FAQs About Bisphenol-A (BPA)
Below you will find answers to Frequently Asked Questions about bisphenol A (BPA). If your questions aren’t answered below, please contact us.
Questions
What is polycarbonate plastic?
Does FDA have anything to say about the safety of BPA/polycarbonate plastic safety?
Is BPA, polycarbonate or any article made from polycarbonate banned anywhere in the world?
Is there a ban in Japan on use of polycarbonate in baby bottles or any other food contact article?
Why hasn’t the U.S. government banned the use of BPA?
I’ve heard about a new mouse study. What does it mean?
Is industry turning over all the data?
Should I be concerned if my baby bottles become cloudy over time?
Can I clean/sterilize polycarbonate articles, including baby bottles, in a dishwasher?
If I microwave my child’s baby bottle, does that increase migration of BPA from the polycarbonate baby bottle?Is it safe to use a bottle warmer to heat my baby’s milk?
Is there a difference in BPA migration from polycarbonate into milk, formula, breast milk or juices?
How should polycarbonate products be cleaned?
What items used by infants and toddlers are made from BPA?
Will playing with toys made from polycarbonate expose my child to dangerous levels of BPA?
Is it safe to let my child use a polycarbonate baby bottle?
If it’s safe to use polycarbonate baby bottles, why did Canada ban them?
Can BPA get into my body through skin contact with polycarbonate?
Do I have BPA in my body right now? Should I be scared?
How would I be exposed to BPA?
What does my body do to BPA when it enters my body?
Is there an alternative to BPA-based polycarbonate in consumer products?
Does BPA in can coatings migrate more readily into liquids than solids?
Answers
Bisphenol A, or BPA, is a compound used to make polycarbonate plastic and epoxy resins. It is also used in dental sealants and composites.
What is polycarbonate plastic?
Polycarbonate plastic is a shatter-resistant, lightweight, high-performance plastic with toughness, optical clarity, high heat resistance, and excellent electrical resistance. It makes everything from life saving medical equipment, like kidney dialyzers, blood oxygenators, and drug infusion units, to bicycle helmets and safety glasses to automobile bumpers to compact discs and DVDs.
Epoxy resins are used in many coating and other applications. One very important application is as protective liners in metal cans for canned foods and beverages.
Metal food and beverage cans have a thin coating on the interior surface, which is essential to prevent corrosion of the can and contamination of food and beverages with dissolved metals. The coating also helps to prevent canned foods from becoming tainted or spoiled by bacterial contamination. In addition to protecting contents from spoilage, these coatings make it possible for food products to maintain their quality and taste while helping the food products to last longer in the can.
Does FDA have anything to say about the safety of BPA/polycarbonate plastic safety?
In mid-April, 2008, FDA stated that, “[b]ased on our ongoing review, we believe there is a large body of evidence that indicates that FDA-regulated products containing BPA currently on the market are safe and that exposure levels to BPA from food contact materials, including for infants and children, are below those that may cause health effects. However, we will continue to consider new research and information as they become available.”
FDA’s statement accompanied its announcement of the formation of agency-wide BPA (Bisphenol A) task force to facilitate cross-agency review of current research and new information on BPA for all FDA regulated products.
FDA reassured the public that it “has been reviewing the emerging literature on BPA on a continuous basis.” After recent review of two recently completed rodent multigeneration reproductive studies FDA noted that “these studies did not indicate a safety concern for BPA at current exposure levels.”
FDA’s position is consistent with two risk assessments for BPA conducted by European and Japanese government authorities. The European and Japanese reviews considered the question of a possible low-dose effect and both concluded that “no current health risk exists for BPA at the current exposure level.”
FDA also issued a message for consumers which notes, “[a]t this time, FDA is not recommending that anyone discontinue using products that contain BPA while we continue our risk assessment process.”
Is there any pending U.S. federal, state or local legislation that contemplates a ban on BPA or articles made from polycarbonate?
There is proposed legislation to ban BPA in a number of states; the proposed legislation is primarily focused on banning BPA in toys and childcare articles for children under the age of 3. To date, these proposals have not been implemented after legislators have had the opportunity to understand the strong science supporting the safety of BPA.
Proposed legislation to ban BPA in children’s products has been introduced in the United States Senate. The bill would apply to consumer products designed for children ages 7 and under.
Is BPA, polycarbonate or any article made from polycarbonate banned anywhere in the world?
