Download Polycarbonate Plastic Containers with BPA are Safe

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Revised July 15, 2014
Position Brief: Polycarbonate Plastic Containers with BPA are Safe
Questions have been raised about the safety of polycarbonate plastic bottles due to
the presence of a substance known as bisphenol A (BPA). Polycarbonate plastic is
used in a wide variety of consumer products, including food and drink containers.
Many 3- and 5-gallon bottled water containers are made of polycarbonate plastic and
consumers can remain confident about the safety of these products.
Bottled water is comprehensively regulated as a food product by the U.S. Food and Drug Administration (FDA).
Plastic food and beverage containers, including polycarbonate plastic bottles made with BPA, must meet or
exceed all FDA requirements. FDA approves all food-contact plastics for their intended use based on
migration and safety data. The approval process includes stringent requirements for estimating the levels at
which such materials may transfer to the diet. FDA's safety criteria require extensive toxicity testing for any
substance that may be ingested at more than negligible levels. This means FDA has affirmatively determined
that, when these plastics are used as intended in food-contact applications, the nature and amount of
substances that may migrate, if any, are safe.
Polycarbonate plastic has been the material of choice for many food and beverage product containers for
nearly 50 years because it is lightweight, highly shatter-resistant, and transparent. During that time, many
International studies have been conducted to assess the potential for trace levels of BPA to migrate from lined
cans or polycarbonate bottles into foods or beverages. The conclusions from those studies and
comprehensive safety evaluations by government bodies worldwide are that polycarbonate plastic bottles are
safe for consumer use.
FDA Continues to Approve BPA for Food Use
A February 14, 2014, FDA study published in the journal, Toxicological Sciences, “Toxicity Evaluation of
Bisphenol A Administered by Gavage to SPRAGUE-DAWLEY Rats from Gestation Day 6 through Postnatal Day
90,” indicates that rats given BPA orally at low doses while in the womb and after birth, demonstrated no
adverse health effects. This study also aimed to address noted shortfalls of previous low-dose animal studies
(such as small number of animals, clear dose-response relationships and litter effects). This study’s findings
are consistent with the current FDA “Consumer Update on BPA” statement that states, “The Food and Drug
Administration’s assessment is that the scientific evidence at this time does not suggest that the very low
levels of human exposure to BPA through the diet are unsafe.”
On June 4, 2013, the FDA clearly confirmed the safety of BPA in a question-and-answer post on its website.
Responding to the question, “Is BPA safe,” FDA’s position is clear:
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“Yes. Based on FDA’s ongoing safety review of scientific evidence, the available information
continues to support the safety of BPA for the currently approved uses in food containers and
packaging.”
Additionally, on March 30, 2013, the FDA issued an update to its previously released Consumer Update on
Bisphenol-A for Use in Food Contact Application. The March 2013 revised Consumer Update on BPA stated:
"FDA’s current assessment is that BPA is safe at the very low levels that occur in some foods. This
assessment is based on review by FDA scientists of hundreds of studies including the latest findings
from new studies initiated by the agency. Because of concerns expressed in the last few years about
the safety of BPA, FDA initiated additional studies to help determine whether or not BPA is safe as it is
currently used in food packaging and containers. Some of these studies have been completed and
others are on-going.”
“The FDA’s studies are being conducted by the agency’s National Center for Toxicological Research
(NCTR). All are conducted under strict quality-assurance guidelines and are designed to produce
information that will enhance our evaluation of BPA’s safety... The results from these new studies so
far support FDA’s assessment that the use of BPA in food packaging and containers is safe."
On March 30, 2012, the FDA rejected a citizen petition from the Natural Resources Defense Council (NRDC)
seeking to ban BPA from all food and drink packaging, including plastic bottles and canned food. The FDA
stated that its "assessment is that the scientific evidence at this time does not suggest that the very low levels
of human exposure to BPA through the diet are unsafe."
FDA has not taken any formal action to prohibit the use of BPA in any food products. In fact, FDA has
previously cautioned against making any changes in food packaging or consumption by either industry or
consumers that could jeopardize food safety or reduce intake of food needed for good nutrition.
IBWA supports additional studies, by both governmental and non-governmental entities, and is confident that
they will confirm the safety of BPA. FDA’s National Center for Toxicological Research is pursuing a set of
studies on the safety of low doses of BPA, including assessment of the novel endpoints where concerns have
been raised. These include studies pursued in collaboration with the National Toxicology Program and with
support and input from the National Institute for Environmental Health Sciences.
As mentioned in FDA’s March 2013 statement, other studies on the safety of BPA are also underway. For
example, the National Institute of Environmental Health Sciences has announced that it is providing $30
million in funding to study BPA, which includes support both for FDA studies and external grants.
European Food Safety Authority proposes Lower Tolerable Daily Intake for BPA
On January 17, 2014, after an extended review of scientific research relating to potential health hazards
associated with BPA, the European Food Safety Authority (EFSA) proposed a lower tolerable daily intake (TDI)
for BPA. The EFSA established the TDI for BPA is currently 50 µg/kg bw/day (0.05 mg/kg/bw/day), which EFSA
is now proposing to reduce temporarily to 5 µg/kg bw/day (0.005 mg/kg/bw/day).
The TDI has been set on a temporary basis pending the outcome of research from the U.S. National Toxicology
Program (NTP), which will address many current uncertainties about the potential health effects of BPA. In
conjunction with this newly set temporary TDI, EFSA has launched a public consultation on its draft
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assessment of the human health risks posed by exposure to BPA and invites all stakeholders and interested
parties to comment on the document. EFSA expects to complete its assessment of BPA by the end of 2014.
Bottled Water-Specific BPA Studies
While there are thousands of consumer products that use polycarbonate plastic containers, two BPA studies
focused specifically on bottled water and concluded that it does not pose a health risk to consumers.
 On September 27, 2012, Health Canada (the Canadian equivalent of FDA) released a report containing
an updated assessment of the health effects of BPA. The report concludes BPA poses no health risk to
any segment of the population. These new government data confirm Health Canada's 2008 conclusion
that exposure to BPA through food packaging uses is not expected to pose a health risk to the general
population, including newborns and young children. As noted by Health Canada, an adult would have
to drink approximately 1,000 liters (or 264 gallons) of water from polycarbonate water cooler bottles
every day to approach the science-based safe intake limit for BPA recently established in Canada.
 In January 2012, the International Journal of Applied Science and Technology published a study
showing that exposure to BPA through the consumption of bottled water would be extremely low. The
study, “Migration of Bisphenol-A into the Natural Spring Water Packaged in Polycarbonate Carboys
[bottles],” concludes that the current dietary exposure to BPA through use of polycarbonate bottled
water products is not expected to pose a health risk to the general population.
For more information, please visit:
FDA, BPA Use in Food Contact Application
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm064437.htm
FDA, Consumer Information about BPA:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm297954.htm
American Chemistry Council, Facts on Plastics
www.factsonplastic.com
Bishpenol-A.Org
www.bisphenol-a.org
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