Product notification and annual reporting obligation
Both manufacturer and importer of e-cigarettes and refill containers are required to submit a product notification to us. This is required for products that are available to consumers in Sweden.
The submission must be made via EU-CEG six months prior to the placing on the Swedish market of a new or modified product. When you no longer provide a product in Sweden, remember to withdraw its Swedish product presentation from the EU-CEG.
A product notification must contain the following information depending on whether the product is an e-cigarette or a refill container:
- The name and contact details of the manufacturer, a responsible legal or natural person within the European Union and, if applicable, the importer into the European Union.
- A list of all ingredients contained in, and emissions resulting from the use of, the product, by brand name and type, including quantities thereof.
- Toxicological data regarding the product's ingredients and emissions, including when heated, referring in particular to their effects on the health of consumers when inhaled and taking into account any addictive effects.
- Information on the nicotine doses and uptake when consumed under normal or reasonably foreseeable conditions.
- A description of the components of the product, including where applicable, the opening and refill mechanism of the e-cigarette or refill container.
- A description of the production process, including whether it involves series production, and a declaration that the production process ensures conformity with the requirements for e-cigarettes and refill containers.
- A declaration that the manufacturer and importer bear full responsibility for the quality and safety of the product, when placed on the market and used under normal or reasonably foreseeable conditions.
Fees for product notification
We charge fees, SEK 10,500 for the notification of e-cigarettes and refill containers. It is the manufacturers and importers that notify the product that must pay a fee for each brand and type:
- The first time a product is notified to Sweden.
- When a product is relaunched on the Swedish market after it has been withdrawn from this market.
- When a new notification is submitted for a rejected product.
- When a substantial modification is submitted, which modifies the composition of a notified product in a way that affects the previously provided information.
We will send you a payment instruction the month after the notifications have been made to us in EU-CEG. This payment instruction will state how much you must pay and to which account the payment must be made. The payment must be made within 30 days from the day the payment instruction was issued.
If we have not received payment within 30 days of issuing of the payment instruction, the product notification may be rejected. If the product notification is rejected the product may not be made available to consumers on the Swedish market.
Annual reporting obligation
Manufacturer and importer of e-cigarettes and refill containers must annually, no later than the 31st of March each year, referring to the previous year, submit the following information about the product to us:
- Comprehensive data on sales volume in Sweden, by brand name and type of the product.
- Information on the preferences of various consumer groups, including young people, non-smokers and the main types of current users.
- The mode of sale of the product.
- Executive summaries of any market surveys carried out in respect of the above, including an English translation thereof.
Submitter ID and EU-CEG
You need an EU Login account and an EU-CEG Submitter ID in order to submit a product notification via EU-CEG to us. You apply for an EU-CEG Submitter ID on the European Commission website EU Common Entry Gate (EU-CEG).
EU Login (webgate.ec.europa.eu)
EU Common Entry Gate (EU-CEG) (health.ec.europa.eu)
EU-CEG Industry Stakeholders (circabc.europa.eu)
Accurate submitter details
It is important that the submitter details in EU-CEG are complete and accurate, such as e-mail address and postal address. We will use this information in our communication with you.
You have the possibility in your submission to mark all information that you consider to be a trade secret or otherwise confidential. You must upon our request, duly justify these claims.
Publicly available information on e-cigarettes and refill containers
Information that is not confidential about notified e-cigarettes and refill containers is displayed in the list:
Publicly available information on electronic cigarettes and refill containers
- Only products that consumers can expect to find on the Swedish market are presented in the list. This means products that were notified at least six months ago, whose submitted launch date has passed and submitted withdrawal date has not passed.
- The list only contains information about products that have been paid for. To sell e-cigarettes and refill containers, manufacturers and importers must notify their products and pay a mandatory fee to us. If the fee is not paid, the product notification will be rejected and the product is not allowed to be available on the Swedish market. Information about the product will not be visible in the list of notified e-cigarettes and refill containers.
- The list only contains information about notified products and does not mean that we have verified that the products meet all legal requirements.
- The ingredients list is not a complete declaration of all of the ingredients in the products. Ingredients in very small amounts are considered to be trade secrets and are not public.
- The list is updated once a month. This may cause some delay before newly launched products are visible in the list, and before products that for various reasons no longer should be available on the Swedish market are removed.