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Food Supplement Registration in Denmark

Regulatory Authority:

The Danish Medicines Agency

Regulatory Website:

Registration Timeline:

1-3 Months

Registration Fee:

10.646 DKK

Registration Process :

  • In Denmark, food supplements are regulated by the Danish Veterinary and Food Administration (Fødevarestyrelsen). The regulations governing food supplements are aimed at ensuring their safety, quality, and proper labeling to protect consumers.

Key aspects of food supplement regulation in Denmark include:

  • Safety and Quality: Food supplements must meet safety standards set by the Danish government. This includes ensuring that ingredients used are safe for consumption and that manufacturing processes adhere to good manufacturing practices (GMP).
  • Labeling Requirements: Labels on food supplements must accurately reflect the contents of the product. This includes listing all ingredients, their quantities, recommended dosage, and any warnings or precautions. Labels must also comply with Danish and EU regulations regarding health claims and nutritional information.
  • Notification and Approval: In Denmark, food supplements must be notified to the Danish Veterinary and Food Administration before they can be marketed. This notification process helps authorities monitor the types of supplements available in the market.
  • Prohibition of Misleading Claims: Danish regulations prohibit food supplement manufacturers from making misleading claims about the benefits of their products. Any health claims must be supported by scientific evidence and approved by the relevant authorities.
  • Maximum Limits: Some vitamins and minerals may have maximum limits established to prevent excessive intake, which could pose health risks. These limits are outlined in Danish regulations and must be adhered to by supplement manufacturers.
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Process:

  • Preparation and Documentation: Food supplement producers or importers should compile all relevant documentation before starting the registration process. This contains details about the composition, components, manufacturing procedure, labeling, and any corroborating scientific evidence.
  • Notification: Before being sold in Denmark, dietary supplements must be reported to the Danish Veterinary and dietary Administration. Usually, this notification can be completed online via the appropriate platform or site that the authorities have established. The notification ought to provide comprehensive details on the product, like its ingredients, purpose, and labeling.
  • Safety Evaluation: The Danish authorities may evaluate the dietary supplement’s safety as part of the notification procedure. This evaluation guarantees that consumers won’t be exposed to any health concerns when using the product. It can be necessary for manufacturers to furnish supplementary data or proof to bolster the safety of their merchandise.
  • Label Compliance: Labels for food supplements must abide by EU and Danish laws pertaining to labeling specifications. This entails giving precise details regarding the components of the product, the suggested dosage, its nutritional value, and any dangers or warnings. Guidelines regarding health claims and other marketing statements should also be followed on labels.
  • Market Authorization: The food supplement may be allowed to be marketed and sold in Denmark if the notification procedure is finished and the product is judged safe to eat. Distributing authorized items can happen through several channels, such as internet shops, health food stores, and pharmacies.