CED EU INFO 2015/02

Issue 2 - May 2015


BPA exposure from dental materials "negligible risk"

On 27 February, the European Commission and SCENIHR published the Final Opinion on the safety of the use of bisphenol A in medical devices. Such medical devices include implants, catheters, and dental devices. SCENIHR concluded that “Long-term oral exposure to BPA via dental material is below the t-TDI of 4μg/kg b.w./day, thus posing a negligible risk for human health. (…)”. SCENIHR concludes that the risk for adverse effects of BPA may exist when the BPA is directly available for systemic exposure after non-oral exposure routes,especially for neonates in intensive care units, infants undergoing prolonged medical procedures and for dialysis patients."

SCENIHR recommends that "Although the benefit of medical devices has also to be considered, (...) where practicable, medical devices that do not leach BPA should be used. The possibility of replacing BPA in these products should be considered against their efficiency in the treatment, as well as the toxicological profile of the alternative materials."

Easy to read Fact sheet of the Opinion



For more information contact:
CED Brussels Office
Tel: + 32 2 736 34 29