New toothpaste regulations

According to “Cosmetic Supervision and Administration Regulation” (CSAR), which took effect in January 2020, toothpastes are managed with reference to the provisions on general cosmetics. In order to implement this provision and standardise the supervision of toothpaste, on 23rd March 2023 China State Administration for Market Regulation (SAMR) issued the finalised “Administrative Measures on Toothpaste” and implemented it 1st December 2023. “Administrative Measures on Toothpaste” stipulates that all toothpaste products must be notified (not registered) after 1st December 2023. With the updated measures, toothpaste placed on the Chinese market should undergo notification, testing (microbiological, physicochemical and toxicological), efficacy evaluation, safety assessment, etc. For Chinese domestic toothpaste, notification should be conducted by the provincial Medical Products Administration (MPA) in the notifier’s location prior to market entry. Imported toothpaste to National Medical Products Administration (NMPA) before importation.
Simplified notification for toothpastes which had already been on the market was available for the transitional period from 1st October to 30th November 2023. However, for the European brands it was almost impossible to prepare all the required documents in such a short time, and have now only one possibility of notification before placing toothpastes on the Chinese market.
"Administrative Measures on Toothpaste” clarifies the responsibilities of all involved parties, the definition of toothpaste, the management requirements for toothpaste products and new ingredients, the ongoing use of the existing toothpaste production licensing system, the requirements for toothpaste safety assessment, efficacy claims and labelling, etc.
“Provisions for Management of Toothpaste Notification Dossiers” was published in November 2023. The Provisions clearly stipulate what documents the toothpaste notifier should submit in accordance with the requirement. The following documents are required for opening account for toothpaste on the NMPA portal:
1. information of notifier and resume of head of quality safety department,
2. information regarding domestic responsible person in China,
3. summary of quality management system of notifier,
4. summary of adverse reaction monitoring and evaluation System of notifier, 5. an apostille certificate of authorisation letter for domestic responsible person that is legalised by the competent authorities in the origin of country (not by China consulate anymore).

The information about complete formulation, every raw material‘s supplier, trade name, annex 14 or submission code, manufacture process, safety assessment, etc. are essential for notification of toothpaste. Overall, the documentation required for toothpaste notification largely aligns with those outlined in general cosmetics regulations. How to protect the confidential information such as formulation, raw material, etc. is now getting very challenging for the notifier.
The specific requirements for children’s toothpastes and test reports of toothpaste products are specified. In addition, matters not specified for toothpastes shall be managed with reference to the published measures for cosmetic products. For example, “Administrative Measures for Supervision and Administration of Cosmetics Production” and “Operation and Standard for Cosmetic Production and Quality Management” both are applicable to the production, quality, and operation management of toothpastes.
So far, the following published measures and provisions apply to toothpastes: 1. Cosmetic Supervision and Administration Regulation (CSAR),
2. Administrative Measures on Toothpaste,
3. Provisions for Management of Toothpaste Notification Dossiers,
4. Administrative Measures on Cosmetics Labelling,
5. Supervision and Administration Provisions on Children Cosmetics.

The following measures have not been published yet and are coming soon:
1. Inventory of Existing Toothpaste Ingredients in China,
2. Toothpaste Efficacy Evaluation Standard,
3. Technical Guidelines for Toothpaste Safety Assessment,
4. Amendments to Safety and Technical Standards for Cosmetics

The definition of toothpaste in the “Administrative Measures on Toothpaste” is: Toothpaste refers to a paste-like product applied to the surface of human teeth in a frictional manner, primarily for the purpose of cleaning. According to this definition mouthwash and tooth powder don’t belong to toothpaste.

The notifier of toothpastes is responsible for the safety and quality of raw materials, toothpaste products and its efficacy claim as well. Efficacy claims should be supported by adequate scientific evidence, and a summary of efficacy should be uploaded to the relevant platform of the NMPA while notification.
Besides the basic efficacy of cleaning, only four efficacies, anti-caries, plaque inhibition, anti-dentine hypersensitivity and relieve gingiva problems are permitted in China, if the relevant proofs are acceptable.
However, the following claims are prohibited:
• content that expressly or impliedly has medical effects; Anti-inflammatory, pain relief and stop bleeding, etc.
• content that is false or misleading,
• the content of the violation of social order and morals,
• laws, administrative regulations, mandatory national standards, technical specifications prohibit the labelling of other content.
For cosmetics, there are alternatives for efficacy tests, i.e. lab test, questionnaire with consumers and human efficacy testing with test persons. However, only human efficacy testing with test persons is acceptable for efficacy claims of toothpaste.
The efficacy claims of toothpaste should have sufficient scientific basis and meet the relevant requirements to ensure the scientificity, accuracy and reliability of the evaluation results.

