Effective from December 1, 2023
Recently, the General Administration of Market Supervision issued the “supervision and management of toothpaste” (State Administration of Market Supervision Decree No. 71), from December 1, 2023 onwards.
Toothpaste is not only a daily consumer product, but also a product closely related to people’s health. The newly revised “Regulations on the Supervision and Administration of Cosmetics” clearly stipulates that “toothpaste shall be managed with reference to the provisions on ordinary cosmetics”. In order to implement the provisions of the Regulations, standardize toothpaste production and management activities, strengthen toothpaste supervision and management, ensure toothpaste quality and safety, protect consumer health, and promote the healthy development of the toothpaste industry, the General Administration of Market Supervision and Administration of Pharmaceutical Affairs of the People’s Republic of China (GAMC) and the State Drug Administration (SDA) adhere to the scientific, democratic and lawful legislation, and formulate the “Measures for Supervision and Management of Toothpaste” (hereinafter hereinafter referred to as “Measures”). There are 25 articles in the Measures, which mainly include the following contents:
The Measures clarify the definition of toothpaste, defining toothpaste as a paste product applied to the surface of human teeth by friction for the main purpose of cleaning; standardize the management of toothpaste efficacy and labeling requirements, requiring that the efficacy claims of toothpaste should be supported by sufficient scientific evidence, clarifying that toothpaste should be labeled and prohibited from labeling, and standardizing the scope of the efficacy claims and the terminology. At the same time, it is clear that the State Drug Administration and the local people’s governments at or above the county level are responsible for the supervision and management of drug supervision and management departments responsible for the supervision of toothpaste.
Measures” stipulates that the implementation of toothpaste record management, toothpaste new raw materials in accordance with the degree of risk of registration or record management, and the implementation of safety monitoring system, safety monitoring period expired without the occurrence of safety issues of toothpaste new raw materials into the State Drug Administration has been used in the development of toothpaste raw materials directory; continue to follow the existing toothpaste production licensing system, the production of toothpaste production of cosmetic production licenses issued to safeguard product quality and safety based on minimizing the impact on the industry On the basis of product quality and safety, minimize the impact on the industry.
The Measures make it clear that the toothpaste filer is responsible for the quality, safety and efficacy claims of toothpaste; toothpaste producers and operators should be in accordance with the laws, regulations, mandatory national standards, technical specifications to engage in production and business activities, strengthen the management, integrity and self-discipline to ensure that the quality of toothpaste products and safety. In addition, the “Measures” in the legal responsibility section also lists the “supervision and management of cosmetics regulations” and reference to the application of “cosmetic registration and filing of administrative measures” “cosmetic production and management supervision and management measures” of the specific circumstances, to further clarify the main responsibility of enterprises.