### in the cases referred to in article 5 , the person whose property is affected by the decision to confiscate shall be represented by a lawyer throughout the proceedings in order to pursue the rights of the defence of the person relating to the establishment of the criminal offence and to the determination of the proceeds and instrumentalities . ### in the cases referred to in article 5 , the person whose property is affected by the decision to confiscate shall be informed that throughout the proceedings he / she has the right to be represented by a lawyer of choice or to be provided with an ex officio lawyer in accordance with the particular rules existent in the member state in order to pursue his / her rights of defence relating to the establishment of the criminal offence and to the determination of the proceeds and instrumentalities .


### each member state shall adopt the necessary measures to enable it to confiscate , either wholly or in part , property belonging to a person convicted of a criminal offence where , based on specific facts , a court finds it substantially more probable that the property in question has been derived by the convicted person from similar criminal activities than from other activities . ### each member state shall adopt the necessary measures to enable competent authorities to confiscate , either wholly or in part , property belonging to a person convicted of a criminal offence where , based on specific facts such as that the value of property is disproportionate to the lawful income of the convicted person , a court finds it on the balance of probabilities that the property in question has been acquired unlawfully .


### proceeds which were transferred to third parties by a convicted person or on his behalf , or by suspected or accused persons under the circumstances of article 5 , or ### proceeds or instrumentalities which were transferred directly or indirectly to or acquired by third parties , or


### each member state shall take the necessary measures to enable it to freeze property in danger of being dissipated , hidden or transferred out of the jurisdiction with a view to possible later confiscation . such measures shall be ordered by a court . ### each member state shall take the necessary measures to enable it to freeze property immediately with a view to possible later confiscation . the person affected by the measures provided for in this article shall have a right of appeal to a court .


### each member state shall take the necessary measures to make it possible to determine the precise extent of the property to be confiscated following a final conviction for a criminal offence or following proceedings as foreseen in article 5 , that has resulted in a decision to confiscate , and to allow further measures to be taken to the extent necessary to effectively execute that decision to confiscate . ### each member state shall take the necessary measures to make it possible to determine the precise extent of the property to be confiscated and to allow further measures to be taken to the extent necessary to effectively execute that decision to confiscate .


### the confiscation of proceeds or property referred to in paragraph 1 shall be possible where the property is subject to restitution or where ### the confiscation of proceeds or property referred to in paragraph 1 shall be possible where


### although existing statistics are limited , the amounts recovered from criminal assets in the union seem insufficient compared to the estimated proceeds of crime . studies have shown that , although regulated by eu legislation and national laws , confiscation procedures remain underutilised . ### although existing statistics are limited , the amounts recovered from criminal assets in the union seem extremely low compared to the estimated proceeds of crime . studies have shown that , although regulated by eu legislation and national laws , confiscation procedures remain underutilised and laws at national level are uneven .


### the main motive for cross - border organised crime is financial gain . in order to be effective , law enforcement and judicial authorities should be given the means to trace , freeze , manage and confiscate the proceeds of crime . ### the main motive for most crime , and particularly cross - border organised crime , including mafia - type criminal organization , is financial gain . in order to be effective , appropriate competent authorities should be given the means to trace , freeze , manage and confiscate the proceeds of crime . however , effective prevention of and fight against organized crime should not be limited to the neutralization of the proceeds of crime but should be extended , in some cases , even to property in any way related to such criminal associations . it is not enough , therefore , merely to ensure mutual recognition in the eu of seizure and confiscation of proceeds of crime . an effective fight against economic crime would also require the mutual recognition of measures taken in a different field from that of criminal law or otherwise adopted in the absence of a criminal conviction and that they have as their object , more broadly , any possible asset or income attributable to a criminal organization or to a person with a criminal conduct or suspected to belong to a criminal organization .


### the proceeds or property were transferred for free or in exchange for an amount lower than their market value when the third party : ### the proceeds or property were transferred for free or in exchange for an amount significantly lower than their market value ;


### each member state shall take the necessary measures to ensure that the persons affected by the measures provided for under this directive have the right to an effective remedy and that suspects have the right to a fair trial , in order to preserve their rights . ### each member state shall take the necessary measures to ensure that the persons whose instrumentalities and proceeds of crime are confiscated under this directive , irrespective of their ownership at the time of confiscation , have the right to an effective remedy , including the right to a fair trial .


### the issuance of confiscation orders generally requires a criminal conviction . in some cases , even where a criminal conviction cannot be achieved , it should still be possible to confiscate assets in order to disrupt criminal activities and ensure that profits resulting from criminal activities are not reinvested into the licit economy . some member states allow confiscation where there is insufficient evidence for a criminal prosecution , if a court considers on the balance of probabilities that the property is of illicit origin , and also in situations where a suspect or accused person becomes a fugitive to avoid prosecution , is unable to stand trial for other reasons or died before the end of criminal proceedings . this is referred to as non - conviction based confiscation . provision should be made to enable non - conviction based confiscation in at least the latter , limited , circumstances in all member states . this is in line with article 54 . 1 . c ) of the united nations convention against corruption , which provides that each state party is to consider taking the necessary measures to allow confiscation of illicitly acquired property without a criminal conviction , including in cases in which the offender cannot be prosecuted by reason of death , flight or absence . ### the issuance of confiscation orders generally requires a criminal conviction . in some cases , even where a criminal conviction cannot be achieved , it should anyhow be possible to confiscate assets in order to disrupt criminal activities and ensure that profits resulting from criminal activities are not reinvested into the licit economy . some member states allow confiscation where there is insufficient evidence for a criminal prosecution or regardless a criminal prosecution , if a court considers , on the balance of probabilities , that the property of a person socially dangerous or having a criminal lifestyle is of illicit origin or disproportionate if compared to his declared income , and also in situations where a suspect or accused person becomes a fugitive to avoid prosecution , is unable to stand trial for other reasons or died before the end of criminal proceedings . this is referred to as non - conviction based confiscation . provision should be made to enable non - conviction based confiscation in at least the above mentioned , limited , circumstances in all member states , including the mutual recognition to such non conviction - based orders . this is in line with article 54 . 1 . c ) of the united nations convention against corruption , which provides that each state party is to consider taking the necessary measures to allow confiscation of illicitly acquired property without a criminal conviction , including in cases in which the offender cannot be prosecuted by reason of death , flight or absence or in other appropriate cases .


### the issuance of confiscation orders generally requires a criminal conviction . in some cases , even where a criminal conviction cannot be achieved , it should still be possible to confiscate assets in order to disrupt criminal activities and ensure that profits resulting from criminal activities are not reinvested into the licit economy . some member states allow confiscation where there is insufficient evidence for a criminal prosecution , if a court considers on the balance of probabilities that the property is of illicit origin , and also in situations where a suspect or accused person becomes a fugitive to avoid prosecution , is unable to stand trial for other reasons or died before the end of criminal proceedings . this is referred to as non - conviction based confiscation . provision should be made to enable non - conviction based confiscation in at least the latter , limited , circumstances in all member states . this is in line with article 54 . 1 . c ) of the united nations convention against corruption , which provides that each state party is to consider taking the necessary measures to allow confiscation of illicitly acquired property without a criminal conviction , including in cases in which the offender cannot be prosecuted by reason of death , flight or absence . ### the issuance of confiscation orders generally requires a criminal conviction . in some cases , even in the absence of a criminal conviction , it should be possible to confiscate assets in order to disrupt criminal activities and ensure that profits resulting from criminal activities are not reinvested into the licit economy or in criminal activities .


### other property of the convicted person , which was transferred to third parties in order to avoid confiscation of property the value of which corresponds to the proceeds . ### other property which was transferred to third parties in order to avoid confiscation of property the value of which corresponds to the proceeds .


### in accordance with the principle of ne bis in idem it is appropriate to exclude from extended confiscation the proceeds of alleged criminal activities for which the affected person has been finally acquitted in a previous trial or in other cases where the ne bis in idem principle applies . extended confiscation should also be excluded where the similar criminal activities could not be the subject of criminal proceedings due to prescription under national criminal law . ### in accordance with the principle of ne bis in idem it is appropriate to exclude from extended confiscation the proceeds of alleged criminal activities for which the affected person has been finally acquitted in a previous trial or in other cases where the ne bis in idem principle applies .


