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.
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?
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,Â 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 AgencyÂ some of the key contradictions between the Statutory Instrument (the Food Supplements Regulations 2003) and the Court's judgment. He showed, for example, that theÂ judgment clearly demonstrates that the Directive does not apply to food supplements whose ingredients include plant extracts and other nutrientsÂ 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 differentÂ countries are fed up with over-zealous EU laws, and this is a landmark case which might help people to regain respect and faithÂ in European law."
Dr Robert Verkerk, Executive & Scientific Director of the ANHÂ adds, "The European Food Supplements Directive, as it was originally proposed,Â would have acted asÂ 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."
The Alliance for Natural Health (ANH) is a Europe-wide and internationalÂ 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:
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