Health Supreme by Sepp Hasslberger

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April 21, 2004

Food Supplements in Europe - What is the Problem?

The European Union has issued a Directive to regulate the commerce of food supplements, which is in the process of being implemented in the member states. If reading the referenced text does not tell you what problems this directive might bring to your ability to either buy or sell supplements in one of the European Community member states, don't feel alone. That is a problem most observers have and I believe it is due to the fact that the draft has been deliberately kept vague in order to deviate any opposition, until it is too late to do anything about the matter.

Nevertheless, two diverse groupings of consumers, practitioners and representatives of the supplements trade and industry have brought legal actions before the London High Court. Both actions, one by the National Association of Health Stores and another by the Alliance for Natural Health have been referred to the European Court of Justice in January this year.

You might be asking yourself, what exactly is the problem with this directive and why should I care? Well, if you either take vitamin and mineral supplements to keep your health at an optimal level or if you are professionally involved in the production or distribution of such products, you should care, because future prospects for the legal availability of food supplements in Europe are not rosy.

ANH's David Hinde explains why this is so and what YOU can do to help.

The Problem

The Food Supplements Directive (“FSD”) was widely promoted (and thus supported) as a measure, designed to distinguish food supplements from drugs and harmonise their EU legal treatment, facilitating their free movement between EU Member States.

This is a laudable aim for promotion of trade between Member States, in view of the great disparities between EU countries as to how food supplements are classified and regulated. Unfortunately as the Directive turned out; it actually has the opposite effect for innovative advanced bioavailable nutrients; many of which are at risk of being banned.

Restricted List of allowable nutrients

The FSD creates a list of permitted ingredients (initially only applying to vitamins and minerals) for food supplements and mandates all Member States to permit the sale of these across the EU from 1 August 2003 at the latest.

However all nutrients not on this ‘positive list’ will be banned right across the EU from 1 August 2005 at the latest, unless a detailed Dossier in respect of each nutrient (at an estimated cost of £80,000 - £250,000 per ingredient for which safety data is not readily available) evidencing their safety is submitted by the Member State to the EU Commission not later than 12 July 2005. This is despite the fact that previously they may have been permitted under one or more Member States’ regulations.

The effect of the Directive will be to ban about 300 of the 420 or so forms of vitamins and minerals present in around 5000 products currently on the UK market, many of which are sold in high street health food stores. The ban will have a similar effect on products in such countries as Sweden, the Netherlands, Ireland and others, which also have advanced markets for food supplements.

Restricted Potency for allowable nutrients

The potency of food supplements comprised of nutrients, which are on the positive list, will also be limited, as the FSD stipulates these nutrients will be subject to maximum permitted amounts taking into account upper safe levels (established by scientific risk assessment and intake of vitamins and minerals from other dietary sources).

In summary, the FSD will ban high potency, organic / food state bioavailable vitamins and minerals, irrespective of the fact that they have been on sale in EU Member States as food for many years.

Initially the FSD will apply only to vitamins and minerals but by 12 July 2007 (if not before) it requires the EU Commission to make proposals for a similar regime for all other “nutrients or substances with a nutritional or physiological effect”.

Thus the FSD provides a legislative model for all food supplements mandating a narrow (positive) list of allowed nutrients and a limited potency.

The Directive is presented as the first part of a plan for the comprehensive regulation of food supplements at the EU level and all the indications are that once this model is in place in the EU it will be exported worldwide via Codex Alimentarius.

The Solution

After detailed analysis, the Alliance for Natural Health (ANH) concluded that the most effective option now left for the protection of the continued supply of safe, natural and effective advanced food supplements in the EU was to challenge the FSD ban on non positive list nutrients, in the Courts. It is not seeking to overturn the FSD as a whole but only the prohibition [see Articles 3, 4(1) and 15 (b)] against sale of any non positive list goods (“the ban”) in Member States which might otherwise allow their sale.

To that end, with specialist EU law barristers, it commenced legal proceedings in October 2003 and in brief, the latest position is as follows:

The legal challenge is viable (successful Reference to ECJ)

On 30 January 2004, Mr Justice Richards, a High Court Judge, (expert in EU law) granted ANH permission for judicial review of the FSD and made a Reference to the European Court of Justice in Luxembourg.

Key grounds of challenge

1) No legal basis for the ban / “Competence Creep”

The EU Commission only has power to propose legislation which is within the powers conferred upon it under EU law. The alleged legal basis for the FSD is Article 95 of the EC Treaty, i.e. the promotion of the internal market. ANH argues that the ban on nutrients previously allowed in Member States is not necessary for the establishment and functioning of the internal market and is thus outside the scope of Article 95 and illegal.

2) Infringement of the principle of Subsidiarity

Under EU law, public powers should normally be located at the lowest tier of government where they can be exercised effectively. Therefore regulation of food supplements sold within a Member State (as opposed to between Member States) is best left to each individual Member State to decide.

3) Infringement of the principle of Proportionality

Even were it legally permissible, the ban is a draconian measure which is neither appropriate nor necessary. Established nutrients with no previous adverse safety record are being required to undergo expensive scientific tests to prove their safety. The disadvantages caused to consumers and traders are thus quite disproportionate to any public interest benefit conferred by these restrictions on trade.

4) Infringement of Fundamental Rights (to property and to carry on an economic activity)

The ban will have a highly detrimental and unjustifiable impact on human rights guaranteed under EU law. It severely restricts the ability to carry on a business in advanced food supplements and will prevent consumers from obtaining significant health benefits from their leading edge food supplements.

5) Infringement of Duty to Give Reasons

Whilst the recitals to the FSD give reasons for the Directive as a whole, contrary to EU law, no reason or justification is given for the ban, which is a key operative part of the Directive.

Most fundamentally, the ban on vitamins and mineral forms excluded from the positive list is unconstitutional under EU law. As The FSD is presented as the first part of a plan for the comprehensive regulation of food supplements at the EU level, it is vital that this legal challenge be pursued otherwise the prospects for a successful challenge to a second or subsequent directives / regulations will be greatly reduced.

Immediate Action

1. Further Funding

In order to proceed with this next phase of the action; as a matter of urgency, ANH must immediately instruct its barristers to prepare written observations for the European Court of Justice. Funds will be needed to proceed. Any contribution you can make will help.

2. Media and other publicity

It will be important to support and publicise the legal challenge to the FSD as widely as possible.

David C. Hinde
Legal Director, Alliance for Natural Health
Tel: +44 (0) 207 738 1640


How proposals for EU, US and Codex regulation could destroy natural healthcare: the critical need for a new regulatory paradigm
By Robert Verkerk PhD, executive director, Alliance for Natural Health

Nutrient Risk Assessment: What You're Not Being Told
The setting of globally-enforced maximum permitted levels for nutrients in supplements is arguably the most crucial of all the various threats currently facing the future of natural therapies and health freedom.

According to this article in 'Alive', ill feeling towards the EU could 'reach the point where it threatens the EU itself'. No wonder with the kind of legislation that is being introduced, quite apart from whether the legislators and the Commission believe they are acting in defense of consumer choice and safety...

ISIS Report 13/01/2003 - Hands Off Vitamins and Herbs
Visits to Complementary Alternative Medicine practitioners throughout Europe outnumber those to doctors by two to one. Government figures show UK citizens spend £70 million per year on nutritional supplements and about 20% of the population use vitamins and minerals in their diets. But European Parliament Directives passed in March 2002 will ban food supplements, in a bid to re-classify them as medical drugs. Sam Burcher reports.


posted by Sepp Hasslberger on Wednesday April 21 2004
updated on Tuesday November 30 2010

URL of this article:


Related Articles

Food Supplements: German Risk Institute Takes Dim View
The German Federal Institute for Risk Evaluation, formerly the Federal Office for Consumer Health Protection, has established a risk assessment model for deducing maximum safe levels of nutrients provided in supplements and fortified foods, according to a recent report of The report was published in two parts, one dealing with minerals, the other with vitamins, both available in PDF format - so far only in German language (Minerals here)... [read more]
January 20, 2005 - Sepp Hasslberger

Supplements: EU Court Hears Case As UK Commons Debate Directive
Luxembourg - The European Court of Justice heard oral arguments yesterday in a case brought by the Alliance for Natural Health, the British Health Food Manufacturers Association and the National Association of Health Food Stores, to overturn the prohibitive provisions of the European food supplements directive. The directive, passed in 2002 for the purpose of harmonizing European laws on health products, is set to require expensive research to prove the... [read more]
January 26, 2005 - Sepp Hasslberger

European Supplements Directive challenged in London Court
The European Union's Directive on Food Supplements, which became EU law last year and is now being transposed into the legal systems of EU member states, has been challenged in a UK court on Monday 13 October by the Alliance for Natural Health (ANH) a pan-European coalition of supplement manufacturers, retailers, independent health practitioners and consumers. The case, filed in the London High Court by Brick Court Chambers and the... [read more]
October 16, 2003 - Sepp Hasslberger

Codex Alimentarius – A threat to your vitamin supplements?
Codex Alimentarius is an international standard-setting body dealing with how to safely process and store food products, avoiding hazards to our health. For about ten years, the Codex Committee on Nutrition and Foods for Special Dietary Uses has been mulling over a guideline for vitamin and mineral supplements, originally proposed by the German delegation to this committee, presumably to eliminate dangers from these additions of vital nutrients to our nutrition.... [read more]
March 22, 2004 - Sepp Hasslberger

Denmark To Eliminate Concept Of Supplements: 'They're All Medicines'
August 2004 - Danish Health Authorities have issued a proposed national "Guidance on Supplements" for public discussion which, according to MayDay, an association campaigning for freedom of choice in health matters, "is worse than any legislation we have ever seen before, as it will erase the concept of supplements, this actually means that Denmark is about to be the most totalitarian state experiment in Europe concerning health." The Danes refer to... [read more]
September 07, 2004 - Sepp Hasslberger

Conventional medicine far riskier than supplements
Barbara Sumner Burstyn, in an article in the New Zealand Herald comments on the recent Australian attack on natural products which of course was felt also by New Zealand's health food aficionados. "...a blanket recall caused people to doubt not only the effectiveness of vitamins and supplements but their safety. We may have been looking in the wrong direction. While the Pan medication put 19 Australians in hospital, and others... [read more]
June 16, 2003 - Sepp Hasslberger




Readers' Comments

Dear Sir,
Where can I find the EU regulations concerning L-carnitin.
Awaiting for your response,
Thank you in advance.

Posted by: Diakakis Dimitris on January 19, 2005 03:02 PM


My personal observation is that the non-prescription drugs, supplements, etc. are almost as hazardous as prescription drugs.

The user must know what he is doing. Ordinary salt can kill you if used improperly.

Good information is needed.

Posted by: Larry Lugar on June 5, 2005 10:12 PM


Thank you for your comment, but I believe you will be hard pressed to substantiate that "personal observation" on the dangers of supplements, seeing the actual statistics on the death rates from pharmaceutical drugs (more than 100,000 a year in the U.S. alone) and the substantial absence of any deaths from supplements.

You can find the statistics in graphical elaboration on this page on

Of course the user must know what he/she is doing. Yes, salt can kill you, and so can too much water, or for that matter, too much oxygen. What is the point?

You say good information is needed. Would you like to provide it?

One day later:
"Larry Lugar" seems not to be reachable at the stated email address - oh well...

Posted by: Sepp on June 5, 2005 11:01 PM


How can vitamins be banned when Tobacco is fine to sell despite being the cause of massive health problems??? Its surreal!

Posted by: Miguel Silva on June 9, 2005 08:05 PM


Where can i find a list of what WILL still be available.

Posted by: Aaron Auton on July 13, 2005 10:52 AM


Ahem! far be it from me to pontificate .. we have asked for what we have got .. all of the Scientific natural healers.

things have come to a pretty pass .. it looks like the Codex .. read Pharmageddon .. has won a great legal victory and we are all consigned to rest homes .. endless medical tests from cradle to grave .. first they poison our children via the placenta .. then they vaccinate and drug our children .. then they become us .. geriatric fossils to be hammered around and experimented on when you cannot resist .. its all your genes or whatever it is for the next scientific medical money making wheeze .. To pay off the next quota of Brainwashed Scientific Student loans!

Every vacant lot you walk past contains most of what you need .. it contains all the vitamins and minerals that you need to bolster our rotten contaminated food chain. What is more .. the plants that grow there have a far clearer idea of how much .. and where .. than the much vaunted RDA,s of Baby Pharmageddon .. Nature knows best about balance .. She knows what you want! She gives it for free .. she does not support student loans .. she supports us all ... cut out the middle man!

Hang about .. or visit all of the other sites that promote Health Freedom .. it may save your life. There are cures for Cancer and all of the other rotten things that have developed as a result of scientific medicine .. one just needs to apply some commonsense.


Posted by: Ivor Hughes on July 13, 2005 01:24 PM



no one has made that list yet. It would be impossible to do so, because there is much in motion to bring nutrient sources onto the "approved" list in the last moment. Over 500 substances were requested to be included, from the UK alone.

If pressure is kept up, which mainly the Alliance for Natural Health is planning to do, then we may end up with most vitamin and mineral supplements continuing to be available. But for now, there is really no telling. Everything is very much in the air.

Posted by: Sepp on July 14, 2005 08:33 PM


Minister pledges support for consumers and industry over Directives
November 23, 2005
The recently appointed health minister, Caroline Flint, has pledged continued government support to consumers and industry over EU regulations that threaten access to safe and effective natural health products.