### each member state shall ensure that the measures referred to in paragraph 1 optimise the economic value of such property , and shall include the sale or transfer of property which is liable to decline in value . ### each member state shall ensure that the measures referred to in paragraph 1 to frozen property optimise the economic value of such property , and shall include , only if necessary , the sale or transfer of property which is liable to decline in value . each member state shall take all the necessary measures to prevent any criminal infiltration in this phase .


### proceeds which were transferred to third parties by a convicted person or on his behalf , or by suspected or accused persons under the circumstances of article 5 , or ### proceeds which were transferred directly or indirectly to third parties , or


### the investigational medicinal products are authorised ; ### the investigational medicinal products , or the placebos , are authorised ;


### member states shall ensure that the persons validating and assessing the application do not have conflicts of interest , are independent of the sponsor , the institution of the trial site and the investigators involved , as well as free of any other undue influence . ### member states shall ensure that the persons validating and assessing the application do not have conflicts of interest , are independent of the sponsor , the institution of the trial site and the investigators involved , as well as free of any other undue influence . where possible , the persons validating the applications shall therefore publish in the eu database a declaration of their interests , or a statement that they have none .


### the reporting member state shall submit part i of the assessment report , including its conclusion , to the sponsor and to the other member states concerned within the following time periods : ### for the purposes of this chapter , the assessment date shall be the date on which the assessment report is submitted to the other member states concerned and the reporting date shall be the date when the final assessment report is submitted to the sponsor and to the other member states concerned . the reporting member state shall submit part i of the assessment report , including its conclusion , to the sponsor and to the other member states concerned within the following time periods , which shall include periods for initial assessment , for joint assessment and for consolidation of the final report .


### the reporting member state shall submit part i of the assessment report , including its conclusion , to the sponsor and to the other member states concerned within the following time periods : ### the assessment date shall , for the purposes of this chapter , be the date on which the assessment report is submitted to the other member states concerned and the reporting date shall be the date when the final assessment report is submitted to the sponsor and to the other member states concerned . the reporting member state shall submit part i of the assessment report , including its conclusion , to the sponsor and to the other member states concerned within the following time periods , which shall include periods for initial assessment , for joint assessment and for consolidation of the final report :


### where , upon receipt of the additional explanations , the remaining time period for submitting part i of the assessment report is less than three days in the case of low - intervention clinical trials , and less than five days for other than low - intervention clinical trials , it shall be extended to three and five days respectively . ### upon receipt of the additional explanations , the member states concerned shall communicate , until 2 days before the reporting date , any considerations to the reporting member state . the reporting member state will take these considerations into account when finalising the assessment report . the time for the joint assessment , and for consolidation by the member states concerned and the reporting member state of the additional explanations shall not be shorter than 15 days for low intervention trials , and 20 days for trials other than low - intervention clinical trials .


### the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in , or to be withdrawn from , the clinical trial at any time , is duly taken into consideration by the investigator in accordance with his or her age and maturity ; ### the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in , or to be withdrawn from , the clinical trial at any time , is duly taken into consideration by the investigator


### within four days following submission of the application dossier , the reporting member state shall notify the sponsor through the eu portal of the following : ### within ten days following submission of the application dossier , the reporting member state shall notify the sponsor through the eu portal of the following :


### the subject has not previously expressed objections known to the investigator ; ### the subject or legal representative has not previously expressed objections known to the investigator ;


### where , upon receipt of the additional explanations , the remaining time period for submitting part i of the assessment report is less than three days in the case of low - intervention clinical trials , and less than five days for other than low - intervention clinical trials , it shall be extended to three and five days respectively . ### upon receipt of the additional explanations the member states concerned shall communicate until two days before the reporting date , any considerations to the reporting member state . the reporting member state will take these considerations into account in finalising the assessment report . the time for the joint assessment and for consolidation by member states concerned and the reporting member state of the additional explanations shall not be shorter than 5 days for low intervention trials and 10 days for trials other than low - intervention clinical trials .


### the sponsor shall propose one of the member states concerned as reporting member state . ### the member states concerned shall determine which state shall be the reporting member state according to an established procedure based on objective criteria which are set by the commission .


### the database should contain all relevant information as regards the clinical trial . no personal data of data subjects participating in a clinical trial should be recorded in the database . the information in the database should be public , unless specific reasons require that a piece of information should not be published , in order to protect the right of the individual to private life and the right to the protection of personal data , recognised by articles 7 and 8 of the charter of fundamental rights of the european union . ### the database should contain all relevant information as regards the clinical trial and allow public dissemination of objective information in order to support european research and to increase knowledge in the field of public health . it should not undermine innovation or competitiveness of european industries . no personal data of data subjects participating in a clinical trial should be recorded in the database , and the protection of commercial interests , including intellectual property , as foreseen by article 4 of regulation 1049 / 2001 , should not be hampered . the information in the database should be public , unless specific reasons require that a piece of information should not be published , in order to protect the right of the individual to private life and the right to the protection of personal data , recognised by articles 7 and 8 of the charter of fundamental rights of the european union , or commercially confidential information , as foreseen by article 4 of regulation 1049 / 2001 .


### – the reliability and robustness of the data generated in the clinical trial , taking account of statistical approaches , design of the trial and methodology ; ### – the reliability and robustness of the data generated in the clinical trial , taking account of statistical approaches , design of the trial , methodology and the prevalence of the condition , especially for rare diseases , and ultra - rare diseases .


### in order to allow for independent control as to whether these principles are adhered to , a clinical trial should be subject to prior authorisation . ### in order to allow for independent control as to whether these principles are adhered to , a clinical trial should be subject to prior authorisation and it should be ensured that those granting the authorisation do not have conflicts of interest and are independent of the sponsor , the institution of the trial site and the investigators involved .


### within 10 days from the validation date for low - intervention clinical trials ; ### within 25 days , but no earlier than 15 days after receipt of the successfully validated application , for low - intervention clinical trials ;


### informed consent shall be written , dated and signed and given freely by the subject or his or her legal representative after having been duly informed of the nature , significance , implications and risks of the clinical trial . it shall be appropriately documented . where the subject is unable to write , oral consent in the presence of at least one impartial witness may be given in exceptional cases . the subject or his or her legal representative shall be provided with a copy of the document by which informed consent has been given . ### informed consent shall be written , dated and signed and given freely by the subject or his or her legal representative after having been comprehensively and comprehensibly informed of the nature , significance , implications and risks of the clinical trial , and after having received the corresponding information in writing . it shall be appropriately documented . where the subject is unable to write , oral consent in the presence of at least one impartial witness may be given in exceptional cases . the subject or his or her legal representative shall be provided with a copy of the document by which informed consent has been given .


### within 25 days from the validation date for clinical trials other than low - intervention clinical trials ; ### within 35 days but no earlier than 20 days after receipt of the successfully validated application for clinical trials other than low - intervention clinical trials ;


### in the assessment , the view of at least one person whose primary area of interest is non - scientific shall be taken into account . the view of at least one patient shall be taken into account . ### in the assessment , the view of at least one person whose primary area of interest is non - scientific shall be taken into account . the view of at least one patient shall be taken into account . an independent ethics committee , as referred to in the declaration of helsinki and the ich - gcp , shall be involved in the assessment of each clinical trial .


### the reporting member state for the application referred to in paragraph 1 shall be the reporting member state for the initial authorisation procedure . ### where there was a reporting member state for the initial authorisation procedure , it shall be the reporting member state for the application referred to in paragraph 1 .


### 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 market participants 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 market participants and competent authorities satisfy the requirements laid down in that legislation .


### in order to efficiently implement bonus - 169 , during the implementation phase , financial support should be granted to participants in bonus - 169 projects selected at the central level under the responsibility of the bonus eeig following calls for proposals . ### in order to efficiently implement bonus , during the implementation phase , financial support should be granted to participants in bonus projects selected at the central level under the responsibility of the bonus eeig following calls for proposals . the grant and payment of such financial support to participants in bonus should be transparent , unbureaucratic and in accordance with common rules in line with the seventh framework programme .


### provided that the results of the evaluation and the ex - ante audit of bonus eeig are positive , the commission and the bonus eeig shall conclude the implementation agreement . ### provided that the conditions as referred to in article 3 are in place and the ex - ante audit of the bonus eeig is positive , the commission and the bonus eeig shall conclude the implementation agreement .


