DIN EN 16274:2012-12

DIN EN 16274 specifies a method for the identification and determination of 24 volatile suspected allergens from ready-to-inject cosmetics and raw materials used in cosmetic products and are compatible with GC analysis. This analysis uses GC-MS after sample preparation. The 24 suspected allergens are restricted under Council Directives (7th amendment to the Cosmetic Directive 2003/15/EC). The method described in this European Standard does not include requirements for the preparation of samples in matrices for which direct injection in GC is not feasible. Human skin exposure to suspected allergenic fragrances can occur through diverse sources such as detergents and cosmetics intended to be rinsed or not. As a result of their possible effect, 26 fragrance substances have been restricted under Council Directives with labelling requirements in order to insure a high level of protection of consumers, particularly for sensitive population. In this context, several analytical methods have been developed to detect and determine their presence in cosmetics such as Gas Chromatography/Flame Ionisation Detector (GC-FID), Gas Chromatography/Mass Spectrometry (GC-MS), comprehensive GC or MS-MS in raw materials and finished products. The present analytical method uses GC-MS by combination of two GC columns of different polarity with a dedicated methodology for quantification. This allows separation and quantification of the 24 volatile suspected allergens above 0,001 % (10 mg/kg) of each, in ready-to-inject sample from a cosmetic ingredient or product matrix. The present protocol has been validated thanks to a ring test. This European Standard has been prepared by CEN/TC 347 "Methods for analysis of allergens", the secretariat of which is held by DS (Denmark). The collaboration of DIN for the field of responsibility of CEN/TC 347 is performed through the national Mirror Committee, Working Committee NA 057-07-01 AA "Kosmetische Mittel" ("Cosmetics") of NAL.