China compliant cosmetic ingredients now have a set of guidelines on how to determine and research their history of safe use. China’s National Institutes for Food and Drug Control (NIFDC) has developed guidelines to streamline the evaluation of new cosmetic raw materials by leveraging their history of safe use. These guidelines align with existing regulatory frameworks including:
- Cosmetic Supervision and Administration Regulation (CSAR)
- Administrative Measures for the Registration and Filing of Cosmetics
- Provisions for the Registration and Filing of New Cosmetic Ingredients (NCI) (referred to below as NCI Provisions).
Scope and Application
This guidance specifically pertains to Scenarios 3* and 4** under the “NCI Provisions” which focus on new cosmetic ingredients that have been safely used for more than 3 (three) years in marketed cosmetics. Registrants are expected to comply with relevant regulatory and technical standards and integrate other applicable guidelines as necessary. *Scenario 3 ingredients are those that have 3 years of safe use and have high-activity functions including antiseptic, sunscreen, coloring, hair dyeing, freckle removal and whitening, hair loss prevention, acne removal, anti-wrinkle (except physical anti-wrinkle), anti-dandruff, deodorization. **Scenario 4 ingredients are those that have 3 years of safe use and have standard functions.
Basic Requirements
- Documentation of Safe Use:
- Evidence must demonstrate the continuous use of the raw material in the market for at least three years, confirming its safety and efficacy.
- Documentation should confirm that the raw material used in the products submitted for registration is identical to that in marketed products regarding composition, quality, and production processes.
- Market Presence and Usage:
- The products containing the cosmetic ingredient must have been on the market for at least three years with significant and continuous sales volume.
- At least one product containing the raw material should have been sold continuously for three years or more.
- Consumer Usage and Safety Monitoring:
Registrants must submit documentation ideally in the form of tables (see original article) that includes:
- Sales Volume: The cumulative sales volume of marketed cosmetic products over three years should not be less than 100,000 pieces, with annual sales not falling below 30,000 pieces.
- Long-term Consumer Use: Details of long
- Adverse Reaction Surveillance: Surveillance data on adverse reactions of listed cosmetics, including channels and methods for collecting adverse reaction events, records of consumer incidents since market introduction, and analysis of adverse reaction types and causes.
Key Issues Explained
- Listed Product Requirements: Products using new raw materials must conform to China’s cosmetic definitions, regardless of how they are managed abroad. For example, products like hair dyes, which may be managed as quasi-drugs in other countries, must include their regulatory status, efficacy, and mechanism of action if they meet the cosmetic definition in China.
- Form of Supporting Materials: The guidelines emphasize the need for comprehensive documentation that demonstrates the safe use and sales of the marketed cosmetics containing the new China compliant cosmetic ingredient. While specific types of documentation are not prescribed due to varying international practices, all supporting materials should clearly show consistency and traceability of the raw materials’ use and safety in marketed products.
These guidelines aim to ensure that new China compliant cosmetic ingredients introduced to the market are backed by verifiable and substantial evidence of safe usage, supporting regulatory compliance, and maintaining consumer trust in cosmetic products.
Further information
Read the original NIFDC announcement on China New Cosmetics Ingredients Safe Use History Research and Determination Trial Guidelines. For more information about new cosmetic ingredients in China, please refer to these recent blog posts:
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