[Food supplements : Legal requirements, borderline issues and other aspects].

Food supplements are classified as foods. They are concentrated sources of vitamins and minerals or other substances with a nutritional or physiological effect. Their purpose is to supplement the normal diet. Food supplements have to comply with the applicable legal provisions of the food law. In order to ensure the health protection of consumers, food supplements that will be put on the market must be safe. For food supplements, regulations exist at the EU level as well as at the national level. Specific requirements are regulated in the Ordinance on Food Supplements, with which the European Directive on Food Supplements was transposed into German law. The European and German legal provisions applicable to food supplements are outlined. Important aspects regarding the delimitation between food supplements and medicinal products are addressed. These borderline issues are of special importance to food supplements which are marketed in dose forms such as capsules, tablets etc., the typical forms of medicinal products. Problems resulting from the lack of harmonized rules are described. The European harmonization of the rules is still incomplete for substances with a nutritional or physiological effect other than vitamins and minerals for use in food supplements. The setting of maximum amounts of vitamins and minerals present in food supplements as envisaged in the Directive on Food Supplements has not yet been implemented.