### the commission shall develop , together with the eib , regional operational guidelines for eib financing under this decision . in drawing up these guidelines the commission and the eib will consult with the european external action service on policy issues , as appropriate . the operational guidelines aim to ensure that eib financing supports eu policies , and shall take as a starting point the wider eu regional policy framework set by the commission and the eeas , as appropriate . notably , the operational guidelines will ensure that eib financing is complementary to corresponding eu assistance policies , programmes and instruments in the different regions , taking into account european parliament resolutions and council decisions and conclusions . the commission will inform the european parliament and the council of the guidelines established . within the framework set out by the operational guidelines , the eib shall define corresponding financing strategies and ensure their implementation . ### the commission shall develop , together with the eib and the eeas , regional operational guidelines for eib financing under this decision . in drawing up these guidelines the commission and the eib shall work together with the european external action service on policy issues falling within its remit . the operational guidelines aim to ensure that eib financing supports eu policies , and shall take as a starting point the wider eu regional policy framework set by the commission and the eeas , as appropriate . furthermore , the operational guidelines will ensure that eib financing is complementary to corresponding eu assistance policies , programmes and instruments in the different regions , taking into account european parliament resolutions council decisions and conclusions and the european consensus on development . the commission shall report to the european parliament and the council on the guidelines established . within the framework set out by the operational guidelines , the eib shall define corresponding financing strategies and ensure their implementation .


### the commission shall develop , together with the eib , regional operational guidelines for eib financing under this decision . in drawing up these guidelines the commission and the eib will consult with the european external action service on policy issues , as appropriate . the operational guidelines aim to ensure that eib financing supports eu policies , and shall take as a starting point the wider eu regional policy framework set by the commission and the eeas , as appropriate . notably , the operational guidelines will ensure that eib financing is complementary to corresponding eu assistance policies , programmes and instruments in the different regions , taking into account european parliament resolutions and council decisions and conclusions . the commission will inform the european parliament and the council of the guidelines established . within the framework set out by the operational guidelines , the eib shall define corresponding financing strategies and ensure their implementation . ### preceded by consultation in the regions concerned , the commission shall develop , together with the eib , regional operational guidelines for eib financing under this decision . in drawing up these guidelines the commission and the eib will consult with the european external action service on policy issues , as appropriate . the operational guidelines aim to ensure that eib financing supports eu policies , and shall take as a starting point the wider eu regional policy framework set by the commission and the eeas , as appropriate . notably , the operational guidelines will ensure that eib financing is complementary to corresponding eu assistance policies , programmes and instruments in the different regions , taking into account european parliament resolutions and council decisions and conclusions . the commission will inform the european parliament and the council of the guidelines established . within the framework set out by the operational guidelines , the eib shall define corresponding financing strategies and ensure their implementation .


### 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 on all 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 wholly economically , financially , environmentally and socially sustainable and do not exacerbate actual or latent conflicts are supported under this decision .


### in addition to the ex - ante assessment of development - related aspects , the eib should strengthen its monitoring during project implementation , inter alia , on the development impact of the project . ### in addition to the ex - ante assessment of development - related aspects , the eib should strengthen its monitoring capacity throughout the whole project cycle in relation to these issues and the performance of financial intermediaries during project implementation , inter alia , on the development impact of the project . if the eib becomes aware of a severe deterioration of the project ' s impact on any of these aspects , it shall inform the commission . jointly , the eib and the commission shall decide on appropriate measures to be taken , including , if necessary , the suspension of the project ' s financing . in case of disagreement between the two institutions , the eib shall follow the recommendations of the commission .


### the consistency of eib external actions with the external policy objectives of the eu shall be strengthened , with a view to maximising synergies between eib financing and eu budgetary resources , in particular through the establishment of the operational guidelines referred to in article 5 as well as through regular and systematic dialogue and early exchange of information on : ### the consistency of eib external actions with the external policy objectives of the eu shall be strengthened , with a view to maximising synergies between eib financing and eu budgetary resources , in particular through the establishment of the operational guidelines referred to in article 5 , of which the european parliament shall be informed in advance , as well as through regular and systematic dialogue and early exchange of information on :


### eib financing operations shall increasingly be carried out , where appropriate , in cooperation with other international financial institutions or european bilateral finance institutions , in order to maximize synergies , cooperation and efficiency and to ensure reasonable sharing of risks and coherent project and sector conditionality . ### eib financing operations shall increasingly be carried out in cooperation with other international financial institutions or european bilateral finance institutions , in order to maximize synergies , cooperation and efficiency and to ensure reasonable sharing of risks and coherent project and sector conditionality .


### cooperation with other international financial institutions ### cooperation with other public financing institutions


### the cooperation referred to in paragraph 1 shall be facilitated by coordination , carried out notably in the context of memoranda of understanding or other eu regional cooperation frameworks , where appropriate , between the commission , the eib and the main international financial institutions and european bilateral finance institutions operating in the different regions . ### the cooperation referred to in paragraph 1 shall be facilitated by coordination , carried out notably in the context of memoranda of understanding or other eu regional cooperation frameworks , where appropriate , between the commission , the eib and the main international financial institutions and european bilateral finance institutions operating in the different regions , whilst taking into account the competences of the eeas .


### for the purposes of paragraph 1 , the west bank and gaza strip is represented by the palestinian authority and kosovo under united nations security council resolution 1244 by the united nations mission in kosovo or an administration designated in the guidelines referred to under article 5 of this decision . ### for the purposes of paragraph 1 , the west bank and gaza strip is represented by the palestinian authority and kosovo under united nations security council resolution 1244 by the united nations mission in kosovo , or the government of the republic of kosovo .


### the eib shall , in consultation with the commission , develop a clear and transparent allocation policy for deciding upon the source of financing of operations which are eligible both for coverage by the eu guarantee and for eib own risk financing . ### the eib shall , in agreement with the commission , develop a clear and transparent allocation policy for deciding upon the source of financing of operations which are eligible both for coverage by the eu guarantee and for eib own risk financing .


### the commission shall report annually to the european parliament and the council on eib financing operations carried out under this decision . the report shall include an assessment of eib financing operations at project , sector , country and regional level as well as the contribution of the eib financing operations to the fulfilment of the external policy and strategic objectives of the eu . the report shall in particular assess the compliance of eib financing operations with this decision , taking into account the operational guidelines referred to in article 5 , and shall include sections on added value for the achievement of eu policy objectives as well as on cooperation with the commission and other international financial institutions and bilateral institutions , including co - financing . ### the commission shall report annually to the european parliament and the council on eib financing operations carried out under this decision . the report shall include an assessment of eib financing operations at programme , project , sector , country and regional level , as well as the contribution of the eib financing operations to the fulfilment of the external policy and strategic objectives of the eu , paying particular attention to the related eu 2020 objectives . the report shall in particular assess the compliance of eib financing operations with this decision , taking into account the operational guidelines referred to in article 5 , and shall include sections on added value for the achievement of eu policy objectives and the extent to which to which the eib has taken into account environmental and social sustainability in the design and monitoring of the projects financed , efficiency , effectiveness and impact of projects and financing operations , as well as on cooperation with the commission and other international financial institutions and bilateral institutions , including co - financing . the report shall also contain an assessment of the eib ' s human and material resources policy relating to its activities outside the eu . finally , it shall contain a specific section devoted to a detailed evaluation of the measures taken by the eib to comply with the provisions of article 1 of the current mandate , excluding from the scope of the guarantee all operations which would allow , or contribute directly or indirectly to , any form of tax evasion , and paying particular attention to eib operations using financial vehicles situated in offshore financial centres .


