### promoting viable fishing activities of their members in full compliance with the conservation policy laid down in the regulation on the common fisheries policy and environmental legislation ; ### promoting viable fishing activities of their members in full compliance with the conservation , management and exploitation policy laid down in the regulation on the common fisheries policy and environmental legislation ;


### planning the fishing activities of their members ; ### planning the fishing activities of their members in a manner fully compliant with measures to ensure , for each member state , relative stability of fishing activities ;


### they represent a significant share of at least two of the following activities in a given area or areas : production , marketing and processing of fishery and aquaculture products or products processed from fishery and aquaculture products ; ### they represent , in a given area , a significant share of the production and processing and / or marketing of fishery and aquaculture products or products processed from fishery and aquaculture products ;


### where applicable , any other name or names accepted or permitted locally or regionally . ### where applicable , in addition to those in paragraphs 43 and 43 , any other name or names that are accepted or permitted locally or regionally .


### in the case of fishery products caught in freshwater , a reference to the member state or third country of provenance of the product ; ### in the case of fishery products caught in freshwater , a reference to the body of water of origin in the member state or third country of provenance of the product ;


### viable food production , with a focus on agricultural income , agricultural productivity and price stability ; ### viable food production , with a focus on farmer ' s income , price margins , agricultural productivity and price stability ;


### property frozen with a view to later confiscation should be managed adequately in order not to lose its economic value . member states should take the necessary measures including sale or transfer of the property to minimise such losses . member states should take relevant measures , such as the establishment of national centralised asset management offices or equivalent mechanisms , in order to properly manage the assets frozen before confiscation and preserve their value , pending judicial determination . ### property frozen with a view to later confiscation should be managed adequately in order not to lose its economic value , to encourage its social reuse and to avoid the risk of further criminal infiltration . towards that end it would be useful to consider the formation of a european fund that will concentrate a fraction of the confiscated assets from member states . such fund should then be open to pilot projects by european citizens , associations , coalitions of ngos and any other organization of civic society , to encourage the effective social reuse of the confiscated assets and to expand the democratic functions of the european union . member states should take the necessary measures including sale or transfer of the property to minimise such losses and to favour the social aims . member states should take relevant measures , such as the establishment of national centralised asset management offices or equivalent mechanisms , in order to properly manage the assets frozen before confiscation and preserve their value , pending judicial determination .


### each member state shall take the necessary measures to enable it to freeze property in danger of being dissipated , hidden or transferred out of the jurisdiction with a view to possible later confiscation . such measures shall be ordered by a court . ### each member state shall take the necessary measures to enable it to freeze property without delay where there is a danger of its being dissipated , hidden or transferred out of the jurisdiction with a view to possible later confiscation , or where there is reason to suppose that the conditions for confiscation are met . such measures shall require an order by the competent national authority , which shall be obtained without delay following the freezing of the property , except where the property consists of movable items , in which case an order shall be required only where it applied for by the person affected . the person affected by the measures under this article shall have a right to contest the order and appeal against it to a court .


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


### member states shall regularly collect and maintain comprehensive statistics from the relevant authorities in order to review the effectiveness of their confiscation systems . the statistics collected shall be sent to the commission each year and shall include for all criminal offences : ### member states shall regularly collect and maintain comprehensive statistics from the relevant authorities in order to review the effectiveness of their confiscation systems . the statistics collected shall be sent to the commission each year and shall include for all criminal offences falling within the scope of this directive :


### the union is founded on the values of democracy , the rule of law , the universality and indivisibility of and respect for human rights and fundamental freedoms , respect for human dignity , the principles of equality and solidarity and respect for the principles of the un charter and international law . it seeks to develop and consolidate commitment to these values in partner countries and regions through dialogue and cooperation . ### the union is founded on the values of democracy , the rule of law , the universality and indivisibility of and respect for human rights and fundamental freedoms , respect for human dignity , gender equality , the principles of equality and solidarity and respect for the principles of the un charter and international law . it seeks to develop and consolidate commitment to these values in partner countries and regions through dialogue and cooperation .


### the union also aims to ensure coherence with other areas of its external action . this should be ensured when formulating the union ' s development cooperation policy and its strategic planning programming and implementation of measures . ### the union also aims to ensure coherence with other areas of its external action . this should be ensured when formulating the union ' s external dimension of notably its security , trade , investment , agriculture and fisheries ' policies and its strategic planning programming and implementation of measures .


### the union ' s policy and international action for development cooperation are guided by the mdgs , such as the eradication of extreme poverty and hunger , including any subsequent modifications thereto , and by the development objectives and principles approved by the union and its member states , including in the context of their cooperation within the united nations and other competent international organisations in the field of development cooperation . ### the union ' s policy and international action for development cooperation are guided by the mdgs , such as the eradication of extreme poverty and hunger , including any subsequent modifications thereto , and by the development objectives and principles approved by the union and its member states , and the european parliament , including in the context of their cooperation within the united nations and other competent international organisations in the field of development cooperation .


### union assistance should focus where it has more impact , having regard to its capacity to act on a global scale and respond to global challenges such as poverty eradication , sustainable and inclusive development and worldwide promotion of democracy , good governance , human rights and the rule of law , its long - term and predictable commitment to development assistance and its role in coordinating with its member states . to ensure such impact , the principle of differentiation should be applied not only at the level of funds allocation , but also at the level of programming , to ensure that bilateral development cooperation targets partner countries most in need , including fragile states and states with high vulnerability , and with limited capacity to have access to other sources of financing for supporting their own development , having regard to the potential impact of the union assistance in partner countries . as a consequence , bilateral programming would target such countries , pursuant to the application of objective criteria based on the needs and capacities of these countries , as well as the impact of eu assistance . ### union assistance should focus where it has more impact , having regard to its capacity to act on a global scale and respond to global challenges such as poverty eradication , sustainable and inclusive development , worldwide promotion of democracy , good governance , human rights and the rule of law , its long - term and predictable commitment to development assistance and its role in coordinating with its member states . to ensure such impact , each country analysis and programming should contain a conflict analysis and the principle of differentiation should be applied not only at the level of funds allocation , but also at the level of programming , to ensure that bilateral development cooperation targets partner countries most in need , including fragile states and states with high vulnerability , and with limited capacity to have access to other sources of financing for supporting their own development , having regard to the potential impact of the union assistance in partner countries . as a consequence , bilateral programming would target such countries , pursuant to the application of objective criteria based on the needs and capacities of these countries , as well as the impact of eu assistance . to ensure the greatest impact of union assistance in the world , the implementation of this regulation should be strictly coordinated with programmes and actions funded under other regulations establishing external financing instruments , namely regulation no [ . . . / . . . ] of the european parliament and of the council establishing an instrument for stability and regulation no [ . . . / . . . ] of the european parliament and of the council establishing a financing instrument for the promotion of democracy and human rights worldwide and regulation eu no [ . . . / . . . ] 843 ) of the european parliament and of the council establishing a partnership instrument for cooperation with third countries .


### this regulation should provide an enabling framework for programming , allowing enhanced consistency between union policies by using a joint framework document as a basis for programming . it should enable full alignment with partner countries and regions by relying , where appropriate , on national development plans or similar comprehensive development documents ; and pursue a better coordination amongst donors , in particular between the union and its member states , through joint programming . ### this regulation should provide an enabling framework for programming , allowing enhanced policy coherence for development between union policies by using a joint framework document as a basis for programming . it should enable full alignment with partner countries and regions by relying , where possible , on national development plans or similar comprehensive development documents adopted by the partner countries ' or regions ' parliaments in consultation with their respective civil societies ; and pursue a better coordination amongst donors , in particular between the union and its member states , through joint programming .


### the achievement of these objectives shall be measured using relevant indicators , in particular mdg 1 for subparagraph and mdgs 1 to 8 for subparagraph , and other indicators agreed by the union and its member states . ### the achievement of these objectives shall be measured using human development indicators , in particular mdg 1 for subparagraph and mdgs 1 to 8 for subparagraph , and other indicators agreed by the un , the union and its member states .


### the following cross - cutting issues shall be mainstreamed in all programmes : the promotion of human rights , gender equality , women empowerment , non - discrimination , democracy , good governance , the rights of the child and indigenous peoples ' rights , social inclusion and the rights of persons with disabilities , environmental sustainability including addressing climate change and combating hiv / aids . ### the following cross - cutting issues shall be mainstreamed in all programmes : the promotion of human rights , gender equality , women empowerment , non - discrimination , democracy , good governance , the rights of the child and indigenous peoples ' rights , social inclusion and the rights of persons with disabilities , environmental sustainability including addressing climate change , conflict prevention and combating hiv / aids .


### the timelines for assessing an application dossier for clinical trials should be sufficiently long to assess the file , while ensuring quick access to new , innovative treatments and ensuring that the union remains an attractive place for conducting clinical trials . against this background , directive 2001 / 20 / ec introduced the concept of tacit authorisation . this concept should be maintained in order to ensure that timelines are adhered to . in the event of a public health crisis , member states should have the possibility to assess and authorise a clinical trial application swiftly . no minimal timelines for approval should therefore be established . ### the timelines for assessing an application dossier for clinical trials should be sufficiently long to assess the file , while ensuring quick access to new , innovative treatments and ensuring that the union remains an attractive place for conducting clinical trials . against this background , directive 2001 / 20 / ec introduced the concept of implicit authorisation if there has been a vote in favour by the ethics committee and the competent authority has not objected within the deadline . this concept should be maintained in order to ensure that timelines are adhered to . in the event of a public health crisis , member states should have the possibility to assess and authorise a clinical trial application swiftly . in the event of a public health crisis no minimal timelines for approval should therefore be established .


### ‘ protocol’ : a document that describes the objectives , design , methodology , statistical considerations and organisation of a clinical trial ; ### ‘ protocol’ : a document that describes the objectives , design , methodology , statistical considerations and organisation of a clinical trial ; the term protocol refers to the protocol , successive protocols and protocol amendments ;


### whether it is the reporting member state or which other member state concerned is the reporting member state ; ### who is the reporting member state ;


### where the proposed reporting member state has not notified the sponsor within the time period referred to in paragraph 2 , the clinical trial applied for shall be considered as falling within the scope of this regulation , the application shall be considered complete , the clinical trial shall be considered a low - intervention clinical trial if this is claimed by the sponsor , and the proposed reporting member state shall be the reporting member state . ### where the appointed reporting member state has not notified the sponsor within the time period referred to in paragraph 2 , an explanation for the delay shall be submitted through the eu portal with an indication of when the notification will be given .


### where the proposed reporting member state has not notified the sponsor according to points to of paragraph 2 within three days following receipt of the comments or of the completed application , the application shall be considered complete , the clinical trial shall be considered as falling within the scope of this regulation , the clinical trial shall be considered as a low - intervention clinical trial if this is claimed by the sponsor , and the proposed reporting member state shall be the reporting member state . ### where the appointed reporting member state has not notified the sponsor according to points to of paragraph 2 within three days following receipt of the comments or of the completed application the appointed member state shall submit an explanation through the eu portal with an indication of when the notification will be given .


### – the relevance of the clinical trial , taking account of the current state of scientific knowledge , and of whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products ; ### – the relevance of the clinical trial , including assurance that the groups of subjects participating in the trial represent the population to be treated in terms of age , gender and whether the subjects are healthy , volunteers or patients , as well as taking account of the current state of scientific knowledge , best current proven intervention and of whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products ;


### – the reliability and robustness of the data generated in the clinical trial , taking account of statistical approaches , design of the trial and methodology ; ### – the reliability and robustness of the data generated in the clinical trial , based on pre - determined primary outcome parameters , taking account of statistical approaches , design of the trial and methodology ;


### compliance with the requirements for informed consent as set out in chapter v ; ### compliance with the requirements for the protection of the subjects and informed consent as set out in chapter v ;


### notification shall be done by way of one single decision within ten days from the validation date . ### notification shall be done by way of one single decision within ten days from the assessment date according to article 6 .


### a reference to the clinical trial or clinical trials which are substantially modified ; ### a reference to the clinical trial or clinical trials which are substantially modified ; by using the registration number in the eu portal ;


### any subject may , without any resulting detriment , withdraw from the clinical trial at any time by revoking his or her informed consent . the withdrawal of consent shall not affect the activities carried out based on consent before its withdrawal . ### any subject or his legal representative may , without any resulting detriment , withdraw from the clinical trial at any time by revoking his or her informed consent . the withdrawal of consent shall not affect the activities carried out based on consent before its withdrawal .


### the informed consent of the legal representative has been obtained , whereby consent shall represent the subject ' s presumed will ; ### the informed consent of the legal representative has been obtained ; consent shall represent the subject ' s presumed will and may be revoked at any time , without detriment to the subject ;


### however , where , for scientific reasons , it is not possible to submit a summary of the results within one year , the summary of results shall be submitted as soon as it is available . in this case , the protocol shall specify when the results are going to be submitted , together with an explanation . ### however , where , for justified scientific reasons , it is not possible to submit the full study report with all results and all the supporting data within one year , it shall be submitted as soon as it is available . in this case , the protocol shall specify when the full clinical study report with all results and all supporting data is going to be submitted , together with a justification . the justification shall be made publicly accessible in the eu database .


### following an inspection , the member state under whose responsibility the inspection has been conducted shall draw up an inspection report . that member state shall make the inspection report available to the sponsor of the relevant clinical trial and shall submit the inspection report through the eu portal to the eu database . ### following an inspection , the member state under whose responsibility the inspection has been conducted shall draw up an inspection report . that member state shall make the inspection report available to the sponsor of the relevant clinical trial and shall submit the inspection report through the eu portal to the eu database , where it shall be publicly available .


### the eu database shall be established to enable the co - operation between the competent authorities of the member states to the extent that it is necessary for the application of this regulation and to search for specific clinical trials . it shall also enable sponsors to refer to previous submissions of an application for authorisation of a clinical trial or a substantial modification . ### the eu database shall be established to enable the co - operation between the competent authorities of the member states to the extent that it is necessary for the application of this regulation and for the public to be able to search for specific clinical trials and for the citizens and professionals to be able to make informed decisions about medicinal products . it shall also enable sponsors to refer to previous submissions of an application for authorisation of a clinical trial or a substantial modification .


