Romania

Policy Summary: 

E-cigarettes are classified as tobacco related products and regulated by Law no. 201/2016 (establishing the conditions for manufacture, presentation and sale of tobacco products and related products and amending Law no. 349/2002 for preventing and combating the effects of tobacco products). The regulation contains a requirement to notify the Ministry of Health 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 sales of e-cigarettes is prohibited.

Nicotine content of e-liquid must be less than or equal to 20mg/mL. Single use e-cigarettes as well as single use e-cigarette tanks must not exceed 2mL, and volume of refill containers 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 a health warning and display a list of the ingredients, the nicotine content and delivery dose, the batch number and a warning that the product must be kept out of reach of children. Leaflet must also include a warning that the product is not recommended for use by young people or nonsmokers. The health warning “Acest produs conține nicotină. Nicotina generează un grad ridicat de dependență.” (“This product contains nicotine which is a highly addictive substance.”) must appear on 30% of the two major surfaces of the unit packaging and any other packaging; must be in black Helvetica bold font on a white background; text must be centralized, and be parallel to the main text on the surface reserved for the warning. The package must not contain misleading information (e.g. pack must not contain misleading elements, including elements suggesting environmental, economic, or health benefits).

The law restricts advertising, promotion and sponsorship related to e-cigarettes. Cross-border promotion or sponsorship is prohibited.

Product Classifications: 
Regulatory Mechanisms: 

Law no. 201/2016 establishing the conditions for manufacture, presentation and sale of tobacco products and related products and amending Law no. 349/2002 for preventing and combating the effects of tobacco products (http://www.webcitation.org/query?url=http%3A%2F%2Flege5.ro%2FGratuit%2Fg...)

WHO Region: 
EURO