### regional institutional cooperation structures covering the coastal zone or the marine region or sub - region concerned , or ### regional sea conventions or other regional institutional cooperation structures covering the coastal zone or the marine region or sub - region concerned , or


### a dedicated network of member states’ competent authorities covering the marine region and / or sub - region concerned . ### a dedicated network of member states’ competent authorities covering the coastal zone , marine region and / or sub - region concerned .


### this report shall at least contain information on the implementation of articles 6 to 13 . ### this report shall at least contain information on the implementation of articles 6 to 13 . where possible , the content and format of the report will be harmonised with the relevant specifications of 2008 / 56 / ec .


### the commission shall submit a progress report to the european parliament and council outlining the progress made in implementing this directive . ### the commission shall , no later than two years after the publication of this directive in the official journal of the european union , submit a progress report to the european parliament and council outlining the progress made in implementing it .


### the commission shall submit a progress report to the european parliament and council outlining the progress made in implementing this directive . ### the commission shall submit a progress report to the european parliament and council at the latest a year after the deadline for the establishment of the maritime spatial plans and integrated coastal management strategies , outlining the progress made in implementing this directive .


### the maritime spatial plans and integrated coastal management strategies referred to in article 4 shall be established within a period of 36 months after the entry into force of this directive . ### the maritime spatial plans and integrated coastal management strategies referred to in article 4 shall be established within a period of 36 months after the entry into force of the legislative , regulatory and administrative provisions needed to comply with this directive .


### the reports referred to in article 15 shall be provided , at the latest , 42 months following the entry into force of the directive , and every six years thereafter . ### the reports referred to in article 15 shall be provided , at the latest , 42 months following the entry into force of the directive , and every four years thereafter .


### the progress report referred to in article 15 shall be submitted at the latest six months after the date referred to in paragraph 5 , and every six years thereafter . ### the progress report referred to in article 15 shall be submitted at the latest six months after the date referred to in paragraph 5 , and every four years thereafter .


### the community needs a specific body responsible for macro - prudential oversight across the eu financial system , which would identify risks to financial stability and , where necessary , issue risk warnings and recommendations for action to address such risks . consequently , a european systemic risk board should be established as a new independent body , responsible for conducting macro - prudential oversight at the european level . ### the community needs a specific body responsible for macro - prudential oversight across the eu financial system , which would identify risks to financial stability and , where necessary , issue risk warnings and recommendations for action to address such risks . consequently , a european systemic risk board should be established as a new independent body , responsible for conducting macro - prudential oversight at the european level . the analyses of the esrb should be confined to the financial sector and should not concern wage policy or fiscal policy issues .


### five other members of the general board who are also members of the general council of the ecb . they shall be elected by and from the members of the general board who are also members of the general council of the ecb for a period of two years . ### five chairmen of national central banks . they shall be elected by and from the members of the general board who are also members of the general council of the ecb for a period of two years .


### if the esrb decides that its recommendation has not been followed and that the addressees have failed to explain their inaction appropriately , it shall inform the council and , where relevant , the european supervisory authorities concerned . ### if the esrb decides that its recommendation has not been followed and that the addressees have failed to explain their inaction appropriately , it shall inform the council , the commission and , where relevant , the european supervisory authorities concerned .


### the esrb shall also examine specific issues at the invitation of the council or the commission . ### the esrb shall also examine specific issues at the invitation of the council , the european parliament or the commission .


### in order to ensure harmonised responses across the community to safety concerns regarding medicinal products for human use , the pharmacovigilance risk assessment advisory committee should support the committee for medicinal products for human use and the coordination group established by directive 2001 / 83 / ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use on any question relating to the pharmacovigilance of medicinal products for human use . however , for the sake of consistency and continuity of the assessments , the final responsibility for the risk - benefit assessment of medicinal products for human use authorised in accordance with this regulation should remain with the committee for medicinal products for human use of the agency and with the authorities competent for the granting of marketing authorisations . ### in order to ensure harmonised responses across the community to safety concerns regarding medicinal products for human use , the committee for medicinal products for human use and the coordination group established by directive 2001 / 83 / ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use should rely on the recommendation of the pharmacovigilance risk assessment committee on any question relating to the pharmacovigilance of medicinal products for human use . however , for the sake of consistency and continuity of the assessments , the final responsibility for the risk - benefit assessment of medicinal products for human use authorised in accordance with this regulation should remain with the committee for medicinal products for human use of the agency and with the authorities competent for the granting of marketing authorisations .


### for the fulfilment of its pharmacovigilance tasks , it shall be assisted by the pharmacovigilance risk assessment advisory committee referred to in article 56 . ### for the fulfilment of its pharmacovigilance tasks , it shall rely on the recommendation of the pharmacovigilance risk assessment committee referred to in article 56 . the word « advisory » should be removed from the title of the pharmacovigilance risk assessment committee so that it better reflects the powers of the committee . if adopted the name will be changed throughout the text .


### within 30 days of receipt of the report by the pharmacovigilance risk assessment advisory committee , the committee for medicinal products for human use shall consider the report and adopt an opinion on the maintenance , variation , suspension or revocation of the marketing authorisation concerned . where the opinion states that regulatory action is necessary , the commission shall adopt a decision to vary , suspend or revoke the marketing authorisation . article 10 of this regulation shall apply to the adoption of that decision . where the commission adopts such decision , it may also adopt a decision addressed to the member states pursuant to article 127a of directive 2001 / 83 / ec . ### within 30 days of receipt of the recommendation by the pharmacovigilance risk assessment committee , the committee for medicinal products for human use shall adopt an opinion on the maintenance , variation , suspension or revocation of the marketing authorisation concerned . the chmp shall only adopt an opinion which differs from the recommendation of the pharmacovigilance risk assessment committee , if there exist strong scientific and public health grounds for doing so . the chmp shall explain these grounds in a justification which it shall annex to its opinion . where the opinion states that regulatory action is necessary , the commission shall adopt a decision to vary , suspend or revoke the marketing authorisation . article 10 of this regulation shall apply to the adoption of that decision . where the commission adopts such decision , it may also adopt a decision addressed to the member states pursuant to article 127a of directive 2001 / 83 / ec .


### the agency shall perform regular audit of its pharmacovigilance tasks and report the results to its management board on a two - yearly basis . ### the agency shall perform regular independent audit of its pharmacovigilance tasks and report the results to its management board on a two - yearly basis .


### representatives of the national competent authorities shall be entitled to attend all meetings of the pharmacovigilance risk assessment advisory committee to facilitate appropriate coordination between the tasks of the agency and the work of national competent authorities . they may provide clarification or information if invited to do so but shall not seek to influence discussions . ” ### representatives of the national competent authorities shall be entitled to attend all meetings of the pharmacovigilance risk assessment advisory committee and to participate in discussions in order to facilitate appropriate coordination between the tasks of the agency and the work of national competent authorities .


### activities relating to pharmacovigilance , to the operation of communications networks and to market surveillance shall be under the permanent control of the management board in order to guarantee the independence of the agency . this shall not preclude the collection of fees to be paid by marketing authorisation holders for the carrying out of these activities by the agency . ### activities relating to pharmacovigilance , to the operation of communications networks and to market surveillance shall be under the permanent control of the management board in order to guarantee the independence of the agency and shall receive public financing commensurate with the tasks set . this shall not preclude the indirect collection of additional resources for the carrying out of these activities by the agency , on condition that its independence is strictly guaranteed .


### the global resources for the implementation of this regulation shall be 3 , 520 eur million . ### the indicative global resources for the implementation of this regulation shall be 3 , 520 eur million .


### the annual appropriations shall be authorised by the budgetary authority within the limits of the financial framework . ### the annual appropriations for the fund shall be authorised by the budgetary authority without prejudice to the provisions of the regulation laying down the multiannual financial framework for the years 2014 - 2020 and the interinstitutional agreement of xxx / 201z between the european parliament , the council and the commission on cooperation in budgetary matters and sound financial management .


