Tobacco products, electronic cigarettes, refill containers, nicotine-containing liquids, liquids other thannicotine-containing liquids for use in electronic cigarettes

Decree of the Ministry of Social Affairs and Health amending the Decree of the Ministry of Social Affairs andHealth on standards and notifications concerning tobacco and related products

The Tobacco Act (549/2016) has been amended by Act xx/2024, which enters into force on [day] [month]202x. A definition of smokeless nicotine products which covers nicotine pouches and products closelyresembling these was added to the Act. Nicotine pouches also meet the definition of tobacco substitutes.

Under Section 29a of the Tobacco Act, the manufacturer or importer of a smokeless nicotine product mustinform the National Supervisory Authority for Welfare and Health (Valvira) in advance of products which itintends to start selling or otherwise making available to consumers. Similarly, any significant changes toproducts must also be notified before the product is offered for sale or otherwise made available to consumers.The notification shall include:
1) the name and contact details of the manufacturer, the legal or natural person responsible for the product inthe EU, and the importer of the product into the EU;
2) a list of all the ingredients contained in the product sorted by brand and type, and the quantities ofingredients;
3) toxicological data on the ingredients and emissions of the product, considering in particular their addictiveeffect;
4) information on the dosage and absorption of nicotine when the product is used under normal or reasonablyforeseeable conditions;
5) information stating that the manufacturer or importer bears full responsibility for the quality and safety of theproduct when it is placed on the market and when it is used under normal or reasonably foreseeableconditions.
Under Section 29b of the Tobacco Act, manufacturers or importers of smokeless nicotine products mustprovide the National Supervisory Authority for Welfare and Health (Valvira) annually with information on thesales volumes of smokeless nicotine products by brand and type of product.
According to section 30, subsection 3 of the Tobacco Act, further provisions may be laid down by decree of theMinistry of Social Affairs and Health on the manner and format for the submission of the information referred toin sections 26, 27, 29a and 29b and on the date of the submission of the information referred to in section 27;section 28, subsection 1; and section 29b.
It is proposed to amend the Decree of the Ministry of Social Affairs and Health on standards and notificationsconcerning tobacco and related products (592/2016) so that section 4 on the date of notification of studies andsales volumes would include notifications of sales volumes for smokeless nicotine products. It is also proposedto add a new section 6b, which would lay down the format for the notification of smokeless nicotine products.