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