### the global resources shall be used indicatively as follows : ### without prejudice to the prerogatives of the budgetary authority , the global resources shall be used indicatively as follows :


### eur 2 , 000 million shall be allocated to the member states indicatively as follows : ### without prejudice to the prerogatives of the budgetary authority , eur 2 , 000 million shall be allocated to the member states indicatively as follows :


### two main political initiatives have shaped the regional cooperation in the european union’s neighbourhood : the eastern partnership between the union and its eastern neighbours , and the union for the mediterranean between the union and its southern mediterranean neighbours . these initiatives are meaningful political frameworks for deepening relations with and among partner countries , based on principles of shared ownership and responsibility . ### two main political initiatives have shaped the regional cooperation in the european union’s neighbourhood : the eastern partnership between the union and its eastern neighbours , and the union for the mediterranean , along with arlem , between the union and its southern mediterranean neighbours . these initiatives are meaningful political frameworks for deepening relations with and among partner countries , based on principles of shared ownership and responsibility .


### a number of major developments have taken place since the european neighbourhood policy was launched and the european neighbourhood and partnership instrument was set up . these include a deepening of the relationship with the partners , the launch of regional initiatives and democratic transition processes in the region . this triggered a new european neighbourhood policy vision set out in 2011 as a result of a comprehensive strategic review of the policy . it outlines key objectives for union cooperation with neighbourhood countries and provides for greater support to partners committed to building democratic societies and undertaking reforms , in line with the ‘ more for more’ and ‘ mutual accountability’ principles . ### a number of major political changes have occurred in both the southern and eastern neighbouring countries since the european neighbourhood policy was launched and the european neighbourhood and partnership instrument was set up . these include a deepening of the relationship with the partners , the launch of regional initiatives and democratic transition processes in the region . this triggered a new european neighbourhood policy vision set out in 2011 as a result of a comprehensive strategic review of the policy . it outlines key objectives for union cooperation with neighbourhood countries and provides for greater support to partners committed to building democratic societies and undertaking reforms , in line with the ‘ more for more’ and ‘ mutual accountability’ principles .


### furthermore , it is important to foster and facilitate cooperation for the common benefit of union and its partners , notably through pooling of contributions from internal and external instruments of the union budget , in particular for cross - border cooperation , infrastructure projects of union interest that will pass through neighbourhood countries and other areas of cooperation . ### furthermore , it is important to foster and facilitate cooperation for the common benefit of the union and its partners , notably through pooling of contributions from internal and external instruments of the union budget , in particular for cross - border cooperation , infrastructure projects of union interest that will pass through neighbourhood countries , in particular those concerning energy production and transport , and other areas of cooperation such as rdi and knowledge transfer and technology in the field of low carbon technologies and energy efficiency .


### cross - border co - operation will contribute as appropriate to the implementation of existing and future macro - regional strategies . ### cross - border co - operation will contribute as appropriate to the implementation of existing and future macro - regional strategies . most notably by prioritising gas , electricity and oil corridors , and natural gas storage infrastructure .


### the union and its member states should improve the coherence and the complementarity of their respective policies on cooperation with neighbouring countries . to ensure that the union ' s cooperation and that of the member states complement and reinforce each other , it is appropriate to provide for joint programming which should be implemented whenever possible and relevant . ### the union and its member states should improve the coherence and the complementarity of their respective policies on cooperation with neighbouring countries , taking also into account the priorities laid down in the europe 2020 strategy . to ensure that the union ' s cooperation and that of the member states complement and reinforce each other , it is appropriate to provide for joint programming which should be implemented whenever possible and relevant .


### fighting climate change is one of the great challenges which the union faces and urgent international action is needed . in accordance with the intent stated in the commission june 2011 mff communication of increasing the climate related proportion of the union budget to at least 20% , this regulation should contribute to that goal . ### fighting climate change is one of the great challenges which the union faces and urgent international action is needed , e . g . promoting renewable energies . in accordance with the intent stated in the commission june 2011 mff communication of increasing the climate related proportion of the union budget to at least 20% , this regulation should contribute to that goal . initiatives such as the mediterranean solar plan ought to strengthen this aim .


### support under this regulation shall promote enhanced political cooperation and progressive economic integration between the union and the partner countries and , in particular , the implementation of partnership and cooperation agreements , association agreements or other existing and future agreements , and jointly agreed action plans . ### support under this regulation shall promote enhanced political cooperation and progressive economic integration between the union and the partner countries and , in particular , the implementation of partnership and cooperation agreements , association agreements or other existing and future agreements , and jointly agreed macro - regional strategies and action plans .


### sustainable and inclusive development in all aspects , poverty reduction , including through private - sector development ; promotion of internal economic , social and territorial cohesion , rural development , climate action and disaster resilience ; ### sustainable , equitable and inclusive development , hunger and poverty reduction , promotion of economic , social and territorial cohesion , rural development , combating climate change , disaster resilience and promotion of r&d ;


### enhancing sub - regional , regional and neighbourhood wide collaboration as well as cross - border cooperation . ### enhancing sub - regional , regional and neighbourhood wide collaboration , as well as cross - border and territorial cooperation , by fostering regional synergies and networks in fields such as the environment , climate change , energy , research , ict , culture and mobility .


### the achievement of these objectives shall be measured using notably the relevant eu periodic reports on the implementation of the policy , and for paragraphs 2 , and , the relevant indicators established by international organisations and other relevant bodies ; for paragraphs 2 , and the uptake of the eu regulatory framework by the partner countries as relevant ; for paragraphs 2 and , the number of relevant agreements and cooperation actions . the indicators will include , among others , adequately monitored democratic elections , level of corruption , trade flows , indicators enabling measuring internal economic disparities , including employment levels . ### the achievement of these objectives shall be measured using notably the relevant eu periodic reports on the implementation of the policy , and for paragraphs 2 , and , the relevant indicators established by international organisations and other relevant bodies ; for paragraphs 2 , and the uptake of the eu regulatory framework by the partner countries as relevant ; for paragraphs 2 and , the number of relevant agreements and cooperation actions . the indicators will include , among others , adequately monitored democratic elections , level of corruption , trade flows , indicators enabling measuring internal economic disparities , such as differences in income and employment levels , access to electricity and other forms of energy , to water and to sanitation .


### for multi - country programmes , a comprehensive programming document including a strategy and a multi - annual indicative programme shall be adopted in accordance with the examination procedure referred to in article 15 of the common implementing regulation . it shall define the priorities for union support towards the region or the sub - region and the indicative level of funding broken down by priority . it shall have an appropriate multi - annual duration . ### for multi - country macro - regional programmes and strategies , a comprehensive programming document including a strategy and a multi - annual indicative programme shall be adopted in accordance with the examination procedure referred to in article 15 of the common implementing regulation . it shall define the priorities for union support towards the region or the sub - region and the indicative level of funding broken down by priority . it shall have an appropriate multi - annual duration .


### the financial envelope available for implementing this regulation over the period 2014 to 2020 shall be eur&#160 ; 18&#160 ; 182&#160 ; 300&#160 ; 000 . up to 5% of the financial envelope shall be allocated to the cross - border cooperation programmes referred to in article 6 . ### the financial envelope available for implementing this regulation over the period 2014 to 2020 shall be eur&#160 ; 18&#160 ; 182&#160 ; 300&#160 ; 000 . up to 15% of the financial envelope shall be allocated to the cross - border cooperation programmes referred to in article 6 , and .


### experience gained from the application of the current legal framework has also shown that certain restrictions on the possibilities of pharmaceutical companies to provide information result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the community . ### experience gained from the application of the current legal framework has also shown that certain restrictions on the possibilities of pharmaceutical companies to provide information result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the community . each notion should be defined and should be interpreted uniformly across all eu member states so to ensure patient safety .


### experience gained from the application of the current legal framework has also shown that certain restrictions on the possibilities of pharmaceutical companies to provide information result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the community . ### experience gained from the application of the current legal framework has also shown that the distinction between the notions of advertising and information is not clear across the community , resulting in exposure of the general public is disguised advertising .


