PARTICULARLY ON HARDWARE
In relation to hardware, the following definitions are used:
Hardware: Electronic cigarette (battery, container/cartridge, burner/coil including wick and mouthpiece), which can be used for consumption of nicotine-containing vapour, cf. §2 of the Act on Electronic Cigarettes.
Battery: A unit, which is part of an electronic cigarette, intended for supplying the electronic cigarette with electric energy during use, rechargeable or not, without containers, liquids or other parts of electronic cigarettes.
Kit: By a kit is meant a complete unit of components, which totally constitutes one electronic cigarette: A battery, a container/cartridge with/without nicotine, a burner/coil including wick and a mouthpiece.
1. Registration of hardware in EUCEG
All hardware products shall be registered in EUCEG by 7 June 2017. The registrations shall ensure transparency to the retailers, importers, manufacturers and consumers.
Registration of new products
The Danish Safety Technology Authority has laid down the practice that all products, also directly comparable products, shall be registered. This shall secure a high health-related level of protection which appears from the Tobacco Directive and the Act on Electronic Cigarettes.
By registration, a unique ID is given in EUCEG (EC ID). If it is wanted to market components of a kit separately, these components shall also be registered separately and be given a unique EC ID.
Products can be marketed in a single package without further notification in the EUCEG to the Danish Safety Technology Authority. To marked in single package, you have to comply to:
• The individual products appear unambiguously from the List of registered products
• The individual products can be identified unambiguously without breaking the packaging
• The individual products must comply with the labeling requirements
The products may be electronic cigarettes and refill containers as defined in the Act on Electronic cigarettes § 2 No. 1) and 2).
Change of products already registered
If significant changes are made of a product already registered, a new registration shall be made. A new registration shall be made, when a change of a product already registered involves a change of the health-related exposure to which the consumer is exposed.
In relation to hardware, such changes could be:
- Change of construction of the electronics of the electronic cigarette
- Change of operation: how the electronic cigarette is operated
- Change of performance
- Change of resistance/material of the burner/coil
- Change of material of wick
- Change of the effect of the power supply
- Change of maximum voltage of the power supply
- Change of the material of container
2. Fee for hardware
The Danish Safety Technology Authority charges a fee for registration and maintenance of notification of all products which are wanted to be marketed and registered, as stated above.
Read more about fees.
Exemption for fee
Some products are exempted for fee:
- Batteries and mouthpieces.
- Products with the same composition and design as an already existing EC ID is exempted for fee. Delimitation of ”the same composition and design” is made based on a health-related perspective. In connection with registration of such products, the already existing EC ID, of which fee has previously been paid, is pointed out.
It is possible to point out the product, which has been paid first, in the following situations:
- When products have different materials, colours, shapes and packaging without the function is changed based on a health-related perspective.
- When products have different decoration of containers, different materials of the mouthpieces and difference surfaces of a lid or other cosmetic changes, which do not have an impact on the function based on a health-related perspective.
- When a product has the same composition and design as a product, which is part of kit already registered.
- When a product, designated ”private label”, has the same composition and design as a product already registered.
3. Demands on hardware
Hardware products shall e.g. meet the following demands:
Marking and health warning must be on hardware products with the exemption of mouthpieces and batteries. By single package is meant the packaging closest to the hardware. Read more about demands on marking.
Size of container
As a maximum, containers and cartridges may have a volume of 2 ml or be intended for a volume of liquid of maximum 2 ml.
Child safety lock
The hardware products must be equipped with child safety lock. The access to the container or the cartridge of the electronic cigarette must be secured to prevent children from getting in contact with the nicotine liquid. Read more about demands on safety.