Message 001
Communication from the Commission - TRIS/(2025) 0257
Directive (EU) 2015/1535
Notification: 2025/0055/PL
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: 20250257.EN
1. MSG 001 IND 2025 0055 PL EN 27-01-2025 PL NOTIF
2. Poland
3A. Ministerstwo Rozwoju i Technologii, Departament Obrotu Towarami Wrażliwymi i Bezpieczeństwa Technicznego,
Plac Trzech Krzyży 3/5, 00-507 Warszawa, tel.: (+48) 22 411 93 94, e-mail: notyfikacjaPL@mrit.gov.pl
3B. Ministerstwo Zdrowia , Departament Prawny
ul. Miodowa 15, 00-952 Warszawa, e-mail: kancelaria@mz.gov.pl lub dep-pr@mz.gov.pl
4. 2025/0055/PL - S00S - HEALTH, MEDICAL EQUIPMENT
5. Draft Act amending the Act on protection of health against the consequences of consumption of tobacco and tobacco products
6. Nicotine-free liquid intended for use in electronic cigarettes, nicotine pouch.
Health protection.
7.
8. The proposed regulations are intended to legally regulate nicotine-free liquids for use in electronic cigarettes; These regulations will result in:
introducing a ban on sales to persons under the age of 18; limiting the places where it will be possible to use them (similarly to electronic cigarettes with nicotine-containing liquid); introducing a ban on sales in vending machines and on distance sales (including via the Internet); Introducing a ban on advertising and promotion; the need to report information on these products to the President of the Office for Chemical Substances; the need to adapt their composition to the requirements of the Act (e.g. ban on the use of substances with CMR properties); the need for appropriate labelling of their packaging.
In addition, it is proposed to include ‘nicotine pouches’ in the statutory regulation. The proposed regulations will result in the classification of nicotine pouches as related products and define them as all products for oral use, except those intended for inhalation, not containing tobacco but containing nicotine, whether or not mixed with other ingredients, which are portioned into pouches or available in pouches; introducing a ban on sales to persons under the age of 18; introducing a ban on sales in vending machines, self-service systems, and distance sales (including via the Internet); introducing a ban on advertising and promotion, the requirement to report information about these products to the President of the Office for Chemical Substances; the need to adapt their composition to the requirements of the Act (e.g. ban on the use of substances with CMR properties); the need for appropriate labelling of their packaging and the setting of a maximum nicotine content of 20 mg/g.
9. During the seventh meeting of the States Parties to the FCTC (the so-called COP7), a decision (FCTC/COP/7/11) was adopted recommending that e-cigarette liquids, whether nicotine-containing or non-nicotine-containing, should be subject to the same regulations as those under the Directive.
These products pose a clear risk to public health, in particular to the young generation and non-smokers.
The synthetic nicotine pouches currently available on the market are not tobacco products; they are non-pharmaceutical and are sold as consumer products. In view of the above, it is essential to regulate the market for nicotine pouches as a matter of urgency. The current lack of regulation on the maximum allowable nicotine concentration in nicotine pouches and the absence of age restrictions on their purchase should be considered a direct threat to consumer health.
10. References to basic texts:
11. No
12.
13. No
14. No
15. Yes
16.
TBT aspects: No
SPS aspects: No
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European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu
