The Public Health Agency of Sweden
Updated 28 September 2018

Rules regarding e-cigarettes and refill containers

The Public Health Agency of Sweden is the main supervisory authority in Sweden regarding the Act (2017:425) on electronic cigarettes and refill containers and the Decree (2017:429) on electronic cigarettes and refill containers.

General information

Rules regarding e-cigarettes and refill containers are mainly regulated in the Act on electronic cigarettes and refill containers and the Decree on electronic cigarettes and refill containers.

There are no official translations of the Act or the Decree into English or any other language. Links to the regulation in Swedish:

New regulations on electronic cigarettes and refill containers

The Public Health Agency of Sweden has decided on new regulations on electronic cigarettes and refill containers. They came into force on 17 September 2018.

The regulations include:

  • A language requirement that stipulates that the information leaflet and the list of ingredients for the electronic cigarettes and refill containers placed on the Swedish market, must be in Swedish.
  • Further requirements on the information included in a self-monitoring program submitted to the Public Health Agency of Sweden in accordance with Section 23 of the Act on electronic cigarettes and refill containers.
  • A form to use for notifications to the Public Health Agency of Sweden in accordance with Section 16 of the Act on electronic cigarettes and refill containers.

Please observe that the section regarding the language requirements will enter into force on 17 March 2019. The regulations came into force on 17 September 2018.

You can find the regulations here (Swedish).

General rules

General rules for chemical products also apply on electronic cigarettes and refill containers.

Read more about general rules for chemical products on Swedish Chemicals Agency's website

How to notify us of a product that is not safe or does not comply with the Act (2017:425) on electronic cigarettes and refill containers

You as a manufacturer, importer or distributor of electronic cigarettes or refill containers must immediately notify the Public Health Agency of Sweden if you believe, or have reason to believe that a product is not safe, is not of good quality, or does not comply with the Act.

Use the form Notification of unsafe product where you state:

  • the defects of the product and the risks involved
  • the measures taken to handle the defects
  • the results of such measures taken.

Unsafe products sold in Sweden

Download and fill in the form Notification of unsafe product

Unsafe products sold in various EU or EFTA countries

In order to facilitate for you as a company, the European Commission has a system called "Product Safety Business Alert Gateway". There you can submit a notification of the measures you have taken after having sold an unsafe product.

Cessation of transitional rules for electronic cigarettes and refill containers

A new law on electronic cigarettes and refill containers came into force on 1 July 2017. Transitional rules are applied to products manufactured or entered into free circulation before the law came into force. The transitional rules will cease to apply on 1 January 2018, and from this date the law will be fully in effect and all products will have to be notified to the Public Health Agency in accordance with the new law.

Fees for electronic cigarettes and refill containers

The Public Health Agency of Sweden levies charges for electronic cigarettes and refill containers

The Public Health Agency of Sweden levies charges for the information that you, as a manufacturer or importer of electronic cigarettes (e-cigarettes) and refill containers, report to us via the EU web portal, EU-CEG. This information relates to electronic cigarettes and refill containers that you intend to make available to consumers in Sweden.

The obligation to pay charges for electronic cigarettes applies to the notifications for products given from and including 15 November 2017.

Those notifying electronic cigarettes and refill containers must pay a charge for each brand and type:

  • the first time that a notification is given
  • for each significant change to a product.

How charges are paid

The Public Health Agency of Sweden will send payment instructions indicating: how much you should pay; the account to which payment should be made; and also the deadline by which payment must be received by the Public Health Agency of Sweden.

We obtain contact details for manufacturers and importers, as well as information about what goods and products have been notified, from EU-CEG. It is therefore important for the information in EU-CEG to be complete and correct, including contact details for email and postal addresses.

How much is the charge?

The charge is:

  • SEK 3,000 for each new notification of products intended to be made available to consumers on the Swedish market
  • SEK 2,500 for each notification of a significant change to a product.

Which rules govern these charges?

The right for the Public Health Agency of Sweden to levy a charge for electronic cigarettes and refill containers is laid down in Section 47 of the Act on electronic cigarettes and refill containers (2017:425).

The amount of the charges and how the charges will be levied is indicated by Sections 6 a-d of the Decree on electronic cigarettes and refill containers (2017:429).

Personal data

See Behandling av personuppgifter for information about how the Public Health Agency of Sweden processes personal data.

