Cosmetic Compliance
Intelligence & Solutions

Ensure Compliance with China's New Toothpaste Notification Regulations

Ethan Sun, Rose Hong
Wednesday , 8th Nov 2023
REACH24H; ChemLinked

On September 25, 2023, China National Medical Products Administration (NMPA) issued an announcement regarding the implementation of toothpastes supervision regulations and the simplification of notification document requirements for toothpastes already available in the market. According to the announcement, toothpaste manufacturers whose products have no incidents related to quality and safety, and are with comprehensive evidence of their history of safe usage can undergo simplified notification from October 1, 2023, to November 30, 2023. Products that have completed the simplified notification can continue to be imported and sold after December 1.

On the same day, NMPA released the Provisions for Management of Toothpaste Notification Dossiers. This is the first update to the notification requirements for toothpaste in over two years since the release of the draft Instructions for Toothpaste Notification Dossiers. Compared to the initial draft, the updated version provides more detailed provisions for each notification requirement, aligning closely with the requirements for cosmetics notification management. There have been some additions and deletions regarding the notification application form, basis for product naming, product formula, product labeling, product executive standards, product testing report, product safety assessment documents, and other aspects.

As revealed by the Administrative Measures on Toothpaste, starting from December 1, 2023, domestically produced toothpaste must be notified with the provincial-level drug supervision and administration department in the jurisdiction of the notification applicant before being marketed and sold. Imported toothpaste must be notified with the NMPA before importation. We are now very close to the launch of toothpaste notification management, and gaining a detailed understanding of this draft can provide significant references for preparing the notification documentation. ChemLinked is pleased to present a webinar featuring Rose Hong, sharing toothpaste notification management requirements. This aims to help you understand the requirements and remove compliance barriers.


  • Additionally, we have prepared the same content in Chinese on Oct 30, 2023 (GMT+8) to help stakeholders understand the current toothpaste notification management requirements. If you wish to participate, kindly register by clicking here.

  • To have a better chance of your questions being addressed, you’re welcome to email us the questions before the webinar.


Part 1. Changes in Toothpaste Regulation and Regulatory Framework

Part 2. Main Requirements for Simplified Notification Period

2.1 Basic Information

2.2 Name, formula, and Labeling information

2.3 Relevant information on safe usage history

Part 3. Requirements for Formal Notification

3.1 User authorization information

3.2 Basis for product naming

3.3 Product formula

3.4 Product executive standards

3.5 Product labeling management

3.6 Toxicology testing and efficacy testing

3.7 Product safety assessment documents

*The final outline may be subjected to subtle revision

Contact Information

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  • Cosmetic Regulatory Specialist
    Mr. Sun Bin holds a bachelor's degree in Applied Chemistry from Hainan University and is a member of the Chinese Society of Toxicology. He is primarily engaged in research on Chinese cosmetics regulations and the registration and notification of finished products. He is familiar with the difficulties involved in various types of cosmetics registration and notification. He has provided registration and notification services and regulatory consulting for several large multinational cosmetics companies, with over a thousand registered and notified cosmetic products. He has also conducted online and offline training for numerous cosmetic product manufacturers and raw material companies. His professionalism and sense of responsibility have earned recognition and trust from clients and partners.
  • ChemLinked Regulatory Analyst
    Rose Hong is an analyst in ChemLinked and focusing on track, research and analysis on laws and regulations on the Food and Cosmetics of Japan. She has published several news and news tickers, especially in those sectors: food safety, food additives, beverages, FCM, and food labeling.