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


### an integrated approach should be ensured by bringing together activities covered by the seventh framework programme for research , the competitiveness and innovation framework programme and the european institute of innovation and technology to make participation easier , create a more coherent set of instruments and increase the scientific and economic impact while avoiding duplication and fragmentation . common rules should apply in order to ensure a coherent framework which should facilitate the participation in programmes receiving union financial contribution from the budget of horizon 2020 , including the participation in programmes managed by the eit , joint undertakings or any other structures under article 187 tfeu or participation in programmes undertaken by member states pursuant to article 185 tfeu . however , flexibility to adopt specific rules should be ensured when justified by the specific needs of the respective actions and with commission consent . ### an integrated approach should be ensured by bringing together activities covered by the seventh framework programme for research , the competitiveness and innovation framework programme and the european institute of innovation and technology to make participation easier , create a more coherent set of instruments and increase the scientific and economic impact while avoiding duplication and fragmentation . common rules should apply in order to ensure a coherent framework which should facilitate the participation in programmes receiving union financial contribution from the budget of horizon 2020 , including the participation in programmes managed by the eit , joint undertakings or any other structures under article 187 tfeu or participation in programmes undertaken by member states pursuant to article 185 tfeu .


### where participants in an action have jointly generated results and where their respective share of the work cannot be ascertained , they shall have joint ownership of those results . the joint owners shall establish an agreement regarding the allocation and terms of exercise of that joint ownership in accordance with their obligations under the grant agreement . ### where participants in an action are jointly generating results and where their respective share of the work cannot be ascertained , they shall have joint ownership of those results . the joint owners shall establish an agreement on how to allocate the ownership and / or on the terms of exercise of that joint ownership in accordance with their obligations under the grant agreement .


### they comply with the provisions in article 23 ; ### the provisions in article 23 ;


### where appropriate , proposals shall include a draft plan for the exploitation and dissemination of the results . ### proposals shall include a draft plan for the exploitation and dissemination of the results , provided the call for proposals explicitly so requires .


### 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 the possibility of additional exploitation and open access or other dissemination conditions in the european strategic or public interest . it is necessary to place more emphasis on the widest possible use and dissemination of knowledge generated by the supported activities , including knowledge generated in the previous framework programmes , up to the commercial or societal exploitation of such knowledge .


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


### 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 .


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


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


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


### ' legal entity’ means undertakings , research centres and universities , encompassing any natural person , or any legal person created under national law , union law or international law , which has legal personality and which may , acting in its own name , exercise rights and be subject to obligations ; ### ' legal entity’ means any natural person , or any legal person created under national law , union law or international law , which has legal personality and which may , acting in its own name , exercise rights and be subject to obligations ;


### on the basis of that recommendation a decision shall be taken by the commission or the relevant funding body and notified to the coordinator of the proposal . ### on the basis of that recommendation a decision shall be taken by the commission or the relevant funding body and notified to the coordinator of the proposal within 30 days of the date when the commission or the relevant funding body receives the request for the review .


### ' background ' means any data , know - how and / or information whatever their form or nature as well as any rights such as intellectual property rights which are held by participants prior to their accession to the action and identified by the participants in accordance with article 42 ; ### ' background ' means any data , know - how and / or information whatever their form or nature as well as any rights such as intellectual property rights which are held by participants prior to their accession to a grant agreement or generated outside the action and contributed to the action by the participant holding the rights and which in both cases and are necessary in order to implement the action or use the results of the action ;


### 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 for reasons other than impossibility under union or national law or the lack of potential for commercial or industrial 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 .


### unless otherwise agreed in the joint ownership agreement , each joint owner shall be entitled to grant non - exclusive licences to third parties to exploit the jointly owned results , without any right to sub - licence , subject to the following conditions : ### unless otherwise agreed in the joint ownership agreement , each joint owner shall be entitled to exploit their jointly owned results , including to grant non - exclusive licences to third parties , without any right to sub - licence , subject to the following conditions :


### specific challenges in the area of research and innovation should be addressed through new forms of funding such as prizes , pre - commercial procurement and public procurement of innovative solutions which require specific rules . ### specific challenges in the area of research and innovation should be addressed through new forms of funding such as prizes , pre - commercial procurement and public procurement of innovative solutions foreseen in the regulation no xx / xx [ financial regulation ] which require specific rules to be provided in the sector - specific regulations .


### where appropriate , proposals shall include a draft plan for the exploitation and dissemination of the results . ### proposals shall examine whether responsible research and innovation dimensions as set out in article 14a of regulation 2011 / 809 establishing horizon 2020 - the framework programme for research and innovation , are relevant and if they have to be taken into account .


### direct eligible personnel costs may be financed on the basis of scale of unit costs determined according to the participant ' s usual cost accounting practices , provided that they comply with the following cumulative criteria : ### direct eligible personnel costs may be financed on the basis of scale of unit costs determined as reference rates for different categories of researchers , updated by the commission on a yearly basis . rates are differentiated by countries and are obtained by applying the correction coefficients for cost of living in the country . scales of unit costs must comply with the following cumulative criteria :


### the grant agreement shall contain the minimum requirements for the time recording system as well as the number of annual productive hours to be used for the calculation of the hourly personnel rates . ### the grant agreement shall contain the minimum requirements for the time recording system which may entail one single document declaring the university / legal entity degree of the involvement of the researchers / participant in the project . the number of annual productive hours to be used for the calculation of the hourly personnel rates shall be based on each participant ' s own normal accounting and management principles , and relevant national rules , and may be expressed as an percentage of working time


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


### 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 .


### participants shall make no commitments which are incompatible with the grant agreement . where a participant fails to comply with its obligations regarding the technical implementation of the action , the other participants shall comply with the obligations without any additional union funding unless the commission or funding body expressly relieves them of that obligation . the financial responsibility of each participant shall be limited to its own debt , subject to the provisions relating to the fund . the participants shall ensure that the commission or funding body is informed of any event which might affect the implementation of the action or the interests of the union . ### participants shall make no commitments which are incompatible with the grant agreement . where a participant fails to comply with its obligations regarding the technical implementation of the action , the other participants shall comply with the obligations without any additional union funding unless the commission or funding body expressly relieves them of that obligation . the financial responsibility of each participant shall be limited to the funding which was directly received , subject to the provisions relating to the fund . the participants shall ensure that the commission or funding body is informed of any event which might affect the implementation of the action or the interests of the union .


### the participant may refuse consent only if it demonstrates that its legitimate interests would suffer significant harm . no dissemination relating to these results may take place until the commission or the funding body has taken a decision or has decided that it will assume ownership and has taken the necessary steps to ensure protection . the grant agreement shall lay down time - limits in this respect . ### the participant may refuse consent only if it demonstrates that its legitimate interests would suffer significant harm . no dissemination relating to these results may take place until the commission or the funding body has taken a decision or has decided that it will assume ownership and has taken the necessary steps to ensure protection . this decision shall be taken within 45 days .


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


### independent experts shall be chosen on the basis of skills , experience and knowledge appropriate to carry out the tasks assigned to them . in cases where independent experts have to deal with classified information , the appropriate security clearance shall be required before appointment . ### independent experts shall be chosen on the basis of skills , experience and knowledge , including knowledge of languages , appropriate to carry out the tasks assigned to them . this will help ensure that proposals for projects submitted in languages other than english can also be evaluated . the skills , experience and knowledge of the experts concerned shall correspond to the priority addressed by the project in question . in cases where independent experts have to deal with classified information , the appropriate security clearance shall be required before appointment .


### direct eligible personnel costs may be financed on the basis of scale of unit costs determined according to the participant ' s usual cost accounting practices , provided that they comply with the following cumulative criteria : ### direct eligible personnel costs may be financed on the basis of scale of unit costs as reference rates for different categories of researchers , updated by the commission on a yearly basis . rates are differentiated by countries and are obtained by applying the correction coefficients for cost of living in the country . scales of unit costs must comply with :


### 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 activity ‘ secure societies’ within the specific objective ‘ inclusive , innovative and secure societies’ , the union institutions and bodies as well as member states ' national and regional 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 .


### specific challenges in the area of research and innovation should be addressed through new forms of funding such as prizes , pre - commercial procurement and public procurement of innovative solutions which require specific rules . ### specific challenges in the area of research and innovation should be addressed through new forms of funding such as prizes , pre - commercial procurement and public procurement of innovative solutions , as well as through specific types of funding bodies such as the existing and newly foreseen programming initiatives based on articles 185 and 187 tfeu and article [ 55 ] of regulation no xx / xx [ the financial regulation ] . these new forms of funding and these different types of funding bodies require specific rules which should be laid down in this regulation .


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


### unless otherwise agreed in the joint ownership agreement , each joint owner shall be entitled to grant non - exclusive licences to third parties to exploit the jointly owned results , without any right to sub - licence , subject to the following conditions : ### unless otherwise agreed in the joint ownership agreement , each joint owner shall be entitled to use their jointly owned results on a royalty - free basis , without requiring the prior consent of the other joint owner .


### additional exploitation obligations may be laid down in the grant agreement . any such additional obligations shall be indicated in the work programme or work plan . ### additional exploitation obligations may be laid down in the grant agreement . any such additional obligations shall be indicated in the work programme or work plan . when research is conducted in a field relevant to tackling societal challenges such as health or climate change , these additional obligations shall aim at ensuring the widest possible uptake of innovative solutions in accordance with intellectual property rights , in the best public interest , both within and outside the union , and licensing of results to third parties shall , by default , take place on non - exclusive terms .


### the financial capacity shall not be verified for legal entities whose viability is guaranteed by a member state or an associated country and for higher and secondary education establishments . ### the financial capacity shall not be verified for legal entities whose viability is guaranteed by a member state or an associated country and for higher and secondary education establishments . similarly , the financial and coordination capacity of under - capitalized subsidiaries or start - ups shall not be verified where their viability is guaranteed by their shareholders as far as this is renewed on a yearly basis .


### ' 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 ;


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


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


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


### ' 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 a published work in any medium 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 .


### a funding body may establish rules which depart from those laid down in this regulation or regulation no xx / 2012 [ the financial regulation ] if this is provided for in the basic act or , subject to the consent of the commission , if its specific operating needs so require . ### the eit may establish rules which depart from those laid down in this regulation or regulation no xx / 2012 [ the financial regulation ] if this is provided for in the basic act or , subject to the consent of the commission , if its specific operating needs so require , in particular in relation to ownership , access rights , exploitation and dissemination of results .


### a proposal which contravenes ethical principles or any applicable legislation , or which does not fulfil the conditions set out in decision no xx / xx / eu [ specific programme ] , the work programme or work plan or in the call for proposals may be excluded from the evaluation , selection and award procedures at any time . ### a proposal which contravenes ethical principles or any applicable legislation , or which does not fulfil the conditions set out in decision no xx / xx / eu [ specific programme ] , the work programme or work plan or in the call for proposals shall be excluded from the evaluation , selection and award procedures .


### these rules for the participation and dissemination should provide a coherent , comprehensive and transparent framework to ensure the most efficient implementation possible , taking into account the need for easy access by all participants , notably small and medium - sized enterprises , through simplified procedures . the financial assistance from the union could be provided through different forms . ### these rules for the participation and dissemination should provide a coherent , comprehensive and transparent framework to ensure the most efficient implementation possible , taking into account the need for easy access by all participants , notably small and medium - sized enterprises , through simplified procedures . horizon 2020 should ensure a significant decrease in bureaucratic burden for beneficiaries . thus , in compliance with the financial regulation , international accounting standards and eligibility criteria , the usual cost accounting practices of the beneficiaries should be accepted to the widest possible extent in order to reduce administrative burden . the financial assistance from the union could be provided through different forms .


