In Italy, the regulation and notification of food supplements are overseen by the Ministry of Health (Ministero della Salute). The primary legal framework governing food supplements includes Legislative Decree No. 169/2004, which transposes Directive 2002/46/EC into Italian law.
Definition of Food Supplements
Food supplements are defined as foodstuffs intended to supplement the normal diet and are concentrated sources of nutrients or other substances with a nutritional or physiological effect. They are marketed in dose form, such as capsules, tablets, powders, or liquids.
Notification Process.
Before marketing a food supplement in Italy, businesses are required to notify the Ministry of Health. This notification must occur prior to placing the product on the Italian market.
Steps for Notification
1.
Preparation of Documentation:
Company Registration: Non-Italian Food Business Operators (FBOs) must register on the Italian food supplement notification platform. This requires:
- A sworn translation into Italian that justifies the company as an FBO.
- A copy of the identity document of the company administrator certified before a notary.
- A letter addressed to the Italian health authorities including all information regarding the company.
Product Information: Detailed data related to the composition of the product, including:
- Trade name.
- Form of presentation (e.g., powder, capsules, tablets).
- Recommended daily dose.
- Ingredients and quantities per recommended daily dose.
Product Label: A copy of the product label in Italian, complying with regulatory requirements.
Notification Fee: Proof of payment of the applicable fee, which amounts to €160.20 per product.
2.
Submission of Notification:
- Access the online notification platform using the credentials provided by the Ministry of Health.
- Enter all relevant product data and upload the required documents.
- Submit the notification through the platform.
3.
Processing:
Once the notification is submitted, a certificate is issued authorizing the marketing of the product in Italy. The notification process is immediate, allowing the product to be marketed from the moment it is notified through the platform.
Labeling Requirements
The labeling of food supplements must comply with the requirements of Regulation (EU) No 1169/2011 and national legislation. All information should be in Italian and include:
- Product Name: Including the term “Integratore Alimentare” (food supplement).
- List of Ingredients: Including active substances and their content per daily dose.
- Recommended Daily Intake: Specified amount for consumption.
- Warnings and Contraindications: As applicable.
- Nutritional Information: Per serving.
- Manufacturer or Distributor Details: Name and address.
- Net Quantity: Amount of the product.
- Storage Instructions: As necessary.
Accurate labeling is crucial to avoid misleading consumers and to ensure compliance with Italian food law provisions.
Additional Considerations
Italy has specific guidelines for botanicals, including a positive list of plants and fungi with specific usage conditions. Maximum levels of vitamins, minerals, and other substances with nutritional and physiological effects are established at the national level. Guidelines for the use of probiotics and prebiotics are also provided.
By meticulously following these guidelines and collaborating with local regulatory experts, companies can ensure their food supplements comply with Italian regulations, facilitating successful market entry and distribution.
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