NMPA published a notification on the enforcement of toothpaste regulation

On 25 September 2023, the National Medical Products Administration (NMPA) published a notification on the enforcement of toothpaste regulation and simplified the information requirements for toothpaste products which have already done registration and record filing. 

1. The enforcement of toothpaste regulation 

According to this notification, since 1 December 2023, imported toothpaste can only be registered via NMPA, while domestic toothpaste registration can be done via provincial MPA. The product label sample and other relevant information in the toothpaste registration materials should comply with the requirements of the CSAR, Cosmetic Label Management Measures and other regulations. Toothpaste filers should, while filing toothpaste, upload through the filing platform the literature, research data or summary of product efficacy evaluation data on which efficacy claims are based, and accept social supervision. Toothpaste products that only claim to have cleaning effects are exempt from uploading and publishing abstracts.

This notification emphasized again that Children's toothpaste refers to toothpaste claimed to be suitable for children under the age of 12 (including 12 years old). The efficacy categories that children's toothpaste can claim are limited to cleaning and preventing caries. Children's toothpaste should be marked with the children's toothpaste logo on the sales package display surface. Children's toothpaste should also be marked with relevant warnings such as "Use under adult supervision", "Not edible", "Beware of swallowing" and other relevant warnings on the visible side of the sales package.

2. Simplify the information requirements for toothpaste products which have already done registration 

From 1 October 2023 to 30 November 2023, toothpaste filers can submit the following simplified information through the registration platform to register toothpaste products that have been on the market:

1. Basic information of toothpaste filer. Include the name, address, contact information, etc. of the filing person. If production is commissioned, the name, address, contact information, etc. of the actual production enterprise must also be submitted at the same time;
2. Basic product information. Including product name, product formula, product sales packaging label pictures, etc.;
3. Relevant information proving that the product has a history of safe use. This includes, but is not limited to, production and material input records, sales invoices, inspection reports and other relevant information since the product was launched, as well as the filing party’s commitments to product safety and the authenticity of the filing materials.

Toothpaste filers should complete the corresponding product registration materials in accordance with relevant laws and regulations before 1 December 2025. If the first batch of products are put on the market before 1 January 2021, the product registration materials can be kept on file by the filer for future reference; if the first batch of products are put on sale after that, the filer should submit complete filing materials through the filing platform.

For toothpaste products with simplified filing, the content of the label must comply with the requirements of the CSAR and Measures for the Administration of Cosmetic Labels. If only the format of the label needs to be adjusted, the already marketed sales can be used during the simplified filing. Packaging labels, and complete product label updates as required before 1 July 2024. In addition to those that only claim to have cleaning efficacy, toothpaste products subject to simplified registration must also upload and publish a summary of the basis for product efficacy claims through the registration platform before 1 December 2025.

For any China related inquiries, please contact GPC China via compliance@gpcregulatory.cn.