Measures for supervision and administration of toothpaste

　　Article 1 These Measures are formulated in accordance with the Regulations on Supervision and Administration of Cosmetics in order to regulate the production and operation of toothpaste, strengthen the supervision and administration of toothpaste, ensure the quality and safety of toothpaste, safeguard the health of consumers and promote the healthy development of the toothpaste industry。

　　Article 2 These Measures shall apply to the production and operation of toothpaste and its supervision and administration within the territory of the People's Republic of China。

　　Article 3 The toothpaste mentioned in these Measures refers to a paste product applied to the surface of human teeth in the way of friction for the main purpose of cleaning。

　　Article 4 The State Medical Products Administration shall be responsible for the supervision and administration of toothpaste throughout the country。

　　The department responsible for drug supervision and administration under the local people's government at or above the county level shall be responsible for the supervision and administration of toothpaste in its administrative area。

　　Article 5 Toothpaste shall be subject to record management, and the person filing the record shall be responsible for the quality and safety of the toothpaste。

　　Toothpaste manufacturers and operators shall engage in production and business activities in accordance with laws, regulations, mandatory national standards and technical norms, strengthen management, integrity and self-discipline, and ensure the quality and safety of toothpaste products。

　　Article 6 The overseas toothpaste recordholder shall designate the domestic enterprise legal person as the domestic responsible person to handle the record, assist in the adverse reaction monitoring of toothpaste, implement product recall, and cooperate with the supervision and inspection work of the drug supervision and administration department。

　　Article 7 The toothpaste industry association shall strengthen the self-discipline of the industry, urge and guide the production and business operators to engage in production and business activities according to law, and promote the construction of industry integrity。

　　Article 8 The natural or artificial raw materials first used in toothpaste within the territory of the People's Republic of China shall be the new raw materials of toothpaste。

　　The new raw materials of toothpaste shall comply with the relevant provisions of the management of new raw materials of cosmetics, and the new raw materials of toothpaste with anti-corrosion, coloring and other functions shall be registered by the State Drug Administration before they can be used;Other new toothpaste raw materials shall be subject to record management。

　　The toothpaste new raw materials that have been registered and completed the filing shall implement the safety monitoring system, and the safety monitoring period shall be 3 years。New toothpaste raw materials that have no safety problems after the safety monitoring period are included in the list of used toothpaste raw materials formulated by the State Drug Administration。

　　Article 9 The recordholder of toothpaste shall select the raw materials that meet the requirements of laws, regulations, mandatory national standards and technical specifications for the production of toothpaste, and shall be responsible for the safety of the toothpaste raw materials used。When the toothpaste recordholder makes the record, it shall clarify the source of raw materials and relevant information about raw materials safety through the record information service platform。

　　Article 10 Domestic toothpaste shall be filed with the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the recordholder is located before being placed on the market for sale。

　　Imported toothpaste shall be filed with the State Drug Administration before import。The State Drug Administration may, according to law, entrust the competent drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government with the implementation of the record administration of imported toothpaste。

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

　　(1) the name, address and contact information of the person filing the record;

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

　　(3) Product name;

　　(4) Product formula;

　　(5) Standards for product implementation;

　　(6) Product label sample;

　　(7) Product inspection report;

　　(8) Product safety assessment data。

　　Record of imported toothpaste，At the same time, the certification documents that the products have been listed in the producing country (region) and the certification materials that the overseas production enterprises meet the quality management standards of cosmetics production should be submitted;For the purpose of export production to our country, unable to submit the product in the producing country (region) has been on the market for sale documents，Data on relevant studies and tests conducted for Chinese consumers should be submitted。

　　Article 12 Before the filing of toothpaste, the filing person shall carry out safety assessment by himself or entrust a professional institution。

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

　　Article 13 The efficacy claims of toothpaste shall be based on sufficient scientific evidence。The toothpaste recordholder shall publish the summary of the literature, research data or product efficacy evaluation data on which the efficacy claim is based on on the record information service platform, and accept social supervision。

　　The State Medical Products Administration shall formulate, publish and adjust the classification catalogue of toothpaste according to the claimed efficacy of toothpaste and the user group。The scope and wording of the efficacy claim of toothpaste shall comply with laws, regulations, mandatory national standards, technical specifications and the provisions of the State Drug Administration。

　　Article 14 The efficacy claim evaluation of toothpaste shall comply with laws, regulations, mandatory national standards, technical specifications and the relevant requirements of quality safety and efficacy claim evaluation stipulated by the State Drug Administration to ensure the scientific, accuracy and reliability of the efficacy claim evaluation results。

　　Article 15 Anyone engaged in the production of toothpaste shall, according to law, apply to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government for a production license。The toothpaste recordholder and the entrusted production enterprise shall establish a production quality management system and organize production in accordance with the requirements of the cosmetic production quality management standards。

　　Article 16 The adverse reaction report of toothpaste follows the principle of suspicious report。Toothpaste manufacturers, operators and medical institutions shall carry out adverse reaction monitoring of toothpaste in accordance with the requirements of the adverse reaction monitoring system for cosmetics formulated by the State Drug Administration。

　　Article 17 The toothpaste label shall mark the following contents:

　　(1) Product name;

　　(2) the name and address of the recordholder and the entrusted production enterprise, and the name and address of the domestic responsible person shall be marked at the same time if the recordholder is overseas;

　　(3) the name and address of the production enterprise, and the production license number of the domestic toothpaste enterprise shall be marked at the same time;

　　(4) the standard number of the product execution;

　　(5) all components;

　　(6) net content;

　　(7) term of use;

　　(8) necessary safety warning words;

　　(9) Other contents that should be marked according to laws, administrative regulations and mandatory national standards。

　　According to the characteristics of the product, the use method of the product needs to be specially marked, which shall be marked on the visible surface of the sales package。

　　Article 18 The name of toothpaste products generally consists of three parts: trademark name, generic name and attribute name。The attribute name of toothpaste uses the word "toothpaste" to express。

　　Non-toothpaste products shall not deceive and mislead consumers by labeling the word "toothpaste" or other means。

　　Article 19 The following contents shall not be marked on the toothpaste label:

　　(1) Content that is expressly or implied to have medical effects;

　　(2) false or misleading content;

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

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

　　Article 20 Toothpaste products claimed to be suitable for children shall comply with laws, administrative regulations, mandatory national standards, technical specifications and other provisions on children's toothpaste, and be marked on the product label in accordance with the provisions of the State Drug Administration。

　　Article 21 Toothpaste and the raw materials used do not meet the mandatory national standards, technical specifications, technical requirements specified in the record materials or the provisions of these measures, in accordance with the relevant provisions of the Regulations on supervision and administration of cosmetics。

　　22nd toothpaste recordholder, entrusted production enterprises, operators and domestic responsible persons, have the following illegal acts, in accordance with the relevant provisions of the Regulations on the supervision and Administration of cosmetics:

　　(1) Applying for the toothpaste administrative license or handling the record to provide false information, or forging, altering, renting, lending, transferring the toothpaste license;

　　(2) engaging in toothpaste production without permission, or failing to organize production in accordance with the requirements of the cosmetic production quality management code;

　　(3) illegal addition of substances in toothpaste that may harm human health;

　　(4) Change the use period of toothpaste;

　　(5) The summary of the basis for the efficacy claim is not published in accordance with the provisions of these Measures;

　　(6) failure to monitor and report adverse reactions of toothpaste in accordance with the provisions of these Measures;

　　(7) refusing to implement the decision made by the drug regulatory department in accordance with law to order a recall or to order the suspension or suspension of production or business;

　　(8) The domestic responsible person fails to perform the obligations stipulated in these measures, or the overseas toothpaste record person refuses to perform the administrative punishment decision made in accordance with the law。

　　Article 23 Supervision and administration of toothpaste, these measures do not make provisions, refer to the application of the "cosmetics registration and record management Measures" "Cosmetics production and management supervision" and other provisions。

　　Article 24 Toothpaste and toothpaste new raw materials shall be numbered according to the following rules after registration or filing:

　　(a) toothpaste new raw materials: the original toothpaste note/prepared word + four years + the number of toothpaste raw materials registered/filed in this year;

　　(2) Domestic toothpaste: provinces, autonomous regions, municipalities directly under the central government referred to as + national toothpaste network name + four years + the number of record products in the administrative region of the year;

　　(3) Imported toothpaste: the national toothpaste network prepared into the word (the province, autonomous region, municipalities directly under the central Government where the responsible person is located) + four years + this year's national record product sequence number;

　　(4) China's Taiwan, Hong Kong, Macao toothpaste: the national toothpaste network prepared word (the province, autonomous region, municipality directly under the central government where the responsible person is referred to as) + four years + the national record of the year product sequence number。

　　Article 25 These Measures shall come into force on December 1, 2023。