On March 23, 2023, China State Administration of Market Regulation (SAMR) issued the Measures for the Supervision and Management of Toothpastes, which will take effect as of December 1, 2023.
The Measures have 25 articles in total, and the main contents include:
First, clarify the definition of toothpaste and regulatory departments. Toothpaste is defined as a paste-like product that is applied to the surface of human teeth by friction for the main purpose of cleaning; Clarify that the National Medical Products Administration (NMPA) and the departments responsible for drug supervision and management at or above the county level are responsible for toothpaste supervision.
Second, clarify the management requirements of toothpaste and toothpaste raw materials. It is stipulated that toothpaste shall be subject to filing management, and new toothpaste raw materials shall be registered or filed for management according to the degree of risk.
Third, continue to use the current toothpaste production licensing system, issuing a cosmetics production license for toothpaste production.
Fourth, clarify toothpaste efficacy management and labeling requirements. It is required that toothpaste efficacy claims should have a sound scientific basis, specifying the contents that should be labeled and prohibited from labeling.
Industry insiders said: This is the first time that toothpaste has been brought into substantive regulation, which may have a greater impact on toothpaste companies than before when cosmetics companies encountered the new cosmetic regulations.
Original website: https://gkml.samr.gov.cn/nsjg/fgs/202303/t20230323_354050.html
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