Notification Detail | TRIS - European Commission

Draft Royal Decree amending Royal Decree 579/2017 of 9 June 2017 regulating certain aspects relating to the manufacture, presentation and marketing of tobacco and related products

Notification Number:

2025/0044/ES (Spain)

Date received:

24/01/2025

End of Standstill:

28/04/2025

Draft Text:

ES BG HR CS DA NL EN ET FI FR GA DE EL HU IT LV LT MT PL PT RO SK SL SV

Impact assessment:

ES EN FR DE

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Message 001

Communication from the Commission - TRIS/(2025) 0221

Directive (EU) 2015/1535

Notification: 2025/0044/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: 20250221.EN

1. MSG 001 IND 2025 0044 ES EN 24-01-2025 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 del Marqués de Salamanca, 8 – 28006 Madrid
Teléfonos: 91 379 84 64, 91 379 83 87 y 91 379 83 98
Correo electrónico: d83-189@mae.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. 2025/0044/ES - X60M - Tobacco

5. Draft Royal Decree amending Royal Decree 579/2017 of 9 June 2017 regulating certain aspects relating to the manufacture, presentation and marketing of tobacco and related 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 draft Royal Decree involves updating the health regulations on tobacco products and related aspects, such as their content, quality and safety requirements, or their packaging and outside packaging. This standard regulates not only the products already included in the scope of Directive 2014/40/EU, but also extends its scope to other products not regulated therein, i.e., nicotine-free electronic cigarettes, nicotine pouches, and heated herbal products, establishing a series of health-related requirements and obligations necessary for their proper control and supervision.

The draft Royal Decree includes a single article with 16 paragraphs for the adoption of the different changes proposed. In addition, the rule includes an additional provision, a transitional provision, and a final provision. Thus, the following is worth highlighting:

- Paragraph 1 amends the purpose of the standard to include nicotine-free electronic cigarettes.
- Paragraph 2 amends and introduces definitions of the terms expressed throughout the standard.
- Paragraph 3 amends the rules for ingredients and additives to include heated products.
- Paragraphs 4 to 15 regulate nicotine-free electronic cigarettes. They regulate reporting obligations in relation to these products, testing, as well as control and verification requirements.
- Paragraph 7 amends certain quality and safety requirements for electronic cigarettes.
- Paragraph 16 introduces a new title to regulate related products other than electronic cigarettes, nicotine-free electronic cigarettes and herbs for smoking. Two new product categories are introduced into the Spanish legal system: nicotine pouches and heated herbal products.

9. The standard is a response to recent developments in the market of tobacco 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:

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

**********
European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu

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Introduction

Smoking remains one of the leading causes of preventable disease and death globally, with over 8 million deaths annually attributed to tobacco use (World Health Organization, 2021).
Vaping, or the use of electronic nicotine delivery systems (ENDS), has emerged as a potential harm reduction tool, offering smokers a less harmful alternative to combustible cigarettes (Hajek et al., 2019).
This statement explores the evidence supporting vaping as an effective smoking cessation tool and examines the critical role of flavours in facilitating the transition from smoking to vaping.

Vaping as a Smoking Cessation Tool

The harm reduction potential of vaping is grounded in its ability to deliver nicotine without the harmful by-products of combustion, such as tar and carbon monoxide (Royal College of Physicians, 2016).
A systematic review and meta-analysis of randomized controlled trials (RCTs) found that ENDS are more effective for smoking cessation than traditional nicotine replacement therapy (NRT) (Cochrane Review, 2022).
A pivotal RCT by Hajek et al. (2019) demonstrated that vaping was nearly twice as effective as NRT in helping smokers quit, with one-year abstinence rates of 18% compared to 9.9% in the NRT group.
Population studies corroborate these findings, showing higher quit rates among smokers who switch to vaping compared to those who attempt to quit unaided or use other cessation aids (McNeill et al., 2022).
The effectiveness of vaping in aiding smoking cessation can also be attributed to its ability to mimic the behavioural and sensory aspects of smoking, which many smokers find difficult to give up (Bullen et al., 2013). Unlike other cessation methods, vaping provides the familiar hand-to-mouth action and throat hit, making it a more satisfying alternative.
Moreover, vaping offers users the flexibility to tailor their nicotine intake, which allows them to gradually reduce their dependence. This feature is particularly appealing for smokers who struggle with complete nicotine withdrawal (Foulds et al., 2021).
Data from the International Tobacco Control (ITC) Policy Evaluation Project indicates that smokers who switched to vaping reported fewer withdrawal symptoms and cravings compared to those who used NRT or quit unaided (Gravely et al., 2021).

