A product legally marketed in an EU-/EEA country may be marketed in other EU-/EEA countries. But if the country’s authorities consider that the product is injurious to health, they can prohibit or restrict the marketing of the product.
The EEA countries are Norway, Iceland, Lichtenstein, and Switzerland.
Vitamins and minerals in food supplements
In the EU, there are no common maximum levels for vitamins and minerals in food supplements. Therefore, it is the responsibility of the companies to ensure that their food supplements are not harmful to human health.
The companies can choose to follow the Danish Veterinary and Food Administration’s guidance values, which can be found in appendices A and B in the guidance on the regulation of food supplements (only in Danish). The guidance values are based on a scientific risk assessment and are regarded as safe.
If the company chooses to exceed the guidance values, the company must document the safety of their product. The company can in their risk assessment, choose to use the tolerable upper intake levels (UL) set by the European Food Safety Authority (EFSA) or temporary guidance level (TGL) set by DTU Food.
Read more about the requirements for safety documentation in the guidance on the regulation of food supplements (only in Danish)
Mutual recognition does not exempt a company from being able to document the safety of their product, when levels exceed the Danish guidance levels.
Other substances in food supplements
As there are no EU rules for fortification with other substances than vitamins and minerals, Denmark has established national rules. These can be seen in the ministerial order on the addition of certain other nutrients than vitamins and minerals to food. Companies that want to market food supplements containing other substances in Denmark must comply with these rules.
The rules contains general acceptances for the addition of other substances. If the fortification is not included in the general acceptances, the company must send an application to the DVFA. The application procedure is included in the ministerial order. If the DVFA finds that the fortification poses a risk for human health after processing the application, then the marketing can be prohibited in Denmark.
Read more about the rules and application process