(3a)

Health warnings serve as part of an organised, effective and long term anti-smoking strategy, with well defined scope and objectives.

(6)

The size of the internal market in tobacco and related products, the increasing tendency of manufacturers of tobacco products to concentrate production for the whole of the Union in only a small number of production plants within the Member States and the resulting significant cross-border trade of tobacco and related products calls for legislative action at Union rather than national level to achieve the smooth operation of the internal market.

(6)

The size of the internal market in tobacco and related products, the increasing tendency of manufacturers of tobacco products to concentrate production for the whole of the Union in only a small number of production plants within the Member States and the resulting significant cross-border trade of tobacco and related products calls for stronger legislative action at Union level to achieve the smooth operation of the internal market.

(7)

Legislative action at Union level is also necessary to implement the WHO Framework Convention on Tobacco Control (hereinafter: ‘FCTC’) of May 2003 to which the European Union and its Member States are Parties . Of relevance are in particular its Articles 9 (regulation of the contents of tobacco products), 10 (regulation of tobacco product disclosures), 11 (packaging and labelling of tobacco products), 13 (advertising) and 15 (illicit trade in tobacco products). A set of guidelines for the implementation of FCTC provisions was adopted by consensus during various Conferences of the Parties to the FCTC with the support of the Union and the Member States.

(7)

Legislative action at Union level is also necessary to implement the landmark WHO Framework Convention on Tobacco Control (‘FCTC’) of May 2003 . All Member States, and the European Union itself, have signed and ratified the FCTC and as a result are bound under international law by its provisions . Of particular relevance are Articles 9 (regulation of the contents of tobacco products), 10 (regulation of tobacco product disclosures), 11 (packaging and labelling of tobacco products), 13 (advertising) and 15 (illicit trade in tobacco products). A set of guidelines for the implementation of FCTC provisions was adopted by consensus during various Conferences of the Parties to the FCTC with the support of the Union and the Member States.

(8)

In accordance with Article 114(3) of the Treaty of the Functioning of the European Union (hereinafter: ‘Treaty’), a high level of health protection should be taken as a basis, regard being had, in particular, to any new developments based on scientific facts. Tobacco products are not ordinary commodities and in view of the particularly harmful effects of tobacco, health protection should be given high importance, in particular to reduce smoking prevalence among young people.

(8)

In accordance with Article 114(3) of the Treaty of the Functioning of the European Union (‘Treaty’), a high level of health protection should be taken as a basis, regard being had, in particular, to any new developments based on scientific facts. Tobacco products are not ordinary commodities and in view of the particularly harmful effects of tobacco, health protection should be given high importance, in particular to reduce smoking prevalence among young people. To that end, Member States should promote smoking prevention campaigns, especially in schools and through the media. In accordance with the principle of producer responsibility, manufacturers of tobacco products should be made responsible for all health costs arising as a consequence of tobacco consumption .

(9a)

Given that in many Member States large percentages of smokers are unlikely to stop smoking entirely, legislation should take into account their right to know objectively the impact the possible use of tobacco has on their health — information which they also receive through the packaging of the product they are likely to use.

(10)

For measuring the tar, nicotine and carbon monoxide yields of cigarettes, reference should be made to ISO standards 4387, 10315 and 8454, which are internationally recognised standards. For other emissions there are no internationally agreed standards or tests for quantifying the yields, but efforts are ongoing to develop them .

(10)

For measuring the tar, nicotine and carbon monoxide yields of cigarettes, reference should be made to ISO standards 4387, 10315 and 8454, which are internationally recognised standards. For other emissions there are no internationally agreed standards or tests for quantifying the yields, but Member States and the Commission should actively encourage ongoing efforts at international level to develop such standards or tests .

(10a)

Polonium 210 has been shown to be a significant carcinogen in tobacco. Its presence in cigarettes could be eliminated almost completely by a combination of simple measures. It is thus appropriate to set a maximum yield for Polonium 210 that would result in a reduction of 95 % of the current average content of Polonium 210 in cigarettes. An ISO standard to measure Polonium 210 in tobacco should be developed.

(11)

In relation to the fixing of maximum yields, it might be necessary and appropriate at a later date to adapt the yields fixed or to fix maximum thresholds for emissions, taking into consideration their toxicity or addictiveness.

(11)

In relation to the fixing of maximum yields, it might be necessary and appropriate at a later date to reduce the yields fixed or to fix maximum thresholds for emissions, taking into consideration their toxicity or addictiveness.

(13)

The current use of different reporting formats makes it difficult for manufacturers and importers to fulfil their reporting obligations and burdensome for the Member States and the Commission to compare, analyse and draw conclusions from the information received. In this light there should be a common mandatory format for the reporting of ingredients and emissions. The greatest possible transparency of product information should be ensured for the general public, while ensuring that appropriate account is taken of the commercial and intellectual property rights of the manufacturers of tobacco products.

(13)

The current use of different reporting formats makes it difficult for manufacturers and importers to fulfil their reporting obligations and burdensome for the Member States and the Commission to compare, analyse and draw conclusions from the information received. In this light there should be a common mandatory format for the reporting of ingredients and emissions. The greatest possible transparency of product information should be ensured for the general public, while ensuring that appropriate account is taken of the commercial and intellectual property rights of the manufacturers of tobacco products , in particular the rights of small and medium sized enterprises (SMEs) .

(14)

The lack of a harmonised approach on ingredients regulation affects the functioning of the internal market and impacts on the free movement of goods across the EU. Some Member States have adopted legislation or entered into binding agreements with the industry allowing or prohibiting certain ingredients. As a result, some ingredients are regulated in some Member States, but not in others. Member States are also taking different approaches as regards additives integrated in the filter of cigarettes as well as additives colouring the tobacco smoke. Without harmonisation, the obstacles on the internal market are expected to increase in the coming years taking into account the implementation of the FCTC and its guidelines and considering experience gained in other jurisdictions outside the Union. The guidelines on Articles 9 and 10 FCTC call in particular for the removal of ingredients that increase palatability, create the impression that the tobacco products have health benefits, are associated with energy and vitality or have colouring properties.

(14)

The lack of a harmonised approach on ingredients regulation affects the functioning of the internal market and impacts on the free movement of goods across the EU. Some Member States have adopted legislation or entered into binding agreements with the industry allowing or prohibiting certain ingredients. As a result, some ingredients are regulated in some Member States, but not in others. Member States are also taking different approaches as regards additives integrated in the filter of cigarettes as well as additives colouring the tobacco smoke. Without harmonisation, the obstacles on the internal market are expected to increase in the coming years taking into account the implementation of the FCTC and its guidelines and considering experience gained in other jurisdictions outside the Union. The guidelines on Articles 9 and 10 FCTC call in particular for the removal of ingredients that increase palatability, create the impression that the tobacco products have health benefits, are associated with energy and vitality or have colouring properties. Ingredients that increase addictiveness and toxicity should also be removed.

(14a)

In order to protect human health, an assessment should be carried out on the safety of additives for use in tobacco products. Additives should only be allowed in tobacco products if they are included in a Union list of authorised additives. That list should also indicate any conditions or restrictions on the use of allowed additives. Tobacco products containing additives not included in the Union list or used in a manner that does not comply with this Directive should not be placed on the Union market.

(14b)

It is important not only to consider the properties of additives as such, but also of their combustion products. Additives as well as their combustion products should not be such that they meet the criteria for classification as hazardous in accordance with Regulation (EC) no 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures  (2) .

(15)

The likelihood of diverging regulation is further increased by concerns over tobacco products , including smokeless tobacco products, having a characterising flavour other than tobacco, which may facilitate uptake of tobacco consumption or affect consumption patterns. For example, in many countries, sales of mentholated products gradually increased even as smoking prevalence overall declined. A number of studies indicated that mentholated tobacco products can facilitate inhalation as well as smoking uptake among young people. Measures introducing unjustified differences of treatment between flavoured cigarettes (e.g. menthol and clove cigarettes) should be avoided.

(15)

The likelihood of diverging regulation is further increased by concerns over tobacco products having a characterising flavour other than tobacco, which may facilitate uptake of tobacco consumption or affect consumption patterns. For example, in many countries, sales of mentholated products gradually increased even as smoking prevalence overall declined. A number of studies indicated that mentholated tobacco products can facilitate inhalation as well as smoking uptake among young people. Measures introducing unjustified differences of treatment between flavoured cigarettes (e.g. menthol and clove cigarettes) should be avoided.

(16)

The prohibition of tobacco products with characterising flavours does not prohibit the use of individual additives altogether, but obliges the manufactures to reduce the additive or the combination of additives to such an extent that the additives no longer result in a characterising flavour. The use of additives necessary for manufacturing of tobacco products should be allowed, as long as they do not result in a characterising flavour.. The Commission should ensure uniform conditions for the implementation of the provision on characterising flavour. Independent panels should be used by the Member States and by the Commission to assist in such decision making. The application of this Directive should not discriminate between different tobacco varieties.

(17)

Certain additives are used to create the impression that tobacco products have health benefits, present reduced health hazards or increase mental alertness and physical performance. These additives should be prohibited in order to ensure uniform rules and a high level of health protection.

(17)

Certain additives are used to create the impression that tobacco products have health benefits, present reduced health hazards or increase mental alertness and physical performance. In order to ensure uniform rules and a high level of health protection , those additives should not be approved. In addition, additives which impart a characterising flavour should not be approved. This should not result in prohibiting the use of individual additives altogether. Manufactures should, however, be required to reduce the use of an additive or of a combination of additives to such an extent that the additives no longer result in a characterising flavour. It should be possible to approve the use of additives that are essential for manufacturing of tobacco products, as long as those additives do not result in a characterising flavour and are not linked to the attractiveness of such products.

(17a)

An increasing number of people, most of them children, suffer from asthma and various allergies. Not all causes of asthma are understood, as indicated by WHO, but it is necessary for risk factors including allergens, tobacco and chemical irritants to be prevented in order to improve people's quality of life.

(18)

Considering the Directive's focus on young people, tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobacco which are mainly consumed by older consumers, should be granted an exemption from certain ingredients requirements as long as there is no substantial change of circumstances in terms of sales volumes or consumption patterns in relation to young people.

(18)

Considering the Directive's focus on young people, tobacco products other than cigarettes, roll-your-own tobacco and water-pipe tobacco which are mainly consumed by older consumers, should be granted an exemption from certain ingredients requirements as long as there is no substantial change of circumstances in terms of sales volumes or consumption patterns in relation to young people.

(18a)

Member States should be encouraged, if they have not already done so, to formulate their national laws on the protection of young people in such a way that tobacco products may not be sold to, or consumed by, young people under the age of 18. Member States should also ensure that such prohibitions are respected.

(18b)

Article 16 of the FCTC points to the responsibility of Parties to the Convention to address products aimed at underage consumers, such as food products and toys in the form of tobacco products that may be appealing to minors. In recent years, several products, such as shisha vaping sticks, have been placed on the market that do not contain nicotine but have the form of cigarettes and try to imitate the smoking process through vaporising substances, the harmless nature of which is not yet scientifically proven, and through an electric light imitating the burning process of a cigarette. Such products are clearly produced to be appealing to young and underage consumers, and are increasingly popular with minors in several Member States. Increasing concern is expressed at the habits created in young consumers and minors by the use of such imitation cigarettes.

(20)

Such disparities are liable to constitute a barrier to trade and to impede the operation of the internal market in tobacco products, and should therefore be eliminated. Also, consumers in some Member States may be better informed about the health risks of tobacco products than in others. Without further action at Union level, the existing disparities are likely to increase in the coming years.

(20)

Such disparities are liable to constitute a barrier to trade and to impede the operation of the internal market in tobacco products, and should therefore be eliminated. Also, consumers in some Member States may be better informed about the health risks of tobacco products than in others. Without further harmonising action at Union level, the existing disparities are likely to increase in the coming years.

(22)

The labelling provisions also need to be adapted to new scientific evidence. For example the indication of the yields for tar, nicotine and carbon monoxide on cigarette packets have proven to be misleading as it makes consumers believe that certain cigarettes are less harmful than others. Evidence also suggests that large combined health warnings are more effective than text-only warnings. In this light combined health warnings should become mandatory throughout the Union and cover significant and visible parts of the packet surface. A minimum size should be set for all health warnings to ensure their visibility and effectiveness.

(22)

The labelling provisions also need to be adapted to new scientific evidence. For example the indication of the yields for tar, nicotine and carbon monoxide on cigarette packets have proven to be misleading as it makes consumers believe that certain cigarettes are less harmful than others. Evidence also suggests that large combined picture and text health warnings are more effective than text-only warnings. In this light combined health warnings should become mandatory throughout the Union and cover significant and visible parts on the field of vision of the packet surface. A minimum size should be set for all health warnings to ensure their visibility and effectiveness.

