Bisphenol A (BPA or 2,2-bis-(4-hydroxiphenil)propane) is a chemical product that has been used for many years as a component for the manufacture of polycarbonate and phenolic epoxy resins. Polycarbonate is a type of rigid transparent plastic that is used to make food packaging, such as returnable beverage bottles, infant feeding bottles, tableware (plates and mugs) and storage containers. Phenolic epoxy resins are used in protective linings and surface coatings for food and beverage cans and vats.

It is included in the list of authorised monomers and other starting substances that are indicated in Part A of annex II of Commission Directive 2002/72/EC under reference number 13480, and in the list of additives fully harmonised at Community level in Part A of annex III of the same Directive, under reference number 39680, therefore its use is authorised in Europe for the manufacture of plastic materials and articles intended to come into contact with foodstuffs.    

As occurs with all materials that come into contact with food, small amounts of BPA may migrate from the plastic or the resinous surface coating to food and beverages. In this case, Directive 2002/72/EC sets out a specific migration limit of 0.6 mg/Kg bodyweight per day.

BPA is one of the numerous substances that has the potential to interact with the hormone systems of the human body (endocrine disruptors). Since the 1930s it is known to be able to mimic oestrogens (female sexual hormones). The effects on fertility and reproduction and the endocrine have been the object of much scientific debate, linked with reports on the effects of low doses of BPA in rodents.

In 2006, The European Food Safety Authority (EFSA) re-evaluated this substance [1] aiming to consider the new extensive scientific information (over 200 publications) generated since it was evaluated in 2002 by the Scientific Committee for Human Food [2].

The EFSA Scientific Panel considered that at a low dosage in rodents these effects had not been absolutely or reliably demonstrated for use as reference studies for risk evaluation. Moreover, the differences between species in toxicokinetic studies by virtue of which the parent BPA compound has a lower bioavailability in humans than in rodents, raises reasonable doubt about the relevance for man of any observation of low doses in rodents.  The more than likely high sensitivity of rats to oestrogen raises doubts about the value of these particular species as a model for evaluating the risk of BPA to man.  

EFSA concluded that 0.05 mg/Kg bodyweight per day could be allocated as the Tolerable Daily Intake (TDI) of BPA by man, based on a study of 3 generations of rats ([1] NOAEL= 5 mg/Kg per day) and an uncertainty factor of 100.

To calculate exposure EFSA made worst-case estimates with conservative migration levels, extreme consumptions (95%) and different segments of the population, including the most sensitive (infants at 3 and 6 months, children at 18 months and adults). The result shows a theoretical exposure ranging between 0.2 and 13 ug/Kg bodyweight per day, which means a level lower than 30% of tolerable daily intake.

Subsequently the [2] AFC panel of EFSA published a new opinion on BPA in July 2008 [3], this time regarding the toxicokintetics of BPA, in which it considered that its earlier evaluation of risk based on a comprehensive NOAEL for the effects on rats, using an uncertainty factor of 100, was a sufficiently conservative estimate for humans.

In September 2008, the European Commission requested from EFSA a new evaluation consequent on the publication of a study in the Journal of the American Medical Association (JAMA), which related levels of BPA in urine in adults to health disorders. The authors concluded that high concentrations in urine were associated with an increase in the prevalence of cardiovascular diseases, diabetes and alterations of liver enzymes.         

Due to the urgency of the matter, EFSA evaluated the publication and issued a statement [4] on 22nd October 2008 in which it said that said study on its own did not provide sufficient evidence to demonstrate the relationship between exposure to BPA and the health disorders indicated above. Therefore, it decided to keep the TDI at 0.05 mg/kg bodyweight per day. It did not, however, rule out making subsequent evaluations as new toxicological information came to the fore.

Having considered over 800 studies, EFSA published a new opinion [5] on 30th September 2010, in which it concluded that it could not identify any new evidence to justify revising the current TDI of 0.05 mg/kg bodyweight per day and that in the light of any new relevant data in the future, it would reconsider its opinion. It also observed that some of these studies conducted on developing animals suggested other effects related to BPA of possible toxicological relevance, but it also acknowledged that the studies had many shortcomings therefore the relevance of their findings in relation to human health could not be evaluated at the present time, though the Panel is prepared to consider new data in the future.

Bottle-fed babies from 3 to 6 months drinking from polycarbonate infant feeding bottles are considered to be the segment of the population to be most vulnerable to BPA due to the fact that infant-formula or breast milk are their only source of nutrition over the first four months and they continue to be an important source of nutrition for several months more and even though bottle-fed babies are sufficiently capable of eliminating BPA, it must be borne in mind that their system of elimination is not fully developed until they are 6 months old.

