### 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 .


### 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 ;


### available studies and market research on preferences of various consumer groups , including young people and ### available studies and market research on the perception and use of the product , including labelling by consumers as well as on the preferences of various consumer groups , especially young people and


### 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 .


### 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 . excluding non - tobacco nicotine - containing products authorised under directive 2001 / 83 / ec from the scope of this directive 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 .


### 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 3 , 3 , 4 , 4 and 4 , 6 , 6 , 6 , 6 , 8 , 9 , 10 , 11 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 ] . .


### 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 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 the commission and may be approved , taking into account the high level of health protection achieved through this directive and the principles and requirements of the common internal market .


### council directive 89 / 622 / eec of 13 november 1989 on the approximation of the laws , regulations and administrative provisions of the member states concerning the labelling of tobacco products and the prohibition of the marketing of certain types of tobacco for oral use prohibited the sale in the member states of certain types of tobacco for oral use . directive 2001 / 37 / ec confirmed this prohibition . article 151 of the act of accession of austria , finland and sweden grants the kingdom of sweden derogation from this prohibition . the prohibition of the sale of oral tobacco should be maintained in order to prevent the introduction to the internal market of a product that is addictive , has adverse health effects and is attractive to young people . for other smokeless tobacco products that are not produced for the mass market , a strict labelling and ingredients regulation is considered sufficient to contain market expansion beyond their traditional use . ### council directive 89 / 622 / eec of 13 november 1989 on the approximation of the laws , regulations and administrative provisions of the member states concerning the labelling of tobacco products and the prohibition of the marketing of certain types of tobacco for oral use prohibited the sale in the member states of certain types of tobacco for oral use . directive 2001 / 37 / ec confirmed this prohibition . article 151 of the act of accession of austria , finland and sweden grants the kingdom of sweden derogation from this prohibition . upholding the ban on tobacco products for oral use should however not affect historically traditional tobacco products for oral use , which may be allowed by individual member states . for other smokeless tobacco products that are not produced for the mass market , a strict labelling and ingredients regulation is considered sufficient to contain market expansion beyond their traditional use .


### the delegation of powers referred to in articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . ### the delegation of powers referred to in articles 4 , 4 , 8 , 9 , 11 and 14 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force .


### 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 use42 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 use42 provides a legal framework to assess the quality , safety and efficacy of medicinal products . nicotine containing products other than the tobacco products covered by this directive should be regulated either under the upcoming review of the pharmaceutical package or by virtue of a specific legal instrument , once the studies currently under way have reached valid conclusions . such an instrument may include provisions allowing the placing on the market of lower - risk nicotine containing products which can help consumers to quit smoking , provided they feature an appropriate health warning .


### 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 prohibit the placing on the market of any novel tobacco product .


### 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 of 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 of the council of 25 october 2011 on consumer rights , as of 13 june 2014 . ### cross - border distance sales of tobacco , and practices such as the free distribution or swapping of tobacco products in public places for promotional purposes , facilitate access to tobacco products by young people and risk undermining compliance with the requirements provided for by tobacco control legislation and in particular by this directive . they should therefore be abolished .


### 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 design characteristics 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’ , ‘ 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 .


### resembles a food product . ### in the case of tobacco for oral use , resembles a food product .


### 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 by means that are false , misleading , deceptive or likely to create an erroneous impression about its characteristics , health effects , hazards or emissions , in particular by suggesting that a particular tobacco product is less harmful than others unless independent scientific evidence substantiates a significantly reduced health risk , or has vitalising , energetic , healing , rejuvenating , natural , organic or otherwise positive health effects ;


### 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 may also introduce more stringent provisions , provided the provisions are justified by the need to protect public health , in accordance with the principle of subsidiarity , and are necessary and proportionate and do not constitute a means of arbitrary discrimination or a disguised restriction on trade between member states and do not distort competition .


### 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 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 , and reviewing certain exemptions granted to tobacco products other than cigarettes , roll - your - own tobacco and smokeless tobacco 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 the council .


### member states shall ensure that manufacturers of tobacco products provide all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet , including importers , warehouses and transporting companies with the necessary equipment allowing for the recording of the tobacco products purchased , sold , stored , transported or otherwise handled . the equipment shall be able to read and transmit the data electronically to a data storage facility pursuant to paragraph 6 . ### member states shall ensure that manufacturers of tobacco products provide all economic operators involved in the trade of tobacco products from the manufacturer to the first customer who is not affiliated with the with the necessary equipment allowing for the recording of the tobacco products purchased , sold to the first customer who is not affiliated with the manufacturer , stored , transported or otherwise handled . the equipment shall be able to read and transmit the data electronically to a data storage facility pursuant to paragraph 6 .


### 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 customer , 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 .


### 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 3 , 3 , 4 , 4 , 6 , 8 , 9 , 10 , 11 , 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 ] .


### 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 could , under certain circumstances , convey the impression to consumers , in particular young people , 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 .


### 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 require that track and trace technology capable of reading and transmitting data electronically to the storage facility pursuant to paragraph 6 , the ownership for which is outside the control of tobacco manufacturers and their partners in the supply chain , is made available to all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet , including importers , warehouses and transporting companies . such economic operators shall 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 . in conformity with article 14 , this obligation shall be fulfilled by recording in aggregated form , e . g . of outside packaging , provided that tracking and tracing of unit packets remains possible .


### the proposal affects several fundamental rights as laid down in the charter of fundamental rights of the european union , notably the protection of personal data , the freedom of expression and information , freedom of economic operators to conduct business , and the right to property . the obligations imposed on manufacturers , importers and distributors of tobacco products are necessary to improve the functioning of the internal market while ensuring a high level of health and consumer protection as set out in articles 35 and 38 of the charter of fundamental rights of the european union . the application of this directive should respect the eu law and relevant international obligations . ### the proposal affects several fundamental rights as laid down in the charter of fundamental rights of the european union , notably the protection of personal data , the freedom of expression and information , freedom of economic operators to conduct business , and the right to property for trademark holders . it is therefore necessary to ensure that the obligations imposed on manufacturers , importers and distributors of tobacco products not only guarantee a high level of health and consumer protection , but also protect all other fundamental rights and are proportionate with respect to the functioning of the internal market . the application of this directive should respect the eu law and relevant international obligations .


### 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 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 the commission taking into account the high level of health protection achieved through 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 manufacture , distribution and consumption should be regulated . it is therefore important to monitor developments as regards novel tobacco products . a notification obligation for novel tobacco products should be put on manufacturers and importers , without prejudice to the power of the member states to ban or to authorise them . the commission should monitor the development and submit a report 3 years after the transposition deadline of this directive , in order to assess whether amendments to this directive are necessary .


### member states shall ensure that manufacturers of tobacco products provide all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet , including importers , warehouses and transporting companies with the necessary equipment allowing for the recording of the tobacco products purchased , sold , stored , transported or otherwise handled . the equipment shall be able to read and transmit the data electronically to a data storage facility pursuant to paragraph 6 . ### member states shall ensure that manufacturers of tobacco products provide all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first purchaser , including importers , warehouses and transporting companies with the necessary equipment allowing for the recording of the tobacco products purchased , sold , stored , transported or otherwise handled . the equipment shall be able to read and transmit the data electronically , in accordance with international standards , to a data storage facility pursuant to paragraph 6 .


### 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 .


### 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 case the package creates a misleading impression that the cigarettes are less harmful , health warnings must be adapted accordingly . the commission is asked to carry out a scientific study of the real influence of these products on tobacco consumption .


### 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 not prohibit the use of additives which are essential for the manufacture of tobacco products , as long as the additives do not result in a product with a characterising flavour . ### member states shall not restrict or prohibit the use of ingredients which are essential for the manufacture of tobacco products , as long as the use of those ingredients does not result in a product with a characterising flavour .


### 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 ] .


### the current use of different reporting formats makes it difficult for manufacturers and importers to fulfil their reporting obligations and burdensome for the member states and the commission to compare , analyse and draw conclusions from the information received . in this light there should be a common mandatory format for the reporting of ingredients and emissions . the greatest possible transparency of product information should be ensured for the general public , while ensuring that appropriate account is taken of the commercial and intellectual property rights of the manufacturers of tobacco products . ### the current use of different reporting formats makes it difficult for manufacturers and importers to fulfil their reporting obligations and burdensome for the member states and the commission to compare , analyse and draw conclusions from the information received . in this light there should be a common mandatory format for the reporting of ingredients and emissions . the greatest possible transparency of product information should be ensured for the general public , while ensuring that appropriate account is taken of the commercial and intellectual property rights of the manufacturers of tobacco products and that world trade organisation agreements are complied with .


