ISO 18416: 2017

Detection of Candida albicans in Cosmetic Products

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Quick understanding of the test

ISO 18416: 2017 - Detection of Candida albicans in Cosmetic Products

The test is used to detect the presence of Candida albicans in cosmetic and personal care products.
This test applies to cosmetic and personal care products, including moisturizers, lotions, serums, shampoos, and more.

Mandatory test strains

The test involves diluting the cosmetic sample in an enrichment broth. The broth is then incubated and transferred to a selective agar medium for further incubation. Candida albicans is identified through colony observation and morphological tests.

Turnaround Time

Approximately 8–9 days.

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

Cosmetics products are an integral part of our daily lives and are frequently used to enhance personal appearance. However, the ingredients used in these products can support the growth of various microorganisms that can be harmful to humans. Hence, it is important to test these products to determine the presence of any form of microbial contamination before they are marketed for use. 

ISO 18416 provides a standard test method for the detection of Candida albicans in cosmetic products. This pathogen is responsible for mild skin infections to severe systemic infections and hence, essential to test cosmetic products for Candida contamination.

Products tested

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: 

  • The cosmetic test sample is directly diluted in an enrichment broth at a 1:10 ratio, given that the sample is homogeneous in water.
  • In case the sample is non-homogenous in water, the sample is mixed with a solubilizing agent before adding it to the enrichment broth.
  • For cosmetic samples that contain any antimicrobial agent acting as a preservative, the enrichment broth is supplemented with a suitable neutralizing agent for the antimicrobial agent.

Incubation: 

  • The enrichment broth inoculated with the cosmetic product is incubated at 32.5°C for 24 to 72 hrs and then transferred to a selective medium.
  • The selective agar medium is incubated at 32.5°C 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 for further identification of Candida albicans.

Importance of ISO 18416 Test

Candida albicans is an opportunistic pathogenic yeast that can cause skin and eye infections if present in cosmetic or personal care products. The detection of such infectious microbes in cosmetics implies a lapse in hygiene during the manufacturing process. Thus, ISO 18416 testing is vital for ensuring the quality of cosmetic products and the safety of consumers.

Pros and cons of ISO 18416

Pros

  • Specificity for Candida albicans: The standard is designed to specifically detect Candida albicans which is a common contaminant of cosmetic products.
  • Standard test protocols: Provides a standard method thus ensuring consistency and reliability across different laboratories and manufacturers.
  • Regulatory compliance: Helps manufacturers comply with regulatory requirements and industry standards thereby ensuring product safety and quality.
  • Consumer safety: Reduces the risk of contamination in cosmetic products thus protecting consumer health and preventing skin infections.
  • Quality assurance: Improves the overall quality assurance process by detecting contamination in the early stages of product development.

Conclusions

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

MIS Labs
1. What is the ISO 18416 test?

ISO 18416 is a standard test method for detecting Candida albicans (qualitative analysis) in cosmetic or other topical skin products.

2. What are the products that can be tested with this test?

This test is applicable for cosmetic and personal care products with microbiological risk for Candida albicans.

3. What is the turnaround time for the ISO 18416 test?

It takes 8-9 days to complete this test.

4. What is a germ tube 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.

5. What types of products require this testing?

Cosmetic products with high water activity, hydro-alcoholic products, and neutral pH products can be tested using this standard.

6. How often should a product 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.



7. What are the main steps involved in the testing process?

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.

8. How does this test differ from other microbiological testing methods?

This test specifically detects Candida albicans in cosmetics. Other tests may focus on diverse microorganisms and samples with varied methods.

9.How does this test help in maintaining regulatory compliance?

The test ensures that cosmetic products are free of Candida albicans contamination thus meeting safety regulations.

10. Are there any limitations to this test that manufacturers should be aware of?

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.

11. Can this test be customized for different types of surface-active agents?

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.

12. What are the potential risks of not performing this test?

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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