The latest interpretation of the toothpaste supervision and management measures.

Recently, the State Administration of Market Supervision and Administration issued the measures for the Supervision and Administration of toothpaste (hereinafter referred to as the "measures"), which will come into effect on December 1, 2023, which means that toothpaste products have entered a new era of record supervision with reference to the regulatory model of cosmetics. Xinanrun Consulting makes the following interpretation on the key contents of the Measures for your reference.
Measures for the Supervision and Administration of Toothpaste
(Promulgate by Order No. 71 of the State Administration for Market Regulation on March 16, 2023 and shall come into force on December 1, 2023)
Article 1 In order to regulate the production and operation of toothpaste, strengthen the supervision and management of toothpaste, ensure the quality and safety of toothpaste, protect the health of consumers, and promote the healthy development of the toothpaste industry, these measures are formulated in accordance with the "Regulations on the Supervision and Administration of Cosmetics.
Article 2 These Measures shall apply to the production and operation of toothpaste within the territory of the People's Republic of China and the supervision and administration thereof.
Article 3 The term "toothpaste" as mentioned in these Measures refers to the paste-like products that are applied to the surface of human teeth by friction and are mainly used for cleaning.
Policy interpretation:
This definition is basically consistent with people's daily understanding of toothpaste products. The measures limit the material properties of toothpaste products to be "paste", which means that toothpowder, mouthwash and other oral care products are excluded.
Considering the wide variety of products included in oral cleaning and care products, there are products such as oral bacteriostatic ointment with "Xiao" name (sanitary disinfection), products such as tooth desensitization gel with "mechanical" name (medical equipment), and products such as butyl boron cream with "medicine" name (medicine). Among these products, those with relatively high safety risks need to be strictly supervised in accordance with drugs and medical devices, and those with relatively low safety risks can be managed in accordance with general industrial products without the need to comply with these measures for filing management.
Article 4 The SDA shall be responsible for the supervision and administration of toothpaste throughout the country.
The departments responsible for the supervision and administration of pharmaceuticals of the local people's governments at or above the county level shall be responsible for the supervision and administration of toothpaste within their respective administrative regions.
Article 5 The toothpaste shall be subject to record management, and the toothpaste filer shall be responsible for the quality, safety and efficacy of the toothpaste.
Toothpaste producers and operators shall engage in production and business activities in accordance with laws, regulations, mandatory national standards, and technical specifications, strengthen management, integrity and self-discipline, and ensure the quality and safety of toothpaste products.
Article 6 The overseas toothpaste filer shall designate an enterprise legal person within the territory of China as the domestic responsible person to handle the filing, assist in the monitoring of toothpaste adverse reactions, implement product recalls, and cooperate with the supervision and inspection of the drug regulatory department.
Article 7 The toothpaste industry association shall strengthen industry self-discipline, supervise and guide producers and operators to engage in production and operation activities in accordance with the law, and promote the construction of industry integrity.
Article 8 The natural or artificial raw materials used for toothpaste for the first time within the territory of the People's Republic of China shall be the new raw materials of toothpaste.
New toothpaste raw materials shall comply with the relevant regulations on the management of new cosmetics raw materials. New toothpaste raw materials with anti-corrosion, coloring and other functions can only be used after being registered by the State Drug Administration; other new toothpaste raw materials shall be subject to record management.
The new toothpaste raw materials that have been registered and completed the record shall be subject to a safety monitoring system, and the period of safety monitoring shall be 3 years. The new toothpaste raw materials with no safety problems at the expiration of the safety monitoring period shall be included in the list of used toothpaste raw materials formulated by the State Drug Administration.
Article 9 The toothpaste filer 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 the toothpaste filer is filing, it shall clarify the raw material source and raw material safety-related information through the filing 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 record holder is located before it is marketed.
Imported toothpaste shall be filed with the SDA before import. The SDA may entrust the drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government with corresponding capabilities to implement the filing management of imported toothpaste.
Article 11 The filing person or the person responsible for the filing of toothpaste shall submit the following materials:
The name, address and contact information of the (I) filing person;
The name, address and contact information of the (II) production enterprise;
(III) product name;
(IV) product formula;
Standards implemented by (V) products;
(VI) product label samples;
(VII) product inspection report;
(VIII) product safety assessment data.
For the record of imported toothpaste, the certification documents that the product has been listed and sold in the producing country (region) and the certification materials that the overseas manufacturer meets the cosmetics production quality management standards shall be submitted at the same time; it is specially designed for export production to my country and cannot submit the product in the producing country (region) If the certification documents have been listed and sold, the relevant research and test materials carried out for Chinese consumers shall be submitted.
Article 12 Before filing a toothpaste, the filing person shall conduct a safety assessment by himself or by entrusting 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 filer shall publish the summary of the literature, research data or product efficacy evaluation data on which the efficacy claim is based on on the filing information service platform, and accept social supervision.
The State Drug Administration formulates, publishes and adjusts the classification catalogue of toothpaste according to the declared efficacy of toothpaste, the population of users and other factors. The scope and terms of the efficacy claim of toothpaste shall comply with laws, regulations, mandatory national standards, technical specifications and the provisions of the State Drug Administration.
Policy interpretation:
The Measures clarify that the State Drug Administration will issue a special toothpaste classification catalog, and the efficacy claims should comply with laws, regulations, mandatory national standards, technical specifications and the regulations of the State Drug Administration, which brings product innovation to enterprises. opportunity.
