In order to standardize the supervision and management of toothpaste, protect consumer health, and promote the healthy development of the toothpaste industry, in accordance with the provisions of the "Regulations on the Supervision and Management of Cosmetics" (hereinafter referred to as the "Regulations") and the "Measures for the Supervision and Management of Toothpaste" (hereinafter referred to as the "Measures"), the following announcement is made regarding the implementation of the requirements of toothpaste supervision regulations and the simplification of the requirements for the filing of listed toothpaste materials:

一、 Implement the requirements of toothpaste regulatory regulations and fulfill the main responsibility of the filing person

According to the provisions of the Regulations and Measures, the toothpaste registrant, as the responsible entity for claiming product quality, safety, and efficacy, should be an enterprise or other organization established in accordance with the law, with the ability to adapt to the quality management system and adverse reaction monitoring and evaluation of the registered products. When the toothpaste registrant first conducts product registration, they shall submit relevant materials with corresponding capabilities through the toothpaste filing information service platform designated by the filing management department (hereinafter referred to as the filing platform) for user registration.

According to the "Measures", starting from December 1, 2023, domestic toothpaste shall be registered with the provincial drug regulatory department where the registrant is located before being put on the market for sale; Imported toothpaste should be filed with the National Drug Administration before importation. The toothpaste filing person shall, in accordance with the regulations on the management of toothpaste filing materials issued by the National Drug Administration, as well as the relevant technical specifications, standards, and guiding principles issued by relevant technical departments, and in accordance with the detailed guidelines for filing work issued by the filing management department, submit corresponding filing materials for toothpaste filing through the filing platform. The filing management department shall organize and carry out toothpaste filing management related work in accordance with the ordinary cosmetics filing management procedures.

The toothpaste registrant is responsible for the quality, safety, and efficacy claims of the toothpaste, and is responsible for the completeness, authenticity, and traceability of the product registration materials and data. The product label samples and other related materials in the toothpaste filing materials should comply with the requirements of the "Regulations", "Measures", and "Cosmetic Label Management Measures". The toothpaste registrant shall upload and publish a summary of the literature, research data, or product efficacy evaluation materials based on which the efficacy claim is based through the filing platform while conducting the toothpaste filing, and accept social supervision. Toothpaste products that only claim to have cleaning effects are exempt from uploading and publishing abstracts.

Children's toothpaste refers to toothpaste claimed to be suitable for children under the age of 12 (including 12 years old). The claimed efficacy categories of children's toothpaste are limited to cleaning and caries prevention. Children's toothpaste should be labeled with the children's toothpaste logo on the sales packaging display, and the pattern of the children's toothpaste logo should comply with the requirements of the Announcement of the National Food and Drug Administration on the Issuance of Children's Cosmetics Logo (No. 143 of 2021). The text part of the logo should be replaced by "Children's Cosmetics" with "Children's Toothpaste". Children's toothpaste should also be labeled with relevant warning phrases such as "Use under adult supervision", "Do not consume", and "Beware of swallowing" on the visible surface of the sales packaging.

二、 Scientifically evaluate safety risks and simplify the requirements for filing materials for listed toothpaste

Before the official implementation of the Regulations and Measures, the toothpaste products sold on the market had a certain history of production, sales, and use. For marketed toothpaste products that had not undergone any quality and safety related events and could fully prove their safety use history, given that their safety had been widely verified during product use, it is necessary to distinguish them from new products and simplify the corresponding filing requirements.From October 1, 2023 to November 30, 2023, toothpaste filers can submit the following simplified materials through the filing platform to record toothpaste products that have already been listed:

（1） Basic information of the toothpaste registrant. Including the name, address, contact information, etc. of the registrant. For commissioned production, the name, address, contact information, etc. of the actual production enterprise should also be submitted at the same time;

（2） Basic product information. Including product name, product formula, product sales packaging label images, etc;

（3） Relevant information proving that the product has a safe use history. This includes but is not limited to the production and feeding records, sales invoices, inspection reports, and other relevant information since the product was launched, as well as the registrant's commitment to the safety of the product and the authenticity of the recorded information.

For simplified filing of toothpaste products, the filing management department shall, in accordance with the provisions of the Regulations and Measures, disclose the basic information of the filing to the society within 5 working days from the date of submission of the simplified filing materials by the filing person. The toothpaste registrant shall complete the corresponding product registration materials in accordance with relevant regulations and requirements before December 1, 2025.If the first batch of products are launched and sold before January 1, 2021, the product registration information can be kept by the registrant for future reference; If the first batch of products are launched and sold after that, the registrant shall submit complete filing materials through the filing platform.For simplified filing of toothpaste products, the content of label labeling complies with the requirements of the "Regulations", "Measures", and "Cosmetic Label Management Measures". If only the format of label labeling needs to be standardized and adjusted, sales packaging labels that have already been listed can be used during simplified filing, and product label updates can be completed as required by July 1, 2024. Except for toothpaste products that only claim to have cleaning effects, simplified filing of toothpaste products should also upload and publish a summary of the basis for product efficacy claims through the filing platform before December 1, 2025.

Hereby announced.

National Drug Administration

September 22, 2023