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


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


### 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 health warnings shall be divided into three sets rotating on an annual basis . member states shall ensure that each health warning is displayed as nearly as possible on equal numbers of each brand .


### 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 developments and submit a report 5 years after the date of transposition of this directive , in order to assess whether amendments to this directive are necessary . ### 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 developments and submit a report 5 years after the date of transposition of this directive , in order to assess whether amendments to this directive are necessary . children and young people must be educated , as this is the simplest and most effective way of preventing young people from starting to smoke . consideration should also be given to creating a fund financed by the manufacturers of tobacco products , which would be used to fund anti - smoking campaigns . member states should harmonise the legal age for purchasing tobacco products at 18 .


### member states shall ensure that manufacturers of tobacco products provide all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet , including importers , warehouses and transporting companies with the necessary equipment allowing for the recording of the tobacco products purchased , sold , stored , transported or otherwise handled . the equipment shall be able to read and transmit the data electronically to a data storage facility pursuant to paragraph 6 . ### member states shall ensure that manufacturers of tobacco products provide all economic operators involved in the trade of tobacco products from the manufacturer to the first customer who is not affiliated with the with the necessary equipment allowing for the recording of the tobacco products purchased , sold to the first customer who is not affiliated with the manufacturer , stored , transported or otherwise handled . the equipment shall be able to read and transmit the data electronically to a data storage facility pursuant to paragraph 6 .


### 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 . ### 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 more than two official languages .


### 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 has vitalising , energetic , healing , rejuvenating or otherwise positive health effects ;


### 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 .


### 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 that appear on packaging , such as ‘ low - tar’ , ‘ light’ , ‘ ultra - light’ , ‘ mild’ , ' natural ' , ' organic ' , ‘ without additives’ , ‘ without flavours’ , ' slim ' , names , pictures , and figurative or other signs .


### the commission shall be empowered to adopt delegated acts in accordance with article 22 to adapt the methods of measurement of the tar , nicotine and carbon monoxide yields , taking into account scientific and technical developments and internationally agreed standards . ### the commission may put forward proposals to adapt the maximum yields laid down in paragraph 1 , taking into account scientific development and internationally agreed standards .


### 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 manufacture , distribution and consumption should be regulated . it is therefore important to monitor developments as regards novel tobacco products . a notification obligation for novel tobacco products should be put on manufacturers and importers , without prejudice to the power of the member states to ban or to authorise them . the commission should monitor the development and submit a report 3 years after the transposition deadline of this directive , in order to assess whether amendments to this directive are necessary .


### member states shall prohibit the use of the following additives in tobacco products : ### the use of the following additives and flavourings in tobacco products and their components shall be prohibited :


### 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 . ### 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 .


### 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 require that track and trace technology capable of reading and transmitting data electronically to the storage facility pursuant to paragraph 6 , the ownership for which is outside the control of tobacco manufacturers and their partners in the supply chain , is made available to all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet , including importers , warehouses and transporting companies . such economic operators shall 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 . in conformity with article 14 , this obligation shall be fulfilled by recording in aggregated form , e . g . of outside packaging , provided that tracking and tracing of unit packets remains possible .


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


### the unique identifier shall allow determining : ### the identifier referred to in paragraph 1 shall allow determining :


### 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 , which is secure and impossible to duplicate , 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 .


### the health warning shall comply with the requirements laid down in article 10 . it shall cover not less than 30 % of the area of the corresponding surface of the unit packet and of 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 . ### the health warning shall comply with the requirements laid down in article 10 . it shall cover not less than 30 % of the area of the corresponding surface of the unit packet and of any outside packaging . that proportion shall be increased to 32 % for member states with two official languages and 35 % for member states with more than two official languages .


### be reproduced in accordance with the format , layout , design and proportions specified by the commission pursuant to paragraph 3 ; ### be reproduced in accordance with the layout , design and proportions specified by the commission pursuant to paragraph 3 ;


### 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 . ### surrounded by a black border of 3 mm in width inside the surface reserved for the text of the warning .


### this tobacco product can damage your health and is addictive ### this tobacco product damages your health and is addictive


### 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 . 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’ , ‘ 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 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 use of certain texts on tobacco packages , for example ‘ low - tar’ , ‘ light’ , ‘ ultra - light’ , or ‘ mild’ , or of names , pictures , and figurative or other signs can mislead consumers by making them think that the products concerned are less harmful , thus inducing them to change their habits . the manner of smoking and the degree of dependence , and not just the levels of given substances contained in a product before it is consumed , also determine how much is inhaled . this aspect involves more than the use of texts such as those mentioned above . it could , indeed , undermine the labelling requirements laid down in this directive .


### 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 on the principal field of vision 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 .


### 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 . ### the general warning shall be printed or affixed by means of non - removable stickers 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 appear on the other most visible surface of the unit packet and any outside packaging .


### the product name ; ### the product description ;


### 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 . in order to protect consumers and promote public health , a fundamental objective of the revision of the directive and its monitoring should be to put an end to the consumption of tobacco products , and legislation will continue to be tightened up to achieve this .


### this product can damage your health ### this product damages your health


### the list shall be accompanied by a statement setting out the reasons for the inclusion of such ingredients in those tobacco products . the list shall indicate their status , including whether the ingredients have been registered under regulation no 1907 / 2006 of the european parliament and of the council of 18 december 2006 concerning the registration , evaluation , authorisation and restriction of chemicals as well as their classification under regulation no 1272 / 2008 of the european parliament and of the council of 16 december 2008 on classification , labelling and packaging of substances and mixtures . the list shall also be accompanied by the toxicological data available to the manufacturer or importer regarding these ingredients in burnt or unburnt form as appropriate , referring in particular to their effects on health of consumers and taking into account , inter alia , any addictive effects . the list shall be established in descending order of the weight of each ingredient included in the product . other than for tar , nicotine and carbon monoxide and for emissions referred to in article 4 paragraph 4 , the manufacturers and importers shall indicate the measurement methods used . member states may also require manufacturers or importers to carry out other tests as may be laid down by the competent national authorities in order to assess the effects of substances on health , taking into account , inter alia , their addictiveness and toxicity . ### the list shall be accompanied by a statement setting out the reasons for the inclusion of such ingredients in those tobacco products . the list shall indicate their status , including whether the ingredients have been registered under regulation no 1907 / 2006 of the european parliament and of the council of 18 december 2006 concerning the registration , evaluation , authorisation and restriction of chemicals as well as their classification under regulation no 1272 / 2008 of the european parliament and of the council of 16 december 2008 on classification , labelling and packaging of substances and mixtures . the list shall also be accompanied by the toxicological data available to the manufacturer or importer regarding these ingredients in burnt or unburnt form as appropriate , referring in particular to their effects on health of consumers and taking into account , inter alia , any addictive effects . the list shall be established in descending order of the weight of each ingredient included in the product . within one year following the entry into force of this directive , manufacturers and importers of tobacco products shall submit the list of ingredients and all the accompanying information referred to above . member states shall penalise manufacturers and importers of tobacco products who fail to submit that list and the accompanying information by the time limit . other than for tar , nicotine and carbon monoxide and for emissions referred to in article 4 paragraph 4 , the manufacturers and importers shall indicate the measurement methods used . member states may also require manufacturers or importers to carry out other tests as may be laid down by the competent national authorities in order to assess the effects of substances on health , taking into account , inter alia , their addictiveness and toxicity .


