Electronic cigarettes, refill containers and nicotine-containing liquids

Electronic cigarette means a product that can be used for consuming nicotine-containing vapour via a mouthpiece. According to the Tobacco Act, any components of such a product are also regarded as electronic cigarettes. It is also worth noting that any products suitable for consuming nicotine-containing liquid are considered electronic cigarettes. Thus, a device filled with nicotine-free liquid is considered an electronic cigarette if it is suitable for consuming nicotine-containing liquid due to its technical properties. A disposable device filled with nicotine-free liquid does not meet the definition of an electronic cigarette provided by the Tobacco Act.

Nicotine-containing liquid means a liquid that contains nicotine, is intended for vaporisation by means of an electronic cigarette, and does not contain nicotine in excess of 20 milligrams per millilitre. If a nicotine-containing liquid has a licence required by the Medicines Act, it is considered a medicine.

Nicotine-free liquid intended for vaporisation means a liquid other than a nicotine-containing liquid that is intended for vaporisation by means of an electronic cigarette or a similar method.

Refill container means a receptacle, typically a bottle, that contains nicotine-containing liquid, which can be used to refill an electronic cigarette.

As regards nicotine-containing liquids, additive means a substance other than nicotine that is added to a nicotine-containing liquid, a unit packet or to any outside packaging. Emissions means substances that are released when an electronic cigarette is consumed.

Restrictions on the characteristics of electronic cigarettes and refill containers as well as on additives in the liquids used in electronic cigarettes are laid down by the Tobacco Act. Provisions on the maximum levels of emissions released from electronic cigarettes have not been issued for the time being.

Electronic cigarettes and refill containers must be child- and tamper-proof. The products must therefore be equipped with childproof labelling, fastenings and opening mechanisms. Furthermore, electronic cigarettes and refill containers must be protected against breakage and leakage and have a mechanism that ensures refilling without leakage. According to section 8 of the decree (592/2016) issued by the Ministry of Social Affairs and Health regarding the standards and notifications concerning tobacco and corresponding products, provisions on the mechanism that ensures the refilling of electronic cigarettes without leakage and on refill containers are issued by the Commission Implementing Decision (EU) 2016/586 on technical standards for the refill mechanism of electronic cigarettes.

The refill mechanism of electronic cigarettes must meet one of the following conditions:

1. it entails the use of a refill container which has a securely attached nozzle at least 9 mm long,
   • which is narrower than the opening of the tank of the electronic cigarette with which it is used
   • which slots comfortably into the opening of the tank, and
   • which has a flow control mechanism that emits no more than 20 drops of refill liquid per minute when positioned vertically and subjected to atmospheric pressure alone at 20 °C ± 5 °C;
2. it operates by means of a docking system which only releases refill liquids into the tank of the electronic cigarette when the electronic cigarette and refill container are connected.

Electronic cigarettes may be sold or otherwise supplied to consumers only if they deliver the nicotine doses at consistent levels under normal conditions of use. The device is considered to deliver nicotine doses at consistent levels when a device of a certain brand and model always delivers the same amount of nicotine when used with the same settings for the same period of time.

Nicotine-containing liquids intended for use in electronic cigarettes may only be sold or otherwise supplied to consumers:

1. in a refill container the volume of which does not exceed 10 millilitres, or in an electronic cigarette or nicotine cartridge the tank volume of which does not exceed 2 millilitres
2. if the liquid does not have properties or contain

a. a characteristic aroma or flavour
b. additives liable to create the impression that the product has a health benefit or presents reduced health risks compared to other tobacco products
c. stimulant compounds or other additives liable to create an impression of energy and vitality
d. additives that have colouring properties for tobacco emissions
e. additives that have CMR properties in unburnt form
f. additives that facilitate inhalation or nicotine uptake

3. if only ingredients of high purity are used in the manufacture of the liquid
4. if, except for nicotine, only ingredients that do not pose a risk to human health when in heated or unheated form are used in the liquid.

Nicotine-containing liquids may not contain ingredients for which no prior notification required for electronic cigarettes or refill containers has been submitted.

Nicotine-free liquids intended for vaporisation may only be sold or otherwise supplied to consumers:

1. if the liquid does not have characteristics or contain

a. a characteristic aroma or flavour
b. additives liable to create the impression that the product has a health benefit or presents reduced health risks compared to other tobacco products
c. stimulant compounds or other additives liable to create an impression of energy and vitality
d. additives that have colouring properties for tobacco emissions
e. additives that have CMR properties in unburnt form
f. additives that facilitate inhalation or nicotine uptake

2. if only ingredients of high purity are used in the manufacture of the liquid
3. if only ingredients are used in the liquid that do not pose a risk to human health in heated or unheated form.

Manufacturers, importers and distributors of electronic cigarettes and refill containers must maintain a system in which information about the suspected harmful effects of electronic cigarettes and refill containers on people’s health is collected. A harmful effect does not have to be verified; a suspicion of a connection between a discovered health hazard and an electronic cigarette or refill container is sufficient. Information must be collected in the system whenever a health hazard has been discovered and a connection between it and an electronic cigarette or refill container is suspected. Such a hazard may be a skin irritation, shortness of breath or any other health hazard that is suspected to be caused by a nicotine-containing liquid or electronic cigarette.

The purpose of the system is to prevent any serious risks associated with national health and enable the Member States to supervise their markets and take proper action if there are any harmful effects.

System requirements

No specific requirements have been set for the monitoring system for harmful effects. In addition to the suspected health hazard, the system must indicate the product in question (product identification), the manufacturer and importer of the product, and other sales steps. 

Information to be reported annually

Notifications of all suspected or verified harmful effects must be submitted to the National Supervisory Authority for Welfare and Health (Valvira) annually by 20 May by emailing tupakka@valvira.fi. Note: Notifications of harmful effects sent by email cannot include any personal data. If a manufacturer, importer or distributor of electronic cigarettes or refill containers suspects that their products are not safe, of a sufficiently high quality or in compliance with regulations, the operator must take corrective measures and immediately notify Valvira and the market surveillance authorities of other possible EU Member States of the situation. 

Corrective measures

If a manufacturer, importer or distributor of electronic cigarettes or refill containers suspects that their products are not safe, of a sufficiently high quality or in compliance with regulations, the operator must immediately take necessary corrective measures to make the products to be in compliance with regulations. Corrective measures include the withdrawal of the product from the market or the arrangement of a product recall procedure. Furthermore, the operator must immediately notify Valvira and the market surveillance authorities of other possible EU Member States of the situation. 
 

Electronic cigarettes, nicotine-containing liquids and nicotine-free liquids intended for vaporisation and their unit packets (pdf)