China Instructions for New Cosmetic Ingredient Registration and Notification Dossiers (Draft for Comments)

China Instructions for New Cosmetic Ingredient Registration and Notification Dossiers (Draft for Comments)

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Basic Information
  • Translated By:ChemLinked
  • Release Date:Aug 28, 2020
    Implement Date:/
     
  • Pages:69
    Format:Electronic Edition (Adobe PDF)
    Language:EN&CN
  • Created On:Sep 03, 2020
    Last Updated On:Sep 03, 2020
     
Background

On August 28, 2020, China National Institutes for Food and Drug Control (NIFDC) released the draft Instructions for New Cosmetic Ingredient Registration and Notification Dossiers for public consultation, which is one of the subsidiary regulations of CSAR. The Instruction is formulated to guide and regulate the NCI registration and notification in China.

Some Key Points of the Instruction

  • Dossiers categories required for registration and notification are consistent.

  • Dossiers requirements for nanomaterials and biotechnology sources ingredients are newly added.

  • Conditional acceptance of alternative method data.

  • Detailed test data, laboratory qualification analysis, etc. shall be attached if the safety assessment report is issued by an international authoritative safety assessment agency.

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Contents

Chapter I Basic Requirements

  • Basis for Formulation

  • Application Scope

  • General Requirements

  • User Permission Requirements

  • Dossiers Form and Submission Requirements

  • Testing Report Requirements

  • Testing Method Requirements

  • Scientific Literature/Regulatory Information Requirements

  • Notification Commitment

Chapter II Registration and Notification Dossiers Requirements

  • Application Form

  • Research Report

  • Preparation Technique

  • Stability

  • Quality Control Standard

  • Safety Assessment

  • Functional Basis

  • Technical Requirements for Ingredient

Chapter III Documents Requirements of the Monitoring Period Management

  • Monitoring Report

  • Emergency Report

Table 1 Requirements for Registration and Notification Documents of New Ingredient

Annex 1 Application Form for Registration and Notification of New Cosmetic Ingredients

Annex 2 Technical Requirements for xx Ingredient Used for Cosmetics

Annex 3 Sample of New Ingredient Monitoring Report

Annex 4 Sample of Emergency Report of New Ingredients