The momentum of the re-structuring and bedding in of key projects in August and September has continued into October making it both a busy and a productive month. As further work continues on the EU Food Supplements Directive (FSD) with regard to interpretation of the European Court of Justice (ECJ) ruling, this does nothing to detract from the other major European legislative threat that came into force on Monday 31st October, namely the Traditional Herbal Medicinal Products Directive (THMPD) – more on this later! But now, on to an update of ANH progress and events.

FSD Update

The ANH has submitted its interpretation of the ECJ ruling based on the Opinion of its lead Counsel, Paul Lasok QC, to the UK Secretary of State, Patricia Hewitt, and to the EU Directorate-General for Health and Consumer Protection (Basil Mathioudakis). We await their responses and hope to be able to report back to you next month on outcomes.

Based on the key gains from the ECJ ruling [silver lining] that the ANH has maintained since the ruling on 12 July, we have also submitted our recommended guidelines with regard to the procedure for gaining admission to the Positive List (specifically to Annex I and Annex II of the Directive). Dr Robert Verkerk (ANH Executive and Scientific Director) and Dr Damien Downing (ANH Medical Director) have also proposed a new classification system for vitamin and mineral food supplement ingredients, which we believe will assist interpretation of the ruling particularly in regard to the exclusion of particular natural sources of vitamins and minerals from the Directive, as confirmed by the European Court.

We aim to publish the above-mentioned letter and appendices on our website in the near future.

'Traditional Herbal Medicines' in the EU

THMPD is not a stand alone Directive, but a ‘sub-Directive’ of the Human Medicines (Pharmaceutical) Products Directive. It is intended for only those herbal products used to treat minor ailments, which have a history of safe traditional use. Products eligible for the THMPD will benefit from a simplified, ‘fast-track’ drugs licensing regime if it can be proved they have a safety record going back 30 years, including at least 15 years in any EU Member State. This means that some products will be restricted purely because they are from non-EU cultures. Particular combinations may also be disallowed and herbal products containing significant amounts of vitamins, minerals, or other nutrients will be prohibited.

Although enforced on Monday, there is a transition period until 2011 for full implementation. Unfortunately current estimates of licensing costs (which may exceed £40,000 [€58,700 or US $71,000] for single-herb products) are likely to be prohibitive for many companies. Licensing costs will inevitably need to be passed on the consumer, so demand may decline due to their increased cost. Another major problem is that products will be subjected to pharmaceutical stability tests and must show 6 months stability before being approved. Such a regime will not suit multi-herb tinctures, such as those used for thousands of years in certain traditional cultures such as Ayurveda.

One key strategy for dealing with unfair or disproportionate impacts of the THMPD is through legal challenge, an avenue that is being considered at present.

ANH on the move

11th – 12th October . Rob, Meleni and Lord Duncan McNair (Strategic Advisory Committee Member) traveled to Brussels to attend the MEP Awards Ceremony for some vital networking. The ANH was one of few non-governmental organizations invited. It was a hugely successful trip and we met and updated some very valuable political contacts. John Bowis MEP, a previous Minister for Health in the UK, with whom ANH has worked in the European Parliament, was given the main award for contributions in the field of health.

28-29 October: Rob and David, each for different reasons, were unable to travel to Minneapolis, Minnesota USA, for the National Conference for Health Freedom Advocates organized by the National Health Freedom Coalition to present “The Judicial Opinion on the Challenge to the EU Food Supplements Directive”. However, with advances in technology being what they are, all was not lost, and they managed to deliver their presentations and take questions in real time over a video link-up! Such technology has opened doors for future ANH communication on the global stage.

29-30 October: Meleni and Rob presented in Dublin, Ireland, at the Irish Association of Health Stores, ‘Your Health Show’. We were given a warm welcome by our Irish supporters and the industry dinner on the Saturday evening had all the hallmarks of good Irish ‘craic’. The show was a success and we have had an offer of fund raising support for which we are very grateful. Thank you to all who came to the presentations and asked such informed questions. Our presentations are available on the website at the following links: Meleni Aldridge: "EU Restrictions on Natural Health: The impact on Practitioners and Consumers." Dr Rob Verkerk: "Natural Health Wars: Building on the Food Supplements Case."

Codex Alimentarius

Rob has provided critical comments to the risk assessment paper produced by the Australian working group and a number of other governments, on behalf of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) which will meet between 21-25 November in Bonn, Germany. These comments have been submitted to the National Health Federation which will, as a recognized Codex NGO (non-governmental organisation) include them as part of its own submission to the CCNFSDU, to be discussed at Bonn.

The ANH is concerned that unless risk assessment procedures currently being considered by the CCNFSDU and the FAO/WHO nutrient risk assessment project are changed considerably, unreasonably low ‘upper safe levels’ and ‘maximum permitted levels’ will be developed for many nutrients used in food (or dietary) supplements compliant with Codex guidelines.

Bird flu ‘fever’

With news reports from around the world hinting at possible imminent human to human transmission of a mutated, highly pathogenic variant of the wild-type avian H5N1 virus, opinions on the threat to humans or otherwise, appears to be deeply divided. Some are convinced that the bird flu issue is another ‘pharma’-sourced manifestation which poses no real risk to humans and its publicity serves solely to increase profits of drugs companies and vaccine producers. Others are more concerned about the actual likelihood of a pandemic, but are concerned that vaccines and anti-viral drugs are unlikely to provide much reprieve.

We have been monitoring the scientific data on this issue for some time and are now able to conclude that the risks of a global pandemic are in our view both real and significant. However, we are also concerned that vaccine and anti-viral drug strategies are unlikely to offer the solution currently being promised, particularly in the earlier stages of a pandemic. We believe that nutrients (food and supplements) may have an important role to play in helping to modulate immune systems so that people are better able to resist viral (and other) infections. We are aware of nutritional companies that are presently conducting experiments (e.g. on H5N1 in mice) using specific products which could be used for this purpose. We are also in the process of establishing an Avian Flu Expert Committee of key scientists so that we can make public carefully considered and scientifically proven natural options for reducing risk from infection.

NB: As a small, already overloaded team, we regret that we are unlikely at this stage to be able to respond to specific public queries on bird flu at this time. Further information will follow in our November eblast.

In health,

Meleni Aldridge
Operations & Communications Manager
Alliance for Natural Health
www.alliance-natural-health.org
 

Today could have seen up to 5,000 vitamin and mineral products being banned from health store shelves in the UK alone, with further products being banned in other EU countries such as Ireland and Sweden.

But, following the legal challenge to this ban implicit in the EU Food Supplements Directive, mounted in 2003 by the Alliance for Natural Health and two UK trade associations, the National Association of Health Stores and the Health Food Manufacturers Association, mutual cooperation between the health industry and government authorities has seen the wide-scale ban circumvented.

The ban would have affected products containing over 200 vitamin and mineral ingredients which had not been subject to extensive safety evaluation by the European Food Safety Authority, but nevertheless had been consumed safely as part of the normal diet for thousands of years.

Dr Robert Verkerk, executive director of the pan-European Alliance for Natural Health said: "Without positive pressure from our legal challenge, and increasing amounts of cooperation between industry and government authorities, thousands of products containing nutrients which are increasingly difficult to find in our normal diet, but known to be of great importance to our health and well being, could have today been removed from our food supply. We are working hard to bed in our barristers' positive interpretation of the European Court ruling. However, we cannot afford to sit back as future provisions in the Directive set to limit maximum potencies of food supplements could have devastating consequences at least equal to those caused by the originally proposed food supplement ingredients ban."

The European Court of Justice handed down its ruling on the legal challenge to the Food Supplements Directive on 12 July. Although the Directive was upheld, the ruling reduced its scope and greatly improved its clarity, so reducing obstacles to the health food industry. In particular the ruling will make it much easier to access the ''positive list'' of allowed ingredients, a process previously described by a senior advisor to the Court, Advocate General Leendert Geelhoed in his 5 April Opinion, as "clear as a black box".

The Directive provided a derogation system which would allow ingredients present on the market prior to 2003 to be used at least to the end of 2009, on the condition that technical dossiers were submitted to governmental authorities, for subsequent consideration by the European Food Safety Authority. The dossier requirements were seen as excessive and pressure from the industry, facilitated by the legal challenge, led the government to agree simplified dossier criteria.

