EMA: Draft information in the package leaflet for fragrances containing allergens in the context of the revision of the guideline on \'Excipients in the label and package leaflet of medicinal products for human use\' (CPMP/463/00 Rev. 1)

This document supports the revision of the European Commission Guideline on \'Excipients in the label and package leaflet of medicinal products for human use\' with regard to fragrance allergens. The European Commission designated 26 fragrances as allergens requiring labelling in cosmetic and detergent products if the concentration of the designated ingredient exceeds 100 parts per million (ppm) for a rinse-off product and 10 ppm for a leave-on product. Some of these allergens are also used in topically applied medicinal products. Since topically applied medicinal products may be applied on a more sensitive skin (if damaged), a zero threshold should be applied.