Food supplements

Registration of food supplements

Food suppleme​​nts must be registered. Only companies established within the EU or the EEA, e.g. EU-manufacturers and EU-importers, are able to register a food supplement in Denmark.

In order to sell food supplements in Denmark, companies are required to register the products no later than the first day of marketing.

The general rule is that all food supplements marketed in Denmark must be registered.

If an EU-manufacturer already has registered the specific food supplement in Denmark, it is not necessary for every single distributor to also register the food supplement as well.

If a food supplement is registered by another EU-importer (parallel import), a registration is necessary for the other EU-importer as well. This means that the same food supplement can be registered by several companies in certain cases.

Download an Englis​h version of the product registration form (pdf)

Changes in the composition of an existing food supplement requires a new registration as if it was a new product. Only changes in the amount of food additives do not require a new registration. 

Companies need to unregister any food supplements they no longer wish to sell in Denmark. Unregistered food supplements are not allowed to be marketed from neither the wholesale company, websites, nor retail stores.

Fee for product safety checks

There is an annual fee for product sa​fety checks. Companies that have registered one or more food supplements in Denmark and have an annual turnover exceeding 50,000 DKK are required to pay an annual fee of 10.646 DKK  and an annual fee of 853 DKK per registered food supplement (2024).

These fees are used to cover the expenses in relation to specialised product safety inspections. The payments are charged for companies and products registered as of February 1 that same year.

Read more about registration of food supplements at the business site virk.dk

Food supplements sold in Denmark are governed by the Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements.

Read more in the Food Supplement Directive

A written guidance on the regulation of food supplements is only available in Danish

The guidance contains the DVFA's recommendation for maximum levels of different vitamins and minerals in the food supplements. If a company wishes to exceed these levels, they must be responsible for documenting the safety of the food supplement. The DVFA typically considers a level above the Tolerable Upper Intake Level  (UL) determined by European Food Safety Authority (EFSA) as a potential health risk.   

National regulation govern the addition of other substances than vitamins and minerals.

Find more information in our guide about fortified food - This guide also explains the legislative difference between plant ingredients and other substances in Denmark.  

A product legally marketed in an EU-/EEA country may be marketed in other EU-/EEA countries. But if the country’s authorities consider that the product is injurious to health, they can prohibit or restrict the marketing of the product.

The EEA countries are Norway, Iceland, Lichtenstein, and Switzerland.

Vitamins and minerals in food supplements

In the EU, there are no common maximum levels for vitamins and minerals in food supplements. Therefore, it is the responsibility of the companies to ensure that their food supplements are not harmful to human health.

​The companies can choose to follow the Danish Veterinary and Food Administration’s guidance values, which can be found in appendices A and B in the guidance on the regulation of food supplements (only in Danish). The guidance values ​​are based on a scientific risk assessment and are regarded as safe.

If the company chooses to exceed the guidance values, the company must document the safety of their product. The company can in their risk assessment, choose to use the tolerable upper intake levels (UL) set by the European Food Safety Authority (EFSA) or temporary guidance level (TGL) set by DTU Food.

Read more about the requirements for safety documentation in the guidance on the regulation of food supplements (only in Danish)

Mutual recognition does not exempt a company from being able to document the safety of their product, when levels exceed the Danish guidance levels.

Other substances in food supplements

As there are no EU rules for fortification with other substances than vitamins and minerals, Denmark has established national rules. These can be seen in the ministerial order on the addition of certain other nutrients than vitamins and minerals to food. Companies that want to market food supplements containing other substances in Denmark must comply with these rules.

The rules contains general acceptances for the addition of other substances. If the fortification is not included in the general acceptances, the company must send an application to the DVFA. The application procedure is included in the ministerial order. If the DVFA finds that the fortification poses a risk for human health after processing the application, then the marketing can be prohibited in Denmark.

Read more about the rules and application process

Food supplements are required to follow the general food labelling rules specified in Regulation (EU) No 1169/2011 and the Danish regulation on labelling  "Mærkningsbekendtgørelsen".

Go to Regulation (EU) No 1169/2011

Go to Mærkningsbekendtgørelsen

The Danish legislation requires that the labelling on a food product in Denmark has to be readable and written in Danish or a similar language. It is required that the labelling contains a list of ingredients, the name of the food as well as the company, which is responsible for the production. 

In addition to the above-mentioned general requirements, food supplements should also be labelled with:

• Information stating that the product is a food supplement.
• Vitamins, minerals or other ingredients that the product contains.
• The amount of vitamins, minerals or other ingredients in the product.
• The Danish and Latin name of any herbal ingredients.
• The recommended daily dose.
• A warning not to consume more than the recommended daily dose.
• Information stating that food supplements should not replace a healthy and varied diet.
• A warning to keep the product out of reach of children.
• The amount of nutrients or substances with a nutritional and/or physiological effect.
• The amount of nutrients or other substances expressed as a percentage of the recommended daily dose.
• The amount of vitamins and minerals expressed as a percentage of the reference values set out in Annex XIII, Part A, Point 1 in Regulation (EU) No 1169/2011 of the European Parliament and the Council of 25 October 2011 on the provision of food information to consumers.

The use of nutrition and health claims on food supplements is voluntary. In order to use the different claims, they must comply with the rules specified in Regulation (EC) No 1924/2006 of the European Parliament and the Council.

See the rules in Regulation (EC) No 1924/2006 of the European Parliament and the Council

Products that are claimed to prevent or cure diseases are considered medicinal products and these are regulated by the Danish Medicines Agency.

Find more information on Danish Medicines Agency's website

An own-check programme is a plan that shows how a company, which sells and/or produces food products regularly ensures that the business and production complies with the rules. The own-check programme deals with foodstuffs as well as cleaning, machinery, and premises. The program must be readable to ensure that all employees can understand it and have no doubt as to what needs to be done.​