Message 001
Communication from the Commission - TRIS/(2024) 1035
Directive (EU) 2015/1535
Notification: 2024/0210/FI
Notification of a draft text from a Member State
Notification – Notification – Notifzierung – Нотификация – Oznámení – Notifikation – Γνωστοποίηση – Notificación – Teavitamine – Ilmoitus – Obavijest – Bejelentés – Notifica – Pranešimas – Paziņojums – Notifika – Kennisgeving – Zawiadomienie – Notificação – Notificare – Oznámenie – Obvestilo – Anmälan – Fógra a thabhairt
Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna
MSG: 20241035.EN
1. MSG 001 IND 2024 0210 FI EN 16-04-2024 FI NOTIF
2. Finland
3A. Työ- ja elinkeinoministeriö
Työllisyys ja toimivat markkinat -osasto
PL 32
FI-00023 VALTIONEUVOSTO
Puhelin +358 29 5047437
maaraykset.tekniset.tem@gov.fi
3B. Sosiaali- ja terveysministeriö
Turvallisuus ja terveys -osasto
PL 33
FI-00023 VALTIONEUVOSTO
Puhelin +358 295 16001
kirjaamo.stm@gov.fi
4. 2024/0210/FI - X00M - GOODS AND MISCELLANEOUS PRODUCTS
5. Government proposal to Parliament for an Act amending the Tobacco Act
6. Tobacco products, electronic cigarettes, refill containers, nicotine-containing liquids, liquids other than nicotine-containing liquids for use in electronic cigarettes
7.
8. The Proposal proposes amendments to the Tobacco Act. The amendment is required because the sale of nicotine pouches has been liberalised as a result of a change in the interpretation of the Medicines Act.
The Proposal would implement the entry in the Government Programme of Prime Minister Petteri Orpo’s Government according to which nicotine pouches will be included in the scope of the Tobacco Act and their sale will be authorised in accordance with the rules set for them to prevent youth use, parallel imports and illicit trafficking, and to combat organised crime. Retail sales are made subject to authorisation, the nicotine limits of the products are aligned with those in use in neighbouring countries, and only flavours aimed at adults will be allowed.
The Proposal proposes to add to the Tobacco Act a definition for a ‘smokeless nicotine product’ that would cover nicotine pouches and products closely resembling these. Typically, these are snus-like products that do not contain tobacco plant but contain nicotine and which are similar to traditional tobacco for oral use in terms of use and appearance.
Smokeless nicotine products would be subject to a nicotine limit (up to 16.6 milligrams of nicotine per gram of product) and adding characterising fragrances and flavours to them would be prohibited with the exception of menthol, mint, tea, ginger, rosemary and wood. In other respects, it is proposed to regulate smokeless nicotine products in a manner similar to that in which the Tobacco Act regulates tobacco products and nicotine-containing liquids. Health warnings would be required for unit packets of the products and the layout of the packaging would be harmonised. The retail sale of products would be subject to authorisation, wholesale sales would be subject to notification and the distance selling of products would be prohibited. Quantity limits and time limits would be imposed on imports, for example. The products and their sale would be subject to supervisory fees. The use of smokeless nicotine products would be prohibited in the indoor and outdoor are-as and playgrounds of kindergartens and pre-primary and basic education institutions and vocational and upper secondary education institutions. The possession and import of all tobacco substitutes would be prohibited for persons under 18 years of age.
The proposed Act is intended to enter into force as soon as possible after the end of the standstill period under the Directive on technical regulations. However, the provisions on the characteristics and unit packets of smokeless nicotine products would only come into force at a later date. In addition, the proposed Act contains a number of transitional provisions.
9. The Government Programme entries on nicotine pouches are part of measures to open up the market and increase competition. In accordance with the Government Programme, the aim of the Proposal is to prevent parallel imports and illegal trade and to combat organised crime. The aim of the Proposal is to encourage Finns who have acquired snus through illegal channels to switch to legally sold nicotine pouches. From this perspective, the regulation must ensure that nicotine pouches remain sufficiently attractive as an alternative to snus.
In contrast, the aim of the Proposal is, in accordance with the Government Programme, to prevent the use of nicotine pouches among young people. The aim is also to reduce the life-threatening nicotine poisoning that small children may experience if they are able to swallow or suck nicotine pouches.
The aims of the Proposal are partly contradictory, as proactive measures to ensure nicotine pouches become established in the Finnish market will increase the likelihood that the products will become a new pathway to nicotine addiction for children and young people and thus to the use of other tobacco and nicotine products. However, this risk can be reduced by limiting the attractiveness and availability of nicotine pouches.
10. Basic text references: 2015/0490/FIN
The basic texts have been provided in connection with an earlier notification:
2015/0490/FIN
11. No
12.
13. No
14. No
15. Yes
16.
TBT aspects:
The draft is a technical regulation or a conformity assessment
SPS aspects: No
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European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu