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

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Download document Draft reflection paper on the use of methyl- and propylparaben as excipients in human medicinal products for oral use
Reference number EMA/CHMP/SWP/272921/2012
Status draft: consultation closed
First published 08/05/2013
Last updated 08/05/2013

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.