Bisphenol A (BPA) is a chemical that is mainly used in combination with other chemicals to manufacture plastics and resins. For example, BPA is used in polycarbonate, a high performance transparent, rigid plastic. Polycarbonate is used to make food containers, such as returnable beverage bottles, infant feeding (baby) bottles, tableware (plates and mugs) and storage containers. Residues of BPA are also present in epoxy resins used to make protective coatings and linings for food and beverage cans and vats. BPA can migrate in small amounts into food and beverages stored in materials containing the substance.
EFSA adopts scientific opinions and provides scientific advice for risk managers on the safety of BPA when used in materials which come into contact with food. This work is carried out by EFSA’s Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF).
BPA is permitted for use in food contact materials in the European Union (EU) under Regulation 10/2011/EU, relating to plastic materials and articles intending to come into contact with foodstuffs. In January 2011, the European Commission adopted Directive 2011/8/EU, prohibiting the use of BPA for the manufacture of polycarbonate infant feeding bottles.
- Regulation EU 10/2011 on plastic materials and food contact materials – EUR-Lex
- Directive 2011/8/EU restricting the use of bisphenol A in plastic infant feeding bottles – EUR-Lex
BPA is also permitted for food contact use in other countries such as the USA and Japan.
EFSA completed its full risk assessment of BPA in 2006 and set a Tolerable Daily Intake (TDI) of 0.05 milligrams/kilogram of body weight (mg/kg bw/day) for this substance. The TDI is an estimate of the amount of a substance, expressed on a body weight basis, that can be ingested daily over a lifetime without appreciable risk. At the same time, EFSA also evaluated intakes of BPA through food and drink, for adults, infants and children and found that they were all below the TDI.
- Press release: EFSA re-evaluates safety of BPA and sets Tolerable Daily Intake
- Scientific opinion on bisphenol A (2006)
EFSA reviewed new scientific information on BPA in 2008, 2009, 2010 and 2011: EFSA’s experts concluded on each occasion that they could not identify any new evidence which would lead them to revise the TDI for BPA of 0.05 mg/kg bw.
In February 2012, following further consideration of new scientific studies, the CEF Panel decided to undertake a full re-evaluation of the human risks associated with exposure to BPA through the diet, also taking into consideration the contribution of non-dietary sources to the overall exposure to BPA. The new opinion will review all the available data and scientific studies on dietary exposure published since EFSA’s 2006 Opinion. The Panel will further evaluate uncertainties about the possible relevance to human health of some BPA-related effects observed in rodents at low dose levels.
In July 2013, EFSA launched a public consultation on the first part of its draft scientific opinion, specifically on its assessment of consumer exposure to BPA. This is the Authority’s first review of exposure to BPA since 2006 and the first to cover both dietary and non-dietary sources (including thermal paper and environmental sources such as air and dust). EFSA’s scientific experts provisionally concluded that for all population groups diet is the major source of exposure to BPA and exposure is lower than previously estimated by EFSA. In January 2014, EFSA presented the second part of the draft opinion relating to the human health risks posed by exposure to BPA. This was also accompanied by the launch of an eight-week public consultation. In the draft opinion, EFSA identified likely adverse effects on the liver and kidney and effects on the mammary gland as being linked to exposure to the chemical. It therefore recommended that the current tolerable daily intake (TDI) be lowered from its current level of 50 µg/kg bw/ day (or 0.05 mg/kg/bw/day) to 5 µg/kg bw/day (0.005 mg/kg/bw/day). The Authority also noted that uncertainties remained over a number of other health hazards considered as less likely. As a result the proposed TDI should be set on a temporary basis pending the outcome of research from the US National Toxicology Program (NTP) which will address many of these current uncertainties about the potential health effects of BPA. However, EFSA concluded that BPA poses a low health risk to consumers as exposure to the chemical is well-below the temporary TDI.
- Press Release: Bisphenol A: EFSA consults on assessment of risks to human health
- Press release: Food is main source of BPA for consumers, thermal paper also potentially significant
- Public consultation on draft Scientific Opinion on the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs – Part: exposure assessment
Since 2006, EFSA and its scientific panels have considered hundreds of scientific publications in peer-reviewed scientific journals as well as reports from studies submitted by industry.
In an opinion adopted in 2008, EFSA addressed the differences in the ability of infants and adults to clear BPA from the body. In this opinion, it was confirmed that exposure to BPA was well below the TDI of 0.05 mg/kg bw for both adults and newborns. Indeed, after exposure to BPA the human body rapidly metabolises and eliminates the substance. This is also true for newborns who can clear BPA at levels far in excess of the TDI. In its evaluation, EFSA took into account both the previous and the most recent information and data available from all sources (industry as well as peer-reviewed scientific literature).
In September 2008 the European Commission asked EFSA to assess the conclusions of a study by Lang et al. (Journal of the American Medical Association, 16 September 2008) that suggested a link between levels of urinary BPA and increased occurrence of heart disease and diabetes. In a statement adopted in October 2008, EFSA noted that the study did not include any information on long-term exposure to BPA which would be needed in order to establish a correlation between BPA and the development of the chronic medical conditions in question. Therefore the study did not provide proof of a causal link between BPA and these health conditions.
In October 2009, EFSA received a request from the Commission to assess the relevance of a new study by Stump on possible neurodevelopmental effects of BPA and, if necessary, to update the existing TDI accordingly. The study in question was commissioned by the American Chemistry Council to address safety concerns raised by the Canadian government, which had introduced legislation to ban the use of polycarbonate in baby feeding bottles.
In March 2010 EFSA received a further related request from the Commission to also take into account any new scientific evidence available that might affect the conclusions of the previously adopted opinions on BPA and to liaise closely with EU Member State risk assessment bodies on this issue. Subsequently EFSA held a meeting with national experts on BPA from EU Member States and representatives of the Commission, in which members of EFSA’s CEF Panel outlined a new draft opinion on BPA. Panel members and national experts stressed that all scientific information needed to be critically analysed to determine its relevance to the safety assessment of BPA in terms of human health. National experts were encouraged to submit any new evidence to EFSA, which would be considered when finalising the opinion.
EFSA updated its advice on BPA in September 2010. Following a detailed and comprehensive review of recent scientific literature and studies on the toxicity of BPA at low doses, the CEF Panel concluded they could not identify any new evidence which would lead them to revise the TDI for BPA of 0.05 mg/kg body weight set by EFSA in its 2006 opinion. The Panel also stated that the data available did not provide convincing evidence of neurobehavioural toxicity of BPA.
One Panel member expressed a minority opinion, considering that some recent studies pointed to uncertainties regarding adverse health effects below the level used to determine the current TDI. Although the Panel member agreed with the rest of the Panel's general view that these studies could not be used to establish a lower TDI, the expert had recommended that the current TDI should become a temporary TDI. The CEF Panel members acknowledged that some recent studies reported adverse effects on animals exposed to BPA during development at doses well below those used to determine the current TDI. These studies deal with biochemical changes in the central nervous system, effects on the immune system and enhanced susceptibility to breast cancer. However, given that these studies had many shortcomings in design or reporting and that they did not meet the quality criteria for inclusion in a risk assessment, their relevance for human health could then not be assessed.
In November 2011, the CEF Panel published a Statement addressing reports on BPA published by the French Health and Safety Agency (Anses) in September 2011. In its Statement, the CEF Panel considered that overall the information in the Anses report on health effects of BPA did not change the views expressed by the Panel in its earlier opinions on the safety of BPA. Following an exchange of information between EFSA and Anses, it was concluded that Anses’ work was limited to a hazard identification while EFSA had carried out a full risk assessment of BPA in 2006.
However, following a preliminary review of new scientific literature emerging from EFSA’s ongoing monitoring of the scientific literature, the CEF Panel confirmed, as in its 2010 opinion, that uncertainties remain about the possible relevance to human health of some BPA-related effects observed in rodents at low dose levels. The Panel also stated that it would reconsider its opinion following further evaluation of new studies and when new data from the low dose studies ongoing in the Unite States become available: these studies involve both the FDA’s National Center for Toxicological Research (NCTR), and the National Institute of Environmental Health Sciences’s (NIEHS) National Toxicology Program.
In 2012, following the CEF Panel’s decision to carry out a new risk assessment of BPA, EFSA established two new working groups to focus, respectively, on the hazard characterisation of BPA (evaluation of possible adverse human health effects of BPA) and on exposure to BPA (how and how much BPA is absorbed by the human body). New findings from ongoing studies on low dose effects as well as on dietary and non-dietary exposure to BPA are being considered as they become available. EFSA will continue to liaise closely with European and national bodies engaged in BPA evaluations as well as with other scientific experts on studies currently in progress.
- News story: Bisphenol A: EFSA launches full re-evaluation focussing on exposure and possible low dose effects
EFSA specifically tackled the issue of low dose effects in toxicology and risk assessment at its dedicated Scientific Colloquium, with the participation of international experts, taking place in Parma on 14-15 June 2012.