ZMUni Compliance Centre

ZMUni Compliance Centre

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ZMUni Compliance Centre
China Cosmetic Compliance
China Cosmetic Compliance


Definition of Cosmetics in China


 

Cosmetics

According to China's Cosmetic Supervision and Administration Regulation (CSAR), cosmetics refer to daily chemical products applied to the skin, hair, nails, lips, and other external parts of the human body through methods such as smearing, spraying, or similar approaches, for the purposes of cleansing, protecting, beautifying, or modifying appearance.

Imported Cosmetics

A cosmetic product is considered an imported cosmetic if the final manufacturing step involving direct contact with the product contents is completed outside mainland China. Products manufactured in Taiwan, Hong Kong, and Macao are also regulated as imported cosmetics.

For products registered or notified under the same product name, if any product component in a multi-dose or combination package completes its final content-contact manufacturing step overseas, the entire product is regulated as an imported cosmetic.

 

Cosmetic Classification and Regulatory Requirements in China


Except for products sold through cross-border e-commerce platforms and general cosmetic soaps, cosmetics sold through other channels in China must complete registration or notification with the National Medical Products Administration (NMPA) or relevant provincial regulatory authorities before entering the market.

Category

Special Cosmetics

General Cosmetics

Definition

Cosmetics with specific functions, including hair dye, perm, whitening, sunscreen, hair loss prevention, and products claiming new efficacy

Cosmetics other than special cosmetics, including skincare, haircare, body care, nail care, depilatory products, deodorants, fragrances, and makeup

Regulatory Process

Registration

Notification

Regulatory Authority

NMPA

Domestic general cosmetics: Provincial MPA where the notifier is located. Imported general cosmetics: NMPA and delegated provincial MPAs

Post-market Requirements

Registration certificate valid for 5 years and renewal required before expiration

Annual reporting required

Estimated Timeline

10–14 months

2–4 months

*Imported cosmetics must appoint a China-based responsible entity (Responsible Person, RP) to complete registration or notification. The RP assumes responsibility for product safety and quality compliance in China.

 

Key Regulations


 

  •  Cosmetic Supervision and Administration Regulation (CSAR)

  • Administrative Measures on Cosmetic Registration and Notification

  • Provisions for Management of Cosmetic Registration and Notification Documentation

  • Cosmetic Labeling Management Measures

  • Regulations on Supervision and Administration of Children's Cosmetics

  • Cosmetic Classification Rules and Classification Catalogue

  • Safety and Technical Standards for Cosmetics (2015 Edition)

  • Technical Guidelines for Cosmetic Registration and Notification Testing

  • Guidelines for Cosmetic Efficacy Claim Evaluation

  • Technical Guidelines for Cosmetic Safety Assessment (2021 Edition)

  • Inventory of Existing Cosmetic Ingredients in China (2021 Edition)

  • Technical Guidelines for Submission of Cosmetic Registration and Notification Documentation (Trial)

 

Cosmetic Registration & Notification Process in China


 

 

化妆品注册备案流程图.png

 

Documentation Requirements for Cosmetic Registration & Notification


  

Product Category

Required documents

Domestic 

Cosmetics

  1. Cosmetic registration/notification information form and related documents

  2. Product name information

  3. Product formula

  4. Product quality standards

  5. Product label artwork

  6. Product testing reports

  7. Product safety assessment documents

 

Reference: Article 26 of the Provisions for Management of Cosmetic Registration and Notification Dossiers

Imported 

Cosmetics

  1. Cosmetic registration/notification information form and related documents

  2. Product name information

  3. Product formula

  4. Product quality standards

  5. Product label artwork

  6. Product testing reports

  7. Product safety assessment documents

  8. Certificate of Free Sale (CFS) or equivalent documents issued by competent authorities, industry associations, or relevant institutions in the country/region of the registrant, notifier, or manufacturer. For cosmetics manufactured by overseas contract manufacturers, documentation proving the entrustment relationship must also be provided.

  9. For imported cosmetics specifically developed for the Chinese market (excluding products manufactured overseas under domestic entrustment), additional documents are required, including:

·Explanation of formula design based on Chinese consumers'skin characteristics and consumption needs

·Consumer testing or human efficacy testing conducted with Chinese consumers in China

 

Reference: Articles 26 and 27 of the Provisions for Management of Cosmetic Registration and Notification Dossiers

 

Cosmetic Testing Requirements


 

Product testing reports required for cosmetic registration or notification must be issued by qualified cosmetic testing institutions and comply with relevant regulations, including the Safety and Technical Standards for Cosmetics and Technical Guidelines for Cosmetic Registration and Notification Testing.

Testing requirements may include:

  • Microbiological testing

  • Physicochemical testing

  • Toxicological testing

  • Human safety testing (for applicable special cosmetics)

  • Human efficacy testing reports

  

Exemption from Animal Toxicology Testing

Since May 1, 2021, general cosmetics may be exempt from toxicological testing if they meet the following conditions and are supported by safety assessment:

  1. All manufacturing sites have obtained GMP certification issued by competent authorities in the country/region where they are located (certification issued by third-party organizations is not accepted; multiple manufacturing sites require separate certification).

  2. The product does not claim to be intended for infants or children.

  3. The product does not contain new cosmetic ingredients currently under safety monitoring.

  4. Based on the quantitative classification scoring results, the notifier, Domestic Responsible Person, and manufacturer are not classified as key regulatory supervision targets.

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