Pharmaceutical Affairs Division of the place of business of the importer (i.e. the general office where the Manufacturing Sales Manager is located) (Article 12 of Act).
Documents required for this application:
Application form
Company registry (登記簿謄本）
Medical certificate to prove that the applicant is mentally fit for conducting business.
Organization chart of the company
Certificates to prove that the representative in charge has the required qualifications (for example as a pharmacist etc.)
The above mentioned Manufacturer's License for Cosmetics is required in the event of the packaging, labeling and storage of the imported products. (Article 13 of Act, Enforcement Regulations Article 26).
In order to ensure that manufacturing (import) will be carried out without any hindrance on health and sanitation, the status of the structural facilities of the manufacturer and personality qualifications etc. will be assessed and permission will be granted for each manufacturing facility. Also, a responsible engineer with the required technical qualifications such as a pharmacist must be hired as a permanent position.
In the case when the manufacturer (importer) has both the Manufacturing & Distributor and the Manufacturer Licence for Cosmetics, the general sales manager and the responsible engineer can be the same person, provided that he is hired as a permanent staff.
2) Verification of Foreign Manufacturer
The manufacturer and distributor in Japan can have their foreign manufacturer verified before import commences in order to import cosmetics that are distributed or manufactured overseas. (Article 13(3) of Act).
Agency responsible for this application:
Pharmaceuticals and Medical Devices Agency: PMDA
However, the manufacturer & distributor approval is not required if the cosmetics in question satisfies the cosmetics standards, and all ingredients are being displayed. In this case, the importer can simply submit the foreign manufacturer's name and address with the Minister of the Ministry of Health, Labor and Welfare (MHLW).
3) Manufacturing and Distribution Approval for Each Item
It is required that cosmetics that contains ingredients specified by the Minister of MHLW be submitted for approval (Article 14 (1) ).
However, approval will not be required if the cosmetics product confirms with the cosmetics standards (prescribed under MHLW Notification no. 331, Sep 29, 2000) (English version), full ingredients is disclosed, and an application is sent to the Prefectural Governor indicating that effect.
Request for approval will have to be submitted directly to PMDA or through the local authorities in the event that the full ingredients list is not disclosed. The item, ingredients, weight, manufacturing method, method of use, amount of us, effects and efficacy, storage method, expiry date, standards, analytical methods and others will be assessed and determined for approval.
4) Standards and Criteria & Mandatory Labeling
Standards and Criteria: All cosmetics imported or to be distributed have to conform to the standards stipulated under the "化粧品基準" (English version: Standards of Cosmetics). The standards provides ingredients prohibited, limitations of ingredients to be used (Negative list) and the compatible ingredients of specific ingredient group (Positive list)
Mandatory Labeling Requirements:
Manufacturing & Distributor's name
Product name
Manufacturing number (etc.)
Ingredients name (in principle Full ingredients list)
False or misleading presentation is prohibited.
5) Customs Act (Items infringing intellectual property rights)
False brands etc that infringes intellectual property rights (trademark, copy right, neighboring rights, patents, utility model patent, desgins）will be prohibited from import. Import will be stopped even if the importer was ignorant that the goods are fake.
Other useful links:
PMDA (Japanese)