The US Food and Drug Administration, European Food Safety Authority and Japan’s Ministry of Health, Labor and Welfare, all specifically allow the use of BPA-based polycarbonate plastic in food contact applications.
There is no ban in place on BPA, polycarbonate resin or any article made from polycarbonate resin anywhere in the world. To date, bans have failed everywhere they have been proposed based on the strong science supporting the safety of BPA.
The Canadian government recently completed a review of the safety of bisphenol A and announced “[t]he preliminary research tells us the general public need not be concerned.” With respect to infants 18 months and under, it said that “[s]cience tells us that exposure levels are below those that could cause health effects, but since they are close to the levels where potential effects could occur, the Government wants to be prudent and reduce exposures further.” The government announced a comment period during which it is considering whether to move forward with a ban of polycarbonate baby bottles In general, most Canadians are exposed to very low levels of bisphenol A and it does not pose a significant health risk.
The Canadian government decided to move forward even though the reviewing scientists concluded “that bisphenol A exposure to newborns and infants is below levels that may pose a risk” because it made a policy decision that the “gap between exposure and effect is not large enough.” Canada also proposed to set limits on BPA in infant formula and to work with industry on alternatives for food packaging.
Canada did not suggest that parents and caregivers stop using polycarbonate bottles while the proposal is being considered. Canada did not suggest that stores stop selling polycarbonate baby bottles while the proposal is being considered. Canada did recommend that parents and caregivers continuing to use polycarbonate baby bottles “do not put boiling water in them.”
Is there a ban in Japan on use of polycarbonate in baby bottles or any other food contact article?
No, there is not a ban on polycarbonate use for baby bottles or for any other food contact application.
Why hasn’t the U.S. government banned the use of BPA?
Many government agencies have reviewed the scientific data on BPA. All have reached the conclusion that current levels of exposure to BPA are within safe levels.
The news articles say that academic and government studies find health effects from BPA while industry funded studies find no issue with BPA. How can that be? Are the industry funded studies biased?
It is important to keep in mind that the government agencies that have reviewed all of the scientific data – academic studies, government studies and industry studies - have relied on the studies funded by industry as well-conducted and well-designed.
Some of the important reasons why the industry studies on BPA are reliable are because they:
- Are commissioned (funded) by industry, but are conducted by independent expert scientists in laboratories and institutions that specialize in such large, complex studies. In contrast, the academic studies are generally very small and some are conducted by students.
- Are large, have a robust study design based on study methods that are accepted world-wide, and employ good laboratory practices.
- Are generally many times larger than academic studies, they typically investigate a range of doses of BPA from very low to high, and they are statistically powerful.
- Use realistic exposure scenarios. Most human exposure to BPA comes from ingestion of food or liquid that has been in contact with polycarbonate bottles or epoxy can linings. Academic studies that use direct injection into the blood or tissue of the study animal bypass the digestive system in which BPA is quickly metabolized and eliminated. The government agencies have rejected studies that use non-realistic routes of exposure (e.g., direct injection), as they are not useful in assessing human health risks.
I’ve heard about a new mouse study. What does it mean?
You may have heard about a large scale “mouse” study being completed. This study found no evidence for reproductive or developmental effects at low doses of BPA. While some small studies have suggested low dose effects from BPA exposure, these effects are not replicated or corroborated by this (and other) comprehensive multi-generation study.
Not all studies are the same in terms of how they are designed and conducted. This study is important for a number of reasons relating to the size and quality of the study. Here are just a few.
- Run as large study. It was a large-scale study (28 animals per dose level) with high statistical power to detect effects.
- Reviewed multiple endpoints. It examined multiple reproductive and developmental endpoints, including a thorough microscopic evaluation of tissues.
- Engineered with positive control. The study included a positive control (estradiol) to confirm that the laboratory animals were sensitive to estrogenic effects.
- Met international guidelines. The study met all requirements of the internationally accepted test guideline for multi-generation reproductive toxicity studies (OECD No. 416), plus enhancements to detect potential estrogenic effects.
- Led by experts. The study was conducted under the direction of a renowned reproductive toxicity expert (Dr. Rochelle Tyl) in a highly qualified research laboratory (RTI International) following Good Laboratory Practices, which is the highest quality standard for toxicology studies.
- Overseen by international steering group. Design, conduct and reporting of the study were under the guidance and supervision of a scientific steering group, composed of expert reproductive and development toxicologists representing the governments of Denmark, Germany, Netherlands, Sweden and UK plus officials of the European Chemicals Bureau Joint Research Center and a WWF representative.
