On November 13, 2020, the National Medical Products Administration（NMPA) issued a notice on the "Toothpaste Supervision and Administration Measures (Draft version, in short, TSAM),This is a comprehensive system adjustment for toothpaste management since the "Regulations on Cosmetics Supervision and Administration" (in short CSAR) proposed that toothpaste should be managed with reference to cosmetics. The TSAM mainly refers to the "Regulations on Cosmetics Supervision and Administration" to standardize the management requirements of toothpaste's raw materials, product filing, and efficacy evaluation, and is specially setting up for toothpaste management, fully adapting to the CSAR for toothpaste management.
The regulation of toothpaste in China history has undergone several major changes. Since the "Regulations of the People's Republic of China on the Administration of Industrial Product Production Licenses" was issued in 2005, the former General Administration of Quality Supervision, Inspection and Quarantine(AQSIQ) has implemented production license management for toothpaste manufacturers and issued cosmetics production licenses; in 2007, the original AQSIQ issued the "Cosmetics Label Management The Regulations also include products used for teeth in cosmetics. After the last round of institutional reforms in 2013, the former Food and Drug Administration assumed a unified role in cosmetics supervision and issued cosmetic production licenses to toothpaste manufacturers, but toothpaste ware still not in the scope. This practice has continued to right now.
According to the newly released "Toothpaste Supervision and Management Measures (TSAM)", although there are only 23 short articles, they are full of content. We have seen the following changes:
Who will Supervise?
The National Regulatory Authority is responsible for the national toothpaste supervision and management. The provincial drug supervision and management department is responsible for the supervision and management of toothpaste in the administrative area. The departments responsible for drug supervision and management of local people's governments at or above the county level are responsible for the supervision and management of toothpaste within their respective administrative regions.
Who will be in charge of Quality and Safety?
The toothpaste filing person will be responsible for claiming the quality, safety and efficacy of the toothpaste. This article is similar to Article 6 of the "Regulations on Cosmetics Supervision and Administration"(CSAR). The registrant and filing person of cosmetics is responsible for the quality, safety and efficacy of cosmetics.
Clear management of new toothpaste ingredient
The TSAM points out that the management of toothpaste materials should be implemented in the catalog, and toothpaste producers and operators should use them reasonably in accordance with the national mandatory standards, technical specifications, and the requirements of the IETIC( Inventory of Existing Toothpaste Ingredient in China) . If a new toothpaste ingredient is intended to be used in toothpaste production, a project proposal for the formulation of safety technical standards for the ingredient shall be put forward, and the ingredient shall be included in the national mandatory standards and technical specifications before use. This article actually pointed out that the new toothpaste ingredient must be strictly controlled in the later stage. When food additives or food materials with national standards are used for toothpaste production for the first time, the safety assessment report of the ingredient used in toothpaste shall be provided when the product is put on record.
Toothpaste Filing Code
Domestic and imported toothpastes follow the new record number system, which is also conclude China Hong Kong, Macao and Taiwan.
Domestic toothpaste
The abbreviation of the province, autonomous region, and municipality directly under the Central Government + the word prepared by the State Dental Network + 4 digits of the year + the serial number of the registered product in the administrative region; Imported toothpaste: National Dental Network (abbreviation of the province where the responsible person is located in China) + 4 digits + serial number of registered products nationwide;
Toothpaste from China Taiwan, Hong Kong and Macau
State Dental Network (abbreviation of the province where the responsible person is located in China) + 4 digits of the year + the serial number of the nationally registered product. T
oothpaste claims
In terms of efficacy claims, the drug regulatory authority needs to formulate a classification catalog of toothpaste efficacy according to the efficacy of toothpaste, and update it in time. Toothpaste’s efficacy claims shall not exceed the scope determined by the efficacy classification catalog. Toothpaste efficacy claims should have sufficient scientific basis. The label of toothpaste shall not express or imply that it has any medical effect. After the efficacy evaluation has been carried out in accordance with national standards and industry standards, it can be claimed that toothpaste has the effects of preventing caries, inhibiting dental plaque, resisting dentin sensitivity, and reducing gum problems.
Punishment mechanism
From Article 18 to Article 22 of the TSAM, it is clear that various illegal acts that violate these Measures will be punished with reference to the "Regulations on Supervision and Administration of Cosmetics."(CSAR)