After the efficacy evaluation of toothpaste according to relevant standards, it can be claimed to have the effects of anti-caries, anti-plaque, anti-dentin sensitivity, and alleviating gum problems. Toothpaste should not be expressed or implied to have a medical effect, and should not make false or misleading claims of efficacy.
Article 14 The efficacy evaluation of toothpaste shall comply with laws, regulations, mandatory national standards, technical specifications and the relevant requirements for quality safety and efficacy evaluation stipulated by the State Drug Administration, so as to ensure the scientificity, accuracy and reliability of the efficacy evaluation results.
Article 15 To engage in toothpaste production activities, an application shall be filed with the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government to obtain a production license. The toothpaste filer and the 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.
Sixteenth toothpaste adverse reaction report to follow the principle of suspicious report. Toothpaste producers, operators and medical institutions shall carry out toothpaste adverse reaction monitoring in accordance with the requirements of the cosmetics adverse reaction monitoring system formulated by the State Drug Administration.
Article 17 The toothpaste label shall be marked with the following contents:
(I) product name;
The name and address of the (II) filing person and the entrusted production enterprise, and the name and address of the domestic responsible person shall be indicated at the same time if the filing person is abroad;
The name and address of the (III) production enterprise, and the production license number of the domestic toothpaste shall be marked at the same time;
Standard number of the (IV) product;
(V) total composition;
Net (VI) content;
(VII) period of use;
(VIII) necessary safety warning terms;
Other contents that shall be marked in (IX) with the provisions of laws, administrative regulations and mandatory national standards.
According to the characteristics of the product, if it is necessary to specially mark the use of the product, it shall be marked on the visible surface of the sales package.
Article 18 The name of a toothpaste product generally consists of three parts: trademark name, generic name and attribute name. The attribute name of toothpaste is expressed by the word "toothpaste.
Non-toothpaste products shall not deceive and mislead consumers by marking the words "toothpaste.
Article 19 Toothpaste labels are prohibited from marking the following contents:
(I) content that expressly or implicitly has a medical effect;
(II) false or misleading content;
(III) content that violates social public order and good customs;
Other contents prohibited by (IV) laws, administrative regulations, mandatory national standards and technical specifications.
Article 20 Toothpaste products declared to be suitable for children shall comply with laws, administrative regulations, mandatory national standards, technical specifications and other provisions on children's toothpaste, and shall be marked on the product label in accordance with the provisions of the State Drug Administration.
Policy Interpretation
The product requirements for children's toothpaste are clarified and consistent with the Regulations on the Supervision and Administration of Children's Cosmetics.
Article 21 If toothpaste and the raw materials used do not meet the mandatory national standards, technical specifications, technical requirements specified in the filing materials or the provisions of these Measures, they shall be dealt with in accordance with the relevant provisions of the Cosmetics Supervision and Administration Regulations.
Article 22 toothpaste filers, entrusted production enterprises, operators and domestic responsible persons who commit the following illegal acts shall be dealt with in accordance with the relevant provisions of the regulations on the supervision and administration of cosmetics:
(I) apply for toothpaste administrative license or provide false information for record, or forge, alter, rent, lend or transfer toothpaste license;
(II) engage in toothpaste production activities without permission, or fail to organize production in accordance with the requirements of the cosmetic production quality management standards;
(III) the illegal addition of substances in toothpaste that may be harmful to human health;
(IV) change the duration of toothpaste use;
The (V) fails to publish a summary of the basis for the claim of efficacy in accordance with the provisions of these Measures;
(VI) fails to monitor and report the adverse reactions of toothpaste in accordance with the provisions of these Measures;
(VII) refusing to implement the decision made by the pharmaceutical supervisory and administrative department in accordance with the law to order a recall, order to stop or suspend production and operation;
(VIII) the domestic responsible person fails to perform the obligations stipulated in these Measures, or the overseas toothpaste filer refuses to perform the administrative penalty decision made in accordance with the law.
Article 23 For the supervision and administration of toothpaste, if these Measures do not provide for it, the provisions of the "Cosmetics Registration and Filing Management Measures" and "Cosmetics Production and Operation Supervision and Administration Measures" shall apply.
Policy interpretation:
In the part of legal liability, the measures also lists the specific circumstances in accordance with the regulations on the supervision and administration of cosmetics and the measures for the supervision and administration of cosmetics registration and filing, and the measures for the supervision and administration of cosmetics production and operation, so as to further clarify the main responsibility of enterprises.
Article 24 After toothpaste and new toothpaste raw materials have been registered or put on record, they shall be numbered according to the following rules:
New raw materials for (I) toothpaste: the number of four-digit years for the original note/preparation of national toothpaste. The number of registered/recorded toothpaste raw materials in this year;
(II) domestic toothpaste: provinces, autonomous regions and municipalities directly under the central government are referred to as the four-digit number of years of the national toothpaste net preparation word number of the record product sequence number within the administrative region of this year;
(III) imported toothpaste: the number of four-digit years of the national toothpaste network (referred to as the province, autonomous region and municipality directly under the Central Government where the responsible person is located) is the number of products in the national record this year;
(IV) Toothpaste from Taiwan, Hong Kong and Macao of China: The four-digit number of years in which the national toothpaste network is prepared (referred to as the province, autonomous region and municipality directly under the Central Government where the responsible person is located) counts the number of products in the national record this year.
Article 25 These Measures shall enter into force as of December 1, 2023.