### the rules for the participation and dissemination should adequately reflect the recommendations of the european parliament , as summarised in the ' report on simplifying the implementation of the research framework programmes ' , and council with regard to the simplification of the administrative and financial requirements of the research framework programmes . the rules should give continuity to the simplification measures already implemented under decision no 1982 / 2006 / ec of the european parliament and of the council of 18 december 2006 concerning the seventh framework programme of the european community for research , technological development and demonstration activities 2 and progress further in reducing the administrative burden for participants and the complexity of the financial provisions in order to decrease financial errors . the rules should also duly consider the concerns and recommendations from the research community resulting from the debate initiated by the commission communication of 29 april 2010 to the european parliament , the council , the european economic and social committee and the committee of the regions ' simplifying the implementation of the research framework programmes ' , and the subsequent green paper of 9 february 2011 ' from challenges to opportunities : towards a common strategic framework for eu research and innovation funding ' 4 . ### the rules for the participation and dissemination should adequately reflect the recommendations of the european parliament , as summarised in the ' report on simplifying the implementation of the research framework programmes ' and council with regard to the simplification of the administrative and financial requirements of the research framework programmes . in its resolution of 8 june 20111the european parliament has furthermore called for a radical simplification of union research and innovation funding stressing that any increase of funds should be coupled with a radical simplification of funding procedures . the rules should give continuity to the simplification measures already implemented under decision no 1982 / 2006 / ec of the european parliament and of the council of 18 december 2006 concerning the seventh framework programme of the european community for research , technological development and demonstration activities and progress further in reducing the administrative burden for participants and the complexity of the financial provisions in order to facilitate participation and decrease financial errors . the rules should also duly consider the concerns and recommendations from the research community resulting from the debate initiated by the commission communication of 29 april 2010 to the european parliament , the council , the european economic and social committee and the committee of the regions ' simplifying the implementation of the research framework programmes ' , and the subsequent green paper of 9 february 2011 ' from challenges to opportunities : towards a common strategic framework for eu research and innovation funding ' 5 . 1p7 ta0256 .


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


### specific challenges in the area of research and innovation should be addressed through new forms of funding such as prizes , pre - commercial procurement and public procurement of innovative solutions which require specific rules . ### specific challenges in the area of research and innovation could be addressed through new forms of funding potentially more efficient such as prizes , pre - commercial procurement and public procurement of innovative solutions which require specific rules .


### the financial interests of the union should be protected through proportionate measures throughout the expenditure cycle . ### the financial interests of the union should be protected through necessary , proportionate and efficient measures throughout the expenditure cycle .


### in order to enhance transparency , the names of experts that have assisted the commission or relevant funding bodies in application of this regulation should be published . where the publication of the name would endanger the security or integrity of the expert or would unduly prejudice his or her privacy , the commission or funding bodies should be able to refrain from the publication of such names . ### in order to enhance transparency , the names the legal entities awarded funding and of experts that have assisted the commission or relevant funding bodies in application of this regulation should be published . where the publication of the names would justifiably prejudice the commercial interests of the participant or endanger the security or integrity of the expert or would unduly prejudice his or her privacy , the commission or funding bodies should be able to refrain from the publication of such names .


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


### in accordance with article 10 of regulation xx / 2012 [ horizon 2020 ] , funding may take one or several of the forms of provided for by regulation no xx / 2012 [ financial regulation ] , in particular grants , prizes , procurement and financial instruments . ### in accordance with article 10 of regulation xx / 2012 [ horizon 2020 ] , funding may take one or several of the forms of provided for by regulation no xx / 2012 [ financial regulation ] , including grants , prizes , procurement and financial instruments .


### directive 2000 / 13 / ec of the european parliament and of the council of 20 march 2000 on the approximation of the laws of the member states relating to the labelling , presentation and advertising of foodstuffs5 , and in particular article 7 and thereof , should apply subject to certain conditions . it should be clearly indicated when a product is a mixture of fruit juice and fruit juice from concentrate , and , for fruit nectar , when it is obtained entirely or partly from a concentrated product . the list of ingredients in the labelling should bear the names of both the fruit juices and fruit juices from concentrate used . ### without prejudice to directive 2000 / 13 / ec of the european parliament and of the council of 20 march 2000 on the approximation of the laws of the member states relating to the labelling , presentation and advertising of foodstuffs5 , it is necessary to amend the specific provisions of directive 2001 / 112 / ec on the labelling of fruit juices and similar products to reflect the new rules on authorised ingredients , such as those pertaining to the addition of sugars , no longer authorised in fruit juices .


### the european parliament or the council may object to a delegated act within a period of two months from the date of notification . at the initiative of the european parliament or the council this period shall be extended by one month . ### the european parliament or the council may object to a delegated act within a period of six months from the date of notification . at the initiative of the european parliament or the council this period shall be extended by one month .


### the number of persons suffering from material or even severe material deprivation in the union is increasing and those persons are often too excluded to benefit from the activation measures of regulation no [ …cpr ] , and , in particular of regulation no [ …esf ] . ### in 2011 a total of 119 . 6 million european citizens were at risk of poverty or social exclusion , and homelessness is increasing , yet the people affected are often too excluded to benefit from the activation measures of regulation no [ …cpr ] , and , in particular of regulation no [ …esf ] .


### without prejudice to the commission’s powers as regards financial control , cooperation between the member states and the commission in the framework of this regulation should be ensured and criteria should be established which allow the commission to determine , in the context of its strategy of control of national systems , the level of assurance it should obtain from national audit bodies . ### without prejudice to the commission’s powers as regards financial control , cooperation between the member states and the commission in the framework of this regulation should be ensured and criteria should be established which allow the commission to determine , in the context of its strategy of control of national systems , the level of assurance , and the extent of the information , it should obtain from national audit bodies .


### ' most deprived persons ' means physical persons , whether individuals , families , households or groups composed of such persons , whose need for assistance has been established according to the objective criteria adopted by the national competent authorities , or defined by the partner organisations and which are approved by those competent authorities ; ### ' most deprived persons ' means physical persons , whether individuals , families , households or groups composed of such persons , and including homeless persons and children , whose need for assistance has been established according to the objective criteria defined and adopted by the national competent authorities in cooperation with the partner organisations ;


### the commission and the member states shall carry out their respective roles in relation to the fund with the aim of reducing the administrative burden for beneficiaries . ### the commission and the member states shall carry out their respective roles in relation to the fund with the aim of laying down simple rules for its operation and of reducing the administrative burden for beneficiaries .


### the european cultural and creative sectors are inherently fragmented along national and linguistic lines . on the one hand , fragmentation results in a culturally diverse and highly independent cultural landscape , providing a voice for the different cultural traditions forming the diversity of our european heritage . on the other hand , fragmentation leads to limited and sub - optimal transnational circulation of cultural and creative works and operators within and outside the union , to geographical imbalances and - subsequently - to a limited choice for the consumer . ### the european cultural and creative sectors are inherently fragmented along national and linguistic lines . on the one hand , fragmentation results in a culturally diverse and highly independent cultural landscape , providing a voice for the different cultural traditions forming the diversity of our european heritage . on the other hand , fragmentation leads to limited and sub - optimal transnational circulation of cultural and creative works and operators within and outside the union , to geographical imbalances and - subsequently - to a limited choice for the consumer . the existence of 27 different intellectual property rights management systems is a particular burden for europe ' s cultural and creative sectors . the current fragmented regime needs to be reformed to facilitate access to , and increase circulation of , content , and in such a way as to enable artists , creators , consumers , businesses and audiences to benefit from digital developments , new distribution channels and new business models and other opportunities .


### the digital shift is having a massive impact on how cultural and creative goods and services are made , disseminated , accessed , consumed and monetised . these changes offer great opportunities for the european cultural and creative sectors . lower distribution costs , new distribution channels and new opportunities for niche products can facilitate access and increase circulation worldwide . in order to seize these opportunities and adapt to the context of the digital shift and globalisation , the cultural and creative sectors need to develop new skills and require greater access to finance to upgrade equipment , develop new production and distribution methods and adapt their business models . ### the digital shift is having a massive impact on how cultural and creative goods and services are made , disseminated , accessed , consumed and monetised . these changes offer great opportunities for the european cultural and creative sectors . lower distribution costs , new distribution channels , larger and global audiences and new opportunities for niche products can facilitate access and increase circulation worldwide . in order to seize these opportunities and adapt to the context of the digital shift and globalisation , the cultural and creative sectors need to develop new skills and require greater access to finance to upgrade equipment , develop new production and distribution methods and adapt their business models .


### one of the greatest challenges of the cultural and creative sectors , especially small operators including small and medium - sized enterprises and micro - enterprises , is their difficulty accessing the funds they need to finance their activities , grow , maintain their competitiveness or internationalise . while this is a common challenge for smes in general , the situation is significantly more difficult in the cultural and creative sectors due to the intangible nature of many of their assets , the prototype profile of their activities , the lack of investment - readiness of the operators in the sectors as well as the insufficient investor - readiness of financial institutions . ### one of the greatest challenges of the cultural and creative sectors , especially small operators including small and medium - sized enterprises and micro - enterprises , is their difficulty accessing the funds – in particular union funds , on account of overly complex application procedures – they need to finance their activities , grow , maintain their competitiveness or internationalise . while this is a common challenge for smes in general , the situation is significantly more difficult in the cultural and creative sectors due to the intangible nature of many of their assets , the prototype profile of their activities , the lack of investment - readiness of the operators in the sectors as well as insufficient investor awareness and readiness on the part of financial institutions .


### there is a need to bring together the current individual union programmes for the cultural and creative sectors within a single comprehensive framework programme in order to more effectively support cultural and creative operators to take advantage of the opportunities the digital shift and globalisation offer and help them to address issues currently leading to market fragmentation . to be effective , the programme should take account of the specific nature of the sub - sectors , their different target groups and their particular needs through tailor - made approaches within independent strands . ### there is a need to bring together and merge the current individual union programmes for the cultural and creative sectors within a single comprehensive framework programme in order to more effectively and efficiently support cultural and creative operators to take advantage of the opportunities the digital shift and globalisation offer and help them to address issues currently leading to market fragmentation . to be effective , the programme should take account of the specific nature of the sub - sectors , their different target groups and their particular needs through tailor - made approaches within independent strands while ensuring that added value and efficiency are also fostered .


### the european capital of culture and the european heritage label help to strengthen the feeling of belonging to a common cultural area , and contribute to enhancing the value of cultural heritage . funding should be provided for these two union actions . ### the european capital of culture and the european heritage label can help to strengthen the feeling of belonging to a common cultural area , and contribute to enhancing the inherent value of cultural heritage . funding should be provided for these two union actions .


### participation in the programme will be open to acceding countries , candidate countries and potential candidates benefiting from a pre - accession strategy , in accordance with the general principles and general terms and conditions for the participation of those countries in union programmes established in the respective framework agreements , association council decisions or similar agreements ; to efta countries which are parties to the eea agreement and to countries of the european neighbourhood area in accordance with the procedures defined with those countries following the framework agreements providing for their participation in european union programmes . the participation of the swiss confederation is subject to specific arrangements with that country . ### participation in the framework programme will be open to member states , acceding countries , candidate countries and potential candidates benefiting from a pre - accession strategy , in accordance with the general principles and general terms and conditions for the participation of those countries in union programmes established in the respective framework agreements , association council decisions or similar agreements ; to efta countries which are parties to the eea agreement and to countries of the european neighbourhood area in accordance with the procedures defined with those countries following the framework agreements providing for their participation in european union programmes . the participation of the swiss confederation is subject to specific arrangements with that country .


### cooperation between the programme and international organisations in the field of culture and audiovisual such as unesco , the council of europe and in particular eurimages , oecd and the world intellectual property organisation needs to be fostered . ### cooperation between the programme and international organisations in the cultural and audiovisual fields such as unesco , the council of europe and in particular eurimages , oecd and the world intellectual property organisation and the european union national institutes for culture , needs to be fostered .


### ' cultural and creative sectors ' means all sectors whose activities are based on cultural values and / or artistic and creative expressions , whether these activities are market or non - market oriented and whatever the type of structure that carries them out . these activities include the creation , the production , the dissemination and the preservation of goods and services which embody cultural , artistic or creative expressions , as well as related functions such as education , management or regulation . the cultural and creative sectors include in particular architecture , archives and libraries , artistic crafts , audiovisual , cultural heritage , design , festivals , music , performing arts , publishing , radio and visual arts ; ### ' cultural and creative sectors ' means all sectors , including the audiovisual sector , whose activities are based on cultural values and / or artistic , creative and audiovisual expressions , whether these activities are market or non - market oriented and whatever the type of structure that carries them out . these activities include the creation , the production , the dissemination and the preservation of goods and services which embody cultural , artistic or creative expressions , as well as related functions .


### ' operator ' means a professional , an organisation , a business or an institution active in the cultural and creative sectors ; ### ' cultural and creative operator ' means a professional , an organisation , a business , including an sme , or an institution in the cultural and creative sectors , in particular the audiovisual sector ;


### to support the capacity of the european cultural and creative sectors to operate transnationally ; ### to support the capacity of the european cultural and creative sectors , in particular the audiovisual sector , to operate transnationally ;


### to strengthen the financial capacity of the cultural and creative sectors , and in particular small and medium - sized enterprises and organisations ; ### to strengthen the financial capacity of cultural and creative operators and audiovisual professionals , and in particular smes and organisations in the cultural and creative sectors ;


### to strengthen the financial capacity of the cultural and creative sectors , and in particular small and medium - sized enterprises and organisations ; ### to strengthen the financial capacity , and the access to financial capacity , of the cultural and creative sectors , and in particular small and medium - sized enterprises and organisations ;


### supporting actions enabling operators to internationalise their careers in europe and beyond ; ### supporting actions enabling cultural and creative operators to internationalise their careers in europe and beyond ;


### facilitating the acquisition of skills and the development of networks and in particular encouraging the use of digital technologies to ensure the adaptation to market development ; ### the acquisition and improvement of skills in the audiovisual field and the development of networks and in particular the use of digital technologies to ensure the adaptation to market developments ;


### increasing the capacity of audiovisual operators to develop audiovisual works with a potential to circulate in europe and beyond and to facilitate european and international co - production including with tv broadcasters ; ### the capacity of european audiovisual operators to design and develop european audiovisual works with a potential to circulate in europe and beyond and to facilitate european and international coproduction including with tv broadcasters ;


### promoting flexibility of new distribution modes in order to allow the emergence of new business models . ### promoting flexibility of new distribution modes and keeping to an absolute minimum obstacles to licensing , including cross border licensing , in order to allow the emergence of new business models with a view to ensuring completion of the digital single market .


### support the development of a comprehensive offer of new skills acquisition , knowledge sharing and networking initiatives ; ### continuing training measures to support the development of a comprehensive offer of new skills acquisition , particularly through the establishment of pan - european training provision enabling those who work in the audiovisual industry to enhance their skills , especially in it , in the international market , as well as well as knowledge sharing and networking initiatives ;


### 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 , regional operational guidelines for eib financing under this decision . these guidelines shall be prepared together with the european external action service , 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 , in line with 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 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 eeas , the eib and the main international financial institutions and european bilateral finance institutions operating in the different regions .


### 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 , 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 .


### neighbourhood and partnership countries : eur 12 400 000 000 ; ### neighbourhood and partnership countries : eur 12 900 000 000 ;


### republic of south africa : eur 900 000 000 . ### republic of south africa : eur 400 000 000 .


### personnel directly involved in the donation , procurement , testing , preservation , transport and transplantation of human organs should be suitable qualified and trained . ### personnel directly involved in the donation , procurement , testing , characterisation , preservation , transport and transplantation of human organs should be suitable qualified and trained .


### member states shall ensure that there is a reporting system in place to report , investigate , register and transmit relevant and necessary information concerning serious adverse events and reactions that may influence the quality and safety of human organs and which may be attributed to the procurement , testing , and transport of organs , as well as any serious adverse reaction observed during or after transplantation which may be connected to those activities . ### member states shall ensure that there is a reporting system in place to report , investigate , register and transmit relevant and necessary information concerning serious adverse events and reactions that may influence the quality and safety of human organs and which may be attributed to the procurement , testing , preservation and transport of organs , as well as any serious adverse reaction observed during or after transplantation which may be connected to those activities .


### member states shall communicate to the commission the text of the main provisions of national law which they adopt in the field covered by this directive . ### member states shall communicate to the commission the text of the provisions of national law which they adopt in the field covered by this directive .


### massive flows of dirty money can damage the stability and reputation of the financial sector and threaten the single market , and terrorism shakes the very foundations of our society . in addition to the criminal law approach , a preventive effort via the financial system can produce results . ### massive flows of illicit money damage the stability and reputation of the financial sector and threaten the single market as well as international development , and terrorism shakes the very foundations of our society . in addition to the criminal law approach , a preventive effort via the financial system can produce results .


### the soundness , integrity and stability of credit and financial institutions and confidence in the financial system as a whole could be seriously jeopardised by the efforts of criminals and their associates either to disguise the origin of criminal proceeds or to channel lawful or unlawful money for terrorist purposes . in order to facilitate their criminal activities , money launderers and terrorist financers could try to take advantage of the freedom of capital movements and the freedom to supply financial services which the integrated financial area entails , if certain coordinating measures are not adopted at union level . ### the soundness , integrity and stability of credit and financial institutions and confidence in the financial system as a whole could be seriously jeopardised by the efforts of criminals and their associates either to disguise the origin of criminal proceeds or to channel lawful or unlawful money for terrorist purposes . in order to facilitate their criminal activities , money launderers and terrorist financers could try to take advantage of the freedom of capital movements and the freedom to supply financial services which the integrated financial area entails , if certain coordinating measures are not adopted at union level . at the same time , the objectives of protection of society from criminals and protection of the stability and integrity of the european financial system shall be balanced against the need to create a regulatory environment that allows companies to grow their businesses without incurring disproportionate compliance costs . any requirement imposed on obliged entities to fight money laundering and terrorist financing must therefore be justified and proportionate .


### money laundering and terrorist financing are frequently carried out in an international context . measures adopted solely at national or even european union level , without taking account of international coordination and cooperation , would have very limited effects . the measures adopted by the european union in this field should therefore be consistent with other action undertaken in other international fora . the european union action should continue to take particular account of the recommendations of the fatf , which constitutes the foremost international body active in the fight against money laundering and terrorist financing . with the view to reinforce the efficacy of the fight against money laundering and terrorist financing , directives 2005 / 60 / ec and 2006 / 70 / ec should be aligned with the new fatf recommendations adopted and expanded in february 2012 . ### money laundering and terrorist financing are frequently carried out in an international context . measures adopted solely at national or even european union level , without taking account of international coordination and cooperation , would have very limited effects . the measures adopted by the european union in this field should therefore be compatible with and at least as stringent as other action undertaken in the international fora . it is noted that avoiding tax and mechanisms of non - disclosure and concealment can be used as strategies employed in money laundering and terrorist financing in order to avoid detection . the european union action should continue to take particular account of the recommendations of the fatf , which constitutes the foremost international body active in the fight against money laundering and terrorist financing . with the view to reinforce the efficacy of the fight against money laundering and terrorist financing , directives 2005 / 60 / ec and 2006 / 70 / ec should be aligned with the new fatf recommendations adopted and expanded in february 2012 .


### money laundering and terrorist financing are frequently carried out in an international context . measures adopted solely at national or even european union level , without taking account of international coordination and cooperation , would have very limited effects . the measures adopted by the european union in this field should therefore be consistent with other action undertaken in other international fora . the european union action should continue to take particular account of the recommendations of the fatf , which constitutes the foremost international body active in the fight against money laundering and terrorist financing . with the view to reinforce the efficacy of the fight against money laundering and terrorist financing , directives 2005 / 60 / ec and 2006 / 70 / ec should be aligned with the new fatf recommendations adopted and expanded in february 2012 . ### money laundering and terrorist financing are frequently carried out in an international context . measures adopted solely at national or even european union level , without taking account of international coordination and cooperation , would have very limited effects . the measures adopted by the european union in this field should therefore be consistent with other action undertaken in other international fora . the european union action should continue to take particular account of the recommendations of the fatf , and other international bodies active in the fight against money laundering and terrorist financing . with the view to reinforce the efficacy of the fight against money laundering and terrorist financing , directives 2005 / 60 / ec and 2006 / 70 / ec should , where appropriate , be aligned with the new fatf recommendations adopted and expanded in february 2012 .


### there is a need to identify any natural person who exercises ownership or control over a legal person . while finding a percentage shareholding will not automatically result in finding the beneficial owner , it is an evidential factor to be taken into account . identification and verification of beneficial owners should , where relevant , extend to legal entities that own other legal entities , and should follow the chain of ownership until the natural person who exercises ownership or control of the legal person that is the customer is found . ### there is a need to identify any natural person who exercises ownership or control over a legal person . while finding a specified percentage shareholding will not automatically result in finding the beneficial owner , it is one evidential factor among others to be taken into account . identification and verification of beneficial owners should , where relevant , extend to legal entities that own other legal entities , and should follow the chain of ownership until the natural person who exercises ownership or control of the legal person that is the customer is found . .


### there is a need to identify any natural person who exercises ownership or control over a legal person . while finding a percentage shareholding will not automatically result in finding the beneficial owner , it is an evidential factor to be taken into account . identification and verification of beneficial owners should , where relevant , extend to legal entities that own other legal entities , and should follow the chain of ownership until the natural person who exercises ownership or control of the legal person that is the customer is found . ### there is a need to identify any natural persons who exercise ownership or control over a legal person . while finding a percentage shareholding will not automatically result in finding the beneficial owner , it is an evidential factor to be taken into account . identification and verification of beneficial owners should , where relevant , extend to legal entities that own other legal entities , and should follow the chain of ownership until the natural persons who exercise ownership or control of the legal persons that is the customer is found .


### the risk of money laundering and terrorist financing is not the same in every case . accordingly , a risk - based approach should be used . the risk - based approach is not an unduly permissive option for member states and obliged entities . it involves the use of evidence - based decision making to better target the money laundering and terrorist financing risks facing the european union and those operating within it . ### the risk of money laundering and terrorist financing is not the same in every case . accordingly , a holistic risk - based approach based on minimum standards should be used . the risk - based approach is not an unduly permissive option for member states and obliged entities . it involves the use of evidence - based decision making to better target the money laundering and terrorist financing risks facing the european union and those operating within it .


