Sweden

Policy Summary: 

E-cigarettes are regulated by Law (2017:425) on electronic cigarettes and refill containers. E-cigarettes that contain tobacco are regulated by the Tobacco Act, while those classified as medical devices, drugs or hazardous substances are regulated by the Medicines Act (2015: 315), Medical Device Act (1993: 584) or Act (1999: 42) on the prohibition of certain hazardous goods, respectively. E-cigarettes must also comply with the Product Safety Act (2004: 451).

Manufacturers and Importers are required to fulfill specific reporting and notification provisions in the law prior to placing e-cigarettes or refill containers on the market. Manufacturers and importers of e-cigarettes and refill containers must notify the Public Health Agency about products to be introduced to the market and comply with other regulations regarding notification related to e-cigarettes.

E-cigarette and refill containers must comply with content and design regulations stated in the law.

Sale of e-cigarettes and refill containers to minors under 18 years is prohibited. Age verification mechanisms must be in place if purchase is made in store or via distance sales.

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

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.

Packaging must contain an information sheet on content of e-cigarette and/or refill container. Information provided must comply with the regulations. Packaging must display the health warning “Denna produkt innehåller nikotin som är ett mycket beroendeframkallande ämne.“ (“This product contains nicotine which is a highly addictive substance”) must appear on 30% of each of the two largest 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 greatest possible proportion of the area reserved for it, and be parallel to the side edge of the unit packaging or outer packaging as well as the main text on the area reserved for the warning. In addition to the health warnings and constituent information on the packaging, a leaflet should be added to all unit packs, containing instructions for use and storage, warnings for specific risk groups, and information on possible adverse effects as well as on addictiveness and toxicity.

There are restrictions on advertising promotion and sponsorships. Provisions regarding the prohibition of sponsorship of radio and television programs and TV product placement are contained in the Radio and Television Act (20101: 696).