### 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 the methodology for determining whether a tobacco product has a characterising flavour , 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 and defining key elements for contracts on data storage with independent third parties . 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 .


### ‘ place on the market’ means to make products available to consumers located in the union , with or without payment , including by means of distance sale ; in case of cross - border distance sales the product is deemed to be placed on the market in the member state where the consumer is located ; ### ‘ place on the market’ means any supply of products for distribution , consumption or use in the union , with or without payment including by means of distance sale ;


### 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 at the bottom edge of the unit packet and any outside packaging ;


### 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 .


### this product contains nicotine and can damage your health . ### this product contains nicotine and damages your health .


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


### 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 ;


### establish and adapt the picture library referred to in point of paragraph 1 of this article taking into account scientific and market developments ; ### establish by …* and if necessary thereafter adapt the picture library referred to in point of paragraph 1 of this article taking into account scientific and market developments ; __________________ * oj : please insert date : six months after the entry into force of this directive .


### 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 .


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


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


### this product can damage your health . ### this product can damage your health and is addictive .


### 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 introduction of combined health warnings should be left to the discretion of each member state , while text warnings are mandatory throughout the union and cover significant and visible parts of the packet surface . a minimum percentage of the external surface should be set for all health warnings to ensure their visibility and effectiveness .


### the likelihood of diverging regulation is further increased by concerns over tobacco products , including smokeless tobacco products , having a characterising flavour other than tobacco , which may facilitate uptake of tobacco consumption or affect consumption patterns . for example , in many countries , sales of mentholated products gradually increased even as smoking prevalence overall declined . a number of studies indicated that mentholated tobacco products can facilitate inhalation as well as smoking uptake among young people . measures introducing unjustified differences of treatment between flavoured cigarettes should be avoided . ### the likelihood of diverging regulation is further increased by concerns over tobacco products , including smokeless tobacco products , having a characterising flavour other than tobacco , which may facilitate uptake of tobacco consumption or affect consumption patterns . the commission is urged to carry out a scientific study of the real influence of these products on smoking uptake .


### the following nicotine - containing products may only be placed on the market if they were authorised pursuant to directive 2001 / 83 / ec : ### nicotine - containing products may only be placed on the market if they were authorised pursuant to directive 2001 / 83 / ec .


### member states should remain free to maintain or introduce national legislations applying to all products alike for aspects falling outside the scope of this directive , provided they are compatible with the treaty and do not jeopardise the full application of this directive . accordingly , member states could , for instance , maintain or introduce provisions providing standardisation of packaging of tobacco products provided that those provisions are compatible with the treaty , with wto obligations and do not affect the full application of this directive . a prior notification is required for technical regulations pursuant to directive 98 / 34 / ec of the european parliament and of the council of 22 june 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and on rules on information society services . ### member states should be able to adopt more stringent rules concerning tobacco products which they deem necessary to protect public health , in - so - far as such rules fall outside the scope of the provisions of this directive . in - so - far as tobacco or related products comply with the requirements of this directive , member states shall not prohibit or restrict the import , sale or consumption of such products .


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


### the commission shall be empowered to adopt delegated acts in accordance with article 22 to adapt the methods of measurement of the tar , nicotine and carbon monoxide yields , taking into account scientific and technical developments and internationally agreed standards . ### the commission shall be empowered to adopt delegated acts in accordance with article 22 to adapt the methods of measurement of the tar , nicotine and carbon monoxide yields , taking into account scientific and technical developments and using internationally agreed standards designed for a specific purpose and validated by the international organisation for standardisation .


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


### member states shall notify the commission of the methods of measurement that they use for other emissions of cigarettes and for emissions of tobacco products other than cigarettes . based on these methods , and taking into account scientific and technical developments as well as internationally agreed standards the commission shall be empowered to adopt delegated acts in accordance with article 22 to adopt and adapt methods of measurement . ### member states shall notify the commission of the methods of measurement that they use for other emissions of cigarettes and for emissions of tobacco products other than cigarettes . such measurement shall be based on scientific evidence . based on these measurements , and taking into account scientific and technical developments as well as using internationally agreed standards designed for a specific purpose and validated by the international organisation for standardisation the commission shall be empowered to adopt delegated acts in accordance with article 22 to adopt and adapt methods of measurement .


### in order to ensure their graphic integrity and visibility , health warnings shall be irremovably printed , indelible and in no way hidden or interrupted , including by tax stamps , price marks , tracking and tracing marks , security features or by any type of wrapper , pouch , jacket , box or other device or by the opening of the unit packet . ### in order to ensure their graphic integrity and visibility , health warnings shall be irremovably printed , indelible and in no way hidden or interrupted , including by tax stamps which shall be placed at the opening of the tobacco product package , price marks , tracking and tracing marks , security features or by any type of wrapper , pouch , jacket , box or other device or by the opening of the unit packet .


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


### in order to ensure uniform conditions for the implementation of this directive , in particular concerning the format of ingredients reporting , the determination of products with characterising flavours or with increased levels of toxicity and addictiveness and the methodology for determining whether a tobacco product has characterising flavour , implementing powers should be conferred on the commission . those powers should be exercised in accordance with regulation no 182 / 2011 . ### in order to ensure uniform conditions for the implementation of this directive , in particular concerning the format of ingredients reporting and the determination of products with characterising flavours or with increased levels of toxicity and addictiveness , implementing powers should be conferred on the commission . those powers should be exercised in accordance with regulation no 182 / 2011 .


### ‘ substantial change of circumstances’ means an increase of the sales volumes by product category , such as pipe tobacco , cigar , cigarillo , by at least 10% in at least 10 member states based on sales data transmitted in accordance with article 5 ; or an increase of the prevalence level in the consumer group under 25 years of age by at least 5 percentage points in at least 10 member states for the respective product category based on ____ [ this date will be set at the moment of adoption of the directive ] eurobarometer report or equivalent prevalence studies ; ### ‘ substantial change of circumstances’ means an increase of the sales volumes by product category , such as pipe tobacco , cigar , cigarillo , by at least 20% in at least 10 member states based on sales data transmitted in accordance with article 5 ; or an increase of the prevalence level in the consumer group under 25 years of age by at least 5 percentage points in at least 10 member states for the respective product category based on ____ [ this date will be set at the moment of adoption of the directive ] eurobarometer report or equivalent prevalence studies ;


### 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 the methodology for determining whether a tobacco product has a characterising flavour , 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 and defining key elements for contracts on data storage with independent third parties . 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 .


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


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


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


### 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 size and appearance of individual cigarettes can mislead consumers by creating the impression that they are less harmful . the commission is urged to carry out a scientific study of the real influence of these products on tobacco consumption .


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


### a delegated act pursuant to articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council . ### a delegated act pursuant to articles 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 18 and 18 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council .


### 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 prohibit the use of additives which are essential for the manufacture of tobacco products , even if the essential additives result in a product with a characterising flavour .


