Update on Bisphenol A for Use in Food Contact Applications 

U.S. Food and Drug Administration 

January 2010 

Overview 

Bisphenol A (BPA) is an industrial chemical that has been present in many hard plastic bottles 

and metal-based food and beverage cans since the 1960s. 

Studies employing standardized toxicity tests have thus far supported the safety of current low 

levels of human exposure to BPA. However, on the basis of results from recent studies using 

novel approaches to test for subtle effects, both the National Toxicology Program at the National 

Institutes of Health and FDA have some concern about the potential effects of BPA on the brain, 

behavior, and prostate gland in fetuses, infants, and young children. In cooperation with the 

National Toxicology Program, FDA’s National Center for Toxicological Research is carrying out 

in-depth studies to answer key questions and clarify uncertainties about the risks of BPA. 

In the interim: 

• FDA is taking reasonable steps to reduce human exposure to BPA in the food supply. 

These steps include: 

o supporting the industry’s actions to stop producing BPA-containing baby bottles 

and infant feeding cups for the U.S. market; 

o facilitating the development of alternatives to BPA for the linings of infant 

formula cans; and 

o supporting efforts to replace BPA or minimize BPA levels in other food can 

linings. 

• FDA is supporting a shift to a more robust regulatory framework for oversight of BPA. 

• FDA is seeking further public comment and external input on the science surrounding 

BPA. 

FDA is also supporting recommendations from the Department of Health and Human Services 

for infant feeding and food preparation to reduce exposure to BPA. 

FDA is not recommending that families change the use of infant formula or foods, as the benefit 

of a stable source of good nutrition outweighs the potential risk from BPA exposure. 

Background 

BPA is an industrial chemical used to make a hard, clear plastic known as polycarbonate, which 

has been used in many consumer products, including reusable water bottles and baby bottles. 

BPA is also found in epoxy resins, which act as a protective lining on the inside of metal-based 

food and beverage cans. These uses of BPA are subject to premarket approval by FDA as 

indirect food additives or food contact substances. The original approvals were issued under 

FDA’s food additive regulations and date from the 1960s. 

1
Studies employing standardized toxicity tests used globally for regulatory decision making thus 

far have supported the safety of current low levels of human exposure to BPA.1

 However, 

results of recent studies using novel approaches and different endpoints describe BPA effects in 

laboratory animals at very low doses corresponding to some estimated human exposures.2

 Many 

of these new studies evaluated developmental or behavioral effects that are not typically assessed 

in standardized tests. 

The National Toxicology Program Center for the Evaluation of Risks to Human Reproduction, 

part of the National Institutes of Health, completed a review of BPA in September 2008.3 The 

National Toxicology Program uses five different terms to describe its level of concern about the 

different effects of chemicals: negligible concern, minimal concern, some concern, concern, and 

serious concern.4

 

In its report on BPA, the National Toxicology Program expressed “some concern for effects on 

the brain, behavior, and prostate gland in fetuses, infants, and children at current human exposures to bisphenol A.”5 The Program also expressed “minimal concern for effects on the 

mammary gland and an earlier age for puberty for females in fetuses, infants, and children at 

current human exposures to bisphenol A” and “negligible concern” for other outcomes.6

The National Toxicology Program does not make regulatory recommendations. With respect to 

neurological and developmental outcomes of BPA, the Program stated that “additional research 

is needed to more fully assess the functional, long-term impacts of exposures to bisphenol A on 

the developing brain and behavior.”7 The Program also stated: 

Overall, the current literature cannot yet be fully interpreted for biological or 

experimental consistency or for relevance to human health. Part of the difficulty for 

evaluating consistency lies in reconciling findings of different studies that use different 

 1

 See, e.g., European Food Safety Authority. Toxicokinetics of Bisphenol A, Scientific 

Opinion of the Panel on Food additives, Flavourings, Processing aids and Materials in Contact 

with Food, Adopted 9 July 2008, The EFSA Journal 2008. Available online at 

http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/afc_ej759_bpa_%20toxicokinetics

_op_en.pdf?ssbinary=true. 

