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 a novel food authorization.
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 are two lists of plants that are admitted. These lists specify the species and the part of the plant that can be used.
Novel foods, also know 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 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 food business operators.
To market a food supplement in Italy, the company responsible for the food safety should start a notification procedure at the Ministry of Health. 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 strictly 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.
Food supplements are instead products intended to integrate the normal diet of the general population to complete its nutritional contribution 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.
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 provides 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, food supplements cannot be attributed with non authorized properties.