On December 1, the filing of toothpaste was officially implemented. Xiang Jianqiang, chairman of the China Oral Cleaning and Care Products Industry Association, said at the press conference on the implementation of the "Measures for the Supervision and Administration of Toothpaste" held a few days ago that the implementation of the new regulatory model of toothpaste is a milestone event in the industry, which has a positive effect on the comprehensive standardization and high-quality development of the industry. At the same time, experts also interpreted the future development of the toothpaste industry and the efficacy and safety of toothpaste products with high social concern.
The toothpaste regulatory model was formally established
On June 16, 2020, the state promulgated the Regulations on the Supervision and Administration of Cosmetics, which stipulates that toothpaste products shall be managed with reference to ordinary cosmetics, and the national market supervision department shall formulate and promulgate special measures for the supervision and administration of toothpaste according to the characteristics of toothpaste products. Since then, the supervision of toothpaste products has been officially assigned to the Department of Cosmetics Supervision of the State Food and Drug Administration. On March 16 this year, the State Administration for Market Regulation issued the Measures for the Supervision and Administration of Toothpaste in accordance with the Regulations on the Supervision and Administration of Cosmetics, clarifying the requirements for the filing, safety, and efficacy claims of toothpaste products.
According to the Measures for the Supervision and Administration of Toothpaste, on September 25 this year, the State Food and Drug Administration issued the "Announcement on Implementing the Toothpaste Regulatory Regulations and Simplifying the Requirements for the Filing Materials of Listed Toothpaste" (No. 124 of 2023) (hereinafter referred to as the "Announcement"), which explained the implementation of the requirements of the regulatory requirements for toothpaste and the simplification of the requirements for the filing materials of marketed toothpaste products. The "Announcement" clarifies that the content of the label of the toothpaste product for simplified filing shall comply with the requirements of the Regulations on the Supervision and Administration of Cosmetics, the Measures for the Supervision and Administration of Toothpaste and the Measures for the Administration of Cosmetics Labeling, and if only the format of the label needs to be standardized and adjusted, the sales packaging label that has been listed can be used when simplifying the filing, and the product label update shall be completed as required before July 1, 2024. This means that toothpaste products that meet the requirements can continue to use the sales packaging labels that have been marketed until July 1, 2024, and enterprises can continue to consume the packaging materials in stock during the transition period, and should also upload and publish a summary of the basis for product efficacy claims through the filing platform before December 1, 2025.
On November 22, the "Regulations on the Administration of Toothpaste Filing Materials" was officially released, which clarified a series of specific requirements for the filing of toothpaste products. So far, the regulatory model of toothpaste has been formally established, and the filing of toothpaste has been officially implemented on December 1.
"The main features of the new regulatory model for toothpaste include focused comprehensive supervision, taking into account the actual development of the industry and ensuring a smooth transition of the industry. Xiang Jianqiang said that by the end of 2022, a total of 218 toothpaste companies had obtained production licenses across the country, mainly in the southeast of the mainland, of which Guangdong Province accounted for half of the country. "The implementation of the new regulatory model of toothpaste is a milestone event for the industry, especially in the current situation of the rapid increase of small and micro enterprises in the industry and the continuous expansion of online sales, which has a positive effect on the comprehensive standardization and high-quality development of the industry. ”
The "Catalogue of Raw Materials Used in Toothpaste" will be dynamically updated
For the efficacy and safety of toothpaste with high social concern, the "Announcement" also gives clear scientific guidance, requiring that the efficacy claim of toothpaste should have a sufficient scientific basis, and the filing person shall carry out efficacy evaluation as required on the basis of ensuring product safety, and the evaluation methods are generally divided into human evaluation methods and other evaluation methods. The filing materials should have a summary of the efficacy claim evaluation prepared based on the efficacy evaluation results.
Gao Wenying, Ph.D. from the Department of Chemistry at Tsinghua University, believes that "the product safety assessment requirements of the Regulations on the Administration of Toothpaste Filing Materials fully reflect the State Food and Drug Administration's understanding of the industry and in-depth consideration of the applicability of the method. Considering that toothpaste has no previous filing history, enterprises are encouraged to actively collect and confirm the safe use history of relevant raw materials of products that have been listed, and sort out the industry's "Catalogue of Raw Materials Used in Toothpaste", which provides a basis for the safety evaluation of toothpaste products in the entire industry to a certain extent. ”
At the same time, the State Food and Drug Administration has also made it clear that in view of the scientific requirements and the urgency of time, the "Catalogue of Raw Materials Used in Toothpaste" will be a dynamic catalog, and the relevant regulatory authorities will first collect and publish the basic raw materials common to the industry, and gradually expand the raw materials with a safe use history and sufficient scientific basis. Therefore, the use of raw materials by enterprises is not limited to the first batch of raw materials to be announced.
Gao Wenying also emphasized that the toothpaste raw materials in the oral products industry have been implementing the national standard GB-22115 "Specification for Raw Materials for Toothpaste". Therefore, at present, the available range of toothpaste raw materials, as well as the catalog of prohibited and restricted raw materials, have laws to follow, and consumers can use and purchase with confidence.
There is no classification of toothpaste, such as elimination number, machine number, etc
After the establishment of the new regulatory model, is it no longer "foggy" for consumers to buy toothpaste?
