Questions about fortified foods

1. I am planning to start the import of energy drinks and other fortified foods. Who can I contact for advice?

– Evira's web site provides plenty of information about e.g. notifications of food establishments, notification procedure for fortified food, and food labelling.

The food control authorities (health inspector) in each municipality advise food sector operators and consumers.

Companies providing consulting services related to food supplement notifications and labelling can be contacted, if necessary.

2. Is an authorisation required for fortification of foods?

– No specific authorisation is required, but a notification shall be submitted to Evira of the fortification of food with vitamins and/or minerals. Evira has opened an electronic online service. Notifications of placing of foods fortified with vitamins and minerals on the market, change in composition and removal from the market can be submitted via the online service. Logging into the service takes place with the usernames and passwords of the “Katso” identification system of the Finnish Tax Administration.

Electronic service

3. Which vitamins and minerals may be added in food?

– The permitted vitamins and minerals (including boron) are listed in Annex I of the Fortification Regulation (1925/2006/EC) and the permitted forms of them in Annex III of Commission Regulation 1170/2009/EC.

Until 19 January 2014, however, fortified foods may contain also other vitamins and minerals and in other forms, provided that the substance in question has been used for addition to foods on 19 January 2007. Another pre-condition is that notification of the use of the substance is submitted to the Commission not later than 19 January 2010 and EFSA has not given an unfavourable opinion in respect of the use of that substance. 

4. Herbal extracts, amino acids and other substances have been added in food in addition to vitamins. How do I know if they are permitted?

– There is no list of prohibited or approved substances, except for vitamins and minerals and their sources (Fortification Regulation 1925/2006/EC Annex I and Commission Regulation 1170/2009 Annex III). The main rule is that the product must be safe for use as food, its ingredients shall have a history of use and the ingredients must not make the product a medicinal product. The operator is responsible for verifying that the product meets these requirements.

5. Is there a maximum limit for vitamins or minerals added in food? Or for other substances, such as caffeine or amino acids?

– There are no national regulations on maximum amounts. The operator is responsible for the product being safe to consumers.

The European Commission is defining maximum limits for vitamins and minerals. The topic can be followed on the web site of the Commission.

6. Must Evira be notified of fortification of food with omega-3 amino acid? What about fortification with caffeine, taurine, ginseng or other herbs?

– No, because the notification obligation only applies to vitamins and minerals.

7. Must energy drinks and other foods fortified with caffeine be provided with some warning notice?

– If a beverage contains caffeine, from whatever source, in a proportion in excess of 150 mg/l, the labelling must show the following message in connection with the name of the product: "High caffeine content". The labelling shall also bear the warning: "Not recommended to children, pregnant women or people sensitive to caffeine", and indicate the maximum dose for daily consumption in precise terms, such as "Maximum two cans per day".

These warnings are not required on coffee and tea, however.

The labelling of sweets, chocolate bars and similar products containing caffeine shall bear the warning: "Not recommended to children, pregnant women or people sensitive to caffeine", and indicate the maximum dose for daily consumption in precise terms, such as "Maximum one carton per day".

8. Does the labelling of industrially manufactured food have to indicate if iodised salt is used in the product?

– Yes, the indication is required.

9. Can a product be marketed although Evira has not yet acknowledged receipt of food fortification notification?

– Yes. The Food Safety Authority considers the notification obligation fulfilled when the notification complete with all the required information and enclosures is received by the Authority.

Evira does not assess the safety, composition or labelling of the product when it receives the notification. In other words, the receipt of the notification does not mean that Evira has authorised the notified fortified food as compliant with food regulations.

Evira enters the product in the register, and sends an acknowledgement letter of the receipt of the notification to the operator. The notification and the enclosures to it are sent to the local food control authorities, and if necessary, to the Customs for information and control.

10. Is Evira contemplating an age limit for purchasing of energy drinks?

– The setting of a purchasing age limit is not within Evira's competence. Plenty of information about energy drinks is provided on Evira's web site.