### the community financial contribution for the implementation phase shall be provided under the following conditions : ### the commission shall , before the end of the strategic phase , assess the following :


### because excessive and imprudent risk - taking may undermine the financial soundness of financial institutions and destabilise the banking system , it is important that the new obligation concerning remuneration policies and practices should be implemented in a consistent manner . it is therefore appropriate to specify core principles on sound remuneration to ensure that the structure of remuneration does not encourage excessive risk - taking by individuals and is aligned with the risk appetite , values and long - term interests of the institution . in order to ensure that the design of remuneration policies is integrated in the risk management of the financial institution , the management body of each credit institution or investment firm should establish the general principles to be applied , and the policies should be subject to at least annual independent internal review . ### because excessive and imprudent risk - taking may undermine the financial soundness of financial institutions and destabilise the banking system , it is important that the new obligation concerning remuneration policies and practices should be implemented in a consistent manner . it is therefore appropriate to specify clear core principles on sound remuneration to ensure that the structure of remuneration does not encourage excessive risk - taking by individuals and is aligned with the risk appetite , values and long - term interests of the institution and of its employees generally . in order to ensure that the design of remuneration policies is integrated in the risk management of the financial institution , the management body of each credit institution or investment firm should establish the general principles to be applied , and the policies should be subject to at least annual independent internal review . credit institutions and investment firms of significant size should set up independent remuneration committees as an integral part of their governance structure and organisation . remuneration committees should cooperate with the risk and compliance function and with the staff representative bodies in order to supervise the incentives created for managing risk , capital and liquidity .


### remuneration policy should aim at aligning the personal objectives of staff members with the long - term interests of the credit institution or investment firm concerned . the assessment of the performance - based components of remuneration should be based on longer - term performance and take into account the outstanding risks associated with the performance . the assessment of performance should be set in a multi - year framework , for example of three to five years , in order to ensure that the assessment process is based on longer - term performance and that the actual payment of performance - based components of remuneration is spread over the business cycle of the firm . ### remuneration policy should aim at aligning the personal objectives of staff members with the long - term interests of the credit institution or investment firm concerned . the assessment of the performance - based components of remuneration should be based on longer - term performance and take into account the outstanding risks associated with the performance . the assessment of performance should be set in a multi - year framework , of at least five years , for example , in order to ensure that the assessment process is based on longer - term performance and that the actual payment of performance - based components of remuneration is spread over the business cycle of the firm . corporate social responsibility targets should be included in the assessment of longer - term performance justifying the deferred payment of variable remuneration .


### in order to ensure adequate transparency to the market of their remuneration structures and the associated risk , credit institutions and investment firms should disclose information on their remuneration policies and practices for those staff whose professional activities have a material impact on the risk profile of the institution . however , this obligation should be without prejudice to directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with the regard to the processing of personal data and the free movement of such data . ### in order to ensure adequate transparency to the market of their remuneration structures and the associated risk , credit institutions and investment firms should disclose detailed information on their remuneration policies and practices and the amounts of remuneration for those members of staff and managers whose professional activities have a significant impact on the risk profile of the institution . that information should be available to all stakeholders . however , this obligation should be without prejudice to directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with the regard to the processing of personal data and the free movement of such data . the right of employees to be informed and consulted should be respected through the involvement of the european works councils . failure to observe this undertaking should be penalised in a sufficient , proportionate and deterrent manner .


### fixed and variable components of total remuneration are appropriately balanced ; the fixed component represents a sufficiently high proportion of the total remuneration to allow the operation of a fully flexible bonus policy , including the possibility to pay no bonus ; ### fixed and variable components of total remuneration are appropriately balanced ; the fixed component represents at least 80% of the total remuneration to allow the operation of a fully flexible policy on variable remuneration components , including the possibility of paying no variable remuneration component ;


### information concerning the decision - making process used for determining the remuneration policy , including if applicable , information about the composition and the mandate of a remuneration committee , the name of the external consultant whose services have been used for the determination of the remuneration policy and the role of the relevant stakeholders ; ### information concerning the decision - making process used for determining the remuneration policy , including if applicable , information about the composition and the mandate of a remuneration committee , the name of the external consultant whose services have been used for the determination of the remuneration policy and the role of the relevant stakeholders , and in particular the opinion delivered by the staff representative bodies ;


### this regulation lays down rules for the creation and proper functioning of the single european sky in order to ensure current air traffic safety standards , to contribute to the sustainable development of the air transport system and to improve the overall performance of air traffic management and air navigation services for general air traffic in europe , with a view to meeting the requirements of all airspace users . the single european sky shall comprise a coherent pan - european network of routes , an integrated operating airspace , network management and air traffic management systems based only on safety , efficiency and interoperability , for the benefit of all airspace users . ### this regulation lays down rules for the creation and proper functioning of the single european sky in order to ensure current air traffic safety standards , to contribute to the sustainable development of the air transport system , such as reducing the climate impact and environmental damage from aviation , and to improve the overall performance of air traffic management and air navigation services for general air traffic in europe , with a view to meeting the requirements of all airspace users . the single european sky shall comprise a coherent pan - european network of routes , an integrated operating airspace , network management and air traffic management systems based only on safety , efficiency and interoperability , for the benefit of all airspace users .


### ‘ route network’ means a network of specified routes for channelling the flow of general air traffic as necessary for the provision of atc services ; ### ‘ route network’ means a network of specified routes for channelling the flow of general air traffic as necessary for the provision of atc services , reduction or avoidance of vapour contrails and climate protection ;


### in choosing the provider of support services , in particular cost efficiency , overall service quality and safety of services shall be taken into account by the entity procuring those services . ### in choosing the provider of support services , in particular cost and energy efficiency , overall service quality and safety , climate and environmentally friendliness of services shall be taken into account by the entity procuring those services .


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


### the commission has committed to mainstream climate change into union spending programmes and to direct at least 20% of the union budget to climate - related objectives . it is important to ensure that climate change mitigation and adaptation as well as risk prevention and management are promoted in the preparation , design and implementation of projects of common interest . infrastructure investments covered by this regulation should contribute to promoting the transition to a low - carbon and climate - and disaster - resilient economy and society . ### taking into account the overall environmental impact of european policies is a priority , and the union has committed to direct at least 20% of the union budget to climate - related objectives . it is important to ensure that environmental impacts are fully assessed and that prevention and management are promoted in the preparation , design and implementation of projects of common interest . infrastructure investments covered by this regulation should contribute to promoting the transition to an economy and society which respect the environment as a whole and which are socially sustainable .


### major investments are needed to modernise and expand europe ' s energy infrastructure and to interconnect networks across borders to meet the union ' s energy and climate policy objectives of competitiveness , sustainability and security of supply in a cost - effective way . the estimated investment needs in energy infrastructure up to 2020 amount to eur 1 trillion , of which ca . eur 200 billion in electricity and gas transmission and storage infrastructures considered of european relevance . among projects of european relevance , approximately eur 100 billion of investments is at risk of not being delivered due to obstacles related to permit granting , regulation and financing . ### major investments are needed to first minimise , through energy efficiency policies , then to modernise and , finally where new infrastructure is needed , to expand national and european electricity infrastructure to meet the union ' s energy and climate policy objectives of competitiveness , sustainability and security of supply in a cost - effective way . not taking into account this hierarchy of importance principle based on cost - effectiveness , the estimated investment needs in energy infrastructure up to 2020 could amount to eur 1 trillion , of which ca . eur 200 billion in electricity and gas transmission and storage infrastructures considered of european relevance .


### this regulation establishes the connecting europe facility and determines the conditions , methods and procedures for providing union financial aid to trans - european networks in order to support projects in the field of transport , energy and telecommunications infrastructures . ### this regulation establishes the connecting europe facility and determines the conditions , methods and procedures for providing union financial aid to trans - european networks in order to support projects in the field of transport , energy and telecommunications infrastructures . in the field of energy , the connecting europe facility shall help the union to invest into energy efficiency , renewable energy and smart transmission and distribution electricity networks .


### contribute to smart , sustainable and inclusive growth by developing modern and high performing trans - european networks , thus bringing forward benefits for the entire european union in terms of competitiveness and economic , social and territorial cohesion within the single market and creating an environment more conducive to private and public investment through a combination of financial instruments and union direct support and by exploiting synergies across the sectors . the achievement of this objective will be measured by the volume of public and private investment in projects of common interest , and in particular the volume of public and private investments in projects of common interest realised through the financial instruments under this regulation . ### contribute to smart , sustainable and inclusive growth by developing modern , high performing and sustainable trans - european networks , thus securing for the entire european union the conditions necessary for improved economic , social and territorial cohesion within the single market and creating an environment more conducive to private and public investment through a combination of financial instruments and union direct support and by exploiting synergies across the sectors . the achievement of this objective will be measured by the volume of public and private investment in projects of common interest , and in particular the volume of public and private investments in projects of common interest realised through the financial instruments under this regulation .


### contribute to smart , sustainable and inclusive growth by developing modern and high performing trans - european networks , thus bringing forward benefits for the entire european union in terms of competitiveness and economic , social and territorial cohesion within the single market and creating an environment more conducive to private and public investment through a combination of financial instruments and union direct support and by exploiting synergies across the sectors . the achievement of this objective will be measured by the volume of public and private investment in projects of common interest , and in particular the volume of public and private investments in projects of common interest realised through the financial instruments under this regulation . ### contribute to smart , sustainable and inclusive development of modern and high performing trans - european networks , thus bringing forward benefits for the entire european union in terms of minimising external costs , improving competitiveness and economic , social and territorial cohesion within the single market and creating an environment more conducive to private and public investment through a combination of financial instruments , such as using revenues from the application of the polluter pays principle , union direct support and by exploiting synergies across the sectors . the achievement of this objective will be measured by the volume of public and private investment in projects of common interest , and in particular the volume of public and private investments in projects of common interest realised through the financial instruments under this regulation as well as the corresponding share of risks , profits and losses between the public and private investors .


### removing bottlenecks and bridging missing links , to be measured by the number of new and improved cross - border connections and removed bottlenecks on transport routes which have benefited from the connecting europe facility ; ### removing bottlenecks , improving connectivity with urban and regional nodes , bridging missing links and improving rail connections with industrial areas and sites , to be measured by the number of cross - border sections and industrial sidings that were abandoned or cut since the second world war and have been rehabilitated or reconstructed , and by the number of removed bottlenecks on transport routes which have benefited from the connecting europe facility ;


### ensuring sustainable and efficient transport in the long run , to be measured by the length of the conventional railway network in the eu - 27 and the length of high - speed railway network in the eu - 27 ; ### ensuring sustainable and efficient transport in the short and long run , to be measured by the modal share of rail transport as well as the length and state of the conventional railway network in the eu - 27 . the length of the high - speed railway network may be taken into account where these lines are part of a network - wide concept for improved railway services .


### promoting the further integration of the internal energy market and the interoperability of electricity and gas networks across borders , including by ensuring that no member state is isolated from the european network , to be measured by the number of projects effectively interconnecting member states ' networks and removing internal bottlenecks ; ### promoting the further integration of the internal energy market and the interoperability of electricity networks , including by ensuring the development of smart grids , the further uptake of renewable energy sources and that no member state is isolated from the european network ,


### contributing to sustainable development and protection of the environment , notably by fostering the integration of energy from renewable sources into the transmission network and developing carbon dioxide networks , to be measured by the transmission of renewable energy from generation to major consumption centres and storage sites , and the sum of co2 emissions prevented by the construction of the projects which benefited from the connecting europe facility . ### contributing to sustainable development , the protection of the environment and the union ' s climate objectives , by reducing the union ' s energy demand and developing and integrating energy from renewable sources into the transmission and distribution network , to be measured by the percentage of renewable energy compared to the total energy consumed in the union , by the number of smart electricity grids and by the total energy consumed by the implementation of projects which benefited from the connecting europe facility .


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


### in the field of transport , only actions contributing to projects of common interest according to regulation no xxx / 2012 [ ten - t guidelines ] and programme support actions , shall be eligible for support through union financial aid in the form of procurement and financial instruments under this regulation . in the form of grants , only the following actions shall be eligible to receive union financial aid under this regulation : ### in the field of transport , only actions contributing to projects of common interest according to regulation no xxx / 2012 [ ten - t guidelines ] and programme support actions , shall be eligible for support through union financial aid in the form of procurement and financial instruments under this regulation , provided that the polluter pays principle enshrined in article 191 of the treaties is applied , namely through the levying of road charges according to eurovignette directive 2011 / 76 / ec and of mark - ups in mountainous regions . in the form of grants , only the following actions shall be eligible to receive union financial aid under this regulation :


### in the field of energy , the specific eligibility conditions of actions implementing projects of common interest for union financial aid in the form of financial instruments and grants under this regulation are set out in article 15 of regulation no xxxx / 2012 [ guidelines for trans - european energy infrastructure ] . ### in the field of energy , the specific eligibility conditions of actions implementing projects of common interest for union financial aid in the form of financial instruments under this regulation are projects of common interest falling within the categories set out in points 1 to of annex ii to and within the priority areas set out in points 4 and of annex i to regulation no xxxx / 2012 [ energy infrastructure guidelines ] , which contribute to innovative solutions and protection of the environment namely projects on energy efficiency , renewable energy and smart electricity networks .


### they may not receive funding under this regulation , except where it is indispensable to achieve the objectives of a given project of common interest . ### they may not receive funding under this regulation , when not respecting the common interest of sustainable development , the eu environmental legislation as listed in art . 42 of the ten - t regulation and its trans - border application in case of trans - border projects .


### rail and inland waterways : the amount of union financial aid shall not exceed 20% of the eligible cost ; the funding rate may be increased to 30% for actions addressing bottlenecks ; the funding rate may be increased to 40% for actions concerning cross - border sections ; ### rail and inland waterways : the amount of union financial aid shall not exceed 20% of the eligible cost ; the funding rate may be increased to 30% for actions addressing bottlenecks ; the funding rate for rail may be increased to 85% for actions concerning cross - border sections that have been abandoned or cut since the second world war . for actions securing and improving rail connections with industrial areas and sites the amount of union financial aid shall not exceed 50% ;


### inland transport connections to ports and airports , actions to reduce rail freight noise by retrofitting of existing rolling stock , as well as development of ports and multi - modal platforms : the amount of union financial aid shall not exceed 20% of the eligible cost . ### inland transport connections to ports , actions to reduce rail freight noise by retrofitting of existing rolling stock , as well as development of ports and rail - road terminals : the amount of union financial aid shall not exceed 20% of the eligible cost .


### traffic management systems , freight transport services , secure parkings on the road core network , as well as actions to support the development of motorways of the seas : the amount of union financial aid shall not exceed 20% of the eligible cost . ### traffic management systems , combined transport services , secure parkings on the road core network , as well as actions to support the development of motorways of the seas : the amount of union financial aid shall not exceed 20% of the eligible cost .


### the amount of union financial aid shall not exceed 50% of the eligible cost of studies and / or works ; ### with regard to grants for studies , the amount of union financial aid shall not exceed 50% of the eligible costs ;


### co - financing rates may be increased to a maximum of 80% for actions which based on the evidence referred to in article 15 of regulation no xxxx / 2012 [ guidelines for trans - european energy infrastructure ] , provide a high degree of regional or union - wide security of supply , or strengthen solidarity of the union or comprise highly innovative solutions . ### with regard to grants for works , no union financial aid shall be provided except for projects - of common interest falling within the categories set out in points 1 to and point 2 of annex ii to regulation no xxxx / 2012 [ energy infrastructure guidelines ] in cyprus , malta and the baltic states and - on energy efficiency , renewable energy and smart electricity networks for which the union co - financing rates may be increased to a maximum of 80% of the project eligible costs .