### the commission shall report annually to the european parliament and the council on eib financing operations carried out under this decision . the report shall include an assessment of eib financing operations at project , sector , country and regional level as well as the contribution of the eib financing operations to the fulfilment of the external policy and strategic objectives of the eu . the report shall in particular assess the compliance of eib financing operations with this decision , taking into account the operational guidelines referred to in article 5 , and shall include sections on added value for the achievement of eu policy objectives as well as on cooperation with the commission and other international financial institutions and bilateral institutions , including co - financing . ### the commission shall report annually to the european parliament and the council on eib financing operations carried out under this decision . the report shall include an assessment of eib financing operations at project , sector , country and regional level andevaluations of the accessibility , transparency and effectiveness of the loans , as well as an assessment of the contribution of the eib financing operations to the fulfilment of the external policy and strategic objectives of the eu . the report shall in particular assess the compliance of eib financing operations with this decision , taking into account the operational guidelines referred to in article&#160 ; 5 , and shall include sections on added value for the achievement of eu policy objectives and on the extent to which to which the eib has taken into account environmental and social sustainability in the design and monitoring of the projects financed , as well as on cooperation with the commission and other international financial institutions and bilateral institutions , including co - financing . the report shall also contain an assessment of the eib ' s human and material resources policy relating to its activities outside the union . finally , it shall contain a specific section devoted to a detailed evaluation of the measures taken by the eib to exclude from the scope of the guarantee all operations which would allow , or contribute directly or indirectly to , any form of tax evasion , and paying particular attention to eib operations which use financial vehicles .


### the eib and the commission shall enter into a guarantee agreement laying down the detailed provisions and procedures relating to the eu guarantee . ### the eib and the commission shall enter into a guarantee agreement laying down the detailed provisions and procedures relating to the eu guarantee and shall inform the european parliament thereof .


### pre - accession countries : eur 8 700 000 000 ; b . neighbourhood and partnership countries : eur 12 400 000 000 ; broken down into the following indicative sub - ceilings : mediterranean countries : eur 8 700 000 000 ; eastern europe , southern caucasus and russia : eur 3 700 000 000 ; c . asia and latin america : eur 3 800 000 000 ; broken down into the following indicative sub - ceilings : latin america : eur 2&#160 ; 800&#160 ; 000&#160 ; 000 ; asia : eur 1 000 000 000 ; d . republic of south africa : eur 900 000 000 . within the regional ceilings of the general mandate , the governing bodies of the eib may decide to reallocate an amount of up to 10 % of the regional ceiling between the indicative sub - regional ceilings . ### pre - accession countries : eur&#160 ; 9&#160 ; 166&#160 ; 000&#160 ; 000 ; b . neighbourhood and partnership countries : eur 13 078 000 000 ; broken down into the following indicative sub - ceilings : mediterranean countries : eur&#160 ; 9&#160 ; 114&#160 ; 000&#160 ; 000 ; eastern europe , southern caucasus and russia : eur 3 964 000 000 ; c . asia and latin america : eur 3 837 000 000 ; broken down into the following indicative sub - ceilings : latin america : eur 2&#160 ; 800&#160 ; 000&#160 ; 000 ; asia : eur 1 037 000 000 ; d . republic of south africa : eur 900 000 000 . within the regional ceilings of the general mandate , the governing bodies of the eib may decide to reallocate an amount of up to 10 % of the regional ceiling between the indicative sub - regional ceilings .


### differences between national rules governing protection measures hamper the sound operation of the internal market . provisions to ensure rapid and simple recognition and , where applicable , enforcement of protection measures from member states bound by this regulation are essential to ensure the protection afforded is maintained when a person travels or moves to another member state . ### differences between national rules governing protection measures hamper the sound operation of the internal market . provisions to ensure rapid and simple recognition and , where applicable , enforcement of protection measures from member states bound by this regulation are essential to ensure the protection , assistance and support afforded are maintained when a victim of violence travels or moves to another member state .


### differences between national rules governing protection measures hamper the sound operation of the internal market . provisions to ensure rapid and simple recognition and , where applicable , enforcement of protection measures from member states bound by this regulation are essential to ensure the protection afforded is maintained when a person travels or moves to another member state . ### differences between national rules governing protection measures hamper the equal treatment of persons at risk of suffering violence and harassment . provisions to ensure rapid and simple recognition and , where applicable , enforcement of protection measures from member states bound by this regulation are essential to ensure the protection afforded is maintained when a person travels or moves to another member state . those provisions should also ensure that the legitimate exercise by citizens of the union of their right to move and reside freely within the territory of member states , in accordance with article 3 of the treaty on european union and article 21 of the treaty on the functioning of the european union , does not result in a loss of their protection .


### the harmonious functioning of justice requires that irreconcilable decisions should not be pronounced in two member states . to this end , this regulation should provide for a ground for refusal of recognition and / or enforcement on application by the person causing the risk in case of irreconcilable decisions . ### the harmonious functioning of justice requires that irreconcilable decisions should not be pronounced in two member states . to this end , this regulation should provide for a ground for refusal of recognition and / or enforcement in case of irreconcilable decisions .


### this regulation applies to protection measures taken in civil matters whatever the nature of the authority . it does not apply to protection measures covered by regulation no 2201 / 2003 . ### this regulation applies to protection measures taken in civil matters whatever the nature of the authority issuing the protection measure . it does not apply to protection measures covered by regulation no 2201 / 2003 or to those covered by directive 2011 / 99 / eu of the european parliament and of the council of 13 december 2011 on the european protection order1 , in order to prevent overlapping between the civil law and criminal law systems . ____________ 1 oj l 338 , 21 . 12 . 2011 , p . 2 .


### an obligation not to enter certain localities , places or defined areas where the protected person resides , works or that he visits ; or ### an obligation not to enter certain localities , places or defined areas where the protected person resides , works or that he or she visits ; or


### ' protection measure ' means any decision , whatever it may be called , of a preventive and temporary nature taken by an authority in a member state in accordance with its national law with a view to protecting a person when serious reasons exist to consider the person ' s physical and / or psychological integrity or liberty to be at risk . it shall include measures ordered without the person causing the risk being summoned to appear . the following are notably protection measures : an obligation not to enter certain localities , places or defined areas where the protected person resides , works or that he visits ; or an obligation not to enter into contact , in any form , with the protected person , including by phone , electronic or ordinary mail , fax or any other means ; or an obligation not to approach the protected person closer than a prescribed distance ; or a decision attributing the exclusive use of the common housing of two persons to the protected person . ### ' protection measure ' means any decision , whatever it may be called , of a preventive and temporary nature taken by an authority in a member state in accordance with its national law with a view to protecting an individual person when serious reasons exist to consider the person ' s life , physical and / or psychological integrity , dignity , personal liberty or sexual integrity to be at risk . it shall include measures ordered without the person causing the risk being summoned to appear . protection measures may include one or more of the following obligations or prohibitions : a prohibition from entering and / or remaining in certain localities , places or defined areas where the protected person resides , works or that he visits ; or a prohibition or regulation of contact , in any form , with the protected person , including by phone , electronic or ordinary mail , fax or any other means ; or a prohibition or regulation on approaching the protected person closer than a prescribed distance ; or a decision attributing the exclusive use of the common housing of two persons to the protected person ; or any other prohibitions or regulations imposed in order to guarantee the protection of the protected person .


### the competent authorities of the member state of recognition may , where necessary , request a transliteration or a translation of the content of the certificate , in accordance with article 15 . ### where necessary , the content of the certificate shall be transliterated or translated by the competent authority of the member state of origin into the official language or one of the official languages of the member state of recognition or any other language that the member state of recognition has indicated it can accept .


### no appeal shall lie against the issuing of a certificate . ### no appeal shall lie against the issuing of a certificate . procedural errors shall be rectified in accordance with paragraph 1 of this article .


