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ISO/NP 25823 Surface active agents — Determination of ethanolamines in nonioni surfcants by HPLC-MS-MS

Scope

This document describes the use of high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) for the specific separation and detection of trace amounts of MEA, DEA and TEA in nonionicsurfactants or product matrices containing ethanolamine derivatives. This standard is applicable to the determination of MEA, DEA and TEA in nonionicsurfactants or product matrices containing ethanolamine derivatives.

Purpose

Non-ionic surfactants, especially those of the polyoxyethylene type, may contain ethanolamine monomers. These surfactants are created by reacting hydrophobic raw materials with ethylene oxide or polyethylene glycol, which can result in residues of monoethanolamine (MEA), diethanolamine (DEA), and triethanolamine (TEA). The presence of free ethylamine monomers in final products is a concern as they can be absorbed through the skin and interact with other ingredients to form nitrosodiethanolamine, a known carcinogen and a health hazard. The International Agency for Research on Cancer, part of the World Health Organization, has classified DEA as a Group 2B carcinogen, which is also found as a synthetic by-product in TEA. Consequently, the EU Regulation (EC) No 1223/2009 on cosmetic products has set rules for the use of certain ethanolamines, limiting DEA to 0.5% and TEA to 2.0% in final products. While MEA is generally considered safe in small amounts, it is recommended to review ingredient lists and perform patch tests for new products, particularly for individuals with sensitive skin or known allergies, due to the potential risks of long-term exposure at high concentrations. Ensuring the accurate measurement of ethanolamine residues in surfactants is vital for maintaining product quality and safety, especially in cosmetics and pharmaceuticals where strict monitoring is essential. As consumer demand for ingredient safety grows, regulatory bodies are imposing stricter limits on harmful substances in cosmetics and personal care products. Manufacturers must adhere to these regulations and develop standardized methods for compliance, ensuring the safety and efficacy of their products. An effective analytical method is needed to measure the concentrations of MEA, DEA, and TEA in nonionic surfactant end-products, guaranteeing that their levels are within a safe range. 

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