China Mainland Toothpastes Regulation

Previously, toothpastes could enter the Chinese market as long as they complied with relevant national and industry standards. However, with the implementation of the Cosmetic Supervision and Administration Regulation (CSAR), toothpastes are now subject to a more stringent management scheme. Under the new regulations, toothpastes are managed with reference to general cosmetic regulations and are required to undergo notification, testing, safety assessment, and efficacy evaluation, etc.

Part I Regulatory Framework and Competent Authority

1. Main Toothpastes Regulations and National Standards in China

Category		Name	Notes	Effective Date	Status
Regulations		Cosmetic Supervision and Administration Regulation (CSAR)	Toothpastes should be managed with reference to the provisions on general cosmetics in CSAR.	Jan. 1, 2021	In force
		Practice for Cosmetics Production Licensing	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	In force
		Technical Guidelines for Cosmetic Safety Assessment	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	In force
		Administrative Measures on Inspection and Quarantine of Import and Export Cosmetics	The regulation stipulates the inspection and quarantine requirements for importing and exporting cosmetics (including toothpastes).	Nov. 23, 2018	In force
		Administrative Measures on Cosmetics Labeling	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	In force
		Administrative Measures on Toothpaste	The regulation stipulates the responsibilities of all stakeholders, toothpaste’s definition, the management requirements for toothpaste products and new ingredients, the ongoing use of the existing toothpaste production licensing system, and the requirements for toothpaste safety assessment, efficacy claims and labeling.	Dec. 1, 2023	In force
		Provisions for Management of Toothpaste Notification Dossiers	The regulation stipulates the documentation requirements for toothpastes notification.	Dec. 1, 2023	In force
		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
National Standards	For product: 5	e.g.: GB/T 8372-2017 Toothpastes GB 22114-2008 Humectants for Toothpastes – Glycerin and Macrogol	/	/	In force
	Testing method: 22	e.g.: 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 22115-2008 General requirements on raw materials of toothpastes GB 29337-2012 General labeling for oral care and cleansing products GB/T 35919-2018 Oral cavity nursing materials classifications and terms

2. Competent Authority

Competent Authority

Main Responsibility

National Medical Products Administration (NMPA)

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.

General Administration of Customs (GAC)

GAC is responsible for the customs import and export inspection and quarantine of cosmetics (including toothpastes).

Part II Regulatory Requirements

According to CSAR, toothpastes shall be regulated with reference to the provisions on general cosmetics, and NMPA is responsible for the pre-market approval and post-market surveillance of toothpastes. To implement this new requirement, NMPA implemented the Administrative Measures on Toothpaste and Provisions for Management of Toothpaste Notification Dossiers, standardizing the manufacture, operation, and pre-market requirements for toothpastes.

1. Definition

Toothpaste is a paste-like product primarily used for frictional application onto the surface of human teeth with the main purpose of cleaning them.

According to this definition, several products can be excluded from the category of toothpaste. Examples include tooth powder, mouthwash, oral antibacterial creams labeled as "消" (meaning "disinfection"), tooth desensitizing gels labeled as "卸" (meaning "makeup removal"), and Dingpeng Emulsion labeled as "药" (meaning "medicine"). These products should not be considered as toothpaste products.

Additionally, based on this definition, it can be inferred that toothpaste should not make claims related to disinfection, antibacterial properties, anti-inflammatory effects, hemostatic abilities, or any other medical terms.

2. Manufacturing Requirements

In January 2016, the former CFDA (now NMPA) introduced the Practice for Cosmetics Production Licensing, regulating toothpastes as an independent unit of cosmetics in implementing production license management. Toothpastes are required to comply with the regulations governing cosmetic production and can only be manufactured after obtaining a production license issued by the provincial FDA (now provincial MPA).

Prior to commencing manufacturing, companies must submit documentation to the local MPAs to obtain the necessary license. The production of toothpastes must adhere to the plant requirements outlined in the Good Manufacturing Practices for Cosmetics. Following document review and on-site inspection by the local MPA, compliant companies will be issued a license, granting them permission to commence manufacturing.

Toothpastes Production License (source: internet)

3. Notification

China implemented a notification scheme for toothpastes. Only toothpastes completing the notification are permitted for sale and import.

Overall, the documentation required for toothpaste notification largely aligns with those outlined in general cosmetics regulations. Nevertheless, given the unique nature of the toothpaste category, certain items entail specific requirements, notably in terms of toothpaste test reports and efficacy evaluations.