2

 See, e.g. vom Saal FS, Akingbemi BT, Belcher SM et al. Chapel Hill bisphenol A 

expert panel consensus statement: integration of mechanisms, effects in animals and potential to 

impact human health at current levels of exposure, Reproductive Toxicology 2007;24:131-8. 

3

 NTP-CERHR Monograph on the Potential Human Reproductive and Developmental 

Effects of Bisphenol A, NIH Publication No. 08-5994, September 2008. 

4

 Ibid, page 6. 

5

 Ibid. 

6

 Ibid. 

7

 Ibid, page 20. 

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experimental designs and different specific behavioral tests to measure the same dimension 

of behavior.8

In August 2008, prior to the release of the final National Toxicology Program report, FDA 

released a document entitled Draft Assessment of Bisphenol A for Use in Food Contact 

Applications.

9

 This draft assessment was then reviewed by a Subcommittee of FDA’s Science 

Board, which released its report at the end of October 2008.10

Since that time, the Center for Food Safety and Applied Nutrition within FDA has reviewed 

additional studies of low-dose toxicity cited by the National Toxicology Program and the 

Science Board Subcommittee as well as other such studies that have become available. The 

Center then prepared a document entitled Bisphenol A (CAS RN. 80-05): Review of Low Dose 

Studies,dated August 31, 2009. In the fall of 2009, FDA’s Acting Chief Scientist asked five 

expert scientists from across the federal government to provide independent scientific 

evaluations of this document. 

FDA is continuing to consider the low dose toxicity studies of BPA as well as other recent peerreviewed studies related to BPA. At this stage, FDA is explaining its current perspective on 

BPA, its support for further studies, its intent to solicit and consider public comment before 

revising its assessment of BPA use in food contact applications, its interim public health 

recommendations, its view of the appropriate regulatory framework for BPA use in food contact 

applications, and our planned collaborations with international partners. 

FDA’s Current Perspective on BPA 

At this interim stage, FDA shares the perspective of the National Toxicology Program that recent 

studies provide reason for some concern about the potential effects of BPA on the brain, 

behavior, and prostate gland of fetuses, infants and children. FDA also recognizes substantial 

uncertainties with respect to the overall interpretation of these studies and their potential 

implications for human health effects of BPA exposure. These uncertainties relate to issues such 

as the routes of exposure employed, the lack of consistency among some of the measured 

endpoints or results between studies, the relevance of some animal models to human health, 

differences in the metabolism (and detoxification) of and responses to BPA both at different ages 

and in different species, and limited or absent dose response information for some studies. 

 8

 Ibid. 

9

 U.S. Food and Drug Administration, Draft Assessment of Bisphenol A for Use in Food 

Contact Applications, 14 August 2008 (Available online at 

http://www.fda.gov/ohrms/dockets/AC/08/briefing/2008-

0038b1_01_02_FDA%20BPA%20Draft%20Assessment.pdf). 

10 FDA Science Board Subcommittee on Bisphenol A. Scientific Peer-Review of the 

Draft Assessment of Bisphenol A for Use in Food Contact Applications, 31 October 2008 

(Available online at http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4386b1-05.pdf). 

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FDA is pursuing additional studies to address the uncertainties in the findings, seeking public 

input and input from other expert agencies, and supporting a shift to a more robust regulatory 

framework for oversight of BPA to be able to respond quickly, if necessary, to protect the public. 

In addition, FDA is supporting reasonable steps to reduce human exposure to BPA, including 

actions by industry and recommendations to consumers on food preparation. At this time, FDA 

is not recommending that families change the use of infant formula or foods, as the benefit of a 

stable source of good nutrition outweighs the potential risk of BPA exposure. 

Additional Studies 

FDA supports additional studies, by both governmental and non-governmental entities, to 

provide additional information and address uncertainties about the safety of BPA. 

FDA’s Studies. 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. Depending on the results, each could influence regulatory decisions about BPA. 

FDA’s studies include: 

• Physiologically based pharmacokinetic modeling studies in both rodents and nonhuman 

primates are under way to predict internal exposure of BPA in both the free and 

conjugated forms, and to provide data on the magnitude of inter-individual differences. 

