Noble Pia
c/o Referat 214, Bundesministerium für Ernährung und Landwirtschaft, Rochusstraße 1, 53123, Bonn, Deutschland.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2017 Mar;60(3):260-267. doi: 10.1007/s00103-016-2499-0.
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.
食品补充剂归类为食品。它们是维生素、矿物质或其他具有营养或生理作用的物质的浓缩来源。其目的是补充正常饮食。食品补充剂必须符合食品法的适用法律规定。为确保消费者的健康保护，投放市场的食品补充剂必须是安全的。对于食品补充剂，欧盟层面以及国家层面均有相关规定。具体要求在《食品补充剂条例》中加以规范，据此欧洲食品补充剂指令被转化为德国法律。概述了适用于食品补充剂的欧洲和德国法律规定。探讨了食品补充剂与药品之间界限划分的重要方面。这些边界问题对于以胶囊、片剂等典型药品剂型销售的食品补充剂尤为重要。描述了因缺乏统一规则而产生的问题。对于用于食品补充剂的除维生素和矿物质之外具有营养或生理作用的物质，欧洲规则的协调仍不完整。食品补充剂指令中所设想的食品补充剂中维生素和矿物质最大含量的设定尚未实施。
