Compliance Checklist

GPSR (General Product Safety Regulation)
Dietary Supplements
Italy 🇮🇹

Complete GPSR compliance checklist for dietary supplements (integratori alimentari) on the Italian market. Covers notification to the Ministero della Salute, D.Lgs. 169/2004, Health Claims Regulation, Novel Food verification, CONAI packaging obligations, and Amazon.it-specific requirements.

Overview

The General Product Safety Regulation (GPSR, Regulation (EU) 2023/988) has been mandatory for all consumer products in the EU since December 13, 2024, including dietary supplements (integratori alimentari) on Amazon.it. Italy is one of the largest markets for dietary supplements in Europe, with particularly strict national requirements. The Ministero della Salute oversees compliance with food law provisions, while MIMIT (Ministero delle Imprese e del Made in Italy) together with the Camere di Commercio monitors general product safety. Before placing on the market, every dietary supplement must be notified via the Ministero della Salute online portal. Additionally, Italian positive lists for permitted ingredients (Decreto Ministeriale 10 agosto 2018) and CONAI packaging obligations apply.

Does this apply to my product?

This checklist applies to all economic operators placing dietary supplements (integratori alimentari) on Amazon.it. This includes: vitamins, minerals, amino acids, plant extracts (estratti vegetali), probiotics, omega-3 fatty acids, sports nutrition, and other dietary supplements in the form of capsules, tablets, powders, or liquids. Covers manufacturers (fabbricanti), importers (importatori), distributors (distributori), and online sellers. Especially relevant for non-EU manufacturers and private-label providers selling via Amazon.it, eBay.it, or own shops to Italy. All information must be in Italian (Codice del Consumo, D.Lgs. 206/2005).

Step-by-Step Guide

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Legal Classification and Ingredient Verification Under Italian Law

Before market entry, you must ensure your product is classified in Italy as a dietary supplement (integratore alimentare) and not as a medicinal product (medicinale) or novel food. Italy has its own positive lists for permitted ingredients that go beyond EU minimum requirements.

Estimated time: 1-3 Wochen

Verify demarcation from medicinal products under Italian lawRequired

In Italy, AIFA (Agenzia Italiana del Farmaco) decides on medicinal product classification. Check whether your product could be classified as a medicinal product due to dosage, dosage form, or claims. Italy has strict maximum levels for certain ingredients: e.g., melatonin max. 1 mg (above that classified as medicine), certain plant extracts with pharmacological effects. Italian classification can differ from other EU countries.

Verify ingredients against Italian positive listsRequired

Italy maintains its own positive lists for permitted ingredients in dietary supplements per Decreto Ministeriale 10 agosto 2018 and subsequent updates. This includes: permitted plants and plant parts (lista delle piante ammesse), permitted vitamin and mineral compounds, permitted other substances (altre sostanze) with maximum levels. Substances not on these lists may not be used in supplements in Italy, even if permitted in other EU countries.

Cross-check of all ingredients against Italian positive lists

Check Novel Food status of all ingredientsRequired

Check every ingredient in the EU Novel Food Catalogue (Regulation (EU) 2015/2283). Ingredients not consumed to a significant degree in the EU before May 15, 1997 qualify as Novel Food and require EFSA authorization. In Italy, the Ministero della Salute is particularly strict in enforcing the Novel Food Regulation and verifies the status of each ingredient during notification.

Novel Food status check for all ingredients

Notification to the Ministero della Salute

In Italy, notification of every dietary supplement to the Ministero della Salute BEFORE market placement is legally required (D.Lgs. 169/2004, Art. 10). Notification is done via an online portal and can take several weeks as the Ministry reviews the documentation substantively.

Estimated time: 2-6 Wochen

Submit notification via the Ministero della Salute online portalRequired

Submit the notification via the Ministero della Salute portal (https://www.salute.gov.it). Required: complete formulation with quantities per daily dose, dosage form, label specimen in Italian, proof of marketability (e.g., sale in another EU country), proof of food safety. The Ministry assigns a notification code after successful review, which is viewable on the public database.

