BS EN ISO 18415:2011

This International Standard gives general guidelines for the detection and identification of specified microorganisms in cosmetic products as well as for the detection and identification of other kinds of aerobic mesophilic non-specified microorganisms in cosmetic products.

Microorganisms considered as specified in this International Standard might differ from country to country according to national practices or regulations. Most of them considered as specified microorganisms include one or more of the following species: Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus and Candida albicans.

In order to ensure product quality and safety for consumers, it is advisable to perform an appropriate microbiological risk analysis in order to determine the types of cosmetic product to which this International Standard is applicable. Products considered to present a low microbiological 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 microbial growth in a non-selective liquid medium (enrichment broth) suitable to detect microbial contamination, followed by isolation of microorganisms on non-selective agar media. Other methods can be appropriate depending on the level of detection required.

In this International Standard specific indications are given for identification of Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus and Candida albicans. Other microorganisms that grow under the conditions described in this International Standard, may be identified by using suitable tests according to a general scheme (see Annex A). Other standards (e.g., ISO 18416, ISO 21150, ISO 22717, ISO 22718) may be appropriate.

Because of the large variety of cosmetic products within this field of application, this method might not be suited in every detail, to some products (e.g. certain water-immiscible products). Other methods (e.g. automated) can be substituted for the test presented here provided that their equivalence has been demonstrated or the method has been otherwise validated.