At present, China implements a simple management scheme for toothpastes. Toothpastes can enter the market as long as they comply with relevant national and industry standards. However, as per Cosmetic Supervision and Administration Regulation (CSAR), toothpastes are managed with reference to general cosmetics regulation and subject to a much more stringent management scheme. In other words, notification, testing, safety assessment, efficacy evaluation, and new ingredient application are required.
Part I Regulatory Framework and Competent Authority
1. Main Toothpastes Regulations and National Standards in China
Toothpastes should be managed with reference to the provisions on general cosmetics in CSAR.
Jan. 1, 2021
In January 2016, the former CFDA (now NMPA) promulgated the Practice for Cosmetics Production Licensing, regulating toothpastes as an independent unit of cosmetics in implementing the production license management. Toothpastes shall refer to the cosmetic production management requirements and can only be produced after obtaining a production license issued by the provincial FDA (now provincial MPA).
Jan. 1, 2016
Toothpastes notifier shall carry out product safety assessment in accordance with Technical Guidelines for Cosmetic Safety Assessment and submit a product safety assessment report during notification.
May 1, 2021
The regulation stipulates the inspection and quarantine requirements for importing and exporting cosmetics (including toothpastes).
Nov. 23, 2018
Toothpastes’Chinese name, warning labeling, and the use of permitted efficacy claims in conjunction with other terms shall comply with the provisions in Administrative Measures on Toothpastes and Administrative Measures on Cosmetics Labeling.
May 1, 2022
To be enforced
The regulation stipulates the definition of toothpastes and new toothpastes ingredients; the obligations of toothpastes manufacturers, importers, and operators; and the management scheme of new toothpastes ingredients.
The regulation stipulates the documentation requirements for toothpastes notification.
Inventory of Existing Toothpastes Ingredients in China
NMPA will formulate and release an inventory of existing toothpastes ingredients for companies to determine the regulatory status of their ingredients used. Basically, a toothpastes ingredient is deemed as "new" if it is not included in the inventory. The company that intends to use a new toothpastes ingredient shall apply to formulating its safety and technical standards to the competent authority.
To be released
For product: 5
GB 22114-2008 Humectants for Toothpastes – Glycerin and Macrogol
Testing method: 22
GB/T 21842-2008 Determination of diethylene glycol in toothpastes
GB/T 32115-2015 Determination of ethylene glycol and diethylene glycol in oral care products
GB/T 32112-2015 Determination of peroxide in oral care products-High performance liquid chromatography method
GB/T 32118-2015 Determination of formaldehyde in toothpastes—High performance liquid chromatography
For basic management: 3
GB/T 35919-2018 Oral cavity nursing materials classifications and terms
2. Competent Authority
NMPA is established under the governance of SAMR to take all the work undertaken by the former CFDA. It is responsible for the national-level supervision and management of toothpastes in China.
Medical products administration (MPA) departments of provinces, autonomous regions, and municipalities directly under the Central Government, are responsible for the supervision and management of toothpastes in their administrative areas, including toothpastes notification and the issuance of production licenses for toothpastes manufacturers.
GAC is responsible for the customs import and export inspection and quarantine of cosmetics (including toothpastes).
Part II Current Regulatory Requirements
According to GB/T 8372-2017 Toothpastes, toothpastes refer to the paste materials formed by mixing main ingredients including abrasives, humectants, thickeners, foaming agents, fragrance compound, water, and other additives (may contain functional ingredients used for improving oral health).
Toothpastes are classified into two categories: general toothpastes and functional toothpastes.
Toothpastes that only have the basic functions: cleaning the oral cavity, reducing teeth stains, reducing tartar, whitening teeth, reducing dental plaque, bringing fresh breath, refreshing taste, maintaining the health of teeth and periodontal tissue (including gingiva), and maintaining oral health.
3. Pre-market Requirements
In January 2016, the former CFDA (now NMPA) promulgated the Practice for Cosmetics Production Licensing, regulating toothpastes as an independent unit of cosmetics in implementing production license management. Toothpastes shall be subject to the cosmetic production management requirements and can only be produced after obtaining a production license issued by the provincial FDA (now provincial MPA).