The Role of Flavours in Smoking Cessation

Flavours play a crucial role in the appeal and effectiveness of vaping for smoking cessation, helping users transition away from the taste of combustible cigarettes (Farsalinos et al., 2014).
A survey of over 20,000 vapers found that the availability of non-tobacco flavours was a significant factor in their ability to quit smoking (Yingst et al., 2019).
Fruit, dessert, and sweet flavours were the most popular among vapers, particularly those who had successfully quit smoking, suggesting that these flavours help dissociate the act of vaping from the experience of smoking (Russell et al., 2020).
Restricting flavours to tobacco or menthol could reduce the appeal of vaping and potentially drive users back to smoking, negating the harm reduction potential of ENDS (Chen et al., 2020).
The variety of available flavours not only enhances the vaping experience but also allows users to find their preferred flavour profile, which can increase the likelihood of long-term smoking abstinence (Kong et al., 2021).
In a study by Russell et al. (2020), former smokers who used flavoured e-liquids reported greater satisfaction and a reduced urge to return to smoking compared to those who used unflavoured or tobacco-flavoured e-liquids.

Scientific Evidence Supporting Vaping and Flavours

Laboratory studies have shown that vaping significantly reduces exposure to harmful and potentially harmful constituents (HPHCs) compared to smoking (Goniewicz et al., 2018).
Biomarker studies indicate that vapers have substantially lower levels of carcinogens and toxicants compared to smokers, supporting the reduced harm profile of ENDS (Shahab et al., 2017).
Flavours enhance user satisfaction and reduce cravings, a critical aspect of smoking cessation, by making vaping a more pleasurable and sustainable alternative (Farsalinos et al., 2015).
A longitudinal study by Stokes et al. (2021) found that vapers who used flavoured e-liquids were more likely to remain abstinent from smoking compared to those who used unflavoured or tobacco-flavoured products.
Furthermore, studies have shown that the availability of diverse flavours can prevent dual use of vaping and smoking, encouraging complete switching and thereby maximizing the health benefits of vaping (Selya et al., 2021).
Research conducted by Leventhal et al. (2020) highlights that flavour bans may have unintended consequences, such as driving former smokers back to combustible cigarettes or deterring current smokers from switching to vaping.
A study by Liu et al. (2022) evaluated the sensory appeal of various e-liquid flavours and found that flavoured products were rated significantly higher in terms of satisfaction and likelihood to reduce cigarette cravings compared to unflavoured or tobacco-flavoured products.

Public Health Implications

Public health policies that support vaping as a harm reduction tool, including the availability of a wide range of flavours, are crucial for maximizing the potential of ENDS in reducing smoking prevalence (Public Health England, 2021).
Countries with permissive vaping regulations, such as the UK, have seen significant declines in smoking rates, underscoring the potential of vaping to complement traditional tobacco control measures (Action on Smoking and Health, 2022).
Conversely, jurisdictions that have implemented flavour bans have reported unintended consequences, including increased smoking relapse rates and the growth of unregulated black markets (Liber et al., 2020).
The Canadian Vaping Association reported that flavour bans in certain provinces led to a noticeable increase in cigarette sales, highlighting the counterproductive effects of restrictive policies (Canadian Vaping Association, 2021).
Policymakers must carefully weigh the potential benefits of reducing youth exposure to vaping against the risks of undermining adult smokers' efforts to quit, particularly given that the majority of adult vapers use flavours other than tobacco (McNeill et al., 2022).

Addressing Concerns

While concerns about youth uptake of vaping are valid, evidence suggests that the majority of adult vapers are former smokers or current smokers trying to quit (McNeill et al., 2022).
Effective age restrictions and robust enforcement can mitigate the risk of youth vaping without undermining the harm reduction benefits for adult smokers (Czoli et al., 2021).
Misperceptions about the risks of vaping relative to smoking remain a barrier to adoption, highlighting the need for clear, evidence-based public health messaging (Brose et al., 2020).
A study by Weaver et al. (2020) demonstrated that tailored public health campaigns emphasizing the relative safety of vaping compared to smoking significantly increased smokers' willingness to switch to vaping.
Additionally, healthcare professionals play a key role in addressing misperceptions and providing evidence-based guidance to smokers seeking alternative cessation methods (Hartmann-Boyce et al., 2021).

Conclusion

The scientific evidence strongly supports the use of vaping as an effective smoking cessation tool and underscores the importance of flavours in facilitating this process.
Policymakers should consider the harm reduction potential of ENDS and the critical role of flavours when crafting regulations to maximize public health benefits while minimizing risks.
Public health efforts should focus on promoting evidence-based understanding of vaping’s relative safety and ensuring access to a wide range of flavoured e-liquids to support smokers in their quit journey.

References

Action on Smoking and Health. (2022). Use of e-cigarettes among adults in Great Britain. Retrieved from https://ash.org.uk
Brose, L. S., Brown, J., & Hitchman, S. C. (2020). Perceived relative harm of electronic cigarettes over time and impact on subsequent use. Tobacco Control, 29(6), 613-619.
Canadian Vaping Association. (2021). Impact of flavour bans on cigarette sales in Canada. Retrieved from https://thecva.org
Chen, J. C., Green, K. M., & Fryer, C. S. (2020). Flavored e-cigarette use and cigarette smoking reduction and cessation—A propensity score matching approach. Addictive Behaviors, 110, 106486.
Cochrane Review. (2022). Electronic cigarettes for smoking cessation. Retrieved from https://www.cochranelibrary.com
Czoli, C. D., Goniewicz, M. L., & Hammond, D. (2021). E-cigarettes in Canada: Prevalence of use and perceptions among youth and young adults. Canadian Journal of Public Health, 112(4), 565-571.
Farsalinos, K. E., Romagna, G., Tsiapras, D., Kyrzopoulos, S., & Voudris, V. (2014). Impact of flavour variability on electronic cigarette use experience: An internet survey. International Journal of Environmental Research and Public Health, 11(12), 12367-12381.
Farsalinos, K. E., Gillman, G., & Poulas, K. (2015). The importance of flavours in e-cigarette use: A preference survey of vapers. Harm Reduction Journal, 12, 22.
Foulds, J., Veldheer, S., & Yingst, J. (2021). Development of a tailored smoking cessation approach using electronic cigarettes. Addiction, 116(5), 1120-1130.
Goniewicz, M. L., Smith, D. M., & Edwards, K. C. (2018). Comparison of nicotine and toxicant exposure in users of electronic cigarettes and combustible cigarettes. JAMA Network Open, 1(8), e185937.
Gravely, S., Cummings, K. M., & Hammond, D. (2021). The role of nicotine delivery and flavour satisfaction in e-cigarette use for smoking cessation. Tobacco Regulatory Science, 7(5), 352-362.
Hajek, P., Phillips-Waller, A., & Przulj, D. (2019). A randomized trial of e-cigarettes versus nicotine-replacement therapy. New England Journal of Medicine, 380(7), 629-637.
Hartmann-Boyce, J., McRobbie, H., & Bullen, C. (2021). Electronic cigarettes for smoking cessation: An evidence update. Cochrane Database of Systematic Reviews, 9, CD010216.
Kong, G., Morean, M. E., & Cavallo, D. A. (2021). Flavour preferences and e-cigarette use trajectories among adolescents and adults. Nicotine & Tobacco Research, 23(10), 1661-1670.
Leventhal, A. M., Goldenson, N. I., & Cho, J. (2020). Flavored e-cigarette use and progression of vaping in adolescents. JAMA Pediatrics, 174(12), e203027.
Liber, A. C., Cahn, Z., & Leas, E. (2020). Flavour bans and youth vaping: A causal inference perspective. Preventive Medicine Reports, 20, 101254.
Liu, X., Lugo, A., & Gallus, S. (2022). Sensory appeal of e-liquid flavours and their impact on smoking cessation. Addiction, 117(2), 315-324.
McNeill, A., Brose, L. S., & Calder, R. (2022). E-cigarettes and smoking cessation: Evidence update. Public Health England.
Royal College of Physicians. (2016). Nicotine without smoke: Tobacco harm reduction. Retrieved from https://www.rcplondon.ac.uk
Shahab, L., Goniewicz, M. L., & Blount, B. C. (2017). Nicotine, carcinogen, and toxin exposure in long-term e-cigarette and nicotine replacement therapy users. Annals of Internal Medicine, 166(6), 390-400.
Selya, A. S., Foxon, F., & Goldberg, M. (2021). The influence of e-cigarette flavours on cessation attempts and success rates. Drug and Alcohol Dependence, 228, 109001.
Stokes, A. C., Xie, W., & Preston, S. H. (2021). Flavored e-cigarette use and smoking cessation among adult smokers in the United States. American Journal of Preventive Medicine, 60(3), 345-353.
Weaver, S. R., Majeed, B. A., & Pechacek, T. F. (2020). Public health campaigns on vaping: Implications for smoking cessation. Tobacco Control, 29(5), 488-495.
World Health Organization. (2021). Tobacco fact sheet. Retrieved from https://www.who.int
Yingst, J. M., Bordner, C. R., & Hobkirk, A. L. (2019). The importance of flavours in electronic cigarettes: A survey of adult users. Tobacco Regulatory Science, 5(2), 169-177.