### this regulation should only refer to fees which are to be levied by the agency , whereas the competence to decide on possible fees levied by the competent authorities of the member states should remain with the member states . marketing authorisation holders should not be charged twice for the same pharmacovigilance activity . member states should therefore not levy fees for the activities which are covered by this regulation . ### this regulation should only refer to fees which are to be levied by the agency , whereas the competence to decide on possible fees levied by the competent authorities of the member states should remain with the member states , notably for signal detection tasks . marketing authorisation holders should not be charged twice for the same pharmacovigilance activity . member states should therefore not levy fees for the activities which are covered by this regulation .


### rapporteurs rely for their assessment on the scientific evaluation and resources of national marketing authorisation bodies , whilst it is the responsibility of the agency to coordinate the existing scientific resources put at its disposal by the member states . in view of that and to ensure adequate resources for the scientific assessments relating to the union - wide pharmacovigilance procedures , the agency should remunerate the scientific assessment services provided by the rapporteurs appointed by member states as members of the pharmacovigilance risk assessment committee referred to in article 56 of regulation no 726 / 2004 or , where relevant , by rapporteurs in the coordination group referred to in article 27 of directive 2001 / 83 / ec . the level of remuneration for the work carried out by those rapporteurs should be based on average estimations of the workload involved and should be taken into account in setting the level of the fees for union - wide pharmacovigilance procedures . ### rapporteurs rely for their assessment on the scientific evaluation and resources of national marketing authorisation bodies , whilst it is the responsibility of the agency to coordinate the existing scientific resources put at its disposal by the member states . in view of that and to ensure adequate resources for the scientific assessments relating to the union - wide pharmacovigilance procedures , the agency should remunerate the scientific assessment services provided by the rapporteurs appointed by member states as members of the pharmacovigilance risk assessment committee referred to in article 56 of regulation no 726 / 2004 or , where relevant , by rapporteurs and co - rapporteurs in the coordination group referred to in article 27 of directive 2001 / 83 / ec . the level of remuneration for the work carried out by those rapporteurs and co - rapporteurs should be based on average estimations of the workload involved and should be taken into account in setting the level of the fees for union - wide pharmacovigilance procedures .


### where the member state has appointed a representative in the coordination group who acts as rapporteur in the context of the assessment of periodic safety update reports referred to in article 4 ; ### where the member state has appointed a representative in the coordination group who acts as rapporteur or co - rapporteur in the context of the assessment of periodic safety update reports referred to in article 4 ;


### in view of the monitoring referred to in paragraph 4 , the commission may , where necessary , adjust the amounts of the fees and the amounts of the remuneration of rapporteurs laid down in the annex , in accordance with article 16 . those adjustments shall take effect on 1 april following the entry into force of the corresponding amending act . ### in view of the monitoring referred to in paragraph 4 , the commission may , where necessary , adjust the amounts of the fees and the amounts of the remuneration of rapporteurs and co - rapporteurs laid down in the annex , in accordance with article 16 . those adjustments shall take effect on 1 april following the entry into force of the corresponding amending act .


### holders of marketing authorisations for medicinal products referred to in article 7 shall pay 80 % of the amount applicable to the chargeable units corresponding to those products . ### holders of marketing authorisations for medicinal products referred to in article 10a of directive 2001 / 83 / ec shall pay 80% of the amount applicable to the chargeable units corresponding to those products . holders of marketing authorisations for authorised homeopathic medicinal products and for authorised herbal medicinal products as defined respectively in article 1 and article 1 of directive 2001 / 83 / ec shall pay 25% of the amount applicable to the chargeable units corresponding to those products .


### transmitting or making information and documents available to the member states , the competent authorities in third countries , or the public . ### transmitting or making information and documents available to the member states , the competent authorities in third countries , the european parliament , or the public .


### draft legislative resolution – having regard to article 294 and article 325 of the treaty on the functioning of the european union , pursuant to which the commission submitted the proposal to parliament , ### – having regard to the treaty on the functioning of the european union , and in particular article 83 thereof ,


### the budgets of institutions , bodies , offices and agencies established under the treaties or budgets managed and monitored by them . ### the budgets of institutions , bodies , offices and agencies established under the treaties or budgets managed and monitored by them directly or indirectly ;


### member states shall take the necessary measures to ensure that money laundering as defined in article 1 of directive 2005 / 60 / ec of the european parliament and of the council33 involving property derived from the offences covered by this directive is punishable as a criminal offence . __________________ 33 oj l 309 , 25 . 11 . 2005 , p . 15 . ### member states shall take the necessary measures to ensure that money laundering as defined in article 1 of directive 2005 / 60 / ec of the european parliament and of the council33 involving property or any other income derived from the offences covered by this directive is punishable as a criminal offence . __________________ 33 oj l 309 , 25 . 11 . 2005 , p . 15 .


### the competent authorities in the member states may exchange information with the commission so as to make it easier to establish the facts and to ensure effective action against the criminal offences referred to in title ii . the commission and the competent national authorities shall take account in each specific case of the requirements of investigation secrecy and data protection . to that end , a member state , when supplying information to the commission , may set specific conditions covering the use of information , whether by the commission or by another member state to which that information may be passed . ### the competent authorities in the member states may exchange information with the commission so as to make it easier to establish the facts and to ensure effective action against the criminal offences referred to in title ii . the commission and the competent national authorities shall in each specific case comply with article 6 of the treaty on the european union and the charter of fundamental rights of the european and the applicable eu legislation on the protection of personal data , and take into account the requirements of investigation secrecy . to that end , a member state , when supplying information to the commission , may set specific conditions covering the use of information , whether by the commission or by another member state to which that information may be passed .


### the scope of these non - financial disclosure requirements should be defined by reference to the average number of employees , total assets and turnover . smes should be exempted from additional requirements , and the obligation to disclose a non - financial statement in the annual report should only apply to those companies whose average number of employees exceeds 500 , and exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million . ### the scope of these non - financial disclosure requirements should be defined by reference to the average number of employees , total assets and turnover . smes should be exempted from additional requirements , and the obligation to disclose a non - financial statement in the annual report should only apply to those companies whose average number of employees exceeds 250 , and exceed either a balance sheet total of eur 17 . 5 million or a net turnover of eur 35 million .


### the risks related to these matters and how the company manages those risks . ### the risks related to the company’s activities , which are likely to cause , or have caused , severe adverse social , environmental and human rights impacts , and how the company manages those risks .


### the risks related to these matters and how the company manages those risks . ### the risks related to these matters linked to the company’s activities , which are likely to cause , or have caused , severe adverse social , environmental and human rights impacts , and how the company manages those risks .


### in providing such information the company may rely on national , eu - based or international frameworks and , if so , shall specify which frameworks it has relied upon . ### in providing such information , the company shall apply the guiding principles on business and human rights implementing the united nations “protect , respect and remedy” framework and the organisation for economic co - operation and development guidelines for multinational enterprises . in addition , the company may also rely on national , eu - based or international frameworks and , if so , shall specify which frameworks it has relied upon . this provision shall apply without prejudice to the requirements of this directive or to other european union legislation or guidance containing more specific rules for companies’ non - financial disclosure .


### in providing such information the consolidated annual report may rely on national , eu - based or international frameworks and if so , shall specify which frameworks it has relied upon . ### in providing such information , the company shall apply the guiding principles on business and human rights implementing the united nations “protect , respect and remedy” framework and the organisation for economic co - operation and development guidelines for multinational enterprises . in addition , the company may also rely on national , eu - based or international frameworks and if so , shall specify which frameworks it has relied upon . this provision shall apply without prejudice to the requirements of this directive or to other european union legislation or guidance containing more specific rules for companies’ non - financial disclosure .


### to the extent necessary for an understanding of the company’s development , performance or position , the analysis shall include both financial and non - financial key performance indicators relevant to the particular business . ### to the extent necessary for an understanding of the company’s development , performance or position , and human rights , social and environmental impacts , the analysis shall include both financial and non - financial key performance indicators relevant to the particular business .


### for parent undertakings of undertakings to be consolidated that together exceed an average number of 500 employees during the financial year , and , on their balance sheet dates , exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million , the review shall also include a non - financial statement containing information relating to at least environmental , social and employee matters , respect for human rights , anti - corruption and bribery matters , including the following : ### for parent undertakings of undertakings to be consolidated that together exceed an average number of 250 employees during the financial year , and , on their balance sheet dates , exceed either a balance sheet total of eur 17 . 5 million or a net turnover of eur 35 million , the review shall also include a non - financial statement containing information relating to at least environmental , social and employee matters , respect for human rights , anti - corruption and bribery matters , taking into account the company’s complete supply chain , including the following :


### this directive shall enter into force on the twentieth day following that of its publication in the official journal of the european union . ### this directive shall enter into force on the twentieth day following that of its publication in the official journal of the european union . no later than [ three years after adoption of this directive ] , the commission shall review the provisions in article 46 and report to the european parliament and council accompanied by legislative proposals if appropriate , regarding : - non - financial information disclosed in practice , including the coverage of the supply chain , whether this is effective , whether adequate guidance and methods are provided ; - progress with non - financial reporting across the world ; - the implementation of the un “protect , respect and remedy” framework and its guiding principles as well as of the oecd guidelines for multinational enterprises ; - the use of indicators for land use , water use , greenhouse gas emissions , and use of materials ; and - effectiveness of existing verification and enforcement mechanisms .


### in order to make the union more attractive for third - country national researchers , family members of researchers , as defined in council directive 2003 / 86 / ec of 22 september 2003 on the right to family reunification , should be admitted with them . they should benefit from intra - union mobility provisions and they should also have access to the labour market . ### in order to make the union more attractive for third - country national researchers and students , family members of researchers and students , as defined in council directive 2003 / 86 / ec of 22 september 2003 on the right to family reunification , should be admitted with them . they should benefit from intra - union mobility provisions and they should also have access to the labour market .


### to make the union more attractive for third - country national researchers , students , pupils , trainees , volunteers and au pairs , it is important to ensure their fair treatment in accordance with article 79 of the treaty . these groups are entitled to equal treatment with nationals of the host member state under directive 2011 / 98 / eu of the european parliament and of the council of 13 december 2011 on a single application procedure for a single permit for third - country nationals to reside and work in the territory of a member state and on a common set of rights for third - country workers legally residing in a member state . more favourable rights to equal treatment with nationals of the host member state as regards branches of social security as defined in regulation no 883 / 2004 on the coordination of social security schemes should be maintained for third - country national researchers , in addition to the rights granted under directive 2011 / 98 / eu . currently the latter foresees a possibility for member states to limit equal treatment with regard to branches of social security , including family benefits , and this possibility of limitation could affect researchers . in addition , independently on whether union or national law of the host member state gives third - country national school pupils , volunteers , unremunerated trainees and au - pairs access to the labour market , they should enjoy equal treatment rights with nationals of the host member state as regards access to goods and services and the supply of goods and services made available to the public . ### to make the union more attractive for third - country national researchers , students , pupils , trainees , volunteers and au pairs , it is important to ensure their fair treatment in accordance with article 79 of the treaty . these groups are entitled to equal treatment with nationals of the host member state under directive 2011 / 98 / eu of the european parliament and of the council of 13 december 2011 on a single application procedure for a single permit for third - country nationals to reside and work in the territory of a member state and on a common set of rights for third - country workers legally residing in a member state . more favourable rights to equal treatment with nationals of the host member state as regards branches of social security as defined in regulation no 883 / 2004 on the coordination of social security schemes should be maintained for third - country national researchers , in addition to the rights granted under directive 2011 / 98 / eu . currently the latter foresees a possibility for member states to limit equal treatment with regard to branches of social security , including family benefits , and this possibility of limitation could affect researchers . other groups covered by this directive should also be entitled to equal treatment with nationals in regard to social security entitlement . in addition , independently on whether union or national law of the host member state gives third - country national school pupils , volunteers , unremunerated trainees and au - pairs access to the labour market , they should enjoy equal treatment rights with nationals of the host member state as regards access to goods and services and the supply of goods and services made available to the public .


### have sickness insurance for all risks normally covered for nationals of the member state concerned ; ### have sickness insurance for the risks normally covered for nationals of the member state concerned ;


### member states may accept , in accordance with their national legislation , an application submitted when the third - country national concerned is already in their territory . ### member states shall examine , in accordance with their national legislation , an application submitted when the third - country national concerned is already in their territory .


### member states shall reject an application in the following cases : ### member states may reject an application in the following cases :


### where the host entity does not meet the legal obligations regarding social security and / or taxation set out in national law or has filed for bankruptcy or is otherwise insolvent ; ### where the host entity does not meet the legal obligations regarding social security and / or taxation set out in national law or has filed for bankruptcy or is otherwise insolvent . where this happens in a course of study , reasonable time should be given for the student to find an equivalent course to enable the completion of his / her studies ;


### for students , where the time limits imposed on access to economic activities under article 23 are not respected or if the respective student does not make acceptable progress in the relevant studies in accordance with national legislation or administrative practice . ### for students , where the time limits imposed on access to economic activities under article 23 are not respected or if the respective student does not make acceptable progress in the relevant studies in accordance with national legislation or administrative practice and there is no compelling mitigating factor to explain this situation .


### for students , where the time limits imposed on access to economic activities under article 23 are not respected or where the student does not make acceptable progress in the relevant studies in accordance with national legislation or administrative practice . ### for students , where the time limits imposed on access to economic activities under article 23 are not respected or where the student does not make acceptable progress in the relevant studies in accordance with national legislation or administrative practice and there is no compelling mitigating factor to explain this situation .


### under this decision , the eib should increase its development orientation in close coordination with the commission and following the principles of the european consensus on development . this should be implemented through a number of concrete measures , in particular by reinforcing its capacity to appraise social and development aspects of projects , including human rights and conflict related risks , and by promoting local consultation . moreover , it should increase its focus on sectors where it has sound expertise from financing operations within the eu and which will further the development of the country in question , such as environmental infrastructure including water and sanitation , sustainable transportation and climate change mitigation , particularly in renewable energy . the eib should also progressively strengthen its activity in support of health and education as well as of climate change adaptation , where appropriate working in cooperation with other international finance institutions and european bilateral finance institutions . this will require access to concessional resources and a progressive increase in human resources devoted to eib external activities . eib activity should also be complementary to eu objectives and priorities relating to institution building and sector reforms . finally , the eib should define performance indicators which are linked to development aspects of the projects and their results . ### while the eib ' s strength remains its distinctiveness as an investment bank , under this decision , the eib should frame the development impact of its external operations in close coordination with the commission and follow the principles of the european consensus on development and those set out in article 208 tfeu , as well as the principles of aid effectiveness outlined in the paris declaration of 2005 and the accra agenda for action of 2008 . this should be implemented through a number of concrete measures , in particular by reinforcing its capacity to appraise environmental , social and development aspects of projects , including human rights and conflict related risks , and by promoting local consultation with public authorities and civil society . local consultations should take place within eib ' s project due diligence . moreover , it should increase its focus on sectors where it has sound expertise from financing operations within the eu and which will further the development of the country in question , , environmental infrastructure including water and sanitation , sustainable transportation and climate change mitigation , particularly in renewable energy . financing could also include projects in support of health and education , particularly in the area of vocational training and infrastructure , when there is clear added value . the eib should also progressively strengthen its activity in support of climate change adaptation , where appropriate working in cooperation with international finance institutions and european bilateral finance institutions . this will require access to concessional resources and an increase , within a reasonable period , in human resources devoted to eib external activities . eib activity should also be complementary to eu objectives and priorities relating to institution building and sector reforms . finally , the eib must define performance indicators which are linked to development and environment aspects of the projects and their results .


