China Challenge Test Cosmetics Guidelines were released by the National Institutes for Food and Drug Control (NIFDC) on July 8, 2024, as part of a significant regulatory update aimed at standardizing safety evaluation practices for cosmetics. The release aligns with the existing regulatory framework established by the “Cosmetics Supervision and Administration Regulation” and the “Cosmetics Safety Evaluation Technical Guidelines (2021 Edition).” The announcement contained 3 annexes; in this article we focus on Annex 2: Technical Guidelines for Cosmetic Challenge Tests. Refer to our other articles on:
- Annex 3: Technical Guidelines for Compatibility Testing Evaluation of Cosmetics with Packaging Materials
Summary of Annex 2: Challenge Testing Cosmetics
The guidelines in “Annex 2: Cosmetic Challenge Test Evaluation Technical Guidance” are mandatory for registering or notifying cosmetic products in China. Compliance with these antiseptic efficacy testing guidelines is essential for obtaining approval from the China National Medical Products Administration (NMPA) for cosmetic products intended for the Chinese market. Cosmetics registrants and record-filing persons may use national standards, technical specifications, industry standards, international standards, this guideline, or self-built methods for relevant research and include these findings in the safety assessment report.
Scope:
This document outlines the requirements, methods, and result evaluation criteria for the antiseptic efficacy testing of cosmetics.
Key Requirements and Methods:
- Anti-corrosion Efficacy Evaluation Test:
- Purpose: Assesses the preservative system by artificially contaminating cosmetics with microorganisms and monitoring viable bacteria over time.
- Process: Involves testing multiple samples for microbial content, preparing microbial suspensions, and ensuring the neutralizers effectively eliminate antibacterial components to allow for accurate microbial counts.
- Equipment and Materials:
- Essential equipment includes biological safety cabinets, autoclaves, balances, incubators, homogenizers, pipettes, microscopes, acidity meters, vortex mixers, sterilization dishes, and sterile glass wool.
- Microbial Testing and Strain Preparation:
- Specifies bacterial (Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa) and fungal strains (Aspergillus niger, Candida albicans).
- Detailed steps for preparing bacterial and fungal suspensions ensure accurate and consistent testing.
- Anti-corrosion Challenge Test:
- Involves contaminating the cosmetic product with specific microbial strains and measuring the reduction in viable bacteria over time to evaluate the preservative system’s effectiveness.
- Compliance and Reporting:
- Maintain thorough documentation of all tests and procedures to demonstrate compliance during regulatory inspections or audits.
- Ensure that the test results meet the limits specified in the “Safety and Technical Standards for Cosmetics.”
Impact for cosmetic manufacturers:
- Mandatory Compliance:
- Companies must conduct antiseptic efficacy tests as part of the registration and notification process for cosmetic products in China. This includes conducting anti-corrosion efficacy evaluation tests to ensure the products’ preservative systems effectively prevent microbial contamination.
- Outsourcing vs. In-House Testing:
- Manufacturers can outsource these tests to certified third-party laboratories, ensuring compliance with the latest standards and potentially reducing costs.
- Alternatively, larger manufacturers may choose to conduct these tests in-house, requiring investment in equipment and trained personnel but allowing greater control over the testing process and timelines.
- Documentation Requirements:
- Detailed test reports and antiseptic efficacy evaluation results must be included in the registration dossier. These reports should demonstrate that the product maintains its intended quality under specified conditions.
- Regulatory Approval:
- Without adherence to these antiseptic efficacy testing requirements, companies cannot successfully register or notify their cosmetic products in China. Regulatory approval is crucial for legal market entry and continued product distribution in the region.
- Quality Assurance:
- Ensuring product safety through these tests helps maintain high standards of quality and consumer safety, a key concern for regulatory authorities.
- Safety Assessment Report:
- The findings from antiseptic efficacy tests must be integrated into the safety assessment report, a critical component of the registration and notification submission.
In summary, conducting these antiseptic efficacy tests is not only a regulatory requirement but also a critical aspect of ensuring that cosmetic products are safe, effective, and reliable throughout their shelf life in the Chinese market. Compliance with these guidelines is essential for successful product registration and market access in China.
Further information
Read the original announcement on China Challenge Test Cosmetics Guidelines Released.
Read our article on Annex 1: Technical Guidelines for Cosmetics Stability Testing Evaluation.
Read our article on Annex 3: Technical Guidelines for Compatibility Testing Evaluation of Cosmetics with Packaging Materials.
Read our previous blog post on China cosmetics stability evaluation and other 3 technical guidelines – draft for comments.
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