### 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 placed on the packages , such as ‘ low - tar’ , ‘ light’ , ‘ ultra - light’ , ‘ mild’ , ‘ natural’ , ‘ organic’ , ‘ without additives’ , ‘ without flavours’ , ‘ slim’ , names , pictures , and figurative or other signs . this should be addressed by defining which text may be placed on the package .


### tobacco products other than cigarettes and roll - your - own tobacco shall be exempted from the application of paragraph 1 to 8 during a period of 5 years following the date referred to in paragraph 1 of article 25 . ### tobacco products other than cigarettes and roll - your - own tobacco shall be exempted from the application of paragraph 1 to 8 during a period of 10 years following the date referred to in paragraph 1 of article 25 .


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


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


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


### ‘ place on the market’ means to make products available to consumers located in the union , with or without payment , including by means of distance sale ; in case of cross - border distance sales the product is deemed to be placed on the market in the member state where the consumer is located ; ### ‘ place on the market’ means any supply of products for distribution , consumption or use in the union , with or without payment including by means of distance sale ;


### the commission shall be empowered to adopt delegated acts in accordance with article 22 : ### the commission shall be empowered , taking into account existing practices , technologies and commercial practicalities as well as global standards for tracking and tracing and authentication of fast moving consumer goods and relevant requirements under the who fctc protocol to eliminate illicit trade in tobacco products to adopt delegated acts in accordance with article 22 :


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


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


### in relation to the fixing of maximum yields , it might be necessary and appropriate at a later date to adapt the yields fixed or to fix maximum thresholds for emissions , taking into consideration their toxicity or addictiveness . ### in relation to the fixing of maximum yields , it might be necessary and appropriate at a later date to adapt the yields fixed or to fix maximum thresholds for emissions , taking into consideration scientific development and internationally agreed standards to assess their toxicity or addictiveness .


### in order to ensure their graphic integrity and visibility , health warnings shall be irremovably printed , indelible and in no way hidden or interrupted , including by tax stamps , price marks , tracking and tracing marks , security features or by any type of wrapper , pouch , jacket , box or other device or by the opening of the unit packet . ### health warnings shall be irremovably printed , indelible and in no way hidden or interrupted , including by tax stamps , price marks , tracking and tracing marks , security features or by any type of wrapper , pouch , jacket , box or other device or by the opening of the unit packet .


### member states shall require that manufacturers and importers of tobacco products notify the competent authorities of member states of any novel tobacco product they intend to place on the markets of the member states concerned . the notification shall be submitted in electronic form six months before the intended placing on the market and shall be accompanied by a detailed description of the product in question as well as information on ingredients and emissions in accordance with article 5 . the manufacturers and importers notifying a novel tobacco product shall also provide the competent authorities in question with : ### member states shall require that manufacturers and importers of tobacco products notify the competent authorities of member states of any novel tobacco product they intend to place on the markets of the member states concerned and in respect of which they intend to make claims , based on solid scientific evidence , alleging reduced harmfulness or risk in comparison with conventional tobacco products . 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 ensure that all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet , record the entry of all unit packets into their possession , as well as all intermediate movements and the final exit from their possession . this obligation can be fulfilled by recording in aggregated form , e . g . of outside packaging , provided that tracking and tracing of unit packets remains possible . ### member states shall ensure that all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet , record the entry of all unit packets and outside packaging into their possession , as well as all intermediate movements and the final exit from their possession . 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 .


### 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 use42 provides a legal framework to assess the quality , safety and efficacy of medicinal products including nicotine containing products . a significant number of nicotine - containing products were already authorised under this regulatory regime . the authorisation takes into account the nicotine content of the product in question . applying 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 .


### member states should remain free to maintain or introduce national legislations applying to all products alike for aspects falling outside the scope of this directive , provided they are compatible with the treaty and do not jeopardise the full application of this directive . accordingly , member states could , for instance , maintain or introduce provisions providing standardisation of packaging of tobacco products provided that those provisions are compatible with the treaty , with wto obligations and do not affect the full application of this directive . a prior notification is required for technical regulations pursuant to directive 98 / 34 / ec of the european parliament and of the council of 22 june 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and on rules on information society services . ### member states should be able to adopt more stringent rules concerning tobacco products which they deem necessary to protect public health , in - so - far as such rules fall outside the scope of the provisions of this directive . in - so - far as tobacco or related products comply with the requirements of this directive , member states shall not prohibit or restrict the import , sale or consumption of such products .


### nicotine containing products below the threshold set out in article 18 ; ### nicotine containing products ;


### establish and adapt the picture library referred to in point of paragraph 1 of this article taking into account scientific and market developments ; ### establish by …* and if necessary thereafter adapt the picture library referred to in point of paragraph 1 of this article taking into account scientific and market developments ; __________________ * oj : please insert date : six months after the entry into force of this directive .


### the commission shall be empowered to adopt delegated acts in accordance with article 22 to adapt the methods of measurement of the tar , nicotine and carbon monoxide yields , taking into account scientific and technical developments and internationally agreed standards . ### the commission shall be empowered to adopt delegated acts in accordance with article 22 to adapt the methods of measurement of the tar , nicotine and carbon monoxide yields , taking into account scientific and technical developments and using internationally agreed standards designed for a specific purpose and validated by the international organisation for standardisation .


### the prohibition of tobacco products with characterising flavours does not prohibit the use of individual additives altogether , but obliges the manufactures to reduce the additive or the combination of additives to such an extent that the additives no longer result in a characterising flavour . the use of additives necessary for manufacturing of tobacco products should be allowed , as long as they do not result in a characterising flavour . . the commission should ensure uniform conditions for the implementation of the provision on characterising flavour . independent panels should be used by the member states and by the commission to assist in such decision making . the application of this directive should not discriminate between different tobacco varieties . ### the prohibition of tobacco products with characterising flavours does not prohibit the use of individual additives altogether , but obliges the manufactures to reduce the additive or the combination of additives to such an extent that the additives no longer result in a characterising flavour . the use of additives necessary for manufacturing of tobacco products should be allowed , as long as they do not result in a characterising flavour . . the commission should ensure uniform conditions for the implementation of the provision on characterising flavour . exemption should be made for menthol cigarettes as they are considered being traditional tobacco flavour products and should not be classified with the other flavoured tobacco products . independent panels should be used by the member states and by the commission to assist in such decision making . the application of this directive should not discriminate between different tobacco varieties .


### monitoring and reporting shall be complete and cover all emissions from the combustion of fuels . companies shall apply appropriate measures to prevent any data gaps within the reporting period . ### monitoring and reporting shall cover co2 emissions from the combustion of fuels . companies shall apply appropriate measures to prevent any data gaps within the reporting period .


### where a service facility referred to in point 2 of annex ii , has not been in use for at least three consecutive years and interest by railway undertakings for access to this facility has been expressed to the operator of that service facility on the basis of demonstrated needs , its owner shall publicise the operation of the facility as being for lease or rent as a rail service facility , as a whole or in part , unless the operator of that service facility demonstrates that an on - going process of reconversion prevents its use by any railway undertaking . ### where a service facility referred to in point 2 of annex ii , has not been in use for at least two consecutive years and interest by railway undertakings for access to this facility has been expressed to the operator of that service facility on the basis of demonstrated needs , its owner shall publicise the operation of the facility as being for lease or rent as a rail service facility , as a whole or in part , unless the operator of that service facility demonstrates that an on - going process of reconversion prevents its use by any railway undertaking .


