Supplements: EU Court Decision Will Preserve Wide Choice Says ANH

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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 judges have clarified in their decision. Those points happen to be what the legal action contested to begin with.

The food supplements directive mandates that sources of vitamins and minerals must be evaluated and be listed when approved. An initial list was published in annex ii of the directive. The court's decision has clarified that the procedure for a substance to obtain listing

...must be accessible in the sense that it must be expressly mentioned in a measure of general application which is binding on the authorities concerned. It must be capable of being completed within a reasonable time. An application to have a substance included on a list of authorised substances 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. If the procedure results in a refusal, the refusal must be open to challenge before the courts.

Another contested point was, whether substances that are normally found in foods and are perhaps extracted to make them a concentrated source of a vitamin or a mineral would have to go through the same tough approval process as their "chemical" cousins. Here the court says that

...if the various recitals in the preamble to Directive 2002/46 are read together, it is apparent that the directive concerns food supplements containing vitamins and/or minerals derived from a manufacturing process using ‘chemical substances’...

the corollary of which is of course that vitamins and minerals that are in a form normally found in foods are not covered by the food supplements directive in its current incarnation. It does not mean that there will not be an attempt to extend the directive to cover other substances. Indeed a review is scheduled for the year 2007 that would have to make recommendations on how to approach such things as amino acids, essential fatty acids, fiber and various plant and herbal extracts. But that is another chapter and, as a friend once said, "when we get to that creek we'll roll up our pant legs and figure out how best to cross it".

The upshot? For the first time in some years, there is hope that perhaps the implementation of the directive will indeed pass without hardly a change for the consumers of food supplements. Much of this is still up to national health authorities, which can grant "derogation", meaning they can accept the continued presence of nutrient sources in supplements, until they are either fully approved or are proven too dangerous to allow on the market. Many substances have "applied for their place on the annex ii list" in the last moment. The UK's Food Standards Agency, 'stimulated' by the Health Food Manufacturers Association, offered encouragement and even some financing to make and file as many dossiers as possible before the 12 July deadline. According to their website, over 500 such dossiers have been filed in the UK. Also the EU has a list of dossiers that were filed to add substances to the list of allowed sources of vitamins and minerals, to be found here.

If we consider the clarifications the court has given regarding the procedure for the acceptance or rejection of such dossiers, we may be looking at an extremely positive development.

Here is the Alliance for Natural Health's take on the meaning of the judgement:

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The tide is turning...

Alliance for Natural Health

15 July 2005

ECJ RULING SECURES FUTURE FOR VITAMINS AND MINERALS

WHY THE ALLIANCE FOR NATURAL HEALTH MAINTAINS THAT THE EUROPEAN COURT RULING ON THE FOOD SUPPLEMENTS DIRECTIVE IS A VICTORY

After further detailed analysis of the ECJ judgment with its expert EU barrister Paul Lasok QC, ANH anticipates that following the ECJ verdict:

o The vast majority of vitamin and mineral food supplements will not be banned on 1 August

o The Directive now does not apply to natural forms of vitamins and minerals normally found in the diet

o Where it is necessary to be on the positive list, gaining admission will now be a much simpler, less time consuming and more affordable process than was previously the case

o The burden of proof for showing an ingredient to be unsafe will now lie with the regulator and not the manufacturer

This successful outcome is, effectively, what ANH has been working towards for over three years.

The initial media reaction on Wednesday to the judgment of the European Court of Justice (ECJ) on the Food Supplements Directive (FSD) was one of disappointment. Yet the Alliance for Natural Health hailed it as a victory. ANH's specialist EU lawyers have now given a more considered interpretation of the ruling and still maintain that ANH has achieved the key objectives it has been working towards in relation to the FSD over the past three years. Crucially, it is highly likely that most vitamin and mineral supplements will continue to be available. Here's why....

