Use of phthalates as excipients in human medicinal products

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/SWP/362974/2012 Corr. 2
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

Adopted guideline


Overview of comments


Draft guideline

In operation: 01/06/2015–present


Published: 06/10/2015


Published: 08/05/2013

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