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Food supplements

Food supplements are food products, even though they may look like and be used in the same way as medicinal products. In the national degree on food supplements (571/2003) food supplement is described as a pre-packed product in the form of briquette, capsule, pastille, tablet, pill, powder, concentrate, extract, liquid or in some other equivalent dose form marketed as a foodstuff to be taken in measured small unit quantities thus so that the amount of energy received has no relevance for the diet as a whole. The purpose of a food supplement is to supplement the ordinary diet or in some other way affect the nutritional or physiological functions of a human being through nutrients or other substances that characterise it.

The Decree on Food Supplements entered into force on August 1, 2003. It is based on European Parliament and Council Directive 2002/46/EC.

Food supplements have notification requirement

According to the national degree on food supplements (571/2003 and it’s revision 672/2007) an economic operator who manufactures, imports or has a food supplement manufactured with a view to placing it on the Finnish market on his own behalf, shall submit a written notification to the Finnish Food Safety Authority before the initiation of the activity. A notification shall also be submitted in the case that the composition of the product is changed as to the substances that characterise it or when the product exits the market.

Obligatory appendix to food supplement notifications is a model of the product labelling showing both the statutory and voluntary information and, as far as possible, illustrations planned for the package.

The Food Safety Authority sends the actor an acknowledgement of receiving the food supplement notification. If the notification is deficient, the Authority will ask the actor to complement it. Acknowledgement does not mean that the Food Safety Authority has assessed the product’s composition or the legality of the labelling or that the Authority has approved the product as being in compliance with the food regulations. Acknowledged notifications are sent for information and control to the municipality of manufacture or importation of the product.

A fee of EUR 52 is charged for processing food supplement notifications. A fee is not charged, however, for notifications concerning withdrawal of a food supplement product from the market. Notifications may be made in free form, but the Food Safety Authority recommends the use of a ready-made form. The form and instructions for filling it are available in Finnish, Swedish and English but Evira sends the acknowledgement only in Finnish or Swedish.

 

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