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Notification process

In Italy, it is possible to market food supplements only after their telematic notification to the Ministry of Health. This also applies to food supplement online sales.

The notification procedure provides for the inclusion of information regarding the FBO and the product as well as the submission of the label used to market the product and the payment receipt of the Ministry fee.

Food supplements with labels complying with the regulations can be marketed in concomitance with the label notification to the Ministry, except for those from third countries, that can be marketed only after 90 days. FBOs submitting the notification to the Ministry of Health remain responsible for the safety of the marketed products.

After submitting the notification, the Ministry of Health will assess the conformity to the regulations in force in order to ensure the product safety and a correct information to consumers. In case gaps or inaccuracies are found in the labelling during the assessment procedure, the Ministry can request that the company includes changes or provide further clarifications or documentation.

Supplements whose notification procedure has a positive outcome are then included in a public register of food supplements, where they are identified by a special authorisation number.

Food supplements notification is also required in many other Member States and extra-EU countries, subject to the product marketing.

Di Renzo Regulatory Affairs has a special unit dedicated to regulatory activities for food supplements and related products (Foods for Specific Groups, novel food etc.), and can assist companies in the notification of product to the Italian Ministry of Health as well as to the competent authorities of other Member States or extra-EU countries. To this purpose, Di Renzo Regulatory Affairs has an international staff and cooperates with local qualified consultants.