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[1] of permitted ingredients (initially only applying to vitamins and minerals) for food supplements and mandates[2] 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 and Ireland, 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[3] 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.

For for further details on the legal action, including outline of grounds of challenge and need for action, please download complete 2-page Legal Executive Summary (April 2004) from Key Documents area on homepage of website.


David C. Hinde
Legal Director
Alliance for Natural Health
Tel: +44 (0) 207 738 1640
e-mail: [email protected]


[1] Often referred to as the ‘positive list'.


[2] That is the theory at least, but a number of Member States (e.g.France) have not yet implemented the FSD and continue to classify even positive list allowed nutrients as medicinal products.


[3] In Articles 3, 4(1) and 15 (b).