Enhanced reporting obligations for cigarettes and roll-your-own tobacco
Manufacturers and importers of cigarettes and roll-your-own tobacco containing certain additives must carry out comprehensive studies of the cigarettes or roll-your-own tobacco and report to us.
Cigarettes and roll-your-own tobacco containing any of the additives below are subjects for the enhanced reporting obligations. As a manufacturer or importer of these products, you shall submit a report of the comprehensive studies via the EU's online portal for ingredient reporting EU-CEG to us at the Public Health Agency of Sweden.
The list of priority additives has been established by the European Commission.
Table 1: List of additives that are subject to an extended reporting obligation
|Additive||Chemical formula |
|CAS number of the substance |
68990-15-8, 977018-53-3, 84625-40-1
|Fruit kernel meal||
84649-99-0, 84649-99-3, 95009-22-6, 8002-31-1
2216-51-5, 15356-60-2, 89-78-1, 8006-90-4, 68606-97-3, 84696-51-5, 8008-79-5
All additives in the list were entered on 1 January 2017.
The analysis shows the additive’s properties and its effects on the product
The comprehensive studies shall take into account the intended use of the cigarettes and roll-your-own tobacco and examine in particular the emissions resulting from the combustion process with the concerned additive included. The studies shall also examine the interaction of the additive with other ingredients contained in the products concerned.
Each additive shall be analysed to determine 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,
- 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.
Manufacturers and importers may carry out joint studies
Manufacturers and importers having the same additive in their cigarettes and roll-your-own tobacco may carry out joint studies if the product composition is comparable.
The studies are collected in a report
The results of these studies shall be collected in a report. The report shall 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.
Time for submission of the report
The report with the comprehensive studies on an additive shall be submitted at the latest 18 months after the additive concerned has been included in the appendix to Implementing Decision (EU) 2016/787, see also when the additive was introduced to the above list.
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.
Some exceptions for smaller companies
SMEs, as defined in Commission Recommendation 2003/361/EC, are not subjects of the enhanced reporting obligations for cigarettes and roll-your-own tobacco if another manufacturer or importer has already submitted or is submitting a report on the concerned additive.
If the rules are not complied with
Tobacco products may not be placed on the Swedish market if the reporting obligation is not fulfilled.
The Public Health Agency of Sweden may issue injunctions and prohibitions to ensure that the rules on reporting obligations are complied with. A decision on an injunction or prohibition may be accompanied by a fine.
The provisions on which this information is based
- Chapter 2 Act on tobacco and similar products
- Chapter 7 Act on tobacco and similar products
- The Public Health Authority’s regulations (HSLF-FS 2016:45) on reporting ingredients in tobacco products, annual reporting on market research etc. and extended reporting obligations, as well as notification and reporting of new tobacco products
You always have an obligation to know what applies by law. The information on this website is intended solely to help you, and does not replace what is written in the law. There may also be other laws or regulations from other authorities that you must be aware of. The Public Health Agency continuously updates the content, but we cannot guarantee that the information on the page is always completely up to date.