title: [Marketability of food supplements - criteria for the legal assessment].
abstract: To be placed on the market legally, food supplements have to meet national and European food law regulations. This is true for all substances used as well as for the labeling on the packaging of and the advertising for food supplements. The food business operator is responsible for its compliance with all regulations. Therefore, in this article, a concise step-by-step assessment is presented, covering all necessary legal requirements to market food supplements. Additionally, all steps are visualized in a flow chart. All vitamins, minerals and other substances used have to meet the legal conditions. Food business operators have to make sure that their products do not contain medicinal ingredients based on their pharmacologic effect. It is prohibited to place medicinal products as food supplements on the market. Furthermore, food business operators have to make sure that their products are not non-authorized novel foods according to the novel food regulation (EC) no. 258/97. Also, food supplements have to meet the requirements of article 14 of Regulation (EC) No. 178/2002 concerning the safety of foodstuff. Food shall not be placed on the market if it is unsafe. For food supplements that fail the German food-related legal standards but are legally manufactured in another EU member state or are legally put into circulation, the importer requires the so-called general disposition, which must be applied for at the BVL according to § 54 of the German Food and Feed Act. Another possibility for food which fails to meet German food law is to apply for a certificate of exemption according to § 68 of the Food and Feed Act. The food business operator has to meet the harmonized regulations concerning maximum and minimum levels of additives, flavors and enzymes. The packaging has to meet the compulsory labeling as well the voluntary labeling, like health claims. The BVL is also the relevant authority for other tasks concerning food supplements. A figure shows all notifications since 2005 of food supplements in Germany at the BVL. Additionally, an overview for notifications in the rapid alert system for food and feed concerning food supplements is given as well as a brief introduction into the survey of food supplements marketed on the internet.
authors.affiliation: Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Mauerstraße 39-42, 10117, Berlin, Deutschland. Evelyn.Breitweg-Lehmann@bvl.bund.de.
authors.forename: Evelyn
authors.initials: E
authors.lastname: Breitweg-Lehmann
mesh_terms: D000329:Advertising / Q000331:legislation & jurisprudence*; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D019587:Dietary Supplements / Q000592:standards*; D005062:European Union; D059022:Food Safety; D005858:Germany; D033161:Government Regulation; D006801:Humans; D007881:Legislation, Food; D040541:Marketing / Q000331:legislation & jurisprudence*
keywords: Evaluation; Food safety; Food supplement; Legal assessment; Step-by-step survey