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China Toothpaste Regulations Unveiled: Follow a Comparable Management Scheme of Cosmetics

China NMPA released the draft Administrative Measures on Toothpaste for public consultation until December 12, 2020. Toothpaste will be subject to a comparable management scheme of cosmetics, requiring notification, testing, safety assessment, efficacy evaluation, new ingredient application, etc.

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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