### rules governing the exploitation and dissemination of results should be laid down to ensure that the participants protect , exploit and disseminate those results as appropriate , in particular the possibility of additional exploitation conditions in the european strategic interest . ### rules governing the exploitation and dissemination of results should be laid down to ensure that the participants protect , exploit and disseminate those results as appropriate , in particular rules for open access to results and data or additional dissemination , exploitation or licensing conditions in the european strategic or public interest .


### each participant shall report to the commission or funding body on its exploitation and dissemination related activities . for the purposes of monitoring and dissemination by the commission or funding body , participants shall provide any information and documents useful in accordance with the conditions laid down in the grant agreement . ### each participant shall report to the commission or funding body on its exploitation and dissemination related activities . for the purposes of monitoring and dissemination by the commission or funding body , participants shall provide any information and documents useful in accordance with the conditions laid down in the grant agreement . to ensure transparency , the reports shall be made publicly available .


### the commission and , where appropriate , funding bodies may appoint independent experts to evaluate proposals or to advise on or assist with : ### the commission and funding bodies shall appoint independent experts to evaluate proposals or to advise on or assist with :


### 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 , open access shall apply as default policy with the aim of free of charge , on - line public access to union funded research publications as soon as possible , and in any event within six months of publication , in a peer - reviewed scientific journal and under the terms and conditions laid down in the grant agreement . with regard to dissemination of other results , including research data , the grant agreement shall 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 public interest areas such as public health , environment or other major societal interest .


### independent experts shall be identified and selected on the basis of calls for applications from individuals and calls addressed to relevant organisations such as national research agencies , research institutions , standardisation organisations or enterprises with a view to establishing a database of candidates . ### independent experts shall be identified and selected on the basis of calls for applications from individuals and calls addressed to relevant organisations such as national research agencies , research institutions , universities , standardisation organisations , civil society organisation , or enterprises with a view to establishing a database of candidates .


### 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 , the participant who owns results may grant licences or otherwise give the right to exploit them to any legal entity . the possibility to grant licenses on an exclusive basis shall be exceptional and shall not conflict with the objective of maximum dissemination and exploitation of results . the conditions for such licenses shall be laid down in the grant agreement .


### regarding actions in the activity ‘ secure societies’ within the specific objective ‘ inclusive , innovative and secure societies’ , the union institutions and bodies as well as member states ' national authorities shall , for the purpose of developing , implementing and monitoring their policies or programmes in this area , enjoy access rights to the results of a participant that has received union funding . notwithstanding article 43 , such access rights shall include the right to authorise third parties to use the results in public procurement in the case of the development of capabilities in domains with very limited market size and a risk of market failure , and where a predominant public interest exists . ### regarding actions in the specific objectives under the pillar ' societal challenges ' , the union institutions and bodies as well as member states ' national authorities shall , for the purpose of developing , implementing and monitoring their policies or programmes in this area , enjoy access rights to the results of a participant that has received union funding . notwithstanding article 43 , such access rights shall include the right to authorise third parties to use the results in public procurement in the case of the development of capabilities in domains with a risk of market failure , or where a predominant public interest exists .


### prior notice of any dissemination activity shall be given to the other participants . following notification , a participant may object if it demonstrates that its legitimate interests in relation to its results or background would suffer significant harm by the intended dissemination . in such cases , the dissemination activity may not take place unless appropriate steps are taken to safeguard these legitimate interests . the grant agreement may lay down time - limits in this respect . ### prior notice of any dissemination activity shall be given to the other participants . following notification , a participant may object if it demonstrates that its legitimate interests in relation to its results or background would suffer significant harm by the intended dissemination . in such cases , the dissemination activity may not take place unless appropriate steps are taken to safeguard these legitimate interests . the grant agreement shall lay down reasonable time - limits in this respect .


### appropriate measures shall be taken to seek gender balance and geographical diversity when appointing independent experts . ### appropriate measures shall be taken to seek interest balance , gender balance and geographical diversity when appointing independent experts . in particular , the commission shall make sure that no specific interest represents more than one third of non - governmental experts . appropriate measures shall be taken to prevent the capture of expert groups by private and / or commercial interests .


### in actions under the activity ‘ secure societies’ within the specific objective ‘ inclusive , innovative and secure societies’ , the commission may make available to union institutions and bodies or member states ' national authorities any useful information in its possession on results of a participant that has received union funding . ### in actions under the activities of the societal challenges pillar the commission may make available to union institutions and bodies or member states ' national authorities any useful information in its possession on results of a participant that has received union funding .


### rules governing the exploitation and dissemination of results should be laid down to ensure that the participants protect , exploit and disseminate those results as appropriate , in particular the possibility of additional exploitation conditions in the european strategic interest . ### rules governing the exploitation and dissemination of results should be laid down to ensure that the participants protect , exploit and disseminate those results as appropriate , in particular rules for open access to results and data , or additional exploitation , dissemination or licensing conditions in the european strategic interest , or in order to tackle societal challenges where predominant global public interests are at stake .


### it is appropriate to establish the terms and conditions for providing union funding for participants in actions under horizon 2020 . in order to reduce the complexity of the existing funding rules and have a higher flexibility in the project implementation , a simplified cost reimbursement system should be adopted with enhanced use of lump sums , flat rates and scale of unit costs . for simplification purposes , a single reimbursement rate should be applied for each type of action with no differentiation according to the type of participant . ### it is appropriate to establish the terms and conditions for providing union funding for participants in actions under horizon 2020 . in order to reduce the complexity of the existing funding rules , a simplified cost reimbursement system should be adopted with enhanced use of lump sums , flat rates and scale of unit costs .


### the commission or the relevant funding body shall take all necessary steps to ensure that the expert is not faced with a conflict of interests in relation to the matter on which the expert is required to provide an opinion . ### the commission or the relevant funding body shall take all necessary steps to ensure that the expert is not faced with a conflict of interests in relation to the matter on which the expert is required to provide an opinion , including through the publication of their full declaration of professional activities and financial interests , such as patents and shareholdings . stakeholders or persons with conflicts of interests shall be prohibited from sitting ' in a personal capacity ' .


### ' dissemination ‘ means the public disclosure of the results by any appropriate means , including by publishing in any medium ; ### ' dissemination ' means the public disclosure of the results by any appropriate means , including by publications in any medium ;


### following notification , a participant may object to the transfer of ownership if it demonstrates that the intended transfer would adversely affect the exercise of its access rights . in such case , the transfer may not take place until agreement has been reached between the participants concerned . the grant agreement may lay down time - limits . ### following notification , a participant may object to the transfer of ownership if it demonstrates that the intended transfer would adversely affect the exercise of its access rights . in such case , the transfer may not take place until agreement has been reached between the participants concerned . the model grant agreement shall lay down time - limits .


### the relevant work programme may restrict the participation in horizon 2020 or parts thereof of legal entities established in third countries where conditions for the participation of legal entities from member states in the third country ' s research and innovation programmes are considered prejudicial to the union ' s interests . ### the relevant work programme shall restrict and exclude the participation in horizon 2020 or parts thereof of .


### ' dissemination ‘ means the public disclosure of the results by any appropriate means , including by publishing in any medium ; ### ' dissemination ‘ means the public disclosure of the results by any appropriate means , including by publishing , in any medium , articles presenting the result of research such as scientific publications in peer - reviewed journals ;


### where a participant that has received union funding intends not to protect results generated by it for reasons other than impossibility under union or national law or the lack of potential for commercial exploitation , and unless the participant intends to transfer them to another legal entity established in a member state or associated country in view of their protection , it shall inform the commission or funding body before any dissemination relating to these results takes place . the commission on behalf of the union or the funding body may assume ownership of these results and take the necessary steps for their adequate protection . ### where a participant that has received union funding intends not to protect results generated by it , it shall inform the commission or funding body before any dissemination relating to these results takes place . the commission on behalf of the union or the funding body may assume ownership of these results and take the necessary steps for their adequate protection , having regard to the public interest and with a view of maximising dissemination of results .


