Health Supreme by Sepp Hasslberger

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June 27, 2005

Scientific Study to Crack 'Black Box' Supplement Regulations

The Alliance for Natural Health, a European activist and campaign organization dedicated to the preservation of natural health options has commissioned a scientific study that will provide an in-depth examination of Europe's legislative approach to food supplements. The EU food supplements directive, which is being gradually implemented in all member states, could severely unsettle the market for nutritional supplements from 1 August 2005. It is feared that consumers will be unable to obtain the most effective natural supplements after that date, unless the European court of justice, due to announce a decision on 12 July, follows the recommendations of its advocate general Geelhoed, who has stated that at least a part of the supplement rules are "as transparent as a black box", recommending that the directive go back to the drawing board.

It is anticipated that the EU court may follow the recommendations, sending the directive back to the EU Parliament and the EU Commission and Council to re-think some of its provisions. Consumers are hoping for such a turn of events if only to be able to continue to take currently available supplements for some more years.

The study, as announced by the Alliance for Natural Health, will be executed by the Heidelberg Appeal group of scientists in the Netherland, under the direction of Dr. Jaap Hanekamp and Prof. Aalt Bast. It will examine the broader implications of the regulation of natural substances for health in the European Union, including not only the risks but also the benefits of using supplements.

So far the equation has been very one-sided. At the first sign of a problem, a natural product can be completely removed from the market, as happened for instance with Kava Kava, a traditional South-Sea island drink with anti stress properties. Kava, made from the roots of piper methysticum was accused of causing liver trouble, and without a proper investigation was removed from the market over most of Europe, leaving the field wide open for pharmaceutical antidepressants which remain on the market, despite widespread reports of suicides connected to their use.

Similarly, the EU supplements directive is heavy on the "risk" part of its assessment of natural products. However it seems to completely overlook the tremendous advantages that the use of these vital nutrients has over the consumption of pharmaceutical drugs which merely treat symptoms, while nutrients, more often than not, go to the root of the problem.

Perhaps this study can help restore some balance.

- - -

27 June 2005  


On 5 April 2005, the European Court of Justice's Advocate General, Leendert Geelhoed, provided his Opinion on a legal challenge filed by the Alliance for Natural Health which concluded that the EU Food Supplements Directive was invalid under EU law. The Advocate General stated that the procedure for admitting ingredients to a positive list had "the transparency of a black box". The Court's ruling, which will take into account the Opinion of the Advocate General, will be issued from the Court in Luxembourg on the 12th of July,

Unless the legal challenge is successful next month, the Food Supplements Directive could potentially ban, as of 1 August 2005, up to 75 percent of vitamin and mineral forms currently on the European market including many of those found naturally in foods. Due to the devastating impact this would have on consumers as well as practitioners and industry, the Alliance for Natural Health, the lead party in the legal challenge of the Directive, has today commissioned, under the sponsorship of the International Nutritional Company (INC BV, Netherlands), an independent group of professional risk analysis scientists to evaluate the overall regulation of food supplements in the EU. The study will focus in particular on developing a new and appropriate scientific risk assessment methodology for vitamins, minerals and other micro-nutrients.

The study, entitled Food Supplements and European Regulation: Black box or level playing field rationality?, will be led by Dr Jaap Hanekamp and Professor Aalt Bast, of the Heidelberg Appeal Nederland (HAN) Foundation, which has previously provided definitive risk assessment studies to assist governments on key human health issues such as nitrates in food and drinking water and antibiotic growth promoters in livestock.

Dr. Hanekamp, CEO of the HAN Foundation, said today:

"In view of the procedural problems that the Directive poses for industry, it is essential to develop a straightforward, rational, transparent, and scientifically coherent benchmark methodology to regulate food supplements cost-effectively within a European, or even a global, level-playing field in which assessment and management are explicitly linked."

INC spokesman Bert Schwitters comments:

"Nutrients deserve our fullest credit because they are essential to life. Their safety must not be evaluated by applying the methods traditionally used in dealing with chemical and pharmaceutical compounds. Nutrients are our safest and most economic means to maintain and restore health. In terms of public health 'too little' poses a far greater risk than 'too much.' Evaluating nutrients‚ safety must be done in a scientific and balanced way that pays respect to the fundamental fact that we cannot do without them."

Dr Robert Verkerk, executive director of the Alliance for Natural Health, added:

"It is essential that the issue of food supplements regulation is looked at by a leading independent group of risk analysis scientists with a blank sheet of paper, before any amendment to the Directive is finalised and before the international guidelines on vitamin and mineral food supplements are finalised through the UN's Codex Alimentarius Commission in July. The HAN Foundation scientists are perfectly set to provide a fully independent, bias-free view on this complex area and it would benefit governments and the UN, as well as consumers, practitioners and industry, to await the findings of the study, due in around 9 months time, before any further regulations or guidelines are finalised."

The Alliance for Natural Health has submitted a detailed report to the Food & Agriculture Organization and the World Health Organization of the UN, which are developing a so-called "nutrient-appropriate risk assessment" system for food supplements likely to be adopted by the Codex Alimentarius Commission, which is in turn about to finalise international guidelines on vitamin and mineral food supplements in its meeting in Rome between 4th and 9th July.

Dr Verkerk also noted:

"The implications of getting risk assessment wrong are horrendous. You could actually deprive very large numbers of people from taking nutrients that improve their health. The cost of this could be very great. And in our opinion, and that of medical doctors practicing clinical nutrition and other scientists around the world who have endorsed our proposal, the existing risk assessment systems being used by Regulators are deeply flawed. We badly need a new model that takes into account both risks and benefits of food supplements. This approach is central to the remit of the HAN Foundation scientists."

The Alliance for Natural Health believes that the results of the study will greatly facilitate legislation being developed for food supplements in Europe as well as globally, and will reduce the likelihood of future legal challenges.

The HAN Foundation study, commissioned and overseen by the Alliance for Natural Health, has been sponsored by International Nutrition Company (INC), the Netherlands-based worldwide supplier of natural products originally developed by Professor Jack Masquelier in France.


Dr Robert Verkerk, Executive Director
Alliance for Natural Health
Tel:   +44 (0)1252 371 275
Fax:  +44 (0)845 280 4910               
Dr. Jaap Hanekamp, CEO
Heidelberg Appeal Nederland
Tel:    + 31 79 346 0304
Fax:   + 31 79 346 0643


posted by Sepp Hasslberger on Monday June 27 2005
updated on Thursday December 9 2010

URL of this article:


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