- Subjected to third party audit. Procedures, data and reports from entire project subjected to comprehensive quality assurance auditing by an expert third party who was independent of the test laboratory.
- Published in premier scientific journal. Published in the peer-reviewed journal Toxicological Sciences, which is the premier scientific journal for the field of toxicology.
- Called “The Gold Standard.” Study reviewed as part of a comprehensive EU risk assessment and described as “the gold-standard, definitive study of the reproductive toxicity of BPA.
Is industry turning over all the data?
Some media articles charge that like the tobacco industry, those who make BPA and polycarbonate are hiding information from the public. Those articles ignore both the hundreds of studies that are publicly available on BPA and the fact that the industry is required by law to provide information to government and the public if it discovers any possible negative effects. (U.S. Toxic Substances Control Act § 8(e))
Do used or scratched polycarbonate bottles release a dangerous level of BPA? Do I have to worry about BPA getting into milk from old, cloudy baby bottles?
No. Numerous experiments with polycarbonate baby bottles, including old baby bottles that have been used repeatedly, demonstrate that the level of BPA migrating from used and scratched bottles is well below science-based safety standards.
See: Dutch Food and Consumer Product Safety Authority Study - Migration of bisphenol A and plasticizers from plastic feeding utensils for babies. Food and Consumer Protection Safety Authority. June 2005.
University of Athens study - Maragou, N. C., Makri, A, Lampi, E. N., Thomaidis, N. S., and Koupparis, M. A. 2008. Migration of bisphenol A from polycarbonate baby bottles under real use conditions. Food Additives and Contaminants. 25(3):373-383. Available on-line at http://dx.doi.org/10.1080/02652030701509998
Should I be concerned if my baby bottles become cloudy over time?
Polycarbonate baby bottles can become cloudy over time and can still be safely used. If the cloudiness impairs your ability to see the contents of the bottle, you may want to consider replacing it.
Can I clean/sterilize polycarbonate articles, including baby bottles, in a dishwasher?
Yes. A number of studies show that polycarbonate baby bottles can be safely cleaned in a dishwasher.
For example, in 2007, researchers from the Norwegian Food Safety Authority and the Official Food Control Authority of the Canton of Zürich, Switzerland conducted a very comprehensive set of experiments designed to assess whether any real-life dishwashing condition, “even rather improbable conditions and scenarios,” could lead to BPA levels above safety standards. Based on the data, they concluded “that even under extreme conditions and scenarios the amount of BPA released from polycarbonate baby bottles is clearly below the TDI [Tolerable Daily Intake; a European science-based safety standard] for babies.”
See: Biedermann-Brem, S., Grob, K., and Fjeldal, P. 2007. Available from the Norwegian Food Safety Authority website at http://matportalen.no/artikler/2007/11/taateflasker_av_polykarbonat_er_trygge_i_bruk.
If I microwave my child’s baby bottle, does that increase migration of BPA from the polycarbonate baby bottle?
A recent study confirmed that even after heating baby bottles in a microwave, migration occurs at very low levels, and those levels are within safety standards.
A 2008 study by TNO, a prominent Dutch research organization, tested polycarbonate baby bottles from eighteen different brands sold in Europe to determine the level of BPA that migrates under real-life microwave heating or sterilizing conditions. Bottles were filled with water, heated to boiling with microwave heating, boiled for one minute, and cooled. The procedure was then repeated two more times for each bottle after rinsing, and BPA was measured in the water from each cycle.
The study showed that microwave heating did not significantly increase the rate of migration of BPA from polycarbonate bottles. This study indicates that microwave heating can be safely used to either warm the contents of a polycarbonate bottle or to sterilize the bottles. Migration levels measured in this and earlier studies using other modes of heating are all well below science-based safety standards set by government agencies.
See Ehlert, K. A., Beumer, C. W. E., and Groot, M. C. E. 2008. Migration study of bisphenol A into water from polycarbonate baby bottles during microwave heating. Food Additives and Contaminants.
Will BPA leach into milk if I microwave my child’s baby bottle? Can I safely heat food/beverages/baby’s milk in polycarbonate items in the microwave?
Physicians generally recommended that you avoid microwave ovens when warming your baby’s bottle, as they can create “hot spots” which may burn your child.
However, if you do heat a baby bottle or other foods and beverages in a microwave, a recent study confirmed that even after heating baby bottles in a microwave oven, migration occurs at very low levels, and those levels.
E. 2008. Migration study of bisphenol A into water from polycarbonate baby bottles during microwave heating. Food Additives and Contaminants.
Is it safe to use a bottle warmer to heat my baby’s milk?
Yes, it is safe to use the recommended bottle warmer following the manufacturer’s instructions.
Is there a difference in BPA migration from polycarbonate into milk, formula, breast milk or juices?
Migration into all food types from polycarbonate baby bottles has been shown to be very low and below safety limits set by government agencies worldwide.
How should polycarbonate products be cleaned?
As with any product, follow the manufacturer’s instructions for cleaning a product made of polycarbonate plastic. Polycarbonate plastics can be safely cleaned in a dishwasher or with a mild detergent and hot water.
What items used by infants and toddlers are made from BPA?
Baby bottles, sippy cups and the hard plastic part of teethers are the primary items made from BPA-based polycarbonate plastic that are intended for use by infants and toddlers.
Will playing with toys made from polycarbonate expose my child to dangerous levels of BPA?
The U.S. Centers for Disease Control has measured amounts of bisphenol A in humans, and the levels measured in the average population – looking at exposures from all sources – are well below levels that government agencies have deemed safe. Agencies worldwide have cleared polycarbonate as safe for use in more sensitive applications, such as in food and drink containers.
Is it safe to let my child use a polycarbonate baby bottle?
Government agencies worldwide have approved baby bottles made from polycarbonate as safe for use. The safety of polycarbonate baby bottles has been supported by numerous science-based safety evaluations of BPA that have been conducted by independent government and scientific bodies worldwide.
- July 2007, the US Food and Drug Administration stated “FDA has determined that the use of polycarbonate-based baby bottles and BPA-based epoxy coated cans used to hold infant formula is safe.”
- January 2007, the European Food Safety Authority concluded that BPA is safe for use in food contact applications, and that exposures to BPA – including by infants and children – are within safe levels.
- January 2006, the German Federal Institute for Risk Assessment (BfR, Bundesinstitut für Risikobewertung), which is the German expert body responsible for opinions on food safety and consumer health protection, stated “The BfR does not recognize any health risk for babies that are fed from baby bottles made of polycarbonate.”
If it’s safe to use polycarbonate baby bottles, why did Canada ban them?
In April 2008, Health Canada opened a comment period on a proposal to ban polycarbonate baby bottles.” Although the reviewing scientists concluded “that bisphenol A exposure to newborns and infants is below levels that may pose a risk”, the Canadian government nevertheless, proposed moving forward with a ban on polycarbonate baby bottles based on a policy decision that the “gap between exposure and effect is not large enough.” Canada also proposed to set limits on BPA in infant formula and to work with industry on alternatives for food packaging.
Canada did not suggest that parents and caregivers stop using polycarbonate bottles while the proposal is being considered. Canada did not suggest that stores stop selling polycarbonate baby bottles while the proposal is being considered. Canada did recommend that parents and caregivers continuing to use polycarbonate baby bottles “do not put boiling water in them.”
I’ve heard some pretty scary stories about birth defects associated with BPA. Is the baby I’m carrying going to be harmed if I’m exposed to it?
Not according to the U.S. Food and Drug Administration (FDA), which said in July 2007 that “FDA is unaware of any specific study in which humans exposed to BPA through any food containers experienced miscarriages, birth defects or cancer. Furthermore, human exposure levels to BPA from its use in food contact materials is in fact many orders of magnitude lower than the levels of BPA that showed no adverse effects in animal studies.”
More recently, in February 2008, the FDA wrote to Congressman Dingell, “FDA believes that this level of exposure to adults and infants is safe as defined in 21 CFR §170.36(i). This conclusion is based on our most recently completed reviews of two pivotal multigenerational oral studies performed under applicable regulatory guidelines. The studies included the examination of reproductive and developmental endpoints and a large range of exposures, including low doses.”FDA also reconfirmed the safety of BPA on its BPA webpage, http://www.fda.gov/oc/opacom/hottopics/bpa.html, which went live in April, 2008: “Based on our ongoing review, we believe there is a large body of evidence that indicates that FDA-regulated products containing BPA currently on the market are safe and that exposure levels to BPA from food contact materials, including for infants and children, are below those that may cause health effects.”
The newspapers say that BPA has been “linked” to certain health effects. Have any studies shown that BPA actually causes these health effects?
Not according to the U.S. Food and Drug Administration (FDA), which said in July 2007 that “FDA is unaware of any specific study in which humans exposed to BPA through any food containers experienced miscarriages, birth defects or cancer. Furthermore, human exposure levels to BPA from its use in food contact materials is in fact many orders of magnitude lower than the levels of BPA that showed no adverse effects in animal studies.”
Can BPA get into my body through skin contact with polycarbonate?
Skin absorption of BPA from bathing or handling canned foods or polycarbonate articles would be expected to be negligible (that is so small as to be approaching zero) based on an in vitro study on dermal penetration using human skin.
See In Vitro Technologies (2001). Assessment of Skin Penetration of Bisphenol-A. In Vitro Technologies, Unpublished Draft Report No IVT M2000-46, Baltimore, Maryland, USA. Available from the EU Risk Assessment document at
http://ecb.jrc.it/DOCUMENTS/Existing-Chemicals/RISK_ASSESSMENT/REPORT/bisphenolareport325.pdf
Do I have BPA in my body right now? Should I be scared?
In 2001, the U.S. Centers for Disease Control and Prevention (CDC) published biomonitoring data on BPA from a large-scale study that is representative of the U.S. population. Overall, the CDC data indicates that human exposure to BPA is very low. More specifically, the data from the CDC indicates that typical human daily intake of BPA is approximately 50 nanograms/kg bodyweight/day. These levels are about 1 million times below the exposure levels at which no adverse effects on reproduction and development were observed in comprehensive multi-generation animal studies.
It is also important to keep in mind that BPA is rapidly metabolized by the human body. A person would have to consume more than 500 pounds of food and beverages in contact with polycarbonate or epoxy resin every day for a lifetime to exceed the acceptable level set by the U.S. Environmental Protection Agency and confirmed in January 2007 by the European Food Safety Authority.
How would I be exposed to BPA?
Human exposure to BPA is typically through ingestion of food or beverages that have been in contact with polycarbonate plastic or epoxy can linings. The exposure levels are many times lower than the safe exposure levels established by government agencies, such as the U.S. Food and Drug Administration (FDA), the European Food Safety Authority (EFSA), the Japanese Ministry of Health, Labor and Welfare, and the German Federal Institute for Risk Assessment (BfR, Bundesinstitut für Risikobewertung).
A person would have to consume more than 500 pounds of food and beverages in contact with polycarbonate or epoxy resin every day for a lifetime to exceed the acceptable level set by the U.S. Environmental Protection Agency and confirmed in January 2007 by the European Food Safety Authority.
What does my body do to BPA when it enters my body?
BPA is rapidly metabolized in the human body and entirely excreted in urine.
Is there an alternative to BPA-based polycarbonate in consumer products?
There are other materials that are marketed as alternatives to BPA-based polycarbonate in consumer products; however, none has the combination of a long history of safe use, extensive scientific test data, cost-effectiveness, and clarity, durability and shatter resistance. http://www.bisphenol-a.org/about/faq.html#p
Does BPA in can coatings migrate more readily into liquids than solids?
Government agencies consider both the migration into liquids and solids when setting the safe level for food contact applications. The potential human exposure to BPA from all sources is more than 400 times lower than the maximum acceptable or “reference” dose for BPA of 0.05 mg/kg body weight/day established by the U.S. Environmental Protection Agency.
When comparing migration levels of BPA into liquids v. solids, data show the level is somewhat higher in solids, but still well below the safe level.
Additional information, if asked for details of the data: The Society of the Plastics Industry, Inc. (SPI) study of BPA migration from a variety of can coatings into food simulating solvents (Howe et al, 1998) showed no detectable migration of BPA from the three beverage/beer can coatings tested was found with an analytical method sensitive to 5 parts per billion. The average level of BPA migration from the 14 cans food cans tested was 37 parts per billion.
In 2001, the UK Food Standards Agency surveyed BPA content in canned foods and beverages purchased in the UK (UK FSA, 2001; Goodson et al, 2002). The levels of BPA found in foods and beverages are generally consistent with the results reported by SPI (Howe et al, 1998). In all but one canned beverage, BPA was not detected at a limit of detection of 2 parts per billion. In most of the canned food samples, BPA, when detected, was found at levels comparable to or lower than the average level of 37 ppb for food cans reported in the SPI study.
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