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European Commission’s
Scientific Committee on Food Confirms That Products
Made with Bisphenol A Are Safe
July 15, 2002
On May 3, 2002, the European Commission’s Scientific
Committee on Food (SCF) issued its Opinion1 confirming
that food contact products made with bisphenol A (BPA)
are, and remain, safe for their intended uses. The Opinion
of the SCF is consistent with the position of the U.S.
Food and Drug Administration, the Japanese Ministry
of Health, Labor and Welfare and other government agencies
worldwide who all conclude that food contact products
made with BPA pose no risk to human health. Consumers
can continue to use products made with BPA with confidence,
knowing that these products fully comply with the SCF’s
requirements.
SCF’s Re-evaluation
of BPA Confirms its Safety in Food Contact Applications
The EU Scientific Committee on Food’s re-evaluation
of BPA was part of an ongoing process in the EU to protect
consumers by evaluating all plastics in food contact
applications and setting specific safety and migration
limits. Only monomers and additives that have been reviewed,
authorised, and listed under Commission Directive 90/128/EEC
may be used in food contact applications.
For BPA, the SCF reviewed recent robust and comprehensive
data on toxicology and migration to set the so-called
Tolerable Daily Intake (TDI), which is a safety threshold
for lifelong daily intake. The TDI itself is derived
from scientific data (No Observed Adverse Effect Level,
NOAEL) by applying safety factors.
More in depth information on the EU food contact legislation
can be found at:
http://europa.eu.int/comm/food/fs/sfp/food_contact/index_en.html
In the case of BPA, which is mainly used in the manufacture
of polycarbonate plastic and epoxy resins, the SCF set
the TDI at 0.01 mg/kg bodyweight/day. This value is
explicitly derived from the results (NOAEL) of a recent
and comprehensive scientific study2, performed at the
Research Triangle Institute in North Carolina, USA,
under the stringent, globally accepted quality control
system known as Good Laboratory Practices (GLP). The
quality of this multigeneration study can be regarded
as the "gold standard" of toxicology.
Part of the SCF process also included an evaluation
of consumer exposure. The SCF concluded in its Opinion
that realistic, worst-case estimates of consumer exposure
via foodstuffs, ranging from 0.00048 mg/kg bw/day to
0.0016 mg/kg bw/day, are well below the TDI.
Recognising that industry is currently in the process
of conducting further research, the Committee recommended
that the temporary TDI be reviewed if data from this
research changes significantly from existing studies.
Industry is confident that the current research will
add to the existing weight of evidence that demonstrates
all products and applications made with BPA are safe
for their intended uses.
References
1Opinion of the Scientific Committee on
Food on Bisphenol A (Expressed on 17 April 2002), ref.
SCF/CS/PM/3936 Final – 3 May 2002 – http://europa.eu.int/comm/food/fs/sc/scf/out128_en.pdf
2“Three-Generation Reproductive Toxicity
Study of Dietary Bisphenol A in CD Sprague-Dawley Rats”,
R. W. Tyl, C. B. Myers, M. C. Marr, B. F. Thomas, A.
R. Keimowitz, D. R. Brine, M. M. Veselica, P. A. Fail,
T. Y. Chang, J. C. Seely, R. L. Joiner, J. H. Butala,
S. S. Dimond, S. Z. Cagen, R. N. Shiotsuka, G. D. Stropp,
and J. M. Waechter, Toxicol. Sci. (2002) 68
(1): 121-146.
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