ISO/TC 217 - Cosmetics

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 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 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 provides answers to questions which can arise when calculating indexes and contents according to ISO 16128-1 and ISO 16128-2. It clarifies conditions on process, solvents and carbon sources to qualify ingredients regarding the ISO 16128 series. Detailed examples, explaining how to use the ISO 16128 series are also provided.

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 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 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 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 defines a global approach for the validation of a quantitative analytical method, based on the construction and interpretation of an accuracy profile, and specifies its characterization procedure. This procedure is particularly applicable for internal validation in a cosmetic testing laboratory, but its scope can be extended to the interpretation of data collected for an interlaboratory study designed according to the recommendations of the ISO 5725-1. It does not apply to microbiological trials. The present approach is particularly suited to handle the wide diversity of matrices in cosmetics. This document only applies to already fully-developed and finalized methods for which selectivity/specificity have already been studied and the scope of the method to be validated has already been defined, in terms of matrix types and measurand (for example analyte) concentrations.

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 describes additional information to use with ISO 16128-2 for the special situation of hydrolates. It clarifies the method of determining the organic index in the absence of measurement of the quantity of water introduced.

This document describes the industry best practices to address the concentration of extracts which is related to ISO 16128-2:2017, 4.2. Evaporation of solvents to dryness it not addressed in this document. This document aims to delineate the cases when an extract is produced and, afterwards the mixture of evaporated solvents used, regardless of the categories, are partially evaporated. The producer of the extract can utilize different approaches (e.g. measurement by instrumentation, characterization of solvent volatility, published values of evaporation rates, etc.) to determine the index (es) of the extract. Despite the approach and justification, the rational and determinations used is made available to interested parties, when requested.

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.

ISO/TR 18811:2018 gives guidelines for the stability testing of cosmetic products. It reviews readily available bibliographic references that provide a resource for the assessment of the stability of cosmetic products. This review of the available guidelines that assess the stability of cosmetic products can serve as a technical/scientific framework to identify the most suitable methods for the assessment of the stability of cosmetic products. ISO/TR 18811:2018 does not aim to specify the conditions, parameters or criteria of stability testing. Considering the wide variety of cosmetic products, storage and use conditions, it is not possible to define a single way to assess product stability. Therefore, it is up to the manufacturer to specify and justify the stability protocol to cover test methods, specifications and conditions at which products will be tested.

ISO 16128-2:2017 describes approaches to calculate natural, natural origin, organic and organic origin indexes that apply to the ingredient categories defined in ISO 16128‑1. This document also offers a framework to determine the natural, natural origin, organic and organic origin content of products based on the ingredient characterization. Neither ISO 16128‑1 nor this document addresses product communication (e.g. claims and labelling), human safety, environmental safety, socio-economic considerations (e.g. fair trade), characteristics of packaging materials or regulatory requirements applicable for cosmetics. ISO 16128-2:2017 builds on and enhances ISO 16128‑1. It is intended to be used in conjunction with ISO 16128‑1.

ISO/TR 18818:2017 describes a screening method for rapid sampling and identifying of diethanolamine (DEA) in cosmetics and raw materials used in cosmetics by gas chromatography ? mass spectroscopy (GC-MS). This method is not applicable to the detection and/or quantification of DEA-related ingredients. When this method is used to analyse unfamiliar sample matrices analysts are advised to confirm the applicability and flexibility of the techniques in their matrix. Under the conditions specified this method is reliable for quantification with DEA level at 1 000 mg/kg (0,1 %). However, samples with lower concentrations (

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 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 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 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/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 16128-1:2016 provides guidelines on definitions for natural and organic cosmetic ingredients. In addition to natural and organic ingredients, other ingredient categories which may be necessary for natural and organic product development are defined with associated restrictions. ISO 16128 does not address product communication (e.g. claims and labelling), human safety, environmental safety and socio-economic considerations (e.g. fair trade), and the characteristics of packaging materials or regulatory requirements applicable for cosmetics.

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 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 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 15819:2014 describes a method for the detection and quantification of N-nitrosodiethanolamine (NDELA) in cosmetics and raw materials used in cosmetics. This method is not applicable to the detection and/or quantification of nitrosamines other than NDELA nor to the detection and/or quantification of NDELA in products other than cosmetics or raw materials used in cosmetics. If a product has a possibility of either NDELA contamination from ingredients or NDELA formation by the composition of ingredients, the method is intended to be applied for quantitative determination of NDELA. Accordingly, the method does not apply to routine testing of cosmetic products. Because of the large variety of cosmetic products within this field of application, this method might need to be adapted for certain matrices (refer to ISO 12787).

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.

ISO/TR 17276:2014 introduces most common and typical analytical approaches for screening and quantification of heavy metals of general interest at both raw material and finished product level. ISO/TR 17276:2014 covers techniques from traditional colourimetric reaction, which can be executed without expensive instrument to the high-end one, like that of inductively coupled plasma-mass spectrometry (ICP-MS), which allows detection of elements at μg/kg level. Thus, ISO/TR 17276:2014 covers the advantages and disadvantages of each analytical technique so that a suitable approach can be chosen.

ISO/TR 14735:2013 aims to contribute to providing general advice on strategies that can be adopted to minimize the likelihood of N-nitrosamine formation in cosmetic products and provide a description of the analytical methodologies available for the reliable determination of N-nitrosamines in cosmetic products. It also seeks to provide some insight into the relevance and limitations of each of the methods described and finally provide an analytical approach for the analysis of N-nitrosamines in cosmetic products and raw materials. ISO/TR 14735:2013 covers the reduction or elimination of adventitious nitrite sources, reduction or elimination of secondary amino sources, incorporation of inhibitors to N-nitrosamine formation and analytical methodologies for total N-nitroso compounds and specific methods for N-nitrosodiethanolamine (NDELA).

ISO 12787:2011 defines validation criteria with which analytical results obtained from the analysis of cosmetic products should comply in order to give confidence in performance, reliability and quality of the final result. It sets out an analytical approach that can be used by a single laboratory to carry out chromatographic analyses on a given sample, or samples.

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 10130:2009 describes a method for the detection and quantification of N‑nitrosodiethanolamine (NDELA) in cosmetics and raw materials used in cosmetics by High Performance Liquid Chromatography (HPLC) coupled with post-column photolysis and derivatization. This method is not applicable to the detection and/or quantification of nitrosamines other than NDELA, nor to the detection and/or quantification of NDELA in products other than cosmetics or raw materials used in cosmetics. If a product has the possibility of either NDELA contamination from the ingredients or NDELA formation by the composition of ingredients, the method will be applied for the testing of cosmetic products and is an alternative to ISO 15819. This method is not applicable to matrices containing oxidation dyes.

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.

ISO 22715:2006 specifies requirements for packaging and labelling of all cosmetic products as defined according to national regulations or practices intended for sale or free distribution.

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 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.