### in order to ensure the appropriate flexibility and update of the information contained in the annexes to this regulation as well as to define the common european risk classification scheme , to update the measures concerning the integration into the european central repository and to extend or restrict the dissemination of information contained in the european central repository , 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 . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### in order to ensure the appropriate flexibility and update of the information contained in the annexes to this regulation as well as to define the common european risk classification scheme , to update the measures concerning the integration into the european central repository and to extend or restrict the dissemination of information contained in the european central repository , 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 . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . the commission should provide full information and documentation on its meetings with experts within the framework of its work on the preparation and implementation of delegated acts . in this respect , the commission should ensure that the european parliament is duly involved , drawing on best practices from previous experience in other policy areas in order to create the best possible conditions for future scrutiny of delegated acts by the european parliament ;


### this regulation shall apply to occurrences which endanger or which , if not corrected , would endanger an aircraft , its occupants or any other person . a list of incidents to be reported is detailed in annex i . ### without prejudice to the implementing rules to regulation no 216 / 2008 , this regulation shall apply to occurrences which endanger or which , if not corrected , would endanger an aircraft , its occupants or any other person . a list of incidents to be reported is detailed in annex i .


### each organisation certified or approved by easa shall report to the easa the details on occurrences collected in accordance with paragraph 1 . ### each organisation certified or approved by easa shall report to easa the details on occurrences collected in accordance with paragraph 1 within 72 hours of becoming aware of the occurrence .


### member states and organisations may establish other safety information collection and processing systems to collect details on occurrences that may not be captured by the reporting systems mentioned in article 4 and in paragraphs 1 and 2 of this article . these systems may include the reporting to other entities than the ones described in article 6 and may involve an active participation of the industry . ### member states , the easa and organisations may establish other safety information collection and processing systems to collect details on occurrences that may not be captured by the reporting systems mentioned in article 4 and in paragraphs 1 and 2 of this article . these systems may include the reporting to other entities than the ones described in article 6 and may involve an active participation of the industry .


### with the increasing diversity in the type of fuels for motorized vehicles coupled with on - going growth in the road mobility of citizens across the union , it is necessary to provide the consumers with a clear and easy to understand information on the compatibility of their vehicle with different fuels offered in the transport fuels market of the union , without prejudice to directive 2009 / 30 / ec of the european parliament and of the council of 23 april 2009 amending directive 98 / 70 / ec as regards the specification of petrol , diesel and gas - oil and introducing a mechanism to monitor and reduce greenhouse gas emissions and amending council directive 1999 / 32 / ec as regards the specification of fuel used by inland waterway vessels and repealing directive 93 / 12 / eec . ### with the increasing diversity in the type of fuels for motorized vehicles coupled with on - going growth in the road mobility of citizens across the union , it is necessary to provide the consumers with a clear and easy to understand information on the compatibility of their vehicle with different fuels offered in the transport fuels market of the union , without prejudice to directive 2009 / 30 / ec of the european parliament and of the council of 23 april 2009 amending directive 98 / 70 / ec as regards the specification of petrol , diesel and gas - oil and introducing a mechanism to monitor and reduce greenhouse gas emissions and amending council directive 1999 / 32 / ec as regards the specification of fuel used by inland waterway vessels and repealing directive 93 / 12 / eec . in particular , eu - wide standardisation of the colours used for the hoses and nozzles to deliver fuel at filling stations should be considered .


### annex i . 1 and the last subparagraph of annex i . 2 of directive 2009 / 72 / ec shall apply to the consumption data and the metering system of the recharging point for electric vehicles . ### annex i . 1 and the last subparagraph of annex i . 2 of directive 2009 / 72 / ec shall apply to the consumption data and the metering system of the recharging point for electric vehicles at private consumer premises .


### direct current fast recharging points for electric vehicles shall be equipped , for interoperability purposes , with connectors of type ‘ combo 2’ as described in the relevant en standard , to be adopted by 2014 . ### direct current fast recharging points for electric vehicles shall be equipped , for interoperability purposes , with multi - standard connectors providing both ' chademo ' and type ‘ combo 2’connection , as described in the relevant en standard to be adopted by 2014 .


### member states shall ensure that any person who is suspected or accused of having committed a criminal offence is provided promptly with information on his procedural rights in simple and accessible language . ### member states shall ensure that any person who is suspected or accused of having committed a criminal offence is provided promptly with information on his procedural rights in simple and accessible language . that information shall be provided at the point when those rights become applicable , and in any event before questioning by law enforcement authorities , in due time to allow their effective exercise .


### the information referred to in paragraph 1 shall include as a minimum : ### the information referred to in paragraph 1 shall include as a minimum , as they apply under national law :


### where a person is arrested by the competent authorities of a member state in the course of criminal proceedings , he shall be promptly provided with information about his procedural rights in writing . he shall be given an opportunity to read the letter of rights and be allowed to keep it in his possession throughout the time he is deprived of his liberty . ### where a person is arrested by the competent authorities of a member state in the course of criminal proceedings , he shall be promptly provided with information about his procedural rights in writing . he shall be given an opportunity to read the letter of rights and be allowed , save in exceptional circumstances , to keep it in his possession throughout the time he is deprived of his liberty .


### where a suspected or accused person is arrested at any stage of the criminal proceedings , member states shall ensure that he or his lawyer is granted access to those documents contained in the case - file which are relevant for the determination of the lawfulness of the arrest or detention . ### where a person is arrested and detained at any stage of the criminal proceedings , member states shall ensure that all information which relates to the specific case in the possession of the competent authorities and which is essential to effectively challenge the lawfulness of the arrest or detention under national law , is made available to the arrested person or his lawyer .


### member states shall require manufacturers and importers of tobacco products to submit to their competent authorities a list of all ingredients , and quantities thereof , used in the manufacture of the tobacco products by brand name and type , as well as their emissions and yields . manufacturers or importers shall also inform the competent authorities of the concerned member states if the composition of a product is modified affecting the information provided under this article . information required under this article shall be submitted prior to the placing of the market of a new or modified tobacco product . ### member states shall require manufacturers and importers of tobacco products to submit to their competent authorities a list of all ingredients , and quantities thereof , used in the manufacture of the tobacco products by brand name and type , as well as their emissions and yields resulting from intended use . manufacturers or importers shall also inform the competent authorities of the concerned member states if the composition of a product is modified affecting the information provided under this article . information required under this article shall be submitted prior to the placing of the market of a new or modified tobacco product .


### in order to ensure their graphic integrity and visibility , health warnings shall be irremovably printed , indelible and in no way hidden or interrupted , including by tax stamps , price marks , tracking and tracing marks , security features or by any type of wrapper , pouch , jacket , box or other device or by the opening of the unit packet . ### in order to ensure their graphic integrity and visibility , health warnings shall be irremovably printed or irremovably affixed , indelible and in no way hidden or interrupted , including by tax stamps , price marks , tracking and tracing marks , security features or by any type of wrapper , pouch , jacket , box or other device or by the opening of the unit packet .


### for cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets . these warnings shall have a width of not less than 20 mm and a height of not less than 43 mm . for roll - your - own tobacco the information message shall be printed on the surface that becomes visible when opening the unit packet . both the general warning and the information message shall cover 50% of the surface on which they are printed . ### for cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets . these warnings shall have a width of not less than 20 mm and a height of not less than 43 mm . for roll - your - own tobacco the information message shall be printed on the surface that becomes visible when opening the unit packet . both the general warning and the information message shall cover 40% of the surface on which they are printed .


