### the activities developed under horizon 2020 should aim at promoting equality between men and women in research and innovation , by addressing in particular the underlying causes of gender imbalance , by exploiting the full potential of both female and male researchers , and by integrating the gender dimension into the content of projects in order to improve the quality of research and stimulate innovation . activities should also aim at the implementation of the principles relating to the equality between women and men as laid down in articles 2 and 3 of the treaty on european union and article 8 tfeu . ### horizon 2020 funded research activities should comply with the eu acquis communautaire with regard to equal opportunities between men and women . horizon 2020 should pay attention to excellent science and to professional qualification of scientific and research personal of both sex involved in research and innovation . in order to assure the effective use of eu funding , the principal distinction for eu research funding should be the excellence of science project and the professional qualification of the research staff .


### a fully functional european bio - economy – encompassing the sustainable production of renewable resources from land and aquatic environments and their conversion into food , bio - based products and bioenergy as well as the related public goods - will generate high european added value . managed in a sustainable manner , it can reduce the environmental footprint of primary production and the supply chain as a whole . it can increase their competitiveness and provide jobs and business opportunities for rural and coastal development . the food security , sustainable agriculture , and overall bio - economy – related challenges are of a european and global nature . actions at union level are essential to bring together clusters to achieve the necessary breadth and critical mass to complement efforts made by a single or groups of member states . a multi - actor approach will ensure the necessary cross - fertilising interactions between researcher , businesses , farmers / producers , advisors and end - users . the union level is also necessary to ensure coherence in addressing this challenge across sectors and with strong links to relevant union policies . coordination of research and innovation at union level will stimulate and help to accelerate the required changes across the union . ### a fully functional european bio - economy – encompassing the sustainable production of renewable resources from land and aquatic environments and their conversion into food , feed , bio - based products and bioenergy as well as the related public goods - will generate high european added value . managed in a sustainable manner , it can reduce the environmental footprint of primary production and the supply chain as a whole . it can increase their competitiveness and provide jobs and business opportunities for rural and coastal development . in parallel to the market oriented functions , the bio - economy sustains also a wide range of public goods function that should be preserved : agricultural and forested landscape , farmland and forest biodiversity , water quality and availability , soil functionality , climate stability , air quality , resilience to flooding and fire . the food security , sustainable agriculture , and overall bio - economy – related challenges are of a european and global nature . actions at union level are essential to bring together clusters to achieve the necessary breadth and critical mass to complement efforts made by a single or groups of member states . a transparent multi - actor approach will ensure the necessary cross - fertilising interactions between researcher , businesses , farmers / producers , advisors , consumers and end - users . the union level is also necessary to ensure coherence in addressing this challenge across sectors and with strong links to relevant union policies . coordination of research and innovation at union level will stimulate and help to accelerate the required changes across the union .


### the aim is to supply sufficient food , feed , biomass and other raw - materials , while safeguarding natural resources and enhancing ecosystems services , including coping with and mitigating climate change . the activities shall focus on more sustainable and productive agriculture and forestry systems which are both resource - efficient and resilient , while at the same time developing of services , concepts and policies for thriving rural livelihoods . ### the aim is to supply sufficient food , feed , biomass and other raw - materials , while safeguarding natural resources and enhancing ecosystems services , including coping with and mitigating climate change . the activities shall focus on more sustainable and productive agriculture and forestry systems which are both resource - efficient and resilient , on increasing the quality and value of agricultural products , and at the same time developing services , concepts and policies for thriving rural livelihoods .


### powered by the expansion of the knowledge of living systems , biotechnology is set to deliver a stream of new applications and to strengthen the union ' s industrial base and its innovation capacity . examples of the rising importance of biotechnology are in industrial applications including bio - chemicals , of which the market share is estimated to increase by up to 12 % - 20 % of chemical production by 2015 . a number of the so - called twelve rules of green chemistry are also addressed by biotechnology , due to the selectivity and efficiency of bio - systems . the possible economic burdens for union enterprises can be reduced by harnessing the potential of biotechnology processes and bio - based products to reduce co2 emissions , estimated to range from between 1 to 2 . 5 billion tons co2 equivalent per year by 2030 . in europe ' s biopharmaceutical sector , already some 20 % of the current medicines are derived from biotechnology , with up to 50 % of new medicines . biotechnology also opens new avenues for exploiting the huge potential of marine resources for producing innovative industrial , health and environmental applications . the emerging sector of marine biotechnology has been predicted to grow by 10 % a year . ### powered by the expansion of the knowledge of living systems , biotechnology is set to deliver a stream of new applications and to strengthen the union ' s industrial base and its innovation capacity . examples of the rising importance of biotechnology are in industrial and agricultural applications including food and feed production , bio - chemicals , of which the market share is estimated to increase by up to 12 % - 20 % of chemical production by 2015 . a number of the so - called twelve rules of green chemistry are also addressed by biotechnology , due to the selectivity and efficiency of bio - systems . the possible economic burdens for union enterprises can be reduced by harnessing the potential of biotechnology processes and bio - based products to reduce co2 emissions , estimated to range from between 1 to 2 . 5 billion tons co2 equivalent per year by 2030 . in europe ' s biopharmaceutical sector , already some 20 % of the current medicines are derived from biotechnology , with up to 50 % of new medicines . biotechnology also opens new avenues for exploiting the huge potential of marine resources for producing innovative industrial , health and environmental applications . the emerging sector of marine biotechnology has been predicted to grow by 10 % a year .


