European Court Decides: Food Supplements Directive May Go Ahead

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LUXEMBOURG, 12 July 2005 - The European Court of Justice has delivered its judgement today in a legal case that challenged the restrictive provisions of the EU's food supplements directive. The judges confirmed the validity of the supplements directive. The verdict states that:

"Examination of the question referred to the Court has revealed no factor of such a kind as to affect the validity of Articles 3, 4(1) and 15(b) of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements."

The decision comes as a surprise to activists and observers, because the court's advocate general had previously expressed serious doubts as to the validity of at least some of the provisions of the directive, which require expensive "proof of safety" to be supplied to the European authorities for ingredients, even if they have been used safely for years.

For a copy of the full judgement, go to this page on the EU Court's site and follow the "Judgement" link.

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The Alliance for Natural Health takes a substantially positive view of the outcome, based on the fact that the judgement, in some of its parts, does provide for accountability in the process of approval of new substances and may even have left a "way out" for substances naturally occurring in our foods. Here is their preliminary evaluation.

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The European Courts of Justice today handed down its judgment and the ruling is far from doom and gloom! See ANH's preliminary interpretation below...

The European Court of Justice in Luxembourg today announced that it is upholding most aspects of the controversial EU Food Supplements Directive, after a landmark legal challenge by the Alliance for Natural Health.

The initial reaction amongst many commentators was that this was disappointing news, as it contradicted the EU Advocate General's recommendation that the directive should be invalidated in its entirety and allowed a positive list system for nutrients.

But on closer analysis there is a silver lining to the judgment. There appear to be very significant and positive details within the verdict which vindicate the arguments presented to the Court by ANH and which may be beneficial to the millions who use vitamin and mineral supplements and key to everything that ANH has been campaigning for all along.

At the heart of the Food Supplements Directive (FSD) is the positive list of vitamin and mineral ingredients allowed for use under the Directive. To get an ingredient onto the positive list, manufacturers have to go through an onerous process to prove that each natural ingredient is safe. With this process costing up to or even more than £250,000 per ingredient, and vitamin and mineral supplement manufacturers typically being small companies, that would effectively lead to an ingredient being excluded, even if it came from natural sources that had been part of the human diet for thousands of years.

With the ruling from the European Court, coupled with the Industry's response in submitting large numbers of simplified dossiers, the wide-reaching bans that were anticipated on 1 August, will now not occur.

In summary, the preliminary analysis of the European Court‚s judgment by ANH's legal and scientific team indicates:

1. Bans of natural vitamins and minerals not on the positive list that are "normally found in or consumed as part of the diet" will now not occur.

2. There must be a greater degree of clarity on what information companies need to submit to admit an ingredient to the positive list.

3. Once an ingredient is submitted for consideration the positive list, it cannot be refused unless a full safety assessment, based on "the most reliable scientific data available and the most recent results of international research" proves the ingredient (or dosage) is unsafe. This returns considerable burden of proof to the Regulator, rather than it being placed only on Industry. Also, any refusal can still be challenged in the courts.

ANH will release much more detailed information on the interpretation of the European Court's judgement in due course, and will be making submissions directly to the European Commission, the European Food Safety Authority, competent authorities in EU Member States, and other relevant organisations.

ANH remains committed to the Food Supplements Directive, where it is doing its job properly as it provides a safe harbour for natural food sources of vitamins and minerals, that can prevent them being considered as medicines. ANH is also ready and willing to work closely with the European Commission institutions, providing its professional expertise to ensure that the processes in the Food Supplement Directive are indeed based on good law and good, leading-edge science, which have been central to ANH's approach from the outset.

If this interpretation of today's ruling is correct, it may be that the David and Goliath challenge brought by the Alliance for Natural Health may have a positive outcome for the millions who choose the leading edge in natural healthcare.

See ANH Press Release

See also:

The Times: Controversial EU vitamins ban to go ahead

Daily Mail: Food supplement restrictions upheld

The Guardian: EU court backs health supplements ban

BBC News: Vitamin controls backed by Europe

BBC: The Balance of Opinion
Do you agree with European vitamin ruling?

A call to action: how we can beat the European Food Supplements Directive

Compromise on EU Vitamins and Minerals
A legal challenge to overturn the EU’s controversial Food Supplements Directive is over, but the corporate takeover of herbal medicine and natural remedies continues, writes Sam Burcher of the Institute for Science in Society.

Jim Turner, the general counsel to The Weston A. Price Foundation, a charity that disseminates knowledge on nutrition, believes that Codex and the EU Directive on food supplements derive from the same basic reductionist model of western science that argues that pharmaceuticals are the only answer to health problems. World food experts refute this model by stating that natural vitamin A supplements can offer developing countries thirty times as much social improvement as one dollar of development aid.

Turner recommends that vitamin and mineral guidelines should be evaluated by nutritional science rather than the toxicological science used to evaluate toxins. Codex categorically states that nutrients should be treated as toxins and that foods and nutrients are not useful in treating disease and therefore supplements are of little value.

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Update:Here a recent communication (February 2006) from the Alliance for Natural Health:

EU FOOD SUPPLEMENT BAN STILL A TICKING TIME BOMB
Alliance for Natural Health keeps the ball rolling in landmark lawsuit

The Alliance for Natural Health, the not-for-profit campaign organisation that pioneered a landmark legal action against a proposed EU ban on thousands of food supplements, has informed the UK government and High Court in London of its intention to continue its legal action.

Publicity following the European Court of Justice (ECJ) judgment, handed down on 12th July 2005, implied that all had been lost since the Food Supplements Directive, the target of the challenge, had been upheld.

The ECJ ruling came as a surprise to many given an opinion issued in April 2005 by a senior advisor to the Court, Advocate General Leendert Geelhoed. Geelhoed had referred to the Food Supplements Directive "as transparent as a black box" and proposed that it contravened basic principles of European Community law and so was invalid under EU law.

The ANH has argued that the Court, in its judgment, has actually delivered a solution that takes into account the main concerns raised in its legal challenge while allowing the Directive to be upheld. This approach by the court has major benefits over invalidating the Directive: it avoids the need to re-negotiate a new Directive, whilst it also allows the European institutions to save face.

Recently appointed Legal Director for the ANH, barrister Robert Collins, says, "The ANH's legal challenge is not yet complete. We need still to go back to the High Court in London where the challenge was initiated. The ANH intends to show how the Statutory Instrument that transposes the EU Directive into English and Welsh law is seriously out of step with the European Court‚s judgment."

Collins continues, "Recently we have had some very constructive discussions with the UK's Food Standards Agency and we are hopeful that we can work collaboratively with the government towards a solution."

Collins apparently demonstrated to the Food Standards Agency some of the key contradictions between the Statutory Instrument (the Food Supplements Regulations 2003) and the Court's judgment. He showed, for example, that the judgment clearly demonstrates that the Directive does not apply to food supplem