### the eib shall carry out thorough due diligence on development - related aspects of projects covered by the eu guarantee . the eib ' s own rules and procedures shall include the necessary provisions on assessment of environmental and social impact of projects and of aspects related to human rights , to ensure that only projects that are economically , financially , environmentally and socially sustainable are supported under this decision . ### the eib shall carry out thorough due diligence , including local public consultation , on development - related aspects of projects covered by the eu guarantee prior to project approval , including , in an appropriate form , the loan activity of financial intermediaries . the eib ' s own rules and procedures shall include the necessary provisions on assessment of environmental and social impact of projects and of aspects related to human rights , to ensure that only projects that are economically , financially , environmentally and socially sustainable are supported under this decision . the project appraisal reports adopted within the due diligence process shall be disclosed to the public . the commission shall report annually to the european parliament on the outcome of the due diligence .


### in order to implement the programme the commission shall adopt annual work programmes which shall satisfy the requirements laid down in article 17 of regulation no 223 / 2009 and shall set out the objectives pursued and the expected results . ### in order to implement the programme the commission shall adopt annual work programmes which shall satisfy the requirements laid down in article 17 of regulation no 223 / 2009 and shall set out the objectives pursued and the expected results , in compliance with the objectives referred in article 4 of the present regulation .


### endorsement of the europe 2020 strategy for ‘ smart , sustainable and inclusive’ growth by the june 2010 european council has shaped to a large extent the strategic agenda for the european union and national policies in the years ahead . this agenda establishes a number of headline targets and flagship initiatives for which statistical indicators have to be delivered by the ess in a number of areas . ### endorsement of the europe 2020 strategy for ' smart , sustainable and inclusive ' growth by the june 2010 european council has shaped to a large extent the strategic agenda for the european union and national policies in the years ahead . this agenda establishes a number of headline targets and flagship initiatives for which statistical indicators have to be delivered by the ess in a number of areas .


### the effects of the financial crisis , the increase in cross - border flows and the fragmentation of production processes have highlighted the need for a more coherent framework and enhanced measurement of globalised production . ### the social and economic effects of the financial crisis , the increase in cross - border flows and the fragmentation of production processes have highlighted the need for a more coherent framework and enhanced measurement of globalised production .


### increase the efficiency and effectiveness of production processes . provide quality statistics on key areas where enterprises are the centre of interest , such as business statistics , short - term indicators , their investment in human capital and skills , international transactions , globalisation , single market monitoring , r&d and innovation , and tourism . special attention should be paid to the availability of data in high value - added industrial or services sectors . ### increase the efficiency and effectiveness of production processes . provide quality statistics on key areas where enterprises are the centre of interest , such as business statistics , short - term indicators , their investment in human capital and skills , international transactions , globalisation , single market monitoring , r&d and innovation , and tourism . special attention should be paid to the availability of data in high value - added industrial or services sectors , especially in green or digital economy sectors .


### a common policy on asylum , including a common european asylum system , is a constituent part of the european union ' s objective of progressively establishing an area of freedom , security and justice open to those who , forced by circumstances , legitimately seek international protection in the union . ### a common policy on asylum , including a common european asylum system , is a constituent part of the european union ' s objective of progressively establishing an area of freedom , security and justice open to those who , forced by circumstances , seek international protection in the union .


### hits obtained from eurodac should be verified by a fingerprint expert in order to ensure the accurate determination of responsibility under regulation no [ … / … ] [ establishing the criteria and mechanisms for determining the member state responsible for examining an application for international protection lodged in one of the member states by a third - country national or a stateless person ] . ### hits obtained from eurodac should be verified by a trained fingerprint expert in order to ensure the accurate determination of responsibility under regulation no [ … / … ] [ establishing the criteria and mechanisms for determining the member state responsible for examining an application for international protection lodged in one of the member states by a third - country national or a stateless person ] .


### in accordance with the principle of subsidiarity as set out in article 5 of the treaty , the objective of the proposed measures , namely the creation of a system for the comparison of fingerprint data to assist the implementation of the community ' s asylum policy , cannot , by its very nature , be sufficiently achieved by the member states and can therefore be better achieved by the community . in accordance with the principle of proportionality as set out in the said article , this regulation does not go beyond what is necessary to achieve those objectives . ### since the objective of this regulation , namely the creation of a system for the comparison of fingerprint data to assist the implementation of the union asylum policy , cannot , by its very nature , be sufficiently achieved by the member states and can therefore be better achieved at union level , the union may adopt measures in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this regulation does not go beyond what is necessary in order to achieve that objective .


### a computerised central fingerprint database composed of – a central unit , – a business continuity system . ### a computerised central fingerprint database composed of : – a central unit , – a business continuity plan .


### operational management of eurodac shall consist of all the tasks necessary to keep eurodac functioning 24 hours a day , 7 days a week in accordance with this regulation , in particular the maintenance work and technical developments necessary to ensure that the system functions at a satisfactory level of operational quality , in particular as regards the time required for interrogation of the central system . ### operational management of eurodac shall consist of all the tasks necessary to keep eurodac functioning 24 hours a day , 7 days a week in accordance with this regulation , in particular the maintenance work and technical developments necessary to ensure that the system functions at a satisfactory level of operational quality , in particular as regards the time required for interrogation of the central system . a business continuity plan shall be developed taking into account maintenance needs and unforseen downtime of the system , including the impact of business continuity measures on data protection and security .


### member states shall designate the authorities which are authorised to access eurodac data pursuant to this regulation . designated authorities shall be authorities of the member states which are responsible for the prevention , detection or investigation of terrorist offences and other serious criminal offences . ### for the purposes laid down in article 1 , member states shall designate the authorities which are authorised to access eurodac data pursuant to this regulation . designated authorities shall be authorities of the member states which are responsible for the prevention , detection or investigation of terrorist offences and other serious criminal offences . designated authorities shall not include agencies or units responsible for intelligence relating to national security .


### at national level , each member state shall keep a list of the operating units within the designated authorities that are authorised to request comparisons with eurodac data through the national access point . ### each member state shall keep a list of the operating units within the designated authorities that are authorised to request comparisons with eurodac data through the national access point .


### at the end of each year , statistical data shall be established in the form of a compilation of the monthly statistics for that year , including an indication of the number of persons for whom hits have been recorded under points , , and . the statistics shall contain a breakdown of data for each member state . ### at the end of each year , statistical data shall be established in the form of a compilation of the monthly statistics for that year , including an indication of the number of persons for whom hits have been recorded under points , and . the statistics shall contain a breakdown of data for each member state . the result shall be made public .


### by way of derogation from paragraph 1 , where it is not possible to take the fingerprints of an applicant on account of measures taken to ensure the health of the applicant or the protection of public health , member states shall take and send the fingerprints of the applicant as soon as possible and no later than 48 hours after these grounds no longer prevail . ### by way of derogation from paragraph 1 , where it is not possible to take the fingerprints of an applicant on account of measures taken to ensure the health of the applicant or the protection of public health , member states shall take and send the fingerprints of the applicant as soon as possible and no later than 48 hours after these grounds no longer prevail . the temporary or permanent impossibility to provide usable fingerprints shall not adversly affect the legal situation of a third - country national or a stateless person . in particular , it shall not represent sufficient grounds to refuse to examine or to reject an asylum application .


### the central system shall inform all member states of origin about the erasure of data for the reason specified in paragraph 1 by another member state of origin having produced a hit with data which they transmitted relating to persons referred to in article 9 or article 14 . ### the central system shall inform as soon as possible and not later than after 72 hours , all member states of origin about the erasure of data for the reason specified in paragraph 1 by another member state of origin having produced a hit with data which they transmitted relating to persons referred to in article 9 or article 14 .


### the central system shall inform all member states of origin about the erasure of data for the reason specified in point or of paragraph 2 or by another member state of origin having produced a hit with data which they transmitted relating to persons referred to in article 14 . ### the central system shall inform as soon as possible and no later than after 72 hours all member states of origin about the erasure of data for the reason specified in point or of paragraph 2 or by another member state of origin having produced a hit with data which they transmitted relating to persons referred to in article 14 .


