Since toothpaste is very different from cosmetics in terms of raw materials and evaluation of efficacy claims, toothpaste cannot fully follow the regulations related to cosmetics.
Until March 16, 2023, the China State Administration for Market Regulation (SAMR) released the Measures for the Supervision and Administration of Toothpaste (hereinafter referred to as "Measures"), which clearly stipulates the definition of toothpaste, notification management, efficacy claims, labeling management, etc. It is of great significance to regulate toothpaste production and operation activities, strengthen the supervision and management of toothpaste, ensure the quality and safety of toothpaste, and promote the healthy and long-term development of the toothpaste industry.
Toothpaste management system is increasingly improved
Toothpaste management has changed as follows:
❑ 【1987】The former Ministry of Light Industry drafted and adopted the "GB 8372-1987 Toothpaste" is the first national standard for toothpaste products in China, and the current standard is "GB/T 8372-2017 Toothpaste".
❑ 【2001】China Toothpaste Industry Association (established in 1984 and renamed as China Oral Care Industry Association) organized to draft the Good Manufacturing Practice for Toothpaste Enterprises, which was released as an industry self-regulatory document.
❑ 【2006】China Oral Care Industry Association organized the drafting of the Implementation Rules for Production License of Toothpaste Products approved by the former State General Administration of Quality Supervision, Inspection and Quarantine. The Production License (Toothpaste) was issued to toothpaste production enterprises, and toothpaste products were officially included in the national production license management.
❑ 【2007】The former State General Administration of Quality Supervision, Inspection and Quarantine issued the Regulations on the Management of Cosmetic Labeling to include toothpaste product labeling management in the scope of cosmetics.
❑ 【2008】China Oral Care Industry Association drafted and released the national standard GB 22115-2008 General requirements on raw materials of toothpastes and the industry standard QB 2966-2008 Functional toothpastes, which played an important guiding role in the safety management and efficacy development of toothpaste industry.
❑ 【2010】The former Ministry of Health issued the industry standard WS/T 326-2010 Efficacy evaluation of toothpaste, which regulated the principles, methods, and standards of toothpaste efficacy evaluation.
❑ 【2016】The former State Food and Drug Administration formulated the Work Specifications for Cosmetics Production License, which included toothpaste production management in the scope of cosmetics and issued the "Cosmetics Production License" to toothpaste production enterprises.
❑ 【2018】The National Medical Products Administration (NMPA) was established, which fulfilled the regulatory function of the former State Food and Drug Administration on toothpastes.
❑ 【2020】The Cosmetics Supervision and Administration Regulations (CSAR) was issued, clarifying that toothpaste shall be managed in accordance with general cosmetics.
❑ 【2021】The State Administration for Market Regulation (SAMR) issued the Provisions for Supervision and Administration of Manufacturing and Marketing of Cosmetics. According to Article 16, cosmetic production license items include toothpaste.
❑ 【2022】The National Medical Products Administration (NMPA) issued the Good Manufacturing Practice for Cosmetics. According to Article 66, the quality management of toothpaste production shall be carried out in accordance with this standard.
❑ 【2023】The Measures for the Supervision and Management of Toothpastes was released, which have made clear provisions on the definition, efficacy claims, labeling requirements, and other aspects of toothpastes, specifying that toothpastes shall be subject to notification management. Toothpastes finally ushered in a more detailed, specific regulatory plan.
Analysis of toothpaste regulation
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.
Specify the definition of toothpaste and regulatory authority
Article 3 specifies the definition of toothpaste. 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. It should be noted that the new regulations limit the physical properties of toothpaste products to "paste", which means that products such as tooth powder and mouthwash are excluded.
Article 4 specifies the regulatory authority of toothpaste. China National Medical Products Administration (NMPA) is responsible for the national supervision and management of toothpaste. The drug regulatory department of local people's governments at or above the county level is responsible for the supervision and management of toothpaste in their respective administrative regions.
Clarify the basic requirements for toothpaste management
Article 5 stipulates that toothpaste is subject to notification management. The toothpaste notification person shall be responsible for the quality safety, and efficacy claims of the toothpaste.
Article 11 clarifies the dossiers required to be submitted for toothpaste notification.
Article 12 stipulates that before the toothpaste notification, the notification person shall conduct safety assessments by itself or entrust a qualified institution.
Article 13 stipulates the requirements for toothpaste efficacy claims. Toothpaste efficacy claims should have a sufficient scientific basis. The toothpaste notification person shall publish the literature, research data, or the summary of efficacy evaluation materials which the efficacy evaluation is based on the Information Service Platform for Notification, and accept social supervision. Article 19 stipulates the prohibited labeling contents.
(1) Explicit or implied content with medical effects;
(2) False or misleading content;
(3) Content that violates social order and good customs;
(4) Other contents prohibited from labeling by laws, administrative regulations, mandatory national standards, and technical specifications.
Toothpaste production license
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.
The Measures for the Supervision and Management of Toothpastes will take effect on December 1, 2023, which will improve the management of the toothpaste industry.
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