Use of phthalates as excipients in human medicinal products

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CHMP/SWP/362974/2012 Corr. 2
Published24/11/2014
Effective from01/06/2015
KeywordsExcipients, phthalates, endocrine disruptors, dibutyl phthalate (DBP), diethyl phthalate (DEP), cellulose acetate phthalate (CAP), polyvinyl acetate phthalate (PVAP), hydroxypropylmethylcellulose phthalate (HPMCP)
DescriptionThis document aims to review the safety of phthalates most commonly used as excipients in the European Union.


Document history

Revision 1

Current version

PDF iconAdopted guideline

PDF iconOverview of comments

PDF iconDraft guideline

In operation: 01/06/2015–present

Published: 06/10/2015

Published: 08/05/2013


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