ANH Brief: What is wrong with the EU Food Supplements Directive

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Alliance for Natural Health

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Wednesday, February 09, 2005 8:55 AM

 

 

 

 

ANH Brief: What is wrong with the EU Food Supplements Directive

 

 

 

There has been much misunderstanding, and dare I say it,

misinformation, regarding the EU Food Supplements Directive and ANH's

legal challenge to it.

 

As ANH Partners and Members it is vital that you understand what is

really going on and I am going to attempt in this letter to put you in

the picture.

 

It is quite involved and may take a little time to read but I urge you

to persevere as your continued access to quality and effective food

supplements depends on YOU taking appropriate informed action.

 

What's wrong with the Food Supplements Directive?

 

The British Government and many MPs and MEPs when asked about the Food

Supplements Directive ( " FSD " ) will insist that it is a good piece of

EU legislation because it harmonises the currently very different laws

of all EU Members States in respect of food supplements and ensures

high quality standards at the same time. Thereby trade in supplements

is increased across the EU and consumers can feel safe.

 

Seems reasonable you might be thinking.

 

But what is the price tag?

 

6 key things principally;

 

1. The FSD reverses the burden of proof as regards showing that

food supplements are safe. Previously a food supplement could

generally be sold as food unless the Regulator could prove

scientifically that it is unsafe. (This is the position in the USA for

example under DSHEA). Now in the EU it will be for the manufacturer to

prove at great cost that it is harmless before he can sell it.

2. It creates a very restricted list (known as the " positive list " )

of allowable nutrients which favours synthetic nutrients over those

much closer to how they are found in nature.

3. It will, in time set what are anticipated to be very low maximum

doses of nutrients

4. In order to get on the positive list of allowablenutrients a

technical and very costly Dossier will required which may or may not

ultimately be acceptable to the EU Regulators

5. If a nutrient (or its source) isnot on the restricted list it

will be banned across the EU from 1 August 2005 regardless of the fact

that it was previously happily allowed to be sold in various EU Member

States for perhaps many years

6. At present the FSD only applies to vitamin & minerals. However

it is a framework Directive and is intended in time to apply to all

nutrients and their sources. So the negative pattern we see here

applying now to vitamins and minerals will in time be applied to all

nutrients.

 

So what have we got?

 

Under the guise of a harmonisation Directive ostensibly seeking to

improve the supply of food supplements across the EU, we in fact end

up with a measure which will ban many nutrients presently on sale in

the EU.

 

And for those that get through, the maximum dose levels are likely to

be very impotent.

 

The Directive thus defeats the whole purpose for which many people

take food supplements, namely to supplement their diet in order to

promote optimal well being through the addition of key vital nutrients

which they cannot get in their normal diets any more (unless they

happen to live in an organic tropical paradise).

 

The fact that the FSD has a negative effect is impossible to hide.

 

The UK Government when it undertook its Regulatory Impact Assessment

(measuring the impact of the implementation of the FSD in the UK)

concluded that on balance the FSD had a negative cost / benefit for

the UK and conceded that the ban on nutrients which are currently

allowed to be sold in the UK (unless they get requalified by

submission of a dossier) was " unnecessary " .

 

You'll see many statistics flying around but in essence we are looking

at the ban of around 75% of the vitamin and mineral sources ( " forms " )

currently on the EU market. This will translate into a banning of some

300 vitamin and mineral ingredients and possibly around 5000 products

currently available.

 

Now remember, if this is what is happening to vitamins and minerals

now what will happen to all other nutrients in the future?

 

Keep well in mind the 3 FSD bogey men:

 

1. The reversal of the burden of proof

2. The restricted list of allowable nutrients unless proved

harmless at huge cost

3. The very low potencies which will be allowed even if a nutrient

gets through and onto the positive list

 

In summary what the FSD is really doing is to impose quite arbitrarily

and unnecessarily, a drugs style licensing regime on food supplements

or more particularly on food nutrients which hitherto we have been

eating happily for thousands of years!

 

Well if this is so bad you might be asking how on earth did it get

passed into EU law?

 

Indeed.

 

ANH has exhaustively researched this question and bottom line no one

seems really to be able to justify what has happened.

 

The usual reason given is as I have explained above. The FSD will

promote trade in safe food supplements across the EU.

 

And yes the price tag for the UK and other more liberal regimes may be

high but that was the best we could get in our negotiations in Europe,

so says the UK Government in particular.

 

But we say at ANH that the price is far too high and quite unnecesary

and unacceptable.

