### subject to safety constraints , where a tarmac delay exceeds one hour , the operating air carrier shall provide free of charge access to toilet facilities and drinking water , shall ensure adequate heating or cooling of the passenger cabin , and shall ensure that adequate medical attention is available if needed . where a tarmac delay reaches a maximum of five hours , the aircraft shall return to the gate or another suitable disembarkation point where passengers shall be allowed to disembark and to benefit from the same assistance as specified in paragraph 1 , unless there are safety - related or security - related reasons why the aircraft cannot leave its position on the tarmac . ' ### subject to safety constraints , where a tarmac delay occurs , the operating air carrier shall provide free of charge access to toilet facilities and drinking water , shall ensure adequate heating or cooling of the passenger cabin , and shall ensure that adequate medical attention is available if needed . where a tarmac delay reaches a maximum of two hours , the aircraft shall return to the gate or another suitable disembarkation point where passengers shall be allowed to disembark and to benefit from the same assistance as specified in paragraph 1 , unless there are safety - related or security - related reasons why the aircraft cannot leave its position on the tarmac . '


### when the delay is of at least two hours , the assistance specified in article 9 and 9 ; and ### the assistance specified in article 9 and 9 ; and


### the assistance specified in article 9 and 9 if the passenger ' s waiting time for the connection is prolonged by at least two hours ; and ### the assistance specified in article 9 and 9 ; and


### an investigation shall be initiated upon request by a member state or on the commission ' s own initiative if it is apparent to the commission that there is sufficient evidence to justify such initiation . ### an investigation shall be initiated upon request by a member state , the european parliament , the domestic advisory group or a representative of producer associations or sectors of the economy or on the commission ' s own initiative if it is apparent to the commission that there is sufficient evidence to justify such initiation .


### the investigation shall , whenever possible , be concluded within six months of the initiation of the investigation . in exceptional circumstances duly justified by the commission , that time limit may be extended by a further period of three months . ### the investigation shall be concluded within 200 days of the initiation of the investigation .


### ' union industry ' means the union producers as a whole of the like or directly competitive products operating within the territory of the union , or those union producers whose collective output of the like or directly competitive products constitutes a major proportion of the total union production of those products ; ### ' union industry ' means the union producers as a whole of the like or directly competitive products operating within the territory of the union , or those union producers whose collective output of the like or directly competitive products constitutes a major proportion of the total union production of those products . in the case where the like or directly competitive product is only one of several products that are made by the producers who constitute the union industry , the industry shall be defined as the specific operations that are involved in the production of the like or directly competitive product ;


### a safeguard measure may be imposed in accordance with the provisions set out in this regulation where a product originating in korea is , as a result of the reduction or the elimination of the customs duties on that product , being imported in the union in such increased quantities , in absolute terms or relative to domestic production , and under such conditions as to cause or threaten to cause serious injury to the union industry producing a like or directly competitive product . ### a safeguard measure may be imposed in accordance with the provisions set out in this regulation where a product originating in korea is , following the reduction or the elimination of the customs duties on that product , being imported in the union in such increased quantities , in absolute terms or relative to domestic production , and under such conditions as to cause or threaten to cause serious injury to the union industry or to the regional industry producing a like or directly competitive product .


### the sst support programme should be financed by the union in accordance with regulation no 966 / 2012 of the european parliament and of the council of 25 october 2012 on the financial rules applicable to the general budget of the union18 . union funding for the sst support programme should be drawn from relevant programmes provided for in the multiannual financial framework for 2014 - 2020 . __________________ 18 oj l 298 , 26 . 10 . 2012 , p . 1 . ### the sst support programme should be financed by the union in accordance with regulation no 966 / 2012 of the european parliament and of the council of 25 october 2012 on the financial rules applicable to the general budget of the union18 . union funding for the sst support programme should be drawn from relevant programmes provided for in the multiannual financial framework for 2014 - 2020 , while ensuring that their own objectives are not jeopardised . __________________ 18 oj l 298 , 26 . 10 . 2012 , p . 1 .


### diversity of competences and views of the members of administrative , management and supervisory bodies of companies facilitates a good understanding of the business organisation and affairs . it enables members of these bodies to exercise a constructive challenge of the management decisions and to be more open to innovative ideas , addressing the similarity of views of members , the ' group - think ' phenomenon . it contributes thus to effective oversight of the management and a successful governance of the company . it would therefore be important to enhance transparency regarding the diversity policy companies have in place . this would inform the market of corporate governance practices and thus put indirect pressure on companies to have more diversified boards . ### diversity of competences and views of the members of administrative , management and supervisory bodies of companies , including gender diversity , facilitates a good understanding of the business organisation and affairs . it has been acknowledged that gender diversity , especially in top positions , contributes to corporate governance , quality of decision - making and to the company ' s performance . moreover , board diversity represents a benefit for the companies as board composition reflects demographic characteristics of key stakeholder groups such as employee , customer and investor . furthermore , it enables members of these bodies to exercise a constructive challenge of the management decisions and to be more open to innovative ideas , addressing the similarity of views of members , the ' group - think ' phenomenon . it contributes thus to effective oversight of the management and a successful governance of the company . it would therefore be important to enhance transparency regarding the diversity policy , especially gender diversity , companies have in place . this would inform the market of corporate governance practices and thus put indirect pressure on companies to have more diversified boards .


### a description of the company ' s diversity policy for its administrative , management and supervisory bodies with regard to aspects such as age , gender , geographical diversity , educational and professional background , the objectives of this diversity policy , how it has been implemented and the results in the reporting period . if the company has no such policy , the statement shall contain a clear and reasoned explanation as to why this is the case . ### a description of the company ' s diversity policy for its administrative , management and supervisory bodies with regard to gender and other aspects such as age , gender , geographical diversity , educational and professional background , the objectives of this diversity policy , how it has been implemented and the results in the reporting period . effective monitoring of equal opportunities and diversity in the workplace is an important part of improved human capital management and equality practice . if the company has no such policy , it shall be subject to administrative and financial sanctions .


