China Toothpaste Notification
China State Administration of Market Regulation (SAMR) issued the toothpaste regulation-------Measures for the Supervision and Management of Toothpastes on March 23, 2023, which will take effect as of December 1, 2023. The Measures clarify the definition, regulatory departments, notification management, efficacy claims, safety assessment, and labeling requirements related to toothpastes. Feel free to hit me up by booking a meeting.
What is 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.
Note: Toothpowder, tooth cleaning gel, mouthwash, and other oral care products are not toothpastes.
New Toothpaste Ingredient Definition:
The natural or artificial ingredients used for toothpaste for the first time in China are new toothpaste ingredients.
Toothpaste and New Toothpaste Ingredient Management
According to the Measures for the Supervision and Management of Toothpastes, toothpastes shall be subject to notification management, and toothpaste notification persons are responsible for the quality and safety of toothpaste and efficacy claims.
New toothpaste ingredients should comply with the relevant provisions of the management of new cosmetic ingredients. The registration management of new toothpaste ingredients with functions of preservatives and colorants shall be implemented. Other toothpaste new ingredients shall be subject to notification management.
Dossier Requirements for Toothpaste Notification
To apply for toothpaste notification, the notification person or the domestic responsible person shall submit the following materials:
(1) Name, address, and contact information of the notification person;
(2) Name, address, and contact information of the production enterprise;
(3) Product name;
(4) Product formula;
(5) The standards for product implementation;
(6) Product label sample;
(7) Product inspection report;
(8) Product safety assessment documents.
For Imported toothpaste notification, documents that prove products have been sold in the producing country (region) and supporting documents that prove overseas manufacturer confirms to Good Manufacturing Practices (GMP) shall be submitted.
For products produced exclusively for export to China, if documents that prove products have been sold in the producing country (region) are unable to be submitted, the relevant research and testing materials conducted for Chinese consumers shall be submitted.
Toothpaste Label Content
The following content shall be marked on the toothpaste label:
(1) Product name;
(2) The name and address of the notification person and the entrusted production enterprise, the name and address of the responsible person in China shall also be marked for the overseas notification person;
(3) The name and address of the production enterprise, as well as the production license number of the domestic toothpaste, shall be marked simultaneously;
(4) The standard number of the product implementation;
(5) All ingredients;
(6) Net content;
(7) Shelf life;
(8) Necessary safety warning language;
(9) Other contents that shall be marked in accordance with laws, administrative regulations, and mandatory national standards.
According to the characteristics of the product, the product's usage method should be labeled on the visible surface of the sales packaging if necessary.
Our Services Related to China Toothpaste Notification
Domestic/imported toothpaste notification in China
Fulfill the responsibility of the domestic responsible person
Toothpaste formula/label/advertisement review
Toothpaste safety assessment report
Toothpaste efficacy evaluation