Q：

ZOOP:

The "Measures" consist of 25 articles, and a series of regulatory systems have been formulated from several aspects, including the definition of toothpaste, regulatory departments, management requirements for toothpaste and toothpaste raw materials, toothpaste production licensing system, toothpaste efficacy management, and labeling requirements.

ZOOP:

The Measures shall come into effect on December 1, 2023.

The toothpaste will be subject to record keeping management, and the toothpaste record holder is responsible for the quality, safety, and efficacy claims of the toothpaste. The registrant shall complete the filing upon submitting the filing materials through the online government service platform of the State Council's drug regulatory department.

At the same time, the "Measures" continue to use the current toothpaste production license system and issue cosmetics production licenses for toothpaste production. Production enterprises can only engage in toothpaste production activities after applying to the drug regulatory department of the province, autonomous region, or municipality directly under the central government where they are located and obtaining a production license.

The toothpaste registrant and entrusted production enterprise shall establish a production quality management system and organize production in accordance with the requirements of the cosmetics production quality management standards.

Q：

ZOOP:

The definition of toothpaste in the "Measures" is a paste like product applied to the surface of human teeth through friction, with the main purpose of cleaning.

The function of toothpaste is friction, which is different from the way cosmetics are applied or sprayed; The action site of toothpaste is the surface of teeth, not including the surrounding tissue of teeth; The main purpose of toothpaste is cleaning, which is different from the purpose of using drugs and medical device products; The characteristics of toothpaste are paste like, excluding tooth powder, mouthwash, and other oral care products.

Q：

ZOOP:

The efficacy claims of toothpaste should have sufficient scientific basis. The toothpaste registrant shall publish on the filing information service platform a summary of the literature, research data, or product efficacy evaluation materials on which the efficacy claim is based, and accept social supervision.

The scope and wording of the efficacy declaration of toothpaste should comply with relevant regulations. The classification catalog of toothpaste shall be formulated, published, and adjusted by the National Drug Administration.

Zongpu reminds that the efficacy claim evaluation of toothpaste should comply with the relevant requirements of laws, regulations, mandatory national standards, technical specifications, and the quality, safety, and efficacy claim evaluation stipulated by the National Drug Administration.

Q：

ZOOP:

Relevant regulations on the use of raw materials:

The toothpaste registrant shall select raw materials that meet the requirements of laws, regulations, mandatory national standards, and technical specifications for toothpaste production, and shall be responsible for the safety of the toothpaste raw materials used. When filing for toothpaste, the filing person should clarify the source of raw materials and information related to raw material safety through the filing information service platform.

Regulations related to new raw materials:

New toothpaste raw materials should comply with the relevant regulations on the management of new cosmetics raw materials. New toothpaste raw materials with functions such as anti-corrosion and coloring can only be used after being registered by the National Drug Administration; Other new toothpaste raw materials shall be subject to filing management.

The safety monitoring system is implemented for new toothpaste raw materials that have been registered and registered, and the safety monitoring period is 3 years. New toothpaste raw materials that have not experienced safety issues during the safety monitoring period shall be included in the list of used toothpaste raw materials formulated by the National Drug Administration.

Q：

ZOOP:

The toothpaste label should indicate the following content:

（1） Product name;

（2） The name and address of the registrant and the entrusted production enterprise, and if the registrant is from overseas, the name and address of the responsible person in China should also be marked;

（3） The name and address of the production enterprise, as well as the production license number of the domestic toothpaste, should be marked simultaneously;

（4） The standard number of the product execution;

（5） All components;

（6） Net content;

（7） Service life;

（8） Necessary safety warning language;

（9） Other contents that should be marked in accordance with laws, administrative regulations, and mandatory national standards.

According to the characteristics of the product, special labeling of the product's usage method should be done on the visible side of the sales packaging.

The comprehensive reminder on toothpaste labels prohibits the following contents from being labeled:

（1） Explicit or implied content with medical effects;

（2） False or misleading content;

（3） Content that violates social order and good customs;

Q：

ZOOP:

The filing person or domestic responsible person shall submit the following materials for toothpaste filing:

（1） The name, address, and contact information of the registrant;

（2） The name, address, and contact information of the production enterprise;

（3） Product name;

（4） Product formula;

（5） The standards for product execution;

（6） Product label sample;

（7） Product inspection report;

（8） Product safety assessment materials.

For the filing of imported toothpaste, proof of market sales and proof of production quality management standards should also be submitted;

For products specifically produced in China, relevant research and experiments conducted for Chinese consumers should also be submitted.

Q：

ZOOP: 

Imported toothpaste should be filed with the National Drug Administration before importation. The National Drug Administration may entrust drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government with corresponding capabilities to implement the filing and management of imported toothpaste in accordance with the law.

Q：

ZOOP:

① The Measures shall come into effect on December 1, 2023. It is recommended that enterprises make corresponding adjustments in advance based on their actual situation to comply with relevant regulations.

② The documents "Classification Catalogue of Toothpaste" and "Catalogue of Used Toothpaste Raw Materials" have not been released yet. In the future, enterprises will need to standardize product efficacy claims according to the "Classification Catalogue of Toothpaste" and the raw materials used in products according to the "Catalogue of Used Toothpaste Raw Materials".

③ In the naming of toothpaste, Zongpu reminds that attribute names should be uniformly expressed using the word "toothpaste", and non toothpaste products should not be labeled with the word "toothpaste".

④ For the parts not specified in the Measures, the provisions of the Measures for the Administration of Cosmetics Registration and Filing, the Measures for the Supervision and Administration of Cosmetics Production and Operation, etc. shall be referred to and applied.

Q：

ZOOP:

① Clarify that the product belongs to toothpaste;

② Standardize product names and efficacy claims;

③ Standardize product labeling and packaging;

④ Establish a production quality management system;

⑤ After the specific specifications are released, efficacy evaluation tests will be conducted according to relevant requirements;

⑥ Prepare relevant documents for filing.