[Updated] China SAMR Implements Administrative Measures on Toothpaste: Notification Mandatory for All Toothpastes

Editor's Note: This article was originally published on March 24, 2023, and was updated on December 5, 2023, as per the latest developments.

Updates

Administrative Measures on Toothpaste (Measures) came into effect on December 1, 2023. Toothpaste must adhere to the requirements outlined in the Measures. For Chinese domestic toothpaste, notification should be submitted to the provincial medical products administration department in the notifier's location prior to market entry. Imported toothpaste must be notified to the National Medical Products Administration (NMPA) before importation.

According to Cosmetic Supervision and Administration Regulation (CSAR), toothpaste shall be managed with reference to the provisions on general cosmetics. In order to implement this provision and standardize the supervision of toothpaste, on March 23, 2023, China State Administration for Market Regulation (SAMR) issued the finalized Administrative Measures on Toothpaste (Measures) and will implement it on December 1, 2023. ¹

Encompassing 25 articles, the Measures mainly

Clarifies the responsibilities of all stakeholders;
Clarifies toothpaste’s definition;
Clarifies the management requirements for toothpaste products and new ingredients;
Clarifies the ongoing use of the existing toothpaste production licensing system;
Clarifies the requirements for toothpaste safety assessment, efficacy claims and labeling.

In addition, the Measures emphasizes that matters not specified shall be managed with reference to Administrative Measures on Cosmetics Registration and Notification and Supervision and Administration Measures on Cosmetics Produce and Operation.

Specifics of the Measures

1. Clarifying the responsibilities of all stakeholders

Type	Stakeholders	Responsibilities
Government	National Medical Products Administration (NMPA)	The supervision and management of toothpaste across China
Government	Medical products administration departments of and above the county level	The supervision and management of toothpaste in the administrative region
Enterprise	Toothpaste notifier	Ensure the qualify, safety and compliance of the efficacy claims of toothpaste; Choose legal ingredients for producing toothpaste, and be responsible for the safety of the toothpaste ingredients; When applying for notification, clarify ingredient’s source and safety-related information through the notification information service platform; Carry out safety assessments on their own or by entrusting professional institutions; Submit the summary of efficacy evaluation on the notification information service platform for disclosure; Establish a production quality management system.
	Toothpaste producer and operator	Obtain a production license before producing toothpaste; Establish a production quality management system; Produce and operate toothpaste in accordance with the laws, regulations, mandatory standards and technical norms, and ensure the quality and safety of toothpaste; Carry out adverse reaction monitoring.
	Chinese domestic responsible person	Handle toothpaste notification on behalf of overseas notifiers, assist in adverse reaction monitoring, implement product recalls, and cooperate with medical products administration departments in supervision and inspection
Industry Association	Toothpaste association	Strengthen industry self-discipline, and urge and guide producers and operators to engage in production and operation in accordance with the law
Institution	Medical institution	Carry out adverse reaction monitoring

2. Clarifying toothpaste’s definition

The Measures stipulates toothpaste’s definition from three aspects: action mode, application area and use purpose: toothpaste refers to paste preparation applied to the surface of human teeth by friction, with the main purpose of cleansing. The definition is consistent with consumers' understanding.

The definition limits the character of toothpaste to "paste", meaning that oral cleansing and care products such as tooth powder, mouthwash, oral antibacterial cream, tooth desensitization gel, butyl boron cream are excluded from the scope of toothpaste. Among these products that are not within the range of toothpaste, those with relatively high safety risks shall be regulated as drugs or medical devices, and those with relatively low safety risks are managed as general industrial products. ²

In addition, the Measures also clarifies that the attribute name of toothpaste shall be expressed with the word "toothpaste". Non-toothpaste products shall not mislead consumers by labeling "toothpaste". Therefore, product names that do not meet the new definition, such as "liquid toothpaste" and "mousse toothpaste", will not be allowed to be used.

3. Clarifying the management requirements for toothpaste products and new ingredients

1) Toothpaste Products

China will implement a notification scheme for toothpaste. Only toothpaste whose notification is completed is permitted for sale and import. Chinese domestic toothpaste is subject to the notification with provincial-level MPA, while imported toothpaste is subject to the notification with NMPA. The Measures also mentions that NMPA can entrust the notification work of imported toothpaste to the provincial-level MPA.

Documents required for toothpaste notification are similar to that of cosmetics. The toothpaste notifier shall submit the following documents:

The name, address and contact information of the notifier;
The name, address, and contact information of the producer;
Product name;
Product formula;
Product executive standard;
Product label manuscript;
Product testing report;
Product safety assessment documents;
Supporting documents that prove those products have been put into market in the manufacturing country (for imported toothpaste);
GMP certification documents (for imported toothpaste);
Documents on research and testing conducted on Chinese consumers (for imported toothpaste exclusively exported to China).

2) New Toothpaste Ingredients

With reference to the regulatory system for new cosmetic ingredients (NCI), NMPA will establish a similar approval and supervision system for new toothpaste ingredients. According to the Measures, new toothpaste ingredients refer to the natural or artificial ingredients used in toothpaste for the first time in China.

New toothpaste ingredients shall comply with the regulations on NCI. New toothpaste ingredients with preservative or colouring efficacy shall be registered with NMPA. Other new toothpaste ingredients shall be subject to notification.

After successful registration or notification of a new toothpaste ingredient, registrants and notifiers shall establish a safety monitoring system for the notified/registered new ingredient within 3 years. If there are no safety issues found within the 3 years, the new ingredient will be included in the Inventory of Existing Toothpaste Ingredients in China.

Currently, the toothpaste industry adopted a negative list system for toothpaste ingredients. Ingredients not prohibited can be used in toothpaste. If Inventory of Existing Toothpaste Ingredients in China is introduced in the future, there may be entry threshold for some innovative ingredients.

4. Clarifying the ongoing use of the existing toothpaste production licensing system

The Measures clarifies that the existing toothpaste production licensing system will continue to be used. Prior to production, enterprises shall submit documents to the provincial-level MPA for obtaining a license.

Toothpaste notifier and entrusted production enterprise shall establish a production quality management system and organize production in accordance with the requirements of Good Manufacturing Practices for Cosmetics.

5. Clarifying the requirements for toothpaste safety assessment, efficacy claims and labeling

1) Safety Assessment

Toothpaste notifier shall carry out safety assessments on their own or by entrusting professional institutions. The qualification requirements for safety assessors are basically the same as those for cosmetics.

Qualification Requirements for Safety Assessors

Safety assessor shall have professional knowledge related to the quality and safety of toothpaste or cosmetics, and have more than 5 years of professional experience in relevant fields.

For cosmetic, registrants and notifiers are allowed to submit a simplified version of the cosmetic safety assessment report before May 1, 2024. However, the Measures does not specify whether the toothpaste safety assessment report should be submitted in a simplified version or a full version. This issue needs to be further clarified by NMPA.

2) Efficacy Claims

The Measures stipulates that the efficacy claims of toothpaste should have a sufficient scientific basis. The toothpaste notifier shall submit the summary of efficacy evaluation on the notification information service platform for disclosure.

According to CSAR, after toothpaste notifiers conduct the efficacy evaluation in accordance with national standards and industry standards, they can claim that the toothpaste has efficacy such as anti-caries, plaque inhibition, anti-dentine hypersensitivity, and relieving gingiva problems, etc.

However, currently the efficacy claims for toothpaste in China are quite confusing. Some enterprises often make non-compliant claims such as "anti-inflammatory, analgesic, hemostasis", "promoting children's teeth growth", "repairing cavities", "closing gaps between teeth", "stabilizing loose teeth", "regenerating teeth", "treating Helicobacter pylori", etc. These non-compliant claims confuse the efficacy of toothpaste with the efficacy of drugs and medical devices, seriously misleading consumers. The supervision requirements of toothpaste claims in the Measures will help to rectify this chaos.

In the future, NMPA will further formulate and release a toothpaste efficacy classification catalog, stipulating the permitted efficacy claims for toothpaste, and will timely update the catalog.

3) Required Contents and Prohibited Contents on the Label

Required Contents

Prohibited Contents

Product name;
The name and address of the notifier and entrusted production enterprise;
The name and address of the Chinese domestic responsible person (for imported toothpaste);
The name and address of the production enterprise;
Production license number (for Chinese domestic toothpaste);
The product executive standard number;
Full ingredients listing;
Net content;
Durability;
Safety warnings;
Application method (if necessary);
Children cosmetics' logo (for Children toothpaste);
Other content prescribed by laws, administrative regulations, and mandatory national standards.

Contents indicating medical effects implicitly or explicitly;
False or misleading content;
Contents violating social public order and good customs;
Other contents prohibited by laws, administrative regulations and mandatory national standards.

Industry Comments

Currently, China implements a simple management scheme for toothpaste. Toothpaste can enter the market as long as they comply with relevant national and industry standards.

Under the framework of CSAR, the Measures puts forward separate and detailed regulatory requirements for toothpaste. Its management approach is similar to that of cosmetics. The promulgation of the Measures is conducive to the standardized development of and the healthy competition in the toothpaste industry.

However, most toothpaste enterprises may not be familiar with the requirements for notification documents preparation. The Measures leaves an eight-month transition period. It is recommended that enterprises pay close attention to the upcoming toothpaste regulations, such as Instructions for Toothpaste Notification Dossiers, Toothpaste Efficacy Classification Catalog, and Inventory of Existing Toothpaste Ingredients in China, as well as make preparations as early as possible to meet new compliance requirements.

ChemLinked expects to assist enterprises in notifying toothpaste in China. If you have any further toothpaste compliance consultation needs, please contact us at [email protected].