The Public Health Agency of Sweden
Updated 25 November 2020

Novel tobacco products

So called "Novel tobacco products" must be notified to the Public Health Agency of Sweden before they can be provided to consumers on the Swedish market.

A novel tobacco product is a tobacco product that does not fall into any of the following categories: cigarettes, roll-your-own tobacco, pipe tobacco, waterpipe tobacco, cigars, cigarillos, chewing tobacco, nasal tobacco or tobacco for oral use, and is placed on the market after 19 May 2014.

A novel tobacco product has to be notified in accordance with the requirement for reporting of ingredients for tobacco products and by the regulations on labelling and packaging of tobacco products.

Who is responsible for reporting information on novel tobacco products?

Manufacturers and importers are responsible for reporting and that the responsibilities between the two follows what is described under reporting of ingredients for tobacco products.

A novel tobacco product that has not been notified to us may not be provided to consumers on the Swedish market.

What information shall be reported?

Notification of a novel tobacco product must include

  • information on ingredients and quantities in the novel tobacco product, see reporting of ingredients
  • a description of the novel tobacco product and instructions for use,
  • available scientific studies of the novel tobacco product on toxicity, addictive properties and attractiveness, in particular on its ingredients and emissions and
  • available studies with summaries, comments and market research of the preferences of different consumer groups, including young people and current smokers.
  • other available and relevant information, including an analysis of the risks and benefits of the product, the expected effects of quitting the consumption of tobacco, the expected effects on the onset of tobacco consumption and expected consumer reactions.

The information shall be reported via the common EU-web portal EU-CEG.

Annual reporting

In addition to the information on annual reporting mentioned under Annual Reporting of Tobacco Products, the following new or updated information must be provided to us annually:

Annual Reporting of Tobacco Products

  • Available scientific studies on the toxicity, addictive properties and attractiveness of the novel tobacco product, in particular with regard to ingredients and emissions.
  • Available studies with summaries and comments and market research of the preferences of different consumer groups, including young people and current smokers.
  • Other available and relevant information, including an analysis of the risks and benefits of the product, the expected effects on quitting the consumption of tobacco products, the expected effects on the onset of tobacco consumption and expected consumer reactions.

The information shall be reported via the common EU-web portal EU-CEG.

Reporting dates

  • Notification of a novel tobacco product must be made no later than six months before the product is provided to consumers in Sweden.
  • Annual reporting must take place every year, no later than 31 January for the previous year.

The provisions on which this information is based

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 acts or regulations of other authorities that you need to be aware of. The Public Health Agency of Sweden does continuously update the content, but we cannot guarantee that the information on the site is always completely up to date.