Notifications of product data for products referred to in the Tobacco Act

In the Tobacco Act, the definition of nicotine refers to nicotine alkaloids. For example, 6-methylnicotine (CAS: 101540-79-8) is classified as a nicotine alkaloid, meaning that products containing it are classified similarly to products containing nicotine under the Tobacco Act. Consequently, they are subject to the same regulations as products containing nicotine. Isomers, salt formations and salt formations of the isomers, if their existence is possible, are included in the 6-methylnicotine classification.

Disposable devices filled with nicotine-free liquid do not meet the definition of an e-cigarette under the Tobacco Act, because due to their disposable nature they are not suitable for the use of nicotine liquid.

The devices in question are classified as tobacco substitutes, and the containing nicotine-free liquid is classified as nicotine-free liquid intended for vaporization. Therefore, these products simultaneously meet two different categories of the Tobacco Act. For such products, the stricter requirements are followed on a case-by-case basis.

The ingredients of the liquid in the device are subject to the same requirements as other nicotine-free liquids intended for vaporization, including, inter alia, the ban of characteristic aroma and flavour. The products are also subject to a ban on selling to minors, as well as marketing and display bans. In addition, a product notification must be submitted to the EU CEG portal, from which Valvira collects notification, sales volume, and supervision fees.

A device used solely for heating a product subject to the Tobacco Act easily meets the definition of an electronic cigarette under the Tobacco Act, that is, a product which allows nicotine-containing vapor to be inhaled through a mouthpiece, or a part of the product in question. A device used for heating herbal products or heated tobacco products is classified as an electronic cigarette if its technical characteristics meet the above-mentioned definition. In such cases, a separate product notification must be submitted for the heating device as an electronic cigarette device.

If the manufacturer or importer intends to sell or otherwise supply to consumers for example, a heating device sold separately from a heated tobacco product, two separate product notifications must be submitted. One notification must be submitted for the heated tobacco product as a tobacco product notification, the product type of which is a novel tobacco product. Correspondingly, the other notification must be submitted for the heating device as an electronic cigarette notification, the product type of which is an electronic cigarette device. Valvira collects fees in accordance with the Tobacco Act for both product notifications.

1. a list with the amount of tar, nicotine and carbon monoxide generated when smoking the cigarettes, as well as information on the laboratory that carried out the measurements and verification
2. a list with the amount of other emissions and the measurement methods thereof (only required if upper limits have been set for said emissions)
3. information on emissions other than what is stated in sections a and b, insofar as that information is available
4. separated by brand name, the study descriptions and statements of the approved verification laboratory or research institute responsible for fire security tests, as well as information on the laboratory or institute
5. a technical document containing an overview of the additives used in the product and the properties thereof.

A technical document containing an overview of the additives used in the product and the properties thereof.

A list, by brand name and type, of all ingredients and quantities thereof used in the manufacture of each tobacco product (check the data submitted with the ingredient notification).

The amounts of emissions when smoking the product (voluntary).
 

A new tobacco product refers to a completely new type of product that does not meet any current definition of a tobacco product. There is an additional requirement that the product must have been made available to consumers no later than 19 May 2014.
The manufacturer or importer of a tobacco product must notify Valvira of a new tobacco product that it intends to sell or distribute to customers at least six (6) months before bringing the product to the market.

The notification must include

1. a detailed description of the product
2. user instructions 
3. information on the product ingredients and emissions (see emissions, ingredient and fire safety notifications)
4. available scientific research on the product’s toxicity, addictive properties and attractiveness, particularly regarding the product ingredients and emissions
5. available research on the product and summaries thereof, as well as market studies on the preferences of different consumer groups
6. a risk-benefit analysis of the product, its possible effects on starting and quitting smoking, the consumers preconceptions of the product, as well as other available and appropriate product information.

Valvira may require the manufacturer or importer to carry out further studies and deliver additional information on the product.

The brand name and type-specific ingredient list for tobacco products must include

1. reasons for the inclusion of the ingredients in the product
2. position of the ingredients, including if the ingredients have been registered in accordance with the regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
3. the classification of the ingredients in accordance with the regulation on the classification, labelling and packaging of substances and mixtures (CLP)
4. the appropriate toxicological on the ingredients, whether in smoked or non-smoked form and which are particularly linked to effects on consumer health (including addictive effect).

Ingredients and the amounts thereof must be reported in descending order by weight of the ingredient. 

The manufacturer or importer of tobacco products must notify Valvira if the composition of a product changes in a way to cause a change in emissions, ingredient and fire safety information. The manufacturer or importer must submit the changed data before the product can be sold or otherwise distributed to consumers.

The manufacturer or importer of cigarettes or loose tobacco must carry out studies regarding the most significant additives on the ingredient list and prepare a report of the study. The report is required to include a summary and a comprehensive overview that lists the literature regarding each studied additive and presents a summary of the internal data on additive’s effects. 

The manufacturer or importer must submit the report on the most significant additives to the European Commission. In addition, a copy of the report must be submitted to Valvira and other competent authorities of the EU Member States, if the tobacco product that contains the particular additive has been brought to the market of said member states. Reports must be submitted within 18 months of the additive being added to the European Commission's list of most significant additives. 

