Bulgaria

Policy Summary: 

E-cigarettes are regulated by Decree 89 (to Promulgate the Law on Amending and Supplementing the Law on Tobacco and Tobacco Products), which contains a requirement to notify the Ministry of Economy 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 Ministry of Economy as specified in the law.

Sale and supply of e-cigarettes to minors (under 18 years) is forbidden. Cross-border distance sale of e-cigarettes is prohibited.

Nicotine content of e-liquid must be less than or equal to 20mg/mL. Single use e-cigarette 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. Pack should contain a leaflet that includes, in addition to other things specified by law, a reference that the product is not recommended for use by young people and nonsmokers, a recommendation to keep the product out of the reach of children, and information on nicotine content and flavorings. The warning “Това изделие съдържа никотин, който води до силно пристрастяване. Не се препоръчва за употреба от непушачи” (‘This product contains nicotine which is a highly addictive substance. It is not recommended for use by nonsmokers’) must appear on 30% of each of the two biggest 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 the greatest possible proportion of the area reserved for it, and be parallel to the main text on the surface reserved for the warning. 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 therapeutic, health or lifestyle benefits).

There are restrictions on e-cigarette advertising (e.g. audiovisual commercial advertising is prohibited).

There are restrictions on the supply and sale of e-cigarettes in certain public places (e.g. premises of nurseries and kindergarten, schools, dormitories, hospitals, etc.).

Product Classifications: