Considerations on COM(2024)55 - - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2024)55 - . |
|---|---|
| document | COM(2024)55 |
| date | September 17, 2024 |
(2) The use of tobacco remains widespread globally and throughout the Union. In 2023, 24% of the European Union population are estimated to be smokers0.
(3) The global annual economic cost of smoking was estimated at US$ 1.4 trillion in 2012, equivalent to 1.8% of the global gross domestic product (GDP). In the EU, already in 2009, tobacco smoking cost €544 billion which is about 4.6% of the EU27 combined GDP.0
(4) It is appropriate to contribute towards the reduction of the smoking level in the Union, in line with the objective of Europe’s Beating Cancer Plan0 to achieve a tobacco-free generation where only 5% of the Union population uses tobacco products compared to the 24% of today.
(5) The World Health Organization Framework Convention on Tobacco Control (FCTC) was developed with the aim of fostering an effective and comprehensive international response to the spread of the global tobacco epidemic. Article 8 of the FCTC requires its parties to provide effective protection from second-hand tobacco smoke in workplaces, public transport and indoor places; the annexed guidelines aim to assist parties in meeting their obligations under Article 8 of the FCTC.
(6) The European Strategy on Tobacco Control adopted by the World Health Organization Regional Committee for Europe in September 2002 recommended that WHO Member States ensure the citizens’ right to a smoke-free environment by, inter alia, making public places, workplaces and public transport smoke-free, banning smoking outdoors in all educational institutions for minors, in all places of healthcare delivery and at public events, as well as classifying environmental tobacco smoke (ETS) as a carcinogen0.
(7) The second-hand emissions of emerging products can have potentially harmful health impacts. The World Health Organization highlights that second-hand emissions from emerging products can expose people to potentially harmful levels of particulate matter and key toxicants.
(8) The World Health Organization0,0,0 has highlighted, among other issues related to emerging products, the negative health effects of exposure to second-hand aerosols. For example, recent evidence has indicated that exposure to second-hand emissions from heated tobacco products were associated with significant respiratory and cardiovascular abnormalities in bystanders0,0,0,0,0,0. In addition, second-hand aerosols from electronic cigarettes, including both ones that do and do not contain nicotine, expose bystanders to quantifiable levels of particulate matter and key toxicants and contaminants 0,0,0,0,0,0,0.
(9) The World Health Organization considers that no level of side-stream exposure is safe or acceptable4 thus, a careful approach should be taken. The World Health Organization recommends applying tobacco control measures, including protection from exposure, to electronic cigarettes,0, 4,5.
(10) In its 2021 opinion on electronic cigarettes0, the Scientific Committee on Health, Environment and Emerging Risks (SCHEER) concluded that there is weak to moderate evidence of risks of respiratory, cardiovascular, and carcinogenic damage due to second-hand exposure to aerosols from electronic cigarettes.
(11) Smoke- and aerosol-free environments are a globally recognised and proven approach to adequately protect the health of people from the effects of second-hand tobacco smoke and aerosols.
(12) In recent years, emerging products such as electronic cigarettes and heated tobacco products have consolidated their market shares and their uptake is increasing. Based on Eurobarometer data, the prevalence of electronic cigarettes use across the Union is 3% and the prevalence of heated tobacco products use is 2%.
(13) An issue of specific concern in relation to the market developments of emerging products, such as electronic cigarettes and heated tobacco products, is their particular uptake and appeal among children and young people.
(14) Exposure to second-hand smoke and aerosols could be particularly dangerous to children and adolescents and could increase the likelihood of them taking up smoking habits 4,5,6.
(15) In 2023, 54% of current and past smokers are estimated to have started regularly smoking before the age of 19; 14% start before the age of 15, during childhood1.
(16) The use of emerging products which contain nicotine, in particular by young people, is associated with addiction and might become a starting point for the later use of traditional tobacco products4.
(17) It is important to take into consideration not only the recent market and technological developments related to emerging products but also to better coordinate and future-proof the national smoke- and aerosol-free regulatory frameworks.
(18) At present, the second-hand exposure to smoke and aerosols in places such as the outdoor spaces of hospitality venues and outdoor spaces intended for use by children and adolescents is significant. Based on 2023 Eurobarometer data, 74% of Eurobarometer respondents say that they have experienced people smoking in outdoor terraces in the past 6 months and 71% of respondents say they have experienced people using electronic cigarettes and heated tobacco products in the same places. 42% of respondents say that people were smoking in outdoor places intended for use by children and adolescents and 49% of respondents say that they experienced people using electronic cigarettes and heated tobacco products in the same places1.
(19) Several Member States have taken protective measures including banning smoking in indoor and outdoor places or banning the use of emerging products in public places0,0.
(20) It is therefore appropriate to extend the scope of the Recommendation to include specific outdoor spaces in order to better protect people in the Union, in particular children, young people and vulnerable people, for instance citizens with chronic diseases or other pre-existing conditions, or pregnant women from exposure to second-hand smoke and aerosols from emerging products, for example heated tobacco products, electronic cigarettes, whether containing nicotine or nicotine-free, and tobacco surrogates, and any other smoke and/or aerosol emitting products.
(21) In support of the revision of the Recommendation, a call for evidence was launched from June until July 2022 and representatives of Member States’ competent authorities, civil society organisations, relevant economic operators and other relevant stakeholders were consulted through targeted consultation activities from March-May 2023.
(22) The Commission intends to support Member States in the effective implementation of the Recommendation through existing EU programmes and collaboration tools.
(23) In particular, the Commission envisages to help strengthen research in this field. These research efforts should encompass emerging products (such as electronic cigarettes, whether containing nicotine or nicotine-free, and heated tobacco products); tobacco surrogates that emit smoke or aerosols and any other smoke and/or aerosol emitting product; nicotine releasing products and products resembling the use of nicotine-releasing products. International cooperation, including on research, on the topics covered by this Recommendation, is also envisaged to be strengthened.
(24) The Commission intends to develop a prevention toolkit supporting the better protection of the health of children and young people in the most vulnerable and formative years of their lives, including a focus on prevention from smoking and nicotine addiction, and addressing the interlinks between mental and physical health and key health determinants.
(25) The annexed ‘Guidelines on protection from exposure to tobacco smoke, as adopted by the Second Conference of the Parties to the WHO Framework Convention on Tobacco Control’ should be taken into account. Member States should be encouraged to expand and go beyond the measures contained in those guidelines.
(26) This Recommendation covers a wider scope than Recommendation 2009/C 296/02 and replaces it, with the objective of better protecting people in the Union from second-hand smoke and aerosols, positively contributing to the tobacco-related objectives of Europe’s Beating Cancer Plan and contributing to the reduction of prevalence and de-normalisation of smoking and use of emerging products
HEREBY RECOMMENDS THAT MEMBER STATES:
1. Provide effective protection from exposure to tobacco smoke in indoor workplaces, indoor public places and public transport as stipulated by Article 8 of the World Health Organization Framework Convention on Tobacco Control (WHO FCTC) and based on the Guidelines on protection from exposure to tobacco smoke in the Annex that were adopted by the Second Conference of the Parties to the FCTC.
2. Provide effective protection in indoor workplaces, indoor public places, and public transport from exposure to second-hand emissions originating from the use of emerging products that emit smoke or aerosols, for example heated tobacco products, electronic cigarettes, whether containing nicotine or nicotine-free, and tobacco surrogates, and any other smoke and/or aerosol emitting products.
3. Provide effective protection from exposure to second-hand smoke and aerosols in designated outdoor recreational areas, especially where children may often be present. These should include public playgrounds, amusement parks, swimming pools, zoos, and other similar outdoor spaces.
4. Provide effective protection from second-hand smoke and aerosols in any outdoor or semi-outdoor (e.g. partially covered, walled, fenced or otherwise delineated areas next or close to an establishment, including rooftops, balconies, porches or patios) areas associated with service establishments. These should include outdoor spaces of restaurants, bars, cafes, and outdoor spaces of other similar premises.
5. Provide effective protection from second-hand smoke and aerosols in any outdoor or semi-open areas related to public transportation, including at bus, tram and train stops and airports.
6. Provide effective protection from second-hand smoke and aerosols in any outdoor area associated to a place of work.
7. Provide effective protection from second-hand smoke and aerosols in any outdoor area of premises related to healthcare. These should include hospitals, clinics, health centres, nursing homes and other similar premises.
8. Provide effective protection from second-hand smoke and aerosols in any outdoor area of premises that provide education and training to children and young people. Such areas should include pre-school childcare institutions, primary and secondary schools, vocational educational and training institutions, universities, youth centres and other similar premises.
9. Consider the inclusion of other outdoor areas in which members of the public, including children, minors or vulnerable people, are likely to congregate, in complementary actions preventing tobacco and nicotine use and addiction, and contributing to comprehensive smoke- and aerosol-free environments. Such spaces could include among others outdoor areas where events are organised, auditoriums and spectator areas at public events, and spaces associated with buildings open to the public that are likely to see heavy foot traffic (e.g. entrances to shopping malls, courtyards of buildings open to the public).
10. Consider the inclusion of other areas, such as private cars where children, minors or vulnerable people, are present, in complementary actions preventing tobacco and nicotine use and addiction, and contributing to comprehensive smoke- and aerosol-free environments.
11. Develop and/or strengthen smoke- and aerosol-free environments policies namely by:
a) Developing national strategies and programmes to ensure effective protection from exposure to second-hand smoke and aerosols.
b) Applying and/or developing prevention, smoking cessation and awareness-raising campaigns such as educational, outreach and information campaigns to ensure compliance with smoke and aerosol-free measures. Such campaigns could also be part of initiatives to reduce addiction. They could be based on and/or supplement prevention initiatives included in Europe’s Beating Cancer Plan.
c) Ensuring that appropriate structures and mechanisms are in place to promote compliance and applying and/or developing best-practices which can improve the implementation and enforcement of smoke- and aerosol-free environments measures.
12. Work together on the exchange of best practices on developing new or strengthening existing smoke and aerosol-free policies, programmes and strategies to ensure they are comprehensive, and on the design and piloting of ambitious and efficient approaches towards achieving smoke- and aerosol-free environments.
13. Cooperate closely among themselves and with the Commission to develop a coherent framework of definitions, benchmarks, and indicators for the effective implementation of this Recommendation, and monitor, evaluate and update its measures, as appropriate.
14. Report to the Commission, namely to the Public Health Expert Group and the Expert Group on Tobacco Policy, on the implementation and progress of the measures taken initially 3 years after the adoption of this Recommendation and every 5 years thereafter.
Recommendation 2009/C 296/02 is replaced by this Recommendation.
Done at Strasbourg,
For the Council
The President
0Council Recommendation of 30 November 2009 on smoke-free environments (OJ C 296, 5.12.2009, p. 4).
0Special Eurobarometer 539. 2023. Attitudes of Europeans towards tobacco and related products. ISBN: 978-92-68-07599-9.
0SCHEER (Scientific Committee on Health, Environmental and Emerging Risks). Opinion on electronic cigarettes. 16 April 2021.
0 www.tackshs.eu/wp-content/uploads/2019/10">https://www.tackshs.eu/wp-content/uploads/2019/10
0World Health Organization. Report on the global tobacco epidemic 2021: addressing new and emerging products. 2021. ISBN: 978 92 4 003209 5, p. 30-38.
0World Health Organization. Report on the global tobacco epidemic 2023: protect people from tobacco smoke. 2023. ISBN: 978-92-4-007716-4, p. 31-32.
0World Health Organization. Technical note on the call to action on electronic cigarettes. 2023. p.3-4. www.who.int/publications/m/item">https://www.who.int/publications/m/item
0World Health Organization. Electronic cigarettes call to action. 2023. www.who.int/publications/m/item">https://www.who.int/publications/m/item
0World Health Organization. Heated tobacco products: summary of research and evidence of health impacts. 2023. p. 12-13. www.who.int/publications/i/item/9789240042490">https://www.who.int/publications/i/item/9789240042490
0World Health Organization: WHO study group on tobacco product regulation: Report on the scientific basis of tobacco product regulation: eighth report of a WHO study group. 2021. www.who.int/publications/i/item/9789240022720">https://www.who.int/publications/i/item/9789240022720
0Yoshioka T, Shinozaki T, Hori A, Okawa S, Nakashima K, Tabuchi T. Association between exposure to secondhand aerosol from heated tobacco products and respiratory symptoms among current non-smokers in Japan: a cross-sectional study. BMJ Open. 2023;13:e065322. doi: 10.1136/ bmjopen-2022-065322
0Imura Y, Tabuchi T. Exposure to secondhand heated-tobacco-product aerosol may cause similar incidence of asthma attack and chest pain to secondhand cigarette exposure: the JASTIS 2019 study. Int J Environ Res Public Health. 2021;18 i:1766. doi: 10.3390/ijerph18041766
0Uguna CN, Snape CE. Should IQOS emissions be considered as smoke and harmful to health? A review of the chemical evidence. ACS Omega. 2022;7(26):22111–24. doi: 10.1021/ acsomega.2c01527.
0Auer R, Concha-Lozano N, JacotSadowski I, Cornuz J, Berthet A. Heat-not-burn tobacco cigarettes: smoke by any other name. JAMA Intern Med. 2017;177(7):1050–2. doi: 10.1001/ jamainternmed.2017.1419.
