China Toothpaste Regulations Unveiled: Follow a Comparable Management Scheme of Cosmetics

According to the Cosmetic Supervision and Administration Regulation (CSAR), toothpaste shall be regulated in accordance with the regulations on general cosmetics, and the NMPA will be responsible for the pre-market approval and post-market surveillance of toothpaste. With an aim of implementing this new requirement and standardizing the manufacture, operation, pre-market approval and post-market surveillance of toothpaste, China NMPA has been formulating a regulation on toothpaste.

On November 13, 2020, China NMPA unveiled the regulation for public consultation, which is named as Administrative Measures on Toothpaste. Stakeholders with any comments can send them to the NMPA via email at [email protected] before December 12, 2020.

Encompassing 23 articles, the measures mainly

Clarify the responsibilities of all stakeholders
Specify the definition of toothpaste and new toothpaste ingredients
Stipulates the requirements for toothpaste manufacturers and importers, including notification dossiers, toothpaste manufacturing licensing, efficacy evaluation, etc.
Put forward the criteria to determine the regulatory status of toothpaste ingredients and the obligations for different kinds of ingredients.

In addition, the measures stress that matters not specified shall be managed in accordance with the regulations on general cosmetics.

Specifics of the Measures

1. Responsibilities of all stakeholders

Type	Stakeholders	Responsibilities
Government	NMPA	The supervision and management of toothpaste in China
	Provincial medical products administration departments	The supervision and management of toothpaste in the administrative region, and the management of production licensing and notifications from production enterprises in the administrative region.
	Medical products administration departments at 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 efficacy claim of toothpaste
Enterprise	Toothpaste manufacturer and operator	Manufacture and operate toothpaste in accordance with the laws, regulations, mandatory standards and technical norms, and ensure the quality and safety of toothpaste
Association	Toothpaste association	Strengthen industry self-discipline, and urge and guide manufacturers and operators to engage in manufacture and operation in accordance with the law
Testing institution	Toothpaste efficacy evaluation institution	Ensure the qualification for efficacy evaluation in accordance with the requirements prescribed, independently carry out the toothpaste efficacy evaluation, and be responsible for the evaluation results

2. Requirements for toothpaste

2.1 Definition

Toothpaste refers to the solid and semi-solid preparation applied to the teeth surface of human and surrounding tissues by friction for the purpose of cleansing, beautifying and protecting.

2.2 Manufacturing requirements

The manufacture of toothpaste shall meet the requirements for plants specified in the Cosmetic Good Manufacturing Practices for Cosmetics. Prior to manufacture, companies shall submit documents to the local MPAs for obtaining a license. After a review of the documents and on-site inspection, the local MPA will issue a license to compliant companies. With the license, companies are permitted to start manufacturing.

2.3 Notification

China will implement a notification scheme for toothpaste. Only toothpaste completing the notification is permitted for sale and import.

To apply for the notification, the notifier shall submit the following documents:

The name, address and contact information of the notifier
The name, address, and contact information of the manufacturer
Product name
Product formula
Product executive standard
Product label
Product testing report
Product safety assessment documents

2.4 Efficacy

The NMPA will formulate and release a toothpaste efficacy classification catalog, stipulating the permitted efficacy claims for toothpaste, and will timely update the catalog based on the possible advice from companies and associations and the actual development of the toothpaste industry. In the future, the naming of toothpaste and efficacy claim used shall fully comply with the catalog.

Furthermore, efficacy evaluation is mandatory for all functional toothpaste except for cleansing toothpaste. Only after the efficacy evaluation, toothpaste can claim the efficacies such as caries prevention, inhibition of dental plaque, anti-dentin hypersensitivity, and decrease of gum problems, and the notifiers can apply for the notification. The evaluation abstracts shall also be submitted to the MPAs together with the notification dossiers and to an information platform established by the NMPA for disclosure.

2.5 Prohibited claims

Apart from the prohibited efficacy claims stipulated in the catalog, the following claims are also not allowed for toothpaste:

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

3. Requirements for new toothpaste ingredients

3.1 Definition

New toothpaste ingredients refer to the natural or artificial ingredients used in toothpaste for the first time in China.

However, food additives or food ingredients complying with existing national standards are not managed as new toothpaste ingredients when they are used in toothpaste for the first time in China.

3.2 Determination criteria

The NMPA will formulate and release an inventory of existing toothpaste ingredients 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.

3.3 Obligations for different kinds of ingredients

Type	Obligations
Ingredients included in the inventory of existing toothpaste ingredients	Manufacturers and operators shall use them reasonably in accordance with the national mandatory standards, technical norms, and the requirements in the inventory.
New toothpaste ingredients	The company that intends to use a new toothpaste ingredient shall submit an application of formulating its safety and technical standards to the competent authority. The ingredient can only be used after it is added to national mandatory standards or technical norms.
Food additives or food ingredients used in toothpaste for the first time	The company shall submit the safety assessment report of the ingredient used in toothpaste.

ChemLinked Comments
It can be expected that toothpaste companies will be posed with significant regulatory burdens. At present, China implements a very simple management scheme for toothpaste. Toothpaste can enter the market as long as they comply with relevant national and industry standards. However, as per the Measures, toothpaste will be subject to a much more stringent management scheme which is comparable to that of cosmetics, requiring notification, testing, safety assessment, efficacy evaluation, new ingredient application, etc. Companies are advised to make preparations as early as possible to meet pending compliance requirements.

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