### manufacturers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by end - users , as determined by the member state concerned . ### manufacturers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by end - users , as determined by the member state concerned . such instructions and safety information as well as any labelling shall be clear , understandable and intelligible .


### before placing a product on the market importers shall ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer . they shall ensure that the manufacturer has drawn up the technical documentation , that the product bears the ce marking and the specific marking of explosion protection and is accompanied by the required documents , and that the manufacturer has complied with the requirements set out in article 6 and . ### before placing a product on the market or putting it into service , importers shall ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer . they shall ensure that the manufacturer has drawn up the technical documentation , that the product bears the ce marking and the specific marking of explosion protection and is accompanied by the required documents , and that the manufacturer has complied with the requirements set out in article 6 and .


### importers shall indicate their name and the address at which they can be contacted on the product or , where that is not possible , on its packaging or in a document accompanying the product . ### importers shall indicate their name , registered trade name or registered trade mark , their web address in a language easily understood by end - users and market surveillance authorities , and the address at which they can be contacted on the product or , where that is not possible , on its packaging or in a document accompanying the product .


### economic operators shall , on request , identify the following to the market surveillance authorities , for at least 10 years after the product has been placed on the market : ### economic operators shall , on request , specify the following to the market surveillance authorities , for 10 years after the product has been placed on the market :


### economic operators shall be able to present the information referred to in the first paragraph for a period of 10 years after they have been supplied with the product and for a period of 10 years after they have supplied the product . ### economic operators shall present the information referred to in the first paragraph for a period of 10 years after they have been supplied with the product and for a period of 10 years after they have supplied the product . economic operators shall not be required to update that information after supply is finalised .


### documents and correspondence relating to the procedures referred to in paragraphs 1 to 4 shall be drawn up in a language easily understood by end - users , as determined by the member state concerned . ### documents and correspondence relating to the procedures referred to in paragraphs 1 to 5 shall be drawn up in one of the official languages of the member states in which those procedures are being applied or in a language accepted by the notified body


### the eu declaration of conformity shall have the model structure set out in annex iii of decision no 768 / 2008 / ec , shall contain the elements specified in the relevant conformity assessment procedures set out in annexes iii to ix of this directive and shall be continuously updated . it shall be translated into the language or languages required by the member state in which market the product is made available . ### the eu declaration of conformity shall have the model structure set out in annex iii of decision no 768 / 2008 / ec , shall contain the elements specified in the relevant conformity assessment procedures set out in annexes iii to ix of this directive and shall be continuously updated . it shall be translated into the language or languages required by the member state in which market the product is made available . upon the request of the market surveillance authorities , the economic operator shall provide a copy of the eu declaration of conformity in paper form or by electronic means .


### by drawing up the eu declaration of conformity , the manufacturer shall assume the full responsibility for the compliance of the product . ### by drawing up the eu declaration of conformity , the manufacturer shall assume the full responsibility for the compliance of the product with the requirements laid down in this directive .


### the ce marking shall be affixed before the product is placed on the market . it shall be accompanied by the specific marking of explosion protection , followed by the symbol of the equipment group and category , as set out in annex ii , point 1 . 0 . 5 . ### the ce marking shall be affixed before the product is placed on the market . it shall be followed by the identification number of the notified body and further marking as set out in point 1 . 0 . 5 of annex ii , including the specific marking of explosion protection


### the ce marking , the specific marking and the symbol referred to in paragraph 2 and , where applicable , the identification number referred to in paragraph 3 , may be followed by a pictogram or any other mark indicating a special risk or use . ### the ce marking , the identification number , where applicable , the specific marking and the symbol referred to in paragraph 2 , may be followed by a pictogram or any other mark indicating a special risk or use .


### member states shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies , including compliance with the provisions of article 23 . ### member states shall designate a single notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies , including compliance with the provisions of article 23 .


### where the market surveillance authorities of one member state have taken action pursuant to article 20 of regulation no 765 / 2008 , or where they have sufficient reason to believe that a product presents a risk to the health or safety of persons or to other aspects of public interest protection laid down in this directive , they shall carry out an evaluation in relation to the product concerned covering all the requirements laid down in this directive . the relevant economic operators shall cooperate as necessary with the market surveillance authorities . ### where the market surveillance authorities of one member state have taken action pursuant to article 20 of regulation no 765 / 2008 , or where they have sufficient reason to believe that a product presents a risk to the health or safety of persons or to other aspects of public interest protection laid down in this directive , they shall carry out an evaluation in relation to the product concerned covering all the relevant requirements laid down in this directive . the relevant economic operators shall cooperate as necessary with the market surveillance authorities .


### where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1 , the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the being made available on their national market , to withdraw the product from that market or to recall it . ### where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1 , the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the making available of the product on their national market , to withdraw the product from that market or to recall it .


### failure of the product to meet requirements relating to the health or safety of persons or to other aspects of public interest protection laid down in this directive ; ### failure of the product to meet requirements relating to the health or safety of persons or to other aspects of public interest protection laid down in this directive ; or


### shortcomings in the harmonised standards referred to in annex ii conferring a presumption of conformity . ### shortcomings in the harmonised standards referred to in article 12 conferring a presumption of conformity .


### where , within 2 months of receipt of the information referred to in paragraph 4 , no objection has been raised by either a member state or the commission in respect of a provisional measure taken by a member state , that measure shall be deemed justified . ### where , within three months of receipt of the information referred to in paragraph 4 , no objection has been raised by either a member state or the commission in respect of a provisional measure taken by a member state , that measure shall be deemed justified .


### member states shall ensure that appropriate restrictive measures are taken in respect of the product concerned without delay . ### member states shall ensure that appropriate restrictive measures are taken in respect of the product concerned , such as withdrawal of the product from their market , without delay .


### member states shall lay down rules on penalties applicable to infringements of the national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are enforced . ### member states shall build upon existing mechanisms to ensure correct application of the regime governing the ce marking and shall take appropriate action in the event of improper use of the marking . member states shall lay down rules on penalties applicable to infringements by economic operators of the national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are enforced . such rules may include criminal penalties for serious infringements .


### the penalties provided for shall be effective , proportionate and dissuasive . ### the penalties referred to in the first paragraph shall be effective , proportionate to the seriousness of the offence , and dissuasive .


### member states shall notify those provisions to the commission by [ the date set out in the second subparagraph of article 40 ] and shall notify it without delay of any subsequent amendment affecting them . ### member states shall notify those provisions to the commission by [ the date set out in the second subparagraph of article 40 ] and shall notify it without delay of any subsequent amendment affecting them . the commission shall make those provisions publicly available by publishing them on the internet .


### member states shall communicate to the commission the text of the main provisions of national law which they adopt in the field covered by this directive . ### member states shall communicate to the commission the text of the main provisions of national law which they adopt in the field covered by this directive . the commission shall make those texts publicly available by publishing them on the internet .


### for each individual product manufactured one or more tests on one or more specific aspects of the product shall be carried out by the manufacturer or on his behalf , in order to verify conformity with the type described in the eu - type examination certificate and with the corresponding requirements of this directive . the tests shall be carried out under the responsibility of a notified body , chosen by the manufacturer . ### for each individual product manufactured one or more tests on one or more specific aspects of the product shall be carried out by the manufacturer or on his behalf , in order to verify conformity with the type described in the eu - type examination certificate and with the corresponding requirements of this directive . the tests shall be carried out by an accredited in - house body or under the responsibility of a notified body , chosen by the manufacturer .


### the national regulatory authority of the home member state shall forward the information received in accordance with paragraph 2 and any change to that information in accordance with paragraph 3 to the national regulatory authorities of the concerned host member states and to the berec office within one week following reception of such information or any change . the berec office shall maintain a publicly accessible registry of notifications made in accordance with this regulation . ### the national regulatory authority of the home member state shall forward the information received in accordance with paragraph 2 and any change to that information in accordance with paragraph 3 to the national regulatory authorities of the concerned host member states and to the berec office within one week following reception of such information or any change . the berec office shall maintain a publicly accessible registry of notifications made in accordance with this regulation . regardless of the format of the registry selected by berec office , the latter should apply adequate security measures in its maintenance of the registry , in accordance with article 22 of regulation no 45 / 2001 .


### within the limits of any contractually agreed data volumes or speeds for internet access services , providers of internet access services shall not restrict the freedoms provided for in paragraph 1 by blocking , slowing down , degrading or discriminating against specific content , applications or services , or specific classes thereof , except in cases where it is necessary to apply reasonable traffic management measures . reasonable traffic management measures shall be transparent , non - discriminatory , proportionate and necessary to : implement a legislative provision or a court order , or prevent or impede serious crimes ; ### within the limits of any contractually agreed data volumes or speeds for internet access services , providers of internet access services shall not restrict the freedoms provided for in paragraph 1 by blocking , slowing down , degrading or discriminating against specific content , applications or services , or specific classes thereof , except in cases where it is necessary to apply reasonable traffic management measures . reasonable traffic management measures shall be transparent , non - discriminatory , proportionate and necessary to : implement a legislative provision or a court order , or for the prevention , investigation , detection and prosecution of criminal offences as laid down in article 15 of directive 2002 / 58 / ec ;


### prevent the transmission of unsolicited communications to end - users who have given their prior consent to such restrictive measures ; ### prevent the transmission of unsolicited communications to end - users who have given their prior consent to such restrictive measures . such consent should be informed , specific and unambiguous , as well as freely given ;


### national regulatory authorities shall closely monitor and ensure the effective ability of end - users to benefit from the freedoms provided for in article 23&#160 ; and , compliance with article 23&#160 ; , and the continued availability of non - discriminatory internet access services at levels of quality that reflect advances in technology and that are not impaired by specialised services . they shall , in cooperation with other competent national authorities , also monitor the effects of specialised services on cultural diversity and innovation . national regulatory authorities shall report on an annual basis to the commission and berec on their monitoring and findings . . ### national regulatory authorities shall closely monitor and ensure the effective ability of end - users to benefit from the freedoms provided for in article 23&#160 ; and , compliance with article 23&#160 ; , and the continued availability of non - discriminatory internet access services at levels of quality that reflect advances in technology and that are not impaired by specialised services . they shall , in cooperation with other competent national authorities and data protection authorities , also monitor the effects of specialised services on cultural diversity and innovation . national regulatory authorities shall report on an annual basis to the commission and berec on their monitoring and findings . this monitoring shall comply with the principle of confidentiality of communications and shall not imply processing of personal data .


### providers of electronic communications to the public shall , save for offers which are individually negotiated , publish transparent , comparable , adequate and up - to - date information on : ### providers of electronic communications to the public shall , save for offers which are individually negotiated , publish transparent , comparable , adequate and up - to - date information in a clear , comprehensive and easily accessible manner on :


### where an obligation exists in accordance with article 25 of directive 2002 / 22 / ec , the end - users ' options as to whether or not to include their personal data in a directory , and the data concerned ; ### where an obligation exists in accordance with article 25 of directive 2002 / 22 / ec , the end - users ' options as to whether or not to include their personal data in a directory , and the data concerned ; the processing of personal data included in such a directory shall comply with provisions of article 12 of the directive 2002 / 58 / ec .


### providers of electronic communications to the public shall offer end - users the opportunity to opt , free of charge for receiving itemised bills . ### providers of electronic communications to the public shall offer end - users the opportunity to opt , free of charge for receiving itemised bills , provided that right to privacy of calling users and called subscribers are duly respected .


### given the increasing usage of satellite navigation across a great number of fields of activity , an interruption in the supply of services could lead to significant harm to modern society . in addition , due to their strategic aspect , satellite navigation systems are sensitive infrastructures , that could be susceptible to malicious use . the abovementioned aspects could affect the security of the union and its member states . security requirements must therefore be taken into account in the design , implementation and operation of the infrastructures emerging from the galileo and egnos programmes . ### given the increasing usage of satellite navigation across a great number of fields of activity , an interruption in the supply of services could lead to significant harm to modern society . in addition , due to their strategic aspect , satellite navigation systems are sensitive infrastructures , that could be susceptible to malicious use by state and non - state actors . the abovementioned aspects could affect the security of the union , its member states and its citizens . security requirements must therefore be taken into account in the design , implementation and operation of the infrastructures emerging from the galileo and egnos programmes .


### responsibility for the progress of the programmes includes , in particular , responsibility for their security and the security of their systems and operation . except in the case of application of joint action 2004 / 552 / cfsp of 12 july 2004 on aspects of the operation of the european satellite radio - navigation system affecting the security of the european union , which could be adapted if necessary to changes in the programmes , their governance and the lisbon treaty , the commission is responsible for security , even if certain security - related tasks are entrusted to the european gnss agency . it is the responsibility of the commission to establish mechanisms to ensure suitable coordination between the various entities responsible for security . ### responsibility for the progress of the programmes includes , in particular , responsibility for their security and the security of their systems and operation . except in the case of application of joint action 2004 / 552 / cfsp of 12 july 2004 on aspects of the operation of the european satellite radio - navigation system affecting the security of the european union , which must necessarily be adapted to changes in the programmes , their governance and the lisbon treaty , the commission is responsible for security , even if certain security - related tasks are entrusted to the european gnss agency . it is the responsibility of the commission to establish mechanisms to ensure suitable coordination between the various entities responsible for security . the commission and council should further create the appropriate procedural security conditions to ensure that the open service can be restricted geographically or switched off in order to prevent any malicious use .


### the union is committed to achieving the europe 2020 strategy , which has set the objectives of smart , sustainable and inclusive growth , highlighting the role of research and innovation as key drivers of social and economic prosperity and of environmental sustainability and setting itself the goal to increase spending on research and development to reach 3 % of gross domestic product by 2020 while developing an innovation intensity indicator . in this context , the innovation union flagship initiative sets out a strategic and integrated approach to research and innovation , setting the framework and objectives to which future union research and innovation funding should contribute . research and innovation are also key factors for other europe 2020 flagship initiatives , notably on resource efficient europe , an industrial policy for the globalisation era , and a digital agenda for europe . moreover , for achieving the europe 2020 objectives relating to research and innovation , cohesion policy has a key role to play through building capacity and providing a stairway to excellence . ### the union is committed to achieving the europe 2020 strategy , which has set the objectives of smart , sustainable and inclusive growth , highlighting the role of research and innovation as key drivers of social and economic prosperity and of environmental sustainability and setting itself the goal to increase spending on research and development to reach 3 % of gross domestic product by 2020 while developing an innovation intensity indicator . in this context , the innovation union flagship initiative sets out a strategic and integrated approach to research and innovation , setting the framework and objectives to which future union research and innovation funding should contribute . research and innovation are also key factors for other europe 2020 flagship initiatives , notably on resource efficient europe , an industrial policy for the globalisation era , and a digital agenda for europe . moreover , for achieving the europe 2020 objectives relating to research and innovation , cohesion policy has a key role to play through building capacity and providing a stairway to excellence . account should be taken of the varying levels of development in the regions and the investment made in research and innovation , supporting the regions that are furthest away from the goals set by the eu 2020 strategy through specific actions and / or programmes ;


### to achieve maximum impact , horizon 2020 should develop close synergies with other union programmes in areas such as education , space , environment , competitiveness and smes , the internal security , culture and media and with the cohesion policy funds and rural development policy , which can specifically help to strengthen national and regional research and innovation capabilities in the context of smart specialisation strategies . ### to achieve maximum impact , horizon 2020 should develop close synergies with other union programmes in areas such as education , space , transport , environment , competitiveness and smes , the internal security , culture and media and with the cohesion policy funds , rural development policy and the connecting europe facility , which can specifically help to strengthen national and regional research and innovation capabilities in the context of smart specialisation strategies .


### horizon 2020 shall play a central role in the delivery of the europe 2020 strategy for smart , sustainable and inclusive growth by providing a common strategic framework for the union ' s research and innovation funding , thus acting as a vehicle for leveraging private investment , creating new job opportunities and ensuring europe ' s long - term sustainable growth and competitiveness . ### horizon 2020 shall play a central role in the delivery of the europe 2020 strategy for smart , sustainable and inclusive growth by providing a common strategic framework for the union ' s research and innovation funding , thus acting as a vehicle for leveraging private investment , creating new job opportunities and ensuring europe ' s long - term sustainable growth and competitiveness , by reducing the research and innovation gap in the eu ' s less developed regions through specific actions and programmes .


### have close economic and geographical links to the union ; ### have close economic and geographical links to the union or maintain special historical and cultural ties with member states of the union ;


### the specific objective ‘ inclusive , innovative and secure societies’ also includes an activity to close the research and innovation divide with specific measures to unlock excellence in less developed regions of the union . ### the specific objective ‘ inclusive , innovative and secure societies’ also includes an activity to close the research and innovation divide with specific measures to unlock excellence in less developed regions of the union , in particular the outermost regions , in line with their specific characteristics referred to in articles 174 , 349 and 355 tfeu .


### speeding up this development will require a strategic approach at union level , spanning energy supply , demand and use in buildings , services , transport and industrial value chains . this will entail aligning resources across the union , including cohesion policy funds , in particular through the national and regional strategies for smart specialisation , emission trading schemes , public procurement and other financing mechanisms . it will also require regulatory and deployment policies for renewables and energy efficiency , tailored technical assistance and capacity - building to remove non - technological barriers . ### speeding up this development will require a strategic approach at union level , spanning energy supply , demand and use in buildings , services , transport and industrial value chains . this will entail aligning resources across the union , including cohesion policy funds , in particular through the national and regional strategies for smart specialisation , emission trading schemes , public procurement and other financing mechanisms . it will also require regulatory and deployment policies for renewables and energy efficiency , tailored technical assistance and capacity - building to remove non - technological barriers . as regards the outermost regions , the possibility of incentives should be considered to enable them to develop renewable energy sources and hence tap their alternative energy potential while reducing their dependence on fossil fuels .


### europe must reconcile the growing mobility needs of its citizens with the imperatives of economic performance and the requirements of a low - carbon society and climate resilient economy . despite its growth , the transport sector must achieve a substantial reduction in greenhouse gases and other adverse environmental impacts , and must break its dependency on oil , while maintaining high levels of efficiency and mobility . ### europe must reconcile the growing mobility needs of its citizens with the imperatives of economic performance and the requirements of a low - carbon society and climate resilient economy . despite its growth , the transport sector must achieve a substantial reduction in greenhouse gases and other adverse environmental impacts , and must break its dependency on oil , while maintaining high levels of efficiency and mobility , without increasing the remoteness of regions that are already isolated , in particular the outermost regions .


### transport is a major driver of europe ' s economic competitiveness and growth . it ensures the mobility of people and goods necessary for an integrated european single market and an open and inclusive society . it represents one of europe ' s greatest assets in terms of industrial capability and quality of service , playing a leading role in many world markets . transport industry and transport equipment manufacturing together represent 6 . 3 % of the union ' s gdp . at the same time , the european transport industry faces increasingly fierce competition from other parts of the world . breakthrough technologies will be required to secure europe ' s future competitive edge and to mitigate the drawbacks of our current transport system . ### transport is a major driver of europe ' s economic competitiveness and growth and its territorial cohesion . it ensures the mobility of people and goods necessary for an integrated european single market and an open and inclusive society , reducing the isolation of european regions at all levels . it represents one of europe ' s greatest assets in terms of industrial capability and quality of service , playing a leading role in many world markets . transport industry and transport equipment manufacturing together represent 6 . 3 % of the union ' s gdp . at the same time , the european transport industry faces increasingly fierce competition from other parts of the world . breakthrough technologies will be required to secure europe ' s future competitive edge and to mitigate the drawbacks of our current transport system .


### transport is a major driver of europe ' s economic competitiveness and growth . it ensures the mobility of people and goods necessary for an integrated european single market and an open and inclusive society . it represents one of europe ' s greatest assets in terms of industrial capability and quality of service , playing a leading role in many world markets . transport industry and transport equipment manufacturing together represent 6 . 3 % of the union ' s gdp . at the same time , the european transport industry faces increasingly fierce competition from other parts of the world . breakthrough technologies will be required to secure europe ' s future competitive edge and to mitigate the drawbacks of our current transport system . ### transport is a major driver of europe ' s economic competitiveness and growth . it ensures territorial cohesion and the mobility of people and goods necessary for the integration of the european market and an open and inclusive society . it represents one of europe ' s greatest assets in terms of industrial capability and quality of service , playing a leading role in many world markets . transport industry and transport equipment manufacturing together represent 6 . 3 % of the union ' s gdp . at the same time , the european transport industry faces increasingly fierce competition from other parts of the world .


### within a few decades the expected growth rates of transport would drive european traffic into a gridlock and make its economic costs and societal impact unbearable . passenger - kilometres are predicted to double over the next 40 years and grow twice as fast for air travel . emissions would grow 35 % by 2050 . congestion costs would increase by about 50 % , to nearly eur 200 billion annually . the external costs of accidents would increase by about eur 60 billion compared to 2005 . ### within a few decades the expected growth rates of transport could drive european traffic into heavy congestion with disastrous economic and societal repercussions . passenger - kilometres are predicted to double over the next 40 years and grow twice as fast for air travel . emissions would grow 35 % by 2050 . congestion costs would increase by about 50 % , to nearly eur 200 billion annually . the external costs of accidents would increase by about eur 60 billion compared to 2005 .


### the problems of pollution , congestion , safety and security are common throughout the union and call for collaborative europe - wide responses . accelerating the development and deployment of new technologies and innovative solutions for vehicles , infrastructures and transport management will be key to achieve a cleaner and more efficient transport system in the union ; to deliver the results necessary to mitigate climate change and improve resource efficiency ; to maintain european leadership on the world markets for transport related products and services . these objectives cannot be achieved through fragmented national efforts alone . ### the problems of pollution , congestion , safety and security are common throughout the union and call for collaborative europe - wide responses . accelerating the development and harmonised deployment of new technologies and innovative solutions for vehicles and which ensure the coherent development of infrastructure and transport management will be key to achieve a cleaner and more efficient transport system in the union ; to deliver the results necessary to mitigate climate change and improve resource efficiency ; to maintain european leadership on the world markets for transport related products and services . these objectives cannot be achieved through fragmented national efforts alone .


### union level funding of transport research and innovation will complement member states’ activities by focussing on activities with a clear european added - value . this means that emphasis will be placed on priority areas that match european policy objectives ; where a critical mass of effort is necessary ; where europe - wide , interoperable transport solutions need to be pursued ; or where pooling efforts trans - nationally can reduce research investment risks , pioneer common standards and shorten time - to - market of research results . ### union level funding of transport research and innovation will complement member states’ activities by focussing on activities with a clear european added - value . this means that emphasis will be placed on priority areas that match european policy objectives where a critical mass of effort is necessary ; where europe - wide transport systems , up - to - date sources of propulsion and power , interoperable transport solutions or multimodal infrastructures need to be pursued ; or where pooling efforts trans - nationally can remove bottlenecks in the transport system and reduce research investment risks , pioneer common standards and standardisation and shorten time - to - market of research results .


### investing in research and innovation for a greener , smarter and more integrated transport system will make an important contribution to the europe 2020 goals of smart , sustainable and inclusive growth and the objectives of the innovation union flagship initiative . the activities will support the implementation of the white paper on transport aiming at a single european transport area . they will also contribute to the policy goals outlined in the flagship initiatives on ' resource efficient europe ' , ' an industrial policy for the globalisation era ' and ' a digital agenda for europe ' . ### investing in research and innovation for a greener , smarter and more integrated reliable transport system will make an important contribution to the europe 2020 goals of smart , sustainable and inclusive growth and the objectives of the innovation union flagship initiative . the activities will support the implementation of the white paper on transport aiming at a single european transport area . they will also contribute to the policy goals outlined in the flagship initiatives on ' resource efficient europe ' , ' an industrial policy for the globalisation era ' and ' a digital agenda for europe ' .


### the aim is to minimise transport ' s impact on climate and the environment by improving its efficiency in the use of natural resources , and by reducing its dependence on fossil fuels . ### the aim is to minimise transport’s impact on climate and the environment , as well as on public health , by improving its quality , efficiency and effectiveness in the use of natural resources , and by reducing its dependence on fossil fuels , while diversifying fuel supply sources .


### the focus of activities shall be to reduce resource consumption and greenhouse gas emissions and improve vehicle efficiency , to accelerate the development and deployment of a new generation of electric and other low or zero emission vehicles , including through breakthroughs in engines , batteries and infrastructure ; to explore and exploit the potential of alternative fuels and innovative and more efficient propulsion systems , including fuel infrastructure ; to optimise the use of infrastructures , by means of intelligent transport systems and smart equipment ; and to increase the use of demand management and public and non - motorised transport , particularly in urban areas . ### the focus of activities shall , as a first step , be to reduce resource consumption and greenhouse gas emissions and improve the energy efficiency of all kinds of vehicles , to accelerate the development and deployment of a new generation of low or zero emission vehicles , including through breakthroughs in engines , batteries and infrastructure and the use of renewables in rail , water and air transport . moreover , all innovation aimed at achieving low or zero emissions in all modes of transport should be encouraged , including developing and harnessing the huge potential of alternative and sustainable fuels , as well as developing innovative and more efficient propulsion systems , work on optimising fuel systems , vehicle weights and aerodynamics , and development and infrastructure , and optimising the use of infrastructures by using intelligent transport systems and smart equipment . it is important to increase the use of public and non - motorised transport , particularly in urban areas . it is also essential to have a waste management policy linked to these innovations .


### the focus of activities shall be to reduce congestion , improve accessibility and match user needs by promoting integrated door - to - door transport and logistics ; to enhance inter - modality and the deployment of smart planning and management solutions ; and to drastically reduce the occurrence of accidents and the impact of security threats . ### the focus of activities shall be to reduce congestion , improve accessibility and match user needs chiefly by removing bottlenecks and promoting users’ transport by promoting integrated door - to - door transport and logistics ; to enhance inter - modality and the deployment of smart planning and management solutions ; and to drastically reduce the occurrence of accidents and the impact of security threats .


### the focus of activities shall be to develop the next generation of innovative transport means and to prepare the ground for the following one , by working on novel concepts and designs , smart control systems and interoperable standards , efficient production processes , shorter development times and reduced lifecycle costs . ### the focus of activities shall be to develop the next generation of innovative transport means and transport systems and to prepare the ground for the following one , by working on novel concepts and designs , smart control systems and interoperable standards , efficient production processes , shorter development times and reduced lifecycle costs .


### in order to exercise their regulatory function , member states and the commission require comprehensive information on ingredients and emissions to assess the attractiveness , addictiveness and toxicity of tobacco products and the risks to health associated with the consumption of such products . to this end , the existing reporting obligations for ingredients and emissions should be reinforced . this is consistent with the obligation placed on the union to ensure a high level of protection for human health . ### in order to exercise their regulatory function , member states and the commission require comprehensive information on ingredients and emissions to assess the attractiveness , addictiveness and toxicity of tobacco products and the risks to health associated with the consumption of such products . to this end , the existing reporting obligations for ingredients and emissions should be reinforced , but should not constitute an unnecessary and disproportionate burden in particular on small and medium - sized enterprises . this is consistent with the obligation placed on the union to ensure a high level of protection for human health .


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


### 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 and menthol , which may facilitate uptake of tobacco consumption or affect consumption patterns .


### 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 .


### 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 warnings as well as regarding certain aspects of the appearance of the tobacco package , including the opening mechanism . the package 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 . this should be addressed . the above mentioned texts and features should be removed and replaced by a common statement ' all cigarettes are equally harmful ' . this would objectively inform the consumer that slim or menthol cigarettes represent the same danger as ordinary 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 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 .


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


### all tobacco products have the potential to cause mortality , morbidity and disability and their consumption should be contained . it is therefore important to monitor developments as regards novel tobacco products . a notification obligation for novel tobacco products should be put on manufacturers and importers , without prejudice to the power of the member states to ban or to authorise them . the commission should monitor the developments and submit a report 5 years after the date of transposition of this directive , in order to assess whether amendments to this directive are necessary . ### all tobacco products have the potential to cause mortality , morbidity and disability and their consumption should be contained . it is therefore important to monitor developments as regards novel tobacco products . a notification obligation for novel tobacco products should be put on manufacturers and importers , without prejudice to the power of the member states to ban or to authorise them . the commission should monitor the developments and submit a report 5 years after the date of transposition of this directive , in order to assess whether amendments to this directive are necessary . children and young people must be educated , as this is the simplest and most effective way of preventing young people from starting to smoke . consideration should also be given to creating a fund financed by the manufacturers of tobacco products , which would be used to fund anti - smoking campaigns . member states should harmonise the legal age for purchasing tobacco products at 18 .


### 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 .


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


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


### ‘ 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 ;


### ‘ pipe tobacco’ means tobacco consumed via a combustion process and exclusively designed for the purpose of being used in a pipe ; ### ‘ pipe tobacco’ means a cut or otherwise split loose or pressed tobacco which can be used without further industrial process and which is further defined in council directive 2011 / 64 / eu of 21 june 2011 ;


### ‘ roll - your - own tobacco’ means tobacco which can be used for making cigarettes by consumers or retail outlets ; ### ‘ roll - your - own tobacco’ means a cut or otherwise split loose or pressed tobacco which can be used without further industrial process and which is further defined in council directive 2011 / 64 / eu of 21 june 2011 ;


### the accuracy of the tar and nicotine indications shall be verified in accordance with iso standard 8243 . ### the accuracy of the tar , nicotine and carbon monoxide indications shall be verified in accordance with iso standard 8243 .


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


### member states shall prohibit the placing on the market of tobacco products with a characterising flavour . ### member states shall prohibit the placing on the market of tobacco products with a characterising flavour . exemption shall be applicable for menthol as it is considered being traditional tobacco flavour and can not be classified with the other tobacco flavours .


### caffeine and taurine and other additives and stimulant compounds that are associated with energy and vitality , or ### caffeine and taurine and other additives and stimulant compounds that have been scientifically proven to increase the level of energy and vitality , or


### the commission shall adopt by means of implemeting acts uniform rules on the procedures for determining whether a tobacco product falls within the scope of paragraph 1 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 21 . ### the commission shall be empowered to adopt delegated acts , in accordance with article 22 , to determine uniform rules on the procedures for determining whether a tobacco product falls within the scope of paragraph 1 .


### 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 visible . all kinds of tax stamps , price marks , tracking and tracing marks , security features or any type of wrapper , pouch , jacket , box or other device when used shall allow the visibility and the readability of the health warnings . the same is applicable for the design of opening of the unit packet .


### member states shall ensure that the health warnings of the main surface of the unit packet and any outside packaging are fully visible , including not being partially or totally hidden or interrupted by wrappers , pouches , jacket , boxes or other devices when tobacco products are placed on the market . ### member states shall ensure that the health warnings of the main surface of the unit packet and any outside packaging are fully visible . when tobacco products are placed on the market , wrappers , pouches , jacket , boxes or other devices when used shall allow the visibility and the readability of the health warnings .


### the health warnings shall in no way hide or interrupt the tax stamps , price marks , tracking and tracing marks , or security features on unit packets . ### the health warnings shall in no way hide or interrupt the tax stamps , which shall be placed at the opening of the tobacco product package , price marks , tracking and tracing marks , or security features on unit packets .


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


### cover 75 % of the external area of both the front and back surface of the unit packet and any outside packaging ; ### cover 43 % of the external area of the front and 62 % of the external area of the back surface of the unit packet and any outside packaging ;


### 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 ;


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


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


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


### the unique identifier shall allow determining : ### the unique identifier , which is secure and impossible to duplicate , shall allow determining :


### the actual shipment route from manufacturing to the first retail outlet , including all warehouses used ; ### the shipment date , consignee , departure and destination from manufacturing to the first customer who is not affiliated with the manufacturer or importer , including his warehouses and all tax warehouses used ;


### the identity of all purchasers from manufacturing to the first retail outlet ; ### the identity of the first customer who is not affiliated with the manufacturer or importer and the identity of any known subsequent purchaser ;


### the invoice , order number and payment records of all purchasers from manufacturing to the first retail outlet . ### the invoice , order number and payment records of the first customer who is not affiliated with the manufacturer or importer .


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


### recorded data cannot be modified or deleted by any economic operator involved in the trade of tobacco products , but the economic operator that introduced the data and other economic operators directly concerned by the transaction such as the supplier or the recipient can comment on previously introduced data . the economic operator concerned shall add the correct data and a reference to the previous entry which requires rectification in their view . in exceptional circumstances and upon submission of adequate evidence , the competent authority in the member state in which the recording took place or if the recording took place outside the union the competent authority in the member state of importation , can authorise the modification or deletion of data previously registered . ### recorded data has to be transmitted to a database in a timely manner . the data cannot be modified or deleted by any economic operator involved in the trade of tobacco products , but the economic operator that introduced the data and other economic operators directly concerned by the transaction such as the supplier or the recipient can comment on previously introduced data . the economic operator concerned shall add the correct data and a reference to the previous entry which requires rectification in their view . in exceptional circumstances and upon submission of adequate evidence , the competent authority in the member state in which the recording took place or if the recording took place outside the union the competent authority in the member state of importation , can authorise the modification or deletion of data previously registered . the recorded data has to be kept for the period of four years from manufacturing unless any member state or the commission request a longer period due to an on - going investigation .


### member states shall ensure that manufacturers and importers of tobacco products conclude data storage contracts with an independent third party , which shall host the data storage facility for data relating to the manufacturer and importer concerned . the data storage facility shall be physically located on the territory of the union . the suitability of the third party , in particular its independence and technical capacities , as well as the contract , shall be approved and monitored by an external auditor , who is proposed and paid by the tobacco manufacturer and approved by the commission . member states shall ensure full transparency and accessibility of the data storage facilities for the competent authorities of the member states , the commission and the independent third party on a permanent basis . in duly justified cases member states or the commission can provide manufacturers or importers access to this information , provided commercially sensitive information remains adequately protected in conformity with the relevant national and union legislations . ### member states shall ensure that manufacturers and importers of tobacco products conclude data storage contracts with an independent third party , which shall host the data storage facility for data relating to the manufacturer and importer concerned . the data storage facility shall be physically located on the territory of the union . the 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 online accessibility of the required data for the competent authorities of the member states , the commission and the independent third party on a permanent basis . member states or the commission shall allow manufacturers or importers access to the information , provided with the condition that commercially sensitive information remains adequately protected in conformity with the relevant national and union legislations . member states shall ensure that access to a database takes place only where it is necessary for the purpose of detection or investigation of illicit trade and the database information is protected and treated confidentially . in particular , data cannot be shared with any person or organisation which is not involved in the investigation or subsequent proceedings .


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


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


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


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


### 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 fine - cut tobacco for the 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 .


### tobacco for oral use ### smokeless tobacco products


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


### member states shall require that manufacturers and importers of tobacco products inform their competent authorities of any new or updated information referred to in point to of paragraph 1 . member states shall be entitled to require tobacco manufacturers or importers to carry out additional tests or submit additional information . member states shall make available to the commission all information received pursuant to this article . member states shall be entitled to introduce an authorisation system and charge a proportionate fee . ### member states shall require that manufacturers and importers of tobacco products inform their competent authorities of any new or updated information referred to in point to of paragraph 1 . member states shall be entitled to require tobacco manufacturers or importers to carry out additional tests or submit additional information . member states shall make available to the commission all information received pursuant to this article . in connection with the placing on the market of reduced - risk tobacco products , member states shall be entitled to introduce an authorisation system and charge a proportionate fee . member states shall be entitled to lay down specific rules for reduced - risk products governing consumer information , packaging and labelling , ingredients and emissions and the methods used to measure tar , nicotine and carbon monoxide . member states shall notify those rules to the commission .


### novel tobacco products placed on the market shall respect the requirements set out in this directive . the provisions applicable depend on whether the products fall under the definition of smokeless tobacco product in point of article 2 or tobacco for smoking in point of article 2 . ### novel and reduced - risk tobacco products placed on the market shall respect the requirements set out in this directive . reduced - risk tobacco products shall be covered by special provisions laid down by member states under paragraph 2 . the provisions applicable depend on whether the products fall under the definition of smokeless tobacco product in point of article 2 or tobacco for smoking in point of article 2 .


### with a view to drafting the report , the commission shall be assisted by scientific and technical experts in order to have all the necessary information available . ### with a view to drafting the report , the commission shall be assisted by scientific and technical experts from the member states in order to have all the necessary information available .


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


### in july 2011 , the international maritime organisation adopted technical and operational measures , in particular the energy efficiency design index for new ships and the ship energy efficiency management plan , which will bring improvement in terms of reducing the expected increase in greenhouse gas emissions , but alone cannot lead to the necessary absolute emission reductions of greenhouse gases from international shipping to keep efforts in line with the global objective of limiting increases in global temperatures to 2°c . ### in july 2011 , the international maritime organisation adopted technical and operational measures , in particular the energy efficiency design index for new ships and the ship energy efficiency management plan , which will bring improvement in terms of reducing the expected increase in greenhouse gas emissions , but alone cannot lead to the necessary absolute emission reductions of greenhouse gases from international shipping .


### this regulation lays down rules for the accurate monitoring , reporting and verification of carbon dioxide emissions and other climate relevant information from ships arriving at , within or departing from ports under the jurisdiction of a member state in order to promote the reduction of co2 emissions from maritime transport in a cost effective manner . ### this regulation lays down rules for the accurate monitoring , reporting and verification of carbon dioxide emissions from ships arriving at , within or departing from ports under the jurisdiction of a member state in order to promote the reduction of co2 emissions from maritime transport in a cost effective manner .


### 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 be complete and cover co2 emissions from the combustion of fuels , while the ship is at sea as well as at berth . companies shall apply appropriate measures to prevent any data gaps within the reporting period .


### amount and emission factor for each type of fuel consumed in total and differentiated between fuel used inside and outside emission control areas ; ### amount and emission factor for each type of fuel consumed in total ;


### from 2019 , by 30 april of each year , companies shall submit to the commission and to the authorities of the flag states concerned , an emission report concerning the emissions and other climate - relevant information during the entire reporting period for each ship under their responsibility , which has been verified as satisfactory by a verifier in accordance with the requirements referred to in article 14 . ### from 2019 , by 30 april of each year , companies shall submit to the commission and to the authorities of the flag states concerned , an emission report concerning the co2 emissions during the entire reporting period for each ship under their responsibility , which has been verified as satisfactory by a verifier in accordance with the requirements referred to in article 14 .


### in particular the verifier shall ensure that the emissions and other climate - relevant information included in the emission report have been determined in accordance with articles 8 , 9 and 10 and the monitoring plan referred to in article 6 . the verifier shall also ensure that the emissions and other climate - relevant information declared in the reports are consistent with data calculated from other sources in accordance with annexes i and ii . ### in particular the verifier shall ensure that the co2 emissions included in the emission report have been determined in accordance with articles 8 , 9 and 10 and the monitoring plan referred to in article 6 . the verifier shall also ensure that the co2 emissions declared in the reports are consistent with data calculated from other sources in accordance with annexes i and ii .


### the commission shall publish an annual report on emissions and other climate - relevant information from maritime transport . ### the commission shall publish an annual report on co2 emissions from maritime transport .


### where an international agreement on global measures to reduce greenhouse gas emissions from maritime transport is reached , the commission shall review this regulation and may , if appropriate , propose amendments to this regulation . ### where an international agreement on global measures to reduce greenhouse gas emissions from maritime transport is reached , the commission undertakes to propose immediately the incorporation of the internationally agreed provisions into community law .


### in order to ensure the interoperability and continuity of the service throughout the union , and reduce the costs of implementation for the union as a whole , it is necessary that all member states deploy the ecall priority action in accordance with the common specifications established in delegated regulation no 305 / 2013 . this should be without prejudice to the right of each member state to deploy additional technical means to handle other emergency calls . ### in order to ensure the full functionality , compatibility , interoperability and continuity of the service throughout the union , and reduce the costs of implementation for the union as a whole , it is necessary that all member states deploy the ecall priority action in accordance with the common specifications established in delegated regulation no 305 / 2013 . this should be without prejudice to the right of each member state to deploy additional technical means to handle other emergency calls .


### proposal for a directive of the european parliament and of the council amending directives 98 / 78 / ec , 2002 / 87 / ec and 2006 / 48 / ec as regards the supplementary supervision of financial entities in a financial conglomerate ### proposal for a directive of the european parliament and of the council amending directives 98 / 78 / ec , 2002 / 87 / ec , 2006 / 48 / ec and 2009 / 138 / ec as regards the supplementary supervision of financial entities in a financial conglomerate


### it is appropriate to ensure consistency with the aim of directive 2002 / 87 / ec and council directives 73 / 239 / eec , 79 / 267 / eec , 92 / 49 / eec , 92 / 96 / eec , 93 / 6 / eec and 93 / 22 / eec , and directives 98 / 78 / ec and 2000 / 12 / ec1 of the european parliament and of the council , to enable supervision of insurance groups as well as appropriate supplementary supervision of insurance and other entities within a mixed financial holding structure . for this reason , directive 98 / 78 / ec of the european parliament and of the council of 27 october 1998 on the supplementary supervision of insurance and reinsurance undertakings in an insurance or reinsurance group2 should be amended to define and include mixed financial holding companies . in order to ensure timely coherent supervision , directive 98 / 78 / ec should be amended , notwithstanding the imminent application of directive 2009 / 138 / ec of the european parliament and of the council of 25 november 2009 on the taking - up and pursuit of the business of insurance and reinsurance 3 . _____ 1 oj l 35 , 11 . 2 . 2003 , p . 1 . 2 oj l 330 , 5 . 12 . 1998 , p . 1 . 3 oj l 335 , 17 . 12 . 2009 , p . 1 . ### it is appropriate to ensure consistency between the aim of directive 2002 / 87 / ec of the european parliament and of the council , council directives 73 / 239 / eec , 79 / 267 / eec , 92 / 49 / eec , 92 / 96 / eec , and directives 98 / 78 / ec , 2004 / 39 / ec1 , 2006 / 48 / ec2 , 2006 / 49 / ec3 and 2009 / 138 / ec4 of the european parliament and of the council , in order to enable appropriate supplementary supervision of insurance and banking groups , including where they are part of a mixed financial holding structure . _____ 1 oj l 145 , 30 . 4 . 2004 , p . 1 . 2 oj l 177 , 30 . 6 . 2006 , p . 1 . 3 oj l 177 , 30 . 6 . 2006 , p . 201 . 4 oj l 335 , 17 . 12 . 2009 , p . 1 .


### it is necessary that financial conglomerates are identified throughout the european union according to the extent to which they are exposed to group risks , based on common guidelines issued by the european banking authority and the european insurance and occupational pensions authority in accordance with article 42 of the regulation no . . / . . establishing a european banking authority and article 42 of the regulation no . . / . . establishing a european insurance and occupational pensions authority , following cooperation within the joint committee of european supervisory authorities . . it is also important that the requirements regarding the waiving of the application of supplementary supervision are applied in a risk - based manner according to these guidelines . this is of particular importance in the case of the larger , internationally operating conglomerates . ### it is necessary that financial conglomerates are identified throughout the union according to the extent to which they are exposed to group risks , based on common guidelines issued by the european supervisory authority , the european supervisory authority and the european supervisory authority in accordance with article 56 of each of regulation no . . / 2010 establishing a european supervisory authority , regulation no . . / 2010 establishing a european supervisory authority and regulation no . . / 2010 establishing a european supervisory authority , following cooperation within the joint committee of the european supervisory authorities . it is also important that the requirements regarding the waiving of the application of supplementary supervision are applied in a risk - based manner according to these guidelines . this is of particular importance in the case of the larger , internationally operating conglomerates .


### 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 supplementary supervision of large , complex , internationally operating conglomerates requires coordination throughout the european union , in order to contribute to the stability of the internal market for financial services . to this end , competent authorities need to agree upon the supervisory approaches applied to these conglomerates . the european banking authority and the european insurance and occupational pensions authority should issue , in accordance with article 42 of the regulation no . . / . . establishing a european banking authority and article 42 of the regulation no . . / . . establishing a european insurance and occupational pensions authority , following cooperation within the joint committee of european supervisory authorities , common guidelines for these common approaches , thus ensuring a comprehensive prudential framework of the supervisory tools and powers available in the banking , insurance and financial conglomerates directives . the guidelines which will be issued as provided for in this directive must reflect the supplementary nature of this directive , and complement the sector - specific supervision as provided for by directives 73 / 239 / eec , 79 / 267 / eec , 92 / 49 / eec , 92 / 96 / eec , 93 / 6 / eec , 93 / 22 / eec , 98 / 78 / ec , 2000 / 12 / ec , 2004 / 39 / ec , 2006 / 48 / ec , 2006 / 49 / ec and 2009 / 138 / ec . ### the supplementary supervision of large , complex , internationally operating conglomerates requires coordination throughout the union , in order to contribute to the stability of the internal market for financial services . to this end , competent authorities need to agree upon the supervisory approaches applied to these conglomerates . the european supervisory authority , the european supervisory authority and the european supervisory authority should issue , in accordance with article 56 of each of regulation no . . / 2010 establishing a european supervisory authority , regulation no . . / 2010 establishing a european supervisory authority and regulation no . . / 2010 establishing a european supervisory authority following cooperation within the joint committee , common guidelines for these common approaches , thus ensuring a comprehensive prudential framework of the supervisory tools and powers available in the banking , insurance , securities and financial conglomerates directives . the guidelines which will be issued as provided for in this directive must reflect the supplementary nature of this directive , and complement the sector - specific supervision as provided for by directives 73 / 239 / eec , 79 / 267 / eec , 92 / 49 / eec , 92 / 96 / eec , 98 / 78 / ec , 2004 / 39 / ec , 2006 / 48 / ec , 2006 / 49 / ec and 2009 / 138 / ec .


### there is a genuine need to monitor and control potential group risks , posed to the conglomerate , coming from participations in other companies . for those cases where the specific supervisory powers provided by this directive appear to be insufficient , the supervisory community should develop alternative methods to address and appropriately take into account these risks , preferably by work conducted by the european banking authority and the european insurance and occupational pensions authority in the forum of the joint committee of the european supervisory authorities . if a participation is the only element of identification of a financial conglomerate , supervisors should be allowed to assess whether the group is exposed to group risks and waive the group from supplementary supervision , if appropriate . ### there is a genuine need to monitor and control potential group risks , posed to the conglomerate , coming from participations in other companies . for those cases where the specific supervisory powers provided by this directive appear to be insufficient , the supervisory community should develop alternative methods to address and appropriately take into account these risks , preferably by work conducted by the european supervisory authority , the european supervisory authority and the european supervisory authority in the forum of the joint committee . if a participation is the only element of identification of a financial conglomerate , supervisors should be allowed to assess whether the group is exposed to group risks and waive the group from supplementary supervision , if appropriate .


### with regard to certain group structures , supervisors were left without powers in the current crisis since the combination of directives had forced them to choose either sector - specific or supplementary supervision . while a complete review of the directive should be undertaken in the context of the g20 work on conglomerates , the necessary supervisory powers should be restored as soon as possible . ### with regard to certain group structures , supervisors were left without powers in the current crisis since the combination of directives had forced them to choose either sector - specific or supplementary supervision . while a complete review of the directive should be undertaken in the context of the g20 work on conglomerates , the necessary supervisory powers should be provided as soon as possible .


### directives 98 / 78 / ec , 2002 / 87 / ec and 2006 / 48 / ec should therefore be amended accordingly , ### directives 98 / 78 / ec , 2002 / 87 / ec , 2006 / 48 / ec and 2009 / 138 / ec should therefore be amended accordingly ,


### article 10 is replaced by the following : 2 . in the case referred to in article 2 , the calculation shall include all related undertakings of the insurance holding company , the mixed financial holding company , the non - member - country insurance undertaking or the non - member country reinsurance undertaking , in the manner provided for in annex ii . ### article 10 is replaced by the following : ' article 10 insurance holding companies , mixed financial holding companies , non - member country insurance undertakings and non - member country reinsurance undertakings in the case referred to in article 2 , member states shall require the method of supplementary supervision to be applied in accordance with annex ii . 2 . in the case referred to in article 2 , the calculation shall include all related undertakings of the insurance holding company , the mixed financial holding company , the non - member country insurance undertaking or the non - member country reinsurance undertaking , in the manner provided for in annex ii . 3 . if , on the basis of that calculation , the competent authorities conclude that the solvency of a subsidiary insurance undertaking or a reinsurance undertaking of the insurance holding company , the mixed financial holding company , the non - member country insurance undertaking or the non - member country reinsurance undertaking is , or may be , jeopardised , they shall take appropriate measures at the level of that insurance undertaking or reinsurance undertaking . '