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Food supplements

 This page contains informations about:


Starting a new business? Here's how
If you want to start a food business in Denmark your company must be registered.

You must therefore fill out a special form and send it to The Danish Veterinary and Food Administration. You can fill out the form online using this link to the homepage virk.dk or you can print the form here.

Please note that the form only exists in a Danish version.

Marketing of food supplements in Denmark

Before selling food supplements in Denmark you must register the products that you wish to sell no later than on the first day of marketing.

Register your products via the webpage
virk.dk or via the official homepage of The Danish Veterinary and Food Administration, follow this link (please note that the registration form is only available in Danish). From this page you can also unregister any food supplements that you do no longer wish to sell in Denmark.

If you change the composition of a food supplement the product must be registered once again as if it was new.

Fees
Since 2011 all companies responsible for the first marketing of a food supplement in Denmark (manufacturer or importer), have to pay an annual fee. The fee covers supplementary safety control.

 

The fees consist of a basic fee of 12 500 DKR per company per year plus an additional fee of 1 000 DKR for each product marketed in Denmark. Companies with a yearly turn over of DKK 50 000 or less are not covered by these fees.

Which products can be marketed as food supplements?
The most common food supplements consist of vitamins and/or minerals. But they can also consist of dietary fibers, essential fatty acids, animal ingredients e.g. fish oil or plant ingredients e.g. extracts of garlic. Food supplements must contain any of these ingredients in quantities that are sufficient to have an effect on the body.

It is moreover required that food supplements are sold in smaller defined quantities, e.g. as pills, fluids or powder, and that they are labeled with information about the recommended daily dose.

Regulations on the composition of food supplements
Food supplements sold in Denmark are regulated by the Commission Regulation (EC) No 1170/2009 and the Danish regulation on food supplements "kosttilskudsbekendtgørelsen" (1440/2009). Follow this link to read a guidance on the regulation of food supplements, which is only available in Danish.

Other substances that are not vitamins or minerals
The use of other substances in food supplements is regulated in “The executive order on the addition of certain substances other than vitamins and minerals to foodstuffs” (888/2011). The order is translated into English, but in an unofficial version only. You can find the English version here.

The order contains a list of substances authorized to be used in foods and food supplements. Permission must be given by The Danish Veterinary and Food Administration prior to marketing, if a company wishes to use an unauthorized ingredient.

Annex 1 of the appendix contains a list of approved substances, the conditions of use and the maximum levels allowed. If a company wishes to use a larger amount in their product, they can apply The Danish Veterinary and Food Administration. If permission is granted the appendix will be changed accordingly. Please note that there is a fee to this authorization procedure.

General principles and requirements of food law
In addition, all foods including food supplements are regulated by Regulation (EC) No 178/2002 of the European Parliament and of the Council. Especially Article 14 concerning food safety requirements and Article 16 concerning labeling, advertising and presentation of food are of relevance when selling food supplements.


Labeling

Food supplements are required to follow the general food labeling rules set down in the Danish regulation on labeling "mærkningsbekendtgørelsen" (1308/2005). According to this regulation the labeling on a food product on the Danish market must be easy to read and written in Danish or a similar language. Furthermore is it required that the labeling contains the name of the food and the company producing it, as well as a list of ingredients.

In addition to the general requirements mentioned above, food supplements must also be labeled with the following:

  • Information that the product is a food supplement.
  • Information about which vitamins, minerals or other ingredients the product contains.
  • Information about the amounts of vitamins, minerals or other ingredients in the product.
  • The recommended daily dose.
     

  • The amount of vitamins and minerals in the product in percentage of the recommended daily intake (RDI) values for adults and children over the age of 11. And if relevant also for children between 1 and 10 years of age. You can find the RDI-values in annex 3 of the Danish regulation on food supplements "kosttilskudsbekendtgørelsen" (1440/2009). The Danish translation for “RDI” is “ADT”.

  • The Danish and Latin name of any herbal ingredients.
  • A warning not to consume more than the recommended daily dose.
     

  • A warning to keep the product out of reach of children.
     

  • Information to the consumer that food supplements should not replace a healthy and varied diet.
     

  • Information that pregnant women and children under the age of 1 should not consume the product without consulting a doctor.

Follow this link to read more about food labeling.

Nutrition and health claims on food supplements
It is voluntary to use nutrition and health claims on food supplements, but if such claims are used they must comply with the rules laid down in Regulation (EC) No 1924/2006 of the European Parliament and of the Council.

Products that claim to be able to prevent or cure diseases are considered as medicinal products and are therefore controlled by the Danish Medicines Agency. Follow
this link to view their homepage.

Read more about nutrition and health claims in Danish here.

Own check program

If your company sells and/or produces food products you must have a plan that shows how you regularly ensure that your business complies with the rules. Such a plan is called an own check program.

 

The extent of the program depends – among other things - on what type of product you wish to sell and on whether your business concerns production or merely resale/import of readymade food supplements.

This link shows and example of an own check program for a small food business.  Please note that the example is not directly applicable to other food businesses.

The Danish Veterinary and Food Administration is preparing a folder on own check program in English. You can find a link to the folder on our English website under “Inspection” when it is issued.

In the meantime you can follow this link to read more about own check programs in Danish.

Additional food regulations
In addition to the above mentioned rules and regulations, there are more specific rules for some types of food products:


Contact
Søren R. B. Langkilde, e-mail: srbl@fvst.dk

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