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).
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.
In February 2012, EFSA 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.
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 an eight-week public consultation.
In the draft opinion, EFSA’s Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) 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
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.
- Press release: EFSA re-evaluates safety of BPA and sets Tolerable Daily Intake
- Scientific opinion on bisphenol A (2006)
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. EFSA reviewed new scientific information on BPA in 2008, 2009, 2010 and 2011: on each occasion EFSA’s experts concluded that they could not identify any new evidence which would lead them to revise the TDI for BPA of 0.05 mg/kg bw.
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 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, 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 United 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.
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. 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.
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.
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.
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).
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.
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.
(e.g. : 01/01/2002)
(e.g. : 31/01/2002)
12 December 2014 News: News in brief
23 April 2014 Brussels
9 April 2014 News: News story
13 March 2014 Public consultation
26 February 2014 News: News in brief
17 January 2014 News: Press release
15 September 2013 Public consultation
25 July 2013 News: Press release
28 June 2013 News: News story
26 March 2013 News: News story
1. What is bisphenol A (BPA) and how is it used?
2. How can BPA get into our diet?
3. Have concerns been raised about BPA in the past?
4. Has EFSA carried out a safety review of BPA?
5. Has EFSA reviewed the safety of BPA since 2006?
6. Why is EFSA carrying out a new full risk assessment of BPA now?
7. In July 2013, EFSA launched a public consultation on part of its new draft opinion on BPA – the “exposure assessment”. Why only one part?
8. What is “exposure assessment”? Is it part of “risk assessment”?
Yes, exposure assessment is a crucial part of risk assessment. Scientific risk assessment involves several steps. These steps include identifying and describing potential hazards, which in EFSA’s case are usually associated with the food chain. A hazard is a possible threat related to the intrinsic properties of a substance (for example its toxicity may be shown to cause cancer). However, the risk that the substance could cause harm, resulting in adverse effects in humans and animals depends on the degree (dose), duration and timing of exposure to this hazard for humans or animals. Hazards may not be harmful if there is no exposure to them, or exposure is too low to cause harm. The aspects of risk assessment dealing with hazards are called ‘hazard assessment’; those parts dealing with exposure are called ‘exposure assessment’.For exposure assessment scientists need extensive and comparable data on the levels of BPA present in food and in food contact material. When no data are available on BPA levels in certain food categories, this can be estimated using information on the types of food contact materials in which BPA is present and how much BPA can migrate into foods. Scientists also need extensive data on food consumption. By comparing these two sets of data and using modelling techniques, experts can predict the likely exposure of different groups of consumers to these potential health hazards.
9. What is important about this exposure assessment?
This is EFSA’s first review of consumer exposure to BPA since 2006 and the first to cover both dietary and non-dietary sources (for example, thermal paper and environmental sources such as air and dust). EFSA’s draft exposure assessment also considers more specific groups of the population than in its previous exposure assessment. For example, these groups include breastfed infants, bottle-fed infants, infants up to 5 days, 3 months, 6 months and 12 months old, teenagers (10-18 years) and women of child-bearing age (18-45 years).
Using scientific data published since 2006 and obtained through an EFSA public call for data, EFSA’s experts have been able to carry out a considerable refinement of exposure estimates compared to 2006. This is especially important following the 2011 EU ban on baby bottles made of PC, which has changed the exposure of infants and toddlers to BPA.
Data on BPA levels in food were combined with figures for food consumption (including human milk) to estimate dietary exposure. Since this exposure assessment also considers non-dietary sources of exposure, data on levels of BPA in and from non-food sources (including dust, thermal paper and cosmetics) were combined with data on behaviour patterns. In addition, the results of biomonitoring (that is, analysis of BPA levels in human urine) were used to corroborate the estimates derived from data modelling, which were found to be consistent.
10. What are the main findings of EFSA’s draft assessment of exposure to BPA?
11. Why are the estimates of dietary exposure from 2006 and 2013 so different?
12. Is exposure to BPA from thermal paper a concern?
13. What are the other key findings?
- Scientists found dietary exposure to BPA to be the highest among children aged three to ten. This is explained by their higher food consumption on a body weight basis.