### with the aim to achieve the greatest possible impact of union funding , horizon 2020 is to develop closer synergies , which may also take the form of public - public partnerships , with national and regional programmes that support research and innovation . ### with the aim to achieve the greatest possible impact of union funding , horizon 2020 is to develop closer synergies , which may also take the form of public - public partnerships , with national and regional programmes as well as mutually beneficial and accessible international programmes that support research and innovation .


### the activities developed under horizon 2020 should aim at promoting equality between men and women in research and innovation , by addressing in particular the underlying causes of gender imbalance , by exploiting the full potential of both female and male researchers , and by integrating the gender dimension into the content of projects in order to improve the quality of research and stimulate innovation . activities should also aim at the implementation of the principles relating to the equality between women and men as laid down in articles 2 and 3 of the treaty on european union and article 8 tfeu . ### horizon 2020 funded research activities should comply with the union acquis communautaire with regard to equal opportunities between men and women . horizon 2020 should pay attention to excellent science and to professional qualification of scientific and research personal of both sexes involved in research and innovation . in order to assure the effective use of union funding , the principal distinction for union research funding should be the excellence of science project and the professional qualification of the research staff .


### key activities shall be to encourage experienced researchers to broaden or deepen their skills by means of mobility by opening attractive career opportunities in universities , research institutions , businesses , smes and other socio - economic groups all over europe and beyond . opportunities to restart a research career after a break shall also be supported . ### key activities shall be to encourage experienced researchers to broaden or deepen their skills by means of mobility by opening attractive career opportunities in universities , research institutions , businesses , smes and other socio - economic groups all over europe and beyond , while taking account of the role of young people in the science sector , offering researchers the opportunity to be trained and to acquire new knowledge in a third - country high - level research organisation , and subsequently return . key regard shall be taken of the role of women in science , and potential barriers to their entry into the field . opportunities to restart a research career after a break and flexible working arrangements shall also be supported .


### biotechnology - based industrial processes ### biotechnology - based products and processes


### the specific objective is to foster radically new technologies by exploring novel and high - risk ideas building on scientific foundations . by providing flexible support to goal - oriented and interdisciplinary collaborative research on various scales and by adopting innovative research practices , the aim is to identify and seize opportunities of long - term benefit for citizens , the economy and society . ### the specific objective is to foster radically new technologies by exploring novel and high - risk ideas building on scientific foundations . by providing flexible support to goal - oriented and interdisciplinary collaborative research on various scales and by adopting innovative research practices , the aim is to identify and seize opportunities of long - term benefit for citizens , the economy and society . smart specialisation platforms have a key role to play in this respect , particularly in terms of network creation and development , the exchange of information , twinning schemes and support for research and innovation policies .


### developing industrial biotechnology for competitive industrial products and processes and its environmental dimension . ### developing biotechnology for competitive products and processes and its environmental dimension .


### research activities intended to create human embryos solely for the purpose of research or for the purpose of stem cell procurement , including by means of somatic cell nuclear transfer . ### research activities intended either to create – by means of somatic cell nuclear transfer or by parthenogenesis or any other means – or to destroy human embryos for any purpose , including that of stem cells procurement ; as well as any research activities involving the use of human embryonic stem cells .


### the aim is to enhance solidarity as well as social , economic and political inclusion and positive inter - cultural dynamics in europe and with international partners , through cutting - edge science and interdisciplinarity , technological advances and organisational innovations . humanities research can play an important role here . research shall support policymakers in designing policies that combat poverty and prevent the development of various forms of divisions , discriminations and inequalities in european societies , such as gender inequalities or digital or innovation divides , and with other world regions . it shall in particular feed into the implementation and the adaptation of the europe 2020 strategy and the broad external action of the union . specific measures shall be taken to unlock excellence in less developed regions , thereby widening participation in horizon 2020 . ### the aim is to enhance intercommunication as well as social , economic , political and cultural inclusion and positive inter - cultural dynamics in europe as well as to gain a greater understanding of societal changes in europe and with international partners , through cutting - edge science and interdisciplinarity , technological advances and organisational innovations . humanities research should play a crucial role here , including through research into the consequences of societal change for the well - being and quality of the lives of individuals , families and societies , and must therefore be properly funded . humanities research can also reveal , develop , preserve and designate the multidimensional european cultural heritage by creating new scientific disciplines , new innovation fields and jobs . there is a need for an increased knowledge base in the areas of social exclusion , health , demographic change and the ageing society , life course , family traditions , shared history and cultural heritage , physical exercise , migration and mobility , education and lifelong learning , multilingualism and governance dynamics . research in the field of human and social sciences can play an important role here . research shall support policymakers in designing policies and identifying activities that combat poverty and prevent the development of various forms of divisions , discriminations and inequalities in european societies , such as gender inequalities or digital or innovation divides , and with other world regions , for example on the basis of comparative studies of cultural and linguistic diversity and intercultural interaction . it shall in particular feed into the implementation and the adaptation of the europe 2020 strategy and the broad external action of the union . specific measures shall be taken to unlock excellence in less developed regions , thereby widening participation in horizon 2020 .


