China has released new dossier requirements for cosmetic notification and registration as part of Rules for Cosmetic Notification and Registration for the cosmetic industry.

SAFEGUARDS | Cosmetics, Personal Care & HouseholdNO. 060/21

 SG 06021 Cosmetics

China’s National Medical Products Administration, NMPA, issued Notice No. 32, namely Provisions for Management of Cosmetic Registration and Notification Dossiers, providing detailed requirements for documents and the process of Notification and Registration of cosmetic products.

The highlights in this new provision include:

   

  •  Data submission requirements are unified for general cosmetics and special cosmetics, with the difference in test items based on product type:
    • Cosmetic registration and notification information form
    • Product name
    • Product formulation
    • Product standards
    • Product label
    • Product testing report
    • Product safety assessment data
  • Animal testing can be replaced by safety assessments for imported general cosmetics if the cosmetic manufacturers receive a manufacturing certificate from originator’s local authority. There are three exceptions:
    •  Products intended for use on infants or children
    • Products containing a new raw material
    • The responsible person has a poor record with the NMPA
  • A performance test report, conducted in an NMPA approved laboratory according to the methods in Safety and Technical Standard for Cosmetics 2015, must be provided during registration for sunscreen, skin whitening and anti-hair loss products
  • Uploading of the cosmetic formulation with exact weight percentages is required during notification and registration. This includes a safety information file for every raw material
  • A raw material safety information file and code shall be provided for every cosmetic ingredient
  • Cosmetic products which will be exported overseas shall proceed with notification to the NMPA with basic information, including product name, countries for exportation and product label. Manufacturers shall conduct testing according to the requirements of the target markets
  • Transition period as below

Completion date of registration Skin whitening products Anti-hair loss products
Before May 1, 2021 Performance test report shall be provided before May 1, 2023
May 1, 2021 to December 31, 2021
Performance test report shall be provided before May 1, 2022
From January 1, 2022 Performance test report shall be provided during registration

This new regulation came into effect on May 1, 2021.

Reference

  1. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210304140747119.html

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