### national competent authorities and health care professionals should remain important sources of information on medicinal products for the general public . member states should facilitate the access of citizens to high - quality information through appropriate channels . marketing authorisation holders may be a valuable source of non promotional information on their medicinal products . this directive should therefore establish a legal framework for the dissemination of specific information on medicinal products by marketing authorisation holders to the general public . the ban on advertising to the general public for prescription - only medicinal products should be maintained . ### national competent authorities and health care professionals should remain the main source of information on medicinal products for the general public . while there is already a lot of independent information on pharmaceuticals , for example by national authorities or health care professionals , the situation differs very much between member states and among the different products available . member states and commission should take much more efforts to facilitate the access of citizens to high - quality information through appropriate channels .


### information to the general public on prescription - only medicinal products should only be provided through specific channels of communication , including internet and health - related publications , to avoid that the effectiveness of the prohibition on advertising is undermined by unsolicited provision of information to the public . where information is disseminated via television or radio , patients are not protected against such unsolicited information and such dissemination should therefore not be allowed . ### communication to the general public on prescription - only medicinal products by marketing authorisation holders should only be provided in writing through specific channels of communication , including internet , to avoid that the effectiveness of the prohibition on advertising is undermined by unsolicited communication to the public . where information is disseminated via television , web tv , video broadcast materials , newspapers , magazines and similar publications , or radio , patients are not protected against such unsolicited communication and such dissemination should therefore not be allowed .


### - the labelling and the accompanying package leaflets , which are subject to the provisions of title v ; ### - the labelling which shall always at least specify the international non - proprietary name and the accompanying package leaflets , which are subject to the provisions of title v ;


### - information by the marketing authorisation holder to the general public on medicinal products subject to medical prescription , which is subject to the provisions of title viiia . ### - officially approved documents on medicinal products subject to medical prescription . .


### member states shall allow the marketing authorisation holder to disseminate , either directly or indirectly through a third party , information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that it is in accordance with the provisions of this title . such information shall not be considered advertising for the purposes of the application of title viii . ### member states shall allow the marketing authorisation holder to disseminate , either directly or indirectly through a third party , information that has been officially approved by national or european competent authorities to the general public or members thereof on authorised medicinal products subject to medical prescription provided that it is in accordance with the provisions of this title . such information shall not be considered advertising for the purposes of the application of title viii . when such information is made available , the marketing authorisation holder and any third party shall be identified , and any third party acting on behalf of the marketing authorisation holder shall be clearly indentified as such .


### a statement indicating that the information is intended to support , not to replace , the relationship between patient and health professionals and that a health professional should be contacted if the patient requires clarification on the information provided ; ### a statement indicating that the announcement is intended to support , not to replace , the relationship between patient and health professionals and that a health professional should be contacted if the patient requires clarification on the information provided ;


### a statement indicating that the information is disseminated by a marketing authorisation holder ; ### a statement starting with the indication that the announcement is disseminated by or on behalf of a marketing authorisation holder ;


### member states shall ensure that marketing authorisation holders ' internet websites for the dissemination of information on medicinal products subject to medical prescription reproduce the summary of product characteristics and the package leaflet of the medicinal products concerned in the official languages of the member states where they are authorised . ### member states shall ensure that marketing authorisation holders ' internet websites reproduce the last updated version as approved by the competent authorities of the summary of product characteristics and of the package leaflet of the medicinal products subject to medical prescription they commercialise in the official languages of the member states where they are authorised .


### member states shall ensure that there are adequate and effective methods of monitoring to avoid misuse when information on authorised medicinal products subject to medical prescription is disseminated by the marketing authorisation holder to the general public or members thereof . ### member states and european commission shall ensure that there are adequate and effective methods of monitoring to avoid misuse when information on authorised medicinal products subject to medical prescription is disseminated by the marketing authorisation holder to the general public or members thereof .


### member states shall allow marketing authorisation holders which have registered internet websites in accordance with paragraphs 1 to 4 to include a statement therein to the effect that the site has been registered and is subject to monitoring in accordance with this directive . the statement shall identify the national competent authority monitoring the website concerned . it shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval . ### member states shall require marketing authorisation holders which have registered internet websites in accordance with paragraphs 1 to 4 to include a message at the top of each website page informing the public that information contained therein is developed by the marketing authorisation holder and is therefore subject to monitoring in order to avoid advertising of prescription medicines . the statement shall identify the national competent authority monitoring the website concerned . it shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval and include a link to the eudrapharm database specifying that validated information is available there .


### the use of electronic identification systems would potentially streamline traceability processes through automated and more accurate reading and recording into the holding register . it would enable also automated reporting of animal movements into the computerised data base and thus improve speed , reliability and accuracy of the system . ### the use of electronic identification systems would potentially streamline traceability processes through automated and more accurate reading and recording into the holding register . it would enable also automated reporting of animal movements into the computerised data base and thus improve speed , reliability and accuracy of the system . it would improve the management of direct payments paid to farmers per animal head through better controls and reduced risk of payment errors .


### the use of electronic identification systems would potentially streamline traceability processes through automated and more accurate reading and recording into the holding register . it would enable also automated reporting of animal movements into the computerised data base and thus improve speed , reliability and accuracy of the system . ### the use of electronic identification systems would potentially streamline traceability processes through automated and more accurate reading and recording into the holding register . it would enable also automated reporting of animal movements into the computerised data base and thus improve speed , reliability and accuracy of the system , even though , following the publication of council regulation no 21 / 2004 in 2003 , there is still no automated reporting of movements in the case of ovine and caprine animals .


### animals entering the union from third countries should be subject to the same identification requirements that apply to animals born in the union . ### animals and meat entering the union from third countries should be subject to the same identification and traceability requirements that apply to animals born in the union .


### regulation no 1760 / 2000 provides that the competent authority is to issue a passport for each animal which has to be identified in accordance with that regulation . this causes a considerable administrative burden for the member states . the computerised databases established by member states sufficiently ensure traceability of domestic movements of bovine animals . passports should therefore be issued only for animals intended for intra - union trade . once the data exchange between national computerised databases is operational , the requirement of issuing such passports should no longer apply for animals intended for intra - union trade . ### regulation no 1760 / 2000 provides that the competent authority is to issue a passport for each animal which has to be identified in accordance with that regulation . this causes a considerable administrative burden for the member states . the computerised databases established by member states sufficiently ensure traceability of domestic movements of bovine animals . passports should therefore be issued only for animals intended for intra - union trade . once the data exchange between national computerised databases is operational , the requirement of issuing such passports should no longer apply for animals intended for intra - union trade . in all cases , the current passport , whether the current paper version or the future electronic version , should include the gene mapping of the sample used for reference , to be carried out when the eid is registered or introduced .


### financial instruments can improve the efficiency of budget spending and achieve high multiplier effects in terms of attracting private sector financing and achieved investment volumes . the expected multiplier effect of the europe 2020 project bond initiative is 15 - 20 . ### financial instruments as governed by the financial regulation can in some cases improve the efficiency of budget spending and achieve high multiplier effects in terms of attracting private sector financing , especially in the context of difficult access to credit and the current constraints on public finances . the commission should , in particular , ensure that the pilot phase for the europe 2020 project bond initiative offers added value , by achieving higher investment volumes . the expected multiplier effect of the europe 2020 project bond initiative is 15 - 20 .


### the europe 2020 project bond initiative has a double objective : first to help finance projects of european policy priorities , and second , to facilitate greater private sector involvement in the long - term capital market financing of infrastructure projects . it will redirect some eu budget spending towards growth - enhancing areas , taking into account the unions budgetary discipline and the ceilings under the current multiannual financial framework . ### the pilot phase for the europe 2020 project bond initiative has a double objective : first to help finance projects of european policy priorities , and second , to facilitate greater private sector involvement in the long - term capital market financing of infrastructure projects . it will redirect some eu budget spending towards growth - enhancing areas , taking into account the union’s budgetary discipline and the ceilings under the current multiannual financial framework .


### alternatively , the union may make a financial contribution to the eib to the provisioning and capital allocation for loans or guarantees to be issued by the eib on its own resources under the risk - sharing instrument for project bonds referred to in paragraphs 2a to 2d . ### alternatively , the union may make , during a pilot phase in 2012 and 2013 , a financial contribution to the eib to the provisioning and capital allocation for loans or guarantees to be issued by the eib on its own resources under the risk - sharing instrument for project bonds referred to in paragraphs 2a to 2da .


### risk - sharing instrument for project bonds means a credit enhancement which fulfils the following criteria : takes the form of a loan or a guarantee granted by the eib in favour of financing provided to projects in the field of ict and broadband ; covers the debt service risk of a project and mitigates the credit - risk of bond holders ; is used only for projects whose financial viability is based on project revenues . ### risk - sharing instrument for project bonds means a joint instrument by the commission and the eib which provides a credit enhancement which fulfils the following criteria : takes the form of a loan or a guarantee granted by the eib with the support of a union budget contribution in favour of financing provided to projects in the field of ict and broadband ; covers the debt service risk of a project and mitigates the credit - risk of bond holders ; is used only for projects whose financial viability is based on project revenues .


### the union exposure to the risk sharing instrument for project bonds , including management fees and other eligible costs , shall be strictly limited to the amount of the union contribution to the risk - sharing instrument for project bonds and there shall be no further liability on the general budget of the union . the residual risk inherent in all operations shall be borne by the eib . ### the union exposure to the risk sharing instrument for project bonds , including management fees and other eligible costs , shall in no case exceed the amount of the union contribution to the risk - sharing instrument for project bonds . there shall be no further liability on the general budget of the union . the residual risk inherent in all operations shall always be borne by the eib .


### ' risk - sharing instrument for project bonds ' means a credit enhancement provided to projects of common interest . the risk - sharing instrument for project bonds covers the debt service risk of a project and mitigates the credit - risk of bond holders . it is used only for projects whose financial viability is based on project revenues . ### ' risk - sharing instrument for project bonds ' means a joint instrument by the commission and the eib which provides a credit enhancement provided to projects of common interest . the risk - sharing instrument for project bonds covers the debt service risk of a project and mitigates the credit - risk of bond holders . it is used only for projects whose financial viability is based on project revenues .


### in 2012 and 2013 , an amount of up to eur 200 million may be redeployed for the risk - sharing instrument for project bonds in the transport sector . ### in 2012 and 2013 , an amount of up to eur 200 million may be redeployed for the pilot phase of the risk - sharing instrument for project bonds in the transport sector .


### a financial contribution to the eib to the provisioning and capital allocation for loans or guarantees to be issued by the eib on its own resources under the risk - sharing instrument for project bonds in the field of ten - t and ten - e . the union exposure to the risk sharing instrument , including management fees and other eligible costs , shall be strictly limited to the amount of the union contribution to the risk - sharing instrument for project bonds and there shall be no further liability on the general budget of the union . the residual risk inherent in all operations shall be borne by the eib . the detailed terms and conditions for implementing the risk - sharing instrument for project bonds , including its monitoring and control , shall be laid down in a delegation agreement between the commission and the eib . in 2012 and 2013 , an amount of up to eur 210 million , of which up to eur 200 million for transport projects and up to eur 10 million for energy projects , may be redeployed for the risk - sharing instrument for project bonds in accordance with the procedure referred to in article 15 from the ten - t and ten - e budget lines , respectively . the risk - sharing instrument for project bonds may reuse any revenues received within the investment period for new loans and guarantees . ### during a pilot phase in the years 2012 and 2013 , a financial contribution to the eib to the provisioning and capital allocation for loans or guarantees to be issued by the eib on its own resources under the risk - sharing instrument for project bonds in the field of ten - t and ten - e . the union exposure to the risk sharing instrument , including management fees and other eligible costs , shall in no case exceed the amount of the union contribution to the risk - sharing instrument for project bonds . there shall be no further liability on the general budget of the union . the residual risk inherent in all operations shall always be borne by the eib . the detailed terms and conditions for implementing the risk - sharing instrument for project bonds , including its monitoring and control , shall be laid down in a delegation agreement between the commission and the eib . in 2012 and 2013 , an amount of up to eur 210 million , of which up to eur 200 million for transport projects and up to eur 10 million for energy projects , may be redeployed for the risk - sharing instrument for project bonds in accordance with the procedure referred to in article 15 from the ten - t and ten - e budget lines , respectively . the risk - sharing instrument for project bonds may reuse any revenues received within the investment period for new loans and guarantees . in addition to the reporting requirements set out in point 49 of the interinstitutional agreement on budgetary discipline and sound financial management and without prejudice to any other regulatory reporting requirements , the commission shall submit a report to the european parliament and the council every 6 months during the pilot phase . on the basis of the evaluation referred to in article 16 of this regulation , the commission shall propose appropriate regulatory changes , in particular if the predicted market uptake is not satisfactory or in the event that alternative sources of long - term debt financing become sufficiently available .


### an effect of the financial crisis has been that investors , including ucits and aifs , rely excessively on credit ratings to carry out their investments on debt instruments , without necessarily conducting their own assessments of the creditworthiness of issuers of such debt instruments . in order to improve the quality of the investments made by ucits and aifs and , therefore , to protect investors in those funds , it is appropriate to require the persons managing ucits and aifs to avoid relying exclusively and automatically on external credit ratings when assessing the risk involved in the investments made by the ucits and aifs they manage . the general principle on the avoidance of excessive reliance on external credit ratings should therefore be integrated into the risk management processes and systems of the managers of ucits and aifs , and adapted to their specificities . ### an effect of the financial crisis has been that investors , including ucits and aifs , rely excessively on credit ratings to carry out their investments on debt instruments , without necessarily conducting their own assessments of the creditworthiness of issuers of such debt instruments . in order to improve the quality of the investments made by ucits and aifs and , therefore , to protect investors in those funds , it is appropriate to require the persons managing ucits and aifs to avoid relying exclusively and automatically on external credit ratings when assessing the risk involved in the investments made by the ucits and aifs they manage . the general principle on the avoidance of excessive reliance on external credit ratings should therefore be integrated into the risk management processes and systems of the managers of ucits and aifs , and adapted to their specificities . however , internal models for risk assessment have not proven to be a more reliable option and a mere shift from external ratings to internal evaluations is unlikely to be beneficial . in the medium term , further initiatives should be evaluated in order to take ratings out of financial regulation and eliminate risk - weighting of assets through external rating or internal models ' .


### in paragraph 1 , the first subparagraph is replaced by the following : ' a management or investment company shall employ a risk - management process which enables it to monitor and measure at any time the risk of the positions and their contribution to the overall risk profile of the portfolio . in particular , it shall not solely or mechanistically rely on external credit ratings for assessing the creditworthiness of the ucits assets . ' ### in paragraph 1 , the first subparagraph is replaced by the following : ' a management or investment company shall employ a risk - management process which enables it to monitor and measure at any time the risk of the positions and their contribution to the overall risk profile of the portfolio . in particular , it shall not solely rely on external credit ratings for assessing the creditworthiness of the ucits assets . ' ;


### in paragraph 2 , the first subparagraph is replaced by the following : ' aifms shall implement adequate risk management systems in order to identify , measure , manage and monitor appropriately all risks relevant to each aif investment strategy and to which each aif is or may be exposed . in particular , aifms shall not solely or mechanistically rely on external credit ratings for assessing the creditworthiness of the aif assets . ' ; ### in paragraph 2 , the first subparagraph is replaced by the following : ' aifms shall implement adequate risk management systems in order to identify , measure , manage and monitor appropriately all risks relevant to each aif investment strategy and to which each aif is or may be exposed . in particular , aifms shall not solely rely on external credit ratings for assessing the creditworthiness of the aif assets . ' ;


### it is appropriate to clarify that for the purpose of verifying compliance with the target of 147 g co2 / km , co2 emissions should continue to be measured in accordance with regulation no 715 / 2007 of the european parliament and of the council of 20 june 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles and on access to vehicle repair and maintenance information and its implementing measures and innovative technologies . ### it is appropriate to clarify that for the purpose of verifying compliance with the target of 147 g co2 / km , co2 emissions should continue to be measured in accordance with regulation no 715 / 2007 of the european parliament and of the council of 20 june 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles and on access to vehicle repair and maintenance information and its implementing measures and innovative technologies . however , studies carried out by the commission have demonstrated that the test procedures used to measure co2 emissions under that regulation have not prevented an increased utilisation of flexibilities by manufacturers which have resulted in alleged co2 emissions reductions that are not attributed to technological improvements and cannot be achieved in real driving on the road . therefore , regulation no 715 / 2007 should be reviewed as a matter of urgency in order to ensure that test procedures reflect adequately the real co2 emissions behaviour of cars .


### to enable the automotive industry to carry out long - term investments and innovation it is desirable to provide indications of how this regulation should be amended for the period beyond 2020 . these indications should be based on an assessment of the necessary rate of reduction in line with the union ' s long term climate goals and the implications for the development of cost effective co2 reducing technology for cars . it is therefore desirable for these aspects to be reviewed , the commission to make a report and if appropriate proposals made for targets beyond 2020 . ### to enable the automotive industry to carry out long - term investments and innovation it is desirable to provide indications for the period beyond 2020 . this should be done by setting a target for 2025 . the target should be based on the necessary rate of reduction to be in line with the union ' s long term climate goals and enhance the development of cost effective co2 reducing technology .


### the regulation requires the commission to carry out an impact assessment in order to review the test procedures to reflect adequately the real co2 emissions behaviour of cars . this work is proceeding through the development of a world light duty test procedure in the framework of the united nations economic commission for europe but is not yet complete . in view of this , annex i to regulation no 443 / 2009 establishes emission limits for 2020 as measured according to regulation no 715 / 2007 and annex xii to regulation no 692 / 2008 . when the test procedures are amended , the limits set in annex i should be adjusted to ensure comparable stringency for manufacturers and classes of vehicles . ### the regulation requires the commission to carry out an impact assessment in order to review the test procedures to reflect adequately the real co2 emissions behaviour of cars . this work is proceeding through the development of a world light duty test procedure in the framework of the united nations economic commission for europe but is not yet complete . in the view of this , and given that the existing test cycle does not sufficiently reflect the actual emissions of cars and vans on the road , the swift development of an improved test cycle is crucial . when the current test procedures , set out in annex i to regulation no 443 / 2009 , which establishes emission limits for 2020 as measured according to regulation no 715 / 2007 and annex xii to regulation no 692 / 2008 , are amended , the limits set in annex i should be adjusted to ensure comparable stringency for manufacturers and classes of vehicles .


### ‘ from 2020 : indicative specific emissions of co2 = 147 + a × where : m = mass of the vehicle in kilograms m0 = the value adopted pursuant to article 13 a = 0 , 096 . ’ ### ‘ from 2020 : indicative specific emissions of co2 = 147 + a × where : m = mass of the vehicle in kilograms m0 = the value adopted pursuant to article 13 , minus 300 kg a = 0 , 096 . ’


### member states shall prepare a set of statistical information on pnr data provided to the passenger information units . such statistics shall as a minimum cover the number of identifications of any persons who may be involved in a terrorist offence or serious crime according to article 4 and the number of subsequent law enforcement actions that were taken involving the use of pnr data per air carrier and destination . ### member states shall prepare a set of statistical information on pnr data provided to the passenger information units . such statistics shall as a minimum cover the number of identifications of any persons who may be involved in a terrorist offence according to article 4 and the number of subsequent law enforcement actions , including the resulting number of convictions , that were taken involving the use of pnr data per air carrier and destination .


### to reduce administrative burdens and ease the exchange of information between member states , vehicle related information should be kept in national registers . ### to reduce administrative burdens and ease the exchange of information between member states , vehicle related information should be kept in national electronic registers .


### given the specific characteristics of eltifs , as well as the targeted retail and professional investors it is important that solid transparency requirements be put in place that are capable of allowing prospective investors to make an informed judgement and be fully aware of the risks implied . in addition to the transparency requirements contained in directive 2011 / 61 / eu , eltifs should publish a prospectus the content of which should necessarily include all information required to be disclosed by collective investment undertakings of the closed - end type in accordance with directive 2003 / 71 / ec of the european parliament and of the council and commission regulation no 809 / 2004 . for the marketing of an eltif to retail investors it should be mandatory to publish a key information document in accordance with regulation no [ … ] of [ … ] of the european parliament and the council . furthermore , any marketing documents should explicitly draw attention to the risk profile of the eltif . ### given the specific characteristics of eltifs , as well as the targeted retail and professional investors it is important that solid transparency requirements be put in place that are capable of allowing prospective investors to make an informed judgement and be fully aware of the risks implied . in addition to the transparency requirements contained in directive 2011 / 61 / eu , eltifs should publish a prospectus the content of which should necessarily include all information required to be disclosed by collective investment undertakings of the closed - end type in accordance with directive 2003 / 71 / ec of the european parliament and of the council and commission regulation no 809 / 2004 . for the marketing of an eltif to retail investors it should be mandatory to publish a key information document in accordance with regulation no [ … ] of [ … ] of the european parliament and the council . furthermore , any marketing documents should explicitly draw attention to the risk profile of the eltif and mention any participation in instruments involving eu budgetary funds .


### esma should be able to exercise all the powers conferred under directive 2011 / 61 / eu with respect to this regulation . ### esma should be able to exercise all the powers conferred under directive 2011 / 61 / eu with respect to this regulation and be endowed with all resources necessary for this purpose , in particular human resources .


### the new uniform rules on eltifs respect the fundamental rights and observe the principles recognised in particular by the charter of fundamental rights of the european union and notably consumer protection , the freedom to conduct a business , the right to remedy and to a fair trial , and the protection of personal data . the new uniform rules on eltifs should be applied in accordance with those rights and principles , ### the new uniform rules on eltifs respect the fundamental rights and observe the principles recognised in particular by the charter of fundamental rights of the european union and notably access to services of general economic interest , consumer protection , the freedom to conduct a business , the right to remedy and to a fair trial , and the protection of personal data . the new uniform rules on eltifs should be applied in accordance with those rights and principles ,


### the eu aifm has not provided the documentation referred to in article 4 . ### the eu aifm has not provided the documentation referred to in article 4 , or any clarification or information requested thereunder .


### it shall be established in a member state , or in a third country provided that the third country : ### it shall be established in a member state , or in a third country provided that it :


### esma shall have the powers necessary to carry out the tasks attributed to it by this regulation . ### esma shall have the powers and resources necessary to carry out the tasks attributed to it by this regulation .


### this directive should not apply to micro , small and medium - sized enterprises , as defined by commission recommendation 2003 / 361 / ec of 6 may 2003 concerning the definition of micro , small and medium - sized enterprises , even if they are listed companies . ### this directive should not apply to micro , small and medium - sized enterprises , as defined by commission recommendation 2003 / 361 / ec of 6 may 2003 concerning the definition of micro , small and medium - sized enterprises . this should be the case for listed , and at a later stage non - listed , companies .


### in several member states , a certain proportion of the non - executive directors can or must be appointed or elected by the company ' s workforce and / or organisations of workers pursuant to national law or practice . the quantitative objectives provided for in this directive should apply to all non - executive directors including employee representatives . however , the practical procedures for ensuring that those objectives are attained , taking into account the fact that some non - executive directors are employee representatives , should be defined by the member states concerned . ### in several member states , a certain proportion of the non - executive directors can or must be appointed or elected by the company ' s workforce and / or organisations of workers pursuant to national law or practice . the quantitative objectives provided for in this directive should apply to all non - executive directors including employee representatives . however , the practical procedures for ensuring that those objectives are attained , taking into account the fact that some non - executive directors are employee representatives , should be defined by the member states concerned on the basis of careful and extensive consultations with social partners at the national level .


