Product requirements on electronic cigarettes and refill containers
Electronic cigarettes and refill containers must meet set product requirements when provided to consumers on the Swedish market. For example, products have to be child- and tamper-proof and must not contain nicotine in excess of 20 mg/ml.
Product requirements
Product requirements regulates the content and design of e-cigarettes and refill containers. You as a manufacturer or importer are responsible to ensure that the product are compliant with these product requirements.
Content requirements
- Only ingredients of high purity may be used in the manufacture of nicotine-containing liquids. Substances other than the ingredients submitted in the product notification may only be present in the nicotine-containing liquid in trace levels, if such traces are technically unavoidable during manufacture.
- Except for nicotine, only ingredients that do not pose a risk to human health in heated or unheated form may be used in the nicotine-containing liquid.
Nicotine-containing liquids must not contain:
- Nicotine in excess of 20 mg/ml.
- Vitamins or other additives that create the impression that an e-cigarette or refill container has a health benefit or presents reduced health risks.
- Caffeine, taurine or other additives or stimulant compounds that are associated with energy and vitality.
- Additives having colouring properties for emissions.
- Additives that have carcinogenic, mutagenic or toxic to reproduction properties in unburnt form.
Design requirements
- E-cigarettes must deliver nicotine doses at consistent levels under normal conditions of use.
- E-cigarettes and refill containers must be child- and tamper-proof.
- E-cigarettes and refill containers must be protected against breakage and leakage and have a mechanism that ensures refilling without leakage.
The volume of:
- Disposable e-cigarettes, single use cartridges or tanks may not exceed 2 ml.
- Refill containers with nicotine-containing liquids may not exceed 10 ml.
Refillable e-cigarettes and refill containers must have a mechanism that meets one of the following conditions when refilling the e-cigarette:
- It entails the use of a refill container possessing a securely attached nozzle at least 9 mm long, which is narrower than and slots comfortably into the opening of the tank of the e-cigarette with which it is used and possessing a flow control mechanism that emits no more than 20 drops of refill liquid per minute when placed vertically and subjected to atmospheric pressure alone at 20°C ± 5 °C.
- It operates by means of a docking system which only releases refill liquids into the tank of the e-cigarette when the e-cigarette and refill container are connected.