### new psychoactive substances , which imitate the effects of substances scheduled under the un conventions , are emerging frequently and are spreading fast in the union . certain new psychoactive substances pose severe health , social and safety risks , as ascertained by [ regulation no … / … on new psychoactive substances ] . under that regulation , measures may be taken to prohibit the production , manufacture , making available on the market including importation to the union , transport , and exportation from the union of new psychoactive substances posing severe health , social and safety risks . to effectively reduce the availability of new psychoactive substances that pose severe risks to individuals and society , and to deter trafficking in those substances across the union , as well as the involvement of criminal organisations , permanent market restriction measures adopted under that regulation should be underpinned by criminal law provisions . ### new psychoactive substances , which imitate the effects of substances scheduled under the un conventions , are emerging frequently and are spreading fast in the union . certain new psychoactive substances pose severe health , social and safety risks , as ascertained by [ regulation no … / … on new psychoactive substances ] . under that regulation , measures may be taken to prohibit the production , manufacture , making available on the market including importation to the union , transport , and exportation from the union of new psychoactive substances posing severe health , social and safety risks . to effectively reduce the availability of new psychoactive substances that pose severe risks to individuals and society , and to deter trafficking in those substances across the union , as well as the involvement of criminal organisations , permanent market restriction measures adopted under that regulation should be underpinned by proportional criminal law provisions , aimed solely to producers , suppliers and distributors rather than individual consumers .


### the proprietor of a registered trade mark shall also be entitled to prevent all third parties from bringing goods , in the context of commercial activity , into the customs territory of the member state where the trade mark is registered without being released for free circulation there , where such goods , including packaging , come from third countries and bear without authorization a trade mark which is identical to the trade mark registered in respect of such goods , or which cannot be distinguished in its essential aspects from that trade mark . ### the proprietor of a registered trade mark shall also be entitled to prevent all third parties from bringing goods , in the context of commercial activity , into the customs territory of the member state where the trade mark is registered without being released for free circulation there , where such goods , including packaging , come from a third country and bear without authorisation a trade mark which is identical to the trade mark validly registered in respect of such goods , or which cannot be distinguished in its essential aspects from that trade mark , on condition that the proprietor proves that the trade mark is also validly registered in the country of destination .


### any medical examination shall be performed in full respect of the individual ' s dignity , selecting the less invasive exams . ### any medical examination shall be performed in full respect of the individual ' s dignity , selecting the most reliable and less invasive examinations .


### member states may use medical examinations to determine the age of unaccompanied minors within the framework of the examination of an application for international protection , where , following his / her general statements or other relevant evidence , member states still have doubts concerning his / her age . ### member states may use medical examinations to determine the age of unaccompanied minors within the framework of the examination of an application for international protection , where , following his / her general statements or other relevant evidence , member states still have doubts concerning his / her age . if those doubts persist after the medical examination , any decision shall always be for the benefit of the unaccompanied minor .


### ensure that the person who conducts the interview is competent to take account of the personal or general circumstances surrounding the application , including the applicant ' s cultural origin , gender , &#160 ; or vulnerability ; ### ensure that the member of staff of the determining authority who conducts the interview is competent to take account of the personal and general circumstances surrounding the application , including the applicant ' s cultural origin , gender , &#160 ; sexual orientation , gender identity or vulnerability ;


### member states should examine all applications on the substance , i . e . assess whether the applicant in question qualifies for international protection in accordance with directive [ … / . . / ec ] [ the qualification directive ] except where the present directive provides otherwise , in particular where it can be reasonably assumed that another country would do the examination or provide sufficient protection . in particular , member states should not be obliged to assess the substance of an application for international protection where a first country of asylum has granted the applicant refugee status or otherwise sufficient protection and the applicant will be readmitted to this country . ### member states should examine all applications on the substance , i . e . assess whether the applicant in question qualifies for international protection in accordance with directive [ … / . . / ec ] [ the qualification directive ] except where the present directive provides otherwise , in particular where it can be ensured that another country would do the examination or provide accessible and efficient protection . in particular , member states should not be obliged to assess the substance of an application for international protection where a first country of asylum has granted the applicant refugee status .


### the competent authorities may search the applicant and the items he / she carries with him / her , provided the search is carried out by a person of the same sex ; ### the competent authorities may search the applicant and the items he / she carries with him / her , provided the search is carried out by a person of the same sex who is age - and culture - sensitive ;


### ‘ applicant with special needs’ means an applicant who due to age , gender , disability , mental health problems or consequences of torture , rape or other serious forms of psychological , physical or sexual violence is in need of special guarantees in order to benefit from the rights and comply with the obligations in accordance with this directive ; ### ‘ applicant with special needs’ means an applicant who due to age , gender , gender identity , disability , mental health problems or consequences of torture , rape or other serious forms of psychological , physical or sexual violence is in need of special guarantees in order to benefit from the rights and comply with the obligations in accordance with this directive ;


### a member state may extradite an applicant to a third country pursuant to paragraph 2 only where the competent authorities are satisfied that an extradition decision will not result in direct or indirect refoulement in violation of international obligations of the member state . ### a member state may extradite an applicant to a third country pursuant to paragraph 2 only where the competent authorities have established through the assessment of the united nations high commissioner for refugees and the european asylum support office that an extradition decision will not result in direct or indirect refoulement in violation of international obligations of the member state or expose the applicant to inhuman or degrading treatment upon arrival in the third country .


### member states shall also ensure that , where an application is rejected with regard to refugee status and / or subsidiary protection status , the reasons in fact and in law are stated in the decision and information on how to challenge a negative decision is given in writing . ### member states shall also ensure that , where an application is rejected or granted with regard to refugee status and / or subsidiary protection status , the reasons in fact and in law are stated in the decision and information on how to challenge a negative decision is given in writing at the time of issuing the decision .


### the personnel examining applications and taking decisions have the knowledge with respect to relevant standards applicable in the field of asylum and refugee law ; ### the personnel examining applications and taking decisions have the knowledge with respect to relevant standards applicable in the field of asylum and refugee law as well as human rights law and have completed the initial and follow - up training programme referred to in article 4 ;


### insofar as member states provide for the possibility of explicit withdrawal of the application under national law , when an applicant explicitly withdraws his / her application for international protection , member states shall ensure that the determining authority takes a decision to either discontinue the examination or reject the application . ### insofar as member states provide for the possibility of explicit withdrawal of the application under national law , when an applicant explicitly withdraws his / her application for international protection , member states shall ensure that the determining authority takes a decision to either discontinue the examination or reject the application , and explain to the applicant the consequences of the withdrawal .


### gender , trauma and age awareness ; ### gender , sexual orientation , trauma and age awareness ;


### provide for free legal assistance or representation in procedures in accordance with chapter v . this shall include , at least , the preparation of the required procedural documents and participation in the hearing before a court or tribunal of first instance on behalf of the applicant . ### provide for free legal assistance and representation in procedures in accordance with chapter v . this shall include , at least , the preparation of the required procedural documents and participation in the hearing before a court or tribunal of first instance on behalf of the applicant .


### member states shall also ensure that , where an application is rejected with regard to refugee status and / or subsidiary protection status , the reasons in fact and in law are stated in the decision and information on how to challenge a negative decision is given in writing . ### member states shall also ensure that , where an application is rejected or granted with regard to refugee status and / or subsidiary protection status , the reasons in fact and in law are stated in the decision and information on how to challenge a negative decision is given in writing .


### they shall be informed in a language which they may reasonably be supposed to understand of the procedure to be followed and of their rights and obligations during the procedure and the possible consequences of not complying with their obligations and not cooperating with the authorities . they shall be informed of the time - frame , as well as the means at their disposal for fulfilling the obligation to submit the elements as referred to in article 4 of directive [ &#8230 ; . / . . / ec ] [ the qualification directive ] . this information shall be given in time to enable them to exercise the rights guaranteed in this directive and to comply with the obligations described in article 12 ; ### they shall be informed in a language which they understand of the procedure to be followed and of their rights and obligations during the procedure and the possible consequences of not complying with their obligations and not cooperating with the authorities . they shall be informed of the time - frame , as well as the means at their disposal for fulfilling the obligation to submit the elements as referred to in article 4 of directive [ &#8230 ; . / . . / ec ] [ the qualification directive ] . this information shall be given in time to enable them to exercise the rights guaranteed in this directive and to comply with the obligations described in article 12 ;


### the competent authority is of the opinion that the applicant is unfit or unable to be interviewed owing to enduring circumstances beyond his / her control . when in doubt , the competent authority shall consult a medical expert to establish whether the condition is temporary or permanent . ### the determining authority is of the opinion that the applicant is unfit or unable to be interviewed owing to enduring circumstances beyond his / her control . when in doubt , the determining authority shall consult a medical expert to establish whether the condition is temporary or permanent .


### in the interests of a correct recognition of those persons in need of protection as refugees within the meaning of article 1 of the geneva convention or as persons eligible for subsidiary protection , every applicant should have an effective access to procedures , the opportunity to cooperate and properly communicate with the competent authorities so as to present the relevant facts of his / her case and sufficient procedural guarantees to pursue his / her case throughout all stages of the procedure . moreover , the procedure in which an application for international protection is examined should normally provide an applicant at least with the right to stay pending a decision by the determining authority , access to the services of an interpreter for submitting his / her case if interviewed by the authorities , the opportunity to communicate with a representative of the united nations high commissioner for refugees and with organizations providing advice or counselling to applicants for international protection , the right to appropriate notification of a decision , a motivation of that decision in fact and in law , the opportunity to consult a legal adviser or other counsellor , and the right to be informed of his / her legal position at decisive moments in the course of the procedure , in a language he / she can reasonably be supposed to understand and , in the case of a negative decision , the right to an effective remedy before a court or tribunal . ### in the interests of a correct recognition of those persons in need of protection as refugees within the meaning of article 1 of the geneva convention or as persons eligible for subsidiary protection , every applicant should have an effective access to procedures , the opportunity to cooperate and properly communicate with the competent authorities so as to present the relevant facts of his / her case and effective procedural guarantees to pursue his / her case throughout all stages of the procedure . moreover , the procedure in which an application for international protection is examined must normally provide an applicant at least with the right to stay pending a decision by the determining authority and , in the case of a negative decision , the time necessary for seeking a judicial remedy , access to the services of an interpreter for submitting his / her case if interviewed by the authorities , the opportunity to communicate with a representative of the united nations high commissioner for refugees and with organizations providing advice or counselling to applicants for international protection , the right to appropriate notification of a decision , a motivation of that decision in fact and in law , the opportunity to consult a legal adviser or other counsellor , and the right to be informed of his / her legal position at decisive moments in the course of the procedure , in a language he / she can understand and , in the case of a negative decision , the right to an effective remedy before a court or tribunal .


### in cases where the determining authority consider that an applicant has been subjected to torture , rape or other serious forms of psychological , physical or sexual violence as described in article 21 of directive [ … / … / ec ] [ laying down minimum standards for the reception of asylum seekers ] , the applicant shall be granted sufficient time and relevant support to prepare for a personal interview on the substance of his / her application . ### in cases where the determining authority consider that an applicant has been subjected to torture , rape or other serious forms of psychological , physical or sexual violence as described in article 21 of directive [ … / … / ec ] [ laying down minimum standards for the reception of asylum seekers ] , the applicant shall be granted sufficient time and relevant support to prepare for a personal interview on the substance of his / her application . special attention shall be given to those applicants who did not mention their sexual orientation immediately .


### applicants for international protection shall cooperate with the competent authorities with a view to establishing their identity and other elements referred to in article 4 of directive [ &#8230 ; . / . . / ec ] [ the qualification directive ] . member states may impose upon applicants other obligations to cooperate with the competent authorities insofar as these obligations are necessary for the processing of the application . ### applicants for international protection shall cooperate , to the extent of their physical and psychological capacities , with the competent authorities with a view to establishing their identity and other elements referred to in article 4 of directive [ &#8230 ; . / . . / ec ] [ the qualification directive ] . member states may impose upon applicants other obligations to cooperate with the competent authorities insofar as these obligations are necessary for the processing of the application .


### each programme , except those where technical assistance is undertaken under a specific programme , shall set out the indicative amount of support to be used for climate change objectives . ### each programme , except those where technical assistance is undertaken under a specific programme , shall set out the indicative amount of support to be used for climate change and biodiversity objectives , including the management of natura 2000 network .


### ‘ substantial modification’ : any change to any aspect of the clinical trial which is made after notification of the decision referred to in articles 8 , 14 , 19 , 20 and 23 and which is likely to have a substantial impact on the safety or rights of the subjects or on the reliability and robustness of the data generated in the clinical trial ; ### ' substantial modification ' : any change to any aspect of the clinical trial , including early termination of the trial , which is made after notification of the decision referred to in articles 8 , 14 , 19 , 20 and 23 which may have a substantial impact on the safety or rights of the subjects or on the reliability and robustness of the data generated in the clinical trial , i . e . change the interpretation of the scientific documents used to support the conduct of the trial , or if the modifications are otherwise significant .


### ‘ substantial modification’ : any change to any aspect of the clinical trial which is made after notification of the decision referred to in articles 8 , 14 , 19 , 20 and 23 and which is likely to have a substantial impact on the safety or rights of the subjects or on the reliability and robustness of the data generated in the clinical trial ; ### ' substantial modification ' : any change to any aspect of the clinical trial , including early termination of the clinical trial and change in number of subjects participating in the trial , which is made after notification of the decision referred to in articles 8 , 14 , 19 , 20 and 23 and which could have a substantial impact on the safety or rights of the subjects , or on the reliability and robustness of the data generated in the clinical trial , i . e . change the interpretation of the scientific documents used to support the conduct of the clinical trial , or if the modifications are otherwise significant .


### the conditions and criteria on the basis of which an application for a single permit can be rejected is laid down in national law including the obligation to respect the principle of community preference as expressed in particular in the relevant provisions of the acts of accession of 16 april 2003 and 25 april 2005 . ### the conditions and criteria on the basis of which an application for a single permit can be rejected should be objective , verifiable and laid down in national law including the obligation to respect the principle of community preference as expressed in particular in the relevant provisions of the acts of accession of 16 april 2003 and 25 april 2005 .


### any decision rejecting the application , not granting , modifying or renewing , suspending or withdrawing a single permit shall be open to challenge before the courts of the member state concerned . the written notification shall specify the possible redress procedures available and the time - limit for taking action . ### any decision rejecting the application , not granting , modifying or renewing , suspending or withdrawing a single permit shall be open to challenge before the courts of the member state concerned . the written notification shall specify the court or administrative authority with which the person concerned may lodge an appeal and the time - limit for the appeal .


### have free access to the entire territory of the member state issuing the single permit within the limits provided for by national legislation for reasons of security ; ### have free access to the entire territory of the member state issuing the single permit . member states may impose territorial restrictions on the right of residence and the right to work within the limits provided for by national legislation for reasons of security , only where the same restrictions apply to their own nationals ;


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


### the 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 , which could include the introduction of harmonised measures to ensure sustainability of advanced transport fuels in the sustainability scheme as of 1st january 2021 .


### biofuels produced from feedstocks listed in part b of annex ix shall be considered to be twice their energy content ; ### biofuels produced from feedstocks listed in part b of annex ix shall be considered to be once their energy content ;


### to prepare for the transition towards advanced biofuels and minimise the overall indirect land use change impacts in the period to 2020 , it is appropriate to limit the amount of biofuels and bioliquids obtained from food crops as set out in part a of annex viii to directive 2009 / 28 / ec and part a of annex v to directive 98 / 70 / ec that can be counted towards targets set out in directive 2009 / 28 / ec . without restricting the overall use of such biofuels , the share of biofuels and bioliquids produced from cereal and other starch rich crops , sugar and oil crops that can be counted towards the targets of directive 2009 / 28 / ec should be limited to the share of such biofuels and bioliquids consumed in 2011 . ### to prepare for the transition towards advanced biofuels and minimise the overall indirect land use change impacts in the period to 2020 , it is appropriate to limit the amount of biofuels and bioliquids obtained from food or energy crops as set out in part a of annex viii to directive 2009 / 28 / ec and part a of annex v to directive 98 / 70 / ec that can be counted towards targets set out in directive 2009 / 28 / ec . without restricting the overall use of such biofuels , the share of biofuels and bioliquids produced from cereal and other starch rich crops , sugar , oil and energy crops that can be counted towards the targets of directive 2009 / 28 / ec should be limited to 3% of the final consumption of energy in transport in 2020 .