### the obligation to disclose their diversity policies for their administrative , management and supervisory bodies with regard to aspects such as age , gender , geographical diversity , educational and professional background should only apply to large listed companies . therefore small and medium - sized companies that may be exempted from certain accounting obligations under article 27 of directive 78 / 660 / eec should not be covered to by this obligation . disclosure of the diversity policy should be part of the corporate governance statement , as laid down by article 46a of directive 78 / 660 / eec . companies not having a such a diversity policy should not be obliged to put one in place , but they should clearly explain why this is the case . ### the obligation to disclose their diversity policies for their administrative , management and supervisory bodies with regard to gender and other aspects such as age , geographical diversity , educational and professional background should only apply to large listed companies . therefore small and medium - sized companies that may be exempted from certain accounting obligations under article 27 of directive 78 / 660 / eec should not be covered to by this obligation . disclosure of the diversity policy should be part of the corporate governance statement , as laid down by article 46a of directive 78 / 660 / eec . companies not having such a diversity policy shall be subject to administrative and financial sanctions .


### for parent undertakings of undertakings to be consolidated that together exceed an average number of 500 employees during the financial year , and , on their balance sheet dates , exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million , the review shall also include a non - financial statement containing information relating to at least environmental , social and employee matters , respect for human rights , anti - corruption and bribery matters , including the following : ### for parent undertakings of undertakings to be consolidated that together exceed an average number of 250 employees during the financial year , and , on their balance sheet dates , exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million , the review shall also include a non - financial statement containing information relating to at least environmental , gender equality , social and employee matters , respect for human rights , anti - corruption and bribery matters , including the following :


### the obligation to disclose their diversity policies for their administrative , management and supervisory bodies with regard to aspects such as age , gender , geographical diversity , educational and professional background should only apply to large listed companies . therefore small and medium - sized companies that may be exempted from certain accounting obligations under article 27 of directive 78 / 660 / eec should not be covered to by this obligation . disclosure of the diversity policy should be part of the corporate governance statement , as laid down by article 46a of directive 78 / 660 / eec . companies not having a such a diversity policy should not be obliged to put one in place , but they should clearly explain why this is the case . ### the obligation to disclose their diversity policies for their administrative , management and supervisory bodies with regard to gender and other aspects such as age , geographical diversity , disability , educational and professional background should only apply to large listed companies . therefore small and medium - sized companies that may be exempted from certain accounting obligations under article 27 of directive 78 / 660 / eec should not be covered to by this obligation . disclosure of the diversity policy should be part of the corporate governance statement , as laid down by article 46a of directive 78 / 660 / eec . companies not having a such a diversity policy should not be obliged to put one in place , but they should clearly explain why this is the case .


### in providing such information the company may rely on national , eu - based or international frameworks and , if so , shall specify which frameworks it has relied upon . ### in providing this information the company should rely on either eu - framework or the united nations guiding principles on business and human rights and the organisation for economic co - operation and development guidelines for multinational enterprises , and if so , the company shall specify which frameworks it relies on .


### in providing such information the consolidated annual report may rely on national , eu - based or international frameworks and if so , shall specify which frameworks it has relied upon . ### in providing this information the company shall rely on either eu - based framework or the united nations guiding principles on business and human rights and the organisation for economic co - operation and development guidelines for multinational enterprises , and if so , the company shall specify which frameworks it relies on .


### the scope of these non - financial disclosure requirements should be defined by reference to the average number of employees , total assets and turnover . smes should be exempted from additional requirements , and the obligation to disclose a non - financial statement in the annual report should only apply to those companies whose average number of employees exceeds 500 , and exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million . ### the scope of these non - financial disclosure requirements should be defined by reference to the average number and gender of employees , total assets and turnover . smes should be exempted from additional requirements , and the obligation to disclose a non - financial statement in the annual report should only apply to those companies whose average number of employees exceeds 250 , and exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million .


### in order to enhance consistency and comparability of non - financial information disclosed throughout the union , companies should be required to include in their annual report a non - financial statement containing information relating to at least environmental matters , social and employee - related matters , respect for human rights , anti - corruption and bribery matters . such statement should include a description of the policies , results , and the risks related to those matters . ### in order to enhance consistency and comparability of non - financial information disclosed throughout the union , companies should be required to include in their annual report a non - financial statement containing information relating to at least environmental matters , gender equality and diversity , social and employee - related matters , respect for human rights , anti - corruption and bribery matters . such statement should include a description of the policies , results , and the risks related to those matters .


### this directive respects the fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union , including the freedom to conduct a business , respect for private life and the protection of personal data . this directive has to be implemented in accordance with these rights and principles . ### this directive respects the fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union , including non - discrimination , equality between women and men , the freedom to conduct a business , respect for private life and the protection of personal data . this directive has to be implemented in accordance with these rights and principles .


### it is crucial to make clear to manufacturers and users that by affixing the ce marking to the product , the manufacturer declares that the product is in conformity with all applicable requirements and takes full responsibility thereof . ### by affixing the ce marking to the product , manufacturers should take full responsibility for the product being in conformity with the applicable requirements . manufacturers and users should be given more information about this in order to achieve the objectives of ce marking .


### in order to ensure that the financial contribution which has been paid by the managing authorities into financial engineering instruments and included in a statement of expenditure is effectively spent within a defined timeframe , it is necessary to introduce an obligation for financial engineering instruments to spend the contribution for eligible expenditure within two years of the date of the relevant certified statement of expenditure . the subsequent statement of expenditure should be corrected accordingly , by deducing the unspent amounts , if the contribution in question has not been spent within the indicated period . ### in order to ensure that the financial contribution which has been paid by the managing authorities into financial engineering instruments and included in a statement of expenditure is effectively spent within a defined timeframe , it is necessary to introduce an obligation for financial engineering instruments to spend the contribution for eligible expenditure within two years of the date of the relevant certified statement of expenditure . the subsequent statement of expenditure should be corrected accordingly , by deducing the unspent amounts , if the contribution in question has not been spent within the indicated period . in such cases the eligible administrative costs or charges must also be adjusted so that they are proportionate to the overall performance of the financial engineering instrument .


### having regard to the need of ensuring appropriate monitoring , by the member states as well as by the commission , of the implementation of financial engineering instruments , inter alia in order to allow the member states to provide appropriate information to the commission on the type of instruments put in place and on the relevant actions undertaken by such instruments on the ground , it is necessary to introduce a provision on reporting . this would also allow the commission to better assess the overall performance of financial engineering instruments . ### having regard to the need of ensuring appropriate monitoring , by the member states as well as by the commission , of the implementation of financial engineering instruments and repayable assistance , inter alia in order to allow the member states to provide appropriate information to the commission on the type of instruments and repayable assistance put in place and on the relevant actions undertaken in the context of such measures on the ground , it is necessary to introduce a provision on reporting . this would also allow the commission to better assess the overall performance of financial engineering instruments and repayable assistance .


### in article 78 , the following sub - paragraph is added : ' the financial contribution to financial engineering instruments as defined in article 44 , which has been included in a statement of expenditure and which has not been paid out as eligible expenditure in line with the second subparagraph of this paragraph within two years of the date of the certified statement of expenditure concerned , shall be deducted from the next certified statement of expenditure . ' ### in article 78 , the following sub - paragraph is added : ' the financial contribution to financial engineering instruments as defined in article 44 , which has been included in a statement of expenditure and which has not been paid out as eligible expenditure in line with the second subparagraph of this paragraph within two years of the date of the certified statement of expenditure concerned , shall be deducted from the next certified statement of expenditure . in such cases eligible administrative costs or charges shall be limited to an amount reflecting the ratio of the eligible expenditure to the financial contribution originally included in the declaration of expenditure . '


### the following article 78a is inserted : ' article 78a requirement to provide information in the statement of expenditure the statement of expenditure to be submitted to the commission shall provide all the information necessary for the commission to produce accounts in accordance with article 61 of the regulation 1605 / 2002 . for the purpose of defining the uniform conditions of application of this article , the commission shall be empowered to adopt implementing acts according to article 291 of the treaty on the functioning of the european union . ' ### the following article 78a is inserted : ' article 78a requirement to provide information in the statement of expenditure the statement of expenditure to be submitted to the commission shall provide all the information necessary for the commission to produce accounts in accordance with article 61 and title vii of the regulation 1605 / 2002 . for the purpose of defining the uniform conditions of application of this article , the commission shall be empowered to adopt implementing acts according to article 291 of the treaty on the functioning of the european union . '


### having regard to the need of ensuring appropriate monitoring , by the member states as well as by the commission , of the implementation of financial engineering instruments , inter alia in order to allow the member states to provide appropriate information to the commission on the type of instruments put in place and on the relevant actions undertaken by such instruments on the ground , it is necessary to introduce a provision on reporting . this would also allow the commission to better assess the overall performance of financial engineering instruments . ### having regard to the need to enhance the transparency of the implementation process and ensure appropriate monitoring , by the member states as well as by the commission , of the implementation of financial engineering instruments , inter alia in order to allow the member states to provide appropriate information to the commission on the type of instruments put in place and on the relevant actions undertaken by such instruments on the ground , it is necessary to introduce a provision on reporting . this would also allow the commission to better assess the overall performance of financial engineering instruments .


### the following article 67a is inserted : ' article 67a reports on implementation of financial engineering instruments by 31 january and by 15 september each year , the managing authority shall send to the commission a specific report covering the operations consisting of financial engineering instruments for the period until 31 december and until 30 june respectively . 2 . the reports referred to in paragraph 1 shall include , for each financial engineering instrument , the following information : description of the financial engineering instrument and implementation arrangements ; identification of the entities which implement the financial engineering instrument , including those acting through holding funds , as well as description of their selection process ; dates of payments and amounts of the assistance from the structural funds and national co - financing paid to the financial engineering instrument ; dates and corresponding amounts included in statements of expenditure submitted to the commission and dates and amounts reimbursed by the commission ; amounts of the assistance from the structural funds and national co - financing paid by the financial engineering instrument . ' ### the following article 67a is inserted : ' article 67a reports on implementation of financial engineering instruments and repayable assistance by 31 january and by 15 september each year , the managing authority shall send to the commission a specific report covering the operations consisting of financial engineering instruments or repayable assistance for the period until 31 december and until 30 june respectively . 2 . the reports referred to in paragraph 1 shall include , for each financial engineering instrument and repayable assistance measure , the following information : description of the financial engineering instrument or repayable assistance and of implementation arrangements ; identification of the entities which implement the financial engineering instrument or repayable assistance , including financial engineering instruments acting through holding funds , as well as description of their selection process ; c ) dates of payments and amounts of the assistance from the structural funds and national co - financing paid to the financial engineering instrument or repayable assistance measure ; dates and corresponding amounts included in statements of expenditure submitted to the commission and dates and amounts reimbursed by the commission ; amounts of the assistance from the structural funds and national co - financing paid by the financial engineering instrument . '


### in respect of any measure which may give rise to expenditure chargeable to the budget , the authorising officer responsible must first make a budgetary commitment before entering into a legal obligation with third parties or transferring funds to a trust fund on the basis of article 178 . ### notwithstanding article 82 , in respect of any measure which may give rise to expenditure chargeable to the budget , the authorising officer responsible must first make a budgetary commitment before entering into a legal obligation with third parties or transferring funds to a trust fund on the basis of article 178 . however , in the case of humanitarian aid operations , civil protection operations and crisis management aid , and when the urgency of the situation so demands , the registration of the amounts may be done immediately after the signature of the corresponding individual legal commitment .


### 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 . ### considering the directive ' s focus on young people , tobacco products other than cigarettes , roll - your - own tobacco and tobacco for oral use , which are mainly consumed by older consumers , should be granted an exemption from certain ingredients requirements . the commission should carefully monitor the use of water - pipe tobacco by young people as there is increasing evidence of its use beyond the traditional , older market .


### member states shall notify the commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes . taking into account internationally agreed standards , where available , and based on scientific evidence and on the yields notified by member states , the commission shall be empowered to adopt delegated acts in accordance with article 22 to adopt and adapt maximum yields for other emissions of cigarettes and for emissions of tobacco products other than cigarettes that increase in an appreciable manner the toxic or addictive effect of tobacco products beyond the threshold of toxicity and addictiveness stemming from the yields of tar , nicotine and carbon monoxide fixed in paragraph 1 . ### member states shall notify the commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes . taking into account internationally agreed standards based on sound and undisputed scientific evidence and on the yields notified by member states , the commission may put forward proposals to adapt maximum yields for other emissions of cigarettes and for emissions of tobacco products other than cigarettes that increase in an appreciable manner the toxic or addictive effect of tobacco products beyond the threshold of toxicity and addictiveness stemming from the yields of tar , nicotine and carbon monoxide fixed in paragraph 1 .


### 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 . ### 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 ' or ' organic ' .


### 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 no 182 / 2011 . ### 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 no 182 / 2011 .


### 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 should be avoided . ### the likelihood of diverging regulation is further increased by concerns over tobacco products , having a characterising flavour other than tobacco and menthol , which may facilitate uptake of tobacco consumption or affect consumption patterns .


### member states shall prohibit the use of flavourings in the components of tobacco products such as filters , papers , packages , capsules or any technical features allowing modification of flavour or smoke intensity . filters and capsules shall not contain tobacco . ### the use of flavourings in the components of tobacco products such as filters , papers , packages , capsules or any technical features allowing modification of flavour or smoke intensity shall be prohibited . filters and capsules shall not contain tobacco .


### 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 . ### 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 .


### member states shall ensure that manufacturers and importers of tobacco products conclude data storage contracts with an independent third party , which shall host the data storage facility for data relating to the manufacturer and importer concerned . the data storage facility shall be physically located on the territory of the union . the suitability of the third party , in particular its independence and technical capacities , as well as the contract , shall be approved and monitored by an external auditor , who is proposed and paid by the tobacco manufacturer and approved by the commission . member states shall ensure full transparency and accessibility of the data storage facilities for the competent authorities of the member states , the commission and the independent third party on a permanent basis . in duly justified cases member states or the commission can provide manufacturers or importers access to this information , provided commercially sensitive information remains adequately protected in conformity with the relevant national and union legislations . ### member states shall ensure that manufacturers and importers of tobacco products conclude data storage contracts with an independent third party which shall host the data storage facility for data relating to the manufacturer and importer concerned . the data storage facility shall be physically located on the territory of the union . the independent third party shall be free from commercial and other vested interests of the tobacco industry and other related industries . the suitability of the third party , in particular its independence and technical capacities , as well as the contract , shall be approved and monitored by the commission , assisted by an independent external auditor , who is paid by the tobacco manufacturer and approved by the commission . member states shall ensure full transparency and accessibility of the data storage facilities for the competent authorities of the member states , the commission and the independent third party on a permanent basis . in duly justified cases member states or the commission can provide manufacturers or importers access to this information , provided commercially sensitive information remains adequately protected in conformity with the relevant national and union legislations .


### in case the experience gained in the application of paragraphs 1 and 2 shows that a certain additive or a combination thereof typically impart a characterising flavour when it exceeds a certain level of presence or concentration the commission shall be empowered to adopt delegated acts in accordance with article 22 to set maximum levels for those additives or combination of additives that cause the characterising flavour . ### in case a certain additive or a combination thereof typically imparts a flavour or increases palatability only when it exceeds a certain level of presence or concentration the commission shall be empowered to adopt delegated acts in accordance with article 22 to set maximum levels for those additives or combination of additives by modifying annex - i accordingly .


### member states shall oblige retail outlets intending to engage in cross - border distance sales to consumers located in the union to register with the competent authorities in the member state where the retail outlet is established and in the member state where the actual or potential consumer is located . retail outlets established outside the union have to register with the competent authorities in the member state where the actual or potential consumer is located . all retail outlets intending to engage in cross - border distance sales shall submit at least the following information to the competent authorities : name or corporate name and permanent address of the place of activity from where the tobacco products are supplied ; the starting date of the activity of offering tobacco products for cross - border distance sales to the public by means of information society services ; the address of the website / - s used for that purpose and all relevant information necessary to identify the website . ### member states shall prohibit retail outlets established on their territory from engaging in cross border distance sales .


### member states shall oblige retail outlets intending to engage in cross - border distance sales to consumers located in the union to register with the competent authorities in the member state where the retail outlet is established and in the member state where the actual or potential consumer is located . retail outlets established outside the union have to register with the competent authorities in the member state where the actual or potential consumer is located . all retail outlets intending to engage in cross - border distance sales shall submit at least the following information to the competent authorities : ### member states shall prohibit the sale of tobacco products over the internet in their territory .