### the central system shall inform all member states of origin about the erasure of data for the reason specified in point of paragraph 2 by another member state of origin having produced a hit with data which they transmitted relating to persons referred to in article 9 or article 14 . ### the central system shall inform as soon as possible and no later than after 72 hours all member states of origin about the erasure of data for the reason specified in point of paragraph 2 by another member state of origin having produced a hit with data which they transmitted relating to persons referred to in article 9 or article 14 .


### non compliance with the 72 hours time limit referred to in paragraph 2 does not relieve member states of the obligation to take and transmit the fingerprints to the central system . where the condition of the fingertips does not allow to take the fingerprints in a quality ensuring appropriate comparison under article 25 , the member state of origin shall retake the fingerprints of such person and resend them as soon as possible and no later than 48 hours after they have been successfully taken . ### where the condition of the fingertips does not allow to take the fingerprints in a quality ensuring appropriate comparison under article 25 , the member state of origin shall retake the fingerprints of such person and resend them as soon as possible and no later than 48 hours after they have been successfully taken .


### by way of derogation from paragraph 1 , where it is not possible to take the fingerprints of such person on account of measures taken to ensure the health of the person or the protection of public health , the member state concerned shall take and send the fingerprints of the person , in accordance with the deadline set out in paragraph 2 , once these grounds no longer prevail . ### by way of derogation from paragraph 1 , where it is not possible to take the fingerprints of such person on account of measures taken to ensure the health of the person or the protection of public health , the member state concerned shall take and send the fingerprints of the person , in accordance with the deadline set out in paragraph 2 , once these grounds no longer prevail . the temporary or permanent impossibility to provide usable fingerprints shall not adversely affect the legal situation of a third - country national or a stateless person .


### in exceptional cases of urgency , the verifying authority may transmit the fingerprint data to the national access point for comparison immediately upon receipt of a request by a designated authority and only verify ex - post whether all the conditions of article 20 or article 21 are fulfilled , including whether an exceptional case of urgency actually existed . the ex - post verification shall take place without undue delay after the processing of the request . ### in exceptional cases of urgency of the need to prevent an imminent danger associated with serious criminal or terrorist offences , the verifying authority may transmit the fingerprint data to the national access point for comparison immediately upon receipt of a request by a designated authority and only verify ex - post whether all the conditions of article 20 or article 21 are fulfilled , including whether an exceptional case of urgency actually existed . the ex - post verification shall take place without undue delay after the processing of the request .


### designated authorities may request the comparison of fingerprint data with those stored in the eurodac central database within the scope of their powers only if comparisons of national fingerprint databases and of the automated fingerprint databases of other member states under decision 2008 / 615 / jha return negative results and where : ### designated authorities may request the comparison of fingerprint data with those stored in the eurodac central database within the scope of their powers only if comparisons of national fingerprint databases , of the automated fingerprint databases of at least a third of other member states under decision 2008 / 615 / jha and of the visa information system return negative results and where :


### the results of the comparison shall be immediately checked in the member state of origin by a fingerprint expert . final identification shall be made by the member state of origin in cooperation with the member states concerned , pursuant to article 32 of the dublin regulation . ### the results of the comparison shall be immediately checked in the member state of origin by a trained fingerprint expert . final identification shall be made by the member state of origin in cooperation with the member states concerned , pursuant to article 32 of the dublin regulation .


### where final identification in accordance with paragraph 4 reveal that the result of the comparison received from the central system is inaccurate , member states shall communicate this fact to the commission and to the agency . ### where final identification in accordance with paragraph 4 reveals that the result of the comparison received from the central system is inaccurate , member states shall communicate this fact as soon as possible and no later than after 72 hours to the commission and to the agency and inform the other member states concerned as soon as possible and no later than after 72 hours on the inaccuracy of the data .


### the authorities of member states which , pursuant to paragraph 1 , have access to data recorded in the central system shall be those designated by each member state for the purpose of article 1 . this designation shall specify the exact unit responsible for carrying out tasks related to the application of this regulation . each member state shall without delay communicate to the commission and the agency a list of those authorities and any amendments thereto . the agency shall publish the consolidated list in the official journal of the european union . where there are amendments thereto , the agency shall publish once a year an updated consolidated list . ### the authorities of member states which , pursuant to paragraph 1 , have access to data recorded in the central system shall be those designated by each member state for the purpose of article 1 . this designation shall specify the exact unit responsible for carrying out tasks related to the application of this regulation . each member state shall without delay communicate to the commission and the agency a list of those units and any amendments thereto . the agency shall publish the consolidated list in the official journal of the european union . where there are amendments thereto , the agency shall publish regularly an updated consolidated list online .


### a person covered by this regulation shall be informed by the member state of origin in writing , and where appropriate , orally , in a language which he or she understands or may reasonably be presumed to understand of the following : ### a person covered by this regulation shall be informed by the member state of origin in writing , and where necessary , orally , in a language which he or she understands or may reasonably be presumed to understand of the following :


### a common leaflet , containing at least the information referred to in paragraph 1 of this article and the information referred to in article 4 of the dublin regulation shall be drawn up in accordance with the procedure referred to in article 40 of the dublin regulation . the leaflet should be ' clear and simple , drafted in a language that the person understands or may reasonably be presumed to understand . ### a common leaflet , containing at least the information referred to in paragraph 1 of this article and the information referred to in article 4 of the dublin regulation shall be drawn up in accordance with the procedure referred to in article 40 of the dublin regulation . the leaflet shall be ' clear and simple , drafted in a language that the person understands or may reasonably be presumed to understand . it shall also include information on the rights of the data subject and the possibility of assistance by the national supervisory authorities as well as the contact details of the controller and the national supervisory authorities .


### whenever a person requests data relating to him or her in accordance with paragraph 2 , the competent authority shall keep a record in the form of a written document that such a request was made , and shall make this document available to the national supervisory authorities without delay , upon their request . ### whenever a person requests data relating to him or her in accordance with paragraph 2 , the competent authority shall keep a record in the form of a written document that such a request was made , and shall make this document available to the national supervisory authorities without delay , upon their request . it shall immediately inform the national supervisory authorities in case a person requests the correction or erasure of its data . no later than three weeks after the request it shall confirm to the national supervisory authorities that it has taken action to correct or erase the data or , in case the member state does not agree that the data recorded in the central system are inaccurate or have been recorded unlawfully , explain why it is not prepared to correct or erase the data .


### the european data protection supervisor shall ensure that an audit of the agency ' s personal data processing activities is carried out in accordance with international auditing standards at least every four years . a report of such audit shall be sent to the european parliament , the council , the agency , the commission and the national supervisory authorities . the agency shall be given an opportunity to make comments before the report is adopted . ### the european data protection supervisor shall ensure that an audit of the agency ' s personal data processing activities is carried out in accordance with international auditing standards at least every two years . a report of such audit shall be sent to the european parliament , the council , the agency , the commission and the national supervisory authorities . the agency shall be given an opportunity to make comments before the report is adopted .


### ensure that all authorities with a right of access to eurodac create profiles describing the functions and responsibilities of persons who are authorised to access , enter , update , erase and search the data and make these profiles available to the national supervisory authorities referred to in article 25 of framework decision 2008 / 977 / jha without delay at their request ; ### ensure that all authorities with a right of access to eurodac create profiles describing the functions and responsibilities of persons who are authorised to access , enter , update , erase and search the data and make these profiles and any other relevant information the authorities may require for the purpose of carrying out supervision available to the national supervisory authorities referred to in article 28 of directive 95 / 46 / ec and in article 25 of framework decision 2008 / 977 / jha without delay at their request ;


### monitor the effectiveness of the security measures referred to in this paragraph and take the necessary organisational measures related to internal monitoring to ensure compliance with this regulation . ### monitor the effectiveness of the security measures referred to in this paragraph and take the necessary organisational measures related to internal monitoring to ensure compliance with this regulation . for the purpose of the business continuity plan , the member states shall inform the agency and the national supervisory authorities of security incidents they detected on their system . the agency shall inform the member states , europol and the european data protection supervisor in case of security incidents . all parties shall collaborate during a security incident .


