### a unit packet of cigarettes shall have a cuboid shape . a unit packet of roll - your - own tobacco shall have the form of a pouch , i . e . a rectangular pocket with a flap that covers the opening . the flap of the pouch shall cover at least 70% of the front of the packet . a unit packet of cigarettes shall include at least 20 cigarettes . a unit packet of roll - your - own tobacco shall contain tobacco weighing at least 40 g . ### a unit packet of roll - your - own tobacco shall have the form of either a pouch , i . e . a pocket with a flap that covers the opening , or a pack with a cuboid or cylindrical base . a unit packet of cigarettes shall include at least 20 cigarettes . a unit packet of roll - your - own tobacco shall contain tobacco weighing at least 20 g .


### directive 2001 / 83 / ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use provides a legal framework to assess the quality , safety and efficacy of medicinal products including nicotine containing products . a significant number of nicotine - containing products were already authorised under this regulatory regime . the authorisation takes into account the nicotine content of the product in question . subjecting all nicotine - containing products , whose nicotine content equals or exceeds the content of a nicotine containing product previously authorised under directive 2001 / 83 / ec , to the same legal framework clarifies the legal situation , levels out differences between national legislations , ensures equal treatment of all nicotine containing products usable for smoking cessation purposes and creates incentives for research and innovation in smoking cessation . this should be without prejudice to the application of directive 2001 / 83 / ec to other products covered by this directive if the conditions set by directive 2001 / 83 / ec are fulfilled . ### directive 2001 / 83 / ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use provides a legal framework to assess the quality , safety and efficacy of medicinal products including nicotine containing products . a significant number of nicotine - containing products were already authorised under this regulatory regime . the authorisation takes into account the nicotine content of the product in question . however , measuring nicotine delivery has proven to be difficult , as it depends on the products and how they are being used . therefore , subjecting all nicotine - containing products regardless of their nicotine content to directive 2001 / 83 / ec clarifies the legal situation , levels out differences between national legislations , ensures equal treatment of all nicotine containing products usable for smoking cessation purposes and creates incentives for research and innovation in smoking cessation . this should be without prejudice to the application of directive 2001 / 83 / ec to other products covered by this directive if the conditions set by directive 2001 / 83 / ec are fulfilled .


### tobacco products ; ### cigarettes and roll - your - own tobacco ;


### each unit packet and any outside packaging of tobacco for smoking shall carry combined health warnings . the combined health warnings shall : ### each unit packet and any outside packaging of tobacco for smoking shall carry health warnings . the health warnings shall :


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


### 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 the measurement methods for emissions , setting maximum levels for ingredients that increase toxicity or addictiveness , 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 .


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


### be positioned at the top edge of the unit packet and any outside packaging , and in the same direction as any other information appearing on the packaging ; ### be positioned in the same direction as any other information appearing on the packaging ;


### tobacco for smoking other than cigarettes and roll - your - own tobacco shall be exempted from the obligations to carry the information message laid down in article&#160 ; 8 and the combined health warnings in article 9 . in addition to the general warning specified in article 8 , each unit packet and any outside packaging of these products shall carry a text warning listed in annex i . the general warning specified in article 8 shall include a reference to the cessation services in accordance with article 9 . the general warning shall be printed on the most visible surface of the unit packet and any outside packaging . the text warnings listed in annex i shall be rotated in such a way as to guarantee their regular appearance . these warnings shall be printed on the other most visible surface of the unit packet and any outside packaging . 2 . the general warning referred to in paragraph 1 shall cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging . that proportion shall be increased to 32 % for member states with two official languages and 35 % for member states with three official languages . 3 . the text warning referred to in paragraph 1 shall cover 40 % of the external area of the corresponding surface of the unit packet and any outside packaging . that proportion shall be increased to 45 % for member states with two official languages and 50 % for member states with three official languages . 4 . the general warning and the text warning referred to in paragraph 1 shall be : printed in black helvetica bold type on a white background . in order to accommodate language requirements , member states may determine the point size of the font , provided that the font size specified in their legislation is such as to occupy the greatest possible proportion of the area set aside for the text required ; centred in the area in which they are required to be printed , parallel to the top edge of the unit packet and any outside packaging ; surrounded by a black border not less than 3 mm and not more than 4 mm in width inside the surface reserved for the text of the warning . 5 . the commission shall be empowered to adopt delegated acts in accordance with article 22 , to withdraw the exemption laid down in paragraph 1 if there is a substantial change of circumstances as established in a commission report . ### tobacco for smoking other than cigarettes and roll - your - own tobacco shall be exempted from the obligations to carry the information message laid down in article&#160 ; 8 and the combined health warnings in article 9 . in addition to the general warning specified in article 8 , each unit packet and any outside packaging of these products shall carry a text warning listed in annex i . the general warning specified in article 8 shall include a reference to the cessation services in accordance with article 9 . the general warning shall be printed or irremovably affixed on the most visible surface of the unit packet and any outside packaging . the text warnings listed in annex i shall be rotated in such a way as to guarantee their regular appearance . these warnings shall be printed or irremovably affixed on the other most visible surface of the unit packet and any outside packaging . 2 . the general warning referred to in paragraph 1 shall cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging . that proportion shall be increased to 32 % for member states with two official languages and 35 % for member states with three official languages . 3 . the text warning referred to in paragraph 1 shall cover 40 % of the external area of the corresponding surface of the unit packet and any outside packaging . that proportion shall be increased to 45 % for member states with two official languages and 50 % for member states with three official languages . 4 . the general warning and the text warning referred to in paragraph 1 shall be : printed in black bold type on a white background . the warnings may be affixed by means of stickers , provided that such stickers cannot be removed . in order to accommodate language requirements , member states may determine the point size of the font , provided that the font size specified in their legislation is such as to occupy the greatest possible proportion of the area set aside for the text required ; centred in the area in which they are required to be printed or irremovably affixed , parallel to the top edge of the unit packet and any outside packaging ; surrounded by a black border not less than 3 mm and not more than 4 mm in width inside the surface reserved for the text of the warning . deleted