Notification confirmation from the Ministero della Salute with notification codeComplete label specimen in Italian

Food business operator registration with the ASLRequired

Per Regulation (EC) No. 852/2004 and Italian law, every food business operator must register with the competent ASL (Azienda Sanitaria Locale). This is done via a SCIA (Segnalazione Certificata di Inizio Attivita) at the local SUAP (Sportello Unico per le Attivita Produttive). For pure online sellers operating through an EU responsible person, this registration can be done by the responsible person.

SCIA registration confirmation from the competent ASL

Use Mutual Recognition if already notified in another EU country

If your product is already lawfully marketed in another EU member state, you can use the mutual recognition procedure (Art. 10 D.Lgs. 169/2004). Provide the notification confirmation from the other country (e.g., BVL notification from Germany). The Ministero della Salute still verifies conformity with Italian positive lists and may require additional adaptations.

Notification confirmation from the EU country of origin (free-sale certificate)

Implement GPSR Requirements and EU Responsible Person

The GPSR introduces additional product safety requirements beyond specific food law. In particular, the designation of an EU Responsible Person, enhanced traceability, and reporting obligations for safety incidents must be implemented.

Estimated time: 1-2 Wochen

Designate EU Responsible Person for the Italian marketRequired

Non-EU manufacturers must designate an EU Responsible Person per GPSR Art. 16. For dietary supplements on the Italian market, the responsible person should have both GPSR and food law expertise and be able to communicate in Italian with MIMIT, the Camere di Commercio, and the Ministero della Salute. Name, postal address, and email must be displayed on the packaging and in the Amazon listing.

Power of attorney or mandate agreement with the EU Responsible Person

Set up GPSR risk analysis and traceabilityRequired

Create a GPSR risk analysis that goes beyond food law HACCP requirements and covers general product safety aspects: packaging safety, child safety, application risks, interactions. Implement a traceability system with batch/lot numbers (numero di lotto) meeting both GPSR requirements and food law provisions of Regulation (EC) No. 178/2002 Art. 18.

GPSR risk analysis documentTraceability protocol with batch linkage

Set up rapid alert system and reporting obligationsRequired

Set up processes to fulfill both RASFF (Rapid Alert System for Food and Feed) and GPSR reporting obligations to the EU Safety Gate in case of safety issues. In Italy, the NAS (Nucleo Antisofisticazioni e Sanita dei Carabinieri) and the ASL can conduct unannounced inspections at any time. Report safety incidents immediately to MIMIT and the Ministero della Salute.

Italian-Language Labeling and Health Claims

Labeling of dietary supplements in Italy must simultaneously comply with the FIC (Regulation (EU) No. 1169/2011), D.Lgs. 169/2004, Health Claims Regulation (EC) No. 1924/2006, and GPSR requirements. All information must be in Italian.

Estimated time: 1-3 Wochen

Create complete mandatory labeling in ItalianRequired

The label must contain in Italian: designation 'Integratore alimentare', nutrition table with nutrient amounts per daily dose and %NRV (Valori Nutritivi di Riferimento), complete ingredient list (elenco degli ingredienti) in descending order, recommended daily intake (dose giornaliera raccomandata), warning 'Non superare la dose giornaliera raccomandata' (Do not exceed recommended daily dose), note 'Gli integratori non vanno intesi come sostituti di una dieta variata' (Supplements are not a substitute for a varied diet), storage instructions (modalita di conservazione), best before date 'Da consumarsi preferibilmente entro', net quantity, lot number (numero di lotto), EU Responsible Person contact details.

