Fortified food are products, which are added vitamins, minerals or other substances with a nutritional or physiological effect. Examples of fortified food are iodine added in salt, vitamins in soft drinks, caffeine in energy drinks or vitamin A in margarine.
Both EU and national legislation govern fortified food. The EU legislation specifies what source of vitamins and minerals are allowed to be added whereas the national legislation specifies how much is allowed to be added.
An EU treaty determines that there should be free movement of goods within EU unless the goods pose a hazard for the public health. In several member states in EU, fortification is permitted without pre-approval. However, this is not the case in Denmark. The Danish Veterinary and Food Administration (DVFA) only prohibits foods that are deemed injurious to health, but companies must apply for pre-approval (see section below).
Particular types of fortifications
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 section below) .
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.
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 to foods.
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 (described below) is maintained until maximum levels are specified in the EU regulation.
Authorisation procedure of 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:
- A registration of the company is required by the DVFA in order to sell or produce fortified food in Denmark (read more here).
The application for approval of a fortified food requires the following information:
Applications for fortification have to be sent to the following address:
- 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)
Att. Chemistry and Food Quality Division
Send an e-mail
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 19,000 per product (2021) for the handling of the approval, but there are no fees for flavour variants. It can take six months from the payment is 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:
They are only available in Danish.
There is no fee 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:
Att. Chemistry and Food Quality Division
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 definition of "other substances" differ from the definition in Regulation (EC) No. 1925/2006. 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 above-mentioned 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:
- are not vitamins or minerals,
- have a purity of minimum 50 % or is concentrated 40 times or more, and
- are not normally ingested as a food on its own nor typically used as an ingredient in foods.
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 (the fee is DKK 19,000 per product in 2021).
A new substance is added (the fee is DKK 47,800 per substance in 2021).
The Danish Order on addition of other substances to food also applies to food supplements (see the section above).
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.