### if a protection measure is not known in the member state of recognition , the competent authority in that member state shall , to the extent possible , adapt the protection measure to one known under its own law which has equivalent effects attached to it and pursues similar aims and interests . ### if a protection measure is not known in the member state of recognition , the competent authority in that member state shall , to the extent possible , adapt the protection measure to one known and already provided for under its own law which has equivalent effects attached to it and pursues similar aims and interests .


### the competent authority in the member state of recognition may , on application by the person causing the risk , refuse the recognition of the protection measure taken by the court of origin if it is irreconcilable with a decision taken in the member state of recognition . ### the competent authority in the member state of recognition may , either on application by the person causing the risk or of its own motion , refuse the recognition of the protection measure taken by the court of origin if it is irreconcilable with a decision taken in the member state of recognition .


### if the protection measure is suspended or withdrawn in the member state of origin , the competent authority of the member state of recognition shall , on application by the person causing the risk , suspend or withdraw the recognition and , when applied , the enforcement of the protection measure . the application shall be submitted using the form set out in annex ii . ### if the competent authority of the member state of origin suspends or withdraws the protection measure , it shall immediately inform the competent authority of the member state of recognition of that suspension or withdrawal .


### the competent authorities of the member state of origin shall , without delay and according to the law of that member state , bring to the notice of the person causing the risk and to the protected person : ### the competent authorities of the member state of origin shall , without delay and according to the law of that member state , bring to the notice of the person causing the risk and to the protected person and , where appropriate , his or her legal representative , guardian or tutor :


### any suspension or withdrawal of the protection measure . ### any refusal of recognition and / or enforcement , suspension or withdrawal of the protection measure .


### upon reception of the certificate pursuant to article 5 provided by the protected person , the competent authorities of the member state of recognition shall , without delay and where necessary according to the rules of regulation no 1393 / 2007 , bring to the notice of the person causing the risk and to the protected person : ### upon reception of the certificate pursuant to article 5 , the competent authorities of the member state of recognition shall , without delay and where necessary according to the rules of regulation no 1393 / 2007 of the european parliament and of the council of 13 november 2007 on the service in the member states of judicial and extrajudicial documents in civil or commercial matters 1 , bring to the notice of the person causing the risk and to the protected person and , where appropriate , his or her legal representative , guardian or tutor , in a language which they understand : _______________ 1 oj l 324 , 10 . 12 . 2007 , p . 79 .


### an applicant who , in the member state of origin , has benefited from complete or partial legal aid or exemption from costs or expenses , shall be entitled , in any proceeding relating to the enforcebility of the protection measure , to benefit from the most favourable legal aid or the most extensive exemption from costs or expenses provided for by the law of the member state of recognition . ### an applicant who , in the member state of origin , has benefited from complete or partial legal aid or exemption from costs or expenses , shall be considered , in any proceeding relating to the enforceability of the protection measure , for entitlement to benefit from legal aid or the most extensive exemption from costs or expenses provided for by the law of the member state of recognition , as decided by that member state .


### by [ five years from the date of application in article 23 ] at the latest , the commission shall submit a report to the european parliament , the council and the european economic and social committee on the application of this regulation . if necessary , the report shall be accompanied by proposals for adaptation . ### by [ four years from the date of application in article 23 ] at the latest , the commission shall submit a report to the european parliament , the council and the european economic and social committee on the application of this regulation and on the interaction between this regulation and directive 2011 / 99 / eu . if necessary , the report shall be accompanied by proposals for adaptation .


### within the framework of the european judicial network in civil and commercial matters established by council decision 2001 / 470 / ec , the member states shall provide a description of the national rules and procedures concerning protection measures , including authorities competent for recognition and / or enforcement with a view to making it available to the public . ### within the framework of the european judicial network in civil and commercial matters established by council decision 2001 / 470 / ec , the member states shall provide a description of the national rules and procedures concerning protection measures , including authorities competent for recognition and / or enforcement with a view to making it available to the public . information concerning individual cases shall remain confidential .


### by [ 1 year before the entry into force of this regulation ] , the member state shall communicate to the commission the authorities having competence in the matters falling within the scope of this regulation ; the languages accepted for translations of the of the certificate as referred to in article 15 . ### by [ 1 year before the entry into force of this regulation ] , each member state shall communicate to the commission the names and contact details of the authorities having competence in the matters falling within the scope of this regulation ; the languages accepted for translations of the certificate as referred to in article 5 .


### annex i ### annex


### annex ii ### annex deleted


### statistics developed , produced and disseminated under this programme should contribute to the implementation of the policies of the european union , as reflected in the treaty on the functioning of the european union , the europe 2020 strategy for smart , sustainable and inclusive growth12 and other policies addressed in the commission ' s strategic priorities for 2010 - 2014 and should be fostered through actions financed under this programme where the european union can bring a clear added value . ### high quality statistics developed , produced and disseminated under this programme are vital for evidence based decision - making and should contribute to the implementation of the policies of the european union , as reflected in the treaty on the functioning of the european union , the europe 2020 strategy for smart , sustainable and inclusive growth12 and other policies addressed in the commission ' s strategic priorities for 2010 - 2014 and should be fostered through actions financed under this programme where the european union can bring a clear added value .


### the programme represents the added value of ensuring that european statistics are focused on the information needed to design , implement , monitor and evaluate union policies . in addition , it contributes to the effective use of resources by fostering actions which provide an essential contribution to the development , production and dissemination of harmonised , comparable and reliable statistical information . ### the programme represents the added value of ensuring that european statistics are focused on the information needed to design , implement , monitor and evaluate union policies . in addition , it contributes to the effective use of resources by fostering actions which provide an essential contribution to the development , production and dissemination of harmonised , comparable and reliable statistical information , on the basis of uniform standards and common quality assessment criteria , in particular ' relevance ' , ' accuracy ' , ' timeliness ' , ' accessibility ' and ' coherence ' .


### the objectives referred to in this article are specified in the annex together with the indicators used for monitoring the implementation of the programme . in accordance with regulation no 223 / 2009 they shall be subject to detailed annual planning that will include a priority - setting mechanism as an integral part of the process . they shall be achieved through a close and coordinated cooperation in the european statistical system , which is the partnership between the union statistical authority and the national statistical institutes and other national authorities . ### the objectives referred to in this article are specified in the annex together with the indicators used for monitoring the implementation of the programme . in accordance with regulation no 223 / 2009 they shall be subject to detailed annual planning that will include a priority - setting mechanism as an integral part of the process . they shall be achieved through a close and coordinated cooperation in the european statistical system , which is the partnership between the union statistical authority and the national statistical institutes and other national authorities . the programme should include the development of appropriate instruments to prioritise statistical activities and enhance quality and greater flexibility of the european statistical system .


### the programme shall be implemented in accordance with the principles of the european statistics code of practice with a view to producing and disseminating high - quality , harmonised european statistics and ensuring the proper functioning of the european statistical system as a whole . appropriate measures shall be taken to ensure good coordination and effective priority setting within the ess in order to contribute to the reduction of administrative burden on statistical respondents . national authorities and the union statistical authority shall ensure that european statistics comply with the european quality standards and serve the needs of european union institutional users , governments , regional authorities , research institutions , civil society organisations , enterprises and the public . ### the programme shall be implemented in accordance with the principles of the european statistics code of practice with a view to producing and disseminating high - quality , harmonised and comparable european statistics and ensuring the proper functioning of the european statistical system as a whole , thus respecting the principles of integrity , independence and accountability . appropriate measures shall be taken to ensure good coordination and effective priority setting within the ess in order to contribute to the reduction of administrative burden on statistical respondents , as well as to the most efficient use of the limited resources at eu and at national level . national authorities and the union statistical authority shall ensure that european statistics comply with the european quality standards and serve the needs of european union institutional users , governments , regional authorities , research institutions , civil society organisations , enterprises and the public .


