European Court Decides: Food Supplements Directive May Go Ahead
LUXEMBOURG, 12 July 2005 - The European Court of Justice has delivered its judgement today in a legal case that challenged the restrictive provisions of the EU's food supplements directive. The judges confirmed the validity of the supplements directive. The verdict states that:
"Examination of the question referred to the Court has revealed no factor of such a kind as to affect the validity of Articles 3, 4(1) and 15(b) of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements."
The decision comes as a surprise to activists and observers, because the court's advocate general had previously expressed serious doubts as to the validity of at least some of the provisions of the directive, which require expensive "proof of safety" to be supplied to the European authorities for ingredients, even if they have been used safely for years.
For a copy of the full judgement, go to this page on the EU Court's site and follow the "Judgement" link.
- - -
The Alliance for Natural Health takes a substantially positive view of the outcome, based on the fact that the judgement, in some of its parts, does provide for accountability in the process of approval of new substances and may even have left a "way out" for substances naturally occurring in our foods. Here is their preliminary evaluation.
- - -
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:
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.
2. There must be a greater degree of clarity on what information companies need to submit to admit an ingredient to the positive list.
3. 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 also:
The Times: Controversial EU vitamins ban to go ahead
The Guardian: EU court backs health supplements ban
BBC News: Vitamin controls backed by Europe
BBC: The Balance of Opinion
Do you agree with European vitamin ruling?
A call to action: how we can beat the European Food Supplements Directive
Compromise on EU Vitamins and Minerals
A legal challenge to overturn the EU's controversial Food Supplements Directive is over, but the corporate takeover of herbal medicine and natural remedies continues, writes Sam Burcher of the Institute for Science in Society.
Jim Turner, the general counsel to The Weston A. Price Foundation, a charity that disseminates knowledge on nutrition, believes that Codex and the EU Directive on food supplements derive from the same basic reductionist model of western science that argues that pharmaceuticals are the only answer to health problems. World food experts refute this model by stating that natural vitamin A supplements can offer developing countries thirty times as much social improvement as one dollar of development aid.
Turner recommends that vitamin and mineral guidelines should be evaluated by nutritional science rather than the toxicological science used to evaluate toxins. Codex categorically states that nutrients should be treated as toxins and that foods and nutrients are not useful in treating disease and therefore supplements are of little value.
- - -
Update:Here a recent communication (February 2006) from the Alliance for Natural Health:
EU FOOD SUPPLEMENT BAN STILL A TICKING TIME BOMB
Alliance for Natural Health keeps the ball rolling in landmark lawsuit
The Alliance for Natural Health, the not-for-profit campaign organisation that pioneered a landmark legal action against a proposed EU ban on thousands of food supplements, has informed the UK government and High Court in London of its intention to continue its legal action.
Publicity following the European Court of Justice (ECJ)Â judgment, handed down on 12th July 2005, implied that all had been lost since the Food Supplements Directive, the target of the challenge, had been upheld.
The ECJ ruling came as a surprise to many given an opinion issued in April 2005 by a senior advisor to the Court, Advocate General Leendert Geelhoed. Geelhoed had referred to the Food Supplements Directive "as transparent as a black box" and proposed that it contravened basic principles of European Community law and so was invalid under EU law.
The ANH has argued that the Court, in its judgment, has actually delivered a solution that takes into account the main concerns raised in its legal challenge while allowing the Directive to be upheld. This approach by the court has major benefits over invalidating the Directive: it avoids the need to re-negotiate a new Directive, whilst it also allows the European institutions to save face.
Recently appointed Legal Director for the ANH, barrister Robert Collins, says, "The ANH's legal challenge is not yet complete. We need still to go back to the High Court in London where the challenge was initiated. The ANH intends to show how the Statutory Instrument that transposes the EU Directive into English and Welsh law is seriously out of step with the European Court's judgment."
Collins continues, "Recently we have had some very constructive discussions with the UK's Food Standards Agency and we are hopeful that we can work collaboratively with the government towards a solution."
Collins apparently demonstrated to the Food Standards Agency some of the key contradictions between the Statutory Instrument (the Food Supplements Regulations 2003) and the Court's judgment. He showed, for example, that the judgment clearly demonstrates that the Directive does not apply to food supplements whose ingredients include plant extracts and other nutrients for which their use remains under national rules.
Says Collins, "We are hopeful that the British government, the party with which we initiated the challenge, will work constructively with us towards a solution. Our lead barrister, Paul Lasok QC at Monckton Chambers, argues that there is now a statutory requirement to change the national laws to bring them into line with the European Court judgment. The UK government is in a strong position to take a lead on this, and this may well force similar changes in other EU member states. Without such changes, the Directive will not serve its intended purposes of harmonising laws across the EU and protecting consumers. Many people in different countries are fed up with over-zealous EU laws, and this is a landmark case which might help people to regain respect and faith in European law."
Dr Robert Verkerk, Executive & Scientific Director of the ANH adds, "The European Food Supplements Directive, as it was originally proposed, would have acted as a massive barrier to innovative, food-form supplements. The ECJ ruling, once adopted into Member State laws, opens the door to natural, food-form nutrients. Instead of running frightened from the Directive, we need to see its potential as a means to a permissive regime with key similarities to the kind of rules offered by the Dietary Supplement Health and Education Act 1994 in the United States."
Contact:
Dr Robert Verkerk, Executive & Scientific Director, Alliance for Natural Health
Tel: +44 (0)1252 371 275
Email: info@alliance-natural-health.org
Web: www.anhcampaign.org
The Alliance for Natural Health (ANH) is a Europe-wide and international non-profit alliance of consumers, doctors, complementary health practitioners, and innovative industry manufacturers and suppliers with interests in food supplements and natural health.
posted by Sepp Hasslberger on Tuesday July 12 2005
updated on Thursday December 16 2010
URL of this article:
http://www.newmediaexplorer.org/sepp/2005/07/12/european_court_decides_food_supplements_directive_may_go_ahead.htm
Related Articles
Supplements: EU Court Decision Will Preserve Wide Choice Says ANH
The recent decision of the European Court of Justice in a case brought by the Alliance for Natural Health, the Health Food Manufacturers Association and the National Association of Health Stores in the UK, will effectively preserve consumer choice for supplements, according to Dr Robert Verkerk of the Alliance for Natural Health. While the Court upheld the directive in its overall structure, there are some important points that the Luxembourg... [read more]
July 15, 2005 - Sepp Hasslberger
EU Court of Justice to Decide Fate of Supplements in Europe
The European Court of Justice is deliberating a challenge to the European Food Supplements Directive, which is expected to sharply decrease availability of nutritional supplements in Europe. The measure is setting tight rules for composition and envisages maximum dosages for vitamins and minerals, threatening to eliminate many of the more advanced supplement formulations from the market. The decision in the case has been announced for 12 July, just three days... [read more]
June 18, 2005 - Sepp Hasslberger
Where Are The Bodies? - The Exceptional Safety of Nutritional Supplements
Canadian Health Authorities are ready to regulate supplements in a similar way as pharmaceutical drugs, but resistance is rallying around a law proposal - Bill C 420 - which would clearly define and distinguish supplements from dangerous drugs, suggesting that supplements are more close to foods than medicines and should therefore be regulated in a similar way as food products. Medicines regulation could crush the supplements industry and make many... [read more]
May 17, 2005 - Sepp Hasslberger
European Health Legislation, Codex And The Sustainability Of Health Care
Brussels has been busy "adjusting" EU food and medicine laws for several years now, bringing increasingly onerous controls for natural products - notably herbs and food supplements. Some observers have criticized these moves as designed to give an unfair advantage to "conventional", pharma-based medicine and will cut across preventive health strategies. Prevention is high on the agenda, but official strategies are largely limited to avoiding and killing off germs. Nutritional... [read more]
April 20, 2005 - Sepp Hasslberger
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... [read more]
April 05, 2005 - Sepp Hasslberger
Scientific Study to Crack 'Black Box' Supplement Regulations
The Alliance for Natural Health, a European activist and campaign organization dedicated to the preservation of natural health options has commissioned a scientific study that will provide an in-depth examination of Europe's legislative approach to food supplements. The EU food supplements directive, which is being gradually implemented in all member states, could severely unsettle the market for nutritional supplements from 1 August 2005. It is feared that consumers will be... [read more]
June 27, 2005 - Sepp Hasslberger
Readers' Comments
Concerned parties beware: a revolution much more dangerous than what affects food supplements is the increasing "liberalization" of judges. For many of these gentle(?)men (and women) "the law" "justice" and such antiquated concepts are obsolete. What matters is the judge's hunch on what flow of feelings the case brings to him/her. Put it another way, the judge's personal ideology determines his sentences. Expect anything from such people but justice.
Silvano Borruso
Posted by: Silvano Borruso on July 12, 2005 02:17 PM
A comment by Martin Walker, author of Dirty Medicine and of SKEWED:
Dear Sepp,
Firstly thanks for providing such a great site.
I just want to say something about the decision today of the European Court of Justice. I have been involved in many court cases over the years, especially helping people to defend themselves. I have also been involved in many political campaigns. I have learnt not to get the two confused.
When it was first announced that the decision had been put off until July, it gave me reason to worry, because it was clear that Codex would be settled by then, my feeling was that the court would simply say that now Codex was in force any decision by the European Court could not be binding. As it is they have found some other peverted logic by which to deny the ANH a legal victory.
Although this decision will come as a terrible blow to the activists and supporters of ANH I have to say that it raises serious questions of strategy. Legal victories even when we get them, can only be a small part of the success in any struggle. And the ANH's determination not to get involved in politics - as if that were possible - was always a sign that they were leaving themselves wide open and without direction, if this legal battle failed.
Please don't think that I am crowing over this. Its just that the EU law is the law of a corporate society which mainly defends the interests of profitable global companies and the EU courts again with the lawyers who work in them are all part of a fraudulent and undemocratic system.
This situation can be seen clearly in the case of Loic Le Ribault whose case against the French Government, which had stolen all his forensic technology, and waged a war of disinformation against him, was thrown out summarily by the EU Court of Human Rights. Thrown out, after six years of process, with an accompanying message that they would 'not reply to any further communications with your lawyers'
Perhaps people only learn from experience, if this is the case then I think one of the most important things which activists have to learn, in this area, is that we are not involved in a discursive courtship of manners with these people. Big Pharma, their political accolytes, their embedded agents and their grass roots activists are involved in a fight to the death (ours) and they will not, unless it suits their purpose be deflected by the noise of party crackers from the garden.
Just while I'm on this subject, could I use this space to say something about Tim Bolen's impossibly optimistic articles which followed the publication of the House of Commons Health Committee report on The Influence of the Pahrmaceutical Industry. Again here, because Tim didn't stop for a second to think where this was coming from, he sent out ludicrously optimistic and misleading stories about it.
Did he really imagine that the British Parliament, in the wake of the most consolidated negotiations that any government has ever held with the pharmaceutical industry, would publish a report which in reality would mean constraints on industry competitiveness or profitability. It was all done for show Tim. It was all part of an elaborate dance called 'mollifying the war damaged public while Big Pharma walks off with the profit.'
Please let's use the political intelligence which we have and which is evident in many of Tim Bolan's emails, to organise ourselves around some central principles and strategies, rather than patting ourselves on the back for rear guard actions which it turns out we have lost.
Regards, Martin J. Walker
Posted by: Sepp on July 12, 2005 04:20 PM
My reply to Martin's comment:
Dear Martin,
sorry for the trouble you had putting the comment directly. I have taken it and inserted it at the end of the article.
You are making some good points, reflecting what I am thinking as well. Although I haven't got a recipe ready, it is clear that this decision should give us pause for reflection and certainly for a change in strategy.
It is becoming more and more obvious that the overall campaign for all but eliminating any effective supplement in favour of medical and pharmaceutical intervention is going ahead full steam.
Of course the more we feel the suppression, the more of us will perhaps wake up.
The pharma camp had two wins in little over a week. 4 July saw the approval of the Codex Alimentarius guidelines and 12 July this court decision. Nevertheless, they are not doing too well. The system of health care is falling apart for two reasons: Pharma is not delivering health, regardless of their PR. They are selling illness and even death at exorbitant prices, bankrupting whole countries.
Someone will realize what is happening, and I guess it may be up to us to point out the reality of the situation.