### taking into account the specific characteristics of urban , suburban and regional regular services , member states should be granted the right to exempt these types of transport from the application of a significant part of this regulation . in order to identify urban , suburban and regional regular services , member states should take into account criteria such as distance , frequency of services , number of scheduled stops , type of buses or coaches employed , ticketing schemes , fluctuations in passenger numbers between services in peak and off - peak periods , bus codes and timetables . ### taking into account the specific characteristics of urban , suburban and regional regular services , member states should be granted the right to exempt these types of transport from the application of part of this regulation . in order to identify urban and suburban regular services , member states should take into account criteria such as the administrative division , geographical situation , distance , frequency of services , number of scheduled stops , type of buses or coaches employed , ticketing schemes , fluctuations in passenger numbers between services in peak and off - peak periods , bus codes and timetables .


### council position taking into account the specific characteristics of urban , suburban and regional regular services , member states should be granted the right to exempt these types of transport from the application of a significant part of this regulation . in order to identify urban , suburban and regional regular services , member states should take into account criteria such as distance , frequency of services , number of scheduled stops , type of buses or coaches employed , ticketing schemes , fluctuations in passenger numbers between services in peak and off - peak periods , bus codes and timetables . ### taking into account the specific characteristics of urban and suburban regular services , member states should be granted the right to exempt these types of transport from the application of part of this regulation . in order to identify urban and suburban regular services , member states should take into account criteria such as the administrative division , geographical situation , distance , frequency of services , number of scheduled stops , type of buses or coaches employed , ticketing schemes , fluctuations in passenger numbers between services in peak and off - peak periods , bus codes and timetables .


### nothing in this regulation shall be understood as constituting technical requirements imposing obligations on carriers or terminal managing bodies to modify or replace buses or coaches or infrastructure or equipment at bus stops and terminals . ### nothing in this regulation shall be understood to constitute technical requirements imposing obligations on carriers to modify or replace buses or coaches .


### where a passenger misses a connecting flight as a result of a delay or change of schedule to a preceding flight , the community air carrier operating the onward connecting flight shall offer the passenger : ### where a passenger misses a connecting flight as a result of a delay or change of schedule to a preceding flight , the community air carrier responsible for the delay shall offer the passenger :


### “extraordinary circumstances” means circumstances which , by their nature or origin , are not inherent in the normal exercise of the activity of the air carrier concerned and are beyond its actual control . for the purposes of this regulation , extraordinary circumstances shall include the circumstances set out in the annex ; ### ' extraordinary circumstances ' is an event that is beyond the actual control of the air carrier . for the purposes of this regulation , extraordinary circumstances shall include but not be limited to the circumstances set out in annex 1 .


### «extraordinary circumstances» means circumstances which , by their nature or origin , are not inherent in the normal exercise of the activity of the air carrier concerned and are beyond its actual control . for the purposes of this regulation , extraordinary circumstances shall include the circumstances set out in the annex ; ### «extraordinary circumstances» means circumstances which , by their nature or origin , are outside the control of the air carrier concerned and , in so far as they do not stem from a failure to comply with safety rules and regulations , are beyond its actual control . for the purposes of this regulation , extraordinary circumstances shall include the circumstances set out in the annex ;


### labour disputes at the operating air carrier or at essential service providers such as airports and air navigation service providers . ### labour disputes at essential service providers such as airports and air navigation service providers .


### in the investigation the commission shall evaluate all relevant factors of an objective and quantifiable nature having a bearing on the situation of the union industry , in particular , the rate and amount of the increase in imports of the product concerned in absolute and relative terms , the share of the domestic market taken by increased imports , changes in the level of sales , production , productivity , capacity utilisation , profits and losses , and employment . ### in the investigation the commission shall evaluate all relevant factors of an objective and quantifiable nature having a bearing on the situation of the union industry , in particular , the rate and amount of the increase in imports of the product concerned in absolute and relative terms , the share of the domestic market taken by increased imports , changes in the level of sales , production , productivity , capacity utilisation , profits and losses , and employment . in the event that third - country content commonly accounts for more than 5 percent of the manufacturing cost of the product concerned , the commission shall also evaluate , as bearing on the situation of the union industry , the production capacity , utilization rates , currency practices and labour conditions of the third countries concerned .


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


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


### ‘ recreational craft’ means any boat of any type intended for sports and leisure purposes of hull length from 2 , 5 m to 24 m , measured according to the harmonised standard , regardless of the means of propulsion ; ### ‘ recreational craft’ means any vessel of any type intended for sports and leisure purposes of hull length from 2 , 5 m to 24 m , measured according to the harmonised standard , regardless of the means of propulsion ;


### offshore : designed for offshore voyages where conditions up to , and including , wind force 8 and significant wave heights up to , and including , 4 m may be experienced . ### a recreational craft given design category b is considered to be designed for wind force up to , and including , 8 and significant wave heights up to , and including , 4 m .


### sheltered waters : designed for voyages on sheltered coastal waters , small bays , small lakes , rivers and canals when conditions up to , and including , wind force 4 and significant wave heights up to , and including , 0 , 3 m may be experienced , with occasional waves of 0 , 5 m maximum height , for example from passing vessels . ### a watercraft given design category d is considered to be designed for a wind force up to , and including , 4 and significant wave heights up to , and including , 0 , 3 m with occasional waves of 0 , 5 m maximum height .


### offshore : designed for offshore voyages where conditions up to , and including , wind force 8 and significant wave heights up to , and including , 4 m may be experienced . ### a recreational craft given design category b is considered to be designed for waves of up to 4 m significant height and a wind of beaufort force 8 or less . such conditions may be encountered on offshore voyages of sufficient length or on coasts where shelter may not always be immediately available . such conditions may also be experienced on inland seas of sufficient size for the wave height to be generated . winds are assumed to gust to 21 m / s .


### in accordance with the principle of subsidiarity , the provisions of this directive should not affect member states’ entitlement to lay down such requirements as they may deem necessary concerning navigation on certain waters for the purpose of protection of the environment , the fabric of waterways , and ensuring safety of waterways , provided that those provisions do not require modification to the watercraft which is in conformity with this directive . ### in accordance with the principle of subsidiarity , the provisions of this directive should not affect member states’ entitlement to lay down such requirements as they may deem necessary concerning navigation on certain waters for the purpose of protection of the environment , the fabric of waterways , and ensuring safety of waterways , provided that those provisions do not require modification to the watercraft which is in conformity with this directive and that those provisions are justified and proportionate to the objective to be achieved . the commission should facilitate the exchange of best practices between member states on the application of article 5 of this directive by setting up an adequate system for such exchange .


### it is also appropriate to provide definitions of ‘ watercraft built for own use’ and of ‘ private importer’ specific to this sector in order to facilitate the understanding and uniform application of this directive . ### it is also appropriate to provide definitions of ' watercraft built for own use ' and of ' private importer ' specific to this sector in order to facilitate the understanding and uniform application of this directive . it is necessary to extend the current definition of ' propulsion engine ' to also cover innovative propulsion solutions .


### ‘ propulsion engine’ means any spark or compression ignition , internal combustion engine used for propulsion purposes ; ### ' propulsion engine ' means any spark or compression ignition , internal combustion engine used directly or indirectly for propulsion purposes ;


### inshore : designed for voyages in coastal waters , large bays , estuaries , lakes and rivers where conditions up to , and including , wind force 6 and significant wave heights up to , and including , 2 m may be experienced . ### a watercraft given design category c is considered to be designed for waves of up to 2 m significant height and a typical steady wind force of beaufort force 6 or less . such conditions may be encountered on exposed inland waters , in estuaries , and in coastal waters in moderate weather conditions . winds are assumed to gust to 17 m / s .


### ocean : designed for extended voyages where conditions may exceed wind force 8 and significant wave heights of 4 m and above but excluding abnormal conditions , and vessels largely self - sufficient . ### a recreational craft given design category a is considered to be designed for winds that may exceed wind force 8 and significant wave heights of 4 m and above but excluding abnormal conditions such as storm , violent storm , hurricane , tornado and extreme sea conditions or rogue waves .


### ventilation shall be provided to prevent the accumulation of gases , which might be emitted from batteries . batteries shall be firmly secured and protected from ingress of water . ### ventilation shall be provided to prevent the accumulation of explosive gases . batteries shall be firmly secured and protected from ingress of water .


### sheltered waters : designed for voyages on sheltered coastal waters , small bays , small lakes , rivers and canals when conditions up to , and including , wind force 4 and significant wave heights up to , and including , 0 , 3 m may be experienced , with occasional waves of 0 , 5 m maximum height , for example from passing vessels . ### a watercraft given design category d is considered to be designed for waves of up to 0 , 3 m significant height and occasional waves of 0 , 5 m height and a typical steady wind force of beaufort force 4 or less . such conditions may be encountered on sheltered inland waters , and in coastal waters in fine weather . winds are assumed to gust to 13 m / s .


### depending on the fuel and power category , the test cycles for engines in marine applications described in the relevant iso standard should be used . ### depending on the fuel and power category , the test cycles for engines in marine applications described in the relevant iso standard should be used . test cycles should be developed for all combustion engines which are part of the propulsion system , including hybrid power installations .


### ocean : designed for extended voyages where conditions may exceed wind force 8 and significant wave heights of 4 m and above but excluding abnormal conditions , and vessels largely self - sufficient . ### a recreational craft given design category a is considered to be designed to operate in winds of beaufort force 10 or less and the associated wave heights , and to survive in more severe conditions . such conditions may be encountered on extended voyages , for example across oceans , or inshore when unsheltered from the wind and waves for several hundred nautical miles . winds are assumed to gust to 28 m / s .


### inshore : designed for voyages in coastal waters , large bays , estuaries , lakes and rivers where conditions up to , and including , wind force 6 and significant wave heights up to , and including , 2 m may be experienced . ### a watercraft given design category c is considered to be designed for a wind force up to , and including , 6 and significant wave heights up to , and including , 2 m .


### member states shall not impede the making available on the market or the putting into service of products covered by directive 94 / 25 / ec which are in conformity with that directive and which were placed on the market or put into service before [ dd / mm / yyyy ] . ### member states shall not impede the making available on the market or the putting into service of products covered by directive 94 / 25 / ec which are in conformity with that directive and which were placed on the market or put into service before . . . * . _____________ * oj : please insert the date referred to in the second paragraph of article 57 , or 31 december 2014 , whichever is the latest .


### in order to take into account the progress of technical knowledge and new scientific evidence , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission to amend section 2 of part b and section 1 of part c of annex i , with the exception of direct or indirect modifications to exhaust or noise emission values and to the froude and p / d ratio values , and annexes v , vii and ix . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . ### in order to take into account the progress of technical knowledge and new scientific evidence , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission to amend section 2 of part b and section 1 of part c of annex i , with the exception of direct or indirect modifications to exhaust or noise emission values and to the froude and p / d ratio values , to include test cycles for hybrid engines , to introduce biofuel blended test fuels in the table of test fuels once these test fuels have been internationally accepted and to amend annexes v , vii and ix . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level .


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


### cover 75 % of the external area of both the front and back surface of the unit packet and any outside packaging ; ### cover 50 % of the external area of both the front and back surface of the unit packet and any outside packaging ;


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


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


### 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 , on an annual basis , 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 .


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


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


### a member state that deems it necessary to maintain more stringent national provisions for aspects falling inside the scope of this directive should be allowed to do so , for all products alike , on grounds of overriding needs relating to the protection of public health . a member state should also be allowed to introduce more stringent provisions , applying to all products alike , on grounds relating to the specific situation of this member state and provided the provisions are justified by the need to protect public health . more stringent national provisions should be necessary and proportionate , not constitute a means of arbitrary discrimination or a disguised restriction on trade between member states . stricter national provisions require prior notification to , and approval from , the commission taking into account the high level of health protection achieved through this directive . ### a member state that deems it necessary to maintain more stringent national provisions for aspects falling inside the scope of this directive should be allowed to do so , for all products alike , on grounds of overriding needs relating to the protection of public health . a member state should also be allowed to introduce more stringent provisions , applying to all products alike , on grounds relating to the specific situation of this member state and provided the provisions are justified by the need to protect public health . more stringent national provisions should be necessary and proportionate , not constitute a means of arbitrary discrimination or a disguised restriction on trade between member states and consistent with wto international obligations . stricter national provisions require prior notification to , and approval from , the commission taking into account the high level of health protection achieved through this directive .


### member states shall ensure the dissemination of information submitted in accordance with paragraph 1 on a dedicated website , which is available to the general public . in doing so member states shall take due account of the need to protect information which constitutes a trade secret . ### member states shall ensure the dissemination of information submitted in accordance with paragraph 1 on a website , which is available to the general public . in doing so member states shall take due account of the need to protect information which constitutes a trade secret .


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


### a cigarette packet can be of carton or soft material and shall not contain an opening that can be re - closed or re - sealed after the opening is first opened , other than the flip - top lid . the flip - top lid of a cigarette packet shall be hinged only at the back of the packet . ### a cigarette packet can be of carton or soft material and may contain an opening that can be re - closed or re - sealed after opening .


### in order to make this directive fully operational and to keep up with technical , scientific and international developments in tobacco manufacture , consumption and regulation , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission , in particular in respect of adopting and adapting maximum yields for emissions and their measurement methods , setting maximum levels for ingredients that increase toxicity , addictiveness or attractiveness , , the use of health warnings , unique identifiers and security features in the labelling and packaging , defining key elements for contracts on data storage with independent third parties , reviewing certain exemptions granted to tobacco products other than cigarettes , roll - your - own tobacco and smokeless tobacco products and reviewing the nicotine levels for nicotine containing products . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### in order to make this directive fully operational and to keep up with technical , scientific and international developments in tobacco manufacture , consumption and regulation , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission , in particular in respect of adopting the measurement methods for emissions , setting maximum levels for ingredients that increase toxicity or addictiveness , the use of health warnings , unique identifiers and security features in the labelling and packaging , defining key elements for contracts on data storage with independent third parties , reviewing certain exemptions granted to tobacco products other than cigarettes , roll - your - own tobacco and smokeless tobacco products and reviewing the nicotine levels for nicotine containing products . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council .


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


### 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 . ### a member state may adopt or maintain more stringent national provisions , applicable to all products alike , in areas covered by the directive , insofar as such provisions are compatible with the treaty .


### a cigarette packet can be of carton or soft material and shall not contain an opening that can be re - closed or re - sealed after the opening is first opened , other than the flip - top lid . the flip - top lid of a cigarette packet shall be hinged only at the back of the packet . ### a cigarette packet can be of carton or soft material and shall not contain an opening that can be re - closed or re - sealed after the opening is first opened .


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


### 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 non - tobacco dominant flavour other than tobacco or traditional flavours such as menthol , which may facilitate uptake of tobacco consumption or affect consumption patterns .


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


### show the same text warning and corresponding colour photograph on both sides of the unit packets and any outside packaging ; ### show the same text warning and , optionally , corresponding colour photograph on both sides of the unit packets and any outside packaging ;


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


### a member state that deems it necessary to maintain more stringent national provisions for aspects falling inside the scope of this directive should be allowed to do so , for all products alike , on grounds of overriding needs relating to the protection of public health . a member state should also be allowed to introduce more stringent provisions , applying to all products alike , on grounds relating to the specific situation of this member state and provided the provisions are justified by the need to protect public health . more stringent national provisions should be necessary and proportionate , not constitute a means of arbitrary discrimination or a disguised restriction on trade between member states . stricter national provisions require prior notification to , and approval from , the commission taking into account the high level of health protection achieved through this directive . ### in order to improve the functioning of the internal market , a member state shall not be allowed to introduce more stringent national provisions , applying to all products falling within the scope of this directive .


### in order to make this directive fully operational and to keep up with technical , scientific and international developments in tobacco manufacture , consumption and regulation , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission , in particular in respect of adopting and adapting maximum yields for emissions and their measurement methods , setting maximum levels for ingredients that increase toxicity , addictiveness or attractiveness , the use of health warnings , unique identifiers and security features in the labelling and packaging , defining key elements for contracts on data storage with independent third parties , reviewing certain exemptions granted to tobacco products other than cigarettes , roll - your - own tobacco and smokeless tobacco products and reviewing the nicotine levels for nicotine containing products . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### in order to make this directive fully operational and to keep up with technical , scientific and international developments in tobacco manufacture , consumption and regulation , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission , in particular in respect of adopting measurement methods for emissions , setting maximum levels for ingredients that increase toxicity or addictiveness , the use of health warnings , unique identifiers and security features in the labelling and packaging , defining key elements for contracts on data storage with independent third parties , reviewing certain exemptions granted to tobacco products other than cigarettes , roll - your - own tobacco and smokeless tobacco products and reviewing the nicotine levels for nicotine containing products . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council .


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


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


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


### a member state that deems it necessary to maintain more stringent national provisions for aspects falling inside the scope of this directive should be allowed to do so , for all products alike , on grounds of overriding needs relating to the protection of public health . a member state should also be allowed to introduce more stringent provisions , applying to all products alike , on grounds relating to the specific situation of this member state and provided the provisions are justified by the need to protect public health . more stringent national provisions should be necessary and proportionate , not constitute a means of arbitrary discrimination or a disguised restriction on trade between member states . stricter national provisions require prior notification to , and approval from , the commission taking into account the high level of health protection achieved through this directive . ### a member state that deems it necessary to maintain more stringent national provisions for aspects falling inside the scope of this directive should be allowed to do so , for all products alike , on grounds of overriding needs relating to the protection of public health . a member state should also be allowed to introduce more stringent provisions , applying to all products alike , on grounds relating to the specific situation of this member state and provided the provisions are justified by the need to protect public health . more stringent national provisions should be necessary and proportionate , not constitute a means of arbitrary discrimination or a disguised restriction on trade between member states . stricter national provisions require prior notification to the commission taking into account the high level of health protection achieved through this directive .


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


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


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


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


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


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


### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by [ publications office , please insert the exact date : entry into force + 18 months ] at the latest . they shall forthwith communicate to the commission the text of those provisions . ### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by [ publications office , please insert the exact date : entry into force + 24 months ] at the latest . they shall forthwith communicate to the commission the text of those provisions .


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


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


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


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


### furthermore , in technical specifications and in award criteria , contracting authorities should be allowed to refer to a specific production process , a specific mode of provision of services , or a specific process for any other stage of the life cycle of a product or service , provided that they are linked to the subject - matter of the public contract . in order to better integrate social considerations in public procurement , procurers may also be allowed to include , in the award criterion of the most economically advantageous tender , characteristics related to the working conditions of the persons directly participating in the process of production or provision in question . those characteristics may only concern the protection of health of the staff involved in the production process or the favouring of social integration of disadvantaged persons or members of vulnerable groups amongst the persons assigned to performing the contract , including accessibility for persons with disabilities . any award criteria which include those characteristics should in any event remain limited to characteristics that have immediate consequences on staff members in their working environment . they should be applied in accordance with directive 96 / 71 / ec of the european parliament and of the council of 16 december 1996 concerning the posting of workers in the framework of the provision of services22 and in a way that does not discriminate directly or indirectly against economic operators from other member states or from third countries parties to the agreement or to free trade agreements to which the union is party . for service contracts and for contracts involving the design of works , contracting authorities should also be allowed to use as an award criterion the organisation , qualification and experience of the staff assigned to performing the contract in question , as this may affect the quality of contract performance and , as a result , the economic value of the tender . ### furthermore , in technical specifications and in award criteria , contracting authorities should be allowed to refer to the monetisation of the life cycle of the works , service or supply and accordingly to social and environmental sustainability , provided that these characteristics are linked to the subject - matter of the contract . the technical specifications and award criteria should be interpreted broadly . contracting authorities may also use the technical specifications and award criteria to minimise damaging social or environmental effects or maximise positive social or environmental effects . as part of the award criteria , contracting authorities should be able to consider the existence of an embedded life - cycle approach aiming at minimising cost and maximising resource efficiency and which should be applied in the framework of the provision of works , services or supplies in a way that does not discriminate directly or indirectly against economic operators from other member states or from third countries which are parties to the wto ' s government procurement agreement , or operators from other third countries with whom the union is party to a free trade agreement . contracting authorities should also be allowed to use as technical specifications and award criteria the organisation , qualification and experience of the staff assigned to performing the contract in question , as this may affect the quality and social sustainability of contract performance and , as a result , the identification of the tender which offers the best value for money . contracting authorities should include these considerations in the award criterion of the most economically advantageous tender .


### ‘ life cycle’ means all consecutive and / or interlinked stages , including production , transport , use and maintenance , throughout the existence of a product or a works or the provision of a service , from raw material acquisition or generation of resources to disposal , clearance and finalisation . ### ‘ life cycle’ means monetising , wherever possible , the full costs associated with the public procurement , including maintenance and resource efficiency costs , end - of - life recycling costs , and social impact costs where these relate to performance of the contract . efficient design , planning and use of electronic means can also be included in life cycle monetisation . for the purposes of public procurement , the life cycle runs from the point of purchase throughout the lifetime of the works , supplies or services and forms an integral and in - dissociable part of the calculation of what constitutes the most economically advantageous tender .


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


### a complete and up - to - date list of all central purchasing bodies ; ### a list of all central purchasing bodies which have awarded public contracts or concluded framework agreements during the year concerned ;


### contracting authorities shall not reveal to the other participants solutions proposed or other confidential information communicated by a candidate participating in the negotiations without its agreement . such agreement shall not take the form of a general waiver but shall be given with reference to the intended communication of specific solutions or other confidential information . ### in accordance with article 18 , contracting authorities shall not reveal to the other participants confidential information communicated by a candidate participating in the negotiations without its agreement . such agreement shall not take the form of a general waiver but shall be given with reference to the intended communication of specific information .


### under article 11 of the treaty on the functioning of the european union , environmental protection requirements must be integrated into the definition and implementation of the union policies and activities , in particular with a view to promoting sustainable development . this directive clarifies how the contracting authorities may contribute to the protection of the environment and the promotion of sustainable development , whilst ensuring that they can obtain the best value for money for their contracts . ### this directive clarifies how the contracting authorities may contribute to the protection of the environment and the promotion of sustainable development , whilst ensuring that they can obtain the best value for money for their contracts .


### the technical specifications drawn up by public purchasers need to allow public procurement to be opened up to competition . to that end , it must be possible to submit tenders that reflect the diversity of technical solutions so as to obtain a sufficient level of competition . consequently , technical specifications should be drafted in such a way to avoid artificially narrowing down competition through requirements that favour a specific economic operator by mirroring key characteristics of the supplies , services or works habitually offered by that economic operator . drawing up the technical specifications in terms of functional and performance requirements generally allows this objective to be achieved in the best way possible and favours innovation . where reference is made to a european standard or , in the absence thereof , to a national standard , tenders based on equivalent arrangements must be considered by contracting authorities . to demonstrate equivalence , tenderers can be required to provide third - party verified evidence ; however , other appropriate means of proof such as a technical dossier of the manufacturer should also be allowed where the economic operator concerned has no access to such certificates or test reports , or no possibility of obtaining them within the relevant time limits . ### the technical specifications drawn up by public purchasers need to allow public procurement to be opened up to competition . to that end , it must be possible to submit tenders that reflect the diversity of technical solutions , standards and specifications in the marketplace so as to obtain a sufficient level of competition . consequently , technical specifications should avoid artificially narrowing down competition through requirements that favour a specific economic operator by mirroring key characteristics of the supplies , services or works commonly offered by that economic operator , or that disadvantage economic operators on the basis of a business or development model or on the basis of specific standards or specifications implemented in a given solution or service . drawing up the technical specifications in terms of functional and performance requirements generally circumvents these problems and favours innovation . where reference is made to a european standard or , in the absence thereof , to a national standard , tenders based on equivalent arrangements must be considered equally by contracting authorities . to demonstrate equivalence , tenderers can be required to provide third - party verified evidence . however , other appropriate means of proof such as a manufacturers ' technical dossier should also be allowed where the economic operator concerned has no access to relevant certificates or test reports , or no possibility of obtaining them within the applicable time limits . contracting authorities must be able to provide justification for not granting equivalence in all cases .


### furthermore , in technical specifications and in award criteria , contracting authorities should be allowed to refer to a specific production process , a specific mode of provision of services , or a specific process for any other stage of the life cycle of a product or service , provided that they are linked to the subject - matter of the public contract . in order to better integrate social considerations in public procurement , procurers may also be allowed to include , in the award criterion of the most economically advantageous tender , characteristics related to the working conditions of the persons directly participating in the process of production or provision in question . those characteristics may only concern the protection of health of the staff involved in the production process or the favouring of social integration of disadvantaged persons or members of vulnerable groups amongst the persons assigned to performing the contract , including accessibility for persons with disabilities . any award criteria which include those characteristics should in any event remain limited to characteristics that have immediate consequences on staff members in their working environment . they should be applied in accordance with directive 96 / 71 / ec of the european parliament and of the council of 16 december 1996 concerning the posting of workers in the framework of the provision of services22 and in a way that does not discriminate directly or indirectly against economic operators from other member states or from third countries parties to the agreement or to free trade agreements to which the union is party . for service contracts and for contracts involving the design of works , contracting authorities should also be allowed to use as an award criterion the organisation , qualification and experience of the staff assigned to performing the contract in question , as this may affect the quality of contract performance and , as a result , the economic value of the tender . ### furthermore , in technical specifications and in award criteria , contracting authorities should be allowed to refer to a specific production process , a specific mode of provision of services , or a specific process for any other stage of the life cycle of a product or service or the production of the subject - matter of the contract . in order to better integrate social considerations in public procurement , procurers may also be allowed to include , in the award criterion of the most economically advantageous tender , characteristics related to the working conditions . contracting authorities may require the production of certificates / labels drawn up by independent bodies attesting that the economic operator complies with rules and standards in the field of health and safety , social and labour law defined by union and national legislation and by collective agreements which apply in the place where the work , service or supply is to be performed .


### public contracts may be subdivided into homogenous or heterogeneous lots . for contracts with a value equal to or greater than the thresholds provided for in article 4 but not less than eur 500 000 , determined in accordance with article 5 , where the contracting authority does not deem it appropriate to split into lots , it shall provide in the contract notice or in the invitation to confirm interest a specific explanation of its reasons . ### to facilitate greater access to public procurement by small and medium - sized enterprise , public contracts may be subdivided into homogenous or heterogeneous lots . for contracts with a value equal to or greater than the thresholds provided for in article 4 but not less than eur 1 000 000 , determined in accordance with article 5 , contracting authorities shall provide justification for not sub - dividing the contract into lots in the contract notice or in the invitation to confirm interest .


### quality , including technical merit , aesthetic and functional characteristics , accessibility , design for all users , environmental characteristics and innovative character ; ### quality , including technical merit , aesthetic and functional characteristics , accessibility , energy efficiency performance , design for all users , environmental characteristics and innovative character including inter alia additional innovative solutions that are in addition to minimum requirements laid down in the contract notice , the descriptive document or the invitation to confirm interest ;


### the report , or its main elements , shall be communicated to the commission or to the national oversight body where they so request . ### the report , or its main elements , shall be communicated to the commission or the national authorities or structures referred to in article 83 where they so request .


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


### furthermore , in technical specifications and in award criteria , contracting authorities should be allowed to refer to a specific production process , a specific mode of provision of services , or a specific process for any other stage of the life cycle of a product or service , provided that they are linked to the subject - matter of the public contract . in order to better integrate social considerations in public procurement , procurers may also be allowed to include , in the award criterion of the most economically advantageous tender , characteristics related to the working conditions of the persons directly participating in the process of production or provision in question . those characteristics may only concern the protection of health of the staff involved in the production process or the favouring of social integration of disadvantaged persons or members of vulnerable groups amongst the persons assigned to performing the contract , including accessibility for persons with disabilities . any award criteria which include those characteristics should in any event remain limited to characteristics that have immediate consequences on staff members in their working environment . they should be applied in accordance with directive 96 / 71 / ec of the european parliament and of the council of 16 december 1996 concerning the posting of workers in the framework of the provision of services and in a way that does not discriminate directly or indirectly against economic operators from other member states or from third countries parties to the agreement or to free trade agreements to which the union is party . for service contracts and for contracts involving the design of works , contracting authorities should also be allowed to use as an award criterion the organisation , qualification and experience of the staff assigned to performing the contract in question , as this may affect the quality of contract performance and , as a result , the economic value of the tender . ### furthermore , in technical specifications and in award criteria , contracting authorities should be allowed to refer to life - cycle characteristics and the socially sustainable production process , provided that these characteristics or this process are linked to the subject - matter of the public contract . the technical specifications and award criteria should be interpreted broadly . accordingly , the technical specifications and award criteria may refer to the life cycle characteristics and the socially sustainable production process , including the social and environmental aspects of the production process or of the provision of products or services . contracting authorities may also use the technical specifications and award criteria to minimise damaging social or environmental effects or maximise positive social or environmental effects . in order to better integrate social considerations in public procurement , procurers may also be allowed to incorporate in the technical specifications and award criteria characteristics related to the working conditions of the persons directly participating in the process of production or provision in question . they should be applied in the framework of the provision of services and in a way that does not discriminate directly or indirectly against economic operators from other member states or from third countries parties to the agreement or to free trade agreements to which the union is party . for service contracts and for contracts involving the design of works , contracting authorities should also be allowed to use as technical specifications and award criteria the organisation , qualification and experience of the staff assigned to performing the contract in question , as this may affect the quality and social sustainability of contract performance and , as a result , the identification of the tender which offers the best value for money .


### they are established for or have the specific purpose of meeting needs in the general interest , not having an industrial or commercial character ; for that purpose , a body which operates in normal market conditions , aims to make a profit , and bears the losses resulting from the exercise of its activity does not have the purpose of meeting needs in the general interest , not having an industrial or commercial character ; ### it is established for the specific purpose of meeting needs in the general interest , not having a merely industrial and commercial character ;


### contracting authorities shall not reveal to the other participants solutions proposed or other confidential information communicated by a candidate participating in the dialogue without its agreement . such agreement shall not take the form of a general waiver but shall be given with reference to the intended communication of specific solutions or other specific confidential information . ### in accordance with article 18 , contracting authorities shall not reveal to the other participants solutions proposed or other confidential information communicated by a candidate participating in the dialogue without its agreement . such agreement shall not take the form of a general waiver but shall be given with reference to the intended communication of specific information .


### in order to foster the involvement of small and medium - sized enterprises in the public procurement market , contracting authorities should be encouraged to divide contracts into lots , and be obliged to state the reasons for not doing so . where contracts are divided into lots , contracting authorities may , for instance in order to preserve competition or to ensure security of supply , limit the number of lots for which an economic operator may tender ; they may also limit the number of lots that may be awarded to any one tenderer . ### public procurement should be adapted to the needs of smes . contracting authorities should make use of the code of best practice providing guidance on how they may apply the public procurement framework in a way that facilitates sme participation . in order to foster the involvement of small and medium - sized enterprises in the public procurement market , contracting authorities should in particular give consideration to dividing contracts into lots and ensure transparency in access to information on their reasons for doing so or choosing not to . member states should introduce measures to promote the access of smes to public procurement , in particular through improved information and guidance on tendering and on the new opportunities offered by the modernised eu legal framework , and to foster the exchange of best practice and the organisation of training and events involving public procurers and smes .


### the bodies established or appointed in accordance with article 84 shall forward to the commission an implementation and statistical report on each year , based on a standard form , not later than 31 october of the following year . ### member states shall forward to the commission a statistical report on each year , based on a standard form , not later than 31 october of the following year .


### they are established for or have the specific purpose of meeting needs in the general interest , not having an industrial or commercial character ; for that purpose , a body which operates in normal market conditions , aims to make a profit , and bears the losses resulting from the exercise of its activity does not have the purpose of meeting needs in the general interest , not having an industrial or commercial character ; ### established for , or which have the specific purpose of , meeting needs in the general interest ; these needs should not have an industrial or commercial character ;