EDF Health

EU gets ready to ban most BPA uses. Once again: Where’s FDA?

By EDF Blogs / Published: March 1, 2024

By Maricel Maffini, PhD, Consultant, and Tom Neltner, Executive Director, Unleaded Kids

Warning message written in bold red letters with words Bisphenol A Exposure. 3d illustration.

What’s Happening?

On February 9, 2024, the European Commission published a proposed regulation [PDF, 502KB] that would ban most uses of bisphenol A (BPA) in materials that contact food—including plastic and coatings applied to metal cans—and restrict other uses. Interested parties can comment on the draft until March 8, 2024. (You must register to comment.)

This proposed regulation is based on the 2023 European Food Safety Authority’s (EFSA) risk assessment of BPA that concluded that dietary exposures are a health concern. The proposed regulation would impact the following bisphenol-based food contact materials:

  • Plastics: Would be banned from use if made from BPA at any stage of manufacturing.1 The only exception is polysulfone resins made from a sodium salt of BPA, which are allowed for use in filtration membranes if there is no detectable migration into food.
  • Varnishes, coatings, printing inks, adhesives, ion-exchange resins, and rubbers: Use of BPA and bisphenol S (BPS)2 would be banned at any stage of manufacture. Use of BPS or other bisphenols may be authorized on a case-by-case basis. The exception to the ban is bisphenol-A diglycidyl ether (BADGE)3 made from BPA and used to make epoxy-based varnishes and coatings, which are allowed only in making materials with capacity of more than 250 liters and there is no detectable migration4 into food.
  • Recycled materials: Unintentional BPA contamination would be allowed if there is no detectable migration into food.

Why It Matters

In its 2023 reassessment, EFSA estimated that the amount of BPA that could be safely consumed daily is 20,000 times less than its 2015 estimate. Among the health problems associated with BPA exposure are harm to the immune and reproductive systems, disruption of the normal function of hormones and reduced learning and memory.

The draft rule would manage the risk of BPA uses to significantly reduce dietary exposure after considering alternatives that are technically feasible at a commercial scale.

Our Take

The European Commission’s proposed rule is an excellent example of a risk management decision that considers safety and achievability. The Commission balanced protecting human health by eliminating as many sources of BPA as fast as possible with the implementation challenges. The Commission has included transition periods to eliminate all uses of food-contact articles manufactured with BPA ranging from 18 months for final food packaging (e.g., plastics, can coating) to 10 years for repeat-use, final food contact articles used in food production equipment.

In a previous blog, we stated that Americans’ exposure to BPA from food is similar to that of Europeans. Unfortunately, FDA doesn’t share the same sense of urgency as the European Commission. While Europe is on track to ban most uses of BPA in food contact materials, FDA is failing to take action to protect our families.

EDF and our allies submitted a food additive petition [PDF, 542KB] asking the agency to limit BPA exposure from food by revoking approvals for using BPA in adhesives and can coatings and to setting strict limits on using BPA in plastic that contacts food. FDA filed the petition on May 2, 2022, and has not made a final decision on it, despite a 180-day statutory deadline. It is now more than 600 days overdue.

Timeline

Once the rules are finalized, compliance would be required within 18 months for most products and within 36 months for:

  • Varnishes and coatings for processed fruit, vegetable, and processed fish products.
  • Varnishes and coatings used outside of metal packaging.
  • Manufacture of repeat-use components in professional food production equipment.

The rule would also allow repeat-use, final food contact articles used in professional food production equipment to remain in service for up to 10 years.

What’s Next?

We will submit comments to the European Commission seeking clarity on some aspects of the proposal. In addition, we will continue to press FDA to make a final decision on our petition, including potentially taking legal action for unreasonable delay in responding to it.

Go Deeper

Read our blogs on BPA.

NOTES

1 The rule is inconsistent regarding status of plastics other than polysulfone. EDF will submit comments seeking clarity.

2 The Commission may expand to more bisphenols if they are added to Annex VI, Part 3 of Regulation (EC) No 1272/2008 due to their harmonized classification as category 1A or 1B “mutagenic,” “carcinogenic,” “toxic to reproduction” or category 1 “endocrine disrupting” for human health.

3 BADGE (CAS No 1675-54-3) – is a type of epoxy resin manufactured from BPA.

4 Rule defines the limit of detection as 0.01 milligram of bisphenol per kilogram of food.

Posted in BPA, EFSA, FDA / Tagged , , | Authors: / Comments are closed

European Commission plans to ban food uses of BPA. We ask again: Where is FDA?

By Maricel Maffini, PhD, Consultant and Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 9, 2023

Maricel Maffini, consultant, and Tom Neltner, Senior Director, Safer Chemicals

What Happened?

On June 2, the European Commission, the executive body of the European Union (EU) responsible for proposing legislation and implementing decisions, announced it is preparing an initiative that “will impose a ban on the use of BPA [bisphenol A] in food contact materials (FCMs), including plastic and coated packaging.” It also said it would “address the use of other bisphenols in FCMs to avoid replacing BPA with other harmful substances.” The Commission’s proposal is based on the European Food Safety Authority’s (EFSA) scientific opinion that exposure to BPA is a “concern for human health.”

Why It Matters

In April, EFSA concluded that Europeans were exposed to levels of BPA from food that were 100 to 1,000 times greater than the estimated safe amount, and that this exposure could lead to an overactive immune system producing out-of-control inflammation. BPA was also associated with disrupting the endocrine system, harming reproduction, and reducing learning and memory. The immune system was most sensitive to BPA exposure. Recognizing these risks, the Commission moved quickly to protect Europeans’ public health by banning uses of BPA.

Our Take

Americans’ exposure to BPA from food is similar to that in Europe. Unfortunately, FDA doesn’t share the same sense of urgency to protect our families as the European Commission is demonstrating by its actions. While Europe is moving forward to ban the use of BPA in food contact materials, the FDA has failed to take action.

EDF and our allies submitted a food additive petition asking the agency to limit BPA exposure from food by revoking approvals for using BPA in adhesives and can coatings and to setting strict limits on using BPA in plastic that contacts food. FDA filed the petition on May 2, 2022 and has not made a final decision on it despite a 180-day statutory deadline. It is now more than 400 days overdue.

In January, FDA Commissioner Califf announced “a new and transformative vision for the FDA Human Food Programs” which includes a Deputy Commissioner for Human Foods with “decision-making authority over policy, strategy and regulatory program activities.” These are important steps, but a real measure is making timely decisions to protect American’s health by restricting the use of toxic chemicals such as BPA.

Pile of silver metal food cans with no labels

Next Steps

We will continue to press FDA to make a final decision on the petition, including potentially taking legal action for unreasonable delay in responding to our petition.

Posted in BPA, EFSA, Endocrine disruptors, FDA, Food contact materials, Food packaging, Health hazards, Plastic, Public health, Reproductive toxicity / Tagged , , | Authors: , / Comments are closed

European Food Safety Authority reaffirms that BPA uses for food are not safe. Where is FDA?

By Tom Neltner, Senior Director, Safer Chemicals Initiative and Maricel Maffini, PhD, Consultant / Published: April 19, 2023

Tom Neltner, Senior Director, Safer Chemicals, and Maricel Maffini, consultant

Warning message written in bold red letters with words Bisphenol A Exposure. 3d illustration.

What Happened?

Today, the European Food Safety Authority (EFSA) finalized its Re-evaluation of the Risks to Public Health Related to the Presence of Bisphenol A (BPA) in Foodstuffs report. After considering public comments on its November 2021 draft, the agency reaffirmed its conclusion that Europeans of all ages are exposed to BPA at levels 100 to 1,000 times greater than EFSA considers to be safe.

Why It Matters

EFSA found that consumers’ dietary exposure should be less than 0.2 nanograms of BPA per kilogram of body weight per day (ng/kg-bw/day) to protect their immune systems from harm.1 Although EFSA didn’t analyze the reality for U.S. consumers, we used FDA’s 2014 estimated dietary exposure for BPA (the most recent available) to calculate that Americans’ exposure is 1,000 times greater than what EFSA deems safe.

Our Take

EFSA’s analysis is primarily based on scientific evidence that FDA had not considered in previous reviews. With the final report in place, EFSA has completed a rigorous, transparent, and comprehensive risk assessment. FDA now has no excuse for delaying action on a food additive petition submitted by EDF and our partners that the agency agreed to consider on May 2, 2022. That petition requested that FDA revoke its approvals for using BPA in adhesives and can coatings and set strict limits on using it in plastic that contacts food. FDA has not yet responded.

EFSA’s Conclusions

EFSA found that extremely low exposures to BPA can lead to an overactive immune system producing out-of-control inflammation. BPA was also associated with disrupting the endocrine system, harming reproduction, and reducing learning and memory. The immune system was most sensitive to BPA exposure.

After calculating a safe level of BPA—known as TDI (tolerable daily intake)—that would prevent anticipated harm, EFSA compared it against the estimated dietary exposure of the European population. The agency concluded that “both the mean and the 95th percentile dietary exposures in all age groups exceeded the TDI by two to three orders of magnitude.”

Putting BPA New Safe Level in Context

EFSA’s safe dose of 0.2 ng/kg-bw/day is extremely low. It may be useful to compare it to exposure from drinking water. For an adult weighing 120-pounds who drinks 2 liters of water a day, it would take only 1.2 parts per trillion of BPA to exceed the safe level.2

Next Steps

We will press FDA to act with greater urgency on our overdue petition. We are also looking at whether there is increased risk to communities near where BPA is made or processed.

NOTES

1 The limit was 0.04 ng/kg-bw/day in the draft EFSA report.

2 0.2 ng/kg-bw/day * 60 kg / 2 liters = 1.2 ng/L = 1.2 ppt. This does not account for other sources of BPA in the diet.

