Policy Summary: 

The manufacture, presentation and sale of e-cigarettes are regulated by the Tobacco Act 2016.

The regulation contains a requirement to notify the Superintendent prior to introducing a product to the market and notification requires compliance with a range of product specifications including on pack warnings. Manufacturers or importers must also submit an annual report to the Superintendent as specified in the law.

Retailers who engage or want to engage in cross-border sales of e-cigarettes must register with the Superintendent and with the competent authority in the Member State where actual or potential consumers are located, and must not transact e-cigarettes via cross-border distance sale to consumers in member states where it is prohibited to do so. Retail outlets that engage in cross-border sales must operate an age verification system consistent with the stipulations in the law.

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 “‘This product contains nicotine which is a highly addictive substance’ and ‘Dan il-prodott fih in-nikotina li hija sustanza li tista’ faċilment twassal għad-dipendenza’” should be printed on a white background in Black Helvetica Bold type, in a font size which ensures that the text occupies the greatest possible proportion of the surface area reserved for it; text must be centralized, and on cuboid packets and any outer packaging they should be parallel to the lateral edge of the packet/packaging. There are provisions that restrict the use of the packaging for advertisement or promotional purposes.

E-cigarette advertisement is through media prohibited except in print media directed exclusively at professionals engaged in marketing e-cigarettes/tobacco products, as well as publications printed and published in non-EU countries. Advertising or promotion through lotteries and other gift schemes is prohibited, as is sale from a vending machine.

Use of e-cigarettes is prohibited in places where traditional cigarettes are banned (enclosed public places).

Product Classifications: