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.

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Over 7 million children exceed FDA’s new daily maximum intake level of lead

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 24, 2022

Tom Neltner, Senior Director, Safer Chemicals

This is the fourth in our Unleaded Juice blog series exploring how the Food and Drug Administration (FDA) sets limits for toxic elements like lead, arsenic, and cadmium in food and the implications for the agency’s Closer To Zero program.

In June, after issuing its proposed action levels for lead in juice, FDA tightened its Interim Reference Levels (IRLs) for lead to 2.2 µg/day for children and 8.8 µg/day for females of childbearing age—a drop of 27% from the original IRLs it established in 2018. We estimate this change increased the number of children over the IRL for lead from 1.2 million to more than 7 million.

The agency describes IRLs as daily maximum intake levels for lead in food and beverages. FDA scientists said the change was made to match the Centers for Disease Control and Prevention’s (CDC) October 2021 revised blood lead reference value.  This value is commonly known as the elevated blood lead level (EBLL).[1] FDA uses the “interim” label in recognition that there is no known safe level of exposure to lead and the neurotoxic harm it can cause. FDA anticipates matching the IRLs to future reductions in CDC’s reference value as the U.S. makes progress in reducing children’s exposure to lead.

We applaud FDA’s decision to tighten the IRLs. It is a good example of the type of continuous improvement to which FDA committed in its Closer to Zero Action Plan, which aims to lower levels of lead, cadmium, mercury, and inorganic arsenic in food that babies and young children eat and drink.

The challenge now is to translate the tighter daily maximum intake level into action levels for specific foods. Next steps for FDA should include:

  • Further tightening its recently proposed action level for lead in juice.
  • Using the revised lead IRLs as:
    • The basis for its proposal for foods commonly consumed by babies and young children – currently stuck in the review process at the White House’s Office of Management and Budget (OMB).
    • A model for FDA’s anticipated IRLs for inorganic arsenic and cadmium under its Closer to Zero program.

Read More »

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FDA takes action to limit lead in juice, proposes significant – but insufficient – limits

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 3, 2022

Tom Neltner, Senior Director, Safery Chemicals

The Food and Drug Administration (FDA) recently released draft action levels for lead in juice, proposing to reduce lead limits from 50 parts per billion (ppb) to 10 ppb for apple juice and 20 ppb for all other juices. However, the draft limits don’t go far enough to protect children. They also risk undermining the agency’s broader Closer to Zero effort to drive down children’s exposure to lead, arsenic, and cadmium in food. 

If finalized, these levels would be the most stringent in the world, including current European standards[1] and anticipated international standards.[2] For that FDA deserves credit. Public comments to FDA are due June 28. 

This blog is the first in our Unleaded Juice blog series where we explore these issues. Heavy metals like lead are potent neurotoxicants that can impair children’s brain development. Lead can also result in lower IQs in children.  Read More »

Posted in FDA, Food, Lead, Unleaded Juice / Tagged , , , | Comments are closed