The use of the industrial chemical bisphenol A (BPA) to make food contact plastics and resins, although questioned for some time as a potential risk to human health by some scientists, is still approved by official authorities in most countries. Polycarbonate baby bottles is a recent exception. Question is, with some new scientific findings, will official risk assessment authorities change their general view and will risk managers take further action?
The European Union situation
BPA is permitted for use in food contact materials in the European Union (EU), most recently as listed under Regulation 10/2011/EU. The European Food Safety Authority (EFSA) completed a full risk assessment of BPA in 2006 and set a Tolerable Daily Intake (TDI) of 0.05 mg/kg body weight per day for the substance – that is the amount that can be ingested daily over a lifetime without appreciable risk. Since the initial opinion, EFSA has been asked three times to review the initial assessment and as a result published updated scientific advice in 2008, 2010 and 2011. EFSA also evaluated intakes of BPA through food and drink, for adults, infants and children and found that they were all well below the TDI.
Due to the controversial debate on BPA and despite EFSA’s view on the safety of BPA, the EU member states Denmark and France banned BPA in baby bottles in 2010. The ban was imposed for reasons of precautionary consumer protection. In order to create a consistent legal framework within the EU and following a similar move in Canada, the European Commission adopted Directive 2011/8/EU in January 2011 prohibiting the use of BPA for the manufacture of polycarbonate infant feeding bottles and their placing on the market within the EU.
Contrary to the prevailing view of EFSA, on 27 September 2011 the French L’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (ANSES) published two reports on bisphenol A reaching a different conclusion. One report related to the health effects associated with exposure to BPA while the other concerned its uses. In the report on health effects – “Effets sanitaires du bisphénol A” – ANSES concluded that health effects have been proven in animals and suspected in humans, even at low levels of exposure below current regulatory thresholds. On the basis of these findings it recommended that exposure to bisphenol A should be limited in the most susceptible populations of infants, young children, pregnant and breastfeeding women. A previous Danish report produced by the DTU Fødevareinstituttet on behalf of the Danish government reached similar conclusions. It noted that neurodevelopment effects were seen in young male rats even at low doses of BPA raising some concern of possible human effects.
The CEF Panel did not consider that the information in the ANSES report would immediately change the views the Panel expressed in 2010, but wanted more time to review in depth the new studies. Consequently, in February 2012, the CEF Panel decided to undertake a full re-evaluation of the human risks associated with exposure to BPA through both dietary and non-dietary sources. The intention is to review all the available data and scientific studies on exposure published since 2006. The Panel will further evaluate uncertainties about the possible relevance to human health of some BPA-related effects observed in rodents at low dose levels. New findings from ongoing studies on low dose effects as well as on dietary and non-dietary exposure to BPA will be considered as they become available during 2012, with the intention to publish the new opinion by May 2013.
The Canadian situation
Health Canada’s Food Directorate has conducted periodic reviews of BPA as new information has become available relating to its toxicity and potential exposure from food packaging applications. The purpose of these reviews was to determine whether dietary exposure to BPA could pose a health risk to consumers. Based on the overall weight of evidence, the view is still that current dietary exposure to BPA through food packaging uses is not expected to pose a health risk to the general population, including newborns and infants.
However, due to the uncertainty raised in some animal studies relating to the potential effects of low levels of BPA, the Government of Canada banned the use of BPA in baby bottles in March 2010 to enhance the protection of infants and young children. It further added BPA to the list of substances deemed potentially harmful to health or the environment in October the same year to make it easier to take further action should this be deemed necessary.
The Bureau of Chemical Safety, in the Food Directorate of Health Canada, is investing further resources in exploring the potential impact of BPA on the health of the Canadian population. It will improve estimates of dietary exposure to BPA from all Canadian food sources. It is also a partner in assessing information gaps on the occurrence and significance of BPA in human milk from Canadian mothers in a project funded by Health Canada, the Canadian Institutes of Health Research and the Ontario Ministry of the Environment.
The situation in the USA
BPA was first approved by the Food and Drug Administration in the early 1960s. Due to some concerns raised, the FDA released a draft report in August 2008 finding that BPA remained safe in food contact materials. However, a few months later a subcommittee of FDA’s science board raised questions about whether the review had adequately considered the most recent scientific information available.
On January 15, 2010 and again on March 30, 2012, the FDA issued interim updates on BPA. They claimed that studies employing standardised toxicity tests had thus far supported the safety of current low levels of human exposure to BPA. However, on the basis of results from recent studies using novel approaches to test for subtle effects, FDA, supported by the view of the National Toxicology Program at the National Institutes of Health, expressed some concern about the potential effects of BPA on the brain, behaviour, and prostate gland in foetuses, infants, and young children. This concern was expressed because it was noted that developmental changes in some animal studies occurred at BPA exposure levels similar to those experienced by humans. A collaborative effort is underway to carry out further in-depth studies to clarify the outstanding uncertainties about the risks of BPA.
While awaiting the new results, FDA expressed support for actions to stop the production of BPA-containing baby bottles and infant feeding cups for the U.S. market and the recommendations issued by the Department of Health and Human Services for infant feeding and food preparation to reduce exposure to BPA.
The Australian situation
The Australian Government has limited its action on BPA to an introduction of a voluntary phase out of BPA use in polycarbonate baby bottles. Food Standards Australia New Zealand (FSANZ) is firm in its view that there are no health issues associated with BPA at the levels people are exposed to. They state that extremely large amounts of food and beverages would have to be consumed to even reach still acceptable intake level.
There is no suggestions of further activities as they claim that countries that banned the use of BPA in some products did so without any support of risk assessment conclusions on the safety of BPA. To further support this view the FSANZ website lists shortcomings in 17 scientific studies purporting to show the toxicity of BPA.
The international view
According to the World Health Organization website the scientific controversy around the safety of BPA is driven by the disparate results reported in the many studies exploring toxicity and endocrine activity of BPA in animals. This has led to different risk management decisions taken by national authorities. The issue has also received much attention in the media and among the general public. In light of possible adverse human health effects at low doses of BPA, especially on reproduction, the nervous system and on behavioural development, and considering the relatively higher exposure of very young children compared with adults, a meeting of ad hoc experts was jointly organised by FAO and WHO in late 2010 to assess the safety of BPA.
It was difficult for the meeting to reach definitive conclusions on the safety of BPA because of a lack of data from experimental animal studies suitable for risk assessment. Controversy persisted over the biological significance of many of the more sensitive end-points and it was uncertain if all relevant end-points had been covered by the studies used for past risk assessments.
It was clear that for many traditional end-points, human exposure was much too low to be of any health concern. However, for some emerging new end-points (sex-specific neurodevelopment, anxiety, pre-neoplastic changes in mammary glands and prostate in rats, and impaired sperm parameters) a few studies showed associations at levels close to the estimated human exposure, which was clearly of concern if their toxicological significance were to be confirmed. Further research would be needed before these results could provide a basis for a realistic estimate of the human health risk.