China toothpaste simplified notification information has been announced by the National Medical Products Administration (NMPA). It concerns toothpaste that has already been marketed in China.
Firstly, the announcement no. 124 of 2023, outlines key regulatory measures and requirements for the toothpaste industry, aimed at standardizing supervision and management, ensuring consumer health, and fostering the industry’s healthy development. And secondly, it importantly outlines the simplification of the notification (filing) requirements for toothpaste products that are already marketed in China.
Here’s a comprehensive summary:
Background:
The introduction of measures specific to the notification (filing) of toothpaste products in China is to ensure compliance with existing regulations such as the “Cosmetics Supervision and Administration Regulation” (CSAR) and the “Toothpaste Supervision and Administration Regulation” (TSAR).
1. Implementation of Toothpaste Notification (Filing) Requirements:
- Toothpaste notifiers (filers) must be legally established entities with the capability to monitor and evaluate quality management systems and adverse reactions for their products
- Domestic toothpaste must be notified (filed) with the provincial Medical Products Administration (MPA) (based on the notifier’s location)
- Imported toothpaste must be notified (filed) with the NMPA
- Toothpaste notifiers are responsible for the quality, safety, and efficacy claims of their products. They must ensure the integrity, authenticity, and traceability of notification (filing) materials and data
- The label and related materials in the notification (filing) must comply with existing regulations, including the “Measures for the Administration of Cosmetics Labels”
- Toothpaste notifiers (filers) are encouraged to upload and publish the basis for efficacy claims through the notification (filing) platform, except for toothpaste products claiming only cleaning benefits. Specific requirements apply to children’s toothpaste, including labeling and warning messages to ensure safe use. Children’s toothpaste is a toothpaste claimed to be suitable for children under the age of 12 inclusive. The categories of efficacy that children’s toothpaste can claim are limited to “cleaning”, “anti-caries”. Children’s toothpaste shall be marked with the children’s toothpaste logo on the display surface of the sales package, and the design of the children’s toothpaste logo shall comply with the requirements of the NMPA’s Announcement on Issuing the Children’s Cosmetics Logo (No. 143 of 2021), in which the text part of the logo replaces “Children’s Cosmetics” with “Children’s Toothpaste“. Children’s toothpaste should also be marked on the visual side of the sales package with relevant warning words such as “use under adult supervision”, “not edible”, “beware of swallowing”.
Please note that Toothpaste Notification (Filing) Information Management rules are currently in draft format – click here for the dedicated article on this subject.
2. Simplification of Notification (Filing) Requirements for Toothpaste that is already Marketed in China:
- Toothpaste products with a history of safe use and no quality or safety incidents can simplify their notification (filing) requirements
- Simplified notification (filing) requires:
- Basic information of the person filing the toothpaste. Including the name, address, contact information, etc. of the person filing the ICP. If the production is commissioned, the name, address, contact information, etc. of the actual production enterprise shall also be submitted at the same time;
- Basic product information. Including product name, product formula, product sales packaging label pictures, etc.;
- Relevant materials that prove that the product has a history of safe use. Including but not limited to production and feeding records, sales invoices, inspection reports and other relevant materials since the product was put on the market, as well as the relevant commitments of the filer to product safety and the authenticity of the filing materials.
- The respective MPA or NMPA department will make basic information publicly available within five (5) working days after submission.
- Companies who wish to use the simplified notification (filing) route must take note of important deadlines:
- Simplified notification (filing) must be completed by November 30, 2023
- Label format updates must be completed before July 7, 2024
- Efficacy claim basis must be uploaded and published by December 1, 2025.
- Full notification (filing) materials must be fully completed in compliance with regulations by December 1, 2025
Further information
Read the original article on China toothpaste simplified notification information.
Read our article on the Toothpaste Supervision and Administration Regulation (TSAR).
Read our article on the draft for comments on China Toothpaste Filing Information Management here.
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