Supplement Directive Lacks Transparency Advocate General's Opinion

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Though this is not the final ruling- it is at least looking

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Misty L. Trepke

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Supplements Directive Lacks Transparency - Advocate General's Opinion

 

http://www.newmediaexplorer.org/sepp/2005/04/05/supplements_directive

_lacks_transparency_advocate_generals_opinion.htm

 

 

5 April 2005 - In a case brought by the Alliance for Natural Health

(ANH)) and others in the UK, challenging the European Supplement

Directive's restrictive provisions, especially the limitation of

allowed ingredients to a short list of mostly synthetic sources of

vitamins and minerals, Advocate General Leendert Geelhoed has filed

his opinion, coming to the following conclusion:

 

" Examination of the provisions of Directive 2002/46/EC of the

European Parliament and of the Council on the approximation of the

laws of the Member States relating to food supplements has disclosed

that the Directive infringes the principle of proportionality,

because basic principles of Community law, such as the requirements

of legal protection, of legal certainty and of sound administration

have not been properly taken into account. The Directive is,

therefore, invalid. "

While this is not the final decision of the court which is expected

only in June, the opinion of the Advocate General gives hope that

the directive may eventually be re-drafted to allow products

currently on the market to remain on sale. Currently, the EU measure

mandates that products not in compliance with the restrictive " short

list " of ingredients would become illegal in August this year.

 

This new development is a great relief for all concerned - a ray of

light at the end of the tunnel so to say. ANH has a press release

which you can find in the second part of this article. There are

also press reports, early examples are (here) and (here).

 

The Advocate General examines the case and all connected laws and

makes a recommendation to the court. In his opinion, Geelhoed

confirms that the supplements directive has legitimate aims of both

health protection and promoting trade in the Community, but he also

harshly criticizes the administrative procedure for adding

substances to the list of allowed ingredients saying it lacks

transparency and even minimal standards of good administrative

practice. His recommendation therefore translates to " back to the

drawing board " - at least as far as procedures go. If you are

interested in the actual text of the Advocate General's opinion, you

can find it here.Download PDF file

 

- - -

 

ADVOCATE GENERAL FINDS FOOD SUPPLEMENTS DIRECTIVE INVALID UNDER EU

LAW

 

There was tremendous news today for the millions of people in Europe

who choose to use food supplements. Following a landmark challenge

in the European Courts of Justice (ECJ) brought by the Alliance for

Natural Health and Nutri-Link Ltd to the contentious Food

Supplements Directive, which effectively proposed to ban 75% of

vitamin and mineral forms, Advocate General Geelhoed, the senior

adviser to the ECJ, gave his Opinion in favour of the Alliance's

case.

 

What does this mean? That the chances of consumers being able to

continue using the natural food supplements they believe are

beneficial to their health are now greatly increased. There has been

uproar about the proposed EU ban, and maybe, against the odds, the

consumer is going to come out on top in what is a remarkable modern

day case of David and Goliath.

 

In a statement released in Luxembourg today at 0830 GMT, the

Advocate General concluded that:

 

• The Food Supplements Directive infringes the principle of

proportionality because basic principles of Community law, such as

the requirements of legal protection, of legal certainty and of

sound administration have not properly been taken into account.

 

• It is therefore invalid under EU law.

 

It should be stressed that the Advocate General's pronouncement is

not a ruling. That will come from the ECJ judges, later - probably

around June. But typically, in the vast majority of cases, the Court

Judgment follows the recommendations of the Advocate General.

 

If the Advocate General's recommendations are adopted, in effect,

the ban on vitamin and mineral forms not included on the

EU's `Positive list,' due to come into effect on 1 August 2005, will

be declared illegal. In essence, the positive list of allowable

nutrient forms will be deemed to be too narrow, too restrictive, and

based on flawed science.

 

This would avoid the totally irrational situations that the Food

Supplements Directive would otherwise create. For example,

synthetically produced selenium would have been allowed on the

positive list, while the natural source found in Brazil nuts would

not; synthetic forms of Vitamin E (often used in `adverse' vitamin

studies reported in the media) would be allowed, but the natural,

most beneficial food forms would not.

 

An outstanding moment for the Alliance for Natural Health

 

The Alliance for Natural Health (ANH) is a Europe-wide professional

organisation dedicated to ensuring that good science and good law

are applied to regulation affecting the leading edge of natural

health. If the Advocate General's recommendations are endorsed by

the ECJ judges, it will represent the culmination of three years

dogged determination, dedication and hard work on the part of ANH

and its many supporters around the world.

