Bisphenol A
Bisphenol A (BPA) is a chemical substance used in combination with other chemicals to manufacture certain plastics and resins.
BPA is used for example in polycarbonate plastic, a transparent and rigid type of plastic used to make water dispensers, food storage containers and reusable beverage bottles.
The substance is also used to produce epoxy resins found in protective coatings and linings for food and beverage cans and vats.
Chemicals such as BPA used in foodstuff containers can migrate in very small amounts to the food and drinks they contain, so EFSA’s scientists regularly review their safety, considering new data.
Latest
In April 2023, EFSA published a re-evaluation of the safety of BPA as used in FCMs, significantly reducing the tolerable daily intake An estimate of the amount of a substance in food or drinking water which is not added deliberately (e.g contaminants) and which can be consumed over a lifetime without presenting an appreciable risk to health. ( TDI The tolerable daily intake (TDI) is an estimate of the amount of a substance in food or drinking water which is not added deliberately (e.g contaminants) and which can be consumed over a lifetime without presenting an appreciable risk to health. ) set in its previous assessment in 2015.
At the time, the TDI was made temporary as EFSA’s scientists identified data gaps and uncertainties, which they committed to reassess when new data became available, in particular a two-year chronic study from the US National Toxicology Program research programme.
Based on all the new scientific evidence assessed, EFSA’s experts established a TDI of 0.2 nanograms (0.2ng or 0.2 billionths of a gram) per kilogram of body weight per day (kg/bw/day), replacing the previous temporary level of 4 micrograms (4μg or 4 millionths of a gram) per kilogram of body weight per day.
The TDI is around 20,000 times lower than before.
By comparing the new TDI with estimates of dietary exposure For the purposes of risk assessment, measurement of the amount of a substance consumed by a person or animal in their diet that is intentionally added or unintentionally present (e.g. a nutrient, additive or pesticide). to BPA, our experts concluded that consumers with both average and high exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time. to BPA in all age groups exceeded the new TDI, indicating health concerns.
News story: Bisphenol A in food is a health risk
EFSA’s scientific advice supports the decision-making of the European Commission and EU Member States, who are responsible for setting limits on the amount of a chemical that may migrate from food packaging into food or introducing other specific restrictions to protect consumers.
Milestones
2023
April
EFSA publishes a scientific opinion on the re-evaluation of the risks to public health related to the presence of BPA in foodstuffs.
EFSA and the European Medicines Agency (EMA) publish a joint report on EFSA's re-evaluation of BPA.
EFSA and the German Federal Institute for Risk Assessment (BfR) publish a joint report on EFSA's re-evaluation of BPA.
January
EFSA meets with the German Federal Institute for Risk Assessment (BfR) to discuss EFSA’s draft scientific opinion Opinions include risk assessments on general scientific issues, evaluations of an application for the authorisation of a product, substance or claim, or an evaluation of a risk assessment. on the re-evaluation of the risks to public health related to the presence of BPA in foodstuffs.
2022
November
EFSA meets with the European Medicines Agency (EMA) to discuss EFSA’s draft scientific opinion on the re-evaluation of the risks to public health related to the presence of BPA in foodstuffs.
January and February
Technical meetings are held with stakeholders, Member State and international competent authorities, including the BfR and the US Food and Drug Administration (FDA), to discuss EFSA’s draft scientific opinion on the re-evaluation of the risks to public health related to the presence of BPA in foodstuffs.
2021
December
EFSA launches a public consultation on its draft scientific opinion on the re-evaluation of the risks to public health related to the presence of BPA in foodstuffs.
2019
November
Prior to being applied to the new BPA re‐evaluation, the study appraisal methodology described in the 2017 BPA hazard A substance or activity which has the potential to cause adverse effects to living organisms or environments. assessment protocol was tested on a selection of studies. The testing phase, its outcome and the resulting refinement of the 2017 methodology is described in a scientific report: Testing the 2017 BPA study appraisal protocol methodology.
2018
September
A new EFSA working group of scientific experts starts evaluating recent toxicological data on BPA.
2017
December
EFSA’s experts endorse the scientific protocol for the re-evaluation of BPA hazards.
June
EFSA launches a public consultation on the draft BPA hazard assessment protocol. Experts from Denmark, France, Germany, the Netherlands, Norway, Sweden and Switzerland were appointed by their governments to take part in the protocol working group as well as four independent scientists appointed by EFSA.
2016
October
New data confirm EFSA’s previous conclusion that BPA might affect the immune system in animals, but the evidence is too limited to draw any conclusions for human health.
2015
January
EFSA publishes a new comprehensive assessment of BPA’s exposure and toxicity The potential of a substance to cause harm to a living organism.. EFSA’s experts reduced the tolerable daily intake The amount of a substance (e.g. nutrient or chemical) that is ingested by a person or animal via the diet. level from 50 micrograms per kilogram of body weight per day (µg/kg of bw/day) to a temporary TDI of 4 µg/kg of bw/day.
2011
December
EFSA publishes a statement on BPA, following a report by the French Agency for Food, Environmental and Occupational Health and Safety (ANSES).
2010
September
EFSA publishes a new review of the latest scientific literature.
2008
July
EFSA issues further scientific advice on BPA related to its toxicokinetics The study of the processes by which potentially toxic substances are handled in the body. This involves an understanding of the absorption, distribution, metabolism and excretion of such substances..
2006
November
EFSA publishes its first risk assessment of BPA.
EFSA's role
EFSA provides scientific advice to the risk managers – the European Commission and EU Member States - on the safety of chemical substances such as 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 (CEP).
As part of its safety evaluations of food contact materials, EFSA establishes, where possible (i.e. when sufficient information is available), a 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 expressed on a bodyweight basis.
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.
Use of BPA has been banned in thermal paper receipts since January 2020.
In February 2018, the EU introduced stricter limits on BPA in food contact materials, derived from the temporary tolerable daily intake set by EFSA in 2015.
BPA was banned in plastic bottles and packaging containing food for babies and children under three years from September 2018.
In January 2011, the European Commission prohibited the use of BPA in the manufacture of polycarbonate infant feeding bottles.
The European Chemicals Agency (ECHA) is also involved in the evaluation of BPA for the purposes of classification under the Classification, Labelling and Packaging (CLP) Regulation and for providing risk assessment A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation. advice in particular cases.
Bisphenols topic page – ECHA website