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

Current effective version

PDF iconReflection paper

Reference numberEMA/CHMP/SWP/272921/2012
Published19/11/2015
Effective from22/10/2015
Keywordsmethylparaben, propylparaben, excipients, preservatives in medicinal products, paediatric use, endocrine disruptors
DescriptionThis 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.


Document history

Revision 1

Current version

Reflection paper

PDF iconOverview of comments

PDF iconDraft reflection paper

In operation: 22/10/2015–present

Published: 19/11/2015

Published: 08/05/2013
Deadline for comments: 31/10/2013

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