Analysis and Quantification of Alkyl (C12-22) Trimethyl Ammonium Chloride Content in Cosmetics: Regulatory Compliance Gap Analysis

Abstract

Background: Exceeding the recommended Alkyl (C12-22) trimethyl ammonium bromide and chloride levels in cosmetics and personal care products is a serious health threat. Objectives: To quantify and investigate Cetrimonium chloride and Behentrimonium chloride in cosmetics and personal care products in the UAE market to gauge whether or not they adhered to requirements for safety and health. Methods: A total of 164 cosmetics products were collected and analyzed in this study. The gas chromatography–mass spectrometry (GC–MS) method was developed and validated for the determination of Cetrimonium chloride and Behentrimonium chloride surfactants in cosmetics products. With each product, Cetrimonium chloride and Behentrimonium chloride (%) were calculated. To test cross-group differences in Cetrimonium chloride and Behentrimonium chloride (%), Kruskal–Wallis test was applied. Results: Of the 125 tested cosmetics and personal care products, five (4%) exceeded the recommended Cetrimonium chloride level in rinse-off hair products (2.5%), 10 (8%) exceeded the recommended Cetrimonium chloride level in leave-on hair products (1%), and 24 (61.5%) exceeded the recommended Cetrimonium chloride level used as a preservative in cosmetics products. Moreover, of the 125 tested cosmetics and personal care products, 21 (53.8%) exceeded the recommended Behentrimonium chloride level used as preservatives in cosmetics products. Conclusions: Although several structures for cosmetics quality and control across the globe are fairly comprehensive and intricate, there is a need to make them more rigorous to apply compliance with GMP and ensure regulatory control. Doing so would help enhance the inspection and regulation of cosmetics containing Behentrimonium chloride/Cetrimonium chloride preservatives. Furthermore, there is a dire need to establish a unified cosmetovigilance worldwide.