Do you have any questions?

Contact us on tobakstillsyn@folkhalsomyndigheten.se if you have any questions relating to charges.

Frequently asked questions

  • Is cross-border distance sales permitted in Sweden?

    Yes, Sweden permits cross-border distance sales of e-cigarettes and refill containers to consumers located in Sweden.

    (21 § lag [2017:425] om elektroniska cigaretter och påfyllningsbehållare)

  • Where do I register cross-border distance sales in Sweden?

    Registration regarding cross-border distance sales to consumers located in Sweden shall be submitted to the Public Health Agency of Sweden, preferably by e-mail: info@folkhalsomyndigheten.se

    (21 § lag [2017:425] om elektroniska cigaretter och påfyllningsbehållare)

    In order to facilitate the registration of cross-border distance sales the Public Health Agency of Sweden has developed a registration form. Please note that it is optional to use this registration form.

    Registration form 

    Retail outlets intending to engage in cross-border distance sales to consumers located within the Union shall register with the competent authorities in the Member State, where the retail outlet is established, and in the Member State, where the actual or potential consumers are located.

    (article 18(1) Directive 2014/40/EU)

  • Are there any fees associated with the registration for cross-border distance sales?

    No, there are no fees associated with the registration of cross-border distance sales.

  • Who is responsible that the packages of e-cigarette and refill containers are fitted with health warnings?

    It is the manufacturers and importers that are responsible that the packages of e-cigarette and refill containers are fitted with health warnings.

    (10 § lag [2017:425] om elektroniska cigaretter och påfyllningsbehållare)

  • What health warning should be used?

    The health warnings on unit packets and any outside packaging of e-cigarettes and refill containers shall have the following wording:

    Denna produkt innehåller nikotin som är ett mycket beroendeframkallande ämne.

    (17 § förordning [2017:429] om elektroniska cigaretter och påfyllningsbehållare)

  • Where should the health warnings be placed?

    The health warnings shall appear on the two largest surfaces of the unit packet and any outside packaging.

    (17 § förordning [2017:429] om elektroniska cigaretter och påfyllningsbehållare)

  • What is the size of the health warnings covering the surfaces of the packets?

    The health warnings shall cover 30 % of the surfaces of the unit packet and any outside packaging.

    (17 § förordning [2017:429] om elektroniska cigaretter och påfyllningsbehållare)

  • How should the health warnings be designed?

    The health warnings shall be:

    • printed in black Helvetica bold type on a white background
    • printed with a font size which means that the health warning occupies the greatest possible proportion of the surface reserved for the health warning
    • at the centre of the surface reserved for them, and on cuboid packets and any outside packaging they shall be parallel to the lateral edge of the unit packet or of the outside packaging
    • parallel to the main text on the surface reserved for the health warning.

    (17 § förordning [2017:429] om elektroniska cigaretter och påfyllningsbehållare)

  • Is there any fee associated with the notification?

    The Public Health Agency of Sweden may charge fees for receiving, storing, handling and analysing the information that is notified to the Agency. See above under the heading "How much is the charge?".

    (47 § lag [2017:425] om elektroniska cigaretter och påfyllningsbehållare)

  • Where do I find information about EU-CEG?

    You can find information about EU-CEG on the following webpage from the European commission ec.europa.eu/health/euceg/

  • Who should submit the notification?

    Manufacturers and importers of e-cigarettes and refill containers.

    (5 § lag [2017:425] om elektroniska cigaretter och påfyllningsbehållare)

  • When should the notification be submitted?

    The notification shall be submitted in electronic form via EU-CEG to the Public Health Agency of Sweden six months before the intended placing of the e-cigarette or refill container on the Swedish market. The same is true for a new notification for each substantial modification of the product.

    When a product is withdrawn from the Swedish market it has to be notified via EU-CEG to the Public Health Agency of Sweden.

    (5 § lag [2017:425] om elektroniska cigaretter och påfyllningsbehållare)

  • Do I have to notify refill containers that doesn't include nicotine?

    It is only refill containers that include nicotine that is regulated by the act on electronic cigarette and refill container. But it is possible that refill containers that doesn't include nicotine is regulated by other legislation.

     (1–2 §§ lagen [2017:425] om elektroniska cigaretter och påfyllningsbehållare)