### listed companies in the union should be imposed obligations of means providing for appropriate procedures with a view of meeting specific objectives regarding the gender composition of their boards . those listed companies in whose boards members of the under - represented sex hold less than 40 per cent of non - executive director positions should make the appointments to those positions on the basis of a comparative analysis of the qualifications of each candidate , by applying pre - established , clear , neutrally formulated and unambiguous criteria , in order to attain the said percentage at the latest by 1 january 2020 . therefore , the directive establishes the objective of at least 40 per cent of non - executive directors of the under - represented sex by that date . this objective in principle only concerns the overall gender diversity among the non - executive directors and does not interfere with the concrete choice of individual directors from a wide pool of male and female candidates in each individual case . in particular , it does not exclude any particular candidates for director positions , nor does it impose any individual directors on companies or shareholders . the decision on the appropriate board members thus remains with the companies and shareholders . ### listed companies in the union should be imposed obligations of means providing for appropriate procedures with a view of meeting specific objectives regarding the gender composition of their boards . those listed companies in whose boards members of the under - represented sex hold less than 40 per cent of non - executive director positions should make the appointments to those positions on the basis of a vacancy announcement opening up for applications and a comparative analysis of the qualifications of each candidate , by applying pre - established , clear , neutrally formulated and unambiguous criteria , in order to attain the said percentage at the latest by 1 january 2020 . therefore , the directive establishes the objective of at least 40 per cent of non - executive directors of the under - represented sex by that date . this objective in principle only concerns the overall gender diversity among the non - executive directors and does not interfere with the concrete choice of individual directors from a wide pool of male and female candidates in each individual case . in particular , it does not exclude any particular candidates for director positions , nor does it impose any individual directors on companies or shareholders . the decision on the appropriate board members thus remains with the companies and shareholders .


### in line with that case - law , member states should ensure that the selection of the best qualified candidates for non - executive directors is based on a comparative analysis of the qualifications of each candidate on the basis of pre - established , clear , neutrally formulated and unambiguous criteria . examples of types of selection criteria that companies could apply include professional experience in managerial and / or supervisory tasks , knowledge in specific relevant areas such as finance , controlling or human resources management , leadership and communication skills and networking abilities . priority should be given to the candidate of the under - represented sex if that candidate is equally qualified as the candidate of the other sex in terms of suitability , competence and professional performance , and if an objective assessment taking account of all criteria specific to the individual candidates does not tilt the balance in favour of a candidate of the other sex . ### in line with that case - law , member states should ensure that the selection of the best qualified candidates for non - executive directors is based on a vacancy announcement opening up for applications and a comparative analysis of the qualifications of each candidate on the basis of pre - established , clear , neutrally formulated and unambiguous criteria . examples of types of selection criteria that companies could apply include professional experience in managerial and / or supervisory tasks , knowledge in specific relevant areas such as finance , controlling or human resources management , leadership and communication skills and networking abilities . priority should be given to the candidate of the under - represented sex if that candidate is equally qualified as the candidate of the other sex in terms of suitability , competence and professional performance , and if an objective assessment taking account of all criteria specific to the individual candidates does not tilt the balance in favour of a candidate of the other sex .


### member states should require listed companies to provide information on the gender composition of their boards as well as information on how they managed to meet the objectives laid down in this directive , on a yearly basis to the competent national authorities in order to enable them to assess the progress of each listed company towards gender balance among directors . such information should be published and , where the company in question has not met the objective , it should include a description of the measures that it has taken so far and intends to take in the future in order to meet the objective . ### member states should require listed companies to provide information on the gender composition of their boards as well as information on how they managed to meet the objectives laid down in this directive , on a yearly basis to the competent national authorities in order to enable them to assess the progress of each listed company towards gender balance among directors . such information should be published in an appropriate and easily accessible manner in the annual report and on the website and , where the company in question has not met the objective , it should include a comprehensive description of the measures that it has taken so far and intends to take in the future in order to meet the objective .


### member states shall ensure that listed companies in whose boards members of the under - represented sex hold less than 40 per cent of the non - executive director positions make the appointments to those positions on the basis of a comparative analysis of the qualifications of each candidate , by applying pre - established , clear , neutrally formulated and unambiguous criteria , in order to attain the said percentage at the latest by 1 january 2020 or at the latest by 1 january 2018 in case of listed companies which are public undertakings . ### member states shall ensure that listed companies in whose boards members of the under - represented sex hold less than 40 per cent of the non - executive director positions make the appointments to those positions on the basis of a vacancy announcement opening up for applications and a comparative analysis of the qualifications of each candidate , by applying pre - established , clear , neutrally formulated and unambiguous criteria , in order to attain the said percentage at the latest by 1 january 2020 or at the latest by 1 january 2018 in case of listed companies which are public undertakings .


### member states shall require listed companies to provide information to the competent national authorities , once a year as from [ two years after adoption ] , about the gender representation on their boards , distinguishing between non - executive and executive directors and about the measures taken in view of the objectives laid down in article 4 and in paragraph 1 of this article , and to publish that information in an appropriate and accessible manner on their website . ### member states shall require listed companies to provide information to the competent national authorities , once a year as from [ two years after adoption ] , about the gender representation on their boards , distinguishing between non - executive and executive directors and about the measures taken in view of the objectives laid down in article 4 and in paragraph 1 of this article , and to publish that information in an appropriate and easily accessible manner in the annual report and on their website .


### where a listed company does not meet the objectives laid down in article 4 or its own individual commitments taken pursuant to paragraph 1 of this article , the information referred to in paragraph 2 of this article shall include the reasons for not reaching the objectives or commitments and a description of the measures which the company has adopted or intends to adopt in order to meet the objectives or commitments . ### where a listed company does not meet the objectives laid down in article 4 or its own individual commitments taken pursuant to paragraph 1 of this article , the information referred to in paragraph 2 of this article shall include the reasons for not reaching the objectives or commitments and a comprehensive description of the measures which the company has adopted or intends to adopt in order to meet the objectives or commitments .


### the global resources for the implementation of this regulation shall be eur 1 , 128 million . ### the indicative global resources for the implementation of this regulation shall be eur 1 , 128 million .


### the annual appropriations shall be authorised by the budgetary authority within the limits of the financial framework . ### the annual appropriations for the fund shall be authorised by the budgetary authority without prejudice to the provisions of the regulation laying down the multiannual financial framework for the years 2014 - 2020 and the interinstitutional agreement of xxx / 201z between the european parliament , the council and the commission on cooperation in budgetary matters and sound financial management .


### the global resources shall be used indicatively as follows : ### without prejudice to the prerogatives of the budgetary authority , the global resources shall be used indicatively as follows :


### the commission shall submit to the european parliament and the council , by 31 december 2015 , a report on the results achieved and on qualitative and quantitative aspects of implementation of council decision 2007 / 125 / jha for the period 2011 to 2013 . ### the commission shall submit to the european parliament and the council , by 31 december 2015 , a report on the results achieved and on qualitative and quantitative aspects of implementation of council decision 2007 / 125 / jha for the period 2011 to 2013 . in this report , the european commission shall provide concrete evidence , if available , of the complementarity and synergies achieved between the eu funds and the members states ' budgets and of the triggering effects on member states of the eu budget in achieving the objectives set in the council decision 2007 / 125 / jha .


### the reports shall , in particular , include details of the names and numbers of the instruments bought or sold , the quantity , the dates and times of execution , the transaction prices , a designation to identify the clients on whose behalf the investment firm has executed that transaction , a designation to identify the persons and the computer algorithms within the investment firm responsible for the investment decision and the execution of the transaction , and means of identifying the investment firms concerned . for transactions not carried out on a regulated market , mtf or otf , the reports shall also include a designation identifying the types of transactions in accordance with the measures to be adopted pursuant to article 19 and article 20 . ### the reports shall , in particular , include details of the type , asset class , names and numbers of the instruments bought or sold , the quantity , the dates and times of execution , the transaction prices , a designation to identify the clients on whose behalf the investment firm has executed that transaction , a designation to identify the persons and the computer algorithms within the investment firm responsible for the investment decision and the execution of the transaction , and means of identifying the investment firms concerned . for transactions not carried out on a regulated market , mtf or otf , the reports shall also include a designation identifying the types of transactions in accordance with the measures to be adopted pursuant to article 19 and article 20 .


