Manufacturing and import of tobacco free nicotine products
On this page you will find information about your responsibilities as a manufacturer or importer of tobacco free nicotine products, such as nicotine pouches.
Your responsibilities as a manufacturer or importer
As a manufacturer or importer of tobacco free nicotine products, you have several responsibilities. You must establish a system for collecting information about harmful effects and take corrective action when you discover deficiencies in a tobacco free nicotine product. You must notify the ingredients of the products to us and report their sales volume annually. The packages must be provided with health warnings and an ingredient declaration in Swedish. There are also specific restrictions limiting the labelling permitted on the packages.
Only tobacco free nicotine products that comply with the regulations in The Act on Tobacco Free Nicotine Products may be sold on the Swedish market.
System for collecting information on harmful effects
As a manufacturer or importer of tobacco free nicotine products, you have to keep a record of information about suspected harmful effects that your products have on human health. You must be able to provide this information to us upon request.
Requirement to take corrective actions
As a manufacturer or importer, you must take immediate action if a tobacco free nicotine product is deficient or does not comply with the Act on Tobacco Free Nicotine Products. This includes taking corrective actions and informing us.
Notify deficiencies in tobacco free nicotine products
Notify and report tobacco free nicotine products
If you manufacture or import tobacco free nicotine products, you must notify the products to us via the notification system for tobacco free nicotine products. The notification fee is SEK 4,200 for each brand and type.
By March 31st of each year, you must, among other things, report the product's Swedish sales volume. The annual reporting fee is SEK 4,200 for each brand and type of product.
- Notify ingredients in tobacco free nicotine products
- List of notified tobacco free nicotine products (tfn.folkhalsomyndigheten.se)
Product requirements for tobacco free nicotine products
When manufacturing tobacco free nicotine products, only high-purity ingredients may be used. These ingredients must not pose a risk to human health. The exception is nicotine. Traces of other substances are only permitted if they cannot be avoided.
Prohibited ingredients in tobacco free nicotine products
Tobacco free nicotine products must not contain:
- Vitamins or other additives that may give the impression of health benefits or reduced health risks.
- Caffeine, taurine or other additives or stimulants associated with energy and vitality.
The CLP Regulation includes regulations on the labelling of products considered to be harmful. The REACH Regulation contains regulations that prohibit the use of certain additives that are carcinogenic, mutagenic, or toxic to reproduction.
For information on the CLP and REACH regulations, as well as general rules for chemical products, contact the Swedish Chemicals Agency or visit their website.
Food legislation equates snus-like products with food. Examples of such products are tobacco free nicotine products that are used in the same way as snus with tobacco. This may mean more requirements for tobacco free nicotine products that are also snus-like products.
Contact the Swedish Food Agency or visit their website for information about food legislation.
Packaging for tobacco free nicotine products sold to consumers in Sweden must have Swedish health warnings and a Swedish ingredient declaration. There are also restrictions on the labelling of the tobacco free nicotine product and its packaging. As a manufacturer or importer, it is your responsibility to ensure that the packaging meets the requirements.
Packaging of tobacco free nicotine products must include health warnings in Swedish. The health warning for this product consists of a warning text with the following wording:
Denna produkt innehåller nikotin som är ett mycket beroendeframkallande ämne.
Packaging of tobacco free nicotine products must have a content declaration in Swedish that includes:
- A list of all ingredients contained in the product in descending order of weight.
- An indication of the nicotine content of the product and the delivery per dose.
- A recommendation to keep the product out of reach of children.
The content declaration may be affixed by means of stickers, provided that such stickers are irremovable, and must:
- appear on one of the largest surfaces of the unit packet and any outside packaging and cover 20 percent of that surface,
- be printed in black Helvetica bold type on a white background,
- use the font size that ensures that the text occupies the greatest possible proportion of the surface reserved for the content declaration, and
- be parallel to the main text on the surface reserved for the content declaration.
There are certain restrictions regarding the labelling on the tobacco free nicotine product or its packaging. The labelling may not:
- Suggest that a particular tobacco free nicotine product is less harmful than other similar products.
- Resemble a food product or a cosmetic product.
We do not give an approval of the design of health warnings or content declarations for tobacco free nicotine products. Nor do we provide prior rulings of whether they comply with the legal requirements. The compliance can be reviewed during our supervision.
Packaging for tobacco free nicotine products can be unit packaging or outer packaging. Both have different functions and uses. Here’s what applies to each type:
- Unit packet is the smallest packaging of a tobacco free product sold to consumers. It contains one or more individual products and is the packaging that the consumer opens and uses.
- Outer packaging is packaging that contains one or more unit packets. It is primarily used to protect and group multiple unit packets. Transparent wrappers are not considered outer packaging.
How to comply with the regulations for tobacco free nicotine products
On the page on how to comply with the regulations, you will find more information on tobacco free nicotine products.
Tobacco free nicotine products – How to comply with the regulations
You need to have knowledge of the legislation
The information on this website is only intended to serve as an aid to you, and does not replace what is stated in the legislation. There may also be laws or regulations of other authorities that you need to be aware of. We continuously update the content but we cannot guarantee that the information on the page is always up-to-date.