European Supplement Rules Distort Economy, Endanger Health
In a recent article published in Environmental Liability, Dr Jaap Hanekamp director of research of the Dutch HAN Foundation has critically analyzed the European food supplements directive, charging that the excessive reliance on precaution to avoid "nutrient toxicity" may lead to a distorted internal market and a worsening of public health. This would be the exact opposite of the intended "high level of consumer protection" and the "level playing field" for producers and sellers of supplements invoked by EU lawmakers when passing the directive.
Food Supplements - Image credit: Sepp
The directive has been subject to a legal challenge and its onerous rules were termed "as transparent as a black box" by the advocate general of the EU Court of Justice. Nevertheless, the EU court upheld the directive, albeit with some important clarifications.The article of Dr Hanekamp is the first step in a comprehensive ideological challenge of the legislation, commissioned by the Alliance for Natural Health, the group that brought the legal action at the EU court.
More than the directive itself, it is the open-ended precautionary philosophy that requires a perfectly normal food-type substance to "prove its innocence" before being allowed to be bought and sold, that has the scientist up in arms. Some quotes from the article make this clear:
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Quotes from "The precautionary principle: a critique in the context of the EU Food Supplements Directive"
(a copy of the article is available here)
Nevertheless, when there is not a certainty, but only a danger of mischief, no one but the person himself can judge of the sufficiency of the motive which may prompt him to incur the risk: in this case, therefore, (unless he is a child, or delirious, or in some state of excitement or absorption incompatible with the full use of the reflecting faculty,) he ought, I conceive, to be only warned of the danger; not forcibly prevented from exposing himself to it.
John Stuart Mill
RDAs currently used for micronutrients are based on the prevention of diseases of deficiency only (short-term issues). This is still the dominant perspective on micronutrients. Numerous papers, however, have dealt with the issue of increased intake of fruit and vegetables and the reduction of cancer incidence and cardiovascular mortality (long-term issues), intrinsically or explicitly addressing the role of micronutrients. Diets rich in fruits and vegetables are known to be protective against, for example, cardiovascular diseases and cancer. Evidence suggests that chronic DNA damage as precursory to, for example, cancer and aging, occurs at levels above the level that causes acute and specific RDA-related micronutrient deficiency diseases. Established RDAs, and this is the emerging paradigm, may in fact have become obsolete in that they are insufficient to prevent long-term DNA damage, resulting in, for example, cancer and aging. In summary, the perspective materialising from state-of-art scientific research in relation to any type of micronutrient is that the actual ‘mandatory’ amount of micronutrients for the human organism that maximises a healthy lifespan, in a number of cases turns out to be
considerably higher than the amount needed to prevent acute deficiency diseases. It seems increasingly clear that RDAs are too restrictive an approach to micronutrients and their health attributes, which are not only a matter of preventing deficiency diseases but, more importantly, lie in the field of long-term benefits such as reduced cancer and cardiovascular incidences and decelerating aging.. . .
In the Supplements Directive, micronutrient food supplements are regulated from an excess toxicity perspective, although, as shown above, straightforward consistency of safety standards for micronutrients seem to be more complicated than the available data would suggest. Whether or not supplements might add to the overall health of European citizens is, from a regulatory point of view, regarded as irrelevant. Thereby, the Directive assumes what actually should be proven, namely, that the health effects of an over-regulatory excess toxicity approach would be superior to alternatives. The concomitant assumption is that there are no health detriments from proposed (over)regulation. A choice is presented between health and money (economy), or even health with no loss at all, as a peripheral presumption is that the market will find a better and a cheaper as well as a safe way. Something (health) is gained with nothing lost (no adverse health effects from over–regulation). The burden of proof of safety corresponding to excess toxicity subsequently lies firmly with the marketing parties.
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Micronutrient deficiency is a well known historic phenomenon; a broad range of food products, including and especially fruits and vegetables, have been available to almost all social groups in the Western world only in the last couple of decades. Indeed, health risks due to micronutrients are habitually and historically related to deficiencies in the diet and not excess. This is so because minerals and the majority of vitamins are water-soluble and are readily eliminated by excretion as well as metabolism, the exceptions being vitamins A and D, which are lipidsoluble.
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Our contention is that within the precautionary context described above, the Supplements Directive is primarily focused on secondary risk management. Regulators and (scientific) experts in the main are being made increasingly accountable for what they do and thereby are becoming increasingly preoccupied with managing their own risks. Particularly, secondary risks to reputation are becoming as significant as the primary risks for which policies should in fact be devised. The increasingly dominant regulatory culture of risk-aversion therefore engenders a food supplements policy singularly focused on excess toxicity risks, while simultaneously lecturing the Europeans to ‘eat a normal healthy diet’. Therefore, the directive avoids responsibility for the human health of European citizens.
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As micronutrients cannot be characterized other than by way of a two-sided symmetrical benefits–risks profile (risk and benefits are on both sides of the micronutrients equation), the benefits of micronutrients must be an integral factor in the regulatory equation.
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[F]ood products as a whole are estimated to consist of many hundreds of thousands of different chemicals. All these food-content chemicals have their own specific pharmaco-toxicological profile, both individually and interactively (synergism and antagonism). There is scant knowledge of all these different compounds, and science will have its hands full to characterise a mere fraction of those compounds.
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From the Conclusion:
Policies directed at human health should, by definition, be wary of the set goals and the possibilities science and regulation have to offer. The Supplements Directive has as its fundamental goal the ‘high level of protection for human life and health’, which, however, is specifically translated in an asymmetric precautionary fashion; only excess toxicity is addressed. This then immediately shows the critical flaw, as risks are on all sides of the regulatory equation.
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From a risk management perspective the Supplements Directive, in our view, first and foremost caters for secondary risk management inclinations (liability and reputation) by explicitly referring to the ‘normal diet’ as a sufficient source of the required micronutrients. In so doing, micronutrient food supplementation is implicitly regarded as superfluous. Therefore, the directive openly avoids responsibility for the human health of European citizens: intoxication toxicity as a result of food supplements intake is an infinitely more ‘visible’ phenomenon, increased by the bias for negative information about possible health risks of products or activities. By comparison, deficiency diseases are not (and cannot be) related to any regulatory activities, yet they have a far greater impact on public health.
If you would like to read the whole article here is a copy...
posted by Sepp Hasslberger on Wednesday May 10 2006
updated on Thursday December 9 2010URL of this article:
http://www.newmediaexplorer.org/sepp/2006/05/10/european_supplement_rules_distort_economy_endanger_health.htm
