Submit products correctly and get e-cigarette products on the market faster

Currently, the Danish Safety Technology Authority is experiencing many flaws in the submissions of e-cigarette products. This leads to delays in the handling of registrations which in the end effect sales because the products cannot be sold on the Danish market before they are correctly submitted.

The problem is mainly products that require payment of fees where product refers to another product which are exactly the same and already has been paid for and thereby avoiding having to pay the fee twice.

If the submission is not correct, however, the Danish Safety Technology Authority cannot approve them. That will cause delay in registration of products.

Below is an overview of the areas where submissions in particular have been inadequate:

Brand name: Products must be identified with accurate names. It is paramount that “Brand name” and “Sub brand name” is correctly spelled. There is no demand that products can be identified by EC ID. Therefore, the names are the only identification of the products.

Regarding “general comment” and “description” in the form, these areas are causing troubles in the submission process:

Liquid volume capacity: Must be filled in for tanks and cartridges and other parts of products which contain nicotine fluids. Cartridges with more than two millilitres of fluid are illegal in Denmark and will not be allowed for sale.

Coil composition: In this field it is important to supply information about the coil material. It is also important that the information correspond with information provided elsewhere in the submission.

Production conformity: The submitter must declare that the production process complies with the rules in the European Tobacco Product Directive (TPD). You need to mark the field in the submission.

Quality safety: The submitter must declare whether the manufacturer and importer have the full responsibility of the quality and safety of the product. Here you also need to mark a field in the submission form.

Child tamper proof: E-cigarettes and refillable cartridges with nicotine must be child and tamper proof. They also have to be secured against damage and leakage of fluids, and has a mechanism that ensures refilling without leakage (where applicable). In the field on the form the submitter must declare whether the product is secure according to the law. This is also done by marking the field in the submission form.

Consistent dosing: E-cigarettes with nicotine must evaporate consistent doses of nicotine when in use. The submitter must declare that the product does this in the “Consistent dosing”-field on the form by marking it.

You can read more about the submission of products her: http://e-cigaretregler.dk/en/registered-products

If you still need information, the Danish Safety Technology Authority can be contacted via e-mail at sik@sik.dk.

Please, be aware that the transition period for e-cigarette products has passed the deadline. The Danish Safety Technology Authority will soon do an oversite of the market and check that products are correctly submitted and comply with the rules of the TPD.

Further explanation about possibility of avoiding payment of fee for registered products:
A submitter can be excepted from fees regarding to products which normally require fees if he or she can refer to a product which is the same and has already been paid for.

The criterion is that the product has the same composition and design. The Danish Safety Technology Authority assesses whether two products have the same composition and design in a health perspective.

Depending on the product type (kit, container, cartridge, coil etc.), we make an individual and specific assessment af the following specifications:

  • Nicotine concentration (when e-liquid with nicotine is included in the product)
  • Wattage
  • Wattage, upper range
  • Airflow adjustable
  • Coil composition
  • Coil resistance

In addition, emission reports can also be included in the assessment. Read more about the Danish Safety Technology Authority’s Administration Guide for the exception of fees, electronic cigarettes (hardware)

Administrationsvejledning.pdf

Updated 09-08-2017