Supplements Directive Lacks Transparency - Advocate General's Opinion
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, an example is (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
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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 Director 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.anhcampaign.org
See also:
Why organized medicine wants to outlaw nutrition and turn healers into criminals
How about some truth for a change about the Food Supplements Directive in the European Union? The proponents of this directive say that it's about protecting patients from all these dangerous vitamins, minerals, supplements, plant extracts and antioxidants that are so dangerous for people. They say, "We're going to keep you safe!"
posted by Sepp Hasslberger on Tuesday April 5 2005
updated on Monday November 29 2010URL of this article:
http://www.newmediaexplorer.org/sepp/2005/04/05/supplements_directive_lacks_transparency_advocate_generals_opinion.htm
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