Toothpastes Production License (source: internet)
At present, the Chinese government does not implement registration or notification management for toothpastes. Products can enter the market as long as they comply with relevant national and industry standards.
Current Pre-market requirements
Notes: 1. For toothpastes in which fluoride acts as the functional ingredient preventing caries, the clinical evaluation of caries prevention is not indispensable.
2. The efficacy evaluation is not required for toothpastes claiming the same efficacy, using the same functional ingredients, and the concentration is no less than the verified products.
4. Labeling Requirements
Information Necessary for Oral Care and Cleansing Products Labeling
Manufacturer name and address (For imported products, country or region of origin, and agent, importer or distributor’s name and address)
Manufacturing date and shelf life; or batch number and expiry date
Storage condition (if necessary)
Product user manual (if necessary)
Oral care and cleansing products are prohibited from labeling or claiming the following content:
False, exaggerated, misleading, or confusing claims
Feudal superstition and violation of public order and good customs
Claims prohibited by other laws, regulations, and national standards.
Toothpastes that have not been verified by efficacy evaluation shall not be marked with additional efficacy (except product basic function) on the product label.
5. Safety Management
Ingredients used in toothpastes shall meet the requirements in GB 22115-2008 General Requirements on Raw Materials of Toothpastes.
Including benzene, benzidine sulphate, carbon monoxide, chlorine, etc.
Including aluminum fluoride, ammonia, calcium fluoride, sodium nitrite, stannous fluoride, etc.
Including chlorobutanol, 2-chloroacetamide, formaldehyde and paraformaldehyde, sodium iodate, etc.
Including CI 11920, CI 12490, CI 13015, CI 14270, CI 14700, etc.
Each ingredient used should be subject to a safety assessment. To assess toothpastes ingredients' safety, stakeholders should first consider its hygiene, sensory and physicochemical indicators, and then follow the four steps of hazard identification, dose-response assessment, exposure assessment, and risk characterization.
The overall safety assessment of the toothpastes should also combine with the part of the safety data of the finished product, including but not limited to
Past formulation experience, adverse reaction statistics of marketed products, epidemiological survey data;
Clinical data of the product;
Tests on the safety of oral soft tissues;
Tests on the safety of teeth/hard tissues, such as the relative dental abrasivity, RDA/Profilometry.
Specific requirements can refer to Administrative Measures for Safety Assessment of Oral Care and Cleansing Products and Guideline for Safety Assessment of Oral Care and Cleansing Products.
Part III Future Regulatory Requirements
According to CSAR, toothpastes shall be regulated with reference to the provisions on general cosmetics, and NMPA will be responsible for the pre-market approval and post-market surveillance of toothpastes. To implement this new requirement, NMPA has released the draft Administrative Measures on Toothpastes and Instructions for Toothpastes Notification Dossiers, standardizing the manufacture, operation, and pre-market requirements for toothpastes.
Notes: The following content is written based on the two draft regulations. The future regulatory requirements for toothpastes are subject to the finalized regulations.
Toothpastes refer to the solid and semi-solid preparation applied to the teeth surface of human and surrounding tissues by friction for cleansing, beautifying, and protecting.
2. Classification Code
Toothpastes are classified according to efficacy and target users and adopt a coding system. The classification code is composed of 2 layers of numbers, and each layer is separated by "-" and represented by a 2-digit number. When applying for toothpastes notification, the notifier needs to fill in the classification code of the toothpastes.
The details of the coding rules are as follows.
Inhibition of dental plaque
Reduce gum problems
Reduce bad breath
Children (6 months to 12 years old)
The classification code of adult whitening toothpastes is 06-01;
The classification code of cleansing and caries prevention toothpastes for children is 0102-02.
3. Manufacturing Requirements
The manufacture of toothpastes shall meet the requirements for plants specified in Good Manufacturing Practices for Cosmetics. Prior to manufacture, companies shall submit documents to the local MPAs for a license. After document review and on-site inspection, local MPA will issue a license to compliant companies. With the license, companies are permitted to start manufacturing.
China will implement a notification scheme for toothpastes. Only toothpastes completing the notification are permitted for sale and import.
To apply for the notification, the notifier shall submit the following documents:
NMPA Notification Platform Account Application
1. Notifier information form and the resume of the person in charge of quality and safety;
2. Overview of the quality management system of the notifier;
3. Overview of the adverse reaction monitoring and evaluation system of the notifier;
4. Domestic responsible person information form (for overseas notifier);
5. The original copy of the authorization letter for the domestic responsible person and the original notarization (for overseas notifier);
6. Manufacturer information form and a resume of the person in charge of quality and safety;
7. The original copy of the GMP certification documents (for overseas manufacturer).
1. Toothpastes notification information form and related documents
2. The naming reason of the product name;
3. Product formula;
4. Product executive standards;
5. Product label sample;
6. Product testing report;
7. Product safety assessment documents.
5. Efficacy Claims Evaluation
1) Permitted and Prohibited Efficacy Claims
Toothpastes shall not claim efficacy beyond the scope specified in the following table. These permitted efficacy claims of each category are fixed combinations and shall not be added, deleted, or adjusted at will. If they are used in conjunction with other words, it shall comply with Administrative Measures on Toothpastes and Administrative Measures on Cosmetics Labeling.
Scope of Permitted Efficacy Claims
Clean teeth/clean mouth, maintain oral hygiene, maintain oral health, reduce soft dirt, freshen breath, refreshing taste
Prevent dental caries, strengthen teeth, prevent cavities, inhibit teeth demineralization, and promote teeth remineralization
Inhibition of dental plaque
Inhibit dental plaque and reduce the formation of dental plaque
Anti-dentin sensitivity, reduce the irritation of hot and sour on the teeth, reduce the irritation caused by hot and sour, alleviate sensitivity, anti-sensitivity, soothing, repair sensitive teeth, seal dentin tubules
Alleviating gum problems
Clear fire, dispel fire, improve gum health, and protect gums
Whiten teeth, whiten teeth through oxidation reaction, reduce exogenous staining, mechanically reduce exogenous staining, chemically reduce exogenous staining, achieve whitening effects through optical effects
Reduce dental calculus, decompose dental calculus, reduce dental calculus formation, prevent dental calculus, inhibit dental calculus formation
Alleviating bad breath
Reduce bad breath, reduce bad odor, remove volatile sulfur compounds, inhibit bad breath-causing bacteria
Moisturize the mouth, improve dry mouth
The following claims are also not allowed for toothpastes:
Contents indicating medical effects implicitly or explicitly;
False or misleading contents;
Contents violating public social order and good customs;
Other contents prohibited by laws, administrative regulations, and mandatory national standards.
2) Efficacy Evaluation
Efficacy evaluation is mandatory for all toothpastes except for cleansing toothpastes. The toothpastes notifier shall submit efficacy evaluation abstracts for the notification and keep the efficacy evaluation report for future reference. The evaluation abstracts should include the efficacy evaluation items, evaluation methods, evaluation institutions, conclusion, etc.
Efficacy evaluation should be carried out based on qualitative or quantitative testing of functional ingredients in the toothpastes. A toothpaste is subject to one of the two evaluations as per the type of its efficacy, 1) clinical evaluation and 2) laboratory evaluation.
Before clinical evaluation, the product's microbiological, physical and chemical, and special safety tests should be completed, and a written report should be issued. Microbiological, physical and chemical tests shall be conducted by testing institutions that have obtained China Inspection Body and Laboratory Mandatory Approval (CMA) and have corresponding testing capabilities.
Efficacy Evaluation Methods
Efficacy Evaluation Institution Qualification
Claims the efficacies of caries prevention, inhibition of dental plaque, anti-dentin hypersensitivity, and alleviating gum problems
Adopt clinical evaluation methods in accordance with the requirements of Administrative Measures on Toothpaste, national standards, industry standards, and technical specifications
1. Class A tertiary oral medical institution with qualifications for clinical trial bases for drugs or devices recognized by the national regulatory agency; or
2. Stomatological hospital awarded the National Key Clinical Specialty (Stomatology) by the health supervision and administration department of the State Council; or
3. Provincial dental specialist hospital with qualifications for clinical trial bases for drugs or devices.
*Laboratory evaluation reports can be issued by testing institutions that have been filed with NMPA.
Claims the efficacies of whitening, anti-dental calculus, alleviating bad breath, and improving oral problems
If a method developed by the laboratory is used, the method should be confirmed in accordance with the CMA/CNAS method, and the complete text of the self-developed method should be included in the evaluation report.
Quantitative efficacy claims (such as efficacy retention time, statistical data, degree, etc.)
Carry out efficacy evaluation according to regulations.
Efficacy Evaluation Exemption
Toothpaste that uses fluoride as a caries prevention ingredient, and meets the fluoride content required by national standards and technical specifications, can be exempt from clinical evaluation of caries prevention efficacy.
The efficacy evaluation is not required for the product of the same notifier, claiming the same efficacy, using the same functional ingredients, and the addition amount is not less than the toothpaste that has been evaluated. But the efficacy of the functional ingredient still needs to be stated in the efficacy evaluation abstracts.
Toothpastes labeling requirements must comply with Administrative Measures on Toothpastes and Administrative Measures on Cosmetics Labeling. The following information shall be indicated on labels of imported toothpastes:
1. Product name
2. Name and address of the notifier and domestic responsible person
3. Name and address of the manufacturer
4. Product executive standard number
5. List of full ingredients
6. Net content
8. Application method
9. Safety warnings
10. Other content prescribed by laws, administrative regulations, and mandatory national standards
7. Requirements for New Toothpastes Ingredients
New toothpastes ingredients refer to the natural or artificial ingredients used in toothpaste for the first time in China. Food additives or food ingredients complying with existing national standards are not managed as new toothpastes ingredients when they are used in toothpastes for the first time in China.
NMPA will formulate and release the Inventory of Existing Toothpastes Ingredients in China for companies to determine the regulatory status of their ingredients used. Basically, a toothpaste ingredient is deemed as "new" if it is not included in the inventory.
Obligations for Different Kinds of Ingredients
Ingredients included in the Inventory of Existing Toothpastes Ingredients in China
Manufacturers and operators shall use them reasonably in accordance with the national standards, technical norms, and requirements in the inventory.
New toothpastes ingredients
The company that intends to use a new toothpastes ingredient shall apply to formulating its safety and technical standards to the competent authority. The ingredient can only be used after it is added to national standards or technical norms.
Food additives or food ingredients used in toothpastes for the first time
The ingredient’s use frequency and exposure in toothpaste should be compared with the corresponding indicators when used in food, and a safety assessment report should be submitted.
Part IV Timeline of Major Regulatory Events for Toothpastes
Before 2006: A production license is not required for toothpastes.
August 2006: The former General Administration of Quality Supervision promulgated the “Implementation Rules for Toothpastes Product Production License." According to this document, toothpastes shall be produced after obtaining a production license and shall label the QS (Quality Safety) mark. Only toothpastes producers with an annual output of more than 2,000 tons are eligible for the production license.
2010: China Oral Care Industry Association (COCIA) was established, and a complete standardization system was set up, covering all the steps in the product cycle from ingredient procurement to the marketed product labeling.
June 2011: The toothpastes production was included in the list of the restricted industries. No new production license would be issued.
2015: CSAR’s draft for approval classified toothpastes and other oral care products as cosmetics, but the specific management methods are not clear.
January 2016: The former CFDA implemented the Practice for Cosmetics Production Licensing, regulating toothpastes as an independent unit of cosmetics to implement production license management. Toothpastes shall refer to the cosmetic management requirements and obtain a production license issued by the provincial FDA (now provincial MPA).
October 2019: Toothpastes was removed from the restricted industries' list, and the restriction on the production license was canceled.
June 2020: The final CSAR stipulated that toothpastes do not belong to cosmetics but shall be managed with reference to the general cosmetics provisions.
July 2020: COCIA released an announcement to collect all the ingredients used in toothpastes that have been on the market in China before July 31, 2020. The Inventory Existing Toothpastes Ingredients in China will be formulated later.
November 2020: Administrative Measures on Toothpastes was issued, which clarified the management scheme for toothpastes, requiring a series of procedures including notification, testing, safety assessment, efficacy evaluation, new ingredient application, etc.
January 2021: Instructions for Toothpastes Notification Dossiers was issued, which clarified the dossiers requirements for toothpastes notification, toothpastes classification and coding system, permitted efficacy claims, requirements for efficacy evaluation and safety assessment.