Tagged: Food and Drug Administration

Are plastic constituents of foods containers and medical devices safe?


Many chemical compounds are used as a plasticizer to improve the flexibility and moldability of polymers such as PVC, making the material soft even at low temperatures. Phthalates, particularly phthalate esters (PEs), among these latter components, are released into any liquid and solution from all PVC materials used for alimentary and/or medical purposes, including pockets for blood transfusions, parenteral nutrition, dialysis tubes, devices for extracorporeal circulation (CEC) and membrane oxygenation (ECMO), etc… PEs are the most abundant man-made pollutants and increase the risk of developing an allergic respiratory disease or a malignancy.


Since 2003, these chemicals were considered potentially hazardous to health with consequences still under discussion: some studies seem to demonstrate that phthalates can produce effects similar to those of the estrogen hormones, causing a feminization of male babies and developmental disorders and maturation of testes. Breast milk is also found to contain detectable levels of phthalates, as well as infant formula and baby food. Europe, for instance, legislated in order to limit use of these compounds and hence prevent adverse effects in development [1]. Recently, a few studies have demonstrated that phthalates could cause oxidative stress which would contribute to the development of insulin resistance which is believed to be the underlying mechanism of metabolic syndrome and type 2 diabetes mellitus [2].

Even though effects, directly correlated to phthalates ingestion, seem to be quite clear but are still under investigation, it is well strengthened that these are harmful when released by several type of plastic surfaces, in contact with blood, of medical devices in prolonged use. The leaching of PE’s in donated packed red blood cells during storage was assessed provoking oxidative stress and increasing the level of pro-inflammatory cytokines [3].

The same effects could be detected in patients where dialysis and extracorporeal circulation devices were used.

Rodent studies also showed that high exposure to phthalates causes damage to some internal organs including liver, kidneys and lungs [4]. All these assumptions led recently FDA to issue a document certifying harmfulness of such chemical agents, concluding that a real risk exists to human health, especially for pediatrics and pregnant women.

The aim of this post is not to create scaremongering in people but to just help diffusion of news so that everyone can create personal and independent opinions.



[1] Human Elimination of Phthalate Compounds: Blood, Urine, and Sweat (BUS) Study.

SJ Genuis, S Beesoon, RA Lobo, D Birkholz – ScientificWorldJournal, 2012: 615068 – doi:10.1100/2012/615068


[2] Diethylhexyl Phthalates Is Associated with Insulin Resistance via Oxidative Stress in the Elderly: A Panel Study

JH Kim, Hy Park, S Bae, YH Lim, YC Hong – PLoS One, 2013 19;8(8):e71392


[3] Phthalate esters used as plasticizers in packed red blood cell storage bags may lead to progressive toxin exposure and the release of pro-inflammatory cytokines.

LT Rael, R Bar-Or, DR Ambruso, CW Mains, DS Slone, ML Craun, D Bar-Or – Oxid Med Cell Longev, 2009;2(3):166-71.


[4] Presence of Plasticizer Di-2(ethylhexyl)phthalate in Primed Extracorporeal Circulation Circuits

Burkhart HM, Joyner N, Niles S, Ploessl J, Everett J, Iannettoni M, Richenbacher W – ASAIO Journal 2007; 53:365–367.