- Total exposure for bottle-fed infants aged 0-6 months was particularly low (38 ng/kg bw/day). This is likely to be the result of the European Union’s decision in 2011 to ban BPA from baby bottles.
- Canned food and non-canned meat and meat products were identified as major contributors to dietary BPA exposure for all age groups. Canned food is known to be a dietary source of BPA because of the substance’s use in the lining of cans. BPA might be present in meat and meat products through contact with packaging, processing equipment or through other forms of contamination (e.g. environment, feed). However, EFSA’s experts have not seen any firm scientific evidence to support this.
14. Will the public be able to comment on the rest of EFSA’s opinion, if at all?
EFSA is committed to holding a two-stage consultation process on its full risk assessment of BPA. The consultation on the first part of EFSA’s draft opinion dealing with exposure to BPA is scheduled to run from 25 July to 15 September. During a later phase, to take place in early 2014, EFSA will publicly consult on the second part of its draft opinion, focussing on its assessment of the potential human health risks associated with BPA.
The results of both consultation phases as well as EFSA’s responses to the comments received will be published in a report together with the final opinion. This process will ensure that no stone is left unturned and that the widest possible range of scientific views and information will be considered before EFSA’s experts adopt their scientific opinion.
15. When will the final opinion on BPA be ready?
16. What does EFSA’s opinion on the toxicity of BPA cover?
EFSA has evaluated the toxicity of BPA for humans, including for specific age groups such as fetuses, infants, other children and adults. Over 450 scientific studies and previous risk assessments from expert bodies have been considered by the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF). The opinion consists of two parts:
- Hazard assessment – using data from animal and human studies to identify any health hazards associated with exposure to BPA.
- Risk characterisation - analysing the extent of the risk posed by the identified hazards to consumers at current levels of exposure to BPA - via oral ingestion, breathing in dust and exposure through the skin.
17. Are ‘hazards’ and ‘risks’ the same?
No, hazards and risks are different. A hazard is a possible threat posed to health because of the intrinsic properties of a substance, such as its capacity to damage the kidney or cause cancer. But the risk that a substance could cause a negative effect depends on:
- how much of the substance humans are exposed to
- the length of time of the exposure
- when exposure occurs i.e. as a fetus, child or adult.
Hazards may not be harmful if there is no exposure to them or exposure is too low to cause an adverse effect. For example: Substance X may be toxic – and therefore it is a hazard. But if humans or animals are never exposed to it, then it poses no risk to health.
18. Has EFSA found health hazards associated with exposure to BPA?
EFSA concludes that BPA is likely to cause an adverse effect in the kidney, and liver and also have effects on the mammary glands of rodents.
19. Does this mean that BPA poses a health risk to humans?
EFSA concludes that bisphenol A (BPA) poses a low health risk to consumers because current exposure to the chemical is too low to cause harm. EFSA’s scientific opinion shows the level of BPA that consumers of all ages are exposed to is well below the estimated level of safe exposure – known as the tolerable daily intake (TDI). EFSA finds there is no health concern as the highest estimates for combined oral and non-oral exposure to BPA are 3-5 times lower than the proposed TDI, depending on the age group. For all population groups, oral exposure on its own is more than 5-fold below the TDI.
20. What is a benchmark dose approach?
The benchmark dose (BMD) approach is a statistical method for estimating the dose at which a particular substance causes a small but measurable effect on a certain organ in the body, i.e. a 5% change in the weight of a kidney or a 10% increase in the incidence of toxicity in the liver. This baseline value – known as a reference point – is used for establishing a health-based guidance value such as a TDI.
For the opinion on BPA, the BMD approach was applied in place of another widely-used method: the NOAEL - or no observed adverse effect level. The NOAEL establishes a baseline value showing the absence of an adverse effect from exposure to a substance.
Testing the safety of a substance involves giving it to animals at different doses and recording their response on a graph. Scientists call the shape of this graph the dose/response curve.
The main difference between the two approaches is that the BMD uses all the data on the dose/response curve whereas the NOAEL is based on a single dose point selected by those carrying out the experiments. By using more data, the BMD is recognised to be a more accurate and sophisticated method.
In this opinion, EFSA calculated a BMD for each of three health hazards that were identified as having a likely association to exposure to BPA in animal (adverse effects on the kidney and liver and effects on the mammary gland. Findings on the kidney weight in mice were used as a basis for setting the t-TDI as they were considered to be critical effects occurring reliably at a low benchmark dose.
