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Industry comments on scientific committee’s draft opinion on the safety of use of BPA in medical devices

SCENIHR preliminary opinion finds margin of safety for polycarbonate
and epoxy resin medical devices
The Polycarbonate/Bisphenol A Group and the Epoxy Resin Committee of PlasticsEurope group note
the publication of the preliminary opinion on the safety of the use of BPA in medical devices prepared
by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). The draft
opinion was prepared following a request by the Commission in December 2011 and it is now open for
consultation until March 26, 2014.
The SCENIHR draft opinion evaluated potential exposure to BPA from a wide range of medical
applications that are characterized by type of use (e.g., external, dental, implants, hemodialysis,
surgical procedures, intensive care unit) and length of contact (i.e., short to long contact times). In
general, SCENIHR found that available exposure data is very limited and it is uncertain whether
the data is reliable or representative of current medical applications. Accordingly, SCENIHR’s
exposure estimates are based on “conservative assumptions and extrapolations” and, as noted,
should be “viewed and used with some caution.”
Within the constraints of the available data, SCENIHR generally found that exposure to BPA from all
medical applications is low, often in the range of the very low consumer exposures through the diet.
Exposures from many medical uses occur for a limited period of time and are estimated to be well
below the conservative temporary TDI (Tolerable Daily Intake for an individual’s lifetime) recently
proposed by EFSA. For other applications, in particular for neonates being treated with multiple
devices in intensive care units, SCENIHR concluded “there may exist some risk for adverse effects,”
but a margin of safety exists even for these applications. As with dietary intake, the Committee noted
that BPA is rapidly eliminated from the body following exposure from medical applications.
Given the limitations of the existing data, SCENIHR notes that there is a need for more and better
information on the release of BPA from medical devices in actual use conditions. As also noted by
SCENIHR, many of the uncertainties regarding potential health hazards of BPA are currently being
addressed in a chronic toxicity study being conducted by the US Food and Drug Administration’s
National Center for Toxicological Research.
Very importantly, SCENIHR states “that the benefit of medical devices has also to be considered”
and, in particular, the survival of premature infants often depends on the availability of medical devices
made with BPA. Accordingly, replacement of BPA in medical devices must “be considered against
their efficiency in the treatment, as well as the toxicological profile of the alternative materials.”
Jasmin Bird of the PlasticsEurope Polycarbonate/Bisphenol A industry group stated “The long track
record of proven life-saving benefits from polycarbonate medical devices coupled with the margin of
safety demonstrated by SCENIHR’s evaluation should give confidence to patients and medical
professionals in the continued use of these products.”