Accordingly, some 505 dossiers for vitamin and mineral ingredients were submitted by 12 July, the official deadline for derogation dossier submissions. To facilitate the process further, the UK's Food Standard Agency has also extended the dossier deadline until today. All products containing ingredients subject to dossiers will remain on the market to at least the end of 2009 unless they are given an unfavourable review, on the grounds of risks to public health, by the European Food Safety Authority.

In the meantime, onus is on the health food industry to make submissions to the previously limited ''positive list'', which currently contains just 112 vitamin and mineral forms, as compared with over 300 used by the industry. As a result of the European Court ruling, exemption for certain natural forms of vitamins and minerals, clarified and simplified requirements for access to the 'positive list', and placement of the primary burden of proof of safety on government authorities rather than industry, the Alliance for Natural Health is confident that the 'positive list' will no longer act as a major barrier to getting products on to the EU's 'positive list' of ingredients allowed in food supplements.

Provisions in the EU Food Supplements Directive which aim to set maximum dosages for vitamin and mineral products are in the process of being finalised by the European Commission and the Codex Alimentarius Commission, which is developing international guidelines for food supplement potencies modelled very closely on the EU Directive. The Alliance for Natural Health has argued, with the support of scientists around the world, that the scientific method being considered to set maximum potencies is flawed.

"We must now move from a legal battle to a scientific battle", adds Verkerk, "the risk assessment framework that is being considered by the authorities has been borrowed from those systems assessing intrinsically toxic substances such as drugs and pesticides, and have no place for use with nutrients that are essential to life. A new paradigm for safety/benefit analysis is needed specifically for nutrients, and we have commissioned the Netherlands-based HAN Foundation to come up with a new framework that could be used EU-wide and internationally through Codex."

We would like to inform all companies that still have vitamin and mineral ingredients that are not present on either the positive list or on the derogation list, that we have been notified by the Food Standards Agency (FSA) in the UK that they have extended the deadline for submission of derogation dossiers from 12 July to 1 August 2005.

The letter from the FSA is provided below, and we include the appropriate contact person (including UK telephone and fax numbers):

From: food_supplements@foodstandards.gsi.gov.uk
Date: Tue, 26 Jul 2005 16:34:22 +0100
To: info@alliance-natural-health.org
Subject: Derogation Extension

Dear Dr Verkerk,

Following advice from the Commission I am writing to advise you that we will still be willing to accept dossiers under the Food Supplements Directive 2002/46 for which derogation will be granted provided, in accordance with Article 4 (6-8), for a short period after the original deadline of 12th July. We will accept any final dossiers until 1st August for submission to the Commission.

The positive lists of the Food Supplements Directive remain open and dossiers maybe submitted at any time after this date, however derogation cannot be granted after this date.

Regards

Iulia

*******************************************
Iulia Young
Novel Foods, Additives and Supplements Division
Food Standards Agency
Tel: 020 7276 8597
Fax: 020 7276 8564
*******************************************

We would also like to inform you that we are working hard to push for the best possible interpretation of the European Court ruling.

Our views, which have been developed through the interaction of our legal team led by leading European and competition law expert, Paul Lasok QC, as well as our Scientific Expert Committee, can be found as a Legal Executive Summary at:

www.alliance-natural-health.org/_docs/ANHwebsiteDoc_173.pdf

In addition, you will also find the discussion documents which are referred to in the Legal Executive Summary at the following link:

www.alliance-natural-health.org/_docs/ANHwebsiteDoc_194.doc

In summary, we urge companies to either submit any ‘missing’ vitamin and mineral ingredients for derogation, or to the positive list. Please review the positive list and the derogation lists to find any such ‘missing’ ingredients.

The key criteria for the derogations will be safety and bioavailability, so following the requirements as set out on pp. 3-4 of the ANH discussion documents (www.alliance-natural-health.org/_docs/ANHwebsiteDoc_194.doc) should provide adequate criteria for acceptance for derogation or Annex II of the positive list.

