Plastics and Bisphenol A Release
Potential Exposure and Margin of
Polycarbonate plastic is a lightweight, high-performance
plastic that possesses a unique balance of toughness,
dimensional stability, optical clarity, high heat resistance
and excellent electrical resistance. Because of these
attributes, polycarbonate is used in a wide variety
of common products including digital media (e.g. CDs,
DVDs), electronic equipment, automobiles, construction
glazing, sports safety equipment and medical devices.
The durability, shatter-resistance and heat-resistance
of polycarbonate also make it an ideal choice for tableware
as well as reusable bottles and food storage containers
that can be conveniently used in the refrigerator and
Bisphenol A (BPA)
is a key building block of polycarbonate
plastic. In recent years a number of researchers from
government agencies, academia and industry worldwide
have studied the potential for low levels of BPA to
migrate from polycarbonate products into foods and beverages.
These studies consistently show that the potential migration
of BPA into food is extremely low, generally less than
5 parts per billion, under conditions typical for uses
of polycarbonate products.
Using these results, the estimated dietary intake of
BPA from polycarbonate is less than 0.0000125 milligrams
per kilogram body weight per day. This level is more
than 4000 times lower than the maximum acceptable or
"reference" dose for BPA of 0.05 milligrams
per kilogram body weight per day established by the
U.S. Environmental Protection Agency.
Stated another way, an average adult consumer would
have to ingest more than 600 kilograms (about 1,300
pounds) of food and beverages in contact with polycarbonate
every day for an entire lifetime to exceed the level
of BPA that the U.S. Environmental Protection Agency
has set as safe.
The European Commission's Scientific Committee on Food
(SCF) has also recently confirmed the safety of polycarbonate
plastic products for contact with foods and beverages.
The SCF estimated total dietary intake of BPA from all
food contact sources, including polycarbonate plastic
products and epoxy resin coatings, to be in the range
of 0.00048 to 0.0016 milligrams per kilogram body weight
per day, which is below the Tolerable Daily Intake set
by the SCF of 0.01 milligrams per kilogram body weight
The study data and analyses show that potential human
exposure to BPA from polycarbonate products in contact
with foods and beverages is very low and poses no known
risk to human health. The use of polycarbonate plastic
for food contact applications continues to be recognized
as safe by the U.S. Food and Drug Administration, the
European Commission Scientific Committee on Food, the
United Kingdom Food Standards Agency, the Japan Ministry
for Health and Welfare and other regulatory authorities
Studies Show Very Low
Migration of BPA from Polycarbonate
Polycarbonate is a lightweight plastic with a unique
combination of attributes that make it an ideal material
for use in a wide variety of applications. Included
are a number of home and kitchen applications involving
direct contact with food and beverages that take advantage
of polycarbonate's inherent shatter-resistance, optical
clarity, and heat-resistance. Common examples include
reusable 5-gallon water bottles, baby bottles, tableware
such as plates and cups, and containers for storing
food and reheating in a microwave oven.
The primary building block used to make polycarbonate
plastic is bisphenol A (BPA). Many researchers have
studied the potential for trace levels of BPA to migrate
from polycarbonate into food and beverages under conditions
typical for uses of polycarbonate products. These studies
include ones conducted by government agencies in the
US, Europe and Japan, as well as studies conducted by
academic researchers and by industry. These studies
generally show that, under typical use conditions, the
potential migration of BPA into food is extremely low.
Some of the most notable examples include studies conducted
- U.S. Food and Drug Administration (FDA) on baby
bottles, water bottles and cut portions of baby bottles
under "typical/normal use" conditions (Biles
et al, 1997);
- U.K. Ministry of Agriculture, Fisheries and Food
(MAFF) on baby bottles subjected to as many as 30
cycles of cleaning, sterilizing and simulated use
(Mountfort et al, 1997; MAFF, 1997);
- U.K. Department of Trade and Industry (DTI), Consumer
Affairs Directorate on baby bottles handled under
"realistic worst-case conditions of use"
(Earls et al, 2000);
- Japanese National Institute of Health Sciences (NIHS)
on tableware and baby bottles under conditions representative
of normal consumer use (Kawamura et al, 1998);
- Society of the Plastics Industry, Inc. (SPI) on
polycarbonate discs under the most rigorous conditions
recommended by FDA (Howe and Borodinsky, 1998).
