November 2024
Bisphenol A (BPA) is an organic compound that is widely used in the production of polycarbonate plastic containers for food use, such as clear single use and multiple use drinks bottles. It is important to note that these are different from polyethylene terephthalate (PET) bottles. BPA is also used in the internal coatings of some food and beverage cans. It is also used in many other consumer goods, such as thermal receipt paper (effectively banned in the EU and UK from 2020) and toys, as well as in medical devices. Typically, BPA is used in combination with other chemicals to manufacture plastics and resins1. Further information on the chemistry of BPA can be found in the PubChem database2 or the European Chemicals Agency website3.
Polycarbonate plastics containing BPA have many food and non-food applications. The former include food and drink packaging, water bottles and other food and liquid containers, tableware, microwave ovenware and cookware. They were formerly used in infant bottles but now banned in polycarbonate drinking cups or bottles specifically intended for infants and young children, up to three years of age4. Polycarbonate non-food applications include impact resistant safety equipment and medical devices. Epoxy resins containing BPA are used as protective lacquers to coat metal products such as food cans, and bottle tops. The current migration limit is 0.05 mg/kg4 except that no migration of BPA shall be permitted (to a detection limit of 0.01 mg/kg) from varnishes or coatings applied to materials and articles specifically intended to come into contact with infant formula, follow-on formula, processed cereal-based food, baby food, food for special medical purposes developed to satisfy the nutritional requirements of infants and young children or milk-based drinks and similar products specifically intended for young children, as referred to in Regulation (EU) No 609/2013. There have been moves to ban it5). Water supply pipes, some dental sealants and composites may also contribute to BPA exposure. It is generally accepted that the main dietary contributor of BPA is canned food, accounting for about 50% of the total exposure. Of the non-canned foods examined, meat, fish and products made from meat or fish were the more important sources of BPA.
In 2015, EFSA established a temporary tolerable daily intake (t-TDI) for BPA of 4 μg/kg body weight (bw) per day and added that there was no health concern from BPA at the levels of exposure through food at that time6. In 2016, the European Commission mandated EFSA to re-evaluate the risks to public health and a TDI of 0.2 ng BPA/kg bw per day was established. Comparing this TDI with the dietary exposure estimates from the 2015, the EFSA CEP Panel concluded that there is a health concern from dietary BPA exposure7. As the current TDI is considered too low to continue the use of BPA subject to a specific migration limit (SML), the commission is proposing to ban the intentional use of BPA in Food Contact Materials (FCMs). This is estimated to apply as from the end of 2025, or the beginning of 20268.
Small amounts of BPA migrate from packaging into food, and the level of ingestion was thought to be well below EFSA’s TDI of 4 µg/kg body weight per day. It has been shown that BPA is rapidly detoxified in the body to harmless constituents and eliminated. However, because it has some hormone-like properties there are some remaining concerns about its effects on the body. In addition, there is uncertainty about the exposure to BPA through non-dietary sources such as dust, cosmetics and thermal paper9.
BPA is considered an endocrine disrupting compound (EDC), defined as an exogenous substance that impacts endocrine function and leads to adverse effects. EDCs can affect the synthesis, secretion, transport, activity and elimination of hormones responsible for the regulation of functions such as reproduction (including embryonic and gonad development), growth, metabolism and behaviour. Endocrine disruption is sometimes also linked to cancer.
The 2015 EFSA Opinion highlighted an incomplete understanding of the effects of BPA on various toxicological outcomes, including effects on the reproductive, mammary gland, neurobehavioural, immune and metabolic systems10. The US Consortium Linking Academic and Regulatory Insights on BPA Toxicity run by the NTP (NTP-CLARITY) is carrying out a two-year study that is expected to address most of the remaining uncertainties. Meanwhile, in expectation of the NTP-CLARITY report, EFSA has prepared a Bisphenol A Hazard Assessment Protocol11, which sets out the methodology to be used for updating its hazard assessment once the new findings become available. In addition, the proposed assessment will consider studies concluded post 2013 that were not considered in the 2015 EFSA Opinion.
