Registration of dietary supplements in Italy

Dietary supplements market has been growing steadily since 2018 in Italy , and even in the last year, despite the pandemic, has not slowed down.

The marketing of food supplements is subject to the electronic notification procedure to the Ministry of Health, which assesses compliance with current legislation in order to guarantee safety and correct information to consumers.

Electronic notification must be made, for each food supplement, to the Italian Ministry of Health through the "Food Subject to Notification" system. In case of findings, the Ministry informs the company by written letter. The operator will also find the requests in the system, but in any case only the registration letter will be valid. The Company has 30 days to adapt to specifications required.  

The electronic request must be submitted using only the electronic notification system.

What you need to submit?

Company general data;
Manufacturing site info;
Formulation, presentation, taste;
Daily dose;
Ingredients list;
Quantity of ingredients, when required by current legislation;
Precise name of the ingredient pursuant to Article 17 of reg. 1169/2011;
Presence on the label of the mandatory indications required by specific legislation (Dir. 2002/46 / EC; DL 169/2004);
Presence on the label of voluntary indications pursuant to Reg. 1924/2006;
A copy of the label conforming to the one used for marketing;
Bank transfer receipt certifying the payment to the MoH.

How long does it take How long does it take?

The notification procedure is carried out, in compliance with current legislation, when the product is placed on the market. The notifying Company is responsible for ensuring compliance with applicable food laws.

How much it costs?
Euro 160.20

Source: Italian Ministry of Health