EFSA to Provide Comprehensive Overview on Bisphenol A Safety by end May

BPA is permitted for use in food contact materials in the European Union, under Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intending to come into contact with foodstuffs. It is also permitted for food contact use in other countries such as the USA and Japan.

13 Apr 2010 --- 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.

BPA is permitted for use in food contact materials in the European Union, under Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intending to come into contact with foodstuffs. It is also permitted for food contact use in other countries such as the USA and Japan.

In its risk assessment on BPA published in January 2007 , EFSA set a Tolerable Daily Intake (TDI) of 0.05 milligram/kg body weight (bw) 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, even for infants and children.

In an opinion published in July 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 published 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.

On 15 October 2009, EFSA received a request from the European Commission to assess the relevance of a new study 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. EFSA aims to complete its evaluation by May 2010, in line with the deadline set by the Commission.

On 8 March 2010 EFSA received a further related request from the European Commission to also take into account in its risk assessment any other new scientific evidence that may be available and to liaise closely with EU Member States risk assessment bodies on this issue. On 26 March 2010 EFSA held a meeting with national experts on BPA from EU Member States, as well as members of EFSA’s scientific Panel on food contact materials, enzymes, flavourings and processing aids (CEF Panel) and representatives of the European Commission.

At the meeting with Member States, EFSA outlined the draft opinion on BPA which is currently being prepared by the CEF Panel, as well as the initial findings of its review of recent scientific literature in this area. Panel members and national experts stressed that all scientific information needs 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 will be considered when finalising the opinion. EFSA has also been in touch with other international risk assessment bodies working on BPA.

On 30 March 2010, EFSA received an urgent request from the European Commission to review scientific arguments supplied by Denmark in support of the government’s decision to ban the use of BPA in food contact materials for infants aged from 0 to 3 years. The Danish risk assessment was based mainly on the study by Stump looking at possible neurodevelopmental effects of BPA at a range of different dose levels. EFSA has responded to the Commission explaining that this study is the same as the one currently being evaluated by the CEF Panel.

EFSA aims to complete its current work on BPA by the end of May 2010. The CEF Panel will by then have had the opportunity to consider not just the Stump study, but also to more widely review the recent scientific literature and any further new evidence that may be submitted by Member States, as well as the already published risk assessments conducted in some countries. EFSA will then be in a position to give the European Commission an up-to-date overview on the safety of BPA.