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.

Last updated: 
28 October 2014

Topics: Completed work

In January 2015, EFSA published its latest comprehensive re-evaluation of BPA exposure and toxicity. EFSA’s experts concluded that BPA poses no health risk to consumers of any age group (including unborn children, infants and adolescents) at current exposure levels. Although new data and refined methodologies led EFSA’s experts to considerably reduce the safe level of BPA from 50 micrograms per kilogram of body weight per day (µg/kg of bw/day) to 4 µg/kg of bw/day, the highest estimates for dietary exposure and for exposure from a combination of sources (diet, dust, cosmetics and thermal paper) are three to five times lower than the new TDI. 

Uncertainties surrounding potential health effects of BPA on the mammary gland, reproductive, metabolic, neurobehavioural and immune systems have been quantified and factored in to the calculation of the TDI. In addition, the TDI is temporary pending the outcome of a long-term study in rats, which will help to reduce these uncertainties.

EFSA completed its first full risk assessment of BPA in 2006. Since then, the Authority and its scientific panels have considered hundreds of scientific publications in peer-reviewed scientific journals as well as reports from studies submitted by industry. EFSA reviewed new scientific information on BPA in 2008, 2009, 2010 and 2011. Its comprehensive re-evaluation was published in January 2015.

Past milestones

2015 - EFSA’s most recent review of BPA exposure and toxicity concluded that BPA poses no health risk to consumers of any age group (including unborn children, infants and adolescents) at current exposure levels.

2014 - EFSA presented the second part of its draft opinion relating to the human health risks posed by exposure to BPA. This was also accompanied by an eight-week public consultation.

2013 - EFSA held a public consultation on the first part of its draft scientific opinion, specifically on its assessment of consumer exposure to BPA. EFSA 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.

2012 - EFSA’s experts 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 would review all the available data and scientific studies on dietary exposure published since EFSA’s 2006 Opinion. The Panel would further evaluate uncertainties about the possible relevance to human health of some BPA-related effects observed in rodents at low dose levels.

2012 - EFSA 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.

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 hazard identification while EFSA had carried out a full risk assessment of BPA in 2006.

However, the CEF Panel confirmed that it would reconsider its opinion following further evaluation of new studies and when new data from the low dose studies ongoing in the United States become available.

2010 - 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.

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.

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 had  been 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.

2008 - EFSA addressed the differences in the ability of infants and adults to clear BPA from the body. EFSA confirmed that exposure to BPA was well below the then TDI of 0.05 mg/kg bw for both adults and newborns. 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).

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 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.

2006 - EFSA completed its first 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. 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.

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).

As part of its safety evaluations of food contact materials EFSA establishes, when possible (i.e. when sufficient information is available), a Tolerable Daily Intake (TDI) for each substance. The TDI is an estimate of the amount of a substance that people can consume on a daily basis during their whole life without any appreciable risk to health. TDIs are usually expressed in mg or µg per kg of body weight per day (mg/kg bw/day).

EFSA liaises closely with European and national bodies engaged in BPA evaluations as well as with other scientific experts on studies currently in progress.

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.

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

Completed work
E.g., 11/30/2015
E.g., 11/30/2015