Provisions for Toothpaste Regulation

(Promulgated by SAMR Decree No. 71, issued on March 16, 2023 and shall go into effect as of December 1, 2023)

Article 1 The Provisions are formulated in accordance with the Regulations on Supervision and Administration of Cosmetics for the purpose of standardizing toothpaste production and marketing, strengthening toothpaste supervision and administration, ensuring the quality and safety of toothpaste, safeguarding the health of consumers, and promoting healthy development of toothpaste industry.

Article 2 The Provisions shall apply to the production, marketing, supervision and administration of toothpaste within the territory of the People’s Republic of China.

Article 3 Toothpaste as mentioned in the Provisions refers to a paste product applied to the surface of human teeth by means of friction, with the main purpose of cleaning.

Article 4 The National Medical Products Administration (NMPA) shall be responsible for the supervision and administration of toothpaste nationwide.

The departments in charge of drug supervision and administration of the local people's governments at or above the county level are responsible for the supervision and administration of toothpaste within their respective administrative areas.

Article 5 Toothpaste shall be subject to filing management. The toothpaste filing entity shall bear responsibility for the quality and safety as well as efficacy claimed of toothpaste.

Toothpaste manufacturers and marketers shall engage in production and marketing activities in accordance with laws, regulations, mandatory national standards, and technical specifications, strengthen management, practice integrity and self-discipline, so as to ensure the quality and safety of toothpaste.

Article 6 The overseas toothpaste filing entity shall designate an enterprise legal person within China as the domestic responsible person to handle the filing and assist in the monitoring of adverse reactions of toothpaste and the implementation of product recalls, and cooperate with the drug regulatory departments in the supervision and inspection.

Article 7 Toothpaste industry associations shall practice strict self-discipline, urge and lead toothpaste manufacturers and marketers to engage in production and marketing activities in accordance with law, and promote the development of integrity of the industry.

Article 8 The natural or artificial ingredients used in toothpaste for the first time within the territory of the People’s Republic of China are defined as new toothpaste ingredients.

The new toothpaste ingredients shall comply with the provisions related to the administration of new cosmetic ingredients. New toothpaste ingredients with preservative, colorant and/or other functions shall not be used until approved for registration by the NMPA; other new toothpaste ingredients are subject to filing management.

The new toothpaste ingredients that have been registered or filed shall be subject to the safety monitoring system, with a monitoring period of 3 years. The new toothpaste ingredients without safety issues within the safety monitoring period will be included in the inventory of existing toothpaste ingredients formulated by the NMPA.

Article 9 The toothpaste filing entity shall select the ingredients that meet the requirements of laws, regulations, mandatory national standards, and technical specifications for toothpaste production, and bear responsibility for the safety of the toothpaste ingredients used. When filing a product, the toothpaste filing entity shall clarify the source of ingredients and safety-related information of the ingredients through the filing information service platform.

Article 10 Domestic toothpaste shall be filed with the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the central government where the filing entity is located prior to marketing.

Imported toothpaste shall be filed with the NMPA prior to importation. The NMPA may, according to law, entrust competent drug regulatory departments of the people's governments of provinces, autonomous regions, or municipalities directly under the central government with the filing management of imported toothpaste.

Article 11 The filing entity or the domestic responsible person shall submit the following materials for toothpaste filing:

(Ⅰ) The name, address, and contact information of the filing entity;

(Ⅱ) The name, address, and contact information of the manufacturer;

(III) The product name;

(Ⅳ) The product formula;

(Ⅴ) Standards that the product complies with;

(Ⅵ) The label sample;

(Ⅶ) The product test report;

(Ⅷ) Product safety assessment materials.

For the filing of imported toothpaste, the documents proving that the products have been for sale on the market in the country (region) and the certification materials proving that the overseas manufacturer complies with the Good Manufacturing Practice (GMP) for Cosmetics shall be submitted. For the filing of products designed specifically for exports to China, the documents of relevant research and testing carried out specifically to Chinese consumers shall be submitted in the absence of the documents proving that the products have been for sale on the market in the country (region).

Article 12 Before toothpaste filing, the filing entity shall conduct a safety assessment by themselves or by an entrusted professional institution.

The personnel engaged in the safety assessment shall possess professional knowledge related to toothpaste or cosmetics quality and safety, and shall have more than 5 years of relevant professional work experience.

Article 13 The efficacy claim of toothpaste shall be supported by sufficient scientific data. Toothpaste filing entities shall disclose the summary of the literature, research data, or product efficacy evaluation documents on which the efficacy claimed is based on the filing information service platform, and accept social supervision.

The NMPA shall formulate, disclose, and adjust the classified catalogue of toothpaste based on factors such as the efficacy claim of toothpaste and the group of users, etc. The scope and wording of the efficacy claim of toothpaste shall conform to laws, regulations, mandatory national standards, technical specifications, and the provisions of the NMPA.

Article 14 The evaluation of the efficacy claim for toothpaste shall conform to relevant requirements for the evaluation of the quality, safety, and the efficacy claim stipulated by laws, regulations, mandatory national standards, technical specifications, and the provisions of the NMPA, so as to ensure the scientificity, accuracy, and reliability of the evaluation results of the efficacy claimed.

Article 15 Toothpaste production activities shall be approved and licensed by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the central governments. The filing entity and the contract manufacturer of toothpaste shall establish a production quality management system and organize the production in accordance with the requirements of the GMP for Cosmetics.

Article 16 Toothpaste adverse reactions shall be reported according to the principle of "reporting when in doubt". Toothpaste manufacturers, marketers, and medical institutions shall, in accordance with the cosmetic adverse reaction monitoring system formulated by the NMPA, carry out toothpaste adverse reaction monitoring.

Article 17 Toothpaste labels shall be indicated with the following contents:

(I) The product name;

(Ⅱ) The name and address of the filing entity and the contract manufacturer; as well as the name and address of the domestic responsible person if the filing entity is an overseas enterprise;

(III) The name and address of the manufacturer, and the production license number of the manufacturer for domestic toothpaste;

(Ⅳ) The standard number that the product complies with;

(Ⅴ) All of the ingredients;

(Ⅵ) Net content;

(Ⅶ) Shelf life;

(Ⅷ) Necessary safety precautions;

(Ⅸ) Other contents that shall be marked as required in laws, administrative regulations, and mandatory national standards.

If the use method of the product needs to be specifically marked according to its characteristics, it shall be marked on the visible surface of the sales package.

Article 18 The toothpaste name generally consists of the trade name, the generic name, and the attribute name. The attribute name of toothpaste shall be expressed with “toothpaste” in a unified manner.

Non-toothpaste products shall not deceive or mislead consumers by labeling "toothpaste" or other means.

Article 19 Toothpaste labels shall be prohibited from being indicated with the following contents:

(I) Expressed or implied contents related to medical effects;

(Ⅱ) False or misleading contents;

(III) Contents that are against public order and good customs;

(Ⅳ) Other contents prohibited by laws, administrative regulations, mandatory national standards, and technical specifications.

Article 20 Toothpaste products claimed to be suitable for children shall conform to the provisions on children's toothpaste in laws, administrative regulations, mandatory national standards, and technical specifications, and shall be marked on the product labels in accordance with the provisions of the NMPA.

Article 21 If the toothpaste and the ingredients used fail to meet the technical requirements specified in the mandatory national standards, technical specifications, and filling documents, or the Provisions, punishment shall be imposed in accordance with the relevant provisions of the Regulations on the Supervision and Administration of Cosmetics.

Article 22 Any filing entity, contract manufacturer, marketer, or domestic responsible person of toothpaste who commits the following illegal acts shall be punished in accordance with the provisions of the Regulations on the Supervision and Administration of Cosmetics:

(I) Provide false materials in applying for toothpaste administrative licensing or handling the filing, or falsify, alter, rent, lend out, or transfer a toothpaste license;

(Ⅱ) Conduct toothpaste production activities without licensing or fail to organize production in accordance with the requirements of the GMP for Cosmetics;

(III) Illegally add the substances that may harm human health into toothpaste;

(Ⅳ) Make an alteration to the shelf life of toothpaste;

(Ⅴ) Fail to publish the summary of the basis for efficacy claimed in accordance with the Provisions;

(VI) Fail to monitor and report adverse reactions of toothpaste in accordance with the Provisions;

(VII) Refuse to implement the decision of ordering to recall the products, or stop/suspend the production or marketing made by the drug regulatory department according to law;

(VIII) Where the domestic responsible person fails to perform the obligations prescribed in the Provisions, or the overseas toothpaste filing entity refuses to fulfill the administrative penalty decision made according to law.

Article 23 Where the supervision and administration of toothpaste is not prescribed in the Provisions, please refer to the applicable clauses in the Provisions for Registration and Filing of Cosmetics and the Provisions for Supervision and Administration of Manufacturing and Marketing of Cosmetics.

Article 24 Toothpaste and its new ingredients shall be numbered according to the following rules after registration or filing:

(I) New toothpaste ingredients: 国牙膏原注/备字+ year (four digits) + serial number of toothpaste ingredients registered/filed in the current year;

(Ⅱ) Domestic toothpaste: Abbreviation of the province, autonomous region, or municipality directly under the central government + 国牙膏网备字 + year (four digits) + serial number of products filed within the administrative area in the current year;

(III) Imported toothpaste: 国牙膏网备进字+ (abbreviation of the province, autonomous region, or municipality directly under the central government where the domestic responsible person is located) + year (four digits) + serial number of products filed in China in the current year;

(IV) Toothpaste from Chinese Taipei, Hong Kong SAR, and Macao: 国牙膏网备制字(abbreviation of the province, autonomous region, or municipality directly under the central government where the domestic responsible person is located) + year (four digits) + serial number of products filed in China in the current year.

Article 25 The Provisions shall go into effect as of December 1, 2023.

Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.