### by the way of derogation from article 10 , and as regards the eur 10 000 000 000 transferred from the cohesion fund [ regulation xxx article xx ] to be spent in member states eligible for funding from the cohesion fund , the maximum funding rates shall be those applicable to the cohesion fund referred to in article 22 and article 110 of regulation no xxx / 2012 [ regulation laying down common provisions on the european regional development fund , the european social fund , the cohesion fund , the european agricultural fund for rural development and the european maritime and fisheries fund covered by the common strategic framework and laying down general provisions on the european regional development fund , the european social fund and the cohesion fund and repealing regulation no 1083 / 2006 ] for the following actions : ### by the way of derogation from article 10 , and as regards the [ eur 10 000 000 000 ] transferred from the cohesion fund [ regulation xxx article xx ] to be spent exclusively in member states eligible for funding from the cohesion fund , the maximum funding rates shall be those applicable to the cohesion fund referred to in article 22 and article 110 of regulation no xxx / 2012 [ regulation laying down common provisions on the european regional development fund , the european social fund , the cohesion fund , the european agricultural fund for rural development and the european maritime and fisheries fund covered by the common strategic framework and laying down general provisions on the european regional development fund , the european social fund and the cohesion fund and repealing regulation no 1083 / 2006 ] for the following actions :


### rail and inland waterways ; ### rail and sustainable navigable inland waterways ;


### inland transport connections to ports and airports , development of multi - modal platforms and of ports ; ### inland transport connections to ports , development of multi - modal platforms , of industrial sidings and of ports as well as interconnecting points , with priority on rail connections ;


### following an evaluation of the progress of the project , in particular in the event of major delays in the implementation of the action . ### following an evaluation of the progress of the project , in particular in the event of major and unjustified delays in the implementation of the action .


### member states shall inform the commission continuously , if relevant through the interactive geographical and technical information systems , which in case of the trans - european transport networks is tentec , about the progress made in implementing projects of common interest and the investments made for this purpose including the amount of support used for climate change objectives . ### member states shall inform the commission continuously , if relevant through the interactive geographical and technical information systems , which in case of the trans - european transport networks is tentec , about the progress made in implementing projects of common interest and the investments made for this purpose including the amount of support used for climate change objectives . the tentec shall be publicly and easily accessible . it shall contain project - specific and updated information on the forms and amounts of eu co - funding as well as on the progress of each project .


### hamburg / rostock – berlin – praha – brno – bratislava – budapest – arad – timişoara – sofia sofia – burgas / tr border sofia – thessaloniki – piraeus – limassol – lefkosia ### hamburg / rostock – berlin – praha – bratislava – budapest – arad – timişoara – sofia sofia – burgas / tr border sofia – thessaloniki – piraeus – limassol – lefkosia


### helsinki – turku – stockholm – malmö – københavn – fehmarn – hamburg – hannover bremen – hannover – nürnberg – münchen – brenner – verona – bologna – roma – napoli – bari napoli – palermo – valletta ### helsinki – turku – stockholm – malmö – københavn – gedser rostock – berlin – nürnberg – münchen – brenner – verona – bologna – roma – napoli – bari napoli – palermo – valletta


### genova – milano / novara – simplon / lötschberg / gotthard – basel – mannheim – köln köln– düsseldorf – rotterdam / amsterdam köln – liège – bruxelles / brussel – zeebrugge ### genova – milano / novara – simplon / lötschberg / gotthard – basel – mannheim – köln köln– düsseldorf – rotterdam / antwerpen köln – liège – bruxelles / brussel – zeebrugge


### amsterdam – rotterdam – antwerp – brussel / bruxelles – luxembourg luxembourg – dijon – lyon luxembourg – strasbourg – basel ### rotterdam – antwerp – brussel / bruxelles – luxembourg luxembourg – dijon – lyon luxembourg – strasbourg – basel


### ‘ services concession’ means a contract for pecuniary interest concluded in writing between one or more economic operators and one or more contracting authorities or contracting entities and having as their object the provision of services other than those referred to in points 2 and 4 where the consideration for the services to be provided consists either solely in the right to exploit the services that are subject of the contract or in that right together with payment . ### ' services concession ' means a contract for pecuniary interest concluded in writing by means of which one or more contracting authorities or contracting entities entrusts the operation of a service for which they are responsible to one or more economic operators , and where the consideration for this delegation consists either solely in the right to exploit the service which is the subject of the contract or in that right together with payment . by contrast , certain state acts such as authorisations , permits or licences , whereby the state or a public authority establishes the conditions for the exercise of an economic activity , having as their object the entitlement to offer social services and / or the right to conclude agreements , by means of which the grantor grants an economic operator the right to exploit certain public domains or resources , or grants rights of way should not be regarded as concessions insofar as they establish only general conditions for their use without turning the public authority into a recipient of specific works or services provided by the contracting partner .


### the right to exploit the works or services as referred to in points 2 , 4 and 7 of the first paragraph shall imply the transfer to the concessionaire of the substantial operating risk . the concessionaire shall be deemed to assume the substantial operating risk where it is not guaranteed to recoup the investments made or the costs incurred in operating the works or the services which are the subject - matter of the concession . ### the right to exploit the works or services shall imply the transfer to the concessionaire of the economic risk in exploiting these works or services , defined as the risk of exposure to the vagaries of the market . the concessionaire shall be deemed to assume the operating risk where , under normal conditions of exploitation , it is not guaranteed to recoup the investments made or the costs incurred in operating the works or the services which are the subject - matter of the concession , however where the operating risk for certain markets is limited from the outset , but this limited risk is fully transferred to the concessionaire , such conditions do not preclude a qualification as a concession


### financial services in connection with the issue , sale , purchase or transfer of securities or other financial instruments within the meaning of directive 2004 / 39 / ec of the european parliament and of the council , central bank services and operations conducted with the european financial stability facility ; ### financial services in connection with the issue , sale , purchase or transfer of securities or other financial instruments within the meaning of directive 2004 / 39 / ec of the european parliament and of the council , central bank services and transactions conducted with the european financial stability facility , as well as operations to raise money or capital for the contracting authority ;


### employment contracts ; ### employment contracts and mandatory social protection arrangements ;


### public passenger transport services within the meaning of regulation 1370 / 2007 of the european parliament and of the council . 19 ### transport services to the extent that they are governed by other community instruments .


