China Seeks Public Input on Revised Provisions for Toothpaste Notification Dossiers Management

More than two years after China National Medical Products Administration (NMPA) released the draft Instructions for Toothpaste Notification Dossiers, an updated version was drafted for public comments by the NMPA on September 25, 2023. This new draft, titled Provisions for Management of Toothpaste Notification Dossiers, consists of 3 chapters and 33 articles, covering general provisions, user-information-related data requirements, toothpaste notification data requirements, and more.

The public consultation period for this round will conclude on October 18, 2023. Stakeholders are encouraged to provide their suggestions by emailing the NMPA at [email protected], using "Provisions for Management of Toothpaste Notification Dossiers" as the subject line.

Key Revisions

Compared to the initial draft released on January 6, 2021, the new draft contains significantly less content. Notable changes include the removal of the Classification Catalog of Toothpaste Efficacy, the List of Allowable Efficacy Claim Terms for Toothpastes, and the qualification requirements for toothpaste testing institutions.

Furthermore, the requirements for the necessary toothpaste notification dossiers are also updated, as shown below.

• Product name information
  

The new draft adds provisions pertaining to trade names, generic names, attribute names, suffixes and general interpretations.

The naming basis for toothpaste products must comply with the Administrative Measures on Cosmetics Labeling, which explicitly states that medical effects or the efficacy that the product does not process must not be claimed in the form of a trade name. This suggests that in the future, product names resembling medical-related trade names may not be permitted.

• Product formula

The new draft adds provisions for the use of new toothpaste ingredients, clarifying that “If a new toothpaste ingredient during its safety monitoring period is used, the notifier or the Chinese domestic responsible person shall fill in the registration certificate number or notification number of the new ingredient, submit the authorization document of the new ingredient’s registrant or notifier which allows the use of the new ingredient, and confirm the authorized use information of the ingredient.

The draft also specifies the required format for filling in the formula table of flavor ingredients and outlines the notification requirements for product sets.

• Product labels

The revised draft refines the labeling content, labeling methods, and formats of product label samples, in accordance with the Administrative Measures on Toothpaste and Administrative Measures on Cosmetics Labeling, and removes provisions related to electronic labels.

However, unlike the requirements for cosmetics, the new draft specifies that notifiers of products with packaging boxes must also submit internal packaging plans and stereograms.

• Product testing report

The new draft clarifies that when notifying toothpaste, the notifier should submit a comprehensive product testing report, including microbiological and physicochemical testing report, toxicological testing report, efficacy evaluation report, etc.

To ensure compliance, priority should be given to test methods outlined in the Safety and Technical Standards for Cosmetics for microbiological and physicochemical tests, as well as toxicological tests for toothpaste.

The toxicological testing reports shall include oral mucosa irritation test items. However, the submission of oral mucosa irritation testing reports can be exempted provided the following conditions are all met:

1. The producer has obtained qualification certification related to the production quality management system from the competent government department of the country (region) where it is located. Additionally, the product safety risk assessment can fully confirm the safety of the product.

2. Toothpaste only claims to have cleaning efficacy.

3. The toothpaste is not intended for children, does not contain new ingredients under safety monitoring, and is not associated with a notifier, domestic responsible person, or production company listed as the key supervision target.

Toothpastes that exclusively claim cleaning efficacy are exempt from efficacy evaluation, while other efficacy claims still require efficacy evaluation. Among them, claims related to preventing caries, inhibiting dental plaque, resisting dentin hypersensitivity, and alleviating gum problems necessitate efficacy claim evaluation via human trials.

In addition, the draft introduces three cases where a full set of product testing reports is not required, simplifying the notification process and reducing costs for enterprises. These cases include:

1. Multiple enterprises producing the same product;

2. The use of multiple toothpaste-making processes;

3. Toothpaste products within the same product series notified by the same notifier that only differ in flavor, color, etc.

ChemLinked Comments

This revised draft of toothpaste regulations brings significant improvements to the notification documentation requirements, specifically addressing concerns related to "documents shared by multiple products" and "products designed for the Chinese market" for imported toothpaste.

Previously, companies engaged in the import of toothpaste had relatively fewer obligations due to the absence of specific notification requirements. However, these refinements effectively close previous industry loopholes such as the lack of notification requirements and unclear responsibilities for imported toothpastes. With the tightening of toothpaste supervision in China, the industry is now reshuffling and entering a new era where stricter regulations are imposed on imported toothpastes.