Food Supplements in Europe - What is the Problem?
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The European Union has issued a Directive to regulate the commerce of food supplements, which is in the process of being implemented in the member states. If reading the referenced text does not tell you what problems this directive might bring to your ability to either buy or sell supplements in one of the European Community member states, don't feel alone. That is a problem most observers have and I believe it is due to the fact that the draft has been deliberately kept vague in order to deviate any opposition, until it is too late to do anything about the matter.
Nevertheless, two diverse groupings of consumers, practitioners and representatives of the supplements trade and industry have brought legal actions before the London High Court. Both actions, one by the National Association of Health Stores and another by the Alliance for Natural Health have been referred to the European Court of Justice in January this year.
You might be asking yourself, what exactly is the problem with this directive and why should I care? Well, if you either take vitamin and mineral supplements to keep your health at an optimal level or if you are professionally involved in the production or distribution of such products, you should care, because future prospects for the legal availability of food supplements in Europe are not rosy.
ANH's David Hinde explains why this is so and what YOU can do to help.
The Problem
The Food Supplements Directive (“FSD”) was widely promoted (and thus supported) as a measure, designed to distinguish food supplements from drugs and harmonise their EU legal treatment, facilitating their free movement between EU Member States.
This is a laudable aim for promotion of trade between Member States, in view of the great disparities between EU countries as to how food supplements are classified and regulated. Unfortunately as the Directive turned out; it actually has the opposite effect for innovative advanced bioavailable nutrients; many of which are at risk of being banned.
Restricted List of allowable nutrients
The FSD creates a list of permitted ingredients (initially only applying to vitamins and minerals) for food supplements and mandates all Member States to permit the sale of these across the EU from 1 August 2003 at the latest.
However all nutrients not on this ‘positive list’ will be banned right across the EU from 1 August 2005 at the latest, unless a detailed Dossier in respect of each nutrient (at an estimated cost of £80,000 - £250,000 per ingredient for which safety data is not readily available) evidencing their safety is submitted by the Member State to the EU Commission not later than 12 July 2005. This is despite the fact that previously they may have been permitted under one or more Member States’ regulations.
The effect of the Directive will be to ban about 300 of the 420 or so forms of vitamins and minerals present in around 5000 products currently on the UK market, many of which are sold in high street health food stores. The ban will have a similar effect on products in such countries as Sweden, the Netherlands, Ireland and others, which also have advanced markets for food supplements.
Restricted Potency for allowable nutrients
The potency of food supplements comprised of nutrients, which are on the positive list, will also be limited, as the FSD stipulates these nutrients will be subject to maximum permitted amounts taking into account upper safe levels (established by scientific risk assessment and intake of vitamins and minerals from other dietary sources).
In summary, the FSD will ban high potency, organic / food state bioavailable vitamins and minerals, irrespective of the fact that they have been on sale in EU Member States as food for many years.
Initially the FSD will apply only to vitamins and minerals but by 12 July 2007 (if not before) it requires the EU Commission to make proposals for a similar regime for all other “nutrients or substances with a nutritional or physiological effect”.
Thus the FSD provides a legislative model for all food supplements mandating a narrow (positive) list of allowed nutrients and a limited potency.
The Directive is presented as the first part of a plan for the comprehensive regulation of food supplements at the EU level and all the indications are that once this model is in place in the EU it will be exported worldwide via Codex Alimentarius.
The Solution
After detailed analysis, the Alliance for Natural Health (ANH) concluded that the most effective option now left for the protection of the continued supply of safe, natural and effective advanced food supplements in the EU was to challenge the FSD ban on non positive list nutrients, in the Courts. It is not seeking to overturn the FSD as a whole but only the prohibition [see Articles 3, 4(1) and 15 (b)] against sale of any non positive list goods (“the ban”) in Member States which might otherwise allow their sale.
To that end, with specialist EU law barristers, it commenced legal proceedings in October 2003 and in brief, the latest position is as follows:
The legal challenge is viable (successful Reference to ECJ)
On 30 January 2004, Mr Justice Richards, a High Court Judge, (expert in EU law) granted ANH permission for judicial review of the FSD and made a Reference to the European Court of Justice in Luxembourg.
Key grounds of challenge
1) No legal basis for the ban / “Competence Creep”
The EU Commission only has power to propose legislation which is within the powers conferred upon it under EU law. The alleged legal basis for the FSD is Article 95 of the EC Treaty, i.e. the promotion of the internal market. ANH argues that the ban on nutrients previously allowed in Member States is not necessary for the establishment and functioning of the internal market and is thus outside the scope of Article 95 and illegal.
2) Infringement of the principle of Subsidiarity
Under EU law, public powers should normally be located at the lowest tier of government where they can be exercised effectively. Therefore regulation of food supplements sold within a Member State (as opposed to between Member States) is best left to each individual Member State to decide.
3) Infringement of the principle of Proportionality
Even were it legally permissible, the ban is a draconian measure which is neither appropriate nor necessary. Established nutrients with no previous adverse safety record are being required to undergo expensive scientific tests to prove their safety. The disadvantages caused to consumers and traders are thus quite disproportionate to any public interest benefit conferred by these restrictions on trade.
4) Infringement of Fundamental Rights (to property and to carry on an economic activity)
The ban will have a highly detrimental and unjustifiable impact on human rights guaranteed under EU law. It severely restricts the ability to carry on a business in advanced food supplements and will prevent consumers from obtaining significant health benefits from their leading edge food supplements.
5) Infringement of Duty to Give Reasons
Whilst the recitals to the FSD give reasons for the Directive as a whole, contrary to EU law, no reason or justification is given for the ban, which is a key operative part of the Directive.
Most fundamentally, the ban on vitamins and mineral forms excluded from the positive list is unconstitutional under EU law. As The FSD is presented as the first part of a plan for the comprehensive regulation of food supplements at the EU level, it is vital that this legal challenge be pursued otherwise the prospects for a successful challenge to a second or subsequent directives / regulations will be greatly reduced.
Immediate Action
1. Further Funding
In order to proceed with this next phase of the action; as a matter of urgency, ANH must immediately instruct its barristers to prepare written observations for the European Court of Justice. Funds will be needed to proceed. Any contribution you can make will help.
2. Media and other publicity
It will be important to support and publicise the legal challenge to the FSD as widely as possible.
David C. Hinde
Solicitor
Legal Director, Alliance for Natural Health
Tel: +44 (0) 207 738 1640
e-mail: [email protected]
web: www.alliance-natural-health.org
