Product requirements on novel tobacco product
Novel tobacco product that are available to consumers on the Swedish market must be compliant with product requirements. These requirements may differ and depends on whether the product fall under the definition of a smokeless tobacco product or of a tobacco product for smoking.
Product requirements for novel tobacco products may differ and the requirements depends on whether the product fall under the definition of a smokeless tobacco product or of a tobacco product for smoking.
There will be additional product requirements for heated tobacco products. These includes additional prohibited additives and a prohibition on characterising flavour. The Commission Delegated Directive (EU) 2022/2100 states that these provisions must be applied from 23 October 2023.
Heated tobacco product is a novel tobacco product that is heated to produce an emission containing nicotine and other chemicals, which is then inhaled by user(s), and that, depending on its characteristics, is a smokeless tobacco product or a tobacco product for smoking.
Commission Delegated Directive (EU) 2022/2100 (eur-lex.europa.eu)
Prohibited additives
Novel tobacco products that is available on the Swedish market must not contain the following additives:
- Vitamins or other additives that create the impression that a product 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 that have colouring properties for emissions.
- Additives that facilitate inhalation or nicotine uptake, for tobacco products for smoking.
- Additives that have carcinogenic, mutagenic or toxic to reproduction properties in unburnt form.
Heated tobacco products must not contain flavourings in any of their components such as filters, papers, packages, capsules or any technical features allowing modification of the smell or taste of heated tobacco products or their smoke intensity.
Filters, papers and capsules for heated tobacco products must not contain tobacco or nicotine.
We can, on the basis of scientific evidence, prohibit the placing on the market of novel tobacco products containing additives in quantities that increase the toxic or addictive effect, or the carcinogenic, mutagenic or toxic to reproduction properties of a product at the stage of consumption to a significant or measureable degree.
Prohibition of heated tobacco products with a characterising flavour
It is prohibited to provide heated tobacco products with a characterising flavour on the Swedish market. Characterising flavour is a clearly noticeable smell or taste other than one of tobacco, resulting from an additive or a combination of additives, including, but not limited to, fruit, spice, herbs, alcohol, candy, menthol or vanilla, which is noticeable before or during the consumption of the tobacco product.
The prohibition of heated tobacco products with a characterising flavour does not exclude the use of additives which are essential for the manufacture of the product provided those additives do not result in a product with a characterising flavour and do not increase to a significant or measureable degree the addictiveness, toxicity or the carcinogenic, mutagenic or toxic to reproduction properties of the product.
There is a procedure that we use when determining whether or not heated tobacco products has a characterising flavour:
Determination of characterising flavours in tobacco products (health.ec.europa.eu)
