Cosmetic Compliance
Intelligence & Solutions
Instructions for New Cosmetic Ingredient Registration and Notification Dossiers (Draft for Comments)
Local Title:
化妆品新原料注册与备案资料规范(征求意见稿)
Country/Region:
Chinese Mainland
Competent Authority:
National Institutes for Food and Drug Control
Type:
Regulation
Status:
Invalid
Release Date:
2020-08-28
Implementation Date:
/
Document
Language Source Title Access
ZH
Official Instructions for New Cosmetic Ingredient Registration and Notification CN
EN
External Instructions for New Cosmetic Ingredient Registration and Notification EN
ChemLinked Translation
Instructions for Cosmetic New Ingredient Registration and Notification Dossiers (Draft for Comments)
File Language : EN
$ 320
Summary

On July 21, China Ministry of Justice opened a public consultation on the Administrative Measures on Cosmetic Registration. 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.

Main Structure of the Instruction:

Chapter One  Basic Requirements

l  Basis for Formulation

l  Application Scope

l  General Requirements

l  User Permission Requirements

l  Dossiers Form and Submission Requirements

l  Testing Report Requirements

l  Testing Method Requirements

l  Scientific Literature/Regulatory Information   Requirements

l  Notification Commitment

Chapter Two  Registration and Notification Dossiers Requirements

l  Application Form

l  Research Report

l  Preparation Technique

l  Stability

l  Quality Control Standard

l  Safety Assessment

l  Function Basis

l  Ingredient Technical Requirements

Chapter Three  Dossiers Requirements for the Monitoring Period Management

l  Monitoring Report

l  Emergency Report

Table One  New Cosmetic Ingredient Registration and Notification Dossiers Requirements

Attachment One  New Cosmetic Ingredient Registration and Notification   Application Form

Attachment Two  Technical Requirements for xx Ingredient Used in Cosmetics

Attachment Three  Sample of Cosmetic New Ingredient Monitoring Report

Attachment Four  Sample of Cosmetic New Ingredient Emergency Report

History
2021-03-04
In force
Release Date: 2021-03-04
Implementation Date : 2021-05-01
2020-11-05
2020-08-28
Instructions for New Cosmetic Ingredient Registration and Notification Dossiers (Draft for Comments)
Invalid
Release Date: 2020-08-28
Implementation Date : /
Noteworthy Information