### the following nicotine - containing products may only be placed on the market if they were authorised pursuant to directive 2001 / 83 / ec : products with a nicotine level exceeding 2 mg per unit , or products with a nicotine concentration exceeding 4 mg per ml or products whose intended use results in a mean maximum peak plasma concentration exceeding 4 ng of nicotine per ml . 2 . the commission shall be empowered to adopt delegated acts in accordance with article 22 to update the nicotine quantities set out in paragraph 1 taking into account scientific developments and marketing authorisations granted to nicotine - containing products pursuant to directive 2001 / 83 / ec . 3 . each unit packet and any outside packaging of nicotine - containing products below the thresholds set out in paragraph 1 shall carry the following health warning : this product contains nicotine and can damage your health . 4 . the health warning referred to in paragraph 3 shall comply with the requirements specified in article 10 . in addition , it shall : be printed on the two largest surfaces of the unit packet and any outside packaging ; 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 . 5 . the commission shall be empowered to adopt delegated acts in accordance with article 22 to adapt the requirements in paragraphs 3 and 4 taking into account scientific and market developments and to adopt and adapt the position , format , layout , designand rotation of the health warnings . ### nicotine - containing products that are presented as having properties for treating or preventing disease in human beings , other than through any message specified in paragraph 3 , may only be placed on the market if they were authorised pursuant to directive 2001 / 83 / ec . 1 a . this directive shall not apply to nicotine - containing products authorised pursuant to directive 2001 / 83 / ec . 1 b . for nicotine - containing products where paragraph 1 does not apply , the products may be placed on the market if they comply with this directive 1 c . member states shall ensure that nicotine containing products comply with european union consumer protection , safety and other relevant legislation in force 1 d . no later than 12 months from entry into force of this directive , each member state shall provide the commission with a report on the measures it has taken to implement and enforce the legislation set out in [ new ] annex iv as it applies to nicotine containing products and the effectiveness of those measures . 1 e . member states shall ensure that nicotine - containing products are not sold to persons below the national legal age for purchasing tobacco products . 2 . the commission shall , by 1 april 2017 , carry out a study on nicotine - containing products in consultation with relevant stakeholders and the member states . this study will consider whether there is a need for specific legislation in regard to nicotine - containing products . 3 . each unit packet and any outside packaging of nicotine - containing products which do not fall under the scope of directive 2001 / 83 / ec shall carry the following health warning : this product contains nicotine which is addictive and may damage your health .


### in the case of adverse developments which may seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the community , the commission , upon its own initiative or following a request by the authority , the council , or the esrb , may adopt a decision addressed to the authority , determining the existence of an emergency situation for the purposes of this regulation . ### in the case of adverse developments which may seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the community , the esrb , upon its own initiative or following a request by the authority , the council , the european parliament or the commission , may issue a warning declaring the existence of an emergency situation in order to enable the authority without further requirements to adopt the individual decisions referred to in paragraph 3 .


### the standards shall be adopted by the commission by means of regulations or decisions and published in the official journal of the european union . ### the commission shall adopt technical standards in accordance with articles 7a to 7d , in the form of regulations or decisions .


### without prejudice to the powers of the commission under article 226 of the treaty , where a competent authority does not comply with the decision of the authority referred to in paragraph 2 within the period laid down therein , the authority may , where the relevant requirements laid down in the legislation referred to in article 1 are directly applicable to financial institutions , adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under that legislation , including the cessation of any practice . ### without prejudice to the powers of the commission under article 258 of the treaty , where a competent authority does not comply with the decision of the authority referred to in paragraph 2 within the period laid down therein , the authority shall , pursuant to the relevant requirements laid down in the legislation referred to in article 1 , adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under that legislation , including the cessation of any practice .


### upon request from one or more competent authorities , from the commission or on its own initiative and after having informed the competent authority concerned , the authority may investigate the alleged incorrect application of community law . ### upon request from one or more competent authorities or from the european parliament , the council , the commission or the banking stakeholder group , or on its own initiative and after having informed the competent authority concerned , the authority may investigate the alleged incorrect application of union law .


### the competent authorities shall make every effort to comply with those guidelines and recommendations . ### within two months of the issuance of a guideline or recommendation , each competent authority shall decide whether it intends to comply with that guideline or recommendation . in the event that it does not intend to comply , it shall inform the authority , stating reasons . the authority shall publish those reasons .


### upon request from one or more competent authorities , from the commission or on its own initiative and after having informed the competent authority concerned , the authority may investigate the alleged incorrect application of community law . ### upon request from one or more competent authorities , from the commission , from the european parliament , the council or a member of the banking stakeholder group , or on its own initiative and after having informed the competent authority concerned , the authority may investigate the alleged incorrect application of union law .


### if , at the end of the conciliation phase , the competent authorities concerned have failed to reach an agreement , the authority may take a decision requiring them to take specific action or to refrain from action in order to settle the matter , in compliance with community law . ### if , at the end of the conciliation phase , the competent authorities concerned have failed to reach an agreement , the authority shall in accordance with the procedure set out in the second subparagraph of article 29 take a decision to settle the disagreement and to require them to take specific action , in compliance with union law with binding effects on the competent authorities concerned .


### given the globalisation of financial services and the increased importance of international standards , the authority should foster the dialogue and cooperation with supervisors outside the community . it shall fully respect the existing roles and competences of the european institutions in relations with authorities outside the community and in international forums . ### given the globalisation of financial services and the increased importance of international standards , the authority should represent the european union in the dialogue and cooperation with supervisors outside the union .


### there is a need to introduce an effective instrument to establish harmonised technical standards in financial services to ensure , also through a single rulebook , a level playing field and an adequate protection of depositors , investors and consumers across europe . as a body with highly specialised expertise , it is efficient and appropriate to entrust the authority , in areas defined by community law , with the elaboration of draft technical standards , which do not involve policy choices . the commission should endorse those draft technical standards in accordance with community law in order to give them binding legal effect . the draft technical standards have to be adopted by the commission . they would be subject to amendment if , for example , the draft technical standards were incompatible with community law , would not respect the principle of proportionality or would run counter to the fundamental principles of the internal market for financial services as reflected in the acquis of community financial services legislation . to ensure a smooth and expedited adoption process for those standards , the commission should be subject to a time limit for its decision on the endorsement . ### there is a need to introduce an effective instrument to establish harmonised technical standards in financial services to ensure , also through a single rulebook , a level playing field and an adequate protection of depositors , investors and consumers across europe . as a body with highly specialised expertise , it is efficient and appropriate to entrust the authority , in areas defined by eu law , with the elaboration of draft technical standards , which do not involve policy choices . the commission should be empowered to adopt delegated acts in accordance with the procedure referred to in article 290 of the treaty on the functioning of the european union concerning technical standards in financial services .


### where the commission has adopted a decision pursuant to paragraph 1 , the authority may adopt individual decisions requiring competent authorities to take the necessary action in accordance with the legislation referred to in article 1 to address any risks that may jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system by ensuring that financial institutions and competent authorities satisfy the requirements laid down in that legislation . ### where the existence of an emergency situation is declared pursuant to paragraph 1 , the authority shall adopt individual decisions necessary to ensure that competent authorities take the necessary action in accordance with the legislation referred to in article 1 to address any risks that may jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system by ensuring that financial institutions and competent authorities satisfy the requirements laid down in that legislation .


### in areas not covered by technical standards , the authority should have the power to issue non - binding guidelines and recommendations on the application of community legislation . in order to ensure transparency and strengthen compliance by national supervisory authorities with those guidelines and recommendations , national authorities should be obliged to state their reasons where they do not comply with those guidelines and recommendations . ### in areas not covered by technical standards , the authority should have the power to issue guidelines and recommendations on the application of eu legislation . in order to ensure transparency and strengthen compliance by national supervisory authorities with those guidelines and recommendations , national authorities should be obliged to state their reasons where they do not comply with those guidelines and recommendations publicly in order to be fully transparent with market participants . in areas not covered by technical standards , the authority should establish and promulgate best practices .


### the authority shall act within the scope of directive 2006 / 48 / ec , directive 2006 / 49 / ec , directive 2002 / 87 / ec , directive 2005 / 60 / ec , directive 2002 / 65 / ec and directive 94 / 19 / ec , including all directives , regulations , and decisions based on these acts , and of any further community act which confers tasks on the authority . ### the authority shall act within the scope of directive 2006 / 48 / ec , directive 2006 / 49 / ec , directive 2002 / 87 / ec , directive 2005 / 60 / ec , directive 2002 / 65 / ec and directive 94 / 19 / ec , including all directives , regulations , and decisions based on these acts , and of any further eu act which confers tasks on the authority . the authority shall also act in the field of activities of credit institutions , financial conglomerates , investment firms , payment institutions and e - money institutions , including matters of corporate governance , auditing and financial reporting , provided that such actions by the authority are necessary to ensure the effective and consistent application of the legislation referred to in this paragraph .


### before submitting them to the commission , the authority shall , where appropriate , conduct open public consultations on technical standards and analyse the potential related costs and benefits . ### the authority shall conduct open public consultations on technical standards and analyse the potential related costs and benefits before adopting draft technical standards . the authority shall also request an opinion or advice of the banking stakeholder group referred to in article 22 .


### the financial crisis in 2007 / 2008 exposed important shortcomings in financial supervision , both in particular cases and in relation to the financial system as a whole . nationally - based supervisory models have lagged behind the integrated and interconnected reality of european financial markets , in which many financial firms operate across borders . the crisis exposed shortcomings in the area of cooperation , coordination , consistent application of community law and trust between national supervisors . ### the financial crisis in 2007 / 2008 exposed important shortcomings in financial supervision , both in particular cases and in relation to the financial system as a whole . nationally - based supervisory models have lagged behind the integrated and interconnected reality of european financial markets , in which many financial firms operate across borders . the crisis exposed shortcomings in the area of cooperation , coordination , consistent application of eu law and trust between national supervisors .


### contribute to a consistent application of community legislation , in particular by contributing to a common supervisory culture , ensuring consistent , efficient and effective application of the legislation referred to in article 1 , preventing regulatory arbitrage , mediating and settling disagreements between competent authorities , promoting a coherent functioning of colleges of supervisors and taking actions in emergency situations ; ### contribute to a consistent application of community legislation , in particular by contributing to a common supervisory culture , ensuring consistent , efficient and effective application of the legislation referred to in article 1 , preventing regulatory arbitrage , mediating and settling disagreements between competent authorities , ensuring effective and consistent supervision of financial institutions with eu dimension and a coherent functioning of colleges of supervisors and taking actions , inter alia , in emergency situations ;


### where a competent authority has not correctly applied the legislation referred to in article 1 , in particular by failing to ensure that a financial institution satisfies the requirements laid down in that legislation , the authority shall have the powers set out in paragraphs 2 , 3 and 6 of this article . ### where a competent authority has not correctly applied the legislation referred to in article 1 , including the technical standards established in accordance with article 7 , in particular by failing to ensure that a financial institution satisfies the requirements laid down in that legislation , the authority shall have the powers set out in paragraphs 2 , 3 and 6 of this article .


### the delegation of tasks and responsibilities can be a useful instrument in the functioning of the network of supervisors in order to reduce the duplication of supervisory tasks , foster cooperation and thereby streamline the supervisory process as well as reduce the burden imposed on financial institutions . the regulation should therefore provide a clear legal basis for such delegation . delegation of tasks means that tasks are carried out by another supervisory authority instead of the responsible authority , while the responsibility for supervisory decisions remains with the delegating authority . by delegation of responsibilities one national supervisory authority , the delegatee , shall be able to decide upon a certain supervisory matter in its name in lieu of another national supervisory authority . delegations should be governed by the principle of allocating supervisory competence to a supervisor which is well placed to take action in the subject matter . a reallocation of responsibilities can be appropriate for example for reasons of economies of scale or scope , of coherence in group supervision , and of optimal use of technical expertise among national supervisory authorities . relevant community legislation may further specify the principles for reallocation of responsibilities upon agreement . the authority should facilitate delegation agreements between national supervisory authorities by all appropriate means . it should be informed in advance of intended delegation agreements to be able to express an opinion where appropriate . it should centralise the publication of such agreements to ensure timely , transparent and easily accessible information about agreements for all parties concerned . ### the delegation of tasks and responsibilities can be a useful instrument in the functioning of the network of supervisors in order to reduce the duplication of supervisory tasks , foster cooperation and thereby streamline the supervisory process as well as reduce the burden imposed on financial institutions . the regulation should therefore provide a clear legal basis for such delegation . delegation of tasks means that tasks are carried out by another supervisory authority instead of the responsible authority , while the responsibility for supervisory decisions remains with the delegating authority . by delegation of responsibilities one national supervisory authority , the delegatee , shall be able to decide upon a certain supervisory matter in its name in lieu of another national supervisory authority . delegations should be governed by the principle of allocating supervisory competence to a supervisor which is well placed to take action in the subject matter . a reallocation of responsibilities can be appropriate for example for reasons of economies of scale or scope , of coherence in group supervision , and of optimal use of technical expertise among national supervisory authorities . relevant eu legislation may further specify the principles for reallocation of responsibilities upon agreement . the authority should facilitate and monitor delegation agreements between national supervisory authorities by all appropriate means . it should be informed in advance of intended delegation agreements to be able to express an opinion where appropriate . it should centralise the publication of such agreements to ensure timely , transparent and easily accessible information about agreements for all parties concerned . it should identify and promulgate best practices regarding delegation and delegation agreements .


### within three months of receipt of the draft standards , the commission shall decide whether to endorse the draft standards . the commission may extend that period by one month . the commission may endorse the draft standards only in part or with amendments where the community interest so requires . ### within three months of receipt of the draft standards , the commission shall decide whether to endorse , reject or amend the draft standards . the commission may extend that period by one month . the commission shall inform the european parliament and the council of its decision , stating the reasons .


### the standards shall be adopted by the commission by means of regulations or decisions and published in the official journal of the european union . ### the commission shall adopt technical standards in accordance with articles 7a to 7d , in the form of regulations or decisions .


### without prejudice to the powers of the commission under article 226 of the treaty , where a competent authority does not comply with the decision of the authority , and thereby fails to ensure that a financial institution complies with requirements directly applicable to it by virtue of the legislation referred to in article 1 , the authority may adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under community law , including the cessation of any practice . ### without prejudice to the powers of the commission under article 258 of the treaty , where a competent authority does not comply with the decision of the authority , and thereby fails to ensure that a financial institution complies with requirements directly applicable to it by virtue of the legislation referred to in article 1 , the authority shall adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under union law , including the cessation of any practice .


### the authority may develop technical standards in the areas specifically set out in the legislation referred to in article 1 . the authority shall submit its draft standards to the commission for endorsement . ### the authority may develop technical standards to complete , update and modify elements that are not essential to the legislative acts referred to in article 1 . the technical standards shall not involve strategic decisions and their content shall be delimited by the legislative acts on which they are based .


### the european system of financial supervisors should be a network of national and community supervisory authorities , leaving day - to - day supervision of financial institutions at the national level , and according a central role in the supervision of cross - border groups to colleges of supervisors . greater harmonisation and the coherent application of rules for financial institutions and markets across the community should also be achieved . a european banking authority should be established , along with a european insurance and occupational pensions authority and a european securities and markets authority . ### the european system of financial supervisors should be a network of national and community supervisory authorities , leaving day - to - day supervision of financial institutions that do not have an eu dimension to the national level . colleges of supervisors should exert supervision over cross - border institutions that do not have an eu dimension . the authority should gradually take over supervision of institutions with an eu dimension . greater harmonisation and the coherent application of rules for financial institutions and markets across the community should also be achieved . a european banking authority should be established , along with a european supervisory authority and a european supervisory authority as well as a european supervisory authority . the european systemic risk board shall form part of a european system of financial supervision .


### without prejudice to the powers of the commission under article 226 of the treaty , where a competent authority does not comply with the decision referred to in paragraph 4 of this article within the period of time specified therein , and where it is necessary to remedy in a timely manner the non compliance by the competent authority in order to maintain or restore neutral conditions of competition in the market or ensure the orderly functioning and integrity of the financial system , the authority may , where the relevant requirements of the legislation referred to in article 1 are directly applicable to financial institutions , adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under community law including the cessation of any practice . ### without prejudice to the powers of the commission under article 258 of the treaty , where a competent authority does not comply with the decision referred to in paragraph 4 of this article within the period of time specified therein , and where it is necessary to remedy in a timely manner the non compliance by the competent authority in order to maintain or restore neutral conditions of competition in the market or ensure the orderly functioning and integrity of the financial system , the authority shall , pursuant to the legislation referred to in article 1 , adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under union law including the cessation of any practice .


### the standards shall be adopted by the commission by means of regulations or decisions and published in the official journal of the european union . ### the commission shall adopt delegated acts in accordance with articles 7a to 7d , designed to establish the technical standards referred to in paragraph 1 . those acts shall be in the form of regulations or decisions .


### in the case of adverse developments which may seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the community , the commission , upon its own initiative or following a request by the authority , the council , or the esrb , may adopt a decision addressed to the authority , determining the existence of an emergency situation for the purposes of this regulation . ### in the case of adverse developments which may seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the community , the esrb , upon its own initiative or following a request by the authority , the council , the european parliament or the commission , may issue a warning declaring the existence of an emergency situation in order to enable the authority without further requirements to adopt the individual decisions referred to in paragraph 3 .