ANH analaysis of Euro directive on Food supplements

[Guest guest]

The tide is turning...

 

As supporters or interested parties of ANH, you may well have been

confused by the conflicting media concerning the European Court of

Justice ruling, handed down on the 12th July.

 

The mass media responded to a hail of press releases issued very

soon after the judgment was handed down at around 10.00 am UK time.

Within minutes of receipt of the judgment, our team was able to

quickly see that although the EU Food Supplements Directive had not

been invalidated, there were some important concessions in the

judgment. The Court seemed to have reached the ultimate compromise:

it was allowing the EU Institutions to avoid major embarrassment

over an invalidated Directive, yet it still had to deal with the

very significant problems that the Directive was going to pose to

the availability of food (dietary) supplements, particularly those

that contained ingredients identical to those found in foods.

 

Given that we knew that we disagreed with the sentiments that were

contained in the 'end of the world' scenario releases that had

travelled around the world early last Tuesday morning, we held off

making a release until we had confirmed our preliminary analysis

with our leading EU barrister, Paul Lasok QC. This enabled us to go

out with our upbeat press release later in the day, but of course,

it missed most of the news, because the wires were saturated with

the earlier salvo of negative releases.

 

We have now had a further 2 days to really dig into the judgement,

and we are now solidly of the view that there are very substantial

gains made as a result of the ruling. The essence of this you will

find in our press release below (also on the Latest News on the ANH

website). However, there is a lot of work still to do to help the EU

institutions, competent authorities as well as the industry

understand all of the complex implications, and to reach mutual

agreement over the interpretation. We may also need to push for

changes in the EU Member State laws which have been transposed from

the EU directive itself.

 

So – all in all – we see a clear win for consumers, a clear win for

practitioners and a clear win for the leading-edge of the innovative

industry. These are the key groups that matter to us, because it is

with these interests that we spearhead the revolution in healthcare

that we all know is within our reach, where the use of natural

products, in combination with positive changes to lifestyle, is at

the heart of the resolution of most of the chronic disease and drug

side-effect problems with which societies around the world are now

burdened.

 

We find ourselves in a minority with our interpretation, but this is

not a new feeling for us. This is how change begins.

 

We again wish to extend our huge gratitude to all of you who have

allowed us to get this far - for believing in what we are trying to

achieve. Please remember, that the road we are on is a long one and

one on which we have to remain if we are to see the bright light of

nutritional health management as the mainstay in future healthcare.

Only with your support, can we continue.

 

Thank you.

 

In health,

 

Dr Robert Verkerk

Executive Director

Alliance for Natural Health

info

www.alliance-natural-health.org

 

 

 

PRESS RELEASE

Alliance for Natural Health

 

15 July 2005

 

 

ECJ RULING SECURES FUTURE FOR VITAMINS AND MINERALS

 

WHY THE ALLIANCE FOR NATURAL HEALTH MAINTAINS THAT THE EUROPEAN

COURT RULING ON THE FOOD SUPPLEMENTS DIRECTIVE IS A VICTORY

 

After further detailed analysis of the ECJ judgment with its expert

EU barrister Paul Lasok QC, ANH anticipates that following the ECJ

verdict:

 

o The vast majority of vitamin and mineral food supplements will not

be banned on 1 August

 

o The Directive now does not apply to natural forms of vitamins and

minerals normally found in the diet

 

o Where it is necessary to be on the positive list, gaining

admission will now be a much simpler, less time consuming and more

affordable process than was previously the case

 

o The burden of proof for showing an ingredient to be unsafe will

now lie with the regulator and not the manufacturer

 

This successful outcome is, effectively, what ANH has been working

towards for over three years.

 

The initial media reaction on Wednesday to the judgment of the

European Court of Justice (ECJ) on the Food Supplements Directive

(FSD) was one of disappointment. Yet the Alliance for Natural Health

hailed it as a victory. ANH's specialist EU lawyers have now given a

more considered interpretation of the ruling and still maintain that

ANH has achieved the key objectives it has been working towards in

relation to the FSD over the past three years. Crucially, it is

highly likely that most vitamin and mineral supplements will

continue to be available. Here's why….

 

It is not a simple question of whether the FSD was lawful or not.

The devil, as always, is in the detail. ANH challenged the

lawfulness of the FSD because to ANH it appeared to have draconian

and quite unnecessary consequences for the food supplements industry

and for consumers. In upholding the lawfulness of the FSD, the ECJ

has clarified what exactly the FSD actually means and has clearly

restricted the scope of the application of the ban on non-FSD

compliant nutrients. There are very significant and positive details

within the judgment that will be beneficial to the millions of

consumers who use vitamin and mineral supplements for their health

and are key to everything that ANH has been campaigning for all

along.

