Use of methyl- and propylparaben as excipients in human medicinal products for oral use - Scientific guideline

This reflection paper addresses methyl- and propylparaben, as those are the parabens predominantly used in oral pharmaceutical formulations. The focus of this document is on possible endocrine-disrupting effects in humans.

Keywords: methylparaben, propylparaben, excipients, preservatives in medicinal products, paediatric use, endocrine disruptors

Current effective version

Reflection paper on the use of methyl- and propylparaben as excipients in human medicinal products for oral use

Adopted Reference Number: EMA/CHMP/SWP/272921/2012

Document history - Revision 1 (current)

Reflection paper on the use of methyl- and propylparaben as excipients in human medicinal products for oral use

Adopted Reference Number: EMA/CHMP/SWP/272921/2012

Overview of comments received on the ‘Reflection paper on the use of methyl- and propylparaben as excipients in human medicinal products for oral use’ (EMA/CHMP/SWP/272921/2012)

Reference Number: EMA/684369/2013

Draft reflection paper on the use of methyl- and propylparaben as excipients in human medicinal products for oral use

Draft: consultation closed Consultation dates: 08/05/2013 to 31/10/2013 Reference Number: EMA/CHMP/SWP/272921/2012 Summary:

Parabens are currently listed in the guideline on excipients in the label and package leaflet of medicinal products for human use for their allergic potential. Further safety concerns have been raised during the last decade by the scientific community, regulatory agencies and the general public as a consequence of possible endocrine-disrupting effects. This paper addresses methyl- and propylparaben, as those are the parabens predominantly used in oral pharmaceutical formulations. The focus of this document is on possible endocrine-disrupting effects in humans.