Use of phthalates as excipients in human medicinal products - Scientific guideline

This document aims to review the safety of phthalates most commonly used as excipients in the European Union.

Keywords: Excipients, phthalates, endocrine disruptors, dibutyl phthalate (DBP), diethyl phthalate (DEP), cellulose acetate phthalate (CAP), polyvinyl acetate phthalate (PVAP), hydroxypropylmethylcellulose phthalate (HPMCP)

Current effective version

Guideline on the use of phthalates as excipients in human medicinal products

AdoptedReference Number: EMA/CHMP/SWP/362974/2012 Corr 2Summary:

Literature data in animals show that certain phthalates are associated with effects on reproduction and development in relation to their hormonal (anti-androgenic) properties. Currently available human data on the impact of phthalate exposure are limited and therefore the clinical relevance of such findings remains to be established.

Document history - Revision 1 (current)

Guideline on the use of phthalates as excipients in human medicinal products

AdoptedReference Number: EMA/CHMP/SWP/362974/2012 Corr 2Summary:

Literature data in animals show that certain phthalates are associated with effects on reproduction and development in relation to their hormonal (anti-androgenic) properties. Currently available human data on the impact of phthalate exposure are limited and therefore the clinical relevance of such findings remains to be established.

Overview of comments received on the 'Guideline on the use of phthalates as excipients in human medicinal products' (EMA/CHMP/SWP/362974/2012)

Reference Number: EMA/CHMP/SWP/684886/2013

Draft guideline on the use of phthalates as excipients in human medicinal products

Consultation dates: 08/05/2013 to 31/10/2013Draft: consultation closedReference Number: EMA/CHMP/SWP/362974/2012Summary:

Literature data in animals show that certain phthalates are associated with effects on reproduction and development in relation to their hormonal (anti-androgenic) properties. Currently available human data on the impact of phthalate exposure are limited and therefore the clinical relevance of such findings remains to be established. This guideline provides recommendations on the use of phthalates as excipients in human medicines.