European ban on bisphenol A in baby bottles — expert reaction

The European Commission decided last week to bar use of the chemical bisphenol A (BPA) in plastic baby bottles.

This follows a similar ban in Canada in 2008, and restrictions imposed in Denmark, France and some US states. The New Zealand Food Safety Authority’s most recent statement and backgrounder on BPA state that they are following emerging research closely, and see no compelling reason to initiate a ban in this country.

UPDATE: Additional comment received from John Reeve, Principal Advisor (Toxicology), New Zealand Food Safety Authority:

“The European Commission proposed ban is not supported by the accepted science and appears to be a political action. It is quite incorrect to say (as some of the commentators do) that this ban in any way reflects the regulator’s opinions. All of the bans put in place so far cite the ‘Precautionary Principle’ but use it incorrectly. This principle essentially states that if there is any evidence that a substance may be harmful and there is no robust evidence to show that the potential harm does not eventuate, then the regulator must assume that the harm does occur. Robust, properly conducted feeding studies clearly establish a level that is without appreciable harm for all population groups. The precautionary principle does not apply when considering potential human risk from Bisphenol A because there no evidence of harm at the levels we are exposed to, as well as very strong evidence that even far higher levels have no harmful effect.

“Europe’s own risk assessment agency, the European Food Safety Authority, concluded in September 2010 that there was still no evidence that the use of Bisphenol A posed a health risk to any age group in the population, and that the study cited by Denmark as the reason for invoking the precautionary principle and banning BPA from baby bottles and cans did not support any such ban.

“Further, the recent (early November this year) WHO Expert Group considering BPA also concluded that there was no reason to take regulatory action against it at this time. There are many scientific problems with much of the cited data claimed to support a ban. These include an inability to reproduce results in follow-up testing in other laboratories, and inappropriate dose regimes that don’t reflect human exposure routes. There are many more. At best, the studies are interesting but do not show any cause for concern.

“The European proposed actions are clearly taken for reasons other than the science and go against the advice of their own experts, as were the Canadian actions. New Zealand continues to base its decisions on sound science. Should any new data arise that indicates action may be necessary, action will be taken.

“In summary – there is strong evidence and little doubt that BPA is safe at the levels found in food.”


Below is expert reaction to news of the EU ban gathered by our colleagues at the UK and Canadian Science Media Centres.

Prof Richard Sharpe, MRC Human Reproductive Sciences Unit at the University of Edinburgh:

“I would be happy for a baby of mine to be bottle fed from a polycarbonate bottle containing bisphenol A. I can only presume this has been done on precautionary grounds as I do not know of any convincing evidence that bisphenol A exposure, in the amounts used in polycarbonate bottles, can cause any harm to babies, as not only are the amounts so minuscule but they are rapidly broken down in the gut and liver. 95% of our exposure comes from our diet and when ingested it is rapidly metabolised and the exposure is absolutely tiny. Babies have the necessary enzymes and are able to metabolise bisphenol A just as effectively as adults.

“There are other endocrine disruptors which are of greater interests to scientists, including phthalates which are ingested from our diet. With both phthalates and bisphenol A there are levels of uncertainty but there are also differences. Whilst the relatively high levels of phthalates that we’re exposed to cause definite problems in animal studies, in contrast, studies of bisphenol A at the levels of human exposure show no consistent effects.

“Personally I think the ban is an overreaction but if satisfactory replacement chemicals are available then it can be put in place to placate those calling for action, but scientifically it’s a retrograde step.

“Parents may ask why, if there’s nothing to worry about, bisphenol A is being banned. That questions needs to be asked of a politician rather than a scientist as the ban is not based on science.”

Prof Warren Foster, Department of Obstetrics & Gynecology, McMaster University, Canada:

“BPA is recognized as a weak estrogenic chemical that is present in many consumer products with the result that there is widespread low level exposure to this chemical in the human population. There are reports in the literature that demonstrate adverse effects of BPA on meiotic resumption in oocytes in mice, protstatic hypertrophy in a strain of mice, altered mammary gland development and carcinogenesis in rodents, and reproductive effects in rodents (advanced reproductive development). However, these reports are conflicted as other competent laboratories have been unable to replicate these findings.

“Although several epidemiological studies have appeared in the recent literature from one group that show adverse effects on libido in men and decreased semen quality in men working in the manufacture of plastics employing BPA, there is no compelling evidence that BPA exposure representative of the concentrations measured in the general population has any impact on human health.

“Consequently, it appears that regulators have reviewed the evidence of:

1. almost universal exposure to BPA in the human population

2. the potential for these exposures in a population sensitive to exposure to estrogenic chemicals to adversely affect estrogen-sensitive target tissue development, and

3. the potential that if the animal studies were to accurately predict effects in the human population then there could be serious long-term health consequences for infants exposed to BPA.

“Hence, I assume that regulators have elected to act with extreme caution and to ban BPA in baby bottles. I emphasize that the decision is likely not to be because BPA will cause health problems, but because it might; and if it did cause a health problem, then because of wide-spread human exposure it could have serious long-term health consequences. From the evidence and the conclusions of EFSA and other regulatory bodies, there is no reason for concern amongst the adult population concerning exposure to BPA.”

Prof Tony Dayan, Emeritus Professor of Toxicology, University of London:

“This is sad news for the sciences of toxicology and risk assessment. The EC ban on bisphenol A is a political action that has allowed emotion and unreasoned concerns to overweigh scientific evidence. It denies the value of much toxicological research in part funded by the European Commission itself.”

Prof Tamara Galloway, Professor of Ecotoxicology at the University of Exeter:

“The precautionary approach now being adopted by the EU to protect vulnerable groups from exposure to BPA brings Europe in line with Canada and many US states. This emphasises the continued need for independent research into the safety of BPA and alternative compounds suspected of causing endocrine disruption.”

Prof J. David Miller, Department of Chemistry, Carleton University, Ottawa:

“Modern regulatory process uses two independent methods to evaluate human exposure to chemicals. The first uses a variety of laboratory animals to determine just how sensitive the body is to the chemical, the mechanism of effect on the body and whether this effect applies to humans. After the application of safety factors, a determination is made of a tolerable daily intake with reasonable certainty of no harm.

“The second is to determine difference between the tolerable daily intake and the actual exposure (in the blood) of the population. This is called the margin of exposure. All regulatory agencies agree that for adult populations, the margin of exposure is very large. As required by Canadian law, Health Canada declared BPA toxic because it accumulates in the environment. The government intervened on BPA in baby bottles because the margin of exposure in babies fed from plastic bottles containing BPA was too small. In other words for their small body weight the amount of BPA babies might be exposed to was too close to the allowable limit by weight. In my opinion, this was required by Parliament, appropriate and wise. This does not affect the evaluation that BPA poses no special risk to groups other than infants. Interventions to protect vulnerable populations are increasingly necessary.”