News

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 micronutrients.

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.

About the HAN Foundation
The HAN Foundation (stichting Heidelberg Appeal Nederland) was established in the Netherlands in 1993 and named after the Heidelberg Appeal, a declaration signed in 1992 by over 3500 scientists. HAN is an independent non-profit making alliance of scientists and science supporters whose aim is to ensure that scientific debates are properly aired, and that decisions which are taken and action that is proposed are founded on sound scientific principles. Members are accepted from all walks of life and all branches of science. HAN has at present over 800 donors, including almost 200 professors.