Download Joint Industry Group (JIG)[1] Statement

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Joint Industry Group (JIG)1 Statement
Bisphenol A Migration from Can Coatings - Health Implications for the Consumer
September 2002
The epoxy resin and can coating industries have already issued a number of statements
and position papers concerning the possible estrogenic activity of bisphenol A and its
implications for consumer health in the context of migration from can coatings into food
(APME Epoxy Resins Committee, July 1994, August 1995, November 1995;
APME/CEPE/SEFEL, November 1995; SPI, November 1999, July 2000). This present
document updates the situation to account for more recent developments.
Please visit web-site http://www.bisphenol-a.org for the latest detailed reports on the
health safety and environmental aspects of bisphenol A, including several of the studies
referenced in this paper, the latest opinion of the EU Scientific Committee on Food
(SCF), and a critique of the WWF paper “bisphenol A - A Known Endocrine Disruptor”
(April 2000), where such aspects as mammalian and environmental toxicology, the
validity of the “low-dose” theory of endocrine disruption, human and environmental
exposure and biodegradability are discussed.
Although this website is large, it contains clear and simple links, so that specific subject
areas can be easily accessed.
Endocrine Effects of Bisphenol A
It has been known for over 50 years that bisphenol A has a weak estrogenic activity
when tested in specialised animal studies. A comprehensive review of all relevant data
available at that time was conducted by the SPI bisphenol A Toxicology Task force in
1995, and it was concluded that bisphenol A does not have a selective effect on the
endocrine system, but that its effects on reproduction and development were observed
only at doses causing other harmful effects (see bisphenol A website,
http://www.bisphenol-a.org). Results of subsequently reported studies, suggesting “lowdose” endocrine effects, have not proved to be reproducible in more comprehensive
repeat experiments, and have not been accepted as being conclusively established as a
APME (Association of Plastics Manufacturers in Europe), CEPE (European Council of Paint, Printing Inks and Artists’ Colours
Industry), SEFEL (European Light Metal Packaging Manufacturers), EPRA (European Phenolic Resins Association), CIAA
(Confederation of the Food and Drink Industries of the EU)
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Europäische Vereinigung der Lack-, Druckfarben- und Künstlerfarbenindustrie
European Council of Paint, Printing Inks and Artists' Colours Industry
Avenue E. Van Nieuwenhuyse 4 - BE-1160 Brussels
Tel:+32 (0)2 676 7480 - Fax: + 32 (0)2 676 7490 - E-mail: [email protected] -Internet: http://www.cepe.org/
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general or reproducible finding by independent expert bodies (for details see the
bisphenol A website). In particular, a recently conducted 3-generation study in rats,
incorporating dose levels in both the so-called “low dose” range and in more traditional
toxicological dose ranges totally failed to demonstrate any “low dose” endocrine effects.
This was the pivotal study used by the SCF to establish the TDI for bisphenol A.
There is absolutely no convincing evidence that bisphenol A exhibits estrogenic effects
at very low doses, below those anyway causing other harmful effects, and no evidence
to suggest that bisphenol A can accumulate in the body.
The temporary Tolerable Daily Intake (TDI) for bisphenol A of 10 microgrammes/kg
bodyweight, established in the EU by the Scientific Committee on Food (SCF) in May
2002 (http://europa.eu.int/comm/food/fs/sc/scf/out128_en.pdf) is based on consideration
of all available relevant toxicological data, including studies which considered effects of
bisphenol A on reproductive organs and functions, and hormonal effects, in living
animals, and incorporates a conservative safety factor. This TDI was derived from a
considered no observed adverse effect level (NOAEL) of 5 mg/kg bodyweight/day.
Further work being conducted under the auspices of the EU Existing Chemicals
Programme will make the toxicological database on bisphenol A even more robust, and
will enable the SCF to establish a definitive TDI in due course. Bearing in mind the
additional conservative assumptions made when converting this TDI to a Specific
Migration Limit (SML) of 0.6 mg/kg food, there is no reason to question the safety of this
limit.
Moreover, the EU’s Scientific Committee on Toxicology, Ecotoxicity and the
Environment (CSTEE) has just published its opinion on the human health section of the
report on the virtually completed EU risk assessment of bisphenol A
(http://europa.eu.int/comm/food/fs/sc/sct/out156_en.pdf), and endorsed the “provisional”
NOAEL of 50 mg/kg cited in that report – i.e. 10-times the level derived by the SCF, and
based on exactly the same data.
Consumer Exposure to Bisphenol A from Can Coatings
Studies by industry in Europe and in the USA (APME, 1995; SPI, 1995-6) on migration
of bisphenol A into food simulants from commercial can coatings and from food and
beverage cans showed that, even under the most conservative migration
considerations, the estimated mean daily intake of bisphenol A via the diet resulting
from migration from epoxy can coatings was below 0.105 microgrammes per kg
bodyweight
per
day
(http://www.bisphenola.org/health/exposure/consumer/epoxy/index.html). Although this figure represents only
the (conservative) mean, and therefore does not take into account extreme consumers,
it is nevertheless nearly 100 times lower than the temporary TDI established by the SCF
and nearly 50,000 times lower than the no observed adverse effect level (NOAEL) of
5mg/kg bodyweight /day, identified by the SCF.
A recently published report from the UK Food Standards Agency
(http://www.food.gov.uk/science/surveillance/fsis-2001/bisphenols)
into
levels
of
Europäische Vereinigung der Lack-, Druckfarben- und Künstlerfarbenindustrie
European Council of Paint, Printing Inks and Artists' Colours Industry
Avenue E. Van Nieuwenhuyse 4 - BE-1160 Brussels
Tel:+32 (0)2 676 7480 - Fax: + 32 (0)2 676 7490 - E-mail: [email protected] -Internet: http://www.cepe.org/
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bisphenol A in canned food estimated a worst case total daily intake of bisphenol A from
canned food of 0.36-0.38 microgrammes per kg for adults and 0.83-0-87 microgrammes
per kg for infants. These are 97.5 percentile figures, and thus represent the extreme
consumer. Nevertheless, they still provide safety factors in comparison with the SCF
temporary TDI of ca. 27 and 12 for adults and infants, respectively. These exposure
figures were accepted by the SCF, who also took into account consumer exposure
estimates from the draft EU risk assessment on bisphenol A, as being “realistic worstcase estimates”. The exposure estimates accepted by the SCF were also considered by
the CSTEE to be valid.
Conclusion
Potential exposure to bisphenol A via the diet resulting from migration from can linings
is, even under worst case conditions, more than order of magnitude below the
temporary Tolerable Daily Intake established by the SCF.
Potential infant consumer exposure to bisphenol A via the diet (the “worst-worst case”),
resulting from migration from can linings, under worst case assumptions (extreme
consumer), is between 0.83 and 0.87 microgrammes per kg bodyweight per day, a
figure ca. 12 times lower than the temporary Tolerable Daily Intake (TDI) established by
the SCF. This TDI already has built into it a considerable safety factor (= 500) relative
to the NOAEL of 5mg/kg bodyweight/day and is, of course, based on the assumption of
lifetime exposure. The factor is even higher for adults (ca. 27), again under worst case
assumptions (extreme consumer).
There is no substantiated evidence that bisphenol A possesses estrogenic activity, or
any other adverse health effects, at doses below the temporary TDI.
N.B. Copies of all documents referenced in the above text are available on request from
any of the JIG member associations.
Europäische Vereinigung der Lack-, Druckfarben- und Künstlerfarbenindustrie
European Council of Paint, Printing Inks and Artists' Colours Industry
Avenue E. Van Nieuwenhuyse 4 - BE-1160 Brussels
Tel:+32 (0)2 676 7480 - Fax: + 32 (0)2 676 7490 - E-mail: [email protected] -Internet: http://www.cepe.org/