EU Court Validates Food Supplements DirectiveEU Court Validates Food Supplements Directive

LUXEMBOURG--The European Court of Justice (ECJ) ruled in favor of the European Commission (EC) Foods Supplement Directive (FSD), uncharacteristically reversing the previously stated opinion by the courts advocate justice. In its ruling, the court validated the laws use of a positive list, restricting supplement manufacturers to approved forms of vitamins and minerals. In response to the ruling, the EC will begin work on implementation of the FSD, which should go into effect in August.

Criticized as too restrictive, the FSD faced stiff opposition from supplement consumers in the more liberal markets of Ireland, the Netherlands and the United Kingdom (U.K.), as well as from numerous trade groups, including the U.K.s Health Food Manufacturers Association (HFMA), the National Association of Health Food Stores (NAHS) and the Alliance for Natural Health (ANH). These groups filed lawsuits in U.K. court following the adoption of the FSD in mid-2002, challenging the validity of making the FSD a U.K. law.

After the U.K. court referred the case to the ECJ in January 2004, Leendert Geelhoed, advocate general for the ECJ, issued an April 2005 statement in opposition of the FSD. European court decisions ordinarily follow the opinion of their advocate generals, but the high court ruled the FSD was legal under Article 95 of the EC Treaty and appropriately ensures free movement of food supplements among EU countries while guaranteeing a high level of consumer protection. Thus, starting Aug. 1, EU member states must prohibit products containing substances not on the positive list.

The news was welcomed by more restrictive markets, such as Spain and Poland, in which supplements were not previously considered as foods. Various consumer and industry groups, such as the British Dietetic Association, also backed the ruling, citing concerns about patients suffering liver failure and stomach problems after taking high doses of vitamins.

Conversely, the HFMA and NAHS reacted to the ruling by calling on the British Prime Minister Tony Blair, who currently holds the EU presidency, to fulfill his promise to get the FSD rewritten to allow the U.K. to include products that otherwise are prohibited by the legislation. Barring any intrusion by the prime minister, the focus of the FSD regulators will be to establish maximum safe levels for approved nutrients, based on scientific evidence.

John Bowis, Tory health spokesperson in the EU parliament, called the court decision a defeat for common sense and a victory for overregulation. The crux of British opposition to the FSD centers on the hundreds of currently marketed supplement ingredients that are excluded from the positive list. However, FSD opponent Chris Davies, the Liberal Democrat's European Parliament spokesman on public health, conceded no currently marketed supplement will be pulled from the shelves unless it does not gain approval following tests that may be years away from completion.

British Public Health Minister Caroline Flint said the government was concerned the FSD would be a burden on supplement manufacturers, particularly small, niche companies that might lack the resources to gain approval for new nutrients. She noted the government will provide small companies with the resources need to submit evidence to allow their products to remain on the market. In its ruling, the ECJ noted an application to have a substance added to the positive list can only be rejected on the basis of a full risk assessment, based on reliable scientific data and the latest international research.

John Hathcock, vice president of scientific and international affairs for the U.S. Council of Responsible Nutrition (CRN), explained the decision is a setback for British industry and American companies operating in the U.K., and affected companies might have to accept the firm decision and take advantage of the provision to amend the list. There is an administrative procedure in place, however expensive and cumbersome, for amending the list via submission of dossiers, he said. As many as 30 to 40 dossiers are in various states of submission, and I hope companies have been working on dossiers throughout the course of this court case. Taking a broader view, he noted that along with the recent adoption of the Codex standard, this EU ruling firmly plants risk assessment as the method for establishing maximum levels in international trade.