EUROPEAN COMMISSION

Strasbourg, 17.9.2024

COM(2024) 55 final

2024/0230(NLE)

Proposal for a

COUNCIL RECOMMENDATION

on Smoke- and Aerosol-Free Environments
replacing Council Recommendation 2009/C 296/02

{SWD(2024) 55 final} - {SWD(2024) 56 final}

EXPLANATORY MEMORANDUM

1.CONTEXT OF THE PROPOSAL

Reasons for and objectives of the proposal

Introduction

In Europe’s Beating Cancer Plan, the Commission announced its intention to update the Council Recommendation on smoke-free environments 1 . One of the plan’s tobacco-related objectives is to help create a ‘Tobacco-Free Generation’ where less than 5% of the population uses tobacco by 2040, compared to around 25% today. The revision of the Council Recommendation on smoke-free environments is an initiative which aims to positively contribute towards this goal, fulfil the objective of better protecting people in the Union from second-hand smoke originating from combustible tobacco products and second-hand aerosols originating from the use of emerging products, and promote smoking cessation and the denormalisation of smoking and nicotine use.

The current Council Recommendation (2009/C 296/02) sets out recommendations for Member States to implement the World Health Organization Framework Convention on Tobacco Control (FCTC) and thus provides guidance for them to comply with their legal commitments to protect people from second-hand smoke in all indoor workplaces, public transport, and indoor public places. Its scope includes traditional tobacco products, perceived to be the main issue at the time, and some public spaces, covered based on a case-by-case hazard assessment.

However, at present, the current Council Recommendation cannot fully achieve its protective purpose due to the lack of coverage of outdoor spaces and because of market developments related to emerging products, which may emit smoke and/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, which were not originally included. The objective of the proposed revision of the Council Recommendation is therefore two-fold, namely, to cover emerging products and specific outdoor spaces. With that, it will better address the risks of second-hand exposure to aerosols from emerging products as well as the risk of second-hand exposure to both smoke and aerosols in certain outdoor spaces. A revision of the Recommendation on these two aspects is thus needed to achieve the objective of better protecting people, in particular children and young people, in the Union from exposure to second-hand smoke and aerosols. The proposal for a revised Council Recommendation, in addition, aims to indirectly support the denormalisation of the use of both tobacco and emerging products and, in this way, contribute to the goal of achieving a tobacco-free generation.

The proposed revision of the Council Recommendation includes an extension of its coverage to certain emerging products and outdoor spaces. A major driver for this extension is the rapid market growth and appeal of emerging products, especially among young people, since 2009 and the currently significant exposure to second-hand smoke and aerosols in certain outdoor spaces. In 2009, heated tobacco products had not yet entered the EU market and electronic cigarettes only to a minor extent; the current Recommendation therefore only targets traditional tobacco products by referring to ‘tobacco smoke’, meaning that it does not cover all emerging products. However, since 2009, emerging products such as electronic cigarettes and heated tobacco products have increased their market shares. Among respondents to the 2023 Eurobarometer on the attitudes of Europeans towards tobacco and related products, 3% are current users of electronic cigarettes compared to 2% in 2020. A particularly concerning aspect of the uptake of emerging products in recent years has been their appeal among children and young people; in fact, 54% of current and past smokers start smoking before the age of 19 and 14% start before the age of 15 2 .

Evidence from research shows that second-hand emissions from emerging products can have potentially harmful health impacts. In its opinion on electronic cigarettes, the European Commission’s advisory committee known as 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 electronic cigarette aerosols 3 . The EU-funded TackSHS project showed that the burden of second-hand smoke continues to be substantial, quantified the health risk and economic costs for several Member States and proposed interventions aiming to decrease second-hand smoke exposure to decrease disease burden among children and adults 4 . The World Health Organization 5 , 6 , 7 , 8 recently highlighted, among other concerns related to emerging products, the negative health effects of exposure to second-hand aerosols. For example, there is evidence that exposure to second-hand emissions from heated tobacco products is associated with significant respiratory and cardiovascular abnormalities in bystanders 9 , 10 , 11 , 12 , 13 , 14 . In addition, second-hand aerosols from electronic cigarettes, both with or without nicotine, expose bystanders to quantifiable levels of particulate matter and key toxicants and contaminants 15 , 16 , 17 , 18 , 19 , 20 , 21 . For context, the World Health Organization considers that electronic cigarettes with nicotine are highly addictive and harmful to health7,8. It also highlights that no level of side-stream exposure is safe or acceptable and that a careful approach should be taken5. Moreover, in order to achieve higher protection levels from second-hand smoke and aerosols, smoke-free legislation should be comprehensive and cover emerging products in its provisions6. Several Member States have already taken protective measures including banning smoking in indoor and outdoor places or banning the use of emerging products in public places. 22

Given the above, and while continuous development of the current evidence base will be pursued, a revision of the Council Recommendation to include emerging products is justified and appropriate to address the risk of exposure to second-hand smoke and aerosols in view of ensuring a high level of public health protection. This approach is also aligned with the Communication from the Commission on the precautionary principle 23 .

