In June 2020, the “Regulations on the Supervision and Administration of Cosmetics” (hereinafter referred to as the “Regulations”) were issued, which clarified that toothpaste should be managed by the National Medical Products Administration (NMPA) in accordance with the provisions of the Regulations on ordinary cosmetics.
In March 2023, the State Administration for Market Regulation (SAMR) issued the “Measures for the Supervision and Administration of Toothpaste” (hereinafter referred to as the “Measures”), which clarifies the system of raw material management, product filing, production licensing, safety assessment, and efficacy claims for toothpaste.
In September 2023, the NMPA issued the “Announcement on the Implementation of Toothpaste Regulatory Regulations and Simplification of the Requirements for Filing Information of Marketed Toothpaste and Other Relevant Matters” (No. 124 of 2023) (hereinafter referred to as the “Announcement”), which clarified that the filing of toothpaste that had been marketed before could be simplified.
In November 2023, the NMPA issued the “Regulations on the Administration of Toothpaste Filing Information” (hereinafter referred to as the “Regulations”) to refine the management of toothpaste filing. Starting from December 1, 2023, the filer shall apply for filing with the drug administration department before the toothpaste is sold or imported, and shall be responsible for the quality, safety and efficacy claims of the toothpaste.
With the release of various new regulations on toothpaste filing in 2023, the development of the toothpaste industry has been gradually standardized, and the regulation of toothpaste in China has entered a new era.
In addition to simplifying the filing of marketed toothpaste, the Announcement also stipulates that:
“The simplified filing of toothpaste packaging should comply with regulatory requirements such as the Regulations, Measures, and Cosmetic Label Management Measures. If only the format of packaging needs to be adjusted, sales packaging that have already been marketed can be used for simplified filing, and product packaging updates should be completed as required by July 1, 2024.”
This means that compliant toothpastes can continue to use marketed sales packages until July 1, 2024, and continue to consume stock packages during the transition period.
With the transition period coming to an end, what are the regulatory requirements for toothpaste packaging? We combed and summarized into the following table:
According to the Measures, the contents that should be labeled in the toothpaste label, the contents that are prohibited to be labeled and the name of the toothpaste are given specific provisions, and the enterprises should be adjusted in time according to the requirements.
It should also be noted that if there is a change in any content other than the labeling format, complete documents should be submitted to apply for the change in accordance with the requirements of the Regulations.
The release of the new toothpaste regulations is not only conducive to the competition of quality products, but also introduces the industry into a more scientific mode of competition, so that the product and the market is more standardized. In the context of increasingly stringent regulation, foreign producers need a professional partner to jointly shape a better future for the industry.
