Policy Summary: 

E-cigarettes are classified as tobacco related products and regulated by a legislative decree.

The regulation contains a requirement to notify the Ministry of Health, and the Ministry of Economy and Finance prior to introducing a product to the market; notification requires compliance with a range of product specifications including on pack warnings. Manufacturers or importers must also submit an annual report to the competent authority as specified in the law. Further, authorization from monopolies and customs agency is required before a product can be sold.

Cross-border distance sale of e-cigarettes is prohibited. Retailers must not transact e-cigarettes via cross-border distance sale to consumers in member states where it is prohibited to do so. Sale to minors (under 18 years) is prohibited.

Nicotine content of e-liquid must be less than or equal to 20mg/mL. Single use e-cigarettes as well as e-cigarette tanks must not exceed 2mL, and volume of refill bottles must not exceed 10mL. E-liquid should not contain certain additives, and only high quality ingredients should be used in their manufacture. Except for nicotine, only ingredients that do not pose a risk to human health in heated or unheated form can be used in the nicotine-containing e-liquid. E-cigarettes must be able to deliver a dose of nicotine at a consistent level under normal conditions of use.

E-cigarettes and refill containers should be child- and tamper-proof, protected against breakage and leakage, and have a mechanism that ensures filling without leakage. Product packaging must contain health warnings and constituent information as specified in the law. The warning “Prodotto contenente nicotina, sostanza che crea un'elevata dipendenza. Uso sconsigliato ai non fumatori” (“This product contains nicotine which is a highly addictive substance. It is not recommended for use by nonsmokers.”) must appear on 30% of each of the two major surfaces of the unit packaging and any other packaging; must be in black Helvetica bold font on a white background; text must be centralized, occupy the greatest possible proportion of the area reserved for it, and be parallel to the main text on the surface reserved for the warning. There are provisions that restrict the use of the packaging for advertisement or promotional purposes.

E-cigarette advertising is prohibited, as is cross-border e-cigarette advertising and sponsorship.

Use in school and school premises is prohibited.

Tax on e-liquid for the year 2019 for e-liquid with nicotine is 10% of the excise tax - and equivalent to cigarettes - and is 0.082074 euros per mL, and e-liquid without nicotine is 5% of the excise tax and is 0.041037 euros per mL; there is also a 22% Value Added Tax (VAT) of the final retail price.

Product Classifications: 
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