For positive list see Food Supplements Directive (see Annexes on pp. 5-7):

www.alliance-natural-health.org/_docs/ANHwebsiteDoc_10.pdf

For UK derogation dossier listing:
www.food.gov.uk/foodindustry/vitmin/supptable

For EU-wide derogation dossier listings (not necessarily fully updated): http://europa.eu.int/comm/food/food/labellingnutrition/supplements/index_en.htm

For a general update on the ECJ ruling and the ANH take on its significance, please refer to recent ‘Latest News items on the ANH website.

Kind regards

Dr Robert Verkerk
Executive Director
Alliance for Natural Health
info@alliance-natural-health.org
www.alliance-natural-health.org

There are two reasons for this mailshot.

Firstly, the ANH team would like to thank you for your support and donations, without which one of the most vigorous battles for health freedom to be fought in recent times would not have been brought to bear. We are a small but highly dedicated team of people, many of whom volunteer their time and energy for nothing, and we would not be where we are now without the strong support of our Partners – so thank you, we are deeply grateful.

Secondly, many of you will by now be aware that there are divided opinions on whether the European Court of Justice (ECJ) ruling provides a ‘silver lining’ or not and we wish to clarify the situation for the benefit of our Members and Supporters.

What really happened

The ANH has always been about using good science and good law to protect natural health and our view of the ECJ judgment handed down on 12th July 2005 is, and continues to be, based on the opinion of our legal team, led by one of the top European and Competition Law barristers, Paul Lasok QC. Had the Food Supplements Directive been invalidated we would now be facing a complicated system of re-negotiation where many competing interests would have attempted to leave their mark. This could have resulted in a long and drawn out affair which may well have left us in a worse position. This now does not need to happen. The Court has made clear some key provisions of the Directive which massively reduce the difficulty of getting on- to the once-feared ‘positive list’.

The legal challenge was only directed at one aspect of the Food Supplements Directive regarding the proposed ban on up to 75% of forms of vitamins and minerals (mainly food forms). The bottom line now, is that this wide-scale ban will not be able to occur, on the basis that companies are prepared to make the minimal effort required to submit ingredients to the ‘positive list’.

Many of the arguments that the ANH was most concerned about have been clarified by the ECJ ruling and the scope of the Directive has been narrowed (please refer to our press release on the website for specifics).

It seems that the ruling may have been a compromise gesture on the part of the Court. It has ensured that the European Institutions (notably the European commission, the Council of Ministers and the European Parliament) were able to avoid the embarrassment of an overturned Directive and that the clarification of the law avoided conflicts with EU law, which had been the key basis of contention in the case brought by the ANH.

Opinions still divided

As you may know, this view is not shared by all and opinions seem to be particularly polarised in the UK, where the two trade associations, the Health Food Manufacturers Association (HFMA), the National Association of Health Stores (NAHS) and a consumer organisation, Consumers for Health Choice (CHC) appear to be of the opinion that the legal challenge has failed dismally and confers no benefits to consumers, practitioners, retailers or manufacturers.

In the latest issue of Health Food Business, a trade magazine that is widely distributed to the UK health industry, which hit the health food shops this week, it is clear that these UK trade and consumer organisations’ present campaign strategy is to create a strong political lobby to push the Government towards national derogation (known legally as ‘subsidiarity’) for the UK, by using the influence of the British Prime Minister Tony Blair while the UK holds the 6-month rotating EU Presidency. It is the opinion of our legal team that there is no currently available mechanism for achieving this and it was actually the ANH that ran this ‘subsidiarity’ argument particularly strongly in its legal challenge but the argument unfortunately was lost for a number of reasons.

Derogation dossiers: just delaying the inevitable ban?

Mainstream industry spokespersons continue to propound the ‘doom and gloom’ scenario about the ECJ ruling. They say that all the work on derogation dossiers has just bought some more time and the inevitable bans will come into place anyway, even if it’s after 2009. The ANH argues that this need not be the case.

The HFMA and NAHS, as well as companies and other trade associations, worked hard to file dossiers for the derogation provision within the Directive which allows ingredients that have been used prior to 2003 to continue to be used at least until 31 December 2009, on the basis that dossiers are not given an unfavourable opinion by the European Food Safety Authority. Assuming that Member States support the principle of mutual recognition, dossiers filed in one country will provide derogation in another. These derogations, assuming they have met the required criteria for safety and bioavailability, will provide sufficient time for applications to be made to the positive list under the now much clearer and simplified procedures. Furthermore, the ECJ ruling makes it much more difficult for derogation or positive list submissions to be rejected as the burden of proof for lack of safety of a given nutrient has been firmly placed back in the regulator’s court.

The ANH therefore urges companies to make full use of the simplified dossier procedures pointed to by the ECJ – and so avoid the ban!

Two bites of the cherry

The ANH finds itself at yet another cross-roads with the UK mainstream industry. To summarise, the UK industry has an agenda that is primarily about protecting UK interests and it wishes to deploy a strategy that, in the view of the ANH, appears to lack any existing legal mechanism. The ANH, on the other hand, has a remit to bring about changes that will have benefits across all EU Member States, and the strategy to achieve this involves trying to secure the best possible interpretation of the Directive and ECJ ruling using available mechanisms.

Rather than wasting resources trying to resolve which strategy is ultimately right, the ANH has chosen to keep its head down and pursue its EU-wide strategy. Surely two bites of the cherry is better than one?

It’s just the beginning…

We have not been afraid to take a unique stand before and we will do it again. We have always been committed towards working for change in all 25 Member States – not just the UK – and this continues to be our mission. The ANH will continue our remit of good science and good law. Particularly with regard to the former, by focussing on developing new and appropriate scientific methods of safety/benefit analysis for vitamins, minerals, and other micro-nutrients so that the question of maximum dosages can be addressed rationally.

The on-going battle for health freedom is far from over. In fact, it has really only just begun. With the Codex Guidelines having been accepted at the Codex Alimentarius Commission in Rome on 4th July 2005 and the EU Traditional Herbal Medicinal Products Directive due to come in to force later this year, we are really only just at the start of what will inevitably be a long battle for our natural right to freedom of choice in health care.

Thank you and we hope this provides some clarification to a complex area.

The ANH Team

A controversial new EU regulation that has threatened to outlaw thousands of mineral supplements and bankrupt health food stores across Britain was upheld this morning.

The European Court of Justice approved the Food Supplements Directive even though the court's own Advocate-General advised that the Directive was invalid under EU law.

The ruling - greeted with surprise - is a defeat for a concerted campaign by more than a million British health food customers and shops. They have argued that the law, which will come into effect on August 1, will impose an unprecedented level of regulation on mineral supplements and could threaten the existence of small suppliers.

The Alliance For Natural Health (ANH), a group backed by the British Health Food Manufacturers’ Association, have contended that it is unfair for health food manufacturers to bear the cost of applying for approval for products they have been selling for many years.

But the judges of the European Court of Justice said today that the new law was necessary to simplify the trade in natural remedies, and to give clear health advice to consumers by instituting an approved list of supplements, known as a "positive list".

The court observed that "before the directive was adopted, food supplements were regulated by differing national rules liable to impede the free movement of those goods and the functioning of the internal market."

But in an apparent concession to the British health food industry, which sells around £300 million of natural remedies every year, the judges did promise to simplify the application process for ingredients. They ruled that the burden of proof should shift from those seeking approval to those seeking to ban a product.

The judges concluded: "An application to have a substance included on a list may be refused only on the basis of a full risk assessment, established on the basis of the most reliable scientific data available and the most recent results of international research. A refusal must also be open to challenge before the courts."

The initial reaction of the British health food industry was mixed, as campaigners said they were still digesting the ruling and analysing the revisions made to the application process.

"We had expected a better verdict," said a spokesman for the Alliance For Natural Health this morning. "On the surface it looks like bad news, because they are upholding the Food Supplements Directive and that is disappointing... However, there may be a positive side to this."

Sue Croft, the director of Consumers for Health Choice, said that their campaign for special allowances for the British health food industry would go on.

"I think that we still have to stick out for a national delegation," she told Times Online. "We have to re-open negotiations with the EU trade commission to keep hold of our supplements and keep the British market intact. I think we have the political will to do that and that would be brilliant."

The Directive was first approved by EU governments in 2002, and health food manufacturers were given until today - July 12, 2005 - to submit detailed scientific dossiers proving their ingredients were safe. Those supplements that failed to qualify would be banned.