### the combined health warnings shall be divided into three sets rotating on an annual basis . member states shall ensure that each combined health warning is displayed as nearly as possible on equal numbers of each brand . ### the combined health warnings shall be divided into three sets rotating on an annual basis . the combined health warnings shall be printed in such a way as to ensure that each brand can be readily recognised .


### 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 measurement methods for emissions , setting maximum levels for ingredients that increase toxicity or addictiveness , 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 .


### 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 . member states and regions of member states with a tradition of using oral tobacco shall have an opportunity to apply for a national or regional derogation from the prohibition on cultural or historical grounds . 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 .


### a unit packet of cigarettes shall have a cuboid shape . a unit packet of roll - your - own tobacco shall have the form of a pouch , i . e . a rectangular pocket with a flap that covers the opening . the flap of the pouch shall cover at least 70% of the front of the packet . a unit packet of cigarettes shall include at least 20 cigarettes . a unit packet of roll - your - own tobacco shall contain tobacco weighing at least 40 g . ### a unit packet of cigarettes shall have a cuboid shape . a unit packet of cigarettes shall include at least 20 cigarettes . a unit packet of roll - your - own tobacco or a unit pack of ' make your own ' tobacco shall contain tobacco weighing at least 40 g .


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


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


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


### member states 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 . ### with the exception of products referred to in article 15 , 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 .


### 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 ;


### member states shall , based on scientific evidence , prohibit the placing on the market of tobacco products with additives in quantities that increase in an appreciable manner at the stage of consumption the toxic or addictive effect of a tobacco product . ### member states shall , based on public scientific evidence originating from impeccably qualified scientific sources and published in annex to any administrative decision , prohibit the placing on the market of tobacco products with additives in quantities that increase in an objective manner at the stage of consumption the toxic or addictive effect of a tobacco product .


### each unit packet and any outside packaging of smokeless tobacco products shall carry the following health warning : ### with the exception of products referred to in article 15 , each unit packet and any outside packaging of smokeless tobacco products shall carry the following health warning :


### member states shall require manufacturers and importers to submit internal and external studies available to them on market research and preferences of various consumer groups , including young people , relating to ingredients and emissions . member states shall also require manufacturers and importers to report the sales volume data per product , reported in sticks or kilograms , and per member state on a yearly basis starting from the full calendar year following that of the entry into force of this directive . member states shall provide alternative or additional sales data , as appropriate , to ensure that information on sales volume requested under this paragraph is reliable and complete . ### member states shall require manufacturers and importers to submit internal and external studies available to them on market research and preferences of various consumer groups , including young people and chronic heavy smokers , relating to ingredients and emissions . member states shall also require manufacturers and importers to report the sales volume data per product , reported in sticks or kilograms , and per member state on a yearly basis starting from the full calendar year following that of the entry into force of this directive . member states shall provide alternative or additional sales data , as appropriate , to ensure that information on sales volume requested under this paragraph is reliable and complete .


### novel tobacco products placed on the market shall respect the requirements set out in this directive . the provisions applicable depend on whether the products fall under the definition of smokeless tobacco product in point of article 2 or tobacco for smoking in point of article 2 . ### lower - risk tobacco products placed on the market shall respect the requirements set out in this directive , with the exception of articles 4 , 6 , 7 , 8 , 9 , 10 , 12 and 13 , which are to be adapted by the member states to take into account lower - risk products . the provisions applicable depend on whether the products fall under the definition of smokeless tobacco product in point of article 2 or tobacco for smoking in point of article 2 .


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


### 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 . a mandatory list of ingredients must be compiled with a view to ensuring the greatest possible transparency for the general public in respect of the contents of tobacco products , while ensuring that appropriate account is taken of the commercial and intellectual property rights of the manufacturers of tobacco products . the list must include a statement of the most dangerous ingredients along similar lines to that required by the us family smoking prevention and tobacco control act , which obliges manufacturers to disclose the presence of any substances in cigarette smoke identified by the us food and drug administration as ‘ hazardous or potentially hazardous’ for human health . annexes i and have been provided for the purposes of setting out such a list .


### cross - border distance sales of tobacco products ### distance sales of tobacco products


### available studies and market research on preferences of various consumer groups , including young people and ### available studies and market research on how consumers perceive and use the product , including its labelling , and on preferences of various consumer groups , including young people and


### member states shall require that manufacturers and importers of tobacco products notify the competent authorities of member states of any novel tobacco product they intend to place on the markets of the member states concerned . the notification shall be submitted in electronic form six months before the intended placing on the market and shall be accompanied by a detailed description of the product in question as well as information on ingredients and emissions in accordance with article 5 . the manufacturers and importers notifying a novel tobacco product shall also provide the competent authorities in question with : ### member states shall require that manufacturers and importers of reduced - risk tobacco products notify the competent authorities of member states of any such 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 any proposed labelling , instructions for use , details of the product ' s composition , the manufacturing process and associated controls and information on ingredients and emissions in accordance with article&#160 ; 5 . the manufacturers and importers notifying a reduced - risk tobacco product shall also provide the competent authorities in question with :


### 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 also be accompanied by the toxicological data available to the manufacturer or importer regarding these ingredients of the tobacco product concerned 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 in connection with cigarettes and for emissions referred to in article 4 paragraph 4 , the manufacturers and importers shall indicate the measurement methods used .


