Quantitative Analysis of the 26 Allergens for Cosmetic Labeling in Fragrance Raw Materials and Perfume Oils

The adoption of the 7th amendment of the European Cosmetic Directive 76/768/EEC requires any cosmetic product containing any of 26 raw materials identified by the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers as likely to cause a contact allergy when present above certain trigger levels to be declared on the package label. Of these 26, 24 are volatile and can be analyzed by GC. This paper describes a method for the quantitative analysis of these volatile raw materials in perfume ingredients as well as complex perfume compositions. The method uses sequential dual-column GC-MS analysis. The full-scan data acquired minimize the false-positive and false-negative identifications that can be observed with alternate methods based on data acquired in the SIM mode. For each sample, allergen levels are determined on both columns sequentially, leading to two numerical results for each allergen. Quantification limits for each allergen in a perfume mixture based on the analysis of a standard are <4 mg/kg. This is well below the level that would trigger label declaration on the consumer good. Calibration curves for all allergens are linear (r > 0.999) and stable for multiple days. Studies on perfumes spiked with multiple allergens at 30, 50, and 70 mg/kg show recoveries close to nominal values.