China News Network on March 3 The reporter learned that recently, the State Administration for Market Regulation issued the Measures for the Supervision and Administration of Toothpaste (Order No. 24 of the State Administration for Market Regulation), which will be implemented from December 71, 2023. The newly revised Regulations on the Supervision and Administration of Cosmetics clearly stipulate: "Toothpaste shall be managed with reference to the provisions on ordinary cosmetics".
The Measures clarify the definition of toothpaste, defining toothpaste as a paste-like product that is applied to the surface of human teeth by friction with the main purpose of cleaning; Standardize the efficacy management and labeling requirements of toothpaste, require that the efficacy claims of toothpaste should have sufficient scientific basis, clarify the content that toothpaste should label and prohibit labeling, and standardize the scope and terminology of efficacy claims. At the same time, it is clarified that the State Food and Drug Administration and the departments responsible for drug supervision and administration of local people's governments at or above the county level are responsible for toothpaste supervision.
The Measures stipulate that toothpaste shall be subject to record-filing management, new toothpaste raw materials shall be registered or record-filed according to the degree of risk, and a safety monitoring system shall be implemented, and new toothpaste raw materials that have no safety problems after the expiration of the safety monitoring period shall be included in the catalogue of used toothpaste raw materials formulated by the State Food and Drug Administration; Continue to use the existing toothpaste production license 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 Measures specify that toothpaste recordators are responsible for the quality, safety and efficacy claims of toothpaste; Toothpaste manufacturers and traders shall engage in production and business 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, in the legal liability section, the Measures also list the specific circumstances in accordance with the provisions of the Regulations on the Supervision and Administration of Cosmetics and the Administrative Measures for the Registration and Filing of Cosmetics and the Measures for the Supervision and Administration of Cosmetics Production and Operation, further clarifying the main responsibilities of enterprises.
According to the policy interpretation of the "Measures for the Supervision and Administration of Toothpaste" released on the website of the State Food and Drug Administration on March 3, relatively speaking, the efficacy claims in China's toothpaste market are relatively confusing, and the random claims of "anti-inflammatory and analgesic, hemostasis", "promote young children's teeth to grow teeth", "repair tooth holes", "close tooth gaps", "stabilize loose teeth", "regenerate teeth", "treat Helicobacter pylori" are endless, and some claims are blurred with drugs and medical devices, which seriously misleads consumers and brings great safety risks to consumers' health.
According to the interpretation, in response to problems such as false and exaggerated claims, the Measures draw on the management experience of other countries (regions), and increase the management of efficacy claims by implementing the main responsibility of enterprises and strengthening social co-governance. The Measures stipulate that the efficacy claims of toothpaste should be based on sufficient scientific evidence. The toothpaste filer shall publish the literature, research data or summary of the product efficacy evaluation data on which the efficacy claim is based at the time of filing, and accept social supervision. The efficacy claim evaluation of toothpaste shall comply with laws, regulations, mandatory national standards, technical specifications and the relevant requirements of quality safety and efficacy claim evaluation stipulated by the State Food and Drug Administration, so as to ensure the scientificity, accuracy and reliability of the efficacy claim evaluation results. (Zhongxin Finance)
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