### 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 .


### available studies and market research on preferences of various consumer groups , including young people and ### working summaries of the available studies and market research on preferences of various consumer groups , including young people and


### the intended shipment route ; ### the intended shipment route from the manufacturer to the first customer and the warehouses used ;


### 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 being sold on the union market in increasing quantities , electronic cigarettes , which come in many different varieties with varying technical characteristics , are proving especially popular . this diversity makes them difficult to define in law , and means that several different european legal regimes apply to them depending on whether or not their purpose is to help people stop smoking and whether they contain addictive substances such as nicotine or toxic chemicals . the different regulatory approaches taken by member states to address possible health and safety concerns associated with these new products , which have been on the eu market for less than 10 years , have an 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 .


### 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 .


### cross - border distance sales of tobacco facilitate access to tobacco products of young people and risk to undermine compliance with the requirements provided for by tobacco control legislation and in particular by this directive . common rules on a notification system are necessary to ensure that this directive achieves its full potential . the provision on notification of cross - border distance sales of tobacco in this directive should apply notwithstanding the notification procedure set out in directive 2000 / 31 / ec of the european parliament and of the council of 8 june 2000 on certain legal aspects of information society services . business to consumer distance sale of tobacco products is further regulated by directive 97 / 7 / ec of the european parliament and the council of 20 may 1997 on the protection of consumers in respect of distance contracts , which will be replaced by directive 2011 / 83 / eu of the european parliament and the council of 25 october 2011 on consumer rights , as of 13 june 2014 . ### internet sales of tobacco facilitate access to tobacco products of young people and risk to undermine compliance with the requirements provided for by tobacco control legislation and in particular by this directive , and should therefore be prohibited , in line with the implementing guidelines of the framework convention on tobacco control . business to consumer distance sale of tobacco products is further regulated by directive 97 / 7 / ec of the european parliament and the council of 20 may 1997 on the protection of consumers in respect of distance contracts , which will be replaced by directive 2011 / 83 / eu of the european parliament and the council of 25 october 2011 on consumer rights , as of 13 june 2014 .


### certain additives are used to create the impression that tobacco products have health benefits , present reduced health hazards or increase mental alertness and physical performance . these additives should be prohibited in order to ensure uniform rules and a high level of health protection . ### certain additives are used to create the impression that tobacco products have health benefits , present reduced health hazards or increase mental alertness and physical performance . for example the action of menthol is problematical . because of its local anaesthetic property , menthol allows a deeper inhalation of the irritating tobacco smoke . as such , more smoke can be inhaled and deeper puffs can be attained , resulting in a higher nicotine dose . these additives that increase the attractiveness of tobacco products should be prohibited in order to ensure uniform rules and a high level of health protection .


### 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 .


### 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 .


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


### 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 . 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 . member states collect a substantial amount of tax revenues from the production and sale of all tobacco products and therefore member states should be strongly encouraged to spend those revenues directly on health care and information campaigns to inform young citizens about the major health risks of smoking .


### 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 .


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


### the competent authorities of the member states shall publish the complete list of all retail outlets registered with them in accordance with the rules and safeguards laid down in directive 95 / 46 / ec . retail outlets may only start placing tobacco products on the market in form of distance sales as of the moment the name of the retail outlet is published in the relevant member states . ### member states which have implemented a national anti - smoking strategy may set quantitative limits on cross - border movements .


### member states shall notify the commission of measures taken pursuant to this paragraph . ### member states shall notify the commission of measures taken pursuant to this paragraph . in order to attain the objective of harmonisation , the commission shall draw up an unambiguous list of ingredients banned as referred to in this paragraph , in addition to which member states shall be required to commit themselves to the paragraph in such a way as to render regulation more stringent .


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


### all tobacco products have the potential to cause mortality , morbidity and disability and their consumption should be contained . it is therefore important to monitor developments as regards novel tobacco products . a notification obligation for novel tobacco products should be put on manufacturers and importers , without prejudice to the power of the member states to ban or to authorise them . the commission should monitor the development and submit a report 5 years after the transposition deadline of this directive , in order to assess whether amendments to this directive are necessary . ### all tobacco products have the potential to cause mortality , morbidity and disability and their consumption should be contained . it is therefore important to 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 . in so doing , member states should take into account the possibility that new tobacco products may have a negative impact on the overall health of the population or the possibility that new tobacco products may limit the damage to the overall health of the population through the mass substitution of products used by smokers and the insignificant use of these products by non - smokers . the commission should monitor the development , bearing in mind both possibilities , and submit a report 3 years after the transposition deadline of this directive , in order to assess whether amendments to this directive are necessary .