 

The international Dimension

 

You might be reading this from a country outside the EU and thinking

well that's pretty tough for those Europeans but we're ok here.

 

True for now, but perhaps not for long.

 

You may be aware that the EU has the dominant vote in the setting of

Codex international standards for food. Thus what they want they can

push through even if other countries protest.

 

This is a complex area of international law but in brief ANH and

others are extremely concerned that an EU regime for the treatment of

food supplements may be exported world wide under the auspices of

Codex and made to have regulatory teeth through the WTO.

 

More, on this complicated subject in another letter.

 

But for the time being I repeat my point.

 

Bad things that happen in Europe may very well in time also negatively

affect the rest of the world.

 

And that means YOU.

 

The ANH Legal Challenge

 

As you are well aware pretty early on ANH came to the view that the

only way to deal with the FSD was to challenge it in the Courts and

ultimately that meant bringing a case in the EU supreme court; the

European Court of Justice ( " ECJ " ).

 

I will not bore you with the details of our case (for those who are

interested, the key documents are available in the " ANH Legal

Challenge " documents area of our web site).

 

But in essence we are saying the following.

 

Food supplements are food, not drug.

 

Therefore they do not need a drugs style regulatory regime imposed

upon them.

 

You do not need a license to sell food.

 

Under existing law throughout the EU, food is perfectly well regulated

from a legal point of view ensuring quality and safety.

 

The Food Supplements Directive, if it really was intended to harmonise

and promote the supply of safe food supplements across the EU, did not

require a ban on nutrients which were not on the positive list.

 

It could have and indeed should have had merely a minimum list of

acceptable nutrients which all Member States were obliged to accept

across the EU (sometimes called a " White List " ).

 

Whilst leaving individual Member States free to allow a wider

selection of nutrients to be used in food supplements within their

particular borders if they wanted to.

 

Indeed we go further and argue that under EU law, the FSD,in imposing

a sweeping and draconian ban across the EU without even attempting to

provide a scientific justification or rationale, actually infringes EU

law.

 

We conclude that the FSD should be allowed to remain and but should do

its job properly.

 

Thus without the ban.

 

It would then act as a minimum white list of vitamin and mineral

nutrients which all Member States would be obliged to accept across

the EU.

 

That would increase trade.

 

What are our chances of success?

 

Cautiously we would say that we are optimistic. EU legal precedent is

on our side.

 

The UK Government chose not to make present oral submissions at the

Hearing of the case in the ECJ on 25 January 2005. Paul Lasok QC, our

barrister said that in his experience it is most rare for the UK to

not attend an oral hearing where it has filed Written Observations as

it has done here.

 

The only Member State to present oral submissions was Greece.

 

And despite repeated questioning from the Advocate-General (a very

senior independent lawyer who advises the ECJ in its deliberations),

none of the Community Institutions were able to adequately explain

exactly how the procedure for getting a nutrient on to the positive

list actually works.

 

Indeed in some consternation the Advocate-general exclaimed at one

point that as far as he could see it the procedure had " the

transparency of a black box " .

 

Aside from being amusing this comment is significant because if the

ECJ finds that there was no proper and transparent procedure for

getting on the positive list that itself would be a ground for finding

the ban as being unlawful under EU law.

 

As you will have seen from our press releases the Advocate-General

will be giving is Opinion on 5th April 2005.

 

Thisis not the judgment of the Court which will follow probably in

June 2005. However as the ECJ tends to follow its Advocate-Generals'

Opinions in 80% of cases this Opinion is going to be very significant.

 

What you can do

 

First and foremost please understand that we are all in this together.

 

It's not a question of you helping the ANH with " its problem. "

 

No, rather we, together with you are in an alliance to protect the

continued supply and availability of natural advanced and safe food

supplements in the EU and indeed the world which are able to do their

job properly.

 

What job?

 

Supplying vital micro-nutrients which are now missing from our western

diet.

 

So when you help the Alliance you need to see that you are helping

yourself and your family and those who are dear to you, to be able to

maintain optimal health.

 

More particularly here are some key actions points for you:

 

1. Tell your friends and contacts about the problem and forward

this and other ANH e-mails to them so that they know what is going on.

2. Recruit your friends and contacts to join the Alliance.

3. Donate urgently needed funds to ANH.

 

PLEASE TAKE ACTION NOW!

 

To make a donation to ANH click here

 

Remember that without you there is no Alliance!

 

Thanks for all that you do.

 

Yours in health!

 

David C. Hinde LLB Solicitor

Legal Director

Alliance for Natural Health

http://www.alliance-natural-health.org