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.
