Reporting of ingredients and annual reporting obligation
Reporting of ingredients
As a manufacturer or importer of smokeless tobacco products you are required to submit the reporting of ingredients of 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 eight weeks 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. This submission must also be made no later than eight weeks before the product is withdrawn.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 reporting of ingredients must contain the following information by brand name and type:
- 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 smokeless 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.
Fees for the reporting of ingredients and the annual reporting obligation
We charge fees, SEK 13,000, for the reporting of ingredients of smokeless tobacco products. It is the manufacturers or importers that submit the product that must pay a fee for each brand and type:
- The first time a product is submitted to Sweden.
- When a product is relaunched on the Swedish market after it has been withdrawn from this market.
- When a substantial modification is submitted, which modifies the composition of a reported product in a way that affects the previously provided information.
We also charge fees, SEK 1,000, for tobacco for oral use, and SEK 1,500, for other smokeless tobacco products than tobacco for oral use, for the annual reporting obligation. It is the manufacturer or importer that submits the annual reporting that must pay a fee for each brand and type.
We will send you a payment instruction the month after the submission have been made 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.
Submitter ID and EU-CEG
You need an EU Login account and an EU-CEG Submitter ID in order to report ingredients of smokeless 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.
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 smokeless tobacco products
Information that is not confidential about submitted smokeless 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 reported at least eight weeks 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.