Last updated: May 20, 2020
Sale of e-cigarettes
The law allows the sale of e-cigarettes and refill containers provided that they meet certain criteria, including but not limited to device requirements, packaging requirements, and other Ministry of Health requirements.
Use in indoor public places, workplaces, and public transport
The law prohibits the use of e-cigarettes on public transport only. The law permits the use of e-cigarettes in workplaces and public places. Therefore, the regulatory status code “Some Restrictions” is given.
Advertising and promotion (excluding point of sale product display)
The law restricts the advertising and promotion of e-cigarettes and refill containers. The law bans some forms of e-cigarette advertising, including but not limited to printed publications, radio, theaters, and billboards. However, the law provides an exception for publications and materials intended exclusively for professionals in the trade of e-cigarettes and refill containers. The law expressly prohibits these types of publications and materials which are printed and published in third countries, where those publications or materials are not principally intended for the EU market.
Point of sale product display
The law does not address point of sale product display; therefore, point of sale product display is allowed.
Sale of e-cigarettes via the internet
The law prohibits cross-border distance sales of e-cigarettes to consumers in Romania (incoming). The law also prohibits retailers in Romania from engaging in cross-border distance sales to consumers in other EU Member States where such sales have been prohibited. These prohibitions are interpreted as banning certain internet sales. The law further requires retailers who engage in permitted cross-border distance sales to use an age verification system and register with the competent authority. The requirement of an age verification system, however, is not interpreted as prohibiting internet tobacco product sales. As some internet sales are permitted and others are not, the regulatory status code “Some Restrictions” is given.
Flavors (other than tobacco flavor)
The law does not address flavors in e-cigarettes; therefore, the use of flavors in e-cigarettes is allowed.
The law requires that e-cigarettes only include ingredients in
nicotine containing liquids that do not pose a risk to human health,
whether heated or unheated. The law specifically prohibits the
following ingredients from being used in e-cigarettes and refill
a) vitamins or other additives that create the impression that a tobacco product has a health benefit or presents a reduced health risk;
b) caffeine or taurine or other additives and stimulating compounds that are associated with energy and vitality;
c) additives having coloring properties for emissions;
d) for tobacco products for smoking, additives that facilitate inhalation or nicotine uptake; and
e) additives that have carcinogenic, mutagenic or reprotoxic properties in unburnt form.
Health warnings on product packaging
The law requires that e-cigarettes packaging have a health warning that covers 30% of the front and back surfaces of the unit and outside packaging. The health warning must state: “[T]his product contains nicotine. Nicotine is a highly addictive substance.”
Other product packaging and labeling requirements
The law requires that unit packs of e-cigarette and retail containers include a leaflet containing information about use and storage, warnings for specific risk groups, possible adverse effects, addictiveness and toxicity, and that the product is not recommended for use by young people and non-smokers.
The law also requires that unit packets and any outside packaging of electronic cigarettes and refill containers include all ingredients contained in the products, information on the nicotine content of the product, recommendation to keep the product out of the reach of children, and carry the following health warning “This product contains nicotine.”
Maximum nicotine concentration
The nicotine content of e-cigarettes and refill containers must not exceed 2 mg per unit. In addition, the nicotine content of e-liquid in e-cigarettes and refill containers must not exceed 20 mg/mL.
The law requires that e-cigarettes and refill containers be tamper resistant and child-proof; protect against breakage and leakage; and have a mechanism that ensures refilling without leakage. In addition, the volume of a refill container may not exceed 10 milliliters and the volume of the tank of disposable/single-use cartridges may not exceed 2 milliliters.
Manufacturer/importer disclosures and/or notification requirements
The law requires that manufacturers and importers of e-cigarettes and refill containers submit the following information yearly to the Ministry of Health: a) data on sales volumes, by brand name and type of products; b) information on preferences of various customer groups including young people, non-smokers and the main groups of current users; c) information on the mode of sales of the products; and d) summaries of any market research conducted in regards to the above.