### space is a rapidly growing sector which delivers information vital to many areas of modern society , meeting its fundamental demands , addresses universal scientific questions , and serves to secure the union ' s position as a major player on the international stage . space research underpins all activities undertaken in space , but is currently fragmented in national programmes run by a subset of union member states . union level coordination and investment in space research are required to maintain the competitive edge , to safeguard union space infrastructure such as galileo and to sustain a future role for the union in space . in addition , innovative downstream services and applications using space derived information represent an important source of growth and job creation . ### space is a rapidly growing sector which delivers information vital to many areas of modern society , meeting its fundamental demands , addresses universal scientific questions and global challenges such as climate change , and serves to secure the union ' s position as a major player on the international stage . space research underpins all activities undertaken in space , but is currently fragmented in national programmes run by a subset of union member states . union level coordination and investment in space research are required to maintain the competitive edge , to safeguard union space infrastructure such as galileo and to sustain a future role for the union in space . in addition , innovative downstream services and applications using space derived information represent an important source of growth and job creation , whilst also contributing to the fulfilment of union external objectives and international commitments in the fields of humanitarian crisis response and environment , for example .


### infectious diseases , are a global concern , accounting for 41% of the 1 . 5 billion disability adjusted life years worldwide , with 8% of these in europe . emerging epidemics and the threat of increasing anti - microbial resistance must also be prepared for . ### infectious diseases , are a global concern , accounting for 41% of the 1 . 5 billion disability adjusted life years worldwide , with 8% of these in europe . emerging and re - emerging epidemics and the threat of increasing anti - microbial resistance must also be prepared for . the specific field of zoonoses requires attention here , in concert with other supported activities that focus on animal health .


### infectious diseases , are a global concern , accounting for 41 % of the 1 . 5 billion disability adjusted life years worldwide , with 8 % of these in europe . emerging epidemics and the threat of increasing anti - microbial resistance must also be prepared for . ### infectious diseases , are a global concern , accounting for 41 % of the 1 . 5 billion disability adjusted life years worldwide , with 8 % of these in europe . emerging and re - emerging epidemics and the threat of increasing anti - microbial resistance must also be prepared for .


### meanwhile , drug and vaccine development processes are becoming more expensive and less effective . persistent health inequalities must be addressed , and access to effective and competent health systems must be ensured for all europeans . ### meanwhile , drug and vaccine development processes are becoming more expensive and less effective . persistent health inequalities must be addressed , and access to effective and competent health systems must be ensured globally , in order to assure the best possible health for all europeans .


### the response depends on excellence in research to improve our fundamental understanding of health , disease , disability , development and ageing , and on the seamless and widespread translation of the resulting and existing knowledge into innovative , scalable and effective products , strategies , interventions and services . furthermore , the pertinence of these challenges across europe and in many cases , globally , demands a response characterised by long term and coordinated support for co - operation between excellent , multidisciplinary and multi - sector teams . ### the response depends on excellence in research to improve our fundamental understanding of health , disease , disability , development and ageing , and on the seamless and widespread translation of the resulting and existing knowledge into innovative , scalable and effective products , strategies , interventions and services . furthermore , the pertinence of these challenges across europe and in many cases , globally , demands a response characterised by long term and coordinated support for co - operation between excellent , multidisciplinary and multi - sector teams globally , including research and development capacity in endemic areas .


### to maximise the impact of union level actions , support will be provided to the full spectrum of research and innovation activities . from basic research through translation of knowledge to large trials and demonstration actions , mobilising private investment ; to public and pre - commercial procurement for new products , services , scalable solutions , which are when necessary , interoperable and supported by defined standards and / or common guidelines . this co - ordinated , european effort will contribute to the ongoing development of the era . it will also interface , as and when appropriate , with activities developed in the context of the health for growth programme and the european innovation partnership on active and health ageing . ### to maximise the impact of union level actions , support will be provided to the full spectrum of research and innovation activities . from basic research through translation of knowledge to large trials and demonstration actions , mobilising private investment ; to public and pre - commercial procurement for new products , services , scalable solutions , which are when necessary , interoperable and supported by defined standards and / or common guidelines . this co - ordinated , european effort will contribute to the ongoing development of the era . it will also complement and create synergies , as and when appropriate , with activities developed in the context of the health for growth programme , the european innovation partnership on active and healthy ageing , the council conclusions on the role of the eu in global health and union external programmes and international commitments in the field of global health .


### specific activities shall include : understanding the determinants of health , improving health promotion and disease prevention ; understanding disease and improving diagnosis ; developing effective screening programmes and improving the assessment of disease susceptibility ; improving surveillance and preparedness ; developing better preventive vaccines ; using in - silico medicine for improving disease management and prediction ; treating disease ; transferring knowledge to clinical practice and scalable innovation actions ; better use of health data ; active ageing , independent and assisted living ; individual empowerment for self - management of health ; promotion of integrated care ; improving scientific tools and methods to support policy making and regulatory needs ; and optimising the efficiency and effectiveness of healthcare systems and reducing inequalities by evidence based decision making and dissemination of best practice , and innovative technologies and approaches . ### specific activities shall include : understanding the determinants of health , improving health promotion and disease prevention ; understanding disease and improving diagnosis ; developing effective screening programmes and improving the assessment of disease susceptibility ; improving surveillance and preparedness ; developing new and better preventive vaccines , therapies and treatments ; using in - silico medicine for improving disease management and prediction ; developing adapted treatments and treating disease ; transferring knowledge to clinical practice and scalable innovation actions including psychosocial aspects ; improving regulatory procedures and support of access related activities ; better collection and use of health data ; standardised data analysis techniques ; healthy and active ageing , independent and assisted living ; individual empowerment for self - management of health ; promotion of integrated care ; improving scientific tools and methods to support policy making and regulatory needs ; and optimising the efficiency and effectiveness of healthcare systems and reducing health disparities and inequalities by evidence based decision making and dissemination of best practice , and innovative technologies and approaches . all of these activities shall properly account for gender and sex analysis .


### over the coming decades , europe will be challenged by increased competition for limited and finite natural resources , by the effects of climate change , in particular on primary production systems and by the need to provide a sustainable , safe and secure food supply for the european and an increasing global population . a 70 % increase of the world food supply is estimated to be required to feed the 9 billion global population by 2050 . agriculture accounts for about 10 % of union greenhouse gases emissions , and while declining in europe , global emissions from agriculture are projected to increase up to 20 % by 2030 . furthermore , europe will need to ensure sufficient supplies of raw materials , energy and industrial products , under conditions of decreasing fossil carbon resources , while maintaining its competitiveness . bio - waste represents a huge problem and cost , despite its high potential added value . for example , an estimated 30 % of all food produced in developed countries is discarded . major changes are needed to reduce this amount by 50 % in the union by 2030 . in addition , national borders are irrelevant in the spread of animal and plant pests and diseases , including zoonotic diseases , and food borne pathogens . while effective national prevention measures are needed , action at union level is essential for ultimate control and the effective running of the single market . the challenge is complex , affects a broad range of interconnected sectors and requires a plurality of approaches . ### over the coming decades , europe will be challenged by increased competition for limited and finite natural resources , by the effects of climate change , in particular on primary production systems and by the need to provide a sustainable , safe and secure food supply for the european and an increasing global population . a 70 % increase of the world food supply is estimated to be required to feed the 9 billion global population by 2050 . agriculture accounts for about 10 % of union greenhouse gases emissions , and while declining in europe , global emissions from agriculture are projected to increase up to 20 % by 2030 . furthermore , europe will need to ensure sustainable supplies of raw materials , energy and industrial products , under conditions of decreasing fossil carbon resources , while maintaining its competitiveness . bio - waste represents a huge problem and cost , despite its high potential added value . for example , an estimated 30 % of all food produced in developed countries is discarded . major changes are needed to reduce this amount by 50 % in the union by 2030 . in addition , national borders are irrelevant in the spread of animal and plant pests and diseases , including zoonotic diseases , and food borne pathogens . while effective national prevention measures are needed , action at union level is essential for ultimate control and the effective running of the single market . the challenge is complex , affects a broad range of interconnected sectors and requires a plurality of approaches .


### the aim is to supply sufficient food , feed , biomass and other raw - materials , while safeguarding natural resources and enhancing ecosystems services , including coping with and mitigating climate change . the activities shall focus on more sustainable and productive agriculture and forestry systems which are both resource - efficient and resilient , while at the same time developing of services , concepts and policies for thriving rural livelihoods . ### the aim is to ensure a sufficient global supply of food , feed , biomass and other raw - materials , while safeguarding natural resources and enhancing ecosystems services , including coping with and mitigating climate change . the activities shall focus on more sustainable and productive agriculture and forestry systems globally which are both resource - efficient and resilient , while at the same time developing of services , concepts and policies for thriving rural livelihoods . attention shall be paid to the health and management of livestock , including vaccines and treatments for diseases , including tropical diseases .


### on the international scene , the action taken at union level provides a ' critical mass ' to attract interest from other technology leaders and foster international partnerships to achieve the union ' s objectives . it will make it easier for international partners to interact with the union to build common action where there is mutual benefit and interest . ### on the international scene , the action taken at union level provides a ' critical mass ' to attract interest from other technology leaders and foster international partnerships to achieve the union ' s objectives . it will make it easier for international partners to interact with the union to build common action where there is mutual benefit and interest . in this regard special consideration will be paid to union initiatives and international commitments on universal energy access and climate change adaptation and mitigation .


### the in - built complexity of these challenges and the evolutions of demands thus make it essential to develop innovative research and new smart technologies , processes and methods , social innovation mechanisms , coordinated actions and policies that will anticipate or influence major evolutions for europe . it calls for understanding the underlying trends and impacts at play in these challenges and rediscovering or reinventing successful forms of solidarity , coordination and creativity that make europe a distinctive model of inclusive , innovative and secure societies compared to other world regions . it requires a more strategic approach to cooperation with third countries . finally , as security policies should interact with different social policies , enhancing the societal dimension of security research will be an important aspect of this challenge . ### the in - built complexity of these challenges and the evolutions of demands thus make it essential to develop innovative research and new smart technologies , processes and methods , social innovation mechanisms , coordinated actions and policies that will anticipate or influence major evolutions for europe . it calls for understanding the underlying trends and impacts at play in these challenges and rediscovering or reinventing successful forms of solidarity , coordination and creativity that make europe a distinctive model of inclusive , innovative and secure societies compared to other world regions . it requires a more strategic and open approach to cooperation with third countries , with targeted actions taken to promote and support international cooperation . finally , as security policies should interact with different social policies , enhancing the societal dimension of security research will be an important aspect of this challenge .


### the aim is to foster the development of innovative societies and policies in europe through the engagement of citizens , enterprises and users in research and innovation and the promotion of coordinated research and innovation policies in the context of globalisation . particular support will be provided for the development of the era and the development of framework conditions for innovation . ### the aim is to foster the development of innovative societies and policies in europe through the engagement of citizens , enterprises and users in research and innovation and the promotion of coordinated research and innovation policies that engage third countries . particular support will be provided for the development of the era and the development of framework conditions for innovation .


### promote coherent and effective cooperation with third countries . ### promote coherent and effective cooperation with third countries including in terms of access to research results and information .


### the international rail corridors for a european rail network for competitive freight should be set up in a manner consistent with the trans - european transport network and / or the european railway traffic management system corridors . to that end , the coordinated development of the networks is necessary , and in particular as regards the integration of the international corridors for rail freight into the existing ten - t and the ertms corridors . furthermore , harmonising rules relating to those freight corridors should be established at the level of the union . if necessary , the creation of those corridors should be supported financially within the framework of the ten - t , research and marco polo programmes , and other policies and funds of the union , such as the european regional development fund or the cohesion fund . ### the european rail network for competitive freight should be set up in a manner consistent with the trans - european transport network and / / or the european railway traffic management system corridors . to that end , the coordinated development of the networks is necessary , and in particular as regards the integration of the international corridors for rail freight into the existing ten - t and the ertms corridors . furthermore , harmonising rules relating to those freight corridors should be established at the level of the union . if necessary , the creation of those corridors should be supported financially within the framework of the ten - t , research and marco polo programmes , and other policies and funds of the union , such as the european regional development fund or the cohesion fund .


### in order to stimulate coordination between the member states and the infrastructure managers , an appropriate governance structure for each freight corridor should be established , taking account of the need to avoid duplication with already existing governance structures . ### in order to stimulate coordination between the member states , infrastructure managers and railway undertakings , each freight corridor should be supported by a governance body comprised of the various infrastructure managers who are involved with the freight corridor , taking account of the need to avoid duplication with already existing governance structures .


### in order to guarantee the consistency and continuity of the infrastructure capacities available along the freight corridor , investment in the freight corridor should be coordinated between member states and the infrastructure managers concerned , and planned in a way which meets the needs of the freight corridor . the schedule for carrying out the investment should be published to ensure that applicants who may operate in the corridor are well - informed . the investment should include projects relating to the development of interoperable systems and the increase in capacity of the trains . ### in order to guarantee the consistency and continuity of the infrastructure capacities available along the freight corridor , investment in the freight corridor should be coordinated between member states , the infrastructure managers and the railway undertakings concerned , as well as , if applicable , between member states and third countries , and planned in a way which meets the needs of the freight corridor . the schedule for carrying out the investment should be published to ensure that railway undertakings that may operate in the corridor are well - informed . the investment should include projects relating to the development of interoperable systems and the increase in capacity of the trains .


### since the objective of this regulation , namely the establishment of a european rail network for competitive freight made up of freight corridors , cannot be sufficiently achieved by the member states alone and can therefore by reason of its scale and effects be better achieved at the level of the union , the union may adopt measures in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this regulation does not go beyond what is necessary in order to achieve that objective . ### since the objective of this regulation , namely the creation of a european rail network for competitive freight made up of freight corridors , cannot be sufficiently achieved by the member states alone and can therefore by reason of its scale and effects be better achieved at the level of the union , the union may adopt measures in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this regulation does not go beyond what is necessary in order to achieve that objective .


### this regulation lays down rules for the establishment and organisation of international rail corridors for a european rail network for competitive freight . it sets out rules for the selection , organisation and management of freight corridors . ### this regulation lays down rules for the establishment and organisation of international rail corridors for a european rail network for competitive freight . it sets out rules for the selection , organisation , management and the investment planning of freight corridors .


### for each freight corridor , member states concerned shall establish an executive board responsible for defining the general objectives of the freight corridor , supervising and taking the measures as expressly provided for in articles 8 , 10 and 20 . the executive board shall be composed of representatives of the authorities of the member states concerned . ### for each freight corridor , member states concerned shall establish an executive board responsible for defining the general objectives of the freight corridor , supervising and , whenever relevant , taking the measures as expressly provided for in articles 8 , 10 and 20 . the executive board shall be composed of representatives of the authorities of the member states concerned .


### the activities of the one - stop shop shall be carried out under transparent and non - discriminatory conditions . these activities shall be subject to control of the regulatory bodies in accordance with article 18 . ### the activities of the one - stop shop shall be carried out in a transparent manner ; to this end a register , made freely available to all interested parties to prevent any discrimination , shall be kept wherein are noted the date requests are made , the names of the applicants , details of documentation supplied and of incidents . these activities shall be subject to the control of the regulatory bodies in accordance with article 18 .


### save in the case of force majeure , a train path allocated to a freight operation under this article may not be cancelled less than one month before its scheduled time in the working timetable except if the applicant concerned gives its approval for such cancellation . in such a case the infrastructure manager concerned shall make an effort to propose to the applicant a train path of an equivalent quality and reliability which the applicant has the right to accept or refuse . this provision shall be without prejudice to any rights the applicant may have under an agreement as referred to in article 19 of directive 2001 / 14 / ec . ### save in the case of force majeure and in the event of safety critical line closures and construction work required at short notice on the railway infrastructure , a train path allocated to a freight operation under this article may not be cancelled less than one month before its scheduled time in the working timetable except if the applicant concerned gives its approval for such cancellation . in such a case the infrastructure manager concerned shall make an effort to propose to the applicant a train path of an equivalent quality and reliability which the applicant has the right to accept or refuse . this provision shall be without prejudice to any rights the applicant may have under an agreement as referred to in article 19 of directive 2001 / 14 / ec .


### sines - lisboa / leixões - madrid - san sebastian - bordeaux - paris - metz sines - elvas / algeciras ### sines - lisboa / leixões - madrid - san sebastian - bordeaux - paris / le havre / metz sines - elvas / algeciras


### delivering or receiving fluorinated greenhouse gases for the tasks listed in points , and . ### delivering or receiving fluorinated greenhouse gases for the tasks listed in points , and . this does not include delivering or receiving sealed drums .


### establishing a closer link between cohesion policy and the economic governance of the union will ensure that the effectiveness of expenditure under the csf funds is underpinned by sound economic policies and that the csf funds can , if necessary , be redirected to addressing the economic problems a country is facing . this process has to be gradual , starting with amendments to the partnership contract and to the programmes in support of council recommendations to address macroeconomic imbalances and social and economic difficulties . where , despite the enhanced use of csf funds , a member state fails to take effective action in the context of the economic governance process , the commission should have the right to suspend all or part of the payments and commitments . decisions on suspensions should be proportionate and effective , taking into account the impact of the individual programmes for addressing the economic and social situation in the relevant member state and previous amendments to the partnership contract . when deciding on suspensions , the commission should also respect equality of treatment between member states , taking into account in particular the impact of the suspension on the economy of the member state concerned . the suspensions should be lifted and funds be made available again to the member state concerned as soon as the member state takes the necessary action . ### establishing a closer link between cohesion policy and the economic governance of the union will ensure that the effectiveness of expenditure under the csf funds is underpinned by sound economic policies and that the csf funds can , if necessary , be redirected to addressing the economic problems a country is facing . this process has to be gradual , starting with amendments to the partnership contract and to the programmes in support of council recommendations to address macroeconomic imbalances and social and economic difficulties . where , despite the enhanced use of csf funds , a member state fails to take effective action in the context of the economic governance process , the commission should have the right to suspend all or part of the payments and commitments . decisions on suspensions should be proportionate and effective , taking into account the impact of the individual programmes for addressing the economic and social situation in the relevant member state and previous amendments to the partnership contract . when deciding on suspensions , the commission should also respect equality of treatment between member states , taking into account in particular the impact of the suspension on the economy of the member state concerned . the suspensions should be lifted and funds be made available again to the member state concerned as soon as the member state takes the necessary action . if a member state fails to take appropriate actions within a period greater than three months , the commission should be able to place the suspended payments and commitments in a programme administered and supervised by the commission . this programme should prioritise maximising growth , for example by providing grants for economy - related infrastructure , to avoid causing further damage to the regional economy and the social situation .


### establishing a closer link between cohesion policy and the economic governance of the union will ensure that the effectiveness of expenditure under the csf funds is underpinned by sound economic policies and that the csf funds can , if necessary , be redirected to addressing the economic problems a country is facing . this process has to be gradual , starting with amendments to the partnership contract and to the programmes in support of council recommendations to address macroeconomic imbalances and social and economic difficulties . where , despite the enhanced use of csf funds , a member state fails to take effective action in the context of the economic governance process , the commission should have the right to suspend all or part of the payments and commitments . decisions on suspensions should be proportionate and effective , taking into account the impact of the individual programmes for addressing the economic and social situation in the relevant member state and previous amendments to the partnership contract . when deciding on suspensions , the commission should also respect equality of treatment between member states , taking into account in particular the impact of the suspension on the economy of the member state concerned . the suspensions should be lifted and funds be made available again to the member state concerned as soon as the member state takes the necessary action . ### establishing a closer link between cohesion policy and the economic governance of the union will ensure that the effectiveness of expenditure under the funds covered by the cpr is underpinned by sound economic policies and that the funds covered by the cpr can , if necessary , be redirected to addressing the economic problems a country is facing . this process has to be gradual , starting with amendments to the partnership contract and to the programmes in support of council recommendations to address macroeconomic imbalances and social and economic difficulties .


### to ensure the effectiveness , fairness and sustainable impact of the intervention of the csf funds , there should be provisions guaranteeing that investments in businesses and infrastructures are long - lasting and prevent the csf funds from being used to undue advantage . experience has shown that a period of five years is an appropriate minimum period to be applied , except where state aid rules foresee a different period . it is appropriate to exclude actions supported by the esf and those not entailing productive investment or investment in infrastructure from the general requirement of durability , unless such requirements are derived from applicable state aid rules , and to exclude contributions to or from financial instruments . ### to ensure the effectiveness , fairness and sustainable impact of the intervention of the csf funds , there should be provisions guaranteeing that investments in businesses and infrastructures are long - lasting and prevent the csf funds from being used to undue advantage . experience has shown that a period of 10 years is an appropriate minimum period to be applied , except where state aid rules foresee a different period . it is appropriate to exclude actions supported by the esf and those not entailing productive investment or investment in infrastructure from the general requirement of durability , unless such requirements are derived from applicable state aid rules , and to exclude contributions to or from financial instruments .


### as regards the funds and with a view to ensuring an appropriate allocation to each category of regions , resources should not be transferred between less developed , transition and more developed regions except in duly justified circumstances linked to the delivery of one or more thematic objectives and for no more than 2 % of the total appropriation for that category of region . ### as regards the funds and with a view to ensuring an appropriate allocation to each category of regions , resources should not be transferred between less developed and more developed regions except in duly justified circumstances linked to the delivery of one or more thematic objectives and for no more than 2 % of the total appropriation for that category of region .


### in accordance with the multi - level governance approach , the partners shall be involved by member states in the preparation of partnership contracts and progress reports and in the preparation , implementation , monitoring and evaluation of programmes . the partners shall participate in the monitoring committees for programmes . ### in accordance with the multi - level governance approach , the partners shall be involved by member states in the preparation of partnership contracts and progress reports and in the preparation , implementation , monitoring and evaluation of programmes . the partners shall participate in the monitoring committees for programmes . the partners shall be ensured equal access to the funding provided for these purposes .


### member states shall concentrate support , in accordance with the fund - specific rules , on actions bringing the greatest added value in relation to the union strategy for smart , sustainable and inclusive growth , addressing the challenges identified in the country - specific recommendations under article 121 of the treaty and the relevant council recommendations adopted under 148 of the treaty , and taking into account national and regional needs . ### member states shall concentrate support , in accordance with the fund - specific rules and in full agreement with the regional authorities , on actions bringing the greatest added value , in relation to the union strategy for smart , sustainable and inclusive growth , and which address the challenges identified in the country - specific recommendations under article 121 of the treaty and the relevant council recommendations adopted under 148 of the treaty , while taking into account national and regional needs .


### each programme , except those where technical assistance is undertaken under a specific programme , shall set out the indicative amount of support to be used for climate change objectives . ### each programme , except those where technical assistance is undertaken under a specific programme , shall set out the indicative amount of support to be used for objectives relating to climate change , social inclusion and reduction of poverty ;


### the financial plan of the strategy , including the planned allocation of each of the csf funds . ### the financial plan of the strategy , including the planned allocation of each of the csf funds , and specifically the use of integrated territorial investments , sustainable urban development and joint action plans .


### as regards financial instruments referred to in article 33 , the request for payment shall include and separately disclose the total amount of support paid to the financial instrument . ### as regards financial instruments referred to in article 33 and financial instruments referred to in article 33 implemented in accordance with article 33 and , phased applications for interim payments shall be made for programme contributions paid to the financial instrument during the period of eligibility in accordance with the following conditions : the amount of the programme contribution paid to the financial instrument included in each application for interim payment submitted during the eligibility period indicated in article 55 shall not exceed 25 per cent of the total amount of programme contributions committed to the financial instrument under the relevant funding agreement , corresponding to expenditure in the meaning of article 36 , and expected to be paid during the eligibility period indicated in article 55 . applications for interim payment submitted after the eligibility period indicated in article 55 shall include the total amount of eligible expenditure in the meaning of article 36 ; each application for interim payment referred to in paragraph may include up to 25 per cent of the total amount of the national co - financing as referred to in article 33 expected to be paid to the financial instrument , or at the level of final recipients for expenditure in the meaning of article 36 , and , within the eligibility period indicated in article 55 ; subsequent applications for interim payment submitted during the eligibility period indicated in article 55 shall only be made : for the second application for interim payment , when at least 60 per cent of the amount included in the first application for interim payments has been spent as eligible expenditure in the meaning of article 36 , and ; for the third and subsequent applications for interim payment , when at least 70 per cent of the amounts included in the previous applications for interim payments have been spent as eligible expenditure in the meaning of article 36 , and ; each application for interim payment , which includes expenditure related to financial instruments , shall separately disclose the total amount of programme contributions paid to the financial instrument and the amounts paid as eligible expenditure in the meaning of article 36 , and . at closure , the application for payment of the final balance shall include the total amount of eligible expenditure as referred to in article 36 .


### at least 25 % of the structural funds resources for less developed regions , 40% for transition regions and 52% for more developed regions in each member state shall be allocated to the esf . for the purposes of this provision , the support to a member state through the [ food for deprived people instrument ] shall be considered as part of the share of structural funds allocated to the esf . ### from the structural funds , each member state will allocate the proportion of the esf best suited to its regional development strategy . for the purposes of this provision , the support to a member state through the [ food for deprived people instrument ] shall be considered as part of the share of structural funds allocated to the esf .


### the maximum co - financing rate under paragraph 3 at the level of a priority axis shall be increased by ten percentage points , where the whole of a priority axis is delivered through financial instruments , or through community - led local development . ### the maximum co - financing rate under paragraph 3 at the level of a priority axis shall be increased by ten percentage points , where 50 % of the resources that contribute to an investment priority are delivered through financial instruments , or through community - led local development .


### to ensure convergent implementation of article 14 , member states shall encourage the use of standards and / or specifications relevant to networks and information security . ### to ensure convergent implementation of article 14 , member states shall encourage the use of international or european standards and / or specifications relevant to networks and information security . market operators shall remain free to use additional measures to achieve a higher level of security .


### consent should not provide a valid legal ground for the processing of personal data , where there is a clear imbalance between the data subject and the controller . this is especially the case where the data subject is in a situation of dependence from the controller , among others , where personal data are processed by the employer of employees ' personal data in the employment context . where the controller is a public authority , there would be an imbalance only in the specific data processing operations where the public authority can impose an obligation by virtue of its relevant public powers and the consent cannot be deemed as freely given , taking into account the interest of the data subject . ### consent should not provide a valid legal ground for the processing of personal data , where there is a clear imbalance between the data subject and the controller . this is especially the case where the data subject is in a situation of dependence from the controller , among others , where personal data are processed by the employer of employees ' personal data in the employment context . in an employment context , data processing intended to have primarily legally or financially advantageous consequences for the employee is an exception . where the controller is a public authority , there would be an imbalance only in the specific data processing operations where the public authority can impose an obligation by virtue of its relevant public powers and the consent cannot be deemed as freely given , taking into account the interest of the data subject .


### consent should not provide a valid legal ground for the processing of personal data , where there is a clear imbalance between the data subject and the controller . this is especially the case where the data subject is in a situation of dependence from the controller , among others , where personal data are processed by the employer of employees ' personal data in the employment context . where the controller is a public authority , there would be an imbalance only in the specific data processing operations where the public authority can impose an obligation by virtue of its relevant public powers and the consent cannot be deemed as freely given , taking into account the interest of the data subject . ### consent should not provide a valid legal ground for the processing of personal data , where there is a clear imbalance between the data subject and the controller . this is especially the case where the data subject is in a situation of dependence from the controller , among others , where personal data are processed by the employer of employees ' personal data in the employment context . in an employment context , data processing intended to have legally or financially advantageous consequences for the employee is an exception . where the controller is a public authority , there would be an imbalance only in the specific data processing operations where the public authority can impose an obligation by virtue of its relevant public powers and the consent cannot be deemed as freely given , taking into account the interest of the data subject .


### the general principles on the protection of individuals with regard to the processing of personal data should also be applicable to the employment context . therefore , in order to regulate the processing of employees ' personal data in the employment context , member states should be able , within the limits of this regulation , to adopt by law specific rules for the processing of personal data in the employment sector . ### the general principles on the protection of individuals with regard to the processing of personal data should also be applicable to the employment context . member states should be able to regulate the processing of employees ' personal data in the employment context , while ensuring compliance with the standards set out in this regulation . where a statutory basis is provided in the member state in question for the regulation of employment matters by agreement between employee representatives and the management of the undertaking or the controlling undertaking of a group of undertakings or under directive 2009 / 38 / ec of the european parliament and of the council of 6 may 2009 on the establishment of a european works council or a procedure in community - scale undertakings and community - scale groups of undertakings for the purposes of informing and consulting employees1 , the processing of personal data in an employment context may also be regulated by such an agreement . __________________ 1 oj l 122 , 16 . 5 . 2009 , p . 28 .


### the general principles on the protection of individuals with regard to the processing of personal data should also be applicable to the employment context . therefore , in order to regulate the processing of employees ' personal data in the employment context , member states should be able , within the limits of this regulation , to adopt by law specific rules for the processing of personal data in the employment sector . ### the general principles on the protection of individuals with regard to the processing of personal data should also be applicable to the employment context . member states should be able to regulate the processing of employees ' personal data in the employment context , while ensuring compliance with the standards set out in this regulation . where a statutory basis exists in the member state in question for the regulation of employment matters by agreement between employee representatives and the management of the undertaking or the controlling undertaking of a group of undertakings or under directive 2009 / 38 / ec of the european parliament and of the council of 6 may 2009 on the establishment of a european works council or a procedure in community - scale undertakings and community - scale groups of undertakings for the purposes of informing and consulting employees , it should also be possible to regulate the processing of personal data in an employment context by such an agreement . ________________ 1 oj l 122 , 16 . 5 . 2009 , p . 28 .


### the processing is carried out by an enterprise employing 250 persons or more ; or ### the processing is carried out by a legal person and relates to more than 250 data subjects per year ; or


### at company level , it is widely acknowledged that the presence of women on boards improves corporate governance , because team performance and the quality of decision - making are enhanced due to a more diverse and collective mind - set incorporating a wider range of perspectives and therefore reaching more balanced decisions . numerous studies have also shown that there is a positive relationship between gender diversity at top management level and a company ' s financial performance and profitability . enhancing female representation on the boards of publicly listed companies in the union can therefore have a positive impact on the performance of companies concerned . ### at company level , it is widely acknowledged that the presence of women on boards improves corporate governance , because team performance is enhanced and the quality of decision making is improved due to the fact that it incorporates a more balanced perspective . numerous studies have also shown that there is a positive relationship between gender diversity at top management level and a company ' s financial performance and profitability . enhancing female representation on the boards of publicly listed companies in the union should therefore have a positive impact on the performance of companies concerned .


### the europe 2020 strategy for smart , sustainable and inclusive growth ascertained that increased female labour force participation is a precondition for boosting growth and for tackling demographic challenges in europe . the strategy set a headline target of reaching an employment rate of 75 per cent for women and men aged 20 - 64 by 2020 , which can only be reached if there is a clear commitment to gender equality and a reinforced effort to tackle all barriers to women ' s participation in the labour market . the current economic crisis has magnified europe ' s ever - growing need to rely on knowledge , competence and innovation and to make full use of the pool of available talent . enhancing female participation in economic decision - making , on company boards in particular , is expected to have a positive spill - over effect on female employment in the companies concerned and throughout the whole economy . ### the europe 2020 strategy for smart , sustainable and inclusive growth ascertained that increased female labour force participation is a precondition for boosting growth and for tackling demographic challenges in europe . the strategy set a headline target of reaching an employment rate of 75 per cent for women and men aged 20 - 64 by 2020 , which can only be reached if there is a clear commitment to gender equality and a reinforced effort to tackle all barriers to women ' s participation in the labour market . the current economic crisis has magnified europe ' s ever - growing need to rely on knowledge , competence and innovation and to make full use of the pool of available talent . enhancing female participation in economic decision - making , on company boards and at all management levels throughout the company , is expected to have a positive spill - over effect on female employment in the companies concerned and throughout the whole economy .


### member states exercise a dominant influence over listed companies which are public undertakings within the meaning of article 2 of commission directive 2006 / 111 / ec of 16 november 2006 on the transparency of financial relations between member states and public undertakings , as well as on financial transparency within certain undertakings . due to that dominant influence , they have the instruments at their disposal to bring about the necessary change more rapidly . therefore , in such companies the objective of least 40 per cent of non - executive directors of the under - represented sex should be set at an earlier date . ### member states exercise a dominant influence over listed companies which are public undertakings within the meaning of article 2 of commission directive 2006 / 111 / ec of 16 november 2006 on the transparency of financial relations between member states and public undertakings , as well as on financial transparency within certain undertakings . due to that dominant influence , they have the instruments at their disposal to bring about the necessary change more rapidly . therefore , in such companies the objective of least 40 per cent of non - executive directors of the under - represented sex should be set at an earlier date and member states should encourage and incentivise these companies to extend the provisions of this directive to executive directors and to all levels of management within the company .


### member states shall take the necessary measures , in accordance with their national judicial systems , to ensure that where an unsuccessful candidate of the under - represented sex establishes facts from which it may be presumed that that candidate was equally qualified as the appointed candidate of the other sex , it shall be for the listed company to prove that there has been no breach of the rule laid down in paragraph 3 . ### member states shall take the necessary measures , in accordance with their national judicial systems , to require that listed companies are able to demonstrate that their appointment process has been carried out in compliance with the rule laid down in paragraph 3 , particularly in cases where an unsuccessful candidate of the under - represented sex establishes facts from which it may be presumed that that candidate was equally qualified as the appointed candidate of the other sex .


### the priority area climate change mitigation should contribute to the development and implementation of union climate - related policy and legislation , in particular with regard to greenhouse gas monitoring and reporting , policies related to land use , land use change and forestry , emissions trading system , member states ' effort to reduce greenhouse gas emissions , carbon capture and storage , renewable energy , energy efficiency , transport and fuels , ozone layer protection and fluorinated gases . ### the priority area climate change mitigation should contribute to the development and implementation of union climate - related policy and legislation , in particular with regard to greenhouse gas monitoring and reporting , policies related to land use , land use change and forestry , emissions trading system , member states ' effort to reduce greenhouse gas emissions , carbon capture and storage , renewable energy , energy efficiency and energy saving , transport and sustainable advanced biofuels , ozone layer protection and fluorinated gases .


### the acquisition or rental , by whatever financial means , of land , existing buildings or other immovable property or concerning rights thereon ; however financial service concessions awarded at the same time as , before or after the contract of acquisition or rental , in whatever form , shall be subject to this directive ; ### the acquisition or rental , by whatever financial means , of land , existing buildings or other immovable property , including maritime areas , or concerning rights thereon ; however financial service concessions awarded at the same time as , before or after the contract of acquisition or rental , in whatever form , shall be subject to this directive ;


### the european parliament has called for a radical simplification of union research and innovation funding in its resolution of 11 november 20101 , has highlighted the importance of the innovation union to transform europe for post - crisis world , in its resolution of 12 may 20112 , has drawn attention to important lessons to be learned following the interim evaluation of the seventh framework programme in its resolution of 8 june 20113 and has supported the concept of a common strategic framework for research and innovation funding in its resolution of 27 september 20114 . ______________ p7 ta0401 . 2p7 ta0236 . 3p7 ta0256 . 4p7 ta0401 . ### the european parliament has called for a radical simplification of union research and innovation funding in its resolutions of 11 november 20101 and 11 june 20112 , that emphasisied that any increase of funds should be coupled with a radical simplification of funding procedures , has highlighted the importance of the innovation union to transform europe for post - crisis world , in its resolution of 12 may 20113 , has drawn attention to important lessons to be learned following the interim evaluation of the seventh framework programme in its resolution of 8 june 20114 and has supported the concept of a common strategic framework for research and innovation funding in its resolution of 27 september 20115 . ______________ p7 ta0401 . 2p7 ta - prov0266 . 3p7 ta0236 . p7 ta0256 . 5p7 ta0401 .


### simplification is a central aim of horizon 2020 which should be fully reflected in its design , rules , financial management and implementation . horizon 2020 should aim to attract the strong participation of universities , research centres , industry and specifically smes and be open to new participants , as it brings together the full range of research and innovation support in one common strategic framework , including a streamlined set of forms of support and uses rules for participation with principles applicable to all actions under the programme . simpler funding rules should reduce the administrative costs for participation and will contribute to a reduction of financial errors . ### simplification is a central requirement of horizon 2020 which should be fully reflected in its design , rules , financial management and implementation . horizon 2020 should aim to attract the strong participation of universities , research centres , industry and specifically smes and be open to new participants , as it brings together the full range of research and innovation support in one common strategic framework , including a streamlined set of forms of support that take due regard of the nature of the activities and of their closeness to the market and uses rules for participation with principles applicable to all actions under the programme . simpler funding rules should reduce the administrative costs for participation and will contribute to a reduction of financial errors .


### it is appropriate to ensure a correct closure of horizon 2020 and its predecessor programmes , in particular regarding the continuation of multi - annual arrangements for their management , such as the financing of technical and administrative assistance . ### it is appropriate to ensure a correct closure of horizon 2020 and its predecessor programmes , in particular regarding the continuation of multi - annual arrangements for their management , such as the financing of strictly necessary technical and administrative assistance .


### smes constitute a significant source of innovation and growth in europe . therefore a strong participation of smes , as defined in commission recommendation 2003 / 361 / ec of 6 may 2003 , is needed in horizon 2020 . this should support the aims of the small business act . ### smes constitute a significant source of innovation and growth in europe . therefore a strong participation of smes , as defined in commission recommendation 2003 / 361 / ec of 6 may 2003 for all union programmes for support , is needed in horizon 2020 . this should support the aims of the small business act .


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


### horizon 2020 shall contribute to building an economy based on knowledge and innovation across the whole union by leveraging sufficient additional research , development and innovation funding . thereby , it shall support the implementation of the europe 2020 strategy and other union policies , as well as the achievement and functioning of the european research area . the relevant performance indicators are set out in the introduction of annex i . ### horizon 2020 shall contribute to building an economy based on knowledge and innovation across the whole union by leveraging sufficient additional research , development and innovation funding . thereby , it shall support the implementation of the europe 2020 strategy and other union policies , as well as the achievement and functioning of the european research area . it is estimated that by 2030 horizon 2020 is expected to generate an extra 0 . 92 per cent of gdp , 1 . 37 per cent of exports , - 0 . 15 per cent of imports , and 0 . 40 per cent of employment . the relevant performance indicators are set out in the introduction of annex i .


### the integrated approach set out in paragraphs 1 and 2 is expected to lead to around 15% of the total combined budget for the specific objective on ' leadership in enabling and industrial technologies ' and the priority ' societal challenges ' going to smes . ### the integrated approach set out in paragraphs 1 and 2 is expected to lead to not less than 15% of the total combined budget for the specific objective on ' leadership in enabling and industrial technologies ' and the priority ' societal challenges ' going to smes , and 50% of participating smes introducing innovations new to the company or the market .


### the long - term commitment from all partners based on a shared vision and clearly defined objectives . ### the long - term financial commitment from all partners based on a shared vision and clearly defined objectives .


### not later than end 2017 , the commission shall carry out , with the assistance of independent experts , a review of the european institute of innovation and technology . the second allocation of funds to the european institute of innovation and technology as set out in article 6 shall be made available following this review . the review shall assess the progress of the european institute of innovation and technology against all of the following : ### not later than end 2017 , the commission shall carry out , with the assistance of independent experts , a review of the european institute of innovation and technology . if the review concludes that the european institute of technology has not fulfilled the criteria set below to a satisfactory degree , the activities of the european institute of technology shall cease and the remaining funds budgeted for the european institute of technology shall be dispersed evenly over the three pillars of horizon 2020 . the review shall assess the progress of the european institute of innovation and technology against all of the following :


### the agreed timing for the creation of the third wave of knowledge and innovation communities and the programmed financial needs of existing ones according to their specific development ; and ### the success in creating new knowledge and innovation communities and the programmed financial needs of existing ones according to their specific development ; and


### the contribution of the european institute of innovation and technologies and the knowledge and innovation communities to the priority on societal challenges and the specific objective on ‘ leadership in enabling and industrial technologies’ of the programme horizon 2020 . ### the contribution of the european institute of innovation and technologies and the knowledge and innovation communities to the priority on societal challenges and the specific objective on ‘ leadership in enabling and industrial technologies’ of the programme horizon 2020 and to the european research area .


### not later than end 2017 , and taking into account the ex - post evaluation of the seventh framework programme to be completed by the end of 2015 and the review of the european institute of innovation and technology , the commission shall carry out , with the assistance of independent experts , an interim evaluation of horizon 2020 , its specific programme , including the european research council , and the activities of the european institute of innovation and technology , on the achievements of the objectives of horizon 2020 and continued relevance of all the measures , the efficiency and use of resources , the scope for further simplification , and union added value . that evaluation shall also take into consideration aspects relating to access to funding opportunities for participants in all regions , for smes and for promoting gender balance . that evaluation shall additionally take into account the contribution of the measures to the union priorities of smart , sustainable and inclusive growth and results on the long - term impact of the predecessor measures . ### not later than end 2017 , and taking into account the ex - post evaluation of the seventh framework programme to be completed by the end of 2015 and the review of the european institute of innovation and technology , the commission shall carry out , with the assistance of independent experts , an interim evaluation of horizon 2020 , its specific programme , including the european research council , and the activities of the european institute of innovation and technology , on the achievements of the objectives of horizon 2020 and continued relevance of all the measures , the efficiency and use of resources , the scope for further simplification , and union added value . that evaluation shall also take into consideration aspects relating to access to funding opportunities for extending the excellence of the union’s science and innovation base in all regions , for smes and for promoting gender balance . that evaluation shall additionally take into account the contribution of the measures to the union priorities of smart , sustainable and inclusive growth and results on the long - term impact of the predecessor measures .


### research infrastructure shall develop european research infrastructure for 2020 and beyond , foster their innovation potential and human capital , and complement this with the related union policy and international cooperation . ### research infrastructure shall develop world - class european research infrastructure for 2020 and beyond , foster and extend the excellence of the union’s science and innovation base and human capital , and complement this with the related union policy and international cooperation . appropriate recourse shall be made to the ' union loan and guarantee service for research and innovation ' in order to leverage additional resources for these investments and promote effective industry - academia links .


### europe must establish an adequate , stable base for building , maintaining and operating research infrastructures if its research is to remain world - class . this requires substantial and effective cooperation between union , national and regional funders for which strong links with the cohesion policy will be pursued to ensure synergies and a coherent approach . ### europe must establish an adequate , stable base for building , maintaining and operating research infrastructures if its research is to remain world - class . this requires that appropriate resources from the ' union loan and guarantee service for research and innovation ' are made available in order to leverage additional resources for these investments and promote effective industry - academia links . effective cooperation between union , national and regional funders for which strong links with the cohesion policy will be pursued to ensure synergies and a coherent approach .


### this specific objective addresses a core commitment of the innovation union flagship initiative , which highlights the crucial role played by world - class research infrastructures in making ground - breaking research and innovation possible . the initiative stresses the need to pool resources across europe , and in some cases globally , in order to build and operate research infrastructures . equally , the digital agenda for europe flagship initiative emphasises the need to reinforce europe’s e - infrastructures and the importance of developing innovation clusters to build europe’s innovative advantage . ### this specific objective addresses a core commitment of the innovation union flagship initiative , which highlights the crucial role played by world - class research infrastructures in making ground - breaking research and in reinforcing and extending the excellence of the union’s science and innovation base . the initiative stresses the need to pool resources across europe , and in some cases globally , in order to build and operate research infrastructures . equally , the digital agenda for europe flagship initiative emphasises the need to reinforce europe’s e - infrastructures and the importance of developing innovation clusters to build europe’s innovative advantage .


### having regard to the treaty on the functioning of the european union , and in particular article 43 , article 74 and 77 , article 91 and 100 , article 173 , article 175 article 188 , article 192 , article 194 and article 195 thereof , ### having regard to the treaty on the functioning of the european union , and in particular article 43 , article 74 and 77 , article 91 and 100 , article 165 and article 166 , article 173 , article 175 , article 188 , article 192 , article 194 and article 195 thereof ,


### to foster the development and implementation of integrated governance of maritime and coastal affairs and integrated sea basin strategies ; ### to put integrated governance of maritime and coastal affairs into practice ;


### to improve and enhance external cooperation and coordination in relation to the objectives of the integrated maritime policy ; ### to enhance the external dimension of the integrated maritime policy and improve its coverage of the outermost regions ;


### specific objectives ### operational objectives


### within the objectives set out in article 2 the programme shall aim to : ### with a view to putting into practice the integrated governance of maritime and coastal affairs referred to in article 2 , the programme shall aim in particular to :


### facilitate the exploitation of synergies , sharing of information and exchange of best practices on maritime policy , including its governance and sectoral policies that have an impact on regional seas and coastal regions or ### facilitate the exploitation of synergies , sharing of information and exchange of best practices on maritime policy , including its governance and sectoral policies that have an impact on regional seas and coastal regions ;


### promote the establishing cross - sectoral cooperation platforms and networks , including interests from industry , research stakeholders , regions , public authorities and ngos ; ### promote the establishment of cross - sectoral cooperation platforms and networks including representatives of the public authorities and of the regions , industry , research stakeholders and ngos ;


### within the objective set out in article 2 , the programme shall aim to foster the development of : ### with a view to developing the cross - sectoral tools referred to in article 2 , the programme shall aim in particular to foster the development of :


### within the objective set out in article 2 and complementing the sectoral policies , the programme shall aim to improve and enhance cooperation for integrated cross - sectoral actions with : third countries including those bordering a european sea basin , actors in third countries , international partners and organisations , particularly in relation to international ecosystem restoration commitments and other pertinent agreements , ### with a view to enhancing the external dimension of the integrated maritime policy as specified in article 2 and complementing the sectoral policies , the programme shall aim to improve and enhance cooperation for integrated cross - sectoral actions with : third countries including those bordering a european sea basin , actors in third countries , international partners and organisations , particularly in relation to international ecosystem restoration commitments and other pertinent agreements ,


### the specific objectives set out in paragraph 3 shall be pursued in accordance with the specific objectives set out in paragraphs 1 and 2 and in coherence with the cooperation instruments of the eu , taking into account the objectives of the national and regional development strategies . ### the operational objectives set out in paragraph 3 shall be pursued in accordance with the operational objectives set out in paragraphs 1 , 2 , 2a , 2b and 2c and in coherence with the cooperation instruments of the eu , taking into account the objectives of the national and regional development strategies .


### studies and cooperative programmes ; ### studies and cooperative programmes , including education and professional training programmes ;


### it is necessary to ensure that the objectives of this directive are not impaired by shortcomings in the applicable testing standards or in case the imo failed to produce appropriate standards for marine equipment falling under the scope of this directive . it is also necessary to adopt appropriate technical criteria so that electronic tags can be affixed and used in a safe and reliable way . moreover , it is necessary to keep up - to - date a number of non - essential elements of this directive , namely the list of international conventions laying down safety requirements for marine equipment contained in article 2 and the references to specific standards contained in annex iii . the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should therefore be delegated to the commission in respect of the adoption , on an interim basis , of harmonised technical specifications and testing standards and in order to amend the said lists and references . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . ### it is necessary to ensure that the objectives of this directive are not impaired by shortcomings in the applicable testing standards or in case the imo failed to produce appropriate standards for marine equipment falling under the scope of this directive . it is also necessary to adopt appropriate technical criteria to make it possible to affix and use electronic tags in a safe and reliable way . moreover , it is necessary to keep up - to - date a number of non - essential elements of this directive , namely the list of international conventions laying down safety requirements for marine equipment contained in article 2 and the references to specific standards contained in annex iii . the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should therefore be delegated to the commission in respect of the adoption , on an interim basis , of harmonised technical specifications and testing standards and in order to amend the said lists and references . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### ‘ conformity assessment’ means the process demonstrating whether marine equipment complies with the requirements laid down in this directive , in accordance with article 15 ; ### ‘ conformity assessment’ means the process carried out by the notified bodies , in accordance with article 15 demonstrating whether marine equipment complies with the requirements laid down in this directive ;


### this directive shall apply to equipment to be placed on board an eu ship and for which the approval of the flag state administration is required by the international instruments . ### this directive shall apply to equipment to be placed on board an eu ship and for which the approval of the flag state administration is required by the international instruments , regardless of whether the ship is located in the community at the time when it is fitted with the equipment .


### this directive shall apply to equipment to be placed on board an eu ship and for which the approval of the flag state administration is required by the international instruments . ### this directive shall apply to equipment to be placed on board an eu ship and for which the approval of the flag state administration is required by the international instruments . it shall not apply to equipment already on board at the time of its entry into force .


### the international instruments , with the exception of testing standards , shall apply in their up - to - date version , without prejudice to article 5 of regulation no 2099 / 2002 of the european parliament and of the council . ### the international instruments , with the exception of testing standards , shall apply in their up - to - date version , without prejudice to article 5 of regulation no 2099 / 2002 of the european parliament and of the council , in accordance with article 35 .


### marine equipment which is considered equivalent pursuant to this article shall be given a certificate by the member state which shall at all times be carried with the equipment . it shall give the flag member state ' s permission for the equipment to be placed on board the ship and imposes any restrictions or lays down any provisions relating to the use of the equipment . ### marine equipment which is considered equivalent pursuant to this article shall be given a certificate by the member state which shall at all times be carried with the equipment . it shall give the flag member state’s permission for the equipment to be kept on board the ship and imposes any restrictions or lays down any provisions relating to the use of the equipment .


### the wheel mark shall be affixed visibly , legibly and indelibly to the product or to its data plate . where that is not possible or not warranted on account of the nature of the product , it shall be affixed to the packaging and to the accompanying documents . ### the manufacturer shall affix the wheel mark visibly , legibly and indelibly to the product or to its data plate . where that is not possible or not warranted on account of the nature of the product , it shall be affixed to the packaging and to the accompanying documents .


### the wheel mark may be supplemented or replaced by an appropriate and reliable form of electronic tag . in such case , articles 9 and 10 shall apply , as appropriate , mutatis mutandi . ### manufacturers shall , as soon as possible , use an appropriate and reliable form of electronic tag instead of or in addition to the wheel mark . in such case , articles 9 and 10 shall apply , as appropriate , mutatis mutandis .


### where compliance of marine equipment with the applicable requirements has been demonstrated by the conformity assessment procedure , manufacturers shall draw up an eu declaration of conformity in accordance with article 16 and affix the conformity marking in accordance with article 9 . ### where compliance of marine equipment with the applicable requirements has been demonstrated by the conformity assessment procedure , manufacturers shall draw up an eu declaration of conformity in accordance with article 16 and affix the conformity marking in accordance with articles 9 and 10 .


### manufacturers shall keep the technical documentation and the eu declaration of conformity referred to in article 16 for a period of time commensurate with the level of risk , and in no case less than the expected lifecycle of the marine equipment , after the wheel mark has been affixed on the last unit . ### manufacturers shall keep the technical documentation and the eu declaration of conformity referred to in article 16 for a period of time commensurate with the level of risk , and in no case less than the expected lifecycle of the marine equipment , and in every case for at least 10 years , after the wheel mark has been affixed on the last unit .


### manufacturers shall ensure that their products bear a type , batch or serial number or other element allowing their identification , or , where the size or nature of the product does not allow it , that the required information is provided on the packaging or in a document accompanying the product . ### manufacturers shall ensure that their products bear a type , batch or serial number or other element allowing their identification , or , where the size or nature of the product does not allow it , that the required information is provided on the packaging and in a document accompanying the product .


### manufacturers shall ensure that the product is accompanied by instructions and all necessary information for safe installation on board and safe use of the product , including limitations of use , if any , in a language which can be easily understood by the end - users , together with any other documentation required by the international instruments or testing standards . ### manufacturers shall ensure that the product is accompanied by instructions and all necessary information for safe installation on board and safe use of the product , including limitations of use , if any , in english or a language which can be easily understood by the end - users , together with any other documentation required by the international instruments or testing standards .


### manufacturers who consider or have reason to believe that a product which they have placed on the market or on board eu ships is not in conformity with the applicable requirements in the international instruments as referred to in article 4 , shall immediately take the necessary corrective measures to bring that product into conformity , to withdraw it or recall it , if appropriate . in addition , where the product presents a risk , manufacturers shall immediately inform the competent national authorities of the member states , giving details , in particular , of the non - compliance and of any corrective measures taken . ### manufacturers who consider or have reason to believe that a product which they have placed on the market or on board eu ships is not in conformity with the applicable requirements in the international instruments as referred to in article 4 , shall immediately take the necessary corrective measures to bring that product into conformity and shall withdraw it or recall it if appropriate . in addition , where the product presents a risk , manufacturers shall immediately inform the competent national authorities of the member states , giving details , in particular , of the non - compliance and of any corrective measures taken .


### manufacturers shall , further to a reasoned request from a competent national authority , promptly provide it with all the information and documentation necessary to demonstrate the conformity of the product , in a language which can be easily understood by that authority , and grant to that authority access to their premises for market surveillance purposes in accordance with article 19 of regulation no 765 / 2008 . they shall cooperate with that authority , at its request , on any action taken to eliminate the risks posed by products which they have placed on the market . ### manufacturers shall , further to a reasoned request from a competent national authority , promptly provide it with all the information and documentation necessary to demonstrate the conformity of the product , in english or a language which can be easily understood by that authority , and grant to that authority access to their premises for market surveillance purposes in accordance with article 19 of regulation no 765 / 2008 . « they shall cooperate with that authority , at its request , on any action taken to eliminate the risks posed by products which they have placed on the market .


### a manufacturer who is not located in the territory of a member state shall , by a written mandate , appoint an authorised representative . ### a manufacturer who is not located in the territory of a member state or a state of the european economic area shall , by a written mandate , appoint an authorised representative in the community .


### keep the eu declaration of conformity and the technical documentation at the disposal of national surveillance authorities for a period of time commensurate with the level of risk , and in no case less than the expected lifecycle of the marine equipment , after the wheel mark has been affixed on the last unit ; ### keep the eu declaration of conformity and the technical documentation at the disposal of national surveillance authorities for a period of time commensurate with the level of risk , and in no case less than the expected lifecycle of the marine equipment , and in every case for at least 10 years , after the wheel mark has been affixed on the last unit ;


### importers shall indicate their name , registered trade name or registered trade mark and the address at which they can be contacted on the product or , where that is not possible , on its packaging or in a document accompanying the product . ### importers shall indicate their name , registered trade name or registered trade mark and the address at which they can be contacted on the product or , where that is not possible , on its packaging and in a document accompanying the product .


### importers and distributors shall , further to a reasoned request from a competent national authority , provide it with all the information and documentation necessary to demonstrate the conformity of a product in a language which can be easily understood by that authority . they shall cooperate with that authority , at its request , on any action taken to eliminate the risks posed by products which they have placed on the market . ### importers and distributors shall , further to a reasoned request from a competent national authority , provide it with all the information and documentation necessary to demonstrate the conformity of a product in english or a language which can be easily understood by that authority . they shall cooperate with that authority , at its request , on any action taken to eliminate the risks posed by products which they have placed on the market .


### member states shall ensure that the manufacturer or his authorized representative carry out the conformity assessment , for a specific item of marine equipment , by using one of the options provided by means of implementing acts adopted by the commission in accordance with the examination procedure referred to in article 38 , from among one of the following procedures : ### member states shall ensure that the manufacturer or his authorized representative carry out the conformity assessment , through a notified body , for a specific item of marine equipment , by using one of the options provided by means of implementing acts adopted by the commission in accordance with the examination procedure referred to in article 38 , from among one of the following procedures :


### – production - quality assurance ; ### – production - quality assurance , or


### the commission shall keep an up - to - date list of approved marine equipment and applications withdrawn or refused and shall make it available to interested parties . ### the commission shall keep an up - to - date list of approved marine equipment and applications withdrawn or refused and shall make it available to interested parties via the information system it has established for such purposes .


### by drawing up the eu declaration of conformity , the manufacturer shall assume the responsibility and undertake the obligations referred to in article 12 . ### by drawing up the eu declaration of conformity , the manufacturer shall assume the responsibility and undertake the obligations referred to in this directive .


### when marine equipment is placed on board an eu ship , a copy of the eu declaration of conformity covering the equipment concerned shall be provided to the ship , and shall be kept on board until the said equipment is removed from the ship . it shall be translated into the language or languages required by the flag state . ### when marine equipment is placed on board an eu ship , a copy of the eu declaration of conformity covering the equipment concerned shall be provided to the ship , and shall be kept on board until the said equipment is removed from the ship . it shall be drawn up in english or translated into the language or languages required by the flag state .


### where the commission ascertains that a notified body does not meet or no longer meets the requirements for its notification , it shall inform the notifying member state accordingly and request it to take the necessary corrective measures , including de - notification if necessary . ### where the commission ascertains that a notified body does not meet or no longer meets the requirements for its notification , it shall inform the notifying member state accordingly and request it to take the necessary corrective measures , including de - notification if necessary , without delay .


### notified bodies shall provide the commission and the member states , on request , with relevant information on issues relating to negative and positive conformity assessment results . notified bodies shall provide the other notified bodies carrying out conformity assessment activities covering the same products with information concerning negative and , on request , positive conformity assessment results . ### notified bodies shall provide the commission and the member states , on request , with relevant information on issues relating to negative and positive conformity assessment results . notified bodies shall provide the other notified bodies carrying out conformity assessment activities covering the same products on request with information concerning the applications submitted .


### they shall inform the commission and the other member states , without delay , of those measures . ### the market surveillance authorities shall inform the commission and the other member states , without delay , of those measures .


### the information referred to in paragraph 4 shall include all available details , in particular the data necessary for the identification of the non - compliant marine equipment , the origin of the product , the nature of the non - compliance alleged and the risk involved , the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator . in particular , the market surveillance authorities shall indicate whether the non - compliance is due to either : ### the information referred to in paragraph 4 on measures taken by the market surveillance authorities shall include all available details , in particular the data necessary for the identification of the non - compliant marine equipment , the origin of the product , the nature of the non - compliance alleged and the risk involved , the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator . in particular , the market surveillance authorities shall indicate whether the non - compliance is due to either :


### where , within four months of receipt of the information referred to in paragraph 4 , no objection has been raised by a member state or by the commission in respect of a provisional measure taken by a member state , that measure shall be deemed justified . ### where , within four months of receipt of the information referred to in paragraph 4 on measures taken by the market surveillance authorities , no objection has been raised by a member state or by the commission in respect of a provisional measure taken by a member state , that measure shall be deemed justified .


### where the national measure is considered justified and the non - compliance of the marine equipment is attributed to shortcomings in the testing standards referred to in article 4 , the commission may confirm , modify or revoke the said measure by means of implementing acts in accordance with the advisory procedure referred to in article 38 . the commission shall furthermore be empowered to adopt , by means of delegated acts in accordance with the procedure referred to in article 37 , interim harmonised requirements and testing standards for that specific item of marine equipment in order to remove the threat to safety or to the environment pending the modification of the testing standard concerned by the relevant international organisation . ### where the non - compliance of the marine equipment is attributed to shortcomings in the testing standards referred to in article 4 , and the member state takes a safeguard measure , the commission may confirm , modify or revoke the said measure by means of implementing acts in accordance with the advisory procedure referred to in article 38 . the commission shall furthermore be empowered to adopt , by means of delegated acts in accordance with the procedure referred to in article 37 , interim harmonised requirements and testing standards for that specific item of marine equipment in order to remove the threat to safety or to the environment pending the modification of the testing standard concerned by the relevant international organisation .


### where , having performed an evaluation under article 28 , a member state finds that although marine equipment is in compliance with this directive , it presents a risk to marine safety or to the environment , it shall require the relevant economic operator to take all appropriate measures to ensure that the marine equipment concerned , when placed on the market , no longer presents that risk , to withdraw the marine equipment from the market or to recall it within a reasonable period , commensurate with the nature of the risk , as it may prescribe . ### where , having performed an evaluation under article&#160 ; 28 , a member state finds that although marine equipment is in compliance with this directive , it presents a risk to marine safety , to the environment or to health , it shall require the relevant economic operator to take all appropriate measures to ensure that the marine equipment concerned , when placed on the market , no longer presents that risk , to withdraw the marine equipment from the market or to recall it within a reasonable period , commensurate with the nature of the risk , as it may prescribe .


### in exceptional circumstances of technical innovation , the flag state administration may permit marine equipment which does not comply with the conformity assessment procedures to be placed on board an eu ship if it is established by trial or otherwise to the satisfaction of the flag state administration that such equipment is at least as effective as marine equipment which does comply with the conformity - assessment procedures . ### in exceptional circumstances of technical innovation , the flag state administration may permit marine equipment which does not comply with the conformity assessment procedures to be placed on board an eu ship if it is established by trial or otherwise to the satisfaction of the flag state administration that such equipment meets the objectives of this directive at least as well as marine equipment which does comply with the conformity - assessment procedures .


### the permission shall be limited to a short period of time ; ### the permission shall be limited to the period of time , which must be as short as possible , deemed necessary by the flag member state for the purposes of testing ;


### the list and essential details of the conformity certificates issued under this directive ; ### the list and essential details of the conformity certificates issued under this directive , provided by the notified bodies ;


### the list and essential details of the declarations of conformity issued under this directive ; ### the list and essential details of the declarations of conformity issued under this directive , provided by the manufacturers ;


### the member states shall notify to the commission the name and contact details of the authorities in charge of the implementation of this directive . the commission shall draw up , periodically update and make public a list of these authorities . ### the member states shall notify to the commission the name and contact details of the authorities in charge of the implementation of this directive . the commission shall draw up , periodically update and make public a list of these authorities via the information system it has established for such purposes .


### the delegation of power referred to in articles 8 , 11 , 29 and 36 shall be conferred on the commission for an indeterminate period of time from the date of entry into force of this directive . ### the delegation of power referred to in articles 8 , 11 , 29 and 36 shall be conferred on the commission for a period of five years from the date of entry into force of this directive . the commission shall draw up a report in respect of the delegation of power no later than nine months before the end of the five - year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period .


### fostering international cooperation with intellectual property offices in third countries to build strategies and developing techniques for the protection of intellectual property rights , skills and tools . ### fostering international cooperation with intellectual property offices in third countries and relevant international organisations with a view to building strategies and developing techniques for the protection of intellectual property rights , skills and tools .


### activities may include national programme activities of participating states and new activities , including calls for proposals managed by the edctp2 - is . ### activities may include activities undertaken by public or private not - for - profit research organisations included in the national programme activities of participating states and new activities , including calls for proposals managed by the edctp2 - is .


### in kind contributions consisting of the costs incurred by the participating states in implementing activities included in the work plan referred to in article 4 or in relation to the administrative budget of the edctp2 - is . ### in kind contributions consisting of the costs incurred by the participating states in implementing activities included upfront in the work plan referred to in article 4 or in relation to the administrative budget of the edctp2 - is .


### an increased number of new or improved medical interventions for hiv / aids , tuberculosis , malaria and other poverty - related diseases , and by the end of the programme to have delivered at least one new medical intervention ; to have issued at least 30 guidelines for improved or extended use of existing medical interventions ; and to have progressed the clinical development of at least 20 candidate medical interventions ; ### an increased number of new or improved medical interventions for poverty - related diseases such as hiv / aids , tuberculosis and malaria , and other poverty - related and neglected diseases , and by the end of the programme to have delivered at least one new medical intervention ; to have issued at least 30 guidelines for improved or extended use of existing medical interventions ; and to have progressed the clinical development of at least 20 candidate medical interventions ;


### fostering capacity development for clinical trials and related research in developing countries through grants for : career development of junior / senior fellows , promoting mobility , staff exchange grants , research training networks , strengthening ethics and regulatory bodies , mentoring and partnerships at individual or institutional level ; ### fostering capacity development for clinical trials and related research in developing countries through grants for : career development of junior / senior fellows , promoting mobility , staff exchange grants , research training networks , strengthening ethics and regulatory bodies , mentoring and partnerships at individual or institutional or regional level ;