### in article 3a , the following subparagraph is added : ' the flexibility scheme , set out in sections 1 . 2 . , 1 . 2 . 1 . and 1 . 2 . 2 . of annex iv shall apply only for the transition from stage iii a to stage iii b and shall expire on 31 december 2013 . ' ### in article 3a , the following paragraph is added : ' the flexibility scheme , set out in sections 1 . 2 . , 1 . 2 . 1 . and 1 . 2 . 2 . of annex iv shall apply only for the transition from stage iii a to stage iii b and shall expire on 31 december 2013 . after this date , no additional flexibility for the transition from stage iii a to stage iiib shall be awarded . '


### member states should ensure that at least one payment service provider offers a payment account with basic features to consumers . access should not be overly difficult and should not entail excessive costs for consumers . in this respect , member states should consider factors such as the location of the designated payment service providers in their territory . in order to minimise the risk for consumers to become financially excluded , member states should improve financial education , including at school , and combat over - indebtedness . furthermore , member states should promote initiatives of payment service providers in order to facilitate the combination of providing payment accounts with basic features and financial education . ### member states should ensure that at least one payment service provider offers a payment account with basic features to consumers . access should not be overly difficult and should not entail excessive costs for consumers . in this respect , member states should consider factors such as the location of the designated payment service providers in their territory . in order to minimise the risk for consumers to become financially excluded , member states should improve financial education , including at school , and combat over - indebtedness . furthermore , member states should promote initiatives of payment service providers in order to facilitate the combination of providing payment accounts with basic features and financial education to advise vulnerable people on aspects of budgeting and over - indebtedness .


### member states shall ensure that when a payment account is offered together with another service or product as part of a package , the payment service provider informs the consumer of whether it is possible to buy the payment account separately and provides separate information regarding the costs and fees associated with each of the products and services offered in the package . ### member states shall ensure that when a services included in the payment account with basic features as defined in article 16 are offered together with other services or products as part of a package , the payment service provider informs the consumer in a timely manner prior to entering into a contract for a payment account with a consumer that it is possible to buy such services or products separately and provides separate information regarding the costs and fees associated with each of the services or products offered in the package .


### payment transactions through a payment card , including online payments ; ### payment transactions through a payment card and online payments ;


### the multiannual indicative programme for the pan - african programme shall be drawn up on the basis of the joint africa - eu strategy and its action plans . ### the multiannual indicative programme for the pan - african programme shall be drawn up on the basis of the joint africa - eu strategy and its action plans . active involvement of the european parliament , civil society as well as the respective african national and regional parliaments in drawing up this programme and monitoring its implementation shall be ensured .


### tax policy and administration ; ### tax policy and administration , in particular : - supporting transparent domestic tax systems for citizens and companies , and developing local monitoring capacities , - fighting tax avoidance and tax evasion , - promoting country by country reporting ,


### corruption ; ### anti - corruption activities ;


### sustainable agriculture and energy . ### sustainable , in particular small - scale agriculture and renewable energy .


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


### complementing resources deployed under this instrument by coherent work and support through other eu instruments , which may focus on wider regional integration , promoting the eu ' s interests in fields such as economy , energy , research , innovation and technology , fighting against production , consumption and trafficking of drugs in the context of the security and development nexus , as well as managing migration and helping displaced persons and refugees in the context of the development and migration nexus . ### complementing resources deployed under this instrument by coherent work and support through other eu instruments , which may focus on wider regional integration , promoting mutual interests in fields such as economic recovery and protection against financial crisis , renewable energy , research , innovation and technology , fighting against production , consumption and trafficking of drugs in the context of the security and development nexus , as well as managing migration and helping displaced persons and refugees in the context of the development and migration nexus .


### ensuring better management of migratory flows in all their dimensions ; ### ensuring better management of migratory flows in all their dimensions and better protection of migrants in all respects , ensuring better protection of refugees and secure entry routes into the union ;


### financial assistance in these areas should in particular support actions promoting cross - border joint operations , access to and exchange of information , exchange of best practices , facilitated and secure communication and coordination , training and exchange of staff , analytical , monitoring and evaluation activities , comprehensive threat and risk assessments , awareness raising activities , testing and validation of new technology , forensic science research and the acquisition of technical interoperable equipment . ### financial assistance in these areas should in particular support actions promoting cross - border joint operations , access to and exchange of information , exchange of best practices , facilitated and secure communication and coordination , training and exchange of staff , analytical , monitoring and evaluation activities , comprehensive threat and risk assessments , awareness raising activities , testing and validation of new technology , forensic science research and the acquisition of technical interoperable equipment . financial assistance in these areas should only support actions , which are in line with union priorities and initiatives that have been endorsed by the european parliament and the council .


### measures in and in relation to third countries supported through this instrument should be taken in synergy and coherence with other actions outside the union supported through union external assistance instruments , both geographic and thematic . in particular , in implementing such actions full coherence should be sought with the principles and general objectives of the union external action and foreign policy related to the country or region in question . they should not be intended to support actions directly development - oriented and they should complement , when appropriate , the financial assistance provided through external aid instruments . coherence will also be sought with the union humanitarian policy , in particular as regards the implementation of emergency measures . ### measures in and in relation to third countries should be supported through union external assistance instruments , both geographic and thematic . in particular , in implementing such actions full coherence should be sought with the principles and general objectives of the union external action and foreign policy related to the country or region in question . they should not be intended to support actions directly development - oriented and they should complement , when appropriate , the financial assistance provided through external aid instruments . coherence will also be sought with the union humanitarian policy , in particular as regards the implementation of emergency measures .


### in order to maintain a level playing field for all undertakings active in the internal market , funding provided by horizon 2020 should be designed in accordance with state aid rules so as to ensure the effectiveness of public spending and prevent market distortions such as crowding - out of private funding , creating ineffective market structures or preserving inefficient firms . ### in order to maintain a level playing field for all undertakings active in the internal market , funding provided by horizon 2020 should be designed in accordance with state aid rules so as to ensure the effectiveness of public spending and prevent market distortions such as crowding - out of private funding , creating ineffective market structures or preserving inefficient firms . in particular , the establishment of public - private partnerships should be subject to conditions that ensure that an effective competitive environment is maintained and that ensures opportunities for new entrants to join in at any stage .


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


### the information concerned is relevant to public policy ; ### the information concerned is relevant to public policy objectives and the promotion of public interest ;


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


### the grant agreement shall , where appropriate , contain provisions ensuring the respect of ethical principles , including the establishment of an independent ethics board and the right of the commission to carry out an ethics audit . ### the grant agreement shall , where appropriate and in any case for all projects in the area of security research , contain provisions ensuring the respect of ethical principles , including the establishment of an independent ethics board and the right of the commission to carry out an ethics audit .


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


### where results are capable of commercial or industrial application , the participant owning these results shall examine the possibility for protection and , if possible and justified given the circumstances , shall adequately protect them for an appropriate period of time and with an appropriate territorial coverage , having due regard to its legitimate interests and the legitimate interests , particularly the commercial interests , of the other participants in the action . ### where results are capable of commercial or industrial application , the participant owning these results may examine the possibility for protection and , if possible and justified given the circumstances , may adequately protect them for an reasonable period of time and with an appropriate territorial coverage , having due regard to the public interest , its legitimate interests and the legitimate interests , particularly the commercial interests , of the other participants in the action .


### the participant may refuse consent only if it demonstrates that its legitimate interests would suffer significant harm . no dissemination relating to these results may take place until the commission or the funding body has taken a decision or has decided that it will assume ownership and has taken the necessary steps to ensure protection . the grant agreement shall lay down time - limits in this respect . ### the participant may refuse consent only if it demonstrates that its legitimate interests would suffer significant harm . no dissemination relating to these results may take place until the commission or the funding body has taken a decision whether it will assume ownership or not and has taken the steps , as relevant , to ensure protection . the grant agreement shall lay down time - limits in this respect .


### subject to any restrictions due to the protection of intellectual property , security rules or legitimate commercial interests , each participant shall through appropriate means disseminate the results it owns as soon as possible . the grant agreement may lay down time - limits in this respect . ### subject to any restrictions due to the protection of intellectual property , security rules or legitimate commercial interests , each participant shall through appropriate means disseminate the results it owns as soon as possible . the grant agreement may lay down time - limits in this respect . in the field of major societal challenges , licensing of results to third parties shall by default take place on non - exclusive terms so as to enable immediate competition and thereby to foster global accessibility .


