China Issued Toothpaste Supervision and Administration Regulations

The State Administration for Market Regulation of China issued the “Toothpaste Supervision and Administration Regulations” (Order No. 71 of the State Administration for Market Regulation), which will come into force on December 1, 2023.

Toothpaste is not only a daily consumer product, but also a product closely related to the health of the people. The newly revised “Toothpaste Supervision and Administration Regulations” clearly stipulates: “Toothpaste shall be managed with reference to the regulations on general cosmetics.”

In order to implement the “Regulations”, standardize toothpaste production and operation activities, strengthen toothpaste supervision and management, ensure the quality and safety of toothpaste, protect the health of consumers, and promote the healthy development of the toothpaste industry, the State Administration for Market Regulation and the State Food and Drug Administration insist on scientific legislation, democratic legislation, and Legislate according to law, and on the basis of extensively listening to opinions, in-depth research, and full demonstration, the “Measures for the Supervision and Administration of Toothpaste” (hereinafter referred to as “Measures”) have been formulated. There are 25 articles in the “Regulations”, which mainly include the following contents:

The “Regulations” clarifies the definition of toothpaste, defining toothpaste as a paste-like product that is applied to the surface of human teeth in a frictional manner, with the main purpose of cleaning; standardizes the management of toothpaste efficacy and label requirements, and requires that the efficacy claims of toothpaste should be fully scientific According to the basis, clarify the content that toothpaste should and cannot be labeled, and standardize the scope and terminology of efficacy claims. At the same time, it is clear that the State Food and Drug Administration and the local people’s government at or above the county level are responsible for the supervision and management of toothpaste.

The “Regulations” stipulate that toothpaste shall be subject to filing management. New toothpaste raw materials shall be registered or filed according to the degree of risk, and a safety monitoring system shall be implemented. New toothpaste raw materials that have no safety problems after the expiration of the safety monitoring period shall be included in the used list formulated by the State Food and Drug Administration. Toothpaste raw material catalog; continue to use the existing toothpaste production licensing system, issue cosmetics production licenses for toothpaste production, and minimize the impact on the industry on the basis of ensuring product quality and safety.

The “Regulations” make it clear that toothpaste filers are responsible for the quality, safety and efficacy claims of toothpaste; toothpaste producers and operators should engage in production and operation activities in accordance with laws, regulations, mandatory national standards, and technical specifications, strengthen management, be honest and self-disciplined, and ensure the quality and safety of toothpaste products . In addition, the “Regulations” also lists specific situations in accordance with the “Regulations on the Supervision and Administration of Cosmetics” and the “Measures for the Administration of Registration and Filing of Cosmetics” and “Measures for the Supervision and Administration of Cosmetics Production and Operation” in accordance with the “Regulations on the Supervision and Administration of Cosmetics”, which further clarifies the main responsibility of the enterprise.

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