### the grant agreement shall contain the minimum requirements for the time recording system as well as the number of annual productive hours to be used for the calculation of the hourly personnel rates . ### the grant agreement shall contain the minimum requirements for the time recording system .


### participants that calculate and claim direct personnel costs on the basis of scale of unit costs may submit to the commission a certificate on the methodology . that methodology shall comply with the conditions set out in article 27 and meet the requirements of grant agreement . ### participants that calculate and claim direct personnel costs on the basis of scale of unit costs or on the basis of indirect eligible costs actually incurred shall submit to the commission a certificate on the methodology . that methodology shall comply with the conditions set out in article 27 .


### ' background ' means any data , know - how and / or information whatever their form or nature as well as any rights such as intellectual property rights which are held by participants prior to their accession to the action and identified by the participants in accordance with article 42 ; ### ' background ' means any data , know - how and / or information whatever their form or nature as well as any rights such as intellectual property rights which are held by participants prior to their accession to a grant agreement or generated outside the action and contributed to the action by the participant holding the rights and which in both cases and are necessary in order to implement the action or use the results of the action ;


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


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


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


### participants that calculate and claim direct personnel costs on the basis of scale of unit costs may submit to the commission a certificate on the methodology . that methodology shall comply with the conditions set out in article 27 and meet the requirements of grant agreement . ### participants may submit to the commission a certificate on the methodology . that methodology shall comply with the conditions set out in articles 23 , 25 and , where appropriate , article 27 and meet the requirements of grant agreement .


### without prejudice to article 3 , the commission shall , upon request , make available to the union institutions and bodies , any member state or associated country , any useful information in its possession on results of a participant that has received union funding , provided that both the following conditions are met : ### without prejudice to article 3 , the commission shall , upon request , make available to the union institutions and bodies , any member state or associated country , any useful information in its possession on results generated by a participant within an action that has received union funding , provided that both the following conditions are met :


### the commission or the relevant funding body shall verify the financial capacity in advance only for coordinators when the requested funding from the union for the action is equal or superior to eur 500 000 , unless where , on the basis of available information , there are grounds to doubt the financial capacity of the coordinator or other participants . ### the commission or the relevant funding body shall verify the financial capacity in advance when the requested funding from the union for the participant is equal or superior to eur 500 000 , unless where , on the basis of available information , there are grounds to doubt the financial capacity of the coordinator or other participants .


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


### these rules for the participation and dissemination should provide a coherent , comprehensive and transparent framework to ensure the most efficient implementation possible , taking into account the need for easy access by all participants , notably small and medium - sized enterprises , through simplified procedures . the financial assistance from the union could be provided through different forms . ### these rules for the participation and dissemination should provide a coherent , comprehensive and transparent framework to ensure the most efficient implementation possible , taking into account the need for easy access by all participants , notably small and medium - sized enterprises , civil society organisations , also including organisations of persons with disabilities , through simplified procedures . the financial assistance from the union could be provided through different forms .


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


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


### by way of derogation from paragraph 1 , in the case of european research council frontier research actions , the sme instrument , programme co - fund actions and in justified cases provided for in the work programme or work plan , the minimum condition shall be the participation of one legal entity established in a member state or associated country . ### by way of derogation from paragraph 1 , in the case of european research council frontier research actions , the sme instrument , programme co - fund actions the minimum condition shall be the participation of one legal entity established in a member state or associated country , given that the legal entity can compete across borders and is addressing societal challenges of a european dimension .


### where appropriate , the grant agreement shall provide that the commission or funding body is to be notified in advance of any such transfer of ownership or grant of an exclusive licence . the grant agreement shall lay down time - limits . ### where appropriate , the grant agreement shall provide that the commission or funding body or any participant in the action is to be notified in advance of any such transfer of ownership or grant of an exclusive licence . the model grant agreement shall lay down time - limits .


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


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


### each participant that has received union funding shall use its best efforts to exploit the results it owns in further research or commercially , or to have them exploited by another legal entity for these purposes , in particular through transfer and licensing of results in accordance with article 41 . ### each participant that has received union funding shall use its best efforts to exploit the results it owns , or to have them exploited by another legal entity for these purposes , in particular through transfer and licensing of results in accordance with article 41 .


### the award of subcontracts for carrying out certain elements of the action shall be limited to the cases provided for in the grant agreement . ### the award of subcontracts for carrying out certain elements of the action shall be limited to the cases provided for in the grant agreement except for those that can not be clearly foreseen at the time of its entry into force . a previous approval of the commission shall be requested ; such an approval can not be unreasonably denied .


### where appropriate , proposals shall include a draft plan for the exploitation and dissemination of the results . ### proposals shall include a draft plan for the exploitation and dissemination of the results , provided the call for proposals explicitly so requires .


### unless otherwise agreed in the joint ownership agreement , each joint owner shall be entitled to grant non - exclusive licences to third parties to exploit the jointly owned results , without any right to sub - licence , subject to the following conditions : ### unless otherwise agreed in the joint ownership agreement , each joint owner shall be entitled to use their jointly owned foreground for non - commercial purposes such as internal research and training activities on a royalty - free basis , and without requiring the prior consent of the other joint owner .


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


### by way of derogation from paragraph 1 , in the case of coordination and support actions and training and mobility actions , the minimum condition shall be the participation of one legal entity . ### by way of derogation from paragraph 1 , in the case of coordination and support actions and training and mobility actions , the minimum condition shall be the participation of one legal entity , given that the legal entity can compete across borders and is addressing societal challenges of a european dimension .


### these rules for the participation and dissemination should provide a coherent , comprehensive and transparent framework to ensure the most efficient implementation possible , taking into account the need for easy access by all participants , notably small and medium - sized enterprises , through simplified procedures . the financial assistance from the union could be provided through different forms . ### these rules for the participation and dissemination should provide a coherent , comprehensive and transparent framework to ensure the most efficient implementation possible , taking into account the need for easy access by all participants , notably small and medium - sized enterprises , through simplified procedures .