(23)

In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism . The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, ‘natural’, ‘organic’, ‘without additives’, ‘without flavours’, ‘slim’, names, pictures, and figurative or other signs. Likewise, the size and appearance of individual cigarettes can mislead consumers by creating the impression that they are less harmful. A recent study has also shown that smokers of slim cigarettes were more likely to believe that their own brand might be less harmful. This should be addressed.

(23)

In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, ‘natural’, ‘organic’, ‘without additives’, ‘without flavours’, ‘slim’, names, pictures, and figurative or other signs. Likewise, the size and appearance of individual cigarettes can mislead consumers by creating the impression that they are less harmful. A recent study has also shown that smokers of slim cigarettes were more likely to believe that their own brand might be less harmful. This should be addressed.

(23a)

Tobacco products have been shown to contain and emit many noxious substances and known carcinogens hazardous to human health when burnt. Scientific studies have clearly proven that passive smoking is a cause of death, illness and disability and that passive smoking is dangerous in particular to unborn children and infants. It can cause or aggravate respiratory problems in persons inhaling smoke. Health warnings should therefore also draw attention to the dangers to health of passive smoking.

(24)

Tobacco products for smoking, other than cigarettes and roll-your-own tobacco products, which are mainly consumed by older consumers, should be granted an exemption from certain labelling requirements as long as there is no substantial change of circumstances in terms of sales volumes or consumption patterns in relation to young people. The labelling of these other tobacco products should follow specific rules. The visibility of the health warnings on smokeless tobacco products needs to be ensured. Warnings should therefore be placed on the two main surfaces of smokeless tobacco product packaging.

(24)

Tobacco products for smoking, other than cigarettes, roll-your-own tobacco products and water pipe tobacco , which are mainly consumed by older consumers, should be granted an exemption from certain labelling requirements as long as there is no substantial change of circumstances in terms of sales volumes or consumption patterns in relation to young people. The labelling of these other tobacco products should follow specific rules. The visibility of the health warnings on smokeless tobacco products needs to be ensured. Warnings should therefore be placed on the two main surfaces of smokeless tobacco product packaging.

(26)

Considerable volumes of illicit products, which do not comply with the requirements laid down in Directive 2001/37/EC, are placed on the market and indications are that these volumes might increase. Such products undermine the free circulation of compliant products and the protection provided for by tobacco control legislations. In addition, the FCTC obliges the Union to fight against illicit products, as part of a comprehensive tobacco control policy. Provision should thus be made for unit packets of tobacco products to be marked in a unique and secure way and their movements to be recorded so that these products can be tracked and traced in the Union and their compliance with this Directive can be monitored and better enforced. In addition, provision should be made for the introduction of security features that will facilitate the verification of whether or not products are authentic.

(26)

Considerable volumes of illicit products, which do not comply with the requirements laid down in Directive 2001/37/EC, are placed on the market and indications are that these volumes might increase. Such products undermine the free circulation of compliant products and the protection provided for by tobacco control legislations. In addition, the FCTC obliges the Union to fight against illicit products, as part of a comprehensive tobacco control policy. Provision should thus be made for unit packets and any outside transport packaging of tobacco products to be marked in a unique and secure way and their movements to be recorded so that these products can be tracked and traced in the Union and their compliance with this Directive can be monitored and better enforced. In addition, provision should be made for the introduction of security features that will facilitate the verification of whether or not products are authentic , and to ensure that the unique identifiers of unit packets are linked to the unique identifier on the outside transport packaging .

(28)

In order to ensure independence and transparency, manufacturers of tobacco products should conclude data storage contracts with independent third parties , under the auspices of an external auditor. The data related to the tracking and tracing system should be kept separate from other company related data and be under the control of and accessible at all times by the competent authorities from Member States and the Commission.

(28)

In order to ensure independence and transparency, manufacturers of tobacco products should conclude data storage contracts with independent third parties. The suitability of such contracts should be approved and monitored by the Commission, assisted by an independent external auditor. The data related to the tracking and tracing system should be kept separate from other company related data and be under the control of and accessible at all times by the competent authorities from Member States and the Commission.

(29)

Council Directive 89/622/EEC of 13 November 1989 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products and the prohibition of the marketing of certain types of tobacco for oral use prohibited the sale in the Member States of certain types of tobacco for oral use. Directive 2001/37/EC confirmed this prohibition. Article 151 of the Act of Accession of Austria, Finland and Sweden grants the Kingdom of Sweden derogation from this prohibition. The prohibition of the sale of oral tobacco should be maintained in order to prevent the introduction to the internal market of a product that is addictive, has adverse health effects and is attractive to young people. For other smokeless tobacco products that are not produced for the mass market, a strict labelling and ingredients regulation is considered sufficient to contain market expansion beyond their traditional use.

(29)

Council Directive 89/622/EEC of 13 November 1989 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products and the prohibition of the marketing of certain types of tobacco for oral use prohibited the sale in the Member States of certain types of tobacco for oral use. Directive 2001/37/EC confirmed this prohibition. Article 151 of the Act of Accession of Austria, Finland and Sweden grants the Kingdom of Sweden derogation from this prohibition. The prohibition of the sale of oral tobacco should be maintained in order to prevent the introduction to the internal market of a product that is addictive, has adverse health effects and is attractive to young people.

(29a)

Given the general prohibition of the sale of oral tobacco (snus) in the Union, there is no cross-border interest in regulating the content of snus. The responsibility for regulating the content of snus thus lies with the Member State where the sale of snus is permitted in accordance with Article 151 of the Act of Accession of Austria, Finland and Sweden. Snus should therefore be exempt from the provisions of Article 6 of this Directive.

(30)

Cross-border distance sales of tobacco facilitate access to tobacco products of young people and risk to undermine compliance with the requirements provided for by tobacco control legislation and in particular by this Directive . Common rules on a notification system are necessary to ensure that this Directive achieves its full potential. The provision on notification of cross-border distance sales of tobacco in this Directive should apply notwithstanding the notification procedure set out in Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services. Business to consumer distance sale of tobacco products is further regulated by Directive 97/7/EC of the European Parliament and the Council of 20 May 1997 on the protection of consumers in respect of distance contracts, which will be replaced by Directive 2011/83/EU of the European Parliament and the Council of 25 October 2011 on consumer rights, as of 13 June 2014.

(30)

Cross-border distance sales of tobacco should be prohibited as they facilitate young people's access to tobacco products and risk undermining compliance with the requirements of this Directive.

(30a)

Directive 2003/33/EC on advertising and sponsorship of tobacco products already prohibits the free distribution of such products in the context of the sponsorship of events. This Directive, which regulates aspects relating to the presentation and sale of tobacco and aims to achieve a high level of health protection and prevention of tobacco consumption among young people, extends the scope of the ban on free distribution to public places and specifically prohibits the distribution of printed material, discount coupons and similar special offers inside packages and wrappings.

(30b)

The Commission and the Member States should commit themselves to the effective implementation of the Protocol to the FCTC to eliminate illicit trade in tobacco products. Efforts should be made to prevent and improve the control of illegal trafficking of tobacco products manufactured in third countries.

(31)

All tobacco products have the potential to cause mortality, morbidity and disability and their consumption should be contained . It is therefore important to monitor developments as regards novel tobacco products. A notification obligation for novel tobacco products should be put on manufacturers and importers, without prejudice to the power of the Member States to ban or to authorise them. The Commission should monitor the development and submit a report 5 years after the transposition deadline of this Directive, in order to assess whether amendments to this Directive are necessary.

(31)

All tobacco products have the potential to cause mortality, morbidity and disability and their manufacture, distribution and consumption should be regulated . It is therefore important to monitor developments as regards novel tobacco products. A notification obligation for novel tobacco products should be put on manufacturers and importers, without prejudice to the power of the Member States to ban or to authorise them. The Commission should monitor the development and submit a report three years after the transposition deadline of this Directive, in order to assess whether amendments to this Directive are necessary.

(33)

Nicotine-containing products are sold on the Union market. The different regulatory approaches taken by Member States to address health and safety concerns associated with these products have a negative impact on the functioning of the internal market, in particular considering that these products are subject to significant cross-border distance sales including via the internet .

(33)

Nicotine-containing products - including e-cigarettes - are sold on the Union market. However Member States have taken different regulatory approaches to address health and safety concerns associated with these products . There is a need for harmonized rules, therefore all nicotine-containing products should be regulated under this Directive as a related tobacco product. Given the potential of nicotine-containing products to aid smoking cessation, Member States should ensure that they can be made available as widely as tobacco products .

(34)

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use  (3) provides a legal framework to assess the quality, safety and efficacy of medicinal products including nicotine containing products. A significant number of nicotine-containing products were already authorised under this regulatory regime. The authorisation takes into account the nicotine content of the product in question. Subjecting all nicotine-containing products, whose nicotine content equals or exceeds the content of a nicotine containing product previously authorised under Directive 2001/83/EC, to the same legal framework clarifies the legal situation, levels out differences between national legislations, ensures equal treatment of all nicotine containing products usable for smoking cessation purposes and creates incentives for research and innovation in smoking cessation. This should be without prejudice to the application of Directive 2001/83/EC to other products covered by this Directive if the conditions set by Directive 2001/83/EC are fulfilled.

(35)

Labelling provisions should be introduced for nicotine containing products below the threshold set out in this Directive drawing the attention of consumers to potential health risks.

(35a)

Member States should ensure that nicotine-containing products are not sold to persons below the age required for purchasing tobacco products or related products.

(37)

In order to ensure uniform conditions for the implementation of this Directive, in particular concerning the format of ingredients reporting, the determination of products with characterising flavours or with increased levels of toxicity and addictiveness and the methodology for determining whether a tobacco product has characterising flavour, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011.

(37)

In order to ensure uniform conditions for the implementation of this Directive, in particular concerning the format of ingredients reporting, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011.

(38)

In order to make this Directive fully operational and to keep up with technical, scientific and international developments in tobacco manufacture, consumption and regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission, in particular in respect of adopting and adapting maximum yields for emissions and their measurement methods, setting maximum levels for ingredients that increase toxicity, addictiveness or attractiveness , the use of health warnings, unique identifiers and security features in the labelling and packaging, defining key elements for contracts on data storage with independent third parties, reviewing certain exemptions granted to tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobacco products and reviewing the nicotine levels for nicotine containing products . It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.

(38)

In order to make this Directive fully operational and to keep up with technical, scientific and international developments in tobacco manufacture, consumption and regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission, in particular in respect of adopting and adapting maximum yields for emissions and their measurement methods, approving additives and setting maximum levels for additives as necessary , the use of health warnings, unique identifiers and security features in the labelling and packaging, defining key elements for contracts on data storage with independent third parties, and reviewing certain exemptions granted to tobacco products other than cigarettes, roll-your-own tobacco and water pipe tobacco . It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.

(39)

The Commission should monitor the developments and submit a report 5 years after the date of transposition of this Directive, in order to assess whether amendments to this Directive are necessary.

(39)

The Commission should monitor the developments and submit a report three years after the date of transposition of this Directive, in order to assess whether amendments to this Directive are necessary , in particular as regards packaging .

(39a)

Member States have an important responsibility in protecting public health and taking preventive action, providing public guarantees, monitoring and advice for young people, and carrying out preventive public anti-smoking campaigns, particularly in schools. Universal free access to smoking cessation consultations and corresponding treatments is considered vital.

(40)

A Member State that deems it necessary to maintain more stringent national provisions for aspects falling inside the scope of this Directive should be allowed to do so, for all products alike , on grounds of overriding needs relating to the protection of public health . A Member State should also be allowed to introduce more stringent provisions, applying to all products alike, on grounds relating to the specific situation of this Member State and provided the provisions are justified by the need to protect public health. More stringent national provisions should be necessary and proportionate, not constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States. Stricter national provisions require prior notification to, and approval from, the Commission taking into account the high level of health protection achieved through this Directive.

(40)

A Member State that deems it necessary to maintain or introduce more stringent national provisions for aspects falling inside the scope of this Directive should be allowed to do so, for all products alike, insofar as such measures are compatible with the TFEU . Stricter national provisions require prior notification to, and approval from, the Commission taking into account the high level of health protection achieved through this Directive.

(42)

Member States should ensure that personal data are only processed in accordance with the rules and safeguards laid down in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data.

(42)

Member States should ensure that personal data are only processed in accordance with the rules and safeguards laid down in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. It is essential that national data protection provisions also be taken into account.

(45)

The proposal affects several fundamental rights as laid down in the Charter of Fundamental Rights of the European Union, notably the protection of personal data (Article 8), the freedom of expression and information (Article 11), freedom of economic operators to conduct business (Article 16), and the right to property (Article 17). The obligations imposed on manufacturers, importers and distributors of tobacco products are necessary to improve the functioning of the internal market while ensuring a high level of health and consumer protection as set out in Articles 35 and 38 of the Charter of Fundamental Rights of the European Union . The application of this Directive should respect the EU law and relevant international obligations.

(45)

The proposal affects several fundamental rights as laid down in the Charter of Fundamental Rights of the European Union, notably the protection of personal data (Article 8), the freedom of expression and information (Article 11), freedom of economic operators to conduct business (Article 16), and the right to property of trademark holders (Article 17). It is therefore necessary to ensure that the obligations imposed on manufacturers, importers and distributors of tobacco products not only guarantee a high level of health and consumer protection , but also protect all other fundamental rights and are proportionate with respect to the functioning of the internal market . The application of this Directive should respect the Union law and relevant international obligations.

(45a)

Member States should respect the right to clean air within the spirit of Article 7 (b) and Article 12 of the International Covenant on Economic, Social and Cultural Rights providing for rights for safe and healthy working conditions and the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. This is within the aim of Article 37 of the Charter of Fundamental rights where a high level of environmental protection and the improvement of the quality of the environment must be integrated into the policies of the Union.

(a)

the ingredients and emissions of tobacco products and related reporting obligations including the maximum yields for tar, nicotine and carbon monoxide for cigarettes;

(a)

the ingredients and emissions of tobacco products and related reporting obligations including the maximum yields for tar, nicotine and carbon monoxide for cigarettes;

(b)

the labelling and packaging of tobacco products including the health warnings to appear on unit packets of tobacco products and any outside packaging as well as traceability and security features to ensure compliance with this Directive;

(b)

the labelling and packaging of tobacco products including the health warnings to appear on unit packets of tobacco products and any outside packaging as well as traceability and security features to ensure compliance with this Directive;

(c)

the prohibition to place on the market tobacco for oral use;

(c)

the prohibition to place on the market tobacco for oral use;

(d)

cross-border distance sales of tobacco products;

(d)

the prohibition of cross-border distance sales of tobacco products;

(e)

the notification obligation for novel tobacco products;

(e)

the notification obligation for novel tobacco products;

(f)

the placing on the market and the labelling of certain products, which are related to tobacco products, namely nicotine-containing products and herbal products for smoking;

(f)

the placing on the market and the labelling of certain products, which are related to tobacco products, namely nicotine-containing products and herbal products for smoking;

(1)

‘addictiveness’ means the pharmacological potential of a substance to cause addiction, a state which affects an individual’s ability to control behaviour typically by instilling a reward or a relief from withdrawal symptoms, or both;

(1)

‘addictiveness’ means the pharmacological potential of a substance to cause addiction, a state which affects an individual’s ability to control behaviour typically by instilling a reward or a relief from withdrawal symptoms, or both;

(2)

‘additive’ means substance contained in a tobacco product, its unit packet or any outside packaging with the exception of tobacco leaves and other natural or unprocessed parts of tobacco plants;

(2)

‘additive’ means substance contained in a tobacco product, its unit packet or any outside packaging with the exception of tobacco leaves and other natural or unprocessed parts of tobacco plants;

(3)

‘age verification system’ means a computing system that unambiguously confirms the consumer's age in electronic form according to national requirements;

(3)

‘age verification system’ means a computing system that unambiguously confirms the consumer's age in electronic form according to national requirements;

(4)

‘characterising flavour’ means a distinguishable aroma or taste other than tobacco, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy, menthol or vanilla observable before or upon intended use of the tobacco product;

(4)

‘characterising flavour’ means a distinguishable aroma or taste other than tobacco, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy, menthol or vanilla which is observable before or upon use of the tobacco product;

(5)

‘chewing tobacco’ means a smokeless tobacco product exclusively designed for the purpose of chewing;

(5)

‘chewing tobacco’ means a smokeless tobacco product exclusively designed for the purpose of chewing;

(6)

‘cigar’ means a roll of tobacco consumed via a combustion process and further defined in Article 4(1) of Council Directive 2011/64/EU of 21 June 2011 on the structure and rates of excise duty applied to manufactured tobacco;

(6)

‘cigar’ means a roll of tobacco consumed via a combustion process and further defined in Article 4(1) of Council Directive 2011/64/EU of 21 June 2011 on the structure and rates of excise duty applied to manufactured tobacco;

(7)

‘cigarette’ means a roll of tobacco consumed via a combustion process and further defined in Article 3(1) of Council Directive 2011/64/EU;

(7)

‘cigarette’ means a roll of tobacco consumed via a combustion process and further defined in Article 3(1) of Council Directive 2011/64/EU;

(8)

‘cigarillo’ means a small type of cigar with a diameter of up to 8 mm ;

(8)

‘cigarillo’ means a small type of cigar and is further defined in Article 8 (1) of Council Directive 2007/74/EC ;

(9)

‘combined health warning’ means a health warning provided for in this Directive and consisting of a combination of a text warning and a corresponding photograph or illustration;

(9)

‘combined health warning’ means a health warning provided for in this Directive and consisting of a combination of a text warning and a corresponding photograph or illustration;

(10)

‘consumer’ means a natural person who is acting for purposes which are outside his trade, business, craft or profession;

(10)

‘consumer’ means a natural person who is acting for purposes which are outside his trade, business, craft or profession;

(11)

‘cross-border distance sales’ means a distance sales service where, at the time the consumer orders the product, the consumer is located in a Member State other than the Member State or the third country where the retail outlet is established; a retail outlet is deemed to be established in a Member State:

(11)

‘cross-border distance sales’ means a distance sales service where, at the time the consumer orders the product, the consumer is located in a Member State other than the Member State or the third country where the retail outlet is established; a retail outlet is deemed to be established in a Member State:

(12)

‘emissions’ means substances that are released when a tobacco product is used as intended, such as substances found in smoke, or substances released during the process of using smokeless tobacco products;

(12)

‘emissions’ means substances that are released when a tobacco product is used as intended, such as substances found in smoke, or substances released during the process of using smokeless tobacco products;

(13)

‘flavouring’ means an additive that imparts aroma and/or taste;

(13)

‘flavouring’ means an additive that imparts aroma and/or taste;

(14)

‘health warning’ means a warning provided for in this Directive, including text warnings, combined health warnings, general warnings and information messages;

(14)

‘health warning’ means a warning provided for in this Directive, including text warnings, combined health warnings, general warnings and information messages;

(15)

‘herbal product for smoking’ means a product based on plants or herbs which contains no tobacco and is consumed via a combustion process;

(15)

‘herbal product for smoking’ means a product based on plants or herbs which contains no tobacco and is consumed via a combustion process;

(16)

‘import of tobacco and related products’ means the entry into the territory of the Union of such products unless the products upon their entry into the Union are placed under a customs suspensive procedure or arrangement, as well as their release from a customs suspensive procedure or arrangement;

(16)

‘import of tobacco and related products’ means the entry into the territory of the Union of such products unless the products upon their entry into the Union are placed under a customs suspensive procedure or arrangement, as well as their release from a customs suspensive procedure or arrangement;

(17)

‘importer of tobacco and related products’ means the owner or a person having the right of disposal over tobacco and related products that have been brought into the territory of the Union;

(17)

‘importer of tobacco and related products’ means the owner or a person having the right of disposal over tobacco and related products that have been brought into the territory of the Union;

(18)

‘ingredient’ means an additive, tobacco (leaves and other natural, processed or unprocessed parts of tobacco plants including expanded and reconstituted tobacco), as well as any substance present in a finished tobacco product including paper, filter, inks, capsules and adhesives;

(18)

‘ingredient’ means an additive, tobacco, as well as any substance present in a finished tobacco product including paper, filter, inks, capsules and adhesives;

(18a)

‘tobacco’ means leaves and other natural processed or unprocessed parts of tobacco plants, including expanded and reconstituted tobacco;

(19)

‘maximum level’ or ‘maximum yield’ means the maximum content or emission, including 0, of a substance in a tobacco product measured in grams;

(19)

‘maximum level’ or ‘maximum yield’ means the maximum content or emission, including 0, of a substance in a tobacco product measured in grams;

(20)

‘nasal tobacco’ means a smokeless tobacco product consumed via the nose;

(20)

‘nasal tobacco’ means a smokeless tobacco product consumed via the nose;

(21)

‘nicotine’ means nicotinic alkaloids;

(21)

‘nicotine’ means nicotinic alkaloids;

(22)

‘nicotine-containing product’ means a product usable for consumption by consumers via inhalation, ingestion or in other forms and to which nicotine is either added during the manufacturing process or self-administered by the user before or during consumption;

(22)

‘nicotine-containing product’ means a product usable for consumption by consumers via inhalation, ingestion or in other forms and to which nicotine is either added during the manufacturing process or self-administered by the user before or during consumption;

(23)

‘novel tobacco product’ means a tobacco product other than a cigarette, roll-your-own tobacco, pipe tobacco, water-pipe tobacco, cigar, cigarillo, chewing tobacco, nasal tobacco or tobacco for oral use placed on the market after entry into force of this Directive;

(23)

‘novel tobacco product’ means a tobacco product other than a cigarette, roll-your-own tobacco, pipe tobacco, water-pipe tobacco, cigar, cigarillo, chewing tobacco, nasal tobacco or tobacco for oral use placed on the market after entry into force of this Directive;

(24)

‘outside packaging’ means any packaging in which products are placed on the market and which include a unit packet or an aggregation of unit packets; transparent wrappers are not regarded as outside packaging;

(24)

‘outside packaging’ means any packaging in which products are placed on the market and which include a unit packet or an aggregation of unit packets; transparent wrappers are not regarded as outside packaging;

(24a)

‘outside transport packaging’ means any packaging, consisting of an aggregation of unit packets, in which tobacco products are transported from the manufacturer to the subsequent economic operators before being placed on the market, such as cartons, master cases and pallets;

(25)

‘place on the market’ means to make products available to consumers located in the Union, with or without payment, including by means of distance sale; in case of cross-border distance sales the product is deemed to be placed on the market in the Member State where the consumer is located;

(25)

‘place on the market’ means to make products available to consumers located in the Union, with or without payment, including by means of distance sale; in case of cross-border distance sales the product is deemed to be placed on the market in the Member State where the consumer is located;

(26)

‘pipe tobacco’ means tobacco consumed via a combustion process and exclusively designed for the purpose of being used in a pipe;

(26)

‘pipe tobacco’ means tobacco consumed via a combustion process and exclusively designed for the purpose of being used in a pipe;

(26a)

‘water pipe tobacco’ means tobacco intended solely for use in a water pipe;

(27)

‘retail outlet’ means any outlet where tobacco products are placed on the market including by a natural person;

(27)

‘retail outlet’ means any outlet where tobacco products are placed on the market including by a natural person;

(28)

‘roll-your-own tobacco’ means tobacco which can be used for making cigarettes by consumers or retail outlets;

(28)

‘roll-your-own tobacco’ means tobacco which can be used for making cigarettes by consumers or retail outlets;

(29)

‘smokeless tobacco product’ means a tobacco product not involving a combustion process, including chewing tobacco, nasal tobacco and tobacco for oral use;

(29)

‘smokeless tobacco product’ means a tobacco product not involving a combustion process, including chewing tobacco, nasal tobacco and tobacco for oral use;

(30)

‘substantial change of circumstances’ means an increase of the sales volumes by product category, such as pipe tobacco, cigar, cigarillo, by at least 10 % in at least 10  Member States based on sales data transmitted in accordance with Article 5(4); or an increase of the prevalence level in the consumer group under 25 years of age by at least 5 percentage points in at least 10 Member States for the respective product category based on ____ [this date will be set at the moment of adoption of the Directive] Eurobarometer report or equivalent prevalence studies;

(30)

‘substantial change of circumstances’ means an increase of the sales volumes by product category, such as pipe tobacco, cigar, cigarillo, by at least 10 % in at least five Member States based on sales data transmitted in accordance with Article 5(4); or an increase of the prevalence level in the consumer group under 25 years of age by at least 5 percentage points in at least five Member States for the respective product category based on ____ [this date will be set at the moment of adoption of the Directive] Eurobarometer report or equivalent prevalence studies;

(31)

‘tar’ means the raw anhydrous nicotine-free condensate of smoke;

(31)

‘tar’ means the raw anhydrous nicotine-free condensate of smoke;

(32)

‘tobacco for oral use’ means all products for oral use, except those intended to be inhaled or chewed, made wholly or partly of tobacco, in powder or in particulate form or in any combination of those forms, particularly those presented in sachet portions or porous sachets;

(32)

‘tobacco for oral use’ means all products for oral use, except those intended to be inhaled or chewed, made wholly or partly of tobacco, in powder or in particulate form or in any combination of those forms, particularly those presented in sachet portions or porous sachets;

(33)

‘tobacco for smoking’ means a tobacco product other than a smokeless tobacco product;

(33)

‘tobacco for smoking’ means a tobacco product other than a smokeless tobacco product;

(34)

‘tobacco products’ means products usable for consumption by consumers and consisting of, even partly, tobacco, whether genetically modified or not;

(34)

‘tobacco products’ means products usable for consumption by consumers and consisting of, even partly, tobacco, whether genetically modified or not;

(35)

‘toxicity’ means the degree to which a substance can cause harmful effects in the human organism, including effects occuring over time, usually upon repeated or continuous consumption or exposure;

(35)

‘toxicity’ means the degree to which a substance can cause harmful effects in the human organism, including effects occuring over time, usually upon repeated or continuous consumption or exposure;

(36)

‘unit packet’ means the smallest individual packaging of a product that is placed on the market.

(36)

‘unit packet’ means the smallest individual packaging of a product that is placed on the market.

(36a)

‘passive smoking’ means the involuntary inhalation of smoke from the combustion of cigarettes or cigars or from the exhalation of one or more smokers.

(a)

vitamins and other additives that create the impression that a tobacco product has a health benefit or presents reduced health hazards;

(b)

caffeine and taurine and other additives and stimulant compounds that are associated with energy and vitality;

(c)

additives having colouring properties for emissions;

(d)

additives that meet the criteria for classification as hazardous substances in accordance with Regulation (EC) No 1272/2008, or that result in such substances upon combustion;

(e)

additives which, when used, may impart a characterising flavour.

(f)

additives that increase at the stage of consumption the toxic or addictive effect of a tobacco product.

(a)

vitamins and other additives that create the impression that a tobacco product has a health benefit or presents reduced health hazards, or

(b)

caffeine and taurine and other additives and stimulant compounds that are associated with energy and vitality, or

(c)

additives having colouring properties for emissions.

(a)

name or corporate name and permanent address of the applicant;

(b)

chemical name of the additive;

(c)

function of the additive and maximum quantity to be used per cigarette;

(d)

clear evidence supported by scientific data that the additive does not fall under any of the exclusion criteria listed in this Article.

(b)

to define the position, format, layout and design of the health warnings laid down in this Article, including their font type and background colour .

(c)

cover 75 % of the external area of both the front and back surface of the unit packet and any outside packaging;

(c)

cover 65 % of the external area of both the front and back surface of the unit packet and any outside packaging;

(i)

height: not less than 64  mm;

(i)

height: not less than 50  mm;

(ii)

width: not less than 55  mm.

(ii)

width: not less than 52  mm.

(c)

define the position, format, layout, design, rotation and proportions of the health warnings;

(d)

by way of derogation from Article 7(3), lay down the conditions under which health warnings may be broken during unit packet opening in a manner that ensures the graphical integrity and visibility of the text, photographs and cessation information

(a)

printed in black Helvetica bold type on a white background. In order to accommodate language requirements, Member States may determine the point size of the font, provided that the font size specified in their legislation is such as to occupy the greatest possible proportion of the area set aside for the text required;

(a)

printed in black Helvetica bold type on a white background. The warnings may be affixed by means of stickers, provided that such stickers are irremovable. In order to accommodate language requirements, Member States may determine the point size of the font, provided that the font size specified in their legislation is such as to occupy the greatest possible proportion of the area set aside for the text required;

(b)

centred in the area in which they are required to be printed, parallel to the top edge of the unit packet and any outside packaging;

(b)

centred in the area in which they are required to be printed, parallel to the top edge of the unit packet and any outside packaging;

(c)

surrounded by a black border not less than 3 mm and not more than 4 mm in width inside the surface reserved for the text of the warning.

(c)

surrounded by a black border not less than 3 mm and not more than 4 mm in width inside the surface reserved for the text of the warning.

(a)

be printed on the two largest surfaces of the unit packet and any outside packaging;

(a)

be printed on the two largest surfaces of the unit packet and any outside packaging;

(b)

cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging. That proportion shall be increased to 32 % for Member States with two official languages and 35 % for Member States with three official languages.

(b)

cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging. That proportion shall be increased to 32 % for Member States with two official languages and 35 % for Member States with more than two official languages

(a)

promotes a tobacco product by means that are false, misleading, deceptive or likely to create an erroneous impression about its characteristics, health effects, hazards or emissions;

(a)

promotes a tobacco product and encourages its consumption by means that are false, misleading, deceptive or likely to create an erroneous impression about its characteristics, health effects, hazards or emissions. Labels shall not include any information about nicotine, tar or carbon monoxide content;

(b)

suggests that a particular tobacco product is less harmful than others or has vitalising, energetic, healing, rejuvenating, natural, organic or otherwise positive health or social effects;

(b)

suggests that a particular tobacco product is less harmful than others or has vitalising, energetic, healing, rejuvenating, natural, organic or otherwise positive health effects;

(c)

refers to flavour, taste, any flavourings or other additives or the absence thereof;

(c)

refers to flavour, taste, any flavourings or other additives or the absence thereof;

(d)

resembles a food product.

(d)

resembles a food or a cosmetic product;

(da)

aims to reduce the effect of some harmful components of smoke or increase the biodegradability of tobacco products.

(a)

several visible print colours and production using gravure printing;

(b)

all white areas are coated;

(c)

complex printing with partially thin structures;

(d)

printing on white base paper;

(e)

pre-perforation situated sufficiently far from the end of the cigarette.

(a)

the date and place of manufacturing;

(a)

the date and place of manufacturing;

(b)

the manufacturing facility;

(b)

the manufacturing facility;

(c)

the machine used to manufacture the products;

(c)

the machine used to manufacture the products;

(d)

the production shift or time of manufacture;

(d)

the production shift or time of manufacture;

(e)

the product name ;

(e)

the product description ;

(f)

the intended market of retail sale;

(f)

the intended market of retail sale;

(g)

the intended shipment route;

(g)

the intended and actual shipment route from the place of manufacturing to the first retail outlet, including all warehouses used, the shipment date, shipment destination, consignee and point of departure;

(h)

where applicable, the importer into the Union;

(h)

where applicable, the importer into the Union;

(i)

the actual shipment route from manufacturing to the first retail outlet, including all warehouses used;

(j)

the identity of all purchasers from manufacturing to the first retail outlet;

(j)

the identity of all purchasers from manufacturing to the first retail outlet;

(k)

the invoice, order number and payment records of all purchasers from manufacturing to the first retail outlet.

(k)

the invoice, order number and payment records of all purchasers from manufacturing to the first retail outlet.

(a)

to define the key elements (such as duration, renewability, expertise required, confidentiality) of the contract referred to in paragraph 6, including its regular monitoring and evaluation;

(a)

to define the key elements (such as duration, renewability, expertise required, confidentiality) of the contract referred to in paragraph 6, including its regular monitoring and evaluation;

(b)

to define the technical standards to ensure that the systems used for the unique identifiers and the related functions are fully compatible with each other across the Union and

(b)

to define the technical standards to ensure that the systems used for the unique identifiers and the related functions are fully compatible with each other across the Union and in line with international standards.

(c)

to define the technical standards for the security feature and their possible rotation and to adapt them to scientific, market and technical development.

(a)

name or corporate name and permanent address of the place of activity from where the tobacco products are supplied;

(b)

the starting date of the activity of offering tobacco products for cross-border distance sales to the public by means of information society ©vices;

(c)

the address of the website/-s used for that purpose and all relevant information necessary to identify the website.

(a)

available scientific studies on toxicity, addictiveness and attractiveness of the product, in particular as regards its ingredients and emissions;

(a)

available scientific studies on toxicity, addictiveness and attractiveness of the product, in particular as regards its ingredients and emissions;

(b)

available studies and market research on preferences of various consumer groups, including young people and

(b)

working summaries of the available studies and market research on preferences of various consumer groups, including young people and chronic heavy smokers;

(c)

other available and relevant information, including a risk/benefit analysis of the product, the expected effects on cessation of tobacco consumption, the expected effects on initiation of tobacco consumption and other predicted consumer perception.

(c)

other available and relevant information, including a risk/benefit analysis of the product, the expected effects on cessation of tobacco consumption, the expected effects on initiation of tobacco consumption and other predicted consumer perception.

(a)

products with a nicotine level exceeding 2 mg per unit, or

(b)

products with a nicotine concentration exceeding 4 mg per ml or

(c)

products whose intended use results in a mean maximum peak plasma concentration exceeding 4 ng of nicotine per ml.

(a)

nicotine-containing products with a nicotine level exceeding 30 mg/ml are not placed on the market;

(b)

manufacturers and importers of nicotine-containing products submit to the competent authorities a list of all ingredients contained in and emissions resulting from the use of the product, by brand name and type, including quantities thereof, as well as any changes. Member States shall then ensure the dissemination of this information on a website with due regard to the protection of trade secrets. Manufacturers and importers shall also report to the authorities about national sales volumes by brand name and type;

(c)

nicotine-containing products with additives listed in Article 6(4) are not placed on the market;

(d)

the unit packet of nicotine-containing products includes a leaflet with instructions for use, including that the reference that the product is not recommended for use by non-smokers, contra-indications, warnings for specific risk groups, reporting of adverse reactions, place of manufacture and contact details of the manufacturer or importer;

(e)

each unit packet and any outside packaging of nicotine-containing products carry the following health warning:

‘This product is intended for use by existing smokers. It contains nicotine which is a highly addictive substance ’;

(f)

the sale of the product is restricted in line with the legal age for sale of tobacco products in the relevant Member State; in any case it should not be allowed under the age of 18;

(g)

the products are available to be sold outside pharmacies;

(h)

flavourings are allowed in the products;

(i)

the limitations on advertising, sponsorship, audiovisual commercial communication and product placement for tobacco products as set out in Directive 2003/33/EC and Directive 2010/13/EC shall apply to nicotine-containing products;

(j)

cross-border distance sales of nicotine-containing products are regulated in accordance with Article 16;

(k)

tobacco trademarks, brand names and symbols are not used on nicotine-containing products.

(a)

be printed on the two largest surfaces of the unit packet and any outside packaging;

(b)

cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging. That proportion shall be increased to 32 % for Member States with two official languages and 35 % for Member States with three official languages.

(ca)

evaluation of the addictive effects of those ingredients which encourage addiction;

(cb)

development of standardised testing methods to measure the yields of constituents in cigarette smoke other than tar, nicotine and carbon monoxide;

(cc)

toxicological data to be required from manufacturers on ingredients and the manner in which they should be tested in order to allow public health authorities to assess their use;

(cd)

development of standards concerning products other than cigarettes.

(a)

tobacco products;

(a)

tobacco products;

(b)

nicotine containing products below the threshold set out in Article 18(1);

(c)

herbal products for smoking.

(b)

herbal products for smoking.

(1)

Smoking causes 9 out of 10 lung cancers

(1)

Smoking causes 9 out of 10 lung cancers

(2)

Smoking causes mouth and throat cancer

(2)

Smoking causes mouth and throat cancer

(2a)

(3)

Smoking damages your lungs

(3)

Smoking damages your lungs

(4)

Smoking causes heart attacks

(4)

Smoking causes heart attacks

(5)

Smoking causes strokes and disability

(5)

Smoking causes strokes and disability

(6)

Smoking clogs your arteries

(6)

Smoking clogs your arteries

(7)

Smoking increases the risk of blindness

(7)

Smoking increases the risk of blindness

(8)

Smoking damages your teeth and gums

(8)

Smoking damages your teeth and gums

(9)

Smoking can kill your unborn child

(9)

Smoking can kill your unborn child

10)

Your smoke harms your children, family and friends

10)

Your smoke harms your children, family and friends

(11)

Smokers’ children are more likely to start smoking

(11)

Smokers’ children are more likely to start smoking

(12)

Quit smoking — stay alive for those close to you

(12)

Quit smoking — stay alive for those close to you

(13)

Smoking reduces fertility

(13)

Smoking reduces fertility

(14)

Smoking increases the risk of impotence

(14)

Smoking increases the risk of impotence

(14a)

(14b)

(14c)