K J Garnett

“…. one of the key challenges as a legislator is to know how to make laws and regulate in the face of emerging technologies in situations where science appears to be questioned by either deeply-rooted conservative groups, societal opposition or for any other reason.” Arūnas Vinčiūnas, Head of Cabinet to Health Commissioner Vytenis Andriukaitis

How to regulate in the face of emerging technologies …

With a highly modern, industrialised and integrated food and farming sector, it is essential that the food consumed by Europeans be safe and fit for consumption. Everyone can agree on that. To this end all laws governing EU food and safety list a series of objectives that it strives to achieve. First and foremost amongst these objectives is to protect, at the highest level, human life and health. Although much has been achieved in the past decade regarding food safety there is compelling evidence to suggest that the existing general principles governing food safety are failing European consumers; that human life and health is not being protected at the highest level; and that current assumptions regarding food safety are in urgent need of reassessment. This assertion is not based on some deeply-rooted conservative thinking. It is based on fact.

Consider these statements:

Worldwide obesity rates have almost doubled since 1980. The epidemic of diabetes, which is closely associated with obesity and urbanization, has skyrocketed in rich and poor countries alike. This is a world in which more than 40 million pre-school children are obese or overweight. Dr Margaret Chan, Director of World Health Organisation, 2011

Of the 57 million global deaths in 2008, 36 million, or 63%, were due to NCDs, principally cardiovascular diseases, diabetes, cancers and chronic respiratory diseases. WHO, Global status report on non-communicable diseases 2010

According to the data, the absolute number of diabetics in the EU-27 will rise from approximately 33 million in 2010 to 38 million in 2030. In 2010, approximately 9% of the adult (20-79 years) EU-27 population was diabetic. IDF (International Diabetes Federation)

Few can dispute that Europe, like so many other global regions, is facing an unprecedented rise in chronic food related diseases. What Europeans, like many other populations both in the developed and developing world, are beginning to fear and become increasingly affected by is the rise in cardio-vascular disease, hyper-tension, food related cancers, diabetes and obesity. With such high levels of chronic diseases Europe needs to ask itself whether the existing general principles governing food safety are working; if not, why not; where is the current approach going wrong; and how can the defect be remedied? Before we begin to answer those questions let us consider, briefly, the existing principles.

The existing General Principle: Strong Science and the Precautionary Principle

The over-arching general principle governing existing EU food safety is strong science. The actual term “strong” science remains undefined; the assumption being that the four-stage risk assessments carried out by the European Food and Safety Agency (EFSA) will deliver the strong science demanded of the general objectives of EU food safety law.  The law then goes on to specify that the four-stage risk assessment “shall be based on the available scientific evidence and undertaken in an independent, objective and transparent manner.”

As with all general principles there are exceptions and the one exception that the EU applies (but which US regulators generally do not) is the by now well known but little understood precautionary principle. The most important element underpinning the precautionary principle with regard to food safety is “scientific uncertainty”. Uncertainty, presumably, being the mirror opposite of “strong” science. Thus, where scientific conclusions are not equivalent or exact – and in food science there is plenty of uncertainty and differing results – provisional risk measures may be adopted. These measures can and do include blocking authorisation for some novel foods until the science has achieved a level of scientific consensus which is irrefutable.

Critics of the precautionary principle believe that the four stage risk assessments should be sufficient to determine safety, that any further discussion regarding safety is superfluous and that the precautionary principle blocks and prevents innovation in the food sector. Thus, any scientific studies that refute or question the results of the risk assessments are “junk” and submitted by quacks with an axe to grind. Or are held by “deeply-rooted conservative thinkers”.

For their part proponents of the precautionary principle believe the principle is essential if the European population is to be protected from unforeseeable illnesses and long-term ill-effects on human health as a result of new foods. To strengthen their arguments and support the “uncertainty” of the science they will produce a slew of scientific studies proving that theirs is the strong science and the results of the risk assessment uncertain.

Sound, strong, irrefutable and independent are not words many associate with food science regardless of the amount of paper used to print risk assessment procedures.

Why existing safety standards are failing Europeans

In the end the risk assessment procedures for food can be subject to a matter of will, confusion and uncertainty rather than conclusions “based on the available scientific evidence and undertaken in an independent, objective and transparent manner.” Most of the European population will agree that expert scientific advice on food and diet over the past few decades has been confusing, subject to change and inconsistent.

