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Japan Cosmetic Product Registration

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Japan Cosmetic Product Registration

COSMETIC REGISTRATION IN JAPAN

Regulatory Authority

Pharmaceuticals and Medical Devices Agency (PMDA) 

Link for Regulatory Authority

https://www.pmda.go.jp/english/index.html

Local Regulation

Pharmaceutical and Medical Devices Law

Who can Register? 

  • Importer
  • Distributer

Data to be Communicated 

  • Ingredients, amount and function
  • Manufacturing methods
  • Usage and dosage
  • Function and efficacy
  • Storage methods and shelf life
  • Specification and testing methods

Process to Register Cosmetic Product

  • Examine your product and determine which category it belongs to, as requirements and rules differ depending on the product category.
  • Conduct ingredient analysis on samples at MHLW-designated testing facilities owned or leased by manufacturers/importers. It entails examining the ingredient list to see if it complies with Japanese cosmetics requirements.
  • Obtaining the necessary licences from the appropriate regulatory bodies, such as a Cosmetic Manufacturing License and a Cosmetic Marketing License. The MHLW must first accredit foreign manufacturers as an “Accredited Foreign Manufacturer.”
  • Manufacturers must file a cosmetic marketing notification to the same prefecture awarded the cosmetics marketing licence before beginning the import and selling process.
  • Cosmetics Import Notification for Manufacture and Sales 
  • Cosmetics (foreign manufacturer, importer) notification 
  • By establishing a local subsidiary, an importer can handle the importation and distribution of its products. In this instance, the regional corporation must adhere to special importer restrictions.
  • For the import of cosmetics and quasi-drugs into Japan, you need to obtain.
    1. Primary distribution Approval
    2. Cosmetic Manufacturing License (packaging, labelling, and storage)

Timeframe and Fees

The registration period for additives is one to two years, while the registration period for active components is at least five years. 

Requirement for Notification

Before commencing sales in the market, manufacturers or importers must submit a notification, a step that can be completed after obtaining the cosmetics license. 

Domestic manufacturers are only required to submit a cosmetic marketing notification to the same regulatory authorities that issued the cosmetic marketing license. However, foreign manufacturers or importers must submit both notification and marketing notification to the regulatory officials.

Additional Information

  • Before marketing your cosmetics product in Japan, it’s essential to conduct ingredient analysis to ensure safety and efficacy, particularly for quasi-drugs. The regulatory processes differ between cosmetics and quasi-drugs. For cosmetics, manufacturers and importers must submit a notification after obtaining the Marketing Authorization Holder (MAH) license before entering the market. The MAH, which can be a local entity or representative, bears responsibility for imported cosmetics in Japan. Labelling must comply with the PMD Act and other pertinent regulations, with mandatory expression in Japanese. Unapproved claims of functioning or efficacy and labelling containing inaccurate or possibly misleading phrases are forbidden.
  • The Japan Cosmetic Industry Association (JCIA) has created a Japanese version of the “List of Cosmetic Ingredient Label Names” to assist in meeting the PMDL’s mandate of listing all ingredient names on labelling. This document serves as a reference for companies to ensure consistency in the Japanese names of ingredients. Companies can utilize this resource to standardize ingredient names in Japanese and submit a request to JCIA for any necessary revisions to labelling.