07.100.40 - Cosmetics microbiology
ICS 07.100.40 Details
Cosmetics microbiology
Microbiologie des produits cosmétiques
Kozmetika - mikrobiologija
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This document specifies the minimum requirements for quality control of microbiological culture
media and diluents in order to demonstrate their ability to detect microorganisms and to ensure
reliability of the microbiological test methods described in the ISO cosmetics microbiology standards.
This document describes mainly growth promotion and microbial control tests and is applicable to
both commercially ready-to-use culture media and culture media prepared from dehydrated culture
media or basic constituents in the user’s laboratory.
Other methods can be substituted provided that their equivalence has been demonstrated.
- Standard30 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the minimum requirements for quality control of microbiological culture media and diluents in order to demonstrate their ability to detect microorganisms and to ensure reliability of the microbiological test methods described in the ISO cosmetics microbiology standards.
This document describes mainly growth promotion and microbial control tests and is applicable to both commercially ready-to-use culture media and culture media prepared from dehydrated culture media or basic constituents in the user’s laboratory.
Other methods can be substituted provided that their equivalence has been demonstrated.
- Standard30 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the minimum requirements for quality control of microbiological culture media and diluents in order to demonstrate their ability to detect microorganisms and to ensure reliability of the microbiological test methods described in the ISO cosmetics microbiology standards. This document describes mainly growth promotion and microbial control tests and is applicable to both commercially ready-to-use culture media and culture media prepared from dehydrated culture media or basic constituents in the user’s laboratory. Other methods can be substituted provided that their equivalence has been demonstrated.
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This document gives guidance for the enumeration and/or detection of microorganisms present in a cosmetic product that is impregnated or coated onto a substrate (i.e. wipes and masks) where sampling and microbiological influence of the manufactured product presents particular challenges in terms of microbiological sampling and testing.
The principle of this document can also be applied to test similar products (e.g. cushion, impregnated sponge, etc.) or applicators (e.g. brush, puff, sponge, etc.) with modification of the procedure as appropriate.
- Standard35 pagesEnglish languagesale 10% offe-Library read for1 day
This document gives guidance for the enumeration and/or detection of microorganisms present in a
cosmetic product that is impregnated or coated onto a substrate (i.e. wipes and masks) where sampling
and microbiological influence of the manufactured product presents particular challenges in terms of
microbiological sampling and testing.
The principle of this document can also be applied to test similar products (e.g. cushion, impregnated
sponge, etc.) or applicators (e.g. brush, puff, sponge, etc.) with modification of the procedure as
appropriate.
- Standard35 pagesEnglish languagesale 10% offe-Library read for1 day
This document gives guidance for the enumeration and/or detection of microorganisms present in a cosmetic product that is impregnated or coated onto a substrate (i.e. wipes and masks) where sampling and microbiological influence of the manufactured product presents particular challenges in terms of microbiological sampling and testing.
The principle of this document can also be applied to test similar products (e.g. cushion, impregnated sponge, etc.) or applicators (e.g. brush, puff, sponge, etc.) with modification of the procedure as appropriate.
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This document gives guidance for the enumeration and/or detection of microorganisms present in a cosmetic product that is impregnated or coated onto a substrate (i.e. wipes and masks) where sampling and microbiological influence of the manufactured product presents particular challenges in terms of microbiological sampling and testing. The principle of this document can also be applied to test similar products (e.g. cushion, impregnated sponge, etc.) or applicators (e.g. brush, puff, sponge, etc.) with modification of the procedure as appropriate.
- Standard32 pagesEnglish languagesale 10% offe-Library read for1 day
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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.
- Standard30 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard30 pagesEnglish languagesale 10% offe-Library read for1 day
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.
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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.
- Standard27 pagesEnglish languagesale 10% offe-Library read for1 day
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).
- Standard30 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard33 pagesEnglish languagesale 10% offe-Library read for1 day
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 their equivalence has been demonstrated or the method has been otherwise shown to be suitable.
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This document gives guidance to cosmetic manufacturers and regulatory bodies to help define those
finished products that, based on a risk assessment, present a low risk of microbial contamination
during production and/or intended use, and therefore, do not require the application of microbiological
International Standards for cosmetics.
- Standard19 pagesEnglish languagesale 10% offe-Library read for1 day
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).
- Standard30 pagesEnglish languagesale 10% offe-Library read for1 day
This document 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 this document 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.
- Standard27 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard33 pagesEnglish languagesale 10% offe-Library read for1 day
This document 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 this document 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 their equivalence has been
demonstrated or the method has been otherwise shown to be suitable.
- Standard28 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 29621:2017 gives guidance to cosmetic manufacturers and regulatory bodies to help define those finished products that, based on a risk assessment, present a low risk of microbial contamination during production and/or intended use, and therefore, do not require the application of microbiological International Standards for cosmetics.
- Standard19 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard19 pagesEnglish languagesale 15% off
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- Standard21 pagesFrench languagesale 15% off
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.
- Standard24 pagesEnglish languagesale 15% off
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- Standard24 pagesFrench languagesale 15% off
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 their equivalence has been demonstrated or the method has been otherwise shown to be suitable.
- Standard19 pagesEnglish languagesale 15% off
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- Standard19 pagesFrench languagesale 15% off
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).
- Standard21 pagesEnglish languagesale 15% off
- Standard21 pagesEnglish languagesale 15% off
- Standard22 pagesFrench languagesale 15% off
- Standard22 pagesFrench languagesale 15% off
ISO 29621:2017 gives guidance to cosmetic manufacturers and regulatory bodies to help define those finished products that, based on a risk assessment, present a low risk of microbial contamination during production and/or intended use, and therefore, do not require the application of microbiological International Standards for cosmetics.
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This Technical Report gives general guidelines to explain the use of ISO cosmetic microbiological
standards depending on the objective (in-market control, product development, etc.) and the product
to be tested.
This Technical Report can be used to fulfil the requirements of the ISO standard on microbiological
limits (ISO 17516).
- Technical report23 pagesEnglish languagesale 10% offe-Library read for1 day