The purpose of food supplements is to supplement the daily diet. They are a concentrated source of nutrients and usually contain vitamins, minerals, plant ingredients, or concentrated substances such as omega-3 fatty acids or amino acids.
Marketing of food supplements in Denmark
In order to sell food supplements in Denmark, any company is required to register the products no later than the first day of marketing. All food business operators have to be registered or approved by the Danish Veterinary and Food Administration (DVFA). This also applies for importers of food from other EU member states or third countries and producers/importers of food contact materials (FCM).
More information regarding starting a new food business in Denmark is found here and you can download an English version of the registration form here.
Changes in the composition of an existing food supplement requires a new registration as if it was a new product. An exception to this rule concerns changes in food additives which 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
Companies that have registered one or more food supplements in Denmark and that have an annual turnover exceeding 50,000 DKK are required to pay an annual fee of 9,573 DKK for extra inspection and an annual fee of 766 DKK per registered food supplement (2020). These fees are used to cover the expenses in relation to product safety checks. The payments are charged for companies and products registered as of February 1 that same year.
Regulations on the composition of food supplements
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- You can find more information in our guide on fortified food. This guide also explains the legislative difference between plant ingredients and other substances in Denmark.
Additional food regulations
In addition to the above-mentioned rules and regulations, there are specific rules for some aspects:
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 (DVFA) guidance values, which can be found in appendices A and B in the guidance on the regulation of food supplements
(only in Danish) as well as on FVST.dk
. 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
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
. Therefore, 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 in https://www.foedevarestyrelsen.dk/english/Food/Fortified_food/Pages/default.aspx
Labelling of food supplements
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".
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.
Nutrition and health claims on food supplements
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. Products that are claimed to prevent or cure diseases are considered medicinal products and these are regulated by the Danish Medicines Agency.
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. There is more information on about own-check programmes
in our guide.