According to the Cosmetics Supervision and Administration Regulations (hereinafter referred to as the Regulations) and the Measures for the Supervision and Management of Toothpastes (hereinafter referred to as the Measures), NMPA issued an Announcement on Matters Related to the Implementation of Toothpaste Regulation and Simplification of Filing Requirements for Marketed Toothpastes on September 25, relevant issues are announced as follows:
1. Implement the requirements of toothpaste regulations and fulfill the main responsibility of the filer
According to the requirements of the Regulations and Measures, the toothpaste filer, as the responsible entity for product quality and safety, and efficacy claims, should be the enterprise or organization established in accordance with the law, which should have a quality management system and the ability to monitor and evaluate adverse reactions that are compatible with the filed products. When toothpaste filers first conduct product filing, they shall submit relevant materials for 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 requirements of the Measures, as of December 1, 2023, domestic toothpastes shall be filed with the provincial drug regulatory department where the filer is located before being put on the market for sale; Imported toothpastes shall be filed with the National Medical Products Administration (NMPA) before importing. The toothpaste filer shall, in accordance with the regulations on the management of toothpaste filing materials issued by NMPA, 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 work in accordance with the filing management procedures of general cosmetics.
The toothpaste filer is responsible for toothpaste quality and safety, and efficacy claims, and is responsible for the completeness, authenticity, and traceability of the product filing 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 the Measures for the Administration of Cosmetics Labels, etc. The toothpaste filer shall upload and publish the efficacy claim summary based on the literature, research data, or product efficacy evaluation materials through the filing platform while conducting toothpaste filing, and accept social supervision. Toothpaste products that only claim a cleaning effect are exempt from uploading and publishing a summary.
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 cleansing and caries prevention. Children's toothpaste should be labeled with the children's toothpaste logo on the display surface of the sales packaging, and the pattern of the children's toothpaste logo should comply with the requirements of the NMPA Announcement on Issuing the Children's Cosmetics Logo (No. 143, 2021), and the text part of the logo should be replaced by "children's toothpaste" instead of "children's cosmetics". In addition, children's toothpaste should also be labeled with relevant warning words such as "Use under adult supervision", " Not for consumption", and "Beware of swallowing" on the visible surface of the sales packaging.
2. Scientifically evaluate safety risks and simplify the requirements for filing materials for marketed toothpaste
Prior to the formal implementation of the Regulations and Measures, for marketed toothpaste products that have already had a certain history of production, sale and use, and 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, the toothpaste filer can submit the following simplified materials through the filing platform for the filing of toothpaste products sold on the market:
1). Basic information of the toothpaste filer. Including the filer's name, address, contact information, etc. For entrusted 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, label images of product sales package, etc.;
3). Relevant materials 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 filer's commitment to the safety of the product and the authenticity of the filing materials.
For toothpaste products with simplified filing, the filing management department shall, in accordance with the requirements of the Regulations and Measures, publish 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 filer. The toothpaste filer shall collect and complete the corresponding product filing 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 filing materials can be kept by the filer for future reference; If the first batch of products are launched and sold after that, the filer shall submit complete filing materials through the filing platform.
For toothpaste products with simplified filing, if the content of the label complies with the requirements of the Regulations, Measures, and the Measures for the Administration of Cosmetics Labels, and only the format of the label needs to be standardized and adjusted, sales packaging labels for marketed products can be used during simplified filing, and product label updates should be completed as required before July 1, 2024. Except for toothpaste products that only claim to have cleansing effects, toothpaste products with simplified filing should also upload and publish a summary of the basis of the product efficacy claims through the filing platform before December 1, 2025.
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