How to market fortified food in Denmark
Products fortified with vitamins, minerals or other substances may be marketed in Denmark when they have been subject to a procedure of prior approval. 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 authorisation procedure as described below.
Authorisation procedure
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 eaten safely by all parts of the population.
In the case of vitamins and minerals the risk assessment includes calculations based on the upper tolerable levels established by international scientific bodies and available data from the 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 Danish method for conducting the risk assessment concerning vitamins and minerals has been published in the European Journal of Nutrition, October 2005.
The requirements for approval are listed below:
1) To sell or produce enriched food in Denmark a company registration is required by the local Food authorities. Contact information to the local Food authorities is available at http://www.fvst.dk/.
2) 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.
- Recommended intake of the food if this information is given on the package.
- Energy contant expressed per 100 ml or 100 g.
When the information listed above has been provided, the company will recieve a receipt wtih the journal number from the Danish Veterinary and Food Administration.
There is a fee of dkr. 6.100 in 2010 for handling of the approval. The fee is to be paid after the applicant has recieved the above mentioned receipt.
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:
Fødevarestyrelsen
Att.: Kontor for Ernæring
Mørkhøj Bygade 19
2860 Søborg
Denmark
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 on pp 143-144 in the Danish document "Positivlisten".
Open document (Positivlisten)
-Unfortunately this information is 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 an application must be sent to the Danish Veterinary and Food Administration and a fee must be paid. Applications should be sent to the following address:
Fødevarestyrelsen
Att.: Kontor for Ernæring
Mørkhøj Bygade 19
2860 Søborg
Denmark
Indirect fortification
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 needs to be pre-approved by the Danish Veterinary and Food Administration.
Mandatory fortification
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 13 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. The Danish Order concerning addition of iodine is unfortunately only available in Danish.
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 addition of iodine.