Fortified foods

Fortified foods

Legal framework

Harmonized rules

Fortified foods are not a legal category of foods defined as such in EU legislation. Instead, EU legislation regulates the addition of vitamins and minerals and of certain other substances with a nutritional or physiological effect to foods. These rules are laid down in Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods.

 

This Regulation does not apply to the addition of vitamins and minerals to food supplements, and it applies without prejudice, among others, to the EU legislation on foods for specific groups.

 

As far as the addition of vitamins and minerals to foods is concerned, the Regulation contains lists of vitamins and minerals and the chemical substances in the form of which they may be added to foods. The Regulation does not contain maximum amounts of vitamins and minerals that may be present in foods after those vitamins and minerals have been added. However, the Regulation provides that the addition of vitamins and minerals to foods must result in the presence of significant amounts of the added vitamins and minerals.

 

The Regulation lays down rules on the labelling, presentation, and advertising of foods to which vitamins and minerals have been added.

 

The Regulation also contains lists of substances other than vitamins and minerals, which have a nutritional or physiological effect, and which are prohibited, restricted, or under EU scrutiny with respect to their use in foods. However, EU legislation applicable to specific foods may provide for restrictions or prohibitions on the use of certain substances in addition to those laid down in this Regulation.

 

The European Commission maintains an EU Register on the addition of vitamins and minerals and of certain other substances to foods.

 

Lastly, the Regulation makes it possible for Member States to have a notification procedure in place within their territory, through which food business operators are required to notify the competent authorities of the placing on or withdrawal from the market of their food products to which vitamins and minerals have been added or which contain other substances restricted or under EU scrutiny pursuant to this Regulation.

Non-harmonized rules

Considering that no maximum amounts of vitamins and minerals that may be present in foods after the addition of those vitamins and minerals have been laid down in EU law, Member States are free to lay down their own national rules in this respect. Some Member States have laid down mandatory minimum and/or maximum amounts in their national law, while some other Member States have adopted guidance documents or recommendations with minimum and/or maximum amounts. The rest of the Member States have not laid down any minimum or maximum amounts. Where national rules exist, food business operators must comply with them. In the absence of national rules, food business operators must ensure that the vitamins and minerals that have been added to their food products are present at least in significant amounts and are not present in amounts that are dangerous to health.

 

Without prejudice to the EU lists of substances other than vitamins and minerals that are prohibited, restricted, or under EU scrutiny with respect to their use in foods, Member States are free to lay down their own national rules on the addition of substances other than vitamins and minerals to foods. Some Member States have laid down national rules, either in the form of positive or negative lists. Positive lists contain the substances that are permitted, while all substances that are not on the lists are prohibited. Negative lists contain the substances that are prohibited, while all substances that are not on the lists are permitted. The rest of the Member States have not laid down national rules. Where national rules exist, food business operators must comply with them. In the absence of national rules, food business operators must ensure that the substances other than vitamins and minerals that are added to their food products have the required nutritional or physiological effect and are not dangerous to health.

 

Member States may have specific national rules for the labelling, presentation, and advertising of foods to which vitamins and minerals or other substances with a nutritional or physiological effect have been added, such as mandatory or recommended warning statements for certain ingredients.

 

Lastly, the majority of Member States have established a notification procedure within their territory, through which food business operators are required to notify the competent authorities of the placing on or withdrawal from the market of their food products to which vitamins and minerals have been added or of any modifications made to those products.

 

How we can assist

We can review the formulation of your product in line with EU and Member State laws.

• Our comprehensive report indicates the legal status of each ingredient, together with the underlying legal reasoning.

 

We can review the label of your product in line with EU and Member State laws.

• Our comprehensive report indicates the labelling requirements and the legal status of each particular on the label, including claims, together with the underlying legal reasoning. The report also includes the proposed legally compliant and translated label text.

 

We can review the marketing materials of your product in line with EU law.

• Our comprehensive report indicates the legal status of each marketing statement,together with the underlying legal reasoning. The report also includes the proposed legally compliant and translated marketing text.

 

We can notify the competent authorities of the Member States of the placing on or withdrawal from the market of your product or of any modifications made to it.

• We let you know which information and documentation is needed for the notification, compile and submit the notification file on your behalf, and follow up with the competent authorities where needed.