Report of the Scientific Committee SCENIHR on DEHP

The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has evaluated the exposure to DEHP for the general population and patients during medical procedures. In some cases the exposure is significant and exceeds the toxic doses observed in animal studies. There is limited evidence suggesting a relation between DEHP exposures and some effects in humans. There is a reason for some concern for prematurely born male neonates for which the DEHP exposure may be transiently above the dose inducing reproductive toxicity in animal studies. Sofar, there is no conclusive scientific evidence that DEHP exposure via medical treatments has harmful effects in humans. But, it is recognised that especially the potentially high exposure during medical treatments may raise a concern, even in the absence of clinical or epidemiological evidence, for harmful effects in humans. Further studies are required to confirm or reject the suggestions of adverse effects of DEHP in humans. For certain uses of DEHP alternative plasticizers for PVC are available. The Committee got access to toxicity data for eight possible alternative plasticizers and compared their toxicity with that of DEHP. In respect to reproductive toxicity in animal studies DEHP induces more severe effects compared with some of the alternatives. A risk assessment of these available alternative plasticizers could not be performed due to a lack of exposure data from medical devices. Each alternative to DEHP, however, must also be evaluated with regard to their functionality in respect to medical devices. The risk and benefits of using alternative plasticizers should be evaluated case by case.