### every two years , the agency shall submit to the european parliament , the council , the commission and the european data protection supervisor a report on the technical functioning of the central system , including the security thereof . ### every one year , the agency shall submit to the european parliament , the council , the commission and the european data protection supervisor a report on the technical functioning of the central system , including the security thereof .


### three years after the start of application of this regulation as provided for in article 46 and every four years thereafter , the commission shall produce an overall evaluation of eurodac , examining results achieved against objectives and assessing the continuing validity of the underlying rationale , and any implications for future operations , as well as make any necessary recommendations . the commission shall transmit the evaluation to the european parliament and the council . ### three years after the start of application of this regulation as provided for in article 46 and every three years thereafter , the commission shall produce an overall evaluation of eurodac , examining results achieved against objectives and assessing the continuing validity of the underlying rationale , and any implications for future operations , as well as make any necessary recommendations . the commission shall transmit the evaluation to the european parliament and the council .


### by [ three months after the date of entry into force of this regulation ] at the latest each member state shall notify the commission of its designated authorities and shall notify without delay any amendment thereto . ### by [ three months after the date of entry into force of this regulation ] at the latest each member state shall notify the commission of its designated authorities and the operation units referred to in article 5 and shall notify without delay any amendment thereto .


### granting union railway undertakings the right of access to railway infrastructure in all member states for the purpose of operating domestic passenger services may have implications for the organisation and financing of rail passenger services provided under a public service contract . member states should have the option of limiting such right of access where it would compromise the economic equilibrium of those public service contracts and where approval has been given by the relevant regulatory body . ### granting union railway undertakings the right of access to railway infrastructure in all member states for the purpose of operating domestic passenger services may have implications for the organisation and financing of rail passenger services provided under a public service contract . member states should have the option of limiting such right of access where it would compromise the economic equilibrium or service quality of those public service contracts and where approval has been given by the relevant regulatory body .


### the commission may adopt measures setting out the common principles and practices of the network , in particular to ensure consistency in benchmarking , and the procedures to be followed for cooperation in the network . those measures shall be adopted by means of an implementing act in accordance with the procedure referred to in article 62 . ’ ### the commission may , where necessary draw up legislative proposals to improve cooperation between infrastructure managers belonging to the network .


### ‘ 1 . member states may limit the right of access provided for in article 10 to passenger services between a given place of departure and a given destination when one or more public service contracts cover the same route or an alternative route if the exercise of this right would compromise the economic equilibrium of the public service contract or contracts in question . ’ ; ### ‘ 1 . member states may limit the right of access provided for in article 10 to passenger services between a given place of departure and a given destination when one or more public service contracts cover the same route or an alternative route if the exercise of this right would compromise the economic equilibrium of the public service contract or contracts in question or erode the quality of the service provided . ’ ;


### ‘ in order to determine whether the economic equilibrium of a public service contract would be compromised , the relevant regulatory body or bodies referred to in article 55 shall make an objective economic analysis and base its decision on pre - determined criteria . they shall determine this after a request from any of the following , submitted within one month from the information on the intended passenger service referred to in article 38 : ### ‘ in order to determine whether the economic equilibrium of a public service contract would be compromised , the relevant regulatory body or bodies referred to in article 55 shall make an objective economic analysis and base its decision on pre - determined criteria , taking into account the cumulative effect of the open - access service provided . they shall determine this after a request from any of the following , submitted within one month from the information on the intended passenger service referred to in article 38 :


### without prejudice to regulation no 1371 / 2007 and directive 2010 / 40 / eu , member states may require railway undertakings operating domestic passenger services to participate in a common information and integrated ticketing scheme for the supply of tickets , through - tickets and reservations or decide to give the power to competent authorities to establish such a scheme . if such a scheme is established , member states shall ensure that it does not create market distortion or discriminate between railway undertakings and that it is managed by a public or private legal entity or an association of all railway undertakings operating passenger services . ### without prejudice to regulation no 1371 / 2007 and directive 2010 / 40 / eu , member states shall require railway undertakings operating domestic passenger services to participate , not later than one year after the adoption of this directive , in a common information and integrated ticketing scheme for the supply of tickets , through - tickets and reservations or decide to give the power to competent authorities to establish such a scheme . where such a scheme is established , member states shall ensure that it is interoperable and can be integrated into other national or european schemes , that it does not create market distortion or discriminate between railway undertakings and that it is managed by a public or private legal entity or an association of all railway undertakings operating passenger services .


### the procedure should be flexible and efficient , in order to avoid administrative delays for starting a clinical trial . ### the procedure should be flexible and efficient , in order to avoid administrative delays for starting a clinical trial , without compromising patient safety or public health .


### the database should contain all relevant information as regards the clinical trial . no personal data of data subjects participating in a clinical trial should be recorded in the database . the information in the database should be public , unless specific reasons require that a piece of information should not be published , in order to protect the right of the individual to private life and the right to the protection of personal data , recognised by articles 7 and 8 of the charter of fundamental rights of the european union . ### the database should contain all relevant information as regards the clinical trial , including the clinical trial report which contains a statistical analysis plan and details of the protocol as well as raw data , and should be in easily searchable form . all personal data of data subjects participating in a clinical trial should be anonymised in the database and the information should be public in line with the specific requirements of regulation no 1049 / 2001 of the european parliament and of the council of 30 may 2001 regarding public access to european parliament , council and commission documents1 and bearing in mind the right of access to documents , recognised by article 42 of the charter of fundamental rights of the european union . ____________ 1 oj l 145 , 31 . 5 . 2001 , p . 43


### this regulation is in line with the major international guidance documents on clinical trials , such as the most recent version of the world medical association’s declaration of helsinki and good clinical practice , which has its origins in the declaration of helsinki . ### this regulation is in line with the major international guidance documents on clinical trials , such as the most recent version of the world medical association’s declaration of helsinki , in particular ethical principles for medical research involving human subjects , including research on identifiable human material and data , and good clinical practice , which has its origins in the declaration of helsinki .


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


### the sponsor may withdraw the application at any time until the assessment date . in such a case , the application may only be withdrawn with respect to all member states concerned . ### the sponsor may withdraw the application at any time until the assessment date . in such a case , the application may only be withdrawn with respect to all member states concerned . a record of withdrawn applications shall remain in the eu database and reasons for each withdrawal shall be given .


### a substantial modification may only be implemented if it has been approved in accordance with the procedure set out in this chapter . ### a substantial modification may only be implemented if it has been approved in accordance with the procedure set out in this chapter and if it has previously been approved by an ethics committee .


### where the clinical trial has been conducted outside the union , it shall comply with principles equivalent to those of this regulation as regards subject rights and safety and reliability and robustness of data generated in the clinical trial . ### where the clinical trial has been conducted outside the union , it shall fully comply with the principles of this regulation as regards subject rights and wellbeing , and the reliability and robustness of data generated in the clinical trial .


### informed consent shall be written , dated and signed and given freely by the subject or his or her legal representative after having been duly informed of the nature , significance , implications and risks of the clinical trial . it shall be appropriately documented . where the subject is unable to write , oral consent in the presence of at least one impartial witness may be given in exceptional cases . the subject or his or her legal representative shall be provided with a copy of the document by which informed consent has been given . ### informed consent shall be written , dated and signed and given freely by the subject or his or her legal representative after having been comprehensively informed of the nature , duration , significance , implications and risks of the clinical trial including if the clinical trial has to be discontinued , the eventual treatment alternatives , and any other information , as provided for in national legislation . the information provided and the informed consent shall be appropriately documented . where the subject is unable to write , oral consent in the presence of at least one impartial witness , trustful for the subject , may be given in exceptional cases . the subject or his or her legal representative shall be provided with a copy of the document by which informed consent has been given . 1a . two mentions shall systematically be on the document by which informed consent is given : - the trial registration number in the eu portal and - a statement that the results will be made available in the eu portal within one year after completion of the trial together with an approximate date .


