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Japan Cosmetics Standards

To sell cosmetics in Japan, U.S. firms need to overcome several requirements to secure an approval from the Pharmaceutical and Medical Devices Agency within the Ministry of Health, Labor and Welfare (MHLW). This is the regulatory agency which reviews quality, safety and efficacy of medical products, including cosmetics, to be marketed in Japan. The process for selling directly to customers via online shopping is an easy way to enter the market. However, customers are limited to 24 items so it is not practical for wholesale. Thus, this report will focus on the process for becoming a business-to-business cosmetics wholesaler in Japan.

Below is the process for registering General Cosmetics. The timeframe for securing the approval for required licenses can take longer than five months, including several forms and communications with Japanese government officials, so we recommend working with a local partner who can support you with the process.

  1. Confirm Product Ingredients Don’t Fall on Banned Substances List. If a product contains any banned substance, it cannot be sold in Japan. Other products have limitations on how much of a particular ingredient can be used. This includes specific chemicals, such as methyl alcohol.
  2. Confirm if Your Products Fall within the General Cosmetics Definition List. If products do meet one of the 56 qualities on the general cosmetics list, they will likely fall under the Quasi-drug category and require a more stringent and drawn-out licensing process.
  3. Obtain a Sales License or Find a Local Partner Who Can Sell Your Products Under Their License. The sales/marketing license for cosmetics (化粧品製造業販売業許可) is required to import, distribute, sell, and market your products in Japan. Th party holding this license is responsible for the product in Japan. Foreign firms tend to work with a local partner who already has a sales license to make this process easier. This process can take more than 2 months. 
  4. Obtain a Manufacturing License or Find a Local Partner. Even if a foreign cosmetics firm is not planning to produce their products in Japan, they are required to obtain a manufacturing license (化粧品製造業許可) in order to package, store, and label their ingredients in Japanese on products, a requirement for selling in the Japanese market. The process for obtaining this license and complying with packaging and labeling requirements in Japan is strict, complex, and done only in Japanese. Thus, many firms choose to outsource the packaging, labeling, and storage of products to a Japanese company. This process can take more than 2 months.  To learn more about the licensing process, please review the Ministry of Health’s web page (Japanese only):  https://web.fd-shinsei.mhlw.go.jp/. The licenses expire after five years.
  5. Register Each Product with the Pharmaceutical and Medical Devices Agency Office for Each Prefecture You Want to Sell Into. This is an online process done through the prefectural government website. Registration of ingredients is required for each product a firm is looking to sell. Once the agency approves the product, it can be sold in Japan. 

Due to the complex nature of submission—as well as the fact that many of the required documents are only in Japanese and most government office employees aren’t fluent in English—the U.S. Commercial Service recommends that U.S. firms find a local partner or hire a Japanese speaker who can apply to the ministry on your behalf.

For more information contact the U.S. Commercial Service in Japan: Office.Tokyo@trade.gov.
 

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