Dr. Rath Health Foundation

Dr. Rath Health Foundation

Responsibility for a healthy world Dr. Rath Research Institute 100+ Studies Published In PubMed

Legal Challenge to the
EU Food Supplements Directive

On April 5, 2005 Advocate General Geelhoed of the European Court of Justice gave his opinion in the cases brought before the European Court by the Alliance for Natural Health and others (the claimants) challenging the validity of European Directive 2002/46/EC – commonly known as the Food Supplements Directive.

In simple terms, the main challenges to the Directive by the claimants can be summarized as follows:

  1. Was the Directive drafted on the correct legal basis?
  2. Does the Directive comply with the principles of subsidiarity (i.e. does it only seek to provide regulations that cannot be achieved by Member States themselves)?
  3. Does the Directive infringe the principle of proportionality (i.e. are its effects proportionate to the identified problem or are they unnecessarily prohibitive)?
  4. Does the Directive provide equal treatment for all parties affected by its regulations?
  5. Does the Directive contravene fundamental human rights?

The Advocate General's opinions on these points of law are as follows:

1. Legal Basis

“In my view, it is beyond doubt that the conditions are met”

2. Subsidiarity

Since the objective of the Directive is to eliminate barriers to trade in food supplements within the Community, the Advocate General argues that this can only be achieved with a European Directive. He therefore confirms that the Directive complies with the principles of subsidiarity.

3. Proportionality

Whilst making the point that the objective of the Directive may have been achieved by less restrictive measures than curtailing the use of certain vitamin and minerals and prescribing the only acceptable forms of those permitted, that doesn’t make the Directive invalid.

In fact, the Advocate General supports the positive list approach, saying: “I also wish to state at this juncture that the choice of a system of positive lists is as such appropriate.”

However, he does conclude that the Commission has seriously failed in its duty to design such a far-reaching measure with all due care. Consequently the Advocate General’s opinion on proportionality is:

“…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.”

4. Equal Treatment

The Advocate General contends that the Directive is not discriminatory but warns that this does not mean that it couldn’t be applied in a discriminatory manner. For this reason, he argues, the Directive should provide adequate and transparent procedures suitable for preventing discrimination and, in his opinion, it currently does not.

5. Fundamental Human Rights

Provided that the procedural guarantees mentioned in points 3 and 4 are inserted into the Directive, then the Advocate General considers that it does not constitute a breach of fundamental human rights.

All in all, the Advocate General rejects most of the claimant’s arguments, but does agree that the Directive falls short of compliance with the principles of proportionality. The important points to note from his opinion are these:

  • The Advocate General supports the need for the Directive and the need to have the so-called positive lists that restrict the use of certain vitamins and minerals. He doesn’t suggest throwing out the Directive altogether, only re-drafting it so that it complies with good legal practice.
  • The Advocate General’s views are non-binding. The European Court will hand down its judgement on the matter, in due course, probably in June 2005. However, it is worth noting that the Court follows the opinion of the Advocate General in the majority of cases.
  • Assuming the Court does follow his opinion, it is likely that the Directive will be referred back to the Commission to be re-drafted. The Advocate General made the following remarks in this context: It should also be noted that the consequences of declaring the Directive invalid on these grounds would remain limited. Such a declaration would not, after all, affect the substantive assessment made by the Community legislature which led to the selection of a restrictive system with positive lists for marketing nutrients enriched with minerals or vitamins. A declaration of invalidity would, however, compel the Community legislature to take better account in such a system of the interests of private parties and to provide for the necessary guarantees for their protection. As the Directive only requires the Member States to prohibit trade in products which do not appear on the positive lists as from 1 August 2005 at the latest, the practical consequences of a declaration of invalidity will be limited if the necessary improvements and amendments to the text of the Directive are adopted quickly.”

In other words, the Directive is badly drafted, but can be fixed.

So, what happens on August 1, 2005? That will depend on the Court’s judgement, the date on which it is given and the speed at which the European Commission respond. Our best guess right now is that this challenge may have bought some extra time and that the Food Supplements Directive may become less restrictive as a result, but will still be enacted in principally the same format as it exists now. However, the issue of annulment may be more pronounced than it might at first appear in the Advocate General’s Opinion, and the European Court could well decide to annul the entire directive.

Whatever the outcome, it is clear that the availability of vitamin and mineral supplements and information about the positive health benefits of these natural remedies will continue to be restricted throughout most countries in the European Union and may yet become more restricted still.

The need for us all to continue to campaign against these restrictions via participation in initiatives such as the Foundation’s EU Referendum campaign and anti-Codex activities is ever more real with each passing day. We must continue to push forward with positive demands for the enactment of European legislation that guarantees our right of free choice to use natural remedies and to receive information about the health benefits of vitamins, minerals and other natural substances for this and all future generations. People’s health and lives depend upon it.