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Fortified food

This section regards fortified food, which are foodstuffs fortified with vitamins, minerals or other substances having a nutritional or physiological effect. This could be e.g. soft drinks or energy drinks. There is also information concerning the legal aspect and guidelines when marketing fortified food.

Fortified food are products, which are added vitamins, minerals or other nutritional substances. Examples of fortified food are iodine added in salt, vitamins in soft drinks, caffeine in energy drinks or vitamin D in margarine.

Both the EU and national legislation govern fortified food where the national legislation is applied if there is not specified any EU legislation. The EU legislation specifies what types of vitamins and minerals, which are allowed to be added whereas the national legislation specifies how much the companies are allowed to add of the specific vitamin, mineral or other substance with nutritional or physiological effect.

The EU treaty determines that there should be free movement of goods within EU unless the goods pose a real hazard for the public health. In several member states in EU, fortification is permitted without pre-approval. The Danish Veterinary and Food Administration (DVFA) only prohibits foods that are deemed injurous to health, but companies must apply for pre-approval (see below section).

​​​Types of fortifications

There are two types of fortifications: indirect and mandatory fortification.

Indirect fortification

If a product contains e.g. margarine fortified with vitamin A, it is defined as indirect fortification. The foodstuff itself containing the margarine is not required a pre-approval before it can be marketed in Denmark. However, the addition of vitamin to the margarine is required to be pre-approved by the DVFA.

Mandatory fortification

The DVFA has introduced mandatory fortification with iodine of household salt, and when salt is used as an ingredient in bread and bakery products with a level of 20 mg iodine per kg salt. The Danish Order concerning addition of iodine applies to bread and bakery products, but also applies to products such as pizza dough, breadcrumbs, crisp bread, tortillas and ready-to-use flour mixes.

Household salt, which is legally produced and marketed in another member state within the EU, can be marketed in Denmark, even though the household salt is not fortified with iodine according the Danish Order concerning addition of iodine. The same applies to bread and bakery products that are legally produced and marketed in another member state in EU. The products can also be marketed in Denmark, even though the bread and bakery product has not been added iodine-fortified salt.

Fortified food with vitamins, minerals or other substances are allowed to be marketed in Denmark when they have been through the procedure of prior approval by the DVFA.

In addition to the required pre-approval, any fortification with vitamins, minerals or other substances needs to comply with Regulation (EC) No. 1925/2006. The EU regulation does not specify any maximum levels for addition of vitamins, minerals or other substances in foodstuffs. However, the DVFA will follow the national authorization procedure (described below) until maximum amounts are specified in the EU regulation.

Authorization procedure of fortified food

Fortification of vitamins, minerals or other substances to a foodstuff needs to be approved by the DVFA in collaboration with the DTU National Food Institute before it can be marketed in Denmark. The DTU National Food Institute bases the approval on an individual risk assessment carried out by a case-by-case basis. The purpose of the risk assessment is to ensure that the entire population can safely consume the fortified food.

The risk assessment includes calculations based on the upper tolerable level (UL) or acceptable daily intake (ADI) values established by international scientific bodies and available data from national dietary surveys. In each case, the fortification is accepted unless the risk assessment concludes that one or more population groups are in risk of exceeding the UTL if the fortified food is marketed.

The requirements for approval are listed below:

  1. A registration of the company is required by the DVFA in order to sell or produce fortified/enriched food in Denmark. Contact information of the DVFA: 
    • Fødevarestyrelsen
      Att. Chemistry and Food Quality Division
      Stationsparken 31-33
      DK-2600 Glostrup

      Send an e-mail

  2. The application for approval of a fortified food requires following information:
    • Name, address and phone number of the company applying for approval
    • Name, address and phone number of the company producing the fortified food (only if the company applying for approval is different from the company responsible for production)
    • The name and type of foodstuff
    • Declaration of ingredients including the source of nutrients
    • The total amount of each nutrient including natural content
    • Added amount of the nutrients, which are applied for (excluding natural content)
    • Recommended intake of the food, if it is informed on the package
    • Energy content expressed per 100 ml or 100 g

The company will receive a receipt with a case number from the DVFA when the above-mentioned information has been provided. After the company has received the receipt, a fee needs to be paid. The fee is DKK 18,700 per product (2020) for handling of the approval but there are no fees for variants.

The company also receives a permission or ban concerning their application based upon an evaluation of safety. If the company obtains final approval, they are allowed to sell the fortified food in which they applied for. Applications have to be sent to the following address:

Fødevarestyrelsen
Att. Chemistry and Food Quality Division
Stationsparken 31-33
DK-2600 Glostrup
Send an e-mail

General acceptances of certain fortified products

The DVFA has given a number of general acceptances for fortification of vitamins and minerals in certain products. The general acceptances are listed in following documents: 

The documents are only available in Danish.

The general acceptances are applied if the added amounts of vitamins and minerals comply with the types and levels specified for the product. In order to use the general acceptances, a copy of the label has to be sent to the DVFA to the following address:

Fødevarestyrelsen
Att. Chemistry and Food Quality Division
Stationsparken 31-33
DK-2600 Glostrup
Send an e-mail

Companies must also inform the DVFA if the marketing of a notified product ceases permanently.

Other substances and plant ingredients

The Danish regulation's definition of other substances such as plant ingredients differ from the definition in Regulation (EC) No. 1925/2006. If a plant ingredient, extract or substance is concentrated to a high degree or a product contains pure substances, it falls under the Danish regulation. This includes having to go through the above-mentioned authorization procedure.

The company needs to send an application for approval to the DVFA, when: 

  • A substance is added in a higher amount than permitted where the fee is DKK 18,700 (2020) per product for handling of the approval.
  • A new substance is added where the fee is DKK 47,200 per substance (2020) for handling of the approval. 

In Denmark, there is not a national legislative list of forbidden or restricted plant ingredients in food supplements, but it is the company's responsibility to ensure that their product does not pose any safety hazards.

The Danish definition of other substances is following:

Substances that have or are added with the purpose of having a nutritional or physiological effect and that:

  1. are not vitamins or minerals,
  2. have a purity of minimum 50 % or is concentrated 40 times or more, and
  3. are not normally ingested as a food on its own nor typically used as an ingredient in foods.

The Danish regulation on addition of other substances also applies to food supplements (see above section).

Last Modified 20. February 2020