### to prepare for the transition towards advanced biofuels and minimise the overall indirect land use change impacts in the period to 2020 , it is appropriate to limit the amount of biofuels and bioliquids obtained from food crops as set out in part a of annex viii to directive 2009 / 28 / ec and part a of annex v to directive 98 / 70 / ec that can be counted towards targets set out in directive 2009 / 28 / ec . without restricting the overall use of such biofuels , the share of biofuels and bioliquids produced from cereal and other starch rich crops , sugar and oil crops that can be counted towards the targets of directive 2009 / 28 / ec should be limited to the share of such biofuels and bioliquids consumed in 2011 . ### to prepare for the transition towards advanced and sustainable biofuels and minimise the overall indirect land use change impacts in the period to 2020 , it is appropriate to limit the amount of biofuels and bioliquids obtained from food crops as set out in part a of annex viii to directive 2009 / 28 / ec and part a of annex v to directive 98 / 70 / ec that can be counted towards targets set out in those directives . the share of biofuels and bioliquids produced from cereal and other starch rich crops , sugar and oil crops that can be counted towards the targets or receive public funding pursuant to directive 2009 / 28 / ec should be limited to the share of such biofuels and bioliquids consumed in 2011 . biofuels and bioliquids imported from third countries are counted towards this target . for the same reason and in order to avoid unequal treatment of biofuels and bioliquids from raw materials with similar impacts , it is appropriate to apply the same treatment to advanced biofuels .


### the 5% limit set up in article 3d does not affect the member states ' freedom to arrange their own trajectory as to compliance with this prescribed share of conventional biofuels within the overall 10% target . as a consequence , the access to the market of the biofuels produced by the installations in operation before the end of 2013 remains fully open . therefore this amending directive does not affect the legitimate expectations of the operators of such installations . ### the 3% limit set up in article 3d does not affect the member states ' freedom to arrange their own trajectory as to compliance with the overall renewable energy target . the access to the market of the biofuels produced by the installations in operation before the end of 2013 remains fully open . therefore this amending directive does not affect the legitimate expectations of the operators of such installations .


### 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 .


### in order to ensure the long - term competitiveness of bio - based industrial sectors , and in line with the 2012 communication ‘ innovating for sustainable growth : a bioeconomy for europe’ and the roadmap to a resource efficient europe , promoting integrated and diversified biorefineries across europe , enhanced incentives under directive 2009 / 28 / ec should be set in a way that gives preference to the use of biomass feedstocks that do not have a high economic value for other uses than biofuels . ### in order to ensure the long - term competitiveness of bio - based industrial sectors , and in line with the 2012 communication ‘ innovating for sustainable growth : a bioeconomy for europe’ and the roadmap to a resource efficient europe , promoting integrated and diversified biorefineries across europe , enhanced incentives under directive 2009 / 28 / ec should be set in a way that gives preference to the use of biomass feedstocks that do not have a high economic value for other uses than biofuels and bioliquids .


### 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 .


### article 3 of directive 2009 / 28 / ec on the promotion of the use of energy from renewable energy sources and amending and subsequently repealing directives 2001 / 777 / ec and 2003 / 30 / ec requires member states to ensure that the share of energy from renewable energy sources in all forms of transport in 2020 is at least 10% of their final energy consumption . the blending of biofuels is one of the methods available for member states to meet this target , and is expected to be the main contributor . ### article 3 of directive 2009 / 28 / ec on the promotion of the use of energy from renewable energy sources and amending and subsequently repealing directives 2001 / 777 / ec and 2003 / 30 / ec requires member states to ensure that the share of energy from renewable energy sources in all forms of transport in 2020 is at least 10% of their final energy consumption . the need for reducing the energy consumption in the transport sector is imperative because a mandatory percentage target for energy from renewable sources is likely to become increasingly difficult to achieve sustainably if overall demand for energy for transport continues to rise . the use of electricity from renewable energy sources and blending of zero and low iluc biofuels are other methods available for member states to meet this target .


### based on forecasts of biofuel demand provided by the member states and estimates of indirect land - use change emissions for different biofuel feedstocks it is likely that greenhouse gas emissions linked to indirect land use change are significant , and could negate some or all of the greenhouse gas savings of individual biofuels . this is because almost the entire biofuel production in 2020 is expected to come from crops grown on land that could be used to satisfy food and feed markets . in order to reduce such emissions , it is appropriate to distinguish between crop groups such as oil crops , cereals , sugars and other starch containing crops accordingly . ### based on forecasts of biofuel demand provided by the member states and estimates of indirect land - use change emissions for different biofuel feedstocks greenhouse gas emissions linked to indirect land use change are significant , and will negate some or all of the greenhouse gas savings of individual biofuels . this is because almost the entire biofuel production in 2020 is expected to come from crops grown on land that could be used to satisfy food and feed markets . furthermore , biofuel production from food crops contributes to food price volatility . in order to reduce such emissions and mitigate such negative effects on food security , it is appropriate to set up the 5% limit laid down in article 3d as well as take into account indirect land - use change emissions when calculating the greenhouse gas emission savings required under the sustainability criteria set out in directive 2009 / 28 / ec and directive 98 / 70 / ec .


### in view of the union ' s objectives to further reduce greenhouse gas emissions and the significant contribution that road transport fuels make to those emissions , article 7a of directive 98 / 70 / ec relating to the quality of petrol and diesel fuels and amending council directive 93 / 12 / ec requires fuel suppliers to reduce by at least 6% by 31 december 2020 the life cycle greenhouse gas emissions per unit of energy of fuels used in the union by road vehicles , non - road mobile machinery , agricultural and forestry tractors and recreational craft when not at sea . the blending of biofuels is one of the methods available for fossil fuel suppliers to reduce the greenhouse gas intensity of the fossil fuels supplied . ### in view of the union ' s objectives to further reduce greenhouse gas emissions and the significant contribution that road transport fuels make to those emissions , article 7a of directive 98 / 70 / ec relating to the quality of petrol and diesel fuels and amending council directive 93 / 12 / ec [ 1 ] requires fuel suppliers to reduce by at least 6% by 31 december 2020 the life cycle greenhouse gas emissions per unit of energy of fuels used in the union by road vehicles , non - road mobile machinery , agricultural and forestry tractors and recreational craft when not at sea . the blending of zero or low greenhouse gas emissions biofuels and other fuels derived from unavoidable waste gas using carbon capture and utilisation for transport purposes are among the methods available for fossil fuel suppliers to reduce the greenhouse gas intensity of the fossil fuels supplied . in order to ensure investment security for such advanced transport fuels , the 2020 target should be complemented with a binding annual trajectory leading to 10% reductions in greenhouse gas intensity of fuels used in the union in 2025 .


### based on forecasts of biofuel demand provided by the member states and estimates of indirect land - use change emissions for different biofuel feedstocks it is likely that greenhouse gas emissions linked to indirect land use change are significant , and could negate some or all of the greenhouse gas savings of individual biofuels . this is because almost the entire biofuel production in 2020 is expected to come from crops grown on land that could be used to satisfy food and feed markets . in order to reduce such emissions , it is appropriate to distinguish between crop groups such as oil crops , cereals , sugars and other starch containing crops accordingly . ### based on forecasts of biofuel demand provided by the member states and estimates of indirect land - use change emissions for different biofuel feedstocks greenhouse gas emissions linked to indirect land use change are significant , and will negate some or all of the greenhouse gas savings of individual biofuels . this is because almost the entire biofuel production in 2020 is expected to come from crops grown on land that could be used to satisfy food and feed markets . furthermore , increased use of biofuels produced from food crops contributes to food price volatility and could have negative impacts on for global food security . this has had significant negative social impacts on livelihoods and the ability to realise human rights including the right to food or access to land for local communities living in poverty in countries outside the union . in order to reduce such emissions and such negative social impacts , it is appropriate to in particular focus on reducing the projected use of biofuels grown on land .


### in point , the following phrase is added : ' this indent shall be without prejudice to articles 17a and 3d ; ' ### point is replaced by the following : ' for the calculation of the numerator , that is the amount of energy from renewable energy sources and from carbon capture and utilisation consumed in transport for the purposes of the first subparagraph , the types of advanced renewable energy from feedstock specified in annex ix , renewable electricity and energy from ccu for transport purposes shall be taken into account . this indent shall be without prejudice to articles 17a and 3d ; '


### for the calculation of biofuels in the numerator , the share of energy from biofuels produced from cereal and other starch rich crops , sugars and oil crops shall be no more than 5% , the estimated share at the end of 2011 , of the final consumption of energy in transport in 2020 . ### the share of energy from biofuels produced from cereal and other starch rich crops , sugars , oil and energy crops shall be no more than 3% , the estimated share at the end of 2011 , of the final consumption of energy in transport in 2020 .


### based on forecasts of biofuel demand provided by the member states and estimates of indirect land - use change emissions for different biofuel feedstocks it is likely that greenhouse gas emissions linked to indirect land use change are significant , and could negate some or all of the greenhouse gas savings of individual biofuels . this is because almost the entire biofuel production in 2020 is expected to come from crops grown on land that could be used to satisfy food and feed markets . in order to reduce such emissions , it is appropriate to distinguish between crop groups such as oil crops , cereals , sugars and other starch containing crops accordingly . ### based on forecasts of biofuel demand provided by the member states and estimates of indirect land - use change emissions for different biofuel feedstocks it is likely that greenhouse gas emissions linked to indirect land use change are significant , and could negate some or all of the greenhouse gas savings of individual biofuels . this is because land - based biofuels have received a large amount of public subsidies and therefore , almost the entire biofuel production in 2020 is expected to come from crops grown on land that could be used to satisfy food and feed markets . indirect land - use changes , according to the recommendations of the commission impact assessment , need to be taken into account so as to prevent these potential sources of emissions . in order to reduce indirect land - use changes , it is appropriate to distinguish between crop groups such as oil crops , cereals , sugars and other starch containing crops accordingly . furthermore , in order to find medium and long - term solutions , it is necessary to encourage research and development in new advanced biofuels sectors that are not in competition with food crops and to further study the impact of different groups of crops on both direct and indirect land use changes .


### efficient management of the external borders through checks and surveillance contributes to combat illegal immigration and trafficking in human beings and to reduce the threats to the internal security , public policy , public health and international relations of the member states . ### efficient management of the external borders through checks and surveillance contributes to combat irregular immigration and trafficking in human beings and to reduce the threats to the internal security , public policy , public health and international relations of the member states .


### the activities referred to in paragraphs 2 and 6 shall be subject to receiving a prior favourable opinion of the commission . ### the activities referred to in paragraphs 2 and 6 shall be subject to receiving a prior favourable opinion of the commission . the european parliament shall be informed at all stages of any working arrangements that the agency concludes with the authorities of third countries .


### the agency may benefit from union funding in accordance with the provisions of the relevant instruments supporting the union ' s external relations policy . it may launch and finance technical assistance projects in third countries regarding matters covered by this regulation . the agency may also invite representatives of third countries , other european union agencies and bodies or international organisations to participate in its activities referred to in articles 3 , 4 and 5 . these representatives shall receive the appropriate training from the agency prior to their participation . ### the agency may benefit from union funding in accordance with the provisions of the relevant instruments supporting the union ' s external relations policy . it may launch and finance technical assistance projects in third countries regarding matters covered by this regulation . the agency shall ensure that assistance to operations within the framework of these projects is not provided to third countries where there are reasons to believe that such operations could lead to violations of fundamental rights . the agency may also invite representatives of third countries , other european union agencies and bodies or international organisations to participate in its activities referred to in articles 3 , 4 and 5 . these representatives shall receive the appropriate training from the agency prior to their participation , in particular in relation to fundamental rights .


### the agency should provide training , including on fundamental rights , at european level for national instructors of border guards and additional training and seminars related to control and surveillance at the external borders and removal of third - country nationals illegally present in the member states for officers of the competent national services . the agency may organise training activities in cooperation with member states on their territory . member states should integrate the results of the agency’s work in this perspective in the national training programs of their border guards . ### the agency should provide training , including on fundamental rights , at european level for national instructors of border guards and additional training and seminars related to control and surveillance at the external borders and removal of third - country nationals irregularly present in the member states for officers of the competent national services . the agency may organise training activities in cooperation with member states on their territory . member states should integrate the results of the agency’s work in this perspective in the national training programs of their border guards .


### the agency shall develop a code of conduct for the return of illegally present third country nationals by air which shall apply during all joint return operations coordinated by the agency , describing common standardized procedures which should simplify the organisation of joint return flights and assure return in a humane manner and in full respect for fundamental rights , in particular the principles of human dignity , prohibition of torture and of inhuman or degrading treatment or punishment , right to liberty and security , the rights to the protection of personal data and non discrimination . ### the agency shall develop a code of conduct for the return of illegally present third country nationals by air which shall apply during all joint return operations coordinated by the agency , describing common standardized procedures which should simplify the organisation of joint return flights and assure return in a humane manner and in full respect for fundamental rights , in particular the principles of human dignity , prohibition of torture and of inhuman or degrading treatment or punishment , right to liberty and security , the rights to the protection of personal data and non discrimination . the code of conduct should allow for the suspension of a return where there are reasons to believe that the return would lead to a violation of fundamental rights .


### when deliberating on an individual entity or a group established only in one participating member state , the board shall take its decisions in its executive sessions by a simple majority of its participating members . in case of a tie the executive director shall have a casting vote . ### when deliberating on an individual entity or a group established only in one participating member state , the board shall take its decisions in its executive sessions by a simple majority of the participating members referred to in article 49 . in case of a tie the executive director shall have a casting vote .


### where a national resolution authority has not applied a decision referred to in article 16 , or has applied it in a way which fails to achieve the resolution objectives under this regulation , the board shall have the power to order an institution under resolution : ### where a national resolution authority has not applied a decision referred to in article 16 , or has applied it in a way which fails to achieve the resolution objectives under this regulation , the board shall have the power to order an institution under resolution or exercise any other powers provided for in directive [ brrd ] :


### the board may contract for the fund borrowings or other forms of support from financial institutions or other third parties , in the event that the amounts raised in accordance with articles 66 and 67 are not immediately accessible or sufficient to cover the expenses incurred by the use of the fund . ### the board may contract for the fund borrowings or other forms of support from , first private and , where this is not possible , public financial institutions or other third parties , in the event that the amounts raised in accordance with articles 66 and 67 are not immediately accessible or sufficient to cover the expenses incurred by the use of the fund .


### the commission shall be empowered to adopt delegated acts in accordance with article 82 to specify the following : ### without prejudice to paragraph 1 second subparagraph , the commission shall be empowered to adopt delegated acts in accordance with article 82 to specify the following :


### for the purposes of point of the first subparagraph , for medicinal products included on the list referred to in article 23 of regulation no 726 / 2004 , the summary shall include the statement : “this medicinal product is under intensive monitoring . all suspected adverse reactions should be reported to . &#8221 ; ### for medicinal products included on the list referred to in article 23 of regulation no 726 / 2004 , the leaflet shall include the statement : “this newly authorised medicinal product is under intensive monitoring in order to increase knowledge on its adverse reactions . all suspected adverse reactions should be reported to &#8221 ; . the statement shall be accompanied by an inverted black triangle &#61553 ; . the black triangle shall also appear on the outer packaging .


### in order to make it possible for the healthcare professionals and patients to identify easily the most relevant information about the medicines they use , the summary of the product characteristics and the package leaflet should include a concise section on the key information about the medicinal product and information how to minimize its risks and maximize its benefits . ### within five years of the entry into force of this directive , the commission shall , following consultations with patient and consumer organisations , health care professional organisations , member states and other interested parties , present to the european parliament and the council an assessment report regarding the readability of the summaries of product characteristics and the packaging leaflets . following an analysis of such data , the commission shall , if appropriate , put forward proposals to improve the layout and the content of the summaries of product characteristics and of the packaging leaflet to ensure they are a valuable source of information for the general public and health care professionals .


### the member states shall record all suspected adverse reactions that occur in their territory which are brought to their attention from healthcare professionals and patients . member states shall ensure that reports of such reactions are submitted by means of the national medicines safety web - portals . 2 . member states shall , within 15 days following the receipt of the reports referred to in paragraph 1 , submit the reports electronically to the eudravigilance database . marketing authorisation holders shall access those reports through the eudravigilance database . 3 . the member states shall ensure that reports of medication errors brought to their attention in the framework of suspected adverse reaction reporting for medicinal products are made available to the eudravigilance database and to any authorities responsible for patient safety within that member state . they shall also ensure that the authorities responsible for medicinal products within that member state are informed of any suspected adverse reactions brought to the attention of the authorities responsible for patient safety within that member state . ### the member states shall record all suspected adverse reactions that occur in their territory which are brought to their attention by healthcare professionals , patients , marketing authorisation holders and programmes for the reporting and prevention of medication errors . member states shall ensure that reports of such reactions can be submitted by means of the national medicines safety web - portals , as well as by mail , telephone and fax . 2 . member states shall , within 15 days following the receipt of the reports referred to in paragraph 1 , submit electronically to the database and data - processing network referred to in article 24 of regulation no 726 / 2004 information on all adverse reactions that occur within their territory within 15 days following the receipt of the report or , in the absence of a report , following the day on which the competent authority gained knowledge of the event . marketing authorisation holders , healthcare professionals and the public shall access those reports through the eudravigilance database , which must be permanently accessible without delay . 3 . the member states shall ensure that reports of medication errors brought to their attention in the framework of suspected adverse reaction reporting for medicinal products are made available to the eudravigilance database , to any authorities responsible for patient safety within that member state and to independent programmes for the reporting and prevention of medication errors . they shall also ensure that the authorities responsible for medicinal products within that member state are informed of any suspected adverse reactions brought to the attention of the authorities responsible for patient safety within that member state .


### the annual general report referred to in article 8 shall record the implementation of the agency work programmes . ### the annual report referred to in article 6 shall include information on : the implementation of the multiannual and annual work programmes , including with regard to the performance indicators ; the budget and staff policy plan ; the agency ' s management and internal control systems ; internal and external audit findings ; the follow - up to the audit recommendations and to the discharge recommendation ; the statement of assurance of the executive director . the annual report shall be made public .


### the commission shall be empowered to adopt delegated acts in accordance with article 59 concerning technical and organisational requirements for the practical implementation of electronic data interchange for the submission of documents and information . ### the commission shall adopt delegated acts in accordance with article 59 concerning technical and organisational requirements for the practical implementation of electronic data interchange for the submission of documents and information no later than . . . * . the commission shall be empowered to adopt delegated acts in accordance with article 59 concerning the update of these technical and organisational requirements . __________ * oj : please insert the date : 18 months after the entry into force of this regulation


### for wild salmon rivers which have reached 50 % of the potential smolt production capacity by the time of the entry into force of this regulation , the wild smolt production shall reach 75 % of the potential smolt production capacity for each river in five years after the entry into force of this regulation . ### for wild salmon rivers which have reached 50 % of the potential smolt production capacity by the time of the entry into force of this regulation , the wild smolt production shall reach 80 % of the potential smolt production capacity for each river in five years after the entry into force of this regulation .


### stocking of salmon may only be conducted in wild salmon river . the number of released smolts in each river shall not exceed the estimated potential smolt production capacity of the river . ### stocking of salmon may only be conducted in wild salmon rivers when required to prevent the extermination of the local stock .


### after ten years from the entry into force of this regulation , the wild salmon smolt production shall be maintained at a level of at least 75% of the potential smolt production capacity in each wild salmon river . ### after ten years from the entry into force of this regulation , the wild salmon smolt production shall be maintained at a level of at least 80 % of the potential smolt production capacity in each wild salmon river .


### for wild salmon rivers which have not reached 50 % of the potential smolt production capacity by the time of the entry into force of this regulation , the wild smolt production shall reach 50% of the potential smolt production capacity for each river in five years and 75 % in ten years after the entry into force of this regulation . ### for wild salmon rivers which have not reached 50 % of the potential smolt production capacity by the time of the entry into force of this regulation , the wild smolt production shall reach 50 % of the potential smolt production capacity for each river in five years and 80 % in ten years after the entry into force of this regulation .


### requests by railway undertakings for access to the service facility may only be rejected if there are viable alternatives allowing them to operate the freight or passenger service concerned on the same route under economically acceptable conditions . the burden of proving for the existence of a viable alternative lies with the operator of the service facility . ### requests by railway undertakings for access to the service facility may only be rejected if excess capacity is insufficient to make it possible to satisfy these requests for access . the operator of the service facility has to provide a justification and has to prove the unavailability of sufficient excess capacity . in case of conflict the applicant can appeal against the denial of access to the regulatory body .


### investment in railway infrastructure is necessary and infrastructure charging schemes should provide incentives for infrastructure managers to make appropriate investments economically attractive . ### increased investment in railway infrastructure - in particular existing infrastructure - is necessary and infrastructure charging schemes should provide incentives for infrastructure managers to make appropriate investments economically attractive and environmentally sustainable .


### the competent authorities and the railway undertakings providing the public services shall provide the relevant regulatory body or bodies with the information reasonably required to reach a decision . the regulatory body shall consider the information provided , consulting all the relevant parties as appropriate , and shall inform the relevant parties of its reasoned decision within a pre - determined , reasonable time , and , in any case , within two months of receipt of all relevant information . ### the competent authorities and the railway undertakings providing the public services shall provide the relevant regulatory body or bodies with the information reasonably required to reach a decision . the regulatory body shall consider the information provided , consulting all the relevant parties as appropriate , and shall inform the relevant parties of its reasoned decision within a pre - determined , reasonable time , and , in any case , within 20 working days of receipt of the request .


### in order to ensure the future development and efficient operation of the railway system , a distinction should be made between the provision of transport services and the operation of infrastructure . given this situation , it is necessary for these two activities to be managed separately and to have separate accounts . ### in order to ensure the future development and efficient operation of the railway system , a distinction should be made between the provision of transport services on the one hand , and the operation of infrastructure on the other hand . given this situation , it is necessary for these two activities to be managed separately and to have separate accounts as originally laid down in article 6 of directive 91 / 440 eec and subsequently amended by directive 2001 / 12 / ec . whether and to what extend member states have so far complied with directive 91 / 440 eec and directive 2001 / 12 / ec is to be assessed by the court and this legislation shall therefore not impede the ongoing infringement procedures concerning the implementation of these directives . given that there is no unambiguous relationship between the degree of market opening and the separation of infrastructure and railway service provisions , the purpose of this recast is to establish an open access within the eu railway network and to abolish illegal national obstacles . this recast therefore intends to clarify and make more effective the existing provisions and not to introduce new requirements in this regard .


### the commission and representatives of the regulatory bodies , which co - operate according to article 57 , shall be informed of and invited to attend as observers all meetings at which common principles and practices for the allocation of infrastructure are developed . in the case of it - based allocation systems , the regulatory bodies shall receive sufficient information from these systems to allow them to perform their regulatory supervision in accordance with the provisions of article 56 . ### the commission and representatives of the regulatory bodies , which co - operate according to article 57 , shall be informed of common principles and practices for the allocation of infrastructure . in the case of it - based allocation systems , the regulatory bodies shall receive sufficient information from these systems to allow them to perform their regulatory supervision in accordance with the provisions of article 56 .


