Denmark

Policy Summary: 

E-cigarettes will be regulated as medicinal products under the Danish Medicines Act if they are marketed as products for the prevention or treatment of diseases, e.g. nicotine dependence and cessation. Medicinal products must be approved by the Danish Medicines Agency or the European Commission before they can be sold, manufactured, imported or distributed in Denmark. So far no electronic cigarettes have been approved as medicinal products in Denmark. Furthermore, manufacturers and importers must carry the relevant authorizations.

E-cigarettes not considered medicines are regulated under the law on electronic cigarettes (Act no. 426 of 18 May 2016) which permits the sale of e-liquids with a nicotine concentration of up to 20 mg/mL. Sale of both nicotine-containing and non-nicotine e-cigarettes to minors (under 18 years) is prohibited. Retailers who engage or want to engage in national or cross-border distance sales of nicotine-containing e-cigarettes must register with the Danish Safety Technology Authority and meet other requirements (e.g. age verification) as set up under the law. 

The regulation contains a requirement to notify the Danish Safety Technology Authority prior to introducing a nicotine-containing product to the market and manufacturers and importers of nicotine-containing e-cigarettes must comply with stipulated product specifications including on pack labeling and warnings.

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. The law contains additional requirements for refillable e-cigarettes that can be used for e-liquid containing nicotine, with respect to refill mechanism, cartridge dimensions and maximum volume allowable for refill tanks. 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.

Nicotine-containing 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 “Dette produkt indeholder nikotin, som er et yderst afhængighedsskabende stof” (“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 main text on the surface reserved for the warning. Warning should be placed in such a way that it is not damaged when package is opened in a normal manner. There are provisions that restrict the use of the packaging for advertisement or promotional purposes (e.g. pack must not contain misleading elements, including elements suggesting environmental, economic, health or lifestyle benefits).

Advertising, promotion or sponsorship related to (nicotine-containing and non-nicotine) e-cigarettes is prohibited. 

Manufacturers and importers of nicotine-containing e-cigarettes must comply with rules on quality and composition as stipulated by the Ministry of Health.

Use of non-nicotine and nicotine-containing e-cigarettes is prohibited in certain public places, including schools, childcare facilities and on public transportation. In workplaces and other areas, the law requires a written policy on the rules for e-cigarette use.

Product Classifications: 
Regulatory Mechanisms: 

Guideline (http://www.webcitation.org/query?url=https%3A%2F%2Fsundhedsstyrelsen.dk%...)

Law on electronic cigarettes (Act no.426 of 18 May 2016) (http://www.webcitation.org/query?url=https%3A%2F%2Fwww.retsinformation.d...)

Decree on quality, labeling, age control systems and advertising etc. of electronic cigarettes and refill containers, etc. (http://www.webcitation.org/query?url=https%3A%2F%2Fwww.retsinformation.dk%2FForms%2FR0710.aspx%3Fid%3D180270&date=2018-09-10)

WHO Region: 
EURO