Amendments regarding the national provisions on the addition of vitamins, minerals and “other substances” to foods

Published 15.11.2019     Modified 15.11.2019

On 26 June 2019, the Norwegian Ministry of Health and Care Services adopted a regulation that amends the supplementary national provisions on the addition of vitamins, minerals and certain "other substances" in the regulations on adding vitamins, etc. to foods.

The amendments will enter into force on 1 January 2020. The amended regulations is announced in Norsk Lovtidend

Addition of vitamins and minerals to foods excluding food supplements

The main purpose of these amendments is to make case management more resource-efficient and simpler, while maintaining the same level of protection for consumers. The amendments will also give the industry more predictable and equal conditions.

The addition of vitamins and minerals to foods, excluding food supplements, is currently prohibited in Norway unless the Norwegian Food Safety Authority, following applications from food business operators, has granted authorisation in individual cases.

From 1 January 2020, a so-called positive list will be introduced. This implies that food business operators 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 food business operator 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 Norwegian 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.

If a food business operator 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 food business operator must notify the Norwegian Food Safety Authority. Please see the relevant procedures as described in the regulation, and appendix 2 to the regulation. 

Addition of certain "other substances" to foods including food supplements

"Other substances" are those 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. "Other substances" are added to foods, including food supplements, to have a positive effect on the person who eats the food. However, excessive intake of certain "other substances" may be associated with health risks. The type and extent of health risk will partly depend on which substance is consumed and in what quantity.

The new provisions apply to a selection of these "other substances". In drawing up the draft regulations, the Norwegian Scientific Committee for Food and Environment (VKM) and the Norwegian Public Health Institute (FHI), as commissioned by the Norwegian Food Safety Authority, have performed a comprehensive risk assessment of the various "other substances". VKM has performed 44 risk assessments on different “other substances”, see the different risk assessments

The main purpose of the new provisions is to provide consumers with better protection and reduce health risk that may arise from excessive intake of these "other substances" in foods, including food supplements. The new provisions will also make the industry more predictable and thus able to compete on equal terms. The new provisions will also make the monitoring of such foods simpler, more efficient and more consistent.

The addition of amino acids to foods, including food supplements, is currently prohibited in Norway unless the Norwegian Food Safety Authority, following applications from food business operators, has granted authorisation in individual cases.

The addition of "other substances" apart from amino acids to foods, including food supplements, is currently, in practice, mainly regulated by the EEA-based general provisions in the food regulations that state that the food business operators concerned are responsible for ensuring the safety of the foods they place on the market.

From 1 January 2020, a so-called positive list for the selected "other substances" will be introduced. 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 food business operator that is responsible for the initial placing on the Norwegian market of a food that contains added certain “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 Norwegian market, must be sent to the Norwegian Food Safety Authority. Please see more about these requirements in the regulation.

If a food business operator 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 the regulation, and appendix 4 to the regulation.

If a food business operator 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 the regulation, and appendix 4 to the regulation.

More information about the amendments

For more information about the amendments written in Norwegian language, please follow the links below to the two relevant regulatory processes on our website. There you will find the consultation documents, the consultation statements and the Norwegian Food Safety Authority's recommendations to the Norwegian Ministry of Health and Care Services following consultations.

Nasjonal forskriftsbestemmelse om tilsetning av vitaminer eller mineraler til vanlige næringsmidler

Nasjonal forskriftsbestemmelse av «andre stoffer» i kosttilskudd / næringsmidler

When the amendments enter into force on 1 January 2020, we will publish more information and notification- and application schemes on our website.

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