24 March 2009

Members of the Sub-Committee present were Lord Crickhowell, Lord Cunningham of Felling, Lord Haskel, Lord Krebs (Chairman), Lord Methuen, Lord Mitchell, Baroness Neuberger, Baroness O'Neill of Bengarve, Lord O'Neill of Clackmannan and the Earl of Selborne. In attendance were Antony Willott (Clerk), Professor Stephen Holgate (Specialist Adviser) and Rachel Newton (Committee Specialist).

Participants were Dr Clair Baynton (Head of Novel Foods, Additives and Supplements Division, Food Standards Agency), Ms Sue Bolton (Head of Health and Biotechnology Issues, Government Office for Science), Dr Dean Burfoot (Special Projects Manger, Campden and Chorleywood Food Research Association), Dr Qasim Chaudhry (Principal Research Scientist, DEFRA Central Science Laboratory), Mr Ian Dalton (Head of International Chemicals and Nanotechnology Branch, DEFRA), Ms Sue Davies (Chief Policy Adviser, Which?), Professor Ken Donaldson (Professor of Respiratory Toxicology, Edinburgh University), Mr Tom Eddy (Secretary to the Royal Commission on Environmental Pollution), Ms Karen Folkes (Head of Public Engagement, Science and Society Unit, DIUS), Ms Kathy Groves (Microscopist, Leatherhead Food International), Dr Sandy Lawrie (Novel Foods Division, Food Standards Agency), Mr Jim Moseley (Managing Director, General Mills UK), Dr Naima Narband (Parliamentary Office of Science and Technology), Professor Nick Pidgeon (School of Psychology, Cardiff University), Dr Dora Pereira (Senior Research Scientist, MRC Collaborative Centre for Human Nutrition Research), Dr Jonathan Powell (Head of Biomineral Research, MRC Collaborative Centre for Human Nutrition Research), Dr Monica WinStanley (Head of External Relations Unit, BBSRC).

Exposures and responses to nanomaterials—an introduction (Professor Stephen Holgate)

Professor Holgate described why nanomaterials are different from bulk substances, and outlined some of the questions surrounding their effect on human health. Nanomaterials had a much bigger surface area compared the same mass of a material in its bulk form. In addition, nanomaterials may have enhanced or radically different physico-chemical properties. Rather than size, it was their novel functionality that makes them 'nano'. Nanomaterials came in many shapes and forms, and their novel properties make their behaviour in the environment or the human body hard to predict. The number of patents involving nanomaterials was increasing rapidly, from around 200 in 2000, to over 1600 in 2006.

People might be exposed to nanomaterials through a number of routes. In the food chain, this exposure might come via nanomaterials intentionally incorporated into food products, or through their use in manufacturing processes or food packaging where some might unintentionally enter food products.

Once they have been ingested nanomaterials might pass straight through the body, or they may be absorbed by the body. Once outside the gut, they have the potential to travel around the body, possibly being deposited in organs where they may accumulate over time. These were only potential risks; a recent report by the Royal Commission on Environmental Pollution had found no evidence of nanomaterials causing harm to human health or the environment to date. There was a very limited amount of toxicological information available however, and governing the use of nanomaterials with limited information posed a challenge.

Nanomaterials which have a functionality which suggests they might pose a risk to human health or the environment should be prioritised for testing, although given how little is known about nanomaterials these characteristics may be difficult to identify.

A (scientific) overview of nanotechnologies in the food sector (Ms Kathy Groves)

Ms Groves outlined the current and potential applications for nanotechnologies in the food sector. Nanotechnologies and nanomaterials were at a very early stage of development and application. Their use in the food sector was shaped by what was happening in other sectors, particularly the pharmaceutical sector. They might offer the potential for healthier and safer products and new or improved manufacturing processes. For example, a grain of ordinary table salt converted into nanoparticles would have increased its surface area 100,000 times, which would allow a far smaller amount to be used in some foods to achieve the same taste.

Nanoscale structures were present in food products already, either because they occurred naturally in food or because they were created by conventional manufacturing processes. An example of natural nanomaterials was the casein micelles which existed in milk products, and an example of manufactured nanomaterials was the nanosilver which was being used as an antibacterial agent, either in packaging or in some cases added directly to products.