Label design with complete Italian labeling

Verify health claims and use only authorized claims in ItalianRequired

Check every health claim in the EU register of authorized health claims (Regulation (EU) No. 432/2012). Use exclusively the officially translated Italian version of claims (e.g., 'La vitamina C contribuisce alla normale funzione del sistema immunitario'). Disease-related claims are prohibited. Italy additionally has strict oversight by the AGCM (Autorita Garante della Concorrenza e del Mercato), which actively pursues misleading advertising for supplements.

Allergen labeling and warnings for special groupsRequired

Label all 14 declarable allergens per FIC Annex II in Italian (e.g., soia, latte, pesce, crostacei). Add warnings for pregnant women (donne in gravidanza), nursing mothers (donne in allattamento), children (bambini), and persons under medical treatment (persone in terapia farmacologica) where relevant. In Italy, it is additionally recommended to include the note 'Tenere fuori dalla portata dei bambini al di sotto dei 3 anni di eta' (Keep out of reach of children under 3 years).

CONAI Packaging Obligations and Amazon.it Listing

For distribution in Italy, CONAI packaging obligations must be met, packaging labeling per D.Lgs. 116/2020 must be applied, and Amazon.it GPSR mandatory fields must be completed.

Estimated time: 3-7 Tage

Complete CONAI registration and packaging labelingRequired

Register with CONAI (Consorzio Nazionale Imballaggi) as a packaging first-importer in Italy and pay the Contributo Ambientale CONAI (CAC). Label all packaging components (container, lid, label, outer carton, package insert) with material codes and disposal instructions per D.Lgs. 116/2020 (e.g., 'Raccolta differenziata - Verificare le disposizioni del proprio comune'). Typical supplement packaging: glass bottles (GL71), HDPE containers (HDPE2), aluminum blisters (ALU41).

CONAI registration confirmationPackaging layout with material codes and disposal instructions

Amazon.it GPSR mandatory fields and listing complianceRequired

Enter all GPSR mandatory information in Amazon Seller Central: complete EU Responsible Person contact details, manufacturer information, safety warnings. Ensure the Amazon.it listing meets FIC distance selling requirements: ingredient list, allergens, nutrition table, net quantity, best before date, storage instructions in Italian. Avoid prohibited health claims in product titles, bullet points, and A+ content.

Quality Control and Ongoing Compliance

Dietary supplements in Italy require ongoing quality controls and monitoring of regulatory developments. The NAS (Nucleo Antisofisticazioni e Sanita dei Carabinieri) and the ASL regularly conduct inspections of supplement providers.

Estimated time: laufend

Regular laboratory analyses and batch controlsRequired

Regularly test retention samples and new batches for microbiological purity, heavy metal contamination (especially lead, cadmium, mercury, arsenic), pesticide residues, and active ingredient content. For supplements, the contaminant maximum levels of Regulation (EC) No. 1881/2006 apply. Laboratories accredited by Accredia (Italian national accreditation body) are preferentially accepted.

Certificates of Analysis (Certificati di Analisi) per batch

Monitor regulatory changes and notification renewalRequired

Continuously monitor: changes to Italian positive lists (Decreto Ministeriale), updates to the health claims positive list, changes in the Novel Food Catalogue, new maximum level requirements from the Ministero della Salute, and updates to CONAI contribution rates. For formulation changes, the notification with the Ministero della Salute must be updated.

Common Mistakes to Avoid

Notification to the Ministero della Salute forgotten or submitted late before sales start

Consequence: Violation of D.Lgs. 169/2004 with fines from EUR 1,600 to EUR 9,500. The NAS or ASL can impose an immediate sales ban. Amazon.it can suspend the listing if the notification code cannot be provided.

Prevention: Submit the notification early - expect 30-90 days processing time. Only start selling after receiving the notification code.

Ingredients used that are not on the Italian positive lists

Consequence: The Ministero della Salute rejects the notification. Products already on sale must be withdrawn from the market. Fines and potentially criminal consequences for health-endangering substances.

