China Releases New Dossier Requirements for Cosmetic Product Registration and Notification

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

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

Reference

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

It is crucial for all cosmetic, personal care and household products to be safe, effective and stable. SGS provides testing, inspection and certification services to manufacturers, distributors and importers to ensure a high level of product quality in every area. Our state-of-the-art laboratories offer tailored solutions for chemical, biophysical, microbiological, stability and biological aspects. We also have extensive capabilities in performance testing, claim support studies and consumer panels. Our testing is conducted according to customer specific or recognized standard methods, some of which were developed by SGS. Our cosmetic safety assessors and other technical experts can support customers by making sure new products comply with regulatory requirements. In the end, it’s only trusted because it’s tested. Contact us for more information or visit our website. 

For enquiries, please contact:

Denny Li
Technical Support
t: +86 020 2909 3881

^{© SGS Group Management SA - 2021 - All rights reserved - SGS is a registered trademark of SGS Group Management SA. This is a publication of SGS, except for 3rd parties’ contents submitted or licensed for use by SGS. SGS neither endorses nor disapproves said 3rd parties contents. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. It is strictly educational and does not replace any legal requirements or applicable regulations. It is not intended to constitute consulting or professional advice. The information contained herein is provided “as is” and SGS does not warrant that it will be error-free or will meet any particular criteria of performance or quality. Do not quote or refer any information herein without SGS’s prior written consent.}