Just under 10 days before the implementation of the new toothpaste filing regulations, today (November 22nd), the National Medical Products Administration officially released the “Regulations on the Management of Toothpaste Filing Information” (Regulation). The Regulation provide clear requirements for the materials, user information, and inspection items for toothpaste filing. The regulations will be effective from December 1st, 2023.
At the same time, CHAILEEDO has noticed that a batch of Chinese and imported toothpastes have already been filed. According to the previous regulations, companies only need to provide simplified filing information before December 1st, leaving limited time for companies to comply.
Full ingredient labeling and transparency required for toothpaste
On March 23rd of this year, the National Medical Products Administration released the “Measures for the Supervision and Administration of Toothpaste,” which provided clear requirements for the definition of toothpaste, new toothpaste ingredients, filing, and efficacy evaluation. This marked the official era of toothpaste filing.
It can be said that the release of Regulation is based on the “Measures for the Supervision and Administration of Toothpaste” as secondary regulations. It is understood that Regulation consist of three main chapters with a total of 32 detailed provisions. In addition, there are three attachments, including instructions for formulating toothpaste product standards, toothpaste product standards (samples), and requirements for microbiological and physicochemical testing for toothpaste filing. These attachments clarify the requirements and document formats for toothpaste filing.
It is worth noting that in addition to the specific requirements for toothpaste filing-related information, the Regulation also mention that when filing toothpaste, the filer should submit product inspection reports, which generally include microbiological and physicochemical test reports, toxicology test reports, efficacy evaluation reports, etc.
Furthermore, toothpaste labels should indicate the standardized Chinese names of all ingredients in the toothpaste in a visible area on the sales packaging. If there are ingredients in the formulation with a content not exceeding 0.1% (w/w), all such ingredients should be indicated as “other trace ingredients” and can be listed in any order without following the descending order of ingredient content.
For formulations reported in the form of compound or blended ingredients, the content of each ingredient in the formulation should be used as the basis for sorting the ingredient content and determining whether it is a trace ingredient. Auxiliary ingredients such as water and volatile solvents that are used in the production process but removed in subsequent production steps, as well as very small amounts of stabilizers, preservatives, antioxidants, etc., added to ensure the quality of raw materials, do not need to be listed in the full ingredient list.
In other words, similar to cosmetics, full ingredient labeling is also required for toothpaste filing.
It is worth noting that the Regulation also stipulate that toothpaste containing fluoride should indicate the amount of fluoride added. Toothpaste claiming to have efficacy in preventing tooth decay, inhibiting dental plaque, alleviating tooth sensitivity, and reducing gum problems should clearly define the control range of efficacy ingredients and submit corresponding test reports. The specific efficacy components should also be labeled on the packaging.
This regulation indicates that toothpaste claiming to have efficacy in preventing tooth decay, inhibiting dental plaque, alleviating sensitivity, and reducing gum problems requires human efficacy evaluation. In addition, toothpaste that only claims cleaning efficacy is exempt from efficacy evaluation.
Toothpaste also requires safety assessment
The complete version of safety assessment for cosmetics will be officially implemented on May 1st next year, which has become the industry’s biggest challenge at present. It is worth noting that the Regulations also explicitly require that “the filer should refer to the relevant principles and requirements of the ‘Technical Guidelines for Cosmetic Safety Assessment,’ combine the actual situation of toothpaste products, conduct product safety assessment scientifically and reasonably, and submit a product safety assessment report.”
This means that toothpaste filing also requires the submission of a product safety assessment report. However, the specific implementation time is not clear, and it is also unclear whether there will be a transition period or synchronization with the implementation of the complete version of cosmetic safety assessment.
According to the Regulations, the safety assessment report for toothpaste needs to assess the safety of each ingredient in the toothpaste formulation, including but not limited to the summary, product introduction, product formulation, safety assessment of each ingredient in the formulation, evaluation of potential risk substances, risk control measures, safety assessment conclusion, resumes and signatures of safety assessors, relevant references, appendices, etc.
However, compared to cosmetics, the requirements for safety assessment of toothpaste are somewhat relaxed. The Regulations state that if the safety of formulation ingredients cannot be confirmed through publicly available data, companies can also conduct assessments through one of the following three methods: “providing objective evidence of safe use history for over three years,” “providing toxicological endpoint assessment data that supports the safety of formulation ingredients at the formulation usage level,” or “conducting toxicological tests such as acute oral toxicity tests, mutagenicity tests, sensitization tests, etc.”
It is worth mentioning that the Regulations also require that toothpaste intended for children’s use, toothpaste claiming efficacy in preventing tooth decay, inhibiting dental plaque, alleviating tooth sensitivity, reducing gum problems, and toothpaste using new ingredients still under safety monitoring must undergo oral mucosal irritation test. This indicates that the aforementioned three types of toothpaste can only be filed after undergoing the oral mucosal irritation test.
Seeing the first wave of toothpaste filing
As early as September 25th this year, the National Medical Products Administration issued Announcement No. 124 of 2023, titled “Regarding the Implementation of Toothpaste Regulatory Regulations and Simplification of Requirements for Marketed Toothpaste Filing Materials” (referred to as the “Announcement”), which clearly stated that for products with a certain production, sales, and usage history and no quality and safety-related incidents, toothpaste filers can submit simplified filing materials for marketed toothpaste products from October 1st, 2023, to November 30th, 2023.
Now, less than 10 days remain until the deadline for this regulation, and as a result, many toothpaste brands are actively filing for their existing products. Cheng Yingqi, the founder of Bingquan, stated that the deadline for filing existing products is approaching, and the brand is currently actively undergoing the filing process.
CHAILEEDO has noticed that the first batch of toothpaste filing has already taken place. When searching for the keyword “牙膏” (toothpaste), a total of 99 records are displayed. It can be seen that some products from brands such as Colgate, Ora2, O-ZONE, and GUM have been filed.
Based on the filing dates, the first batch of toothpaste filing mainly occurred in November, with only a few products showing filing dates in October. For example, Colgate Renewal Whitening Toothpaste, filed by Colgate-Palmolive Company, was filed on October 25th. According to the filing information, in addition to the basic information of the filing company, it also includes the full ingredient information of the toothpaste, but no efficacy evaluation-related information has been seen yet.
It is worth mentioning that according to the “Cosmetic Query” section on the official website of the National Medical Products Administration, toothpaste filing is now classified under the original category of “Imported General Cosmetics,” with the category name displayed as “Imported General Cosmetics (including toothpaste) filing information.”
Industry insiders have revealed that “the information for Chinese toothpaste filing has not yet been integrated with the information for Chinese cosmetic filing, but it is expected that they will be integrated in the future.”
Furthermore, the Announcement also states that “former products only need to provide simplified filing materials, and the efficacy summary can be extended until 2025.” Therefore, there is no immediate need to supplement the efficacy summary for old products before December 1st this year.
The statements of several third-party organizations also confirm this phenomenon. Luo Qinghuan, the Chief Operating Officer of Zongpu Consulting, told CHAILEEDO, “There are not many companies currently conducting efficacy evaluations for toothpaste. Everyone is rushing to prepare the simplified filing materials.” Shu Tingting, the General Manager of Zhejiang ZMUni, also stated, “There are many brand clients currently filing for toothpaste.”
Furthermore, regarding whether toothpaste brands that previously included the word “药”(Medicine) in their names can be successfully filed, most industry professionals are in a wait-and-see state. Some industry professionals believe that they can be filed normally, stating, “Perhaps they have already been exempted.” One industry insider, who preferred to remain anonymous, said.
It can be seen that after December 1st, the toothpaste market will undergo a reshuffle. Not only do former products need to complete the “materials” before this date, but new products will also face new filing requirements starting from this day. From then on, the toothpaste industry will enter a new competitive cycle.
