Public Health (19-03-2008)
SCENIHR opinion on the safety of DEHP and its alternatives in medical devices
DG Health and Consumers
The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has reviewed the safety of DEHP, the most used plasticizer in medical devices, and has examined the availability, suitability and safety of alternative plasticizers. SCENIHR remarked that certain medical procedures used in high risk patients result in a significant exposure to DEHP. The Committee concluded that in view of the reproductive toxicity observed in animal studies, in which young, immature animals were more susceptible to DEHP toxicity, exposure from medical devices remains of special concern in relation to newborn and pre-term born male infants
The new information on DEHP indicates that there is still a reason for having some concerns about the exposure of prematurely born male babies to medical devices containing DEHP. This concern is instigated by the potential high human exposure to DEHP especially during certain medical procedures, which may be transiently above the dose inducing reproductive toxicity in animal studies.
There are alternative plasticizers to polyvinylchloride (PVC) and also non-PVC alternative materials available. Regarding the alternative plasticizers a generic exposure assessment could not be performed due to a lack of relevant use and human exposure data. There are some alternative plasticizers though, for which there is sufficient toxicological data to indicate a lower hazard compared to DEHP. Nevertheless, the functionality of these plasticizers should be assessed before they can be used as an alternative for DEHP in PVC medical devices. For other possible alternatives, information on the toxicological profile was lacking.
DEHP is a plasticizer that is added to 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, tubing systems used for neonates and respiratory therapy, etc.
The opinion can be found at: