China Cosmetic Product Registration/Notification


Overview


The new overarching rule on cosmetics in China – Cosmetic Supervision and Administration Regulation (CSAR) was released by China State Council on June 29, 2020. With CSAR that came into effect on January 1, 2021, the cosmetics industry in China is entering a new era.

Cosmetic products now must be notified/registered with NMPA before being imported and sold legally in China.

 

Definition of Cosmetic Products 


Aspects Cosmetics Not Cosmetics
Usage Spreading, spraying, or other similar ways like rubbing Injection, digestion, or oral administration
Applied body parts External parts of the human body, such as skin, hair, nails, lips Oral mucosa or internal genitalia
Functions and purpose of use For cleansing, protecting, beautifying, or improving the appearance Disease prevention or treatment
N.B.:

• Toothpaste is not defined as cosmetics but shall be regulated with reference to general cosmetics regulations.

• CSAR does not apply to soaps, excluding those claimed to have special cosmetics efficacy (e.g., whitening).

 

Classification of Cosmetic Products


Special Cosmetics vs. General Cosmetics

Special Cosmetic Products General Cosmetic Products
i. Hair dyes

ii. Hair perming products

iii. Freckle-removing (whitening) products    

iv. Anti-hair loss products                  

v. Sunscreens

vi. Cosmetics with new efficacy

Other cosmetics except for special cosmetics.
N.B.:

• The five previously classified as special-use cosmetics – hair growth, depilating, breast beauty, slimming, and deodorant products registered before January 1, 2021, can continue to be manufactured, imported, and sold in China during the 5-year transition period.

Domestic Cosmetics vs. Imported Cosmetics

Domestic cosmetics The last process of contacting cosmetics contents is completed in Chinese Mainland.
Imported cosmetics The last process of contacting cosmetics contents is completed out of Chinese Mainland.
N.B.:

• If the product’s last process of contacting cosmetic contents is completed in Hong Kong S.A.R, Macao S.A.R, or Chinese Taipei, it shall be managed with reference to the requirements of imported cosmetics.

 

Notification/Registration of Cosmetic Products


Classification Special cosmetics General cosmetics
Pre-Market Obligation Registration Notification
Involved Entities Registrant (domestic)

Responsible Person (imported)

Notifier (domestic)

Responsible Person (imported)

Competent Authority NMPA NMPA or local provincial MPA
Certificate Registration license

(Valid for five years)

E-certificate

(Permanent)

Post-Market Obligation Registrational renewal Annual report submission

 

Steps for Imported Cosmetic Registration/Notification


 

Steps for Imported Cosmetic Registration/Notification  

Competent Authorities in China


  • National Medical Product Administration (NMPA)

It is responsible for the registration of imported/domestic special cosmetics, the notification of imported general cosmetics, and the registration and notification of new cosmetic ingredients.

  • State Administration for Market Regulation (SAMR)

Its main responsibilities include market management and quality and safety supervision.

  • General Administration of Customs (GAC)

It is in charge of the inspection of imported and exported goods and quarantine of cosmetics.

 

Notification/Registration Dossiers


Account Application and User Permission Opening

  1. Registrant and notifier information form and resume of the person in charge of quality and safety
  2. Quality management system overview of registrants and notifiers
  3. Adverse reaction monitoring and evaluation system overview form of registrants and notifiers
  4. Domestic responsible person information form (applicable to overseas registrants and notifiers)
  5. The original authorization letter of the domestic responsible person and its original notarial certificate

Registration and Notification Application

  1. Cosmetics registration and notification information form and related documents (classification code)
  2. Product name information
  3. Product formula (ingredient submission code)
  4. Product executive standards
  5. Product label sample manuscript
  6. Product testing report
  7. Product safety assessment documents
  8. Other supporting documents

N.B:

  • Imported cosmetics are required to submit certifications relating to manufacturing quality control of the overseas manufacturers.
  • For products specially produced for the China market without the supporting documents, the applicant shall submit relevant research and test data for Chinese consumers.

 

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  • A professional, global, multilingual, and multicultural team with the capability to deliver services with high efficiency through a systematic approach

 

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