The Public Health Agency of Sweden
Updated 24 November 2020

Labelling and packaging of e-cigarettes and refill containers

Here you will find out about requirements for labelling and packaging of nicotine-containing electronic cigarettes and refill containers. These products must carry health warnings, a leaflet with information on instructions on use, a list of all the ingredients contained in the products.

E-cigarette products are regulated by the Act on tobacco and similar products. The act imposes a number of requirements on manufacturers, importers, and wholesalers with regard to labelling and packaging, everything from health warnings to product presentation and accompanying information. The act only covers electronic cigarettes and liquids with nicotine.

The regulation aims to protect consumers from products that may pose a serious risk to human health.

Health warning

Packages for e-cigarettes and refill containers must be provided with a health warning:
Denna produkt innehåller nikotin som är ett mycket beroendeframkallande ämne

E-cigarettes and nicotine-containing liquids sold on the Swedish market must carry a health warning in Swedish.

Some refill containers may have outside packaging. The outside packaging must also have correct labelling and carry a health warning.

Design of the health warning

The health warning should:

  • appear on the two largest surfaces of the unit packet and any outside packaging,
  • cover 30 % of the relevant surface of the unit packet and any outside packaging,
  • be printed in black Helvetica bold type on a white background,
  • cover the largest possible proportion of the area reserved for the warning,
  • be located in the centre of the reserved surface, and on rectangular packets and any outer packaging; the health warning shall be parallel to the side edge of the unit or outside packaging, and
  • be parallel to the main text on the surface reserved for the warning.

Product presentation and an information leaflet

The labelling of unit packets or any outside packaging of e-cigarette products shall not

  • suggest that a particular e-cigarette or refill container is less harmful than other such products,
  • contain information about the content of tar or carbon monoxide in the product,
  • resemble a food or a cosmetic product,
  • suggest that a particular product has environmental advantages,
  • refer to fragrances or additives, except for flavourings.

Unit packets and any outside packaging of e-cigarettes and refill containers must also not imply economic advantages by including printed vouchers, offering discounts, free distribution, two-for-one or similar offers.

Leaflet

Manufacturers and importers are responsible that packets of nicotine-containing e-cigarettes and refill containers include an information leaflet. Leaflets in unit packets of e-cigarettes and refill containers provided to consumers on the Swedish market must be in Swedish.

The leaflet must include information about

  • instructions for use and storage of the product, including a reference that the product is not recommended for use by young people and non-smokers
  • contra-indications
  • warnings for specific risk groups
  • possible adverse effects
  • addictiveness and toxicity
  • contact details of the manufacturer or importer and a legal or natural person within the Union.

Refillable e-cigarettes and refill containers must contain appropriate refilling instructions, including diagrams, as part of the instructions for use. Depending on the type of filling mechanism, the operating instructions must state either:

  • the width of the nozzle or tank opening, so that consumers can determine whether the refill containers and e-cigarettes are compatible, or
  • the types of docking systems that are compatible with such e-cigarettes and refill containers.

A full list of ingredients

Manufacturers and importers are responsible that packages of e-cigarettes and refill containers include a full list of all ingredients contained in Swedish:

  • a list of all ingredients included in the product in descending order of weight
  • an indication of nicotine content in the product and the distribution per dose
  • the batch number
  • a recommendation to keep the product out of the reach of children.

If the rules are not followed

The Public Health Agency of Sweden supervises manufacturers, importers and wholesalers of e-cigarettes and refill containers. We check that nicotine-containing e-cigarettes and refill container provided to consumers on the Swedish market meet the requirements of the law. E-cigarette products that do not meet labelling requirement or have labelling that does not comply with the regulations may not be provided to consumers.

The Public Health Agency may, as a supervisory authority, decide on the injunctions or prohibitions that are necessary to ensure that manufacturers, importers and retailers comply with the law or a regulation issued pursuant to the law.

The regulations on which this information is based:

Chapter 3 Act on tobacco and similar products
3 kap. Lagen om tobak och liknande produkter

Chapter 3 Ordinance (2019: 223) on tobacco and similar products
3 kap. Förordning (2019:223) om tobak och liknande produkter

The Swedish Public Health Agency's regulations (HSLF 2018: 41) on electronic cigarettes and refill containers
Folkhälsomyndighetens föreskrift (HSLF 2018:41) om elektroniska cigaretter och påfyllningsbehållare

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