ISO 21149:2017 gives general guidelines for enumeration and detection of aerobic mesophilic bacteria present in cosmetics - by counting the colonies on agar medium after aerobic incubation, or - by checking the absence of bacterial growth after enrichment. Because of the large variety of cosmetic products within this field of application, this method may not be appropriate for some products in every detail (e.g. certain water immiscible products). 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. If needed, microorganisms enumerated or detected may be identified using suitable identification tests described in the standards given in the Bibliography. 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 products to which this document is applicable. Products considered to present a low microbiological risk (see ISO 29621) include those with low water activity, hydro-alcoholic products, extreme pH values, etc.
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Sisällysluettelo
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
4.1 General
4.2 Plate count
4.3 Membrane filtration
4.4 Detection of bacteria by enrichment
5 Diluents, neutralizers and culture media
5.1 General
5.2 Neutralizing diluents and diluents
5.3 Diluent for the bacterial suspension (tryptone sodium chloride solution)
5.4 Culture media
6 Apparatus and glassware
7 Strains of microorganisms
8 Handling of cosmetic products and laboratory samples
9 Procedure
9.1 General recommendation
9.2 Preparation of the initial suspension
9.3 Counting methods
9.4 Enrichment
10 Counting of colonies (plate counts and membrane filtration methods)
11 Detection of growth (enrichment method)
12 Expression of results
12.1 Method of calculation for plate count
12.2 Interpretation
12.3 Examples
12.4 Detection after enrichment
13 Neutralization of the antimicrobial properties of the product
13.1 General
13.2 Preparation of inoculum
13.3 Suitability of counting methods
13.4 Suitability of the detection method by enrichment
13.5 Interpretation of suitability test results
14 Test report
Annex A Other neutralizing diluents (informative)
Annex B Other diluents (informative)
Annex C Other culture media (informative)
Annex D Neutralizers of antimicrobial activity of preservatives and rinsing liquids (informative)
EN 12353:2013 Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
EN 12353:2021 Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
ISO 21148:2017 Cosmetics -- Microbiology -- General instructions for microbiological examination
EN 12353:2013 Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
EN 12353:2021 Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
ISO 21148:2017 Cosmetics -- Microbiology -- General instructions for microbiological examination