It is not a simple question of whether the FSD was lawful or not. The devil, as always, is in the details. ANH challenged the lawfulness of the FSD because to ANH it appeared to have draconian and quite unnecessary consequences for the food supplements industry and for consumers. In upholding the lawfulness of the FSD, the ECJ has clarified what exactly the FSD actually means and has clearly restricted the scope of the application of the ban on non-FSD compliant nutrients. There are very significant and positive details within the judgment that will be beneficial to the millions of consumers who use vitamin and mineral supplements for their health and are key to everything that ANH has been campaigning for all along.

At the heart of the FSD is the positive list of vitamin and mineral ingredients that are permitted. On 5 April 2005 the ECJ's Advocate General described the procedure by which ingredients are added to the positive list as being "as transparent as a black box." Because of the FSD's lack of clarity and restrictive interpretation by regulators, it was widely understood that to get an ingredient onto the positive list, manufacturers would have to go through a very time consuming, onerous and costly process for them to prove that each nutrient was safe. This might have cost more than £250,000 per ingredient. With many innovative, leading-edge supplements containing sometimes upwards of 30 ingredients each, this burden upon many leading-edge manufacturers, typically being small companies, would effectively lead to them being put out of business. This would be the case even if the products included natural sources of vitamins and minerals that had been part of the human diet for thousands of years.

However, the judgment of the ECJ has now gone a long way to make the black box more transparent, and to require (although not define) simplified procedures for getting ingredients onto the positive list. In summary, the analysis of the ECJ'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. This coupled with the natural health industry's response in submitting large numbers of simplified dossiers, the wide-reaching bans that were anticipated to come into force on 1 August 2005, are now unlikely to occur.

2. There must be a greater degree of clarity on what information companies need to submit to admit an ingredient on to the positive list. This is likely to be considerably simpler, shorter and less expensive than previously feared, making it easily viable for companies to get ingredients on to the approved list.

3. Once an ingredient is submitted for inclusion in the positive list, it cannot be refused unless the regulator finds the ingredient to be unsafe. If the regulator believes the ingredient should be rejected, it will have to undertake a full risk/safety assessment, based on "the most reliable scientific data available and the most recent results of international research," that will then prove the ingredient (or dosage) to be unsafe. This transfers a considerable burden of proof from the manufacturer to the regulator, principally the European Food Safety Authority. Furthermore, any rejection can then be challenged in the courts.

ANH is very confident of the validity of its view, but is aware that as a result of the ECJ's judgment, a controversy about the scope of the FSD has emerged. ANH says that the ECJ has limited the scope of the FSD to vitamins and minerals obtained from non-natural sources, while some other bodies maintain that naturally sourced vitamins and minerals are covered by the FSD.

Commenting, Dr Robert Verkerk, Executive Director of ANH, said:

"The fact that the necessary requirements for admission to the positive list have been fundamentally changed now means that the vast majority of high quality and innovative vitamin and mineral food supplements will now, with relative ease and limited expense, be able to join the positive list and thus not face a ban.

"These changes to the positive list have been at the heart of what the ANH has been campaigning for over the last three and a half years and indeed, formed the major part of its legal challenge to aspects of the Food Supplements Directive.

"In achieving this, ANH has therefore gained a very significant victory for consumers, practitioners, retailers and manufacturers in protecting their right to buy, supply and produce safe, innovative and leading-edge food supplements across Europe."

While some organisations have relied more on emotional outcry, calling for an all-or-nothing annulment of the Food Supplements Directive, this has never been the case with ANH. All it has wanted is sensible regulation, which is why it has worked at the coalface in Brussels, Strasbourg and Luxembourg, with leading scientists, medical doctors and experts in EU law.

ANH has always been committed to the Food Supplements Directive properly doing its job as it provides a safe harbour for food supplements that maintains them as a category of foods and prevents them from being considered medicines.

In light of the judgment, ANH is ready and willing to work closely with the European Union Institutions and Competent Authorities in Member States, providing its professional expertise to ensure that the processes in the Food Supplements Directive are indeed based on good law and good, leading-edge science, which have been central to ANH's approach from the outset.

A quick reminder on why ANH has b