Commission launches consultation on SCENIHR report on the safety of DEHP and its alternatives in medical devices

15 Oct 2007
The Commission launched today a public consultation on the preliminary report of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on the "Safety of medical devices containing DEHP-plasticized PVC or other plasticizers on neonates and other groups possibly at risk." The online consultation, which will run until 26 November 2007, aims to gather feedback on the toxicity evaluation of DEHP and its alternative plasticizers in medical devices.

The preliminary report of the SCENIHR concludes that in many cases the exposure to DEHP during medical procedures may be significant and may exceed the toxic doses observed in animal studies. The high exposure during some medical treatments raises concerns, even in the absence of clinical or epidemiological evidence, for harmful effects on humans. For certain uses of DEHP, alternative and less toxic plasticizers for PVC are available, but a risk assessment of these available alternative plasticizers could not be performed due to a lack of use and human exposure data from medical devices. The SCENIHR recommends that risks and benefits of using alternative plasticizers should be evaluated case by case.

DEHP is a plasticizer that is added to polyvinylchloride (PVC) to make it flexible, resilient and easier to handle. Plasticizers are not chemically bound to PVC, and may therefore leach into the surrounding environment, including the human body. DEHP-plasticized PVC is used in medical devices, where flexibility is essential. Examples include blood bags, catheters, dialysis equipments, gastrointestinal tubes and tubing systems used for neonates and respiratory therapy.