Reporting obligations on roll-your-own tobacco

Reporting of ingredients and annual reporting obligation

Roll-your-own tobacco intended for consumers in Sweden must be reported 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 reporting of ingredients 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.

Fees for the reporting of ingredients and the annual reporting obligation

We charge mandatory fees:

• SEK 14,500, for the reporting of ingredients of each brand and type of roll-your-own tobacco. A fee for the reporting of ingredients is charged:
  • 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  • When a product is relaunched on the Swedish market after it has been withdrawn from this market.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.
• SEK 6,000, for the annual reporting of each brand and type of roll-your-own tobacco.

We will send the manufacturer or importer that submits the reporting a payment instruction the month after the submission has 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.

Information about invoicing

The Public Health Agency of Sweden would like to inform you, as a manufacturer or importer of tobacco products in EU-CEG, that the Agency has implemented a new financial system.

For reported tobacco products or annual reports submitted in EU-CEG during the period of June to October, we plan to send invoices in November 2024. Note that the new invoices will have a different layout and will be sent from ekonomi@folkhalsomyndigheten.se.

Reporting of ingredients

The submission must be made via EU-CEG 8 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 the Swedish product presentation in EU-CEG. This submission must also be made no later than 8 weeks before the product is withdrawn. If the withdrawal could not have been foreseen, this submission must be made immediately.

Information in the reporting of ingredients

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 has 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.
  • A technical document setting out a general description of the additives used and their properties.
• Roll-your-own tobacco containing any of the additives in the priority list in the appendix to Implementing Decision (EU) 2016/787 are subject to the enhanced reporting obligations.
  • For each additive in the product, you must carry out comprehensive studies, which must examine whether it:
    • contributes to toxicity or addictiveness of the products concerned, and whether this has the effect of increasing the toxicity or addictiveness of any of the products concerned to a significant or measurable degree,
    • results in a characterising flavour,
    • facilitates inhalation or nicotine uptake, or
    • leads to the formation of substances that have CMR properties (carcinogenic, mutagenic or toxic to reproduction), the quantities thereof, and whether this has the effect of increasing the CMR properties in any of the products concerned to a significant measurable degree.
    • The comprehensive studies must take into account the intended use of the roll-your-own tobacco and examine in particular the emissions resulting from the combustion process with the concerned additive included. The studies must also examine the interaction of the additive with other ingredients contained in the products concerned.
• The results of these studies must be collected in a report submitted no later than 18 months after the additive concerned has been included in the appendix to Implementing Decision (EU) 2016/78. The report must include an executive summary, a comprehensive overview compiling the available scientific literature on that additive and summarising internal data on the effects of the additive.
• The European Commission or we may request supplementary information, regarding the additive concerned, from manufacturers or importers. If this is the case, please supplement your report including the requested information and then submit a new full report to us.
• Manufacturers and importers having the same additive in their roll-your-own tobacco may carry out joint studies if the product composition is comparable.
• Small and medium-sized enterprises as defined in Commission Recommendation 2003/361/EC, are not subjects of the enhanced reporting obligations if a report on that additive is prepared by another manufacturer or importer.

Regulation (EC) No 1907/2006 (eur-lex.europa.eu)

Regulation (EC) No 1272/2008 (eur-lex.europa.eu)

Implementing Decision (EU) 2016/787 (eur-lex.europa.eu)

Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (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 roll-your-own tobacco 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.

Publicly available information on smokeless 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 report ingredients 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)