European Food Supplements Directive

[Guest guest]

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:

 

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.

 

There must be a greater degree of clarity on what information

companies need to submit to admit an ingredient to the positive list.

 

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:

 

 

 

 

 

To , please go to www.alliance-natural-

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