Bisphenol A (BPA) is primarily used as a building block (monomer) in the production of polycarbonate plastics and epoxy resins by polymerization (reaction in which monomers combine to form polymers). Polymerized BPA is basically bound in a chemically stable manner. However, it can be released again under certain circumstances. Thus, free BPA residues may still be present in small quantities in these materials and may be released.
Polycarbonate and epoxy resins are used in a variety of applications. Polycarbonate has high strength, toughness, hardness, good electrical insulating properties, and high resistance to weathering and radiation. Because of these properties, it is used, for example, in vehicle construction, in the building industry, in consumer products, such as DVDs, and in food contact materials, made of polycarbonate, such as some drinking bottles and containers for food.
Liquid epoxy resins react with the use of hardeners to form hard, insoluble as well as chemical-resistant plastics and are used, for example, in adhesives, paints, and as internal coatings for food and beverage cans. In addition, BPA is also used as an additive (additive) in unbound form, for example, in brake fluids.
According to a 2015 assessment by the European Food Safety Authority(EFSA), food is the main source of BPA (dietary intake). Thermal paper, from which, for example, sales slips, parcel labels or parking tickets were made, was also a significant source of BPA (absorption via the skin). However, this has been banned since January 2020 and has therefore now lost importance as a source of BPA.
Food contact materials play an important role in the uptake of BPA via the diet, as BPA can migrate from them into food. According to EFSA(2015), canned foods contribute significantly more to BPA intake than non-canned foods. For those foods that were not canned, meat and meat products and fish and fish products were found to contribute most to dietary BPA intake.
Due to its hormone-like (especially estrogen-like) mode of action, bisphenol A has been identified by the European Chemicals Agency(ECHA) as a Substance of Very High Concern (SVHC) with endocrine disrupting properties.
The acute toxicity of BPA is low, but various adverse health effects have been shown in studies of long-term (chronic) ingestion of BPA. According to the current 2023 assessment of the European Food Safety Authority (EFSA), adverse effects on the immune system, reproduction and development, the nervous system, and metabolism, among others, are possible from dietary intake of BPA.
Situation in Austria
BPA is regulated in Regulation (EU) No. 10/2011, as amended, on plastic food contact materials as a starting material for the production of plastics. The use of BPA is prohibited in the production of infant bottles, drinking vessels and bottles for infants and young children.
In addition, the Austrian Ministry of Health has banned the use of BPA also in teething rings and soothers (pacifiers) with the regulation BGBl. 327/2011 as amended. This ban takes into account both our test results and studies by other testing institutes that repeatedly detected traces of BPA in such products before 2011, and is in line with the principle of preventive health protection for young children.
Since January 2, 2020, on the basis of Regulation (EC) No. 1907/2006 as amended (Annex XVII), bisphenol A may no longer be placed on the market in thermal paper in concentrations of 0.02 percent by weight and above.
Compliance with the prohibitions and prescribed migration limits is regularly checked as part of official food inspections. In recent years, we have investigated food contact articles, soothers and foodstuffs in a series of focus actions, and none of the samples were found to exceed the specific migration limit in force at the time of the investigation. In the most recent investigation of epoxy-coated food cans, one sample was found to significantly exceed the specific migration limit of BPA
Focus actions on bisphenol A
EFSA Evaluation 2015
BPA has been evaluated by EU bodies on several occasions and a Tolerable Daily Intake ( TDI) value has been established. The TDI value is the estimated amount of a chemical that can be ingested daily over a lifetime without posing a significant health risk.
The original TDI value had been set by EFSA in 2010 and was 50 µg per kg body weight per day. In early 2015, EFSA published a re-evaluation of BPA with a new temporary TDI value of 4 µg per kg body weight per day.
The TDI value was derived from kidney effects in mice that had been included in previous assessments. However, a new calculation approach was used in the reassessment (benchmark dose lower limit approach, BMDL) and new more accurate data were available, especially in the toxicokinetic area. Furthermore, uncertainties regarding possible effects on the mammary gland, reproductive organs, metabolic, nervous and immune systems were quantified using new methods and taken into account in the calculation of the TDI.
For example, the maximum total exposure in adults (including women of childbearing age) was estimated to be 1.063 µg/kg body weight per day. Adolescents have the highest exposure with a maximum of 1.449 µg/kg per body weight per day. EFSA considered in 2015 that there is no health concern as the highest estimates for combined oral and non-oral exposure to BPA in all age groups are about three to four times lower than the TDI of 4 µg per kg body weight per day.
EFSA Assessment 2023
Based on new available scientific studies published as of January 2013, EFSA published a re-evaluation of BPA in food in April 2023 to set the hitherto temporary TDI at a full TDI level.
In addition to potential adverse health effects of BPA, for example on reproduction, development and metabolism, relevant effects on the immune system were also considered in the re-evaluation. The most sensitive endpoint identified for deriving the TDI was an increase in certain white blood cells, so-called T helper cells (Th17 cells), which may be associated with an increased risk of developing allergic pneumonia and autoimmune diseases. Consequently, as part of EFSA's re-evaluation of BPA, the TDI was lowered to 0.2 ng/kg bw/day.
It should be noted that the increase in Th17 cells represents an intermediate endpoint. EFSA points out corresponding uncertainties in the derivation of this endpoint, but at the same time notes that adverse health effects in similar dose ranges were also observed for other endpoints such as reproduction, development and metabolism. Therefore, this endpoint was used as the most sensitive endpoint.
The comparison of the new TDI with the exposure was based on the 2015 exposure assessment, thus a possible reduction of exposure to BPA due to appropriate regulatory minimization measures could not be evaluated. Based on the exposure assessment from 2015, the dietary intake of BPA was shown to be significantly above the newly derived TDI of 0.2 ng/kg bw/day for all age groups at both average and high consumption levels. Therefore, according to EFSA, there are health concerns due to dietary exposure to BPA for all age groups.
European Food Safety Authority (EFSA) 2023: Scientific Opinion on the re-evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs. EFSA Journal 2023;21(4):6857, 392 pp.
European Food Safety Authority (EFSA) 2015: Scientific Opinion on the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs: Executive summary. EFSA Journal 2015; 13 (1):3978.
Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No. 793/93, Commission Regulation (EC) No. 1488/94, Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC.
Last updated: 10.10.2023