### width : not less than 55 mm . ### width : the full width of the front and back surfaces of the packaging .


### the following nicotine - containing products may only be placed on the market if they were authorised pursuant to directive 2001 / 83 / ec : ### nicotine - containing products may only be placed on the market if they are authorised pursuant to directive 2001 / 83 / ec , taking into account the well - established use of nicotine .


### the commission shall be empowered to adopt delegated acts in accordance with article 22 to adapt the maximum yields laid down in paragraph 1 , taking into account scientific development and internationally agreed standards . ### the commission shall be empowered to adopt delegated acts in accordance with article 22 to reduce the maximum yields laid down in paragraph 1 , taking into account scientific development and internationally agreed standards .


### 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 . ### 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 scientific development and internationally agreed standards to assess their toxicity or addictiveness .


### this directive shall not affect the right of member states to maintain or introduce , in accordance with the treaty , national provisions concerning aspects not regulated by this directive . these national provisions must be justified by overriding reasons of public interest and be necessary and proportionate to their aim . they must not be a means of arbitrary discrimination or a disguised restriction on trade between the member states and must not jeopardise the full application of this directive . ### this directive shall not affect the right of member states to maintain or introduce , in accordance with the treaty , national provisions concerning aspects not regulated by this directive . these national provisions must be justified by overriding reasons of public interest and be necessary and proportionate to their aim . they shall apply to all products alike , including those imported from another member state or a third country , must not be a means of arbitrary discrimination or a disguised restriction on trade between the member states , and must not jeopardise the full application of this directive .


### 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 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 . ### 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 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 . however , measuring nicotine delivery has proven to be difficult , as it depends on the products and how they are being used . therefore , subjecting all nicotine - containing products regardless of their nicotine content to directive 2001 / 83 / ec 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 .


### 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 ; ### 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 ;


### member states shall , based on scientific evidence , prohibit the placing on the market of tobacco products with additives in quantities that increase in an appreciable manner at the stage of consumption the toxic or addictive effect of a tobacco product . ### member states shall , based on scientific evidence , prohibit the placing on the market of tobacco products with additives in quantities that increase significantly , on the basis of an international standard , at the stage of consumption the toxic or addictive effect of a tobacco product .


### member states shall ensure that manufacturers and importers of tobacco products conclude data storage contracts with an independent third party , which shall host the data storage facility for data relating to the manufacturer and importer concerned . the data storage facility shall be physically located on the territory of the union . the suitability of the third party , in particular its independence and technical capacities , as well as the contract , shall be approved and monitored by an external auditor , who is proposed and paid by the tobacco manufacturer and approved by the commission . member states shall ensure full transparency and accessibility of the data storage facilities for the competent authorities of the member states , the commission and the independent third party on a permanent basis . in duly justified cases member states or the commission can provide manufacturers or importers access to this information , provided commercially sensitive information remains adequately protected in conformity with the relevant national and union legislations . ### member states shall conclude data storage contracts with an independent third party , which shall host the data storage facility for data relating to manufacturers and importers of tobacco products under their jurisdiction . the data storage facility shall be physically located on the territory of the union . the suitability of the third party , in particular its independence and technical capacities , as well as the contract , shall be approved and monitored by an external auditor , who is paid by the tobacco manufacturer and appointed by the commission . member states shall ensure full transparency and accessibility of the data storage facilities for the competent authorities of the member states , the commission and the independent third party on a permanent basis . in duly justified cases member states or the commission can provide manufacturers or importers access to this information , provided commercially sensitive information remains adequately protected in conformity with the relevant national and union legislations .


### member states shall oblige retail outlets intending to engage in cross - border distance sales to consumers located in the union to register with the competent authorities in the member state where the retail outlet is established and in the member state where the actual or potential consumer is located . retail outlets established outside the union have to register with the competent authorities in the member state where the actual or potential consumer is located . all retail outlets intending to engage in cross - border distance sales shall submit at least the following information to the competent authorities : 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 services ; c ) the address of the website / - s used for that purpose and all relevant information necessary to identify the website . 2 . the competent authorities of the member states shall publish the complete list of all retail outlets registered with them in accordance with the rules and safeguards laid down in directive 95 / 46 / ec retail outlets may only start placing tobacco products on the market in form of distance sales as of the moment the name of the retail outlet is published in the relevant member states . 3 . if it is necessary in order to ensure compliance and facilitate enforcement , member states of destination may require that the retail outlet nominates a natural person who is responsible for verifying the tobacco products before reaching the consumer comply with the national provisions adopted pursuant to this directive in the member state of destination 4 . retail outlets engaged in distance sales shall be equipped with an age verification system , which verifies at the time of sale , that the purchasing consumer respects the minimum age foreseen under the national legislation of the member state of destination . the retailer or nominated natural person shall report to the competent authorities a description of the details and functioning of the age verification system . 5 . personal data of the consumer shall only be processed in accordance with directive 95 / 46 / ec and not be disclosed to the manufacturer of tobacco products or companies forming part of the same group of companies or to any other third parties . personal data shall not be used or transferred beyond the purpose of this actual purchase . this also applies if the retail outlet forms part of a manufacturer of tobacco products . ### member states shall prohibit the sale of tobacco products over the internet in their territory .


