ISO 16212:2017 gives general guidelines for enumeration of yeast and mould present in cosmetics by counting the colonies on selective agar medium after aerobic incubation. 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 ISO 16212:2017 is applicable. Products considered to present a low microbiological risk (see ISO 29621) include those with low water activity or extreme pH values, hydro-alcoholic products, etc. Because of the large variety of cosmetic products within this field of application, this method might not be suited to some products in every detail (e.g. certain water-immiscible products). Other methods (e.g. automated) can be substituted for the tests presented here provided that their equivalence has been demonstrated or the method has been otherwise shown to be suitable. Yeast enumerated can be identified using suitable identification tests, for example, tests described in the standards listed in the Bibliography. Mould enumerated can be identified by other appropriate methods, if necessary.
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Sisällysluettelo
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Principles
4.1 General
4.2 Plate count
4.3 Membrane filtration
5 Diluents, neutralizers and culture media
5.1 General
5.2 Neutralizing diluents and diluents
5.3 Diluent for yeast suspension (tryptone sodium chloride solution)
5.4 Culture media
6 Apparatus and glassware
7 Strain 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
10 Counting of colonies (plate counts and membrane filtration methods)
11 Expression of results
11.1 Method of calculation for plate count
11.2 Interpretation
12 Neutralization of the antifungicidal properties of the product
12.1 General
12.2 Preparation of inoculum
12.3 Suitability of counting methods
13 Test report
Annex A Other neutralizing diluents (informative)
Annex B Other diluents (informative)
Annex C Other culture media (informative)
Annex D Neutralizers of antifungicidal 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