China’s Toothpaste Supervision & Administration Regulation was released last week by the State Administration for Market Regulation (SAMR). The Measures standardize the production and operation of toothpaste, with the aim of ensuring quality, safety, and efficacy, protecting consumers’ health, and promoting the healthy development of the industry. In this article, we’ll give you an overview of the key points you need to know as a regulatory affairs professional in cosmetics.
Scope of the Measures
The Measures apply to toothpaste production and trading activities, as well as their supervision and management, within the territory of the People’s Republic of China. They define toothpaste as paste-like products that are applied to the surface of human teeth by friction with the main purpose of cleaning. If you are involved in the production or trading of toothpaste in China, you will need to comply with the requirements of the Measures which come into effect on December 1, 2023.
Toothpaste Filing and Registration Requirements
One of the key requirements of the Measures is that toothpaste must be subject to filing or registration, depending on whether the toothpaste is categorized as general or special cosmetics. The filer or registrant of the toothpaste is responsible for the quality, safety, and efficacy claims of the toothpaste.
If you are an overseas toothpaste filer or registrant, you will need to designate an Domestic Responsible Agent within China as the responsible person to handle the filings or registrations, monitor adverse toothpaste reactions, implement product recalls, and cooperate with the NMPA’s supervision and inspection department.
New Raw Materials
If you are using natural or artificial raw materials in toothpaste for the first time within China, these are considered new raw materials for toothpaste. You will need to ensure that these raw materials are safe and comply with the relevant regulations.
Imported toothpaste must be filed or registered with the NMPA before import. If you are involved in importing toothpaste into China, you will need to ensure that you comply with this requirement.
Production Quality Management System
To ensure the quality and safety of toothpaste, the filer, registrant or entrusted manufacturer must establish a production Quality Management System (QMS) and organize production in accordance with the requirements of China’s Cosmetic’s Good Manufacturing Practice (GMP). If you are involved in toothpaste production in China, you will need to ensure that you have a robust quality management system in place.
If any adverse reactions to toothpaste are reported, the principle of suspicious reporting applies. This means that any suspected adverse reactions should be reported promptly to the NMPA via the National Cosmetic Adverse Reaction Monitoring System.
Penalties for Illegal Acts
Finally, the Measures set out a range of penalties for illegal acts related to toothpaste production and operation. These illegal acts include providing false information when applying for an administrative license or handling filings and registrations, illegally adding substances to toothpaste that may endanger human health, and failing to publish a summary of the basis for efficacy claims. If you are involved in toothpaste production or operation in China, you will need to ensure that you comply with all relevant regulations and guidelines to avoid these penalties.
China’s new Toothpaste Supervision & Administration Regulation is designed to promote the healthy development of the toothpaste industry while ensuring quality, safety, and efficacy for consumers. As a regulatory affairs professional in cosmetics, it’s essential to stay up-to-date with these regulations and guidelines to ensure that your products comply with all relevant requirements.
Read the original SAMR announcement (No.71-2023) on China’s Toothpaste Supervision & Administration Regulation.
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We offer comprehensive services to help you navigate the complex regulatory landscape in China, including cosmetics filing & registrations, adapting your Quality Management System to China’s GMP standards, adverse reaction monitoring, and more. Our team of experts is well-versed in the latest regulations and can help ensure the quality, safety, and efficacy of your toothpaste products.