According to the Danish Order on Food Additives, addition of vitamins, minerals and other substances needs to be approved by the Danish Veterinary and Food Administration before the product can be placed on the Danish market.
In addition to the required pre-approval, any fortification with vitamins, minerals and other substances needs to comply with Regulation (EC) No. 1925/2006.
Regulation (EC) No. 1925/2006 does not at this stage specify any maximum levels for addition of vitamins, minerals and other substances to food. Until maximum amounts are specified in the regulation, the Danish Veterinary and Food Administration will follow the national authorization procedure as described below.
Addition of vitamins, minerals and other substances to a food product needs to be approved by the Danish Veterinary and Food Administration before it can be placed on the Danish market. The approval is based on an individual risk assessment carried out on a case-by-case basis by the National Food Institute. The purpose of the risk assessment is to ensure, that the fortified product can be safely consumed by the entire population.
The risk assessment includes calculations based on the upper tolerable levels or acceptable daily intake values established by international scientific bodies and available data from national dietary surveys. In each case, the addition is accepted unless the risk assessment concludes that one or more population groups risk exceeding the upper tolerable level if the fortified product is placed on the market.
The requirements for approval are listed below:
To sell or produce enriched food in Denmark, a company registration is required by the DVFA. Contact information to the DVFA: Fødevarestyrelsen
Att. Chemistry and Food Quality Division
DK-2600 GlostrupSend an e-mail
The information listed below must be included in the application for approval of a fortified food product:
- Name, address and phone number of the company applying for approval
- Name, address and phone number of the company producing the food product
(if different from the company applying for approval)
- The name and type of food product
- Declaration of ingredients including the source of nutrients
- The total amount of each nutrient including natural content
- Added amount of the nutrients applied for (excluding natural content)
- Recommended intake of the food if this information is given on the package
- Energy content expressed per 100 ml or 100 g
When the information listed above has been provided, the company will receive a receipt with a case number from the Danish Veterinary and Food Administration.
There is a fee of DKK 12,600 per product (2019) for handling of the approval. There are no fees for variants. The fees are to be paid after the applicant has received the receipt mentioned above.
The company receives a permission or refusal concerning their application based upon an evaluation of safety.
If the permission is obtained, the company is allowed to sell this specific food product fortified with the substances and the amounts applied for.
Applications should be sent to the following address:
Att.: Chemistry and Food Quality Division
General acceptances for certain products
The Danish Veterinary and Food Administration has given a number of general acceptances for addition of vitamins and minerals to certain products. The general acceptances can be found in two documents, namely:
Unfortunately, these acts are only available in Danish.
The general acceptances can be used provided that the added levels of vitamins and minerals are in accordance with the types and levels specified for the product in the general acceptance.
In order to use the general acceptances, a copy of the label must be sent to the Danish Veterinary and Food Administration. This copy should be sent to the following address:
Att.: Chemistry and Food Quality Division
Companies must also inform the Danish Veterinary and Food Administration if the marketing of a notified product ceases permanently.
Other substances and plant ingredients
The Danish regulation on other substances differ in the definition of other substances compared to the one in Regulation (EC) No. 1925/2006 which is broader.
In Denmark we do not have a national legislative list of forbidden or restricted plant ingredients in food supplements. The National Food Institute has made a guidance list (see under "1998" and open "Drogelisten" and "tillæg") and it is the company’s responsibility to ensure their
products do not pose a safety risk.
If a plant ingredient (or extract) is concentrated to a high degree or a product contains pure substances, then the Danish regulation apply for those ingredients/extracts/substances. This includes having to go through the abovementioned authorization procedure.
There is a fee of DKK 31,700 per product (2019) for handling of the approval.
The Danish definition of other substances is as follows:
Substances that have or are added with the purpose of having a nutritional or physiological effect and that
a) are not vitamins or minerals,
b) have a purity of minimum 50 % or is concentrated 40 times or more, and
c) are not normally ingested as a food on its own nor typically used a an ingredient in foods.
Lastly, note that the Danish regulation on addition of other substances also applies to food supplements.
When a product contains e.g. margarine fortified with vitamin A, this is regarded as indirect fortification. In this situation, the product containing the margarine does not need a pre-approval before the product can be placed on the Danish market.
However, the addition of vitamin A to the margarine must be pre-approved by the Danish Veterinary and Food Administration.
The Danish Veterinary and Food Administration has introduced mandatory fortification with iodine of household salt, and salt used as an ingredient in bread and bakery products with iodine at a level of 20 mg iodine per kg salt.
Please note that, as the Danish Order concerning addition of iodine
applies to bread and bakery products, it also applies to products such as pizza dough, breadcrumbs, crisp bread, tortillas and ready-to-use flour mixes.
Household salt produced and legally placed on the market in another member state within the European Union can be legally placed on the Danish market, even though the household salt is not fortified with iodine in accordance with the Danish Order concerning addition of iodine.
Similarly, bread and bakery products produced and legally placed on the market in another member state within the European Union can be legally placed on the Danish market, even though the bread and bakery product has not been added iodine-fortified salt in accordance with the Danish Order concerning the addition of iodine.