Bisphenol A (BPA) is a high-volume chemical first identified in 1891 that manufacturers have used in various plastics for over 50 years. BPA is used in many consumer products and can be found at very low (trace) levels in the environment and in human breast milk. Over two million tonnes of BPA is produced across the world each year. The most common form of plastic that uses BPA is polycarbonate. BPA is also used in epoxy resin coatings used on the inside of most food and beverage cans.
The weight of scientific evidence currently available indicates that BPA in plastics does not present a risk to human health.
People experience minimal levels of exposure to the chemical. Minute traces of BPA can leach into food from the protective internal epoxy resin coatings on:
food storage containers
Food Standards Australia New Zealand (FSANZ) has published a factsheet (updated December 2011) that discusses BPA in food packaging.
The degree to which BPA leaches from containers into food or liquid may depend on the type of food or liquid and its temperature. People may also gain exposure to BPA daily through food, drinks, air, dust, and water.
Some evidence from animal feeding studies suggests that long-term exposure to BPA can disrupt the endocrine system because the chemical mimics hormones that regulate body functions. These adverse affects on the health of animals were observed after the animals had experienced very high exposures to BPA. The exposures were much greater than those adults and children experience from daily use of consumer products that contain BPA.
Studies also show that BPA does not accumulate in the bodies of animals. Laboratory animals rapidly metabolise BPA and excrete it extensively.
People who have concerns about BPA in consumer products can choose to use products in containers made from glass rather than plastics or metals.
The ACCC, in conjunction with the other relevant Australian government regulatory agencies namely; Food Standards Australia New Zealand (FSANZ), the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), the Therapeutic Goods Administration (TGA) and the Australian Pesticides and Veterinary Medicines Authority (APVMA) have collectively considered the possible risks of BPA and they remain convinced that the weight of evidence, obtained from an extensive range of safety studies, indicates that BPA is safe for the whole population at the very low levels of current exposure.
FSANZ’s dietary exposure assessment was based on the conservative assumption that all polycarbonate infant feeding bottles contained BPA. This dietary modelling showed that a 5 kg baby would need to drink around 80 bottles of formula a day every day for many years before it would get up to the safety limit. Based on this level of exposure, FSANZ’s opinion remains that the risk is very low. However, since infant feeding bottle manufacturers have been offering alternatives to BPA polycarbonate bottles, the overall exposure to BPA is likely to be even lower. FSANZ is currently seeking further data on the use and occurrence of BPA in infant food from the food and packaging industry in Australia and New Zealand to update the current dietary exposure to BPA.FSANZ will also be conducting a broad survey of BPA exposure to confirm the reduced risk.
In early 2010, the ACCC completed a study which shows no detectable amounts of BPA migrate from typical infant feeding bottles, infant sip cups and two leading brands of infant formula supplied in Australia. In terms of potential infant exposure to BPA, there is no discernable difference in safety between the use of glass, non-polycarbonate plastic and polycarbonate plastic infant feeding vessels. BPA is also not present in detectable quantities in Melbourne tap water. These results are consistent with other international studies that reflect actual use conditions and reaffirm the ACCC’s position that there is no detectable risk to Australian infants from polycarbonate feeding vessels.
The ACCC continues to work with FSANZ and to closely monitor scientific studies assessing the safety of BPA and other chemicals. If future evidence shows any risks to human health and safety, the ACCC has the power to ban products or develop mandatory standards with compulsory safety requirements that products must meet to minimise risks.
In August 2008, the Health Canada’s Food Directorate assessed the safety of BPA from dietary sources and concluded the overall weight of evidence was that the current dietary exposure to BPA was not expected to pose a health risk to the general population, including newborns and young children. However, there were uncertainties in the animal study dataset relating to neurodevelopmental and behavioural endpoints. Because of these uncertainties, Health Canada recommended that the general principle of ALARA (As Low as Reasonably Achievable) be applied to limit BPA exposure, from food sources, for the most sensitive groups in the population - newborns and infants. The Food Directorate of Health Canada did not revise the provisional tolerable daily intake (pTDI) for BPA of 0.025 mg/kg b.w./day, which had been set in 1996 based on the lowest NOEL of 25 mg/kg b.w./day observed in a 90-day study in rats.
The Canadian Consumer Product Safety Directorate subsequently amended the Canadian Hazardous Products Act to include polycarbonate baby bottles that contain BPA.The prohibition on the advertisement, sale and importation in Canada of these products came into force on 11 March 2010.
In January 2010, the US Food and Drug Administration (FDA) advised that some uncertainties remain about the safety of BPA for infants and children and this has caused concern among consumers worldwide. To resolve these uncertainties, the US FDA has undertaken to conduct a number of additional studies. In the meantime, the US FDA will be taking steps to reduce exposure to BPA for consumers by working with industry to phase in alternative plastics. Importantly, however, the US FDA has not recommended that families change the use of infant formula or foods or infant feeding bottles because the benefit of a stable source of good nutrition outweighs any potential risk from BPA exposure.
The World Health Organisation (WHO) in conjunction with the Food and Agriculture Organisation (FAO) conducted a joint expert meeting to review toxicological and health aspects of Bisphenol A (BPA) in November 2010.The ACCC will review the conclusions and any recommendations from this meeting.
In April 2011, the German Society of Toxicology did a comprehensive review of the safety of BPA and concluded that the current tolerable daily intake (TDI) level was justified and that available evidence indicates BPA exposure represents no significant risk to human health, including to babies.
In December 2011, the European Food Safety Authority (EFSA) again reviewed recent evidence on BPA. EFSA said this evidence did not change its 2010 opinion that BPA was safe at the levels people are exposed to.
Other international organisations have conducted separate risk assessments for BPA and have also concluded that no current health risk exists for BPA at the current exposure levels. These authorities include the:
Suppliers should always consider the safety and suitability of any chemicals used in their products regardless of whether there are specific regulations.Manufacturers, importers and other suppliers must ensure that their products meet community safety expectations or face possible liability for injuries sustained as a result from chemicals present in a product.
5 mg/kg body weight per day is the No-Observed-Adverse-Effect-Level (NOAEL) for BPA. This was confirmed in multiple laboratory tests on animals.
People consume less than 0.000118 mg/kg body weight/day of BPA. The main dietary sources of BPA are foods and drinks stored in containers and made from polycarbonate plastic, and epoxy resin utensils and polycarbonate utensils. This estimate is based on consistent results of multiple migration studies.
Potential human exposure to BPA is at least 400 times lower than the accepted safe daily limit of 0.05 mg/kg body weight/day established by the US Environmental Protection Agency.