### in order to ensure dependable and adequate services , it is necessary to ensure that , at all times , railway undertakings meet certain requirements in relation to good repute , financial fitness and professional competence . ### in order to ensure dependable and adequate services , it is necessary to ensure that , at all times , railway undertakings meet certain requirements in relation to good repute , financial fitness , social standards and professional competence .


### member states shall ensure that authorisation and selection procedures avoid delays and promote effective competition . ### member states shall ensure that authorisation and selection procedures avoid delays and promote effective competition by preventing any potential anti - competitive outcomes for the benefit of eu citizens and consumers .


### the commission , assisted by the member states , which shall provide all appropriate information on spectrum use , shall create an inventory of existing spectrum use and of possible future needs for spectrum in the union , in particular in the range from 300 mhz to 3 ghz . ### the commission , assisted by the member states , which shall provide all necessary information on spectrum use , shall create an inventory of existing spectrum use . the provided information shall be sufficiently detailed to allow for the inventory to assess the efficiency of the spectrum use as well as identify possible future needs for spectrum in the union , in particular in the range from 300 mhz to 3 ghz . if necessary the member states shall supply information on a licence - specific basis both including commercial and public sector users without prejudice to the withholding of business sensitive and confidential information .


### member states shall foster , in cooperation with the commission , the collective use of spectrum as well as shared use of spectrum . ### member states shall foster , in cooperation with the commission , the collective use of spectrum as well as shared and unlicensed use of spectrum .


### member states shall ensure that authorisation and selection procedures avoid delays and promote effective competition . ### member states shall ensure that authorisation and selection procedures avoid delays , are non - discriminatory and promote effective competition .


### guaranteeing the functioning of the internal market , in particular by ensuring effective competition . ### guaranteeing the development of the internal market and digital services by ensuring effective competition , a level playing field and by promoting the emergence of pan - european operators .


### in order to implement fully the obligations of paragraph 1 , and in particular to ensure that competition is not distorted by any accumulation , transfer or modification of rights of use for radio frequencies , member states may adopt inter alia the following measures , which are without prejudice to the application of competition rules : ### in order to fully implement the obligations of paragraph 1 , and in particular to ensure that competition is not distorted by any assignment , accumulation , transfer or modification of rights of use for radio frequencies , member states shall , prior to a planned spectrum assignment , conduct a thorough market analysis examining whether the assignment is likely to distort or reduce competition in the mobile markets concerned , taking into account existing spectrum rights held by relevant market operators . if the spectrum assignment is likely to distort or reduce competition , member states shall adopt the most appropriate measures to promote effective competition , and at least one of the following measures , which are without prejudice to the application of competition rules :


### if necessary , the commission shall ensure that sufficient spectrum is made available under harmonised conditions to support the development of safety services and the free circulation of related devices as well as the development of innovative interoperable solutions for public safety and protection , civil protection and disaster relief . ### the commission shall ensure that sufficient spectrum is made available under harmonised conditions to support the development of safety services and the free circulation of related devices as well as the development of innovative interoperable solutions for public safety and protection , civil protection and disaster relief .


### optimal and efficient spectrum use requires continuous monitoring of developments , and up - to - date transparent information on spectrum use throughout the union . while commission decision 2007 / 344 / ec on harmonised availability of information regarding spectrum use within the community6 requires member states to publish information on usage rights , a detailed inventory of existing spectrum use together with an effective review and assessment methodology are necessary in the union to improve the efficiency of spectrum and radio equipment use , in particular between 300 mhz and 3 ghz . this would help to identify inefficient technologies and usages in both the commercial and public sectors , as well as unused assignments and sharing opportunities , and to evaluate future consumer and business needs . ### optimal and efficient spectrum use requires continuous monitoring of developments , and up - to - date transparent information on spectrum use throughout the union . while commission decision 2007 / 344 / ec on harmonised availability of information regarding spectrum use within the community6 requires member states to publish information on usage rights , a detailed inventory of existing spectrum use together with an effective review and assessment methodology are necessary in the union to improve the efficiency of spectrum and radio equipment use , in particular between 300 mhz and 6 ghz . this would help to identify inefficient technologies and usages in both the commercial and public sectors , as well as unused assignments and sharing opportunities , and to evaluate future consumer and business needs .


### applying the least onerous authorisation system possible in such a way as to maximise flexibility and efficiency in spectrum usage ; ### applying the most appropriate , non - discriminatory and least onerous authorisation system possible in such a way as to maximise flexibility and efficiency in spectrum usage ;


### as underlined in the digital agenda for europe , wireless broadband is an important means to boost competition , consumer choice and access in rural and other areas where deployment of wired broadband is difficult or economically unviable . however , spectrum management may affect competition by changing the role and power of market players , for example if existing users receive undue competitive advantages . limited spectrum access , in particular when appropriate spectrum becomes scarcer , can create a barrier to entry for new services or applications and hamper innovation and competition . acquisition of new usage rights , including through spectrum trading or other transactions between users , and the introduction of new flexible criteria for spectrum use can have an impact on the existing competitive situation . member states should therefore take appropriate ex ante or ex post regulatory measures to avoid distortions of competition in line with the principles underpinning article 5 of directive 2002 / 20 / ec and article 1 of directive 87 / 372 / eec . ### as underlined in the digital agenda for europe , wireless broadband is an important means to boost competition , a pan - european level playing field , consumer choice and access in rural and other areas where deployment of wired broadband is difficult or economically unviable . however , spectrum management may affect competition by changing the role and power of market players , for example if existing users receive undue competitive advantages . limited spectrum access , in particular when appropriate spectrum becomes scarcer , can create a barrier to entry for new services or applications and hamper innovation and competition . acquisition of new usage rights , including through spectrum trading or other transactions between users , and the introduction of new flexible criteria for spectrum use can have an impact on the existing competitive situation . member states should therefore take appropriate ex ante or ex post regulatory measures to avoid distortions of competition in line with the principles underpinning article 5 of directive 2002 / 20 / ec and article 1 of directive 87 / 372 / eec . member states may also take steps to achieve more even spectrum allocation between economic operators by reserving spectrum for new entrants to a frequency band or group of bands with similar characteristics .


### member states may limit the amount of spectrum for which rights of use are granted to any economic operator or may attach conditions to such rights of use , such as the provision of wholesale access , in certain bands or in certain groups of bands with similar characteristics , for instance the bands below 1 ghz allocated to electronic communication services ; ### member states may limit the amount of spectrum for which rights of use are granted to any economic operator or may attach conditions to such rights of use , such as the provision of wholesale access , national or regional roaming , in certain bands or in certain groups of bands with similar characteristics , for instance the bands below 1 ghz allocated to electronic communication services ;


### where the appropriate safeguards with respect to the protection of personal data are not provided for in a legally binding instrument , the controller or processor shall obtain prior authorisation for the transfer , or a set of transfers , or for provisions to be inserted into administrative arrangements providing the basis for such transfer . such authorisation by the supervisory authority shall be in accordance with point of article 34 . if the transfer is related to processing activities which concern data subjects in another member state or other member states , or substantially affect the free movement of personal data within the union , the supervisory authority shall apply the consistency mechanism referred to in article 57 . authorisations by a supervisory authority on the basis of article 26 of directive 95 / 46 / ec shall remain valid , until amended , replaced or repealed by that supervisory authority . ### authorisations by a supervisory authority on the basis of article 26 of directive 95 / 46 / ec shall remain valid for two years after the entry into force of this regulation , or until amended , replaced or repealed by that supervisory authority .


### in cases where data subjects in several member states are likely to be affected by processing operations , a supervisory authority of each of those member states shall have the right to participate in the joint investigative tasks or joint operations , as appropriate . the competent supervisory authority shall invite the supervisory authority of each of those member states to take part in the respective joint investigative tasks or joint operations and respond to the request of a supervisory authority to participate in the operations without delay . ### in cases where the controller or processor has establishments in several member states or where data subjects in several member states are likely to be affected by processing operations , a supervisory authority of each of those member states shall have the right to participate in the joint investigative tasks or joint operations , as appropriate . the lead authority as defined in article 54a shall invite the supervisory authority of each of those member states to take part in the respective joint investigative tasks or joint operations and respond to the request of a supervisory authority to participate in the operations without delay . the lead authority shall act as the single contact point for the controller or processor .


### in order to fulfil the objectives of this regulation , namely to protect the fundamental rights and freedoms of natural persons and in particular their right to the protection of personal data and to ensure the free movement of personal data within the union , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . in particular , delegated acts should be adopted in respect of lawfulness of processing ; specifying the criteria and conditions in relation to the consent of a child ; processing of special categories of data ; specifying the criteria and conditions for manifestly excessive requests and fees for exercising the rights of the data subject ; criteria and requirements for the information to the data subject and in relation to the right of access ; the right to be forgotten and to erasure ; measures based on profiling ; criteria and requirements in relation to the responsibility of the controller and to data protection by design and by default ; a processor ; criteria and requirements for the documentation and the security of processing ; criteria and requirements for establishing a personal data breach and for its notification to the supervisory authority , and on the circumstances where a personal data breach is likely to adversely affect the data subject ; the criteria and conditions for processing operations requiring a data protection impact assessment ; the criteria and requirements for determining a high degree of specific risks which require prior consultation ; designation and tasks of the data protection officer ; codes of conduct ; criteria and requirements for certification mechanisms ; criteria and requirements for transfers by way of binding corporate rules ; transfer derogations ; administrative sanctions ; processing for health purposes ; processing in the employment context and processing for historical , statistical and scientific research purposes . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### in order to fulfil the objectives of this regulation , namely to protect the fundamental rights and freedoms of natural persons and in particular their right to the protection of personal data and to ensure the free movement of personal data within the union , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . in particular , delegated acts should be adopted specifying the technical standars to give consent ; specifyng conditions of icon - based mode for provision of information ; specifying the criteria and conditions for fees for exercising the rights of the data subject ; criteria and requirements for the information to the data subject and in relation to the right of access ; the right to be forgotten and to erasure ; criteria and requirements for verification of the responsibility of the controller ; criteria and requirements for establishing a personal data breach and for its notification to the supervisory authority , and on the circumstances where a personal data breach is likely to adversely affect the data subject ; the criteria and conditions for processing operations requiring a data protection impact assessment ; the criteria and requirements for determining a high degree of specific risks which require prior consultation ; codes of conduct ; criteria and requirements for certification mechanisms ; the adequate level of protection afforded by a third country or an international organisation ; administrative sanctions ; processing for health purposes ; processing in the employment context and processing for historical , statistical and scientific research purposes . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level in particular with the european data protection board . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council .


### the conditions for deleting links , copies or replications of personal data from publicly available communication services as referred to in paragraph 2 ; ### the conditions for deleting personal data from publicly available communication services as referred to in paragraph 2 ;


### the identity and the contact details of the controller and , if any , of the controller ' s representative and of the data protection officer ; ### the identity and the contact details of the controller and , if any , of the controller ' s representative , of the data protection officer and of joint controllers ; in the case of joint controllers , an indication of their respective roles and responsibilities ;


### the commission may adopt implementing acts for deciding that the codes of conduct and amendments or extensions to existing codes of conduct submitted to it pursuant to paragraph 3 have general validity within the union . those implementing acts shall be adopted in accordance with the examination procedure set out in article 87 . ### the commission shall be empowered to adopt , after requesting an opinion of the european data protection board , delegated acts in accordance with article 86 for deciding that the codes of conduct and amendments or extensions to existing codes of conduct submitted to it pursuant to paragraph 3 are in line with this regulation and have general validity within the union . this delegated act shall confer enforceable rights on data subjects .


### the processing of personal data solely for journalistic purposes , or for the purposes of artistic or literary expression should qualify for exemption from the requirements of certain provisions of this regulation in order to reconcile the right to the protection of personal data with the right to freedom of expression , and notably the right to receive and impart information , as guaranteed in particular by article 11 of the charter of fundamental rights of the european union . this should apply in particular to processing of personal data in the audiovisual field and in news archives and press libraries . therefore , member states should adopt legislative measures , which should lay down exemptions and derogations which are necessary for the purpose of balancing these fundamental rights . such exemptions and derogations should be adopted by the member states on general principles , on the rights of the data subject , on controller and processor , on the transfer of data to third countries or international organisations , on the independent supervisory authorities and on co - operation and consistency . this should not , however , lead member states to lay down exemptions from the other provisions of this regulation . in order to take account of the importance of the right to freedom of expression in every democratic society , it is necessary to interpret notions relating to that freedom , such as journalism , broadly . therefore , member states should classify activities as ‘ journalistic’ for the purpose of the exemptions and derogations to be laid down under this regulation if the object of these activities is the disclosure to the public of information , opinions or ideas , irrespective of the medium which is used to transmit them . they should not be limited to media undertakings and may be undertaken for profit - making or for non - profit making purposes . ### whenever necessary , exemptions or derogations from the requirements of certain provisions of this regulation for the processing of personal data should be possible in order to reconcile the right to the protection of personal data with the right to freedom of expression , and notably the right to receive and impart information , as guaranteed in particular by article 11 of the charter of fundamental rights of the european union . this should apply in particular to processing of personal data in the audiovisual field and in news archives and press libraries . in accordance with the protocol on the system of public broadcasting in the member states annexed treaty on european union , the treaties establishing the european communities and certain related acts , the competence of member states to define and organize public service broadcasting shall also be respected in the field of data protection . therefore , member states should adopt legislative measures , which should lay down exemptions and derogations which are necessary for the purpose of balancing these fundamental rights . such exemptions and derogations should be adopted by the member states on general principles , on the rights of the data subject , on controller and processor , on the transfer of data to third countries or international organisations , on the independent supervisory authorities and on co - operation and consistency . this should not , however , lead member states to lay down exemptions from the other provisions of this regulation . in order to take account of the importance of the right to freedom of expression in every democratic society , it is necessary to interpret notions relating to that freedom , such as journalism , broadly .


### the recipients or categories of recipients to whom the personal data are to be or have been disclosed , in particular to recipients in third countries ; ### the recipients to whom the personal data are to be or have been disclosed , including to recipients in third countries ;


### the supervisory authority shall establish and make public a list of the processing operations which are subject to prior consultation pursuant to point of paragraph 2 . the supervisory authority shall communicate those lists to the european data protection board . ### the european data protection board shall establish and make public a list of the processing operations which are subject to prior consultation pursuant to paragraph 2 .


### each supervisory authority should be provided with the adequate financial and human resources , premises and infrastructure , which is necessary for the effective performance of their tasks , including for the tasks related to mutual assistance and cooperation with other supervisory authorities throughout the union . ### each supervisory authority should be provided with the adequate financial and human resources , paying particular attention to ensuring adequate technical and legal skills of staff , premises and infrastructure , which are necessary for the effective performance of their tasks , including for the tasks related to mutual assistance and co - operation with other supervisory authorities throughout the union .


### a delegated act adopted pursuant to article 6 , article 8 , article 9 , article 12 , article 14 , article 15 , article 17 , article 20 , article 22 , article 23 , article 26 , article 28 , article 30 , article 31 , article 32 , article 336 ) , article 34 , article 35 , article 37 , article 39 , article 43 , article 44 , article 79 , article 81 , article 82 and article 83 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or the council . ### a delegated act adopted pursuant to article 7 , article 11 , article 12 , article 14 , article 17 , article 22 , article 31 , article 32 , article 33 , article 38 , article 39 , article 41 , article 41 , article 79 , article 81 and article 82 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of four months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or the council .


### the controller or processor shall ensure that the data protection officer performs the duties and tasks independently and does not receive any instructions as regards the exercise of the function . the data protection officer shall directly report to the management of the controller or the processor . ### the controller or processor shall ensure that the data protection officer performs the duties and tasks independently and does not receive any instructions as regards the exercise of the function . the data protection officer shall in each member state be given procedural guarantees ensuring his or her independence and penalising any attempts to obstruct him in the full performance of his or her duties . the data protection officer shall directly report to the management of the controller or the processor .