### 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 consortium may propose to add or remove a participant in accordance with the respective provisions of the grant agreement , provided that this change is in conformity with the conditions for participation , does not adversely affect the implementation of the action and is not contrary to the principle of equal treatment . ### the consortium may propose to add or remove a participant or change a coordinator in accordance with the respective provisions of the grant agreement , provided that this change is in conformity with the rules for participation , does not adversely affect the implementation of the action and is not contrary to the principle of equal treatment .


### 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 .


### 60 % to the progress axis , of which at least 17 % shall be allocated to promoting social experimentation as a method for testing and evaluating innovative solutions with a view to scaling them up ; ### 50 % to the progress axis ;


### 20 % to the microfinance and social entrepreneurship axis . ### 30 % to the microfinance and social entrepreneurship axis .


### two years after the expiry of the programme at the latest , the commission shall carry out an ex - post evaluation measuring its impact and union added value and shall forward a report on that evaluation to the european parliament , the council , the european economic and social committee and the committee of the regions . ### two years after the expiry of the programme at the latest , the commission shall carry out an ex - post evaluation measuring its impact and union added value and shall forward a report on that evaluation to the european parliament , the council , the european economic and social committee and the committee of the regions . the report shall be published and made available for the public in the interests of better transparency .


### the new psychoactive substances subjected to permanent market restriction pursuant to [ regulation no … / … on new psychoactive substances ] should , therefore , be covered by the union criminal law provisions on illicit drug trafficking . this would also help streamline and clarify the union legal framework , as the same criminal law provisions would apply to substances covered by the un conventions and to the most harmful new psychoactive substances . the definition of ' drug ' in the framework decision 2004 / 757 / jha should , therefore , be amended . ### the new psychoactive substances subjected to permanent market restriction pursuant to [ regulation no … / … on new psychoactive substances ] should , therefore , be covered by the union criminal law provisions on illicit drug trafficking . this would also help streamline and clarify the union legal framework , as the same criminal law provisions would apply to substances covered by the un conventions and to the most harmful new psychoactive substances . the definition of ' drug ' in the framework decision 2004 / 757 / jha should , therefore , be amended to respond to current circumstances .


### in order to improve and facilitate access to trade mark protection and to increase legal certainty and predictability , the procedure for the registration of trade marks in the member states should be efficient and transparent and should follow rules similar to those applicable to european trade marks . with a view to achieving a consistent and balanced trade mark system both at national and union level , all the central industrial property offices of the member states should therefore limit their examination ex officio of whether a trade mark application is eligible for registration to the absence of absolute grounds for refusal only . this should , however , not prejudice the right of those offices to provide , upon request of applicants , searches for earlier rights on a purely informative basis and without any prejudice to or binding effect on the further registration process , including subsequent opposition proceedings . ### in order to improve and facilitate access to trade mark protection and to increase legal certainty and predictability , the procedure for the registration of trade marks in the member states should be efficient and transparent and should follow rules similar to those applicable to european trade marks .


### a trade mark may consist of any signs , in particular words , including personal names , designs , letters , numerals , colours as such , the shape of goods or of their packaging , or sounds , provided that such signs are capable of : ### a trade mark may consist of any signs , in particular words , including personal names , designs , models , motifs , devices , logos , letters , numerals , colours as such , the shape of goods or of their packaging , or sounds , provided that such signs are capable of :


### a trade mark shall not be refused registration or be declared invalid in accordance with paragraph 1 , or if , before the date of application for registration or after the date of registration , and following the use which has been made of it , it has acquired a distinctive character . ### a trade mark shall not be refused registration in accordance with paragraph 1 , or if , before the date of application for registration following use which has been made of it , it has acquired a distinctive character . a trade mark shall not be declared invalid for the same reasons if , before the date of application for invalidity , following use which has been made of it , it has acquired a distinctive character .


### ‘ agency’ means the european union trade marks and designs agency established in accordance with article 2 of regulation no 207 / 2009 ; ### ‘ agency’ means the european union intellectual property agency established in accordance with article 2 of regulation no 207 / 2009 ;


### in order to more effectively prevent the entry of infringing goods , particularly in the context of sales over the internet , the proprietor should be entitled to prohibit the importing of such goods into the union where it is only the consignor of the goods who acts for commercial purposes . ### in order to more effectively prevent the entry of infringing goods , particularly in the context of sales over the internet , the proprietor , assisted by the national authorities , should be entitled to prohibit the importing or offering of such goods into the union where it is only the consignor , intermediary , agent or online sales services provider of the merchandise of the goods who acts for commercial purposes .


### 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 , assisted by the national authorities , shall also be entitled to prevent all third parties from bringing goods infringing this registered trade mark into the customs territory of the member state where the trade mark is validly registered , 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 ; and are intended to be the subject of commercial activity without being released for free circulation in that territory .


### with the aim of strengthening trade mark protection and combatting counterfeiting more effectively , the proprietor of a registered trade mark should be entitled to prevent third parties from bringing goods into the customs territory of the member state without being released for free circulation there , where such goods come from third countries and bear without authorization a trade mark which is essentially identical to the trade mark registered in respect of such goods . ### with the aim of strengthening trade mark protection and combating counterfeiting more effectively , the proprietor of a registered trade mark , assisted by the national authorities , should be entitled to prevent third parties from bringing goods into the customs territory of the member state without being released for free circulation there , where such goods come from third countries and bear without authorization a trade mark which is essentially identical to the trade mark registered in respect of such goods .


### in administrative proceedings for a declaration of invalidity based on a registered trade mark with an earlier filing date or priority date , if the proprietor of the later trade mark so requests , the proprietor of the earlier trade mark shall furnish proof that , during the period of five years preceding the date of the application for a declaration of invalidity , the earlier trade mark has been put to genuine use as provided for in article 16 in connection with the goods or services in respect of which it is registered and which he cites as justification for his application , or that there are proper reasons for non - use , provided that the period of five years within which the earlier trade mark must have been put to genuine use has expired at the date of the application for a declaration of invalidity . ### in proceedings for a declaration of invalidity based on a registered trade mark with an earlier filing date or priority date , if the proprietor of the later trade mark so requests , the proprietor of the earlier trade mark shall furnish proof that , during the period of five years preceding the date of the application for a declaration of invalidity , the earlier trade mark has been put to genuine use as provided for in article 16 in connection with the goods or services in respect of which it is registered and which he cites as justification for his application , or that there are proper reasons for non - use , provided that the period of five years within which the earlier trade mark must have been put to genuine use has expired at the date of the application for a declaration of invalidity .


### 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 less invasive exams and carried out by qualified and impartial medical experts .


### the personnel examining applications and taking decisions are instructed and have the possibility to seek advice , whenever necessary , from experts on particular issues , such as medical , cultural , child or gender issues . ### the personnel examining applications and taking decisions are instructed and have the possibility to seek advice , whenever necessary , from experts on particular issues , such as medical , cultural , child , religious or sex issues .


### with respect to the procedures provided for in chapter v , member states may choose to only make free legal assistance and / or representation available to applicants insofar as such assistance is necessary to ensure their effective access to justice . member states shall ensure that legal assistance and / or representation granted pursuant to this paragraph is not arbitrarily restricted . ### member states shall ensure that legal assistance and / or representation granted pursuant to point is not arbitrarily restricted .


### member states shall ensure that the applicant who reports again to the competent authority after a decision to discontinue as referred to in paragraph 1 of this article is taken , is entitled to request that his / her case be reopened . ### member states shall ensure that the applicant who reports again to the competent authority after a decision to discontinue as referred to in paragraph 1 of this article is taken , is entitled to request that his / her case be reopened unless the request is examined in accordance with articles 32 and 34 .


### where an authority is designated in accordance with paragraph 3 , member states shall ensure that the personnel of that authority have the appropriate knowledge or receive the necessary training to fulfil their obligations when implementing this directive . ### where an authority is designated in accordance with paragraph 3 , member states shall ensure that the personnel of that authority have the appropriate knowledge and receive the necessary training to fulfil their obligations when implementing this directive .


### subject to the conditions set out in article 18 , unaccompanied minors shall be granted free legal assistance with respect to all procedures provided for in this directive . ### subject to the conditions set out in article 18 , unaccompanied minors shall be granted free legal assistance with respect to all procedures provided for in this directive , in so far as this is necessary or possible in the light of personal circumstances . with respect to the procedures provided for in chapter v , the member states may provide for this to be limited to cases where the appeal or review is likely to succeed .


### any serious incident in respect of devices made available on the union market ; ### any incident in respect of devices made available on the union market ;


### the traceability of in vitro diagnostic medical devices by means of a unique device identification system based on international guidance should significantly enhance the effectiveness of the post - market safety of in vitro diagnostic medical devices due to improved incident reporting , targeted field safety corrective actions and better monitoring by competent authorities . it should also help to reduce medical errors and to fight against counterfeit devices . use of the udi system should also improve purchase - policy and stock - management by hospitals . ### the traceability of in vitro diagnostic medical devices by means of a unique device identification system based on international guidance should significantly enhance the effectiveness of the post - market safety of in vitro diagnostic medical devices due to improved incident reporting , targeted field safety corrective actions and better monitoring by competent authorities . it should also help to reduce medical errors and to fight against counterfeit devices . use of the udi system should also improve purchase policy and stock management by hospitals , pharmacies and wholesalers . the udi system should be compatible with other systems already on the market .


### it shall apply from [ five years after entry into force ] . ### it shall apply from [ three years after entry into force ] .


### the traceability of in vitro diagnostic medical devices by means of a unique device identification system based on international guidance should significantly enhance the effectiveness of the post - market safety of in vitro diagnostic medical devices due to improved incident reporting , targeted field safety corrective actions and better monitoring by competent authorities . it should also help to reduce medical errors and to fight against counterfeit devices . use of the udi system should also improve purchase - policy and stock - management by hospitals . ### the traceability of in vitro diagnostic medical devices by means of a unique device identification system based on international guidance should significantly enhance the effectiveness of the post - market safety of in vitro diagnostic medical devices due to improved incident reporting , targeted field safety corrective actions and better monitoring by competent authorities . it should also help to reduce medical errors and to fight against counterfeit devices . use of the udi system should also improve purchase policy and stock management by hospitals , and , where possible , the system should be compatible with the other authentication systems already in place in such environments .


### support for and services to enterprises , in particular smes ; ### support for and services to enhance innovation in enterprises , in particular smes ;


### promoting low - carbon strategies for urban areas ; ### promoting low - carbon strategies for urban areas and the adaptation of these to reduce carbon emissions .


### developing new business models for smes , in particular for internationalisation ; ### developing and applying new business models for smes including new value chains and marketing organisation , in particular for internationalisation ;


### support to public research and innovation bodies and investment in technology and applied research in enterprises ; ### support to research and innovation bodies and investment in technology and applied research in enterprises ;


### in more developed regions , the erdf shall not support investments in infrastructure providing basic services to citizens in the areas of environment , transport , and ict . ### in more developed regions , the erdf shall not primarily support investments in infrastructure providing basic services to citizens in the areas of environment , transport , and ict .


### developing new business models for smes , in particular for internationalisation ; ### developing and applying new business models for smes , including corresponding advisory services , in particular for internationalisation ;


### enhancing research and innovation infrastructure and capacities to develop r&amp ; i excellence and promoting centres of competence , in particular those of european interest ; ### enhancing research and innovation infrastructure and capacities to develop r&amp ; i excellence and promoting centres of competence , in particular those of european interest and those presenting possible synergies with other european programmes , for example with the competition to create top research institutions under horizon 2020 ;


### the erdf shall contribute to the financing of support which aims to reinforce economic , social and territorial cohesion by redressing the main regional imbalances through support for the development and structural adjustment of regional economies , including the conversion of declining industrial regions and regions lagging behind . ### the erdf shall contribute to the financing of support which aims to reinforce economic , social and territorial cohesion by redressing the main regional imbalances through support for the development and structural adjustment of regional economies , including the conversion of declining industrial regions and regions lagging behind , as well as regions facing demographic challenges .


