Lu Chia-Hui, Fang Ming-Chih, Chen Yu-Zi, Huang Shou-Chieh, Wang Der-Yuan
Food and Drug Administration, Ministry of Health and Welfare, Executive Yuan, 161-2 Kunyang St., Nangang Dist., Taipei 11561, Taiwan.
Department of Food Science, National Taiwan Ocean University, Keelung, Taiwan.
J Food Drug Anal. 2021 Dec 15;29(4):700-708. doi: 10.38212/2224-6614.3373.
Fragrances are the most common chemicals in cosmetics to which people expose every day. However, the unwanted allergic reactions such as contact dermatitis caused by direct contact with fragrances may happen. In Directive 2003/15/EC of the EU, cosmetic product containing one or more of 26 fragrance allergens must be declared on the package label. In addition, commission regulation (EU) 2017/1410 amending Annexes II and III of cosmetic regulation 1223/2009 restricted fragrance chemical of methyl eugenol, and prohibited Lyral, atranol, chloroatranol to be used in cosmetic. In this study, an efficient and sensitive GC-MS method for 3 banned fragrances, 26 fragrance allergens along with restricted methyl eugenol in cosmetics was established. Sample preparation by liquid-liquid extraction was developed by testing various solvent systems to simplify traditional complex extraction methodologies. Validation of the proposed method showed good linearities in a wide concentration ranges of 0.1-10 μg/mL. The intra-day and inter-day recoveries were between 84.4 and 119% with coefficient of variation (CV) below 13.5%. The limit of quantifications (LOQs) of 27 fragrance allergens were in the range of 2-20 μg/g. A surveillance study consisted with 82 cosmetics was conducted, among which 31 products claimed fragrance-free. The results showed some fragrance-free claims were false. In the other hand, there were seven cosmetics labeled containing Lyral, but only four were detected. The top fragrance allergens detected in the samples were linalool, limonene, and geraniol. The analysis of fragrance allergens in cosmetics indicated that potential contact allergy related to these products should be considered, even though some fragrance allergens were from natural extracts, such as oak moss absolute.
香料是人们日常接触的化妆品中最常见的化学成分。然而，直接接触香料可能会引发不良过敏反应，如接触性皮炎。欧盟2003/15/EC指令规定，含有26种香料过敏原中一种或多种的化妆品必须在包装标签上声明。此外，欧盟委员会法规（EU）2017/1410对化妆品法规1223/2009的附件II和III进行了修订，限制了丁香酚的使用，并禁止在化妆品中使用莱雅尔、阿特拉诺尔、氯阿特拉诺尔。本研究建立了一种高效、灵敏的气相色谱-质谱联用（GC-MS）方法，用于测定化妆品中3种禁用香料、26种香料过敏原以及受限的丁香酚。通过测试各种溶剂体系，开发了液液萃取样品前处理方法，以简化传统的复杂萃取方法。该方法在0.1-10μg/mL的宽浓度范围内具有良好的线性。日内和日间回收率在84.4%至119%之间，变异系数（CV）低于13.5%。27种香料过敏原的定量限（LOQ）在2-20μg/g范围内。对82种化妆品进行了监测研究，其中31种产品宣称无香料。结果表明，一些无香料宣称是虚假的。另一方面，有7种化妆品标签标注含有莱雅尔，但仅检测到4种。样品中检测到的主要香料过敏原为芳樟醇、柠檬烯和香叶醇。化妆品中香料过敏原的分析表明，即使有些香料过敏原来自天然提取物，如橡苔净油，也应考虑与这些产品相关的潜在接触性过敏。