### 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 . a mandatory list of ingredients must be compiled with a view to ensuring the greatest possible transparency for the general public in respect of the contents of tobacco products , while ensuring that appropriate account is taken of the commercial and intellectual property rights of the manufacturers of tobacco products . the list must include a statement of the most dangerous ingredients along similar lines to that required by the us family smoking prevention and tobacco control act , which obliges manufacturers to disclose the presence of any substances in cigarette smoke identified by the us food and drug administration as ‘ hazardous or potentially hazardous’ for human health . annexes i and have been provided for the purposes of setting out such a list .


### 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 also be accompanied by the toxicological data available to the manufacturer or importer regarding these ingredients of the tobacco product concerned 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 in connection with cigarettes and for emissions referred to in article 4 paragraph 4 , the manufacturers and importers shall indicate the measurement methods used .


### herbal products for smoking ### tobacco substitutes


### member states shall require manufacturers and importers of tobacco products to submit to their competent authorities a list of all ingredients , and quantities thereof , used in the manufacture of the tobacco products by brand name and type , as well as their emissions and yields . manufacturers or importers shall also inform the competent authorities of the concerned member states if the composition of a product is modified affecting the information provided under this article . information required under this article shall be submitted prior to the placing of the market of a new or modified tobacco product . ### member states shall require manufacturers and importers of tobacco products to submit to their competent authorities a list of all ingredients , and quantities thereof , used in the manufacture of the tobacco products by brand name and type , as well as their emissions and yields resulting from intended use . manufacturers or importers shall also inform the competent authorities of the concerned member states if the composition of a product is modified affecting the information provided under this article . information required under this article shall be submitted prior to the placing of the market of a new or modified tobacco product .


### 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 being sold on the union market in increasing quantities , electronic cigarettes , which come in many different varieties with varying technical characteristics , are proving especially popular . this diversity makes them difficult to define in law , and means that several different european legal regimes apply to them depending on whether or not their purpose is to help people stop smoking and whether they contain addictive substances such as nicotine or toxic chemicals . the different regulatory approaches taken by member states to address possible health and safety concerns associated with these new products , which have been on the eu market for less than 10 years , have an 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 .


### 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 to completely prevent novel tobacco products from entering the market .


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


### all tobacco products have the potential to cause mortality , morbidity and disability and their consumption should be contained . it is therefore important to monitor developments as regards novel tobacco products . a notification obligation for novel tobacco products should be put on manufacturers and importers , without prejudice to the power of the member states to ban or to authorise them . the commission should monitor the development and submit a report 5 years after the transposition deadline of this directive , in order to assess whether amendments to this directive are necessary . ### all tobacco products have the potential to cause mortality , morbidity and disability and their consumption should be contained . therefore a complete ban on the production and sale of all tobacco products in the european union should be imposed .


### 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


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


### 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 .


### the european procurement passport shall be recognised by all contracting authorities as proof of fulfilment of the conditions for participation covered by it and shall not be questioned without justification . such justification may be related to the fact that the passport was issued more than six months earlier . ### the european procurement passport shall be recognised by all contracting authorities as proof of fulfilment of the conditions for participation covered by it and shall not be questioned without justification . such justification may be related to the fact that the passport was issued more than one year earlier .


### at least five tenders have been submitted . ### at least three tenders have been submitted .


### contracting authorities may lay down special conditions relating to the performance of a contract , provided that they are indicated in the call for competition or in the specifications . those conditions may , in particular , concern social and environmental considerations . they may also include the requirement that economic operators foresee compensations for risks of price increases that are the result of price fluctuations and that could substantially impact the performance of a contract . ### contracting entities may lay down special conditions relating to the performance of a contract , provided that they are indicated in the call for competition or in the specifications . those conditions may , in particular , concern training measures for unemployed and young people . they may also include the requirement that economic operators foresee compensations for risks of price increases that are the result of price fluctuations and that could substantially impact the performance of a contract .


### by reference to technical specifications and , in order of preference , to national standards transposing european standards , european technical approvals , common technical specifications , international standards , other technical reference systems established by the european standardisation bodies or ‐ when those do not exist ‐ national standards , national technical approvals or national technical specifications relating to the design , calculation and execution of the works and use of the supplies ; each reference shall be accompanied by the words ‘ or equivalent’ ; ### by reference to specifications and standards , as defined in point 2 of annex viii , with preference given to european and international standards , and only in the absence thereof to national standards ; each reference shall be accompanied by the words ' or equivalent ' ;


### the technical specifications drawn up by public purchasers need to allow public procurement to be opened up to competition . to that end , it must be possible to submit tenders that reflect the diversity of technical solutions so as to obtain a sufficient level of competition . consequently , technical specifications should be drafted in such a way to avoid artificially narrowing down competition through requirements that favour a specific economic operator by mirroring key characteristics of the supplies , services or works habitually offered by that economic operator . drawing up the technical specifications in terms of functional and performance requirements generally allows this objective to be achieved in the best way possible and favours innovation . where reference is made to a european standard or , in the absence thereof , to a national standard , tenders based on equivalent arrangements must be considered by contracting authorities . to demonstrate equivalence , tenderers can be required to provide third - party verified evidence ; however , other appropriate means of proof such as a technical dossier of the manufacturer should also be allowed where the economic operator concerned has no access to such certificates or test reports , or no possibility of obtaining them within the relevant time limits . ### the technical specifications drawn up by public purchasers need to allow public procurement to be opened up to competition . to that end , it must be possible to submit tenders that reflect the diversity of technical solutions so as to obtain a sufficient level of competition . consequently , the purpose of the technical specifications is to define the function that the subject - matter of a contract is to deliver and should in all cases be drafted in such a way to avoid artificially narrowing down competition through requirements that favour a specific economic operator by mirroring key characteristics of the supplies , services or works habitually offered by that economic operator . drawing up the technical specifications in terms of functional and performance requirements generally allows this objective to be achieved in the best way possible and favours innovation . where reference is made to a european standard or , in the absence thereof , to a national standard , tenders based on equivalent arrangements must be considered by contracting authorities . to demonstrate equivalence , tenderers can be required to provide third - party verified evidence ; however , other appropriate means of proof such as a technical dossier of the manufacturer should also be allowed where the economic operator concerned has no access to such certificates or test reports , or no possibility of obtaining them within the relevant time limits .


