Finland has introduced updated labeling and health warning requirements for tobacco and related products, including specific standards for unit packets and retail packaging, through a series of draft decrees.
Finland Tightens Health Warning Labels on Tobacco Products
Importers and manufacturers must use new, standardized health messages on packaging.
What changed
Standardized labeling required for unit packets of tobacco and related products.
New standards and notifications apply to the classification of tobacco and similar products.
Enhanced health warnings are now mandatory on retail packaging for tobacco and similar products.
Who it affects
Importers of tobacco products must ensure all retail packaging meets the new labeling standards.
Manufacturers of similar products must follow new standards and notification procedures for product classification.
Updated Labeling and Health Warning Requirements for Tobacco and Related Products in Finland
Finland has recently updated its regulatory framework for the labeling and health warning requirements of tobacco and related products, including electronic cigarettes, refill containers, and smokeless nicotine products. These changes are implemented through amendments to existing decrees under the Tobacco Act (549/2016) and align with EU Directive 2014/40/EU. Below is a structured overview of the key requirements:
1. Scope of Products Covered
The updated regulations apply to:
- Tobacco products (e.g., cigarettes, cigars, smoking tobacco)1.
- Electronic cigarettes and refill containers (as defined in Articles 2(16) and 2(17) of Directive 2014/40/EU)1.
- Nicotine-containing liquids for e-cigarettes (e.g., CCCN codes 8543 70 90, 3824 90/18, 3824 90/19, 8543 70/5)1.
- Smokeless nicotine products (e.g., nicotine pouches), which are now explicitly included under the Tobacco Act (549/2016), as amended in 20242.
2. Labeling and Health Warning Requirements
A. General Provisions
- Plain Packaging: The draft decrees introduce plain packaging standards for tobacco products and similar items, including standardized colors, fonts, and layouts to reduce appeal1.
- Health Warnings: All retail packaging must display health warnings as prescribed in the Decree on Health Warnings for the Retail Packing of Tobacco Products and Similar Products (591/2016), as amended3, 1.
B. Specific Requirements for Unit Packets and Retail Packaging
| Product Type | Key Requirement | Authority/Source |
|---|---|---|
| Tobacco Products | Must comply with plain packaging standards, including health warnings covering 65% of the front and back surfaces of the packet1. | Ministry of Social Affairs and Health |
| Electronic Cigarettes | Health warnings must be displayed on unit packets and refill containers, following the same format as tobacco products3. | Decree 591/2016 (as amended)3 |
| Smokeless Nicotine Products | Must include health warnings identical to those for e-cigarettes and refill containers, as specified in Section 14a of the amended decree3. These warnings must cover a significant portion of the packaging. | Tobacco Act (549/2016), Section 39a(1)(5)3 |
C. Language and Format
- Health warnings must be in Finnish and Swedish1.
- The size, font, and placement of warnings are strictly regulated to ensure visibility3, 1.
3. Notification and Reporting Obligations
A. Pre-Market Notifications
- Smokeless Nicotine Products: Manufacturers or importers must submit a pre-market notification to the Finnish Medicines Agency (Fimea) or Valvira (Finnish Health and Social Welfare Authority) before introducing a product to the market. The notification must include:
- Manufacturer’s details and EU-based responsible entity2.
- List of ingredients (by brand and type) and their quantities2.
- Toxicological data on ingredients and emissions, focusing on addictive effects2.
- Nicotine dosage and absorption data under normal use conditions2.
- Manufacturer’s liability statement for product quality and safety2.
- Notification Portal: Notifications must be submitted via the EU-CEG portal (Common Entry Gate), using the smokeless tobacco product category (despite the national sales ban on smokeless tobacco in Finland)2.
B. Annual Reporting
- Sales Volume Data: Manufacturers/importers must submit annual sales data for smokeless nicotine products to Valvira by May 20 each year, covering the previous calendar year2.
- Research Data: Additional reporting requirements may apply for research-related data2.
4. Enforcement and Compliance
- Authority: The Ministry of Social Affairs and Health and Valvira are responsible for enforcement3, 2.
- Deadlines:
5. Key Differences from Previous Regulations
| Aspect | Previous Regulation | Updated Regulation |
|---|---|---|
| Smokeless Nicotine Products | Not explicitly regulated under health warning requirements. | Now subject to mandatory health warnings and pre-market notifications3, 2. |
| Notification Portal | Smokeless nicotine products were not categorized in EU-CEG. | Must now be reported under the smokeless tobacco product category in EU-CEG2. |
| Plain Packaging | Limited to traditional tobacco products. | Extended to e-cigarettes, refill containers, and smokeless nicotine products1. |
Summary Answer
Finland’s updated labeling and health warning requirements for tobacco and related products introduce plain packaging standards, mandatory health warnings (covering 65% of packaging surfaces), and pre-market notification obligations for smokeless nicotine products. These changes are implemented through amendments to the Decree on Health Warnings for the Retail Packing of Tobacco Products and Similar Products (591/2016)3, 1 and the Decree on Standards and Notifications for Tobacco and Similar Products (592/2016)2. Key deadlines include 1 January 2023 for plain packaging and health warnings1 and 20 May annually for sales data reporting2. Manufacturers must submit notifications via the EU-CEG portal2, and all warnings must be in Finnish and Swedish1. The regulations align with EU Directive 2014/40/EU and aim to enhance public health protection3, 2, 1.
Sources
- ↩ Draft Decree for Amending the Decree on Health Warnings for the Retail Packing of Tobacco Products and Similar Products https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/G/TBTN21/FIN82.pdf&Open=True
- ↩ Draft Decree of the Ministry of Social Affairs and Health amending the Decree of the Ministry of Social Affairs and Health on the standards and notifications concerning tobacco and similar products https://members.wto.org/crnattachments/2024/TBT/FIN/24_03918_01_x.pdf
- ↩ Draft Decree of the Ministry of Social Affairs and Health amending the Decree of the Ministry of Social Affairs and Health on the labelling and other layout elements of tobacco and related products and their unit packets https://members.wto.org/crnattachments/2024/TBT/FIN/24_03917_00_x.pdf