The current approach to settling safety standards for food is a perpetual cycle of ‘tis too – ‘tis not! between experts who are beginning to sound more like infants on the play-ground who assume that whoever shouts the loudest or has the final word will have won the argument rather than objective, impartial guardians of the truth. Clearly, such an approach is not going to be able to settle what is and what is not safe food, fit for human consumption. Nor indeed, on a more practical level, has the current approach managed to reverse or even halt the alarming rise in chronic food related diseases.

Where the existing approach is going wrong : the continuing rise in modern malnutrition

Although experts refer to them either as “chronic food related illnesses” or “non-communicable diseases” perhaps a more easily understood term would be “modern malnutrition”, for as with traditional malnutrition, these diseases are caused by the diet many are eating today. As with traditional malnutrition these diseases are debilitating, potentially lethal and are related, in large part, to what we eat and how. To demonstrate this assertion a comparison between traditional malnutrition and modern malnutrition is helpful since it explains, with clarity, the difference between scientific certainty and scientific uncertainty.

Traditional Malnutrition: Scientific Certainty

No one anywhere has read of disagreements amongst experts as to whether Vitamin C is or is not the cause of scurvy. 

In the past malnutrition took the form of nutrient deficiencies and manifested itself in the form of, inter alia, scurvy, beriberi, pellagra and rickets. It was thanks to scientific endeavours at the turn of the twentieth century that we are now able to affirm with scientific certainty what causes these debilitating diseases. In the case of scurvy it is a lack of vitamin C, in the case of beriberi a lack of vitamin B1 (thiamine), in the case of pellagra a lack of Vitamin B3 (niacin) and in the case of rickets a lack of Vitamin D and calcium.

It was always the poor with limited access to a balanced diet who suffered the most from malnutrition, whether it was rickets in the slums of Victorian England, beriberi amongst Asia’s poor who survived on a diet of white rice, pellagra amongst impoverished Italians who survived on a diet of polenta or scurvy amongst sea-farers who had no access to fresh fruit and vegetables.

Thys, modern populations now know with scientific certainty what causes these diseases and how we can prevent or treat them. The best cure being a return to a balanced, nutrient dense and varied diet.

Modern Malnutrition: Scientific Uncertainty

Everyone, everywhere has read of disagreements between experts over whether GMO’s are or are not safe to consume.

Sadly, the same can not be said of modern malnutrition.

We are still grappling with the exact causes of modern malnutrition and figuring out how it can be prevented, limited and potentially reversed. Unlike traditional malnutrition where it can be asserted with scientific certainty what the cause of these diseases are there is still too much scientific uncertainty identifying exactly what it is that is causing the rise, not the halt, in cases of modern malnutrition.

Up until now the approach to dealing with modern malnutrition has been to single out individual groups of foods as the cause in the alarming rise in these diseases. Efforts to date, have concentrated on identifying one source of food that have traditionally formed an essential part of mankind’s diet and eliminate or significantly reduce them from modern diets: saturated animal and vegetable fats; salt; red meats, dairy products or grains. Each has been singled out for derision. Most have been rehabilitated. Just about the only branch of food that seems to stay above the fray and float, saint-like, free from all controversy are fruit and vegetables.

Yet, regardless of efforts over the past few decades the cases of modern malnutrition continue to rise not stabilise or even decrease. Although deaths from cardio vascular disease have decreased in modern industrialised countries, thanks to medical intervention, the incidence of heart disease has not.

The fact that rates are not decreasing suggests that singling out individual branches of our traditional omnivorous diet is flawed. It also suggests that the real cause is keeping a low profile, relying on our trust in the risk assessments to remain unobserved, untargeted and protected but is ever present in our modern diet and eating habits. The real cause of our current malaise has enmeshed itself so thoroughly into our modern food choices it has become hard for experts to distinguish the culprit from the innocent bystander.

Novel foods.

Could it be that the real cause of food related chronic disease is not natural saturated fats, or salt, or grains, or dairy, or red meats, or even (dare one suggest) gluttony but novel foods of which there are literally hundreds on the market today and which are forming an ever larger percentage of our diet? Novel foods are so common and form such a substantial part of what used to be our traditional diet that the food sleuth trying to pin-point the causes of modern malnutrition has erroneously focused all their efforts on just one branch of them.

