Fortified foods
Foods to which vitamins, minerals or certain "other substances" have been added, may be marketed in Norway only if the comply with the supplementary Norwegian provisions to the regulation (EF) 1925/2006 on the addition of vitamins, minerals and certain "other substances" to foods and the provisions in the regulation (EF) 1925/2996 itself.
The Norwegian supplementary provisions
The Norwegian supplementary provisions entered into force in the Norwegian regulation Forskrift om tilsetning av vitaminer, mineraler og visse andre stoffer til næringsmidler (the regulation) on the 1st of January 2020.
The addition of vitamins, minerals and certain “other substances” is regulated in two positive lists in Annex 1 and Annex 3 to the regulation. The main purpose of these supplementary Norwegian provisions is to make case management more resource-efficient and simpler, while maintaining the same level of protection for consumers concerning the intake of vitamins and minerals and provide consumers with better protection and reduce health risk that may arise from excessive intake of "other substances" in foods, including food supplements. The provisions will also give the industry more predictable and equal conditions than they had before the provisions entered into force.
Addition of vitamins and minerals to foods excluding food supplements
The addition of vitamins and minerals to foods other than food supplements is regulated in the positive list in Annex 1. This implies that food business operators (FBOs) may add the vitamins and minerals that appear in the positive list to the relevant food categories. Any addition is required to take place in accordance with the terms and conditions stated in the positive list.
The FBO that is responsible for the initial placing on the Norwegian market of a food that contains added vitamins or minerals in accordance with the requirements in Annex 1, must send certain information to the Norwegian Food Safety Authority before the food can be placed on the market. Also, subsequent changes to the information, and notice of the permanent cessation of the placing of the food on the Norwegian market, must be sent to the Norwegian Food Safety Authority. Please see more about these requirements in the regulation, section 5.
If a FBO wishes to add vitamins and minerals to foods in different quantities or to other categories of food from those stated in the positive list, the FBO must notify the Norwegian Food Safety Authority. Please see the relevant procedures as described in section 4, and Annex 2 to the regulation.
Addition of certain other substances to foods including food supplements
The addition of certain other substances to foods including food supplements is regulated in the positive list in Annex 3.
"Other substances" are substances that have a nutritional or physiological effect but are not vitamins or minerals. Examples of "other substances" include fatty acids, amino acids, coenzyme Q10 and caffeine. This implies that food business operators may add the "other substances" mentioned in the positive list to the relevant food categories. Any addition is required to take place in accordance with the terms and conditions stated in the positive list.
The FBO that is responsible for the initial placing on the Norwegian market of a food that contains added “other substances” in accordance with the requirements in Annex 3, must send certain information to the Norwegian Food Safety Authority before the food can be placed on the Norwegian market. Also, subsequent changes to the information, and notice of the permanent cessation of the placing of the food on the market, must be sent to the Norwegian Food Safety Authority. Please see more about these requirements in the regulation, section 11.
If a FBO wishes to add relevant "other substances" in different quantities or under different conditions from those stated in the positive list, the food business operator must notify the Norwegian Food Safety Authority. Please see the relevant procedures as described in section 9, and Annex 4 to the regulation.
If a FBO wishes to add relevant "other substances" covered by the scope of the positive list but not included in the list, the food business operator must apply for authorisation to the Norwegian Food Safety Authority. Please see the relevant procedures as described in section 10, and Annex 4 to the regulation.
Forms for notification, application and submission of information
Submission of information about a food supplement to which certain "other substances" are added