### underpinning the risk - based approach is a need for member states to identify , understand and mitigate the money laundering and terrorist financing risks it faces . the importance of a supra - national approach to risk identification has been recognised at international level , and the european supervisory authority , established by regulation no 1093 / 2010 of the european parliament and of the council of 24 november 2010 establishing a european supervisory authority , amending decision no 716 / 2009 / ec and repealing commission decision 2009 / 78 / ec29 ; the european supervisory authority , established by regulation no 1094 / 2010 of the european parliament and of the council of 24 november 2010 establishing a european supervisory authority , amending decision no 716 / 2009 / ec and repealing commission decision 2009 / 79 / ec30 ; and the european supervisory authority , established by regulation no 1095 / 2010 of the european parliament and of the council of 24 november 2010 establishing a european supervisory authority , amending decision no 716 / 2009 / ec and repealing commission decision 2009 / 77 / ec31 , should be tasked with issuing an opinion on the risks affecting the financial sector . __________________ 29 oj l 331 , 15 . 12 . 2010 , p . 12 . 30 oj l 331 , 15 . 12 . 2010 , p . 48 . 31 oj l 331 , 15 . 12 . 2010 , p . 84 . ### underpinning the risk - based approach is a need for member states to identify , understand and mitigate the money laundering and terrorist financing risks it faces . the importance of a supra - national approach to risk identification has been recognised at international level , and the european supervisory authority , established by regulation no 1093 / 2010 of the european parliament and of the council of 24 november 2010 establishing a european supervisory authority , amending decision no 716 / 2009 / ec and repealing commission decision 2009 / 78 / ec29 ; the european supervisory authority , established by regulation no 1094 / 2010 of the european parliament and of the council of 24 november 2010 establishing a european supervisory authority , amending decision no 716 / 2009 / ec and repealing commission decision 2009 / 79 / ec30 ; and the european supervisory authority , established by regulation no 1095 / 2010 of the european parliament and of the council of 24 november 2010 establishing a european supervisory authority , amending decision no 716 / 2009 / ec and repealing commission decision 2009 / 77 / ec31 , should be tasked with issuing an opinion on the risks affecting the financial sector and , in cooperation with member states , develop minimum standards for risk assessments conducted by competent national authorities . this process shall involve the industry and other relevant stakeholders through public consultations and private stakeholders meetings as appropriate . __________________ 29 oj l 331 , 15 . 12 . 2010 , p . 12 . 30 oj l 331 , 15 . 12 . 2010 , p . 48 . 31 oj l 331 , 15 . 12 . 2010 , p . 84 .


### certain aspects of the implementation of this directive involve the collection , analysis , storage and sharing of data . the processing of personal data should be permitted in order to comply with the obligations laid down in this directive , including carrying out of customer due diligence , ongoing monitoring , investigation and reporting of unusual and suspicious transactions , identification of the beneficial owner of a legal person or legal arrangement , sharing of information by competent authorities and sharing of information by financial institutions . the personal data collected should be limited to what is strictly necessary for the purpose of complying with the requirements of this directive and not further processed in a way inconsistent with directive 95 / 46 / ec . in particular , further processing of personal data for commercial purposes should be strictly prohibited . ### certain aspects of the implementation of this directive involve the collection , analysis , storage and sharing of data . the processing of personal data should be permitted in order to comply with the obligations laid down in this directive , including carrying out of customer due diligence , ongoing monitoring , investigation and reporting of unusual and suspicious transactions , identification of the beneficial owner of a legal person or legal arrangement , sharing of information by competent authorities and sharing of information by financial institutions and obliged entities . the personal data collected should be limited to what is strictly necessary for the purpose of complying with the requirements of this directive and not further processed in a way inconsistent with directive 95 / 46 / ec . in particular , further processing of personal data for commercial purposes should be strictly prohibited .


### the fight against money - laundering and terrorist financing is recognised as an important public interest ground by all member states . ### the fight against money - laundering , terrorist financing and aggressive tax avoidance is recognised as an important public interest ground by all member states .


### the importance of combating money laundering and terrorist financing should lead member states to lay down effective , proportionate and dissuasive sanctions in national law for failure to respect the national provisions adopted pursuant to this directive . member states currently have a diverse range of administrative measures and sanctions for breaches of the key preventative measures . this diversity could be detrimental to the efforts put in combating money laundering and terrorist financing and the union ' s response is at risk of being fragmented . this directive should therefore include a range of administrative measures and sanctions that member states shall have available for systematic breaches of the requirements relating to customer due diligence measures , record keeping , reporting of suspicious transactions and internal controls of obliged entities . this range should be sufficiently broad to allow member states and competent authorities to take account of the differences between obliged entities , in particular between financial institutions and other obliged entities , as regards their size , characteristics and areas of activity . in the application of this directive , member states should ensure that the imposition of administrative measures and sanctions in accordance with this directive and of criminal sanctions in accordance with national law does not breach the principle of ne bis in idem . ### the importance of combating money laundering and terrorist financing should lead member states to lay down effective , proportionate and dissuasive sanctions in national law for failure to respect the national provisions adopted pursuant to this directive . member states currently have a diverse range of administrative measures and sanctions for breaches of the key preventative measures . this diversity could be detrimental to the efforts put in combating money laundering and terrorist financing and the union ' s response is at risk of being fragmented . this directive should therefore include a range of administrative measures and sanctions that member states shall have available for systematic breaches of the requirements relating to customer due diligence measures , record keeping , reporting of suspicious transactions and internal controls of obliged entities . this range should be sufficiently broad to allow member states and competent authorities to take account of the differences between obliged entities , in particular between financial institutions and other obliged entities , as regards their size , characteristics , level of risk and areas of activity . in the application of this directive , member states should ensure that the imposition of administrative measures and sanctions in accordance with this directive and of criminal sanctions in accordance with national law does not breach the principle of ne bis in idem .


### member states shall ensure that the provisions of this directive are extended in whole or in part to professions and to categories of undertakings , other than the obliged entities referred to in article 2 , which engage in activities which are particularly likely to be used for money laundering or terrorist financing purposes . ### member states shall ensure that the provisions of this directive are extended in whole or in part to professions and to categories of undertakings , other than the obliged entities referred to in article 2 , which engage in activities which are particularly likely to be used for money laundering , terrorist financing purposes , criminal activity as defined in article 3 or aggressive tax avoidance .


### each member state shall take appropriate steps to identify , assess , understand and mitigate the money laundering and terrorist financing risks affecting it , and keep the assessment up - to - date . ### each member state shall take appropriate steps to identify , assess , understand and mitigate the money laundering and terrorist financing risks affecting it , and keep the assessment up - to - date . this assessment shall comply with , but not be limited to , the minimum standards referred to in article 6 .


### member states shall make the results of their risk assessments available to the other member states , the commission , and eba , eiopa and esma upon request . ### member states shall make the results of their risk assessments publicly available to the other member states , the commission , and eba , eiopa and esma upon request .


### identifying the beneficial owner and taking reasonable measures to verify his identity so that the institution or person covered by this directive is satisfied that it knows who the beneficial owner is , including , as regards legal persons , trusts and similar legal arrangements , taking reasonable measures to understand the ownership and control structure of the customer ; ### identifying the beneficial owners and taking reasonable measures to verify their identity so that the institution or person covered by this directive is satisfied that it knows who the beneficial owners are , including , as regards legal persons , trusts and similar legal arrangements , taking reasonable measures to understand the ownership and control structure of the customer ;


### member states shall require obliged entities to examine , as far as reasonably possible , the background and purpose of all complex , unusual large transactions , and all unusual patterns of transactions , which have no apparent economic or lawful purpose . in particular , they shall increase the degree and nature of monitoring of the business relationship , in order to determine whether those transactions or activities appear unusual or suspicious . ### member states shall require obliged entities to examine the background and purpose of all complex , unusual large transactions , and all unusual patterns of transactions , which have no apparent economic or lawful purpose , or which constitute tax crimes amounting to criminal activity within the meaning of point f of article 3 , or which are constitutive of aggressive tax planning as defined by commission recommendation c 8806 . in particular , they shall increase the degree and nature of monitoring of the business relationship , in order to determine whether those transactions or activities appear unusual or suspicious . in case an obliged entity determines such unusual or suspicious transaction or activity , it shall without delay inform the fius of all member states that might be concerned .


