While Di-2ethylhexylphthalate (DEHP) has been medically approved for many years for use in medical devices, it was permanently banned for use in children's products the US in 2008 by US Congress ; the PVC-DEHP combination had proved to be very suitable for making blood bags because DEHP stabilises red blood cells, minimising haemolysis (red blood cell rupture). However, DEHP is coming under increasing pressure in Europe. The assessment of potential risks related to phthalates, and in particular the use of DEHP in PVC medical devices, was subject to scientific and policy review by the European Union authorities, and on 21 March 2010, a specific labeling requirement was introduced across the EU for all devices containing phthalates that are classified as CMR (carcinogenic, mutagenic or toxic to reproduction). The label aims to enable healthcare professionals to use this equipment safely, and, where needed, take appropriate precautionary measures for patients at risk of over-exposure.
DEHP alternatives, which are gradually replacing it, are Adipates, Butyryltrihexylcitrate (BTHC), Cyclohexane-1,2-dicarboxylic acid, diisononylester (DINCH), Di(2-ethylhexyl)terephthalate, polymerics and trimellitic acid, 2-ethylhexylester (TOTM).