Regulatory Affairs
We help you with the FDA/ EU registration and approval of your dietary supplements
European market: According to the EU Regulation (EC) No. 178/200) dietary supplements are considered food. The responsibility for the safety of these products lies with the food business marketer. As part of the development process, it must first be clarified whether a dietary supplement/ food supllement can be marketed as food at all. Here it is important that your product is classified as a food or dietary supplement and not, for example, as a drug. Only if the examination of the product shows that it is not covered by the regulatory area for medicinal products according to § 2 of the German Medicinal Products Act (AMG) e.g., on the German market, is it possible to market it as a dietary/ food supplement.
Labeling and admissibility of food supplements
On the European market dietary supplements must comply with the requirements of Directive 2002/46/EC (Food Supplements Regulation. The requirements contain harmonized lists of vitamins and minerals that are permitted for manufacture, as well as the labeling regulations EU Health claim regulation for food supplements. These are based on, among other things, the scientific opinions of the European Food Safety Authority (EFSA).
In order for foods and dietary supplements to be permissible, correct and complete labeling is mandatory. Mandatory labeling and health claims are defined in the Health Claims Regulation and in Regulation (EU) 1169/2011. In addition, Directive 2002/46/EC and the NemV must be checked with regard to further specific requirements. It must also be checked whether the food supplement or its ingredients are a novel food according to Regulation (EU) 2015/2283. Anyone wishing to place a novel food on the market that is not yet on the Union list of approved novel foods must submit an application for approval to the European Commission in accordance with Article 10 of the Novel Food Regulation (EU) 2015/2283.
On the US market dietary supplements must comply with the FDA Dietary Supplement Health and Education Act of 1994 (the DSHEA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). Dietary supplements must also be in accordance with the FDA CFR 21 Part 101 in regard to dietary supplement labeling.
Marketability and placing on the market of food supplements.
All ingredients and constituents must be evaluated with regard to their admissibility (marketability) (e.g. food additives according to Regulation (EC) 1333/2008, food enzymes according to Regulation (EC) 1332/2008), and flavors according to Regulation (EC) 1334/2008). Likewise, the specified quantities that can lead to the corresponding effects must be observed. For additives, for example, the Food Additives Regulation (EC) 1333/2008 applies with its defined additive maximum quantities.
In addition, the distributor must comply with regulations governing quality and safety: the Hazard Analysis Critical Control Points (HACCP) concept of food hygiene according to Regulation (EC) 852/2004), microbiological criteria for food (Regulation (EC) 2073/2005), and maximum levels of heavy metals or other contaminants according to Regulation (EC) 1881/2006.
Compliance with the aforementioned legal requirements is monitored by the respective competent food monitoring authority in the federal states.
The distributor of foods/food supplements must prepare comprehensive product documentation (reduction of liability risks, inspections by the authorities, etc.). The product documentation contains complete data on the raw materials, the manufacturing process and the end product (certificates of analysis, stability data, etc.) of the respective batches, quantitative and qualitative data on ingredients of the respective batches, etc.
Notification of food supplements
The NemV specifies a notification procedure for food supplementsbefore the product is placed on the market for the first time. The notification is made to the Federal Office of Consumer Protection and Food Safety (BVL). The BVL forwards it to the state authorities responsible for food monitoring and the Federal Ministry of Food and Agriculture (BMEL).
Depending on the country of introduction, different notification and notification obligations or applications for approval are required.
We would be happy to support you with the strategy for the approval of your food supplement. Just contact us!