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ISO 18416: 2017
Detection of Candida albicans in Cosmetic Products
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ISO 18416: 2017 - Detection of Candida albicans in Cosmetic Products
Mandatory test strains
- Candida albicans
- Ensures consumer safety by detecting harmful contaminants.
- Supports regulatory compliance and quality assurance.
Turnaround Time
The presence or absence of Candida albicans is determined through colony observation and further identification tests.
Passing criteria
The absence of Candida albicans in the tested sample ensures the product meets safety and quality standards.
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Abstract
ISO 18416:2015 is an international standard that describes an enumeration method for determining the amount of Candida albicans present in cosmetic products in order to assess their microbiological quality. Candida albicans causes skin and mucosal infections, which pose consumer health risks. Contamination typically results from poor hygiene, improper ingredient handling, or inadequate preservatives during manufacturing. This standard allows manufacturers to identify and prevent microbial contamination, ensuring product quality and consumer safety.
Scope and Applications of ISO 18416
Products tested include cosmetic and personal care products such as moisturizers, creams, lotions, serums, shampoos and conditioners, hair gels and sprays, foundations, CC creams, eye makeup products, and more.
Test Method
Sample preparation:
Sample preparation is the most significant first step in the ISO 18416 test. This involves:
Collection: A representative sample of the cosmetics is taken.
Dilution: The sample is diluted with an adequate buffer solution, achieving an optimal concentration for the microbial analysis.
Homogenization: The sample is homogenized for uniformity, necessary for the accurate detection of Candida albicans.
Incubation:
- The enrichment broth is inoculated with the cosmetic product and incubated at 32.5ยฐC for 24-72 hours before transferring the cultures to a selective medium. Selective agar medium is incubated at 32.5ยฐC and examined at 24 and 48 hours.
Detection of Candida albicans:
- The presence or absence of Candida albicans in the cosmetic sample is detected by observing compatible colonies.
- Phenotypic and morphological tests are performed on the recovered colonies to further identify Candida albicans.
Importance of ISO 18416 Test
Candida albicans is an opportunistic pathogenic yeast that can cause infections on the skin and in the eyes. Such infectious microbes in cosmetics signify a failure in hygiene in the manufacturing process. Hence, ISO 18416 testing is essential for the quality assurance of cosmetic products and consumer protection.
Benefits of ISO 18416
- Specificity for Candida albicans: This standard promotes testing specifically for Candida albicans-a, a common contaminant found in cosmetic product formulations.
- Standard test protocol: This establishes a general test method to produce reproducible and consistent testing outcomes with respect to laboratories and industries.
- Regulatory compliance: It allows the manufacturer to comply with regulatory requirements and industry standards for the verification of safety and quality.
- Protection of health standards: The standard greatly limits the probability of contamination of cosmetics, thus safeguarding health by preventing any possibility of skin infections.
Conclusion
At MIS, we provide a comprehensive range of testing services tailored to meet your testing needs. Our state-of-the-art laboratories are equipped with advanced instruments to ensure your products are analyzed with utmost precision. We also conduct ISO 18415 tests for water-immiscible cosmetic products.
For more information on ISO 18416, or to receive a quote contact our experts today.
Frequently Asked Questions
DR. Martinoz Scholtz
ISO 18416 is a standard test method for detecting Candida albicans (qualitative analysis) in cosmetic or other topical skin products.
This test is applicable for cosmetic and personal care products with microbiological risk for Candida albicans.
It takes 8-9 days to complete this test.
Germ tube test is a diagnostic method used to identify Candida albicans by observing the growth of germ tubes which is a tube-like structure that arises from yeast cells.
Cosmetic products with high water activity, hydro-alcoholic products, and neutral pH products can be tested using this standard.
The frequency of testing depends on the product and manufacturing process. It is recommended to conduct testing during product development, batch production, and periodically as part of quality control to ensure ongoing compliance and safety.
The main steps of this test include the preparation of the initial suspension in an enrichment broth followed by incubation of the inoculated broth to increase microbial count. After incubation, Candida albicans is isolated on a selective agar medium and identification is performed through morphological and biochemical tests.
This test specifically detects Candida albicans in cosmetics. Other tests may focus on diverse microorganisms and samples with varied methods.
The test ensures that cosmetic products are free of Candida albicans contamination thus meeting safety regulations.
Limitations include potential false negatives due to antimicrobial agents inhibiting microbial growth and that the test is specific to Candida albicans which might miss other contaminants.
Yes, the test can be adapted to suit various product formulations by using specific neutralizers and diluents to neutralize the effects of antimicrobial agents thus aiding in accurate detection of Candida albicans.
Not performing this test can result in undetected microbial contamination, leading to product spoilage, health issues, non-compliance, recalls, and legal problems.
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