M/426 - Cosmetic products

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.

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.

This document gives general instructions for carrying out microbiological examinations of cosmetic
products, in order to ensure their quality and safety, in accordance with an appropriate risk analysis
(e.g. low water activity, hydro-alcoholic, extreme pH values).
Because of the large variety of products and potential uses within this field of application, these
instructions might not be appropriate for some products in every detail (e.g. certain water-immiscible
products).

This document 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.

ISO 21148:2017 gives general instructions for carrying out microbiological examinations of cosmetic products, in order to ensure their quality and safety, in accordance with an appropriate risk analysis (e.g. low water activity, hydro-alcoholic, extreme pH values).
Because of the large variety of products and potential uses within this field of application, these instructions might not be appropriate for some products in every detail (e.g. certain water-immiscible products).

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.

This International Standard gives general guidelines for the detection and identification of the specified
microorganism Escherichia coli i n c osmetic p roducts. M icroorganisms c onsidered a s s pecified i n t his
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.

This International Standard gives general guidelines for the detection and identification of the specified
microorganism Candida albicans i n c osmetic products. M icroorganisms c onsidered a s s pecified i n t his
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.

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.

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.

ISO 22718:2015 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.

ISO 22717:2015 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.

ISO 18416:2015 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.

ISO 21150:2015 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.

This International Standard comprises: - a preservation efficacy test; - a procedure for evaluating the overall antimicrobial protection of a cosmetic product which is not considered low risk, based on a risk assessment described in ISO 29621. This International Standard provides a procedure for the interpretation of data generated by the preservation efficacy test or by the microbiological risk assessment, or both.

ISO 11930:2012 comprises a preservation efficacy test and a procedure for evaluating the overall antimicrobial protection of a cosmetic product which is not considered low risk.
ISO 11930:2012 provides a procedure for interpretation of data generated by the preservation efficacy test or by the microbiological risk assessment, or both.

ISO 21148:2005 gives general instructions for carrying out microbiological examinations of cosmetic products, in order to ensure their quality and safety, in accordance with an appropriate risk analysis (e.g. low water activity, hydro-alcoholic, extreme pH values).
Because of the large variety of products and potential uses within this field of application, these instructions might not be appropriate for some products in every detail (e.g. certain water-immiscible products).

ISO 21149:2006 gives general guidelines for enumeration and detection of mesophilic aerobic 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 validated.
If needed, microorganisms enumerated or detected may be identified using suitable identification tests described in the standards given in the Bibliography.

ISO 22717:2006 gives general guidelines for the detection and identification of the specified micro-organism Pseudomonas aeruginosa in cosmetic products. Micro-organisms considered as specified in this ISO 22717:2006 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 ISO 22717:2006 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 ISO 22717:2006 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.
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 validated.

ISO 21150:2006 gives general guidelines for the detection and identification of the specified microorganism Escherichia coli in cosmetic products. Microorganisms considered as specified in ISO 21150:2006 might differ from country to country according to national practices or regulations.
ISO 21150:2006 specifies a method that 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.
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 may be more appropriate.

ISO 22718:2006 gives general guidelines for the detection and identification of the specified micro-organism Staphylococcus aureus in cosmetic products. Micro-organisms 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 ISO 22718:2006 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 ISO 22718:2006 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.
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 validated.

ISO 18416:2007 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.
The method described in ISO 18416:2007 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.
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 International Standards (e.g. ISO 18415) might 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 validated.