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FAQs – Food supplements

It is a food product intended for the integration of the usual diet and constituting a concentrated source of nutritional substances, such as vitamins and minerals, or other substances with a nutritional or physiological effect, in particular but not limited to amino acids, essential fat acids, fibres and herbal extracts, alone or in combination, in pre-dosed forms.

The substances allowed in food supplements are: vitamin and minerals, substances with nutritional or physiological effects (e.g. caffeine, amino acids, essential fat acids, fibres and herbal extracts) and other co-formulants.  If an ingredient is not included among those approved for the use in food supplements/food and if there is no significant history of consumption for this in Europe before 1997, the only procedure allowing its introduction in the European territory as food/food ingredient is to apply for an authorization as novel food.

Yes, there are limits for some substances.  These limits are regulated at national level, also based on the European guidelines.  For the protection of consumers’ health, the Italian Ministry of Health periodically updates and publishes a list of nutrients and substances with nutritional or physiological effect used in food supplements, reporting their limits, if any. However, the list is not exhaustive.

Yes, it is possible to include herbal substances in food supplements. In Italy there is a list of plants that are admitted. The list specifies the species, the part of the plant that can be used, as well as any warnings and limits.

Novel foods, commonly known as novel food ingredients, are all those products and/or food substances for which it is not possible to demonstrate a significant use in food until 15th May 1998 in the European Union. Therefore, these ingredients must be authorised by the EU Commission as novel foods for the intended food category in order to be used.

According to article 3 of Regulation (CE) 178/2002 the Food Business Operator is «the natural or legal persons responsible for ensuring that the requirements of food law are met within the food business under their control».

All operators taking part to the manufacturing, processing and distribution of food products must be registered as FBO.

To market a food supplement in Italy, the company responsible for the food safety should start a notification procedure at the Ministry of Health via the new NSIS information system.  Before starting this procedure, the company must ensure that the product complies with the European and Italian regulations on composition and labelling.

During the notification, the label is to be submitted, that will be accurately and rigorously assessed by the Ministry of Health.

The labelling of food supplements follows the provisions of the European Regulation on food information to consumers and of the legislative decree implementing the directive on food supplements. There are some mandatory elements: name, product category, list of the ingredients and mandatory warnings.

Moreover, the regulations provide for additional or optional warnings to be established depending on the composition or type of product.

FSGs are products presented as exclusive or partial food sources, intended for specific groups of population with special nutritional needs.

On the other hand, food supplements are products intended to integrate the normal diet of the general population to complete its nutritional supply or to exploit the beneficial effects of some food ingredients.

Yes. The food business operator can apply for a free sale certificate at the Ministry of Health, once the notification procedure is concluded. This document states that the product is duly notified to the Competent Authority and is therefore present on the Italian market. The FSC is not valid as export certificate.

There is no authorization procedure in Italy for the advertising of food and food supplements; the product holder is fully responsible for the control of the compliance of the advertisement with the regulations in force.

However, regulations provide for vigilance and control by the Ministry of Health, the Antitrust Authority (AGCM) and the special anti-counterfeiting task force of the Italian police (Carabinieri NAS).

Yes. It can be advertised on the internet, provided that the advertisement complies with Leg. Dec. 169/2004, Reg. 1924/2006 and the guidelines of the Italian Ministry of Health and of the European Commission.  Therefore, advertising cannot attribute non authorized properties to food supplements.