### contracting authorities may use electronic auctions , in which new prices , revised downwards , and / or new values concerning certain elements of tenders are presented . ### for fully standardised supplies and services , contracting authorities may use electronic auctions , in which new prices , revised downwards , and / or new values concerning certain elements of tenders are presented .


### contracts should be awarded on the basis of objective criteria that ensure compliance with the principles of transparency , non - discrimination and equal treatment . these criteria should guarantee that tenders are assessed in conditions of effective competition , also where contracting authorities require high - quality works , supplies and services that are optimally suited to their needs , for instance where the chosen award criteria include factors linked to the production process . as a result , contracting authorities should be allowed to adopt as award criteria either ‘ the most economically advantageous tender’ or ‘ the lowest cost’ , taking into account that in the latter case they are free to set adequate quality standards by using technical specifications or contract performance conditions . ### contracts should be awarded on the basis of objective criteria that ensure compliance with the principles of transparency , non - discrimination and equal treatment . those criteria should guarantee that tenders are assessed in conditions of effective competition , also where contracting authorities require high - quality works , supplies and services that are optimally suited to their needs . as a result , contracting authorities should be allowed to adopt as award criteria either ' the most economically advantageous tender ' or , in case of standardised goods , ' the lowest prize ' .


### contract performance conditions are compatible with this directive provided that they are not directly or indirectly discriminatory , are linked to the subject - matter of the contract and are indicated in the contract notice , the prior information notice used as a means of calling for competition or the procurement documents . they may , in particular , be intended to favour on - site vocational training , the employment of people experiencing particular difficulty in achieving integration , the fight against unemployment , protection of the environment or animal welfare . for instance , mention may be made , amongst other things , of the requirements ‐ applicable during performance of the contract ‐ to recruit long - term job - seekers or to implement training measures for the unemployed or young persons , to comply in substance with fundamental international labour organisation conventions , even where such conventions have not been implemented in national law , and to recruit more disadvantaged persons than are required under national legislation . ### contract performance conditions are compatible with this directive provided that they are not directly or indirectly discriminatory , are linked directly to the subject - matter of the contract and are indicated in the contract notice , the prior information notice used as a means of calling for competition or the procurement documents . they may , in particular , be intended to favour on - site vocational training or the employment of people experiencing particular difficulty in achieving integration .


### without prejudice to national laws , regulations or administrative provisions concerning the remuneration of certain services , the criteria on which contracting authorities shall base the award of public contracts shall be one of the following : ### without prejudice to national laws , regulations or administrative provisions concerning the remuneration of certain services , the criterion on which contracting authorities shall base the award of public contracts shall be the most economically advantageous and sustainable tender .


### the most economically advantageous tender referred to in point of paragraph 1 from the point of view of the contracting authority shall be identified on the basis of criteria linked to the subject - matter of the public contract in question . those criteria shall include , in addition to the price or costs referred to in point of paragraph 1 , other criteria linked to the subject - matter of the public contract in question , such as : ### the most economically advantageous tender referred to in point of paragraph 1 from the point of view of the contracting authority shall be identified on the basis of criteria linked to the subject - matter of the public contract in question . those criteria shall include , in addition to the price , other criteria linked to the subject - matter of the public contract in question , such as :


### however , in the case of public service and public works contracts as well as public supply contracts covering in addition services or siting and installation operations , legal persons may be required to indicate , in the tender or the request to participate , the names and relevant professional qualifications of the staff to be responsible for the performance of the contract in question . ### however , in the case of public service and public works contracts as well as public supply contracts covering in addition services or siting and installation operations , legal persons may be required to indicate , in the tender or the request to participate , relevant professional qualification levels of the staff to be responsible for the performance of the contract in question .


### the contracting authorities may specify prizes or payments to the participants in the dialogue . ### the contracting authorities shall specify prizes or payments to the participants in the dialogue on terms laid down by the contract .


### member states shall ensure that contracting authorities may take into account the need to ensure quality , continuity , accessibility , availability and comprehensiveness of the services , the specific needs of different categories of users , the involvement and empowerment of users and innovation . member states may also provide that the choice of the service provider shall not be made solely on the basis of the price for the provision of the service . ### member states shall ensure that contracting authorities take into account the need to ensure a high level of quality , continuity , accessibility , affordability , availability and comprehensiveness of the services , the specific needs of different categories of users , including disadvantaged and vulnerable groups , users ' satisfaction , social inclusion , the involvement and empowerment of users and , where relevant , innovation . member states shall provide that the choice of the service provider is not made solely on the basis of the price for the provision of the service . when drawing up quality criteria , contracting authorities may refer to the criteria set out in the voluntary european quality framework for social services . 2a . contracting authorities may choose to limit the participation in a tender procedure for the provision of social and health services to non profit organisations , provided that a national law that is compatible with european law provides for restricted access to certain services for the benefit on non profit organisations , in line with the ecj ' s jurisprudence . the call for competition shall make reference to this provision . the basic principles of transparency and equal treatment should be respected .


