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China NMPA Consults on the Key Points for Reviewing of Cosmetic Safety Assessment Report

The Key Points is applicable to the review of general cosmetics' safety assessment report. It clarifies the requirements for data collation and technical review of the safety assessment report, stipulates the judgment principles for reviewing the safety assessment report, etc.

Starting from Jan. 1, 2022, cosmetic registrants and notifiers shall conduct cosmetic safety assessments in accordance with Technical Guidelines for Cosmetic Safety Assessment. Before May 1, 2024, a simplified version of the safety assessment report can be submitted when applying for special cosmetics registration or general cosmetics notification.

Starting from Feb. 21, 2022, a draft of Key Points for Reviewing of General Cosmetics Safety Assessment Report (Simplified Version) (hereinafter referred to as “Key Points”) proposed by National Medical Products Administration (NMPA) is being discussed among cosmetic industry insiders. 1 National Institutes for Food and Drug Control, provincial MPAs, and inspection centers are required to provide feedback before Mar. 31.

The Key Points sets a unified standard for the review of the safety assessment report, and has great reference significance for companies to prepare safety assessment report in a standardized manner.

Main Content

The Key Points is applicable to the review of the safety assessment report of general cosmetics. It clarifies the requirements for data collation and technical review of the safety assessment report, stipulates the judgment principles for reviewing the safety assessment report, etc.

Chapter I General Principles

Chapter II Data Collation Requirements (including the paper's size, font color, page numbering, the standardization of Chinese characters, unit of measurement, punctuation, charts, normative terms, sealing, signature, etc.)

Chapter III Technical Review Requirements

Chapter IV Judgment Principles

Attachment Guidelines for Review of General Cosmetics Safety Assessment Report (Simplified Version)

  • Data Collation Requirements

  • Technical Review Requirements

  • Annex I Cosmetic Exposure Information Sheet

  • Annex II IFRA Product Classification

  • Annex III List of Common Risk Substances

  • Annex IV Description of Adverse Reaction Monitoring

化妆品合规BANNER 810 150  gif.gifJudgment Principle

The Key Points stipulates three review conclusions of the safety assessment report. If the safety assessment data is true and complete, and the assessment conclusion can fully prove that the product is safe and meets the requirements of the Key Points, the report will be judged as "Pass."

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