Notification on novel tobacco product
Manufacturers and importers of novel tobacco products are required to notify each product intended to be available to consumers on the Swedish market. Each year you must also fulfil the annual reporting obligation for your notified products.
Product notification and annual reporting obligation
Novel tobacco products intended for consumers in Sweden must be notified to us before they can be sold. Each year there is an annual reporting obligation. In Sweden, manufacturer or importers of the product must submit the product notification and fulfill the annual reporting obligation.
- If the manufacturer is established in the EU, it is primarily the manufacturer who is obliged to report the information.
- If the manufacturer is established in a country that is not a member of the EU or the EEA (European Economic Area), but the importer is established in the EU, it is primarily the importer who is required to report the information.
- If both the manufacturer and the importer are established in a country that is not a member of the EU or the EEA, they are jointly obliged to report the information.
Product notification
The submission must be submitted via EU-CEG 6 months prior to the placing on the Swedish market of a new product. You must also submit the reporting of ingredients via EU-CEG 8 weeks prior to the placing on the Swedish market of a modified novel tobacco product. When you no longer provide a product in Sweden, remember to withdraw the Swedish product presentation in EU-CEG. This submission must also be made no later than 8 weeks before the product is withdrawn. However, if the withdrawal could not have been foreseen, this submission must be made immediately.
Information in the product notification
The notification must contain the following information by brand name and type:
- A detailed description of the concerned product and instructions for its use.
- Available studies, executive summaries thereof and market research on the preferences of various consumer groups, including young people and current smokers.
- Available scientific studies on toxicity, addictiveness and attractiveness of the product, in particular as regards its ingredients and emissions.
- Other available and relevant information, including a risk/benefit analysis of the product, its expected effects on cessation of tobacco consumption, its expected effects on initiation of tobacco consumption and predicted consumer perception.
- A list of all ingredients, and quantities thereof, used in the manufacture of the product. The ingredients must be sorted in descending order according to the weight of each ingredient included in the product.
- Each reported ingredient must also:
- Be accompanied by a statement setting out the reasons for the inclusion of such in the product.
- Indicate the status of the ingredient, including whether it have been registered under the REACH regulation.
- Indicate the classification of the ingredient under the CLP regulation.
- Be accompanied by the relevant toxicological data regarding the ingredients in burnt or unburned form, as appropriate, referring in particular to their effects on the health of consumers and taking into account, inter alia, any addictive effects.
Regulation (EC) No 1907/2006 (eur-lex.europa.eu)
Regulation (EC) No 1272/2008 (eur-lex.europa.eu)
You have the option to mark any information that you consider to be confidential or a trade secret in your submission. At our request, you must substantiate these claims.
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.
Annual reporting obligation
As a manufacturer or importer of novel tobacco products you must annually, no later than the 31st of January each year, for the previous year, submit the following information about the product to us via EU-CEG:
- Available internal and external studies on market research and preferences of various consumer groups, including young people and current smokers, relating to ingredients and emissions. You do not have to re-report previously submitted internal and external studies.
- Executive summaries of any market surveys you have carried out when launching new products.
- The Swedish sales volume per brand and type, in sticks or kilograms.
- New or updated scientific studies on toxicity, addictiveness and attractiveness of the novel tobacco product, in particular as regards to its ingredients and emissions.
- New or updated studies, executive summaries thereof and market research of the preferences of various consumer groups, including young people and current smokers.
- Other available and relevant information that is new or updated, including a risk/benefit analysis of the product, its expected effects on cessation of tobacco consumption, its expected effects on initiation of tobacco consumption and predicted consumer perception.
Publicly available information on novel tobacco products
Publicly available information on tobacco products
Submitter ID and EU-CEG
You need an EU Login account and an EU-CEG Submitter ID in order to notify products 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)
