Reporting obligations on cigarettes

Reporting of ingredients and annual reporting obligation

Reporting of ingredients

As a manufacturer or importer of cigarettes 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 This submission must also be made no later than eight weeks before the product is withdrawn.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.
  • A technical document setting out a general description of the additives used and their properties.
• Emission levels of tar, nicotine and carbon monoxide. These emission levels must be measured on the basis of:
  ISO standard 4387 for tar.
  ISO standard 10315 for nicotine.
  ISO standard 8454 for carbon monoxide.
  The accuracy of these measurements must be determined in accordance with ISO standard 8243 and also be verified by approved laboratories.

• Cigarettes 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 cigarette 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 at the latest 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 addictive 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 cigarettes 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)

List of approved laboratories [Article 4(2) of the TPD] (health.ec.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)

Annual reporting obligation

As a manufacturer or importer of cigarettes 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 14,500, for the reporting of ingredients of cigarettes. 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 12,000, for cigarettes, 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 cigarettes 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 smokeless tobacco products

Information that is not confidential about submitted cigarettes 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.