December 2018
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. BPA is also used in the internal coatings of some food and beverage cans. BPA is additionally used in many other consumer goods such as thermal receipt paper (to be banned in the EU from 2020), toys and compact discs (CDs), as well as in medical devices1. Typically, BPA is used in combination with other chemicals to manufacture plastics and resins.
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. BPA is also used in the internal coatings of some food and beverage cans. BPA is additionally used in many other consumer goods such as thermal receipt paper (to be banned in the EU from 2020), toys and compact discs (CDs), as well as in medical devices1. Typically, BPA is used in combination with other chemicals to manufacture plastics and resins2. Further information on the chemistry of BPA can be found in the PubChem database3 or the European Chemicals Agency website4.
Polycarbonate plastics containing BPA have many food and non-food applications. Food applications include food and drink packaging, water and infant bottles, other food and liquid containers, tableware, microwave ovenware and cookware. Polycarbonate non-food applications include compact discs, impact resistant safety equipment and medical devices. Epoxy resins containing BPA are used as protective lacquers to coat metal products such as food cans, bottle tops, and 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 BPA5,6.
According to the latest scientific study carried out by EFSA6, there is no health concern from BPA at current levels of exposure through food. Small amounts of BPA migrate from packaging into food, but the level of ingestion of BPA is currently well below EFSA’s Tolerable Daily Intake (TDI) of 4µg/kg body weight per day. It has been shown that BPA is rapidly detoxified in the body to harmless constituents and eliminated6. However, because BPA 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 paper4.
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. Numerous studies have been carried out, mostly in laboratory animals, to assess the relevance of BPA’s endocrine activities to human health. The outcomes of these experiments have proved difficult to interpret, leading to some controversy within the scientific community. In-depth reviews by the US National Toxicology Program (NTP)7, Health Canada8,9, EFSA6 and others have concluded that the risk to human health at current exposure levels through food is negligible. EFSA concluded that a temporary TDI of 4µg/kg body weight per day was sufficiently protective of human health6. For comparison, the highest human dietary intake, which is in toddlers and infants, is estimated to be just below 0.9µg/kg body weight per day. A risk assessment by the French Agency for Food, Environmental and Occupational Health & Safety on the other hand concluded that maternal exposure to BPA during pregnancy may be a risk factor5.
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 systems6. 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 Protocol10, 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.
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.
The Commission has published a new Regulation, Commission Regulation No. 2018/21311, that significantly tightens the restrictions on 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 the use of BPA to manufacture 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 new Regulation applies from 6 September 2018. The international regulation of BPA is not harmonized with some countries, notably France and Sweden, restricting BPA beyond EFSA’s recommendations.
- European Commission (2018a). Q&A. February 2018. Available from: https://ec.europa.eu/food/sites/food/files/safety/docs/cs_fcm_qa_bisphen...
- EFSA (2017a). Bisphenol A. Available from: https://www.efsa.europa.eu/en/topics/topic/bisphenol
- NIH (2015). PubChem Identifier CID 6623. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/6623
- EChA (2018). European Chemicals Agency, https://echa.europa.eu/
- ANSES (2013). Opinion of the French Agency for Food, Environmental and Occupational Health & Safetyon the assessment of the risks associated with bisphenol A for human health, and on toxicological data and data on the use of bisphenols S, F, M, B, AP, AF and BADGE. Available from: https://www.anses.fr/en/system/files/CHIM2009sa0331Ra-0EN.PDF
- 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. Available from: https://www.efsa.europa.eu/en/efsajournal/pub/3978
- Shelby MD (2008). NTP-CERHR monograph on the potential human reproductive and developmental effects of bisphenol A. NTP CERHR MON 22, No. 08-5994, v, vii-ix, 1-64 passim. Available from: https://ntp.niehs.nih.gov/ntp/ohat/bisphenol/bisphenol.pdf
- Health Canada (2008). Health risk assessment of bisphenol A from food packaging applications. Available from: https://www.canada.ca/en/health-canada/services/food-nutrition/food-safe...
- Health Canada (2012). Updated assessment of Bisphenol A (BPA) Exposure from Food Sources. Available from: https://www.canada.ca/en/health-canada/services/food-nutrition/food-safe...
- EFSA (2017b). Bisphenol A (BPA) hazard assessment protocol. EFSA Supporting publication 2017:EN-1354. Available from: https://www.efsa.europa.eu/en/supporting/pub/1354e
- 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. Available from http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32018R0213
Institute of Food Science & Technology has authorised the publication of this statement, prepared by Sarah Howarth and Ivan Bartolo, 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.