Compliance requirements for e-cigarettes in Iceland

Background:

Iceland is a member of the European Economic Area but not of the European Union, so TPD Directive 2014/40/EU does not apply to Iceland, and Iceland does not have access to the EU's TPD Unified CEG. In September 2018, Iceland issued the Act on electronic cigarettes and refill containers for electronic cigarettes, No. 87/2Effective 1 March 2019. The decree refers to the EU 2014/40/EU, including the prohibition of the use of tobacco oil ingredients, registration of six months after the sale of provisions.

Based on this decree, Iceland also issued two regulations:

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 specifies what warnings and other information should be displayed on packaging, and what instructions should be included in the product

Content.

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, a one-time charge of 75000ISK per nicotine concentration, with no limit on the number of flavors.

For nicotine-free products (open devices), a one-time charge of 75000ISK per product is charged. A product can contain the product and its accessories, such as a

Its electronic box, atomizer core, atomizer, these all only charge one time.

3. Provide the required information

a. Name and contact information: Manufacturer, Authorized Representative, Importer (where applicable)

b. ECID of each product

c. The ingredient list of the tobacco oil includes the content of each ingredient, the release test results (TPD test report), and the brand/name/classification of the product

d. Toxicological data of tobacco oil

e. Normal and reasonably predictable doses of nicotine

f. Description of the product and its components, including, where applicable, instructions for opening and filling the electronic atomizer with soot

g. Description of the production process

h. A declaration that the manufacturer or importer takes full responsibility for the quality or safety of the product

i. Packaging pictures of the product

j. EMC test report

k. RoHS test report

l. SDS

m. Instructions/mechanisms for preventing children from opening products or packaging

n. Declaration of compliance

4. Iceland's official HMS audit information, if you will be posted on its website, https://hms.is/media/11435/rafrettulisti-2122022.pdf

1. What products need to register with Iceland TPD?

a) Discharge electronic atomizer, atomizer core, atomizer, battery box (MOD)

b) Set: open electronic atomizer + fume oil

c) Disposable electronic atomizer

d) Change-over electronic atomizer

e) Accessories for product maintenance only such as O-rings, extra glass for atomizers, batteries for other products, etc., do not need to be registered.

2. When do I need to submit the registration?

6 months before the product is sold on the market. The six-month period is calculated from the date of payment.

3. Who will submit the registration?

Importer or manufacturer. If submitted by the manufacturer, information of the importer or local representative will be required

4. How to submit registration information?

Submit to HMS

5. What products might be allowed to be sold in Iceland?

Iceland will regularly update the list of approved products, which is linked below

https://hms.is/media/11435/rafrettulisti-2122022.pdf

6. Do you need to provide samples to HMS?

When submitting registration information, you only need to provide a picture of the product. If a sample is specifically requested by HMS, it must be provided.

7. How much is the registration fee?

One product line (a nicotine-enriched liquid product or an open electronic atomizer product and accessories) 75000ISK. Registration information will not be audited

Fees paid by the applicant.