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ISO 21149
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Quick understanding of the test
ISO 21149:2017 - Standard Method for Detecting Aerobic Mesophilic Bacteria in Cosmetics
- Ensures consumer safety by identifying harmful bacteria.
- Helps avoid costly product recalls due to contamination.
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Abstract
ISO 21149:2017 provides a standardized framework for evaluating the microbiological quality of cosmetic products, targeting the enumeration and detection of aerobic mesophilic bacteria.
The scope of the ISO 21149 standard encompasses both quantitative assessment, which determines the level of bacterial contamination, and qualitative assessment, which confirms the presence or absence of microorganisms, providing manufacturers and regulatory bodies with actionable information on product safety.
Scope of products for testing with ISO 21149
ISO 21149 applies to a wide range of cosmetic products, including:
- Creams and lotions (oil-in-water or water-in-oil emulsions)
- Shampoos and conditioners
- Liquid soaps and shower gels
- Make-up and skincare products
- Raw materials used in cosmetic production
While this standard is applicable to a wide range of cosmetic products, alternative methods may be required for testing certain water-immiscible formulations.
How is the ISO 21149 Test Conducted?
Plate method for ISO 21149 testing
- Pour plates or spread plates are prepared by using a specified culture medium.
- The plates are inoculated with a known quantity of initial suspension.
- The inoculated plates are incubated aerobically at 32.5ยฐC ยฑ 2.5ยฐC for 72 ยฑ 6 hours.
- After the incubation period, the number of colony-forming units (CFU) is counted and the number of aerobic mesophilic bacteria per ml per gram of the cosmetic product is calculated.
Membrane filtration in ISO 21149 test procedure
- A defined amount of sample is filtered through a membrane filter and washed in a filtration apparatus containing a small amount of suitable sterile diluent.
- The membrane filter is then transferred onto an agar plate and incubated at 32.5ยฐC ยฑ 2.5ยฐC for 72 ยฑ 6 hours.
- After incubation, the number of colony-forming units (CFU) is counted and the number of aerobic mesophilic bacteria per milliliter or per gram of the cosmetic product is calculated.
Detection of aerobic mesophilic bacteria by enrichment broth
- The sample mixture is then incubated at 32.5ยฐC ยฑ 2.5ยฐC for at least 20 hours.
- After incubation, an aliquot of the previously inoculated liquid medium is transferred to a non-selective solid agar medium.
- The plates are subjected to aerobic incubation at 32.5ยฐC ยฑ 2.5ยฐC for 48 to 72 hours.
- The plates are observed for any bacterial colonies and the results are expressed as the โpresence or absenceโ of aerobic mesophilic bacteria per sample of the cosmetic product.
Importance of ISO 21149 testing in cosmetic safety
Consumer Safety: ISO 21149 helps identify the aerobic mesophilic bacteria that can cause infections and irritation to skin, eyes, and mucous membranes.
Product Quality: Regular microbiological testing ensures cosmetic products are safe, high-quality, and market-ready.
Regulatory Compliance: Adhering to ISO 21149 helps manufacturers meet legal requirements and ensures compliance with safety standards.
Process Monitoring: This testing enables early detection of microbial contamination during production, allowing manufacturers to implement corrective measures and improve production processes to maintain product safety and quality.
At Microbe Investigations Switzerland (MIS), we provide ISO 21149 testing services that help cosmetic manufacturers ensure their products meet the highest standards of microbiological safety.
Alongside this test, MIS also offers related services including ISO 16212, USP 61, ISO 11930, ISO 18415, and custom microbial risk assessments tailored to your unique product formulations.
Our expert microbiologists work closely with your team to identify the most relevant tests for your product type, intended use, and market requirements โ ensuring full compliance with regulatory standards.
Contact us today to learn more about our services and how we can assist in safeguarding your cosmetic products.
Frequently Asked Questions
DR. Martinoz Scholtz
The test specifies methods for the enumeration and detection of mesophilic aerobic bacteria present in cosmetic products using plate count, membrane filtration or enrichment broth methods.
The test applies to cosmetics, beauty products and personal care products that are prone to microbial contamination by aerobic bacteria.
The test takes 4 weeks to complete.
The standard outlines the methods for detecting and enumerating aerobic mesophilic bacteria in cosmetic products.
Microbial contamination is detected either by counting colonies on an agar plate after incubation or by using an enrichment broth method for detecting low levels of bacteria.
Regular testing throughout the product life cycle, including during the development, manufacturing and shelf-life phases, is generally recommended.
ISO 21149 tests for the presence of bacteria while ISO 16212 tests for the presence of yeast and mold.
Yes, the standard can be used to test raw materials too.
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