Cosmetic Compliance
Intelligence & Solutions
Key Points for Reviewing of General Cosmetics Safety Assessment Report (Simplified Version)
Local Title:
普通化妆品安全评估报告(简化版)审查要点(征求意见稿)
Country/Region:
China
Competent Authority:
National Medical Products Administration
Type:
Regulation
Status:
Draft
Release Date:
2022-02-21
Implementation Date:
/
Document
Language Source Title Access
ZH
Official Key Points for Reviewing of General Cosmetics Safety Assessment Report (Simplified Version)
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Summary

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. 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


Noteworthy Information