LANGUAGE
Last updated: September 18th 2019

Main Policies

Sale of e-cigarettes

Sale of e-cigarettes

Allowed
Analysis

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.


Main policies

Use in indoor public places, workplaces, and public transport

Some Restrictions
Expand to view related litigation.
Analysis

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, promotion and sponsorship

Some Restrictions
Analysis

The law restricts the advertising and promotion of e-cigarettes and refill containers. The law bans sponsorship of e-cigarettes, including on the radio, television and at any events. 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.

Health claims in advertising (modified risk claims)

Allowed
Analysis

There is no law addressing health claims in e-cigarette advertising; therefore, health claims in e-cigarette advertising are allowed.

Sale of e-cigarettes via the internet

Allowed
Analysis

The law does not specifically address the sale of e-cigarettes via the internet. However, the law allows the retail 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. Thus, the regulatory status code “Allowed” is given.

Flavors

Allowed

Health warnings on product packaging

Required
Analysis

The law requires that e-cigarettes packaging have a health warning that covers 30% of the surface on the unit packaging, and the health warning state include the message “[T]his product contains nicotine. Nicotine is a highly addictive substance.”

Other product packaging and labeling requirements

Required
Analysis

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

Required
Analysis

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.

Specified ingredients

Banned
Analysis

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 containers: 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) additivesthat have carcinogenic, mutagenic or reprotoxic properties in unburnt form.

Device requirements

Required
Analysis

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.

Cross-border sales

Some Restrictions
Analysis

The law requires that Romanian retail outlets that intend to engage in cross- border sales register with the National Agency for Tax Administration and the competent authorities in the European Union Member States (Member States) where they intend to sell their product. The law requires that retailers based in Romania sale electronic cigarettes and refill containers to Member States when they have received confirmation of their registration with the competent national authorities in those Member States.

Manufacturers and importers disclosure requirements

Required
Analysis

The law requires that manufacturers and importers of electronic 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.