Various Cosmetic Regulatory Updates Supporting CSAR

Since the implementation of the CSAR (Cosmetics Supervision and Administration) was officially announced in June 2020, China has been preparing for the regulation to become effective on January 1, 2021. In November 2020, the NMPA (National Medical Products Administration) released 5 regulatory updates to support the CSAR. We have summarised these below.

Draft instructions for cosmetic registration and filing dossiers

In order to implement the CSAR, this draft includes a total of 6 chapters and 57 articles to further clarify and refine the specific information requirements for cosmetics registration and filing.

The CSAR requires the manufacturers to register their special cosmetic products with hair coloring, hair perming, freckle whitening, sunscreen, anti-hair loss functions or with new efficacy claims, whilst filing would be required for general cosmetics (in the past referred to as non-special cosmetics).

The public consultation period is open until November 30, 2020.

Draft instructions for new cosmetic ingredient registration and filing

This draft includes a total of 28 articles addressing the requirements for the registration and filing for new cosmetic ingredients:

• Registrants are responsible for the safety monitoring of the new cosmetic ingredients and required to submit an annual report for three years
• Registration will be required for new cosmetic ingredients with higher risk functions such as antiseptics, sun protection, hair coloring, freckle removal, whitening, etc., while filing will be required for other cosmetic ingredients

The public consultation period is open until November 30, 2020.

Draft guidelines for cosmetic efficacy claim evaluation

This draft consists a total of 22 articles to provide technical guidance on the evaluation of efficacy claims for the cosmetics industry. Different types of efficacy claims require their own evaluation method and are identified in the draft to ensure their scientific character and accuracy.

The public consultation period is open until November 30, 2020.

Draft measures for the management of cosmetic supplementary testing methods

This draft consists of 6 chapters and 29 articles covering the scope, procedures, guidelines and rules of cosmetic supplementary testing methods. Such supplementary testing methods will be applied for sampling inspections, quality and safety investigations and adverse reaction investigation.

The public consultation period is open until December 10, 2020.

Draft administrative measures on toothpaste products

This draft consists of 23 articles addressing the requirements of ingredients, product filing and efficacy evaluation of toothpaste products:

• If the toothpaste product uses a new ingredient for the first time in the market, the registrant must ensure that a mandatory technical standard is implemented before marketing. If there is a standard already, only the safety evaluation report of the ingredient would be required for submission
• The NMPA will formulate the classification catalogue for efficacy claims and keep it updated in a timely manner
• There should be sufficient and reliable scientific evidence to support the efficacy claims
• The product labelling should not claim to have medical effects in an expressive or implicit manner
• Any violations including, but not limited to, the following will be punished:
  • Not registering or filing the product as required
  • Illegal use of other ingredients
  • Violation of labelling requirements
  • Not verifying the efficacy claims as required

The public consultation period is open until December 12, 2020.

If you are interested in making a public submission, please share your opinions with us before the consultation period ends.

By Jacky Li. Contact Cisema if you would like to learn more.