### the strategic research agenda shall be developed and agreed upon in consultation among participating states , a broad range of stakeholders and the commission . it shall be the basis for a policy - driven programme . it shall broaden the research focus to embody , in addition to the marine ecosystem , a basin approach that addresses the key issues affecting the quality and productivity of the baltic sea region ecosystems . ### the strategic research agenda shall be developed and agreed upon in consultation among participating states , a broad range of stakeholders and the commission . it shall be the basis for a policy - driven programme . it shall broaden the research focus to embody , in addition to the marine ecosystem , a basin approach that addresses the key issues affecting the quality and productivity of the baltic sea region ecosystems . it shall include an estimate of the economic cost of environmental damage and the loss of biodiversity in the region .


### at the end of the strategic phase , the commission , assisted by independent expert should evaluate the maturity and the readiness of the initiative to enter the implementation phase . ### at the end of the strategic phase , the commission , assisted by independent experts , should verify and assess the quality and readiness of the strategic phase and , if appropriate , suggest improvements . the transition to the implementation phase should be seamless and without unnecessary delays .


### the implementation phase shall last for a minimum of five years . during the implementation phase at least three calls for proposals shall be published with a view to funding projects which address the objectives of the bonus - 169 . these calls shall be targeted at multi - partner and trans - national projects , and include research , technological development , training and dissemination activities . projects shall be selected according to the principles of equal treatment , transparency , independent evaluation , co - financing , no - profit , financing not cumulated with other community sources , as well as the principle of non - retroactivity . ### the implementation phase shall last for a minimum of five years . during the implementation phase the calls for proposals shall be published with a view to funding projects which address the objectives of the bonus . these calls shall be targeted at multi - partner and trans - national projects , and include research , technological development , training and dissemination activities . projects shall be selected according to the principles of equal treatment , transparency , independent evaluation , co - financing , no - profit , financing not cumulated with other community sources , as well as the principle of non - retroactivity . the grant and payment of financing to participants in bonus shall comply with common rules in line with the seventh framework programme .


### member states shall take all necessary measures to ensure that , in accordance with this article , providers of support services can compete within the union on the basis of equitable , non - discriminatory and transparent conditions for the purpose of providing these services . ### member states shall take all necessary measures to ensure that , in accordance with this article , there are no statutory impediments to the providers of terminal air navigation and / or support services that would prevent their ability to compete within the union on the basis of equitable , non - discriminatory and transparent conditions for the purpose of providing these services .


### member states , as well as air traffic service providers shall cooperate to the fullest extent possible with each other in order to ensure compliance with this article . where relevant , cooperation may also include air traffic service providers from third countries taking part in functional airspace blocks . ### member states , national supervisory authorities as well as air traffic service providers shall cooperate to the fullest extent possible with each other , in order to ensure compliance with this article . where relevant , cooperation may also include national supervisory authorities and air traffic service providers from third countries taking part in functional airspace blocks ' .


### the provision of communication , navigation and surveillance services , as well as meteorological and aeronautical information services , should be organised under market conditions whilst taking into account the special features of such services and maintaining a high level of safety . ### the provision of air navigation services , communication , navigation and surveillance services , as well as meteorological , airspace design and aeronautical information services , together with services formatting and delivering data to general air traffic , should be organised under market conditions whilst taking into account the special features of such services and maintaining a high level of safety .


### the national supervisory authorities that are not legally distinct from any air navigation service providers or any private or public entity having an interest in the activities of such providers , as provided for in paragraph 2 , on the date of entry into force of this regulation shall meet this requirement by 1 january 2020 at the latest . ### national supervisory authorities which are not compliant with paragraph 2 of this article shall meet this requirement by 1 january 2020 .


### the national or functional airspace block plans referred to in paragraph 1 , shall be drawn up by national supervisory authorities and adopted by the member state . these plans shall include binding local targets and an appropriate incentive scheme as adopted by the member state . drafting of the plans shall be subject to consultation with air navigation service providers , airspace users ' representatives , and , where relevant , airport operators and airport coordinators . ### the national or functional airspace block plans referred to in paragraph 1 , shall be drawn up by national supervisory authorities and adopted by the member state . these plans shall include binding local targets and an appropriate incentive scheme as adopted by the member state . drafting of the plans shall be subject to consultation with the european commission , the performance review body , air navigation service providers , airspace users ' representatives , and , where relevant , airport operators and airport coordinators .


### member states shall take all necessary measures to ensure that , in accordance with this article , providers of support services can compete within the union on the basis of equitable , non - discriminatory and transparent conditions for the purpose of providing these services . ### member states shall take all necessary measures to ensure that , in accordance with this article , there are no statutory impediments to the providers of terminal air navigation and / or support services that would prevent their ability to compete within the union on an equitable and non - discriminatory basis . the requirement set out in this article shall be achieved not later than five years after publication of the study referred to in paragraph 2 of this article .


### union - wide and associated local performance targets on the key performance areas of safety , the environment , capacity and cost - efficiency ; ### union - wide performance targets on the key performance areas of safety , the environment , capacity and cost - efficiency ;


### in the event that the commission identifies that the national or functional airspace block plans or the local targets do not comply with the union - wide targets , it may require the member states concerned to take the necessary corrective measures . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 27 . ### in the event that the commission identifies that the national or functional airspace block plans or the local targets do not demonstrate consistency with or contribute to the union - wide targets , it may require the member states concerned to take the necessary corrective measures . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 27 .


### national plans or plans for functional airspace blocks , including performance targets , ensuring compliance with the union - wide and associated local performance targets ; and ### national plans or plans for functional airspace blocks , including performance targets , ensuring consistency with and their contribution to union–wide and associated local performance targets .


### ‘ airspace management’ means a planning service with the primary objective of maximising the utilisation of available airspace by dynamic time - sharing and , at times , the segregation of airspace among various categories of airspace users on the basis of short - term needs ; ### ‘ airspace management’ means a planning function with the primary objective of maximising the utilisation of available airspace by dynamic time - sharing and , at times , the segregation of airspace among various categories of airspace users on the basis of short - term needs and a strategic function associated with infrastructure planning ;


### establishment and revision of union - wide and associated local performance targets that shall be defined taking into consideration inputs identified at national level or at the level of functional airspace blocks ; ### establishment and revision of union - wide performance targets that shall be defined taking into consideration inputs identified at national level or at the level of functional airspace blocks ;


### the compliance of the national or functional airspace block plans and local targets with the union - wide performance targets shall be assessed by the commission in co - operation with the performance review body . ### the consistency of the national or functional airspace block plans and local targets with the union - wide performance targets shall be assessed by the commission in co - operation with the performance review body .


### , member states shall take all necessary measures in order to ensure the establishment and implementation of functional airspace blocks based on integrated provision of air traffic services with a view to achieving the required capacity and efficiency of the air traffic management network within the single european sky and maintaining a high level of safety and contributing to the overall performance of the air transport system and reduced environmental impact . ### member states shall take all necessary measures in order to ensure the establishment and implementation of operational functional airspace blocks based on integrated provision of air navigation services with a view to achieving the required capacity and efficiency of the air traffic management network within the single european sky and maintaining a high level of safety and contributing to the overall performance of the air transport system and reduced environmental impact .


### be selected in a transparent procedure on the basis of their specific qualifications , including appropriate competence and relevant experience inter alia in the field of auditing , air navigation services and systems ; ### be selected in a transparent procedure on the basis of their specific qualifications , experience or competencies .


### the financial envelope for the implementation of the connecting europe facility for the period 2014 to 2020 shall be eur 50 000 000 0001 . that amount shall be distributed among the sectors referred to in article 3 as follows : transport : eur 31 694 000 000 , out of which eur 10 000 000 000 shall be transferred from the cohesion fund to be spent in line with this regulation in member states eligible for funding from the cohesion fund ; energy : eur 9 121 000 000 ; telecommunications : eur 9 185 000 000 . __________________ 1all figures in constant 2011 prices . the corresponding amounts , expressed in current prices , can be found in the legislative financial statement . ### the estimated investment requirement for trans - european networks in the transport , energy and telecommunications sectors for the period up to 2020 is eur&#160 ; 970&#160 ; 000&#160 ; 000&#160 ; 000 . the financial envelope for the implementation of the connecting europe facility for the period 2014 to 2020 shall be [ eur 50 000 000 000 ] 1 . that amount shall be distributed among the sectors referred to in article 3 as follows : transport : [ eur 31 694 000 000 ] , out of which [ eur 10 000 000 000 ] shall be transferred from the cohesion fund to be spent in line with this regulation in member states eligible for funding from the cohesion fund ; energy : [ eur 9 121 000 000 ] ; telecommunications : [ eur 9 185 000 000 ] . __________________ 1 pending agreement on the multiannual financial framework for the period 2014 - 2020 . all figures in constant 2011 prices . the corresponding amounts , expressed in current prices , can be found in the legislative financial statement .