### supplement measurement of economic performance by different dimensions of globalisation , the quality of life , environmental sustainability , health , well - being and social cohesion . develop a framework for the analysis of globalised production . ### supplement measurement of economic performance by different dimensions of globalisation , the quality of life , access to goods and services , environmental sustainability , health , well - being , social cohesion and social inclusion . develop a framework for the analysis of globalised production .


### harmonised housing and related statistics available for all member states . ### harmonised housing and related statistics , available for all member states , including the affordability and accessibility of housing .


### 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 high - 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 .


### provide quality statistics on key areas of social policy where the citizen is the centre of interest , such as social cohesion , poverty , demographic challenges , the labour market , education and training , including learning mobility of young people , culture , physical activity , quality of life , safety , health , disability , consumption , free movement and the single market , mobility of young people , technological innovation and new lifestyle choices . ### provide quality statistics on key areas of social policy where the citizen is the centre of interest , such as social cohesion , poverty , demographic challenges , the labour market , education and training , including early childhood education , adult learning , and mobility of young people , culture , physical activity , quality of life , including housing and access to services , safety , health , disability , consumption , free movement and the single market , mobility of young people , technological innovation and new lifestyle choices .


### provide quality statistics on key areas of social policy where the citizen is the centre of interest , such as social cohesion , poverty , demographic challenges , the labour market , education and training , including learning mobility of young people , culture , physical activity , quality of life , safety , health , disability , consumption , free movement and the single market , mobility of young people , technological innovation and new lifestyle choices . ### provide high - quality statistics on key areas of social policy where the citizen is the centre of interest , such as social cohesion , poverty , disability , demographic challenges , the labour market , education and training , including learning mobility of young people , culture , physical activity , quality of life , safety , health , disability , consumption , free movement and the single market , mobility of young people , technological innovation and new lifestyle choices .


### quality of life indicators to measure progress of societies provided . ### quality of life indicators , including housing and access to services , to measure progress of societies provided .


### statistics on transport safety , passenger mobility , road traffic measurement and intermodal freight transport produced and disseminated . ### statistics on transport safety and accessibility , passenger mobility , road traffic measurement and intermodal freight transport produced and disseminated .


### europol shall designate a specialised unit with duly empowered europol officials to act as its verifying authority and shall designate in agreement with any member state the national access point of that member state which shall communicate its requests for comparison of fingerprint data to the central system . ### europol shall designate a specialised unit with duly empowered europol officials to act as its verifying authority , which will neither seek nor receive instructions as regards the exercise of the verification , and shall designate in agreement with any member state the national access point of that member state which shall communicate its requests for comparison of fingerprint data to the central system .


### 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 , the visa information system and of the automated fingerprint databases of at least a third of other member states under decision 2008 / 615 / jha return negative results and where all the following cumulative conditions are met :


### there are reasonable grounds to consider that such comparison with eurodac data will contribute to the prevention , detection or investigation of any of the criminal offences in question . ### there is an overriding public security concern which makes proportionate the querying of a database registering persons with a clean criminal record , and there are reasonable grounds to consider that such comparison with eurodac data will substantially contribute to the prevention , detection or investigation of any of the criminal offences in question because there are serious grounds to believe that persons in respect of whom comparison with eurodac is requested will commit or have committed terrorist offences or other serious criminal offences or are victims of a terrorist or serious criminal offence .


### 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 appropriate , orally , in a language which he or she understands of the following :


### regarding the purpose for which his or her data will be processed within eurodac including a description of the aims of the dublin regulation , in accordance with article 4 of that regulation . ### the purpose for which his or her data will be processed within eurodac including a description of the aims of the dublin regulation , in accordance with article 4 of that regulation and a full and clear explanation of the access that may be granted to law enforcement authorities and europol for law enforcement purposes .


### personal data obtained pursuant to this regulation from eurodac shall only be processed for the purposes of the prevention , detection and investigation of terrorist offences or of other serious criminal offences . ### personal data obtained pursuant to this regulation from eurodac for the purposes as laid down in article 1 shall only be processed for the purposes of the prevention , detection and investigation of the specific criminal investigation for which the data has been requested by that member state , or europol .


### personal data obtained by a member state or europol pursuant to this regulation from the eurodac central database shall not be transferred or made available to any third country or international organisation or a private entity established in or outside the european union . this prohibition shall be without prejudice to the right of member states to transfer such data to third countries to which the dublin regulation applies . ### personal data obtained by a member state or europol pursuant to this regulation , including personal data obtained by a member state and processed further in national databases for law enforcement purposes , from the eurodac central database shall not be transferred or made available to any third country or international organisation or a private entity established in or outside the european union . this prohibition shall be without prejudice to the right of member states to transfer such data to third countries to which the dublin regulation applies provided that the member state transferring such data has obtained the commitment of the third country that it will not transfer or made available to any third country or international organisation or a private entity established in or outside the european union this personal data .


### 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 four years thereafter , the commission shall produce an overall evaluation of eurodac , examining the results achieved against objectives and the impact on fundamental rights and assessing the continuing validity of the underlying rationale , and any implications for future operations , including whether the operation of the search functionality for law enforcement purposes will have led to the stigmatisation of persons seeking international protection , as well as make any necessary recommendations . the commission shall transmit the evaluation to the european parliament and the council .


### the financial envelope for the implementation of the programme shall be eur 472 million . ### within the meaning of point [ 17 ] of the interinstitutional agreement of . . . / . . . . between the european parliament , the council and the commission on cooperation in budgetary matters and on sound financial management , the financial envelope for the implementation of the programme for the period from 2014 to 2020 , representing the prime reference for the budgetary authority during the annual budgetary procedure , shall be eur 472 million .


### the budgetary authority shall authorise the available annual appropriations within the limits of the multiannual financial framework established by council regulation no xx / xx of xx laying down the multiannual financial framework for the years 2014 - 2020 . ### the budgetary authority shall authorise the available annual appropriations without prejudice to the provisions of the regulation laying down the multiannual financial framework for the years 2014 - 2020 and the interinstitutional agreement of xxx / 201z between the european parliament , the council and the commission on cooperation in budgetary matters and sound financial management .


### for the entire duration of gmes initial operations , a financial envelope of eur 107m constituting the prime reference , within the meaning of point 37 of the interinstitutional agreement of 17 may 2006 between the european parliament , the council and the commission on budgetary discipline and sound financial management should be established . it is envisaged that this financial envelope will be complemented by an amount of eur 43 million from the space theme of the seventh framework programme for research actions accompanying gmes initial operations . ### for the entire duration of gmes initial operations , a financial envelope of eur 317m constituting the prime reference , within the meaning of point 37 of the interinstitutional agreement of 17 may 2006 between the european parliament , the council and the commission on budgetary discipline and sound financial management should be established . it is envisaged that this financial envelope will be complemented by an amount of eur 43 million from the space theme of the seventh framework programme for research actions accompanying gmes initial operations .


### community grants may be provided in specific forms , including framework partnership agreement , or co - funding of operating or action grants . operating grants to bodies pursuing objectives of general european interest shall not be subject to the degressivity provisions of the financial regulation . for grants , the maximum rate of co - financing shall be adopted in accordance with the procedure of article 11 . ### public procurement should be the preferred funding instrument for implementing the gmes programme . where this is justified , community grants may be provided in specific forms , including framework partnership agreement , or co - funding of operating or action grants . operating grants to bodies pursuing objectives of general european interest shall not be subject to the degressivity provisions of the financial regulation . for grants , the maximum rate of co - financing shall be adopted in accordance with the procedure of article 11 .


### in a clinical trial the safety and rights of subjects should be protected and the data generated should be reliable and robust . ### in a clinical trial the safety , rights and well - being of subjects should be protected and the data generated should be relevant , reliable and robust .


