Alliance for Natural Health

July 12, 2005 12:07 ET

'Natural forms of food supplements not banned by directive. Victory for alliance For Natural Health'

ST ALBANS, ENGLAND--(CCNMatthews - July. 12, 2005) -

Major Victory For Alliance For Natural Health

Vitamins and Minerals found in human diet NOT to be banned - ECJ rules Food Supplements Directive is valid but has clarified and sharply restricted its scope of application

The Court has accepted and addressed key arguments uniquely put by the Alliance for Natural Health

The ban on non-positive list vitamin and minerals does not apply at all to vitamins and minerals normally found in or consumed as part of the diet which therefore are not banned as of 1 August 2005.

Where the FSD does apply (which is to vitamins and minerals derived from "chemical substances" i.e. not naturally derived) an application to have a substance included on the positive list may be refused by the competent authorities only on the basis of a full assessment of the risk posed to public health by the substance, established on the basis of the most reliable scientific data available and the most recent results of international research

A real 'David and Goliath' Victory

In a remarkable David and Goliath action, the Alliance for Natural Health (ANH) has today succeeded in getting a ruling from the European Court of Justice that requires the controversial EU Food Supplements Directive to be very sharply circumscribed in its application.

Two main concerns motivated the challenge to the Food Supplements Directive.

The first was that the Directive appeared to ban food supplements obtained from natural sources forming part of the normal diet, about which there was no reason to believe that there was any risk to health. ANH maintained that that was inconsistent with certain recitals in the preamble to the Directive, which had not been followed through when the lists of permitted food supplements were compiled. On that point, none of the opposing parties disputed the fact that the Directive did indeed prohibit naturally-sourced food supplements, although there had been some confusion about this among different Government agencies in the UK.

The second point was the absence of adequate procedures for obtaining amendments to the positive lists: the Advocate General described the procedures as having the "transparency of a black box" and considered that the Directive should be annulled for that reason alone.

The Court has upheld the validity of the Directive but, in doing so, has addressed ANH's main concerns.

On the first point, the Court has stated that the Directive is to be interpreted as applying only to "food supplements containing vitamins and/or minerals derived from a manufacturing process using 'chemical substances'", not other food supplements (paragraph 63 of the judgment).

On the second point, while criticising some aspects of the drafting of the Directive (see paragraph 92 of the judgment), the Court had recourse to the general principles of EC law and has identified the main characteristics of the procedures that must be followed (thus clearing up an obscurity in the Directive) and has effectively laid down the basic criteria to be applied when operating those procedures and deciding whether or not to amend the positive lists. (paragraphs 72-92 of the judgment).

In doing that, the Court has followed the well-established principle that legislation is, wherever possible, to be interpreted so as to avoid it having to be annulled. The fact that the Court was able to satisfy ANH's main concerns by that means without invalidating the Directive (which has undoubtedly some good features) means that the judgment has produced a win-win situation.

This is great news for the tens of millions of consumers across Europe who take vitamin and mineral supplements - and the thousands of practitioners, retailers and manufacturers whose small businesses rely upon them. Well done David. Bad luck Goliath. Had the Directive gone through in its proposed form, around 5000 vitamin and mineral supplement products that people take for natural and preventative healthcare would have disappeared from the shelves from 1st August this year. And who in their right minds would have really wanted that?

Alliance for Natural Health reaction

Commenting on the verdict, Dr Robert Verkerk, Executive Director of ANH said: "This is a fantastic day for the Alliance, the greatest in its short history. All we have ever wanted is for regulation in natural health to be based on good science and good law. ANH is now ready and willing to place its professional expertise and skills in nutrition and science at the disposal of the EU to make sure that the same mistakes are not made again. This is not a reprieve - this is a real result for the consumer and for common sense"

Legal Director and Solicitor David Hinde added: "I would like to thank our external legal team; our barristers were led by Paul Lasok QC, and solicitors were led by Jonathan Coad. Many people voiced concerns from the outset over the implications of the Food Supplements Directive, but ANH remained committed to working hard at the only means that would deliver a successful outcome - a professional legal challenge. This result is a victory for natural healthcare and a landmark legal precedent for EU law."

A brief history of the Food Supplements Directive

The controversial Food Supplements Directive passed through the European Parliament with a narrow margin of support in early 2002. Its purpose was ostensibly to harmonise regulation across Europe and thereby benefit trade. As often happens with EU legislation, most people are unaware of it until it is too late. ANH was formed in 2002 specifically to oppose punitive legislation affecting natural health worldwide and has campaigned for three years to have the irrational parts of the Food Supplements Directive amended. First in January 2004, ANH won the right in the UK High Court to mount the challenge. This was followed by the hearing in the European Court in January 2005 and then by the Opinion of the ECJ Advocate General on 5 April this year, when he declared that the Directive was 'invalid under EU law' and that key aspects of the legislation were 'as transparent as a black box'. And now, ANH has successfully contested the Food Supplements Directive in a landmark legal case.

ANH secures the future of the leading edge of natural health

From the outset, ANH vigorously promoted the concept of mounting the legal challenge and has worked 'at the coal face' in Brussels, Strasbourg and Luxembourg, using the best EU lawyers. ANH's approach is based on the use of good science and good law in order to shape appropriate and proportionate regulation of the natural health industry. It is not an emotions-driven campaign organisation. ANH is based in the UK, but is now a worldwide organisation.

Drawing its support from thousands of consumers, manufacturers, retailers, practitioners and some of the world's leading experts in nutritional medicine, ANH has taken on the Goliath of the European Commission and those who support the unscientific and unlawful ban of vitamin and mineral supplements, to protect the interests of everyone concerned with the leading-edge of food supplements and natural healthcare.

Supplements are safe without the Directive

There is concern from some quarters that without the Directive, food supplements will not always be safe. This is not true as existing UK and EU food law already provides perfectly effective protection from unsafe products getting onto the market through existing, comprehensive food laws. Indeed, ANH firmly endorses the banning of ingredients or dosages that are patently not safe. It adds however, 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 in the Food Supplements Directive.

The system proposed by the EU was going to ban ingredients simply because supplement 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 effect of today's ruling will avoid these prohibitive costs having to be incurred because if a vitamin and mineral in a food supplement is normally found in and consumed as part of the diet it cannot be banned under the Directive on 1st August 2005 (paragraph 135).

Worldwide negative regulation affecting natural health
This is just the beginning for the Alliance for Natural Health. Through a United Nations sponsored organisation, the Codex Alimentarious Commission, there are many other regulatory and industry pressures on natural health. Without having to justify any health hazard, and without considering any benefits, safety is being used as a reason to restrict the availability of natural food products and maximum dosages to ludicrously low levels. The victory with the Food Supplements Directive is encouraging, but the fight goes on. There are many opponents to those who support the right to natural health and much work remains ahead here in the EU and in the US.

What can people do?
If journalists believe in the cause pursued by Alliance and Natural Health, they can help by advising their readers what they can do to help. ANH is not a large, well-funded organisation and donations are needed to maintain its work. There are many other ways in which ordinary people can help - such as 'adopting a health store', and writing to their MP/MEP. More information can be found on the ANH web site,


Notes for editors:

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

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.

Had the ban on vitamins and minerals been implemented without the restrictions imposed now by the ECJ:

Over 5000 products would have disappeared 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, among 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 would have been removed - 40% of the UK's population take vitamins and minerals.

Products would have been 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 would 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 year and next These include restrictions on herbal products, 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'.

Alliance for Natural Health

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