Food Supplement Registration in Italy

Regulatory Authority

Ministry of Health.

Timeline

unpredictable

Overview of Notification Procedure for Food Supplement in Italy

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. 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.

Administrative Requirements to market Food Supplements in Italy

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

Sworn translation into Italian that describes that the company is categorized as Food Business Operator (FBO).
Copy of the identity document of the company administrator certified before a notary.
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.

Document Required for Food Supplement Registration in Italy

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

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Frequently Asked Questions

1. Is Food Supplement Registration Mandatory in Italy?

Yes. Food supplements must be notified electronically to the Italian Ministry of Health before being placed on the Italian market. The notification process is required for each individual product.

2. Which Authority Regulates Food Supplements in Italy?

The Italian Ministry of Health is responsible for overseeing food supplement notifications and checking compliance with applicable food legislation.

3. What Regulations Apply to Food Supplements in Italy?

Food supplements in Italy are regulated under EU Directive 2002/46/EC and Italian Legislative Decree No. 169/2004. Other applicable EU food safety, labelling and health claims regulations must also be considered.

4. What Documents Are Required for Food Supplement Notification in Italy?

Required information includes Food Business Operator (FBO) details, manufacturing site information, product composition, ingredient list, daily dosage where applicable, product label and proof of payment of the applicable notification fee.

5. Can Foreign Companies Notify Food Supplements in Italy?

Yes, foreign companies can access the notification procedure subject to the applicable requirements. Companies established outside the EU must use an EU-based Food Business Operator (FBO) to submit the notification and take responsibility for the product's compliance.

6. Is Product Approval Granted After Food Supplement Notification in Italy?

No. Notification is not an authorisation or implicit approval of the product. The notifying Food Business Operator remains responsible for ensuring that the product complies with all applicable regulations.