European Union Dietary Supplement Regulation

In europe the food supplements directive fsd directive 2002 46 ec as amended establishes a definition for food supplements and a list of allowable vitamins and minerals and it sets requirements for labeling.
European union dietary supplement regulation. L404 26 30 december 2006. Regulation ec no 1925 2006 of the european parliament and of the council of 20 december 2006 on the addition of vitamins and minerals and of certain other substances to foods. This regulation provides opportunities for the use of health claims on foods in europe.
Official journal of the european union. Directive 2002 46 ec of the european parliament and of the council of 10 june 2002 on the approximation of the laws of the member states relating to food supplements text with eea relevance oj l 183 12 7 2002 p. While dietary supplements are subject to food laws provisions dealing with herbs are primarily to be found in pharmaceutical regulations.
In europe food supplements are foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological function alone or in combination marketed in dose form namely forms such as capsules pastilles tablets pills and other similar forms sachets of powder ampules of liquids drop. Food supplements are defined as foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a. Novel foods food supplements also need to comply with the eu novel foods regulation which lays down rules in european food safety authority efsa for novel foods that were not used before 1997.
In the european union the manufacturing of and the trade in herbs and dietary supplements are regulated by pharmaceutical and food laws. Taking into account this study and other available information the commission in accordance with the requirement set out in article 4 8 of directive 2002 46 ec on food supplements has prepared a report to the council and the european parliament on the use of substances other than vitamins and minerals in food supplements. The article discusses aspects of the regional the european union and national european countries regulation of food supplements.
For food and supplements containing novel ingredients to be allowed on the eu market an application for authorization must be submitted to the. L327 1 11 december 2015. The contemporary issues of nutrition in developed countries are discussed and the essential role of food supplements in the diet is emphasized.
Official journal of the european union. The definition of the supplement category is given.