In contact with food safety - the Bisphenol A debate
Bisphenol A and its safety in food contact packaging is making the headlines. Addressing the associated negative public opinion was therefore one of the topics up for discussion at the Food Contact 2010 conference, from 28-30 September in Alexandria, USA. Conference Chairman and Director, Nick Kernoghan at Pira International in Leatherhead, UK, reports
The world has comprehensive legislative systems in existence for food contact in the USA and Canada, the EU, the Mercosur countries of Latin America, Japan and South Korea. In addition, legislation is developing quickly in China and India and is gathering pace in various smaller countries around the Pacific rim. The regulations are guided by the underlying principles that chemical migration from food contact materials should not endanger human health, bring about an unacceptable change in the composition of the food, or adversely affect taste, smell or texture. However, there are many differences globally regarding how new food contact substances are authorised, what kinds of restrictions are applied, the testing necessary and the relevant systems for compliance. All this adds up to a fragmented sector rather than a global marketplace.
It will take a company several years and significant financial investment to make use of a new food contact substance legal in all the world’s different jurisdictions. This covers proprietary use in a defined application in the USA, material specific uses in Japan and generic use in any application in the EU. There are then varying restrictions – either controlling exposure through limits on the amount of the substance added to food contact materials (USA and Japan), or migration limits (EU and Mercosur).
The best we can hope for is that countries that do not have their own legislation develop their protocols based on existing regulations, for example, the Mercosur countries, whose legislation is reasonably closely aligned with the European model. South Korea’s regulations, meanwhile, are largely identical to Japan’s. This principle can also be seen in China where they have accepted the use of food contact substances already approved in two or more of the EU, USA or Japan.
Better still is the approach of Australia and New Zealand, where food contact materials that are compliant with either EU harmonised legislation or US Food and Drug Administration (FDA) legislation are accepted. The Food Contact 2010 conference in Alexandria, USA, from 28-30 September, brought together speakers and delegates from these nations to discuss food contact safety on this broader international level. Two key areas that were up for debate were negative public perceptions about the safety of food packaging and the use of new technology and how to regulate it.
The general public has become increasingly aware of the existence of food contact substances in food. This awareness has been driven by – Scientists who grab headlines with studies that use experimental protocols not accepted by food contact regulators.
Parts of the media that use scare stories to increase their sales and advertising revenue. Activist communities on the internet that often cause the stories to take hold and be believed. The result is a section of public opinion that believes that food packaging is poisoning them, despite rising life expectancy and operating in a highly regulated environment in the developed world where packaging use is greatest.
The recent media fascination with Bisphenol A (BPA) is both typical and instructive. There is widespread acceptance in some mainstream media that BPA is a chemical that humans are exposed to at dangerous levels. However, BPA is one of the most extensively reviewed chemicals for effects on human health. The need for further review has not been generated by regulator concerns about BPA’s safety, but by the adverse media coverage. The conclusions drawn by the reviewing agencies have, without exception, supported the continued use of BPA at current exposure levels and emphasised that claims that BPA is either a carcinogen or a developmental or reproductive toxicant are unfounded.
Typical of the scientific position is the conclusion of the European Food Safety Authority (EFSA) in 2006, which states that the scientific evidence supports a five-fold increase in the Tolerable Daily Intake (TDI), a conclusion that it has maintained in two more recent reviews in 2008 and 2010. The EFSA estimates that, in the EU, daily intake of BPA is at 0.34% of the TDI for infants and 0.092% of the TDI for adults. This means that infants would have to increase their food intake 294 times, and adults 1,086 times, to reach the limit.
The science is overwhelming, but balanced reporting is lacking beyond the trade press. The problem facing industry is that the science is complicated while the headlines are simplistic. Bisphenol A is targeted today and other perfectly safe food contact substances will be in future. The overall problem is therefore a long-term one, requiring scientific education of the public, so consumers feel comfortable with the language and build trust with industry. Furthermore, when a new chemical is targeted in this way, there needs to be an immediate coordinated response to explain its use, the resulting human exposure, toxicological effects and the negative impact of its withdrawal. These facts need to be kept in the public eye beyond the immediate crisis. The activist community that attacks food contact substances is relentless, so the industry also needs to be relentless in both education and communication programmes to counter it effectively.
Regulating new technology
Japan has 46% of the world’s active packaging applications, the USA 24% and the EU 18%. Japan and the USA consider their current regulations suitable for control of active packaging, while the EU specifically regulates it with Regulation (EC) No 450/2009. In future it will be interesting to see whether this difference in attitude is maintained for other new technologies.
