In a draft guideline on phthalates and a draft reflection paper on parabens published on May 8, 2013, the European Medicines Agency recommended limits to the use of phthalates in medicines. The Agency’s Committee for Medicinal Products for Human Use (CHMP) recommends permitted-daily-exposure (PDE) levels of 0.01, 4 and 2 mg/kg/day for dibutyl phthalate (DBP), diethyl phthalate (DEP) and polyvinyl acetate phthalate (PVAP), respectively due to phthalate’s reproductive and developmental toxicity. With regards to parabens, the CHMP concludes that current data does not preclude that methyl- and propylparaben are hazardous to humans in general. Nonetheless further data is needed to evaluate the risk for young children.
Phthalates are used in the manufacture of polyvinyl chloride (PVC) plastics. In Europe, DBP is authorized for plastic food contact and both DBP and DEP are known to be used in rubber food contact materials (EC 10/2011, ESCO WG). Phthalates are also found in a variety of other consumer products and medicines. Recently the German Institute for Risk Assessment confirmed diet as the main source of phthalate exposure (see FPF article). Methyl- and propylparaben are used in a variety of consumer products and authorized for use in plastic food contact under European law (EC 10/2011). They are also known to be used in non-plastic food contact materials (ESCO WG). The European Medicines Agency’s guideline and the reflection paper are open for public consultation until October 2013.
Draft guideline on the use of phthalates as excipients in human medicinal products – European Medicines Agency