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Major independent scientific study launched on food supplement regulation

The Netherlands-based HAN Foundation, an independent group of leading risk assessment scientists, today commences a 9-month study to shed light on the EU's 'black box' regulation of food supplements.

PRESS RELEASE

For immediate release

27 June 2005

MAJOR INDEPENDENT SCIENTIFIC STUDY LAUNCHED TO SHED LIGHT ON EU’S ‘BLACK BOX’ REGULATION OF FOOD SUPPLEMENTS

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.

For enquiries and further information contact:

Dr Robert Verkerk, Executive Director
Alliance for Natural Health
Tel: +44 (0)1252 371 275
Fax: +44 (0)845 280 4910
E-mail: info@alliance-natural-health.org
www.alliance-natural-health.org

Dr. Jaap Hanekamp, CEO
Heidelberg Appeal Nederland
Tel: + 31 79 346 0304
Fax: + 31 79 346 0643
E-mail: jaapchan@euronet.nl
www.stichting-han.nl

Notes for editors:

ALLIANCE FOR NATURAL HEALTH

The Alliance for Natural Health (ANH) is a Europe-wide non-profit alliance of consumers, doctors, complementary health practitioners, and innovative industry manufacturers and suppliers who have an interest in food supplements and natural health. More information, including details of the ANH’s support base, will be found at www.alliance-natural-health.org.

Good science and good law underpin all of the ANH’s work, and the scientific reports produced by the ANH are endorsed by many of the world’s leading doctors and scientists working in the field of nutrition.

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.

EU FOOD SUPPLEMENTS DIRECTIVE

If the proposed ban on vitamins and minerals is implemented on 1 August 2005 across Europe, there is much at stake:

· Over 5000 products will disappear from the shelves of UK health stores as a result of the ban removing access to over 300 vitamin and mineral ingredients (out of a total of about 420). These include, amongst others, the main natural forms of Vitamin E, several forms of vitamin C, the key natural form of folic acid, MSM and a range of minerals such as vanadium, silicon and boron, all being products which millions of consumers choose to take as part of their regular health regime and have done so without any ill effects for many years.

· An individual’s freedom of choice to take safe natural health products will be removed; 40-45% of the UK, Irish and Swedish populations take vitamins and minerals.

· Products are to be banned with absolutely no scientific justification. Many of the world’s leading scientific and medical experts in nutrition support the absence of any proper basis for the proposed bans.

· Although the proposed bans related only to vitamins and minerals, unless overturned, the ‘Positive list’ system will most likely be transferred to other nutrients used in food supplements, such as plant extracts, amino acids and enzymes. The precedent set by an ANH victory will drastically reduce the chance of future bans on these other nutrient forms.

· Further regulatory proposals by the EU and Codex Alimentarius are due to be considered by later this and next year. These include restrictions on maximum dosages of vitamins and minerals and restrictions on health claims of foods and food supplements. Again, the ANH is working to help positively shape such legislation using its mantra of ‘good science and good law’.

CODEX GUIDELINES ON VITAMIN AND MINERAL FOOD SUPPLEMENTS

The Codex Alimentarius Commission develops international guidelines for a very wide range of food products. These guidelines are used by governments with the intention of harmonising rules on food products to assist international trade as well as ensuring consumer safety.

The Codex Guidelines on Vitamin and Mineral Food Supplements have been in development for approximately 10 years. It is one of a large number of Guidelines pertaining to food products that has been developed under the auspices of the Codex Alimentarius Commission (established in 1963), which is a subsidiary body of the World Health Organization (WHO) and the Food & Agricultural Organization (FAO) of the United Nations. Codex Guidelines are frequently implemented into laws of Codex member countries (172 in total), and they are used as reference points in any trade disputes brought to the World Trade Organization.

The text for the Guidelines was agreed by consensus in the Codex Committee for Nutrition and Foods for Special Dietary Uses (CCNFSDU) in Bonn in November 2004, and the Guidelines are due to be ratified at the next CCNFSDU meeting in Rome on 4-9 July 2005.

The key area of the Guidelines which has yet to be agreed is the nature of the ‘nutrient appropriate’ scientific risk assessment, which will be used to establish Upper Safe Levels for the vitamins and minerals. The process of determining this science has effectively, although unofficially, been handed to the FAO/WHO, who, in turn, have allowed an open consultation phase for input from external parties. The Alliance for Natural Health (ANH) was one of 16 organisations to submit comments for this consultation in December 2004, and the ANH submission revealed, with extensive reference to peer-reviewed science, very substantial flaws in the various existing models that have been used by US and European authorities. These models are assumed to form the basis of the risk assessment science to be employed in establishing upper levels. The ANH’s submission has subsequently been endorsed by over 100 leading clinical nutritionists in the US and Europe.


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