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Cosmetics & Hygiene Regulatory Watch

Get ready for new Chinese toothpaste regulation, December 1, 2023

April 28 2023

The State Administration for Market Regulation (SAMR) has issued ‘Notice No. 71 - Measures for the supervision and administration of toothpaste’. This is the first time China has released a dedicated regulation focused on toothpaste.

The State Administration for Market Regulation (SAMR) has issued ‘Notice No. 71 - Measures for the supervision and administration of toothpaste’. This is the first time China has released a dedicated regulation focused on toothpaste.

Highlights of the regulation include:

  • The term ‘toothpaste’, as used in these measures, refers to a paste-like product that is applied to the surface of human teeth by friction for the main purpose of cleaning. The key point is, the product must have a paste-like appearance with a friction agent and be used mainly for cleaning.
  • Before being launched on the market, all toothpastes must be notified to:
    • Imported – National Medical Products Administration (NMPA);
    • Domestic – provincial Medical Products Administration (MPA);
  • Concept of ‘new raw materials for toothpaste’ is introduced, relating to natural or artificial raw materials that are used in toothpastes for the first time in China. The rules for judging new raw materials are still being drafted but all new raw materials must be notified or registered with the NMPA before use.
  • Safety assessment is needed during notification. Safety assessor requirements and the rules for safety assessment are the same as for cosmetic products.
  • Responsible person must publish an evidence abstract to support product claims on the NMPA platform for consumers to easily check.

We are still waiting for more details on the regulation to be published by the NMPA.

Here is a summary comparing the new regulation with previous controls.

Item

Before

From 1 Dec 2023

Notification

No requirement

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New raw materials for toothpaste

No definition

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Definition of toothpaste

Definition in GB/T 8372-2017 with a focus on ingredients used and function

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Safety assessment

No requirement

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Evidence supports of claim

Yes

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Labeling requirements

Follow GB/T 29339-2012 - General labeling for oral care and cleansing products

 

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This new regulation will enter into force on December 1, 2023.

Next step: The industry must be aware of the new regulation and be prepared for any necessary changes to products before December 1, 2023


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