### contracting authorities may authorise tenderers to submit variants . they shall indicate in the contract notice or , where a prior information notice is used as a means of calling for competition , in the invitation to confirm interest whether or not they authorise variants . variants shall not be authorised without such indication . ### contracting authorities may authorise tenderers to submit variants . they shall as a general rule authorise variants unless otherwise stated in the contract notice or , where a prior information notice is used as a means of calling for competition , in the invitation to confirm interest . variants shall be authorised without such indication to the contrary .


### contracting authorities authorising variants shall state in the procurement documents the minimum requirements to be met by the variants and any specific requirements for their presentation . they shall also ensure that the chosen award criteria can be usefully applied to variants meeting those minimum requirements as well as to conforming tenders which are not variants . ### where variants are not prohibited , contracting authorities shall state in the procurement documents the minimum requirements to be met by the variants and any specific requirements for their presentation . they shall also ensure that the chosen award criteria can be usefully applied to variants meeting those minimum requirements as well as to conforming tenders which are not variants .


### the agreement is governed only by considerations relating to the public interest ; ### the agreement is governed only by public interest considerations ; this includes subordinate ancillary services which are necessary in order to perform the services in the public interest ;


### in the contract notice or in the invitation to confirm interest contracting authorities shall describe the procurement and the minimum requirements to be met and specify the award criteria so as to enable economic operators to identify the nature and scope of the procurement and decide whether to request to participate in the negotiations . in the technical specifications , contracting authorities shall specify which parts thereof define the minimum requirements . ### in the procurement documents , contracting authorities shall indicate which elements define the minimum requirements to be met . the indications shall be sufficiently precise as to enable economic operators to identify the precise nature and scope of the procurement and decide whether to request to participate in the procedure .


### contracting authorities shall not reveal to the other participants solutions proposed or other confidential information communicated by a candidate participating in the dialogue without its agreement . such agreement shall not take the form of a general waiver but shall be given with reference to the intended communication of specific solutions or other specific confidential information . ### contracting authorities shall behave with utmost good faith and shall not reveal to the other participants solutions proposed or other confidential information communicated by a candidate participating in the dialogue without its agreement , which cannot be imposed as a condition for participating in the competitive dialogue procedure .


### contracting authorities may decide not to award a contract to the tenderer submitting the best tender where they have established that the tender does not comply , at least in an equivalent manner , with obligations established by union legislation in the field of social and labour law or environmental law or of the international social and environmental law provisions listed in annex xi . ### contracting authorities shall not award a contract to the tenderer submitting the best tender where they have established that the tender does not comply with obligations in the field of social and labour law or environmental law established by union or national legislation or collective agreements which apply in the place where the work , service or supply is performed , or by the international social and environmental law provisions listed in annex xi .


### the agreement establishes a genuine cooperation between the participating contracting authorities aimed at carrying out jointly their public service tasks and involving mutual rights and obligations of the parties ; ### the agreement establishes a genuine cooperation between the participating contracting authorities aimed at carrying out jointly their public service tasks ;


### the contracting authorities shall document the progress of all procurement procedures , whether or not those are conducted by electronic means . to that end , they shall document all stages in the procurement procedure , including all communications with economic operators and internal deliberations , preparation of the tenders , dialogue or negotiation if any , selection and award of the contract . ### the contracting authorities shall document the progress of all procurement procedures , whether or not those are conducted by electronic means . to that end , they shall document all stages in the procurement procedure , including all communications with economic operators , preparation of the tenders , dialogue or negotiation if any , selection and award of the contract .


### indication of the period of validity of the passport , which shall be not less than 6 months . ### indication of the period of validity of the passport , which shall be not less than 12 months .


### financial services in connection with the issue , sale , purchase or transfer of securities or other financial instruments within the meaning of directive 2004 / 39 / ec of the european parliament and of the council27 , central bank services and operations conducted with the european financial stability facility ; ### financial services in connection with the issue , sale , purchase or transfer of securities or other financial instruments within the meaning of directive 2004 / 39 / ec of the european parliament and of the council27 , transactions to enable contracting authorities to raise money or capital , as well as central bank services and operations conducted with the european financial stability facility ;


### member states shall put in place appropriate procedures for the award of contracts subject to this chapter , ensuring full compliance with the principles of transparency and equal treatment of economic operators and allowing contracting authorities to take into account the specificities of the services in question . ### member states shall put in place appropriate procedures for the award of contracts subject to this chapter , ensuring full compliance with the principles of transparency , non - discrimination and equal treatment of economic operators and allowing contracting authorities to take into account the specificities of the services in question .


### there is no private participation in any of the contracting authorities involved . ### the private participation in any of the contracting authorities does not exceed 50% of its voting shares .


### by reference to technical specifications and , in order of preference , to national standards transposing european standards , european technical approvals , common technical specifications , international standards , other technical reference systems established by the european standardisation bodies or ‐ when those do not exist ‐ national standards , national technical approvals or national technical specifications relating to the design , calculation and execution of the works and use of the supplies ; each reference shall be accompanied by the words ‘ or equivalent’ ; ### by reference to technical specifications and , in order of preference , and without discrimination as to development method , to national standards transposing european standards , european technical approvals , common technical specifications , international standards , other technical reference systems established by the european standardisation bodies or ‐ when those do not exist ‐ national standards , national technical approvals or national technical specifications relating to the design , calculation and execution of the works and use of the supplies ; each reference shall be accompanied by the words ' or equivalent ' ;


### the technical specifications as defined in point 1 of annex viii shall be set out in the procurement documents . they shall define the characteristics required of a works , service or supply . ### the technical specifications as defined in point 1 of annex viii shall be set out in the procurement documents . they shall define the functionality that a work , service or supply is to deliver .


### contract performance conditions are compatible with this directive provided that they are not directly or indirectly discriminatory , are linked to the subject - matter of the contract and are indicated in the contract notice , the prior information notice used as a means of calling for competition or the procurement documents . they may , in particular , be intended to favour on - site vocational training , the employment of people experiencing particular difficulty in achieving integration , the fight against unemployment , protection of the environment or animal welfare . for instance , mention may be made , amongst other things , of the requirements ‐ applicable during performance of the contract ‐ to recruit long - term job - seekers or to implement training measures for the unemployed or young persons , to comply in substance with fundamental international labour organisation conventions , even where such conventions have not been implemented in national law , and to recruit more disadvantaged persons than are required under national legislation . ### contract performance conditions are compatible with this directive provided that they are not directly or indirectly discriminatory , are linked to the subject - matter of the contract and are indicated in the notice used to make the call for competition , or in the procurement documents . they may , in particular , be intended to favour on - site vocational or professional training . for example , mention may be made of the requirements applicable during the performance of the contract to implement training measures for the unemployed or for young persons .


### member states may provide that contracting authorities may apply innovation partnerships as regulated in this directive . ### member states shall provide that contracting authorities may apply innovation partnerships as regulated in this directive .


### contracting authorities may decide not to award a contract to the tenderer submitting the best tender where they have established that the tender does not comply , at least in an equivalent manner , with obligations established by union legislation in the field of social and labour law or environmental law or of the international social and environmental law provisions listed in annex xi . ### contracting authorities may decide not to award a contract to the tenderer submitting the best tender where they have established that the tender does not comply , at least in an equivalent manner , with obligations established by union legislation in the field of social and labour law , data protection law or environmental law or of the international social and environmental law provisions listed in annex xi .


### contracting authorities that wish to purchase works , supplies or services with specific environmental , social or other characteristics should be able to refer to particular labels , such as the european eco - label , national eco - labels or any other label provided that the requirements for the label are linked to the subject - matter of the contract , such as the description of the product and its presentation , including packaging requirements . it is furthermore essential that these requirements are drawn up and adopted on the basis of objectively verifiable criteria , using a procedure in which stakeholders , such as government bodies , consumers , manufacturers , distributors and environmental organisations , can participate , and that the label is accessible and available to all interested parties . ### contracting authorities that wish to purchase works , supplies or services with specific environmental , social or other characteristics should be able to refer to particular labels , such as the european eco - label , national eco - labels or any other label provided that the requirements for the label are linked to the subject - matter of the contract , such as the description of the product and its presentation , including packaging requirements . it is furthermore essential that these requirements are drawn up and adopted on the basis of objectively verifiable criteria , using a procedure in which stakeholders , such as government bodies , consumers , manufacturers , distributors , social organisations and environmental organisations , can participate , and that the label is accessible and available to all interested parties .


### member states shall ensure that contracting authorities may take into account the need to ensure quality , continuity , accessibility , availability and comprehensiveness of the services , the specific needs of different categories of users , the involvement and empowerment of users and innovation . member states may also provide that the choice of the service provider shall not be made solely on the basis of the price for the provision of the service . ### member states shall ensure that contracting authorities take into account the need to ensure a high level of quality , continuity , accessibility , affordability , availability and comprehensiveness of the services , the specific needs of different categories of users , including disadvantaged and vulnerable groups , users ' satisfaction , social inclusion , the involvement and empowerment of users and , where relevant , innovation . member states shall provide that the choice of the service provider is not made solely on the basis of the price for the provision of the service . when drawing up quality criteria , contracting authorities may refer to the criteria set out in the voluntary european quality framework for social services . 2a . contracting authorities may choose to limit the participation in a tender procedure for the provision of social and health services to non profit organisations , provided that a national law that is compatible with european law provides for restricted access to certain services for the benefit on non profit organisations , in line with the ecj ' s jurisprudence . the call for competition shall make reference to this provision . the basic principles of transparency and equal treatment should be respected .


### not later than 48 days after the award of a contract or the conclusion of a framework agreement , contracting authorities shall send a contract award notice on the results of the procurement procedure . ### not later than 14 days after the award of a contract or the conclusion of a framework agreement , contracting authorities shall send a contract award notice on the results of the procurement procedure . in case of an incomplete or incoherent contract award notice , the commission will contact the contracting authority with the aim to receive completion or clarification of the contract award notice .


### during the negotiations , contracting authorities shall ensure the equal treatment of all tenderers . to that end , they shall not provide information in a discriminatory manner which may give some tenderers an advantage over others . they shall take particular care to ensure that all tenderers , whose tenders have not been eliminated pursuant to paragraph 5 , are informed in writing of any changes to the technical specifications other than those setting out the minimum requirements , in adequate time to allow such tenderers to modify and re - submit amended tenders following these changes , as appropriate . ### during the negotiations , contracting authorities shall ensure the equal treatment of all tenderers . to that end , they shall not provide information in a discriminatory manner which may give some tenderers an advantage over others . they shall take particular care to ensure that all tenderers , whose tenders have not been eliminated pursuant to paragraph 5 , are informed in writing of any changes to the technical specifications or other procurement documents , other than those setting out the minimum requirements , providing sufficient time for such tenderers to modify and re - submit amended tenders following these changes .


### the most economically advantageous tender referred to in point of paragraph 1 from the point of view of the contracting authority shall be identified on the basis of criteria linked to the subject - matter of the public contract in question . those criteria shall include , in addition to the price or costs referred to in point of paragraph 1 , other criteria linked to the subject - matter of the public contract in question , such as : ### the most economically advantageous tender referred to in point of paragraph 1 from the point of view of the contracting authority shall be identified on the basis of criteria linked to the subject - matter of the public contract in question and , wherever possible , on the basis of the monetisation of the life cycle as defined in article 2 , point 22 . those criteria may include , in addition to the price or costs referred to in point of paragraph 1 , other criteria linked to the subject - matter of the public contract in question , such as :


### where contracting authorities lay down environmental , social or other characteristics of a works , service or supply in terms of performance or functional requirements as referred to in point of article 40 they may require that these works , services or supplies bear a specific label , provided that all of the following conditions are fulfilled : ### where contracting authorities lay down environmental characteristics of a works , service or supply in terms of performance or functional requirements as referred to in point of article 40 they may require that these works , services or supplies bear a specific label , provided that all of the following conditions are fulfilled :


### contracts should be awarded on the basis of objective criteria that ensure compliance with the principles of transparency , non - discrimination and equal treatment . these criteria should guarantee that tenders are assessed in conditions of effective competition , also where contracting authorities require high - quality works , supplies and services that are optimally suited to their needs , for instance where the chosen award criteria include factors linked to the production process . as a result , contracting authorities should be allowed to adopt as award criteria either ‘ the most economically advantageous tender’ or ‘ the lowest cost’ , taking into account that in the latter case they are free to set adequate quality standards by using technical specifications or contract performance conditions . ### contracts should be awarded on the basis of objective criteria that ensure compliance with the principles of transparency , non - discrimination and equal treatment . those criteria should guarantee that tenders are assessed in conditions of effective competition , also where contracting authorities require high - quality works , supplies and services that are optimally suited to their needs . as a result , contracting authorities should be allowed to adopt as award criteria either ' the most economically advantageous tender ' or , in case of standardised goods , ' the lowest prize ' .


### contracting authorities shall limit any conditions for participation to those that are appropriate to ensure that a candidate or tenderer has the legal and financial capacities and the commercial and technical abilities to perform the contract to be awarded . all requirements shall be related and strictly proportionate to the subject - matter of the contract , taking into account the need to ensure genuine competition . ### contracting authorities shall limit any conditions for participation to those that are appropriate to ensure that a candidate or tenderer has the legal and financial capacities and the commercial and technical abilities to perform the contract to be awarded . consequently , in no case can a tender be rejected solely because it does not include a reference to previous contracts . all requirements shall be related and strictly proportionate to the subject - matter of the contract , taking into account the need to ensure genuine competition .


### in innovation partnerships , any economic operator may submit a request to participate in response to a contract notice with a view to establishing a structured partnership for the development of an innovative product , service or works and the subsequent purchase of the resulting supplies , services or works provided that they correspond to the agreed performance levels and costs . ### in innovation partnerships , any economic operator may submit a request to participate in response to a contract notice with a view to establishing a structured partnership for the development of an innovative product , service or works and the subsequent purchase of the resulting supplies , services or works , provided that they correspond to the agreed performance levels and costs . the contract setting up the innovation partnership shall be awarded on the sole basis of the award criterion of the most economically advantageous tender in accordance with article 66 .


### contracting authorities may lay down special conditions relating to the performance of a contract , provided that they are indicated in the call for competition or in the specifications . those conditions may , in particular , concern social and environmental considerations . they may also include the requirement that economic operators foresee compensations for risks of price increases that are the result of price fluctuations and that could substantially impact the performance of a contract . ### contracting authorities may lay down special conditions relating to the performance of a contract , provided that they are indicated in the call for competition or in the specifications and are of direct relevance to the contract ' s works , goods , or services . those conditions may include the requirement that economic operators foresee compensations for risks of price increases that are the result of price fluctuations and that could substantially impact the performance of a contract .


### where contracting authorities assess the costs using a life - cycle costing approach , they shall indicate in the procurement documents the methodology used for the calculation of the life - cycle costs . the methodology used must fulfil all of the following conditions : ### where contracting authorities use a life - cycle costing approach , they shall indicate in the procurement documents the data to be provided by the tenderers and the method which the contracting authority will use to determine the life - cycle costs on the basis of these data .


### however , in the case of public service and public works contracts as well as public supply contracts covering in addition services or siting and installation operations , legal persons may be required to indicate , in the tender or the request to participate , the names and relevant professional qualifications of the staff to be responsible for the performance of the contract in question . ### however , in the case of public service and public works contracts as well as public supply contracts covering in addition services or siting and installation operations , legal persons may be required to indicate , in the tender or the request to participate , relevant professional qualification levels of the staff to be responsible for the performance of the contract in question .