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Industry further comments on certain aspects of the EFSA draft opinion

Exposure to Bisphenol A well below the new safety level for all age groups
Scientifically highly conservative t-TDI provides solid protection
The PC/BPA and ERC Groups of PlasticsEurope continue to thoroughly review EFSA’s latest draft
assessment on the potential health risks of Bisphenol A (BPA). The Groups will provide their detailed
scientific input within the framework of the ongoing public consultation.
Based on the analysis conducted so far, and to avoid potential misinterpretations, industry would like to
provide responses on a number of aspects which have, in some cases, been misleadingly reported:
 EFSA did not conclude that BPA causes effects on the liver, kidney and the mammary
gland at dose levels relevant to human exposure, but identified these areas to require risk
assessment
EFSA applied a comprehensive and fully transparent weight of the scientific evidence approach in
assessing over 450 studies for possible effects and then assessed whether human exposure was high
enough to risk any effects. Importantly, EFSA concluded that “exposure even for the highest exposed
groups in the population is well below the t-TDI of 5 µg/kg/bw per day, indicating that the health concern
for BPA is low at the current level of exposure.”
EFSA ranked the studies based on potential association of BPA to particular health effects. The likelihood
of an association was classified in a six-staged ranking system, from “very likely” to “very unlikely”.
Two areas were classified to show “likely” associations: liver and kidney. “Likely” association was also
identified for the mammary gland, with however, a larger amount of uncertainty on the likelihood
compared to liver and kidney. Other endpoints, including reproduction and fertility, brain and behavioural
development, immune, cardiovascular, metabolic, genotoxic and carcinogenic effects, were judged to be
“less than likely”.
Therefore, whilst EFSA pointed at possible associations, at no time does the Authority conclude that there
is a “likely” risk for humans. The “likely” association with kidney, liver and mammary gland is related to
effects on the three organs which were observed in animals exposed to dose levels of BPA 1000 times
above the new temporary Tolerabale Daily Intake (t-TDI) proposed by EFSA.
 The new temporary TDI is the result of a highly conservative approach – not of increased
uncertainty
EFSA consistently selected the most sensitive data to conduct its assessment; it used both the lowest
value for which an effect could be associated with the substance, and it applied the most conservative
calculation factors.
EFSA derived the t-TDI by using worst case data and by applying a modern, sophisticated mathematical
model. The new t-TDI actually covers remaining uncertainty related to liver, kidney and mammary gland
as well as all other effects which were found “less than likely” by EFSA.
ASSOCIATION OF PLASTICS MANUFACTURERS IN EUROPE AISBL
Avenue E. Van Nieuwenhuyse 4/3 – B -1160 Brussels – Belgium
Tel (32-2) 675 32 97 – Fax (32-2) 675 39 35
VAT BE 416 155 338 – WWW.PLASTICSEUROPE.ORG
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 Exposure to BPA for consumers remains extremely low and is well below the new t-TDI
Even after setting the new t-TDI, EFSA confirmed that exposure to BPA is extremely low, and well below
the temporary TDI. This applies also to the highest exposed groups among fetuses, newborns, young
children and adults. It confirms once again that the health concern for BPA is low at the current level of
exposure.
Based on the considerations above, the PC/BPA and Epoxy Resin Groups of PlasticsEurope believe any
call for further restriction on the use of BPA based food contact applications is unwarranted.
For further information, please contact:
Jasmin Bird
Communications Manager
PC/BPA-Group
PlasticsEurope
Tel: +32 2 676 17 38
Fax: +32 2 675 39 35
Email: jasmin.bird@plasticseurope.org
Website: www.bisphenol-a-europe.org