Food Supplement Registration in Italy

Regulatory Authority

Ministry of Health.

unpredictable

• It is an electronic notification procedure to the ministry of health. The notification, submitted electronically, involves a verification of the compliance by the Ministry of health.

1. 1. Food Business Operator (FBO)]
   2. Comply with Directive 2002/46/EC and implemented with the Legislative Decree No. 169 of 21 May 2004.
   3. The declaration should be sent to the Ministry of Health (MoH) by electronic notification procedure.
   4. An online form is provided for the notification of food supplements followed by fee payment.
   5. Ministry of health receives the notification and processes it.
   6. An automatically created confirmation of receipt is received. The FBO has 10 days to provide corrections in case of any errors.
   7. The notification does not provide authorization or implied approval of the product, whose compliance with current legislation must be guaranteed by notifying the FBO.
   8. The product is ready to launch on the market.

• Registration on the Italian food supplement notification platform.
• To access this platform, following documents are required:

1.  Sworn translation into Italian that describes that the company is categorized as Food Business Operator (FBO).
2. Copy of the identity document of the company administrator certified before a notary.
3. Letter addressed to the Italian health authorities that includes all the information regarding the company.

• Once all the documentation are available, the request for credentials should be submitted to the Italian health authorities who, after a few weeks, will inform the company of the access credentials to the notification portal for food supplements in Italy.

1. FBO data (to be entered ONLY at the first access in the system)
2. Information on the product to be notified:
3. Production plant
4. Composition, form of presentation/format/tastes, if applicable
5. Daily dose, if applicable
6. Ingredient list
7. Amount of ingredients, when required by current legislation
8. Precise name of the ingredient according to art.17 of reg. 1169/2011
9. Presence on the label of the mandatory indications provided by the specific legislation (Dir. 2002/46/CE; DL 169/2004)
10. Presence on the label of voluntary indications pursuant to Reg. 1924/2006
11. A copy of the label in accordance with the one used for marketing in pdf format
12. Bulletin or bank transfer certifying the payment of the rights due to the Ministry of Health