Overview:

On June 29,2020 The National Medical Products Administration (NMPA) published a new cosmetic regulation known as the “Cosmetic Supervision and Administration Regulation”.  This new regulation will replace the Cosmetic Hygiene Supervision Regulation of 1989 and will be effective as of January 1 ,2021.

The new regulation includes numerous new provisions including the requirements to include safety assessment to be carried out prior to registration or filling, efficacy claims need to be backed by sufficient scientific evidence and Good Manufacturing Practices (GMP) certificates required for imported cosmetics.

 

Cosmetics in China:

The new regulation defines cosmetics as:

“daily chemical industrial products applied to skin, hair, nails, lips and other human surfaces by scrubbing, spraying or other similar methods for the purpose of cleaning, protection, beautification and modification.”

In comparison to the older definition “eliminate unpleasant odor” has been removed. 

In china cosmetics are divided into two categories Special-use cosmetics and non-special use cosmetics. Special-use cosmetics must be registered while non-special use cosmetics sometimes referred to as “general cosmetics” or “ordinary cosmetics” must be notified or filled with the NMPA.

Cosmetics to be removed from special-use cosmetic category:

The regulation points out that cosmetics products registered before the implementation of these regulations,  will be given a transition period of 5 years.  The  production importation and sale can be continued during the transition period however, after the transition period, the cosmetics may not be produced, imported, or sold.

The products removed from the category are:

  • hair growth products
  • depilation/hair removal products
  • breast beauty
  • slimming products
  • deodorization products

Cosmetic Ingredients:

In China, cosmetic ingredients are classified as either new  or used ingredients. Used ingredient implying that they have been used in cosmetics in prior products in China. New ingredients  considered high-risk must be registered  by the administration and new raw cosmetic ingredient not considered high-risk will be notified known as “filling management”

Ingredient Considered high risk such as preservations, UV-filters, colorants, and whitening agents need to register or file a dossier with the NMPA. The following information is needed to complete a dossier to the NMPA:

  • General information of applicant
  • Manufacturing Process
  • Stability information
  • Quality Control Standards
  • Research and development report
  • Safety Assessment Data

Timelines & Reporting

 The regulations outlines that the complete process will take 117 working days for the cosmetic ingredient to be published on the online government platform.

Once the new cosmetic ingredient has been registered, the registers of the new ingredient must submit  safety information and use of the ingredient every year for three years to the NMPA.

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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