GPSR (General Product Safety Regulation)
Beauty & Cosmetics
Italy 🇮🇹

Document economic operator roleRequired

Document in writing whether you are a manufacturer (fabbricante), importer (importatore), or distributor (distributore). Private label sellers are considered manufacturers. For cosmetic products, this overlaps with the 'Persona responsabile' role under the EU Cosmetics Regulation.

Designate EU Responsible Person for the Italian marketRequired

Designate a person established in the EU as Responsible Person (Responsabile). For the Italian market, it is advantageous if the responsible person can communicate in Italian, as Italian authorities frequently correspond in Italian. The responsible person must be able to present technical documentation within 10 days upon request.

Prepare safety assessment per Cosmetics Regulation and GPSR risk analysisRequired

The safety assessment per Annex I of the EU Cosmetics Regulation by a qualified Safety Assessor is mandatory and can serve as the basis for the GPSR risk analysis. Additionally, a GPSR-specific risk analysis must cover general product safety (packaging, application risks, allergens).

Complete Product Information File (PIF) and CPNP registrationRequired

The PIF must contain product description, safety assessment, manufacturing method, evidence for claims, and animal testing negative declaration. Each cosmetic product must be registered in the CPNP before market placement. In Italy, the Agenzia delle Dogane randomly checks CPNP registration during import.

Prepare traceability documentationRequired

Document the complete supply chain with batch/lot numbers (numero di lotto). Each product unit must be traceable from production to end customer. For Amazon FBA, batch numbers must be linked with shipment IDs.

Create complete product labeling in ItalianRequired

For cosmetics on Amazon.it, the following must be in Italian: product name, INCI list, batch/lot number, best-before date (da usarsi preferibilmente entro) or PAO symbol, usage instructions (modalita d'uso), warnings (avvertenze), and allergen warnings. All 26 notifiable fragrance allergens must be listed separately.

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

Register with CONAI (Consorzio Nazionale Imballaggi) as a packaging first-importer in Italy. Since January 1, 2023, all packaging in Italy must be labeled with material codes and disposal instructions (e.g., 'Raccolta differenziata - Verificare le disposizioni del proprio comune'). CONAI contributions (Contributo Ambientale CONAI - CAC) vary by packaging material.

EU Responsible Person contact details on packaging and listingRequired

Name, postal address, and email of the EU Responsible Person must appear on the packaging or an accompanying document. Additionally, the data must be entered in the GPSR mandatory fields of the Amazon.it listing. A website URL alone is not sufficient.

Complete GPSR mandatory fields in Amazon Seller Central for Amazon.itRequired

Enter the complete EU Responsible Person data, manufacturer information, and safety warnings in the Amazon GPSR fields. Ensure all data matches the physical packaging.

Set up complaint management and reporting channels to Italian authoritiesRequired

Set up a complaint register and define reporting channels to MIMIT and the EU Safety Gate. In Italy, consumers can also file complaints via the Guardia di Finanza or local ASL (Aziende Sanitarie Locali) for cosmetic-related safety issues. Regularly monitor RAPEX/Safety Gate notifications.