While nanotechnologies and nanomaterials may offer huge potential for the food industry, there also needed to be an awareness of potential health risks, and consumer attitudes and perceptions. Leatherhead's NanoWatch Working Group was at the forefront, researching the use of these technologies within food manufacturing practices and applications. The NanoWatch Working Group had set up, with the Nanotechnology Knowledge Transfer Network (nano-KTN), a food focus group to influence and shape regional and national policy, assemble pre-competitive research and development consortia, identify capability and skills gaps and enable networking opportunities.

Market access and barriers to entry for nanotechnologies in the food sector (Mr Jim Moseley)

Mr Moseley gave an overview of nanotechnologies from the food industry's perspective. The food industry represented 15 per cent of UK manufacturing and was the fourth largest food and drink manufacturing industry in the world. It comprised of 6,500 companies, the majority being small and medium size enterprises.

Direct applications of nanotechnologies in food were currently very limited, restricted to a few food supplements containing nano-encapsulated ingredients, and some developments relating to oil-in-water and water-in-oil emulsions. Current research was focused on the nano-encapsulation of ingredients to maintain flavour and texture, whilst reducing ingredients such as fat and salt, or to improve shelf-life or enhance nutrient delivery.

Indirect applications were closer to market and were attracting greater interest. Current research was investigating nano-coatings for packaging to improve shelf life, and reduce spoilage and waste, as well as looking at making packaging more intelligent (for example, by telling consumers when food is spoiled).

Research was driven by potential consumer benefits; consumers want food that is safe and nutritious, followed by convenience, quality and price. Nanotechnologies needed to deliver against one or more of these requirements, or against a wider environmental or sustainability need. Consumer acceptance was a pre-requisite, and the food industry had suffered in the past over issues such as the genetic modification of food. The food industry wanted to develop nanotechnologies if they could prove to yield consumer benefits, and this benefit must be seen and appreciated by consumers if this technology was to gain public acceptance. The regulatory framework needed to be robust along the whole length of the supply chain. Self-regulation by the industry would probably not suffice. Consumers must be given factual, objective and balanced information which was application specific, rather than general references to 'nanofood'.

The toxicology of nanoparticles (Professor Ken Donaldson)

Professor Donaldson gave an overview of the toxicology of nanoparticles. Human exposure to nanomaterials came from four main sources, these were: combustion-derived nanoparticles; bulk manufactured nanoparticles; engineered manufactured nanoparticles; and medical nanoparticles. Nanoparticles may have presented a range of hazards, depending on where they accumulated in the body. Unlike normal particles, nanoparticles may be able to move (translocate) around the body and reach organs such as the heart, kidney, liver and brain. However, there was little data on translocation and there was no proper indication of what dose of nanoparticles might prove toxic to these organs. Some nanoparticles are small enough to enter individual cells, and may have a number of toxic impacts including inflammation, genetic damage or cell death. Some nanoparticles were turning out to be less hazardous than others when tested, but there were many that have yet to be tested.

To risk assess ingested nanoparticles there were three factors that need to be determined: the hazard (the intrinsic harmfulness of the materials to the gut); the exposure (the amount of material that the gut might be exposed to); and the dose (this is derived from the exposure and is how much of the material actually interacts with the body and poses a hazard).

There were a number of key questions that needed to be answered to address the toxicology of nanoparticles. Those included:

• Was there much exposure to nanoparticles;
• Was the gut affected by nanoparticles;
• Could nanoparticles be screened to classify those more, or less, hazardous;
• How did nanoparticles exert their inflammatory effects; and
• Would nanoparticles impact the cardiovascular system?

The behaviour and function of nanoparticles in the gut (Dr Jonathan Powell)

Dr Powell described the work done by the Medical Research Council Human Nutrition Unit. The gut was exposed to nanoparticles of all sizes. Some nanoparticles were beneficial, and as a result the body was designed to absorb some types of nanomaterials from the gut. For example, ferretin iron nanoparticles of around 10-15 nm in diameter were absorbed from the gut and then used by the body for nutritional benefit.

