Message 001
Communication from the Commission - TRIS/(2025) 2888
Directive (EU) 2015/1535
Notification: 2025/0602/ES
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: 20252888.EN
1. MSG 001 IND 2025 0602 ES EN 14-10-2025 ES NOTIF
2. Spain
3A. Ministerio de Asuntos Exteriores, Unión Europea y Cooperación
Dirección General de Coordinación del Mercado Interior y Otras Políticas Comunitarias
Subdirección General de Asuntos Industriales, Energéticos, de Transportes y Comunicaciones, y de Medio Ambiente
Plaza Marqués de Salamanca 8, 28006 Madrid
d83-189@maec.es
3B. Unidad de Prevención y Control del Tabaquismo
Subdirección General de Promoción, Prevención y Equidad en Salud
D.G. de Salud Pública y Equidad en Salud
Ministerio de Sanidad
Paseo del Prado, 18-20, 28071 – Madrid
prevenciondeltabaquismo@sanidad.gob.es
+34915961249
4. 2025/0602/ES - X00M - GOODS AND MISCELLANEOUS PRODUCTS
5. Preliminary Draft Law amending Law 28/2005 of 26 December on health measures against smoking and regulating the sale, supply, consumption and advertising of tobacco products.
6. Tobacco and related products
Electronic cigarettes and nicotine refill containers
Electronic cigarettes and nicotine-free refill containers
Nicotine pouches
Heated herbal products
7.
8. The regulation focuses on improving the health of smokers and non-smokers, promoting healthy spaces with greater protection of different social groups and, on the other hand, improving the regulations applicable to tobacco products and related products. Therefore, its main objectives are:
Expand smoke-free spaces, especially outdoors. Ban disposable electronic cigarettes. Include the new categories of related products in the scope of the regulation, in particular nicotine pouches and heated herbal products. Prohibit the consumption of tobacco products by minors.
The preliminary draft law consists of an expository part, a single article with twenty-five sections. In a disaggregated way, it is worth noting:
Section 1 extends the scope of the rule to related products and tobacco consumption devices.
Section 2 adds new definitions.
Section 3 introduces a ban on the consumption of tobacco products by minors.
Section 4 expands the spaces where smoking is prohibited.
Section 5 amends the advertising, promotion and sponsorship regime, extending it to tobacco consumption devices.
Section 6 extends the application of the rules on common names to tobacco consumption devices.
Sections 7 and 8 introduce specific regulations for new categories of related products in our legal order; adding, respectively, a new Chapter IIIa, which sets out the limitations on the sale, supply and consumption of related products in order to update the regulation of these products in the interests of the protection of public health; and a new Chapter IIIb, which establishes the regulation of advertising, promotion and sponsorship of related products. Among other provisions, the prohibition on the sale and supply of single-use electronic cigarettes stands out as a new feature.
Section 9 amends the title of Chapter IV, which is now entitled ‘Measures to prevent smoking, promote health and facilitate smoking cessation’.
Sections 10 and 12 replace the term “tobacco withdrawal” with “tobacco cessation”.
Section 11 introduces the creation of the Observatory for the Prevention of Smoking.
Sections 13 to 18 modify the system of penalties, infringements, the amount of penalties and the persons responsible.
Section 19 extends the scope of the signage obligation in centres or premises where there is a ban on consumption by extending it to tobacco products and related products.
Sections 20, 21 and 23 set out the consumption requirements in prisons and psychiatric centres and residential centres for the elderly or persons with disabilities.
Section 22 removes the ninth additional provision, concerning the special exemption for private smoking clubs.
Section 24 adds Additional provision on signage obligations.
Section 25 deletes the twelfth additional provision, on the consumption and sale to minors of nicotine delivery devices and similar products, and the thirteenth additional provision, on restrictions on the advertising, promotion and sponsorship of nicotine delivery devices and refill containers.
9. The regulation is a response to recent developments in the market of tobacco products and related products, with a wide and diverse variety of products with differentiated characteristics emerging in Spain, with or without tobacco, with or without nicotine, with or without electronic components, and even with hybrid aspects of complex classification. These developments pose a challenge, making it necessary to provide an appropriate technical response to ensure the adequate protection of individuals who consume these new unconventional products. These products are in many cases not covered by any health regulations, whether local, national, or European, and it is therefore necessary to offer an urgent response to them.
This standard is the development of one of the main measures set out in the recently approved 2024-2027 Comprehensive Plan for the Prevention and Control of Tobacco. The Plan, agreed upon with different social, governmental, and scientific sectors, has identified the need to introduce various improvements not yet contemplated in the harmonised regulation of the Union, as a result of significant changes experienced both at epidemiological level and in consumption patterns, as well as in the current configuration of the market for tobacco products and related products in Spain.
10. References to basic texts: 2005/0067/E
The basic texts were forwarded with an earlier notification:
2005/0067/E
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