### be printed on the two largest surfaces of the unit packet and any outside packaging ; ### be printed or affixed on the two largest surfaces of the unit packet and any outside packaging ;


### a unit packet of cigarettes shall have a cuboid shape . a unit packet of roll - your - own tobacco shall have the form of a pouch , i . e . a rectangular pocket with a flap that covers the opening . the flap of the pouch shall cover at least 70% of the front of the packet . a unit packet of cigarettes shall include at least 20 cigarettes . a unit packet of roll - your - own tobacco shall contain tobacco weighing at least 40 g . ### a unit packet of cigarettes shall have a cuboid shape . a unit packet of cigarettes shall include at least 20 cigarettes . a unit packet of roll - your - own tobacco shall contain tobacco weighing at least 40 g .


### the identity of all purchasers from manufacturing to the first retail outlet ; ### the identity of all purchasers from manufacturing to the first customer ;


### the invoice , order number and payment records of all purchasers from manufacturing to the first retail outlet . ### the invoice , order number and payment records of all purchasers from manufacturing to the first customer .


### member states shall ensure that all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet , record the entry of all unit packets into their possession , as well as all intermediate movements and the final exit from their possession . this obligation can be fulfilled by recording in aggregated form , e . g . of outside packaging , provided that tracking and tracing of unit packets remains possible . ### member states shall ensure that all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first customer , record the entry of all unit packets into their possession , as well as all intermediate movements and the final exit from their possession . this obligation can be fulfilled by recording in aggregated form , e . g . of outside packaging , provided that tracking and tracing of unit packets remains possible .


### member states shall ensure that manufacturers of tobacco products provide all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet , including importers , warehouses and transporting companies with the necessary equipment allowing for the recording of the tobacco products purchased , sold , stored , transported or otherwise handled . the equipment shall be able to read and transmit the data electronically to a data storage facility pursuant to paragraph 6 . ### member states shall ensure that manufacturers of tobacco products provide all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first customer , including importers , warehouses and transporting companies with the necessary equipment allowing for the recording of the tobacco products purchased , sold , stored , transported or otherwise handled . the equipment shall be able to read and transmit the data electronically to a data storage facility pursuant to paragraph 6 .


### the competent authorities shall conclude cooperation agreements on exchange of information with the competent authorities of third countries only where the information disclosed is subject to guarantees of professional secrecy which are at least equivalent to those set out in article 29 . such exchange of information must be intended for the performance of the tasks of those competent authorities . ### the competent authorities may not enter into cooperation arrangements with third countries which result in obligations for member states other than those concerning the provision of information . cooperation arrangements on exchange of information may be entered into only where the information disclosed is subject to guarantees of professional secrecy which are at least equivalent to those set out in article 29 . such exchange of information must be intended for the performance of the tasks of those competent authorities .


### the security of supply aspects of long - term planning of investments in sufficient cross - border capacities and other infrastructures , ensuring the long - term ability of the system to guarantee security of supply and meet reasonable demands , are addressed by directive . . . / … / ec of the european parliament and of the council [ concerning common rules for the internal market in natural gas and repealing directive 2003 / 55 / ec ] . meeting the security of supply standards may require a transitional period to allow the necessary investments to be made . the 10 - year network development plan drawn up by the entso - g and supervised by acer is a fundamental tool to identify the required investments needed at community level . ### the security of supply aspects of long - term planning of investments in sufficient cross - border capacities and other infrastructures , ensuring the long - term ability of the system to guarantee security of supply and meet reasonable demands , are addressed by directive 2009 / 73 / ec of the european parliament and of the council [ concerning common rules for the internal market in natural gas and repealing directive 2003 / 55 / ec ] . since this regulation builds on directive 2009 / 73 / ec , directive 2009 / 73 / ec shall be implemented prior to the entry into force of this regulation . the 10 - year network development plan drawn up by the entso - g and supervised by acer is a fundamental tool to identify the required investments needed at community level .


