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Food supplements: electronic notification, marketing and FSC

The electronic notification of food supplements has been active for more than 2 years. This new procedure has certainly generated a greater workload for some companies, that in some cases found themselves bound to notify their supplements again. However, such kind of notification allows the Authorities to have a better overview of the food supplement market in Italy.

Over the years, in fact, the use of food supplements has been growing continuously in Italy. These are products that can support a good maintenance of a state of wellness.
According to the legal definition, food supplements are in fact those “foodstuffs that are meant to supplement the normal diet and which are concentrated sources of nutrients or other substances, such as vitamins and minerals, and other substances with a nutritional or physiological effect, especially but not exclusively amino acids, essential fatty acids, fibres, herbal extracts, alone or in combination, in dose forms.”

The company responsible for a food supplement is the FBO (Food Business Operator) that markets the supplement and notifies its label to the Ministry of Health. In this context, in fact, regulations are clear and specify that the notification of food supplements is performed on the first marketing. Therefore, FBOs notifying food supplements are concomitantly declaring, under their responsibility, that they are marketing them contextually.

The only exception concerns food supplements manufactured in extra EU-countries for which 90 days should elapse between the notification date and their marketing.
However, the Ministry of Health has recently become aware of unfair practices by some FBOs. In particular, food supplements were identified for which the notification of the label was not accompanied by the concomitant marketing in Italy of the product concerned by the notification, or in other cases the notified labels do not correspond to food supplements actually on the market.

This unfair practice has a double effect of preventing a realistic view of the Italian market of food supplements and interfering with the official controls on the national territory on products notified to the Ministry.

Moreover, the role of the Free Sale Certificate (FSC) should be considered. This is released by the Ministry of Health on request of the FBO that notified the product to the Ministry and is a document intended for the EU, certifying the actual notification to the Ministry, and therefore the material existence of the notified product on the Italian market, based on the declarations of the notifying FBO.

It is therefore essential that only food supplements actually on the market are notified, as provided for by the regulations. The Ministry of Health has thus invited all competent bodies to carry out more controls and to report any notification that are not compliant. FBOs are also invited to delete non compliant notifications from the notification system, proceeding to the discontinuation of non compliant supplements.

The Ministry can also intervene autonomously in the deletion of food supplements that were not notified in compliance with the norms. The Ministry has also the faculty to request to Italian FBOs to include the documentation released by the relevant health unit (ASL) about the actual existence of the products concerned by the notification in the electronic notification system.

Written by: Federica Montozzi

Foto di Monfocus da Pixabay