By BCPP Senior Policy Manager Lisette van Vliet 

Europe radically reduced the BPA Safe Level.

You probably missed it. It mostly caused waves amongst those who work in the policy trenches to stop the widespread use of toxic chemicals in our hazardous chemical-addicted economies. While it was a couple of years ago, the repercussions continue today.

In April 2023, the European Food Safety Authority (EFSA) released its final report on Bisphenol A (BPA), something that had been promised since 2015, when EFSA started waiting for the results of a huge and groundbreaking set of studies called CLARITY BPA.

Bisphenol A, commonly known as BPA, is a hormone-disrupting chemical to which almost all US residents are exposed. Most of our exposure is thought to be through food.[1] It was banned from baby bottles, sippy cups, and infant formula containers over a decade ago in the US. In the last decade, it was widely used on the inside lining of tin food cans. Since then, many companies have switched to linings with new chemical formulas. However, 5-6 billion pounds of BPA are produced worldwide for a huge variety of uses every year.[2] Common uses include materials for food packaging and food production. Toxic BPA pollution from materials that come into contact with our food gets into our bodies. Recent testing has found consumers are exposed to BPA through metal cans and various foods.[3]

The European Food Safety Authority’s conclusions are not just a minor update; they are a seismic shift. This radical revision of the longtime estimated level of safety for BPA has profound implications for food safety policies worldwide. So, what insights do the Europeans possess that the we have yet to acknowledge? Or rather, what are the Europeans willing to confront that our U.S. FDA is struggling to recognize, and why?

The Class of Bisphenols: BPA, BPS, BPF, and more

BPA is one of many chemicals in the ‘Bisphenol’ family or class, and the entire class are suspected endocrine disruptors, with perhaps one exception. Other bisphenols include Bisphenol S, Bisphenol F, Bisphenol AF, Bisphenol B, Bisphenol C, and many others. Starting with a non-exhaustive group of 148 bisphenols, at least 34 other bisphenols have already been officially identified in Europe as being of concern whose risks must be addressed.[4] Meanwhile, sufficient basic safety studies on others have not yet been conducted or are unavailable in the public realm. Here, I’m focusing on Bisphenol A, but the information also applies to Bisphenol S and other regrettable Bisphenol substitutes.

Scientists Express Concern over BPA; Governments Recognize Harm

Scientists and NGOs, such as Breast Cancer Prevention Partners, have flagged deep concern about our BPA exposure for well over two decades.[6] In that time, BPA became widely recognized as a hazardous substance that negatively impacted our health, garnering various authoritative classifications worldwide. For example:

• The EU officially lists BPA as a ‘Substance of Very High Concern’ for its reproductive toxicity and hormone-disrupting properties both for human health and the environment.
  • This means that the vast EU REACH chemical management system is geared towards phasing out BPA and other ‘Substances of Very High Concern.’
• Nearly a dozen US states recognize Bisphenol A as a harmful chemical.
  • States have banned BPA in various food containers (baby bottles, sippy cups, infant formula, children’s food containers, and reuse containers) and childcare products.
• In California, BPA is on the state’s Proposition 65 list of cancer-causing and reproduction-harming chemicals.[7]
  • Female reproductive toxicity since 2015
  • Developmental toxicity since 2020

The list of health effects from BPA continues to expand. It includes:

• cancers, including breast cancer in females and prostate cancer in males
• reproductive disorders involving all reproductive organs and functions in males and females, including low fertility and pregnancy complications, increased incidence of miscarriage;
• neuroendocrine disorders impacting reproduction, such as timing of puberty in women and decreased libido and the neuroendocrine control of testicular function in men;
• metabolic diseases such as obesity, diabetes, fatty liver disease, disruption of insulin secretion by the pancreas and disruption of glucose regulation,
• cardiovascular disease, including heart attack and death;
• immune disorders, including asthma, allergies, and chronic inflammation;
• neurological disorders in children (ADHD, autism)

It is worth noting that a recent study found that the impact of plastic chemicals, including BPA, totaled $249 billion in annual healthcare costs.[8]

Europe’s Prior BPA Safety Level

In 2015, the European Food Safety Authority set out a Tolerable Daily Intake level (TDI)[9] of 4000 nanograms or 4 micrograms per kilogram of bodyweight per day (abbreviated as ng/kg bw/d or µg/kg bw/d) for BPA.[10] Because of certain acknowledged uncertainties in the science at that time, they made it a temporary level to be revised when the new groundbreaking CLARITY BPA series of studies (2013 – 2019) were completed.[11]

In November 2022, the European Food Safety Authority put out a draft scientific opinion, proposing a massively decreased safety level of 0.04 nanograms.[12] This is a 100,000 fold decrease. This proposed TDI was based on BPA’s impacts on the immune system, as the most sensitive of the body’s systems, where BPA generates excessive inflammation. EFSA also found that BPA disrupts the endocrine system, harms reproduction, and reduces learning and memory. With respect to breast cancer, the EFSA scientists, because they changed their systematic review protocol for this opinion compared to the one used in 2015, omitted studies published prior to 2013. In the public consultation on this draft opinion, the Endocrine Society pointed out that the evidence about key endpoints including mammary gland effects was incompletely assessed in the draft study.[13] EFSA did find that from histological evidence (study of the microscopic structure of tissues), mammary glands were as likely as not to be targets of BPA-induced toxicity – and they used this finding in the uncertainty analysis which contributed to the lower TDI they proposed.

Europe’s New BPA Safety Level

Because our understanding of harm from chemicals is always advancing, there is a phenomenon called expansion of harm. This phenomenon is where the knowledge about a chemical’s toxicity widens and deepens as the advancing science moves from the first concerns, say reproductive toxicity, to showing damage to other body systems and organs, such as neurotoxicity – brain development. Harm expansion usually includes harm at even lower levels of exposure and from combination or cumulative effects with other chemicals or risk factors.[14] Technically, it expands the knowledge of harm; the harm existed earlier but was unrecognized. Therefore, it is important to qualify any naming of a level of safety with the term ‘currently estimated.’ Below is the newest currently estimated level of safety for BPA, according to the European Food Safety Agency.

The EFSA final report, issued in April 2023, says a safe level of exposure to BPA is 0.2 ng/kg bw/ day.[15] That is five times higher than the draft opinion but still a 20,000-fold decrease from their 2015 level.[16]

In the U.S., if we rely on an FDA 2014 estimation of US dietary exposure to BPA of 200 nanograms per kg bodyweight/day, which the FDA has continued to state is safe, our exposure is 1,000 times greater than the European safe level. Put simply, we are all exposed to dangerous levels of BPA from our food and drink. If the FDA’s estimation of our dietary exposure was not correct in 2014, or incorrect now a decade later, and there are scientific suggest that it is, we could be more than 1000 over the currently estimated safe level.[17] And that’s not even counting our additional exposure from non-dietary sources.

One compelling reason to trust the European scientific community’s assessment of BPA safety is their unbiased approach. Unlike the U.S. FDA, which showed a bias in its handling of the outcomes of CLARITY BPA studies, the EFSA report integrated these studies into their assessment, demonstrating a commitment to scientific integrity.

If one were to interpret the pullback EFSA made from 0.04 ng in the draft report to 0.2 ng in the 2023 final report as a result of pressure from industry lobbying to manufacture doubt and from certain EU member state governments whose positions are similar to those of chemical manufacturer lobby groups,[19] then one would hold the 0.04 nanogram as a more reliable, protective level. At that 0.04 ng level, pegged to the FDA’s 2014 exposure estimate, our exposure here in the US is 5,000 times greater than what is safe under current scientific knowledge.

EU Acts Quickly on BPA

By March 2024, just a year after the final EFSA report, the EU took decisive action and published its draft regulation for public comment.[20] It is on track to issue a BPA regulation in 2024, demonstrating its commitment to safeguarding its public. The EU’s regulatory action is set to prohibit the use of BPA in both plastic and coated packaging of food contact materials.[21] Furthermore, it is poised to address other bisphenols in food contact materials to prevent the substitution of BPA with other harmful substances. It will only permit unintentional BPA contamination of the materials if the migration into food is undetectable, ensuring health-protective safety standards.

FDA asleep at the wheel

By contrast, the US FDA’s track record on FDA has been disappointing, particularly concerning its position on the CLARITY BPA studies.[22] As for a thorough re-assessment of safety, the FDA conducted literature reviews in 2008 and 2014 but does not seem to have engaged in a fully transparent, detailed risk assessment with public comment the way EFSA has.[23] The FDA has also shown predictable inertia in not responding to the petition several NGOs and scientists submitted to change the BPA safety level (see below).

BCPP Campaigns: Stop BPA Exposure

BCPP has long held the position that Bisphenol A is hazardous and people are over-exposed in the US and globally. As a hormone disruptor, and a recognized reproductive toxicant, BPA increases our risk of Breast Cancer and other serious health problems. Given that new cases of breast cancer affect over 310,700 people every year, let alone over 42,000 deaths in the US, this constitutes a major dereliction of the FDA’s duty to protect public health from toxicants in food.

Chart source [25]

We call on our government representatives to hold the FDA accountable and ensure prompt and swift action on BPA, so that everyone’s exposures are minimized, especially from any food packaging or other materials that contact food. It is also important that our government tackle any other unnecessary uses (in consumer products and industrial processes) that generate emissions of BPA to air and water, including drinking water sources.

