China’s new toothpaste regulations are set to be implemented starting from December 1, 2023, onwards.
In a move to safeguard public health and uphold product quality, the State Administration for Market Regulation (SAMR) announced the release of the “Regulations on Supervision and Administration of Toothpaste” (SAMR Order No. 71) in March 2023.
Toothpaste serves not only as a daily consumer product but also as a vital component linked to public health. The revised “Regulations on Supervision and Administration of Cosmetics” explicitly state that toothpaste should be managed in accordance with provisions related to general cosmetics. After extensive consultations, in-depth research, and thorough deliberation, the “Regulations on Supervision and Administration of Toothpaste” (referred to as the “Regulations”) were formulated, consisting of 25 articles.
Defining toothpaste and managing efficacy
The “Regulations” explicitly define toothpaste as a paste-like product intended for cleaning the surface of human teeth by friction, primarily for the purpose of oral hygiene. The document regulates toothpaste efficacy claims and label requirements, mandating that efficacy claims should be scientifically substantiated. It outlines what should and should not be labeled on toothpaste packaging, setting the scope and language for efficacy claims.
Registration-based management for toothpaste
Under the “Regulations,” toothpaste is subjected to a registration-based management system. New toothpaste raw materials are to be registered or recorded based on their level of risk. A safety monitoring system is established for such materials. Toothpaste raw materials that pass safety monitoring without incident are then incorporated into the list of approved toothpaste ingredients set by the NMPA. The existing toothpaste production license system will be maintained, with cosmetic production licenses issued for toothpaste production. This approach aims to minimize industry disruptions while ensuring product quality and safety.
Accountability and compliance
The “Regulations” stipulate that the party filing for toothpaste registration or filing is accountable for the quality, safety, and efficacy claims of the toothpaste. Manufacturers must conduct their production and operations in compliance with relevant laws, regulations, mandatory national standards, and technical specifications. This includes enhancing management practices and adhering to ethical principles.
Additionally, the “Regulations” outline legal liabilities in accordance with the Cosmetic Supervision and Administration Regulation (CSAR) and make reference to the applicable “Regulations on the Registration and Filing of Cosmetics” and “Regulations on Production and Operation of Cosmetics,” further clarifying the responsibilities of industry players.
With these regulations set to take effect, consumers can anticipate a heightened level of confidence in the toothpaste products they rely on daily.
Please contact us if you would like an English translation of the new regulation.
As the landscape of toothpaste regulations in China undergoes a significant transformation, it’s crucial for companies to stay ahead of the curve and ensure compliance with the new guidelines. Cisema is here to guide you through the intricacies of the registration process, ensuring a smooth and efficient journey towards market entry. With our experienced team well-versed in the nuances of Chinese regulatory requirements, we offer expert assistance in preparing and submitting your toothpaste product registrations, so you can navigate the evolving regulatory landscape with confidence.