1. What is the definition of toothpaste?
According to Article 3 of the Measures for the Supervision and Management of Toothpastes (hereinafter referred to as Measures), toothpaste is defined as a paste-like product that is applied to the surface of human teeth through friction, with the main purpose of cleaning. The definition reiterates that the mode of action of toothpaste is to assist friction, the site of action is the tooth surface, and the purpose of use is mainly cleaning, which is basically consistent with people's daily perception of toothpaste products. It can be seen from this definition that the material properties of toothpaste products are defined in the Measures, which must be "paste". Toothpowder, tooth cleaning gel, mouthwash, and other oral care products are not toothpastes.
2. Does toothpaste need to be filed?
The toothpaste needs to be filed before being sold or imported. According to Article 10 of the Measures, domestic toothpaste shall be filed with the drug regulatory department of the province, autonomous region, or municipality directly under the central government where the filing person is located before being put on the market for sale. Imported toothpaste shall be filed with the National Medical Products Administration (NMPA) before import. The NMPA can entrust drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government with corresponding capabilities to implement the filing and management of imported toothpaste in accordance with the law.
3. What materials are required for toothpaste filing?
According to Article 11 of the Measures, the filing person or domestic responsible person shall submit the following materials for toothpaste filing:
(1) The name, address, and contact information of the filer;
(2) The 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 materials.
For the filing of imported toothpaste, supporting documents that the product has been sold in the producing country (region) and supporting materials that the overseas production enterprise meets the quality management standards for cosmetics production shall be submitted at the same time; For products produced specifically for export to China, if supporting documents that the product has been sold in the producing country (region) are unable to be submitted, relevant research and experimental materials conducted for Chinese consumers shall be submitted.
4. According to the Measures, how to claim toothpaste efficacy?
According to Article 13 of the Measures, toothpaste efficacy claims shall have sufficient scientific basis. Toothpaste filer shall publish literature, research data for efficacy claims, or a summary of product efficacy evaluation data in the filing information service platform and accept social supervision.
The NMPA shall formulate, publish, and adjust the toothpaste classification catalogue based on factors such as the toothpaste efficacy claims, and user groups of toothpaste. The scope and words of toothpaste efficacy claims shall be consistent with the laws, regulations, mandatory national standards, technical specifications, and the provisions of NMPA.
5. What shall be marked on the toothpaste label?
According to the Article 17 of the Measures, the following content shall be marked on the toothpaste label:
(1) Product name;
(2) The name and address of the filer and the entrusted production enterprise, the name, and address of the responsible person in China shall also be marked for the overseas filer;
(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.
6. How to name toothpaste?
The name of toothpaste products generally consists of three parts: trademark name, generic name, and attribute name. The attribute name of toothpaste shall use the word "toothpaste (牙膏)" for expression.
Non-toothpaste products shall not be marked by the "toothpaste (牙膏)" words and other ways to deceive and mislead consumers.
7. What content is prohibited from being marked on toothpaste labels?
According to Article 19 of the Measures, it is prohibited to label toothpaste with the following content:
(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.
Note: According to the NMPA Announcement on Issuance and Implementation of the Measures for the Administration of Cosmetics Labels (No.77 of 2021), cosmetic products filed before May 1, 2022, which are not labeled in accordance with the provisions of the Measures for the Administration of Cosmetics Labels, the cosmetic filer shall complete the update of the product label before May 1, 2023, to ensure that the labeling of products listed after May 1, 2023, in line with the provisions and requirements of the Measures for the Administration of Cosmetics Labels.
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