Preservative efficacy testing
Standard / Test method
DIN EN ISO 11930
Assessment of the antimicrobial protection of cosmetic products using a preservative efficacy test.
Overview
DIN EN ISO 11930 describes how the antimicrobial protection of cosmetic products is evaluated. Its preservative efficacy test assesses whether a cosmetic formulation is adequately protected against a defined microbial challenge.
The test is suitable for cosmetic formulations whose preservation system and microbiological stability are to be assessed under defined test conditions. The results contribute to the overall evaluation of antimicrobial protection alongside the product's microbiological risk assessment.
Testing in accordance with DIN EN ISO 11930 must meet the standard's requirements for test organisms, inoculum levels, sampling intervals and assessment. Project-specific modifications can be agreed for development studies and are identified as adaptations based on DIN EN ISO 11930.
Typical applications
Cosmetic products
For cosmetic formulations whose antimicrobial protection is to be assessed.
Preservation systems
For assessing whether a preservation system supports the microbiological stability of a cosmetic product.
Product development
For testing formulations, product matrices and preservation strategies during cosmetic product development.
Frequently asked questions
What is DIN EN ISO 11930 suitable for?
DIN EN ISO 11930 is used to evaluate the antimicrobial protection of cosmetic products. Its challenge test assesses the preservation of a formulation under defined conditions. The test is primarily intended for water-soluble or water-miscible cosmetic products; products assessed as microbiologically low risk are outside the scope of this challenge test.
What is a preservative efficacy test?
In a preservative efficacy test, also known as a challenge test, a product is inoculated with defined microorganisms. Changes in viable microbial counts are then measured at specified intervals.
Which products can be tested?
Typical samples include cosmetic products such as creams, lotions, gels and aqueous formulations. The suitability of the test and any necessary adaptations are assessed for the specific product matrix.
How does DIN EN ISO 11930 differ from Ph. Eur. 5.1.3?
DIN EN ISO 11930 is used to evaluate the antimicrobial protection of cosmetic products. Ph. Eur. 5.1.3 assesses the efficacy of antimicrobial preservation in pharmaceutical preparations, using its own test procedure and acceptance criteria. The appropriate method depends on the product type, study objective and applicable testing requirements.
Can test parameters be adapted?
Product-specific requirements are reviewed before testing. Modified test organisms, inoculum levels, sampling intervals or other conditions can be agreed for development studies where scientifically appropriate. Deviations must be clearly identified, and adapted studies are described as based on DIN EN ISO 11930.