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.
