Size really does matter

| 19th June 2008
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Nanofoods are the next big thing, but whatever happened to the precautionary principle asks Naomi Salmon

The battle to keep GMOs off the menu has now been all but lost. It has taken little more than a decade for GM food to mutate from the ‘novel’ to the mundane. Despite significant consumer opposition and concerns over safety, today none but the most diligent of consumers can reasonably expect to avoid the routine consumption of genetically engineered material with their daily bread.

As we move towards the end of the first decade of the 21st century, it seems that the next stage in the corporate-led agricultural and food revolution is already upon us: we are moving from the era of the genetically engineered into the era of the atomically engineered. ‘Nanotechnology’ – loosely defined by Friends of the Earth as ‘the manipulation of materials and the creation of structures and systems at the scale of atoms and molecules, the nanoscale’ – is rapidly becoming the buzzword of the decade. By the end of the next decade it seems likely that nanofoods too will have become standard fare.

Enthusiasm for nanosciences and nanotechnologies (N&N) is currently running high, as is so often the case with new technologies. The corporate giants at the forefront of the life sciences industry and nations eager to reserve for themselves a generous slice of the profitable nanotech pie are energetically leaping on to this latest research and development (R&D) bandwagon. Understandably, however, institutional optimism at EU level is tempered somewhat by painful memories of the consumer backlash over GM and a desire to avoid a repeat of ‘the European “paradox” witnessed for other technologies’.

According to Friends of the Earth, there are already more than 100 food-related nanoproducts available on the global market, and many more in the R&D pipeline. These are still very early days, however, and although such figures are rather alarming, as with GM foods, the delights of the nanofood industry are reaching US supermarkets first. According to the European Commission and industry groups there is, as yet, hardly any use of nanotechnology in food production and processing in Europe. Here, for the moment, nanofood remains more science fiction than science fact for EU consumers.

Over the past few years, a number of NGOs have published reports lamenting the current dearth of nano-specific safety and labelling legislation. The tone of such publications tends to leave the reader with a rather disconcerting sense of dejà vu, for many of the assertions made in relation to nanotech products could so easily have been lifted straight from the pages of the biotech reports published by the same groups in the 1990s. For example, in a recent report, Friends of the Earth called for a moratorium on the commercial release of new nanofoods, asserting that products are entering the food chain ‘in the absence of mandatory product labelling, public debate or laws to ensure their safety’. Can it be possible that the concerns expressed by this and other NGOs are justified?

The first important point is that the agro-food sector is of central importance to the European economy. The food and drink industry is worth more than €600 billion annually, accounting for around 15 per cent of total manufacturing output. Consequently, it should come as no surprise to find that the food supply chain has been subject to extensive regulatory control since the earliest years of the market integration project.

Moreover, in the wake of the series of high-profile food crises that have dogged the European food industry in recent years, a concerted effort has been made to ‘remodel EU food policy into a proactive, dynamic, coherent and comprehensive instrument to ensure a high level of human health and consumer protection’ – as per the European Commission’s 1999 White Paper on Food Safety.

Similarly to other, more conventional foods, nanofoods are subject to fairly extensive regulatory controls – simply by virtue of the fact that they are products intended for human consumption. Similarly to other types of foodstuffs, they will have to comply with the requirements of, for example, EC legislation relating to food hygiene, additives and flavourings. This is not the place to comment upon the efficacy of such measures, though. Here, it is more useful to consider safety in more general terms, with reference to the overarching principles and rules of food safety law set down in Regulation 178/2002, before turning briefly to the Commission’s proposal to update the regulatory framework governing the entry of ‘novel’ foods on to the market.

Regulation 178/2002 now sits at the very heart of Community food law. In line with the ‘high level’ of consumer and public health protection prescribed by the EC Treaty, Article 14 of this core regulation firmly ascribes the status of core principle to the concept of ‘safety’: ‘food shall not be placed on the market if it is unsafe’.

But what does this general prohibition mean in real terms? The concept of ‘safety’ is necessarily a qualified and inherently subjective one. At both personal and regulatory levels, the determination of safety must, in the end, be reduced to a determination of acceptable risk; a balancing exercise wherein the ‘benefits’ of particular foods are weighed (implicitly or explicitly) against the short and longer term, direct and indirect risks associated with their consumption.

This seems reasonable enough. However, within the context of the EU system, governance is underpinned by a free trade imperative, and thus a strong presumption in favour of the free movement of goods. By its very nature, Community law is driven to demand that trade-restrictive (and potentially protectionist) regulatory hurdles – such as food safety measures – are set no higher than is strictly necessary. This in turn leads to a rigorous policing of such measures against the legitimising benchmark of ‘sound scientific’ risk assessment. This is all very well in those cases where science is able to provide a reliable evaluation of a product’s characteristics and potential toxicity, but in the absence of overwhelming evidence supporting an outright prohibition on the marketing of a particular product (e.g. Sudan dyes), the question of risk management – ‘safety’ – tends to be reduced to an economically driven balancing of predicted harm/fatalities against the overall value of trade in the particular product in question.

