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 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 transfer from them into food (migration). 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 hormone-disrupting properties (endocrine disruptor).
BPA has a low acute toxicity. Long-term (chronic) ingestion of BPA has shown adverse health effects in animal studies, such as damage to the kidneys and liver, reproductive damage, evidence of possible damage to the immune system and metabolism, and possible effects on the development of young rodents, such as premature onset of puberty and changes in mammary gland tissue.
Situation in Austria
A draft re-evaluation of BPA was published by EFSA on December 15, 2021 and put out for public consultation until February 08, 2022. A lowering of the TDI (amount of a substance that can be ingested daily for a lifetime without posing a health risk to humans) is expected.
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 manufacture 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 bans and prescribed migration limits is regularly checked as part of official food inspections. In 2010, plastic baby bottles were tested for migration of bisphenol A into the food. In the case of polycarbonate drinking bottles, all measured values were 300 to 1000 times lower than the EU-wide limit valid at the time. Since then, numerous focus actions have been carried out in food contact articles, soothers and foodstuffs, 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 previously valid 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, setting a new temporary TDI of 4 µg per kg body weight per day. EFSA has thus lowered the TDI value by more than a factor of 10.
No new health concerns about BPA were identified in the re-evaluation. The new 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 on possible effects on mammary gland, reproductive organs, metabolic, nervous and immune systems were quantified with new methods and taken into account in the calculation of the TDI.
EFSA proposed to set the value of 4 µg per kg body weight per day as a temporary TDI value (t-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 new TDI of 4 µg per kg body weight per day.
EFSA Assessment 2021
A re-evaluation of BPA by EFSA is currently underway and has been open for public consultation since December 15, 2021, and will be published in 2022. A further lowering of the TDI is expected - the proposed level in the consultation is 0.04 µg per kg body weight per day. According to EFSA, the lowering of the TDI results from the assessment of studies published in the scientific literature from 2013 to 2018 (in particular, studies indicating adverse effects of BPA on the immune system). In animal studies, an increase in the number of "T-helper" cells was observed, which play a key role in cellular immune mechanisms and which, if increased, can lead to the development of allergic pneumonia.
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 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC
Last updated: 20.01.2022