The discerning investigator, on the other hand, will notice that there is one thing common to all branches of the food consumed today. Novel ingredients. Over the past couple of decades we have witnessed the migration of novel foods from the laboratory into all of our traditional, natural foods – be it fats, grains, sugars, salts, dairy, meat and/or vegetables. There they have enmeshed themselves so thoroughly they have confounded scientific endeavours to identify the cause of our current malaise.

New fats with with less saturated fats, new sugars with higher fructose and less glucose, new sugars with no sucrose, new artificial salts to flavour savoury dishes, new soya beans with more omega-3, new milks with less lactose, new MSG flavourings to flavour salty foods, to name just a few. As populations switch from the diet of nature to a diet of artifice not only are they asking their bodies to metabolise completely new foods they are also failing to consume the balanced diet present in natural foods so essential to robust well being.

That modern populations are switching to novel foods is not surprising. The justification for new foods is invariably founded on the proposition that certain aspects of natural, traditional foods are unhealthy. We can see this in the case of saturated animal fats found in butter, lard, tallow and geese where for at least three decades it was assumed that invented polyunsaturated hydrogenated fats were safer to consume. To find acceptance for novel foods, for which there is no actual need, proponents of these products must first try to justify their inventions on the premise that they are safer to consume than what went before or at the very least “to prove” that they are as safe as, if not safer, than traditional foods.

It is my assertion, however, that novel foods, combined with decades of health experts advising modern populations to abandon either one or two of the traditional foods we have always relied upon to form part of our balanced diets, are the cause of – not the remedy to – modern malnutrition. This assertion, like novel foods, is novel and requires justification. The below seeks to set out why novel foods are problematic and not safe for modern populations to consume.

The reason why novel foods are unsafe

Novel foods are unsafe because the human body is being asked to metabolise types of food which it has no history or experience of digesting. The fall-out of this onslaught manifests itself in the form of diabetes, cardio-vascular disease, hyper-tension, certain food related cancers and obesity.

A bold assertion? Perhaps. Before we examine the science consider the logic. Chronic food related diseases, in the past, existed but they were rare. The one thing that European populations never ate – and what modern European populations are eating ever more of – are highly refined convenience foods laced with novel ingredients. Formerly rare diseases such a diabetes, childhood diabetes, obesity, childhood obesity, hyper-tension, certain food cancers and cardio vascular disease are worryingly common amongst the general population today.

We can say, with absolute certainty, that earlier European populations never ate novel foods and chronic food related diseases were rare. Modern European populations are eating ever more novel ingredients and chronic food related diseases are  common. This logic, alone, leads us to conclude that it is not natural fats, or salts, or sugars, or dairy products, or grains, or meats or dairy foods or fruit and vegetables that are individually responsible for modern malnutrition. The trail leads us to invented, novel foods.

Consider the picture below. It was taken by Peter Menzel and published in his book “Hungry Planet: What the World Eats”. The picture is of the Bainton family in the UK. They are  fairly representative of most families in the UK today and are a fair reflection of what the general population in the UK will purchase and consume during the course of one week. Around 80% of their purchases are convenience packaged foods with the remaining 20% of their purchases being fresh produce. The packaged, convenience foods which forms the bulk of the food consumed during the course of the week will contain a high percentage of novel foods and ingredients their ancestors would not, indeed could not, have consumed – be it in the form of new seed oils (rapeseed), new flavourings, new sugars or new chemical preservatives.

The complexity of mankind’s metabolism

Turning to the science there are many compelling studies that prove a link between novel foods and chronic food related disease. They, however, are few. The sad reality is that more RT&D research funding has been devoted to the development of novel foods than it has into researching the link between the consumption of novel foods and the human physiology.

What most – scientists and non-scientists alike – can agree on is that the human body has evolved over thousands of years to digest natural, never novel, foods. Novel foods with artificial nutrient levels, exaggerated balances in nutrient content and entirely new structures, simply did not exist until relatively recently in the history of human evolution.

In the past few decades our intellectual abilities have been racing ahead of our metabolic capabilities. Our brains can be compared to a Formula 1 racing car with all cylinders operating under full capacity, happily inventing and devising new foods. The human metabolism, on the other hand, is plodding along like a horse and cart at the pace of evolution. The rope that binds the two together – intellect and metabolism – is put under great strain and when it snaps, as inevitably it will, the fall out is chronic disease.

The proposition of a food scientist in support of novel foods

Many food scientists and inventors of new foods propose that all food – both natural and novel – is nothing more than a chemical construct. Food, like a Lego brick is made up of thousands of different colours and like a Lego brick can be reassembled, reorganised and restructured to our preferences. Nature provides one shape. Novel foods another. If these chemical molecules can be re-jigged in mankind’s favour (vegetables with higher omega-3 and omega-6, wheat with higher protein content, strawberries with lower sucrose levels, apples with an enzyme removed to prevent browning, beef-burgers with less saturated fats) surely this is an advancement? A protein is a protein is a protein and whether we eat if from a calf born in the barn-yard or from cells harvested in the laboratory there is no difference – they all form the sum total of the food’s constituent parts. See, by way of example, this comment from a spokesperson for the new sugar Stevia: “The important point – that I think a “reasonable consumer” would understand – is that if I open a pack of Reb-A sweetener or if I went to my backyard and chewed on a stevia leaf, the same molecule would pass my lips. And it is natural.” This is certainly the contention put forward by Marc Post inventor of the lab-grown hamburger. Questioning the safety of a lab-grown hamburger is humbug.

An alternative view – the nutritionist’s proposition

We know that altering the chemical make-up of food is, relatively speaking, a simple exercise. Our metabolism, on the other hand, is not. Mankind’s ability to digest food is a complex, highly-integrated and finely balanced recital. For the performance to succeed a number of actors (enzymes, bacteria, nutrients, acids, genes etc.) must perform their lines and steps with precision.

The performers have been dancing their complex, integrated choreography for thousands of years. Any changes to the food consumed that may have occurred over the centuries, such as natural mutations or cross-breeding would have been limited, occurred slowly and been gradually introduced. This more modest, slower and natural introduction of changes to the food eaten allowed the metabolic performers to adjust to their new choreography without too much of a strain on the human physiology. With the onslaught of novel foods in recent decades the chorus-line now focuses all its energies on learning their new script, neglecting their set pieces, getting confused and gifting us chronic food related illnesses as opposed to robust good health.

A nutritionist may argue that whilst huge amounts of funding has been given to innovation in the food sector very little has been given to researching how our bodies metabolise food.  Thus, the typical sequence of events is as follows:

Step one: the introduction of a new food.

Step two: a lengthy period of consumption.

Step three: hitherto rare diseases beginning to emerge in the general population.

Step four: research into the cause of the disease.

Step five: banning the new food.

Step six: inventing a new food to address the problem of the old/new food…

By way of example:

Monosodium glutamate (MSG), which (amongst others) mimics the savoury flavour of cured meats and cheeses, was invented by Ikeda Kikunae and was patented in 1908. Mankind’s universal love of savoury flavours, is succinctly explained by Prof Paul Breslin from the Department of Nutritional Sciences, Rutgers University , Adjunct Professor, Department of Anatomy and Cell Biology, School of Dental Medicine, University of Pennsylvania.

“Humans have developed a preference for glutamate taste, perhaps as markers of easily digested protein in slightly aged or cooked meats…..Our strong interest in the taste of free amino acids … may arise from an inclination to ingest fermented foods, including slightly aged and/or cooked meat. This category of food would have multiple advantages to the survival of our species. Fermentation not only provides more ready access to macro- and micronutrients, but it also provides access to probiotic bacteria, which help maintain overall nutritional health, prevent diseases, and fight gastrointestinal infections…. It is the fermentation or aging of these foods that releases glutamate and savoury taste from protein. Thus, our attraction to amino acids, especially glutamate, and savoury taste may be born of a desire for fermented foods and the advantages of the improved nutrition and probiotic bacteria ….”

