CEN/TC 392 - Cosmetics

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.

This document specifies a method for the in vivo determination of UVA protection factor (UVAPF) of sunscreen products. It is applicable to products that contain any component able to absorb, reflect or scatter ultraviolet (UV) rays and which are intended to be placed in contact with human skin.
This document provides a basis for the evaluation of sunscreen products for the protection of human skin against UVA radiation induced by solar ultraviolet rays.

This document specifies an analytical procedure for direct determination of traces of mercury in finished cosmetic products by thermal decomposition – atomic absorption spectrometry (mercury analyser).
This document aims to provide a procedure of quantification of mercury traces in cosmetic products that consumers can be exposed to in their usage. This method describes the determination of mercury traces in cosmetics by direct solid analysis with no need of prior digestion. Total mercury (both inorganic and organic species) can be quantified either in solid or liquid samples.

This document specifies a method for determination of mercury in cosmetics by means of cold vapour atomic absorption spectrometry (AAS) with a prior pressure digestion.

This document specifies an in vitro procedure to characterize the UVA protection of sunscreen products. Specifications are given to enable determination of the spectral absorbance characteristics of UVA protection in a reproducible manner.
In order to determine relevant UVA protection parameters, the method has been created to provide an UV spectral absorbance curve from which a number of calculations and evaluations can be undertaken. These include calculation of the Ultraviolet-A protection factor (UVA-PF) [correlating with in vivo UVA-PF from the persistent pigment darkening (PPD) testing procedure], critical wavelength and UVA absorbance proportionality. These computations are optional and relate to local sunscreen product labelling requirements. This method relies on the use of static in vivo SPF results for scaling the UV absorbance curve.
This document is not applicable to powder products such as pressed powder and loose powder products.

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.

This document specifies a procedure for evaluating the water resistance retention percentage, by comparing the sun protection factor (SPF) before water immersion (hereafter referred to as the "static" SPF) and after a fixed period of water immersion (hereafter referred to as the "wet" SPF).

This document specifies a procedure of water immersion for the in vivo determination of the water resistance of sunscreen products.
This document is applicable to products intended to be placed in contact with human skin including any component able to absorb, reflect or scatter UV rays and which, in addition, are designed to be less readily removed from the skin by water and/or during water immersion. It is intended to be read in conjunction with ISO 24444.

This document provides a method for quantification of trace levels of heavy metals in cosmetic products.
This document refers only to chromium, cobalt, nickel, arsenic, cadmium, antimony and lead. The methodology can apply to other elements, however, it is the responsibility of the analyst to demonstrate that it fits that purpose.

This document specifies a method for the in vivo determination of the sun protection factor (SPF) of sunscreen products. It is applicable to products that contain any component able to absorb, reflect or scatter ultraviolet (UV) rays and which are intended to be placed in contact with human skin.
This document provides a basis for the evaluation of sunscreen products for the protection of human skin against erythema induced by solar ultraviolet rays.

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 an analytical method, based on liquid-chromatography (LC) with ultraviolet/visible spectrometry (UV/Vis) detection for the detection and quantitative determination of 22 organic UV filters in use in the EU framework. This method has been validated for emulsion-based cosmetic products, lip-balms, lotions and waters.

This European Standard specifies a HPLC/UV method for the identification and quantification of hydroquinone, 3 ethers of hydroquinone and 4 corticosteroids most frequently found in illegally sold skin whitening cosmetic products: clobetasol propionate, betamethasone dipropionate, fluocinonide and fluocinolone acetonide.
This standard also gives HPLC/UV methods for the identification of 38 corticosteroids that may be found in skin whitening cosmetic products (see Annex D).
This standard is not dedicated to artificial nail products or soaps.

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.

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.

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 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.

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.

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.

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/TR 19838:2016 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.
ISO/TR 19838:2016 can be used to fulfil the requirements of the ISO standard on microbiological limits (ISO 17516).

ISO 17516:2014 is applicable for all cosmetics and assists interested parties in the assessment of the microbiological quality of the products. Microbiological testing does not need to be performed on those products considered to be microbiologically low risk.

This European Standard describes a GC/MS method for the assay of 12 phthalates, amongst which the 8 phthalates regulated by the European cosmetic regulation 1223/2009 [16]. This method is given for the analysis of samples ready for analytical injection from cosmetic products or raw materials used in cosmetic products. Samples should be compatible with GC analysis possibly after dilution. This method does not include requirements for the preparation of samples in cosmetic matrices for which direct injection in GC is not feasible.