Kind regards
Sepp
Posted by: Sepp on July 12, 2005 04:36 PM
Yes, Big Pharma has gotten their way. I also feel that any kind of "alternative" practice of medicine, whether CAM, herbalists, "natural" nutritionists, are also targeted along with the food supplement industry. I feel there is a "pharmaceutical control" over people's lives similar to the Germany of the 1920s and 1930s, leading to the incredible inhumane treatment of German citizens, Jews and non-Jews alike. Unfortunately, there appears to be a sort of step type of conditioning both society and also the Physicians. When the Physicians and also the Pharmacists training is controlled in part by Big Pharma, good diagnosis goes out the window. It is only when you begin to understand the basic biochemical processes of the human body that you understand what good health is, and that chemical medications for the most part do not cure any disease, only mask the symptoms, and forward an early death. I think we all must watch and be on guard. The people especially now, need to be taught, at least those who are willing, to change lifestyles and diet to a healthy (perhaps vegan-raw, live plant food based diet) in order to preserve their health.
Thanks.
Kern Stafford, RPh
(renegade pharmacist)
Posted by: Kern Stafford, RPh on July 13, 2005 04:32 AM
BEUC, the European Consumers Federation that is financed by the EU Commission (in 2004 the amount was Euro 1,172,790), said it welcomes the directive:
The Judgement of the European Court today on the Directive on Food Supplements represents a clear victory for European consumers and for the EU's right to regulate on the safety of food products.
BEUC and our 40 independent national consumer organizations have long pressed for the regulation of food supplements in order to protect and promote the health of consumers.
"We are very pleased that the Court rejected the misguided and unfounded attack by vested interests on the validity of the directive�? said Jim Murray BEUC Director.
The discussion on the proposal for a directive was characterized by a well-funded and misleading campaign that sought by every possible means to block, obstruct or weaken the Commission's initiative. Happily the directive was passed and the Court has now rejected a wide ranging challenge to its validity."
Certainly BEUC does not seem to be representing the interests of those people who do consume supplements. They are gloating over this court decision, but then, what did they say - he who pays the piper calls the tune...
Posted by: Sepp on July 14, 2005 04:23 PM
A letter from Scott Tips to Sue Davies of "Which?", a UK association which says it protects consumers. Certainly they aren't protecting consumers of supplements who rely on vitamins to keep in good health...
From: SCT
To: sue.davies@which.co.uk
Sent: Wednesday, July 13, 2005 5:42 PM
Subject: Your recent quote in BBC News re ECJ Ruling on Vitamins
Dear Ms. Davies:
I read with interest your comments provided to the BBC in an article that was just issued by it about the recent decision by the European Court of Justice against the case brought by the Alliance for Natural Health and others to stop the EU from implementing its Food Supplements Directive to restrict the sale of vitamins and minerals within the EU.
I was very surprised to see that you, a purported protector of the consumer, would side with Big Business and Big Government against the interests of those of us consumers who value freedom of choice in health care.
Instead of speaking out for consumers, as you claim to do, you instead cheered the Court's ruling as a "victory for the European consumer." Incredible!
  How can you explain any reduction in choice as a benefit to consumers?
I know that you think that the public is being "protected" by the removal of these products that you do not personally consume, but then there are certainly others that you consume and I do not. Would I be justified in reducing your choices by removing those products you love to consume?
I also know that you think it's okay to require these companies to spend hundreds of thousands of pounds to "prove" in a drug-like way that these natural products are "safe" even though virtually all of them have been quite safely consumed for hundreds, if not thousands, of years by humans throughout the world. Moreover, ALL of these products have an enviable safety record that makes them far safer than the aspirin you can buy at the corner shop. Why do you want to force these products to be proven "safe" at great expense? Do you expect that of potatoes or carrots or other such natural foods?
Our nonprofit organization represents thousands of consumers (not industry) worldwide who wish nothing more than to be left alone to enjoy their freedom to take those dietary supplements they wish to consume. You do not speak for our interests. Rather, it is quite clear that you very happily support the large pharmaceutical interests that wish nothing more than to use legislation to drive natural competition from the marketplace.
In doing so, you hurt all of the small companies and consumers. I am sure that your large pharmaceutica-industry friends and Big Business interests absolutely adore you. You certainly make a nice lap dog for them. I hope you can look yourself in the mirror every time you get up in the morning. If I were you, I sure couldn't.