### maintenance facilities , with the exception of heavy maintenance services supplied in maintenance facilities exclusively dedicated to specific types of rolling stock , and other technical facilities , including cleaning and washing facilities ; ### light maintenance , including repairs , to enable commercial service to continue ;


### the accounts for the different areas of activity referred to in paragraphs 1 and 3 shall be kept in a way that allows for monitoring of the prohibition on transferring public funds paid to one area of activity to another . ### in order to ensure the complete transparency of infrastructure costs , the accounts for the different areas of activity referred to in paragraphs 1 and 3 shall be kept in a way that allows monitoring of compliance with the preceding paragraphs and of the use of income arising from infrastructure charges , and of surpluses from other commercial activities of , and public and private funding paid to , the infrastructure manager . the revenues of the infrastructure manager shall in no way be used by a railway undertaking or a body or firm controlling a railway undertaking as this may strengthen its market position or enable it to gain economic advantages over other railway undertakings .


### member states shall deploy no later than 1 october 2015 the necessary ecall psap infrastructure required for the proper receipt and handling of all ecalls , if necessary purged of non - emergency calls , on their territory , in accordance with the specifications laid down by delegated regulation no 305 / 2013 , in order to ensure the compatibility , interoperability and continuity of the interoperable eu - wide ecall service . this is without prejudice to the right of each member state to organise its emergency services in the way most cost effective and appropriate to its needs , including the possibility to filter calls that are not emergency calls and may not be handled by ecall psaps , in particular in the case of manually triggered ecalls . ### member states shall deploy no later than 1 october 2015 the necessary ecall psap infrastructure required for the proper receipt and handling of all ecalls , in accordance with the specifications laid down by delegated regulation no 305 / 2013 , in order to ensure the compatibility , interoperability and continuity of the interoperable eu - wide ecall service . this is without prejudice to the right of each member state to organise its emergency services in the way most cost effective and appropriate to its needs , including the possibility to filter calls that are not emergency calls and may not be handled by ecall psaps , in particular in the case of manually triggered ecalls . to deal with such calls more efficiently and avoid mobilizing emergency call centres unnecessarily , manufacturers are encouraged to fit a manual call button for use in contacting the technical assistance services .


### member states shall deploy no later than 1 october 2015 the necessary ecall psap infrastructure required for the proper receipt and handling of all ecalls , if necessary purged of non - emergency calls , on their territory , in accordance with the specifications laid down by delegated regulation no 305 / 2013 , in order to ensure the compatibility , interoperability and continuity of the interoperable eu - wide ecall service . this is without prejudice to the right of each member state to organise its emergency services in the way most cost effective and appropriate to its needs , including the possibility to filter calls that are not emergency calls and may not be handled by ecall psaps , in particular in the case of manually triggered ecalls ; ### member states shall deploy no later than 1 june 2016 the necessary ecall psap infrastructure required for the proper receipt and handling of all ecalls , if necessary purged of non - emergency calls , on their territory , in accordance with the specifications laid down by delegated regulation no 305 / 2013 , in order to ensure the compatibility , interoperability and continuity of the interoperable eu - wide ecall service . member states shall also ensure that the level of accuracy and reliability of caller location of a call to 112 with a gnss - enabled mobile terminal is equivalent to that of an ecall , in accordance with directive 95 / 46 / ec on data protection . this is without prejudice to the right of each member state to organise its emergency services in the way most cost effective and appropriate to its needs , including the possibility to filter calls that are not emergency calls and may not be handled by ecall psaps , in particular in the case of manually triggered ecalls ;


### decisions taken in accordance with this paragraph shall be notified to the other competent authorities concerned . ### decisions taken in accordance with this paragraph shall be notified to the other competent authorities concerned and shall be made public by the relevant competent authorities .


### the european banking authority and the european insurance and occupational pensions authority shall issue common guidelines aimed at the consistency of supervisory coordination arrangements according to article 131a of directive 2006 / 48 / ec and article 248 of directive 2009 / 138 / ec . ### the european supervisory authority , the european supervisory authority and the european supervisory authority shall , through the joint committee , issue common guidelines aimed at the consistency of supervisory coordination arrangements according to article 131a of directive 2006 / 48 / ec and article 248 of directive 2009 / 138 / ec .


### competent authorities shall align the application of the supplementary supervision of internal control mechanisms and risk management processes as provided for in this article with the supervisory review processes as provided for by article 124 of directive 2006 / 48 / ec and article 36 of directive 2009 / 138 / ec . to this end , the european banking authority and the european insurance and occupational pensions authority shall issue common guidelines aimed at the convergence of supervisory practices with regard to the application of supplementary supervision of internal control mechanisms and risk management processes as provided for in this article , as well as on the consistency with the supervisory review processes as provided for by article 124 of directive 2006 / 48 / ec and article 36 of directive 2009 / 138 / ec . they shall issue specific common guidelines for the application of this article to participations of the financial conglomerate , in cases where national company law provisions obstruct the application of article 14 . ### competent authorities shall align the application of the supplementary supervision of internal control mechanisms and risk management processes as provided for in this article with the supervisory review processes as provided for by article 124 of directive 2006 / 48 / ec and article 36 of directive 2009 / 138 / ec . to this end , the european supervisory authority , the european supervisory authority and the european supervisory authority shall , through the joint committee , issue common guidelines aimed at the convergence of supervisory practices with regard to the application of supplementary supervision of internal control mechanisms and risk management processes as provided for in this article , as well as on the consistency with the supervisory review processes as provided for by article 124 of directive 2006 / 48 / ec and article 36 of directive 2009 / 138 / ec . they shall issue specific common guidelines for the application of this article to participations of the financial conglomerate , in cases where national company law provisions obstruct the application of article 14 .


### the european banking authority and the european insurance and occupational pensions authority shall issue common guidelines aimed at the convergence of supervisory practices with regard to the application of supplementary supervision of intra - group transactions as provided for in paragraphs 1 to 4 . . they shall issue specific common guidelines on the application of paragraphs 1 to 4 to participations of the financial conglomerate in cases where national company law provisions obstruct the application of article 14 . ### the european supervisory authority , the european supervisory authority and the european supervisory authority shall , through the joint committee , issue common guidelines aimed at the convergence of supervisory practices with regard to the application of supplementary supervision of intra - group transactions as provided for in paragraphs 1 to 4 . they shall issue specific common guidelines on the application of paragraphs 1 to 4 to participations of the financial conglomerate in cases where national company law provisions obstruct the application of article 14 .