 

At the heart of the FSD is the `positive list' of vitamin and

mineral ingredients that are permitted. On 5 April 2005 the ECJ's

Advocate General described the procedure by which ingredients are

added to the positive list as being " as transparent as a black box. "

Because of the FSD's lack of clarity and restrictive interpretation

by regulators, it was widely understood that to get an ingredient

onto the `positive list', manufacturers would have to go through a

very time consuming, onerous and costly process for them to prove

that each nutrient was safe. This might have cost more than £250,000

per ingredient. With many innovative, leading-edge supplements

containing sometimes upwards of 30 ingredients each, this burden

upon many leading-edge manufacturers, typically being small

companies, would effectively lead to them being put out of business.

This would be the case even if the products included natural sources

of vitamins and minerals that had been part of the human diet for

thousands of years.

 

However, the judgment of the ECJ has now gone a long way to make

the `black box' more transparent, and to require (although not

define) simplified procedures for getting ingredients onto

the `positive list'. In summary, the analysis of the ECJ'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. This coupled with the natural health industry's

response in submitting large numbers of `simplified dossiers', the

wide-reaching bans that were anticipated to come into force on 1

August 2005, are now unlikely to occur.

 

2. There must be a greater degree of clarity on what information

companies need to submit to admit an ingredient on to the positive

list. This is likely to be considerably simpler, shorter and less

expensive than previously feared, making it easily viable for

companies to get ingredients on to the approved list.

 

3. Once an ingredient is submitted for inclusion in the positive

list, it cannot be refused unless the regulator finds the ingredient

to be unsafe. If the regulator believes the ingredient should be

rejected, it will have to undertake a full risk/safety assessment,

based on " the most reliable scientific data available and the most

recent results of international research, " that will then prove the

ingredient (or dosage) to be unsafe. This transfers a considerable

burden of proof from the manufacturer to the regulator, principally

the European Food Safety Authority. Furthermore, any rejection can

then be challenged in the courts.

 

ANH is very confident of the validity of its view, but is aware that

as a result of the ECJ's judgment, a controversy about the scope of

the FSD has emerged. ANH says that the ECJ has limited the scope of

the FSD to vitamins and minerals obtained from non-natural sources,

while other bodies maintain that naturally sourced vitamins and

minerals are covered by the FSD.

 

Commenting, Dr Robert Verkerk, Executive Director of ANH, said:

 

" The fact that the necessary requirements for admission to the

positive list have been fundamentally changed now means that the

vast majority of high quality and innovative vitamin and mineral

food supplements will now, with relative ease and limited expense,

be able to join the positive list and thus not face a ban.

 

" These changes to the positive list have been at the heart of what

the ANH has been campaigning for over the last three and a half

years and indeed, formed the major part of its legal challenge to

aspects of the Food Supplements Directive.

 

" In achieving this, ANH has therefore gained a very significant

victory for consumers, practitioners, retailers and manufacturers in

protecting their right to buy, supply and produce safe, innovative

and leading-edge food supplements across Europe. "

 

While some organisations have relied more on emotional outcry,

calling for an all-or-nothing annulment of the Food Supplements

Directive, this has never been the case with ANH. All it has wanted

is sensible regulation, which is why it has worked `at the coalface'

in Brussels, Strasbourg and Luxembourg, with leading scientists,

medical doctors and experts in EU law.

 

ANH has always been committed to the Food Supplements Directive

properly doing its job as it provides a `safe harbour' for food

supplements that maintains them as a category of foods and prevents

them from being considered as medicines.

 

In light of the judgment, ANH is ready and willing to work closely

with the European Union Institutions and Competent Authorities in

Member States, providing its professional expertise to ensure that

the processes in the Food Supplements Directive are indeed based on

good law and good, leading-edge science, which have been central to

ANH's approach from the outset.

 

A quick reminder on why ANH has been the driving force in

challenging this legislation.

 

• ANH was formed in 2002 specifically to contest the Food

Supplements Directive, two weeks before it was due to be approved in

the European Parliament. Few even knew of this controversial EU

legislation at this time

 

• ANH raised media awareness of the issues at the time, including

the positive list and the prospect that thousands of food

supplements could disappear

 

• ANH brought the landmark legal challenge to the FSD in the

European Courts

 

• ANH provided the technical, scientific and nutritional data in

support of its challenge, also sharing its information with other

parties involved in mounting a parallel challenge

 

Without the efforts of this small, spirited organisation, the

situation we are in today, where most food supplements should remain

freely available, would not have happened, as the Directive would

have been misunderstood and applied incorrectly.

 

 

On the basis of this interpretation of the ECJ ruling, the `David

and Goliath' challenge brought by the Alliance for Natural Health

should have a positive outcome for the millions who choose the

leading edge in natural healthcare.

 

 

 

ENDS