In this regard, Xu Chunsheng, deputy director of the Science and Technology Working Committee of the China Oral Cleaning and Care Products Industry Association and president of the Guangzhou Dental Doctor Oral Care Research Institute, said that the new regulations have promoted the development of the toothpaste industry to be more standardized, the products are safer, the efficacy is more scientific, and the competition is more orderly, which has greatly improved the attention of consumers to toothpaste products. However, from a practical point of view, there are still many misunderstandings in the public's understanding of toothpaste, which affects consumers' correct understanding and choice of toothpaste.
Xu Chunsheng said, "The statements of makeup toothpaste, elimination toothpaste, and mechanical toothpaste are incorrect, and there is no such classification of toothpaste." ”
Xu Chunsheng explained that oral products can only be called oral antibacterial cream or oral antibacterial cream. According to the current medical device regulations, oral products are specifically divided into oral anti-caries cream, oral desensitization cream, tooth whitening gel, etc. It is worth noting that the oral products of the elimination brand and the mechanical brand number have a relatively single functional role and a relatively fixed functional component, and the product needs to be registered and approved before it is launched. The main function of toothpaste is to clean teeth and mouth, which can make teeth whiter and less odorous.
In addition, consumers should be assured about the safety of toothpaste ingredients. The safety of toothpaste ingredients is strictly controlled, and in the early years of the mainland, there was a mandatory national standard, namely the "Specification for Raw Materials for Toothpaste", to control the safety of toothpaste ingredients. "The new regulations require that in the filing of toothpaste products, if the formula is all used toothpaste raw materials that have been verified for safety, they can be filed normally. If there is a new raw material, it is necessary to register or record the new raw material first. Among them, preservatives and colorants are high-risk raw materials, which need to be registered and approved, and other types of raw materials can be used after filing. Regardless of whether it is a new raw material for filing or registration, the enterprise must conduct three-year safety monitoring of the corresponding toothpaste products, and provide safety monitoring reports to the local provincial bureau every year. If there is no safety risk after three years of use, it can be officially included in the list of used toothpaste raw materials. Xu Chunsheng further said.
Consumption tips
Gao Wenying, Ph.D., Department of Chemistry, Tsinghua University:
Toothpaste claims don't have to be fixed
The "Provisions on the Administration of Toothpaste Filing Materials" clarifies the classification of the efficacy claims of toothpaste in different user groups: first, the toothpaste used by the general population can be claimed to be clean, anti-caries, anti-dentin sensitivity, anti-plaque and alleviate gum problems; second, children's toothpaste refers to the toothpaste that is claimed to be suitable for children under the age of 12 (including 12 years old), and the efficacy categories that can be claimed for children's toothpaste are limited to cleaning and anti-caries.
Gao Wenying, a Ph.D. in the Department of Chemistry at Tsinghua University, pointed out that the term used in the claim is not limited to a fixed word. For example, the cleaning effect of toothpaste can include claims such as whitening, whitening, fresh breath or reduced bad breath achieved by cleaning, and claims that prevent caries, inhibit plaque, resist dentin sensitivity, and alleviate gum problems can be expressed in different languages without changing the core theme of the effect. For example, anti-caries can also be expressed as preventing tooth decay, and the clinical indicators of reducing gum redness and swelling in reducing gum problems can be expressed as repairing the gums, etc. For example, anti-caries can be expressed according to the experimental mechanism to inhibit tooth demineralization and promote tooth remineralization, and anti-dentin sensitivity can be expressed to reduce the stimulation of tooth cold, hot, sour and sweet and stress.
Industry standards
Xiang Jianqiang, Chairman of China Oral Cleaning and Care Products Industry Association:
The construction of the standard system empowers the high-quality development of the industry
Xiang Jianqiang, chairman of the China Oral Cleaning and Care Products Industry Association, said that toothpaste is a light industrial product. After the founding of the People's Republic of China, toothpaste products have been managed by the national light industry department, and the supervision work is carried out according to relevant laws and regulations according to general industrial products. In March 2000, the State Light Industry Administration was abolished, and the management of the toothpaste industry was changed to self-discipline management by industry organizations in accordance with relevant laws and regulations under the guidance of the China Light Industry Federation and the Ministry of Industry and Information Technology.
Industry organizations attach great importance to the quality and safety of toothpaste products, and have successively promulgated and implemented a number of self-regulatory documents, covering toothpaste and its main upstream and downstream products. At the same time, the industry is also actively promoting standardized management. In 1957, the first ministerial standard for toothpaste products was promulgated. In 1987, the first national standard for toothpaste was promulgated, which has been revised four times. In 2010, with the approval of the National Standards Committee, the National Technical Committee for the Standardization of Oral Care Products and the Sub-Technical Committee for Toothpaste, Chinese Herbal Toothpaste and Toothbrush were established, and the toothpaste standards were rapidly improved. At present, there are 24 national standards, 67 industry standards and 23 group standards in the toothpaste industry, and an industry standard system has been initially formed, which provides a reliable and effective guarantee for the quality and safety of toothpaste products. Xiang Jianqiang said that during this period, some adjustments were also made to the supervision of toothpaste products, such as in 2005, the former General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China included toothpaste in the management of production licenses, and in 2008, the management of toothpaste labeling was included in the scope of cosmetics. "The continuous improvement of the toothpaste industry standard system has played an escort role in the high-quality development of the industry. ”
Author: Shi Xiaofei
Source: The official platform of Consumer Daily
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