Bacon, cured meats, cheddar cheeses, gravlax … all of these desirable and tasty foods are delicious precisely because they are nutritious. Food that has been flavoured with MSG and the thousands of related novel food flavourings MSG has begat since it was first patented since 1908, on the other hand, taste delicious but are neither fermented nor slightly aged. They are typically sterile food products (such as frozen pizzas, crisps, snacks or dry-soups) but flavoured with MSG that tricks the brain into thinking it is consuming something nutritious. For years food scientists saw no problem in this. Since MSG appears not to be toxic it is assumed that it is safe to consume.

In the past decade or so, nearly 100 years after MSG received its first patent, scientists are beginning to understand the hugely important role natural, beneficial, bacteria play in boosting digestion and immunity. It is only now that the lack of probiotic bacteria in our savoury food is one of the leading causes of a new syndrome referred to as sterile gut. Where populations once ate an abundance of naturally cured meats, cheeses and fish they now eat sterile food products flavoured with MSG. Those who suffer from sterile guts have resorted to eating another persons faeces to restore their gut health when all they had to do was eat natural foods.

Hydrogenated Vegetable Fats, are liquid seed vegetable oils (sunflower, rapeseed oil, soya oil, cotton seed oil) that have been solidified with a catalyst (typically nickel oxide). The process was first invented by Wilhelm Normann and patented in 1901. Initially, vegetable shortenings were unpopular and not commercially successful simply because they tasted unpalatable and they had a greyish hue. So, the novel food industry invented food colourings to remedy the defect in colour and artificial flavours to mimic the flavour of butter to remedy the defects in taste. Following government sponsored health campaigns, which erroneously claimed that polyunsaturated vegetable margarines and shortenings were healthier than natural saturated fats, populations switched from consuming traditional saturated fats to novel vegetable shortenings.

Yet, it is only in the past decade – a full century after Normann was granted his patent – that governments have begun to fully appreciate how the artificial trans-fats found in hydrogenated polyunsaturated vegetable oils are one of the leading causes of cardio vascular disease. After 100 years of use there is now sufficient scientific certainty to conclude that the trans-fats found in polyunsaturated partially hydrogenated vegetable oils are categorically not safe to consume and they have now been banned in most food products.

High Fructose Corn Syrup, was invented by Marshall and Kooi and patented in 1960. Since then it has been common practice in the US – and more recently in the EU – to add high fructose corn syrup (or isoglucose as it is known in the EU) to convenience foods and beverages.

Yet, it is only in the past few years (approx. 60 years since the first patent for this novel sugar was granted) that medical doctors and some nutritionists have been warning that such high concentrations of fructose is causing havoc with our metabolism and believe there is a strong link between the obesity epidemic and the increasing use of novel sweeteners such as HFCS. The link is not, yet, conclusive but if and when it is the regulatory body will seek to have it banned. In anticipation of this happening and in light of the bad press HFCS has been receiving in recent years novel food experts are inventing and devising new sugars that eliminate sucrose all together. Truvia, for example, is an entirely new sugar patented by Cargill and Coca-Cola which contains no sucrose. We wait with interest to see how our metabolism will enjoy refined stevia extract rebaudioside A the chemical compounds which lends sweetness to a food and beverage (which is FDA and EFSA approved) whilst whole leaf stevia (consumed for hundreds of years by native Paraguayans) is not.

The new general principle governing food safety in Europe

For all of the reasons set out above it is proposed that the new general principle governing food safety in Europe should be that novel foods are chronically toxic and unsafe to consume, their use and consumption should be strictly limited to the most necessary and urgent of cases only and that law-makers will decide when conditions are such that novel foods are called for.

Defining novel foods

Distinguishing natural safe food from novel chronic foods has been particularly problematic in the past and has thus far eluded precise legal definition. In large part because until now law-makers have erred in favour of the proposition that all food is a chemical construct. At it’s basic level all food nutrients are nothing more than a chemical molecule as opposed to a complex, integrated and functional whole of a finely balanced food chain.

Existing EU law defines novel foods as those that were not substantially consumed prior to 1997. Although useful, this definition is limited. Many non-traditional, new foods, such as the examples set out above (HFCS, hydrogenated fats and MSG) have been widely consumed prior to 1997 and as we have seen above they are problematic. Very problematic, in fact.

