Guidelines and Standards for Stability Testing
The Cosmetic Guidelines on Stability Testing of Cosmetics developed by the EU, along with the ISO/EU 18811:2018 technical report, provide industry best practices for conducting stability tests.
The guidelines recommend testing under various conditions to simulate real-life scenarios, such as temperature fluctuations, exposure to light, and humidity.
Key Aspects of Stability Testing
Stability testing typically involves two main types:
Accelerated Stability Testing: This method subjects the product to elevated temperatures (e.g., 40°C ± 2°C) and humidity levels to predict its shelf life over a shorter period. These tests are usually conducted over 3 to 6 months and provide insights into how the product will perform over its intended lifespan.
Real-Time Stability Testing: This long-term approach assesses the product under normal storage conditions (e.g., room temperature) for a period that reflects the product’s intended shelf life, usually 12 months or longer. Real-time stability testing is essential for confirming the results obtained from accelerated tests.
Factors Assessed During Stability Testing
- Physical and Chemical Stability: Evaluates changes in the product’s appearance, color, fragrance, pH, viscosity, and other physical attributes over time.
- Microbiological Stability: Ensures that the product remains free from microbial contamination throughout its shelf life, especially for water-based formulations.
- Packaging Compatibility: Assesses the interaction between the product and its container to ensure that the packaging does not compromise the product’s stability. This includes checking for leaks, corrosion, or degradation of packaging materials.
Importance of Stability Testing in the Cosmetic Product Safety Report (CPSR)
Stability testing is a vital part of the Cosmetic Product Safety Report (CPSR), required by the EU Cosmetics Regulation before a product can be placed on the market. The CPSR includes:
Part A: Cosmetic product safety information, where stability test results are documented to confirm the product’s durability.
Part B: Cosmetic product safety assessment, which relies on the stability data to determine the product’s safety profile.
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