Over the last three years, health food suppliers have either reformulated their goods, replacing natural substances with synthetic chemicals that already have EU approval, or waited as their legal challenge made its way through the courts.

As part of their campaign, a petition of more than one million signatures and a letter of protest has been sent to Tony Blair signed by more than 300 doctors and scientists.

Today's deadline means that health food retailers and manufacturers have sent in hundreds of dossiers for their ingredients over the last week, leaving the current list of which products are banned and which are approved in flux.

"There is no current accurate list," said Ms Croft.

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.

To see a copy of the C-154-04 Judgment 12 July 2005, click here.

The European Court of Justice judgement on the Alliance for Natural Health (and joined) case against the EU Food Supplements Directive will be handed down on 12 July, 09:30 h.

This comes just three days following the close of the Codex Committee on Nutrition and Foods for Dietary Uses meeting (4-9 July) in Rome, in which the decision to take the Guidelines to Step 8 will be considered.

EUROPEAN COURT ANNOUNCES DATE OF RULING
EU Food Supplements Directive Legal Challenge

Consumers, practitioners, retailers, and innovative food supplement companies came together in 2003 under the umbrella of the Alliance for Natural Health, to challenge the European Food Supplements Directive. This Directive, set to affect over 30% of Europeans who regularly consume food supplements, has the potential to ban some 75% of vitamin and mineral forms, especially those found naturally in foods, affecting around 5000 products in the UK alone.

The case was brought initially in the High Court in London in October 2003, and was successfully referred and expedited to the European Court of Justice in Luxembourg in January 2004. Oral hearings were presented to the Court a year later, culminating in an Opinion from the Court’s Advocate General, issued on 5 April this year.

The Advocate General, Leendert Geelhoed, declared in his Opinion that the Directive was fundamentally flawed, and contravened EU law. He concluded:

“…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.”

The European Court of Justice has now declared that the judgment, made by the thirteen Judges presiding over the case, will be handed down at 09:30 on 12 July 2005, in the Courtroom of the Court, Boulevard Konrad Andenauer, Luxembourg-Kirchberg.

Executive director of the Alliance for Natural Health, Dr Robert Verkerk, commented:

“The judgement will hopefully give rise to an amendment to the Directive that will result in much greater clarity for consumers and manufacturers of food supplements across Europe. This amendment is needed to prevent important nutrients being lost in food supplements. The Alliance for Natural Health is now close to commissioning an independent group of risk assessment scientists in Europe to help develop a new regulatory framework that is based on good science and good law. Such a framework would be likely to suggest that a Regulator should not determine which ingredients are allowed in supplements without also determining, based on all available science, the maximum dosages. The Food Supplements Directive currently separates these two issues. If this work had been undertaken before the Directive had been finalised, we would never have seen the attempted implementation of a defective Directive.”

The ruling will potentially have significant impacts on the parallel development of international guidelines for vitamin and mineral food supplements by the Codex Alimentarius Commission, which are near finalisation. This body, composed of delegates from around 90 governments and 40 non-governmental organisations, will meet in Rome on 4 to 9 July to decide whether to finalise these guidelines.

Since this Codex meeting occurs just before the date of the European Court ruling, the Alliance for Natural Health argues that it would be premature to finalise the Codex guidelines on vitamin and mineral food supplements before both the EU Food Supplements Directive is amended, and an improved system for risk assessment of nutrients is developed.

Dr Verkerk adds, drawing a further parallel with the Food Supplements Directive case:

“There is good evidence that in the effort to push through the Codex guidelines, procedural errors have again been made. Governments and regulators, as well as the many interests in this area, need to work together to put these right. There is a huge amount at stake for the future of natural healthcare.”

Click here to view actual delivery of judgement notice.

Dr Robert Verkerk, Executive Director, Alliance for Natural Health
Tel: +44 (0)1252 371 275
Mobile:+44 (0)771 484 7225
E-mail: info@alliance-natural-health.org
www.alliance-natural-health.org

The European Court of Justice's Advocate General Geelhoed has provided his opinion today. His opinion was read out in the European Court in Luxembourg at 08.30 this morning.

Please find our Press Release on the subject below.

