Notification on novel tobacco product

Notification and annual reporting obligation

Notification

As a manufacturer or importer of novel tobacco products you are required to notify these products to us. This is required for products that are available to consumers in Sweden.

• 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.

The submission must be made via EU-CEG six months prior to the placing on the Swedish market of a new product. You must also submit the reporting of ingredients via EU-CEG eight 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 its Swedish product presentation from the EU-CEG. This submission must also be made no later than eight weeks before the product is withdrawn. However, if the withdrawal could not have been foreseen, this submission must be made immediately.

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)

Annual reporting obligation

As a manufacturer or importer of novel tobacco products you must annually, no later than the 31st of January each year, referring to 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.

Submitter ID and EU-CEG

You need an EU Login account and an EU-CEG Submitter ID in order to notify novel tobacco 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)

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.

Confidential data

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 novel tobacco products

Information that is not confidential about submitted novel tobacco products is displayed in the list:

Publicly available information on tobacco products

• Presented in the list are products that consumers can expect to find on the Swedish market. Meaning products that were notified at least six month ago, whose submitted launch date has passed and submitted withdrawal date has not passed.
• The list only contains information about reported products. We have not verified that these products meet all legal requirements.
• Published ingredients per product is not a complete declaration of all the ingredients in the product. Ingredients that make up a very small amount of the product 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 have been withdrawn from the Swedish market are removed from the list.