### ‘ bottleneck’ means a physical barrier that leads to a system break affecting the continuity of long - distance flows . such a barrier can be absorbed by new infrastructure such as bridges or tunnels that address problems as for example gradients , curve radii , gauge . the need to upgrade existing infrastructure shall not be considered as a bottleneck ; ### ‘ bottleneck’ in the transport sector means a physical or technical barrier that leads to a system break affecting the continuity and disruption of long - distance and cross - border flows . such a barrier can be absorbed by creating new , or substantially upgrading existing infrastructure in order to increase its capacity such as bridges or tunnels that address problems as for example gradients , curve radii , gauge . the need to upgrade existing infrastructure shall not be considered as a bottleneck ;


### the european parliament in its resolution of 6 july 2010 on a sustainable future for transport emphasised that an efficient transport policy required a financial framework that was appropriate to the challenges arising and that , to that end , the current resources for transport and mobility should be increased ; it further considered necessary the creation of a facility to coordinate the use of different sources of transport funding , funds available under cohesion policy , public - private partnerships or other financial instruments such as guarantees . ### the european parliament in its resolution of 6 july 2010 on a sustainable future for transport emphasised that an efficient transport policy required a financial framework that was appropriate to the challenges arising and that , to that end , the current resources for transport and mobility should be increased , in the various budget lines relating to them ; it further considered necessary the creation of a facility to coordinate and optimise the use of different sources of transport funding and of all the financial means and mechanisms available at eu level .


### ' bottleneck ' means a physical barrier that leads to a system break affecting the continuity of long - distance flows . such a barrier can be absorbed by new infrastructure such as bridges or tunnels that address problems as for example gradients , curve radii , gauge . the need to upgrade existing infrastructure shall not be considered as a bottleneck ; ### ' transport bottleneck ' means a physical and / or functional barrier that leads to a system break affecting the continuity of long - distance flows and which can be surmounted by creating new infrastructure


### ensuring sustainable and efficient transport in the long run , to be measured by the length of the conventional railway network in the eu - 27 and the length of high - speed railway network in the eu - 27 ; ### ensuring sustainable and efficient transport in the long run on networks created or improved by means of this regulation , to be measured by the length of transport infrastructure running across the eu - 27 without major bottlenecks ;


### accelerating the deployment of fast and ultrafast broadband networks and their uptake , including by small and medium sized enterprises , to be measured by the level of broadband and ultrafast broadband coverage and the number of households having subscribed for broadband connections for above 100 mbps ; ### accelerating the deployment of fast and ultrafast broadband networks and their uptake , including by small and medium sized enterprises , to be measured by the level of broadband and ultrafast broadband coverage and the number of households having subscribed for broadband connections of 100 mbps and above ;


### rail and inland waterways : the amount of union financial aid shall not exceed 20% of the eligible cost ; the funding rate may be increased to 30% for actions addressing bottlenecks ; the funding rate may be increased to 40% for actions concerning cross - border sections ; ### for rail and inland waterways and for road networks in the case of member states with no railway network established in their territory or in the case of a member state with an isolated network as defined in article 3 of regulation no xxxx / 2012 [ ten - t guidelines ] without long distance rail freight transport , 20% of the eligible cost ; the funding rate may be increased up to 30% for actions addressing bottlenecks ; the funding rate may be increased up to 40% for actions concerning cross - border sections and enhancing rail interoperability actions ;


### the committee shall ensure a horizontal overview of the work programmes referred to in article 17 to ensure consistency and that synergies are identified and exploited between sectors . ### the coordination committee shall ensure a horizontal overview of the work programmes referred to in article 17 to ensure consistency and that synergies are identified and exploited between sectors . the committees of respective sectors shall help the commission monitor implementation of the respective guidelines and shall take part in their reviews .


### before the commission takes any of the decisions provided for in paragraphs 1 , 2 and 3 , it shall examine the case at hand and inform the beneficiaries concerned so that they may present their observations within a given timeframe . ### before the commission takes any of the decisions provided for in paragraphs 1 , 2 and 3 , it shall examine the case at hand and inform the beneficiaries concerned so that they may present their observations within a given timeframe . it shall inform the european parliament and the council of all the decisions taken on the annual adoption of the programmes under article 17 .


### transport : eur 31 694 000 000 , out of which eur 10 000 000 000 shall be transferred from the cohesion fund to be spent in line with this regulation in member states eligible for funding from the cohesion fund ; ### transport : [ eur 31 694 000 000 ] , out of which [ eur 10 000 000 000 ] shall be transferred from the cohesion fund to be spent for projects listed in the annex to this regulation , respecting the national allocations ;


### ‘ bottleneck’ means a physical barrier that leads to a system break affecting the continuity of long - distance flows . such a barrier can be absorbed by new infrastructure such as bridges or tunnels that address problems as for example gradients , curve radii , gauge . the need to upgrade existing infrastructure shall not be considered as a bottleneck ; ### ‘ transport bottleneck’ means a physical barrier that leads to a system break affecting the continuity of traffic flows and which can be surmounted by creating new infrastructure .


### as regards the eur 10 000 000 000 transferred from the cohesion fund [ regulation xxx article xx ] to be spent in member states eligible for funding from the cohesion fund , specific calls shall be launched for projects implementing the core network exclusively in member states eligible for funding from the cohesion fund . ### as regards the [ eur 10 000 000 000 ] transferred from the cohesion fund [ regulation xxx article xx ] to be spent exclusively in member states eligible for funding from the cohesion fund , specific calls shall be launched for projects implementing the core network exclusively in member states eligible for funding from the cohesion fund .


### ‘ cross - border section’ means the section , which ensures the continuity of a project of common interest between at least two member states or between a member state and a neighbouring country ; ### ‘ cross - border section’ means the section which ensures the continuity of a project of common interest between at least two member states or between a member state and a neighbouring country , which includes maritime port hinterlands as well as ports ;


### helsinki – tallinn – riga – kaunas – warszawa – katowice gdynia – katowice katowice – ostrava – brno – wien katowice – žilina – bratislava – wien wien – graz – klagenfurt – villach – udine – venezia – bologna – ravenna graz – ljubljana – koper / trieste ### helsinki – tallinn – riga – kaunas – warszawa – katowice gdynia – katowice katowice – ostrava – brno – wien katowice – žilina – bratislava – wien wien – graz – klagenfurt – villach – udine – venezia – bologna – ravenna graz – ljubljana – koper / trieste szczecin / świnoujście - poznań / zielona góra - wrocław - ostrava


### the financial instruments shall aim to preserve the value of assets provided by the union budget . they may generate acceptable returns to meet the objectives of other partners or investors . ### the financial instruments shall aim to preserve the value of assets provided by the union budget . they may generate acceptable returns without in any way jeopardising the implementation of the actions supported under this regulation or placing liabilities onto the eu budget .


### as regards the eur 10 000 000 000 transferred from the cohesion fund [ regulation xxx article xx ] to be spent in member states eligible for funding from the cohesion fund , specific calls shall be launched for projects implementing the core network exclusively in member states eligible for funding from the cohesion fund . ### as regards the [ eur 10 000 000 000 ] transferred from the cohesion fund [ regulation xxx article xx ] to be spent in member states eligible for funding from the cohesion fund , financial envelopes shall be proposed by the commission for member states eligible for funding from the cohesion fund .