We wish to thank all of you who have contributed, financially and in other ways, to this landmark challenge that has the potential to rock the entire agenda on ever-tightening restrictions worldwide on natural health.

We will be giving you further updates in due course.

PRESS RELEASE

5 April 2005

ADVOCATE GENERAL FINDS FOOD SUPPLEMENTS DIRECTIVE INVALID UNDER EU LAW

ALLIANCE FOR NATURAL HEALTH SET TO WIN ITS LANDMARK CHALLENGE TO THE EU FOOD SUPPLEMENTS DIRECTIVE

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.’

UK RESIDENTS

Please note that despite a busy news day with elections being announced along with further news of the Pope's funeral and altered plans for the Royal wedding, the ANH case is still likely to make the national news in the UK.

BBC News at 10 has indicated it will cover the issue tonight, and have interviewed Dr Verkerk in Guildford, while Channel 4 will make a mention of the story and follow up later in the week.

The Times, Telegraph, Independent, Guardian, Financial Times, Daily Mail and Daily Express should also have some coverage on the Advocate General's opinion and of the ANH tomorrow.

Best wishes

Adrian Shaw
IKON Associates (PR consultants to the ANH)
adrian@ikonassociates.com
Tel: 01483 535 102
Mobile: 0797 99 00 733
 

For enquiries and further information contact:

Alliance for Natural Health
www.alliance-natural-health.org

Dr Robert Verkerk, Executive Director
Tel.              +44 (0)1252 371 275
E-mail:         robv@alliance-natural-health.org 

David C. Hinde, Solicitor, Legal Director
Tel:              +44 (0)20 7738 1640
E-mail:          davidh@alliance-natural-health.org

IKON Associates
(PR advisers to the Alliance for Natural Health)

Adrian Shaw
Tel:             +44 (0)1483 535102
Mobile:         +44 (0)797 990 0733
E-mail:         adrian@ikonassociates.com

Paul Donkersley
Tel:             +44 (0)1483 535101
Mobile:         +44 (0)796 764 6046
E-mail:         paul@ikonassociates

1.      The Alliance for Natural Health is a Europe-wide association of manufacturers, distributors, retailers, consumers and complementary practitioners who have an interest in food supplements. More information, including details of members, will be found at www.alliance-natural-health.org

Good science and good law underpin all of the ANH’s work, and the scientific reports produced by the ANH are endorsed by many of the world’s leading doctors and scientists working in the field of nutrition.

2.      If the ban on vitamins and minerals is implemented there is much at stake:

·         Over 5000 products will disappear from the shelves of UK health stores as a result of the ban removing access to over 300 vitamin and mineral ingredients (out of a total of about 420). These include, amongst others, the main natural forms of Vitamin E, several forms of vitamin C, the key natural form of folic acid, MSM and a range of minerals such as vanadium, silicon and boron, all being products which millions of consumers choose to take as part of their regular health regime and have done so without any ill effects for many years.

·         An individual’s freedom of choice to take safe natural health products will be removed – 40% of the UK’s population take vitamins and minerals.

·         Products are to be banned with absolutely no scientific justification. Many of the world’s leading scientific and medical experts in nutrition support the absence of any proper basis for the proposed bans.

·         Although the proposed bans related only to vitamins and minerals, unless overturned, the ‘Positive list’ system will most likely be transferred to other nutrients used in food supplements, such as plant extracts, amino acids and enzymes. The precedent set by an ANH victory will drastically reduce the chance of future bans on these other nutrient forms.

·         Further legislative proposals by the EU are due to be considered by the European Parliament later this and next year. These include restrictions on maximum dosages of vitamins and minerals and restrictions on health claims of foods. Again, the ANH is working to help positively shape such legislation using its mantra of ‘good science and good law’.

In health,

Robert Verkerk PhD
Executive Director, ANH

David Hinde, Solicitor
Legal Director, ANH

and the rest of the Core Team of the ANH in the UK, Sweden, Ireland and Denmark.

E-mail: info@alliance-natural-health.org
Web: www.alliance-natural-health.org

EU Advocate General's Preliminary Opinion on the Legal Challenge to the

Food Supplements Directive
The Court of Justice of the European Communities
April 5, 2005

delivered on 5 April 2005 (1)