Belgium

Policy Summary: 

According to a science policy advisory report nicotine-containing e-cigarettes can be brought to the market as medicinal products and have to obtain marketing authorization. The medicines act stipulates rules on advertising of medicines.

The Royal Decree on the Manufacture and Marketing of Electronic Cigarettes contains a requirement to notify the Service (the Directorate-general for Animals, Plants and Food of the Federal Public Service Public Health, Food Chain Safety and Environment) 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 Federal Ministry of Health as specified in the law. 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. Product packaging must contain health warnings and constituent information as specified in the law, in Dutch, French and German. Pack should contain a leaflet that includes, in addition to other things specified by law, a recommendation that product be kept out of the reach of children. The warning “Said product bevat of zeer verslavende stof nicotine. Het gebruik ervan wordt afgeraden voor niet-rokers. Dieses Produkt enthält Nikotin: einen Stoff, der sehr stark abhängig macht.” (‘This product contains nicotine which is a highly addictive substance. It is not recommended for use by nonsmokers’) must appear on 35% of each of the two main surfaces of the unit packaging and any other outer packaging of e-cigarettes and refill containers; 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 energizing, curative, vitalizing, natural, biological, economic, health or lifestyle benefits).

The use of e-cigarettes (with or without nicotine) is prohibited in enclosed public places and on public transportation by the tobacco control law.

Product Classifications: 
Regulatory Mechanisms: 

Science and Policy Advisory Report (http://www.webcitation.org/query?url=http%3A%2F%2Fwww.health.belgium.be%...)

Royal Order of October 28, 2016 on the Manufacture and Sale of E-cigarettes (http://www.webcitation.org/query?url=http%3A%2F%2Fwww.tobaccocontrollaws...)

Tobacco Control Law (http://www.webcitation.org/query?url=http%3A%2F%2Fwww.tobaccocontrollaws...)