This European Standard specifies a multi-screening method using reversed-phase HPLC for the detection of UV-filters listed in the cosmetic regulations. The method is applicable for the quantitative determination of 10 UV-filters, which are mainly used in emulsion-based cosmetic products and sunscreen sprays particularly with regard to the maximum concentration listed in the cosmetic regulation.
Other analytical methods for the qualification and quantification of UV-filters may be used if they lead to comparable results.

This European Standard specifies a method for the quantitative determination of 3 iodo 2 propynyl butylcarbamate (IPBC) in the concentration range from 0,005 g/100 g to 0,1 g/100 g - Annex V No. 56 in Regulation (EC) No 1223/2009 on cosmetic products.

This European Standard specifies an analytical method for the detection and quantitative determination of the following anti-dandruff agents: zinc pyrithione, piroctone olamine and climbazole in surfactant-containing cosmetic products in the concentration range from 0,1 g/100 g to 1,0 g/100 g.
NOTE   The method is also suitable for the determination of ketoconazole and ciclopirox olamine (q.v. Annex A) in surfactant-containing cosmetic products and it is probably applicable for the determination of the substances in non surfactant-containing cosmetic products. For these purposes, the method has not been validated.

ISO/TR 24475:2010 is aimed at contributing to the training of personnel in cosmetic production plants within the context of the introduction of Good Manufacturing Practices.
It is intended to complement personal involvement and reasoning in the implementation of ISO 22716.
ISO/TR 24475:2010 covers the quality aspects of the cosmetic product, but does not take into account safety aspects for the personnel, nor does it cover aspects of protection of the environment or those concerning the safety and efficacy of the finished products.
ISO/TR 24475:2010 cannot be used alone and needs as a prerequisite a good knowledge of ISO 22716 which is the reference document.

ISO/TR 26369:2009 reviews and evaluates the methods which are currently used to assess, for regulatory or self-regulatory purposes, the photoprotection of sun protection products applied on human body.
It is applicable to SPF and UVA protection, and both in vivo and in vitro methods.

ISO 22716:2007 gives guidelines for the production, control, storage and shipment of cosmetic products.
These guidelines cover the quality aspects of the product, but as a whole do not cover safety aspects for the personnel engaged in the plant, nor do they cover aspects of protection of the environment.
The guidelines in ISO 22716:2007 are not applicable to research and development activities and distribution of finished products.

This International Standard specifies a method for the in vitro determination of Sun Protection Factor. This International standard is applicable to sunscreen products with an emulsion chassis, which are intended to be placed in contact with human skin.

ISO 24442:2011 specifies an in vivo method for assessment of the UVA protection factor (UVAPF) of topical sunscreen products. It is applicable to cosmetics, drugs and other products intended to be topically applied to human skin, including any component able to absorb, reflect or scatter UV rays.
ISO 24442:2011 provides a basis for the evaluation of sunscreen products for the protection of human skin against UVA radiation from solar or other light sources.

ISO 24443:2012 specifies an in vitro procedure to characterize the UVA protection of sunscreen products. Specifications are given to enable determination of the spectral absorbance characteristics of UVA protection in a reproducible manner.
In order to determine relevant UVA protection parameters, the method has been created to provide a UV spectral absorbance curve from which a number of calculations and evaluations can be undertaken. This method relies on the use of in vivo SPF results for scaling the UV absorbance curve.

ISO 24444:2010 specifies a method for the in vivo determination of the sun protection factor (SPF) of sunscreen products. This International Standard is applicable to products that contain any component able to absorb, reflect or scatter ultraviolet (UV) rays and which are intended to be placed in contact with human skin.
ISO 24444:2010 provides a basis for the evaluation of sunscreen products for the protection of human skin against erythema induced by solar ultraviolet rays.

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 16212:2008 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, so as to determine the types of cosmetic products to which ISO 16212:2008 is applicable. Products considered to present a low microbiological risk include those with low water activity, hydro-alcoholic products, extreme pH values, etc.

ISO 18415:2007 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 International Standard 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.
The method described in ISO 18415:2007 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 18415:2007 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 International Standard, may be identified by using suitable tests according to a general scheme.

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.

The objective of ISO 29621:2010 is to help cosmetic manufacturers and regulatory bodies define those finished products that, based on a risk assessment, present a low risk of microbial contamination during production and/or use, and therefore, do not require the application of microbiological International Standards for cosmetics.