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