Engineered nanomaterials (ENMs) are much less established in food contact applications, although examples do exist, and there is a lack of legislation specifically for ENMs. However, that will change in the EU when the Plastics Implementing Measure (PIM) comes into force on 1 May 2011. This will mean substances in nano form that are added to food contact plastics need specific authorisation from the EFSA. Although the PIM applies only to plastics, it will become a default best practice to notify either the EFSA or a member state of any use of ENMs for food contact.
There is no change to the FDA regulations in the works to specifically cover ENMs. The FDA believes that its current protocols are sufficient. However, a food contact substance in nano form that does not have a clearance at the conventional scale will have to be notified to FDA unless it cannot become a food additive because it does not migrate. Even in the latter case, a company may decide to notify the FDA to overcome customer concerns regarding nanotechnology.
More complex is the case where a clearance, either by regulation or Threshold of Regulation exemption, does exist at the conventional scale. The key question then becomes – ‘Can humans become exposed to the nanoparticles?’ If not, then it may be reasonable, all other things being equal, to rely on the existing clearance. But if there is a mechanism by which nanoparticles can be ingested, a Food Contact Notification is necessary and a Pre-Notification Consultation with the FDA is strongly advised.
Where there is no possibility of nanoparticle migration, because a material is completely insoluble in food or food simulants, clearance by EFSA and FDA can be straightforward. This was illustrated by the recent example of titanium nitride nanoparticles as an additive in PET bottles. Both regulatory systems cleared this without the need for any toxicology based on its insolubility. It is the less straightforward cases where exposure to nanoparticles is possible that will vex food contact professionals until the differences in toxicological effects caused by nanoparticles are better understood.
More on Bisphenol A in the news
Please note the following stories are independently written by The Packaging Professional team
The European Commission looks set to pursue a strict line on Bisphenol A (BPA) in plastics, despite the assertion of the European Food Safety Authority (EFSA) that current regulations are sufficient. An EFSA report has concluded that it ‘could not identify any new evidence to revise the current tolerable daily intake.’ However, the EU Health Commissioner, John Dalli, says, ‘It cannot be excluded that there might be an effect on the development, immune response or tumour promotion,’ as a result of BPA. He adds that steps will be taken to ensure infants and babies have minimum exposure to the substance. Website: www.efsa.europa.eu
A study of male Chinese factory workers claims to have found that increased levels of BPA correlated with decreased sexual desire and fertility. Researchers at USA healthcare consortium Kaiser Permanente used high-performance liquid chromatography to compare levels of BPA in the urine of the workers in BPA production facilities with those in other factories. The authors say this is the first study on the reproductive effect of the chemical in humans. The plastics industry insists that consumers are exposed to much lower levels of the chemical than the factory workers who produce it, but the study’s lead author, De-Kun Li, claims, ‘Similar dose-response associations were observed among participants with only environmental BPA exposure at levels comparable to men in the general United States population.’ Website: www.dor.kaiser.org
The World Health Organisation (WHO) and the UN’s Food and Agriculture Organisation held a conference of experts on 1-5 November to try to establish a consensus on the toxicity of BPA. The meeting was not open to the media and delegates were asked to sign a confidentiality agreement in view of the controversy surrounding the subject. The WHO said in a statement that typical exposure in humans, including babies fed with plastic bottles, is hundreds of times lower than the ‘No Observed Adverse Effect’ level accepted by regulators in most countries. Also noted that some studies have claimed to find hormonal disruption in animals at far lower doses, but was cautious about extrapolating the animal studies to humans, in some cases questoning the methodology. Website: www.who.int/en
Canada became the first country to class BPA as a toxic substance in October, after initially banning it for use in baby bottles in March. A study by the Government found that the chemical was almost universally present in the bodies of the general population. The Government said it felt obliged to pursue a ‘precautionary’ approach where a possible risk to human health was concerned. It cited the potential effects on pregnant women and infants in particular. Canadian policy is also focused on preventing discharge of BPA into the environment. The authorities said BPA was ‘acutely toxic to aquatic organisms and is considered highly hazardous to the aquatic environment’. Website: www.gazette.gc.ca
France and Denmark have already introduced bans on BPA in products for young children. ‘The precautionary principle dictates the introduction of protective measures,’ said Denmark’s Veterinary and Food Administration. Website: www.fvm.dk/english
Some major manufacturers, including Heinz, Nestlé and General Mills have already begun phasing out BPA in their products. ‘Although scientific bodies worldwide have concluded that minute levels of BPA are safe, Heinz is exploring alternatives to BPA in response to consumer opinion,’ the company said. Website: www.heinz.com