Kosmetikans mikrobiologi

Kommittébeteckning: SIS/TK 495 (Kosmetik samt analysmetoder för allergener)
Källa: CEN
Svarsdatum: den 9 feb 2022
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This document specifies a procedure for the interpretation of data generated by the preservation efficacy test or by the microbiological risk assessment, or both, when evaluating the overall antimicrobial protection of a cosmetic product.
It comprises:
— a preservation efficacy test;
— a procedure for evaluating the overall antimicrobial protection of a cosmetic product that is not considered low risk, based on a risk assessment described in ISO 29621.
The preservation efficacy test is a reference method to evaluate the preservation of a cosmetic formulation. It is applicable to cosmetic products in the marketplace.
This test does not apply to those cosmetic products for which the microbiological risk has been determined to be low according to Annex A and ISO 29621.
This test is primarily designed for water-soluble or water-miscible cosmetic products and can be used with modification to test products in which water is the internal (discontinuous) phase.
NOTE This test can be used as a guideline to establish a development method during the development cycle of cosmetic products. In this case, the test can be modified or extended, or both, for example, to make allowance for prior data and different variables (microbial strains, media, incubation conditions exposure time, etc.). Compliance criteria can be adapted to specific objectives. During the development stage of cosmetic products, other methods, where relevant, can be used to determine the preservation efficacy of formulations.

Kommittébeteckning: SIS/TK 495 (Kosmetik samt analysmetoder för allergener)
Källa: CEN
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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.

Kommittébeteckning: SIS/TK 495 (Kosmetik samt analysmetoder för allergener)
Källa: CEN
Svarsdatum: den 9 feb 2022
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ISO 18415:2017 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 document 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 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.
The method described in this document 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 ISO 18415:2017 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 document 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 tests presented here provided that thei ...

Kommittébeteckning: SIS/TK 495 (Kosmetik samt analysmetoder för allergener)
Källa: CEN
Svarsdatum: den 9 feb 2022
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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.

Kommittébeteckning: SIS/TK 495 (Kosmetik samt analysmetoder för allergener)
Källa: CEN
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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.

Kommittébeteckning: SIS/TK 495 (Kosmetik samt analysmetoder för allergener)
Källa: CEN
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This International Standard gives general guidelines for the detection and identification of the specified microorganism Escherichia coli 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, so as to determine the types of cosmetic products 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 Escherichia coli in a non-selective liquid medium (enrichment broth), followed by isolation on a selective agar medium. Other methods may be appropriate, depending on the level of detection required.NOTE For the detection of Escherichia coli, 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 might not be suited to some products in every detail (e.g. certain water-immiscible products). Other International Standards (ISO 18415) may be appropriate. 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 shown to be suitable.

Kommittébeteckning: SIS/TK 495 (Kosmetik samt analysmetoder för allergener)
Källa: CEN
Svarsdatum: den 9 feb 2022
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This International Standard gives general guidelines for the detection and identification of the specified microorganism Pseudomonas aeruginosa 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 Pseudomonas aeruginosa in a non-selective liquid medium (enrichment broth), followed by isolation on a selective agar medium. Other methods may be appropriate, depending on the level of detection required.NOTE For the detection of Pseudomonas aeruginosa, 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.

Kommittébeteckning: SIS/TK 495 (Kosmetik samt analysmetoder för allergener)
Källa: CEN
Svarsdatum: den 9 feb 2022
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This International Standard gives general guidelines for the detection and identification of the specified microorganism Staphylococcus aureus 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 Staphylococcus aureus 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 Staphylococcus aureus, 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 for some products in every detail (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.