The Public Health Agency of Sweden
Updated 12 May 2021

Content and product notification

Here you can find out about requirements for manufacturers and importers of electronic cigarettes and refill containers who wish to sell these products on the Swedish market. The products must be notified to us before they can be placed on the market. Certain information, such as comprehensive data on sales volumes, shall also be provided annually. We charge fees for product notification.

Product notification

Manufacturers and importers of nicotine-containing e-cigarettes and refill container are responsible for notifying of all such products that they intend to provide to consumers on the Swedish market. A new notification shall be submitted for every significant modification of the product. The notification shall be submitted no later than six months before the product is intended to be provided to consumers on the Swedish market. Product notification shall also be made when the product is withdrawn from the market.

Reporting system

The EU has a dedicated web portal for ingredient reporting:
EU-CEG (Common Entry Gate).
Information about EU-CEG can be found here

To be able to report information through the EU-CEG, you first need to create an EU Login (formerly ECAS account) and apply for an identification number (the Submitter ID).

Trade secrets or other confidential information

It is possible, when reporting, to indicate whether the information provided constitutes trade secrets or is otherwise confidential.

Product notification

A notification shall be submitted to the Public Health Agency of Sweden via the EU-CEG no later than six months before the product is intended to be sold to consumers on the Swedish market. Depending on whether the product is an electronic cigarette or refill container, a product notification shall contain the following information:

  • the name and contact details of the manufacturer, a responsible legal or natural person in the European Union and, if applicable, the importer into the Union,
  • a list of all ingredients contained in, and emissions resulting from the use of, the product, by brand and type, including quantities thereof,
  • toxicological data regarding the product’s ingredients and emissions, including when heated, referring in particular to their effects on the health of consumers when inhaled and taking into account any addictive effects, among other things,
  • information on the nicotine doses and uptake when consumed under normal or reasonably foreseen conditions,
  • a description of the components of the product, including  where applicable, the opening and refill mechanism of the electronic cigarette or refill container,
  • a description of the production process, including whether it involves series production, and a declaration that the production process ensures conformity with the requirements for electronic cigarettes and refill containers, and
  • a declaration that the manufacturer and importer bear full responsibility for the quality and safety of the product when placed on the market and used under normal or reasonably foreseeable conditions.

Withdrawal of the notification

As a manufacturer or importer of electronic cigarettes and refill containers, you shall also submit a notification when the product is withdrawn from the market.

Electronic cigarette products for which no product notification has been submitted or that do not comply with the notification requirements, e.g. missing certain information or containing incorrect information, may not be provided to consumers on the Swedish market.

 

Annual reports on sales volumes

Manufacturers and importers of e-cigarettes and refill containers are required to submit, annually, to the Public Health Agency:

  • comprehensive data on sales volume, by brand name and type of the product ,
  • information on the preferences of various consumer groups, including young people, non-smokers and the main types of current users,
  • the mode of sale of the product,
  • executive summaries of  any market surveys carried out in respect of  the above, including an English translation thereof.

Annual reports on sales volumes must be submitted each year by the 31st of March and should cover the whole of the preceding year. Electronic cigarettes and refill containers may not be supplied to consumers on the Swedish market if the annual reporting obligation is not met.

Product content

Electronic cigarettes and nicotine-containing liquids must meet certain content and design requirements in order to be provided to consumers on the Swedish market.

Nicotine-containing liquids may only be provided in:

  • dedicated refill containers in a volume not exceeding 10 millilitres, or
  • disposable electronic cigarettes ,or single use cartridges, or tanks not exceeding a volume of 2 millilitres.

Nicotine-containing liquids must not contain:

  • nicotine in excess of 20 milligrams per millilitre
  • vitamins or other additives that give the impression that an electronic cigarette or refill container has a health benefit or presents reduced health risks,
  • caffeine, taurine or other additives or stimulant compounds that are associated with energy and vitality,
  • additives having  colouring properties for emissions,
  • additives that are carcinogenic, mutagenic or toxic to reproduction in unburnt form.

Only ingredients of high purity are be used in the manufacture of nicotine-containing liquids. Substances other than the ingredients submitted in the product notification are only to be present in the nicotine-containing liquid in trace levels, if such traces are technically unavoidable during manufacture.

Except for nicotine, only ingredients that do not pose a risk to human health in heated or unheated form may be used in the manufacture of nicotine-containing liquids.

Electronic cigarettes should deliver nicotine doses at consistent doses under normal conditions of use.

Electronic cigarettes and refill containers must be child- and tamper-proof, be protected against breakage and leakage and have a mechanism that ensures refilling without leakage.

The filling mechanism should:

  • involve the use of a refill container possessing a security attached nozzle at least 9 millimeters long which is narrower than, and slots comfortably into, the opening of the tank of the electronic cigarette, and in case with refill containers, a flow control mechanism that emits no more than 20 drops of refill liquid per minute when placed vertically and subject only to atmospheric pressure at a temperature between 20 ± 5 ° C, or
    operate by means of a docking system which only releases refill liquids into the tank of an electronic cigarette when the electronic cigarette and refill container are connected.

Nicotine-containing products exceeding the maximum volume of 10 ml, nicotine concentration exceeding 20 mg/ml, emissions of disproportionately high nicotine doses etc. must not be provided to consumers on the Swedish market.

Restrictions on volume, nicotine concentration and emissions in electronic cigarette products are necessary to avoid risks associated with nicotine, such as accidental consumption of nicotine liquid, or if the liquid comes into contact with the skin, poisoning. This can be fatal – especially for children. Read more about poisoning risks and advice about accidents.

Nicotine-containing liquids for electronic cigarettes are chemical products and are also subject to legislation for which the Swedish Chemicals Agency is responsible. Read more about rules for electronic cigarettes and e-liquids at Kemi.

If the requirements are not complied with

The Public Health Agency of Sweden performs supervision and market surveillance on manufacturers and importers of electronic cigarettes and refill containers. We check that electronic cigarettes and nicotine-containing liquids supplied to consumers on the Swedish market comply with the requirements of the law.

E-cigarette products may not be provided to consumers on the Swedish market if:

  • they have not been submitted to the Public Health Agency
  • notification has been rejected because the notification is not complete or incorrect
  • notification has been rejected because the notification fee has not been paid
  • the annual reporting obligation is not met

Here you can see which electronic cigarettes and refill containers have been notified to us

The Public Health Authority may decide on injunctions and prohibitions if the rules are not complied with.

If you wish to read more about our supervision and market surveillance, see the Authority's Supervisory and Market Surveillance Plan 2020.

The provisions on which this information is based

Act (2018:2088) on tobacco and similar products

Decree (2019:223) on tobacco and similar products

  • Chapter 2 of the Act (2018:2088) on tobacco and similar products
  • Chapter 7 of the Act (2018:2088) on tobacco and similar products
  • Chapter 2 of the Decree (2019:223) on tobacco and similar products

You always have an obligation to know what applies by law. The information on this website is intended solely to help you, and does not replace what is written in the law. There may also be other laws or regulations from other authorities that you must be aware of. The Public Health Agency continuously updates the content, but we cannot guarantee that the information on the page is always completely up to date.