### obliged entities shall take reasonable measures to determine whether the beneficiaries of a life or other investment related insurance policy and / or , where required , the beneficial owner of the beneficiary are politically exposed persons . those measures shall be taken at the latest at the time of the payout or at the time of the assignment , in whole or in part , of the policy . where there are higher risks identified , in addition to taking normal customer due diligence measures , member states shall require obliged entities to : ### obliged entities shall take reasonable measures , in line with the risk - based approach , to determine whether the beneficiaries of a life or other investment related insurance policy and / or , where required , the beneficial owner of the beneficiary are politically exposed persons . those measures shall be taken at the latest at the time of the payout or at the time of the assignment , in whole or in part , of the policy . where there are higher risks identified , in addition to taking normal customer due diligence measures , member states shall require obliged entities to :


### for the purposes of this section , ' third parties ' shall mean obliged entities who are listed in article 2 , or other institutions and persons situated in member states or a third country , who apply customer due diligence requirements and record keeping requirements equivalent to those laid down in this directive and their compliance with the requirements of this directive is supervised in accordance with section 2 of chapter vi . ### for the purposes of this section , ' third parties ' shall mean obliged entities who are listed in article 2 ; and other institutions and persons situated in member states or a third country , who apply customer due diligence requirements and record keeping requirements equivalent to those laid down in this directive and their compliance with the requirements of this directive is supervised in accordance with section 2 of chapter vi ; and self - regulatory bodies as defined in article 33 ; and member organisations and or federations performing due diligence on their members ;


### for the purposes of this section , ' third parties ' shall mean obliged entities who are listed in article 2 , or other institutions and persons situated in member states or a third country , who apply customer due diligence requirements and record keeping requirements equivalent to those laid down in this directive and their compliance with the requirements of this directive is supervised in accordance with section 2 of chapter vi . ### for the purposes of this section , ' third parties ' shall mean obliged entities who are listed in article 2 , or other institutions and persons situated in member states or a third country , who apply customer due diligence requirements and record keeping requirements consistent with those laid down in this directive and their compliance with the requirements of this directive is supervised in accordance with section 2 of chapter vi .


### the commission may lend such assistance as may be needed to facilitate coordination , including the exchange of information between fius within the union . it may regularly convene meetings with representatives from member states ' fius to facilitate co - operation and to exchange views on co - operation related issues . ### the commission shall lend such assistance as may be needed to facilitate coordination , including the exchange of information between fius within the union . it shall regularly convene meetings with representatives from member states ' fius , eba , eiopa and esma to facilitate co - operation and to exchange views on co - operation related issues .


### member states shall ensure that their fius co - operate with each other to the greatest extent possible irrespective of whether they are administrative , law enforcement or judicial or hybrid authorities . ### member states shall ensure that their fius co - operate with each other and with fius from non - member states to the greatest extent possible irrespective of whether they are administrative , law enforcement or judicial or hybrid authorities .


### member states shall ensure that the fiu to whom the request is made is required to use the whole range of its powers which it has domestically available for receiving and analysing information when it replies to a request for information referred to in paragraph 1 from another fiu based in the union . the fiu to whom the request is made shall respond in a timely manner and both the requesting and requested fiu shall use secure digital means to exchange information , wherever possible . ### member states shall ensure that the fiu to whom the request is made is required to use the whole range of its powers which it has domestically available for receiving and analysing information when it replies to a request for information referred to in paragraph 1 from another fiu . the fiu to whom the request is made shall respond in a timely manner and both the requesting and requested fiu shall use secure digital means to exchange information , wherever possible .


### third countries having effective anti - money laundering / combating terrorist financing systems ; ### third countries identified by credible sources , such as fatf public statements , mutual evaluation or detailed assessment reports or published follow - up reports , as having effective anti - money laundering / combating terrorist financing systems ;


### ' 4 . where a company prepares a comprehensive report corresponding to the same financial year relying on national , eu - based or international frameworks and which covers the information provided for in paragraph 1 , it shall be exempt from the obligation to prepare the non - financial statement set out in paragraph 1 , provided that such report is part of the annual report . ' ### ' 4 . where a company prepares a comprehensive report corresponding to the same financial year relying on national , eu - based or international frameworks and which covers the information provided for in paragraph 1 , it shall be exempt from the obligation to prepare the non - financial statement set out in paragraph 1 , provided that such report is part of the annual report , published together with it or referenced in it . '


### where a parent undertaking prepares a comprehensive report corresponding to the same financial year , referring to the whole group of consolidated undertakings , relying on national , eu - based or international frameworks and covering the information provided for in the third subparagraph of paragraph 1 , the parent undertaking shall be exempt from the obligation to prepare the non - financial statement set out in the third subparagraph of paragraph 1 , provided that such comprehensive report is part of the consolidated annual report . ### where a parent undertaking prepares a comprehensive report corresponding to the same financial year , referring to the whole group of consolidated undertakings , relying on national , eu - based or international frameworks and covering the information provided for in the third subparagraph of paragraph 1 , the parent undertaking shall be exempt from the obligation to prepare the non - financial statement set out in the third subparagraph of paragraph 1 , provided that such comprehensive report is part of the consolidated annual report , published together with it or referenced in it .


### the european railway agency was originally established by regulation 881 / 2004 of the european parliament and of the council of 29 april 2004 , in order to promote the establishment of a european railway area without borders and to help revitalise the railway sector while reinforcing its essential advantages in terms of safety . regulation 881 / 2004 has to be replaced by a new act due to substantial amount of changes to the tasks of the agency and its internal organisation . ### the european railway agency was originally established by regulation 881 / 2004 of the european parliament and of the council of 29 april 2004 , in order to promote the establishment of a european railway area without borders and to help revitalise the railway sector while reinforcing its essential advantages in terms of safety . regulation 881 / 2004 has to be replaced by a new act due to the substantial changes which should be made to the tasks of the agency and its internal organisation .


### the agency , while performing its tasks , and particularly in relation to drafting recommendations , should take upmost account of external railway expertise . this expertise should predominantly consist of professionals from the railway sector and the relevant national authorities . they should form competent and representative working parties of the agency . ### the agency , while performing its tasks , and particularly in relation to drafting recommendations , should take upmost account of external railway expertise . this expertise should predominantly consist of experts from the national safety authorities and other relevant national authorities as well as professionals from the railway sector . they should form competent and representative working parties of the agency .


### railway undertakings have been faced with various problems when applying for safety certificates to competent national authorities , ranging from protracting procedures and excessive costs to unfair treatment , especially of new entrants . the certificates issued in one member state have not been unconditionally recognised in other member states , with a detriment to the single european rail area . in order to make the procedures for issuing safety certificates to railway undertakings more efficient and impartial , it is essential to migrate towards a single safety certificate valid throughout the union and issued by the agency . the revised directive … [ railway safety directive ] provides a basis for this . ### railway undertakings have been faced with various problems when applying for safety certificates to competent national authorities , ranging from protracting procedures and excessive costs to unfair treatment , especially of new entrants . the certificates issued in one member state have not been unconditionally recognised in other member states , with a detriment to the single european rail area . in order to make the procedures for issuing safety certificates to railway undertakings more efficient and impartial , it is essential to migrate towards a single safety certificate valid throughout the union within the specified areas of use and issued by the agency . the revised directive … [ railway safety directive ] provides a basis for this .


### in order to further pursue the development of single european rail area , in particular with relation to providing appropriate information to freight customers and passengers , and taking into account current involvement of the agency , it is necessary to give it a strengthened role in the field of telematics applications . this would ensure their consistent development and swift deployment . ### in order to further pursue the development of single european rail area , in particular with relation to providing appropriate information to freight customers and passengers , and taking into account current involvement of the agency , it is necessary to give it a strengthened role in the field of telematics applications within a flexible framework ensuring interoperability as well as enabling innovative commercial strategies to coexist . this would ensure their consistent development and swift deployment .


### in order to further pursue the development of single european rail area , in particular with relation to providing appropriate information to freight customers and passengers , and taking into account current involvement of the agency , it is necessary to give it a strengthened role in the field of telematics applications . this would ensure their consistent development and swift deployment . ### in order to further pursue the development of single european rail area , in particular with relation to providing appropriate information to freight customers and passengers , and taking into account current involvement of the agency , it is necessary to give it a strengthened role in the field of telematics applications . this would ensure their consistent development and swift deployment , excluding commercial applications , which remain the responsibility of the operators .


### the interoperability of the trans - european network should be enhanced and the new investment projects chosen for support by the union should be in line with the objective of interoperability set in decision no 1692 / 96 / ec of the european parliament and of the council of 23 july 1996 on community guidelines for the development of the trans - european transport network . the agency is the right institution to contribute to these objectives . ### the interoperability of the trans - european network should be enhanced and both ongoing and new investment projects chosen for support by the union should be in line with the objective of interoperability set in decision no 1692 / 96 / ec of the european parliament and of the council of 23 july 1996 on community guidelines for the development of the trans - european transport network . the agency is the right institution to contribute to these objectives .


### in order to ensure the greatest possible transparency and equal access for all parties to relevant information , the documents envisaged for the railway interoperability and safety processes should be accessible to the public . the same applies to licences , safety certificates and other relevant railway documents . the agency should provide an efficient means of exchanging and publishing this information . ### in order to ensure the greatest possible transparency and equal access for all parties to relevant information , the documents envisaged for the railway interoperability and safety processes should be accessible to the public . the same applies to licences , safety certificates and other relevant railway documents . the agency should provide efficient , user friendly and easily accessible means of exchanging and publishing this information .


### in order to increase the efficiency of the union financial support , its quality and compatibility with relevant technical regulations , the agency , as the only union body with reputable competence in the railway field , should play an active role in the assessment of rail projects . ### in order to increase the efficiency of the union financial support , its quality and compatibility with relevant technical regulations , the agency should play an active role in the assessment of rail projects with european added value , in close cooperation with national infrastructure managers .


### railway interoperability and safety legislation , implementation guides or recommendations of the agency may sometimes pose interpretation and other problems to the stakeholders . proper and uniform understanding of those acts is a precondition for effective implementation of the railway acquis and the functioning of the railway market . therefore , the agency should actively engage in training and explanatory activities in that regard . ### railway interoperability and safety legislation , implementation guides or recommendations of the agency may sometimes pose interpretation and other problems to the stakeholders . proper and uniform understanding of those acts is a precondition for effective implementation of the railway acquis and the functioning of the railway market . therefore , the agency should actively engage in training and explanatory activities in that regard , with a particular attention to be given to small and medium - sized enterprises .


### certification of train drivers provided for in directive 2007 / 59 / ec of the european parliament and of the council of 23 october 2007 on the certification of train drivers operating locomotives and trains on the railway system in the community [ train drivers directive ] . ### certification of train drivers provided for in directive 2007 / 59 / ec of the european parliament and of the council of 23 october 2007 on the certification of train drivers operating locomotives and trains on the railway system in the community [ train drivers directive ] and certification of all safety - relevant staff .


### the agency shall set up a limited number of working parties for drawing up recommendations , in particular related to technical specifications for interoperability , common safety targets and common safety methods . ### the agency shall set up a limited number of working parties for drawing up recommendations , in particular related to technical specifications for interoperability , common safety targets and common safety methods . the agency shall set up a cross - cutting working party on occupational health and safety made up of equivalent ohs specialists from trade unions and from employer organisations .


### the agency may , if necessary , appoint to the working parties independent experts and representatives of international organisations recognised as competent in the field concerned . staff of the agency may not be appointed to the working parties . ### the agency may , if necessary , appoint to the working parties independent experts and representatives of international organisations recognised as competent in the field concerned . staff of the agency may not be appointed to the working parties , except for the chair of the working parties , who shall be a representative of the agency .


### each representative body referred to in article 34 shall forward to the agency a list of the most qualified experts mandated to represent them in each working party . ### each year , each representative body referred to in article 34 shall forward to the agency a list of the most qualified experts mandated to represent them in each working party .


### these consultations shall be held before the agency submits its recommendations to the commission . the agency shall take due account of these consultations , and shall , at all times , be available to expound on its recommendations . the opinions expressed by the sectoral dialogue committee shall be forwarded by the agency to the commission and by the commission to the committee referred to in article 75 . ### these consultations shall be held before the agency submits its recommendations to the commission . the agency shall take due account of these consultations , and shall , at all times , be available to expound on its recommendations . the opinions expressed by the sectoral dialogue committee shall be forwarded , within two months , by the agency to the commission and by the commission to the committee referred to in article 75 .


### these consultations shall be held before the agency submits its proposals to the commission . the agency shall take due account of these consultations , and shall , at all times , be available to expound on its proposals . the opinions expressed by the organisations concerned shall be forwarded by the agency to the commission and by the commission to the committee referred to in article 75 . ### these consultations shall be held before the agency submits its proposals to the commission . the agency shall take due account of these consultations , and shall , at all times , be available to expound on its proposals . the opinions expressed by the organisations concerned shall be forwarded , within two months , by the agency to the commission and by the commission to the committee referred to in article 75 .


### where after the examination referred to paragraph 1 the agency considers that national rules enable the essential requirements for interoperability to be fulfilled , csms to be respected and the csts to be achieved , and that they would not result in arbitrary discrimination or a disguised restriction on rail transport operation between member states , the agency shall inform the commission and the member state concerned about its positive assessment . the commission may validate the rule in the it system referred to in article 23 . ### where after examination and within the deadlines referred to in paragraph 1 the agency considers that national rules enable the essential requirements for interoperability to be fulfilled , csms to be respected and the csts to be achieved , and that they would not result in arbitrary discrimination or a disguised restriction on rail transport operation , the agency shall inform the commission and the member state concerned about its positive assessment . the commission may validate the rule in the it system referred to in article 23 .


### issue a recommendation addressed to the member state concerned stating the reasons why the rule in question should be modified or repealed ; ### issue a recommendation addressed to the member state concerned , that the problematic rule be repealed or modified immediately , and stating the reasons why that rule has to be modified or repealed ;


### if the agency considers that the deficiencies referred to in paragraph 3 prevent the national safety authority concerned from effectively performing its tasks in relation to railway safety and interoperability , the agency shall recommend to the national safety authority to take appropriate steps within a time limit to be defined taking into account the importance of the deficiency . ### if the agency considers that the deficiencies referred to in paragraph 3 prevent the national safety authority concerned from effectively performing its tasks in relation to railway safety and interoperability , the agency shall recommend to the national safety authority to take appropriate steps within a time limit which it defines taking into account the importance of the deficiency .


### the agency shall make the following documents and registers provided for by directive … [ interoperability directive ] and directive … [ railway safety directive ] publicly available : ### the agency shall make the following documents and registers provided for by directive … [ interoperability directive ] and directive … [ railway safety directive ] publicly available through an implemented , user - friendly and easily accessible it solution :


### the national rules notified to the commission in accordance with article 8 of directive … [ railway safety directive ] and articles 14 of directive … [ interoperability directive ] ; ### the national rules notified to the commission in accordance with article 8 of directive … [ railway safety directive ] and article 14 of directive … [ interoperability directive ] and the agency ' s assessment of them ;


### the vehicle registers , including via links to relevant national registers ; ### the european vehicle register ;


### the vehicle registers , including via links to relevant national registers ; ### european vehicle register ;


### the agency shall establish a network of representative bodies from the railway sector acting at the union level . the list of these bodies shall be defined in an implementing act adopted by the commission , in accordance with advisory procedure referred to in article 75 . the agency shall provide the network with a secretariat . the tasks of the network shall , in particular , be : ### the agency shall establish a network of representative bodies from the railway sector acting at the union level , including representatives of passengers and of workers . the list of these bodies shall be defined in an implementing act adopted by the commission , in accordance with advisory procedure referred to in article 75 . the agency shall provide the network with a secretariat . the tasks of the network shall , in particular , be :


### without prejudice to the derogations provided for by article 9 of directive [ … ] [ railway interoperability directive ] , the agency shall , at the commission ' s request , examine , from the point of view of interoperability and safety , any project involving the design , construction , renewal or upgrading of the subsystem for which an application for union financial support has been submitted . ### without prejudice to the derogations provided for by article 9 of directive [ … ] [ railway interoperability directive ] , the agency shall , at the commission ' s request , examine , from the point of view of interoperability and safety , any project involving the design , construction , renewal or upgrading of the subsystem for which an application for union financial support has been submitted . in the case of projects funded under the trans european network – transport programme , the agency should closely cooperate with the ten - t executive agency .


### the term of office of the members shall be four years and may be renewed . ### the term of office of the members shall be five years and may be renewed once .


### the term of office of the chairperson and deputy chairperson shall be four years and may be renewed . if , however , their membership of the management board ends at any time during their term of office , their term of office shall automatically expire on that date also . ### the term of office of the chairperson and deputy chairperson shall be five years and may be renewed once . if , however , their membership of the management board ends at any time during their term of office , their term of office shall automatically expire on that date also .


### the work programme shall be adopted without prejudice to the union’s annual budgetary procedure . if , within 15 days of the date of adoption of the work programme , the commission expresses its disagreement with the programme , the management board shall re - examine the programme and adopt it , as amended if necessary , within a period of two months , in second reading either by a two - thirds majority of its members entitled to vote , including by all commission representatives , or by unanimity of the representatives of the member states . ### the work programme shall be adopted without prejudice to the union’s annual budgetary procedure . if , within 15 days of the date of adoption of the work programme , the commission expresses its disagreement with the programme , the management board shall re - examine the programme and adopt it , as amended if necessary , within a period of two months , in second reading by a two - thirds majority of its members entitled to vote , including all commission representatives .


### the term of office of the members and alternates of a board of appeal shall be four years and may be renewed . ### the term of office of the members and alternates of a board of appeal shall be five years and may be renewed once .


### the members of a board of appeal shall be independent and may not perform any other duties within the agency . in making their decisions they shall not be bound by any instructions . ### the members of a board of appeal shall be independent and may not perform any other duties within the agency or the commission . in making their decisions they shall not be bound by any instructions .


### the members of the board of appeal may not take part in any appeal proceedings if they have any personal interest in the proceedings , if they have previously been involved as representatives of one of the parties to the proceedings , or if they participated in the decision under appeal . ### the members of the board of appeal shall not take part in any appeal proceedings if they have any personal interest in the proceedings , if they have previously been involved as representatives of one of the parties to the proceedings , or if they participated in the decision under appeal .


### an appeal may be brought before the board of appeal against decisions taken by the agency pursuant to articles 12 , 16 , 17 and 18 . ### an appeal may be brought before the board of appeal against decisions taken , or not taken within the prescribed time limits , by the agency pursuant to articles 12 , 16 , 17 and 18 .


### when examining the appeal , the board of appeal shall act expeditiously . it shall , as often as necessary , invite the parties to the appeal proceedings to file , within specified time limits , observations on its notifications or on communications from other parties to the appeal proceedings . parties to the appeal proceedings shall be entitled to make oral presentations . ### when examining the appeal , the board of appeal shall act expeditiously and within a maximum of two months . it shall , as often as necessary , invite the parties to the appeal proceedings to file , within one month , observations on its notifications or on communications from other parties to the appeal proceedings . parties to the appeal proceedings shall be entitled to make oral presentations .


### the revenue of the agency shall consist of : ### the revenue of the agency shall consist , in particular , of :


### the agency may also make use of seconded national experts or other staff not employed by the agency under the staff regulations and the conditions of employment of other servants . ### the agency shall make use of seconded national experts and in particular staff from national safety authorities , or other staff not employed by the agency under the staff regulations and the conditions of employment of other servants .


### the protocol on the privileges and immunities of the european union shall apply to the agency and its staff . ### the protocol on the privileges and immunities of the european union shall apply to the agency and its staff without prejudice to judicial and / or extra - judicial proceedings relating to the agency’s remit .


### combating fraud ### combating fraud and monitoring performance


### in order to further improve road safety , the communication ‘ ecall : time for deployment’6 proposes new measures to accelerate the deployment of an in - vehicle emergency call service in the union . one of the suggested measures is to make mandatory the fitting of ecall in - vehicle systems in all new vehicles starting with m1 and n1 vehicle categories as defined in annex ii to directive 2007 / 46 / ec . __________________ 6 com 434 final . ### in order to further improve road safety , the communication ‘ ecall : time for deployment’6 proposes new measures to deploy an in - vehicle emergency call service in the union without neglecting the principle of technology neutrality . one of the suggested measures is to make mandatory the fitting of ecall in - vehicle systems in all new vehicles starting with m1 and n1 vehicle categories as defined in annex ii to directive 2007 / 46 / ec . __________________ 6 com 434 final .


### the union ecall system is expected to reduce the number of fatalities in the union as well as the severity of injuries caused by road accidents . the mandatory introduction of the ecall system would make the service available to all citizens and thus contribute to reduce human suffering and healthcare and other costs . ### the union ecall system is expected to reduce the number of fatalities in the union as well as the severity of injuries caused by road accidents , thanks to the optimum speed of the emergency services in rescuing victims . the mandatory introduction of the ecall system would make the service available to all citizens and thus contribute to reduce human suffering and costs relating to healthcare , congestion caused by accidents and the installation of emergency roadside telephones .


### the provision of accurate and reliable positioning information is an essential element of the effective operation of the ecall in - vehicle system . therefore , it is appropriate to require its compatibility with the services provided by satellite navigation programmes , including the systems established under the galileo and egnos programmes set out in regulation no 683 / 2008 of the european parliament and of the council of 9 july 2008 on the further implementation of the european satellite navigation programmes 8 . __________________ 8 oj l 196 , 24 . 7 . 2008 , p . 1 . ### the provision of accurate and reliable positioning information is an essential element of the effective operation of the ecall in - vehicle system . therefore , it is appropriate to require its compatibility with the operational services provided by satellite navigation programmes , for example the systems established under the galileo and egnos programmes set out in regulation no 683 / 2008 of the european parliament and of the council of 9 july 2008 on the further implementation of the european satellite navigation programmes 8 . __________________ 8 oj l 196 , 24 . 7 . 2008 , p . 1 .


### the mandatory equipping of vehicles with the ecall in - vehicle system should be without prejudice to the right of all stakeholders such as car manufacturers and independent operators to offer additional emergency and / or added value services , in parallel with or building on the 112 - based ecall in - vehicle system . however , these additional services should be designed not to increase driver distraction . ### the mandatory equipping of vehicles with the ecall in - vehicle system should be without prejudice to the right of all stakeholders such as car manufacturers and independent operators to offer additional third - party emergency and / or added value services , in parallel with or building on the 112 - based ecall in - vehicle system . however , any additional services should be designed not to increase driver distraction and should be in line with the applicable data privacy protection legislation . it should also be ensured that the efficient work of emergency call centres is under no circumstances hampered by vehicle manufacturers ' parallel emergency services .


### in order to ensure open choice for customers and fair competition , as well as encourage innovation and boost the competitiveness of the union ' s information technology industry on the global market , the ecall in - vehicle system should be accessible free of charge and without discrimination to all independent operators and based on an interoperable and open - access platform for possible future in - vehicle applications or services . ### in order to ensure open choice for customers and fair competition , as well as encourage innovation and boost the competitiveness of the union ' s information technology industry on the global market , the 112 - based ecall in - vehicle system should be accessible free of charge and without discrimination to all independent operators and based on an interoperable , open - access , secured and standardised platform for possible future in - vehicle applications or services .


### according to the recommendations made by the article 29 data protection working party and contained in the ' working document on data protection and privacy implications in ecall initiative ' , adopted on 26 september 20069 , any processing of personal data through the ecall in - vehicle system should comply with the personal data protection rules provided for in directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data10 and in directive 2002 / 58 / ec of the european parliament and of the council of 12 july 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector 11 , in particular to guarantee that vehicles equipped with ecall in - vehicle systems , in their normal operational status related to 112 ecall , are not traceable and are not subject to any constant tracking and that the minimum set of data sent by the in - vehicle ecall system includes the minimum information required for the appropriate handling of emergency calls . __________________ 9 1609 / 06 / en – wp 125 . 10 oj l 281 , 23 . 11 . 1995 , p . 31 . 11 oj l 201 , 31 . 7 . 2002 , p . 37 . ### according to the recommendations made by the article 29 data protection working party and contained in the ' working document on data protection and privacy implications in ecall initiative ' , adopted on 26 september 20069 , any processing of personal data through the ecall in - vehicle system should comply with the personal data protection rules provided for in directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data10 and in directive 2002 / 58 / ec of the european parliament and of the council of 12 july 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector , in particular to guarantee that vehicles equipped with ecall in - vehicle systems , in their normal operational status related to 112 ecall , are not traceable and are not subject to any constant tracking and that the minimum set of data sent by the in - vehicle ecall system includes the minimum information required for the handling of emergency calls by public service answering points . __________________ 9 1609 / 06 / en – wp 125 . 10 oj l 281 , 23 . 11 . 1995 , p . 31 . 11 oj l 201 , 31 . 7 . 2002 , p . 37 .


### ' e - call in - vehicle system ' means a system activated either automatically via in - vehicle sensors or manually , which carries , by means of mobile wireless communications networks , a standardised minimum set of data and establishes a 112 - based audio channel between the occupants of the vehicle and a public safety answering point ; ### ' 112 - based ecall in - vehicle system ' or ' public ecall ' means a sleeping system activated either automatically via in - vehicle sensors or manually , which carries , by means of public mobile wireless communications networks , a standardised minimum set of data and establishes a 112 - based audio channel between the occupants of the vehicle and a public safety answering point ;


### manufacturers shall demonstrate that all their new types of vehicle are constructed to ensure that in the event of a severe accident which occurs in the territory of the union , an ecall to the single european emergency number 112 is triggered automatically . ### manufacturers shall demonstrate that all their new types of vehicle are constructed to ensure that in the event of a severe accident , detected through activation of one or more sensors and / or processors within the vehicle , which occurs in the territory of the union , an ecall to the emergency number 112 is triggered automatically .


### manufacturers shall ensure that the receivers in the in - vehicle systems are compatible with the positioning services provided by satellite navigation systems including the galileo and the egnos systems . ### manufacturers shall ensure that the receivers in the embedded in - vehicle appliance are compatible with the operational positioning services provided by satellite navigation systems including the galileo and the egnos systems .


### the minimum set of data sent by the ecall in - vehicle system shall include only the minimum information required for the appropriate handling of emergency calls . ### the minimum set of data sent by the 112 - based ecall in - vehicle system to psaps shall include only the minimum information required for the appropriate handling of emergency calls by psaps . this msd should be reviewed periodically for revaluation of optional msd to mandatory msd , or for the possible addition of beneficial information to the msd .


### manufacturers shall ensure that ecall users are provided with clear and comprehensive information about the processing of data carried out through the ecall in - vehicle system , in particular about : ### manufacturers shall ensure that ecall users can freely choose from among services supplied by private ecall service providers and are provided with clear and comprehensive information , by those providers , about the processing of data carried out through the private ecall system , in particular about :


### the time limit for the retention of data in the in - vehicle system ; ### the time limit for the retention of data in the embedded in - vehicle appliance ;


### exemptions ### exemptions and retrofitting


### the power to adopt delegated acts referred to in article 5 , article 6 and in article 8 shall be conferred on the commission for an indeterminate period of time from [ … ] [ publications office , please insert the exact date of entry into force ] . ### the power to adopt delegated acts referred to in article 5 , article 6 and in article 8 shall be conferred on the commission for a period of five years from the date of entry into force of this regulation . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the 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 .


### member states shall lay down the rules on penalties applicable to non - compliance by manufacturers with the provisions of this regulation and shall take all measures to ensure that they are implemented . the penalties provided for shall be effective , proportionate and dissuasive . members states shall notify those provisions to the commission , and shall notify it without delay of any subsequent amendment affecting them . ### member states shall lay down the rules on penalties applicable to non - compliance by manufacturers with the provisions of this regulation and the corresponding delegated acts and shall take all measures to ensure that they are implemented . the penalties provided for shall be effective , proportionate and dissuasive , in particular where article 6 of this regulation is violated . member states shall notify those provisions to the commission , and shall notify it without delay of any subsequent amendment affecting them .


### it is therefore necessary to ensure a more level playing field for undertakings operating in the internal market and to improve the conditions for consumers to exercise the rights they derive from the internal market . it is also appropriate to increase legal certainty and to reduce the differences between the member states as to the national rules governing actions for damages for infringements of european competition law and , when applied in parallel to the latter , national competition law . an approximation of these rules will also help to prevent the emergence of wider differences between the member states ' rules governing actions for damages in competition cases . ### it is therefore necessary to ensure a more level playing field for undertakings operating in the internal market and to improve the conditions for consumers to exercise the rights they derive from the internal market . it is also appropriate to increase legal certainty and to reduce the differences between the member states as to the national rules governing actions for damages for infringements of european competition law and , when applied in parallel to the latter , national competition law . an approximation of these rules and an obligation for the member states to introduce collective redress mechanisms based on defined common principles will also help to prevent the emergence of wider differences between the member states ' rules governing actions for damages in competition cases .


### relevant evidence should be disclosed upon decision of the court and under its strict control , especially as regards the necessity and proportionality of the disclosure measure . it follows from the requirement of proportionality that disclosure requests can only be triggered once an injured party has made it plausible , on the basis of facts which are reasonably available to him , that the party has suffered harm that was caused by the defendant . the request for disclosure should refer to categories of evidence which are as precise and narrow as possible on the basis of reasonably available facts . ### relevant evidence should be disclosed upon decision of the court and under its strict control , especially as regards the necessity and proportionality of the disclosure measure . it follows from the requirement of proportionality that disclosure requests can only be triggered once an injured party has provided a reasoned justification , on the basis of facts which are reasonably available to him , that the party has suffered harm that was caused by the defendant . the request for disclosure should refer to evidence which is defined as precisely and narrowly as possible on the basis of reasonably available facts .


### while relevant evidence containing business secrets or otherwise confidential information should in principle be available in actions for damages , such confidential information needs to be appropriately protected . national courts should therefore have at their disposal a range of measures to protect such confidential information from being disclosed during the proceedings . these may include the possibility of hearings in private , restricting the circle of persons entitled to see the evidence , and instruction of experts to produce summaries of the information in an aggregated or otherwise non - confidential form . measures protecting business secrets and other confidential information should not practically impede the exercise of the right to compensation . ### while relevant evidence containing business secrets or otherwise confidential information should in principle be available in actions for damages , such confidential information needs to be appropriately protected . national courts should therefore have at their disposal a range of measures to protect such confidential information from being disclosed during the proceedings . these may include the possibility of hearings in private , redacting that confidential information , restricting the circle of persons entitled to see the evidence , and instruction of experts to produce summaries of the information in an aggregated or otherwise non - confidential form . measures protecting business secrets and other confidential information should not practically impede the exercise of the right to compensation .