The proposed extension of the scope of the Recommendation is a major step towards de-normalising smoking and the use of emerging products which might mimic the action of smoking which is a crucial element of achieving a tobacco-free generation in the Union by 2040. This extension of scope is particularly important given the fact that the use of emerging products especially those that contain nicotine and particularly by young people, might become a starting point for the subsequent use of traditional combustible tobacco products. This can result in ‘dual use’ where users consume both conventional tobacco and emerging products at the same time and often switch between the two depending on where smoke-free rules apply 24 , 25 , 26 , 27 , 28 .

Regarding the outdoor spaces not explicitly covered by the current Recommendation, there is at present significant exposure to second-hand smoke and aerosols in places such as the outdoor spaces of hospitality venues and outdoor spaces intended for use by children and adolescents. In fact, 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 places2. The proposal to extend the coverage of the current Council Recommendation to include specific outdoor spaces aims to better protect people, in particular children and young people, from exposure to second-hand smoke and aerosols.

Commission supportive actions

The proposed Council Recommendation contains recommendations to Member States to better address the risks from exposure to second-hand smoke and aerosols in certain outdoor spaces. The Commission is planning to carry out a series of measures to support countries in implementing the recommendations.

First, the Commission intends to encourage and/or reinforce cooperation between Member States on the exchange of best practices on strengthening and/or developing comprehensive smoke- and aerosol-free policies, programmes, and strategies, and support the design and piloting of ambitious and efficient approaches towards achieving smoke and aerosol-free environments. Second, the Commission envisages to provide support, through existing EU programmes, discussion fora and collaboration tools, for the implementation of the Recommendation by Member States and for the enforcement of tobacco and nicotine control measures.

The Commission also intends to support tobacco and nicotine control, and prevention of addiction, by further promoting research. These research efforts are envisaged to encompass emerging products that emit smoke or aerosols, including heated tobacco products, electronic cigarettes, whether containing nicotine or nicotine-free, and tobacco surrogates that emit smoke or aerosols 29 , and any other smoke and/or aerosol emitting product, and nicotine-releasing products and products resembling the use of nicotine-releasing products. The Commission also intends to strengthen international cooperation, including on research, on the topics covered by this Recommendation.

Finally, 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.

The Commission intends to implement all supportive actions in close cooperation with Member States.

Consistency with existing policy provisions in the policy area

This proposal is complementary to Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC 30 . This Directive lays down rules for tobacco and related products on the EU market. It provides a regulatory framework for, among others, heated tobacco products and electronic cigarettes. The Directive aims to improve the functioning of the internal market for tobacco and related products, while ensuring a high level of health protection for people in the Union.

This proposal will also contribute towards the tobacco-related objectives of Europe’s Beating Cancer Plan, notably the objective of achieving a tobacco-free generation. Working in close synergy with the Plan, the EU Mission on Cancer 31 supports this objective by generating new evidence around prevention and behavioural changes, building on research on tobacco supported through the Horizon 2020 and Horizon Europe programmes. 32

This proposal is complementary to the Healthier Together- EU non-communicable diseases initiative which aims to tackle risk factors common to cancer and other non- communicable diseases, including tobacco use. Among other things, this proposal deals with health determinants. Through various measures under the EU4Health Programme, it provides Union funding for measures on health determinants aimed at addressing risk factors related to various non-communicable diseases and developing interventions on major cross-cutting themes such as tobacco control.

This proposal is complementary to, but has a broader scope, than the global tobacco control measures laid down in the WHO Framework Convention on Tobacco Control (FCTC), which is an international treaty, to which the European Union and its Member States are Parties, with the main objective of fostering international cooperation to bring about an effective, appropriate, and comprehensive international response to the spread of the global tobacco epidemic. More specifically, this revision is complementary to Article 8 of the FCTC which deals with the protection from exposure to tobacco smoke.

Consistency with other Union policies

This initiative is consistent with the Zero Pollution action plan 33 which, under the European Green Deal, sets out the objective of reducing, by 2050, air, water and soil pollution to levels no longer harmful to human health and natural ecosystems and that respect the boundaries our planet can cope with, thus creating a toxic-free environment. The revision of the Council Recommendation on smoke-free environments may have a positive environmental impact by reducing smoke and aerosols originating from the use of emerging products, and by reducing waste and littering from the disposal of cigarette butts, plastic filters and devices, most notably disposable devices, used in association with emerging products. In addition, the consumption of traditional tobacco and emerging products can be an environmental fire and safety hazard.

This proposal is also consistent with the EU strategy on the rights of the child 34 , which highlights that the EU and Member States must respect, protect, promote and fulfil children’s rights. In one of its thematic areas, the strategy refers to the right to good living, education, and health for all children in the EU. The revision of the Council Recommendation on smoke-free environments aims in particular to protect children and young people from exposure to second-hand smoke and aerosols.

2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

Legal basis

This proposal is based on Article 168(6) of the Treaty on the Functioning of the EU (TFEU) according to which the Council, on a proposal from the Commission, may adopt recommendations for the purposes set out in Article 168, which concerns the protection of public health. The primary objective of this proposal is to better protect people in the Union in particular children and young people from exposure to second-hand smoke and aerosols. This proposal for a Council Recommendation may thus be adopted on the basis of Article 168(6) TFEU.

Subsidiarity (for non-exclusive competence)

This proposal will help increase the levels of human health protection from second-hand smoke and aerosol exposure both between and within Member States. Union action, that would complement national policies, would bring clear added value to national efforts by providing Member States that have not yet implemented comprehensive smoke-free legislation with recommendations for doing so. The proposed Council Recommendation respects the responsibility of Member States for the definition of their health policy.

Proportionality

This proposal for a Council recommendation based on Article 168(6) TFEU takes into account that EU action, which, as set out in Article 168(1) TFEU, shall complement national policies, shall be directed towards improving public health. The objective of this proposal is to better protect people in the Union from second-hand smoke and aerosols, with a focus on including emerging products and specific outdoor spaces in its scope. The proposed revision of the current Council Recommendation1 is suitable to achieve the intended objective and does not go beyond what is necessary and proportionate because it would result in increased positive health benefits. In addition, the economic impacts are overridden by the public health benefits and the expected savings for healthcare systems and reduced environmental costs.

Choice of the instrument

The policy instrument for this revision, a proposal for a Council Recommendation, remains unchanged and fully respects the principles of subsidiarity and proportionality in the field of public health. It is a non-binding instrument that allows Member States to adapt their approaches to their national needs.

3.RESULTS OF EX-POSTEVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS

Ex-post evaluations/fitness checks of existing legislation

N/A

Stakeholder consultations

Input and feedback for this initiative was gathered through a call for evidence 35 and various targeted consultation activities (targeted surveys, targeted interviews and focus groups). The following stakeholder groups were consulted: 1) representatives of Member States competent authorities; 2) civil society organisations; 3) representatives from the tobacco and related products industry; 4) representatives from the HORECA sector; 5) other relevant stakeholders, such as those in education and sports associations. Input on the revisions was also gathered through a meeting of the Expert Group on Tobacco Policy on 3 May 2023. Finally, written feedback on the proposed revisions of the Recommendation was received from the Joint Action on Tobacco Control (JATC-2).

The call for evidence, was open for contribution from 22 June to 20 July 2022 and prompted 207 responses 36 . The majority of Non-Governmental Organisations, academic/research institutions, and representatives of national competent authorities largely supported the proposed updates to the 2009 Recommendation. Some of the points which were highlighted concern the importance of adding emerging products (including nicotine-free products) and the positive impact that the updates to the Recommendation would have in tackling the rising popularity, advertising, and use of emerging products, notably among children and young people. Moreover, the importance of ensuring the harmonisation of smoke- and aerosol-free laws across Member States was highlighted. The feedback received from businesses largely opposes any updates to the Recommendation.

During the targeted consultation activities, most representatives of national competent authorities highlighted that the proposed amendments to the Recommendation would help to protect the public from exposure to second-hand smoke and aerosols. They noted that it would have a positive effect in terms of harmonisation of smoke-free rules within and across Member States and that the resultant economic impact and administrative burden would be minor and outweighed by the health benefits. Possible enforcement and compliance challenges were highlighted.

Most civil society organisations that were consulted agreed that the proposed extension to cover emerging products and outdoor spaces would have a positive impact in reducing exposure to second-hand smoke/aerosols and that this would consequently help to protect people, in particular children, adolescents, and other more vulnerable people, for instance citizens with chronic diseases or other pre-existing conditions, or pregnant women. They also noted that revising the Recommendation would contribute to the denormalisation of smoking and use of emerging products. Some organisations highlighted the importance of ‘futureproofing’ the revised Recommendation against possible developments and trends in emerging tobacco products. Several organisations also pointed to environmental benefits against a background of significant concern about the negative environmental impacts of smoking and use of emerging products, such as cigarette butts discarded as litter, disposable/single use ‘vapes’ and discarded batteries. Finally, most civil society organisations saw industry interference and lobbying, enforcement, and compliance as challenges related to the revision.

Representatives from the tobacco and related products industry who were consulted were mostly opposed to changes to the current Recommendation regarding the inclusion of emerging products and outdoor spaces. They highlighted that emerging products should not be subject to the same level of restrictions as traditional combustible tobacco products in the context of smoke-free rules. However, some tobacco industry representatives also agreed that extending the rules to outdoor spaces where children and adolescents are present might help to protect them from second-hand smoke and aerosols.

Representatives from the HORECA sector had varying views. Some largely supported the proposed amendments with regard to the scope of both products and spaces; they noted it would have a positive effect on the health of employees in the sector as it would help to protect them from exposure to second-hand smoke and aerosols. Others expressed a certain level of reservation to the proposed revision of the Recommendation, in particular to the measure of including the outdoor spaces of hospitality establishments. In particular, representatives from HORECA businesses highlighted their concerns about losing customers, their fear that they might potentially have to spend resources on adjusting to new measures and that, in the case of the hotel industry, their customers could shift to the short-term rental sector, resulting in unfair business competition. No quantitative information or factual estimations were provided to support the negative economic impacts that were mentioned. In contrast, representatives of employees in the HORECA sector thought that the economic impact would be neutral and negligible.

Representatives from the tobacco industry mentioned that the initiative would lower demand for both traditional tobacco products and emerging products such as electronic cigarettes which would also adversely impact employment in the tobacco and emerging products industry.

The Expert Group on Tobacco Policy and the Joint Action on Tobacco Control (JATC-2) supported the inclusion of emerging products and outdoor spaces.

The input, suggestions and recommendations of Member States and other stakeholders were analysed and taken into account as much as possible and in line with relevant and available scientific evidence. The detailed outcomes of all the consultation activities and how these were taken into account are described in the accompanying staff working document.

Collection and use of expertise

As mentioned above, to support this Recommendation, several consultation activities targeting relevant stakeholder groups were organised to gather opinions and evidence.

Impact assessment

An impact assessment was not considered necessary because the proposed initiative is a non-binding recommendation for Member States and leaves room for different national approaches. This initiative aims to update the former 2009 Recommendation in response to technological developments since 2009 regarding emerging products and to avoid a case-by-case approach when applying smoke-free rules to public spaces. The 2021 study 37 on smoke-free environments and advertising of tobacco and related products showed that the revision is expected to have a positive health and social impact and that the magnitude of the negative economic impacts economic operators might face are limited and/or insignificant. The supporting evidence and conclusions from the study are presented in the accompanying staff working document.

Regulatory fitness and simplification

N/A.

Fundamental rights

[…]

4.BUDGETARY IMPLICATIONS

N/A

5.OTHER ELEMENTS

Implementation plans and monitoring, evaluation and reporting arrangements

The Commission intends to report on the progress made in implementing this Recommendation, on the basis of the information provided by Member States, within 5 years after its adoption.

Explanatory documents (for directives)

N/A

Detailed explanation of the specific provisions of the proposal

N/A

2024/0230 (NLE)

Proposal for a

COUNCIL RECOMMENDATION

on Smoke- and Aerosol-Free Environments
replacing Council Recommendation 2009/C 296/02

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 168(6) thereof,

Having regard to the proposal from the European Commission,

Whereas:

(1)According to the World Health Organization, exposure to second-hand tobacco smoke is a widespread source of mortality, morbidity, and disability in the Union. Such exposure is associated with tobacco consumption which remains the leading cause of preventable cancers with 27% of all cancers being attributed to the use of tobacco.

(2)The use of tobacco remains widespread globally and throughout the Union. In 2023, 24% of the European Union population are estimated to be smokers 38 .

(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. 39

(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 Plan 40 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 carcinogen 41 .

(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 Organization 42 , 43 , 44  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 bystanders 45 , 46 , 47 , 48 , 49 , 50 . 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 51 , 52 , 53 , 54 , 55 , 56 , 57 .

(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, 58 , 4,5.

(10)In its 2021 opinion on electronic cigarettes 59 , 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 places 60 , 61 .

(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,

(1)    Council Recommendation of 30 November 2009 on smoke-free environments (OJ C 296, 5.12.2009, p. 4).

(2)    Special Eurobarometer 539. 2023. Attitudes of Europeans towards tobacco and related products. ISBN: 978-92-68-07599-9.

(3)    SCHEER (Scientific Committee on Health, Environmental and Emerging Risks). Opinion on electronic cigarettes. 16 April 2021.

(4)       https://www.tackshs.eu/wp-content/uploads/2019/10/TackSHS-leaflet_20191023.pdf

(5)    World Health Organization. Report on the global tobacco epidemic 2021: addressing new and emerging products. 2021. ISBN: 978 92 4 003209 5, p. 30-38.

(6)    World Health Organization. Report on the global tobacco epidemic 2023: protect people from tobacco smoke. 2023. ISBN: 978-92-4-007716-4, p. 31-32.

(7)    World Health Organization. Technical note on the call to action on electronic cigarettes. 2023. p.3-4. https://www.who.int/publications/m/item/technical-note-on-call-to-action-on-electronic-cigarettes  

(8)    World Health Organization. Electronic cigarettes call to action. 2023. https://www.who.int/publications/m/item/electronic-cigarettes---call-to-action  

(9)    World 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  

(10)    World 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  

(11)    Yoshioka 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

(12)    Imura 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(4):1766. doi: 10.3390/ijerph18041766

(13)    Uguna 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.

(14)    Auer 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.

(15)    Fernández 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(4):423–9. doi: 10.1007/s40572- 015-0072-x.

(16)    Li 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.

(17)    Hess 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).

(18)    Borgini 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.

(19)    Exposure to aerosols from smoking-proxy electronic inhaling systems: a systematic review. Barcelona: Tobacco Control Unit, Institut Català d’Oncologia; 2016.

(20)    Lerner 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

(21)    Glantz, 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.

(22)    Some 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).

(23)    Communication from the Commission on the precautionary principle (COM/2000/0001 final).

(24)    Special Eurobarometer 506. 2021. Attitudes of Europeans towards tobacco and electronic cigarettes. ISBN: 978-92-76-27171-0, p. 10.

(25)    World Health Organization. Report on the global tobacco epidemic 2021: addressing new and emerging products. 2021. ISBN: 978 92 4 003209 5, p. 36.

(26)    Kalkhoran 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.

(27)    Felicione 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.

(28)    Wang 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.

(29)    In 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.

(30)    OJ L 127, 29.4.2014, p. 1.

(31)   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

(32)      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.

(33)    Pathway to a Healthy Planet for All EU Action Plan: 'Towards Zero Pollution for Air, Water and Soil' (COM/2021/400 final)).

(34)    EU strategy on the rights of the child (COM/2021/142 final)

(35)    Have Your Say. Smoke-free environments- updated recommendation. Call for evidence . 22 June 2022- 20 July 2022.

(36)    Replies were received from EU citizens (101), businesses, consumer, and trade organisations (47), Non-Governmental Organisations (28), academic/research institutions (6) and Member State Public authorities (4).

(37)    European 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.

(38)    Special Eurobarometer 539. 2023. Attitudes of Europeans towards tobacco and related products. ISBN: 978-92-68-07599-9.

(39)      Health Promotion (who.int), Tobacco and Smoking | Knowledge for policy (europa.eu)

(40)    Communication from the Commission on the Europe's Beating Cancer Plan, COM/2021/44 final.

(41)    World Health Organization. 2002. European Strategy for Tobacco Control. https://iris.who.int/handle/10665/107455

(42)    World Health Organization. Report on the global tobacco epidemic 2023: protect people from tobacco smoke. 2023. ISBN: 978-92-4-007716-4, p. 31-32.

(43)    World Health Organization. Technical note on the call to action on electronic cigarettes. 2023. p. 3-4. https://www.who.int/publications/m/item/technical-note-on-call-to-action-on-electronic-cigarettes  

(44)    World Health Organization. Electronic cigarettes call to action. 2023. https://www.who.int/publications/m/item/electronic-cigarettes---call-to-action  

(45)    World 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

(46)    World 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

(47)    Yoshioka 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

(48)    Imura 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(4):1766. doi: 10.3390/ijerph18041766

(49)    Uguna 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.

(50)    Auer 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.

(51)    Fernández 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(4):423–9. doi: 10.1007/s40572- 015-0072-x.

(52)    Li 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.

(53)    Hess 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).

(54)    Borgini 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.

(55)    Exposure to aerosols from smoking-proxy electronic inhaling systems: a systematic review. Barcelona: Tobacco Control Unit, Institut Català d’Oncologia; 2016.

(56)    Lerner 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

(57)    Glantz, 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.

(58)    “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 ).

(59)    SCHEER (Scientific Committee on Health, Environmental and Emerging Risks). Opinion on electronic cigarettes. 16 April 2021.

(60)    Staff working document accompanying the Council Recommendation on Smoke- and Aerosol-Free Environments replacing Council Recommendation 2009/C 296/02, [reference]

(61)    Study on smoke-free environments and advertisement of tobacco and related products, 2021 

EUROPEAN COMMISSION

Strasbourg, 17.9.2024

COM(2024) 55 final

ANNEXES

to the

Proposal for a
COUNCIL RECOMMENDATION

on Smoke- and Aerosol-Free Environments



replacing Council Recommendation 2009/C 296/02

{SWD(2024) 55 final} - {SWD(2024) 56 final}

ANNEX

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

PURPOSE, OBJECTIVES AND KEY CONSIDERATIONS

Purpose of the guidelines

1.Consistent with other provisions of the WHO Framework Convention on Tobacco Control and the intentions of the Conference of the Parties, these guidelines are intended to assist Parties in meeting their obligations under Article 8 of the Convention. They draw on the best available evidence and the experience of Parties that have successfully implemented effective measures to reduce exposure to tobacco smoke.

2.The guidelines contain agreed upon statements of principles and definitions of relevant terms, as well as agreed upon recommendations for the steps required to satisfy the obligations of the Convention. In addition, the guidelines identify the measures necessary to achieve effective protection from the hazards of second-hand tobacco smoke. Parties are encouraged to use these guidelines not only to fulfil their legal duties under the Convention, but also to follow best practices in protecting public health.

Objectives of the guidelines

3.These guidelines have two related objectives. The first is to assist Parties in meeting their obligations under Article 8 of the WHO Framework Convention, in a manner consistent with the scientific evidence regarding exposure to second-hand tobacco smoke and the best practice worldwide in the implementation of smoke-free measures, in order to establish a high standard of accountability for treaty compliance and to assist the Parties in promoting the highest attainable standard of health. The second objective is to identify the key elements of legislation necessary to effectively protect people from exposure to tobacco smoke, as required by Article 8.

Underlying considerations

4.The development of these guidelines has been influenced by the following fundamental considerations:

(a)The duty to protect from tobacco smoke, embodied in the text of Article 8, is grounded in fundamental human rights and freedoms. Given the dangers of breathing second-hand tobacco smoke, the duty to protect from tobacco smoke is implicit in, inter alia, the right to life and the right to the highest attainable standard of health, as recognised in many international legal instruments (including the Constitution of the World Health Organisation, the Convention on the Rights of the Child, the Convention on the Elimination of all Forms of Discrimination against Women and the Covenant on Economic, Social and Cultural Rights), as formally incorporated into the preamble of the WHO Framework Convention and as recognised in the constitutions of many nations.

(b)The duty to protect individuals from tobacco smoke corresponds to an obligation by governments to enact legislation to protect individuals against threats to their fundamental rights and freedoms. This obligation extends to all persons, and not merely to certain populations.

(c)Several authoritative scientific bodies have determined that second-hand tobacco smoke is a carcinogen. Some Parties to the WHO Framework Convention (for example, Finland and Germany) have classified second-hand tobacco smoke as a carcinogen and included the prevention of exposure to it at work in their health and safety legislation. In addition to the requirements of Article 8, therefore, Parties may be obligated to address the hazard of exposure to tobacco smoke in accordance with their existing workplace laws or other laws governing exposure to harmful substances, including carcinogens.

STATEMENT OF PRINCIPLES AND RELEVANT DEFINITIONS UNDERLYING PROTECTION FROM EXPOSURE TO TOBACCO SMOKE

Principles

5.As noted in Article 4 of the WHO Framework Convention, strong political commitment is necessary to take measures to protect all persons from exposure to tobacco smoke. The following agreed upon principles should guide the implementation of Article 8 of the Convention.

Principle 1

6.Effective measures to provide protection from exposure to tobacco smoke, as envisioned by Article 8 of the WHO Framework Convention, require the total elimination of smoking and tobacco smoke in a particular space or environment in order to create a 100 % smoke-free environment. There is no safe level of exposure to tobacco smoke, and notions such as a threshold value for toxicity from second-hand smoke should be rejected, as they are contradicted by scientific evidence. Approaches other than 100 % smoke-free environments, including ventilation, air filtration and the use of designated smoking areas (whether with separate ventilation systems or not), have repeatedly been shown to be ineffective and there is conclusive evidence, scientific and otherwise, that engineering approaches do not protect against exposure to tobacco smoke.

Principle 2

7.All people should be protected from exposure to tobacco smoke. All indoor workplaces and indoor public places should be smoke free.

Principle 3

8.Legislation is necessary to protect people from exposure to tobacco smoke. Voluntary smoke-free policies have repeatedly been shown to be ineffective and do not provide adequate protection. In order to be effective, legislation should be simple, clear and enforceable.

Principle 4

9.Good planning and adequate resources are essential for successful implementation and enforcement of smoke-free legislation.

Principle 5

10.Civil society has a central role in building support for and ensuring compliance with smoke-free measures, and should be included as an active partner in the process of developing, implementing and enforcing legislation.

Principle 6

11.The implementation of smoke-free legislation, its enforcement and its impact should all be monitored and evaluated. This should include monitoring and responding to tobacco industry activities that undermine the implementation and enforcement of the legislation, as specified in Article 20.4 of the WHO Framework Convention.

Principle 7

12.The protection of people from exposure to tobacco smoke should be strengthened and expanded, if necessary; such action may include new or amended legislation, improved enforcement and other measures to reflect new scientific evidence and case study experiences.

Definitions

13.In developing legislation, it is important to use care in defining key terms. Several recommendations as to appropriate definitions, based on experiences in many countries, are set out here. The definitions in this section supplement those already included in the WHO Framework Convention.

‘Second-hand tobacco smoke’ or ‘environmental tobacco smoke’

14.Several alternative terms are commonly used to describe the type of smoke addressed by Article 8 of the WHO Framework Convention. These include ‘second-hand smoke’, ‘environmental tobacco smoke’, and ‘other people's smoke’. Terms such as ‘passive smoking’ and ‘involuntary exposure to tobacco smoke’ should be avoided, as experience in France and elsewhere suggests that the tobacco industry may use these terms to support a position that ‘voluntary’ exposure is acceptable. ‘Second-hand tobacco smoke’, sometimes abbreviated as ‘SHS’, and ‘environmental tobacco smoke’, sometimes abbreviated ‘ETS’, are the preferable terms; these guidelines use ‘second-hand tobacco smoke’.

15.Second-hand tobacco smoke can be defined as ‘the smoke emitted from the burning end of a cigarette or from other tobacco products usually in combination with the smoke exhaled by the smoker’.

16.‘Smoke-free air’ is air that is 100 % smoke free. This definition includes, but is not limited to, air in which tobacco smoke cannot be seen, smelled, sensed or measured 1  

‘Smoking’

17.This term should be defined to include being in possession or control of a lit tobacco product regardless of whether the smoke is being actively inhaled or exhaled.

‘Public places’

18.While the precise definition of ‘public places’ will vary between jurisdictions, it is important that legislation define this term as broadly as possible. The definition used should cover all places accessible to the general public or places for collective use, regardless of ownership or right to access.

‘Indoor’ or ‘enclosed’

19.Article 8 requires protection from tobacco smoke in ‘indoor’ workplaces and public places. Because there are potential pitfalls in defining ‘indoor’ areas, the experiences of various countries in defining this term should be specifically examined. The definition should be as inclusive and as clear as possible, and care should be taken in the definition to avoid creating lists that may be interpreted as excluding potentially relevant ‘indoor’ areas. It is recommended that ‘indoor’ (or enclosed) areas be defined to include any space covered by a roof or enclosed by one or more walls or sides, regardless of the type of material used for the roof, wall or sides, and regardless of whether the structure is permanent or temporary.

‘Workplace’

20.A ‘workplace’ should be defined broadly as ‘any place used by people during their employment or work’. This should include not only work done for compensation, but also voluntary work, if it is of the type for which compensation is normally paid. In addition, ‘workplaces’ include not only those places at which work is performed, but also all attached or associated places commonly used by the workers in the course of their employment, including, for example, corridors, lifts, stairwells, lobbies, joint facilities, cafeterias, toilets, lounges, lunchrooms and also outbuildings such as sheds and huts. Vehicles used in the course of work are workplaces and should be specifically identified as such.

21.Careful consideration should be given to workplaces that are also individuals' homes or dwelling places, for example, prisons, mental health institutions or nursing homes. These places also constitute workplaces for others, who should be protected from exposure to tobacco smoke.

‘Public transport’

22.Public transport should be defined to include any vehicle used for the carriage of members of the public, usually for reward or commercial gain. This would include taxis.

THE SCOPE OF EFFECTIVE LEGISLATION

23.Article 8 requires the adoption of effective measures to protect people from exposure to tobacco smoke in (1) indoor workplaces, (2) indoor public places, (3) public transport, and (4) ‘as appropriate’ in ‘other public places’.

24.This creates an obligation to provide universal protection by ensuring that all indoor public places, all indoor workplaces, all public transport and possibly other (outdoor or quasi- outdoor) public places are free from exposure to second-hand tobacco smoke. No exemptions are justified on the basis of health or law arguments. If exemptions must be considered on the basis of other arguments, these should be minimal. In addition, if a Party is unable to achieve universal coverage immediately, Article 8 creates a continuing obligation to move as quickly as possible to remove any exemptions and make the protection universal. Each Party should strive to provide universal protection within five years of the WHO Framework Convention's entry into force for that Party.

25.No safe levels of exposure to second-hand smoke exist, and, as previously acknowledged by the Conference of the Parties in decision FCTC/COP1(15), engineering approaches, such as ventilation, air exchange and the use of designated smoking areas, do not protect against exposure to tobacco smoke.

26.Protection should be provided in all indoor or enclosed workplaces, including motor vehicles used as places of work (for example, taxis, ambulances or delivery vehicles).

27.The language of the treaty requires protective measures not only in all ‘indoor’ public places, but also in those ‘other’ (that is, outdoor or quasi-outdoor) public places where ‘appropriate’. In identifying those outdoor and quasi-outdoor public places where legislation is appropriate, Parties should consider the evidence as to the possible health hazards in various settings and should act to adopt the most effective protection against exposure wherever the evidence shows that a hazard exists.

28.Raising awareness among the public and opinion leaders about the risks of second-hand tobacco smoke exposure through ongoing information campaigns is an important role for government agencies, in partnership with civil society, to ensure that the public understands and supports legislative action. Key stakeholders include businesses, restaurant and hospitality associations, employer groups, trade unions, the media, health professionals, organisations representing children and young people, institutions of learning or faith, the research community and the general public. Awareness-raising efforts should include consultation with affected businesses and other organisations and institutions in the course of developing the legislation.

29.Key messages should focus on the harm caused by second-hand tobacco smoke exposure, the fact that elimination of smoke indoors is the only science-based solution to ensure complete protection from exposure, the right of all workers to be equally protected by law and the fact that there is no trade-off between health and economics, because experience in an increasing number of jurisdictions shows that smoke-free environments benefit both. Public education campaigns should also target settings for which legislation may not be feasible or appropriate, such as private homes.

30.Broad consultation with stakeholders is also essential to educate and mobilise the community and to facilitate support for legislation after its enactment. Once legislation is adopted, there should be an education campaign leading up to implementation of the law, the provision of information for business owners and building managers outlining the law and their responsibilities and the production of resources, such as signage. These measures will increase the likelihood of smooth implementation and high levels of voluntary compliance. Messages to empower non-smokers and to thank smokers for complying with the law will promote public involvement in enforcement and smooth implementation.

ENFORCEMENT

Duty of compliance

31.Effective legislation should impose legal responsibilities for compliance on both affected business establishments and individual smokers, and should provide penalties for violations, which should apply to businesses and, possibly, smokers. Enforcement should ordinarily focus on business establishments. The legislation should place the responsibility for compliance on the owner, manager or other person in charge of the premises, and should clearly identify the actions he or she is required to take. These duties should include:

(a)a duty to post clear signs at entrances and other appropriate locations indicating that smoking is not permitted. The format and content of these signs should be determined by health authorities or other agencies of the government and may identify a telephone number or other mechanisms for the public to report violations and the name of the person within the premises to whom complaints should be directed;

(b)a duty to remove any ashtrays from the premises;

(c)a duty to supervise the observance of rules;

(d)a duty to take reasonable specified steps to discourage individuals from smoking on the premises. These steps could include asking the person not to smoke, discontinuing service, asking the person to leave the premises and contacting a law enforcement agency or other authority.

Penalties

32.The legislation should specify fines or other monetary penalties for violations. While the size of these penalties will necessarily reflect the specific practices and customs of each country, several principles should guide the decision. Most importantly, penalties should be sufficiently large to deter violations or else they may be ignored by violators or treated as mere costs of doing business. Larger penalties are required to deter business violators than to deter violations by individual smokers, who usually have fewer resources. Penalties should increase for repeated violations and should be consistent with a country's treatment of other, equally serious offences.

33.In addition to monetary penalties, the legislation may also allow for administrative sanctions, such as the suspension of business licences, consistent with the country's practice and legal system. These ‘sanctions of last resort’ are rarely used, but are very important for enforcing the law against any businesses that choose to defy the law repeatedly.

34.Criminal penalties for violations may be considered for inclusion, if appropriate within a country's legal and cultural context.

Enforcement infrastructure

35.Legislation should identify the authority or authorities responsible for enforcement, and should include a system both for monitoring compliance and for prosecuting violators.

36.Monitoring should include a process for inspection of businesses for compliance. It is seldom necessary to create a new inspection system for enforcement of smoke-free legislation. Instead, compliance can ordinarily be monitored using one or more of the mechanisms already in place for inspecting business premises and workplaces. A variety of options usually exists for this purpose. In many countries, compliance inspections may be integrated into business licensing inspections, health and sanitation inspections, inspections for workplace health and safety, fire safety inspections or similar programmes. It may be valuable to use several such sources of information gathering simultaneously.

37.Where possible, the use of inspectors or enforcement agents at the local level is recommended; this is likely to increase the enforcement resources available and the level of compliance. This approach requires the establishment of a national coordinating mechanism to ensure a consistent approach nationwide.

38.Regardless of the mechanism used, monitoring should be based on an overall enforcement plan, and should include a process for effective training of inspectors. Effective monitoring may combine regular inspections with unscheduled, surprise inspections, as well as visits made in response to complaints. Such visits may well be educative in the early period after the law takes effect, as most breaches are likely to be inadvertent. The legislation should authorise inspectors to enter premises subject to the law and to collect samples and gather evidence, if these powers are not already established by existing law. Similarly, the legislation should prohibit businesses from obstructing the inspectors in their work.

39.The cost of effective monitoring is not excessive. It is not necessary to hire large numbers of inspectors, because inspections can be accomplished using existing programmes and personnel, and because experience shows that smoke-free legislation quickly becomes self- enforcing (that is, predominantly enforced by the public). Only a few prosecutions may be necessary if the legislation is implemented carefully and active efforts are made to educate businesses and the public.

40.Although these programmes are not expensive, resources are needed to educate businesses, train inspectors, coordinate the inspection process and compensate personnel for inspections of businesses outside of normal working hours. A funding mechanism should be identified for this purpose. Effective monitoring programmes have used a variety of funding sources, including dedicated tax revenues, business licensing fees and dedicated revenues from fines paid by violators.

Enforcement strategies

41.Strategic approaches to enforcement can maximise compliance, simplify the implementation of legislation and reduce the level of enforcement resources needed.

42.In particular, enforcement activities in the period immediately following the law's entrance into force are critical to the law's success and to the success of future monitoring and enforcement. Many jurisdictions recommend an initial period of soft enforcement, during which violators are cautioned but not penalised. This approach should be combined with an active campaign to educate business owners about their responsibilities under the law, and businesses should understand that the initial grace period or phase-in period will be followed by more rigorous enforcement.

43.When active enforcement begins, many jurisdictions recommend the use of high-profile prosecutions to enhance deterrence. By identifying prominent violators who have actively defied the law or who are well known in the community, by taking firm and swift action and by seeking maximum public awareness of these activities, authorities are able to demonstrate their resolve and the seriousness of the law. This increases voluntary compliance and reduces the resources needed for future monitoring and enforcement.

44.While smoke-free laws quickly become self-enforcing, it is nevertheless essential that authorities be prepared to respond swiftly and decisively to any isolated instances of outright defiance. Particularly when a law first comes into force, there may be an occasional violator who makes a public display of contempt for the law. Strong responses in these cases set an expectation of compliance that will ease future efforts, while indecisiveness can rapidly lead to widespread violations.

Mobilise and involve the community

45.The effectiveness of a monitoring-and-enforcement programme is enhanced by involving the community in the programme. Engaging the support of the community and encouraging members of the community to monitor compliance and report violations greatly extends the reach of enforcement agencies and reduces the resources needed to achieve compliance. In fact, in many jurisdictions, community complaints are the primary means of ensuring compliance. For this reason, smoke-free legislation should specify that members of the public may initiate complaints and should authorise any person or non- governmental organisation to initiate action to compel compliance with measures regulating exposure to second-hand smoke. The enforcement programme should include a toll-free telephone complaint hotline or a similar system to encourage the public to report violations.

MONITORING AND EVALUATION OF MEASURES

46.Monitoring and evaluation of measures to reduce exposure to tobacco smoke are important for several reasons, for example:

(a)to increase political and public support for strengthening and extending legislative provisions;

(b)to document successes that will inform and assist the efforts of other countries;

(c)to identify and publicise the efforts made by the tobacco industry to undermine the implementation measures.

47.The extent and complexity of monitoring and evaluation will vary among jurisdictions, depending on available expertise and resources. However, it is important to evaluate the outcome of the measures implemented, in particular, on the key indicator of exposure to second-hand smoke in workplaces and public places. There may be cost-effective ways to achieve this, for example through the use of data or information collected through routine activities such as workplace inspections.

48.There are eight key process and outcome indicators that should be considered 2 : (2)

Processes

(a)Knowledge, attitudes and support for smoke-free policies among the general population and possibly specific groups, for example, bar workers;

(b)enforcement of and compliance with smoke-free policies;

Outcomes

(a)reduction in exposure of employees to second-hand tobacco smoke in workplaces and public places;

(b)reduction in content of second-hand tobacco smoke in the air in workplaces (particularly in restaurants) and public places;

(c)reduction in mortality and morbidity from exposure to second-hand tobacco smoke;

(d)reduction in exposure to second-hand tobacco smoke in private homes;

(e)changes in smoking prevalence and smoking-related behaviours;

(f)economic impacts.

(1)    It is possible that constituent elements of tobacco smoke may exist in air in amounts too small to be measured. Attention should be given to the possibility that the tobacco industry or the hospitality sector may attempt to exploit the limitations of this definition.

(2)    The publication ‘WHO policy recommendations: protection from exposure to second- hand tobacco smoke’ (Geneva, World Health Organisation, 2007) provides references and links to monitoring studies conducted elsewhere on all of these indicators.