Food Supplement Registration in Italy – Overview
Italy is the first market for food supplements in the European Union (EU), and companies operating in the sector find it highly attractive. Food supplements in Italy are regulated by Legislative Decree No. 169/2004, implementing Directive 2002/46/EC. However, it is important to note that a product's classification as a food supplement, dietary supplement, nutraceutical, Natural Health Product (NHP), complementary medicine, health food, health functional food, or health supplement in other markets does not automatically qualify it as such in the EU or Italy.
Compliance with the substances allowed, maximum levels, and banned substances in food supplements in Italy is essential. Adhering to proper food labeling, advertising, and health claim verification is crucial to ensuring safety and avoiding sanctions, product withdrawals, and recalls. The Ministry of Health (MoH) Italy is the competent authority for food safety in Italy.
The Ministry of Health (MoH) Italy has published guidelines and opinions to guide Food Business Operators (FBOs) on selling and advertising food supplements in Italy. The country has specific legislation for botanicals, including a positive list of plants (plants and fungi) and a positive list of health claims for botanicals. FBOs are responsible for complying with claim conditions and adhering to the EU regulatory framework.
Italy establishes maximum levels of vitamins, minerals, and other substances with nutritional and physiological effects. The Ministry of Health (MoH) Italy, provides guidance on the use of probiotics, allowing the term "probiotic" and references to their ability to promote balanced gut flora.
Even if market distortions and non-conformities exist throughout the EU, the Italian market is disciplined, making it appealing for companies specializing in sports nutrition, probiotics, botanicals, and mushroom food supplements. Importing and selling food supplements in Italy, including online platforms like Amazon, requires compliance with the notification procedure to the MoH. After completing the notification, the product receives a unique registration code and is included in a specific list. Compliance with formula and label requirements is necessary for the notification process.
For a nutrient to be used in food, it must have a History of Safe Use (HoSU) within the EU. Failure to meet this criterion categorizes the substance as a "novel food" and requires prior authorization, even for use in supplements. Novel food registration is at the EU level. Non-EU registered companies or those affected by Brexit need to establish a legal entity in an EU member state or appoint a third-party Legal Representative (LR).
Food products other than supplements typically do not require notification in Italy. However, exceptions exist for Foods for Specific Groups (FSG), such as infant formulas, follow-on formulas, Foods for Special Medical Purposes (FSMP), total diet replacement products for weight control, and fortified foods. These products are supervised by the MoH, and FBOs, and must ensure compliance with regards to composition and labeling regulations.
The dynamic food market in Italy and the EU requires companies to stay updated on Regulatory changes. Freyr, with its operational center in the EU, offers comprehensive food Regulatory services in Italy to assist manufacturers, distributors, and other FBOs with Regulatory assessments, health claims, labeling, notifications, Legal Representation (LR), and related procedures, such as surveillance, vigilance, and food supplement registration.
Food Supplement Registration in Italy
Expertise
- Food Product Classification/Food Supplement Classification.
- Formula Review/Ingredients Assessment.
- Safety Assessment of Finished Products/Food Ingredients.
- Label and Claims Review.
- Nutritional and Health Claims Consultation and Substantiation.
- NHCR Claims Application (EU Register on Nutrition and Health Claims).
- Environmental Labeling/Recycling Labeling Review and Review of Green Claims.
- Packaging Material Requirements.
- Dossier Gap Analysis.
- Dossier Compilation and Submission.
- Food Product Compliance.
- Product Notification/Food Supplement Registration in Italy.
- EU Country-specific Regulatory Support.
- Regulatory Strategy for the EU.
- EU Legal Representation (LR).
- Regulatory Intelligence (RI) Report.
- Product-specific Updates on the Regulatory Guidelines/Standards.
- Novel Food Authorization Request/Traditional Food from a Third Country Registration.
- Consultation Processes for Determining the Status (novel/not novel) of a Food Ingredient.
- Regulatory Guidance on Food Products/Food Supplements Import Services in the EU.
- Translation Support Services.
- Review of Advertising Promotional Material.
- Food Surveillance and Vigilance.
- Post-notification/Post-marketing Follow-up.
- Management of Alerts and Authorities’ Remarks.
- Food Business Operators - Registration Support.
- Communication with Health Authorities (HAs).
- Product Compliance for European Economic Area Countries Outside the EU (Switzerland, Norway, and Iceland).
- End-to-end Services for Fortified Foods, Food for Special Medical Purposes (FSMP), Infant Formula, Follow-on Formula, and other Foods for Specific Groups (FSG).
Advantages
- End-to-end Regulatory consultation.
- Market-specific Regulatory consulting and advice.
- Harmonized compliance, local labeling, and local market support.
- Qualified team of experts with hands-on experience across all categories of foods.
- Support for region-specific Regulatory activities.
- Extensive partner network across the globe.
- A strong relationship with various HAs.