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Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers

Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers

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Basic Information
  • Translated By:ChemLinked
  • Release Date:Mar 04, 2021
    Implement Date:May 01, 2021
     
  • Pages:72
    Format:Electronic Edition (Adobe PDF)
    Language:EN&CN
  • Created On:Mar 10, 2021
    Last Updated On:Mar 10, 2021
     
Background

After two rounds of public consultation, on Mar. 4, 2021, China NMPA finally released the finalized Instructions for New Cosmetic Ingredient Registration and Notification Dossiers and renamed it as Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers. 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 Provisions.

The Provisions are scheduled to come into force on May 1, 2021. Starting from the date, companies shall submit the registration/notification dossiers in accordance with the requirements specified in the Provisions.

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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 Format of Document

  • Requirements for Consistency

  • User Information Registration

  • User Information Update

  • Authorization Letter of Domestic Responsible Person

  • Requirements for Documents Concerning New Ingredients

  • R&D Report

  • Preparation Process

  • Quality Control Standards

  • Safety Assessment Documents

  • Requirements for Samples

  • Monitoring Report

  • Safety Risk Control Report

  • Implementation Date

Annexes

1. Safety Risk Monitoring and Evaluation System Overview of Registrant/Notifier of New Cosmetic Ingredients (Template)

2. Information Update Form of Registrant/Notifier of New Cosmetic Ingredients (Template)

3. Requirements for Registration and Notification Documents of New Cosmetic Ingredients

4. Technical Requirements for New Cosmetic Ingredients (Template)

5. Requirements for Preparation of R&D Reports for New Cosmetic Ingredients

6. Requirements for Preparation of Quality Control Standards for New Cosmetic Ingredients

7. Requirements for Preparation of Annual Safety Monitoring Reports for New Cosmetic Ingredients

8. Requirements for Preparation of Safety Risk Control Reports for New Cosmetic Ingredients