Notification of Tobacco Free Nicotine Products

Product notification and annual reporting obligation

Tobacco free nicotine products intended for consumers in Sweden must be notified to us before they can be sold. Each year there is an annual reporting obligation for each product. Manufacturer and importers of the product must submit the product notification and fulfil the annual reporting obligation via our notification system.

About the notification system

The notification system for tobacco free nicotine products is accessed through the link below.

Notification system for tobacco free nicotine products (tfn.folkhalsomyndigheten.se) (in Swedish)

On the login page of the notification system, you will create an account for the company that manufactures or imports tobacco free nicotine products. You will also create an administrator account, which is an account for those authorised to manage the information for your organisation. It will be possible to register multiple administrator accounts and user accounts if needed.

When creating an account, the company is assigned a unique Submitter-ID consisting of six digits, which can be used when communicating with us. It also form the basis for all your products' unique Product-ID.

Fees for product notification and annual reporting

We charge mandatory fees:

• SEK 4,200, for the notification of each brand and type of tobacco free nicotine products.
• SEK 4,200, for the annual reporting of each brand and type of tobacco free nicotine products.

Invoices will be 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 e-invoices. The payment terms are 30 days.

Unpaid fee will lead to rejected product notification

If the fee is not paid, the product notification will be reject. A rejected product notification means that the product must not be sold to consumers on the Swedish market.

Product notification

Manufacturers and importers of tobacco free nicotine products must notify all products they intend to provide on the Swedish market. Products sold under different brand names, flavors, or nicotine strengths should all be notified separately and are subject to the six-month waiting period.

The submission must be made, via the notification system, 6 months prior to the placing on the Swedish market of a new or modified product. You must also notify us of product withdrawal, via the notification system, when you no longer provide the product in Sweden.

This is what the product notification must include

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 the product’s ingredients. In the notification system it is possible to search an ingredient database to find the right ingredient.
• Quantities of the ingredients. These must be stated in mg/1 000 mg. The total quantity of all ingredients per product must amount to 1 000 mg.
• Toxicological data about the product’s ingredients. The information to be submitted for each ingredient is whether it has carcinogenic, mutagenic or reprotoxic properties. You should not attach copies or otherwise disclose conducted studies.

• 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 declaration that you bear full responsibility for the quality and safety of the product when provided to consumers and used under conditions that are normal or reasonably foreseeable.

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.

Reporting of sales must be made annually

Manufacturer and importer of tobacco free nicotine product must annually, no later than 31 March each year, referring to the previous year, submit the following information about the product to us through the notification system:

• Comprehensive data on the Swedish sales volume.
• Information on the preferences of various consumer groups, including young people who have not reached the age of 25.

If the annual reporting is not submitted, or if the annual fee is not paid, we may prohibit the product from being provided to consumers on the Swedish market.

Please note that existing products notified in January 2024, information on sales volume and preferences among different consumer groups for the year 2023 must be reported in the system by 31 March, 2024. In the notification system there is a form for annual reporting for you to complete.

Information that is made public

Information provided in the product notification that does not constitute trade secrets will be published. Since the notification requirement applies to products intended for retail, only information about products that consumers can be expected to find on the Swedish market will be published, i.e., products where the notification fee has been paid and the launch date has been reached.

In the published information, you can also find information on when manufacturers and importers have fulfilled their annual reporting obligation.