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


### provided that any access rights to the results can be exercised and that any additional exploitation obligations are complied with , the participant who owns results may grant licences or otherwise give the right to exploit them to any legal entity , including on an exclusive basis . ### provided that any access rights to the results can be exercised and that any additional exploitation obligations are complied with , the participant who owns results may grant licences or otherwise give the right to exploit them to any legal entity . the possibility to grant licenses on an exclusive basis shall be exceptional and should not conflict with the objective of maximum dissemination and exploitation of results . terms for its conditions shall be laid down in the grant agreement .


### with regard to results which are generated by participants that have received union funding , the commission or funding body may object to transfers of ownership or to grants of an exclusive licence , to third parties established in a third country not associated to horizon 2020 , if it considers that the grant or transfer is not in accordance with the interests of developing the competitiveness of the union economy or is inconsistent with ethical principles or security considerations . ### with regard to results which are generated by participants that have received union funding , the commission or funding body may object to transfers of ownership or to grants of an exclusive licence , to third parties established within the union or in a third country not associated to horizon 2020 , if it considers that the grant or transfer is not in accordance with the interests of developing the competitiveness of the union economy or is inconsistent with ethical principles or security considerations .


### in the case of actions involving security - related activities , the grant agreement may lay down specific provisions , in particular on changes to the consortium ' s composition , classified information , exploitation , dissemination , transfers and licences of results . ### in the case of actions involving ' societal challenges ' related activities , the grant agreement may lay down specific provisions , in particular on changes to the consortium ' s composition , classified information , exploitation , dissemination , transfers and licences of results .


### in the case of erc frontier research actions , the grant agreement may lay down specific provisions , in particular on access rights , portability and dissemination , relating to participants , researchers and any party concerned by the action . ### in the case of erc frontier research actions , or research actions that address a societal challenge the grant agreement shall lay down specific provisions , in particular on access rights , portability and dissemination , relating to participants , researchers and any party concerned by the action .


### consumption of plastic carrier bags results in high levels of littering and an inefficient use of resources and is expected to increase if no action is taken . littering of plastic carrier bags contributes to the problem of marine litter that threatens marine eco - systems worldwide . ### consumption of plastic carrier bags results in high levels of littering and an inefficient use of resources and is expected to increase if no action is taken . littering of plastic carrier bags has adverse consequences for the environment and contributes to the problem of marine litter that threatens marine eco - systems worldwide .


### plastic carrier bags with a thickness below 50 microns , which represent the vast majority of the total number of plastic carrier bags consumed in the union , are less frequently re - used than thicker plastic carrier bags and more prone to littering . ### plastic carrier bags with a thickness below 50 microns , which represent the vast majority of the total number of plastic carrier bags consumed in the union , are less reusable than thicker plastic carrier bags and more prone to littering .


### to promote similar reductions of the average consumption level of lightweight plastic carrier bags , member states should take measures to reduce the consumption of plastic carrier bags with a thickness below 50 microns in line with the overall objectives of the union’s waste policy and the union ' s waste hierarchy as provided for in directive 2008 / 98 / ec of the european parliament and of the council of 19 november 2008 on waste and repealing certain directives7 . such reduction measures should take account of current consumption levels of plastic carrier bags in individual member states , with higher levels requiring more ambitious efforts . to monitor progress in reducing the use of lightweight plastic carrier bags national authorities will provide data on their use under article 17 of directive 94 / 62 / ec . ______________ 7 oj l 312 , 22 . 11 . 2008 , p . 3 . ### to promote similar reductions of the average consumption level of lightweight plastic carrier bags , member states should take measures to significantly reduce the consumption of plastic carrier bags with a thickness below 50 microns in line with the overall objectives of the union’s waste policy and the union ' s waste hierarchy as provided for in directive 2008 / 98 / ec of the european parliament and of the council of 19 november 2008 on waste and repealing certain directives7 . such reduction measures should take account of current consumption levels of plastic carrier bags in individual member states , with higher levels requiring more ambitious efforts . to monitor progress in reducing the use of lightweight plastic carrier bags national authorities will provide data on their use under article 17 of directive 94 / 62 / ec . ______________ 7 oj l 312 , 22 . 11 . 2008 , p . 3 .


### measures to be taken by member states may involve the use of economic instruments such as taxes and levies , which have proved particularly effective to reduce the use of plastic carrier bags , as well as marketing restrictions such as bans in derogation of article 18 of directive 94 / 62 / ec , subject to the requirements laid down in articles 34 to 36 of the treaty on the functioning of the european union . ### measures to be taken by member states should involve the use of levies , which have proved particularly effective to reduce the use of plastic carrier bags . member states should ensure that retailers do not provide carrier bags , and in particular plastic carrier bags other than very lightweight plastic carrier bags or alternatives to such very lightweight plastic carrier bags , free of charge at the point of sale of goods or products . member states should also be able to use economic instruments such as taxes as well as marketing restrictions such as bans in derogation of article 18 of directive 94 / 62 / ec , subject to the requirements laid down in articles 34 to 36 of the treaty on the functioning of the european union .


### ' 2a . ' lightweight plastic carrier bags” shall mean bags made of plastic materials as defined in article 3 of commission regulation no 10 / 2011* with a wall thickness below 50 microns and which are supplied to consumers at the point of sale of goods or products . ______________ * oj l 12 , 15 . 01 . 2011 , p . 1 . ' ### ' 2a . ' lightweight plastic carrier bags” shall mean bags made of plastic materials as defined in article 3 of commission regulation no 10 / 2011* with a wall thickness below 50 microns and which are supplied to consumers at the point of sale of goods or products , except very lightweight plastic carrier bags ; _______________ * oj l 12 , 15 . 01 . 2011 , p . 1 . '


### these measures may include the use of national reduction targets , economic instruments as well as marketing restrictions in derogation from article 18 of this directive . ### in article 4 , the following paragraph 1d is inserted : ' 1d . member states may use economic instruments such as taxes as well maintain or introduce marketing restrictions in derogation from article 18 of this directive to achieve the reduction target referred to in paragraph 1a of this article . '


### biodegradable packaging waste shall be of such a nature that it is capable of undergoing physical , chemical , thermal or biological decomposition such that most of the finished compost ultimately decomposes into carbon dioxide , biomass and water . ### in annex ii , point of paragraph 3 is amended as follows : ' biodegradable packaging waste shall be of such a nature that it is capable of undergoing physical , chemical , thermal or biological decomposition such that all of the material decomposes into carbon dioxide , biomass and water under natural conditions within less than one year . '


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


### the new psychoactive substances subjected to permanent market restriction pursuant to [ regulation no … / … on new psychoactive substances ] should , therefore , be covered by the union criminal law provisions on illicit drug trafficking . this would also help streamline and clarify the union legal framework , as the same criminal law provisions would apply to substances covered by the un conventions and to the most harmful new psychoactive substances . the definition of ‘ drug’ in the framework decision 2004 / 757 / jha should , therefore , be amended . ### the new psychoactive substances subjected to permanent market restriction pursuant to [ regulation no … / … on new psychoactive substances ] should be covered by the union criminal law provisions on illicit drug trafficking , supported by effective identification , early warning , prevention , treatment , and information dissemination measures . this would also help streamline and clarify the union legal framework , as the same criminal law provisions would apply to substances covered by the un conventions and to the most harmful new psychoactive substances . the definition of ‘ drug’ in the framework decision 2004 / 757 / jha should , therefore , be amended .


