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CSAR Subsidiary Regulations: China Indicates the End of Mandatory Animal Testing for Imported General Cosmetics

China released the Draft Instructions for Cosmetic Registration and Notification Dossiers, specifying the documentation requirements for the application, modification, renewal, and cancellation of cosmetic registration/notification. The high-profile animal testing exemption for general cosmetics are impending. Abstracts of safety assessment can be used as alternatives under certain conditions.

On August 28, 2020, China National Institutes for Food and Drug Control (NIFDC) opened a public consultation on the draft Instructions for Cosmetic Registration and Notification Dossiers [1], one of the subsidiary regulations of Cosmetic Supervision and Administration Regulation (CSAR). Cosmetic stakeholders with any suggestions can send to us at before September 14. We will submit them to NIFDC on your behalf.

General Information of the Instruction

The Instruction consists of 7 chapters with 65 articles. The 7 chapters are as follows:

  1. Basic Requirements

  2. Format requirements

  3. The opening and maintenance of user permissions

  4. Requirements for registration and notification dossiers

  5. Requirements for modifications

  6. Requirements for registration renewal and cancellations

  7. Supplementary provisions

The Instruction is designed to standardize cosmetic registration and notification, shift the focus of cosmetic supervision from pre-market assessment to in-and post-market management, and promote the industry's development.

Highlights of the Instruction

1. Dossiers for First Imported or Notified Cosmetics: Same Category, Detailed Requirements

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