### the comprehensive and adequate monitoring of group risks in large , complex , internationally operating conglomerates , as well as the supervision of the group - wide capital policies of these groups , is only possible when competent authorities gather supervisory information and plan supervisory measures beyond the national scope of their mandate . it is therefore necessary that competent authorities coordinate supplementary supervision on international conglomerates among the competent authorities which are regarded as most relevant for the supplementary supervision of a conglomerate . the college of a financial conglomerate ' s relevant competent authorities should reflect the supplementary nature of this directive , and as such it should add value to existing colleges for the banking subgroup and the insurance subgroup in the conglomerate , without replicating , duplicating or replacing them . ### the comprehensive and adequate monitoring of group risks in large , complex , internationally operating conglomerates , as well as the supervision of the group - wide capital policies of these groups , is only possible when competent authorities gather supervisory information and plan supervisory measures beyond the national scope of their mandate . it is therefore necessary that competent authorities coordinate supplementary supervision on international conglomerates among the competent authorities which are regarded as most relevant for the supplementary supervision of a conglomerate through the joint committee . the college of a financial conglomerate ' s relevant competent authorities should reflect the supplementary nature of this directive , and as such it should add value to existing colleges for the banking subgroup and the insurance subgroup in the conglomerate , without replicating , duplicating or replacing them . it is also necessary that the legal and operational structure of financial conglomerates with cross - border activities , including all legal entities within the financial conglomerate , is tracked by the joint committee and made available to the relevant competent authorities , the commission and the european systemic risk board and , where appropriate , made public .


### the european banking authority and the european insurance and occupational pensions authority shall issue the common guidelines referred to in article 3 , article 7 , article 8 , article 9 and article 11 in accordance with the procedure laid down in article 42 of the regulation no . . / . . establishing the european banking authority , and in article 42 of the regulation no . . / . . establishing the european insurance and occupational pensions authority , following cooperation within the joint committee of the european supervisory authorities . ### the european supervisory authority , the european supervisory authority and the european supervisory authority shall , through the joint committee , issue the common guidelines referred to in article 3 , article 7 , article 8 , article 9 , article 11 and article 18 in accordance with the procedure laid down in article 56 of each of regulation no . . / 2010 establishing the european supervisory authority , regulation no . . / 2010 establishing the european supervisory authority and regulation no . . / 2010 establishing the european supervisory authority , following cooperation within the joint committee .


### for the application of paragraphs 1 and 2 , the relevant competent authorities may , in exceptional cases and by common agreement , replace the criterion based on balance sheet total with one or more of the following parameters or add one or more of these parameters , if they are of the opinion that these parameters are of particular relevance for the purpose of supplementary supervision under this directive : income structure , off - balance sheet activities , assets under management . ### for the application of paragraphs 1 and 2 , the relevant competent authorities may , in exceptional cases and by common agreement , replace the criterion based on balance sheet total with one or more of the following parameters or add one or more of these parameters , if they are of the opinion that these parameters are of particular relevance for the purpose of supplementary supervision under this directive : income structure , off - balance sheet activities , total assets under management .


### asset management companies within the meaning of article 30 are added to the sector they belong to within the group ; if they do not belong exclusively to one sector within the group , they are added to the smallest financial sector . ### asset management companies within the meaning of article 30 are added to the investment services sector ; if they provide services exclusively to one other sector within the group , they are added to that financial sector .


### ‘ reinsurance undertaking’ means a reinsurance undertaking within the meaning of article 13 and of directive 2009 / 138 / ec ; ### ‘ reinsurance undertaking’ means a reinsurance undertaking within the meaning of article 13 , , and of directive 2009 / 138 / ec ;


### asset management companies within the meaning of article 30 are added to the sector they belong to within the group ; if they do not belong exclusively to one sector within the group , they are added to the smallest financial sector . ### asset management companies within the meaning of article 30 are added to the investment services sector ; if they do not belong exclusively to one sector within the group , they are added to the smallest financial sector .


### the average wholesale charge referred to in paragraph 1 shall apply between any pair of operators and shall be calculated over a twelve - month period or any such shorter period as may remain before the end of the period of application of a maximum average wholesale charge as provided for in this paragraph or the expiry of this regulation . the maximum average wholesale charge shall decrease to eur 0 , 10 and eur 0 , 06 , on 1 july 2013 and on 1 july 2014 respectively . without prejudice to article 13 , the maximum average wholesale charge shall remain at eur 0 , 06 for the duration of this regulation . ### the average wholesale charge referred to in paragraph 1 shall apply between any pair of operators and shall be calculated over a twelve - month period or any such shorter period as may remain before the end of the period of application of a maximum average wholesale charge as provided for in this paragraph or the expiry of this regulation . the maximum average wholesale charge shall decrease to eur 0 , 08 and eur 0 , 05 , on 1 july 2013 and on 1 july 2014 respectively . without prejudice to article 13 , the maximum average wholesale charge shall remain at eur 0 , 05 for the duration of this regulation .


### the retail charge of a eurotariff which a home provider may levy from its roaming customer for the provision of a regulated roaming call may vary for any roaming call but shall not exceed eur 0 , 32 per minute for any call made or eur 0 , 11 per minute for any call received as of 1 july 2012 . the price ceiling for calls made shall decrease to eur 0 , 28 and eur 0 , 24 on 1 july 2013 and on 1 july 2014 respectively , and for calls received to eur 0 , 10 on 1 july 2013 . without prejudice to articles 13 and 19 these regulated maximum retail charges for the eurotariff shall remain valid until 30 june 2016 . ### the retail charge of a eurotariff which a home provider may levy from its roaming customer for the provision of a regulated roaming call may vary for any roaming call but shall not exceed eur 0 , 21 per minute for any call made or eur 0 , 09 per minute for any call received as of 1 july 2012 . the price ceiling for calls made shall decrease to eur 0 , 16 and eur 0 , 11 on 1 july 2013 and on 1 july 2014 respectively , and for calls received to eur 0 , 07 on 1 july 2013 , and eur 0 , 05 on 1 july 2014 . without prejudice to articles 13 and 19 these regulated maximum retail charges for the eurotariff shall remain at eur 0 , 05 for the duration of this regulation .


### with effect from 1 july 2012 , the retail charge of a euro - data tariff which a home provider may levy from its roaming customer for the provision of a regulated roaming data shall not exceed eur 0 , 90 per megabyte . the price ceiling for data used shall decrease to eur 0 , 70 and eur 0 , 50 , per megabyte used on 1 july 2013 and on 1 july 2014 respectively . without prejudice to articles 13 and 19 , the regulated maximum retail charge shall remain at eur 0 , 50 , per megabyte used until 30 june 2016 . ### with effect from 1 july 2012 , the retail charge of a euro - data tariff which a home provider may levy from its roaming customer for the provision of a regulated roaming data shall not exceed eur 0 , 50 per megabyte . the price ceiling for data used shall decrease to eur 0 , 30 and eur 0 , 20 , per megabyte used on 1 july 2013 and on 1 july 2014 respectively . without prejudice to article 19 , the regulated maximum retail charge shall remain at eur 0 , 20 , per megabyte used until 30 june 2017 .


### any switch to or from an alternative roaming provider shall be free of charge and shall not entail conditions or restrictions pertaining to elements of the subscription other than roaming , and shall be carried out within five working days , save that where a roaming customer who has subscribed to a domestic package which includes roaming prices other than the eurotariff , euro - sms tariff or euro - data tariff , the home provider may delay the switch from the old to the new subscription concerning roaming services for a specified period not exceeding three months . ### any switch to or from an alternative roaming provider or between alternative roaming providers shall be free of charge and shall not entail conditions or restrictions pertaining to elements of the subscription other than roaming , and shall be carried out within three working days , save that where a roaming customer who has subscribed to a domestic package which includes roaming prices other than the eurotariff , euro - sms tariff or euro - data tariff , the home provider may delay the switch from the old to the new subscription concerning roaming services for a specified period not exceeding two months .


### sending regulated roaming sms messages while in the visited member state . ### sending regulated roaming sms messages while in the visited country .


### in order to improve the transparency of retail prices for making and receiving regulated roaming calls within the union and to help roaming customers make decisions on the use of their mobile telephones while abroad , providers of mobile telephony services should enable their roaming customers easily to obtain information free of charge on the roaming charges applicable to them when making or receiving voice calls in a visited member state . moreover , providers should give their customers , on request and free of charge , additional information on the per - minute or per - unit data charges for the making or receiving of voice calls and also for the sending and receiving of sms , mms and other data communication services in the visited member state . since certain customer groups might be well informed about roaming charges operators should provide a possibility to easily opt - out from this automatic message service . ### in order to improve the transparency of retail prices for the use of roaming services and to help roaming customers make decisions on the use of their mobile telephones while abroad , when travelling both within and outside the union , providers of mobile telephony services should enable their roaming customers easily to obtain information free of charge on the roaming charges applicable to them when using roaming services in a visited country . moreover , providers should give their customers , provided that they are located in the union , on request and free of charge , additional information on the per - minute or per - unit data charges for the making or receiving of voice calls and also for the sending and receiving of sms , mms and other data communication services in the visited member state . since certain customer groups might be well informed about roaming charges operators should provide a possibility to easily opt - out from this automatic message service .


### with effect from 1&#160 ; july 2012 , the average wholesale charge that the operator of a visited network may levy from the customer ' s home provider , for the provision of a regulated roaming sms message originating on that visited network , shall not exceed eur 0 , 03 per sms message . the maximum average wholesale charge for the provision of a regulated roaming sms message shall decrease to eur 0 , 02 on 1 july 2014 . without prejudice to article 13 the regulated wholesale charge for the provision of regulated roaming sms messages shall remain at eur 0 , 02 for the duration of this regulation . ### with effect from 1&#160 ; july 2012 , the average wholesale charge that the operator of a visited network may levy from the customer ' s home provider , for the provision of a regulated roaming sms message originating on that visited network , shall not exceed eur 0 , 03 per sms message and shall decrease to eur 0 , 02 on 1 july 2013 and to eur 0 , 01 on 1 july 2014 . without prejudice to article 19 the regulated wholesale charge for the provision of regulated roaming sms messages shall remain at eur 0 , 01 for the duration of this regulation .


### an automatic message from the home provider shall inform the roaming customer that he is roaming and provide basic personalised tariff information on the charges applicable to the provision of regulated data roaming services to that roaming customer in the member state concerned , except where the customer has notified his home provider that he does not require this information . ### an automatic message from the home provider shall inform the roaming customer that he is roaming and provide basic personalised tariff information on the actual charges applicable to the provision of regulated data roaming services to that roaming customer in the country concerned , except where the customer who is at least 18 years old has notified his home provider that he does not require this information . since the bill is charged per megabyte , the automatic message shall also give a clear example of what a megabyte of data accounts for .


### the commission shall review the functioning of this regulation and , after a public consultation , shall report to the european parliament and the council no later than 30&#160 ; june&#160 ; 2015 . the commission shall evaluate in particular whether the objectives of this regulation have been achieved . in so doing , the commission shall review , inter alia : ### the commission shall review the functioning of this regulation and , after a public consultation , shall report to the european parliament and the council no later than 30&#160 ; june&#160 ; 2016 . the commission shall evaluate in particular whether the objectives of this regulation have been achieved . in so doing , the commission shall review , inter alia :


### with effect from 1 july 2012 , the retail charge of a euro - data tariff which a home provider may levy from its roaming customer for the provision of a regulated roaming data shall not exceed eur 0 , 90 per megabyte . the price ceiling for data used shall decrease to eur 0 , 70 and eur 0 , 50 , per megabyte used on 1 july 2013 and on 1 july 2014 respectively . without prejudice to articles 13 and 19 , the regulated maximum retail charge shall remain at eur 0 , 50 , per megabyte used until 30 june 2016 . ### with effect from 1 july 2012 , the retail charge of a euro - data tariff which a home provider may levy from its roaming customer for the provision of a regulated roaming data shall not exceed eur 0 , 50 per megabyte . the price ceiling for data used shall decrease to eur 0 , 30 and eur 0 , 10 , per megabyte used on 1 july 2013 and on 1 july 2014 respectively , after which data roaming charges will be aligned with domestic rates , which must not exceed the eurotariff set here , by 1 july 2015 .


### with effect from 1 july 2012 , the retail charge of a euro - data tariff which a home provider may levy from its roaming customer for the provision of a regulated roaming data shall not exceed eur 0 , 90 per megabyte . the price ceiling for data used shall decrease to eur 0 , 70 and eur 0 , 50 , per megabyte used on 1 july 2013 and on 1 july 2014 respectively . without prejudice to articles 13 and 19 , the regulated maximum retail charge shall remain at eur 0 , 50 , per megabyte used until 30 june 2016 . ### with effect from 1 july 2012 , the retail charge of a euro - data tariff which a home provider may levy from its roaming customer for the provision of a regulated roaming data shall not exceed eur 0 , 60 per megabyte . the price ceiling for data used shall decrease to eur 0 , 45 and eur 0 , 30 per megabyte used on 1 july 2013 and on 1 july 2014 respectively . without prejudice to articles 13 and 19 , the regulated maximum retail charge shall remain at eur 0 , 30 per megabyte used until 30 june 2018 .


### such basic personalised tariff information shall be delivered to the roaming customer ' s mobile telephone or other device , for example by an sms message , an e - mail or a pop - up window on the computer , every time the roaming customer enters a member state other than that of his home network and initiates for the first time a regulated data roaming service in that particular member state . it shall be provided free of charge at the moment the roaming customer initiates a regulated data roaming service , by an appropriate means adapted to facilitate its receipt and easy comprehension . ### such basic personalised tariff information shall be delivered to the roaming customer ' s mobile telephone or other device , for example by an sms message , an e - mail or a pop - up window on the computer , every time the roaming customer enters a country other than that of his home network and initiates for the first time a regulated data roaming service in that particular country . it shall be provided free of charge at the moment the roaming customer initiates a regulated data roaming service , by an appropriate means adapted to facilitate its receipt and easy comprehension .


