Thursday, 01 August 2024 / Published in Cosmetics, News, NMPA Registration in China

Cosmetics Stability Testing

Cosmetic Stability Testing in China now has new guidelines. On July 8, 2024, the National Institutes for Food and Drug Control (NIFDC) released 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 1: Technical Guidelines for Cosmetic Stability Testing Evaluation. Refer to our other articles on:

Annex 2: Technical Guidelines for Cosmetics Preservative Challenge Testing Evaluation

Annex 3: Technical Guidelines for Compatibility Testing Evaluation of Cosmetics with Packaging Materials

Summary of Annex 1: Stability Testing Cosmetics Evaluation

The newly published guidelines are designed to ensure the orderly implementation of cosmetic safety evaluation systems and provide clear directives for the stability testing of cosmetic products. Compliance with these stability testing cosmetics 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. This document outlines the requirements, methods, and result evaluation criteria for the stability testing of cosmetics.

Terms and Definitions:

Influencing Factor Test: Conducted under extreme conditions to identify key factors affecting cosmetic quality and provide references for accelerated and long-term tests.
Accelerated Testing: Assesses stability under conditions different from standard storage to predict quality trends.
Long-term Experiments: Evaluates stability during transport and storage to confirm storage conditions and shelf life.

Test Requirements:

Test Samples: Stability tests use at least one batch of samples consistent with post-marketing cosmetics in formulation, production process, and packaging.
Pilot Projects: Tests should reflect cosmetic characteristics and include items like appearance, colour, odour, pH, microbial counts, and others based on product specifics.
Test Frequency: Determined by the test item, with a detailed basis for the frequency provided.

Test Methods:

Influencing Factor Test: Includes high temperature, high humidity, light, and freeze-thaw tests, with conditions set based on cosmetic characteristics and storage scenarios.
Accelerated Testing: Conducted under specific temperature and humidity conditions (e.g., 40°C±2°C, 75% RH±5%) with multiple time points for quality change analysis.
Long-term Experiments: Conducted under set conditions (e.g., 25°C±2°C, 60% RH±10%) with multiple time points for extended quality assessment.

Outcome Evaluation:

Systematic analysis of stability research results, considering physical and chemical properties, product forms, formulas, process conditions, and packaging materials, to provide a comprehensive evaluation basis and conclusions in a stability evaluation report.

Impact on Cosmetic Manufacturers:

Mandatory Compliance: Companies must conduct stability tests as part of the registration and notification process for cosmetic products in China. This includes influencing factor tests, accelerated tests, and long-term tests to ensure the products’ quality and safety over time.

Documentation Requirements: Detailed test reports and stability evaluation results must be included in the registration dossier. These reports should demonstrate that the product maintains its intended quality under specified storage conditions.

Regulatory Approval: Without adherence to these stability testing requirements, companies cannot successfully register or notify their cosmetic products in China. This regulatory approval is crucial for legal market entry and continued product distribution in the region.

Quality Assurance: Ensuring product stability through these tests helps in maintaining high standards of quality and consumer safety, which is a key concern for regulatory authorities.

Safety Assessment Report: The findings from cosmetic stability testing must be integrated into the safety assessment report, which is a critical component of the registration and notification submission.

In summary, conducting these stability 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. These guidelines highlight the importance of cosmetic stability testing, underscoring the need for rigorous evaluation to maintain product integrity and consumer safety.