Notify ingredients in tobacco free nicotine products
On this page you will find information on how you, as a manufacturer or importer of tobacco free nicotine products, notifies ingredients, fulfill the annual reporting obligation and pay fees to us.
When and how should I notify my tobacco free nicotine product?
The notification is done via our notification system. You must do this no later than six months before a new or modified product is released on the market. There is a fee for the notification. It is your responsibility to ensure that we receive this information.
Report substantial modifications to a product
You must submit a new notification for each substantial modification to a product. Examples of substantial modifications include modifications to the product’s composition, such as ingredients and nicotine content. Please note that modifications that do not affect the product’s content or characteristics, such as brand name or product/packaging design, are not considered to be substantial modifications.
Withdraw a product that no longer is sold
If a product is no longer sold in Sweden, you must withdraw it via the notification system.
Fee for product notification
We charge a fee of 4 200 SEK for each brand and type of tobacco free nicotine product. If the fee is not paid, we will reject the product notification, and the product will not be allowed for sale in Sweden.
Invoices are issued at the beginning of each month and include all product notifications submitted during the previous month. You can choose whether you want to receive invoices by email or as an e-invoice. The payment terms are 30 days.
Payment information
- Beneficiary: Folkhälsomyndigheten, Nobels väg 18, 171 82 Solna
- VAT no: SE202100654501
- Bank address: Danske Bank, Box 7523, 103 92 Stockholm
- Account No: 12810101868
- IBAN: SE58 1200 0000 0128 1010 1868
- BIC/SWIFT: DABASESX
Create an account in the notification system
Manufacturers and importers of tobacco free nicotine products can create an account on the notification system's login page. To this account, you need to add an administrator account. The administrator account is for those who have the authority to manage the data for your organization. You can register multiple administrator and user accounts if necessary.
When creating an account, your company will be assigned a unique Submitter-ID consisting of six digits, which can be used when communicating with us. It is also the basis for the unique product-id of all your products.
Notification system for tobacco free nicotine products (tfn.folkhalsomyndigheten.se)
When submitting information via the notification system for tobacco free nicotine products, it is important that you:
- Confirm the email addresses you have registered in the system.
- Your email address is correct and active.
- Your postal address is complete, including street address, postal code, and city.
We use this information to contact you as the manufacturer or importer.
A product notification must include the following information:
- State if you are the manufacturer or importer of the product. If you imported the product, you must submit information about the manufacturer.
- A complete list of all ingredients in the product and their quantity. The quantity is given in mg/1,000 mg. The total quantity of all ingredients per product must amount to 1,000 mg. The notification system has an ingredient database where you can search for ingredients.
- Toxicological properties of the ingredients. You must state whether the ingredient has carcinogenic, mutagenic or reproductive toxic properties. You do not need to attach copies or report studies conducted on the toxicity of the ingredient.
- Nicotine dose and nicotine uptake. Nicotine dose should be stated as mg/g. Nicotine uptake should be stated as a percentage (%) and indicate the proportion of nicotine the body absorbs from the total amount of nicotine in the product.
- If the product is manufactured by mass production or batch production.
- A declaration that the manufacturing process is compatible with the requirements for tobacco free nicotine products.
- A statement that you take full responsibility for the quality and safety of the product when used by consumers under normal conditions.
Please note that each product notification must be unique. To facilitate the notification of multiple products, you can copy an existing product notification and then adjust the information before submitting the notification to us.
We do not have an approval procedure and do not provide advance notice regarding products. We will contact the manufacturer or importer if any deficiencies in a product are discovered during inspections.
It is allowed to sell tobacco free nicotine products to other parts of the distribution chain before six months have passed. But you may not sell the products to consumers until six months have passed since the notification was submitted. This is prohibited by law.
Annual reporting of tobacco free nicotine products
As a manufacturer or importer, you must report information about your tobacco-free nicotine products every year. This must be completed by March 31st and applies to the previous year. The reporting is done in the notification system for tobacco free nicotine products. You need to report:
- The Swedish sales volume of the product.
- Information on the preferences of various consumer groups, including young people who have not reached the age of 25.
In the notification system you will find a form for the annual reporting. Fill in the form with the requested information. If you do not report on time, we may ban the sale of the products in Sweden.
Notification system for tobacco free nicotine products (tfn.folkhalsomyndigheten.se)
Fee for annual reporting
For the annual reporting, we charge a fee of SEK 4,200 for each brand and type of tobacco free nicotine products. If the fee is not paid, we may prohibit the sale of the product in Sweden.
Invoices for the annual fee are issued after the deadline for submitting the annual report has expired on March 31st each year. You can choose whether you want to receive invoices via email or as an e-invoice. The payment terms are 30 days.
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.