### after analysing the information obtained , require any such person to take steps to reduce the size of the position or exposure ; ### after analysing the information obtained , require any such person to take steps to reduce the size of or to eliminate the position or exposure ;


### does significantly address the threat to the orderly functioning and integrity of financial markets or of delivery arrangements for physical commodities , or the stability of the whole or part of the financial system in the union or significantly improve the ability of competent authorities to monitor the threat ; ### does significantly address the threat to the orderly functioning and integrity of financial markets or of delivery arrangements for physical commodities , or the stability of the whole or part of the financial system in the union or significantly improve the ability of competent authorities to monitor the threat , and in particular the extent to which the measure : supports liquidity as necessary to facilitate transactions which objectively reduce risks directly related to commercial activities related to the commodity ; prevents market abuse ; supports orderly pricing and settlement conditions ; ensures price discovery for the physical market ; prevents the build - up of market distorting positions ;


### attacks against information systems , in particular as a result of the threat from organised crime , are a growing menace , and there is increasing concern about the potential for terrorist or politically motivated attacks against information systems which form part of the critical infrastructure of member states and the union . this constitutes a threat to the achievement of a safer information society and an area of freedom , security and justice , and therefore requires a response at the level of the european union . ### attacks against information systems are a growing menace and may come from a variety of actors such as terrorists , organized crime , states or isolated individuals . there is increasing concern about the potential for terrorist or politically motivated attacks against information systems which form part of the critical infrastructure of member states and the union . the cross - border nature of certain offences and the relatively low risk and cost for offenders , coupled with the huge benefits that may be gained and damage that may be caused through the attacks , adds greatly to the level of this menace . this constitutes a threat to the achievement of a safer information society and an area of freedom , security and justice , and therefore requires a response not just at the level of the european union but also by the international community .


### there is evidence of a tendency towards increasingly dangerous and recurrent large scale attacks conducted against information systems which are critical to states or to particular functions in the public or private sector . this tendency is accompanied by the development of increasingly sophisticated tools that can be used by criminals to launch cyber - attacks of various types . ### there is evidence of a tendency towards increasingly dangerous and recurrent large scale attacks conducted against information systems which are critical to international organisations and states or to particular functions in the public or private sector . such attacks can occasion significant financial losses both by taking down information and communications systems , and by causing the loss or alteration of data . this tendency is being accompanied , unfortunately , by the availability and development of increasingly sophisticated tools that can be used by criminals to launch cyber - attacks of various types .


### there is evidence of a tendency towards increasingly dangerous and recurrent large scale attacks conducted against information systems which are critical to states or to particular functions in the public or private sector . this tendency is accompanied by the development of increasingly sophisticated tools that can be used by criminals to launch cyber - attacks of various types . ### there is evidence of a tendency towards increasingly dangerous and recurrent large scale attacks conducted against information systems which are critical to states or to particular functions in the public or private sector . this tendency is accompanied by the development of increasingly sophisticated tools that can be used by criminals to launch cyber - attacks of various types . furthermore , distributed denial - of - service attacks on information systems and / or attacks on critical information infrastructures for disruption purposes might be used as a means of cyber warfare and / or terrorism .


### there is evidence of a tendency towards increasingly dangerous and recurrent large scale attacks conducted against information systems which are critical to states or to particular functions in the public or private sector . this tendency is accompanied by the development of increasingly sophisticated tools that can be used by criminals to launch cyber - attacks of various types . ### there is evidence of a tendency towards increasingly dangerous and recurrent large scale attacks conducted against information systems which are critical to states , the union or to particular functions in the public or private sector . this tendency is accompanied by the rapid development of information technology and thus of increasingly sophisticated tools that can be used by criminals to launch cyber - attacks of various types , some of which have significant potential to cause economic and social damage .


### common definitions in this area , particularly of information systems and computer data , are important in order to ensure a consistent approach in the member states to the application of this directive . ### common definitions in this area , particularly of information systems , computer data and criminal offences in respect of information systems and computer data are essential in order to ensure a consistent and uniform approach in the member states to the application of this directive .


### common definitions in this area , particularly of information systems and computer data , are important in order to ensure a consistent approach in the member states to the application of this directive . ### common definitions and norms of behaviour in this area , particularly of information systems and computer data , are important in order to ensure a consistent approach in the member states to the application of this directive .


### member states should provide for penalties in respect of attacks against information systems . the penalties provided for should be effective , proportionate and dissuasive . ### member states should provide for penalties in respect of attacks against information systems which should be adopted within broader national strategies to deter and combat such attacks . the penalties provided for should be effective , proportionate and dissuasive . convergence in the sanctions and penalties applied by member states is necessary on account of the often cross - border nature of the threats and is aimed at reducing differences between member states when it comes to dealing with offences committed within the union .


### member states should provide for penalties in respect of attacks against information systems . the penalties provided for should be effective , proportionate and dissuasive . ### member states should provide both for harmonised penalties in respect of attacks against information systems and for effective measures to prevent such attacks . the penalties provided for should be effective , proportionate and dissuasive .


### the council conclusions of 27 - 28 november 2008 indicated that a new strategy should be developed with the member states and the commission , taking into account the content of the 2001 council of europe convention on cybercrime . that convention is the legal framework of reference for combating cybercrime , including attacks against information systems . this directive builds on that convention . ### the council conclusions of 27 - 28 november 2008 indicated that a new strategy should be developed with the member states and the commission , taking into account the content of the 2001 council of europe convention on cybercrime . the council and commission should encourage member states that have not yet ratified the convention to do so as soon as possible . that convention is the legal framework of reference for combating cybercrime , including attacks against information systems . this directive builds on that convention .


### this directive strengthens the importance of networks , such as the g8 or the council of europe ' s network of points of contact available on a twenty - four hour , seven - day - a - week basis to exchange information in order to ensure the provision of immediate assistance for the purpose of investigations or proceedings concerning criminal offences related to information systems and data , or for the collection of evidence in electronic form of a criminal offence . given the speed with which large - scale attacks can be carried out , member states should be able to respond promptly to urgent requests from this network of contact points . such assistance should include facilitating , or directly carrying out , measures such as : the provision of technical advice , the preservation of data , the collection of evidence , the provision of legal information , and the locating of suspects . ### this directive strengthens the importance of networks , such as the g8 or the council of europe ' s network of points of contact available on a twenty - four hour , seven - day - a - week basis to exchange information in order to ensure the provision of immediate assistance for the purpose of investigations or proceedings concerning criminal offences related to information systems and data , or for the collection of evidence of a criminal offence or intent to commit a criminal offence . given the speed with which large - scale attacks can be carried out , member states should be able to respond promptly and effectively to urgent requests from this network of contact points . such assistance should include facilitating , or directly carrying out , measures such as : the provision of technical assistance , including as regards restoring information system functionality , the preservation of data in line with personal data protection principles , the collection of evidence , the provision of legal information , and the locating and identification of suspects .


### this directive strengthens the importance of networks , such as the g8 or the council of europe ' s network of points of contact available on a twenty - four hour , seven - day - a - week basis to exchange information in order to ensure the provision of immediate assistance for the purpose of investigations or proceedings concerning criminal offences related to information systems and data , or for the collection of evidence in electronic form of a criminal offence . given the speed with which large - scale attacks can be carried out , member states should be able to respond promptly to urgent requests from this network of contact points . such assistance should include facilitating , or directly carrying out , measures such as : the provision of technical advice , the preservation of data , the collection of evidence , the provision of legal information , and the locating of suspects . ### this directive strengthens the importance of networks , such as the g8 or the council of europe ' s network of points of contact available on a twenty - four hour , seven - day - a - week basis to exchange information in order to ensure the provision of immediate assistance for the purpose of investigations or proceedings concerning criminal offences related to information systems and data , or for the collection of evidence in electronic form of a criminal offence . given the speed with which large - scale attacks can be carried out , member states the eu and the european network and information security agency should be able to respond promptly to urgent requests from this network of contact points . such assistance should include facilitating , or directly carrying out , measures such as : the provision of technical advice , the preservation of data , the collection of evidence , the provision of legal information , and the locating of suspects .


