Novel tobacco products

What is a novel tobacco product?

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.

Clarification

A Heated Tobacco Product (HTP) belongs to product type novel tobacco product. HTP that is provided without any tobacco sticks, i.e. only the device is provided, does not need to be notified.

Who is responsible for notification of novel tobacco products?

Manufacturers and importers are responsible for the notification. Which of the manufacturer or importer that should provide this information is the same as in the reporting of ingredients for tobacco products.

What information shall be notified and when?

Notification of a novel tobacco product shall be done to us via EU-CEG no later than six months before the product is provided to consumers in Sweden. The notification shall include: 

• information on ingredients and quantities in the novel tobacco product. This is the same reporting as the ones for other tobacco products,
• a detailed description of the novel tobacco product concerned and instructions for its use,
• available scientific studies on toxicity, addictiveness and attractiveness of the novel tobacco product, in particular as regards to its ingredients and emissions,
• available studies, executive summaries thereof and market research of the preferences of various consumer groups, including young people and current smokers, and
• other available and relevant information, including a risk/benefit analysis of the product, its expected effects on cessation of tobacco consumption, its expected effects on initiation of tobacco consumption and predicted consumer perception.

Annual reporting

The following new or updated information shall be provided to us annually in addition to the information in annual reporting of tobacco products. This should be submitted no later than the 31st of January for the previous year, via EU-CEG:

• Available scientific studies on toxicity, addictiveness and attractiveness of the novel tobacco product, in particular as regards to its ingredients and emissions.
• Available studies, executive summaries thereof and market research of the preferences of various consumer groups, including young people and current smokers.
• Other available and relevant information, including a risk/benefit analysis of the product, its expected effects on cessation of tobacco consumption, its expected effects on initiation of tobacco consumption and predicted consumer perception.

Other rules

There are other rules in the regulation than notification and the annual reporting of novel tobacco products that is applicable. For example shall the packaging of these tobacco products be provided with health warnings. 

If the rules are not followed

Only novel tobacco products that is compliant with the regulation may be made available on the Swedish market.

Read more

• Annual Reporting of Tobacco Products
• Labelling and packaging of tobacco products
• EU Common Entry Gate (EU-CEG (ec.europa.eu)
• Reporting of ingredients for tobacco products

The regulations on which this information is based

• Chapter 2 and 7 in the Act (2018:2088) on tobacco and similar products (riksdagen.se) (in Swedish)
• The Public Health Agency of Sweden's regulations on Reporting of Ingredients in Tobacco Products, Annual Reporting on Market Research etc. and Enhanced Reporting Obligation as well as Notification and Reporting of Novel Tobacco Products, HSLF-FS 2016:45 (in Swedish)

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 Agency cannot guarantee that the information on the website is always up to date.