Speaking at the Consumers for Health Choice (CHC) Annual Parliamentary Reception Flint said that since taking office she had personally been involved with a series of discussions and briefings with the Food Standards Agency (FSA) on the Food Supplements Directive (FSD). She was confident that these, and other on-going discussions, would enable Britain to negotiate the best deal in Europe for British consumers and industry. She added that she had recently given ministerial approval to the FSA Board's proposal that Britain should seek a 'national exception' in Europe which, if successfully agreed with the EC, would enable higher dose VMS products to stay on the shelves.

Flint, a pro-European, said that the biggest challenges facing the natural products industry in Europe were cultural not institutional. "Sometimes it is simply a case that there is someone in Germany who doesn't understand the different trading and consumer traditions in, say, Britain or the Netherlands. We need to find ways of dealing with these cultural differences sensibly and effectively.‚Ä??

Speaking on the subject of the Herbals Directive, Flint commented: "This is an area where I know there are differing views. Some people believe that the regulations are welcome and overdue. But at the same time I accept that government should be giving maximum support to industry to help manufacturers get their products registered.‚Ä??

In his speech CHC chair, Michael Peet, said he welcomed the interest the new minister had given to consumer and industry concerns over the FSD and other EU legislation.
He commented: "I believe that we are witnessing a paradigm shift in government thinking on these issues and am hopeful that this could, finally, set us on a route to finding a safe home in Europe for our products.‚Ä?? But he added that CHC's own message to government had become increasingly hard-hitting politically, largely because of the inaction of previous ministers.

CHC director, Sue Croft, said she had been delighted with the way the reception had gone. "It was very well attended, with good representations from both Houses of Parliament. In terms of getting across our message to individual MPs and Peers I think this was probably our best ever House of Commons reception.‚Ä??

However Croft agreed with long-time CHC supporter, Austin Mitchell MP, who said that the "fight against overzealous EU regulations‚Ä?? had to continue if the battle was to be won. Switching his attention to recent media scares about supplements, Mitchell said: "The streets would be littered with the dead if vitamins were half as dangerous as some people would have you believe.‚Ä??

Posted by: Sepp on November 25, 2005 10:46 PM


Is it just me or is anyone else wondering whether the big pharmaceutical companies had any part in this directive? After all, the directive can be seen as a one-off tax on every company in the industry, but of course the big companies have no problem paying, it's only the smaller, natural health ones that will struggle, possibly pushing them out of business. Result being more market share for the survivors. I can't believe that Coenzyme B5, shown to decrease cholesterol and help break down the toxins which build up in our body, has been banned. Europe goes on and on about being for the people and consumer choice, this directive shows how the reality is completely different.

Posted by: Sarah Stone on December 12, 2005 02:30 PM


Dear Sir/Madam

can you help me, where do i get information about statutory details for herbal medicine or as food supplements..

looking forward for a reply.

With warm wishes

Dr Suresh Babu J

Posted by: Dr Suresh Babu on May 18, 2006 08:40 AM


Dr Suresh,

you will have to contact an industry association (like the European EHPM)

for such detailed information.

Posted by: Sepp on May 18, 2006 11:49 AM


I would like to receive some advice on what type of food supplements that is good for somebody who has suffered stroke?

Thanks very much.

Posted by: Eddugle Akwetey on June 1, 2006 03:58 PM


Mr. Ivor Hughes! Top statement! You express my thoughts and fears and I dread to think how I will get my cell fuel in the future. In the meantime we have a battle on both sides. The other is doubley convincing others who badly need to supplement their diets with bioavailable minerals and vitamins in the face of all this hype and scare tactics. Jamesina Goulbourne

Posted by: Jamesina Goulbourne on November 1, 2006 06:44 AM


I would like to receive some advice on what type of food supplements that is good for somebody who has suffered stroke?

Thanks very much.

Posted by: HR Wallace on July 9, 2007 02:10 PM


Is there more information about "detailed Dossier in respect of each nutrient " and else well as registration fee for each substance ?

Posted by: Ray on August 5, 2010 02:09 AM


The agency now in charge of evaluating nutrient sources for supplements is the European Food Safety Agency. Here is an article that gives some news on such approvals: You can contact them if you need further details.

Posted by: Sepp on August 8, 2010 02:03 PM


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The Individual Is Supreme And Finds Its Way Through Intuition


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These articles are brought to you strictly for educational and informational purposes. Be sure to consult your health practitioner of choice before utilizing any of the information to cure or mitigate disease. Any copyrighted material cited is used strictly in a non commercial way and in accordance with the "fair use" doctrine.



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