### in order to allow for independent control as to whether these principles are adhered to , a clinical trial should be subject to prior authorisation . ### in order to allow for independent control as to whether these principles are adhered to , a clinical trial should be subject to prior authorisation . the conduct of a clinical trial should be conditioned to prior approval by an ethics committee .


### ‘ sponsor’ : an individual , company , institution or organisation which takes responsibility for the initiation and management of the clinical trial ; ### ‘ sponsor’ : an individual , company , institution or organisation which takes responsibility for the initiation , management and / or financing of the clinical trial ;


### ‘ subject’ : an individual who participates in a clinical trial , either as recipient of an investigational medicinal product or as a control ; ### ' subject ' : an individual who freely and voluntarily participates in a clinical trial , either as recipient of an investigational medicinal product or as a control ;


### ‘ informed consent’ : a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial , after having been informed of all aspects of the trial that are relevant to the subject ' s decision to participate ; ### ' informed consent ' : a process by which a subject freely and voluntarily confirms his or her willingness to participate in a particular trial , after having been informed of all aspects of the trial that are relevant to the subject ' s decision to participate ;


### – the reliability and robustness of the data generated in the clinical trial , taking account of statistical approaches , design of the trial and methodology ; ### – the reliability and robustness of the data generated in the clinical trial , taking account of statistical approaches , design of the trial , methodology and the prevalence of the condition , especially for rare diseases , and ultra - rare diseases .


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


### where the sponsor so requests , the application for authorisation of a clinical trial , its assessment and the decision shall be limited to the aspects covered by part i of the assessment report . ### where the sponsor so requests , the application for authorisation of a clinical trial shall be limited to the aspects covered by part i of the assessment report .


### this chapter is without prejudice to the possibility for the sponsor to submit , following the refusal to grant an authorisation or the withdrawal of an application , an application for authorisation to any intended member state concerned . that application shall be considered as a new application for authorisation of another clinical trial . ### this chapter is without prejudice to the possibility for the sponsor to submit , following the refusal to grant an authorisation or the withdrawal of an application , an application for authorisation to any intended member state . that application shall be considered as a resubmission of the application . it must be accompanied by any previous assessment report , by the considerations of concerned members states , and it must highlight the changes or the reasons justifying the resubmission of the application file .


### the commission shall be empowered to adopt delegated acts in accordance with article 85 in order to amend annexes i and ii with the objective to adapt them to technical progress or to take account of global regulatory developments . ### the commission shall be empowered to adopt delegated acts in accordance with article 85 in order to complete annexes i and ii with the objective to adapt them to technical progress or to take account of global regulatory developments .


### 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 for each trial 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 witness who represents the subject ' s interests 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 .


### written information given to the subject and / or the legal representative for the purposes of obtaining his or her informed consent shall be kept concise , clear , relevant , and understandable to a lay person . it shall include both medical and legal information . it shall inform the subject about his or her right to revoke his or her informed consent . ### written information given to the subject and / or the legal representative for the purposes of obtaining his or her informed consent shall be kept concise , clear , relevant , and understandable to a lay person . it shall include both medical and legal information that shall be explained orally by a medical doctor to the subject . it shall inform the subject about his or her right to revoke his or her informed consent .


### any sponsor may delegate any or all of its tasks to an individual , a company , an institution or an organisation . such delegation shall be without prejudice to the responsibility of the sponsor . ### any sponsor may delegate any or all of its logistic tasks to an individual , a company , an institution or an organisation . such delegation shall be without prejudice to the scientific and ethical responsibility of the sponsor .


### no personal data of subjects shall be publicly accessible . ### no personal data of subjects shall be publicly accessible and such data shall be protected in accordance with applicable union legislation .


### the exchange of confidential data relating to intra - eu trade statistics should be allowed between member states with a view to increasing the efficiency of the development , production and dissemination or to improving the quality of those statistics . ### the exchange of confidential data relating to intra - eu trade statistics should be allowed between member states with a view to increasing the efficiency of the development , production and dissemination or to improving the quality of those statistics , or with a view to facilitating the work of tax administrations in the member states .


### the exchange of confidential data , as defined by article 3 of regulation no 223 / 2009 of the european parliament and of the council of 11 march 2009 on european statistics , shall for statistical purposes only , be allowed between the respective national authorities of each member state , where the exchange serves the efficient development , production and dissemination of european statistics relating to the trading of goods between member states or improves their quality . __________________ oj l 87 , 31 . 3 . 2009 , p . 164 . ' ### the exchange of confidential data , as defined by article 3 of regulation no 223 / 2009 of the european parliament and of the council of 11 march 2009 on european statistics , shall , for statistical purposes , be allowed between the respective national authorities of each member state , where the exchange serves the efficient development , production and dissemination of european statistics relating to the trading of goods between member states or improves their quality . the exchange of confidential data may also be authorised for fiscal purposes by the member states or in the interest of better academic research under the supervision of the relevant judicial authorities and in accordance with the principle of statistical confidentiality ; __________________ oj l 87 , 31 . 3 . 2009 , p . 164 . '


### the budgetary resources allocated to the programme shall be entered in the annual appropriations of the general budget of the european union . the available annual appropriations shall be authorised by the budgetary authority within the limits of the financial framework . ### the budgetary resources allocated to the programme shall be entered in the annual appropriations of the general budget of the european union . the available annual appropriations shall be authorised by the budgetary authority within the limits of the current financial framework , without jeopardising the implementation of current programmes and activities , thus avoiding redeployment within the relevant heading of the current financial framework .


### consequently it is desirable to temporarily consider the requirements set out in directive 2003 / 87 / ec of the european parliament and of the council4 as satisfied , when obligations are met in respect of a certain percentage of the emissions from flights to and from aerodromes in third countries . in doing so , the union emphasises that requirements can be applied in respect of certain percentages of emissions from flights to and from aerodromes in countries of the european economic area , in the same manner as legal requirements can be placed on more of the emissions from flights to and from such aerodromes . __________________ 4 directive 2003 / 87 / ec of the european parliament and of the council of 13 october 2003 establishing a scheme for greenhouse gas emission allowance trading within the community and amending council directive 96 / 61 / ec ### consequently , in order to support global discussions and the development of a global market - based mechanism by 2016 , it is desirable to temporarily consider the requirements set out in directive 2003 / 87 / ec of the european parliament and of the council4 as satisfied for the period until 2016 , when obligations are met in respect of a certain percentage of the emissions from flights to and from aerodromes in third countries . in doing so , the union emphasises that requirements can be applied in respect of certain percentages of emissions from flights to and from aerodromes in countries of the european economic area , in the same manner as legal requirements can be placed on more of the emissions from flights to and from such aerodromes . __________________ 4 directive 2003 / 87 / ec of the european parliament and of the council of 13 october 2003 establishing a scheme for greenhouse gas emission allowance trading within the community and amending council directive 96 / 61 / ec


### the application of a percentage to verified emissions for flights to and from aerodromes in third countries , or the use of an alternative approach by operators , should relate to emissions from 2014 onwards to give time for operators to understand these approaches when planning their flight activities , ### the application of a percentage to verified emissions for flights to and from aerodromes in third countries , or the use of an alternative approach by operators , should relate to emissions from 2014 to 2016 to give time for operators to understand these approaches when planning their flight activities ,


### without prejudice to the global market - based measure applying from 2020 , emissions from flights to and from countries which are developing countries and whose share of total revenue ton kilometres of international civil aviation activities is less than 1% should be exempted for the period 2014 to 2020 . countries considered to be developing for the purposes of this proposal should be those which benefit at the time of adoption of this proposal from preferential access to the union market in accordance with regulation no 978 / 2012 of the european parliament and of the council , that is those which are not classified in 2013 by the world bank as high - income or upper - middle income countries . ### without prejudice to the global market - based measure applying from 2020 , emissions from flights to and from countries which are developing countries and whose share of total revenue ton kilometres of international civil aviation activities is less than 1% should be exempted for the period 2014 to 2016 . countries considered to be developing for the purposes of this proposal should be those which benefit at the time of adoption of this proposal from preferential access to the union market in accordance with regulation no 978 / 2012 of the european parliament and of the council , that is those which are not classified in 2013 by the world bank as high - income or upper - middle income countries .


### in order to supplement or amend certain non - essential elements of regulation no 774 / 94 , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission in respect of the adoption of adjustments to that regulation , should the volumes and other conditions of quota arrangements be adjusted , in particular by a decision to approve an agreement with one or more third countries . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### in order to supplement or amend certain non - essential elements of regulation no 774 / 94 , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission in respect of the adoption of adjustments to that regulation , should the volumes and other conditions of quota arrangements be adjusted , in particular by a council decision to conclude an agreement with one or more third countries . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . the commission should provide full information and documentation on its meetings with national experts within the framework of its work on the preparation and implementation of delegated acts . in this respect , the commission should ensure that the european parliament is duly involved , drawing on best practices from previous experience in other policy areas in order to create the best possible conditions for future scrutiny of delegated acts by the european parliament .


### those implementing acts shall be adopted in accordance with the examination procedure referred to in article [ 323 ] of regulation no [ / ] of the european parliament and of the council [ aligned single cmo regulation ] * . ### those implementing acts shall be adopted in accordance with the examination procedure referred to in article 7a .


### the delegation of power referred to in article 8 shall be conferred on the commission for an indeterminate period of time from [ insert date of entry into force of this amending regulation ] . ### the delegation of power referred to in article 8 shall be conferred on the commission for a period of five years from . . . * . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five - year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period . __________ * oj : please insert the date of entry into force of this regulation .


### a delegated act adopted pursuant to article 8 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 8 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 four months at the initiative of the european parliament or the council


### proper attention should be given to conflict prevention , state and peace building , post - conflict reconciliation and reconstruction measures . ### proper attention should be given to conflict prevention , state and peace building , post - conflict reconciliation and reconstruction measures and to preventing the marginalisation of women in decision - making and peace - building processes , so as not to waste the knowledge and skills they accumulated during periods of conflict .


### rules on training and certification of seafarers have been agreed at an international level by means of the international convention on standards of training , certification and watchkeeping for seafarers , adopted in 1978 by conference at the international maritime organization , entered into force in 1984 and significantly amended in 1995 . ### the training and certification of seafarers is regulated by the international maritime organisation convention on standards of training , certification and watchkeeping for seafarers 1978 , which entered into force in 1984 and which had been significantly amended in 1995 .


### in 2010 a conference between the state parties to the stcw convention was held in manila and introduced several significant changes to the convention , namely on the prevention of fraudulent practices for certificates , in the field of medical standards , in the matter of training on security and with respect to training in technology - related matters . the manila amendments have also introduced requirements for able seafarers and established new professional profiles , such as electro - technical officers . ### a conference of parties to the stcw convention held in manila in 2010 introduced significant amendments to the stcw convention , namely on the prevention of fraudulent practices for certificates , in the field of medical standards , in the matter of training on security and with respect to training in technology - related matters . the manila amendments have also introduced requirements for able seafarers and established new professional profiles , such as electro - technical officers .


### at the manila conference the state - parties intended , amongst others , to set objective limits to the exceptions to the minimum rest hours for watchkeeping personnel and seafarers with designated safety , security and prevention of pollution related tasks . also such new provisions should be integrated into eu law . however , they should respect the provisions on hours of rest applicable to seafarers under council directives 1999 / 63 / ec of 21 june 1999 and 2009 / 13 / ec of 16 february 2009 . furthermore , the faculty of authorising exceptions should be limited in terms of maximum duration , frequency and scope . provisions to this effect should be introduced in the directive . ### the manila amendments intended , amongst others , to set objective limits to the exceptions to the minimum rest hours for watchkeeping personnel and seafarers with designated safety , security and prevention of pollution related tasks . the manila amendments should be incorporated into eu law . however , such new provisions should respect the provisions on hours of rest applicable to seafarers under council directives 1999 / 63 / ec of 21 june 1999 and 2009 / 13 / ec of 16 february 2009 . furthermore , the faculty of authorising exceptions should be limited in terms of maximum duration , frequency and scope . provisions to this effect should be introduced in directive 2008 / 106 / ec .


### directive 2008 / 106 / ec also contains a mechanism for the recognition of the systems of training and certification of seafarers of the third countries . the recognition is realised by a decision of the commission further to a procedure within which the commission is assisted by the european maritime safety agency established by regulation no 1406 / 2002 and by the committee on safe seas and the prevention of pollution from ships , established by regulation no 2099 / 2002 ; the experience gained in applying the provisions of directive 2008 / 106 / ec on recognition of third countries for stcw purposes suggests that a change should be introduced in the relevant procedure , namely with respect to the three - month deadline for deciding on the recognition currently imposed on the commission by article 19 of the said directive . since the recognition requires an inspection to be performed by the agency , which has to be planned and carried out , and , in most cases , significant adjustments to the stcw requirements by the involved third country , the whole process cannot be realised in three months ; on the basis of experience , a more realistic time - frame in this respect appears to be eighteen months . the mentioned deadline should therefore be modified accordingly , while the possibility for the requesting member state to provisionally recognise the third country should be kept in order to preserve flexibility . ### directive 2008 / 106 / ec also contains a mechanism for the recognition of the systems of training and certification of seafarers of the third countries . the recognition is realised by a decision of the commission further to a procedure within which the commission is assisted by the european maritime safety agency established by regulation no 1406 / 2002 and by the committee on safe seas and the prevention of pollution from ships , established by regulation no 2099 / 2002 ; the experience gained in applying the provisions of directive 2008 / 106 / ec on recognition of third countries for stcw purposes suggests that a change should be introduced in the relevant procedure , namely with respect to the three - month deadline for deciding on the recognition currently imposed on the commission by article 19 of the said directive . since the recognition requires an inspection to be performed by the agency , which has to be planned and carried out , and , in most cases , significant adjustments to the stcw requirements by the involved third country , the whole process cannot be realised in three months ; on the basis of experience , a more realistic time - frame in this respect appears to be eighteen months . the mentioned deadline should therefore be modified accordingly , while the possibility for the requesting member state to provisionally recognise the third country should be kept in order to preserve flexibility . furthermore , the provisions for recognition of professional qualifications under directive 2005 / 36 / ec of 7 september 2005 are not applicable with regard to the recognition of certificates of seafarers under this directive .


### available statistics on european seafarers are incomplete and often inaccurate , which makes policy - making in this delicate sector more difficult . detailed data on certification of seafarers can not entirely solve this problem but they would clearly help . under the stcw convention state parties are obliged to maintain registers of all certificates and endorsements and the relevant revalidations or other measures affecting them ) . member states , under article 11 of directive 2008 / 106 , have the obligation to maintain a register of issued certificates and endorsements . in order to have a complete as possible picture of the labour employment situation in europe , member states should be required to send to the commission selected information already contained in their registers of seafarers ' certificates . this information should be used for statistical purposes and be in line with the data protection requirements of the union . a provision to that effect should be introduced in directive 2008 / 106 / ec . ### available statistics on european seafarers are incomplete and often inaccurate , which makes policy - making in this delicate sector more difficult . detailed data on certification of seafarers can not entirely solve this problem but they would clearly help . under the stcw convention state parties are obliged to maintain registers of all certificates and endorsements and the relevant revalidations or other measures affecting them ) . member states , under article 11 of directive 2008 / 106 / ec , have the obligation to maintain a register of issued certificates and endorsements . in order to have a complete as possible picture of the labour employment situation in europe , member states should be required to send to the commission selected information already contained in their registers of seafarers ' certificates . this information should be limited to what is necessary to enable evidence - based policy - making , should be used for statistical purposes only and should be collected , stored and analysed in full compliance with the data protection requirements of the union .


