IRENE WOHLFAHRT
analyze & realize GmbH, Berlin, Germany

Abstract

Food supplements are regulated in Europe by the Food Supplements Directive. Since this only clearly regulates vitamins and minerals, Member States have begun to devise their own legislation for the so-called “other substances” such as botanicals, which leads to increasing dis-harmonization of the European marketplace.
A similar situation is developing for the maximum permitted levels of vitamins and minerals, which are also not stipulated by EU regulations. This is beginning to impede free trade in Europe. In some cases, e.g. questions of whether a given food supplement really is a food product and not a drug, only court decisions are binding. The restrictive health claims situation is hindering innovation for food supplements containing certain ingredients such as botanicals or probiotics. This shows that the regulatory situation of food supplements in Europe requires improvement.

FOOD SUPPLEMENTS – HARMONIZED YET NOT HARMONIZED IN EUROPE

Food supplements are intended to be added to a normal, varied diet. They are offered as concentrated sources of nutrients and can be tablets, capsules, shots, or even liquids, as long as the definition of “concentrated nutrient source” is upheld. They are marketed in a “dose” form that can and should be defined on the label as part of the mandatory label statements.

In Europe, food supplements are regulated by the Directive 2002/46/EC (Supplement Directive). The directive is not a regulation, so Member States are relatively free in adopting it into national legislation, which has led to some interesting EU-wide consequences, as will be covered later.

The main point about the regulation of food supplements is that they are food, not medicines. They are regulated as part of the food category as far as labelling and general safety is concerned. Food supplements are intended to supplement the diet and to maintain health, not to prevent or cure any disease.

The Supplement Directive regulates the definition of food supplements, the labelling requi ...