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