### however , since the entry into force of the amendments introduced by regulation no 544 / 2009 , it has been observed that it is less probable that customers under pre - paid tariffs suffer from ‘ bill shocks’ for the use of data roaming services , given that the amount of credit available is already chosen in advance . in addition , with the transitory euro - data tariff with regulated rates for data roaming charges , these consumers will also benefit from additional protection against high prices for these services . for these reasons , the cut off limit provisions should not apply to customers under pre - paid contracts . ### customers under pre - paid tariffs may also suffer from ' bill shocks ' for the use of data roaming services . for this reason the cut off limit provisions should also apply to those customers . in addition , customers under pre - paid contracts should receive a timely warning indicating that they are approaching their credit limit .


### with effect from 1&#160 ; july 2012 the average wholesale charge that the operator of a visited network may levy from the roaming customer ' s home provider for the provision of regulated data roaming services by means of that visited network shall not exceed a safeguard limit of eur&#160 ; 0 , 30 , eur&#160 ; 0 , 20 as of 1&#160 ; july 2013 and eur&#160 ; 0 , 10 as of 1&#160 ; july 2014 per megabyte of data transmitted . without prejudice to article 13 the maximum average wholesale charge for the provision of regulated data roaming services shall remain at eur&#160 ; 0 , 10 per megabyte of data transmitted for the duration of this regulation . ### with effect from 1 july 2012 the average wholesale charge that the operator of a visited network may levy from the roaming customer ' s home provider for the provision of regulated data roaming services by means of that visited network shall not exceed a safeguard limit of eur&#160 ; 0 , 22 , eur&#160 ; 0 , 15 as of 1&#160 ; july 2013 and eur&#160 ; 0 , 10 as of 1&#160 ; july 2014 per megabyte of data transmitted . without prejudice to article 13 the maximum average wholesale charge for the provision of regulated data roaming services shall remain at eur&#160 ; 0 , 10 per megabyte of data transmitted for the duration of this regulation .


### with effect from 1 july 2012 , the retail charge of a euro - sms tariff which a home provider may levy from its roaming customer for a regulated roaming sms message sent by that roaming customer may vary for any roaming sms message but shall not exceed eur 0 , 10 . without prejudice to articles 13 and 19 , the regulated maximum retail charge for the euro - sms tariff shall remain at eur 0 , 10 until 30 june 2016 . ### with effect from 1 july 2012 , the retail charge of a euro - sms tariff which a home provider may levy from its roaming customer for a regulated roaming sms message sent by that roaming customer may vary for any roaming sms message but shall not exceed eur 0 , 07 . the price ceiling shall decrease to 0 , 06 on 1 july 2013 and to 0 , 05 on 1 january 2014 . the regulated maximum retail charge for the euro - sms tariff shall remain at eur 0 , 05 until 30 june 2016 . price differentiation between domestic and roaming calls shall be no longer possible from 1 july 2014 .


### the average wholesale charge that the operator of a visited network may levy from the customer ' s home provider for the provision of a regulated roaming call originating on that visited network , inclusive inter alia of origination , transit and termination costs , shall not exceed eur 0 , 14 per minute as of 1 july 2012 . ### the average wholesale charge that the operator of a visited network may levy from the customer ' s home provider for the provision of a regulated roaming call originating on that visited network , inclusive inter alia of origination , transit and termination costs , shall not exceed eur 0 , 10 per minute as of 1 july 2012 .


### consumers should have the right to opt for the separate sale of roaming services from their domestic mobile package . basic principles should be laid down with regard to the provision of a separate sale of roaming services which should be introduced in a coordinated manner across the union . consumers should be able to choose a different provider for roaming services without changing their number , and in a manner which ensures interoperability of services , with roaming services being provided anywhere in the union and with the same level of quality . ### customers should have the right to opt for the separate sale of roaming services from their domestic mobile package . basic principles should be laid down with regard to the provision of a separate sale of roaming services which should be introduced in a coordinated manner across the union . the conditions offered by home providers of roaming services should be easy for customers to compare . to that end , the commission should propose uniform criteria for the provision of such information . for this purpose 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 . it is of particular importance that the commission carry out appropriate consultations with berec and the stakeholders , 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 to the council . until such criteria are adopted , national regulatory authorities should encourage the provision of comparable information , for instance by means of guides which use as a reference the regulated tariffs applied to the relevant roaming services . customers should be able to choose a different provider for roaming services without changing their number , and in a manner which ensures interoperability of services , with roaming services being provided anywhere in the union and with the same level of quality .


### with effect from 1 july 2012 , the retail charge of a euro - data tariff which a home provider may levy from its roaming customer for the provision of a regulated roaming data shall not exceed eur 0 , 90 per megabyte . the price ceiling for data used shall decrease to eur 0 , 70 and eur 0 , 50 , per megabyte used on 1 july 2013 and on 1 july 2014 respectively . without prejudice to articles 13 and 19 , the regulated maximum retail charge shall remain at eur 0 , 50 , per megabyte used until 30 june 2016 . ### with effect from 1 july 2012 , the retail charge of a euro - data tariff which a home provider may levy from its roaming customer for the provision of a regulated roaming data shall not exceed eur 500 per gigabyte . the price ceiling for data used shall decrease to eur 300 and eur 200 , per gigabyte used on 1 july 2013 and on 1 july 2014 respectively . without prejudice to articles 13 and 19 , the regulated maximum retail charge shall remain at eur 200 , per gigabyte used for the duration of this regulation .


### the retail charge of a eurotariff which a home provider may levy from its roaming customer for the provision of a regulated roaming call may vary for any roaming call but shall not exceed eur 0 , 32 per minute for any call made or eur 0 , 11 per minute for any call received as of 1 july 2012 . the price ceiling for calls made shall decrease to eur 0 , 28 and eur 0 , 24 on 1 july 2013 and on 1 july 2014 respectively , and for calls received to eur 0 , 10 on 1 july 2013 . without prejudice to articles 13 and 19 these regulated maximum retail charges for the eurotariff shall remain valid until 30 june 2016 . ### the retail charge of a eurotariff which a home provider may levy from its roaming customer for the provision of a regulated roaming call may vary for any roaming call but shall not exceed eur 0 , 21 per minute for any call made or eur 0 , 09 per minute for any call received as of 1 july 2012 . the price ceiling for calls made shall decrease to eur 0 , 16 and eur 0 , 11 on 1 july 2013 and on 1 july 2014 respectively , and for calls received to eur 0 , 07 on 1 july 2013 , and eur 0 , 05 on 1 july 2014 . without prejudice to articles 13 and 19 these regulated maximum retail charges for the eurotariff shall remain at eur 0 , 05 for the duration of this regulation .


