Analysis of the Toothpaste Products Supervision in China

At present, the major oral care products on the market include toothpaste, mouthwash and oral. Among them, the supervision on toothpaste is relatively comprehensive. On June 29, 2020, the State Council issued the Regulations on the Supervision and Administration of Cosmetics which made it clear that the pre-market as well as post-market supervision of toothpaste are handed over to the National Medical Products Administration (NMPA) and that toothpaste shall be managed as ordinary cosmetics. On November 13, 2020, the NMPA issued the Toothpaste Supervision and Management Measures (Draft), clarifying the basic principles and requirements of toothpaste supervision. On January 6, 2021, NMPA publicly solicited comments on the Specification for Toothpaste Filing Data (Draft).

After being regulated as cosmetics, toothpaste products are subject to product filing, raw material filing/ registration, product efficacy claims, efficacy evaluation, etc., in addition to the existing production license management.

Timeline

• In 1984, upon approval of the former National Economic Commission, China Toothpaste Industry Association was established, starting to formulate guiding policies for the toothpaste industry and guide the production of toothpaste according to the standards of the former Ministry of Light Industry.
• In 1987, GB 8372-1987 Toothpaste (GB8372-1987) drafted by the former Ministry of Light Industry was approved. It is the first national standard for toothpaste products in China. The prevailing standard is GB/T 8372-2017 Toothpaste.
• In 2001, China Toothpaste Industry Association drafted the Production Management Standards for Toothpaste Enterprises as a self-regulatory document of the industry.
• In 2005, China Toothpaste Industry Association changed its name to China Oral Care Industry Association. Enterprises that involved in the other oral care and cleaning products such as mouthwash and toothbrush also joined the association.
• In 2006, China Oral Care Industry Association drafted the Implementation Rules of Toothpaste Product Production License. The Implementation Rules were approved and issued by the former General Administration of Quality Supervision. According to the requirements of the Implementation Rules, toothpaste products are subject to the management of national manufacturing license and its manufacturers should be issued with a National Industrial Product Production License (toothpaste).
• In 2007, the former General Administration of Quality Supervision issued the Provisions on the Management of Cosmetics Labels, in which it is clear that labels of toothpaste product should also conform to the Provisions.
• In 2008, China Oral Care Industry Association drafted and published the Standards for Toothpaste Raw Materials (GB22115-2008) and Functional Toothpaste (QB2966-2008), both of which are important in guiding safety management and efficacy development of toothpaste industry.
• In 2010, the former Ministry of Health issued the Efficacy Evaluation of Toothpaste (WS/T326-2010), which standardized the principles, methods, and standards for efficacy evaluation of toothpaste products.
• In 2016, the former China Food and Drug Administration (CFDA) formulated the Work Standards for Cosmetics Production Licensing, under which the toothpaste production is subject to the supervision of cosmetic regulations. The Cosmetics Production License shall be issued to toothpaste manufacturing enterprises.
• In 2018, with a new round of institutional reform, NMPA was established to continue the function of the former CFDA on toothpaste.
• In 2020, the Cosmetics Supervision and Administration Regulations were issued, making it clear that toothpaste should be managed as ordinary cosmetics. Based on Article 16 of the Measures for the Supervision and Administration of Cosmetics Production and Operation, the management and operation of toothpaste products shall comply with the Measures. According to Article 66 of Cosmetics Production Quality Management Standard, the quality of toothpaste products are under the administration of the Standard.

Management Trend

Toothpaste Raw Material

Standardization Administration China issued the General Requirements on Raw materials of Toothpastes (GB22115-2008) on June 27, 2008. This standard specified the requirement for toothpaste raw materials. It is clearly mentioned in the standard that the raw material used to produce toothpastes should ensure the safety of the finished products. That is to say, in the normal and reasonable and foreseeable use conditions, toothpaste should not do harm to the human health. The standards also stated the 1466 prohibited components, 39 restricted components, 48 allowed preservatives and 102 allowed pigments.

NMPA issued the Measures for Toothpaste Supervision and Administration (Draft for Comments) on November 13, 2020, which defined new toothpaste raw materials and formulated the judgment basis. The Measures also put forward the management requirements for used toothpaste raw materials.

Article 8 of the Measures for Toothpaste Supervision and Administration (Draft for Comments) specifies that natural or artificial raw materials used in toothpaste for the first time in the territory of the People's Republic of China are considered as toothpaste new raw materials. National Regulatory Authority (NRA) shall formulate and publish Inventory of Existing Toothpaste Ingredients in China, which served as the basis for the determination of toothpaste new raw materials, based on the use condition of toothpaste raw materials. If a toothpaste new raw material is to be used in toothpaste production, a proposal on the formulation of safety technical standards for the raw material shall be put forward. The new raw material can be used in toothpaste product only after it is listed into mandatory national standards and technical specifications. If food additives or food raw materials that fall within the administration of relevant national standards are used for toothpaste production for the first time, they shall not be managed as toothpaste new raw materials. When the toothpastes using the aforementioned raw material are submitted for filing, the safety assessment report of the raw material used in the toothpaste shall be provided. Up to now, China has not released any regulations on the declaration of toothpaste new raw materials.

Article 9 of the Measures for Toothpaste Supervision and Administration (Draft for Comments) specifies that raw materials that have been included in the Inventory of Existing Toothpaste Ingredients in China shall used in a reasonable manner by the toothpaste producers and operators according to the mandatory national standards, technical specifications and the requirements of Inventory of Existing Toothpaste Ingredients in China. Article 19 points out that those who fail to use toothpaste raw materials under the requirements of the compulsory national standards, technical specifications, and the Inventory of Existing Toothpaste Ingredients in China shall be punished in accordance with Article 60 of the Cosmetics Supervision and Administration Regulations.

To implement the Cosmetics Supervision and Administration Regulations and further standardize the management of toothpaste raw materials, the Department of Drug and Cosmetics Supervision under NMPA commissioned China Oral Care Industry Association to collect the information of all the raw materials of toothpastes that were put on Chinese market before 31 Jul. 2020. (See Drug Administration Cosmetic Letter [2020] No.76 "on the commissioning of the collection of raw materials used in toothpastes"). Up to now, the Inventory of Existing Toothpaste Ingredients in China has not been released.

Toothpaste Filing

The Notice of NMPA on the implementation of the Cosmetics Supervision and Administration Regulations (No. 144, 2020) points out that before the release and implementation of the supporting regulations on the supervision and administration of toothpaste, NRA shall supervise and administer toothpastes by the existing regulations.

GB/T 8372-2017 Toothpaste applies to toothpaste used for cleaning and nursing the oral cavity. It specifies the terms and definitions, requirements, test methods, inspection rules, marking, transportation, and storage of toothpastes.

In November 2020, NMPA issued the Measures for the Supervision and Administration of Toothpaste (Draft), which defines toothpaste as solid or semi-solid preparations applied to the surface and surrounding tissues of human teeth by friction for the purposes of cleaning, beautification, and protection. The toothpastes are not allowed to put on Chinese market or imported unless they are approved for filing by NRA. The toothpaste filers shall be responsible for the quality safety and efficacy claims of their toothpaste products.

The Measures for Toothpaste Supervision and Administration (Draft for Comments) consists of six chapters with a total of 53 articles. The Measures specify the requirements for user information-related materials, requirements for filing materials, requirements for change and cancellation, etc., to standardize the management of toothpaste filing and ensure the standardized submission of all materials for toothpaste filing.

According to the Measures for Toothpaste Supervision and Administration (Draft for Comments), toothpaste filers shall submit Toothpaste Filing Information Sheet and related materials, the basis of product naming, product formula, product implementation standards, product label samples, product test report and product safety assessment materials, seven items in total, when handling filing. Certain testing items shall be completed by inspection and testing institutions that are accredited by China Metrology Accreditation (CMA) with corresponding inspection capabilities. The inspection reports of toothpaste products shall include microbial, physical, and chemical tests and other safety test reports. For toothpaste with a pH value lower than 5.5, relevant filers shall provide a report on the safety evaluation of oral hard tissues (including enamel and dentin) by inspection and testing institutions designated by the NMPA.

Efficacy Management

On October 30, 2019, China Oral Care Industry Association issued the Instructions on Efficacy Claims of Toothpaste Products (Temporary).

