Instructions for New Cosmetic Ingredient Registration and Notification Dossiers (Second Draft for Comment)

Instructions for New Cosmetic Ingredient Registration and Notification Dossiers (Second Draft for Comment)

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Basic Information
  • Translated By:ChemLinked
  • Release Date:Nov 05, 2020
    Implement Date:/
     
  • Pages:101
    Format:Electronic Edition (Adobe PDF)
    Language:EN&CN
  • Created On:Nov 13, 2020
    Last Updated On:Nov 13, 2020
     
Background

On Aug. 28, 2020, China National Institutes for Food and Drug Control (NIFDC) released the first draft Instructions for New Cosmetic Ingredient Registration and Notification Dossiers for public consultation. The registration and notification dossiers of a natural or artificial ingredient that is applied in cosmetic products for the first time in China shall meet the requirements stipulated in the Instructions.

Based on the collected public opinions, National Medical Products Administration (NMPA) drafted and released the second edition of the Instructions on Nov. 5. The second draft modifies new cosmetic ingredients registration and notification dossiers requirements and refines the requirements for testing institutions qualification and testing method.

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Contents
  • Formulation Basis

  • Application Scope

  • Overall Requirements

  • Requirements for Text and Translation

  • Requirements for Signature and Seal

  • Requirements for Standardization

  • Requirements for Consistency

  • Requirements for Format of Document

  • Informatization

  • General Requirements for New Ingredient

  • Requirements for the Form of New Ingredient

  • Requirements for Reports

  • Requirements for Test Methods

  • Requirements for Scientific Literature and Regulation Documents

  • User Information Registration in the Information System

  • Requirements for Authorization Letter of Domestic Responsible Person

  • Management of Authorization Period

  • Requirements for Documents Concerning New Ingredients

  • R&D Report

  • Preparation Process

  • Quality Control Standards

  • Safety Assessment Documents

  • Functional Basis

  • Technical Requirements

  • Monitoring Report

  • Emergency Report

  • Right of Interpretation

  • Implementation Date

Annexes

1 Information Form for Registrant/Notifier of New Cosmetic Ingredients

2 Adverse Reaction Monitoring and Evaluation System Overview Form

3 Domestic Responsible Person Information Form

4 Authorization Letter of Domestic Responsible Person for Registration and Notification of New Cosmetic Ingredients

5 Information Form for Registration or Notification of New Cosmetic Ingredients

6 Item Requirements for Registration and Notification Documents of New Cosmetic Ingredients

7 Requirements for Preparation of R&D Reports for New Cosmetic Ingredients

8 Requirements for Preparation of Quality Control Standards for New Cosmetic Ingredients

9 Technical Guidelines for Toxicological Assessment of New Cosmetic Ingredients

10 Technical Requirements for New Cosmetic Ingredients

11 Template of New Ingredients Monitoring Report

12 Template of New Ingredients Emergency Report