Bisphenol A

Bisphenol A

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's role

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).

EU framework

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 manufacture in the EU of baby bottles containing BPA and banning the placing on the market and importing into the EU of such products.

BPA is also permitted for food contact use in other countries such as the USA and Japan.

EFSA's activities

EFSA’s full risk assessment of BPA took place in 2006 when it set a Tolerable Daily Intake (TDI) of 0.05 mg/kg body weight 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. EFSA found that intakes of BPA through food and drink were well below the TDI, also for infants and children.

EFSA has updated its scientific advice on BPA several times since 2006, most recently updating its risk assessment in 2010 (see below).

Latest activities

At the request of the European Commission, in November 2011 EFSA published a statement on BPA following September 2011 reports by the French Health and Safety Agency (Anses). Scientific experts on EFSA’s CEF Panel considered overall that the information in the Anses report on health effects of BPA did not change the views expressed by the Panel in its 2010 opinion on the safety of BPA. Following an exchange of information with Anses, the Panel explained that Anses’ work was limited to a hazard identification while EFSA has carried out a full risk assessment of BPA (first in 2006 and reaffirmed in 2008 and 2010). Following a preliminary review of new literature emerging from EFSA’s ongoing monitoring of the scientific literature, the CEF Panel confirmed, as in 2010, that uncertainties remain about the possible relevance to human health of some BPA-related effects observed in rodents at low dose levels. The Panel will reconsider its opinion following further evaluations of new studies and after new data from low dose studies being conducted in the United States (US) become available in 2012.

In late 2011, EFSA decided to establish a multidisciplinary working group of experts to further evaluate new scientific studies and data on BPA as they become available. EFSA continues to closely monitor these developments which will help inform reconsideration of the Panel’s scientific advice in 2012. EFSA will also liaise closely with US scientific experts on the studies that are currently in progress.

Main milestones

In an opinion adopted in 2008, EFSA addressed the difference between infants and adults in clearing BPA from the body. Results 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. Newborns can similarly 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, both from industry and from peer-reviewed scientific literature.

In September 2008 the European Commission asked EFSA to assess the conclusions of a study by Lang et al. published in the Journal of the American Medical Association (JAMA, 16 September 2008) that suggested a link between raised levels of urinary BPA to increased occurrence of serious medical conditions, including heart disease and diabetes.

In a statement adopted in October 2008, EFSA noted that the study included no information on long term exposure to BPA, which would be important in order to establish a correlation between BPA and the development of the chronic medical conditions in question. EFSA found that the study did not provide sufficient proof of a causal link between BPA and these health conditions and did not therefore bring into question the established TDI.

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 has 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 other new scientific evidence that may be available that might affect the conclusions of the previously adopted opinions on BPA and to liaise closely with EU Member States 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, scientists of EFSA’s CEF Panel concluded they could not identify any new evidence which would lead them to revise the current TDI for BPA of 0.05 mg/kg body weight set by EFSA in its 2006 opinion and re-confirmed in its 2008 opinion. The Panel also stated that the data currently available do not provide convincing evidence of neurobehavioural toxicity of BPA.

One Panel member had expressed a minority opinion, saying 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 report adverse effects on animals exposed to BPA during development at doses well below those used to determine the current TDI. These studies show 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 or did not comply with the quality criteria for inclusion in a risk assessment, their relevance for human health could then not be assessed.

Last updated: 1 December 2011

See also