FAQs on the Filing of Toothpaste in China Vol. 21

The Measures for Toothpaste Supervision and Administration will be formally implemented from December 1, 2023. To help filers better understand the requirements and comply with the Measures, we have collated and translated the FAQs on the filing of toothpaste in China.

1. What is the scope of application of the "Measures for Toothpaste Supervision and Administration" and how to clarify the powers among regulatory departments at all levels?

According to Article 2 of the Measures for Toothpaste Supervision and Administration, these Measures are applicable to the toothpaste production and operation activities and their supervision and administration in China. According to Article 4 of the Measures, the National Medical Products Administration (NMPA) is responsible for the supervision and administration of toothpaste in China. The drug supervision and management departments 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.

2. What are the basic requirements for toothpaste management?

According to Article 5 of the Measures, toothpaste products are subject to filing management, and the toothpaste filers will be responsible for the quality, safety, and efficacy claims of the toothpaste products. Article 6 stipulates that toothpaste manufacturers and operators shall engage in business activities in accordance with laws, regulations, mandatory national standards, and technical specifications. They should strengthen management, integrity, self-discipline, and ensure the quality and safety of toothpaste products. Article 7 stipulates that the toothpaste industry associations must strengthen industry self-discipline, supervise and guide production and business operators to engage in business activities in accordance with the law, and promote the construction of industry integrity.

3. What are the management requirements for toothpaste raw materials?

According to Article 8 of the Measures, the natural or artificial raw materials used in toothpaste for the first time in China are new toothpaste materials. New raw materials for toothpaste should be registered or filed in accordance with the regulations on the management of new cosmetic ingredients. Article 9 stipulates that the toothpaste filers shall select raw materials that meet the requirements of laws, regulations, mandatory national standards, and technical specifications for toothpaste production, and shall be responsible for the safety of the toothpaste raw materials used in the products. When processing toothpaste filing, filers should clarify the source of raw materials and information related to raw material safety via the filing information service platform.

4. What do we need to pay attention to regarding the labels of children’s toothpaste?

Article 20 of the Measures stipulates that the toothpaste products declared to be applicable to children must comply with laws, administrative regulations, mandatory national standards, technical specifications, and other provisions on children's toothpaste. And must be marked on the product labels.

Article 6 of the Provisions on the Supervision and Administration of Children’s Cosmetics stipulates that children's cosmetics must be marked with the children's cosmetics logo specified by the NMPA on the display surface of the sales package. Non-children's cosmetics are not allowed to bear the children's cosmetics logo. Children's cosmetics should be guided by "caution" or "warning", and warning phrases such as "should be used under adult supervision" should be marked on the visible surface of the sales packaging. Article 13 stipulates that children's cosmetics labels must not indicate words such as "food grade" or "edible" or food-related patterns.

5. Who can be the domestic responsible person for the filing of imported toothpaste?

According to Article 6 of the Measures, overseas filers should designate a Chinese enterprise legal person as the domestic responsible person to handle the filing of their products, assist them in monitoring toothpaste adverse reactions, implementing the product recall, and cooperating with the drug supervision and administration department in the supervision and inspection.

6. What is the basis for the management of the contents not clearly specified in the "Measures for Toothpaste Supervision and Administration"?

Article 23 of the Measures stipulates that the Measures for the Administration of Cosmetic Registration and Filing and the Measures for the Supervision and Administration of Cosmetic Production and Operation will apply if there are no specific requirements recorded in the Measures for the Toothpaste Supervision and Administration.

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Further Information

FAQs on the Filing of Ordinary Cosmetic Products - Toothpaste