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Management of foodvigilance

Food safety has become a crucial element in a world undergoing growing control, and more and more characterised by food products such as food supplements or products containing herbal substances.

It is therefore necessary to monitor any possible adverse reaction. Competent authorities of the EU Member States (in Italy, the Ministry of Health) ensure an alert vigilance, thanks to the use of the rapid alerts European system (RASFF – Food and Feed Safety Alerts), monitoring free consumption products on sale, including food.

In Italy, a Corp of the Carabinieri (NAS) is employed in health monitoring as an operative tool for the active research of the reported items. The NASs are also the focus for the reports/charges by consumers.

Food Business Operators that are responsible for the marketing of products are bound to ensure their safety and quality. If there is any reason to believe that a product distributed by FBOs is not compliant with the food safety requirements, the latter shall promptly start the appropriate procedures.

In order to face the need to monitor food supplements containing nutrients or other substances having a “physiologic” effect (such as herbal extracts and preparations), and to identify the potential risks associated with the use of some products, the Italian High Health Institute (Istituto Superiore della Sanità, ISS), the Ministry of Health and the Italian Medicine Agency (AIFA) have instituted a vigilance system collecting spontaneous reports of suspected adverse reactions.

The so called “VigiErbe” also allows reporting by individual consumers, in order to ensure a higher safety in the use of these products.

The FBOs should arrange a foodvigilance system, inside or outside their company organisation, so that any adverse reactions associated with the use of particular ingredients/products can be collected and managed.

Di Renzo Regulatory Affairs has a special unit dedicated to the vigilance of food products (foodvigilance), and can therefore assist companies in the management of the reports received by the Competent Authorities and in post-marketing vigilance activities. Thanks to its international cooperation with several consultants in the EU countries as well as extra-EU countries, Di Renzo Regulatory Affairs can perform this service not only in Italy, but also in the other Member States where the products are marketed.