Prevention: Cross-check ALL ingredients against the Italian positive lists (DM 10 agosto 2018) before finalizing the formulation. A product approved for sale in Germany or France is not automatically permitted in Italy.

Unauthorized or incorrectly translated health claims on label or listing

Consequence: The AGCM (Autorita Garante della Concorrenza e del Mercato) imposes fines up to EUR 5 million for misleading advertising. In practice, fines for supplement providers typically range from EUR 50,000 to EUR 500,000. Additionally, listing suspension on Amazon.it.

Prevention: Use exclusively health claims from the EU positive list in the official Italian translation. Have all texts reviewed by an attorney specializing in Italian food law.

CONAI registration and packaging labeling per D.Lgs. 116/2020 ignored

Consequence: Fines up to EUR 40,000 per D.Lgs. 152/2006. The Guardia di Finanza increasingly inspects CONAI obligations for online sales. Missing disposal instructions on packaging lead to additional sanctions.

Prevention: Register with CONAI (conai.org) in time and apply material codes and the 'Raccolta differenziata' note on all packaging components.

Labeling not in Italian or incomplete mandatory labeling

Consequence: Violation of the Codice del Consumo (D.Lgs. 206/2005) and D.Lgs. 169/2004. Fines from EUR 1,000 to EUR 18,000. Amazon.it suspends listings with missing or incomplete Italian labeling.

Prevention: Ensure ALL mandatory markings (including warnings and intake recommendation) are in Italian on the label. Have the label reviewed by a native speaker with food law knowledge.

Frequently Asked Questions

Q1How long does the notification to the Ministero della Salute take?

Processing time is typically 30-90 days. Unlike the German BVL notification (pure notification obligation), the Italian Ministry reviews the documentation substantively. If objections arise (e.g., non-permitted ingredients, missing documents), the procedure is extended significantly. Use the mutual recognition procedure if your product is already notified in another EU country - this can speed up the process.

Q2Can I sell a supplement approved in Germany directly in Italy?

No, not without further steps. Although the mutual recognition principle applies, Italy has its own positive lists for permitted ingredients and maximum levels that can differ from German regulations. You must: 1) verify the formulation against Italian positive lists, 2) submit a notification to the Ministero della Salute, 3) adapt the label to Italian, 4) complete CONAI registration. SpaceGoats supports you in expanding from Germany to Italy and handles the entire compliance process.

Q3Does the GPSR also apply to dietary supplements in Italy?

Yes. The GPSR applies to all consumer products, including food and supplements, insofar as not regulated by specific EU food law. For supplements in Italy, this means additional obligations: designating an EU Responsible Person, enhanced traceability, GPSR mandatory fields on Amazon.it, and reporting obligations for safety incidents to the EU Safety Gate. These GPSR obligations apply in addition to D.Lgs. 169/2004 and food law requirements.

Q4Which authorities inspect dietary supplements in Italy?

In Italy, several authorities are responsible: the Ministero della Salute for notification and food law oversight, MIMIT for general product safety (GPSR), the NAS (Nucleo Antisofisticazioni e Sanita dei Carabinieri) for food fraud and unannounced inspections, the ASL (Aziende Sanitarie Locali) for local food inspections, the AGCM for misleading advertising and health claims, and the Guardia di Finanza for customs and import controls. The Camere di Commercio additionally conduct GPSR inspections.

Q5How much does GPSR compliance cost for a single supplement on Amazon.it?

For a single dietary supplement, expect EUR 500-3,000: notification to the Ministero della Salute incl. service provider (EUR 200-800), laboratory analyses (EUR 100-800), EU Responsible Person (EUR 50-200/month), Italian label adaptation (EUR 100-500), health claims legal advice (EUR 200-800), CONAI registration (EUR 50-300/year). For multiple products, unit costs decrease significantly through shared notification procedures and framework agreements.

GPSR (General Product Safety Regulation)Dietary SupplementsItaly 🇮🇹