In more detail, the EFSA re-evaluation of BPA published in 2023 found it unlikely to very unlikely that BPA presents a genotoxic hazard through a direct mechanism. However, the immune system was identified as most sensitive to BPA exposure, with a critical cellular effect on immune mechanisms and the development of inflammatory conditions, including autoimmunity and lung inflammation. A TDI of 0.2 ng BPA/kg bw per day was established. Comparison of this TDI with the dietary exposure estimates from the 2015 EFSA opinion showed that both the mean and the 95th percentile dietary exposures in all age groups exceeded the TDI by two to three orders of magnitude. Even considering the uncertainty in the exposure assessment, the exceedance being so large, the CEP Panel concluded that there is a health concern from dietary BPA exposure7.
BPA has well established technical functions, which must be replicated by any alternative replacement. This particularly applies to the seal integrity of canned food internal lacquers and to the properties of thermal cashier receipt paper. Alternatives include chemicals with a similar molecular structure to BPA, such as bisphenol S (BPS). The toxicological risk of exposure to these chemicals has been less well studied than for BPA.
Commission Regulation No. 2018/21312 restricts the use of BPA in food contact materials. It lowers the regulatory limit i.e. the specific migration limit (SML), which is the amount allowed to migrate from the plastic material into food while keeping it safe and extends this restriction to coating materials that are used to line food and drink cans. As a precautionary measure, the Regulation also extends the ban from 2011 on the use of BPA in baby bottles by prohibiting its use in the manufacture of infant 'sippy' cups, as well as the migration of BPA from coated materials containing food intended for infants and children up to 3 years old. The international regulation of BPA is not harmonised with some countries, notably France and Sweden, restricting BPA beyond EFSA’s recommendations.
[1] EFSA (2017a). Bisphenol A: https://www.efsa.europa.eu/en/topics/topic/bisphenol
[2] NIH (2015). PubChem Identifier CID 662: https://pubchem.ncbi.nlm.nih.gov/compound/6623
[3] EChA (2018). European Chemicals Agency: https://echa.europa.eu/
[4] New rules on bisphenol A in food contact materials: https://www.europarl.europa.eu/RegData/etudes/ATAG/2018/614705/EPRS_ATA(2018)614705_EN.pdf
[5] EFSA (2015). Scientific Opinion on the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs. EFSA Journal 13(1), 3978: https://www.efsa.europa.eu/en/efsajournal/pub/3978
[6] Ramírez et al. (2023). Risk assessment of food contact materials. EFSA Journal 21, e211015: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2023.e211015
[7] EFSA (2023): Bisphenol A: https://www.efsa.europa.eu/en/topics/topic/bisphenol
[8] Q&A on BPA webinar - Food Safety: https://food.ec.europa.eu/system/files/2023-08/cs_fcm_wg_20230804_qandas.pdf
[9] EFSA (2013). Sources of BPA: https://www.efsa.europa.eu/en/press/news/130725
[10] EFSA (2015). Scientific Opinion on the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs. EFSA Journal 13(1), 3978: https://www.efsa.europa.eu/en/efsajournal/pub/3978
[11] EFSA (2017b). Bisphenol A (BPA) hazard assessment protocol. EFSA Supporting publication 2017:EN-1354: https://www.efsa.europa.eu/en/supporting/pub/1354e
[12] European Commission (2018b). Commission Regulation (EU) 2018/213 of 12 February 2018 on the use of bisphenol A in varnishes and coatings intended to come into contact with food and amending Regulation (EU) No 10/2011 as regards the use of that substance in plastic food contact materials: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32018R0213
Institute of Food Science & Technology has authorised the publication of this statement "Bisphenol A: Occurrence in Food and the Risk to Health", dated November 2024, replacing that of December 2018.
This updated Information Statement has been prepared and peer reviewed by professional members of IFST and approved by the IFST Scientific Committee.
The Institute takes every possible care in compiling, preparing and issuing the information contained in Information Statements, but can accept no liability whatsoever in connection with them. Nothing in them should be construed as absolving anyone from complying with legal requirements. They are provided for general information and guidance and to express expert professional interpretation and opinion, on important food-related issues.