China Toothpaste Notification: Overview and Notification Procedures
This article provides an overview of the regulations for toothpaste in China, including the recent changes in regulations and the notification requirements for toothpaste products.
Overview of Toothpaste Notification in China
In June 2020, the Cosmetic Supervision and Administration Regulation (CSAR) was officially released, which included toothpaste as a regulated product under the regulations for general cosmetics. The National Medical Products Administration (NMPA) then regulates toothpaste before and after it is launched in the market.
Children’s toothpaste is regulated under the Supervision and Administration Provisions on Children Cosmetics, which was released in October 2021. Therefore, children’s toothpaste also needs to be notified as children’s cosmetics and labeled with a special mark to signify that the product is intended for use by those under 12 years old.
From December 1, 2023, the Administrative Measures on Toothpaste (hereinafter referred to as the Measures) issued by China’s State Administration for Market Regulation (SAMR) will come into effect. These measures clarify toothpaste’s definition, regulatory methods, responsible entities, allowable efficacy claims, and notification requirements.
Definition of Toothpaste
Under the Measures, toothpaste is defined as a paste preparation applied to the surface of human teeth by friction for cleansing.
What is Enterprise’s Obligation?
Enterprises producing or operating toothpaste products in China must ensure compliance with the Measures, including notifying their product formulas and labels before launching their products on the market.
Procedures of Toothpaste Notification in China
Notification of Toothpaste
The process for notifying toothpaste is similar to that of general cosmetics.
Domestic toothpaste must be notified to the medical products administration departments of the provinces, autonomous regions, or municipalities directly under the Central Government where the notifier is located before being marketed. Imported toothpaste must be notified with the NMPA before import.
To notify toothpaste, the notifier or the domestic responsible person must submit the following documents:
- name, address, and contact information of the notifier,
- name, address, and contact information of the manufacturer,
- product name,
- product formula,
- executive standard,
- label sample manuscript,
- testing report,
- safety assessment documents.
When notifying imported toothpaste, it is necessary to submit certification documents that demonstrate that the product has been sold in the producing country (region) and that the overseas manufacturer complies with Good Manufacturing Practices (GMP) for Cosmetics. These documents must be submitted at the same time as the toothpaste notification.
If the toothpaste product is produced exclusively for export to China and certification documents proving that the product has been sold in the producing country (region) cannot be obtained, the notifier must submit relevant documents of research and testing conducted based on Chinese consumers.
Requirements of Toothpaste Label
Toothpaste labels should indicate:
- product name,
- name and address of the notifier, and the domestic responsible person (for an overseas notifier),
- name and address of the manufacturer, and the production license number (for domestic toothpaste),
- executive standard number,
- full ingredients,
- net content,
- necessary safety warnings,
- other contents required by laws, administrative regulations, and mandatory national standards.
If necessary, the use method of the product should be marked on the visible panel of the sales package.
Prior to notification of toothpaste, the notifiers should carry out safety assessments on their own or by entrusting a professional institution. Personnel engaged in the safety assessment of toothpaste should have over 5-year relevant work experience and master professional knowledge related to the quality and safety of toothpaste or cosmetics.
How Can REACH24H Help
At REACH24H, we leverage our extensive experience in cosmetics compliance and our accurate interpretation of regulations to help clients achieve compliance with toothpaste ingredient and labeling requirements. Our team of cosmetic safety assessors and toxicologists conducts scientific safety assessments of toothpaste products objectively and efficiently, providing reasonable reports to our clients.
- Formula and Labeling Reviews
- Toothpaste Notification
- Safety Assessment