The latest official interpretation-toothpaste supervision and management measures.

Release time:

2023-05-05 09:17

The Measures for the Supervision and Administration of Toothpaste promulgated by Order No. 71 of the State Administration for Market Regulation on March 16, 2023 will be implemented on December 1, 2023. In order to help toothpaste filers better understand and master the requirements of the "measures", the Beijing Cosmetics Evaluation and Inspection Center specially compiled a "one question and one answer (toothpaste special issue)" to publicize the relevant contents to guide toothpaste filers to prepare in advance.
Question 1: What is the definition of toothpaste?
Answer: According to Article 3 of the "Toothpaste Supervision and Management Measures", toothpaste refers to a paste product that is applied to the surface of human teeth by friction and is mainly used for cleaning. The definition reiterates that the mode of action of toothpaste is auxiliary friction, the site of action is the surface of the teeth, and the purpose of use is mainly to clean, which is basically consistent with people's daily understanding of toothpaste products. From this definition, it can be seen that the material properties of toothpaste products are limited in the measures, which must be "paste", and tooth powder, tooth cleaning gel, mouthwash and other oral care products do not belong to toothpaste.
Question 2: Does toothpaste need to be filed?
A: Toothpaste needs to be filed before it is listed or imported. According to Article 10 of the measures for the Supervision and Administration of toothpaste, domestic toothpaste shall be filed with the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the holder is located before it is put on the market. 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.
Question 3: What information is required for toothpaste filing?
Answer: According to Article 11 of the Measures for the Supervision and Administration of Toothpaste, the filing person or the domestic responsible person shall submit the following materials for toothpaste filing:
The name, address and contact information of the filer;
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.
Question 4: From the perspective of "Toothpaste Supervision and Management Measures", how should toothpaste be declared effective?
Answer: According to Article 13 of the "Toothpaste Supervision and Management Measures", the efficacy of toothpaste claims should have sufficient scientific basis. 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.
Question 5: What should be on the toothpaste label?
Answer: According to Article 17 of the Measures for the Supervision and Administration of Toothpaste, 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.
Question 6: How is toothpaste named?
Answer: The name of 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.
Question 7: What is forbidden on toothpaste labels?
Answer: According to Article 19 of the Measures for the Supervision and Administration of Toothpaste, the following contents are prohibited on toothpaste labels:
(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.
Question 8: What is the numbering rule for toothpaste filing?
Answer: According to Article 24 of the Measures for the Supervision and Administration of Toothpaste, after toothpaste and new toothpaste raw materials are registered or filed, they will 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.
Special reminder:
According to the requirements of the announcement of the State Food and Drug Administration on the issuance and implementation of the Measures for the Administration of Cosmetic Labels (No. 77, 2021), if the cosmetics filed before May 1, 2022 are not labeled in accordance with the provisions of the Measures for the Administration of Cosmetic Labels, the cosmetic filer must complete the updating of the product labels before May 1, 2023, to ensure that the labels of products on the market after May 1, 2023 comply with the regulations and requirements of the Measures for the Administration of Cosmetics Labels.