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 aspartame. Aspartame (L-aspartyl L-phenylalanine methylester) is an artificial sweetener used to substitute sugar in food and beverages and to make pharmaceuticals more palatable.The main reason for reassessing the information on the package leaflet was new scientific data becoming available through the European Food Safety Authority’s full re-evaluation of the safety of aspartame as a food additive in the EU (E951) published in December 2013. The EFSA assessment served as the basis for the present evaluation of aspartame as excipient in medicinal products.