Iceland is a member of the European Economic Area, but not a member of the European Union, so the TPD Directive 2014/40/EU does not apply to Iceland, and Iceland cannot access the EU's unified TPD submission system EU-CEG.
In September 2018, Iceland issued the Act on electronic cigarettes and refill containers for electronic cigarettes, No. 87/2018, which came into force on March 1, 2019. The decree refers to the content of the European Union 2014/40/EU, including the banned e-liquid ingredients, which can only be sold after 6 months of registration.
Regulation, no. 803/2018, which specifies the information required for registration and the fees charged by Iceland during the registration process.
Regulation, no. 255/2019, which stipulates what warnings and other information should be displayed on the packaging, and the product should contain an instruction sheet and specify the contents of the instruction sheet.
Iceland TPD registration process:
1.Fill out the registration application form
2.HMS issues an invoice, and the applicant pays the fee according to the invoice
For products containing nicotine e-liquid, a fee of 75,000ISK is charged for each nicotine concentration, and the number of flavors is not limited.
For products that do not contain nicotine e-liquid (open devices), each product will be charged 75,000ISK once. A product can contain the product and its accessories, such as an open device and its electronic box, coil, atomizer, all for a one-time fee.
3.Provide the required information
a）Name and Contact: Manufacturer, Authorized Representative, Importer (where applicable)
b）ECID for each product
c）The ingredient list of e-liquid includes the content of each ingredient, emission test results (TPD test report), brand/name/classification of the product
d）Toxicological data of e-liquid
e）The dose of nicotine used in normal and reasonably encountered situations
f）A description of the product and its components, including, where applicable, instructions for opening and filling the e-cigarette
g）Production process description
h）The manufacturer or importer generates a statement that takes full responsibility for the quality or safety of the product
i）Product packaging pictures
j）EMC test report
k）RoHS Test Report
l）SDS
m）Instructions/mechanisms for product or packaging to prevent opening by children
n）Declaration of Conformity
4.The information provided by the official HMS audit of Iceland, if passed, will be published on its website https://hms.is/media/11435/rafrettulisti-2122022.pdf
Q&A：
1.What products need to be registered with Iceland's TPD?
a) Disposable electronic cigarette, atomizing core, atomizer, battery box (MOD)
b) Set: open electronic cigarette + e-liquid
c) Disposable electronic cigarettes
d) Refillable electronic cigarette
e) Accessories such as O-rings, extra glass for atomizers, batteries that can be used for other products, etc. only for product repair do not need to be registered.
2.When do I need to submit a registration?
6 months before the product is on the market. The 6-month period is calculated from the day the fee is paid.
3.Who will submit the registration?
importer or manufacturer. If submitted by the manufacturer, the information of the importer or local representative is required.
4.How to submit registration information?
Submit to HMS
5.Which products may be allowed to be sold in Iceland?
Iceland will regularly update the list of approved products, the link is below
https://hms.is/media/11435/rafrettulisti-2122022.pdf
6.Do I need to provide samples to HMS?
When submitting registration materials, only product images need to be provided. Samples must be provided if expressly requested by HMS.
7.How much registration fee do I need to pay?
One product line (a nicotine-concentrated e-liquid product or an open e-cigarette product and its accessories) 75000ISK. Registration materials will not be reviewed until HMS has received the fee paid by the applicant.
