NAMPA Frequently Asked Questions (FAQ)

How can we be sure bisphenol A (BPA)-based epoxy coatings are safe?

Why does the metal packaging industry use BPA-based epoxy coatings?

Industry states BPA is safe; certain special interest groups say it is not. Whom should I believe?

Is exposure to BPA from can coatings harmful to my pets?

A recent Centers for Disease Control and Prevention (CDC) study reported BPA in a high percentage of people; is this a concern?

Some scientists are saying that very low exposures to BPA may be harmful; should I be concerned?

If I consume canned foods, will I ingest BPA and what happens to it?

Why should I buy canned food when I see all the news about it containing BPA?

I have heard there is low parts per billion of BPA in canned food; what is a part per billion?

How can some (organic) food packers claim they use only BPA-free coatings when there reportedly are no commercial alternatives?

I have been told that BPA is a sex hormone. Is this true?

 

How can we be sure bisphenol A (BPA)-based epoxy coatings are safe?

Expert regulatory authorities around the world have unanimously determined that BPA-based epoxy coatings are safe*The dictionary defines safe as "free from harm," dangerous as the "ability or likelihood to inflict injury or harm," and risk as "the probability that something will cause injury or harm." Safe and dangerous are subjective terms, and we balance safety and danger by assessing risk. Eliminating all risk is highly improbable. A safe situation, however, is one where risks of injury are low and manageable. for food packaging.

Epoxy can coatings are an essential technology that provides consumers with safe food and beverage packaging. Regulatory authorities around the world are charged with assessing the safety associated with the use of all materials that are either added to our food or are in contact with our food. The regulatory review process is well established, continually evaluates new information, and has safely protected our food supply for more than 50 years. The North American Metal Packaging Alliance, Inc. (NAMPA) supports the use of sound science to develop public policy, and to address health and environmental issues affecting the world’s food supply.

  • Regulatory agencies that have recently completed safety assessments of BPA include:
  • U.S. Food and Drug Administration (FDA);
  • The National Toxicology Program (NTP) Center for the Evaluation of Risks to Human Reproduction (CERHR);
  • U.S. Environmental Protection Agency (EPA);
  • European Food Safety Authority (EFSA); and
  • Japan’s Ministry of Health, Labour and Welfare (MHLW).

 

Regulatory experts have assessed the safety of BPA numerous times since 2001, and in each instance have determined that BPA-based epoxy coatings are safe:

2001 Japanese National Institute of Health Sciences (NIHS) study: 1

  • This animal study found no adverse health effects to low doses of BPA over three generations.


2002 European Scientific Committee on Food (now known as EFSA) review: 2

  • Confirmed the safety of BPA in food contact applications.


2002 European Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) review of European Union (EU) Risk Assessment: 3

  • Concluded “there is no convincing evidence that low doses of bisphenol A have effects on developmental parameters in offspring.”


2005 FDA Letter: 4

  • Affirms safety: “[B]ased on all the evidence available at this time, FDA sees no reason to change its long-held position that our current uses with food are safe.”


2006 German Federal Institute for Risk Assessment (BfR): 5

  • Concluded that it “does not recognize any health risk for babies that are fed from baby bottles made of polycarbonate.”


2007 EFSA Review: 6

  • The EFSA Expert Panel adjusted the Tolerable Daily Intake (TDI) for BPA to 0.05 mg BPA/kg bw. This increased TDI would calculate to a specific migration limit (SML) (or level that can migrate into food) of 3,000 ppb.

  • “In its 2006 evaluation EFSA’s AFC Panel gave special attention to infants and children as they belong to the groups with the highest potential dietary exposure to BPA relative to the body weight. The Panel’s estimates of intake were based on conservative (‘worst case’) estimations. Potential intakes for infants and children are estimated to be well below the TDI.”


2007 Japanese National Institute of Advanced Industrial Science and Technology (AIST) Assessment: 7

  • Found “current exposure levels of BPA will not pose any unacceptable risk to human health.”


2007 FDA Statement: 8

  • “The 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. . . . Furthermore, FDA has determined that the use of polycarbonate-based baby bottles and BPA-based epoxy coated cans used to hold infant formula is safe.”


