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ISO 11930: 2019
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Quick understanding about test
ISO 11930: 2019 – Preservative Efficacy Test
- Staphylococcus aureus (ATCC 6538P)
- Escherichia coli (ATCC 8739)
- Pseudomonas aeruginosa (ATCC 15442)
- Candida albicans (MTCC 3017)
- Aspergillus niger (ATCC 16888)
- The test method involves inoculating cosmetic products with specific microorganisms, incubating them, and measuring microbial survival at defined intervals. Log reduction values are calculated. The results are compared against acceptance criteria.
- Ensures regulatory compliance with global standards.
- Enhances consumer safety by preventing contamination.
- Bacteria: ≥3 log reduction within 7, 14, and 28 days (Criteria A).
- Yeast and Fungi: No increase or ≥1 log reduction, depending on the interval and criteria.
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Abstract
ISO 11930 is a standard test method used to evaluate the overall antimicrobial protection of cosmetic products. It ensures that cosmetic products are free from microbial contamination throughout their shelf life by assessing the effectiveness of their preservative systems. The standard involves testing the product using specific microorganisms such as bacteria, yeast, and mold to verify its safety and efficacy.
The standard includes :
- preservative efficacy test
- challenge test to assess antimicrobial protection of cosmetic products that are not considered as microbiologically low-risk products, based on risk assessment described in ISO 29621
Products Tested
This test is primarily intended for water-soluble or water-miscible cosmetic products. It can also be adapted for testing products where water is the internal (discontinuous) phase.
Test organisms
The test evaluates the effectiveness of preservatives against a spectrum of microorganisms commonly found in cosmetic products. Organisms typically used in this method include Staphylococcus aureus (ATCC 6538P), Escherichia coli (ATCC 8739), Pseudomonas aeruginosa (ATCC 15442), Candida albicans (MTCC 3017), Aspergillus niger (ATCC 16888)
ISO 11930 Test Method – Determining Antimicrobial Protection of Cosmetic Product
- Inoculation: The test product sample is inoculated with mandatory test organisms.
- Incubation: Inoculated samples are incubated for a time of period of 28 days
- Sampling and enumeration: The number of surviving microorganisms is measured at defined intervals over a period of 28 days.
- Assessment: For each time and each strain, log reduction values are calculated and compared to the following recommended criteria –
Test microorganisms | Acceptance criteria A & B* | Log reduction | ||
7 days | 14 days | 28 days | ||
Bacteria | A | ≥ 3 | ≥ 3 | ≥ 3 |
B | – | ≥ 3 | ≥ 3 | |
Yeast (Candida albicans) | A | ≥ 1 | ≥ 1 | ≥ 1 |
B | – | ≥ 1 | ≥ 1 | |
Fungus (Aspergillus niger) | A | – | No increase from the initial count | ≥ 1 |
B | – | No increase from the initial count | No increase from the initial count | |
*Criteria A and B outline different antimicrobial efficacy criteria for bacteria, fungi, and yeast at specified time intervals (days).
Importance of the Test
Many regulatory bodies such as the European Union’s Cosmetics Regulation (EC) No 1223/2009, require manufacturers to demonstrate the microbiological safety of their products. ISO 11930 testing is a recognized method to fulfill these requirements as it aids in compliance and market approval.
This test helps ensure that cosmetic products remain safe for consumer use by evaluating their ability to resist microbial contamination. This is essential to prevent adverse health effects from using contaminated products.
Benefits of Testing
1. Regulatory compliance
2. Consumer safety
3. Product stability
4. Brand reputation
Frequently Asked Questions
DR. Martinoz Scholtz
ISO 11930 specifies test procedures to assess the antimicrobial protection of cosmetic products to ensure product safety to end users.
This test is performed for water-soluble cosmetic formulations or where water is used in the internal phase of product development.
The test takes 3 – 4 weeks to complete.
At Microbe Investigations Switzerland, we perform this test using the following strains: Staphylococcus aureus (ATCC 6538P), Escherichia coli (ATCC 8739), Pseudomonas aeruginosa (ATCC 15442), Aspergillus niger (ATCC-16888), and Candida albicans (MTCC 3017). Additional strains can be added at the customer’s request.
The antimicrobial activity of preservatives is measured by monitoring the reduction in viable microorganism count over a 28-day period.
This test typically takes 28 days to complete, as the preservation efficacy test involves measuring the reduction in microorganisms over this period.
This test contributes to product safety and compliance by ensuring that cosmetic formulations have adequate antimicrobial protection to prevent microbial contamination.
Non-compliance results in inadequately preserved products. This leads to microbial contamination, reduced shelf life, health risks for consumers, and regulatory actions such as recalls or market withdrawals.
Yes, this test can be modified to assess different cosmetic formulations.
Cosmetic products should be tested for antimicrobial activity as part of the initial product development and periodically during their shelf life, especially if there are changes in manufacturing processes that could affect preservation efficacy.
Other related tests are ISO 16212 (enumeration of yeast and mold), ISO 18415 (detection of specified and non-specified microorganisms), and ISO 21149 (enumeration and detection of aerobic mesophilic bacteria).
Benefits of having this test done by a certified lab include ensuring accurate and reliable results, meeting regulatory standards, and providing documented evidence of product safety and efficacy.
This test supports marketing claims by providing scientific proof of the product’s antimicrobial efficacy.
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