China Simplifies Notification Document Requirements for Marketed Toothpastes

Unmarketed toothpastes

Starting from December 1, 2023

• For Chinese domestic toothpastes, the notifier is required to apply to provincial MPA for notification prior to selling;

• For imported toothpastes, the notifier must apply to NMPA for notification prior to importation.

1) Reference for notification document preparation

The preparation of notification documents for toothpastes can be guided by the Instructions for Toothpaste Notification Dossiers (open for public opinions from September 22 to October 18, 2023).

2) Notification Process

The management department responsible for toothpaste notifications shall organize and conduct the work in line with the general cosmetics notification procedures.

3) Labeling

The toothpaste notification documents   should include a sample of the product label that complies with the requirements outlined in the Cosmetic Supervision and Administration Regulation (CSAR), Administrative Measures on Toothpastes and Administrative Measures on Cosmetics Labeling.

4) Efficacy

Notifiers of the toothpastes that solely claim cleaning efficacy are not required to upload and publish the summary of the basis for the efficacy claim.

Toothpastes already on the market

From October 1, 2023 to November 30, 2023

1) First, conduct a label compliance check. If the label content does not meet the requirements set forth in the relevant regulations for cosmetics and toothpaste (excluding format issues), the label must be adjusted accordingly;

2) Proceed with a simplified notification process by submitting the basic information of the notifier and the product, along with relevant   documentation demonstrating the product's history of safe usage.

Simplified Notification Documents:

• Basic information of the toothpaste notifier: The notifier's name, address, contact information, and, if applicable, the name, address, and contact information of the actual production enterprise if the production is commissioned;

• Basic information of the product: The product name, product formula, and pictures of the product sales packaging label, etc.;

• Supporting documents demonstrating the product's history of safe use: Production and material input records, sales invoices, testing reports, other relevant evidence since the product was introduced to the market, the notifier's commitment to product safety, and the authenticity of the notification documents.

Before July 1, 2024

If the product label only has formatting issues, it should be updated in accordance with the regulations.

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Before December 1, 2025

If the simplified notification has been   completed and the first batch of products has been put on sale before January 1, 2021, the notifier is required to compile the remaining notification documents and keep them for future reference.

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If the simplified notification has been   completed and the first batch of products were put on sale after January 1, 2021, the notifier must submit complete notification documents through the notification platform.

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For toothpaste that has undergone simplified notification and claims an efficacy other than cleaning, the notifier must upload and publish a summary of the basis for the product's efficacy claim through the notification platform.

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