Finland

Policy Summary: 

E-cigarettes are classified as tobacco related products (non-nicotine single use e-cigarettes are classified as tobacco substitutes) and regulated by the Tobacco Act 2016. Nicotine products used in smoking cessation and approved by the Finnish Medicines Agency are classified as medicines; however, no e-cigarettes have been approved as medicines to date.

The Tobacco Act 2016 contains a requirement to notify Valvira (the National Supervisory Authority for Welfare and Health) prior to introducing a product to the market. Manufacturers or importers must also submit an annual report to Valvira as specified in the law. Authorization is required for retail sale of nicotine-containing e-cigarettes.

Sale via vending machines (or other automated machines) is prohibited. Cross-border distance sales of e-cigarettes is prohibited, as is customs auction sales. Sale to, as well as sale and possession by, minors (under 18) is prohibited. Retail signage should indicate prohibition on sale to minors.

Nicotine content of e-liquid must be less than or equal to 20mg/ml. Single-use e-cigarettes must not exceed 2ml, and volume of refill bottles must not exceed 10mL. E-liquid should not contain certain additives and flavorings (they must not contain flavorings such as candy or fruit flavors), 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 Finnish and Swedish. The warning “Tämä tuote sisältää nikotiinia, joka on voimakkaasti riippuvuutta aiheuttava aine” (“This product contains nicotine which is a highly addictive substance.”) must appear on 32% of the two largest surfaces of unit packaging of e-cigarettes and refill containers; must be in black Helvetica bold font on a white background; text must be centralized, occupy entire area reserved for it, and be parallel to the main text on the surface concerned. 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 environmental, economic, or health benefits). Detailed provisions on the health warning text and position are provided by a decree from the Ministry of Social Affairs and Health.

Importation of e-cigarettes by minors is prohibited, as is importation of e-cigarettes containing greater than 20mg/ml of nicotine or acquired through distance sales. Transiting passengers must comply with import restrictions as specified in the law. A person is, for personal use only, allowed to bring into Finland no more than 10mL of nicotine-containing liquid when the liquid contains more than 20mg/mL nicotine. E-liquids not exceeding 10ml can be imported for personal use only.

Advertising, promotion and sponsorship (including at the point-of-sale) is banned as is display at point-of-sale.

Use is banned in places where smoking is prohibited, including in vehicles where minors under 15 years are present.

Regulatory Mechanisms: 

Tobacco Act 2016 (http://www.webcitation.org/query?url=http%3A%2F%2Fwww.finlex.fi%2Ffi%2Fl...)

Health Ministry’s Regulation on warning labels on Packaging of tobacco and related products, (effective January 1, 2017) (http://www.finlex.fi/fi/laki/ajantasa/2016/20160591)