### the investigator shall immediately report serious adverse events to the sponsor unless the protocol provides , for certain adverse events , that no reporting is required . the investigator shall record all serious adverse events . where necessary , the investigator shall send a follow - up report to the sponsor . ### the investigator shall immediately report serious adverse events to the sponsor . the investigator shall record all serious adverse events , and send copies to the ethics committee and shall submit copies to the eu database through the eu portal . where necessary , the investigator shall send a follow - up report to the sponsor . the immediate report shall be followed by detailed , written reports , and sent to the ethics committees and member states and stored in the eu database .


### when making the inspection report available to the sponsor , the member state referred to in the first subparagraph shall ensure that confidentiality is protected . ### a summary of the inspection report shall be made publicly available .


### the commission may conduct inspections where it considers necessary . ### the commission may conduct inspections where it considers necessary . a summary of the commission ' s inspection report shall be made publicly available .


### the eu database shall be publicly accessible unless , for all or parts of the data and information contained therein , confidentiality is justified on any of the following grounds : ### the eu database shall be publicly accessible in line with regulation no 1049 / 2001 . when the protection for commercially confidential information is to be applied , unreasonable degree of prejudice to the commercial interests if the information is disclosed should be duly justified and documented , the period of time for which commercial confidentiality is required should be duly specified and notified to the requesting person , and there should be no overriding public interest that justifies immediate disclosure .


### the growing proportion of older people in europe makes it more important than ever to promote healthy ageing . healthy ageing can help raise labour market participation of older people , enable them to be active in society for longer , improve their individual quality of life and curb the strains on health and social care systems . ### the growing proportion of older people in europe makes it more essential than ever to preserve intergenerational solidarity . such solidarity must be based on improving social and intergenerational cohesion and promoting a good quality of life in order to combat social exclusion . enabling those older people who so desire to stay in employment , even part - time , can be a vehicle for social inclusion , giving such people a positive image thanks to their participation and in some cases making it possible to improve their individual quality of life and curb the strains on health and social care systems .


### the commission emphasised it its communication on ‘ europe 2020 — a strategy for smart , sustainable and inclusive growth’ the importance to the european union of promoting a healthy and active ageing population in the interests of social cohesion and higher productivity . it proposed a flagship initiative ‘ an agenda for new skills and jobs’ , under which member states should notably promote active ageing policies , and a flagship initiative on a ‘ european platform against poverty’ . achieving these policy goals requires action from all levels of government and various non - governmental stakeholders ; they can in turn be supported , at the union level , by european year activities aimed at raising awareness and fostering the exchange of good practice . national coordinators should see to it that national action is coordinated and is consistent with the overall objectives of the european year . the participation of other institutions and stakeholders is also planned . ### the commission emphasised it its communication on ‘ europe 2020 — a strategy for smart , sustainable and inclusive growth’ the importance to the european union of promoting a healthy and active ageing population in the interests of social cohesion . it proposed a flagship initiative ‘ an agenda for new skills and jobs’ , under which member states should notably promote active ageing policies , and a flagship initiative on a ‘ european platform against poverty’ . achieving these policy goals requires action from all levels of government and various non - governmental stakeholders ; they can in turn be supported , at the union level , by european year activities aimed at raising awareness and fostering the exchange of good practice . national coordinators should see to it that national action is coordinated and is consistent with the overall objectives of the european year . the participation of other institutions and stakeholders is also planned .


### active ageing is targeted by several union programmes , such as the european social fund , the european regional and development fund , the progress programme , the life long learning programme , the public health programme , the specific programmes on information and communication technologies and on socio - economic sciences and humanities in the seventh framework programme for research and development , the action plan on ‘ ageing well in the information society’ , the ambient assisted living joint programme for research and innovation , the competitiveness and innovation programme with pilot deployment projects on ict for ageing well and the action plan on urban mobility . union co - financing of european year activities will be in accordance with the priorities and rules applying , on an annual or multi - annual basis , to existing programmes and autonomous budget lines in the field of employment , social affairs and equal opportunities . where appropriate , programmes and policies in other fields , such as education and culture , health , research , the information society , regional policy and transport policy , may support the european year . ### active ageing is targeted by several union programmes , such as the european social fund , the european regional and development fund , the progress programme , the life long learning programme , the public health programme , the specific programmes on information and communication technologies and on socio - economic sciences and humanities in the seventh framework programme for research and development , the action plan on ‘ ageing well in the information society’ , the ambient assisted living joint programme for research and innovation , the competitiveness and innovation programme with pilot deployment projects on ict for ageing well and the action plan on urban mobility . union co - financing of european year activities will be in accordance with the priorities and rules applying , on an annual or multi - annual basis , to existing programmes and autonomous budget lines in the field of employment , social affairs and equal opportunities . where appropriate , programmes and policies in other fields , such as education and culture , health , research , the information society , regional policy and transport policy , may support the european year . in various sectors , therefore , the european year will also afford an opportunity to raise public awareness and mobilise stakeholders to combat social exclusion , financial security and poverty among older people , inter alia as part of the europe 2020 strategy flagship initiative on a ‘ european platform against poverty’ .


### the overall purpose of the european year shall be to encourage and support the efforts of member states , their regional and local authorities , social partners and civil society to promote active ageing and to do more to mobilise the potential of the rapidly growing population in their late 50s and above , thereby preserving solidarity between generations . active ageing means creating better opportunities and working conditions to enable older workers to play their part in the labour market , combating social exclusion by fostering active participation in society , and encouraging healthy ageing . on this basis , the objectives shall be : ### the overall purpose of the european year shall be to encourage and support the efforts of member states , their regional and local authorities , social partners and civil society to take practical steps to promote better social inclusion of people over the age of 50 , bearing in mind the contribution they can make in economic , social and cultural terms to preserving intergenerational solidarity . efforts to promote the social inclusion of older people must take account of their specific needs on the basis of a residential approach . to this end , it is key for the european year to support and leverage local and regional projects in order to promote intergenerational mixing , appropriate housing modifications and access to public services and care , in a manner able to be tailored to urban and rural environments and demographic trends in a given area . coupled with the creation of better opportunities and working conditions , these measures will serve as a basis for enabling older people to play their part in the labour market and volunteering activities , and for combating social exclusion by fostering active participation in society and encouraging healthy ageing . on this basis , the objectives shall be :


### to raise general awareness of the value of active ageing in order to highlight the useful contribution older persons make to society and the economy , to promote active ageing and to do more to mobilise the potential of older persons ; ### to raise general awareness at all administrative levels in member states , cities and regions of the value of active ageing in order to highlight the useful contributions older persons make to society and the economy by passing on their knowledge and skills , to promote active ageing , to do more to combat isolation , financial insecurity and social exclusion , and to put intergenerational solidarity high up on the policy agenda of stakeholders at national , regional and local level ;


### to stimulate debate and develop mutual learning between member states and stakeholders at all levels in order to promote active ageing policies , to identify and disseminate good practice and to encourage cooperation and synergies ; ### to stimulate debate and support and develop mutual learning between public and private actors and civil society at national , regional and local level in order to promote active ageing policies more successfully , to identify and disseminate good practices and to encourage cooperation and synergies ;


### to offer a framework for commitment and concrete action to enable member states and stakeholders at all levels to develop policies through specific activities and to commit to specific objectives related to active ageing . ### to offer a framework for commitment and concrete action to enable member states and stakeholders at all levels to develop policies through specific activities and to commit to specific , concrete objectives related to active ageing by devising long - term strategies .


### particular attention shall be given to strengthening the rule of law , improving access to justice and supporting civil society , trade and sustainable development , access to icts , health and food security , as well as promoting dialogue , participation and reconciliation , and institution - building . ### particular attention shall be given to strengthening the rule of law , improving access to justice and supporting civil society , combating discrimination in access to economic , political and social resources , especially discrimination against women , trade and sustainable development , access to icts , health and food security , as well as promoting dialogue , participation , reconciliation and institution - building .


### promoting constitutional reform and legislative , regulatory and administrative approximation with the union , including further democratisation and organised civil society , support for the rule of law , good governance , taxation and strengthening of national institutions and bodies , such as election bodies , parliaments , public administration reform and public financial management ; ### promoting constitutional reform and legislative , regulatory and administrative approximation with the union , including further democratisation and organised civil society , support for the rule of law , good governance , taxation and strengthening of national institutions and bodies , such as election bodies , parliaments , public administration reform and judicial reform , and public financial management ;


### promoting inclusive and sustainable economic growth , addressing social and regional inequalities , and supporting policies in areas such as education , research , innovation and technology , health , decent work , sustainable energy , agriculture and rural development , fostering smes , while stimulating the development of a market economy , trade and investment , including regulatory reforms and the support for integration into the wto ; ### promoting inclusive and sustainable economic growth , addressing social and regional inequalities , and supporting policies in areas such as education , research , innovation and technology , health , decent work , creating independent trade unions , sustainable energy , agriculture and rural development , fostering smes , while stimulating the development of a market economy , trade and investment , including regulatory reforms and the support for integration into the wto ;


### supporting efficient border management and cross - border cooperation to promote sustainable economic , social and environmental development in border regions ; in the context of the security and development nexus , fighting organized crime and all forms of trafficking , including the fight against production and consumption of drugs as well as negative effects thereof , including hiv / aids ; ### supporting efficient border management and cross - border cooperation to promote sustainable economic , social and environmental development in border regions ; in the context of the security and development nexus , fighting organized crime and all forms of trafficking , particularly the trafficking of women , the fight against production and consumption of drugs as well as negative effects thereof , including hiv / aids ;


### promoting implementation of union initiatives and agreed commitments at international and regional level and / or of a transboundary character particularly in the areas of climate change through the promotion of climate resilient strategies especially adaption strategies with biodiversity co - benefits , biodiversity and ecosystems services , forests including flegt , desertification , integrated water resource management , natural resource management , sound chemical and waste management , resource efficiency and the green economy ; ### promoting implementation of union initiatives and agreed commitments at international and regional level and / or of a transboundary character particularly in the areas of climate change through the promotion of climate resilient strategies especially adaption strategies with biodiversity co - benefits , biodiversity and ecosystems services , forests including flegt , desertification , integrated water resource management , natural resource management , sound chemical and waste management , resource efficiency and the green economy , while integrating the gender dimension to promote women’s participation in the development and implementation of these strategies , and to halt all kinds of discrimination against them , especially in access to resources and in participation in political life ;


### promoting access to secure , affordable , clean and sustainable energy services as a key driver for poverty eradication and inclusive growth , with a special emphasis on the use of local energy sources ; ### promoting access to secure , affordable , clean and sustainable energy services for all , while taking into account groups that are victims of discrimination , especially women , as a key driver for poverty eradication and inclusive growth , with a special emphasis on the use of local energy sources ;


### land , soil , water , air and climate change ; ### land , soil , subsoil , water , air , climate and climate change and natural resources ;


### when a decision to grant or refuse development consent has been taken , the competent authority or authorities shall inform the public and the authorities referred to in article 6 thereof , in accordance with the appropriate procedures , and shall make available to the public the following information : ### when a decision to grant or refuse development consent has been taken , the competent authority or authorities shall inform the public and the authorities referred to in article 6 thereof , as soon as possible in accordance with the appropriate procedures , and at the latest within 10 working days . the competent authority or authorities shall make available to the public the following information :


### a description of the measures envisaged to prevent , reduce and , where possible , offset any significant adverse effects on the environment referred to in point 5 and , where appropriate , of any proposed monitoring arrangements , including the preparation of a post - project analysis of the adverse effects on the environment . this description should explain the extent to which significant adverse effects are reduced or offset and should cover both the construction and operational phases . ### a description of the measures envisaged , as a priority , to prevent , to reduce and , as last resort , to offset any significant adverse effects on the environment referred to in point 5 and , where appropriate , of any proposed monitoring arrangements , including the preparation of a post - project analysis of the adverse effects on the environment . this description should explain the extent to which significant adverse effects are reduced or offset and should cover both the construction and operational phases .


### protecting and restoring biodiversity , including through green infrastructures ; ### protecting and restoring biodiversity , including through green infrastructures and natura 2000 ;


### promoting sustainable transport and removing bottlenecks in key network infrastructures , by : ### promoting intermodal sustainable transport and mobility while focusing on removing bottlenecks , and on completing missing transborder links in sustainable and intermodal transport infrastructures , by


### enhancing institutional capacity and an efficient public administration by strengthening of institutional capacity and the efficiency of public administrations and public services related to implementation of the cohesion fund . ### enhancing institutional capacity and an efficient public administration by strengthening of institutional capacity , innovation capacity , and the efficiency of public administrations and public services related to implementation of the cohesion fund .


### according to data provided by the imo , the specific energy consumption and co2 emissions of ships could be reduced by up to 75% by applying operational measures and implementing existing technologies ; a significant part of those measures can be regarded as cost - effective as the reduced fuel costs ensure the pay - back of any operational or investment costs . ### according to data provided by the imo , the specific energy consumption and co2 emissions of ships could be reduced by up to 75% by applying operational measures and implementing existing technologies ; a significant part of those measures can be regarded as cost - effective - or even offer net benefits to the sector - as the reduced fuel costs ensure the pay - back of any operational or investment costs .


### the introduction of a union mrv system is expected to lead to emission reductions of up to 2% compared to business - as - usual and aggregated net costs reductions of up to 1 . 2 billion eur by 2030 as it could contribute to the removal of market barriers , in particular those related to the lack of information about ship efficiency . this reduction of transport costs should facilitate international trade . furthermore , a robust mrv system is a prerequisite for any market - based measure or efficiency standard , whether applied at union level or globally . it also provides reliable data to set precise emission reduction targets and to assess the progress of maritime transport ' s contribution towards achieving a low carbon economy . ### the introduction of a union mrv system is expected to lead to emission reductions of up to 2% compared to business - as - usual and aggregated net costs reductions of up to 1 . 2 billion eur by 2030 as it could contribute to the removal of market barriers , in particular those related to the lack of information about ship efficiency . this reduction of transport costs should facilitate international trade and reduce market distortions that currently exist at the expense of other transport modes , such as unequal tax treatment where railways are subject to energy taxes whereas air and maritime transport are exempted . furthermore , a robust mrv system is a prerequisite for any market - based measure or efficiency standard , whether applied at union level or globally . it also provides reliable data to set precise emission reduction targets and to assess the progress of maritime transport ' s contribution towards achieving a low carbon economy .


### in order to minimise the administrative burden for ship owners and operators , in particular for small and medium sized enterprises , and to optimise the benefits - costs - ratio of the mrv system without jeopardising the objective to cover a widely predominant share of greenhouse gas emissions from maritime transport , the rules for mrv should only apply to large emitters . a threshold of 5000 gross tonnage has been selected after detailed objective analysis of sizes and emissions of ships going to and coming from union ports . ships above 5000 gt account for around 55% of the number of ships calling into union ports and represent around 90% of the related emissions . this non - discriminatory threshold would ensure that that the most relevant emitters are covered . a lower threshold would result in higher administrative burden while a higher threshold would limit the coverage of emissions and thus the environmental effectiveness of the system . ### in order to ensure coherence with the existing international law , in particular with marpol vi , the mrv system should apply to ships of 400 gt and above .


### in order to make use of the best available practices and scientific evidence , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission in respect of reviewing certain technical aspects of monitoring and reporting of co2 emissions from ships and of further specifying rules for the verification of emission reports and the accreditation of verifiers . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### in order to make use of the best available practices and scientific and technical progress , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission in respect of reviewing certain technical aspects of monitoring to improve the quality of the data and reporting of climate - and health - relevant emissions from ships and of further specifying rules for the verification of emission reports and the accreditation of verifiers . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council .


### the objective of the proposed action , namely to monitor , report and verify co2 emissions from ships as first step of a staged approach to reduce these emissions cannot be sufficiently achieved by the member states acting individually , due to the international nature of maritime transport and can therefore , by reason of scale and effects of the action , be better achieved at union level . the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty . in accordance with the principle of proportionality , as set out in that article , this regulation does not go beyond what is necessary in order to achieve those objectives . ### the objective of the proposed action , namely to monitor , report , verify and reduce climate - and health - relevant emissions from ships as first step of a staged approach to achieve the targets set in the commission white paper ' roadmap to a single european transport area ' cannot be sufficiently achieved by the member states acting individually , due to the international nature of maritime transport and can therefore , by reason of scale and effects of the action , be better achieved at union level . the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty . in accordance with the principle of proportionality , as set out in that article , this regulation does not go beyond what is necessary in order to achieve those objectives .


### this regulation lays down rules for the accurate monitoring , reporting and verification of carbon dioxide emissions and other climate relevant information from ships arriving at , within or departing from ports under the jurisdiction of a member state in order to promote the reduction of co2 emissions from maritime transport in a cost effective manner . ### this regulation defines a legal framework for the cost - effective reduction of climate - and health - relevant emissions from maritime transport through emission - related charges within eu waters in order to achieve the targets set in the 2011 commission white paper ' roadmap to a single european transport area ' of - 40% compared to 2005 levels by 2050 . for this purpose , it defines accurate mechanisms for the monitoring , reporting , verification and reduction of climate and health - relevant emissions and other climate relevant information from ships arriving at , within or departing from ports under the jurisdiction of a member state .


### this regulation applies to ships above 5000 gross tons in respect of emissions released during their voyages from the last port of call to a port under the jurisdiction of a member state and from a port under the jurisdiction of a member state to their next port of call , as well as within ports under the jurisdiction of a member state . ### this regulation applies to ships above 400 gross tons in respect of emissions released during their voyages from the last port of call to a port under the jurisdiction of a member state and from a port under the jurisdiction of a member state to their next port of call , as well as within ports under the jurisdiction of a member state .


### companies shall use standardised monitoring plans based on templates . technical rules establishing the templates for the monitoring plans referred to in paragraph 1 shall be determined by means of implementing acts . those implementing acts shall be adopted by the commission in accordance with the procedure referred to in article 25 of this regulation . ### companies shall use standardised templates to submit their monitoring plans . presentation and content of the templates for the monitoring plans referred to in paragraph 1 shall be determined by means of delegated acts . those delegated acts shall be adopted by the commission in accordance with the procedure referred to in article 24 of this regulation .


### from 1 january 2018 , companies shall , based on the monitoring plan approved in accordance with article 13 , monitor emissions for each ship on a per - voyage and an annual basis by applying the appropriate method among those set out in part b of annex i and by calculating emissions in accordance with part a of annex i ### from 1 january 2016 , companies shall , based on the monitoring plan approved in accordance with article 13 , monitor emissions for each ship on a per - voyage and an annual basis by applying the appropriate method among those set out in article 5 and elaborated in part b of annex i and by calculating emissions in accordance with part a of annex i


### aggregated co2 emissions from all voyages between ports under a member state ' s jurisdiction ; ### aggregated co2 , nox , sox , methane , pm and bc emissions per voyage for every route from all voyages between ports under a member state ' s jurisdiction ;


### aggregated co2 emissions from all voyages which departed from ports under a member state ' s jurisdiction ; ### aggregated co2 , nox , sox , methane , pm and bc emissions from emissions per voyage for every route which departed from ports under a member state ' s jurisdiction ;


### aggregated co2 emissions from all voyages to ports under a member state ' s jurisdiction ; ### aggregated co2 , nox , sox , methane , pm and bc emissions per voyage for every route from all voyages to ports under a member state ' s jurisdiction ;


### co2 emissions which occurred within ports under a member state ' s jurisdiction at berth ; ### co2 , nox , sox , methane , pm and bc emissions which occurred within ports under a member state ' s jurisdiction at berth ;


### the emission report referred to in article 11 shall be submitted using automated systems and complete data exchange formats , including electronic templates . ### the emission report referred to in article 11 shall be submitted using automated systems , data exchange standards and electronic templates .


### technical rules establishing the data exchange format including electronic templates referred to in paragraph 1 shall be determined by means of implementing acts . those implementing acts shall be adopted by the commission in accordance with the procedure referred to in article 25 of this regulation . ### arrangements for submitting the data to the commission , including data exchange standards and format of electronic templates referred to in paragraph 1 , shall be determined by means of delegated acts . those delegated acts shall be adopted by the commission in accordance with the procedure referred to in article 24 of this regulation .


### technical rules establishing the data exchange format including electronic templates referred to in paragraph 4 shall be determined by means of implementing acts . those implementing acts shall be adopted by the commission in accordance with the procedure referred to in article 25 of this regulation . ### arrangements for submitting the data to the commission , including data exchange standards and format of the electronic templates referred to in paragraph 4 , shall be determined by means of delegated acts . those delegated acts shall be adopted by the commission in accordance with the procedure referred to in article 24 of this regulation .


### without delay , the verifier shall inform the commission and the authority of the flag state on the issuance of any document of compliance and transmit the information referred to in paragraph 2 using automated systems and complete data exchange formats , including electronic templates established by the commission in accordance with the procedure established in the present regulation . ### without delay , the verifier shall inform the commission and the authority of the flag state on the issuance of any document of compliance and transmit the information referred to in paragraph 2 using automated systems , data exchange standards and electronic templates established by the commission in accordance with the procedure established in the present regulation .


### the commission shall inform the imo and other relevant international bodies on a regular basis of the implementation of this regulation with a view to facilitate the development of international rules within the imo for the monitoring , reporting and verification of greenhouse gas emissions from maritime transport . ### the commission shall inform the imo and other relevant international bodies on a regular basis of the implementation of this regulation with a view to facilitate the development of international rules within the imo for the monitoring , reporting and verification of climate and health - relevant emissions from maritime transport .


### the power to adopt delegated acts in order to supplement and amend the provisions of annexes i and ii to take into account up - to - date scientific evidence available , as well as the relevant data available on board of ships and the relevant international rules and internationally accepted standards , to identify the most accurate and efficient methods for monitoring of emissions , and to improve the accuracy of the information requested related to the monitoring and reporting of emissions is conferred on the commission subject to the conditions laid down under article 24 to the extent it concerns non - essential elements of this regulation . ### the commission shall be empowered to adopt delegated acts in accordance to article 24 amending annex i to adapt the monitoring methods to scientific and technical progress and internationally accepted standards in order to improve the reliability , validity and accuracy of the emission data . the commission shall be empowered to adopt delegated acts in accordance to article 24 amending annex ii to further specify and adapt the monitoring of climate - relevant information methods to scientific and technical progress and internationally accepted standards in order to improve the reliability , validity and accuracy of the emission data .


### the power to adopt delegated acts referred to in articles 15 , 16 and 23 shall be conferred on the commission for a period of five years from 1 july 2015 . ### the power to adopt delegated acts referred to in articles 12 a , 15 , 16 and 23 shall be conferred on the commission for a period of five years from [ dd / mm / yyyy ] [ date of entry into force of this regulation ] . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the 5 - year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period .


### the delegation of power referred to in article 23 may be revoked at any time by the european parliament or by the council . a decision of revocation shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . ### the delegation of power referred to in article 12 a , 15 , 16 and 23 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force .


### a delegated act adopted pursuant to article 23 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or the council . ### a delegated act adopted pursuant to article 12 a , 15 , 16 and 23 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or the council .


### notwithstanding the specific focus on global players , the scope of this regulation should be worldwide enabling to support cooperation measures with developing countries where the union has significant interests in accordance with the objectives of this regulation . ### notwithstanding the specific focus on global players , the scope of this regulation should be worldwide enabling to support cooperation measures with developing countries where there are significant mutual interests in accordance with the objectives of this regulation .


### the union should be able to respond in a flexible and timely manner to evolving and / or unforeseen needs in order to make its commitment to promote its interests in its relations with third countries more effective , by adopting special measures not covered by multi - annual indicative programmes . ### the union should be able to respond in a flexible and timely manner to evolving and / or unforeseen needs in order to make its commitment to promote mutual interests in its relations with third countries more effective , by adopting special measures not covered by multi - annual indicative programmes .