2007 NTP CERHR Expert Panel Review: 9

  • The Panel of 12 independent experts in reproductive health concluded that relevant levels of human exposure to BPA presents negligible or minimal risk to human health in all but one area. In that one area of “some concern,” the Expert Panel concluded that there was inadequate research to rate confidently the level of concern as minimal or negligible.


2008 FDA Letter to the Committee on Energy and Commerce of the U.S. House of Representatives: 10

  • “FDA believes that this level of exposure to adults and infants is safe as defined in 21 CFR §170.3(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.”


2008 EFSA Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids, and Materials in Contact with Food Regarding the Toxicokinetics of BPA: 11

  • The EFSA Panel specifically addressed the low-dose theory, stating that the body of evidence “further limits the relevance” of low-dose effects of BPA. EFSA went on to say that the current regulatory limit in Europe “provides a sufficient margin of safety for the protection of the consumer, including foetuses and newborns.” It is this rigorous European standard that is met by the metal packaging industry in North America and worldwide.


Each of these rigorous, independent expert reviews has concluded that BPA is safe for use in can coatings.

Epoxy can coatings are an essential technology that provides consumers with safe food and beverage packaging, and its use is supported by scientific evidence and evaluations by government agencies worldwide.

Why does the metal packaging industry use bisphenol A (BPA)-based epoxy coatings?

The superior performance of BPA-based epoxy coatings has made them the global standard for metal packaging.

The metal can has made nutritious high quality, shelf-stable food available everywhere. Through continuous innovation, metal packaging has changed the way food is produced, preserved, and consumed around the world. Today, more than 1,500 different varieties of food are packed in metal packaging, making seasonal foods available globally year round. The nature of many of the food products packed today requires the use of FDA-approved “food contact grade” coatings to ensure the safety and wholesomeness of the food. Today’s use of BPA-based epoxy resins is the result of over 50 years of research to develop and provide can coatings with the safest and most effective food contact performance. With the advent of advanced high performance epoxy coatings, BPA-based epoxy coatings have become the preferred choice for metal packaging globally. The can, in combination with the protective coatings’ durability, adhesion, formability, and resistance to the wide range of food and beverage products (product resistance) provide:

  • Unsurpassed food safety;

  • The ability to be used at the high temperature food processing conditions required for sterilization;

  • Dramatic decreases in food waste due to product expiration;

  • Global distribution of high quality nutritious food;

  • Shelf-lives of two years or more for today’s canned food;

  • The only lightproof and oxygen-proof container; and

  • The lowest energy utilization for providing food from the farm to the table.

 

Industry states bisphenol A (BPA) is safe; certain special interest groups say it is not. Whom should I believe?

Expert regulatory authorities around the world have unanimously declared that BPA-based epoxy coatings are safe for food packaging.

Participants in this debate have different perspectives on the safety of BPA. BPA is one of the most extensively tested materials in use today. The toxicological effects of BPA are well understood. As with most chemicals, BPA exhibits toxic effects only at very high levels of exposure. BPA is not a carcinogen, and it is not a reproductive or developmental toxin.

Some studies, however, have shown BPA to exhibit extremely weak hormonal activity. Activity has also been observed in compromised laboratory animals at high doses of BPA. Reproduction and development were not affected by relatively high levels of BPA in multi-generational studies, which were designed to detect disruptions in normal hormone activity. Estrogenic activity was seen in animals that were administered large doses of BPA or animals exposed via only experimental routes of exposure, such as direct injection (intraperitoneal or subcutaneous).

Based on studies using irrelevant routes of exposure, some special interest groups opposed to BPA have labeled BPA as “dangerous” and are challenging the safety of BPA and its use in consumer products. In contrast, government regulatory agencies in Europe, Japan, and the U.S. have all concluded that normal use of consumer products made from BPA is of little or low risk.

Is exposure to bisphenol A (BPA) from can coatings harmful to my pets?

No -- The science does not support this concern.

The incidence of feline hyperthyroidism has been increasing since 1979. Advances in diagnosis do not appear to be the sole contributor in the rise in confirmed cases of hyperthyroidism. This increase is the source of intense investigation with no current scientific answers. A number of epidemiological studies have identified many potential correlating factors ranging from the type of food and associated food packaging to genetic and numerous environmental factors.