The testing report for some toothpaste products needs to include toxicological tests (animal test) i.e. oral mucosal irritation test. However, if toothpaste manufacturers have obtained relevant quality management system certifications issued by the competent authorities of their respective countries or regions (all production enterprises, including multiple manufacturers, have obtained the necessary certifications), moreover, the product safety risk assessment results sufficiently confirm the safety of the toothpaste product, so the toothpaste can enjoy the exempting from the oral mucosal irritation test, i.e. free animal test. However, the toxicological test is mandatory, if any of the following 3 circumstances exists:
• products claimed for use by children,
• products claimed to have the effects of anti-cavity (not by fluoride), anti-plaque, anti-dentin hypersensitivity and alleviation of gum issues,
• products using new raw materials that are still under 3-year safety monitoring.
Except efficacy of cleaning and anti-caries with fluoride, the other four efficacy claims (anti-caries, plaque inhibition, anti-dentine hypersensitivity and relieve gingiva problems) need submit human efficacy evaluation. For a fluoride-containing toothpaste aimed at achieving anti-caries efficacy, the toothpaste is exempt from evaluation of its anti-caries effectiveness, if the total fluoride percentage lies between 0.05 – 0.15% for adults or 0.05 – 0.11% for children. In general, free animal test is available for toothpastes for adults and with efficacy of cleaning or efficacy with anti-caries by fluoride, toothpastes contain no new ingredients that are under 3-year safety monitoring. If there is new raw material in toothpaste, the new raw material should be notified or registered at first.

Toothpaste’s safety assessment should be conducted with reference to the requirements in the Technical Guidelines for Cosmetic Safety Assessment. To create safety assessment of toothpaste on its own or entrusted to a professional organisation, the safety assessor should possess specialised knowledge in quality and safety of toothpaste or cosmetics, with more than 5 years of relevant professional experience. Monitoring of adverse reactions to toothpaste must follow the requirements of the related cosmetics adverse reaction monitoring system. Production of toothpastes should be in accordance with the requirements of the Good Manufacturing Practice for Cosmetics.
Until 1st May 2025 a simplified safety assessment report is enough for notification of toothpaste. However, after 1st May 2025 a complete safety assessment is demanded. More documents such as package compatibility test, certificate of non-hazardousness of packaging materials, preservative challenge test, safety information of every raw material, etc. are demanded. It will be very challenging for toothpaste notifier.

Toothpaste labelling requirements must comply with “Administrative Measures on Toothpastes” and “Administrative Measures on Cosmetics Labelling”. A Chinese label muss be sticked on the folding box of imported toothpastes. The contents are as follows:
• product name,
• name and address of notifier, contracted manufacturer and domestic responsible person,
• product executive standards, it is the notification no. as well,
• complete ingredients: The list of ingredients shall be established in descending order of weight of the ingredients. However, ingredients in concentrations of less than 0.1 % (w/w) should be separately preceded by the term “other trace ingredients “and may be listed in any order,
• net content
 best use before and lot no.,
• golden shied logo for children’s toothpaste,
• other contents should be marked in accordance with laws, administrative regulations and mandatory national standards.
Toothpastes with fluoride need to state the concentration of fluoride. Active ingredients of anti-caries, plaque inhibition, anti-dentine hypersensitivity and relieve gingiva problems should be declared on the package if toothpaste has the related efficacy claim.

Children’s toothpaste refers to toothpaste that is claimed to be suitable for children aged 12 and under (including 12 years old). The permissible efficacy claims for children’s toothpaste are limited to cleaning and cavity prevention. Products labeled with expressions such as “suitable for all age groups” or “for the whole family” and those implying product use for children through trademarks, patterns, homophones, letters, Pinyin, numbers, symbols, packaging, etc., are regulated as children’s toothpaste.
Children’s toothpaste should include phrases such as “Caution” or “Warning” as introductory statements. On the visible surface of the sales packaging, warning phrases such as “Should be used under adult supervision,” “Not for consumption,” and “Beware of swallowing” should be prominently displayed. Children’s toothpaste containing fluoride should also specify the recommended single-use quantity.
The logo for children’s toothpaste “little golden shield” with the Chinese letters for children’s toothpaste is designated to appear in the upper left corner of the main visual surface of the packaging.
China’s new toothpaste regulations and provisions raise barrier, increase costs and time. It raises entry thresholds and bring challenges for toothpaste brands and manufactures. Companies with toothpaste planning to enter the market need a thorough understanding of the regulations and measures, preparing the necessary information for notification and protecting the confidential information properly.