ISO/TC 217/WG 3 - Analytical methods

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 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 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.

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/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 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/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 15819:2008 describes a method for the detection and quantification of 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.