European Union Directive on Dietary Supplements

Among the 25 European Union nations (representing more than 450 million people), the European Union Directive on Dietary Supplements directive reclassifies vitamin supplements as "medical drugs," mandates low dosage levels, and outlaws many supplement ingredients that are currently widely available.

Under the European Union directive, a "positive list" has been created to mandate which dietary supplements will be allowed for sale.

Various ingredients have been omitted from the positive list including around 40 trace elements as well as the mineral boron.

Vitamin E is another victim of the positive list. Occurring naturally in many different forms, the positive list only contains alpha tocopherol which is a synthetic variant.

Most consumers aren't aware that eight different compounds make up vitamin E. But alpha-tocopherol is the only one that you'll be allowed to buy. This ignores the fact that the three other tocopherols and four tocotrienols also serve a purpose.

Similarly, two organic forms of selenium are missing from the while two other synthetic forms are included.

Favouring synthetic variants is in the interest of large pharmaceutical companies which can produce ingredients in bulk at low cost, while standardisation allows for their distribution over the whole of the European Union.

Let's say, for example, that you're a supplement manufacturer in a European Union country, and you produce a supplement that contains boron. Under the new rules, you'll be required to remove it from the supplement by August 2005.

But there is another option. You can submit a "technical dossier" to argue the case that a particular ingredient (such as boron) should be included on the positive list.

But this process is so expensive and time consuming that many manufacturers simply can't afford the costs involved.

The directive also puts an upper limit on the amount of vitamins and minerals contained in supplements based on the recommended daily allowance. Three times the Recommended Daily Amount will most likely become the highest dose allowed.

Consumer groups, such as the Alliance for Natural Health, argue that this undermines the freedom of consumers to make their own informed choices.

The good news is that Advocate General Geelhoed, a senior advisor to the European Court of Justice, gave an opinion which supports the Alliance for Natural Health's contention that the Food Supplements Directive 2002/46/EC is illegal.

In the statement released by the European Court of Justice in Luxembourg, Geelhoed concludes that "The Food Supplements Directive infringes the principle of proportionality because the 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."

It is noted, however, that the Advocate General's pronouncement is not a legal ruling and that this will come from the ECJ judges, probably in June 2005.

If the Advocate General's recommendations are adopted by the judges, then the ban on vitamin and mineral forms not included in the positive list, and due to come into force on 1 August 2005, will be declared illegal. This would avoid many of the inconsistencies which arise from the Directive in its present form.

For example, synthetically produced selenium would have been allowed on the positive list of vitamins and minerals, while the natural form of selenium found in Brazil nuts would not. Similarly, synthetic forms of vitamin E would be allowed but natural forms found in food would not.

In practice, the ANH believes that Directive created a situation in which vitamins and minerals were to be banned because small companies in the sector did not have the financial capacity to meet the high cost of preparing the dossiers required by the EU authorities.

In its long press statement, the ANH says that it supports many aspects of the Directive and endorses the banning of ingredients which are not safe but would prefer to see a negative list of ingredients for which there was proper evidence for a lack of safety. Comments on the Advocate General's opinion are also discussed by the Scotsman and BBC News.

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References
Directive 2002/46/EC of the European Parliament and of the Council