Food supplements are food products, which differ from normal foods by either their appearance or the way in which they are used. Food supplements often resemble medicines in their formulation, i.e. they are pills, capsules or herbal extracts, for example. On the basis of their composition, however, food supplements are foods and governed by the Food Act.
Food supplements are regulated by the Decree on Food Supplements (78/2010), which entered into force on 1 March 2010. It is based on Directive 2002/46/EC of the European Parliament and Council, and its amendments.
In the national degree on food supplements (78/2010) a food supplement is described as a pre-packed product in the form of a briquette, capsule, pastille, tablet, pill, powder, concentrate, extract or liquid, or in some other equivalent dose form, marketed as a foodstuff to be taken in measured small unit quantities whereby the amount of energy received has no relevance to the diet as a whole. The purpose of food supplements is to supplement the ordinary diet or in some other way affect the nutritional or physiological functions of the person through nutrients or other substances that characterise it.
Food supplements include e.g. products designed for the intake of e.g. vitamins, minerals, fibre, fatty acids and lecithin as well as herbal, garlic and bee products.
Food supplements have notification requirement
According to the national degree on food supplements (78/2010) 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 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.