 

 

Posted in BPA, EFSA, Emerging science, Emerging testing methods, Environment, FDA, Health science, Public health / Tagged , , , | Authors: , / Read 1 Response

What does BPA have to do with metabolism, mazes and my mom?

By Jonathan Choi / Published: November 5, 2015

Jonathan Choi is a chemicals policy fellow.

flickr user: ebarney

Creative Commons. flickr user: ebarney

[CORRECTED 11-6-15:  Two statements in this post have been corrected as indicated below.]

Last week my mom called me out of the blue with a question on chemicals. You see, in my family, we make (and eat) a lot of kimchi—that spicy, wonderful, fermented cabbage that is ubiquitous in Korean cuisine. For my entire life, we’ve been using the same hard plastic containers to store and ferment kimchi in the basement fridge. My mom was calling me because those containers were getting pretty old and she wanted to replace them. She was wondering whether she should pay a bit more to buy kimchi containers that were explicitly labeled “BPA free.”

Read More »

Posted in Emerging science, Health science / Tagged | Comments are closed

Evidence mounts on BPA’s adverse effects on human health

By Lindsay McCormick / Published: January 26, 2015

Lindsay McCormick is a Research Analyst.

Bisphenol A (BPA) is a high production volume chemical that is used to make polycarbonate plastics and epoxy resins.  It is commonly found in food and beverage packaging, such as plastic bottles and the lining of food cans, as well as thermal paper receipts (see our previous blog).  BPA is widely-recognized as an endocrine-disrupting chemical, meaning that it can alter the normal functioning of the body’s hormonal system.  Hundreds of studies have been published associating BPA exposure with health effects, ranging from cancer to obesity to attention-deficit hyperactivity disorder.  Data from the Center for Disease and Control (CDC) show that nearly all people tested have BPA in their bodies.

Despite a plethora of data, numerous calls for action (for example, see here, here and here), and comprehensive regulation in France, it does not seem that national regulation of BPA in food packaging in the U.S. will be happening any time soon.  The official position of the U.S. Food and Drug Administration (FDA) is that, while BPA exhibits endocrine-disrupting properties at high doses, it is safe at the current levels occurring in food.  Although the FDA banned the use of BPA-based materials in baby bottles, sippy cups, and infant formula packaging in 2012, FDA said it based this action on changes in the market, rather than safety concerns.

In the fall of 2014, FDA completed a four-year review of the literature, including more than 300 scientific studies, and concluded that the information does not “prompt a revision of FDA’s safety assessment of BPA in food packaging at this time.”

The European Food Safety Authority (EFSA) recently followed suit with their announcement that BPA does not pose a health risk to consumers, including children, at current exposure levels.  (This is in contrast to the action of several EU member states, which have banned BPA in food contact materials for children under 3 years of age over the past few years.)

Meanwhile, scientists continue to churn out studies linking low-level BPA exposure to a variety of health effects.  In this post, we discuss several new studies.   Read More »

Posted in Emerging science, Health science / Tagged , | Comments are closed

More than skin-deep: Have we underestimated the role of dermal exposures to BPA?

By Lindsay McCormick / Published: October 23, 2014

Lindsay McCormick is a Research Analyst.  Richard Denison, Ph.D., is a Lead Senior Scientist. 

Bisphenol A (BPA) is an endocrine-disrupting chemical, and has been associated with health effects such as premature puberty and developmental neurotoxicity.  Massive quantities of BPA – about 10 billion pounds and rising – are produced each year, making it one of the highest volume chemicals in commerce.  For that reason alone, it may not be surprising that scientists find BPA in the urine of nearly all people they test. 

It has generally been thought that exposure to BPA primarily comes from dietary sources (see here and here) due to its use in food packaging products such as metal cans and polycarbonate bottles.  Based on these concerns and market pressure, FDA amended its regulations to no longer provide for the use of BPA-based materials in baby bottles, sippy cups, and infant formula packaging, and France passed a law banning BPA in all food packaging containers as a precautionary measure. 

However, there is growing evidence that non-dietary sources of BPA exposure may be important.  One potentially overlooked but significant source of exposure is the use of BPA to make thermal receipts, which are commonly used in cash registers and ATMs.  Unlike BPA used to make food packaging, which uses polymerized or otherwise chemically bound BPA molecules, thermal receipts are coated with BPA in free form, only loosely attached to the paper.

A study just published by researchers at the University of Missouri and the Universite de Toulouse suggests that we may be underestimating the role of dermal exposure to BPA from handling of thermal receipts, especially in certain common settings.  The researchers tested the impact that use of a hand sanitizer immediately preceding handling a thermal paper receipt has on the transfer and absorption of BPA.  Hand sanitizers and other skin care products may contain chemicals called “dermal penetration enhancers,” which increase skin permeability, for example, to facilitate drug delivery.  Read More »

Posted in Emerging science, General interest, Health policy, Health science, Regulation / Tagged , | Comments are closed