The Alliance for Natural Health, a group campaigning for sustainable health care in Europe, states in a newly released paper, that the European Commission's proposed model for limiting the amounts of nutrients allowed to be sold in food supplements is seriously flawed. Robert Verkerk says, “The Commission claims that its methods are scientific but we have found that they do not stand up to scientific scrutiny”.

Billed as an effort to protect consumer health, the limitations under consideration are set to seriously restrict options for active prevention of ill health through nutrition. The European directive on food supplements mandates that a decision be made which of the vitamins and minerals we find in supplements should have maximum dosage limits and what those limits should eventually be. It is expected that the levels will be finalised in 2009 and early indications are that Member States such as the UK, Netherlands, Sweden and Ireland, that have until now allowed relatively high levels, might have to face big reductions in dosages.

“You know something is wrong when they are thinking of limiting the dose of beta-carotene to the amount you’d find in just two carrots, and restricting selenium to the amount present in less than two brazil nuts. There seems to have been no attempt to test the models against real data. If the Commission really believed these doses might be the highest safe doses, why aren’t they screaming for warning labels to be put on bags of carrots and brazil nuts”, adds Dr. Verkerk.

Damien Downing, who is President of the British Society of Ecological Medicine and Editor of the peer reviewed scientific Journal of Nutritional & Environmental Medicine, says: “It is the multiple use of safety or uncertainty factors that further compounds the reduction of levels from so-called Safe Upper Levels, that are often overly cautious to begin with. The resulting maximum levels, should these be implemented in law, would prevent many consumers from ingesting the levels of vitamins and minerals needed for optimal health and would also greatly interfere with consumer choice.”

The Alliance's position paper includes a statement of how a proper, scientifically valid and proportionate risk management model should look.

That of course leaves the question open of why we need to "manage the risks" of supplements in the first place. These nutrient containing pills have been found to be much safer than normal, everyday foods, let alone medicines which are specifically formulated to fight disease and increase health. By rights, there should be no talk of limiting nutrient availability because there is no problem of any appreciable size. People aren't overdosing on nutrients. And worse yet, limits on nutrient dosages are likely make a negative contribution to public health. People who supplement nutrients to stay in good health today may find they can no longer do so when the European Commission is done legislating against vitamins and minerals.

The Alliance for Natural Health brings together scientists, medical doctors, integrative practitioners, lawyers and consumers, as well as suppliers of food supplements and other health foods, as a means of working towards the development of sustainable approaches to healthcare. Their critique and position paper on the European Commission's proposals is summarized below:

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PROPOSED EUROPEAN MODEL FOR MPLs NOT FIT FOR PURPOSE

EXECUTIVE SUMMARY

The European Commission (EC) is in the process of finalising approaches that allow the determination of Maximum Permitted Levels (MPLs) of vitamins and minerals for both food supplements and fortified foods. Although the EC has undertaken a public and stakeholder consultation, it appears that a significant number of flaws and inconsistencies are at risk of being built into the modelling process. The likelihood is that the proposed methodology will yield levels that cannot be matched against what is already known about nutrients and their interaction with humans.

This Position Paper clearly focuses on the weaknesses of the methodologies under consideration, explains why they are not fit for purpose, and provides commentary on the EC’s Orientation Paper, dated July 2007.

The Paper goes on to demonstrate why existing risk management models under consideration need to be altered as they yield outputs that are both scientifically flawed and not biologically meaningful when validated against the results of food analyses and clinical data. The paper provides examples which show that determinations of MPLs, and even Upper Levels (ULs) from which they are derived, may be so low that they can easily be exceeded through the consumption of small amounts of conventional foods. For example, the amount of beta-carotene in two carrots would likely exceed the UL for beta-carotene, whilst just two brazil nuts would probably provide sufficient selenium to exceed both the UL as well as the MPL.

Most of the recent focus on methodologies for determining MPLs has been on the process which moderates the UL, but this Paper explains succinctly why even the starting point of MPL determinations, the UL, is seriously flawed scientifically. It is the sequential use of multiple ‘safety’ or uncertainty factors that further compounds the unwarranted reduction of levels. The resultant MPLs, should these be implemented in law, would curtail consumer choice to such an extent that many would be prevented from ingesting levels of vitamins and minerals required for optimal health.

This Position Paper includes a consideration of features that would be required for the development of a new, scientifically valid and proportionate risk management model. It is concluded that such a model would likely be best developed within an independent, academic setting rather than being subject to the often conflicting pressures of industrial stakeholders and political processes. The paper calls for a reconsideration by the EC of its approach to the determination of MPLs, which would otherwise be disproportionate in its effect and may in turn be subject to legal challenge.

To read the whole paper, download it in PDF file format here.