Food-contact chemical (packaging migrant)

Bisphenol A (BPA)

Also known as: BPA, 4,4'-isopropylidenediphenol, 2,2-bis(4-hydroxyphenyl)propane, CAS 80-05-7

Bisphenol A (BPA) is an industrial chemical used since the 1960s to make polycarbonate plastics and epoxy resins. In food applications it is found in some reusable beverage containers and, most significantly, in the epoxy-resin linings of metal cans and jar lids, from which trace amounts can migrate into food and beverages. Regulatory bodies diverge sharply on its safety: in 2023 the European Food Safety Authority (EFSA) drastically lowered its tolerable daily intake citing immune-system effects, and the EU subsequently banned BPA in food-contact materials, while the U.S. FDA maintains that BPA is safe at the low levels currently occurring in food.

The record

4 findings

Exhibit 01

Warning

The use of BPA and its salts in the manufacture of food contact materials and articles ... and the placing on the Union market of food contact materials and articles manufactured using BPA, is prohibited. ... the Authority concluded that there is a health concern from dietary BPA exposure for all population groups.

Commission Regulation (EU) 2024/3190 of 19 December 2024 prohibits the use of BPA in food-contact materials and the placing of BPA-made food-contact articles on the EU market, citing EFSA's conclusion of a health concern for all population groups.

Tier 1 · RegulatoryEUEUR-Lex (Official Journal of the European Union)· 2024-12-19

Exhibit 02

Warning

EFSA's experts established a tolerable daily intake (TDI) of 0.2 nanograms per kilogram of body weight per day... The newly established TDI is around 20,000 times lower than the previous level... consumers with both average and high exposure to BPA in all age groups exceeded the new TDI, indicating health concerns.

EFSA's 2023 re-evaluation set a new TDI for BPA of 0.2 ng/kg bw/day, about 20,000 times lower than its 2015 temporary TDI, and concluded that average and high consumers across all age groups exceed it, indicating a health concern.

Tier 1 · RegulatoryEUEuropean Food Safety Authority (EFSA)· 2023-04-19

Exhibit 03

ReassuranceInformational

FDA's current perspective, based on its most recent safety assessment, is that BPA is safe at the current levels occurring in foods. Based on FDA's ongoing safety review of scientific evidence, the available information continues to support the safety of BPA for the currently approved uses in food containers and packaging.

The U.S. FDA's stated position is that BPA is safe at the current levels occurring in foods and that available evidence continues to support its safety for currently approved uses in food containers and packaging.

Tier 1 · RegulatoryUSU.S. Food and Drug Administration (FDA)· 2023-04-20

Exhibit 04

ContextInformational

FDA has amended its regulations to no longer provide for the use of BPA-based polycarbonate resins in baby bottles and sippy cups ... and BPA-based epoxy resins as coatings in packaging for infant formula ... An amendment of the food additive regulations based on abandonment is not based on safety, but is based on ... abandonment.

The FDA amended its food-additive regulations to no longer authorize BPA-based polycarbonate in baby bottles and sippy cups (2012) and BPA-based epoxy resins in infant-formula packaging (2013) because those uses had been abandoned by industry, not because of a safety determination.

Tier 1 · RegulatoryUSU.S. Food and Drug Administration (FDA)· 2023-04-20

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