Codex Food Supplements Directive Deemed Invalid Under EU Law

Alliance for Natural Health set to win its landmark challenge to the EU food supplements directive

April 5, 2005 - Following a landmark challenge in the European Courts of Justice (ECJ) to the controversial Food Supplements Directive, Advocate General Geelhoed, senior adviser to the ECJ, issued an opinion in opposition to the ban that would have been imposed by the Codex Alimentarius Commission.  Its Food Supplements Directive (FSD) effectively proposed to ban 75 percent of vitamin and mineral forms.  The suit was brought by the Alliance for Natural Health (ANH) and Nutri-Link Ltd.

This was tremendous news for the millions of people in Europe who choose to use food supplements.  The Advocate General's opinion increases the probability that consumers can continue using the natural food supplements they believe are beneficial to their health.

In a statement released in Luxembourg on April 5, 2005, the Advocate General concluded that:

• The Food Supplements Directive infringes the principle of proportionality, because basic principles of Community law, such as the requirements of legal protection, of legal certainty, and of sound administration, have not properly been taken into account.

• It is therefore invalid under EU law.

There has been uproar about the proposed EU ban, and against the odds, the consumer may perhaps come out on top in what is a remarkable modern-day case of David and Goliath.

It must be stressed that the Advocate General's pronouncement is not a ruling.  That will come later from the ECJ judges, probably around June 2005.  But typically, in the vast majority of cases, the Court Judgment adopts the recommendations of the Advocate General.

If the Advocate General's recommendations are adopted, in effect, the ban on vitamin and mineral forms not included on the EU's "Positive List," which was due to come into effect on August 1, 2005, will be declared illegal.  In essence, the Positive List of allowable nutrient forms will be deemed too narrow, too restrictive, and based on flawed science.

This would avoid the irrational situations that the Food Supplements Directive would have created.  For example, synthetically produced selenium would have been allowed on the Positive List, while the natural source found in Brazil nuts would not.  Synthetic forms of vitamin E (often used in "adverse" vitamin studies reported in the media) would have been allowed, but the natural, most beneficial food forms would not.

If the ban on vitamins and minerals is implemented, much is at stake:

• Over 5,000 products would disappear from the shelves of UK health stores, as the ban would remove access to over 300 vitamin and mineral ingredients (out of a total of about 420).  These include, among 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 products which millions of consumers choose to take as part of their regular health regime and have done without any ill effects for many years.
   

• An individual's freedom of choice to take safe natural health products would be removed.  Forty percent of the UK's population takes vitamins and minerals.
   

• Products would 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 could be transferred to other nutrients used in food supplements, such as plant extracts, amino acids, and enzymes.  The precedent set by an ANH victory would drastically reduce the chance of future bans on these other nutrient forms.

The Alliance for Natural Health (ANH) is a European professional organization dedicated to ensuring that good science and good law are applied to regulation affecting the leading edge of natural health.  If the Advocate General’s recommendations are endorsed by the ECJ judges, it will represent the culmination of three years of hard work on the part of ANH and its many supporters around the world.

"It is commendable that the EU Advocate General has seen through the flawed science and law of the Food Supplements Directive and reached his recommendations today," said Dr. Robert Verkerk, Executive Director of the ANH.  "All that ANH is campaigning for is the right for consumers to have access to safe natural healthcare, and for legislation to be based on good science and good law.  This is a great day for the tens of millions of people who believe in the benefits of natural, preventative healthcare."

Supporting safe supplements

While ANH supports many aspects of the Directive and firmly endorses the banning of ingredients that are patently unsafe, the existing UK and EU food law already provides effective protection from unsafe products.  Furthermore, ANH says that it is not scientifically rational to classify an ingredient as being unsafe without taking dosage levels into account.  This was not a condition for a supplement to be admitted onto the Positive List.

ANH believes that a far more appropriate system for banning any substances that might pose a risk to health would be to produce a "Negative List" for ingredients where there was proper evidence of lack of safety.  The system proposed by the EU would have banned ingredients on the basis that companies did not have the financial capacity to meet the high data threshold required for the scientific dossiers demanded by EU authorities.  In this way, ingredients that have been part of the human diet for thousands of years and which are increasingly difficult to derive from conventional foods would not have been able to be supplemented.

"None of the major EU countries opposed our application for a declaration that the ban on vitamins and minerals in the Food Supplements Directive was unlawful," added Anthony Haynes, Technical Director of Nutri-Link Ltd., a UK food supplements company that brought the legal challenge jointly with ANH.

A wide welcome across the industry if the ban is overturned

Greg Watts, Chief Executive of Ultralife, a manufacturer of leading-edge food supplements, said, "This is very encouraging news.  If the ban were to come into force we would have to reformulate down to simpler, more basic products that consumers and practitioners find less effective."

Dr. Damien Downing, a medical doctor and one of the UK's leading practitioners in nutritional medicine, said, "Practitioners of nutritional therapy -- and there are thousands of them in the UK -- largely use leading-edge food supplements.  If these nutrient forms remain, we can continue to treat our patients with meaningful solutions and provide the products that we know are so beneficial.  A ban would, in one fell swoop, remove the vital tools of our trade."

Sara Novakovic, owner of Oliver’s Wholefood Store in Richmond, Surrey, said, "At last, it is now highly likely we can continue to offer the products that our customers ask for and want, rather than have to remove them all from the shelves for no good reason and supply them with inferior-quality alternatives."

Regulatory and industry pressure through the EU Food Supplements Directive was always likely to translate globally, particularly to the U.S., through Codex and the World Health Organization.  Without having to justify any health hazard and without considering any benefits, safety has been used as a reason to restrict the availability of natural food products.

"Food supplements are the safest things that people put into their mouths -- considerably safer even than conventional foods," said Dr Robert Verkerk.  "With rapidly declining vitamin and mineral content in fruit vegetables and other foods, and continuing increases in degenerative diseases such as heart disease and cancer in the West, this has always been a very big issue worth fighting for.  Fundamentally, an amended Directive would help to slow down the agenda of the Codex Alimentarius Commission to export worldwide an onerous, EU-style regime for food supplements."

Further legislative proposals by the EU are due to be considered by the European Parliament later this and next year.  These include restrictions on maximum dosages of vitamins and minerals, and restrictions on health claims of foods.

The Alliance for Natural Health is a European association of manufacturers, distributors, retailers, consumers, and complementary practitioners who have an interest in food supplements.  The ANH is working to help positively shape such legislation using its mantra of "good science and good law."

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