Aspartame and phenylalanine - Scientific guideline

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 aspartame and phenylalanine. It includes the updated information for the package leaflet and the background scientific review.

 Keywords: Excipients, package leaflet, aspartame, E951, phenylalanine

Current version

Information for the package leaflet regarding aspartame and phenylalanine used as excipients in medicinal products for human use

Adopted Reference Number: EMA/CHMP/134648/2015 Corr.1

Document history

Information for the package leaflet regarding aspartame and phenylalanine used as excipients in medicinal products for human use

Adopted Reference Number: EMA/CHMP/134648/2015 Corr.1

Overview of comments received on the draft 'Information in the package leaflet for aspartame'

Reference Number: EMA/CHMP/581993/2016

Draft information in the package leaflet for aspartame 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)

Draft: consultation closed Consultation dates: 04/05/2016 to 03/08/2016 Reference Number: EMA/CHMP/134648/2015 Summary:

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.