### with the aim of strengthening trade mark protection and combatting counterfeiting more effectively , the proprietor of a registered trade mark should be entitled to prevent third parties from bringing goods into the customs territory of the member state without being released for free circulation there , where such goods come from third countries and bear without authorization a trade mark which is essentially identical to the trade mark registered in respect of such goods . ### with the aim of strengthening trade mark protection and combatting counterfeiting more effectively , the proprietor of a registered european trade mark shall also be entitled to prevent all third parties from bringing goods , in the context of commercial activity , into the customs territory of the union without being released for free circulation there , where such goods , including packaging , come from a third country and bear without authorization a trade mark which is essentially identical to the european trade mark validly registered in respect of such goods and which cannot be distinguished in its essential aspects from that trade mark . in order not to hamper the production , circulation and distribution of legitimate goods , this rule should only apply if the proprietor of the trade mark is able to demonstrate clear and documented evidence of a substantial risk of fraudulent diversion of the allegedly counterfeit goods into a member state . the european commission shall develop and implement guidelines for national customs authorities with clear indicators on how to establish such substantial risk of fraudulent diversion . the list of clear indicators shall reflect the importance of unrestricted trade in , inter alia , generic medicines , and shall be in line with prevailing cjeu case law .


### the proprietor of a registered trade mark shall also be entitled to prevent all third parties from bringing goods , in the context of commercial activity , into the customs territory of the member state where the trade mark is registered without being released for free circulation there , where such goods , including packaging , come from third countries and bear without authorization a trade mark which is identical to the trade mark registered in respect of such goods , or which cannot be distinguished in its essential aspects from that trade mark . ### the proprietor of a registered european trade mark shall also be entitled to prevent all third parties from bringing goods , in the context of commercial activity , into the customs territory of the union without being released for free circulation there , where such goods , including packaging , come from a third country and bear without authorization a trade mark which is essentially identical to the european trade mark validly registered in respect of such goods and which cannot be distinguished in its essential aspects from that trade mark . in order not to hamper the production , circulation and distribution of legitimate goods , this rule should only apply if the proprietor of the trade mark is able to demonstrate clear and documented evidence of a substantial risk of fraudulent diversion of the allegedly counterfeit goods into a member state . the european commission shall develop and implement guidelines for national customs authorities with clear indicators on how to establish such substantial risk of fraudulent diversion . the list of clear indicators shall reflect the importance of unrestricted trade in , inter alia , generic medicines , and shall be in line with prevailing cjeu case law .


### this directive respects the fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union . in particular this directive seeks to promote the application of articles 1 , 18 , 19 , 21 , 24 and 47 of the charter and has to be implemented accordingly . ### this directive respects the fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union . in particular this directive seeks to promote the application of articles 1 , 4 , 18 , 19 , 21 , 24 and 47 of the charter and has to be implemented accordingly .


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


### in addition , special procedural guarantees for vulnerable applicants , such as minors , unaccompanied minors , persons who have been subjected to torture , rape or other serious acts of violence or disabled persons , should be laid down in order to create the conditions necessary for their effective access to procedures and presenting the elements needed to substantiate the application for international protection . ### in addition , special procedural guarantees for vulnerable applicants , such as minors , unaccompanied minors , pregnant women , persons who have been subjected to torture , rape or other serious acts of violence or disabled persons , should be laid down in order to create the conditions necessary for their effective access to procedures and presenting the elements needed to substantiate the application for international protection .


### with a view to ensuring substantive equality between female and male applicants , examination procedures should be gender sensitive . in particular , personal interviews should be organised in a way which makes its possible for both female and male applicants to speak about their past experiences in cases involving gender based persecution . the complexity of gender related claims should be properly taken into account in procedures based on the safe third country concept , the safe country of origin concept or the notion of subsequent applications . ### with a view to ensuring substantive equality between female and male applicants , examination procedures should be gender sensitive . in particular , personal interviews should be organised in a way which makes its possible for both female and male applicants to speak about their past experiences in cases involving gender based persecution to an interviewer of the same sex if so requested , who has specific training on the issue of interviews regarding gender based prosecution . the complexity of gender related claims should be properly taken into account in procedures based on the safe third country concept , the safe country of origin concept or the notion of subsequent applications .


### procedures for examining international protection needs should be organised in a way that makes it possible for the competent authorities to conduct a rigorous examination of applications for international protection . ### procedures for examining international protection needs should be organised in a way that makes it possible for the determining authorities to conduct a rigorous examination of applications for international protection .


### member states shall ensure that border guards , police and immigration authorities , and personnel of detention facilities have instructions and receive necessary training for dealing with applications for international protection . if these authorities are designated as competent authorities pursuant to paragraph 1 , the instructions shall include an obligation to register the application . in other cases , the instructions shall require to forward the application to the authority competent for this registration together with all relevant information . ### member states shall ensure that border guards , police and immigration authorities , and personnel of detention facilities have instructions and receive necessary training for accepting and registering applications for international protection . the instructions shall then require the application to be forwarded to the authority competent for processing the registered application together with all relevant information .


### member states shall ensure that organizations providing advice and counseling to applicants for international protection have access to the border crossing points , including transit zones , and detention facilities subject to an agreement with the competent authorities of the member state . ### member states shall ensure that organizations providing advice , counselling and legal representation to applicants for international protection have access to the border crossing points , including transit zones , and detention facilities .


### member states shall ensure that organizations providing advice and counseling to applicants for international protection have access to the border crossing points , including transit zones , and detention facilities subject to an agreement with the competent authorities of the member state . ### member states shall ensure that organizations providing advice and counseling to applicants for international protection have unobstructed access to the border crossing points , including transit zones , and detention facilities subject to an agreement with the competent authorities of the member state .


### applicants shall be allowed to remain in the member state , for the sole purpose of the procedure , until the determining authority has made a decision in accordance with the procedures at first instance set out in chapter iii . this right to remain shall not constitute an entitlement to a residence permit . ### applicants shall be allowed to remain in the member state , for the sole purpose of the procedure , until the determining authority has made a decision in accordance with the procedures at first instance set out in chapter iii .


### precise and up - to - date information is obtained from various sources , such as the united nations high commissioner for refugees and the european asylum support office , as to the general situation prevailing in the countries of origin of applicants and , where necessary , in countries through which they have transited , and that such information is made available to the personnel responsible for examining applications and taking decisions and , where the determining authority takes it into consideration for the purpose of taking a decision , to the applicant and his / her legal adviser ; ### precise and up - to - date information is obtained from various sources , such as the united nations high commissioner for refugees , the european asylum support office and international human rights organisations , as to the general situation prevailing in the countries of origin of applicants and , where necessary , in countries through which they have transited , and that such information is made available to the personnel responsible for examining applications and taking decisions and , where the determining authority takes it into consideration for the purpose of taking a decision , to the applicant and his / her legal adviser ;


### paragraph 3 shall not apply to cases where disclosure of particular circumstances of a person to members of his / her family can jeopardize the interests of that person , including cases involving gender and / or age based persecution . in such cases , a separate decision shall be issued to the person concerned . ### paragraph 3 shall not apply to cases where disclosure of particular circumstances of a person to members of his / her family can jeopardize the interests of that person , including cases involving gender , gender identity , sexual orientation and / or age based persecution . in such cases , a separate decision shall be issued to the person concerned .