On November 22, the National Medical Products Administration of China (NMPA) issued the "Regulations on the Administration of Toothpaste Archival Information" (hereinafter referred to as the "Regulations"), refining the requirements of toothpaste archival information, further regulating the administration of toothpaste archival information, and guiding the filing of toothpaste. The Provisions shall come into force on December 1, 2023.

According to the "Regulations", when filing the toothpaste recordholder, it shall submit the name, address and contact information of the recordholder, the name, address and contact information of the manufacturing enterprise, product name information, product formula, product execution standards, product label sample, product inspection report, product safety assessment data. The "Regulations" detailed the eight items of information article by article, and put forward technical requirements for each item of information based on security considerations.

Regarding the product formula, the "Regulations" clearly define the basic principles of formula filling. The product formula is the production feed formula, and the recordholder has priority to fill in the relevant technical specifications and standards and technical guidelines issued by the State Food and Drug Administration for toothpaste, or refer to the relevant technical specifications and standards and technical guidelines for cosmetics. The filing person shall mark the main purpose of use according to the main role of the raw materials actually played in the product, which is consistent with the physical and chemical properties of the raw materials, product attributes, formula technology, etc. If the active ingredient is not a single ingredient, its specific active ingredient should be specified in the purpose column of the formulation table.

Regarding product inspection reports, the "Regulations" clearly specify that when toothpaste is filed, the filing person shall submit product inspection reports including microbial and physical and chemical inspection reports, toxicology test reports, efficacy evaluation reports and other product inspection reports. In the efficacy evaluation part, the "Regulations" point out that toothpaste only claims the cleaning effect, can be exempted from the efficacy evaluation. The toothpaste claims to have the effect of preventing caries, suppressing dental plaque, anti-dentin sensitivity, reducing gum problems, etc. It is necessary to evaluate the human efficacy, submit the efficacy evaluation data at the time of filing, and compile and publish the efficacy claim evaluation abstract according to the efficacy evaluation results.

The regulations also make clear provisions on children's toothpaste. Children's toothpaste means toothpaste that claims to be suitable for children under the age of 12 years. The categories of claims that children's toothpaste can make are limited to cleaning and preventing caries. Products labeled with words such as "for the whole population" and "for the whole family" are regulated as children's toothpaste. At the same time, children's toothpaste needs to submit oral mucosal irritation test report, and children's toothpaste with fluoride should be marked with a single use limit.

See the original announcement: https://www.nmpa.gov.cn/xxgk/ggtg/hzhpggtg/jmhzhptg/20231122100802124.html