Notification System’s Account Application for Initial Toothpaste Notification

Toothpaste Notification

a. Notifier information form and the resume of the person in charge of quality and safety;

b. Overview of the quality management system of the notifier;

c. Overview of the adverse reaction monitoring and evaluation system of the notifier;

d. Chinese domestic responsible person’s information form (for overseas notifier);

e. The original copy of the authorization letter of the Chinese domestic responsible person, and the original notarization (for overseas notifier);

f. Manufacturer information form and resume of the person in charge of quality and safety (for notifiers engaged in self-production or entrusting overseas enterprises to produce). Notably, for overseas manufacturer, the original copy of the GMP certification documents is also required.

i. Name, address, and contact information of the notifier;

ii. Name, address, and contact information of the production enterprise;

iii. Product name information;

iv. Product formula;

v. Product executive standards;

vi. Product label sample;

vii. Product testing report;

viii. Product safety assessment documents.

4. Safety Assessment

The safety assessment requirements for toothpaste are somewhat more relaxed compared to cosmetics.

Toothpaste’s safety assessment should be conducted with reference to the requirements in the Technical Guidelines for Cosmetic Safety Assessment, taking into account the specific characteristics of the toothpaste product. The safety assessment report encompasses summary, product introduction, product formula, safety assessment of each ingredient, assessment of potential risky substances, risk control measures, safety assessment conclusions, resumes and signatures of safety assessors, relevant references, appendices, etc.

The challenge of the safety assessment lies in evaluating each ingredient in the formula. Recognizing that it may be impossible to access the complete basic data of some toothpaste ingredients, and solely confirm the safety of these ingredients through public data, Provisions for Management of Toothpaste Notification Dossiers allows notifiers to optimize product safety assessment data. This can be achieved through methods such as providing objective proof of a safe usage history exceeding 3 years for the ingredients.

5. Efficacy Claims

In addition to the basic cleaning function, toothpaste is limited to only four permissible efficacy claims: anti-caries, anti-plaque, anti-dentin hypersensitivity, and relief of gingiva problems.

The following claims are 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.

No.	Examples of prohibited claims of toothpaste
1	Anti-inflammatory, pain relief, and stop bleeding
2	Tooth regeneration
3	Treatment of Helicobacter pylori
4	Promoting the growth of children's teeth, repairing cavities, closing tooth gaps, stabilizing loose teeth
5	Preventing gum bleeding and periodontal looseness
6	Reducing pain, decreasing sensitivity, and minimizing bleeding
7	……

6. Testing Requirements for Toothpaste Safety and Efficacy

When notifying toothpaste, the notifiers should submit product testing reports, which generally include microbiological and physicochemical testing reports, toxicological testing reports, efficacy evaluation reports, etc. The specific testing criteria for toothpaste differ somewhat from those applicable to general cosmetics.

Toothpaste Testing Items	Requirements
Microbiological and Physicochemical Tests	Previously, the microbiological and physicochemical tests for toothpaste followed the national standard GB/T 8372-2017 Toothpaste, including routine microbiological testing items, the detection of heavy metal content like lead and arsenic, and content detection of total fluorine, soluble fluorine or free fluorine. Provisions for Management of Toothpaste Notification Dossiers (Provisions) expands on these by introducing tests for heavy metal mercury and cadmium, along with the content detection of hazardous substances such as methanol, dioxane, free formaldehyde, diethylene glycol, and glycol. Detailed testing items and corresponding limits shall comply with Annex 3 "Microbiological and Physical and Chemical Testing Items for Toothpaste Notification" of the Provisions. In terms of the selection of test methods, priority should be given to test methods outlined in the Safety and Technical Standards for Cosmetics.
Toxicological Tests	Three types of toothpaste, including those for children, those containing new ingredients under safety monitoring, and those claiming efficacy of preventing caries, inhibiting dental plaque, resisting dentin hypersensitivity, and alleviating gum-related problems, must undergo oral mucosa irritation tests. A corresponding test report shall be submitted upon the notification. For other toothpaste types, if the producer holds qualification certification related to the production quality management system from local government, and product safety risk assessment can confirm product safety, these toothpaste products can enjoy exemption from oral mucosa irritation testing reports.
Efficacy Evaluation	Toothpaste with different efficacy claims shall undergo different efficacy evaluations. a. For those claiming efficacy of preventing caries, inhibiting dental plaque, resisting dentin hypersensitivity, and alleviating gum-related problems: Human efficacy evaluation is required due to the associated safety risk. b. For those achieving caries prevention efficacy through fluoride, and the fluoride content meets the relevant requirements in Annex 3 of the Provisions: the efficacy evaluation of preventing caries efficacy can be exempted. c. For those exclusively claiming cleaning efficacy: Efficacy evaluation can be exempted. d. For those claiming efficacy beyond cleaning: Human efficacy evaluation or other efficacy evaluation methods are required based on the claims.