One possibility is for food law to turn to the existing law of intellectual property rights to help us distinguish novel food from natural. Patent law has very rigid requirements of what is and what is not new food. The prior art (legalistic jargon for the concept of newness) is an essential feature of patent law and all inventors of new foods must prove that their food is entirely new before they can be awarded a twenty year patent. All novel foods have been patented. Thanks to this helpful interpretation of novelty devised by patent law, revised EU law on novel foods should state that food which has been patented – both in the past and present – is novel and assumed to be chronically toxic and unsafe to consume. Food which has not been patented is natural and safe to consume. The law of intellectual property rights has, unintentionally but highly conveniently, given us the perfect means to determine novelty.

The logic of applying intellectual property rights law to defining novelty

The law of intellectual property rights is all about monopoly which is why over the years it has set out strict requirements as to who can and who can not benefit from intellectual rights. This specialised body of law is quite rigid when it comes to what food can benefit from an intellectual monopoly. Those unfamiliar with copyright law, by way of example, may be surprised to read that recipes can not be copyrighted. Recipes are what the law deems to be the “common ground” – a place where all can graze and no recipe should be ring-fenced by a monopoly.

Similarly, no one person would be able to claim intellectual rights and a patent on butter, apples or eggs. These are natural foods that have been used, consumed and shared since time immemorial. No one individual intellect can claim they invented butter or apples or spelt or eggs. To be able to benefit from any intellectual property rights in the area of food the person must prove that their invention is entirely new, that they alone were responsible for devising and creating a completely new product that simply did not exist before their invention and that they are the sole creator/inventor of this new food. Since a patent grants the inventor a 20 year monopoly (one of the tightest, most profitable of all intellectual rights) the bar is set high and the novelty of an invention is one of the central planks determining whether the inventor can be granted what he seeks – a 20 year monopoly. This is a very strict legal requirement.

We can therefore, in all confidence, propose that all foods that have been granted a patent, all foods which are seeking a patent or which are currently under patent are novel foods and should be assumed to be chronically toxic and unsafe to consume for the reasons set out above.

Non-patented novel foods

Novel foods, which have not been granted a patent, which are not going through the process of being approved for a patent or which currently do not enjoy a patent can be defined as “all modern, invented foods which have been devised by mankind in a laboratory but which nature, alone, could never have achieved.” In this way natural mutations and hybrids would not fall under this definition and could be deemed safe.

It goes without saying that the new general principles would have to come with certain exceptions. One exception, by way of example, would be if conditions are such that there is an urgent need for a new food. Law-makers alone should determine whether they feel there is a genuine need for a novel food. The criteria set should be high and can only be invoked in a situation of crises such as a threat to national interest, famine, drought or disease. Inventing new foods for profit alone would not be considered a strong enough reason to deviate from the general principle that novel foods are chronically toxic and unsafe.

Given that there are literally thousands of traditional foods and recipes already on the market, which have a proven track-record of being safe to consume, the general rule strictly limiting the placing of novel foods on the market should not result in Europeans becoming food deprived. Quite the contrary – the reduction of novel foods in our modern diet will result in Europeans once again eating a more natural, balanced diet which the average, healthy European has been designed to digest and which we know, from thousands of years of use, offers them optimal well being and robust good health. It is my assertion that once novel foods are significantly reduced, if not eliminated, from our modern diet the rise in chronic food will gradually stabilise, if not begin to decrease.

Conclusion

In this piece I have sought to set out why the current general principles governing food safety is failing Europeans. I have sought to explain why the four-stage risk assessment procedures are of limited help in determining food safety given the lack of scientific certainty regarding their consumption, the apparent chronic toxicity of novel foods and the fact that it can decades for the problems to emerge. I have sought to explain why with so much money at stake it is impossible for the science to remain impartial and independent and I have sought to offer a viable, working alternative to the regulation of novel foods in Europe.

In response to Mr Vinčiūnas opening question …. how to make laws and regulate in the face of emerging technologies? – the above offers him some food for thought. The real question is not so much how to regulate novel foods. Logic, common sense – and yes even science – tells us that adopting a new principle assuming that novel foods are chronically toxic is the sensible thing to do. The big question is not whether this new general approach should be adopted – it is whether the EU will have the appetite or the stomach to face the powerful food industry? Rising medical bills and the chronic diseases that will touch every European family in the decades ahead may just force the issue for Europe’s food regulators in a way that “deeply rooted conservative thinking” does not.