Denmark has its food supplements notified to the Danish Veterinary and Food Administration (DVFA) prior to or at the same time as they are placed on the market. Before commercialisation, companies have to make sure to meet the Danish and EU requirements for composition, labelling and health claims. This guide provides an overview of the notification procedure and some of the important regulatory aspects for marketing health supplements in Denmark.
Regulatory Authority for Health Supplements in Denmark
In Denmark, health supplements are regulated by the Danish Veterinary and Food Administration (DVFA), which also monitors the products, labels them, ensures compliance with the Danish and EU food legislation, and notifies the products. The Danish Medicines Agency is responsible for medicines according to their composition and/or according to any claims that are made about them.
What Are Health Supplements Under Danish Regulations?
Food supplements are foods for special medical purposes in accordance with Directive 2002/46/EC, which can be defined as foods intended to be consumed as such by the general public as food supplements, and are concentrated sources of nutrients or of other substances with nutritional and/or physiological effects, marketed in a dose form.
They include:
- Vitamins and minerals
- Amino acids
- Essential fatty acids
- Fibre
- Herbal extracts, other materials of a nutritional or physiological effect.
- Measured-Dose Forms: capsules, tablets, pills, powders, ampoules, drop-dispensing bottles, etc.
The products that contain medicinal ingredients, have a pharmacological effect, or make medicinal claims can be regulated as medicines.
Compliance Checklist for Health Supplement Approval in Denmark
Verify that, prior to notifying a food supplement:
- The product is properly labelled as a food supplement.
- Ingredients are in accordance with the relevant Danish and EU legislation.
- Where required, safety documentation is available.
- The label meets the Danish and EU labelling laws.
- Nutrition and health claims are in accordance with Regulation (EC) No 1924/2006.
- Technical documentation can be provided to prove compliance.
Health Supplements Registration Process in Denmark
To market a health supplement in Denmark, the company responsible for the first marketing of the product in Denmark must notify the product to the Danish Veterinary and Food Administration (DVFA) no later than the first day it is placed on the market. Below is the step-by-step registration process.
Step 1: Register your food business
Before submitting a product notification, manufacturers, importers, and other food business operators must be registered or approved by the DVFA, where applicable.
Step 2: Prepare the product notification
Complete the official Food Supplement Notification Form with the required information, including:
- The company responsible for the first marketing in Denmark
- Product name and dosage form
- Recommended daily dose
- Complete qualitative and quantitative composition
- Label information and other required product details
Step 3: Submit the notification to the DVFA
Submit the completed notification form to the DVFA before or no later than the first day the product is marketed in Denmark.
Step 4: Market the product
Once the notification has been submitted, the product may be placed on the Danish market. Companies do not need to wait for the DVFA’s acknowledgement of receipt before marketing the product.
Step 5: Maintain the product registration
- Submit a new notification if the product composition changes, except where the only change relates to the amount of technological additives.
- Unregister the product if it is no longer marketed in Denmark, as unregistered food supplements cannot be sold through wholesalers, retail stores, or websites.
Documents Required for Health Supplements Registration in Denmark
Create the following documents:
- Completed DVFA notification form
- Company details
- Product name and dosage form
- Complete qualitative and quantitative composition
- Label artwork
- Recommended daily dose
- Safety documentation will be included if applicable
Technical documentation to support should be preserved to prove compliance for inspection purposes.
Danish Labelling Requirements for Health Supplements
Labels have to meet the requirements of Regulation (EU) No. 1169/2011, Directive 2002/46/EC and Danish labelling guidelines.
Mandatory information includes:
- Name of the product (“Food supplement”)
- The different types and quantities of nutrients or other substances
- Latin names of the herbal ingredients (where applicable), followed by the Danish common names
- Recommended daily dose
- Not to be exceeded, warn users
- Stating that food supplements should not be used to replace a balanced diet
- A statement to prevent access by young children to the product
- Ingredients, net quantity, responsible food business operator, durability date
- Label information in Danish or in another language, as is appropriate for the language of the applicant
Licensing Requirements for Health Supplements in Denmark
There is no need for marketing authorisation of food supplements in Denmark.
However:
- Registered or approved food business operators (where applicable) by the DVFA.
- Product notifications are only accepted from businesses registered in the countries of the European Union/European Economic Area (EEA).
GMP Requirements for Health Supplements in Denmark
Manufacturers and importers are responsible for complying with the EU food hygiene legislation, and they are required to do the following:
- Adopting a HACCP system of food safety practice
- Manufacturing under hygienic conditions
- Traceability and Recall procedures – keeping it in place
- Qualifying suppliers
- Keeping up-to-date compliance records on inspections
Health Claims and Advertising Regulations in Denmark
The claims in the range of products should be in line with Regulation (EC) No 1924/2006.
- Authentic nutrition and health claims are only allowed.
- Disease prevention, treatment or cure claims are not allowed.
- The claims on the label and on marketing materials shall not mislead consumers.
Import Regulations for Health Supplements in Denmark
Importers are required to make sure that:
- Products meet the food legislation in Denmark and the EU.
- The importer is registered/approved as a food business operator.
- Products from outside the EU do meet the EU import requirements.
Health Supplement Registration Timelines in Denmark
Denmark does not have a statutory approval period – food supplements are notified.
- Send notification prior to or on the first day of marketing.
- After notification, products can be marketed straight away.
- A new notification is required for reformulated products.
Health Supplement Registration Costs in Denmark
Denmark does not charge a fee to notify of a food supplement.
The annual product safety inspection fees are paid by companies with a turnover of above DKK 50,000 per year and one or more registered food supplements:
- DKK 2,736 annual company fee (2026)
- DKK 219 per registered food supplement (2026)
Conclusion
Denmark does not have a pre-market approval process for food supplements; however, the companies are responsible for making sure the food supplements comply with the Danish and EU legislation before they go to market. To get products onto the market, it is important to classify them appropriately, label them in line with the regulations, and ensure that the product is fully notified.
Artixio provides assistance to manufacturers with product classification, health supplement regulatory strategy, product notification, labelling review and continued compliance to aid in expediting the launch of health supplements in Denmark and throughout the EU. Get in touch with us today at info@artixio.com.
FAQs
Do health supplements require approval in Denmark?
No. Food supplements are subject to a notification requirement rather than pre-market approval.
Who may notify a health supplement in Denmark?
Notification can only be made by companies that are established in the EU or EEA.
Is there a notification fee for health supplements in Denmark?
No, Denmark does not have a fee for product notification.
How long does the Health Supplement Registration Process in Denmark take?
The statutory review period is not applicable. Products can be sold as soon as they are notified.
Is Danish labelling mandatory for health supplements?
Yes. The mandatory information on the label should be in Danish or another accepted language.
