Food supplement notification
Since food supplements are considered to be food products, no authorisation is required for their marketing. This means that there is no advance inspection system for the assessment and verification of the composition and safety of the products before they are placed on the market.
When placing a food supplement on the Finnish market, a notification shall be submitted to the Finnish Food Safety Authority Evira.
According to the national Decree on Food Supplements (78/2010), a commercial operator who manufactures or imports a food supplement or has a food supplement manufactured with a view of placing it on the Finnish market shall submit a notification to the Finnish Food Safety Authority before marketing the new product. A notification shall also be submitted in case the composition of the product is changed as to the substances that characterise it or when the product is withdrawn from the market.
Food supplement notifications shall be accompanied with a model of the product label showing both statutory and voluntary information and, as far as possible, the illustrations planned for the package.
A food supplement notification is filed using Evira’s electronic service. The electronic service can be used for submitting a notification on placing a food supplement on the market and on its changed composition. The "Katso" user credentials of the Finnish Tax Administration are needed for logging in to Evira's electronic service. When the notification has been successfully submitted, the notifier will receive an acknowledgment from Evira that the notification has been received. The notification will also be forwarded for information and control purposes to the control authorities of the municipality where the company is located. Evira also informs other relevant authorities of the notifications (such as the Customs, the Finnish Medicines Agency Fimea and the National Supervisory Authority for Welfare and Health Valvira). If the food business operator cannot, for one reason or another, submit the notification via the electronic service, the food supplement notification can also be filed using the notification form, which is to be sent, complete with enclosures, to Evira’s Registry at: Finnish Food Safety Authority Evira / Registry, Mustialankatu 3, FI-00790 Helsinki, or email@example.com .
Note! New processing fees as of 1 January 2017. There have been changes in processing fees related to the reception of notifications concerning food supplements and fortified foods as of 1 January 2017. From now on, different processing fees apply to notifications depending on the method of their submission. The fee for notifications submitted via the electronic service is 42 euro per notification, and the fee for notifications submitted by post (incl. email) is 95 euro per notification (Decree 1425/2016 of the Ministry of Agriculture and Forestry on fees to be collected for services performed by the Finnish Food Safety Authority).
The acknowledgement does not mean that the Food Safety Authority has assessed the composition of the product or the legality of the labelling or that the Authority has approved the product as being in compliance with the food regulations.
The responsibility for the compliance of the product with the Decree on Food Supplements and other food regulations rests with the operator. The in-house control obligation of the operator stipulated in the Food Act also entails this.
A fee is charged for the processing of food supplement notifications (Decision of the Ministry of Agriculture and Forestry on the fees charged for services produced by the Finnish Food Safety Authority Evira). A fee is not charged, however, for notifications that concern the withdrawal of a food supplement product from the market.
Operators can submit free-form notifications, but the Food Safety Authority recommends the use of the notification form provided for this purpose. The form and the instructions for filling it out are available in Finnish, Swedish and English, but the acknowledgement is only sent in Finnish or Swedish.
- Food Supplement notification
- Evira's guidelines for submittal of food supplement notification
- Evira's guideline for the use of Electronic Service
- Food supplement notification (form)
- Food supplement guide