 

`It is commendable that the EU Advocate General has seen through the

flawed science and law of the Food Supplements Directive and reached

his recommendations today,' said Dr. Robert Verkerk, Executive of the ANH. `All that ANH is campaigning and working

cooperatively for is the right for consumers to have access to safe

natural healthcare and for legislation to be based on good science

and good law. This is a great day for the tens of millions of people

who believe passionately in the benefits of natural, preventative

healthcare.'

 

David C. Hinde, Solicitor and ANH Legal Director, added: `This is a

very significant Opinion in a landmark case. What we want to see in

the EU is the Food Supplements Directive doing the job for which it

was created which is to provide a " safe harbour " for food

supplements so that they are not classified as drugs, and to promote

their availability across the EU. Advocate General Geelhoed is the

most senior Advocate General at the ECJ and his considered reasoning

vindicates ANH's legal analysis and position. We are very optimistic

that the Court will adopt his recommendations.'

 

Supporting safe supplements

 

ANH supports many aspects of the Directive, and firmly endorses the

banning of ingredients that are patently not safe, stating that

existing UK and EU food law already provides perfectly effective

protection from unsafe products getting onto the market.

Furthermore, ANH says that it is not scientifically rational to

classify an ingredient as being unsafe without taking dosage levels

into account, something that was not a condition of being admitted

onto the positive list.

 

ANH believes that a far more appropriate system for banning any

substances that might pose a risk to health would be to produce

a `Negative list' for ingredients where there was proper evidence of

lack of safety. The system proposed by the EU was going to ban

ingredients on the basis that companies did not have the financial

capacity to meet the high data threshold required for the scientific

dossiers demanded by EU authorities. In this way, ingredients that

have been part of the human diet for thousands of years, and which

are increasingly difficult to derive from conventional foods, would

be lost, and would not be able to be supplemented.

 

The future of the leading edge of natural health secured

 

Drawing its support European-wide from consumers, manufacturers,

retailers, practitioners and some of the leading experts in

nutritional medicine, ANH has taken on the Goliath of the European

Commission and those that support the unscientific and unlawful ban

in the Food Supplements Directive, to protect the interests of

everyone concerned with the leading-edge of food supplements and

natural healthcare.

 

`None of the major EU countries felt the need to oppose our

application for a declaration that the ban on vitamins and minerals

in the Food Supplements Directive was unlawful,' added Anthony

Haynes, Technical Director of Nutri-Link Ltd., a UK food supplements

company that brought the legal challenge jointly with ANH. `It's

bizarre how this regulation got this far.'

 

A wide welcome across the industry if the ban is overturned…..

 

Greg Watts, Chief Executive of Ultralife, a manufacturer of leading-

edge food supplements, said: `This is very encouraging news. If the

ban came into force we would have to reformulate down to simpler,

more basic products that consumers and practitioners find are less

effective.'

 

Dr Damien Downing, a medical doctor and one of the UK's leading

practitioners in nutritional medicine, said: `Practitioners of

nutritional therapy, and there are thousands of them in the UK,

largely use leading-edge food supplements. If these nutrient forms

remain, we can continue to treat our patients with meaningful

solutions and provide the products that we know are so beneficial. A

ban would in one fell swoop remove the vital tools of practitioners'

trade.'

 

Sara Novakovic, owner of Oliver's Wholefood Store in Richmond,

Surrey, said: `At last it is now highly likely we can continue to

offer the products that our customers ask for and want, rather than

have to remove them all from the shelves for no good reason and

supply them with inferior quality alternatives.'

 

The end of the beginning

 

This is just the beginning for the Alliance for Natural Health.

Regulatory and industry pressure through the EU Food Supplements

Directive was always likely to translate globally, particularly to

the US, through Codex and the World Health Organisation. Without

having to justify any health hazard, and without considering any

benefits, safety has been used as a reason to restrict the

availability of natural food products.

 

`Yet food supplements are the safest things that people put into

their mouths – considerably safer even than conventional foods',

said Dr Robert Verkerk. `With rapidly declining vitamin and mineral

content in fruit vegetables and other foods, and continuing

increases in degenerative diseases such as heart disease and cancer

in the West, this has always been a very big issue worth fighting

for.'

 

`Fundamentally, an amended Directive would help to slow down the

agenda of the Codex Alimentarius Commission to export worldwide an

onerous, EU-style regime for food supplements.'

 

David Hinde added. `The ANH is now going to be working on getting a

proper procedure in place for the Food Supplements Directive and in

addition, the next challenges will be on legislation proposing to

reduce dosages to ineffective levels, and to restrict other nutrient

forms such as amino acids, enzymes and plant nutrients. Traditional

herbal remedies are also under threat. In its work, the Alliance for

Natural Health will continue its thorough, professional approach

based, as always, on `good science, good law.'

 

For enquiries and further information contact:

 

Alliance for Natural Health

www.alliance-natural-health.org