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On August 28, 2020, China National Institutes for Food and Drug Control (NIFDC) released the draft Instructions for Cosmetic New Ingredient Registration and Notification Dossiers for public consultation [1], which is one of the subsidiary regulations of CSAR. Any suggestions can be mailed to ChemLinked ([email protected]) prior to September 14, 2020, and we'll submit to the NIFDC.
Background
Before a new cosmetic ingredient is used to produce cosmetics in China, it must be registered with NMPA. Since there is no classified management and the review criteria have not been refined with the ingredient characteristics, only 10 new ingredients have been approved from 2008 to 2020.
The CSAR issued on June 29 stipulates that new cosmetic ingredients shall be managed based on risks [2]. New high-risk ingredients are required to be registered with NMPA and obtain approval, while low-risk ingredients will be subject to notification management. Registrants and notifiers need to report the new ingredients' use and safety data to the NMPA annually for three years.
This Instruction is formulated to guide and regulate the NCI registration and notification in China.
Key Points of the Instruction
1. Dossiers categories required for registration and notification are consistent.
Although new low-risk ingredients are subject to notification management, the safety standards are not relaxed. The dossiers categories required for registration and notification are the same.
No. | Dossiers |
1 | Application Form |
2 | Research Report |
3 | Preparation Technique |
4 | Stability |
5 | Quality Control Standard |
6 | Safety Assessment |
7 | Function Basis |
8 | Technical Requirements |
9 | Sample |
For anti-hair loss, anti-acne, anti-wrinkle, anti-dandruff, and antiperspirant ingredients subject to notification management, the requirements on safety dossiers are the same with high-risk ingredients (preservatives, sunscreens, colorants, hair dyes and freckle-removing/whitening agents).
2. Dossiers requirements for nanomaterials and biotechnology sources ingredients are newly added.
In this Instruction, the definition of nanomaterials is given, and specific dossiers (such as research reports, preparation technique, quality control standards, and safety assessment) requirements for nanomaterials and biotechnology sources ingredients are proposed.
3. Conditional acceptance of alternative method data
Although China has been actively promoting the research and validation of alternative methods, due to the late start, currently only 6 alternative methods have been included in Safety and Technical Standards for Cosmetics 2015 (STSC). The current dossiers' requirements for NCI registration are still based on toxicological data on animal testing.
The safety assessment documents of new cosmetic ingredients used abroad may involve multiple alternative methods not included in STSC. In order to be in line with international regulations, the Instruction stipulates that the data derived from the alternative method (not in the STSC but is validated by an international authoritative alternative method validation agency) can be accepted, if the evidence proving the consistency of results obtained from the alternatives and the existing testing methods in China is submitted.
If animal testing alternative methods are used, appropriate Integrated Approaches to Testing and Assessment (IATA) should be selected according to the ingredient's structural characteristics and specific toxicological endpoints to evaluate the ingredient safety.
*International Authoritative Alternative Method Validation Agencies include: OECD, ICCR, ICCVAM, EURL-ECVAM, JaCVAM, etc.
Other Noteworthy Points
Detailed test data, laboratory qualification analysis, etc. shall be attached if the safety assessment report is issued by an international authoritative safety assessment agency.
When notifying a new cosmetic ingredient, the notifier shall commit that the ingredient does not have preservative, sunscreen, coloring, hair dyeing or freckle-removing/whitening function.
The registrant and notifier shall submit a monitoring report through the registration and notification system annually for three years. If an emergency occurs, the registrant or notifier shall submit an emergency report.
Main Structure of the Instruction
Chapter One Basic Requirements |
|
Chapter Two Registration and Notification Dossiers Requirements |
|
Chapter Three Dossiers Requirements for the Monitoring Period Management |
|
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 | |
Related Resources:
News 5: CSAR Subsidiary Regulations: China Releases the Draft Cosmetic Classification Rules and Catalog
Webinar: Understanding China's New Draft Subsidiary Measures of CSAR
Webinar (Live Streaming): Interpretation of China's Cosmetic Supervision and Administration Regulation (Final Version)
English Translation: Supervision and Administration Measures on Cosmetics Manufacture and Operation
English Translation: Administrative Measures on Cosmetic Registration
English Translation: Cosmetic Classification Rules and Catalog
English Translation: Technical Guidelines for Cosmetic Safety Assessment
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