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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
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.
English (EN) (168.79 KB - PDF)
Document history - Revision 1 (current)
Guideline on the use of phthalates as excipients in human medicinal products
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.
English (EN) (168.79 KB - PDF)
Overview of comments received on the 'Guideline on the use of phthalates as excipients in human medicinal products' (EMA/CHMP/SWP/362974/2012)
English (EN) (325.31 KB - PDF)
Draft guideline on the use of phthalates as excipients in human medicinal products
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.
English (EN) (165.22 KB - PDF)
Related content
- Non-clinical: toxicology
- Annex to the European Commission guideline on 'Excipients in the label and package leaflet of medicinal products for human use'
- Guideline on Summary of Product Characteristics
CHMP scientific Article-5(3) opinion on the potential risks of carcinogens, mutagens and substances toxic to reproduction when these substances are used as excipients of medicinal products for human use
- ICH Q3C (R5) Residual solvents