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Zhejiang MPA Announcement on Matters Related to the Filing Management of Domestic Toothpastes

Zhejiang Toothpaste Filing

On September 28, Zhejiang Medical Products Administration (MPA) issued an announcement on matters related to domestic toothpaste filing management, relevant issues are announced as follows:

1. According to the Cosmetics Supervision and Administration Regulations (hereinafter referred to as the Regulations) and the Measures for the Supervision and Management of Toothpastes (hereinafter referred to as the Measures), as of December 1, 2023, the filing person of domestic toothpaste within Zhejiang Province shall before the placing on the market of toothpaste products, complete toothpaste filing through the Toothpaste Filing Information Service Platform and with the Zhejiang MPA, and submit the following complete materials:

1). Name, address, contact information of the filing person;

2). Name, address, contact information of the production enterprise;

3). Product name;

4). Product formula;

5). Product implementation standard;

6). Product label template;

7). Product inspection report;

8). Product safety assessment materials.

The toothpaste filer shall upload and publish the efficacy claim summary based on the literature, research data, or product efficacy evaluation materials through the filing platform while conducting toothpaste filing, and accept social supervision. Toothpaste products that only claim a cleaning effect are exempt from uploading and publishing a summary.

2. From October 1, 2023, to November 30, 2023, the toothpaste filer can submit the following simplified materials through the filing platform for the filing of toothpaste products that are sold on the market:

1). Basic information of the toothpaste filer. Including the filer's name, address, contact information, etc. For entrusted production, the name, address, contact information, etc. of the actual production enterprise should also be submitted at the same time;

2). Basic product information. Including product name, product formula, label images of product sales package, etc.;

3). Relevant materials proving that the product has a safe use history. This includes but is not limited to the production and feeding records, sales invoices, inspection reports, and other relevant information since the product was launched, as well as the filer's commitment to the safety of the product and the authenticity of the filing materials.

For toothpaste products with simplified filing, toothpaste filers shall before December 1, 2025, in accordance with the requirements of the relevant regulations, finish the corresponding product filing materials. If the first batch of products are sold before January 1, 2021, the product filing materials can be kept by the filer for future reference; If the first batch of products are sold after that, the filer shall submit complete filing materials through the filing platform.

For toothpaste products with simplified filing, if labeling content complies with the requirements of the Regulations, Measures, and the Measures for the Administration of Cosmetics Labels, and only the format of the label needs to be standardized and adjusted, sales packaging labels for marketed products can be used during simplified filing, and product label updates should be completed as required before July 1, 2024. Except for toothpaste products that only claim to have cleaning effects, toothpaste products with simplified filing should also upload and publish a summary of the basis of the product efficacy claims through the filing platform before December 1, 2025.

3. The toothpaste filing information service platform was officially launched on October 1, 2023.

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