In the case of nanofoods (similarly to GM foods) the issue of ‘safety’ or ‘acceptable risk’ is complicated somewhat by the fact that technological innovation has a tendency to outpace scientific understanding. As the EC commented last year, ‘while [nanosciences and nanotechnologies] offer a number of beneficial applications, the potential impact on the environment and human health of certain nanomaterials and nanoproducts is not yet fully understood.’

But what of the precautionary principle; the policy tool that dictates that where scientific uncertainty prevails, regulators should err on the side of caution? Article 7(1) of Regulation 178/2002 provides that: ‘In specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk assessment.’ It might be assumed, then, that where ‘knowledge gaps’ prevent a full scientific evaluation of, for example, potential toxicity, trade restrictive measures will be lawful.

In line with the version of the principle entrenched in Article 174 of the EC Treaty, however, and in keeping with the underlying ethos of the EU, the exercise of precaution is subject to important limitations designed to minimise the potential for protectionist abuse. Under the second paragraph of Article 7 of Regulation 178/2002, these include the requirement that precautionary measures must be ‘proportionate’ – i.e. no more restrictive of trade than absolutely necessary – and an express requirement that regulators consider the technical and economic feasibility of precautionary measures. Thus, what might be termed ‘economic precaution’ prevails, as, even in the face of scientific uncertainty, ‘acceptable risk’ fails to be determined against the legitimising benchmark of ‘sound science’ and cost/benefit analyses.

Finally, then, the Commission’s draft Novel Foods Regulation. Is the revised and updated text likely to appease concerned NGOs? A couple of points are worthy of note. First, the draft legislation contains no direct reference to the precautionary principle. Although this omission may not be significant in substantive terms, and certainly does not preclude the possibility of recourse to ‘economic precaution’ in appropriate circumstances (as per Article 7 of Regulation 178/2002) it is nonetheless interesting. If nothing else, it reflects the Commission’s natural desire to play down rather than highlight the extent of the uncertainties associated with ‘novelty’ in this highly sensitive context.

The second feature of the draft Regulation worth noting is the definition of ‘novel’ food. Although the relevant text has been revised and updated, in terms of substance very little has changed – other than the removal of references to GMOs (now governed by a separate framework). Unfamiliarity remains the baseline trigger for Community-level pre-market assessment and authorisation: any food that has ‘not been used for human consumption to a significant degree within the Community before 15 May 1997’ qualifies as ‘novel’. As under the current legislation, the label of ‘novelty’ is extended to foods produced using new processes (e.g. nanotechnologies), but only where that process ‘gives rise to significant changes in the composition or structure of the food which affect its nutritional value, metabolism or level of undesirable substances’. Importantly, these regulatory definitions take no account of the inherent ‘novelty’ of nanofoods. In particular, despite growing evidence that ‘size matters’ and (small) particle size plays a key role in bio-reactivity and toxicity of nanoparticles, no express reference to the nano-scale has been incorporated into the regulatory definition of novelty.

Despite the consumer-oriented rhetoric of European food safety policy, the reality is that the Community’s mandate and its ambitions of becoming a leading ‘knowledge-based economy’ effectively preclude the routine prioritisation of consumer safety. Yes, the precautionary principle does provide a safety net when technology outpaces scientific knowledge and risk assessment becomes something of a guessing game; from the consumer perspective, however, the value of regulatory precaution – ‘economic precaution’, that is – is somewhat compromised by the requirement of scientific evidence of risk, as well as the cost-benefit proviso built into it.

Despite the ample warnings of recent history, such as the emergence of BSE and CJD, or the widespread contamination of the food chain and the environment with GMOs, the fundamental premise of food law has not changed. The unfortunate truth is that within the free-trade arena, food-safety law must, inevitably, be primarily reactive – particularly in so far as it seeks to mitigate uncertain risks.

This being the case, a more robust approach to the regulation of highly profitable new technologies will only be brought to bear if, or when, scientific uncertainties recede in the face of sound scientific evidence of risk. Then politically and economically ‘risky’ precaution becomes legitimate prevention – or, perhaps more correctly, an exercise in damage limitation. A frightening thought indeed.

Dr Naomi Salmon teaches law at the University of Wales Aberystwyth. Her research interests centre around the regulation of the European food market, focusing in particular on issues of risk analysis and consumer rights.

This article first appeared in the Ecologist June 2008


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