Breitweg-Lehmann Evelyn
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Mauerstraße 39-42, 10117, Berlin, Deutschland.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2017 Mar;60(3):277-285. doi: 10.1007/s00103-016-2504-7.
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.
为了合法投放市场，食品补充剂必须符合国家和欧洲的食品法律法规。这适用于所有使用的物质以及食品补充剂包装上的标签和广告。食品经营者有责任遵守所有法规。因此，本文提出了一个简洁的逐步评估，涵盖了销售食品补充剂的所有必要法律要求。此外，所有步骤都在流程图中进行了可视化展示。所有使用的维生素、矿物质和其他物质都必须符合法律条件。食品经营者必须确保其产品根据药理作用不含有药用成分。禁止将药品作为食品补充剂投放市场。此外，食品经营者必须确保其产品不是根据第258/97号（EC）新食品法规未经授权的新食品。此外，食品补充剂必须符合关于食品安全性的第178/2002号（EC）法规第14条的要求。如果食品不安全，则不得投放市场。对于不符合德国食品相关法律标准但在另一个欧盟成员国合法生产或合法投入流通的食品补充剂，进口商需要所谓的一般处置，必须根据德国食品和饲料法第54条向德国联邦风险评估研究所（BVL）申请。不符合德国食品法的食品的另一种可能性是根据食品和饲料法第68条申请豁免证书。食品经营者必须符合关于添加剂、香料和酶的最大和最小含量的统一规定。包装必须符合强制标签以及自愿标签，如健康声明。德国联邦风险评估研究所（BVL）也是与食品补充剂相关的其他任务的主管当局。一个图表显示了自2005年以来德国联邦风险评估研究所（BVL）收到的所有食品补充剂通知。此外，还给出了食品和饲料快速预警系统中关于食品补充剂通知的概述，以及对互联网上销售的食品补充剂调查的简要介绍。