7. Labeling

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 the entrusted production enterprise. For an overseas notifier, the name and address of the domestic responsible person should also be labeled;

3. Name and address of the production enterprise. For domestic toothpaste, the production license number of the production enterprise should also be labeled;

4. Product executive standard number;

5. Full ingredients;

6. Net content;

7. Durability;

8. Necessary safety warnings;

9. Other contents to be labeled according to laws, administrative regulations, and mandatory national standards.

Notes:

For small-size packaged cosmetic products with a net content of no more than 15g or 15mL, only the Chinese name, the notifier name, the net content, and the durability shall be labeled on the visible panel of the sales packaging. Other information can be indicated in the instructions attached to the products;
For small-sized packaged products with a packaging box, the Chinese name and the durability of the products shall also be labeled on the inner packing in direct contact with the contents;
According to the characteristics of the product, if it is necessary to specifically label the use method of the product, it should be marked on the visible panel of the sales package;
Children's toothpaste packaging should prominently display the designated children's toothpaste logo on its visible surface and include cautionary terms such as "Caution" or "Warning." The visible panel of the sales packaging must also feature appropriate warnings, such as "should be used under adult supervision," "not edible," and "beware of swallowing." Furthermore, if children's toothpaste contains fluoride, it should have a label indicating the single-use limit.

8. Ingredient Use Requirements

1) Ingredient Use Requirements

Ingredients used in toothpastes shall meet the requirements in GB 22115-2008 General Requirements on Raw Materials of Toothpastes.

Prohibited Ingredients	1466 Including benzene, benzidine sulphate, carbon monoxide, chlorine, etc.
Restricted Ingredients	39 Including aluminum fluoride, ammonia, calcium fluoride, sodium nitrite, stannous fluoride, etc.
Permitted Preservatives	48 Including chlorobutanol, 2-chloroacetamide, formaldehyde and paraformaldehyde, sodium iodate, etc.
Permitted Colorants	102 Including CI 11920, CI 12490, CI 13015, CI 14270, CI 14700, etc.

2) New Toothpaste Ingredients

New toothpastes ingredients refer to the natural or artificial ingredients used in toothpaste for the first time in China. China Oral Care Industry Association (COCIA) released the Inventory of Existing Toothpastes Ingredients on January 12, 2024, to help companies determine the regulatory status of their ingredients used. Basically, a toothpaste ingredient is deemed as "new" if it is not included in the Inventory.

The Inventory comprises 1,026 ingredients, including information such as the Chinese name, INCI/English name, highest historical use concentration, and note. For ingredients with specific usage requirements stated in GB 22115 General Requirements on Raw Materials of Toothpastes, the note in the Inventory indicates that these ingredients should be used in accordance with the requirements of GB 22115.

All the ingredients listed in the Inventory have a usage history of three years or more. When conducting safety assessments for toothpaste, companies can reference to the highest use concentration of ingredients in the Inventory as an evidence of ingredient safety.

For ingredients not included in the Inventory:

If the marketed product contains such ingredients and has undergone simplified notification, the company is responsible for monitoring the product's adverse reactions;
If such ingredients have not been used in toothpaste product, the company must register or notify the ingredients in accordance with the Provisions for Management of Toothpaste Notification Dossiers.

The full Inventory can be found in Coslist.

Part III 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: The draft 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: The draft 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.
Dec 1, 2023: The implementation of the finalized Administrative Measures on Toothpaste and the Provisions for Management of Toothpaste Notification Dossiers signifies the official commencement of toothpaste notification procedures, marking a new era for toothpaste regulation.
Further Reading
China SAMR Implements Administrative Measures on Toothpaste: Notification Mandatory for All Toothpastes
China Finalizes Detailed Dossier Requirements for Toothpaste Notification
China Simplifies Notification Document Requirements for Marketed Toothpastes
China NIFDC Consults on 20 Testing Methods for Toothpaste, Cosmetic Ingredients, and Toxicological Test
Webinar | Ensure Compliance with China's New Toothpaste Notification Regulations

Tags: Chinese Mainland Pre-market Approval Ingredients Labeling/Claim/Advertising Efficacy Safety Assessment Testing CSAR Toothpaste