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Table of Contents
• National Regulatory Framework in Italy
• Product, Labeling, and Packaging Requirements
• Market Access Requirements
• Marketing and Advertising Restrictions
• Vape Taxation
• Sales Channel Limitations
Italy, as a pioneer in e-cigarettes within Europe, has cultivated a mature and diversified market: its scale is valued at $1.045 billion, with over 2 million active users. Backed by over ten million smokers, strong consumer purchasing power, and a solid economy, Italy presents both immense opportunities and fierce competition.
As the e-cigarette industry continues to mature, regulatory scrutiny in Italy is tightening. The country is accelerating the establishment of a comprehensive compliance framework, with key measures that include: higher excise duties on nicotine-containing e-liquids effective from 1 January 2025; stricter packaging and labelling requirements in line with the Classification, Labelling and Packaging (CLP) Regulation, which may require adjustments to packaging and labelling practices; and a complete ban on both domestic and cross-border online sales of nicotine-containing products, compelling a fundamental shift in distribution strategies. Together, these measures significantly raise market entry barriers, making strong compliance management critical for long-term success.
For businesses aiming to enter the Italian market, a thorough grasp of local regulations and early integration of compliance into product development are critical.
National Regulatory Framework in Italy
Legislative Decree 6/2016 is Italy’s primary legal framework for implementing the EU Tobacco Products Directive (TPD). It regulates the manufacture, presentation, and sale of e-cigarettes to enhance the protection of public health.
Law 128/2013 establishes restrictions to limit public vaping and regulate advertising.
Decree 504/1995 regulates excise duties and related sanctions.
Decree 67/1999 and Circular 83685/RU establish rules for setting up tax warehouses, registering products with ADM, conducting online sales, and tax remittance.
Regulation (EC) 1334/2008 requires that product flavorings ensure safety and that ingredients meet food-grade standards.
Product Requirements
• Nicotine concentration shall not exceed 20 mg/ml (maximum 2%).
• Refill bottles (e-liquid) not exceed 10 mL (with nicotine).
• Disposable vapes/ Replaceable Pods/ Refillable tanks not exceed 2 ml.
Ingredient Requirements
• Ingredients must not pose a risk to human health in either heated or unheated form.
• Any substances not declared in the notification may only be present at trace levels, where technically unavoidable during production.
• Only high-purity ingredients are permitted, including pharmaceutical-grade nicotine.
• Flavouring agents, including menthol, must comply with food-grade standards under Regulation (EC) No. 1334/2008.
Banned Ingredients
• Vitamins or other additives that give the impression of health benefits or reduced risk.
• Caffeine, taurine, or other stimulants with connotations of energy or vitality.
• Additives that impart coloring properties to emissions.
• For smoked tobacco products, additives that facilitate inhalation or nicotine absorption.
• Additives with carcinogenic, mutagenic, or reprotoxic (CMR) properties in their unburned form.
• Flavourings present in filters, papers, capsules, or packaging that alter the smell, taste, or intensity of smoke.
Safety Design
• Child-resistant closure (CRC) and tamper-evident features required.
• Leak-proof and drop-resistant construction
Refill mechanisms
• Nozzle Length ≥ 9 mm.
• Nozzle diameter must be smaller than the tank opening.
• Drip rate ≤ 20 drops/min under normal pressure.
• The liquid may only be released when the container is connected to the e-cigarette or refillable tank.
Nicotine Delivery
Device must deliver consistent doses; manufacturers must retain compliance and quality records.
Labeling & Packaging Requirements
Health Warnings
Nicotine-containing Products
“Prodotto contenente nicotina, sostanza che crea un’elevata dipendenza. Uso sconsigliato ai non fumatori. Per info chiama il numero verde 800554088 dell’Istituto Superiore di Sanità.”
Nicotine-free Products
“Il prodotto può contenere sostanze pericolose per la salute. Per info chiama il numero verde 800554088 dell’Istituto Superiore di Sanità.”
The text must be printed in Helvetica Bold on a white background, with the font size maximized to utilize the allocated space. It must be in Italian, clearly legible, indelible, and permanently visible. The text shall cover 30% of each of the two largest surfaces of the unit packet and any outside packaging.
Ingredient & Content Disclosure
• List all ingredients in descending order by weight.
• Declare nicotine concentration (mg/ml) and nicotine delivery per dose.
• Disclose e-liquid volume in the container.
• Provide the manufacturing date and batch number for traceability.
Prohibited Claims & Elements
No text, names, trademarks, or imagery may be used that:
•Suggests the product is less harmful than others.
•Implies any health benefits or lifestyle advantages.
•Conveys vitality, energy, or therapeutic effects.
•Imitates or resembles food, cosmetics, or non-tobacco products in a way that may mislead consumers.
•Describes taste, smell, additives, or the absence of additives, except for factual information on flavours.
•Promotes economic incentives, including vouchers, discounts, or similar offers.
Leaflet Requirements
• Instructions for use and storage.
• Clearly state that the product is not recommended for use by non-smokers or minors.
• Nicotine addiction & toxicity warnings.
• Contraindications and adverse effects.
• Potential interactions with medications (if relevant).
• Manufacturer/importer contact details.
Environmental Labeling
• Material Identification must display alphanumeric material codes per EU 97/129/EC.
• Labeling Format can be printed or digital (QR codes/websites).
• Recycling Info requires clear consumer recycling instructions.
Market Access Requirements
Premarket Notification
All nicotine-containing e-liquids and devices require mandatory premarket notification. This submission must be completed through the EU-CEG system at least six months before product launch or any significant modification.
Required Documentation
• Complete manufacturer and EU representative contact details.
