Collaborative validation of the quantification method for 57 allergens in ready to inject fragrance samples

Abstract

This publication presents the collaborative work conducted in CEN/TC 347/WG4 ‘Fragrance and colophony’ working group to evaluate the robustness of a GC–MS analytical methodology to quantify the extended list of 57 fragrance allergens in ‘ready to inject’ samples. The intention of this group was to provide an updated and consensual standard for the quantification of the extended allergen list. The analytical approach was based on the similar methodology than the original one developed for the 26 allergens, using a universal GC–MS simple quadrupole instrument. A ring test was performed among the different end-user experiences of the CEN group to test the method on a representative fragrance matrix. Accuracy profile method was used to validate the analytical method within the 2–240 mg/kg concentration range. Thanks to the use of commercial standard mixes and dedicated automation of decisional tree for data treatment, 89% of tolerance intervals of targeted allergens were included into the acceptance limits in the whole 2–240 mg/kg concentration range. The objective of this article was to provide some complementary data to implement the NF EN 16274 standard in an analytical laboratory and to highlight the inherent difficulties linked to extended data treatment and complexity for the recovery of low concentration analytes and potential coelutions in a wide diversity of ready-to inject samples.