### available statistics on european seafarers are incomplete and often inaccurate , which makes policy - making in this delicate sector more difficult . detailed data on certification of seafarers can not entirely solve this problem but they would clearly help . under the stcw convention state parties are obliged to maintain registers of all certificates and endorsements and the relevant revalidations or other measures affecting them ) . member states , under article 11 of directive 2008 / 106 , have the obligation to maintain a register of issued certificates and endorsements . in order to have a complete as possible picture of the labour employment situation in europe , member states should be required to send to the commission selected information already contained in their registers of seafarers ' certificates . this information should be used for statistical purposes and be in line with the data protection requirements of the union . a provision to that effect should be introduced in directive 2008 / 106 / ec . ### available statistics on european seafarers are incomplete and often inaccurate , which makes policy - making in this sector more difficult . detailed data on certification of seafarers can not entirely solve this problem but they would clearly help . under the stcw convention parties are obliged to maintain registers of all certificates and endorsements and the relevant revalidations or other measures affecting them ) . member states , under article 11 of directive 2008 / 106 , have the obligation to maintain a register of issued certificates and endorsements . in order to have a complete as possible picture of the labour employment situation in europe , member states should be required to send to the commission selected information already contained in their registers of seafarers ' certificates of competency . this information should be communicated for the purposes of statistical analysis only , it may not be used for administrative , legal or verification purposes and it must be in line with the data protection requirements of the union . a provision to that effect should be introduced in directive 2008 / 106 / ec .


### in order to gather data on the seafaring profession consistently with the evolution of the latter and of technology , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of adaptations of annex v of directive 2008 / 106 / ec . those delegated acts would regard , in particular , the content of the information on endorsements , on certificates of competency or proficiency and on the number and details of seafarers whose certificates are issued or endorsed , taking into account the safeguards on data protection indicated in the mentioned annex . also , the commission should have the power to adopt delegated acts in order to establish measures for collecting , storing and analysing this kind of statistical information by member states with a view to accommodating new statistical needs on seafarers , and with a view to gathering information up - to - date and consistent with reality . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### in order to gather data on the seafaring profession consistently with the evolution of the latter and of technology , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of adaptations of annex v of directive 2008 / 106 / ec . those delegated acts would regard , in particular , updating provisions on the content of the information on endorsements , on certificates of competency or proficiency and on the number and details of seafarers whose certificates are issued or endorsed , taking into account the safeguards on data protection indicated in the mentioned annex . also , the commission should have the power to adopt delegated acts in order to establish measures for collecting , storing and analysing this kind of statistical information by member states with a view to accommodating new statistical needs on seafarers , and with a view to gathering information up - to - date and consistent with reality . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council .


### in order to gather data on the seafaring profession consistently with the evolution of the latter and of technology , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of adaptations of annex v of directive 2008 / 106 / ec . those delegated acts would regard , in particular , the content of the information on endorsements , on certificates of competency or proficiency and on the number and details of seafarers whose certificates are issued or endorsed , taking into account the safeguards on data protection indicated in the mentioned annex . also , the commission should have the power to adopt delegated acts in order to establish measures for collecting , storing and analysing this kind of statistical information by member states with a view to accommodating new statistical needs on seafarers , and with a view to gathering information up - to - date and consistent with reality . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### in order to gather data on the seafaring profession consistently with the evolution of the latter and of technology , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of adaptations of annex v of directive 2008 / 106 / ec . those delegated acts would regard , in particular , the content of the information on endorsements , on certificates of competency or proficiency and on the number and details of seafarers whose certificates are issued or endorsed , taking into account the safeguards on data protection indicated in the mentioned annex . those delegated acts should not modify the provisions on anonymising data referred to in that annex . also , the commission should have the power to adopt delegated acts in order to establish measures for collecting , submitting , storing , analysing and disseminating this kind of statistical information by member states with a view to accommodating new statistical needs on seafarers , and with a view to gathering information up - to - date and consistent with reality . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council .


### the amendments to the convention enter into force on 1 january 2012 , while transitional arrangements until 1 january 2017 have been provided for in the manila agreement in order to allow for a smooth transition to the new rules . the present directive should provide for the same timeframe and transitional arrangements . ### the manila amendments were due to enter into force on 1 january 2012 . however , those amendments provide for transitional arrangements until 1 january 2017 . in order to allow for a smooth transition to the new rules , this directive should provide for the same transitional arrangements .


### ' 18 . ' radio regulations ' means the revised radio regulations , adopted by the world radiocommunication conference for the maritime mobile service in their up - to - date version ; ' . ### ' 18 . ' radio regulations ' means the radio regulations annexed to , or regarded as being annexed to , the most recent international telecommunication convention ; ' .


### ' 24 . ' stcw code ' means the seafarers’ training , certification and watchkeeping code as adopted by resolution 2 of the 2010 stcw conference of parties , in its up - to - date version ; ' . ### ' 24 . ' stcw code ' means the seafarers’ training , certification and watchkeeping code as adopted by the 1995 conference resolution 2 , in its up - to - date version ; ' .


### ' 35 . ' security duties ' include all security tasks and duties on board ships as defined by chapter xi / 2 of the international convention for the safety of life at sea convention and the international ship and port facility security code ; ' ### ' 35 . ' security duties ' include all security tasks and duties on board ships as defined by chapter xi / 2 of the international convention for the safety of life at sea and the international ship and port facility security code ; '


### ' 1 . member states shall take the measures necessary to ensure that seafarers serving on ships as referred to in article 2 are trained as a minimum in accordance with the requirements of the stcw convention , as laid down in annex i to this directive , and hold certificates as defined in article 1 and . ' ### ' 1 . member states shall take the measures necessary to ensure that seafarers serving on ships as referred to in article 2 are trained as a minimum in accordance with the requirements of the stcw convention , as laid down in annex i to this directive , and hold certificates as defined in article 1 and , and / or documentary evidence as defined in article 1 . '


### each candidate for certification shall provide satisfactory proof : ### candidates for certification shall provide satisfactory proof :


### of his identity ; ### of&#160 ; their identity ;


### provide satisfactory proof of his identity ; and ### provide satisfactory proof of their identity ; and


### that his age is not less than that prescribed in the regulations listed in annex i relevant to the certificate applied for ; ### that their age is not less than that prescribed in the regulations listed in annex i relevant to the certificate applied for ;


### that he meets the standards of medical fitness , specified in section a - i / 9 of the stcw code ; ### that they meet the prescribed standards of medical fitness as applicable to the specific duties to be performed ;


### that he meets the standards of competence prescribed in the regulations listed in annex i for the capacities , functions and levels that are to be identified in the endorsement to the certificate . ### that they meet the standards of competence prescribed in the regulations listed in annex i for the capacities , functions and levels that are to be identified in the endorsement to the certificate .


### all training , assessment of competence , certification , including medical certification , endorsement and revalidation activities carried out by non - governmental agencies or entities under its authority are continuously monitored through a quality standards system to ensure the achievement of defined objectives , including those concerning the qualifications and experience of instructors and assessors ; ### all training , assessment of competence , certification , including medical certification , endorsement and revalidation activities carried out by non - governmental agencies or entities under its authority are continuously monitored through a quality standards system to ensure the achievement of defined objectives , including those concerning the qualifications and experience of instructors and assessors , in accordance with the provisions of sections a - i / 6 and&#160 ; a - i / 8 of the stcw code ;


### education and training objectives and related quality standards of competence to be achieved are clearly defined and that the levels of knowledge , understanding and skills appropriate to the examinations and assessments required under the stcw convention identified . the objectives and related quality standards may be specified separately for different courses and training programmes and shall cover the administration of the certification system ; ### education and training objectives and related quality standards of competence to be achieved are clearly defined and the levels of knowledge , understanding and skills appropriate to the examinations and assessments required under the stcw convention are identified .