The European Commission and Valvira may request additional information on the studied additive from the manufacturer or importer. The Commission and Valvira may also request an independent scientific body to peer review the report.

The manufacturer or importer of a tobacco product must submit the available market studies and consumer focus group studies on the tobacco product’s ingredients and emissions to Valvira. Additionally, the manufacturer or importer must submit a summary of all market studies that the manufacturer or importer carries out in bringing new tobacco products to the market.

The manufacturer or importer must also report brand name and type-specific sales volumes to Valvira on a once-per-year basis. Cigarette, cigar and cigarillo sales volumes must be reported in pieces, and sales volumes for other tobacco products is reported in kilograms. Sales volume data must be submitted for the previous calendar year. The sales volumes must be reported even in the case that there is no sales.

This data must be submitted to Valvira by 20 May of each year.

Any significant change to electronic cigarettes (including components of electronic cigarettes), refill containers and nicotine-free liquids intended for vaporisation must be notified before the product can be sold or otherwise distributed to consumers. A significant change refers to any change that could have an effect on the user’s system. Such a notification must be submitted at least six months in advance of the product being introduced to the market.

A change and advance notification must include

1. the name and contact details of the manufacturer, the legal or natural person responsible for the product in the EU, and the EU importer of the product
2. a list of all the ingredients of the product and the emissions it causes by product name and type, as well as the amounts and emissions of the ingredients
3. toxicological data of the product ingredients and emissions (including heated ingredients), considering the addictive effect and effects on the consumer’s health when breathed in
4. data on the nicotine dosage and absorption when the product is used in normal or reasonably predictable conditions
5. A description of the product parts (including a description of the electronic cigarette's open and refill mechanism)
6. a description of the production process (including if it involved serial production) and a notification of Tobacco Act compliance in the production process
7. a commitment from the manufacturer or importer of bearing full responsibility of the quality and safety of the product when it is brought to market and used in normal or reasonably predictable conditions.

The manufacturer or importer of electronic cigarettes (including components of electronic cigarettes), refill containers and nicotine-free liquids intended for vaporisation must submit the following information to Valvira annually, by 20 May:

1. comprehensive data on sales volumes by product name and type for the previous calendar year. The sales volumes must be reported even in the case that there is no sales.
2. data on consumer group preferences
3. data on product sales methods
4. summaries of the market research referred to in sections 1–3 and an English translation of the summaries.

Manufacturers or importers of nicotine-free liquids intended for vaporisation must submit the aforementioned data to Valvira for the first time in 2023.

The manufacturer or importer of a herbal product intended for smoking must provide Valvira a list of the ingredients used in the manufacture of the product, by product name and type, and their quantities, before the product can be sold or otherwise made available to consumers.

The manufacturer or importer must notify Valvira if the composition of a product changes in a way to cause a material change to previously submitted ingredient data. The manufacturer or importer must submit the changed data before the product can be sold or otherwise given to consumers. 

A change and advance notification must include:

1. the name and contact details of the manufacturer, the legal or natural person responsible for the product in the EU, and the EU importer of the product,
2. a list of all the ingredients of the product by product name and type, as well as the amounts of the ingredients,
3. toxicological data of the product ingredients considering the addictive effects,
4. data on the nicotine dosage when the product is used in normal or reasonably predictable conditions,
5. a commitment from the manufacturer or importer of bearing full responsibility of the quality and safety of the product when it is brought to market and used in normal or reasonably predictable conditions.

The manufacturer or importer of smokeless nicotine products must submit information on the sales volumes of smokeless nicotine products by product name and type to Valvira by 20 May each year.

The information on sales volumes must be submitted to Valvira for the first time by 20 May 2026.

Valvira collects fees for active and notified products that are subject to the Tobacco Act. 

Valvira collects EUR 150/product notification fee for the first submission of tobacco products, electronic cigarettes, nicotine liquids, nicotine-free liquids for vaporisation, herbal products intended for smoking or smokeless nicotine products that are subject to the Tobacco Act.

Valvira collects EUR 75/annual sales volume notification fee for sales volume submissions of tobacco products, electronic cigarettes, nicotine liquids, nicotine-free liquids for vaporisation or smokeless nicotine products that are subject to the Tobacco Act.

In addition, Valvira can collect a fee for researching and analyzing prohibited additives, ensuring emission measurements and peer evaluation in accordance with Section 18 of the Tobacco Act.

To cover expenses resulting from the supervision of the Tobacco Act, Valvira collects an annual supervision fee from manufacturers and importers of tobacco products, nicotine liquids, nicotine-free liquids for vaporization and smokeless nicotine products. The supervision fee is determined as follows, based on the sales volumes manufacturers or importers have reported to Valvira during the previous year:

• Cigarettes: EUR 0.001 per cigarette;
• Cigars: EUR 0.02 per cigar;
• Cigarillos: EUR 0.001 per cigarillo;
• Tobacco products other than those mentioned in items 1–3: EUR 1.7 per kg;
• Nicotine liquids and nicotine-free liquids for vaporisation: EUR 0.01 per ml.
• Smokeless nicotine products sold in single units: EUR 0.001 per unit;
• Other smokeless nicotine products: EUR 1.7 per kilogram.

However, the aforementioned supervision fee is a minimum of EUR 300 and a maximum of EUR 70,000 per manufacturer or importer.