These data will facilitate comparisons of exposure across all stages of development and 

development of relationships between the results of rodent and nonhuman primate 

feeding studies, and will allow comparisons of internal doses of BPA when given by oral 

and intravenous routes. This approach has been identified as critical in order to fully 

evaluate the potential human health implications of studies that have used novel 

endpoints or non-oral dosing, particularly in rodents, which may metabolize BPA 

differently than humans. These data will also allow the agency to assess the magnitude of 

the potential differential exposure (and risk) to neonates. Results from this study are 

expected to be available to FDA to inform the agency’s decisionmaking starting in spring 

2010. 

• Rodent subchronic studies are in progress to characterize potential effects, and, where 

observed, the dose-response relationship in the prostate and mammary glands for orally 

administered BPA. In addition, these studies will explore other issues including potential 

effects of BPA on metabolic changes and cardiovascular endpoints. These studies will 

include an in utero phase, mimic bottle feeding in neonates, and employ a dose range that 

will cover the low doses where effects have been previously reported in some animal 

studies, as well as higher doses where estrogenic effects have been measured in guideline 

oral studies. Results from this study are expected to be available to FDA to inform the 

agency’s decisionmaking starting in 2012. 

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• Rodent behavioral/neuroanatomical pilot studies are also already in progress as part of 

the sub-chronic study to characterize dose levels at which behavioral, neuroanatomical, 

neurochemical and hormonal endpoints may be affected by developmental exposure to 

BPA. These data are intended to evaluate possible effects of exposure to BPA during 

development that have been reported in some published studies on sexually dimorphic 

behavioral endpoints such as anxiety, as well as on standard developmental neurotoxicity 

tests. Results from this study are expected to be available to FDA to inform the agency’s 

decisionmaking starting in 2012. 

Other Studies. Other studies on the safety of BPA are also underway. For example, the 

National Institute of Environmental Health Sciences has recently announced that it is providing 

$30 million in funding to study BPA, which includes support both for FDA studies and external 

grants. 

Public Comment and Next Steps for FDA’s Assessment of BPA 

FDA will open a public docket for comment on BPA. The docket will contain the Center for 

Food Safety and Applied Nutrition’s review of the low dose toxicity studies and recently 

published studies, the five expert reviews, and other relevant material. The agency welcomes 

comments on these documents, other available evidence, and the agency’s regulatory options. 

This docket will be open for public comment for 60 days. 

FDA will also continue to consult with other expert agencies in the federal government, 

including the National Institutes of Health (and National Toxicology Program), Environmental 

Protection Agency, Consumer Product Safety Commission, and the Centers for Disease Control 

and Prevention. 

Based on this outside input and the results of new studies, FDA will update its assessment of 

BPA and will be prepared to take additional action if warranted. As the scientific field is 

evolving rapidly, FDA anticipates providing further updates on BPA to the public as significant 

new information becomes available. 

Interim Public Health Recommendations 

At this interim stage, FDA supports reasonable steps to reduce exposure of infants to BPA in the 

food supply. In addition, FDA will work with industry to support and evaluate manufacturing 

practices and alternative substances that could reduce exposure to other populations. 

Given that these are preliminary steps being taken as a precaution, it is important that no harmful 

changes be made in food packaging or consumption, whether by industry or consumers, that 

could jeopardize either food safety or reduce access to and intake of food needed to provide good 

nutrition, particularly for infants. 

Infants. Infants are a potentially sensitive population for BPA because (1) their neurological 

and endocrine systems are developing; and (2) their hepatic system for detoxification and 

elimination of such substances as BPA is immature. 

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• FDA is supporting the industry’s actions to stop producing BPA-containing bottles and 

infant feeding cups for the U.S. market. FDA understands that over the past year, the 

major manufacturers of these products have stopped selling new BPA-containing bottles 

and infant feeding cups for the U.S. market. Glass and polypropylene bottles and plastic 

disposable “bag” liners have long been alternatives to polycarbonate nursing bottles. 

• FDA is facilitating the development of alternatives to BPA for the linings of infant 

formula cans. FDA has already noted increased interest on the part of infant formula 

manufacturers to explore alternatives to BPA-containing can linings, and has received 

notifications for alternative packaging. The agency is supporting efforts to develop and 

use alternatives by (1) working with manufacturers regarding the regulatory status and 

safety of alternative liners; (2) giving technical assistance to those wishing to prepare 

applications for approval of alternatives; and (3) expeditiously reviewing any such new 

applications for alternatives. Because reliable can lining materials are a critical factor in 

ensuring the quality of heat processed liquid infant formula, safe replacement of such 

materials requires not only that they both be safe for food contact but also allow for 

processing that is fully functional in protecting the safety and quality of the infant 

formula itself. 

The American Academy of Pediatrics and other health authorities recommend breastfeeding as 

the optimal nutrition for infants. Infant formula, including infant formula packaged in cans, is a 

safe and acceptable alternative that provides known nutritional benefits and prevents lifethreatening nutritional deficiencies. 

FDA is not recommending that families change the use of infant formula or foods, as the benefit 

of a stable source of good nutrition outweighs the potential risk of BPA exposure. 

Other Populations. With respect to uses of BPA in packaging of food intended for other 

populations, FDA will support changes in food can linings and manufacturing to replace BPA or 

minimize BPA levels where the changes can be accomplished while still protecting food safety 

and quality. FDA will support efforts to develop alternatives for other can lining applications 

similar to those which are already being tested for liquid infant formula packaging. Reliable can 

lining materials are a critical factor in ensuring the quality of heat processed foods. Therefore, 

FDA will work to encourage and facilitate changes that minimize exposure to BPA and avoid 

other adverse impacts on food safety or quality. 

Other Advice. FDA is supporting recommendations by the Department of Health and Human 

Services for infant feeding and food preparation to reduce exposure to BPA 

The Regulatory Framework for BPA 

Current BPA food contact uses were approved under food additive regulations issued more than 

40 years ago. This regulatory structure limits the oversight and flexibility of FDA. Once a food 

additive is approved, any manufacturer of food or food packaging may use the food additive in 

accordance with the regulation. There is no requirement to notify FDA of that use. For example, 

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today there exist hundreds of different formulations for BPA-containing epoxy linings, which 

have varying characteristics. As currently regulated, manufacturers are not required to disclose 

to FDA the existence or nature of these formulations. Furthermore, if FDA were to decide to 

revoke one or more approved uses, FDA would need to undertake what could be a lengthy 

process of rulemaking to accomplish this goal. 

Since 2000, FDA has regulated new food contact substances through the Food Contact 

Notification Program. Under this program: 

• FDA receives notification from each manufacturer of the basis for the safe use of a food 

contact substance, detailing the conditions of the substance’s use, allowing the agency 

and public to know how much is being used, and for what applications; 

• FDA can work with individual manufacturers to minimize exposure if a potential or 

actual safety concern is identified after approval; 

• FDA can require the submission of additional safety and exposure data from individual 

manufacturers to address a significant safety concern; 

• FDA can require additional studies by individual manufacturers to address a significant 

safety concern; and 

• If FDA were to reach a conclusion that revocation of one or more approved uses is 

justified, FDA could quickly protect the public by revoking the use through a notice 

published in the Federal Register. 

Given concern about BPA, and the ongoing evaluation of and studies on its safety, FDA believes 

that the more modern framework is more robust and appropriate for oversight of BPA than the 

current one. 

FDA will encourage manufacturers to voluntarily submit a food contact notification for their 

currently marketed uses of BPA-containing materials. 

In addition, FDA will explore additional options to regulate BPA under the more modern 

framework. 

Collaboration with International Partners 

FDA will continue to participate in discussions with our International regulatory and public 

health counterparts who have also been engaged in assessing the safety of BPA. 

For example, FDA has participated with Health Canada in encouraging industry efforts to refine 

their manufacturing methods for the production of infant formula can linings to minimize 

migration of BPA into the formula. 

In addition, FDA is planning to support and participate in an upcoming planned Expert 

Consultation on BPA to be convened by World Health Organization and the Food and 

Agriculture Organization of the United Nations. Information about this expert consultation is 

available from the WHO web site: 

http://www.who.int/foodsafety/fs_management/infosan_archives/en/