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CSAR Subsidiary Regulations: China Consults on the Draft Administrative Measures on Cosmetic Registration

The consultation document is one of the significant subsidiary regulations of China’s CSAR. The Administrative Measures on Cosmetic Registration clarifies the basic requirements for registration and filing management of cosmetics and new cosmetic ingredients, including some new concepts, patent protection for the new ingredients, ingredient traceability management, cosmetic efficacy claims, annual reporting, etc.

On July 21, China Ministry of Justice opened a public consultation on the Administrative Measures on Cosmetic Registration, one of the subsidiary regulations of the Cosmetic Supervision and Administration Regulation (CSAR). The deadline for the consultation is August 20, 2020.

Stakeholders can feedback suggestions in one of the following ways within the period:

  1. Log in to the official website of China Ministry of Justice, and enter the "Legislative Opinion Collection" section of the main menu on the home page to submit opinions.

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  2. Submit comments by mail or by courier, with the envelope indicating “化妆品注册管理办法征求意见 (Consultation on Administrative Measures on Cosmetic Registration)”.

    * Address: No. 1, Beiluyuan, Zhanlan Road, Xicheng District, Beijing

    * Zip Code: 100037

  3. Email to huazhuangpinchu@163.com.

Main Content

The Administrative Measures on Cosmetic Registration (hereinafter referred to as “The Measures”) encompasses 7 chapters and 88 articles and are primarily designed to specify the basic requirements for the administration of cosmetic pre-market approval coupled with new cosmetic ingredients registration and filing.

Specifics are as follows:

1. Clarification of Some Basic Concepts

There are some new concepts in the CSAR and the Measures make further explanations on them.

  • Registration refers to the activity in which the registrant submits a registration application in accordance with legal conditions, procedures and requirements, and the medical products administration department reviews the safety and quality controllability of the cosmetics or new cosmetic ingredients applied for registration, and decides whether to approve the registration application.

  • Filing refers to the activity that the filer submits documents indicating product safety and quality controllability to the medical products administration department for archiving for future reference in accordance with legal conditions, procedures and requirements.

  • Registrant or filer refers to the enterprise or other organization that brings products to the market in its own name, and can bear civil liabilities independently.

    The registration/filer shall have quality management capability, establish systems relating to quality control, cosmetic safety risk assessment, adverse reaction monitoring and evaluation, and cosmetic recall, and shall be equipped with institutions and personnel capable of implementing the above systems.

    If the registrant or filer is an overseas enterprise, a corporate legal person in the territory of China shall be designated as the domestic responsible person to handle cosmetics/new ingredient registration and filing, market the products and assist in monitoring of cosmetics adverse reactions and implementation of product recalls.

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