### every candidate for certification shall : ### candidates for medical certification shall :


### meet the applicable medical fitness standards established by the member state concerned . ### meet the medical fitness standards established by the member state concerned as applicable to the specific duties to be performed .


### ' at all times on board its ships there shall be effective oral communication in accordance with chapter v , regulation 14 , paragraphs 3 and 4 of the solas convention . ' ### ' at all times on board its ships there shall be effective oral communication in accordance with chapter v , regulation 14 , paragraphs 3 and 4 of the solas convention as amended . '


### the member states shall communicate the information listed in annex v to the commission for statistical purposes . ### the member states shall communicate the information listed in annex v to the commission for the purposes of statistical analysis only . such information may not be used for administrative , legal or verification purposes .


### this information shall be made available by member states to the commission on a yearly basis and in electronic format and will include information registered until 31 december of the previous year . ### this information shall be made available by member states to the commission on a yearly basis and in electronic format and will include information registered until 31 december of the previous year . member states shall retain all property rights to the information in its raw data format . statistics drawn up on the basis of such information shall be publicly available .


### the commission shall be empowered to adopt delegated acts in accordance with article 27a in order to establish appropriate measures for collecting , storing and analysing this information . ' . ### the commission shall be empowered to adopt delegated acts in accordance with article 27a in order to establish appropriate measures for collecting , storing and analysing this information in compliance with the data protection requirements as established in eu legislation . the information , as well as the results of analyses based on it , shall be communicated , collected , stored and analysed in an anonymous format . ' .


### the commission shall be empowered to adopt delegated acts in accordance with article 27a in order to establish appropriate measures for collecting , storing and analysing this information . ### the commission shall be empowered to adopt delegated acts in accordance with article 27a in order to establish appropriate measures for collecting , submitting , storing , analysing and disseminating this information .


### the commission shall be empowered to adopt delegated acts amending annex v to this directive with respect to specific and relevant content and details of the information that need to be reported by member states , while taking into account the safeguards on data protection , in accordance with article 27a . ### the commission shall be empowered to adopt delegated acts amending annex v to this directive with respect to specific and relevant content and details of the information that need to be reported by member states , while respecting the safeguards on data protection established by applicable eu legislation , in accordance with article 27a .


### ' the commission shall be empowered to adopt delegated acts amending annex v to this directive with respect to specific and relevant content and details of the information that need to be reported by member states , while taking into account the safeguards on data protection , in accordance with article 27a . ' . ### ' the commission shall be empowered to adopt delegated acts amending annex v to this directive with respect to specific and relevant content and details of the information that need to be reported by member states , while respecting the safeguards on data protection , in accordance with article 27a . such delegated acts may not change the provisions on anonymisation of data as required by paragraph 2a of article 25a . ' .


### in respect of those seafarers who commenced approved seagoing service , approved education and training programme or an approved training course before 1 july 2013 , a member state may continue to issue , recognise and endorse , until 1 january 2017 , certificates in accordance with the requirements of this directive as they were before the present directive entered into force . until 1 january 2017 , a member state may continue to renew and revalidate certificates and endorsements in accordance with the requirements of this directive as they were before the present directive entered into force . ' ### in respect of those seafarers who commenced approved seagoing service , approved education and training programme or an approved training course before 1 july 2013 , a member state may continue to issue , recognise and endorse , until 1 january 2017 , certificates of competency in accordance with the requirements of this directive as they were before &#8230 ; * . until 1 january 2017 , a member state may continue to renew and revalidate certificates of competency and endorsements in accordance with the requirements of this directive as they were before …* . _________________ * oj : please insert date of entry into force of this directive .


### radio communication and radio personnel ### radio communication and radio operators


### radio personnel on ships not required to comply with the provisions of the gmdss in chapter iv of the solas 74 are not required to meet the provisions of this chapter . radio operators on these ships are , nevertheless , required to comply with the radio regulations . the administration shall ensure that the appropriate certificates as prescribed by the radio regulations are issued to or recognised in respect of such radio operators . ### radio operators on ships not required to comply with the provisions of the gmdss in chapter iv of the solas 74 are not required to meet the provisions of this chapter . radio operators on these ships are , nevertheless , required to comply with the radio regulations . member states shall ensure that the appropriate certificates as prescribed by the radio regulations are issued to or recognised in respect of such radio operators .


### every person in charge of or performing radio duties on a ship required to participate in the gmdss shall hold an appropriate certificate related to the gmdss , issued or recognised by the administration under the provisions of the radio regulations . ### every person in charge of or performing radio duties on a ship required to participate in the gmdss shall hold an appropriate certificate related to the gmdss , issued or recognised by the member state under the provisions of the radio regulations .


### where reference is made to this annex , the following information specified in section a - i / 2 , paragraph 9 of the stcw code for all certificates of competency or endorsements attesting their issue , all endorsements attesting the recognition of certificates of competency issued by other countries , and all certificates of proficiency issued to ratings , shall be provided : certificates of competency / endorsements attesting their issue : – seafarer’s unique identifier ; – seafarer’s name ; – seafarer ' s date of birth ; – seafarer ' s nationality ; – seafarer ' s gender ; – coc endorsed number ; – eai number ; – capacity ; – date of issue or the most recent date of revalidation of the document ; – date of expiry ; – status of the certificate ; – limitations . endorsements attesting the recognition of certificates of competency issued by other countries : – seafarer’s unique identifier ; – seafarer’s name ; – seafarer ' s date of birth ; – seafarer ' s nationality ; – seafarer ' s gender ; – country issuing the original coc ; – original coc number ; – ear number ; – capacity ; – date of issue or the most recent date of revalidation of the document ; – date of expiry ; – status ; – limitations . certificates of proficiency for ratings : – seafarer’s unique identifier ; – seafarer’s name ; – seafarer ' s date of birth ; – seafarer ' s nationality ; – seafarer ' s gender ; – cop number ; – capacity ; – date of issue or the most recent date of revalidation of the document ; – date of expiry ; – status . 2 . the items of information subject to data protection legislation can be provided in an anonymised format . ### where reference is made to this annex , the following information specified in section a - i / 2 , paragraph 9 of the stcw code for all certificates of competency or endorsements attesting their issue , all endorsements attesting the recognition of certificates of competency issued by other countries , shall be provided and where marked this provision shall be in an anonymised form as required by paragraph 2a of article 25a : certificates of competency / endorsements attesting their issue : – seafarer’s unique identifier , if available , * ; – seafarer’s name* ; – seafarer ' s date of birth ; – seafarer ' s nationality ; – seafarer ' s gender ; – coc endorsed number* ; – eai number* ; – capacity ; – date of issue or the most recent date of revalidation of the document ; – date of expiry ; – status of the certificate ; – limitations . endorsements attesting the recognition of certificates of competency issued by other countries : – seafarer’s unique identifier , if available , * ; – seafarer’s name* ; – seafarer ' s date of birth ; – seafarer ' s nationality ; – seafarer ' s gender ; – country issuing the original coc ; – original coc number* ; – ear number* ; – capacity ; – date of issue or the most recent date of revalidation of the document ; – date of expiry ; – status of the endorsement ; – limitations . certificates of proficiency issued to ratings in accordance with chapters ii , iii , and vii of the annex to the stcw convention , such as : – seafarer’s unique identifier , if available , * ; – seafarer’s name* ; – seafarer ' s date of birth ; – seafarer ' s nationality ; – seafarer ' s gender ; – cop number* ; – capacity ; – date of issue or the most recent date of revalidation of the document ; – date of expiry ; – status of the cop .