Cosmetic

China Cosmetic Product Registration or Notification/Filing

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 registered, notified/filed with NMPA before being imported and sold legally in China.

Definition of Cosmetic Products 


AspectsCosmeticsNot Cosmetics
UsageSpreading, spraying, or other similar ways like rubbingInjection, digestion, or oral administration
Applied body partsExternal parts of the human body, such as skin, hair, nails, lipsOral mucosa or internal genitalia
Functions and purpose of useFor cleansing, protecting, beautifying, or improving the appearanceDisease 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 ProductsGeneral Cosmetic Products

i. Hair dyes 

ii. Hair perming products 

iii. Freckle-removing (whitening) products 

iv. Anti-hair loss products v. Sunscreensvi. 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 cosmeticsThe last process of contacting cosmetic contents is completed in the 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.

NMPA Registration or Notification/Filing of Cosmetic Products


ClassificationSpecial cosmeticsGeneral cosmetics
Pre-Market ObligationRegistrationNotification/Filing
Involved EntitiesRegistrant (domestic) Responsible Person (imported)Notifier (domestic) Responsible Person (imported)
Competent AuthorityNMPANMPA or local provincial MPA
CertificateRegistration license (Valid for five years)E-certificate (Permanent)
Post-Market ObligationRegistrational renewalAnnual report submission

Steps for Imported Cosmetic Registration or Notification/Filing


 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.

NMPA Registration and Notification/Filing Dossiers


Account Application and User Permission Opening

  1. The 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/Filing 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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