Pop-top canned packaging initially had specifically drawn attention but further analysis does not support the significance of pop-top packaging, considering nearly all wet pet food utilizes this type of packaging.

In the U.S., FDA requires all pet food packaging to comply with human food standards.

The following references support these conclusions:

 

A recent Centers for Disease Control and Prevention (CDC) study reported bisphenol A (BPA) in a high percentage of people; is this a concern?

No -- The BPA levels reported are extremely small and are significantly below all safety limits established by FDA, EPA, and other regulatory authorities globally.

The CDC recently completed a biomonitoring study that included BPA. Biomonitoring is the analysis of body fluids or tissues for the presence of a substance. 12

For BPA, urine is a good measure of oral exposure and is the preferred biological sample for direct measurement of BPA in humans for two primary reasons:

  • Validated and reliable analytical methods exist to measure BPA in urine; 13,14 and

  • Samples are easily obtained.


BPA is efficiently and rapidly metabolized to a non-estrogenic metabolite (BPA-glucuronide) after oral exposure, which is then rapidly excreted from the body through urination, and scientific studies have shown that BPA does not bioaccumulate. 15

Several biomonitoring studies which included BPA have been recently published. 16,17,18  The results of these studies show that BPA exposure is over 500 times below the TDI recently set by EFSA for BPA of 50 μg/kg bw/day 19 based on a comprehensive evaluation of BPA, and 500,000 times below the No Observed Adverse Effect Level (NOAEL) of 5,000 μg/kg bw/day established in comprehensive multi-generation studies. 20

Furthermore, there is a concern with how a number of the published human biomonitoring studies report BPA levels. These studies report the non-estrogenic BPA-glucuronide as “free-BPA.” This practice of reporting glucuronide levels as if they were “free BPA” is misleading, over-estimates the impact of BPA exposure, and unduly alarms consumers.

Some scientists are saying that very low exposures to bisphenol A (BPA) may be harmful; should I be concerned?

No -- The low-dose hypothesis is not supported by any of the comprehensive reviews of the science.

Allegations of low-dose health effects of BPA are linked to unsubstantiated claims that BPA produces estrogenic toxicity at very low doses. These claims have raised concerns because they were reported at doses well below those which did not produce any toxicity in a battery of well-accepted international toxicity tests.

These reported “low-dose” effects of BPA have never been replicated in multiple high-quality studies that specifically looked for possible low-dose estrogenic toxicity. BPA has been extensively tested across a wide range of possible exposure levels, and exhibits toxic effects only at very high levels of exposure. The low-dose hypothesis for BPA is just that, a hypothesis that has not been accepted by any scientific regulatory agency.

The low-dose hypothesis is not supported by the comprehensive reviews of the science that have been conducted by FDA, 21 EFSA, 22 and CERHR. 23 The CERHR report, issued in 2007 by a scientific panel of independent experts, indicates that studies reporting low-dose effects of BPA have not been replicated nor corroborated in multiple studies employing internationally approved test protocols, significant sample size, a wide range of doses, appropriate experimental design and route of exposure, and conducted under Good Laboratory Practices.

In 2006, the Gradient Corporation conducted an independent review of the “low dose hypothesis” and concluded “. . . the weight of evidence does not support the hypothesis that low oral doses of BPA adversely affect human reproductive and developmental health.” 24

If I consume canned foods, will I ingest bisphenol A (BPA) and what happens to it?

You may ingest BPA in very small amounts that are substantially below those which have produced any toxicity in comprehensive well-accepted toxicity tests.

Simply knowing that you could be exposed to a substance in food, beverages, or drinking water is not enough to know whether or not such exposure is safe. One of the key questions that should be answered to help understand this is: What happens in the body following exposure? Answering this question helps explain whether or not dietary exposure presents a health risk. The area of science that helps answer this question is known as pharmacokinetics.

Pharmacokinetic studies measure how much of a chemical is absorbed into the body and if the chemical is changed (“metabolized”) to something else that may have more or less toxicity. These studies provide key information to understand better the safety of the substance.