For this reason and given that there are alternative materials to polycarbonate for the manufacture of infant feeding bottles, it is not considered appropriate to continue with the use of BPA in the manufacture of infant feeding bottles, but rather to reduce the exposure of bottle-fed babies to BPA as much as is reasonable until existing doubts are clarified by new scientific data.

In the light of the above, the European Commission, on consensus with the Member States and applying the precautionary principle laid down in article 7 of Regulation 178/2002, issued Commission Directive 2011/8/EU of 28th January 2011, amending Directive 2002/72/EC on the restriction of the use of bisphenol A in infant feeding bottles given to bottle-fed babies [ 6], which prohibits the use of BPA in polycarbonate infant feeding bottles, substituting the text that existed regarding the same compound set forth in Directive 2002/72/EC.

Directive 2011/8/EU laid down that from 1st March 2011 the manufacture of polycarbonate infant feeding bottles containing said substance was to be prohibited as was from 1st June 2011 the placing on the market and import into the European Union of plastic materials and articles intended to come into contact with foodstuffs that do not comply with this Directive. This Directive was transposed into Spanish law by virtue of Order PRE/628/2011 of 22nd March 2011 amending Annex II of Royal Decree RD 866/2008 of 23rd May 2008 approving the list of substances permitted for the manufacture of plastic materials and articles intended to come into contact with food and certain testing conditions were regulated [7].

On 2nd April 2011 the Commission Implementing Regulation (EU) no. 321/2011 of 1st April 2011 amending Regulation (EU) no. 10/2011 as regards the restriction of use of Bisphenol A in plastic infant feeding bottles [8], which ratifies the timeframes indicated prior thereto in the Directive, was published. Therefore, since 1st June 2011, polycarbonate infant feeding bottles containing Bisphenol A may not be placed on the market nor imported, that is, these products may not exist on the market.

In October 2011, the European Commission requested a review by EFSA of the two reports on Bisphenol A published by the French Agency for Food, Environmental and Occupational Health and Safety (ANSES). EFSA will analyse these reports in close collaboration with ANSES, taking into account the risk assessment previously carried out and considering the background of the different points of view regarding the potential effects of Bisphenol A on health. The European Commission will have the final result of this work in late November 2011.

Lastly, on 1 December 2011 [9], EFSA published their opinion on this study on their web page. Following assessment of the above-mentioned report, EFSA believes that the data within are not sufficient to modify the opinion published in October 2010 on the safe use of Bisphenol A.

NOTE: This information is an update of the information published on this web on 4 November 2008, 14 April 2010, 16 July 2010, 4 October 2010, 3 February 2011, 25 March 2011, 1 June 2011 and 26 October 2011.

[1] Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) related to 2,2-BIS(4-HYDROXYPHENYL)PROPANE. The EFSA Journal (2006) 428

[2] Opinion of the Scientific Committee on Food on Bisphenol A. SCF/CS/PM/3936 Final 3 May 2002

[3] Toxicokinetics of Bisphenol A - Scientific Opinion of the Panel on Food additives, Flavourings, Processing aids and Materials in Contact with Food (AFC).The EFSA Journal(2008) 759

[4] Statement of EFSA on a study associating bisphenol A with medical disorders – Prepared by the Unit on food contact materials, enzymes, flavourings and processing aids (CEF) and the Unit on Assessment Methodology (AMU).The EFSA Journal (2008) 838

[5] Scientific Opinion on Bisphenol A: evaluation of a study investigating its neurodevelopmental toxicity, review of recent scientific literature on its toxicity and advice on the Danish risk assessment of Bisphenol A.TheEFSA Journal 2010;8(9):1829

[6]   Commission Directive 2011/8/EU of 28th January 2011 amending Directive 2002/72/EC regarding the restriction of use of Bisphenol A in plastic infant feeding bottles(OJEU L-026, 29th January 2011)

[7] Orden PRE/628/2011 de 22 de marzo, por la que se modifica el Anexo II del Real Decreto 866/2008, de 23 de mayo, por el que se aprueba la lista de sustancias permitidas para la fabricación de materiales y objetos plásticos destinados a entrar en contacto con los alimentos y se regulan determinadas condiciones de ensayo. (B.O.E. 25 de marzo de 2011)

[8] Reglamento de Ejecución (UE) Nº 321/2011 de la Comisión de 1 de abril de 2011, que modifica el Reglamento (UE) Nº 10/2011 por lo que respecta a la restricción del uso de bisfenol A en biberones de plástico para lactantes.

[9] EFSA advises on safety of bisphenol A and confirms review of opinion in 2012.