### this directive strengthens the importance of networks , such as the g8 or the council of europe ' s network of points of contact available on a twenty - four hour , seven - day - a - week basis to exchange information in order to ensure the provision of immediate assistance for the purpose of investigations or proceedings concerning criminal offences related to information systems and data , or for the collection of evidence in electronic form of a criminal offence . given the speed with which large - scale attacks can be carried out , member states should be able to respond promptly to urgent requests from this network of contact points . such assistance should include facilitating , or directly carrying out , measures such as : the provision of technical advice , the preservation of data , the collection of evidence , the provision of legal information , and the locating of suspects . ### this directive strengthens the importance of networks , such as the g8 or the council of europe ' s network of points of contact available on a twenty - four hour , seven - day - a - week basis to exchange information in order to ensure the provision of immediate assistance for the purpose of investigations or proceedings concerning criminal offences related to information systems and data , or for the collection of evidence in electronic form of a criminal offence . given the speed with which large - scale attacks can be carried out , member states should be able to respond promptly to urgent requests from this network of contact points . such assistance should include facilitating , or directly carrying out , measures such as : the provision of technical advice , the preservation of data , the collection of evidence , the provision of legal information , the identification of the jeopardised and / or extracted information and the locating of suspects .


### there is a need to collect data on offences under this directive , in order to gain a more complete picture of the problem at union level and thereby contribute to formulating more effective responses . the data will moreover help specialised agencies such as europol and the european network and information security agency to better assess the extent of cybercrime and the state of network and information security in europe . ### there is a need to collect data on offences under this directive , in order to gain a more complete picture of the problem at union level and thereby contribute to formulating more effective responses . member states need to improve the exchange of information on attacks against information systems , with the support of the commission and the european network and information security agency . the data will moreover help specialised agencies such as europol and the european network and information security agency to better assess the extent of cybercrime and the state of network and information security in europe . better knowledge about present and future risks will help reach more appropriate decisions on deterring , combating or limiting the damage caused by attacks against information systems .


### there is a need to collect data on offences under this directive , in order to gain a more complete picture of the problem at union level and thereby contribute to formulating more effective responses . the data will moreover help specialised agencies such as europol and the european network and information security agency to better assess the extent of cybercrime and the state of network and information security in europe . ### there is a need to collect data on offences under this directive , in order to gain a more complete picture of the problem at union level and thereby contribute to formulating more effective responses . the data will moreover help specialised agencies such as europol and the european network and information security agency to better assess the extent of cybercrime and the state of network and information security in europe and to support member states in the adoption of responses to information security incidents .


### there is a need to collect data on offences under this directive , in order to gain a more complete picture of the problem at union level and thereby contribute to formulating more effective responses . the data will moreover help specialised agencies such as europol and the european network and information security agency to better assess the extent of cybercrime and the state of network and information security in europe . ### there is a need to collect data on offences under this directive , in order to gain a more complete picture of the problem at union level and thereby contribute to formulating more effective responses . the data will moreover help specialised bodies and agencies such as member states ' certs , europol and the european network and information security agency to better assess the extent of cybercrime and the state of network and information security in europe .


### significant gaps and differences in member states’ laws in the area of attacks against information systems area may hamper the fight against organised crime and terrorism , and may complicate effective police and judicial cooperation in this area . the transnational and borderless nature of modern information systems means that attacks against such systems have a trans - border dimension , thus underlining the urgent need for further action to approximate criminal legislation in this area . besides that , the coordination of prosecution of cases of attacks against information systems should be facilitated by the adoption of council framework decision 2009 / 948 / jha on prevention and settlement of conflict of jurisdiction in criminal proceedings . ### significant gaps and differences in member states’ laws in the area of attacks against information systems area may hamper the fight against organised crime and terrorism , and may complicate effective police and judicial cooperation in this area . the transnational and borderless nature of modern information systems means that attacks against such systems have a trans - border dimension , thus underlining the urgent need for further action at union level to approximate national criminal legislation in this area . likewise , the union should pursue greater international cooperation in the field of network and information system security involving all relevant international actors . besides that , the coordination of prosecution of cases of attacks against information systems should be facilitated by the adoption of council framework decision 2009 / 948 / jha on prevention and settlement of conflict of jurisdiction in criminal proceedings .


### this directive defines criminal offences in the area of attacks against information systems and establishes minimum rules concerning penalties for such offences . it also aims to introduce common provisions to prevent such attacks and improve european criminal justice cooperation in this field . ### this directive defines criminal offences in the area of attacks against information systems and establishes harmonised minimum rules concerning penalties for such offences . it also aims to introduce common provisions both to prevent and combat such attacks and to improve european cooperation in this field , particularly as regards criminal justice .


### ' without right ' means access or interference not authorised by the owner , other right holder of the system or of part of it , or not permitted under national legislation . ### ' without right ' means access or interference not authorised by the owner , other right holder of the system or of part of it , or not permitted under national or european legislation .


### member states shall take the necessary measures to ensure that the offences referred to in articles 3 to 6 are punishable by criminal penalties of a maximum term of imprisonment of at least five years when committed through the use of a tool designed to launch attacks affecting a significant number of information systems , or attacks causing considerable damage , such as disrupted system services , financial cost or loss of personal data . ### member states shall take the necessary measures to ensure that the offences referred to in articles 3 to 6 are punishable by criminal penalties of a maximum term of imprisonment of at least five years when committed through the use of a tool designed to launch attacks affecting a significant number of information systems , or attacks causing considerable damage , such as disrupted system services , financial cost or loss of personal data or sensitive information .


### for the purpose of exchange of information relating to the offences referred to in articles 3 to 8 , and in accordance with data protection rules , member states shall make use of the existing network of operational points of contact available 24 hours a day and seven days a week . member states shall also ensure that they have procedures in place so that they can respond within a maximum of eight hours to urgent requests . such response shall at least indicate whether and in what form the request for help will be answered and when . ### for the purpose of exchange of information relating to the offences referred to in articles 3 to 8 , and in accordance with data protection rules , member states shall ensure that they have an operational national point of contact and make use of the network of operational points of contact available 24 hours a day and seven days a week . member states shall also ensure that they have procedures in place so that they can respond within a maximum of eight hours to urgent requests . such response must be effective and include , where appropriate , the facilitation or direct implementation of the following measures : the provision of technical advice , including as regards restoring information system functionality , the preservation of data in line with personal data protection principles , the collection of evidence , the provision of legal information , and the locating and identification of suspects . the points of contact shall indicate the form and timescale in which requests for assistance will be answered .


### member states shall transmit the data collected according to this article to the commission . they shall also ensure that a consolidated review of these statistical reports is published . ### member states shall transmit the data collected according to this article to the commission and the european network and information security agency and shall also ensure that a periodic consolidated review of these statistical reports is published . the european network and information security agency shall centralise that data at an eu level and use it as a basis for drawing up reports on the state of information system and computer data security across europe .


### member states shall send to the commission all the information that is appropriate for drawing up the report referred to in paragraph 1 . the information shall include a detailed description of legislative and non - legislative measures adopted in implementing this directive . ### member states and the european network and information security agency shall send to the commission all the information that is appropriate for drawing up the report referred to in paragraph 1 . the information shall include a detailed description of legislative and non - legislative measures adopted in implementing this directive .


### there is a clear correlation between the level of road safety and the number of technical deficiencies of vehicles . in 2009 , 35 , 000 fatalities have been reported on european roads . assuming that technical deficiencies contribute to fatalities proportionately to their contribution to accidents , more than 2 , 000 fatalities per year in the union may be linked to technical deficiencies of vehicles . based on available studies , between 900 and 1 , 100 of these could be avoided if adequate improvements to the roadworthiness testing system were put in place . ### it is suspected that there is a correlation between the level of road safety and technical deficiencies in vehicles . in 2009 , 35 , 000 fatalities have been reported on european roads . adequate improvements to the roadworthiness testing system can help to reduce to a minimum the number of fatal accidents .


### in order to supplement this regulation with further technical details , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission with a view to take into account , when appropriate , evolution of the union type - approval legislation in relation with vehicle categories , as well as the need to update the annexes in the light of technical progress . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### in order to supplement this directive with further technical details , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission with a view to take into account , when appropriate , evolution of the union type - approval legislation in relation with vehicle categories , as well as the need to update the annexes in the light of technical progress . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### in order to ensure uniform conditions for the implementation of this regulation , implementing powers should be conferred on the commission . the implementing powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers . ### in order to ensure uniform conditions for the implementation of this directive , implementing powers should be conferred on the commission . the implementing powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers .