Preliminary Report on the Safety of Medical Devices Containing Dehp-plasticized Pvc or Other Plasticizers on Neonates and Othe

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 many cases the exposure is significant and exceeds the toxic doses observed in animal studies. There is limited evidence indicating a relation between DEHP exposures and certain effects in humans. However, it is recognised that especially the potentially high exposure during medical treatments raise a concern, even in the absence of clinical or epidemiological evidence, for harmful effects 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.