According to the Cosmetic Supervision and Administration Regulation (CSAR), toothpaste shall be regulated in accordance with the regulations on general cosmetics, and the NMPA will be responsible for the pre-market approval and post-market surveillance of toothpaste. With an aim of implementing this new requirement and standardizing the manufacture, operation, pre-market approval and post-market surveillance of toothpaste, China NMPA has been formulating a regulation on toothpaste.
On November 13, 2020, China NMPA unveiled the regulation for public consultation, which is named as Administrative Measures on Toothpaste. Stakeholders with any comments can send them to the NMPA via email at huazhuangpinchu@163.com before December 12, 2020.
Encompassing 23 articles, the measures mainly
Clarify the responsibilities of all stakeholders
Specify the definition of toothpaste and new toothpaste ingredients
Stipulates the requirements for toothpaste manufacturers and importers, including notification dossiers, toothpaste manufacturing licensing, efficacy evaluation, etc.
Put forward the criteria to determine the regulatory status of toothpaste ingredients and the obligations for different kinds of ingredients.
In addition, the measures stress that matters not specified shall be managed in accordance with the regulations on general cosmetics.
Specifics of the Measures
1. Responsibilities of all stakeholders
Type | Stakeholders | Responsibilities |
Government | NMPA | The supervision and management of toothpaste in China |
Provincial medical products administration departments | The supervision and management of toothpaste in the administrative region, and the management of production licensing and notifications from production enterprises in the administrative region. | |
Medical products administration departments at and above the county level | The supervision and management of toothpaste in the administrative region | |
Enterprise | Toothpaste notifier | Ensure the qualify, safety and compliance of efficacy claim of toothpaste |
Toothpaste manufacturer and operator | Manufacture and operate toothpaste in accordance with the laws, regulations, mandatory standards and technical norms, and ensure the quality and safety of toothpaste | |
Association | Toothpaste association | Strengthen industry self-discipline, and urge and guide manufacturers and operators to engage in manufacture and operation in accordance with the law |
Testing institution | Toothpaste efficacy evaluation institution | Ensure the qualification for efficacy evaluation in accordance with the requirements prescribed, independently carry out the toothpaste efficacy evaluation, and be responsible for the evaluation results |
2. Requirements for toothpaste
2.1 Definition
Toothpaste refers to the solid and semi-solid preparation applied to the teeth surface of human and surrounding tissues by friction for the purpose of cleansing, beautifying and protecting.
2.2 Manufacturing requirements
The manufacture of toothpaste shall meet the requirements for plants specified in the Cosmetic Good Manufacturing Practices for Cosmetics. Prior to manufacture, companies shall submit documents to the local MPAs for obtaining a license. After a review of the documents and on-site inspection, the local MPA will issue a license to compliant companies. With the license, companies are permitted to start manufacturing.
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