Policy Summary: 

The manufacture, presentation and sale of e-cigarettes are regulated by the Subsidiary Legislation 315.10, Manufacture, Presentation and Sale of Tobacco and Related Products Regulations, enacted under the Tobacco (Smoking Control) Act (CAP 315 of Laws of Malta).

These regulations require manufacturers and importers of e-cigarettes and refill containers to submit a notification to the competent authority (i.e. the Superintendent for public health) of any such products which they intend to place on the market.

There are specific regulations for retailers who engage or intend to engage in cross-border sales of e-cigarettes.

Manufacturers or importers must submit an annual report to the Superintendent containing info as specified in the law.

Nicotine content of e-liquid cannot exceed 20mg/mL; single use e-cigarettes as well as e-cigarette tanks cannot exceed 2mL; and volume of refill bottles cannot exceed 10mL. E-liquids cannot contain certain additives, must contain only high quality ingredients and except for nicotine, only ingredients that do not pose a risk to human health in heated or unheated form can be used in their manufacture. 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 must 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 ‘This product contains nicotine which is a highly addictive substance’ and its Maltese translation ‘Dan il-prodott fih in-nikotina li hija sustanza li tista’ faċilment twassal għad-dipendenza’ and must abide with other specifications set out under these regulations.

Commercial communication in information society services, in the press and other printed publications, with the aim of promoting electronic cigarettes and refill containers is prohibited (except for publications that are intended exclusively for professionals in the trade of these products and for publications which are printed and published in third countries, where those publications are not principally intended for the Union market). Commercial communication on the radio, audiovisual commercial communications, any form of public or private contribution to radio programs or any form of public or private contribution to any event, activity or individual person with the aim of promoting electronic cigarettes and refill containers is prohibited.

Use of e-cigarettes is prohibited in places where traditional cigarettes are banned including in enclosed public places, precincts of a playground or public garden in which there is playing equipment for children, and in private vehicles when a minor (under 16 years) is present.

Product Classifications: 
Regulatory Mechanisms: 

Legal Notice 67 of 2016; Tobacco (Smoking Control) Act (; (

Legal Notice 493 of 2011 Tobacco (Smoking Control) Act; Smoking in Public Places (Amendment) Regulations, 2011 (

Legal Notice 386 of 2016 Tobacco (Smoking Control) Act (CAP. 315) Smoking Control in Private Vehicles Regulations, 2016 (

Legal Notice 23 of 2010 Tobacco (Smoking Control) Act (CAP. 315); Smoking in Public Places Regulations, 2010 (

Tobacco-free Campaign and Products Directive (

Legal Notice 22 of 2010 Tobacco (Smoking Control) Act (CAP. 315); Products and Smoking Devices (Simulating Cigarettes of Tobacco) (Control) Regulation, 2010 (

WHO Region: