ISO 18416:2015 pdf download

ISO 18416:2015 pdf download.Cosmetics — Microbiology — Detection of Candida albicans
1 Scope
This International Standard gives general guidelines for the detection and identification of the specified microorganism Candida albicans in cosmetic products. Microorganisms considered as specified in this International Standard might differ from country to country according to national practices or regulations. In order to ensure product quality and safety for consumers, it is advisable to perform an appropriate microbiological risk analysis to determine the types of cosmetic product to which this International Standard is applicable. Products considered to present a low microbiological (see ISO 29621) risk include those with low water activity, hydro-alcoholic products, extreme pH values, etc. The method described in this International Standard is based on the detection of Candida albicans in a non-selective liquid medium (enrichment broth), followed by isolation on a selective agar medium. Other methods may be appropriate dependent on the level of detection required. NOTE For the detection of Candida albicans , subcultures can be performed on non-selective culture media followed by suitable identification steps (e.g. using identification kits). Because of the large variety of cosmetic products within this field of application, this method may not be appropriate in every detail for some products (e.g. certain water immiscible products). Other International Standards (ISO 18415) may be appropriate. Other methods (e.g. automated) may be substituted for the tests presented here provided that their equivalence has been demonstrated or the method has been otherwise shown to be suitable.
3.4 sample dilution
dilution of the initial suspension
3.5 specified microorganism
aerobic mesophilic bacterium or yeast that is undesirable in a cosmetic product and is recognized as a skin pathogen species that may be harmful for human health or as an indication of hygienic failure in the manufacturing process
3.6 Candida albicans
yeast that form white to beige, creamy and convex colonies on the surface of a selective medium
Note 1 to entry: The main characteristic for identification is the production of germ tube and/or pseudomycelium and chlamydospore when the test is performed following the method specified in this International Standard.
3.7 enrichment broth
non-selective liquid medium containing suitable neutralizers and/or dispersing agents and demonstrated to be suitable for the product under test
4 Principle
The first step of the procedure is to perform an enrichment by using a non-selective broth medium to increase the number of microorganisms without the risk of inhibition by the selective ingredients that are present in selective/differential growth media. The second step of the test (isolation) of the test is performed on a selective medium followed by identification tests. The possible inhibition of microbial growth by the sample shall be neutralized to allow the detection of viable microorganisms. [1] In all cases and whatever the methodology, the neutralization of the antimicrobial properties of the product shall be checked and demonstrated (see Clause 11).