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Bisphenol A and Endocrine Disruptors – A Global Threat?

How much do we really know about the chemicals we are exposed to in food packaging, and might there be an association with hormone disruption, fertility issues and cancer?

Bisphenol A ("BPA") is back in the news, after a "Toxic BPA" report produced by the Breast Cancer Fund and other organisations found that 129 of 192 food cans tested contained "BPA-based epoxy in the body and/or the lid".

A 2011 study found that BPA migrated into water stored in polycarbonate plastic bottles and in the same year the EU banned BPA from plastic infant feeding bottles. In 2015 France went further and banned the import and marketing of BPA-based food contact materials, although paradoxically the production and export is permitted following a Constitutional Council decision in September 2015.

What is the concern about BPA, what steps will be taken in the future, and what is the likelihood of successful product liability/illness claims?

Endocrine disruptors

BPA is considered by many to be an 'endocrine disruptor', particularly in relation to estrogen. The human body's endocrine system produces and releases hormones into the blood to regulate various functions. Speaking generally, endocrine disruptors can affect reproduction, neural function and the immune system, with potential association with diseases including testicular, prostate and breast cancer, and type 2 diabetes.

The European Agency for Safety and Health at Work ("EASHW") states that "many endocrine-related diseases are on the rise. Disease risk owing to EDCs may be significantly underestimated". The World Health Organisation states that "this is a global threat that needs to be resolved."

Aside from food and drink packaging, BPA is used in products including toys, medical devices, thermal paper (e.g. cash register receipts), paints, coatings and other products. We can also be exposed through the air and water, making exposure ubiquitous.

Food and drink packaging

Regulation EC 1935/2004 requires food contact materials to be "sufficiently inert to preclude substances from being transferred to food in quantities large enough to endanger human health". Regulation EU 10/2011 sets a specific migration limit of BPA, in plastic food contact materials, of 0.6 mg/kg.

In a 2014 article by Muncke and others, epidemiologists are encouraged to explore the association between food contact material exposure and chronic diseases. The article states that more than 4,000 chemical substances are intentionally used in food contact materials, and that in addition there may be non-intentionally added substances.

What steps are being taken?

In March 2015 the EFSA published an opinion on the risks relating to the presence of BPA in foodstuffs, concluding that "there is no health concern for any age group from dietary exposure and low health concern from aggregated exposure", although this was based on estimated levels of dietary exposure. However, it expressed "uncertainties surrounding this risk assessment of BPA" particularly around estimates of non-dietary exposure. It recommended further research in a number of areas. It also proposed a reduction in the Tolerable Daily Intake (TDI) from 50 micrograms per kg of body weight per day to 4.

An EFSA 'roadmap' published in November 2015 set out a range of options for future regulation of BPA in the EU, and it appears likely that the outcome will be a reduction in the BPA specific migration limit, in plastic food contact materials, from 0.6 mg/kg to 0.05 mg/kg. In addition it is likely that the same BPA limit will also apply, for the first time, to varnishes and coatings applied to food packaging.

Although there is substantial lobbying in favour of a ban of BPA, the EFSA have stated that imposing such a ban "would not reflect the current scientific advice from EFSA".

In February 2012 Campbelll Soup Company announced an intention to move away from BPA linings. However, in the March 2016 "Toxic BPA" report 15 of 15 Campbell Soup products were found to contain BPA-based epoxy, although it should be noted that the amount of BPA was not quantified in either the can or the food contained within it. On 28 March 2016 Campbell Soup Company stated it would complete a transition to cans which do not use BPA in the linings by mid 2017. Nestle and other food producers are also conducting a transition to non-BPA packaging.

Given that there is unlikely to be an outright ban on BPA in the near future in the EU (and probably the US, given the FDA's stance is similar to the EFSA), and that revised EU migration limits are not likely to be difficult to comply with, it appears that food producers' decisions to move to non-BPA packaging do not arise out of a sense of legal obligation, but seemingly out of public pressure and to protect brand and reputation.

It should be appreciated that the reason for using BPA has been to maintain food quality and longevity; the health implications of widespread adoption of a replacement chemical need to be considered too.

Is a successful product liability claim likely?

Taking as an example a hypothetical claim that BPA exposure has caused cancer, a claimant who contends that a particular producer is liable for that illness would have to overcome 2 significant hurdles; firstly, whether the producer is in breach of duty, and secondly whether the producer caused the illness.

One of the most likely causes of action would be to pursue a claim under the Consumer Protection Act 1987. To prove breach of duty, the claimant would have to show that the products from that particular producer were defective. To determine defect, the court must consider whether "the safety of the product is not such as persons generally are entitled to expect".

What must be considered is whether and to what extent is has migrated into the food consumed and/or whether dermal absorption arises from transient handling of the packaging.

The claimant would have to establish that BPA ingestion and/or absorption in the quantities determined makes the product unsafe. A logical starting point might be to consider whether the products complained of comply with the specific migration limit set for BPA at the relevant time. However, this may be complex and expensive, or even impossible, to measure. It is also not necessarily a determinative factor in the minds of the hypothetical "persons generally".

Causation is likely to prove an even more difficult hurdle for a claimant. 'Generic causation' requires the claimant to establish that BPA exposure can cause the cancer suffered. As the Muncke article indicates, there is a lack of clear epidemiological evidence on the issue of association between endocrine disrupting chemicals and specific illnesses. The burden of proof is on the claimant.

The claimant must then establish 'individual causation' i.e. that their specific condition would not have occurred but for their exposure to the specific products from the specific producer. This would most likely be considered on a balance of probabilities basis. Given that exposure to BPA inevitably will have come from multiple sources, this will be very difficult to establish.

Even where there is accepted exposure from a single source, and a clearly identifiable condition, group litigation has failed in establishing causation (e.g. the MMR litigation and the allegation that it causes autism). The EASHW report mentioned above further sets out the difficulties of determining the consequences of exposure (p80). 

Conclusion

BPA and other endocrine disruptors will continue to attract the attention of the public eye as well as public health organisations and epidemiologists. The likelihood of successful litigation is low, but this is not a driver for public health decisions. Future research on the risks of endocrine disruptors, and identification of methods to reduce exposure, will benefit all of us. 

David Kidman is a product liability partner, with a specialism in emerging risks

This information is intended as a general discussion surrounding the topics covered and is for guidance purposes only. It does not constitute legal advice and should not be regarded as a substitute for taking legal advice. DWF is not responsible for any activity undertaken based on this information.

David Kidman

Partner

I specialise in product liability, with particular expertise in resolving claims involving property damage and injuries / fatalities.