### protecting the environment and promoting resource efficiency ; ### protecting the environment , biodiversity and ecosystems and promoting resource efficiency ;


### the member states and the commission shall ensure that environmental protection requirements , resource efficiency , climate change mitigation and adaptation , disaster resilience and risk prevention and management are promoted in the preparation and implementation of partnership contracts and programmes . member states shall provide information on the support for climate change objectives using the methodology adopted by the commission . the commission shall adopt this methodology by means of an implementing act . the implementing act shall be adopted in accordance with the examination procedure referred to in article 143 . ### the member states and the commission shall ensure that environmental protection requirements , resource efficiency , protection of biodiversity and ecosystems , climate change mitigation and adaptation , disaster resilience and prevention and management of ecosystem - based risk are promoted in the preparation and implementation of partnership contracts and programmes . member states shall provide information on the support for climate change and biodiversity objectives using the methodology adopted by the commission . the commission shall adopt this methodology by means of an implementing act . the implementing act shall be adopted in accordance with the examination procedure referred to in article 143 .


### the indicative allocation of support by the union by thematic objective at national level for each of the csf funds , as well as the total indicative amount of support foreseen for climate change objectives ; ### the indicative allocation of support by the union by thematic objective at national level for each of the csf funds , as well as the total indicative amount of support foreseen for climate change and environmental , including biodiversity and resource efficiency , objectives ;


### where the proposed reporting member state has not notified the sponsor within the time period referred to in paragraph 2 , the clinical trial applied for shall be considered as falling within the scope of this regulation , the application shall be considered complete , the clinical trial shall be considered a low - intervention clinical trial if this is claimed by the sponsor , and the proposed reporting member state shall be the reporting member state . ### where the proposed reporting member state has not notified the sponsor within the time period referred to in paragraph 2 , the clinical trial applied for shall be considered as falling within the scope of this regulation , the application shall be considered complete , the clinical trial shall be regarded as posing a minimal risk if this is claimed by the sponsor , and the proposed reporting member state shall be the reporting member state .


### the risk to subject safety in a clinical trial mainly stems from two sources : the investigational medicinal product and the intervention . many clinical trials , however , pose only a minimal additional risk to subject safety compared to normal clinical practice . this is in particular the case where the investigational medicinal product is covered by a marketing authorisation and where the intervention poses only very limited additional risk to the subject compared to normal clinical practice . those ‘ low - intervention clinical trials’ are often of crucial importance to assess standard treatments and diagnoses , thereby optimising the use of medicinal products and thus contributing to a high level of public health . they should be subject to less stringent rules , such as shorter deadlines for approval . ### the risk to subject safety in a clinical trial mainly stems from two sources : the investigational medicinal product and the intervention . many clinical trials , however , pose only a minimal additional risk to subject safety compared to normal clinical practice . this is in particular the case where the investigational medicinal product is covered by a marketing authorisation and where the intervention poses only very limited additional risk to the subject compared to normal clinical practice . those ‘ minimal - risk clinical trials’ are often of crucial importance to assess standard treatments and diagnoses , thereby optimising the use of medicinal products and thus contributing to a high level of public health . given that minimal - risk clinical trials have only a very limited and temporary adverse effect – if any – on the subject’s health , they should be subject to less stringent rules , such as shorter deadlines for approval . they should , however , be subject to the vigilance and traceability rules governing normal clinical practice .


### the language of the information on the label shall be determined by the member state concerned . the medicinal product may be labelled in several languages . ### the language of the information on the label shall be determined by the member state concerned and shall be one of the official languages of the union . the medicinal product may be labelled in several languages .


### the european medicines agency established by regulation no 726 / 2004 shall set up and maintain an electronic database for the reporting provided for in articles 38 and 39 . ### the european medicines agency established by regulation no 726 / 2004 shall set up and maintain an electronic database for the reporting provided for in articles 38 and 39 . that electronic database shall be a module of the database referred to in article 24 paragraph 1 of regulation no 726 / 2004 .


### for the purpose of this regulation , if a suspended or temporarily halted clinical trial is not restarted , the date of the decision of the sponsor not to restart the clinical trial shall be considered as the end of the clinical trial . in the case of early termination , the date of the early termination shall be considered as the date of the end of the clinical trial . ### for the purpose of this regulation , if a suspended or temporarily halted clinical trial is not restarted , the date of the decision of the sponsor not to restart the clinical trial shall be considered as the end of the clinical trial . in the case of early termination , the date of the early termination shall be considered as the date of the end of the clinical trial . if a clinical trial is discontinued , the sponsor shall notify the reasons thereof to the member state concerned through the eu portal within 15 days from the decision to discontinue the clinical trial .


### ‘ 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 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 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 ;


### according to the protocol of the clinical trial , the investigational medicinal products are used in accordance with the terms of the marketing authorisation or their use is a standard treatment in any of the member states concerned ; ### according to the protocol of the clinical trial , the investigational medicinal products are used in accordance with the terms of the marketing authorisation or their use is in line with normal clinical practice in any of the member states concerned ;


### where the member state concerned disagrees with the conclusion on the basis of point of the second subparagraph , it shall communicate its disagreement , together with a detailed justification based on scientific and socio - economic arguments , and a summary thereof , through the eu portal to the commission , to all member states , and to the sponsor . ### where the member state concerned disagrees with the conclusion of the reporting member state on the basis of point of the second subparagraph , it shall communicate its disagreement , together with a detailed justification based on scientific and socio - economic arguments , and a summary thereof , through the eu portal to the commission , to all member states , and to the sponsor .


### this chapter is without prejudice to the possibility for the sponsor to submit , following the refusal to grant an authorisation or the withdrawal of an application , an application for authorisation to any intended member state concerned . that application shall be considered as a new application for authorisation of another clinical trial . ### following the refusal to grant an authorisation or the withdrawal of an application , the sponsor may submit a new application for authorisation to any intended member state concerned . that application shall be considered as a new application for authorisation of another clinical trial . the new application shall , however , specify the grounds on which the original application was rejected or withdrawn and the changes made to the original version of the protocol .


### in the assessment , the view of at least one person whose primary area of interest is non - scientific shall be taken into account . the view of at least one patient shall be taken into account . ### in the assessment , the view of at least one person whose primary area of interest is non - scientific shall be taken into account . the view of at least one patient shall be taken into account . where possible , that patient shall be a representative of a patients ' organization in the disease area for which the investigational medicinal product is intended .


### reasons shall be given in the written notification for a decision rejecting the application , not granting , not modifying or not renewing , suspending or withdrawing the single permit on the basis of criteria specified in national or community law . ### reasons shall be given in the written notification for a decision rejecting the application for a single permit , not modifying or not renewing the single permit , or withdrawing the single permit on the basis of criteria provided for by national or union law .


### in an increasingly global labour market , the eu should enhance its appeal to attract third - country workers . this should be facilitated by administrative simplification and by facilitating access to relevant information . provisions for a single application procedure leading to one combined title encompassing both residence and work permit within one administrative act should contribute to simplifying and harmonizing the diverging rules currently applicable in member states . such procedural simplification has already been introduced by the majority of member states and has made for a more efficient procedure both for the migrants and for their employers , and allowed easier controls of the lawfulness of their residence and employment . ### provisions for a single application procedure leading to one combined title encompassing both residence and work permit within one administrative act should contribute to simplifying and harmonizing the rules currently applicable in member states . such procedural simplification has already been introduced by several member states and has made for a more efficient procedure both for the migrants and for their employers , and allowed easier controls of the lawfulness of their residence and employment .


### who have been admitted to the territory of a member state for a period not exceeding six months in any 12 month period to work on a seasonal basis ; ### who have been admitted to the territory of a member state as seasonal workers or au pairs ;


### this directive respects the fundamental rights and observes the principles recognized by the charter of fundamental rights of the european union and the european convention on human rights and fundamental freedoms and has to be implemented accordingly . ### this directive respects the fundamental rights and observes the principles recognized by article 6 of the treaty on european union and reflected in the charter of fundamental rights of the european union .


### member states may request applicants to pay fees for handling applications in accordance with this directive . the level of fees must be proportionate and may be based on the principle of the service actually provided . ### member states may request applicants to pay fees . where appropriate , these fees are collected for handling applications in accordance with this directive . in such cases , the level of fees must be proportionate and be based on the principle of the service actually provided .


### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by &#8230 ; . . at the latest . they shall forthwith communicate to the commission the text of those provisions and a correlation table between those provisions and this directive . ### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by [ two years after the entry into force of this directive ] at the latest . they shall forthwith communicate to the commission the text of those provisions .


### if the information supporting the application is inadequate , the designated authority shall notify the applicant of the additional information that is required . the period referred to in paragraph 2 shall be suspended until the authorities have received the additional information required . ### if the information or documents supporting the application are inadequate , the designated authority shall notify the applicant of the additional information or documents that are required and may set a reasonable deadline to provide them . the period referred to in paragraph 2 shall be suspended until the authorities have received the additional information or documents required .


### 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 within the limits provided for by national legislation ;


### whose expulsion has been suspended for reasons of fact or law . ### whose removal has been suspended for reasons of fact or law ;


### an application to reside and work in the territory of a member state shall be submitted in a single application procedure . ### an application for a single permit shall be submitted in a single application procedure .


### to third - country workers legally residing in a member state . ### to third - country nationals who have been admitted for purposes other than work under national or other union rules , are allowed to work and are issued a residence permit in accordance with regulation no 1030 / 2002 , and


### the european council , at its special meeting in tampere on 15 and 16 october 1999 , acknowledged the need for harmonisation of national legislation governing the conditions for admission and residence of third - country nationals . in this context , it stated in particular that the european union should ensure fair treatment of third - country nationals residing lawfully on the territory of the member states and that a more vigorous integration policy should aim to grant them rights and obligations comparable to those of citizens of the european union . the european council accordingly asked the council to rapidly adopt the legal instruments on the basis of commission proposals . the need for achieving the objectives defined at tampere was reaffirmed by the hague program of 4 and 5 november 2004 . ### the european council , at its special meeting in tampere on 15 and 16 october 1999 , acknowledged the need for harmonisation of national legislation governing the conditions for admission and residence of third - country nationals . in this context , it stated in particular that the european union should ensure fair treatment of third - country nationals residing lawfully on the territory of the member states and that a more vigorous integration policy should aim to grant them rights and obligations comparable to those of citizens of the european union . the european council accordingly asked the council to rapidly adopt the legal instruments on the basis of commission proposals . the need for achieving the objectives defined at tampere was reaffirmed by the stockholm programme of 10 and 11 december 2009 .


### 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 .


### in order to permit adaptation to technical and scientific progress of directive 2009 / 28 / ec , 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 respect of the list of biofuel feedstocks that are counted multiple times towards the target set in article 3 , the energy content of transport fuels , criteria and geographic ranges for determining highly biodiverse grassland , the methodology for the calculation of indirect land - use change emissions , and the methodological principles and values necessary for assessing whether sustainability criteria have been fulfilled in relation to biofuels and bioliquids . ### in order to permit adaptation to technical and scientific progress of directive 2009 / 28 / ec , 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 respect of the list of advanced biofuels , the energy content of transport fuels , criteria and geographic ranges for determining highly biodiverse grassland , and the methodological principles and values necessary for assessing whether sustainability criteria have been fulfilled in relation to biofuels and bioliquids .


### 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 europe12 , 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 industrial or economic value for other uses than biofuels , that use waste materials for energy purposes only in accordance with the waste hierarchy , that do not compete for the use of land and water so to protect land and food rights .


### liquid renewable fuels are likely to be required by the transport sector in order to reduce its greenhouse gas emissions . advanced biofuels , such as those made from wastes and algae , provide high greenhouse gas savings with low risk of causing indirect land use change and do not compete directly for agricultural land for the food and feed markets . it is appropriate , therefore , to encourage greater production of such advanced biofuels as these are currently not commercially available in large quantities , in part due to competition for public subsidies with established food crop based biofuel technologies . further incentives should be provided by increasing the weighting of advanced biofuels towards 10% target for transport set in directive 2009 / 28 / ec compared to conventional biofuels . in this context , only advanced biofuels with low estimated indirect land use change impacts and high overall greenhouse gas savings should be supported as part of the post 2020 renewable energy policy framework . ### liquid renewable fuels are likely to be required by the transport sector in order to reduce its greenhouse gas emissions . advanced biofuels , such as those made from wastes and algae , provide high greenhouse gas savings with low risk of causing indirect land use change and do not compete directly for agricultural land for the food and feed markets . it is appropriate , therefore , to encourage greater production of such advanced biofuels as these are currently not commercially available in large quantities , in part due to competition for public subsidies with established food crop based biofuel technologies . further incentives should be provided by laying down a separate - target of at least 3% for advanced biofuels for transport in directive 2009 / 28 / ec . in this context , only biofuels with low estimated indirect land use change impacts and high overall greenhouse gas savings should be supported as part of the post 2020 renewable energy policy framework .


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


### liquid renewable fuels are likely to be required by the transport sector in order to reduce its greenhouse gas emissions . advanced biofuels , such as those made from wastes and algae , provide high greenhouse gas savings with low risk of causing indirect land use change and do not compete directly for agricultural land for the food and feed markets . it is appropriate , therefore , to encourage greater production of such advanced biofuels as these are currently not commercially available in large quantities , in part due to competition for public subsidies with established food crop based biofuel technologies . further incentives should be provided by increasing the weighting of advanced biofuels towards 10% target for transport set in directive 2009 / 28 / ec compared to conventional biofuels . in this context , only advanced biofuels with low estimated indirect land use change impacts and high overall greenhouse gas savings should be supported as part of the post 2020 renewable energy policy framework . ### liquid renewable fuels are likely to be required by the transport sector in order to reduce its greenhouse gas emissions . advanced biofuels , such as those made from wastes , residues , algae , microorganisms and biodegradation by bacteria , provide high greenhouse gas savings with low risk of causing indirect land use change and do not compete directly for agricultural land for the food and feed markets . it is appropriate , therefore , to encourage greater production of such advanced biofuels as these are currently not commercially available in large quantities . further incentives should be provided by increasing the weighting of advanced biofuels towards 10% target for transport set in directive 2009 / 28 / ec compared to conventional biofuels . establishing progressively more ambitious mandatory targets for advanced biofuels in the transport sector will send a clear signal of support for them at union level . in this context , advanced biofuels with estimated low indirect land use change impacts and high overall greenhouse gas savings should be especially supported as part of the post 2020 renewable energy policy framework provided that this does not result in yet greater dependence of member states on foreign sources of energy carriers and raw materials . however , to avoid market distortions and frauds related to the production of advanced biofuels also the latter should comply with relevant sustainability criteria .


### member states shall ensure that no raw materials are intentionally modified to be covered by categories to . ### member states shall refer to an independent european - wide registration system for verifying the origin and the traceability of all biofuels and particularly of advanced biofuels listed under annex ix or eligible for an extra - incentive or for a separate target at eu or national level : such register should consist in a single database certifying all biofuels volumes from their origin until their final consumption . the register shall be aimed to avoid untrustworthy multiple declarations of the same volumes under two or more national or european schemes , shall register biofuels as from their origination and shall ensure that no raw materials are intentionally modified to be covered by categories to .


### 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 . ligno - cellulosic residues are one of the rare forms of biomass in large supply in europe . the setting of a blending sub - target for ligno - cellulosic biofuels would provide investors with the visibility needed to build on their potential .


### 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 , that use waste materials for energy purposes only in accordance with the waste hierarchy set out in article 4 of directive 2008 / 98 / ec , that do not compete for the use of land and water and hence protect land and food rights and that do not reduce organic matter , thereby having adverse environmental repercussions on the local ecosystem .


### 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 . ’ ### for the calculation of biofuels in the numerator , the share of energy from biofuels on the list of feedstocks in parts a and b of annex ix shall be at least 2% of the final consumption of energy in transport in 2020 and the share of energy from biofuels produced from cereal and other starch rich crops and sugars shall be 8% of the final consumption of energy in petrol 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 there exists a risk that greenhouse gas emissions linked to indirect land use change could be significant . 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 avert this risk in the short , medium and long term , research and development should be encouraged into the production of new forms of advanced biofuels that do not directly compete with food crops .


### in order to permit adaptation to technical and scientific progress of directive 2009 / 28 / ec , 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 respect of the list of biofuel feedstocks that are counted multiple times towards the target set in article 3 , the energy content of transport fuels , criteria and geographic ranges for determining highly biodiverse grassland , the methodology for the calculation of indirect land - use change emissions , and the methodological principles and values necessary for assessing whether sustainability criteria have been fulfilled in relation to biofuels and bioliquids . ### in order to permit adaptation to technical and scientific progress of directive 2009 / 28 / ec , 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 respect of the energy content of transport fuels , criteria and geographic ranges for determining highly biodiverse grassland , the methodology for the calculation of the amount of biomass not causing any indirect land - use change emissions , and the methodological principles and values necessary for assessing whether sustainability criteria have been fulfilled in relation to biofuels and bioliquids .