Notifications
Manufacturers and importers must provide Valvira with the product-related notifications and other information referred to in the Tobacco Act in electronic form.
A decree issued by the Ministry of Social Affairs and Health contains provisions on the method and format of providing the information. These are based on the implementing decisions of the European Commission. The decisions confirm a shared model for the provision of information required by the Tobacco Act. The annexes to the implementing decisions define the information that manufacturers or importers must submit to the authorities.
- Commission Implementing Decision (EU) 2015/2186 (tobacco products)
- Commission Implementing Decision (EU) 2015/2183 (electronic cigarettes and refill containers)
In practice, the information required by the Directive must be submitted to the authorities electronically through the EU Common Entry Gate (EU-CEG) system provided by the European Commission. Notifications of the ingredients of herbal products for smoking must also be submitted through the same system. All notifications are subject to a fee (see ’Fees’ below).
The data will be stored in the Member States’ own databanks. Operators submitting the information must apply to the Commission for submitter IDs necessary for reporting and notification purposes. When providing the information, manufacturers and importers shall specify which information they consider to constitute a trade or professional secret. Further information is available on the Commission’s EU-CEG website.
Valvira may charge a fee from manufacturers or importers for the following tasks:
- examining whether a tobacco product contains prohibited properties or additives
- verifying the measurements of tar, nicotine and carbon monoxide yields of cigarettes
- receiving, storing, handling, analysing and publishing the information submitted to Valvira by virtue of the Tobacco Act, and for related measures
- peer reviews commissioned by Valvira.
Provisions on the amount of the fee are laid down by the Act on Criteria for Charges Payable to the State. According to the Decree of the Ministry of Social Affairs and Health concerning activities of the National Supervisory Authority for Welfare and Health (Valvira) subject to fees, Valvira may charge the following product supervision fees:
- examination of prohibited additives (Tobacco Act, section 90(3)(1)): EUR 300/examined additive
- verification of emission measurements (Tobacco Act, section 90(3)(2)): EUR 1,500/product
- notifications submitted by virtue of the Tobacco Act (Tobacco Act, section 90(3)(3)): EUR 150/notification
- except for yearly made notifications on sales volumes: 75€/notification
To cover expenses resulting from the supervision of the Tobacco Act, the National Supervisory Authority for Welfare and Health (Valvira) collects an annual supervision fee from manufacturers and importers of tobacco products, nicotine liquids and nicotine-free liquids for vaporisation. 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.
However, the aforementioned supervision fee is a minimum of EUR 300 and a maximum of EUR 70,000 per manufacturer or importer.
The aforementioned supervision fee will not be collected in 2022 if a manufacturer or importer issues a notification to withdraw their product from the market no later than on 20 September 2022 as laid down in provisions based on section 21, subsection 3 or section 30, subsection 3.
The manufacturer is primarily responsible for submitting the required information if the manufacturer is established in the European Union. The obligation to provide the information lies primarily with the importer, if the manufacturer is established outside the EU and the importer is established inside the European Union. The obligation to provide the information lies jointly with the manufacturer and the importer if they are both established outside the EU.