Updated 1 March 2021

Rules regarding e-cigarettes and refill containers

The Public Health Agency of Sweden is the main supervisory authority in Sweden regarding the Act (2018:2088) on tobacco and similar products and the Decree (2019:223) on tobacco and similar products.

General information

Rules regarding e-cigarettes and refill containers are mainly regulated in the Act on tobacco and similar products, the Decree on tobacco and similar products and The Public Health Agency of Sweden issued rules.

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

Language requirements

The information leaflet and the list of ingredients for the electronic cigarettes and refill containers placed on the Swedish market, must be in Swedish.

General rules for chemical products

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

Cross-border distance sale

How to register details of your cross-border distance sales

If your business intends to offer cross-border distance sales of e-cigarettes or refill containers, you must first register details of your activity with the Public Health Agency of Sweden. You must also have received confirmation of your registration with us. We will provide confirmation promptly.

The following form is provided to make it easier for you to register your cross-border distance sales activity with us:

Registration – Cross-border distance sales of electronic cigarettes and refill containers.docx (37 kB)

There is no obligation to use this form.

When you register your cross-border distance sales, you must also submit your own self-monitoring programme.

If any details of your sales activity change, you must notify the Public Health Agency of Sweden without delay.

Where to send your registration details

You should send registration details for your cross-border distance sales of electronic cigarettes and refill containers to the Public Health Agency of Sweden, either by email or by post.

Email: info@folkhalsomyndigheten.se

Postal addresses:
Public Health Agency of Sweden, Enheten för produktkontroll/Product Control Unit, 831 40 Östersund, Sweden
Public Health Agency of Sweden, Enheten för produktkontroll/Product Control Unit, 171 82 Solna, Sweden

Definition of 'cross-border distance sales of e-cigarettes or refill containers'

Cross-border distance sales are when a trader supplies e-cigarettes or refill containers for sale to consumers in a country other than the country in which the trader's registered office or business activity is located.

Self-monitoring and self-monitoring programme for cross-border distance sales

If your business involves cross-border distance sales of electronic cigarettes or refill containers, you must exercise self-monitoring to manage your sales and make sure your business has an appropriate self-monitoring programme.

The self-monitoring and self-monitoring programme are there to support you in your business. The programme will also act as a checklist to help ensure your business complies with legal requirements. You will undertake all control activities yourself. This includes making sure that your business is making the appropriate checks on age and that your staff do not sell e-cigarettes to anyone under the age of 18.

For guidance on what to include in an internal control programme, see the link below. The guidance includes specific sections for anyone intending to offer, or already offering, cross-border distance sales.

Guidance

Handling personal data in cross-border distance sales

Businesses whose trade involves cross-border distance sales of tobacco products, electronic cigarettes or refill containers may not disclose consumers' personal details to the producers of such goods and products, companies who are part of the same group of companies or a third party.

In addition, personal details must not be used or transferred for any purpose other than for the current purchase.

Where can I find the regulations?

The regulations on cross-border distance sales are set out in Chapter 5, paragraphs 16, 17 and 21 of the Act on Tobacco and Similar Products (2018:2088).

How to notify us of a product that is not safe or does not comply with the Act (2018:2088) on tobacco and similar products

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.

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 manufacturers and importers of electronic cigarettes and refill containers, notify to us via the EU web portal, EU-CEG. This information relates to ingredients in electronic cigarettes and refill containers that are intended to be made available to consumers on the Swedish market.

The obligation to pay charges for electronic cigarettes and refill containers applies to the product notifications from the 15th of November 2017.

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

the first time information of a product is notified
for the relaunch of a withdrawn product
for a new notification of a previously rejected product
if the composition of a notified product is modified in a way that affects the previously provided information (substantial modification).

Product notifications will be rejected if the charges are not payed, which means that the products may not be made available to consumers on the Swedish market.

How charges are paid

The Public Health Agency of Sweden (the Agency) 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 Agency.

If payment has not been received by the Agency within 30 days of the Agency instructing how the payment is to be made, the product notification may be rejected. If the product notification is rejected, this means that the product may not be made available to consumers on the Swedish market.

We obtain contact details for manufacturers and importers, as well as information on which products have been notified, from EU-CEG. It is therefore important that the information in EU-CEG is correct and up to date, including contact details for email and postal addresses.

How much is the charge?

The charge is:

SEK 3,000 the first time a product is notified or a new notification is submitted for a previously withdrawn or rejected product
SEK 2,500 for each notification of a substantial modification of 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 chapter 8 Section 4 of the Act (2018:2088) on tobacco and similar products.

The amount of the charges and how the charges will be levied is indicated by chapter 7 Section 5-8 of the Decree (2019:223) on tobacco and similar products.

Personal data

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

Do you have any questions?

Frequently asked questions

Is cross-border distance sales permitted in Sweden?
Listen

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

Updated: 5/31/2018 2:53:30 PM
Where do I register cross-border distance sales in Sweden?
Listen

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

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 in Swedish (Blankett för Registreringsblankett för gränsöverskridande distansförsäljning av e-cigaretter)

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)

Updated: 5/31/2018 2:57:34 PM
Are there any fees associated with the registration for cross-border distance sales?
Listen

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

Updated: 5/31/2018 2:59:28 PM
Who is responsible that the packages of e-cigarette and refill containers are fitted with health warnings?
Listen

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

Updated: 6/1/2018 3:18:02 PM
What health warning should be used?
Listen

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.

Updated: 6/1/2018 3:19:37 PM
Where should the health warnings be placed?
Listen

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

Updated: 6/1/2018 3:21:07 PM
What is the size of the health warnings covering the surfaces of the packets?
Listen

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

Updated: 6/1/2018 3:22:54 PM
How should the health warnings be designed?
Listen
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.
Updated: 6/1/2018 3:25:08 PM
Is there any fee associated with the notification?
Listen

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?".

Updated: 6/1/2018 3:27:01 PM
Where do I find information about EU-CEG?
Listen

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

Updated: 6/1/2018 3:29:30 PM
Who should submit the notification?
Listen

Manufacturers and importers of e-cigarettes and refill containers.

Updated: 6/1/2018 3:30:44 PM
When should the notification be submitted?
Listen

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.

Updated: 6/1/2018 3:32:14 PM
Do I have to notify refill containers that doesn't include nicotine?
Listen

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.

Updated: 6/1/2018 3:33:48 PM