Pharmacokinetic studies of BPA demonstrate that it is rapidly and efficiently converted by enzymes in the gastrointestinal (GI) tract and liver to a harmless metabolite (BPA-glucuronide). This metabolite has been proven to be non-estrogenic in scientific studies. 25 The rapid metabolism of BPA to the glucuronide metabolite and clearance from the body has been confirmed in both animal 26,27 and human volunteer studies. 28,29 Additionally, studies have shown that BPA does not accumulate in body fat or sex organs of either male or female test animals. 30

The oral route, eating and drinking, is the only relevant route of human exposure from canned food. Studies based on other routes of exposure, such as direct injections (intraperitoneal or subcutaneous) circumvent the gastrointestinal and liver metabolism of BPA and thus are not comparable to relevant human exposures. Recognized experts have concluded that non-oral studies are not relevant to human exposure and should not be used for human safety assessments. 31 Taken out of proper scientific context, some studies are being reported in ways that raise unwarranted alarm.

Why should I buy canned food when I see all the news about it containing bisphenol A (BPA)?

Through continuous innovation, the metal food can is one of the most economical, recycled, sustainable, and above all, safest packaging forms.

Food and beverage cans provide a way for consumers to maintain environmentally conscious behavior. Metal food and beverage cans are 100 percent recyclable. The recycling rate is more than two-and-a-half times higher than that of most other packaging options. Metal food and beverage containers can be recycled again and again without losing strength or quality. And every ton of recycled steel saves 2,500 pounds of iron ore, 1,000 pounds of coal, and 40 pounds of limestone. Every ton of aluminum recycled saves ten tons of carbon dioxide versus making virgin aluminum.

Metal food cans are the most tamper evident package available. It is virtually impossible to tamper with a metal can without leaving obvious evidence.

Metal food cans enable the longest shelf life for food of any food packaging choice. The metal packaging allows for a complete oxygen and light barrier.

High performance BPA-based epoxy coatings enjoy an unsurpassed record of safety and effectiveness. BPA is one of the most studied chemical components of coatings, and the results of those accepted, peer-reviewed studies support its safety at levels found in food and beverage cans today.

I have heard there is low parts per billion of bisphenol A (BPA) in canned food; what is a part per billion?

Numerous studies have confirmed that the level people are exposed to BPA from canned food is very low.

The levels reported typically show that in canned food coated with an epoxy liner, low parts per billion (ppb) levels of BPA are found. The lowest regulatory level in the world is 600 ppb (recommended to be raised to 3,000 ppb by EFSA), and the levels in food are far below that. What really is a ppb? A ppb in food is typically described as a microgram of a substance per kilogram of food weight. A microgram is 106 grams and a kilogram is 103 grams. Putting this ratio into a relationship that people can understand better, the following are one ppb:

  • One second in 31.5 years, or one minute in 2,000 years; or

  • One drop in 22,000 gallons (similar to one drop in an Olympic-sized swimming pool).


How can some (organic) food packers claim they use only bisphenol A (BPA)-free coatings when there reportedly are no commercial alternatives?

Not all canned food and beverage packaging applications require the use of BPA-based epoxy technology to deliver the highest level of food packaging safety and performance.

There are thousands of commercial can specifications used in the U.S. alone to package the wide variety of unique food stuffs found on local grocer shelves. Each container specification is designed to optimize performance, environmental friendliness, and safety for any given application.

BPA-based epoxy can liners routinely deliver the highest level of performance with respect to protecting food quality under high temperature food sterilization requirements that eliminate the dangers of e.coli and listeria contamination.

I have been told that bisphenol A (BPA) is a sex hormone. Is this true?

No.

BPA has been extensively tested across a wide range of possible exposure levels, and exhibits hormone like effects only at very high levels of exposure. These levels are far above the amount of BPA that we may be exposed to in the diet.

In 2006, Gradient Corporation issued a report developed by an independent panel of scientists not associated with BPA production or sales. This report concluded: “Taken together, the weight of evidence does not support the hypothesis that low oral doses of BPA adversely affect human reproductive and developmental health.” 32 Said another way, an average adult would have to ingest more than 500 pounds of canned food and beverages every day for an entire lifetime to exceed the safe level of BPA set by EPA. A three-month old infant would need to consume more than 340 13-ounce cans of concentrated formula every day to exceed the established safety limits set by EPA. This is clearly impossible.

Footnotes