### with effect from 1 july 2012 , the retail charge of a euro - sms tariff which a home provider may levy from its roaming customer for a regulated roaming sms message sent by that roaming customer may vary for any roaming sms message but shall not exceed eur 0 , 10 . without prejudice to articles 13 and 19 , the regulated maximum retail charge for the euro - sms tariff shall remain at eur 0 , 10 until 30 june 2016 . ### with effect from 1 july 2012 , the retail charge of a euro - sms tariff which a home provider may levy from its roaming customer for a regulated roaming sms message sent by that roaming customer may vary for any roaming sms message but shall decrease to eur 0 , 10 on 1 july 2012 , to 0 , 08 on 1 july 2013 and to 0 , 06 on july 2014 . without prejudice to articles 13 and 19 , the regulated maximum retail charge for the euro - sms tariff shall remain at eur 0 , 06 until 30 june 2018 .


### with effect from 1 july 2012 , the average wholesale charge that the operator of a visited network may levy from the customer ' s home provider , for the provision of a regulated roaming sms message originating on that visited network , shall not exceed eur 0 , 03 per sms message . the maximum average wholesale charge for the provision of a regulated roaming sms message shall decrease to eur 0 , 02 on 1 july 2014 . without prejudice to article 13 the regulated wholesale charge for the provision of regulated roaming sms messages shall remain at eur 0 , 02 for the duration of this regulation . ### with effect from 1 july 2012 , the average wholesale charge that the operator of a visited network may levy from the customer ' s home provider , for the provision of a regulated roaming sms message originating on that visited network , shall not exceed eur 0 , 03 per sms message , and shall decrease to eur 0 , 02 on 1&#160 ; july 2013 and to eur 0 , 01 on 1 july 2014 . without prejudice to article 13 the regulated wholesale charge for the provision of regulated roaming sms messages shall remain at eur 0 , 01 for the duration of this regulation .


### consumers should have the right to opt for the separate sale of roaming services from their domestic mobile package . basic principles should be laid down with regard to the provision of a separate sale of roaming services which should be introduced in a coordinated manner across the union . consumers should be able to choose a different provider for roaming services without changing their number , and in a manner which ensures interoperability of services , with roaming services being provided anywhere in the union and with the same level of quality . ### consumers should have the right to opt for the separate sale of roaming services from their domestic mobile package in the union . basic principles should be laid down with regard to the provision of a separate sale of roaming services which should be introduced in a coordinated manner across the union . consumers should be able to choose a different provider for roaming services without changing their number , and in a manner which ensures interoperability of services , with roaming services being provided anywhere in the union and with the same level of quality .


### to alert a roaming customer to the fact that he will be subject to roaming charges when making or receiving a call or when sending an sms message , each home provider shall , except when the customer has notified his home provider that he does not require this service , provide the customer , automatically by means of a message service , without undue delay and free of charge , when he enters a member state other than that of his home network , with basic personalised pricing information on the roaming charges that apply to the making and receiving of calls and to the sending of sms messages by that customer in the visited member state . ### to alert a roaming customer to the fact that he will be subject to roaming charges when making or receiving a call or when sending an sms message , each home provider shall , except when the customer has notified his home provider that he does not require this service , provide the customer , automatically by means of a message service , without undue delay and free of charge , when he enters a country other than that of his home network , with basic personalised pricing information on the roaming charges that apply to the making and receiving of calls and to the sending of sms messages by that customer in the visited country .


### with effect from 1 july 2012 the average wholesale charge that the operator of a visited network may levy from the roaming customer ' s home provider for the provision of regulated data roaming services by means of that visited network shall not exceed a safeguard limit of eur 0 , 30 , eur 0 , 20 as of 1 july 2013 and eur 0 , 10 as of 1 july 2014 per megabyte of data transmitted . without prejudice to article 13 the maximum average wholesale charge for the provision of regulated data roaming services shall remain at eur 0 , 10 per megabyte of data transmitted for the duration of this regulation . ### with effect from 1 july 2012 the average wholesale charge that the operator of a visited network may levy from the roaming customer ' s home provider for the provision of regulated data roaming services by means of that visited network shall not exceed a safeguard limit of eur 200 , eur 150 as of 1 july 2013 and eur 100 as of 1 july 2014 per gigabyte of data transmitted . without prejudice to article 13 the maximum average wholesale charge for the provision of regulated data roaming services shall remain at eur 100 per gigabyte of data transmitted for the duration of this regulation .


### each home provider shall grant to all their roaming customers the opportunity to opt deliberately and free of charge for a facility which provides information on the accumulated consumption expressed in volume or in the currency in which the roaming customer is billed for regulated data roaming services and which guarantees that , without the customer ' s explicit consent , the accumulated expenditure for regulated data roaming services over a specified period of use does not exceed a specified financial limit . ### each home provider shall grant to all their roaming customers the opportunity to opt deliberately and free of charge for a facility which provides information on the accumulated consumption expressed in volume or in the currency in which the roaming customer is billed for retail data roaming services provided both inside and outside the union and which guarantees that , without the customer ' s explicit consent , the accumulated expenditure for such retail data roaming services over a specified period of use does not exceed a specified financial limit .


### with effect from 1 july 2012 , the retail charge of a euro - data tariff which a home provider may levy from its roaming customer for the provision of a regulated roaming data shall not exceed eur 0 , 90 per megabyte . the price ceiling for data used shall decrease to eur 0 , 70 and eur 0 , 50 , per megabyte used on 1 july 2013 and on 1 july 2014 respectively . without prejudice to articles 13 and 19 , the regulated maximum retail charge shall remain at eur 0 , 50 , per megabyte used until 30 june 2016 . ### with effect from 1 july 2012 , the retail charge of a euro - data tariff which a home provider may levy from its roaming customer for the provision of a regulated roaming data shall not exceed eur 0 , 90 per megabyte . the price ceiling for data used shall decrease to eur 0 , 70 and eur 0 , 30 , per megabyte used on 1 july 2013 and on 1 july 2014 respectively . without prejudice to article 19 , the regulated maximum retail charge shall remain at eur 0 , 30 , per megabyte used until 30 june 2017 .


### any switch to or from an alternative roaming provider shall be free of charge and shall not entail conditions or restrictions pertaining to elements of the subscription other than roaming , and shall be carried out within five working days , save that where a roaming customer who has subscribed to a domestic package which includes roaming prices other than the eurotariff , euro - sms tariff or euro - data tariff , the home provider may delay the switch from the old to the new subscription concerning roaming services for a specified period not exceeding three months . ### any switch to or from an alternative roaming provider or between alternative roaming providers shall be free of charge and shall not entail conditions or restrictions pertaining to elements of the subscription other than roaming , and shall be carried out within three working days , save that where a roaming customer who has subscribed to a domestic package which includes roaming prices other than the eurotariff , euro - sms tariff or euro - data tariff , the home provider may delay the switch from the old to the new subscription concerning roaming services for a specified period not exceeding two months .


### ‘ regulated data roaming service’ means a roaming service enabling the use of packet switched data communications by a roaming customer by means of his mobile telephone or other mobile device while it is connected to a visited network . a regulated data roaming service does not include the transmission or receipt of regulated roaming calls or sms messages , but does include the transmission and receipt of mms messages ; ### ‘ regulated data roaming service’ means a roaming service enabling the use of packet switched data communications by a roaming customer by means of his mobile telephone or other mobile device while it is connected to a visited network . a regulated data roaming service does not include the transmission or receipt of regulated roaming calls or sms messages , the transmission and receipt of mms messages and machine to machine data communication ;


### such basic personalised tariff information shall be delivered to the roaming customer ' s mobile telephone or other device , for example by an sms message , an e - mail or a pop - up window on the computer , every time the roaming customer enters a member state other than that of his home network and initiates for the first time a regulated data roaming service in that particular member state . it shall be provided free of charge at the moment the roaming customer initiates a regulated data roaming service , by an appropriate means adapted to facilitate its receipt and easy comprehension . ### such basic personalised tariff information shall be delivered to the roaming customer ' s mobile telephone or other device , for example by an sms message , an e - mail or a pop - up window on the computer , every time the roaming customer enters a country other than that of his home network and initiates for the first time a regulated data roaming service in that particular country . it shall be provided free of charge at the moment the roaming customer initiates a regulated data roaming service , by an appropriate means adapted to facilitate its receipt and easy comprehension .


### with effect from 1 july 2012 the average wholesale charge that the operator of a visited network may levy from the roaming customer ' s home provider for the provision of regulated data roaming services by means of that visited network shall not exceed a safeguard limit of eur 0 , 30 , eur 0 , 20 as of 1 july 2013 and eur 0 , 10 as of 1 july 2014 per megabyte of data transmitted . without prejudice to article 13 the maximum average wholesale charge for the provision of regulated data roaming services shall remain at eur 0 , 10 per megabyte of data transmitted for the duration of this regulation . ### with effect from 1 july 2012 the average wholesale charge that the operator of a visited network may levy from the roaming customer ' s home provider for the provision of regulated data roaming services by means of that visited network shall not exceed a safeguard limit of eur 0 , 20 , eur 0 , 15 as of 1 july 2013 and eur 0 , 10 as of 1 july 2014 per megabyte of data transmitted . without prejudice to article 13 the maximum average wholesale charge for the provision of regulated data roaming services shall remain at eur 0 , 10 per megabyte of data transmitted for the duration of this regulation .


### with effect from 1&#160 ; july 2012 the average wholesale charge that the operator of a visited network may levy from the roaming customer ' s home provider for the provision of regulated data roaming services by means of that visited network shall not exceed a safeguard limit of eur&#160 ; 0 , 30 , eur&#160 ; 0 , 20 as of 1&#160 ; july 2013 and eur&#160 ; 0 , 10 as of 1&#160 ; july 2014 per megabyte of data transmitted . without prejudice to article 13 the maximum average wholesale charge for the provision of regulated data roaming services shall remain at eur&#160 ; 0 , 10 per megabyte of data transmitted for the duration of this regulation . ### with effect from 1 july 2012 the average wholesale charge that the operator of a visited network may levy from the roaming customer ' s home provider for the provision of regulated data roaming services by means of that visited network shall not exceed a safeguard limit of eur&#160 ; 0 , 22 , eur&#160 ; 0 , 15 as of 1&#160 ; july 2013 and eur&#160 ; 0 , 10 as of 1&#160 ; july 2014 per megabyte of data transmitted . without prejudice to article 13 the maximum average wholesale charge for the provision of regulated data roaming services shall remain at eur&#160 ; 0 , 10 per megabyte of data transmitted for the duration of this regulation .


### for the purpose of separate sale of roaming services , operators shall make sure that facilities are in place by 1 july 2014 at the latest , to ensure that the customer can use domestic mobile services and separate roaming services offered by an alternative roaming operator while keeping their mobile number . in order to enable the separate sale of roaming services , operators may in particular allow the use of an ‘ eu roaming profile’ on the same sim card and the use of the same terminal alongside domestic mobile services . pricing for interconnection related to the provision of this facility shall be cost - orientated and there should be no direct charges to consumers for the use of this facility . ### for the purpose of separate sale of roaming services , operators shall make sure that facilities are in place by 1 july 2014 , and meet the criteria set out in paragraph 1 . there shall be no direct charges to customers for the use of the facility in respect of separate sale of roaming services .


### for the purpose of separate sale of roaming services , operators shall make sure that facilities are in place by 1 july 2014 at the latest , to ensure that the customer can use domestic mobile services and separate roaming services offered by an alternative roaming operator while keeping their mobile number . in order to enable the separate sale of roaming services , operators may in particular allow the use of a ‘ eu roaming profile’ on the same sim card and the use of the same terminal alongside domestic mobile services . pricing for interconnection related to the provision of this facility shall be cost - orientated and there should be no direct charges to consumers for the use of this facility . ### for the purpose of separate sale of roaming services , operators shall make sure that facilities are in place by 1 july 2014 at the latest , to ensure that the customer can use domestic mobile services and separate roaming services offered by an alternative roaming operator while keeping their mobile number . in order to enable the separate sale of roaming services , operators may in particular allow the use of the same terminal alongside domestic mobile services . pricing for interconnection related to the provision of this facility shall be cost - orientated and there should be no direct charges to consumers for the use of this facility .


### the average wholesale charge referred to in paragraph 1 shall apply between any pair of operators and shall be calculated over a twelve - month period or any such shorter period as may remain before the end of the period of application of a maximum average wholesale charge as provided for in this paragraph or the expiry of this regulation . the maximum average wholesale charge shall decrease to eur 0 , 10 and eur 0 , 06 , on 1 july 2013 and on 1 july 2014 respectively . without prejudice to article 13 , the maximum average wholesale charge shall remain at eur 0 , 06 for the duration of this regulation . ### the average wholesale charge referred to in paragraph 1 shall apply between any pair of operators and shall be calculated over a twelve - month period or any such shorter period as may remain before the end of the period of application of a maximum average wholesale charge as provided for in this paragraph or the expiry of this regulation . the maximum average wholesale charge shall decrease to eur 0 , 10 and eur 0 , 07 , on 1 july 2013 and on 1 july 2014 respectively . without prejudice to article 19 , the maximum average wholesale charge shall remain at eur 0 , 07 for the duration of this regulation .


### for the purpose of separate sale of roaming services , operators shall make sure that facilities are in place by 1 july 2014 at the latest , to ensure that the customer can use domestic mobile services and separate roaming services offered by an alternative roaming operator while keeping their mobile number . in order to enable the separate sale of roaming services , operators may in particular allow the use of a ‘ eu roaming profile’ on the same sim card and the use of the same terminal alongside domestic mobile services . pricing for interconnection related to the provision of this facility shall be cost - orientated and there should be no direct charges to consumers for the use of this facility . ### for the purpose of separate sale of roaming services , operators shall make sure that facilities meeting the criteria set out in paragraph 1 are in place by 1 march 2014 at the latest , to ensure that the customer can use domestic mobile services and separate roaming services offered by an alternative roaming operator while keeping their mobile number . pricing for interconnection related to the provision of this facility shall be cost - orientated and there should be no direct charges to consumers for the use of this facility .