Fortified Food

Voluntary fortification

All additions of vitamins, minerals and other substances to food that are not reguired by law constitutes voluntary fortification. Voluntary fortification requires a pre-approval before the product can be marketed in Denmark (see marketing section below).

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 (see marketing section below) .

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.

Find the Danish Order on mandatory iodine fortification of salt (retsinformation.dk)

Any fortification with vitamins, minerals or other substances needs to comply with Regulation (EC) No. 19​25/2006 on the addition of vitamins and minerals and of certain other substances to foods. The EU regulation does not specify any maximum levels for addition of vitamins, minerals or other substances to foods. 

Go to Regulation (EC) No. 19​25/2006 (eur-lex.europa.eu)

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. This national authorisation procedure is maintained until maximum levels are specified in the EU regulation.

Authorisation procedure for fortified food

Fortification of vitamins, minerals or other substances to a foodstuff needs to be approved by the DVFA before it can be marketed in Denmark. The DTU National Food Institute performs an individual risk assessment which is used to decide whether an application can get an approval. The purpose of the risk assessment is to ensure that the Danish population can safely consume the fortified food as a part of the ordinary diet.

The risk assessment includes calculations based on the upper tolerable intake 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 UL/ADI.

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 food in Denmark.
2. The application for approval of a fortified food requires the following information:
   • Name, address and phone number of the company applying for approval.
   • The name and category of the food.
   • Ingredient and nutrient declaration, including the total amount of each nutrient (added and natural content).
   • Added amount of the nutrients, which are applied for (excluding natural content)
3. Applications for fortification have to be sent to the following address:
   • Fødevarestyrelsen
     Att. Chemistry and Food Quality Division
     Stationsparken 31-33
     DK-2600 Glostrup
     How to contact the DVFA

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, they need to verify the information before the risk assessment can begin. It can take six months from the date where all relevant information has been received until the application process is finalised.

General acceptances of certain fortified products

The DVFA has given a number of general acceptances for the addition of vitamins, minerals and other substances to food. They are listed in the annex of the following orders: 

• Ministerial Order on the addition of nutrients to food (ordinary food).
  Go to Order on the addition of nutrients to food (retsinformation.dk)
• Ministerial Order on the addition of certain other nutrients than vitamins and minerals to food (ordinary food and food supplements).
  Go to Order on the addition of certain other nutrients than vitamins and minerals to food (retsinformation.dk)

These orders are only available in Danish.

There is no application process for using the general acceptances, but a copy of the label has to be sent to the DVFA to the following address no later than the first day of marketing:

Fødevarestyrelsen
Att. Chemistry and Food Quality Division
Stationsparken 31-33
DK-2600 Glostrup
How to contact the Danish Veterinary and Fod Administration

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

Danish definition of other substances

The Danish definition of "other substances" differ from the definition in the Regulation No. 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods. If an ingredient, extract or substance is concentrated to a high degree or if a product contains pure substances, it falls under the Danish regulation. This includes having to go through the authorisation procedure.

The Danish definition of "other substances" is the 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.

Authorisation procedure for other substances

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

• A substance is added in a higher amount or in a different category than already permitted.
• A new substance is added.

The Danish Order on addition of other substances to food also applies to food supplements.

Regulation of plant ingredients

In Denmark, there is no national legislative list of forbidden or restricted plant ingredients used in food, including food supplements. It is the responsibility of the company to ensure that their product does not pose any safety hazards.