These studies are not identical in design but all aimed
to measure the potential migration of BPA into foods
and beverages under temperature and time conditions
considered to be typical of how polycarbonate products
are actually used. Study design aspects that vary among
the studies are the type of polycarbonate product or
article tested (i.e., baby bottles, water bottles, tableware,
molded discs or cut pieces), the nature of the "food"
in contact with polycarbonate (i.e., an actual food
such as water, fruit juice or infant formula, or a solvent
such as 10% ethanol to simulate food), and the specific
time/temperature conditions used. Considered together,
these studies cover a complete range of polycarbonate
food contact products and use conditions, which provides
reassurance that the collective results fully represent
the potential migration of BPA into foods and beverages.
The results of these studies are briefly summarized
below in reference to the type of polycarbonate product
or article that was tested.
Each of the studies conducted by the government agencies
included or focused entirely on baby bottles. In most
cases, new baby bottles were studied under well-characterized
laboratory conditions. In each case, migration of BPA
from new baby bottles, when detected, was less than
5 parts per billion.
The Japanese National Institute of Health Sciences
et al, 1998) conducted the most sensitive
study on 4 commercially available baby bottles. Because
of the use of food simulants (i.e., water, 20% ethanol,
4% acetic acid, heptane), which facilitate the analytical
measurement of BPA, the limit of detection was 0.5 parts
per billion. Temperature and time conditions as severe
as 30 minutes at 95oC followed by 24 hours
at room temperature were examined. With the exception
of one data point, migration of BPA was less than 1
part per billion for all test conditions and, for the
majority of samples, no BPA was detected at the 0.5
part per billion limit of detection. The one exception
involved a new unwashed bottle, which resulted in migration
of 3.9 parts per billion. After washing, migration from
this bottle decreased to the limit of detection.
A similar study was sponsored by the United Kingdom's
Department of Trade and Industry (DTI), Consumer Affairs
Directorate, Consumer Safety Research program and conducted
by LGC Ltd (Earls et al, 2000). The study examined
21 new baby bottles purchased from various retail outlets
in the London area and tested under "realistic
worst-case conditions of use." The bottles were
washed and sterilized, filled with either boiling water
or 3% acetic acid solution, capped, and placed in a
refrigerator for 24 hours at 1-5oC. After warming briefly,
the contents were analyzed using a method with a 10
part per billion limit of detection. In every case,
no BPA was detected.
The U.S. Food and Drug Administration and the U.K.
Ministry of Agriculture, Fisheries and Food (MAFF) both
measured migration of BPA from polycarbonate baby bottles
into infant formula or fruit juice. In the FDA study
(Biles et al, 1997), bottles were washed, sterilized,
filled with apple juice or infant formula and refrigerated
for 72 hours. These conditions were characterized as
typical or normal. No BPA was found in any sample with
a 100 part per billion limit of detection.
Likewise, in the extensive UK MAFF study (Mountfort
et al, 1997; MAFF, 1997), baby bottles were repeatedly
processed through a sequence in which the bottles were
washed, sterilized (three methods tested), filled with
fruit juice or infant formula, warmed in a microwave
oven, cooled, and analyzed. After as many as 30 cycles,
BPA was not detected in any sample with a 30 part per
billion limit of detection. In addition, no detectable
levels of BPA were found when the bottles were periodically
filled with water and held at 40oC for 10 days.
In the UK DTI study, a small number of used baby bottles
of uncertain age and history were also tested under
the same conditions as the new bottles. For both water
and 3% acetic acid solution, no migration was detected
in 8 of the 12 bottles tested. In 4 bottles, migration
of BPA was detected at levels of 20 to 50 parts per
billion. However, the results were inconsistent and
there was no correlation between migration levels and
the food simulant, estimated age of the bottles or sterilization
method reported to have been used. After reviewing all
available migration data on new and used bottles as
well as other polycarbonate articles, the European Commission's
Scientific Committee on Food concluded, "There
is no significant effect from repeated-use, abrasion,
heating, or chemical sterilization of these plastic
In the US FDA study, water from several 5-gallon polycarbonate
bottles from a bottled water supplier was analyzed with
a detection limit of 0.05 parts per billion. In water
that had been stored in the bottles for up to 39 weeks,
BPA was found only at very low levels ranging from 0.1
to 4.7 parts per billion.
The Japanese NIHS study evaluated several mugs and
ricebowls along with a measuring cup. As with baby bottles,
water and 20% ethanol were used as food simulants, which
allowed a 0.5 part per billion limit of detection. No
BPA was detected after 3 of 5 articles were exposed
to either water (95oC for 30 minutes) or
20% ethanol (60oC for 30 minutes). Migration
of BPA was observed from the other 2 articles, but only
at levels below 5 parts per billion.
Molded Discs or Cut
In addition to evaluation of whole baby bottles, the
US FDA study also tested migration from baby bottles
that had been cut into pieces. The pieces were immersed
in a simulant (either water or 10% ethanol), heated
to 100oC for 30 minutes and refrigerated for 72 hours.
For both simulants, the amount of BPA detected was estimated
to be equivalent to migration of approximately 2 ng/ml
(equal to 2 parts per billion) from a whole baby bottle.
The authors of the US FDA study concluded, "When
whole PC baby bottles were tested by using typical fill
conditions and less severe, normal use conditions, neither
BPA migration nor hydrolysis were observed (limit of
detection was 2 ng/ml)."
The Society of the Plastics Industry, Inc. conducted
a study (Howe and Borodinsky, 1998) to measure migration
from molded discs that were prepared from a blend of
polycarbonate resin from three American manufacturers.
The three resins were blended and pressed into small
discs such that all surfaces were similar to that of
a finished polycarbonate product. The study was conducted
according to procedures developed by the US FDA (FDA,
1995, revised 2002) and performed using storage
time and temperature conditions recommended by the US
The discs were immersed in food simulating solvents
(water, 3% acetic acid, 10% ethanol, coconut oil) and
held at 212oF for 6 hours or at 120oF for 10 days. No
BPA migration was detected in any of the samples with
a 5 part per billion limit of detection.
and Margin of Safety
The potential dietary exposure to BPA from polycarbonate
products that contact food and beverage can be estimated
using procedures recommended by the US FDA (FDA,
|dietary concentration = CF x [(fwater-based
x Mwater-based) + (facidic
+ (flow alcohol x Mlow
alcohol) + (ffatty
In this equation, "CF" is the "consumption
factor," the fraction of the average individual's
diet that is likely to contact a specific type of food-contact
material, such as polycarbonate plastic. Also in this
equation, "f" is the "food-type distribution
factor", the fraction of each food or beverage
type that contacts the material, "M" is the
migration value for that type of food in contact with
the material, and the type is indicated by the subscript
description (water-based, acidic, low (<15%) alcohol
Migration testing under conditions that are typical
of how polycarbonate products are actually used indicates
that migration of BPA, when it is detected at all, is
generally less than 5 parts per billion. This value
(<5 parts per billion) can then be used as the M
value for each food type. Standard or "default"
values for CF and f are prescribed by the US FDA (FDA,
2002) for food-contact materials for which actual
consumer usage data is not available. The default f
values for polycarbonate are 0.97, 0.01, 0.01 and 0.01
for water-based, acidic, low alcohol and fatty foods
and beverages, respectively. With these parameters,
the average concentration of BPA in all food and beverages
that contact polycarbonate is <5 parts per billion.
Polycarbonate plastic is classified in the "all
other" category for which the CF value is 0.05,
corresponding to the estimate that a maximum of 5% of
the food and beverages consumed in an average diet are
in contact with polycarbonate. Thus, the potential concentration
of BPA in the entire diet from food and beverages that
contact polycarbonate is <0.25 parts per billion.
