Electronic cigarettes, refill containers, nicotine liquids and nicotine-free liquids for vaporisation
The Tobacco Act imposes restrictions on the features of electronic cigarettes and refill containers as well as on the additives in e-cigarette liquids. Currently, there are no emissions limits for electronic cigarettes.
Electronic cigarettes refer to products that are used to breathe in nicotine-containing steam through a mouthpiece. Parts of these products are also defined as electronic cigarettes in the Tobacco Act. It is good to keep in mind that all products that are suited for breathing in nicotine-containing steam through a mouthpiece are considered to be electronic cigarettes. Therefore, a device filled with a nicotine-free liquid is considered an electronic cigarette product if it has the technical features to also use nicotine-containing liquid. A disposable device that is filled with nicotine-free liquid does not meet the Tobacco Act’s definition of an electronic cigarette.
A 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 as a permit in accordance with the Medicine Act, it is considered a medical product. A refill container means a receptacle for nicotine-containing liquid, which can be used to refill an electronic cigarette.
A 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.
Regarding nicotine-containing liquids, an additive refers to a substance other than nicotine that has been added to the liquid, its retail package or sales wrapper. Emissions mean substances that are released during the operation of an electronic cigarette.
Electronic cigarettes and refill containers must be child and tamper-proof. Therefore, these products require child-safe markings, fasteners and opening mechanisms. Additionally, electronic cigarettes and refill containers must be protected against breakage and leakage and have a mechanism that ensures refilling without leakage. Based on the Decree of the Ministry of Social Affairs and Health (decree on standards and notifications concerning tobacco and similar products), the technical standards for the refill mechanisms that ensure the refilling of electronic cigarettes and refill containers without leakage are set forth in the Commission Implementing Degree.
An electronic cigarette refill mechanism must meet one of the following criteria:
1. It entails the use of a refill container with a securely attached nozzle at least 9 mm long,
- which is narrower than the opening of the tank of the electronic cigarette
- which fits comfortably into said opening
- which possesses a flow control mechanism that emits no more than 20 drops of the refill liquid per minute when placed 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.
Retail sales and other distribution of an electronic cigarette is only allowed if the device releases nicotine at a steady rate in normal conditions. A device releases nicotine doses at consistent levels when a device of a certain brand or model always releases the same amount of nicotine over the same time and at the same intensity of use.
Nicotine-containing liquids for use in electronic cigarettes may only be sold or otherwise supplied to consumers:
1. in a refill container of no more than 10 millilitres, an electronic cigarette of no more than 2 millilitres, or a disposable nicotine cartridge
2. if the liquid does not:
- have characteristics or contain additives that have a characterising flavour or aroma
- contain additives that are liable to create the impression that the product has a health benefit or presents reduced health risks compared to other tobacco products
- contain stimulant compounds or other additives that are liable to create an impression of energy and vitality
- contain additives that have colouring properties for emissions
- contain additives that have CMR properties (carcinogenic, mutagenic or reprotoxic) in unburnt form
- contain additives that facilitate nicotine uptake or the inhalation of smoke;
3. if only ingredients of high purity are used in the manufacture of the liquid
4. if, except for nicotine, only ingredients are used in the liquid that do not pose a risk to human health in heated or unheated form.
No ingredients that are not included in the advance notification submitted to Valvira regarding an electronic cigarette or refill container can be included in nicotine-containing liquids.
A nicotine-free liquid intended for vaporisation may be sold or otherwise distributed to consumers:
1. if the liquid does not:
- have characteristics or contain additives that have a characterising flavour or aroma
- contain additives that are liable to create the impression that the product has a health benefit or presents reduced health risks compared to other tobacco products
- contain stimulant compounds or other additives that are liable to create an impression of energy and vitality
- contain additives that have colouring properties for emissions
- contain additives that have CMR properties (carcinogenic, mutagenic or reprotoxic) in unburnt form
- contain additives that facilitate nicotine uptake or the inhalation of smoke;
2. if only ingredients of high purity are used in the manufacture of the liquid
3. if, except for nicotine, 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. 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 recorded 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 European Union (EU) Member States to supervise their markets and take proper action if any harmful effect were to emerge.
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.
This information must 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 via email to tupakka(at)valvira.fi. Please note that notifications of harmful effects sent by email must not include any personal data. If a manufacturer, importer or distributor of electronic cigarettes or refill containers suspects that their products are not safe, are of a sufficiently high quality or in compliance with regulations, in addition to taking corrective measures, the operator must 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, are of a sufficiently high quality or in compliance with regulations, the operator must immediately take the necessary corrective measures to establish the products’ 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.