China Finalizes Detailed Dossier Requirements for Toothpaste Notification

On November 22, 2023, China National Medical Products Administration (NMPA) unveiled the definitive edition of the Provisions for Management of Toothpaste Notification Dossiers (the Provisions). Shaped by two rounds of public consultations in January 2021 and September 2023, this final version is set to be enforced from December 1, 2023. Comprising 3 chapters, 32 articles, and 3 annexes, the Provisions specifies the responsibilities and obligations of toothpaste notifiers, the user-information-related dossiers, and the necessary documentation for initial toothpaste notification, etc.

Key Highlights

1. Dossiers for User Account Application and Toothpaste Notification

Overall, the documentation required for toothpaste notification largely aligns with those outlined in general cosmetics regulations. Nevertheless, given the unique nature of the toothpaste category, certain items entail specific requirements, notably in terms of toothpaste test reports and efficacy evaluations.

Notification System’s Account Application for Initial Toothpaste Notification

Toothpaste Notification

Notifier information form and the resume of the person in charge of quality and safety;
Overview of the quality management system of the notifier;
Overview of the adverse reaction monitoring and evaluation system of the notifier;
Chinese domestic responsible person’s information form (for overseas notifier);
The original copy of the authorization letter of the Chinese domestic responsible person, and the original notarization (for overseas notifier);
Manufacturer information form and resume of the person in charge of quality and safety (for notifiers engaged in self-production or entrusting overseas enterprises to produce). Notably, for overseas manufacturer, the original copy of the GMP certification documents is also required.

Name, address, and contact information of the notifier;
Name, address, and contact information of the production enterprise;
Product name information;
Product formula;
Product executive standards;
Product label sample;
Product testing report;
Product safety assessment documents.

2. Increased Testing Requirements for Toothpaste Safety and Efficacy

When notifying toothpaste, the notifiers should submit product testing reports, which generally include microbiological and physicochemical testing reports, toxicological testing reports, efficacy evaluation reports, etc. The specific testing criteria for toothpaste differ somewhat from those applicable to general cosmetics, and have largely expanded its coverage compared to the initial toothpaste regulations.

Toothpaste Testing Items	Requirements
Microbiological and Physicochemical Tests	Previously, the microbiological and physicochemical tests for toothpaste followed the national standard GB/T 8372-2017 Toothpaste, including routine microbiological testing items, the detection of heavy metal content like lead and arsenic, and content detection of total fluorine, soluble fluorine or free fluorine. The new Provisions expands on these by introducing tests for heavy metal mercury and cadmium, along with the content detection of hazardous substances such as methanol, dioxane, free formaldehyde, diethylene glycol, and glycol. Detailed testing items and corresponding limits shall comply with Annex 3 "Microbiological and Physical and Chemical Testing Items for Toothpaste Notification" of the Provisions. In terms of the selection of test methods, priority should be given to test methods outlined in the Safety and Technical Standards for Cosmetics.
Toxicological Tests	Three types of toothpaste, including those for children, those containing new ingredients under safety monitoring, and those claiming efficacy of preventing caries, inhibiting dental plaque, resisting dentin hypersensitivity, and alleviating gum-related problems, must undergo oral mucosa irritation tests. A corresponding test report shall be submitted upon the notification. For other toothpaste types, if the producer holds qualification certification related to the production quality management system from local government, and product safety risk assessment can confirm product safety, these toothpaste products can enjoy exemption from oral mucosa irritation testing reports.
Efficacy Evaluation	Toothpaste with different efficacy claims shall undergo different efficacy evaluations. For those claiming efficacy of preventing caries, inhibiting dental plaque, resisting dentin hypersensitivity, and alleviating gum-related problems: Human efficacy evaluation is required due to the associated safety ris. For those achieving caries prevention efficacy through fluoride, and the fluoride content meets the relevant requirements in Annex 3: The efficacy evaluation of preventing caries efficacy can be exempted. For those exclusively claiming cleaning efficacy: Efficacy evaluation can be exempted. For those claiming efficacy beyond cleaning: Human efficacy evaluation or other efficacy evaluation methods are required based on the claims.

3. Relaxed Safety Assessment Requirements for Toothpastes

The safety assessment requirements for toothpaste are somewhat more relaxed compared to cosmetics.

As per the Provisions, toothpaste’s safety assessment should be conducted with reference to the requirements in the Technical Guidelines for Cosmetic Safety Assessment, taking into account the specific characteristics of the toothpaste product. The safety assessment report encompasses summary, product introduction, product formula, safety assessment of each ingredient, assessment of potential risky substances, risk control measures, safety assessment conclusions, resumes and signatures of safety assessors, relevant references, appendices, etc.

The challenge of the safety assessment lies in evaluating each ingredient in the formula. Recognizing that it may be impossible to access the complete basic data of some toothpaste ingredients, and solely confirm the safety of these ingredients through public data, the Provisions allows notifiers to optimize product safety assessment data. This can be achieved through methods such as providing objective proof of a safe usage history exceeding 3 years for the ingredients.

4. Specific Requirements for Children's Toothpaste

Specific guidelines are established for children's toothpaste, encompassing definitions, permitted claims, and labeling warnings.

Children's toothpaste, as defined, is tailored for children of and under 12 years old, whose efficacy claims are limited to cleaning and caries prevention. Any products employing terms like "applicable to all people" or "family use," or utilizing trademarks, patterns, homophones, letters, Chinese pinyin, numbers, symbols, or packaging forms to suggest the inclusion of children as target users, fall under the purview of children's toothpaste.

Children's toothpaste should bear "Caution" or "Warning" as guiding terms. The visible panel of the sales packaging must bear relevant warnings such as "should be used under adult's supervision," "not edible," and "beware of swallowing." Additionally, children's toothpaste containing fluoride should carry a label indicating the single-use limit.

ChemLinked Comments

The Provisions represents a crucial supporting regulation of the Administrative Measures on Toothpaste, detailing the toothpaste notification requirements and offering specific compliance guidance. With the Provisions set to be implemented on December 1, 2023, the toothpaste industry, which has traditionally operated in a regulatory "grey" area, will formally transfer to an era marked by stringent supervision and standardized development.

It is essential to highlight that three pivotal toothpaste categories, including functional toothpastes (which claim efficacy in preventing caries, inhibiting dental plaque, resisting dentin hypersensitivity, or alleviating gum-related problems), children's toothpaste, and toothpaste containing new ingredients, are subject to heightened scrutiny under the new regulation. Their notification requirements surpass those of toothpastes exclusively claiming cleaning efficacy, necessitating, for instance, an oral mucosa irritation test prior to notification. Moreover, the notification process for these categories involves greater investment of both time and cost. Relevant stakeholders are advised to conduct market research and formulate compliance strategies in advance to navigate these changes effectively.