Sincerely,
Scott Tips
General Counsel
National Health Federation,
a true representative of consumer interests
Posted by: Sepp on July 14, 2005 06:34 PM
Minister pledges support for consumers and industry over Directives
November 23, 2005
The recently appointed health minister, Caroline Flint, has pledged continued government support to consumers and industry over EU regulations that threaten access to safe and effective natural health products.
Speaking at the Consumers for Health Choice (CHC) Annual Parliamentary Reception Flint said that since taking office she had personally been involved with a series of discussions and briefings with the Food Standards Agency (FSA) on the Food Supplements Directive (FSD). She was confident that these, and other on-going discussions, would enable Britain to negotiate the best deal in Europe for British consumers and industry. She added that she had recently given ministerial approval to the FSA Board's proposal that Britain should seek a 'national exception' in Europe which, if successfully agreed with the EC, would enable higher dose VMS products to stay on the shelves.
Flint, a pro-European, said that the biggest challenges facing the natural products industry in Europe were cultural not institutional. "Sometimes it is simply a case that there is someone in Germany who doesn't understand the different trading and consumer traditions in, say, Britain or the Netherlands. We need to find ways of dealing with these cultural differences sensibly and effectively.�?
Speaking on the subject of the Herbals Directive, Flint commented: "This is an area where I know there are differing views. Some people believe that the regulations are welcome and overdue. But at the same time I accept that government should be giving maximum support to industry to help manufacturers get their products registered.�?
In his speech CHC chair, Michael Peet, said he welcomed the interest the new minister had given to consumer and industry concerns over the FSD and other EU legislation.
He commented: "I believe that we are witnessing a paradigm shift in government thinking on these issues and am hopeful that this could, finally, set us on a route to finding a safe home in Europe for our products.�? But he added that CHC's own message to government had become increasingly hard-hitting politically, largely because of the inaction of previous ministers.
CHC director, Sue Croft, said she had been delighted with the way the reception had gone. "It was very well attended, with good representations from both Houses of Parliament. In terms of getting across our message to individual MPs and Peers I think this was probably our best ever House of Commons reception.�?
However Croft agreed with long-time CHC supporter, Austin Mitchell MP, who said that the "fight against overzealous EU regulations�? had to continue if the battle was to be won. Switching his attention to recent media scares about supplements, Mitchell said: "The streets would be littered with the dead if vitamins were half as dangerous as some people would have you believe.�?
Posted by: Sepp on November 25, 2005 10:54 PM
Dear LEVA di ARCHIMEDE
I am a distributor of food supplements in Italy and in these days – based on the Italian law – they have closed my shop and have led me in prison.
Why?
Because in different food supplements that sold my firm were present the following forbidden substances in Italy:
-mucuna pruriens
-yohimbine
-epimedium grandiflorum
-digestive enzymes ( |aminogen| – |zytryx| )
-|vimpocetina| (Vinca Major and Vinca minor )
Can you say me if these products are forbidden also in the rest of Europe?
Could I call me to some European law?
I thank you for the help.
Nicola Ferrazzano
Posted by: Nicola Ferrazzano on February 24, 2007 11:18 AM
Dear Nicola,
as far as I know, the situation is the following:
The European directive on food supplements only regulates vitamins and minerals, leaving the regulation of other substances to the health authorities in each country.
Herbs also have a European directive, which defines them as traditional medicines, and provides for a registration that is less stringent than the registration of pharmaceutical medicines, but it still is a very onerous process.
The Italian ministry of health has adopted a list of herbs that can be used in supplements and if a herb is not on that list, it is normally considered to be "forbidden". In your case, the products you have been selling probably contained herbs that cannot be found on the ministry's list of herbs allowed to be used in foods and supplements.
Probably the best thing for you to do will be to get a good lawyer and see how you can "limit the damage".
Kind regards
Sepp Hasslberger
Posted by: Sepp on February 24, 2007 01:03 PM
This work is licensed under a Creative Commons License.
These articles are brought to you strictly for educational and informational purposes. Be sure to consult your health practitioner of choice before utilizing any of the information to cure or mitigate disease. Any copyrighted material cited is used strictly in a non commercial way and in accordance with the "fair use" doctrine.