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


### however , a member state may maintain more stringent national provisions , applicable to all products alike , in areas covered by the directive , on grounds of overriding needs relating to the protection of public health . a member state may also introduce more stringent provisions , on grounds relating to the specific situation of this member state and provided the provisions are justified by the need to protect public health . such national provisions shall be notified to the commission together with the grounds for maintaining or introducing them . the commission shall , within six months from the date of receiving the notification , approve or reject the provisions after having verified , taking into account the high level of health protection achieved through this directive , whether or not they are justified , necessary and proportionate to their aim and whether or not they are a means of arbitrary discrimination or a disguised restriction on trade between the member states . in the absence of a decision by the commission within this period the national provisions shall be deemed to be approved . ### however , a member state may maintain more stringent national provisions in areas covered by the directive , on grounds of overriding needs relating to the protection of public health . a member state may also introduce more stringent provisions on grounds relating to the specific situation of this member state and provided the provisions are justified by the need to protect public health . such national provisions shall apply to all products alike , including those imported from another member state or a third country . they shall be notified to the commission together with the grounds for maintaining or introducing them . the commission shall , within six months from the date of receiving the notification , approve or reject the provisions after having verified , taking into account the high level of health protection achieved through this directive , whether or not they are justified , necessary and proportionate to their aim and whether or not they are a means of arbitrary discrimination or a disguised restriction on trade between the member states . in the absence of a decision by the commission within this period the national provisions shall be deemed to be approved .


### member states shall , based on scientific evidence , prohibit the placing on the market of tobacco products with additives in quantities that increase in an appreciable manner at the stage of consumption the toxic or addictive effect of a tobacco product . ### annex - i shall not contain , based on scientific evidence , additives in quantities that increase at the stage of consumption the toxic or addictive effect of a tobacco product .


### in accordance with article 114 of the treaty of the functioning of the european union , 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 . ### in accordance with article 114 of the treaty on the functioning of the european union , 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 , and especially where primary schools are concerned , smoking prevention campaigns should be organised in member states , as should information programmes on the harmful effects of smoking from the health point of view .


### member states shall send the commission a list of approved laboratories , specifying the criteria used for approval and the methods of monitoring applied , and update it whenever any change is made . the commission shall make the list of approved laboratories as indicated by member states publicly available . ### member states shall send the commission a list of approved laboratories , specifying the criteria used for approval , any economic ties the laboratories may have and the methods of monitoring applied , and update it whenever any change is made . member states shall document the independence of the laboratories . additional checks may be carried out on laboratories , if the commission so wishes , and the commission can decide to exclude a laboratory . the commission shall make the list of approved laboratories as indicated by member states publicly available .


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


### the power to adopt delegated acts referred to in articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 shall be conferred on the commission for an indeterminate period of time from [ office of publications : please insert the date of the entry into force of this directive ] . ### the power to adopt delegated acts referred to in articles 6 and 14 , shall be conferred on the commission for a period of five years from [ office of publications : please insert the date of the entry into force of this directive ] .


### be comprised of a text warning listed in annex i and a corresponding colour photograph specified in the picture library ; ### be comprised of a text warning listed in annex i and a corresponding colour photograph specified in the picture library in annex i bis ;


### 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 . ### tobacco products for smoking , other than cigarettes and roll - your - own tobacco products , should be subject to the same labelling requirements as cigarettes and roll - your - own tobacco products . 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 .


### in order to ensure their graphic integrity and visibility , health warnings shall be irremovably printed , indelible and in no way hidden or interrupted , including by tax stamps , price marks , tracking and tracing marks , security features or by any type of wrapper , pouch , jacket , box or other device or by the opening of the unit packet . ### in order to ensure their graphic integrity and visibility , and without prejudice to the labelling provisions in article 10 and 11 , health warnings shall be irremovably printed or irremovable affixed , indelible and in no way hidden or interrupted , including by tax stamps , price marks , tracking and tracing marks , security features or by any type of wrapper , pouch , jacket , box or other device or by the opening of the unit packet .


### 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 . ### 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 methodology for determining whether a tobacco product has characterising flavour , 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 .


### 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 . ### nicotine - containing products are sold on the union market . however , member states have taken different regulatory approaches which are undermining the internal market , in particular considering that these products are subject to significant cross - border distance sales including via the internet . there is a need for harmonized rules , and given the potential of these products to aid with the harm reduction agenda , there should be an option for a light - touch regulatory regime to guarantee safety and quality , which is a middle - way between medicines and tobacco regulation .


### member states shall notify the commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes . taking into account internationally agreed standards , where available , and based on scientific evidence and on the yields notified by member states , the commission shall be empowered to adopt delegated acts in accordance with article 22 to adopt and adapt maximum yields for other emissions of cigarettes and for emissions of tobacco products other than cigarettes that increase in an appreciable manner the toxic or addictive effect of tobacco products beyond the threshold of toxicity and addictiveness stemming from the yields of tar , nicotine and carbon monoxide fixed in paragraph 1 . ### member states shall notify the commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes . taking into account internationally agreed standards , where available , and based on scientific evidence and on the yields notified by member states , the commission shall be empowered to adopt delegated acts in accordance with article 22 to adopt and reduce maximum yields for other emissions of cigarettes and for emissions of tobacco products other than cigarettes that increase in an appreciable manner the toxic or addictive effect of tobacco products beyond the threshold of toxicity and addictiveness stemming from the yields of tar , nicotine and carbon monoxide fixed in paragraph 1 .


### member states shall notify the commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes . taking into account internationally agreed standards , where available , and based on scientific evidence and on the yields notified by member states , the commission shall be empowered to adopt delegated acts in accordance with article 22 to adopt and adapt maximum yields for other emissions of cigarettes and for emissions of tobacco products other than cigarettes that increase in an appreciable manner the toxic or addictive effect of tobacco products beyond the threshold of toxicity and addictiveness stemming from the yields of tar , nicotine and carbon monoxide fixed in paragraph 1 . ### member states shall notify the commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes .


### 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 data45 . ### 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 data45 . national data protection provisions should also be taken into account .


### cover 75 % of the external area of both the front and back surface of the unit packet and any outside packaging ; ### continue to cover 30 % of the external area of the front and 40% of the back surface of the unit packet and any outside packaging ;


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


### member states shall require that manufacturers and importers of tobacco products notify the competent authorities of member states of any novel tobacco product they intend to place on the markets of the member states concerned . the notification shall be submitted in electronic form six months before the intended placing on the market and shall be accompanied by a detailed description of the product in question as well as information on ingredients and emissions in accordance with article 5 . the manufacturers and importers notifying a novel tobacco product shall also provide the competent authorities in question with : ### member states shall require that manufacturers and importers of tobacco products submit an application to the competent authorities of member states for any novel tobacco product they intend to place on the markets of the member states concerned . the application shall be submitted in electronic form and shall contain a detailed description of the product in question as well as information on ingredients and emissions in accordance with article 5 . the manufacturers and importers applying for marketing authorisation for a novel tobacco product shall also provide the competent authorities in question with :


### member states shall ensure that all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet , record the entry of all unit packets into their possession , as well as all intermediate movements and the final exit from their possession . this obligation can be fulfilled by recording in aggregated form , e . g . of outside packaging , provided that tracking and tracing of unit packets remains possible . ### member states shall ensure that all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet , record the entry of all unit packets and outside packaging into their possession , as well as all intermediate movements and the final exit from their possession , and transmit the data electronically to a data storage facility pursuant to paragraph 6 . this obligation can be fulfilled by recording in aggregated form , e . g . of outside packaging , provided that tracking and tracing of unit packets remains possible .


### 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 no 182 / 2011 . ### 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 no 182 / 2011 .


### member states shall ensure that the health warnings of the main surface of the unit packet and any outside packaging are fully visible , including not being partially or totally hidden or interrupted by wrappers , pouches , jacket , boxes or other devices when tobacco products are placed on the market . ### member states shall ensure that the health warnings of the main surface of the unit packet and any outside packaging are fully visible , and shall adopt the necessary rules to prevent the placing on the market of any type of wrapper , pouch , jacket , box or other device which partially or entirely hides or interrupts the health warnings .


### 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 . ### 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 of the packet surface .


### 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 . ### tobacco products for smoking , other than cigarettes , roll - your - own tobacco products and tobacco for water pipes , 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 .


### tobacco for smoking other than cigarettes and roll - your - own tobacco shall be exempted from the obligations to carry the information message laid down in article&#160 ; 8 and the combined health warnings in article 9 . in addition to the general warning specified in article 8 , each unit packet and any outside packaging of these products shall carry a text warning listed in annex i . the general warning specified in article 8 shall include a reference to the cessation services in accordance with article 9 . the general warning shall be printed on the most visible surface of the unit packet and any outside packaging . the text warnings listed in annex i shall be rotated in such a way as to guarantee their regular appearance . these warnings shall be printed on the other most visible surface of the unit packet and any outside packaging . 2 . the general warning referred to in paragraph 1 shall 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 . 3 . the text warning referred to in paragraph 1 shall cover 40 % of the external area of the corresponding surface of the unit packet and any outside packaging . that proportion shall be increased to 45 % for member states with two official languages and 50 % for member states with three official languages . 4 . the general warning and the text warning referred to in paragraph 1 shall be : 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 ; 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 ; 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 . 5 . the commission shall be empowered to adopt delegated acts in accordance with article 22 , to withdraw the exemption laid down in paragraph 1 if there is a substantial change of circumstances as established in a commission report . ### tobacco for smoking other than cigarettes and roll - your - own tobacco shall be exempted from the obligations to carry the information message laid down in article&#160 ; 8 and the combined health warnings in article 9 . in addition to the general warning specified in article 8 , each unit packet and any outside packaging of these products shall carry a text warning listed in annex i . the general warning specified in article 8 shall include a reference to the cessation services in accordance with article 9 . the general warning shall be printed or irremovably affixed on the most visible surface of the unit packet and any outside packaging . the text warnings listed in annex i shall be rotated in such a way as to guarantee their regular appearance . these warnings shall be printed or irremovably affixed on the other most visible surface of the unit packet and any outside packaging . 2 . the general warning referred to in paragraph 1 shall 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 . 3 . the text warning referred to in paragraph 1 shall cover 40 % of the external area of the corresponding surface of the unit packet and any outside packaging . that proportion shall be increased to 45 % for member states with two official languages and 50 % for member states with three official languages . 4 . the general warning and the text warning referred to in paragraph 1 shall be : printed in black bold type on a white background . the warnings may be affixed by means of stickers , provided that such stickers cannot be removed . 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 ; centred in the area in which they are required to be printed or irremovably affixed , parallel to the top edge of the unit packet and any outside packaging ; 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 . deleted


### 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 . ### 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’ , names , pictures , and figurative or other signs . likewise , the appearance of individual cigarettes can mislead consumers by creating the impression that they are less harmful .


### member states shall ensure that all unit packets of tobacco products shall be marked with a unique identifier . in order to ensure their integrity , unique identifiers shall be irremovably printed / affixed , indelible and in no way hidden or interrupted in any form , including through tax stamps and price marks , or by the opening of the packet . in relation to products manufactured outside the union the obligations laid down in this article apply only to those destined to or placed on the union market . ### member states shall ensure that all unit packets of tobacco products and any outside transport packaging shall be marked with a unique identifier . in order to ensure their integrity , unique identifiers shall be irremovably printed / affixed , indelible and in no way hidden or interrupted in any form , including through tax stamps and price marks , or by the opening of the packet . in relation to products manufactured outside the union the obligations laid down in this article apply only to those destined to or placed on the union market .


### 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 . ### 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 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 the illegal trafficking of tobacco and tobacco products can be combated , particularly along the external borders of the union but also from non - eu countries ; and so that their compliance with this directive can be monitored and better enforced . in addition , provision should be made for the introduction of security features for individual authentication that will facilitate the verification of whether or not products are authentic . the eu and the member states must take and must reinforce adequate steps to combat contraband and counterfeiting by improving checks of the product supply chain and imposing penalties on criminal networks .


### 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 . ### 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 .


### 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 . ### 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 domestic and imported 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 domestic and imported 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 .


### the combined health warnings shall be divided into three sets rotating on an annual basis . member states shall ensure that each combined health warning is displayed as nearly as possible on equal numbers of each brand . ### the combined health warnings shall be divided into three sets rotating on an annual basis , except for the warnings referred to in paragraph 1 . member states shall ensure that each combined health warning is displayed as nearly as possible on equal numbers of each brand .


### 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 . ### internet 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 , and should therefore be prohibited , in line with the implementing guidelines of the framework convention on tobacco control . 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 .


### the power to adopt delegated acts referred to in articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 shall be conferred on the commission for an indeterminate period of time from [ office of publications : please insert the date of the entry into force of this directive ] . ### the power to adopt delegated acts referred to in articles 6 and 14 shall be conferred on the commission for an indeterminate period of time from [ office of publications : please insert the date of the entry into force of this directive ] .


### 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 . ### all tobacco products have the potential to cause mortality , morbidity and disability and their consumption should be contained . it is therefore important to pre - authorise any novel tobacco products . an obligation to apply for a marketing authorisation for novel tobacco products should be put on manufacturers and importers .


### for cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets . these warnings shall have a width of not less than 20 mm and a height of not less than 43 mm . for roll - your - own tobacco the information message shall be printed on the surface that becomes visible when opening the unit packet . both the general warning and the information message shall cover 50% of the surface on which they are printed . ### for cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets . these warnings shall have a width of not less than 20 mm and a height of not less than 43 mm . for roll - your - own tobacco the information message shall be printed on the surface that becomes visible when opening the unit packet . both the general warning and the information message shall cover 50% of the surface on which they are printed . for tobacco for smoking other than cigarettes and roll - your - own tobacco , the general warning and the information message shall be printed on the lateral sides of the unit packets . both the general warning and the information message shall cover 50% of the surface on which they are printed .


### member states shall ensure that manufacturers and importers of tobacco products conclude data storage contracts with an independent third party , which shall host the data storage facility for data relating to the manufacturer and importer concerned . the data storage facility shall be physically located on the territory of the union . the suitability of the third party , in particular its independence and technical capacities , as well as the contract , shall be approved and monitored by an external auditor , who is proposed and paid by the tobacco manufacturer and approved by the commission . member states shall ensure full transparency and accessibility of the data storage facilities for the competent authorities of the member states , the commission and the independent third party on a permanent basis . in duly justified cases member states or the commission can provide manufacturers or importers access to this information , provided commercially sensitive information remains adequately protected in conformity with the relevant national and union legislations . ### member states shall ensure that manufacturers and importers of tobacco products conclude data storage contracts with an independent third party which shall host the data storage facility for data relating to the manufacturer and importer concerned . the data storage facility shall be physically located on the territory of the union . the independent third party shall be free from commercial and other vested interests of the tobacco industry and other related industries . the suitability of the third party , in particular its independence and technical capacities , as well as the contract , shall be approved and monitored by the commission , assisted by an independent external auditor , who is paid by the tobacco manufacturer and approved by the commission . member states shall ensure full transparency and accessibility of the data storage facilities for the competent authorities of the member states , the commission and the independent third party on a permanent basis . in duly justified cases member states or the commission can provide manufacturers or importers access to this information , provided commercially sensitive information remains adequately protected in conformity with the relevant national and union legislations .


### 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 . ### in order to make this directive operational , 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 for non - essential elements of the directive . 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 . in order to keep up with technical , scientific and international developments in tobacco manufacture , consumption and regulation , the commission should submit a report three years after the date of transposition of this directive , in order to assess whether amendments to this directive are necessary .


### 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 . ### 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 .


### each unit packet and any outside packaging of tobacco for smoking shall carry combined health warnings . the combined health warnings shall : ### each unit packet and any outside packaging of tobacco for smoking shall carry combined health warnings ensuring the right of consumers to have access to sufficient and reliable information . the warnings shall :


### the labelling of a unit packet and any outside packaging and the tobacco product itself shall not include any element or feature that : ### the labelling of a unit packet and any outside packaging and the tobacco product itself and / or its brand name shall not include any element or feature that :


### in addition to the unique identifier , member states shall require that all unit packets of tobacco products which are placed on the market carry a visible , tamper proof security feature of at least 1 cm² , which shall be irremovably printed or affixed , indelible and in no way hidden or interrupted in any form , including through tax stamps and price marks , or other elements mandated by legislation . ### in addition to the unique identifier , member states shall require that all unit packets of tobacco products which are placed on the market carry a visible and invisible , tamper proof security feature of at least 1 cm² , which shall be irremovably printed or affixed , indelible and in no way hidden or interrupted in any form , including through tax stamps and price marks , or other elements mandated by legislation .


### member states shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are enforced . the penalties provided for shall be effective , proportionate and dissuasive . ### member states shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are enforced . the penalties provided for shall be effective , proportionate and dissuasive . all fines shall be greater than any financial rewards for infringement .


### 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 . ### 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 .


### the combined health warnings shall be divided into three sets rotating on an annual basis . member states shall ensure that each combined health warning is displayed as nearly as possible on equal numbers of each brand . ### the combined health warnings shall be divided into three sets rotating on an annual basis . member states shall ensure that each combined health warning available for use in any one year is displayed as nearly as possible on equal numbers of each brand .