However, this left pathways which could be 'hijacked' by other nanomaterials. As an example, it was found that ingested titanium dioxide particles of around 200nm were quickly absorbed from the gut and found their way into the circulatory system from where they travelled to other organs such as the liver. In addition, these nanoparticles were also absorbed into the tissue of the gut itself.

There were a variety of mechanisms that allowed the uptake of nanomaterials. These uptake mechanisms were size dependent; some could only be accessed by small nanomaterials under 100nm or even smaller, while others could be accessed by larger nanoscale materials.

Nanotechnologies and food: regulatory aspects (Dr Clair Baynton)

Dr Baynton summarised the current regulatory regime for food, and its application to the use of nanomaterials in the food sector. Virtually all legislation was harmonised at an EU level. There were a number of pieces of legislation that regulated different aspects of the food sector, ranging from food supplements, food additives and novel foods to animal feed.

The Novel Food Regulation required novel foods or ingredients to undergo pre-market assessment and authorisation before they could be marketed. Novel foods included foods with a new molecular structure, or those subjected to a new process that changed their nutritional value, metabolism or levels of undesirable substances. In January 2008 the European Commission published a proposal to revise the Novel Food Regulation, which was being considered by the European Parliament and Council. If adopted, the new Regulation was unlikely to take effect before 2012.

A new food additives Regulation would apply from January 2010, which would only allow those additives included on a Community list to be used in the European Union. It explicitly defined a change in particle size of approved additives as a trigger for a re-assessment of its safety before it could be allowed on the market. Food contact materials were also covered by an EU regulation. One of its requirements was that packaging may not transfer its any of its constituents into the product it was containing under normal circumstances. Animal feed was also the subject of regulation which requires case-by-case safety assessment of any new ingredients.

EU authorisations were based on risk assessments carried out by the European Food Safety Authority (EFSA), with the exception of novel foods which were currently evaluated at a national level (although this might change when the Novel Food Regulation was revised). The EFSA released an Opinion on the risk assessment of nanomaterials in March 2009.

Current legislation generally predated the current interest in nanotechnologies, and most legislation was 'technology neutral'; nanotechnologies and nanomaterials were not specifically mentioned in legislation, and products are regulated on their identity and properties rather than the type of production method used. However, updates to legislation would clarify the status of products containing nanomaterials.

Public perceptions and engagement with nanotechnologies (Professor Nick Pidgeon)

Professor Pidgeon gave an overview of the public's views of nanotechnologies and how they perceived risk. There were a number of qualitative factors that affected how the public viewed novel risks. These included whether the risk was involuntary or not, how equitable the distribution of risk was, whether it was 'natural' or man-made, and whether it was hidden or irreversible. A number of other, unquantifiable factors also played a role in creating public controversies over new technologies: the social and historical context; the institutional performance of related organisations; social 'amplification effects' (such as the media, NGOs, etc); and the trust the public placed in the governance of risks associated with the technology.

The debate over genetically modified (GM) food was affected by a number of these factors. Besides a number of qualitative factors (for example, the risks were invisible, unnatural and involuntary) there was also a distrust of food regulation following a number of crises in the 1990s (BSE, Salmonella), and an amplification effect from the media (for example, the Daily Mail's 'Frankenfoods' campaign) and NGOs.

While there were some similarities between the introduction of GM foods and nanotechnologies, it was not an exact comparison. GM provided some background context, but not a complete model against which to measure nanotechnologies.

There had been a number of studies looking at public perceptions of nanotechnologies (in general, rather than specifically in food). Public awareness was generally low, and did not appear to be changing much over time. Although people continued to think that the benefits may outweigh the risk, many more remained unsure. Importantly, there had not been any history of crises involving nanotechnologies; any accident or health scare involving nanotechnologies would change this balance.

The context in which nanotechnologies was applied was also important; for example, their use in the energy sector was viewed far more positively than their use in the health sector in both the United States and the United Kingdom. The use of nanotechnologies in food packaging was viewed more positively than their application in food products where the consumer was actually ingesting the technology.