Article

China Compliance: Cosmetic Products

Posted on: January 18, 2019

By Erik Shao

This article provides an overview of the main Chinese regulatory requirements on cosmetic products, and has been designed to help you to comply with the relevant regulations.

Overview

China Cosmetics are regulated by the National Medical Products Administration (NMPA) under the Regulations Concerning the Hygiene Supervision over Cosmetics.

To enter into the Chinese market, a few steps must be taken to ensure compliance with China cosmetics regulations:

  1. All imported cosmetic products must be approved by the NMPA or notified to the NMPA for record-keeping purposes prior to import.
  2. Even if your cosmetics have been tested overseas, you still need to send your cosmetic products to a NMPA-designated testing Institution in China for testing. Please keep in mind that China still requires animal testing for cosmetics, but they are working on developing alternative methods.
  3. Prepare the labels for your cosmetic products in accordance with the Regulations on Cosmetic Label Management (former AQSIQ Decree No. 100) and the National Standard: GB 5296.3-2008 General Labelling for Cosmetics.

After the above steps have been completed, the products may be imported into China and are subject to the import inspection and quarantine at the port of entry.

Regulatory Framework

  • The main regulatory body is the National Medical Products Administration, also known as the NMPA (formerly the China Food and Drug Administration)[1]
  • The Regulations Concerning the Hygiene Supervision over Cosmetics[2]
    • Provides definitions of cosmetics and general rules on supervision of cosmetics
    • Under revision, the draft version was published in July 2015
  • Detailed Rules for the Implementation of the Regulation on the Hygiene Supervision over Cosmetics[3]
  • Safety and Technical Standards for Cosmetics 2015[4]
    • Contains banned, restricted or permitted substances in cosmetic products
    • Under revision, a TBT notification was sent to the WTO for the amendment[5]

Registrations for Cosmetic Products

  • All imported cosmetic products must be approved by NMPA or notified to the NMPA for record-keeping purposes prior to entering the Chinese market
  • There are two types of cosmetic product:
    • Non-special use cosmetics, commonly used in hair care, skin care and nail products, and fragrances
    • Special use cosmetics, such as hair regrowth products, deodorants and sunscreens
  • These require different pre-market applications depending on the type of cosmetic product and whether it has a domestic or foreign manufacturer
    • An administrative license is required for domestic special use cosmetics, as well as for imported cosmetics which include special use and non-special use cosmetic products
    • Record-filing is required for domestic non-special use cosmetics
    • From March 2018, non-special use cosmetics imported through any port of the 11 free trade zones of China may follow the record-filling procedure instead of going through the registration process. The application dossier is essentially the same, but the process is much faster. [6]
  • New Cosmetic ingredients not listed in the Inventory of Existing Cosmetic Ingredients in China (IECIC) must be registered with the NMPA prior to firstly being used in cosmetic products.[7]
  • Cosmetic products that contain a new ingredient or a prohibited ingredient specified in Safety and Technical Standards for Cosmetics 2015 won’t be approved by the NMPA.
  • Exporters should appoint a Chinese legal entity for the pre-market application. The legal entity could be your importer, subsidiary, or a third party. The CFDA doesn’t charge a registration fee.

Testing

  • Cosmetics must be tested in NMPA-designated testing Institutions in China. Thirty-three Chinese testing Institutions have been authorized to perform the tests[8]
  • Administrative approvals of cosmetics require hygiene testing, which might include a sanitary chemical test, microbiological test, toxicological test, and human safety tests[9]
  • China is reducing the requirements on animal testing for cosmetics. Animal testing are required for imported cosmetics products, but have been waived for domestic non-special use cosmetics since 2014. China is working on establishing alternative methods and verification institutions [10]

Labelling

  • The Regulation on Cosmetic Label Management (former AQSIQ Decree No. 100)[11]
    • Provides guidance and requirements on the contents and elements of labels
    • Prohibited contents
    • Way of marking and labelling
  • Regulations Concerning the Hygiene Supervision over Cosmetic[2]
    • Article 12 provides general requirements on labelling
    • Under revision, the draft version was published in July 2015
  • Official Reply of the Food and Drug Administration on the Application of Laws Related to Cosmetic Labelling and Marking[12]
  • Before the revision of Regulations Concerning the Hygiene Supervision over Cosmetics has been completed, former AQSIQ Decree No. 100 is the legal reference for Labelling requirements
  • GB 5296.3-2008 General Labelling for Cosmetics[13]
  • Way of labelling
  • General principle
  • Contents
  • General requirements
  • Announcement on the issuing of the management requirements for sunscreen cosmetics’ effect identification[14]
  • Modified SPF and PA value marking requirements

Customs Supervision, etc.

  • Detailed Rules for the Implementation of the Regulation on the Hygiene Supervision over Cosmetic[3]
  • Measures for supervision and administration of inspection and Quarantine of import and export cosmetics[15]
    • Import cosmetics inspection and quarantine
    • Export cosmetics inspection and quarantine
    • Non trade use cosmetics inspection and quarantine
    • Supervision and management
    • Legal liability

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References:

  1. Lexology: Clarification of the role of China National Medical Products Administration
  2. Gov.CN: Cosmetic Hygiene Supervision Regulations (化妆品卫生监督条例)
  3. AsianLII: Regulations Concerning the Hygiene Supervision over Cosmetics
  4. ORI.ZHCIQ.gov.CN: Safety and Technical Standards for Cosmetics 2015 [PDF]
  5. World Trade Organization: Notification 1287 [PDF]
  6. Hong Kong Means Business: Pre-Approval Waived for First Import of Non-Special-Use Cosmetics via any Mainland FTZ
  7. China Food & Drug Administration: Inventory of Existing Cosmetic Ingredients in China
  8. China Food & Drug Administration: Testing Institutions
  9. China Food & Drug Administration: Notice of the State Food and Drug Administration on Printing and Distributing the Administrative Measures for the Examination of Cosmetics: National Food and Drug Administration Xu [2010] No. 82
  10. Cosmetics Design-Asia: China makes strides in improving safety evaluation and cosmetics technical regulations
  11. State Administration of Market Regulation: Regulation on Cosmetic Label Management (former AQSIQ Decree No. 100) 化妆品标识管理规定(总局第100号令)
  12. Law.Foodmate.net: Official Reply of the Food and Drug Administration on the Application of Laws Related to Cosmetic Labelling and Marking 食品药品监管总局关于化妆品标签标识相关法律适用问题的批复(食药监稽函〔2014〕113号)
  13. GB 5296.3-2008 General Labelling for Cosmetics 消费品使用说明 化妆品通用标签
  14. Announcement on the issuing of the management requirements for sunscreen cosmetics’ effect identification《关于发布防晒化妆品防晒效果标识管理要求的公告
  15. Measures for supervision and administration of inspection and Quarantine of import and export cosmetics 进出口化妆品检验检疫监督管理办法 (2018第二次修正)
  16. Detailed Rules for the Implementation of the Regulation on the Hygiene Supervision over Cosmetics (化妆品卫生监督条例实施细则)
  17. http://www1.lawinfochina.com/Display.aspx?lib=law&Cgid=59039