In May 2022, we joined with Environmental Defense Fund, Clean Water Action/Clean Water Fund, Consumer Reports, the Endocrine Society, Environmental Working Group (EWG), Healthy Babies Bright Futures (HBBF), EDF consultant Dr. Maricel Maffini, and Dr. Linda Birnbaum, former director of the National Institute of Environmental Health Sciences and National Toxicology Program and petitioned the FDA to reconsider the safe level of BPA which applies here in the US.[24] While the FDA did agree to consider the petition, it has not responded within the required 6 month deadline and is now 18 months overdue.

What you can do to avoid BPA exposure

While it is impossible for members of the general public to completely eliminate your exposure to BPA, by carefully selecting which products you buy, you can still reduce your exposure. One study demonstrated that just a three-day period of limiting intake of packaged foods decreased the concentrations of BPA found in urine by an average 65 percent.[25] A good place to start is by removing plastic materials, containers, and utensils from the kitchen thereby reducing one exposure route to plastic.

Simple changes can reduce your BPA exposure:

• Avoid canned foods. Where fresh alternatives are not available, choose frozen.
• Avoid clear, shatterproof plastic food and drink containers (sometimes labeled with the recycling code 7).
• Avoid handling thermal receipts.
• Choose BPA-free baby bottles and child cups.
  • It is important to be aware that the alternatives to BPA have not been adequately tested. Glass and stainless steel containers are your safest bet. BPA-free labels do not mean products are safe.

Take Action! Tell Congress to stop toxic food packaging

Footnotes:

[1] Although most of our exposure is thought to come from food, it is worth noting that not all BPA in food may come directly from leaching out of food contact materials. BPA can also get into food through the industrial production emissions into air and water, and through the disposal phase of products containing BPA.
[2] In 2015 EFSA described the uses as “in the manufacture of Polycarbonate (PC) plastics, epoxy resins and other polymeric materials. PC is used for manufacturing food and liquid containers, such as tableware (plates and mugs), microwave ovenware, cookware and reservoirs for water dispensers. BPA is also used in the manufacturing of a number of non-food-related applications, e.g. epoxy resin-based paints, medical devices, surface coatings, printing inks, flame retardants, toys and pacifiers with PC shields. BPA has also been used for certain paper products (thermal paper e.g. for cash receipts or recorders). BPA-based epoxy phenolic resins are used as protective linings for food and beverage cans and as a coating on residential drinking water storage tanks and supply systems. BPA is also found in clothes mainly those made from polyester and spandex. It may occur as an intermediate chemical in the manufacturing of antioxidants for textile finishing and in dyes production.” Re‐evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs – – 2023 – EFSA Journal – Wiley Online Library
[3] BPA from beverages in metal cans: https://www.ehn.org/beverages-in-metal-cans-may-be-a-significant-source-of-chemical-contamination-study-finds-2666912692.html BPA in grocery and fast foods: https://www.consumerreports.org/health/food-contaminants/the-plastic-chemicals-hiding-in-your-food-a7358224781/
[4] Soto AM, Schaeberle C, Maier MS, Sonnenschein C, Maffini MV. Evidence of Absence: Estrogenicity Assessment of a New Food-Contact Coating and the Bisphenol Used in Its Synthesis. Environ Sci Technol. 2017 Feb 7;51(3):1718-1726. doi: 10.1021/acs.est.6b04704. Epub 2017 Jan 18. PMID: 28098991. https://pubmed.ncbi.nlm.nih.gov/28098991/
and
Maffini MV, Canatsey RD. An expanded toxicological profile of tetramethyl bisphenol F (TMBPF), a precursor for a new food-contact metal packaging coating. Food Chem Toxicol. 2020 Jan;135:110889. doi: 10.1016/j.fct.2019.110889. Epub 2019 Oct 17. PMID: 31629790.
https://pubmed.ncbi.nlm.nih.gov/31629790/
[5] https://www.echa.europa.eu/-/group-assessment-of-bisphenols-identifies-need-for-restriction
[6] vom Saal FS, et al, 2007 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. Reprod Toxicol 24:131–138 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2967230/
[7] It was listed for its effects on the female reproductive system based on work from the National Toxicology Program Center for the Evaluation of Risks to Human Reproduction, and for its developmental effects, as per California’s State’s Qualified Experts in the Developmental and Reproductive Toxicant Identification Committee (DARTIC).
[8] Trasande L, et. al., Chemicals Used in Plastic Materials: An Estimate of the Attributable Disease Burden and Costs in the United States. J Endocr Soc. 2024 Jan 11;8(2):bvad163. doi: 10.1210/jendso/bvad163. Erratum in: J Endocr Soc. 2024 Feb 14;8(3):bvae019. PMID: 38213907; PMCID: PMC10783259. https://pubmed.ncbi.nlm.nih.gov/38213907/
[9] The Tolerable Daily Intake estimates how much a person can be safely exposed to every day over a lifetime, (via air, food or drinking water) over their lifetime, without no appreciable increase in risk to their health.
[10] 2015 European Food Safety Authority ‘Scientific Opinion on the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs’ https://doi.org/10.2903/j.efsa.2015.3978
The scientific panel did benchmark dose response modelling (BMDL10) for “likely” adverse effects in animals, but could not calculate a BMDL for mammary gland effects. The Panel applied a total uncertainty factor of 150 (for inter- and intra-species differences and uncertainty in mammary gland, reproductive, neurobehavioural, immune and metabolic system effects) to establish a temporary Tolerable Daily Intake (t-TDI) of 4 μg/kg bw per day.
[11] The CLARITY research is its own saga. Useful publications are: Heindel JJ, et al., Data integration, analysis, and interpretation of eight academic CLARITY-BPA studies. Reprod Toxicol. 2020 Dec;98:29-60. doi: 10.1016/j.reprotox.2020.05.014. Epub 2020 Jul 16. PMID: 32682780; PMCID: PMC7365109.https://pubmed.ncbi.nlm.nih.gov/32682780/
[12] https://www.efsa.europa.eu/en/news/bisphenol-efsa-draft-opinion-proposes-lowering-tolerable-daily-intake
[13] See https://www.endocrine.org/-/media/endocrine/files/advocacy/society-letters/2022/february-2022/bpi-tdi-consultation-response-final.pdf
[14] See Late Lessons for Early Warnings I & II from the European Environment Agency for more on the principle of harm expansion. https://www.eea.europa.eu/publications/late-lessons-2
https://www.eea.europa.eu/publications/environmental_issue_report_2001_22
[15] April 2023, EFSA press release https://www.efsa.europa.eu/en/news/bisphenol-food-health-risk
EFSA Report: Re-evaluation of the Risks to Public Health Related to the Presence of Bisphenol A (BPA) in Foodstuffs https://www.efsa.europa.eu/en/efsajournal/pub/6857
[16] See https://www.foodpackagingforum.org/news/efsa-dietary-exposure-to-bpa-is-unsafe
[17] https://www.ehn.org/how-much-bpa-in-our-bodies-2641524955.html
[18] See this article and in particular in particular the FDA’s premature statement in February 2018 which interpreted a selected subset of results as confirming its existing policy position. https://www.ehn.org/is-bpa-dangerous-for-health-2641153205.html A final integrative report has never been issued.
[19] the German Federal Institute for Risk Assessment spent considerable time critiquing EFSA’s analysis
[20] https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13832-Food-safety-restrictions-on-bisphenol-A-BPA-and-other-bisphenols-in-food-contact-materials_en. Over 200 NGOs, companies and trade associations/industry lobby groups have commented, and these can be viewed and downloaded. A recent study from the US found that plastic chemicals, including BPA, amounted to 249 billion US $ in annual health care costs in 2018 (Trasande et al. 2024)
[21] The technical details of the ban in the plastic, varnishes, coatings, printing inks, adhesives, resins and rubbers and recycled materials used in food contact are listed in the draft regulation. See here: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13832-Food-safety-restrictions-on-bisphenol-A-BPA-and-other-bisphenols-in-food-contact-materials_en
[22] See: Exposed: How willful blindness keeps BPA on shelves and contaminating our bodies https://www.ehn.org/is-bpa-dangerous-for-health-2641153205.html
[23] Having said that, risk assessments with their calculations of ‘Risk Characterization Ratios’ have been the subject of many critiques that point to biases in the type of data used; including gaps in solid evidence about actual exposures. See for example, Making Better Environmental Decisions: An Alternative to Risk Assessment, O’Brien, 2000 
[24] Specifically this is a Food Additive Petition submitted to the FDA, asking it to limit dietary BPA exposure by revoking approvals for BPA use in adhesives and can coatings and to set strict limits on BPA use in food contact plastics.
[25] New cases come from National Cancer Institute’s Surveillance, Epidemiology and End Results Program (SEER) 12. https://seer.cancer.gov/statfacts/html/breast.html Deaths come from U.S. Mortality. All Races, Females. Rates are Age-Adjusted. The 2020 incidence rate is displayed but not used in the fit of the trend line(s). Impact of COVID on SEER Cancer Incidence 2020 data. 
[26] Rudel RA, Gray JM, Engel CL, Rawsthorne TW, Dodson RE, Ackerman JM, Rizzo J, Nudelman JL, Brody JG. Food packaging and bisphenol A and bis(2-ethyhexyl) phthalate exposure: findings from a dietary intervention. Environ Health Perspect. 2011 Jul;119(7):914-20. doi: 10.1289/ehp.1003170. Epub 2011 Mar 30. PMID: 21450549; PMCID: PMC3223004. Food packaging and bisphenol A and bis(2-ethyhexyl) phthalate exposure: findings from a dietary intervention – PubMed (nih.gov)