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Functional Toothpastes and Relevant Toothpaste Efficacy Regulations

According to the QB/T 2966-2014 Functional toothpastes, functional toothpaste refers to a toothpaste that not only has the basic functions of toothpastes, but also assists in preventing or reducing certain oral problems, promoting oral health with the addition of efficacy ingredients.

In accordance with the Specification for Toothpaste Filing Dossiers (Draft for Comments), there are nine categories of toothpaste efficacy as follows: 01 Basic cleaning; 02 Anti-caries; 03 Inhibition of dental plaque; 04 Anti-dentin sensitive; 05 Reducing gum problems; 06 Whitening; 07 Anti-tartar; 08 Reducing bad breath; 09 Other effects.

Note: The toothpaste for children (6 months-12 years) can only claim 01 Basic cleansing and 02 Anti-caries.

Toothpaste claims and efficacy

On March 23, 2023, China State Administration for Market Regulation (SAMR) released the Measures for the Supervision and Management of Toothpastes (hereinafter referred to as Measures), which will take effect on December 1, 2023.

For false, exaggerated claims of toothpaste efficacy and other issues, Measures stipulates that the efficacy of toothpaste claims should have a sufficient scientific basis. Toothpaste filers should publish the literature, research data, on which the efficacy claim is based, or the summary of product efficacy evaluation materials, and accept social supervision.

The efficacy claim evaluation of toothpaste should comply with the relevant laws, regulations, mandatory national standards, technical specifications, and requirements related to quality and safety, and efficacy claim evaluation stipulated by the National Medical Products Administration (NMPA), to ensure the scientific, accurate, and reliable results of efficacy claim evaluation.

Toothpaste efficacy evaluation

Except for the basic cleaning type, other efficacy toothpastes should undergo efficacy evaluation in accordance with the specified requirements. At present, the efficacy evaluation of toothpaste is divided into clinical evaluation and laboratory evaluation. Before conducting a clinical efficacy evaluation, toothpaste should first complete the microbiological, physicochemical, and special safety tests of the product with providing a written report.

The Measures for the Supervision and Management of Toothpastes helps to effectively curb various chaos in the toothpaste market, and the toothpaste industry will usher in a more standardized era. Toothpaste production enterprises also need to conduct in-depth learning and take effective measures to implement the new regulations. The toothpaste filer should conduct an efficacy evaluation and submit filing dossiers in accordance with the relevant regulations.

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