• Efficacy claims of toothpaste products shall comply with the requirements of Advertisement Law of the People's Republic of China. Contents of the claim shall be true and legal, and expressed in a healthy manner. Medical terms or terms that can easily make consumers confused by mistaking toothpaste products for drugs or medical devices shall not be used. It is not allowed to use false or misleading information to deceive or mislead consumers.
• Under GB/T8372-2017, the basic functions of toothpaste are cleaning the mouth, reducing tooth stains, flossing the teeth, whitening teeth, reducing dental plaque, refreshing breath, refreshing taste, maintaining the health of teeth and periodontal tissues (including gums), and maintaining oral health. Toothpaste products making the above claims should be regarded as compliance with relevant national standards.
• Toothpaste with functions of preventing caries, inhibiting dental plaque, anti-dentin sensitivity, alleviating gingival problems, removing stains and whitening, anti-calculus, and reducing halitosis should be tested in accordance with Functional Toothpaste (QB/T 2966-2014) and Efficacy Evaluation of Toothpaste (WST 326-2010) promulgated and implemented by the former Ministry of Health to ensure the efficacy Claims of the aforementioned toothpastes are consistent with testing results. When necessary, related enterprises shall provide the testing report to competent authorities as the basis for efficacy claims. In addition, toothpastes that have been evaluated for the function of solving oral problems" shall be verified for other efficacies they have claimed according to the general requirements and method of Efficacy Evaluation of Toothpaste (WST 326-2010). The results shall be submitted to the industrial expert team for comments.

Efficacy claims will be the focus of further regulations. The Measures for Toothpaste Supervision and Administration (Draft for Comments) point out that toothpaste efficacy claims should be made with sufficient scientific basis. The toothpaste filers can only be approved for filing after they have completed the product efficacy evaluation. The abstract of efficacy evaluation basis should be submitted to a specific website for filing designated by NMPA, open to the public. The efficacy of toothpaste is classified into 9 categories: basic cleaning, anti-caries, anti-plaque, anti-dentin sensitivity, gingival problems easing, whitening, anti-calculus, halitosis reducing, and others. Terms of toothpaste efficacy claims are fixed and shall not add, delete or adjust at will when using. At the same time, the toothpaste users were divided into two groups: adults and children (6 months to 12 years old). The children’s toothpaste can only claim basic cleaning and anti-caries efficacy. Efficacy evaluation shall be carried out for toothpastes with functions other than basic cleansing care.

The following table shows the existing industry standards for the nine efficacy categories of toothpastes:

Number 1	Category	Related Standards
01	Basic Cleaning	/
02	Anti-caries	WS/T 326.1-2010 Efficacy Evaluation of Toothpaste Part1：General WS/T 326.2-2010 Efficacy Evaluation of Toothpaste Part2：Anti-caries WS/T 326.3-2010 Efficacy Evaluation of Toothpaste Part3：Inhibit dental plaque and/or reduce gum inflammation WS/T 326.4-2010 Efficacy Evaluation of Toothpaste Part4：Anti-dentin sensitivity
03	Anti-plaque
04	Anti-dentin sensitivity
05	Gingival problems easing
06	Whitening	T/COCIA 7-2020 Oral hygiene care products Efficacy Evaluation of Toothpaste Laboratory evaluation method for removal of exogenous stains T/COCIA 10-2020 Oral hygiene care products Efficacy Evaluation of Toothpaste Clinical methods of anti-calculus effect T/COCIA 9-2020 Oral hygiene care products Efficacy Evaluation of Toothpaste Clinical method of anti-halitosis effect ……
07	Anti-calculus
08	Halitosis reducing
09	Others

It is worth mentioning that some toothpastes on the market claims that they have the function of "anti-pylori helicobacter", "removing halitosis by eradicating pylori helicobacter”, etc, in fact, many of these products are not toothpastes. The Toothpaste Cannot Cure Disease issued by NMPA points out there is no evidence that using toothpaste to brush your teeth can eradicate the helicobacter pylori, which mainly exist in one’s stomach. There is no medical evidence to support the correlation between oral helicobacter pylori and digestive diseases including periodontal disease, halitosis, gastric cancer. Products claiming to have the function of "anti-helicobacter pylori " may add broad-spectrum antibacterial agent. Long-term and extensive use of broad-spectrum antibacterial agents may lead to disorder of oral bactria, which is bad for oral health.

As most toothpaste related regulations have not been implemented, the above information is collected based on the current toothpaste regulations, as well as the draft of cosmetics regulations and toothpaste regulations released for public comments. Details are not clear for the time being. But as China continues to step up its supervision on toothpaste products and an increasing number of rules and regulations regarding the administration of toothpaste products are to be released, there is no doubt that the toothpaste industry in China will gradually be standardized and systematic.

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