0Fernández E, Ballbè M, Sureda X, Fu M, Saltó E, Martínez-Sánchez JM. Particulate matter from electronic cigarettes and conventional cigarettes: a systematic review and observational study. Curr Environ Health Rep. 2015;2 i:423–9. doi: 10.1007/s40572- 015-0072-x.
0Li L, Lin Y, Xia T, Zhu Y. Effects of electronic cigarettes on indoor air quality and health. Annu Rev Public Health. 2020;41(1):363–80. doi: 10.1146/ annurev-publhealth-040119-094043.
0Hess I, Lachireddy K, Capon A. A systematic review of the health risks from passive exposure to electronic cigarette vapour. Public Health Research & Practice. 2016;26(2).
0Borgini A, Veronese C, De Marco C, Boffi R, Tittarelli A, Bertoldi M et al. Particulate matter in aerosols produced by two last generation electronic cigarettes: a comparison in a real-world environment. Pulmonology. 2021.
0Exposure to aerosols from smoking-proxy electronic inhaling systems: a systematic review. Barcelona: Tobacco Control Unit, Institut Català d’Oncologia; 2016.
0Lerner CA, Sundar IK, Yao H, Gerloff J, Ossip DJ, McIntosh S et al. Vapors produced by electronic cigarettes and e-juices with flavorings induce toxicity, oxidative stress, and inflammatory response in lung epithelial cells and in mouse lung. PLoS One. 2015;10(2):e0116732
0Glantz, S.A., Nguyen, N., & Oliveira da Silva, A.L. (2024). Population-Based Disease Odds for E-Cigarettes and Dual Use versus Cigarettes. NEJM Evidence, 3(3). DOI: 10.1056/EVIDoa2300229.
0Some examples of Member States that have already taken protective measures include Spain, Latvia and Sweden (Staff working document accompanying the Council Recommendation on Smoke- and Aerosol-Free Environments replacing Council Recommendation 2009/C 296/02).
0Communication from the Commission on the precautionary principle (COM/2000/0001 final).
0Special Eurobarometer 506. 2021. Attitudes of Europeans towards tobacco and electronic cigarettes. ISBN: 978-92-76-27171-0, p. 10.
0World Health Organization. Report on the global tobacco epidemic 2021: addressing new and emerging products. 2021. ISBN: 978 92 4 003209 5, p. 36.
0Kalkhoran S, Glantz SA. E-cigarettes and smoking cessation in real-world and clinical settings: a systematic review and meta-analysis. Lancet Respiratory Medicine. 2016;4(2):116–28.
0Felicione NJ, Ozga-Hess JE, Ferguson SG, Dino G, Kuhn S, Haliwa I et al. Cigarette smokers’ concurrent use of smokeless tobacco: dual use patterns and nicotine exposure. Tobacco Control. 2021;30(1):24–29.
0Wang JB, Olgin JE, Nah G, Vittinghoff E, Cataldo JK, Pletcher MJ et al. Cigarette and e-cigarette dual use and risk of cardiopulmonary symptoms in the Health eHeart Study. PLoS One. 2018;13(7):e0198681.
0In the context of this proposal for a Council Recommendation, tobacco surrogates are non-tobacco products that emit smoke or aerosols that can be used at the same time as tobacco products or can mirror the use of tobacco products.
0OJ L 127, 29.4.2014, p. 1.
0 https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-open-calls/horizon-europe/eu-missions-horizon-europe/eu-mission-cancer_en
0 Under the Horizon 2020 and Horizon Europe programmes, more than 55 projects related to research on tobacco were funded, with a total budget of around EUR 110 million.
0Pathway to a Healthy Planet for All EU Action Plan: Towards Zero Pollution for Air, Water and Soil (COM/2021/400 final)).
0EU strategy on the rights of the child (COM/2021/142 final)
0Have Your Say. Smoke-free environments- updated recommendation. Call for evidence. 22 June 2022- 20 July 2022.
0Replies were received from EU citizens (101), businesses, consumer, and trade organisations (47), Non-Governmental Organisations (28), academic/research institutions i and Member State Public authorities i.
0European Commission, Directorate-General for Health and Food Safety. Study on smoke-free environments and advertising of tobacco and related products. 2021. ISBN: 978-92-76-42343-0.
0Special Eurobarometer 539. 2023. Attitudes of Europeans towards tobacco and related products. ISBN: 978-92-68-07599-9.
0 Health Promotion (who.int), Tobacco and Smoking | Knowledge for policy (europa.eu)
0Communication from the Commission on the Europe's Beating Cancer Plan, COM/2021/44 final.