### rail and inland waterways : the amount of union financial aid shall not exceed 20% of the eligible cost ; the funding rate may be increased to 30% for actions addressing bottlenecks ; the funding rate may be increased to 40% for actions concerning cross - border sections ; ### rail and inland waterways and for road networks in the case of member states with no railway network established in their territory or in the case of a member state with an isolated network as defined in article 3 of regulation no xxx / 2012 [ ten - t guidelines ] without long distance rail freight transport , the amount of union financial aid shall not exceed 20% of the eligible cost ; the funding rate may be increased up to 30% for actions addressing bottlenecks ; the funding rate may be increased up to 40 % for actions concerning cross - border sections and enhancing rail interoperability actions ;


### removing bottlenecks and bridging missing links , to be measured by the number of new and improved cross - border connections and removed bottlenecks on transport routes which have benefited from the connecting europe facility ; ### removing bottlenecks and bridging missing links , to be measured by the number of new and improved internal and cross - border connections and removed bottlenecks on transport routes which have benefited from the connecting europe facility ;


### co - financing rates mentioned above may be increased by up to 10 percentage points for actions having cross - sector synergies , reaching climate mitigation objectives , enhancing climate resilience or reducing the greenhouse gas emissions . this increase should not apply to co - financing rates referred to in article 11 . ### co - financing rates mentioned above may be increased by up to 10 percentage points for actions having cross - sector synergies , reaching climate mitigation objectives , enhancing climate resilience , reducing the greenhouse gas emissions or , in the case of broadband , rural broadband projects . this increase should not apply to co - financing rates referred to in article 11 .


### the commission shall implement information and communication actions on the connecting europe facility projects and results . moreover , budget allocated to communication under this regulation shall also cover corporate communication on the political priorities of the union . ### the commission shall implement information and communication actions on the connecting europe facility projects and results .


### the delegation of power referred to in articles 6 third subparagraph , 7 , 8 , 9 , 11 and , 12 , 19 , 28 and 30a shall be conferred for an indeterminate period of time from [ opoce insert date of entry into force of this amending regulation ] ### the power to adopt delegated acts referred to in articles 6 third subparagraph , 7 , 8 , 9 , 11 and , 19 and 30a shall be conferred for a period of five years from [ opoce insert date of entry into force of this amending regulation ] the commission shall , not later than nine months before the expiry of the five - year period , submit a report on the delegated powers . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period .


### the delegation of power referred to in articles 6 third subparagraph , 7 , 8 , 9 , 11 and , 12 , 19 , 28 and 30a shall be conferred for an indeterminate period of time from [ opoce insert date of entry into force of this amending regulation ] ### the power to adopt delegated acts referred to in articles 6 third subparagraph , 7 , 8 , 9 , 11 and , 12 , 19 , 28 and 30a shall be conferred for a period of five years from [ opoce insert date of entry into force of this amending regulation ] with provision for a review as to whether or not to extend the delegation of power at the end of the period .


### send the receiving payment service provider the information indicated in points , and of paragraph 3 within seven calendar days of receiving the request ; ### send the receiving payment service provider the information indicated in points , and of paragraph 3 within seven business days of receiving the request ;


### set up within seven calendar days the standing orders for credit transfers requested by the consumer and execute them from the date specified in the authorisation ; ### set up within seven business days the standing orders for credit transfers requested by the consumer and execute them from the date specified in the authorisation ;


### member states shall ensure that the competent authorities referred to in article 20 , determine a provisional list of at least 20 payment services accounting for at least 80% of the most representative payment services subject to a fee at national level . the list shall contain terms and definitions for each of the services identified . ### member states shall ensure that the competent authorities referred to in article 20 , determine a list of payment services accounting for at least 80% of the most representative payment services subject to a fee at national level . the list shall contain terms and definitions for each of the services identified .


### in order to help consumers compare payment account fees throughout the single market easily , payment service providers should provide consumers with a list of fees charged for the services listed in the standardised terminology . this would also contribute towards establishing a level playing field between credit institutions competing in the payment account market . the fee information document should only contain information on the most representative payment services in each member state , using the terms and definitions established at eu level where relevant . in order to help consumers understand the fees they have to pay for their payment account , a glossary providing explanations for at least the fees and services contained in the list should be made available to them . the glossary should serve as a useful tool to encourage a better understanding of the meaning of fees , contributing towards empowering consumers to choose from a wider choice of payment account offers . an obligation should also be introduced for payment service providers to inform consumers , at least annually , of all the fees charged on their account . ex - post information should be provided in a dedicated summary . it should provide a complete overview of the fees incurred to enable a consumer to understand what fee expenditures relate to , and to assess the need to either modify consumption patterns or move to another provider . this benefit would be maximised by the ex - post fee information covering the same services as the ex - ante information . ### in order to help consumers compare payment account fees throughout the single market easily , payment service providers should provide consumers with a list of fees charged for the services listed in the standardised terminology at national level . this would also contribute towards establishing a level playing field between credit institutions competing in the payment account market . the fee information document should only contain information on the most representative payment services in each member state . in order to help consumers understand the fees they have to pay for their payment account , a glossary providing explanations for at least the fees and services contained in the list should be made available to them . the glossary should serve as a useful tool to encourage a better understanding of the meaning of fees , contributing towards empowering consumers to choose from a wider choice of payment account offers . an obligation should also be introduced for payment service providers to inform consumers , at least annually , of all the fees charged on their account . ex - post information should be provided in a dedicated summary . it should provide a complete overview of the fees incurred to enable a consumer to understand what fee expenditures relate to , and to assess the need to either modify consumption patterns or move to another provider . this benefit would be maximised by the ex - post fee information covering the same services as the ex - ante information .


### member states shall ensure that when a payment account is offered together with another service or product as part of a package , the payment service provider informs the consumer of whether it is possible to buy the payment account separately and provides separate information regarding the costs and fees associated with each of the products and services offered in the package . ### without prejudice to article 4 , member states shall ensure that when a payment account is offered together with another financial service or product as part of a package , the payment service provider informs the consumer of whether it is possible to buy the payment account separately and , if so , provides separate information regarding the fees associated with each of the other financial products and services offered in the package , where it is possible to buy each of those financial products and services separately .


### consumers who are legally resident in the union and who do not hold a payment account in a certain member state should be in a position to open and use a payment account with basic features in that member state . in order to ensure the widest possible access to such accounts , consumers should have access to them irrespective of their financial circumstances , such as unemployment or personal bankruptcy , and of their place of residence . moreover , the right to access a payment account with basic features in any member state should be granted in conformity with the requirements set out in directive 2005 / 60 / ec of the european parliament and of the council of 26 october 2005 on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing , in particular with regard to customer due diligence procedures . ### consumers who have previously been denied access to a basic payment account , are resident in and can justify a sufficient relationship with the member state of the psp where they apply for access to a payment account with basic features should be in a position to open and use a payment account with basic features in that member state . in order to ensure the widest possible access to such accounts , consumers should have access to them irrespective of their financial circumstances , such as unemployment or personal bankruptcy . moreover , the right to access a payment account with basic features in any member state should be granted in conformity with the requirements set out in directive 2005 / 60 / ec of the european parliament and of the council of 26 october 2005 on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing , in particular with regard to customer due diligence procedures .


### the fee terminology should be determined by national competent authorities , allowing for consideration of the specificities of local markets . to be considered representative , services should be subject to a fee at a minimum of one payment service provider in member states . in addition , where possible , fee terminology should be standardised at eu level , thus allowing for comparison across the union . the european banking authority should establish guidelines to assist member states to determine the most representative payment services subject to a fee at national level . ### the fee terminology should be determined by national competent authorities , allowing for consideration of the specificities of local markets . to be considered representative , services should be subject to a fee at a minimum of one payment service provider in member states .


### member states shall ensure that when a payment account is offered together with another service or product as part of a package , the payment service provider informs the consumer of whether it is possible to buy the payment account separately and provides separate information regarding the costs and fees associated with each of the products and services offered in the package . ### member states shall ensure that when a payment account is offered together with another financial service or product as part of a package , the payment service provider informs the consumer in an appropriate time prior to entering into a contract for a payment account that it is possible to buy the payment account separately and if so provides separate information regarding the costs and fees associated with each of the financial products and services offered in the package , insofar as they can also be bought separately .


### it is current practice for payment service providers to offer a payment account in a package with other financial products or services . this practice can be a means for payment service providers to diversify their offer and to compete against each other , and in the end it can be beneficial for consumers . however the commission study on tying practices in the financial sector conducted in 2009 as well as relevant consultations and consumer complaints have showed that payment service providers may offer bank accounts packaged with products not requested by consumers and which are not essential for payment accounts , such as household insurance . moreover , it has been observed that these practices may reduce transparency and comparability of prices , limit purchasing options for consumers and negatively impact upon their mobility . therefore , member states should ensure that when payment service providers offer packaged payment accounts consumers are provided with information on the applicable fees for the payment account and for each other financial service included in the package separately . these obligations should not apply to services which are naturally connected to the use of the payment account , such as withdrawals , wire transfers or payment cards . as a result , these services should be excluded from the scope of this provision . ### it is current practice for payment service providers to offer a payment account in a package with other financial products or services . this practice can be a means for payment service providers to diversify their offer and to compete against each other , and in the end it can be beneficial for consumers . however the commission study on tying practices in the financial sector conducted in 2009 as well as relevant consultations and consumer complaints have showed that payment service providers may offer bank accounts packaged with products not requested by consumers and which are not essential for payment accounts , such as household insurance . moreover , it has been observed that these practices may reduce transparency and comparability of prices , limit purchasing options for consumers and negatively impact upon their mobility . therefore , member states should ensure that when payment service providers offer payment accounts bundled with other financial services consumers are provided with information on whether it is possible to buy the components of the package separately and , if so , whether such services are to be provided with the information on the costs and charges of each financial service included in the package separately , electronically or on paper .


### promoting democracy , the rule of law , good governance and respect for human rights . ### promoting democracy , including through fair and transparent elections , the rule of law , good governance in both the public and private sector , and respect for human rights , as enshrined in the united nations ' universal declaration of human rights .


### promoting sustainable economic reform and diversification , trade , the development of a market economy , productive and sustainable investment in the main sectors , public private partnerships , and partner countries ' integration in the wto ; ### promoting sustainable economic reform and diversification , open and fair trade , the development of a market economy , productive and sustainable investment in the main sectors , public private partnerships , and partner countries ' integration in the wto ;


### strategy papers may be reviewed at their mid - term , or ad hoc if necessary , in accordance , as appropriate , with the principles and procedures laid down in the partnership and cooperation agreements concluded with the partner countries and regions . ### strategy papers may be reviewed at their mid - term , or ad hoc if necessary , in accordance , as appropriate , with the principles and procedures laid down in the partnership and cooperation agreements concluded with the partner countries and regions . the review process shall be conducted in consultation with the responsible committees of the european parliament and its delegations to the beneficiary countries , such as the acp - eu joint parliamentary assembly .


### union assistance should focus where it has more impact , having regard to its capacity to act on a global scale and respond to global challenges such as poverty eradication , sustainable and inclusive development and worldwide promotion of democracy , good governance , human rights and the rule of law , its long - term and predictable commitment to development assistance and its role in coordinating with its member states . to ensure such impact , the principle of differentiation should be applied not only at the level of funds allocation , but also at the level of programming , to ensure that bilateral development cooperation targets partner countries most in need , including fragile states and states with high vulnerability , and with limited capacity to have access to other sources of financing for supporting their own development , having regard to the potential impact of the union assistance in partner countries . as a consequence , bilateral programming would target such countries , pursuant to the application of objective criteria based on the needs and capacities of these countries , as well as the impact of eu assistance . ### union assistance should focus where it has more impact , having regard to its capacity to act on a global scale and respond to global challenges such as poverty eradication , sustainable and inclusive development through open and fair trade and worldwide promotion of democracy , good governance , human rights and the rule of law , its long - term and predictable commitment to development assistance and its role in coordinating with its member states . to ensure such impact , the principle of differentiation should be applied not only at the level of funds allocation , but also at the level of programming , to ensure that bilateral development cooperation targets partner countries most in need , including fragile states and states with high vulnerability , and with limited capacity to have access to other sources of financing for supporting their own development , having regard to the potential impact of the union assistance in partner countries . as a consequence , bilateral programming would target such countries , pursuant to the application of objective criteria based on the needs and capacities of these countries , as well as the impact of eu assistance .


### a request for access under paragraphs 1 , 2 and 3 may be made up to one year after the end of the action . however , the participants may agree on a different time - limit . ### a request for access rights under paragraphs 1 , 2 and 3 may be made up to one year after the end of the action or after the termination of the requesting participant ' s participation in the action . however , the participants may agree on a different time - limit .


### where participants in an action have jointly generated results and where their respective share of the work cannot be ascertained , they shall have joint ownership of those results . the joint owners shall establish an agreement regarding the allocation and terms of exercise of that joint ownership in accordance with their obligations under the grant agreement . ### where participants in an action have jointly generated results and where it is not possible to separate such joint invention , design or work for the purpose of applying for , obtaining and / or maintaining the relevant patent protection or any other intellectual property right , they can decide to attribute ownership of those results to one of the participants , or they can have joint ownership of those results . in case of joint ownership , the joint owners shall establish an agreement regarding the allocation and terms of exercise of that joint ownership in accordance with their obligations under the grant agreement .


### where participants in an action have jointly generated results and where their respective share of the work cannot be ascertained , they shall have joint ownership of those results . the joint owners shall establish an agreement regarding the allocation and terms of exercise of that joint ownership in accordance with their obligations under the grant agreement . ### where participants in an action have jointly generated results and where their respective share of the work cannot be ascertained , they can decide to attribute ownership of those results to one of the participant or they can have joint ownership of those results . in case of joint ownership , the joint owners shall establish an agreement regarding the allocation and terms of exercise of that joint ownership in accordance with their obligations under the grant agreement .


### the certificate on financial statements shall cover the total amount of the grant claimed by a participant under the form of reimbursement of actual costs and under the form of scale of unit costs referred to article 27 . the certificate shall only be submitted when that amount is equal to or greater than eur 325 000 at the time of claiming the payment of the balance of the grant . ### the certificate on financial statements shall cover the total amount of the grant claimed by a participant under the form of reimbursement of actual costs and under the form of scale of unit costs referred to article 27 . the certificate shall only be submitted when that amount is equal to or greater than eur 375 000 at the time of claiming the payment of the balance of the grant .


### ' results ‘ means any data , knowledge and information whatever their form or nature , whether or not they can be protected , which are generated in the action as well as any attached rights , including intellectual property rights ; ### ' results ' means any artefacts and other tangible outputs , data , knowledge and information whatever their form or nature , whether or not they can be protected , which are generated in the action as well as any rights attached to them , including intellectual property rights ;


### a participant shall enjoy access rights to the results of another participant in the same action , if such access is needed by the former to exploit its results . ### a participant shall enjoy access rights to the results of another participant in the same action , if such results are needed by the former to exploit its own results .


### ' results ‘ means any data , knowledge and information whatever their form or nature , whether or not they can be protected , which are generated in the action as well as any attached rights , including intellectual property rights ; ### ' results ' means any data , knowledge , information , objects and other tangible outputs , whatever their form or nature , whether or not they can be protected , which are generated in the action as well as any attached rights , including intellectual property rights . for the purposes of this regulation , publications shall not be considered as results ;


### an affiliated entity established in a member state or associated country shall , unless otherwise provided for in the consortium agreement , also have access rights to results or background under the same conditions if such access is needed to exploit the results generated by the participant to which it is affiliated . ### an affiliated entity shall , unless otherwise provided for in the consortium agreement , also have access rights to results or background under fair and reasonable conditions if such access is needed to exploit the results generated by the participant to which it is affiliated .


### with regard to dissemination through research publications , open access shall apply under the terms and conditions laid down in the grant agreement . with regard to dissemination of other results , including research data , the grant agreement may lay down the terms and conditions under which open access to such results shall be provided , in particular in erc frontier research or in other appropriate areas . ### with regard to dissemination through research publications which describe , interpret , or analyse data , knowledge or information generated as a direct result of horizon 2020 funding , sustainable open access may apply under the terms and conditions laid down in the grant agreement . with regard to dissemination of other results , including research data , the grant agreement may lay down the terms and conditions under which sustainable open access to such results shall be provided , in particular in erc frontier research or in other appropriate areas .


### provided that any access rights to the results can be exercised and that any additional exploitation obligations are complied with , the participant who owns results may grant licences or otherwise give the right to exploit them to any legal entity , including on an exclusive basis . ### provided that any access rights to the results can be exercised and that any additional exploitation obligations are complied with by the participant who owns results , that participant may grant licences or otherwise give the right to exploit the results to any legal entity , including on an exclusive basis .


### ' background’ means any data , know - how and / or information whatever their form or nature as well as any rights such as intellectual property rights which are held by participants prior to their accession to the action and identified by the participants in accordance with article 42 ; ### ' background’ means any data , know - how and / or information whatever their form or nature as well as any rights such as intellectual property rights which are held by participants prior to their accession to the action or prior to the application which has been filed before their accession to the action and identified by the participants in accordance with article 42 and which is needed for carrying out the indirect action or for using the results of the indirect action ;


### the grant agreement shall establish the rights and obligations of the participants , of the commission or the relevant funding bodies . it shall also establish the rights and obligations of legal entities which become participants during the implementation of the action . ### the grant agreement shall establish the rights and obligations of the participants and either of the commission or the relevant funding bodies . it shall also establish the rights and obligations of legal entities which become participants during the implementation of the action as well as the role and tasks of a consortium coordinator .


### the commission or the relevant funding body shall verify the financial capacity in advance only for coordinators when the requested funding from the union for the action is equal or superior to eur 500 000 , unless where , on the basis of available information , there are grounds to doubt the financial capacity of the coordinator or other participants . ### the commission or the relevant funding body shall verify the financial capacity in advance only for coordinators when the requested funding from the union for the action is equal or superior to eur 500 000 , unless where , on the basis of available information , there are grounds to doubt the financial capacity of the coordinator or other participants . the commission shall provide a simple , user - friendly electronic tool to applicants to carry out their financial viability check .


### an affiliated entity established in a member state or associated country shall , unless otherwise provided for in the consortium agreement , also have access rights to results or background under the same conditions if such access is needed to exploit the results generated by the participant to which it is affiliated . ### an affiliated entity shall , unless otherwise provided for in the consortium agreement , also have access rights to results or background under fair and reasonable conditions if such results or background are needed to exploit the results generated by the participant to which it is affiliated . such access shall be requested and obtained directly from the participant owning the results or background .


### such access shall be granted on a royalty - free basis . ### such access shall be granted on terms to be agreed .


### where a participant that has received union funding intends to abandon the protection of results or not to seek extension of such protection for reasons other than the lack of potential for commercial exploitation , it shall inform the commission or the funding body which may continue or extend protection by assuming ownership thereof . the participant may refuse consent only if it demonstrates that its legitimate interests would suffer significant harm . the grant agreement shall lay down time - limits in this respect . ### where a participant that has received union funding intends to abandon the protection of results or not to seek extension of such protection for reasons other than the lack of potential for commercial exploitation , it shall inform the commission or the funding body which may , with the consent of the owning participant , continue or extend protection by assuming ownership thereof . the participant may refuse consent only if it demonstrates that its legitimate interests would suffer significant harm . the grant agreement shall lay down time - limits in this respect .


### the members of a consortium participating in an action shall conclude an internal agreement , except in duly justified cases provided for in the work programme or work plan or call for proposals . ### the members of a consortium participating in an action shall conclude an internal agreement that establishes the rights and obligations of the members in the consortium . this however shall not prevent individual members of the consortium from being able to enter into direct dialogue with the commission or the relevant funding body , in particular when they have concerns over the actions of the coordinator .


### actions which fall within the scope of this regulation should respect fundamental rights and observe the principles acknowledged in particular by the charter of fundamental rights of the european union . such actions should be in conformity with any legal obligation and with ethical principles , which include avoiding any kind of plagiarism . ### actions which fall within the scope of this regulation shall respect fundamental rights and observe the principles acknowledged in particular by the charter of fundamental rights of the european union . such actions should be in conformity with any legal obligation and with ethical principles , which include avoiding any kind of plagiarism .


### a request for access under paragraphs 1 , 2 and 3 may be made up to one year after the end of the action . however , the participants may agree on a different time - limit . ### a request for access rights under paragraphs 1 , 2 and 3 may be made up to one year after the end of the action or after the termination of the requesting participant ' s participation in the action . however , the participants may agree on a different time - limit .


### subject to agreement , such access shall be granted under fair and reasonable conditions . ### unless otherwise agreed , such access shall be granted under fair and reasonable conditions .


### where participants in an action have jointly generated results and where their respective share of the work cannot be ascertained , they shall have joint ownership of those results . the joint owners shall establish an agreement regarding the allocation and terms of exercise of that joint ownership in accordance with their obligations under the grant agreement . ### where participants in an action have jointly generated results and where it is not possible to separate such joint invention , design or work for the purpose of applying for , obtaining and / or maintaining the relevant patent protection or any other intellectual property right , they can decide to attribute ownership of those results to one of the participants , or they can have joint ownership of those results . in case of joint ownership , the joint owners shall establish an agreement regarding the allocation and terms of exercise of that joint ownership in accordance with their obligations under the grant agreement .


### the members of a consortium participating in an action shall conclude an internal agreement , except in duly justified cases provided for in the work programme or work plan or call for proposals . ### the members of a consortium participating in an action shall conclude an internal agreement that establishes the rights and obligations of the members in the consortium .


### any proposal for research on human embryonic stem cells shall include , as appropriate , details of licensing and control measures that will be taken by the competent authorities of the member states as well as details of the ethical approvals that will be provided . as regards the derivation of human embryonic stem cells , institutions , organisations and researchers shall be subject to strict licensing and control in accordance with the legal framework of the member states involved . ### any proposal for research on human embryonic stem cells shall include details of licensing and control measures that will be taken by the competent authorities of the member states as well as details of the ethical approvals that will be provided . as regards the derivation of human embryonic stem cells , institutions , organisations and researchers shall be subject to strict licensing and control in accordance with the legal framework of the member states involved .


### subject to the conditions established in the implementing agreements , decisions or contracts , any data , knowledge and information communicated as confidential in the frame of an action shall be kept confidential , taking due account of any rules regarding the protection of classified information . ### subject to the conditions established in the implementing agreements , decisions or contracts , any data , knowledge and information communicated as confidential in the frame of an action shall be kept confidential by the union institutions and bodies and the participants in an action , taking due account of any rules regarding the protection of classified information .


### a participant shall enjoy access rights to the results of another participant in the same action , if such access is needed by the former to exploit its results . ### a participant shall enjoy access rights to the results of another participant in the same action , if such results are needed by the former to exploit its own results .


### where a participant that has received union funding intends to abandon the protection of results or not to seek extension of such protection for reasons other than the lack of potential for commercial exploitation , it shall inform the commission or the funding body which may continue or extend protection by assuming ownership thereof . the participant may refuse consent only if it demonstrates that its legitimate interests would suffer significant harm . the grant agreement shall lay down time - limits in this respect . ### where a participant that has received union funding intends to abandon the protection of results or not to seek extension of such protection for reasons other than the lack of potential for commercial exploitation within five years following the end of the action , it shall inform the commission or the funding body which may , with the consent of the owning participant , continue or extend protection by assuming ownership thereof . the commission or the funding body shall take this decision within 45 days . the participant may refuse consent only if it demonstrates that its legitimate interests would suffer significant harm . the grant agreement shall lay down time - limits in this respect .


### a participant shall enjoy access rights to background of another participant in the same action , if such access is needed by the former to carry out its work under the action and subject to any restrictions pursuant to article 43 . ### a participant shall enjoy access rights to background of another participant in the same action , if such background is needed by the former to carry out its own work under the action and subject to any restrictions pursuant to article 43 .


### the clinical trial poses a minimal risk to , and imposes a minimal burden on , the subject . ### the clinical trial poses only a proportionate risk with reference of the underlying medical condition , and imposes only a proportionate burden on , the subject .


### article 17 of directive 2009 / 28 / ec establishes sustainability criteria that biofuels and bioliquids need to comply with in order to be counted towards the targets in the directive and to qualify for inclusion in public support schemes . these criteria include requirements on the minimum greenhouse gas emission savings that biofuels and bioliquids need to achieve compared to fossil fuels . identical sustainability criteria are established for biofuels under article 7b of directive 98 / 70 / ec . ### article 17 of directive 2009 / 28 / ec establishes sustainability criteria that biofuels and bioliquids need to comply with in order to be counted towards the targets in the directive and to qualify for inclusion in public support schemes . these criteria include requirements on the minimum greenhouse gas emission savings that biofuels and bioliquids need to achieve compared to fossil fuels . identical sustainability criteria are established for biofuels under article 7b of directive 98 / 70 / ec . these criteria should be supplemented with safeguards to ensure cascade of use and respect of waste - hierarchy .


### the commission shall , before 31 december 2017 , submit a report to the european parliament and to the council reviewing , on the basis of the best latest available scientific evidence , the effectiveness of the measures introduced by this directive in limiting indirect land - use change greenhouse gas emissions associated with the production of biofuel and bioliquids . the report shall , if appropriate , be accompanied by a legislative proposal based on the best available scientific evidence , for introducing estimated indirect land use change emissions factors into the appropriate sustainability criteria to be applied from 1st january 2021 and a review of the effectiveness of the incentives provided for biofuels from non - land using feedstocks and non - food crops under article 3d of directive 2009 / 28 / ec . ### the commission shall , before 31 december 2018 , submit a report to the european parliament and to the council analyzing , on the basis of the best evidence that adheres to the scientific method , the effectiveness of the measures introduced by this directive in limiting indirect land - use change greenhouse gas emissions associated with the production of biofuel and bioliquids . the report shall include an impact assessment of biofuel production on the timber industry and the availability of wood . the commission shall , before 31 december 2015 , submit a report to the european parliament , incorporating experience from iluc - models implemented in other countries and developed in close corporation with all relevant stakeholders , on the progress on the robustness and reliability of scientific evidence for the use of indirect land use change factors ; the report shall , if appropriate , be accompanied by a legislative proposal introducing a requirement for fuel suppliers to regularly report on the estimated indirect land - use change emissions of the biofuels they market , based on iluc factors and with effect from september 2016 .


### the delegation of power referred to in article 3 , article 5 , the third subparagraph of article 17 , articles 19 , 19 and 19 may be revoked at any time by the european parliament or by the council . a decision of revocation shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . ### the delegation of power referred to in article 5 , the third subparagraph of article 17 , articles 19 and 19 may be revoked at any time by the european parliament or by the council . a decision of revocation shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force .


### the delegation of power referred to in article 3 , article 5 , the third subparagraph of article 17 , articles 19 , 19 and 19 shall be conferred on the commission for an indeterminate period of time from [ the date of entry into force of this directive ] . ### the delegation of power referred to in article 5 , the third subparagraph of article 17 , articles 19 and 19 shall be conferred on the commission for a period of 5 years from [ publications office is to fill in the date of entry into force of this amending act ] . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of five - year period . the delegation of power shall be tacitly extended for periods of identical duration unless the european parliament or council opposes such an extension not later than 3 months before the end of each period .


### the commission should review the effectiveness of the measures introduced by this directive , based on the best and latest available scientific evidence , in limiting indirect land - use change greenhouse gas emissions and addressing ways to further minimise that impact , which could include the introduction of estimated indirect land - use change emission factors in the sustainability scheme as of 1st january 2021 . ### the commission should review the effectiveness of the measures introduced by this directive , based on the best and latest available scientific evidence , in limiting indirect land - use change greenhouse gas emissions and addressing ways to further minimise that impact .


### liquid renewable fuels are likely to be required by the transport sector in order to reduce its greenhouse gas emissions . advanced biofuels , such as those made from wastes and algae , provide high greenhouse gas savings with low risk of causing indirect land use change and do not compete directly for agricultural land for the food and feed markets . it is appropriate , therefore , to encourage greater production of such advanced biofuels as these are currently not commercially available in large quantities , in part due to competition for public subsidies with established food crop based biofuel technologies . further incentives should be provided by increasing the weighting of advanced biofuels towards 10% target for transport set in directive 2009 / 28 / ec compared to conventional biofuels . in this context , only advanced biofuels with low estimated indirect land use change impacts and high overall greenhouse gas savings should be supported as part of the post 2020 renewable energy policy framework . ### liquid renewable fuels are likely to be required by the transport sector in order to reduce its greenhouse gas emissions . advanced biofuels , such as those made from wastes and and residues , by bacteria , algae , provide high greenhouse gas savings with low risk of causing indirect land use change and do not compete directly for agricultural land for the food and feed markets . it is appropriate , therefore , to encourage greater production of such advanced biofuels as these are currently not commercially available in large quantities .


### the delegation of power referred to in article 7a , the second subparagraph of article 7b , articles 7d , 7d , 7d , 8a and 10 shall be conferred for an indeterminate period of time from the date of entry into force of this directive . ### the delegation of power referred to in article 7a , the second subparagraph of article 7b , articles 7d , 7d , 8a and 10 shall be conferred on the commission for a period of 5 years from [ the date of entry into force of this amending act ] . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of five - year period . the delegation of power shall be tacitly extended for periods of identical duration unless the european parliament or council opposes such an extension not later than 3 months before the end of each period .


### fuel suppliers shall by 31 march each year report to the authority designated by the member state , the biofuel production pathways , volumes , and the life cycle greenhouse gas emissions per unit of energy , including the estimated indirect land - use change emissions set out in annex v member states shall report these data to the commission . ### from 2015 , fuel suppliers shall by each year report to the authority designated by the member state , the biofuel production pathways , volumes , and the life cycle greenhouse gas emissions per unit of energy , including the estimated indirect land - use change emissions set out in annex v member states shall report these data to the commission .


### the delegation of power referred to in article 3 , article 5 , the third subparagraph of article 17 , articles 19 , 19 and 19 shall be conferred on the commission for an indeterminate period of time from [ the date of entry into force of this directive ] . ### the delegation of power referred to in article 3 , article 5 , the third subparagraph of article 17 , articles 19 , 19 and 19 shall be conferred on the commission for a period of five years from [ the date of entry into force of this directive ] .


### the greenhouse gas emission saving from the use of biofuels shall be calculated in accordance with article 7d . ### the greenhouse gas emission saving from the use of biofuels shall be calculated in accordance with article 7d and shall take into consideration the total ghg savings for biofuels , starting from their production through to their impact on the energy used to create the final fuel . therefore the methodology to achieve a realistic assessment of the life cycle of co2 savings of individual biofuels should be amended as each biofuel will have a different impact on the finished fuel .


### the delegation of power referred to in articles 1 , 7 and , 8 , 11 , 20 , 22 , 25 , 30 , 32 , 34 , 38 , 44 , 45 , 46 , 48 , 61 , 67 , 71 , 76 , 78 , 82 , 84 , 86 , 91 , 92 and , 93 , 94 , 95 and 96 shall be conferred on the commission for an indeterminate period of time from the entry into force of this regulation . ### the delegation of power referred to in articles 1 , 5 , 6 , 7 and , 8 , 11 , 20 , 22 , 25 , 27 , 30 , 32 , 34 , 37 , 38 , 44 , 45 , 46 , 48 , 61 , 67 , 71 , 76 , 78 , 82 , 84 , 86 , 91 , 92 and , 93 , 94 , 95 and 96 shall be conferred on the commission for a period of 5 years from the entry into force of this regulation . unless the european parliament and the council have an objection , this period will be renewed for another 5 years after the lapsing of the first period .


### adequate planning of waste shipment inspections is necessary to establish the capacity needed for waste shipment inspections and effectively prevent illegal shipments . the provisions on enforcement and inspections in article 50 of regulation no 1013 / 2006 should therefore be strengthened with a view to ensuring regular and consistent planning of inspections . planning should include a number of key elements , including risk assessments , strategies , objectives , priorities , numbers and types of planned inspections , assignment of tasks , means of cooperation between authorities and provisions on training of inspectors . ### adequate planning of waste shipment inspections is necessary to establish the capacity needed for waste shipment inspections and effectively prevent illegal shipments . the provisions on enforcement and inspections in article 50 of regulation no 1013 / 2006 should therefore be strengthened with a view to ensuring regular and consistent planning of inspections . however , real progress in the prevention of illegal shipments can only be achieved by the proper implementation of plans together with a robust enforcement activity by the member states .


### ' 2a . member states shall ensure that their competent authorities establish plans for inspections aimed at checking compliance with this regulation . the plans shall cover the entire geographical area of the member state concerned and shall apply to all waste shipment inspections carried out pursuant to paragraph 2 , including inspections of establishments and undertakings , road - and railway transports and consignments in ports . those plans shall include the following : ### ' 2a . member states shall ensure that their competent authorities establish plans for inspections aimed at checking compliance with this regulation . the plans shall cover the entire geographical area of the member state concerned and shall apply to all waste shipment inspections carried out pursuant to paragraph 2 , including inspections of establishments and undertakings , road - and railway transports and consignments in ports . those plans may include provisions such as :