On March 23, 2023, China State Administration for Market Regulation (SAMR) issued the Measures for the Supervision and Management of Toothpastes (hereinafter referred to as the Measures), which shall be effective as of December 1, 2023.
EnterCo has sorted out the Measures, and listed the main contents.
The Measures Specify Six Key Important Contents
The Measures have a total of 25 articles, which specify the definition of toothpaste and regulatory authorities, toothpaste and toothpaste raw materials management requirements, toothpaste efficacy claims requirements, etc.
1. Specify the definition of toothpaste and regulatory authority
Measures Article 3 specifies the definition of toothpaste, Article 4 specifies the regulatory authority of toothpaste.
2. Specify the basic requirements of toothpaste product management
Article 5 stipulates that toothpaste is subject to filing management. Article 6 refines the obligations of the domestic responsible person. Article 11 clarifies the materials required to be submitted for toothpaste filing. Article 12 stipulates that before the toothpaste filing, the filer shall conduct safety assessments by itself or entrust a qualified institution. Article 15 stipulates that those engaging in toothpaste production activities shall apply to the drug regulatory department of local provinces, autonomous regions, and municipalities to obtain a production license, that is, continue to use the current toothpaste production licensing system, issue cosmetic production license for the toothpaste production.
3. Specify the management requirements of toothpaste raw materials
Article 8 specifies the definition of toothpaste new raw materials and the basis for determining toothpaste new raw materials. It stipulated that toothpaste new raw materials are subject to registration or filing management in accordance with the degree of risk. Article 9 clarifies the management requirements for toothpaste raw materials, and refines the toothpaste raw material regulation.
4. Specify the efficacy management of toothpaste and labeling requirements
Article 13 stipulates the requirements for toothpaste efficacy claims. Article 14 clarifies the requirements for toothpaste efficacy claim evaluation. Article 17 stipulates the contents that toothpaste shall be labeled. Article 19 stipulates the prohibited labeling contents. Article 18 standardizes the naming of toothpaste, and specifies that "toothpaste (牙膏)" shall be the attribute name of toothpaste products. Non-toothpaste products shall not be marked with the word "toothpaste (牙膏)" and use other means to deceive and mislead consumers. Article 20 makes special provisions for the toothpaste claimed to be suitable for children.
5. Specify the disposal requirements of illegal behavior in the field of toothpaste
Article 21 and Article 22 list the common illegal situations and stipulate that if there are related illegal behaviors, they shall be dealt with in accordance with the relevant provisions of the Cosmetics Supervision and Administration Regulations (CSAR).
6. Specify the content not specified in the Measures shall refer to cosmetics-related regulations
According to the Cosmetics Supervision and Administration Regulations (CSAR), toothpaste shall be managed in accordance with the regulations related to general cosmetics. Therefore, the Measures do not specify all the contents involved in toothpaste management, while only clarifying the differences between toothpaste and cosmetics management. Article 23 stipulates the supervision and management of toothpaste. For contents not involved in Measures, refer to the Provisions for Registration and Filing of Cosmetics, the Provisions for the Supervision and Administration of Cosmetics Manufacture and Distribution, and other relevant regulations.
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