• Full ingredient list with exact quantities and emission profiles.
• Comprehensive toxicological reports including heating effects and addiction potential.
• Detailed nicotine absorption characteristics under normal usage conditions.
• Technical specifications of product components and refill mechanisms.
• Quality control procedures and batch production documentation.
• Legal compliance declarations.
ADM Registration
Secondary notification is required after the EU-CEG submission.
Additional Requirements
• Exact container/device specifications (capacity in ml) and nicotine concentration (mg/ml)
• Manufacturer/importer details (Company name/EU registered office address/VAT number, and country of origin)
• EC-ID number (EU-CEG) and MoH notification date
• Physical product sample submission
• Declaration of full regulatory compliance
Market Data Reporting
Annual Obligation is due by December 31 each year.
Data Requirements
• Breakdown of sales volumes by product category and brand
• Consumer demographic analysis (including youth uptake monitoring)
• Sales channels
• Translated executive summaries of all relevant market studies
Post-Market Surveillance
The information Collection System must track and document all consumer health complaints.
Reporting Protocol
• The immediate notification is required for any safety concerns.
• Mandatory corrective action plans for non-compliant products. Cross-border reporting to all affected EU member states.
CLP Compliance
Products classified as toxic under Regulation (EC) No 1272/2008
Registration and Notification Fees
According to our compliance department, no additional fees are currently charged for ADM registration. Although a Ministerial Decree of 7 March 2022 introduced notification fees, it was subsequently annulled in 2023.
Marketing & Advertising Restrictions
• Advertising of e-cigarettes is allowed only if the ad clearly states “presenza di nicotina (contains nicotine)” and warns of nicotine’s addictive risk.
• E-cigarette advertising is strictly prohibited from making any therapeutic or smoking cessation claims, depicting individuals under 18 using the products, or appearing in spaces commonly frequented by minors.
• Advertising of e-cigarettes is prohibited in publications for minors, in cinemas showing films mainly intended for minors, and via billboards/posters in public areas.
• E-cigarette advertising is permitted in limited circumstances, including outdoor billboards and posters (provided these do not target or mislead minors), sponsorship of non-cross-border events, factual online presence on official channels, and point-of-sale displays within licensed retail locations such as vape shops and pharmacies.
Vape Taxation
As of 1 February 2025, pursuant to Article 62-quater, paragraph 1-bis, of Legislative Decree No. 504 of 26 October 1995, consumption tax shall apply to non-combustible inhalation products consisting of liquid substances, excluding those authorized for placing on the market as medicinal products under Legislative Decree No. 219 of 24 April 2006, in the following amounts:
• €0.146966 per millilitre for non-combustible inhalation products consisting of liquid substances containing nicotine;
• €0.101039 per millilitre for non-combustible inhalation products consisting of liquid substances not containing nicotine and for flavourings.
Sales Channel Limitations
Permitted Retail Channels
• Specialist stores include vape shops and tobacconists.
• Pharmacies and parapharmacies sell vape products as over-the-counter items.
• A dedicated sign must be displayed outside vape product retail points, similar to traditional tobacconists.
Online sales
• Only nicotine-free vape products are permitted.
• Sales must be conducted exclusively by authorized tax warehouse operators.
Online Sales Requirements (Circular 83685/RU, 18 March 2021)
The sale of nicotine-containing e-cigarette products is banned online starting 1 January 2025. However, nicotine-free products, including aroma shots and flavor concentrates, remain available for purchase via e-commerce platforms.
Requirements for authorised online sales include:
• Display the tax warehouse code assigned by the ADM on the seller’s website.
• Ensure secure and traceable payments.
• Require account registration and ID verification to prevent sales to minors.
Vending Machine Regulation (Circular 92923/RU, 29 March 2021)
• Vending machines are permitted if equipped with an age-verification system.
• Retailers must notify the ADM before installing a vending machine.
Regulatory Authorities
Ministry of Health: Responsible for monitoring potential health risks associated with vaping products and reviewing product notifications.
Ministry of Economy and Finance: Oversees the economic aspects of regulation, including fiscal measures linked to e-cigarettes.
Customs and Monopolies Agency (ADM): Handles applications for distance sales, manages excise duties, and ensures proper collection of e-cigarette taxes.
National Institute of Health (ISS): Evaluates the chemical composition of e-liquids and supervises compliance with CLP (Classification, Labelling and Packaging) rules.
Italian Medicines Agency (AIFA): Issues licenses for medical and pharmaceutical use of e-cigarette products where applicable.
Anafe Confindustria: Acts as the main industry association, representing Italian e-cigarette manufacturers and retailers in regulatory and market discussions.
Legislative Decree No. 6 of 12 January 2016 (Decreto legislativo 12 gennaio 2016, n. 6)
ADM Determination prot (Determinazione direttoriale prot. n. 71960 del 27 gennaio 2025)
Italy-tailored OEM/ODM E-liquid Services
Italy has tightened its e-cigarette regulatory framework in 2025, raising the bar for market entry. Companies must ensure compliance with the TPD and Italian Decree 6/2016, plan for tax stamps and excise duties, and operate strictly through licensed retail channels. As evidence of this stricter enforcement, authorities had penalized 972 illegal websites by August 2025.
In this environment, success depends on a proactive compliance strategy. Refillable open-system products, which account for 72% of the Italian market, remain the most promising pathway for sustainable growth.
With decades of experience navigating regulated markets worldwide, Hangsen provides end-to-end support—from Italian-tailored flavor development and compliance guidance to reliable EU-wide logistics.
For fully compliant OEM/ODM e-liquid solutions tailored to the Italian market, contact us at service@hangsen.com
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