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ISO 21150: 2015 – Detection of Escherichia coli in Cosmetic Products
ISO 21150 is a standard test method established by the International Organization for Standardization (ISO) for microbial evaluation of cosmetic products. It describes a test method for the detection of Escherichia coli contamination in cosmetic products.
The importance of ISO 21150 test
Escherichia coli is one of the most common microbial contaminants found in cosmetic products. This contamination is a direct consequence of unhygienic practices followed during the production phase. The use of such contaminated products can lead to several health issues including skin irritation and rashes. Therefore, it is important to test cosmetic products for any possible microbial contamination before they can be marketed. ISO 21150 standard provides guidelines pertaining to appropriate sampling techniques and test protocols to identify the presence or absence of Escherichia coli in the test sample products.
Test conditions and target organisms
The standard is specifically designed for the detection of Escherichia coli using a non-selective liquid medium (enrichment broth) followed by microbial isolation on a selective agar medium. The test conditions include maintaining a temperature of 30 °C to 35 °C and an incubation period of 24 hrs to 48 hrs.
Scope
- Water-miscible products such as shampoos, liquid soaps, creams and lotions
- Water-immiscible products such as lipsticks, ointments, oil-based makeup removers
- Filterable products such as toners, perfumes, aqueous serums
- Low water activity products such as face powders, talcum powder, anhydrous balms
- Hydro-alcoholic products such as hand sanitizers, aftershaves, alcohol-based perfumes
- Products with extreme pH values such as chemical peels (acidic), depilatory creams (alkaline), and anti-acne treatments with high or low pH
- General cosmetic products such as Facial cleansers, Moisturizers, Hair conditioners
ISO 21150 test method
- Initial Suspension: Product samples are dispersed into enrichment broth to create an initial suspension. For water-miscible products, 1 ml of the sample is mixed with 9 ml of broth. For water-immiscible products, 1g of the sample is mixed with a dispersing agent (e.g., polysorbate 80) before being added to the broth. For filterable products, the sample is filtered through a membrane before preparing the initial suspension.
- Incubation: The initial suspension is incubated at 32.5°C for 20 to 72 hours.
- Isolation: An aliquot of the incubated enrichment broth is streaked onto MacConkey agar medium, inverted, and incubated at 32.5°C for 24 to 48 hours.
- Identification: After incubation, the plates are examined for Escherichia coli colonies, followed by additional cultural and biochemical tests to confirm its presence
Pros and Cons of ISO 21150 method
Pros
- Ensures consumer safety – Identifies and minimizes the risk of Escherichia coli contamination ensuring cosmetic products are safe for consumer use.
- Standard test methods – Provides a uniform, standard methodology for the detection of Escherichia coli in various cosmetic products
- Regulatory compliance – Helps manufacturers in complying with national and international regulatory requirements on microbiological safety in cosmetics.
- Risk management – Helps in assessing the risk associated with microbial contamination in cosmetic products.
- Versatility – Applies to a wide range of cosmetic products including those with low water activity, hydro-alcoholic products, and products with extreme pH values.
Cons
- Limited scope – Specifically focused on the detection of Escherichia coli, hence other potentially harmful microorganisms are not covered by this standard.
- Resource intensive – Requires specific equipment, materials, and trained personnel to conduct the tests accurately.
- Time-consuming – Testing processes like enrichment, incubation, and identification can be time-consuming which can cause delay in product release.
- Potential for false positives/negatives – Factors such as variability in sample handling and preparation and the efficiency of the neutralizers may influence the results leading to false positive or false negative results.
- Requires regular updates – The standard needs to be regularly updated to keep pace with advancements in microbiological testing methods and changes in regulatory requirements which can be a logistical challenge.
At MIS, we offer a full suite of microbiological testing services for cosmetic products. We have a team of experts who create entire frameworks and SOPs for microbiological analysis of cosmetic products. We work closely with our clients to fully understand their unique requirements and deliver tailored solutions. Our focused approach is to maintain accuracy and precision in every step of our testing process. Apart from ISO 21150, ISO 21149 also comes within the scope of our testing services.
To get a quote for the ISO 21150 test and turnaround times, contact our experts here.
FAQs
ISO 21150 is a standard test method for determining the presence of Escherichia coli in cosmetic products. This method aims to ensure product quality and safety of customers.
This test is applicable to cosmetics and personal care products.
This test method takes 1 week to complete.
At Microbe Investigations, we perform this test using Escherichia coli (ATCC 8739).
This test detects the presence or absence of Escherichia coli using a non-selective liquid medium, the enrichment broth, which allows for an increase in the number of microorganisms without the risk of inhibition. The technique includes isolation on a selective agar medium to detect Escherichia coli and subsequent identification tests to confirm its presence.
The passing criteria for cosmetic products involve the absence of detectable levels of Escherichia coli in the tested samples. If Escherichia coli is detected, it indicates a failure in the hygienic conditions during manufacturing.
The enrichment step is important in increasing the count of the microorganisms to detectable levels without the risk of inhibition by ingredients used in the selective media. It also ensures that even low counts of Escherichia coli are detected effectively.
Cosmetic samples need to be handled and processed carefully to prevent contamination, and to yield accurate results. The samples are mixed with enrichment broth, and as necessary, with neutralizers against the possible antimicrobial properties of the products. The mixes are then incubated to allow for the growth of any microorganisms present at detectable levels.
The results of this test are interpreted by confirming the presence or absence of Escherichia coli in the cosmetic samples, and the findings shall be reported in a form that states whether or not the product fulfills the hygienic criteria set by the standard.
Certain challenges might be faced with cosmetic products that are either water-immiscible or those that possess strong antimicrobial activity. In such cases the standard must be adapted or alternative methods need to be used to allow for accurate detection.
Compliance with this standard ensures that the cosmetic products are free from Escherichia coli contamination, which may indicate poor hygiene practices during their manufacture. It also adds to safety, quality, and consumer confidence in a product.
ISO 21150 specifically deals with the detection of Escherichia coli in cosmetic products while other international standards such as ISO 18415 are applicable for the assessment of a wider range of microorganisms.
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