According to FDA, the average individual consumes 3000
grams of food and beverages per day. Based on this value,
the potential dietary concentration of <0.25 parts
per billion corresponds to a potential daily intake
of <0.00075 milligrams per person per day. Based
on FDA's estimate that a typical individual weighs 60
kilograms, the estimated dietary intake of BPA is <0.0000125
milligrams per kilogram body weight per day.
This level is more than 4000 times lower than the maximum
acceptable or "reference" dose for BPA of
0.05 milligrams per kilogram body weight per day established
by the U.S. Environmental Protection Agency (EPA,
1993). When the dietary intake of BPA from polycarbonate
is combined with other sources of dietary exposure to
BPA, the total dietary intake of BPA (<0.00012 milligrams
per kilogram body weight per day) from all sources is
still more than 400 times lower than the reference dose
INFO, 2002). The reference dose is defined by the
US EPA as an estimate of a daily oral exposure to the
human population (including sensitive subgroups) that
is likely to be without an appreciable risk of deleterious
effects during a lifetime.
With an average concentration of BPA in all food and
beverages that contact polycarbonate of <5 parts
per billion (equal to <0.005 milligrams BPA per kilogram
food/beverage), an average adult consumer weighing 60
kilograms would have to consume more than 600 kilograms
(or about 1300 pounds) of food and beverages in contact
with polycarbonate every day for an entire lifetime
to exceed the reference dose of 0.05 milligrams per
kilogram body weight per day.
The reference dose for BPA has recently been confirmed
by a three-generation study in rats (Tyl et al, 2002),
which found no adverse effects on reproduction from
BPA at doses of 50 milligrams per kilogram body weight
per day and lower. The US EPA calculated the reference
dose by dividing the Lowest-Observed-Adverse-Effect-Level
(LOAEL, 50 milligrams per kilogram body weight per day)
from an earlier chronic toxicity study by an uncertainty
factor of 1000. Applying that same uncertainty factor
to the No-Observed-Adverse-Effect-Level (NOAEL, 50 milligrams
per kilogram body weight per day) from the Tyl study
confirms the safety of the reference dose, 0.05 milligrams
BPA per kilogram body weight per day. Since the maximum
estimate of BPA exposure from polycarbonate products
in contact with food and beverages is over 4000-fold
lower than the reference dose, the potential human exposure
to BPA from polycarbonate products is minimal and poses
no known risk to human health.
The Scientific Committee on Food (SCF), which is an
independent advisory committee to the European Commission
on food safety matters, has recently evaluated the safety
of BPA from all food contact sources (SCF, 2002). The
SCF set a Tolerable Daily Intake (TDI) for BPA of 0.01
milligrams per kilogram body weight per day after a
comprehensive review of all robust scientific data covering
all aspects of toxicity.
Similar to the US EPA reference dose, the TDI represents
a lifetime exposure level that is considered to be safe.
Based on the existing migraition data, total exposure
to BPA from all food contact sources, including polycarbonate
plastic and epoxy resin coatings, was estimated to be
in the range of 0.00048 to 0.0016 milligrams per kilogram
body weight per day for adults and infants respectively,
which is below the TDI value set by the SCF. Only a
small portion of the exposure was estimated to be from
polycarbonate plastic. This assessment confirms that
polycarbonate products are safe for use in contact with
food and beverage and pose no known risk to human health.
Human exposure to BPA from food-contact use of polycarbonate
plastic is very low and poses no known risk to human
health. The use of polycarbonate plastic for food contact
applications has been and continues to be recognized
as safe by the U.S. Food and Drug Administration, the
European Commission's Scientific Committee on Food,
the United Kingdom Food Standards Agency, the Japanese
Ministry of Health, Labor and Welfare, and other regulatory
APME (Association of Plastics Manufacturers in Europe).
Additional information on the versatility and many uses
of polycarbonate plastic is http://www.apme.org/polycarbonate.
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