Fragrances containing allergens

This document supports the revision of the annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' with regard to fragrances containing allergens. It includes new information for the package leaflet and the background scientific review.

Keywords: Excipients, package leaflet, fragrances containing allergens

Current effective version

Information for the package leaflet for fragrances containing allergens used as excipients in medicinal products for human use

AdoptedReference Number: EMA/CHMP/273718/2014

Document history

Overview of comments received on the draft 'Information in the package leaflet for fragrances containing allergens'

Reference Number: EMA/CHMP/579645/2016

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/...

Consultation dates: 04/05/2016 to 03/08/2016Draft: consultation closedReference Number: EMA/CHMP/273718/2014Summary:

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.