0World Health Organization. 2002. European Strategy for Tobacco Control. https://iris.who.int/handle/10665/107455
0World Health Organization. Report on the global tobacco epidemic 2023: protect people from tobacco smoke. 2023. ISBN: 978-92-4-007716-4, p. 31-32.
0World Health Organization. Technical note on the call to action on electronic cigarettes. 2023. p. 3-4. www.who.int/publications/m/item">https://www.who.int/publications/m/item
0World Health Organization. Electronic cigarettes call to action. 2023. www.who.int/publications/m/item">https://www.who.int/publications/m/item
0World Health Organization. Heated tobacco products: summary of research and evidence of health impacts. 2023. p. 12-13. https://www.who.int/publications/i/item/9789240042490
0World Health Organization: WHO study group on tobacco product regulation: Report on the scientific basis of tobacco product regulation: eighth report of a WHO study group. 2021. https://www.who.int/publications/i/item/9789240022720
0Yoshioka T, Shinozaki T, Hori A, Okawa S, Nakashima K, Tabuchi T. Association between exposure to secondhand aerosol from heated tobacco products and respiratory symptoms among current non-smokers in Japan: a cross-sectional study. BMJ Open. 2023;13:e065322. doi: 10.1136/ bmjopen-2022-065322
0Imura Y, Tabuchi T. Exposure to secondhand heated-tobacco-product aerosol may cause similar incidence of asthma attack and chest pain to secondhand cigarette exposure: the JASTIS 2019 study. Int J Environ Res Public Health. 2021;18 i:1766. doi: 10.3390/ijerph18041766
0Uguna CN, Snape CE. Should IQOS emissions be considered as smoke and harmful to health? A review of the chemical evidence. ACS Omega. 2022;7(26):22111–24. doi: 10.1021/ acsomega.2c01527.
0Auer R, Concha-Lozano N, JacotSadowski I, Cornuz J, Berthet A. Heat-not-burn tobacco cigarettes: smoke by any other name. JAMA Intern Med. 2017;177(7):1050–2. doi: 10.1001/ jamainternmed.2017.1419.
0Fernández E, Ballbè M, Sureda X, Fu M, Saltó E, Martínez-Sánchez JM. Particulate matter from electronic cigarettes and conventional cigarettes: a systematic review and observational study. Curr Environ Health Rep. 2015;2 i:423–9. doi: 10.1007/s40572- 015-0072-x.
0Li L, Lin Y, Xia T, Zhu Y. Effects of electronic cigarettes on indoor air quality and health. Annu Rev Public Health. 2020;41(1):363–80. doi: 10.1146/ annurev-publhealth-040119-094043.
0Hess I, Lachireddy K, Capon A. A systematic review of the health risks from passive exposure to electronic cigarette vapour. Public Health Research & Practice. 2016;26(2).
0Borgini A, Veronese C, De Marco C, Boffi R, Tittarelli A, Bertoldi M et al. Particulate matter in aerosols produced by two last generation electronic cigarettes: a comparison in a real-world environment. Pulmonology. 2021.
0Exposure to aerosols from smoking-proxy electronic inhaling systems: a systematic review. Barcelona: Tobacco Control Unit, Institut Català d’Oncologia; 2016.
0Lerner CA, Sundar IK, Yao H, Gerloff J, Ossip DJ, McIntosh S et al. Vapors produced by electronic cigarettes and e-juices with flavorings induce toxicity, oxidative stress, and inflammatory response in lung epithelial cells and in mouse lung. PLoS One. 2015;10(2):e0116732
0Glantz, S.A., Nguyen, N., & Oliveira da Silva, A.L. (2024). Population-Based Disease Odds for E-Cigarettes and Dual Use versus Cigarettes. NEJM Evidence, 3(3). DOI: 10.1056/EVIDoa2300229.
0“Applying tobacco control measures to e-cigarettes, including the supply and demand reduction measures of the WHO FCTC” (page 3, https://cdn.who.int/media/docs/default-source/tobacco-hq/regulating-tobacco-products/ends-call-to-action.pdf?sfvrsn=ea4c4fdb_12&download=true , referring to the Framework Convention on Tobacco Control (page 8, https://iris.who.int/bitstream/handle/10665/42811/9241591013.pdf?sequence=1).
0SCHEER (Scientific Committee on Health, Environmental and Emerging Risks). Opinion on electronic cigarettes. 16 April 2021.
0Staff working document accompanying the Council Recommendation on Smoke- and Aerosol-Free Environments replacing Council Recommendation 2009/C 296/02, [reference]
0Study on smoke-free environments and advertisement of tobacco and related products, 2021
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