21. What are EFSA’s recommendations regarding the tolerable daily intake (TDI)?
EFSA proposes that the 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). EFSA recommends the TDI be set on a temporary basis because of uncertainties about the health risks of the chemical.
22. Why is EFSA proposing the current TDI for BPA be reduced?
To understand why EFSA is recommending a lower TDI it is necessary to look at the method the Authority used to establish this level in its previous assessment of BPA in 2010 and compare it to the method used for the current draft opinion:
a) In 2010, EFSA set a TDI of 50 µg/kg bw/day as follows:
The starting point was a NOAEL of 5 mg /kg bw/day from toxicological studies in rats and mice. In accordance with accepted scientific practice, this value was then scaled by an overall uncertainty factor of 100 composed of:
- A factor of 10 to account for differences between animals and humans. This default factor of 10 consists of a value of 4 for kinetic differences multiplied by 2.5 for toxic effects.
- This value is multiplied by a further factor of 10 to account for possible differences in sensitivity between humans.
By doing so, CEF Panel concluded the estimated safe exposure – or TDI - for BPA was 50 µg/kg bw/day.
b) In the current draft opinion, EFSA has used a different approach and proposed a t-TDI of 5 µg/kg bw/day as follows:
Experts analysed the same toxicological studies used in 2010 and calculated the lowest benchmark dose (BMDL) that caused a small adverse effect in the kidneys of mice – in this case a 10% change in the weight of the organ. EFSA established this effect occurred at a dose of 3.6 mg /kg bw/day.
New robust studies that have become available since 2010 have allowed EFSA to better assess how the chemical behaves in various animal species compared to humans. Based on these new so-called kinetic data it was possible to covert the dose that causes the adverse effect in mice (BMDL) into an oral equivalent dose for humans. EFSA said this oral human equivalent dose is 113 µg/kg bw per day. The next step involved applying an uncertainty factor to derive a TDI. EFSA noted the default uncertainty factor of 4 connected to kinetics differences between animal species was already accounted for in the calculation for converting the animal dose into a human equivalent dose. Thus, the remaining component of the default uncertainty factor of 25 that accounts for (i) difference in toxicity between animals and humans and (ii) between sensitivities in humans was applied to the equivalent human dose of 113 µg/kg bw per day to derive the new proposed t-TDI of 5 µg/kg bw/day.
23. Why is EFSA recommending a temporary TDI (t-TDI) for BPA?
EFSA is proposing the TDI be set as a temporary value to reflect the current uncertainties surrounding effects of BPA on the reproductive, nervous, immune, metabolic and cardiovascular systems, as well as in the development of cancer. While an association between BPA and these latter effects is not considered likely at present, EFSA concludes they may be of potential concern for human health and they add to the overall uncertainty about the risks of the substance. EFSA proposes that the TDI remain a temporary one pending the outcome of research from the US National Toxicology Program (NTP) which will address many of the current uncertainties about these potential health effects of BPA.
24. What is a weight of evidence approach?
A weight of evidence (WOE) approach assesses the strengths and weaknesses of experimental data or a study in being able to provide a scientifically rigorous answer to a specific question. In the BPA opinion, this approach estimated the degree to which the newly considered evidence strengthened or weakened the likelihood of an association between BPA exposure and a certain health hazard. The conclusions of earlier assessments of BPA by EFSA in 2006 and/or 2010 were taken as the starting point for the new evaluation. EFSA assessed the strength of the evidence linking BPA to each hazard and graded them on a six-point sliding scale. This ranged from ‘very likely’ and ‘likely’, to signify the strongest links, to ‘unlikely’ and ‘very unlikely’ where the link was considered weakest. EFSA said that only those health hazards evaluated has having a likely or very likely link to BPA exposure would be considered directly in characterising the risk posed by the chemical.
It is important to emphasise that the WoE approach refers only to hazard identification, i.e. the likelihood of an association between BPA and the effect under consideration. It does not refer to the likelihood or frequency of the effect actually occurring in humans, (considered in hazard characterisation) and the levels of human exposure to BPA (considered in exposure assessment).