### the competent authority shall take the measures to ensure the gas supply to the protected customers of the member state in the case of : ### the competent authority shall take the measures to ensure the gas supply to the protected customers and vulnerable customers of the member state in the case of :


### the competent authority shall take the measures to ensure the gas supply to the protected customers for the period of sixty days also in the event of an emergency as defined in article 9 . the competent authority shall endeavour to maintain the supply for the protected customers as long as necessary . ### the competent authority shall take the measures to ensure the gas supply to the protected customers and vulnerable customers for the period of sixty days also in the event of an emergency as defined in article 9 . the competent authority shall endeavour to maintain the supply for the protected customers and vulnerable customers as long as necessary .


### it is not appropriate to extend limitations of the use of phosphates and other phosphorus compounds in household laundry detergents to household automatic dishwasher detergents or to industrial and institutional detergents because suitable technically and economically feasible alternatives to the use of phosphates in those detergents are not yet available . ### efficient household automatic dishwasher detergents with a limited concentration of phosphorus are currently available on the market . it is thus appropriate to extend limitations of the use of phosphates and other phosphorus compounds in household laundry detergents to household automatic dishwasher detergents . it is not appropriate , however , to extend these limitations to industrial and institutional detergents because suitable technically and economically feasible alternatives to the use of phosphates in those detergents are not yet available .


### it is appropriate to provide for deferred application of the restriction established in this regulation so as to allow operators , in particular small and medium–sized enterprises , to reformulate their phosphate–based household laundry detergents using alternatives during their usual reformulation cycle in order to minimise the costs . ### it is appropriate to provide for deferred application of the restrictions established in this regulation so as to allow operators , in particular small and medium–sized enterprises , to reformulate their phosphate–based household laundry detergents and household automatic dishwasher detergents using alternatives during their usual reformulation cycle in order to minimise the costs .


### in article 12 , paragraph 3 is deleted . ### article 12 is replaced by the following : ' article 12 committee procedure the commission shall be assisted by a committee . that committee shall be a committee within the meaning of regulation no 182 / 2011 . 2 . where reference is made to this paragraph , article 5 of regulation no 182 / 2011 shall apply . ”


### the commission may adopt , by means of delegated act in accordance with articles 13a , 13b and 13c , amendments necessary for adapting the annexes to scientific and technical progress . the commission shall , wherever possible , use european standards . 2 . the commission may adopt , by means of delegated act in accordance with articles 13a , 13b and 13c , amendments to the annexes of this regulation regarding solvent - based detergents . 3 . where individual risk - based concentration limits for the fragrance allergens are established by the scientific committee on cosmetics and non - food products , the commission shall , in accordance with articles 13a , 13b and 13c , adapt the limit of 0 . 01% set out in section a of annex vii accordingly . ### the commission shall be empowered to adopt , by means of delegated acts in accordance with article 13a , amendments necessary for adapting the annexes to scientific and technical progress . the commission shall , wherever possible , use european standards . 2 . the commission shall be empowered to adopt , by means of delegated acts in accordance with article 13a , necessary amendments to the annexes of this regulation regarding solvent - based detergents . 3 . where individual risk - based concentration limits for the fragrance allergens are established by the scientific committee on cosmetics and non - food products , the commission shall be empowered to adopt delegated acts in accordance with article 13a to adapt the limit of 0 . 01% set out in section a of annex vii accordingly .


### the following articles 13a , 13b and 13c are inserted : ' article 13a exercise of the delegation the powers to adopt the delegated acts referred to in article 13 shall be conferred on the commission for an indeterminate period of time . 2 . as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament and to the council . 3 . the powers to adopt delegated acts are conferred on the commission subject to the conditions laid down in articles 13b and 13c . article 13b revocation of the delegation the delegation of power referred to in article 13 may be revoked at any time by the european parliament or by the council . 2 . the institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the commission within a reasonable time before the final decision is taken , indicating the delegated powers which could be subject to revocation and possible reasons for a revocation . 3 . the decision of revocation shall put an end to the delegation of the powers specified in that decision . it shall take effect immediately or at a later date specified therein . it shall not affect the validity of the delegated acts already in force . it shall be published in the official journal of the european union . article 13c objections to delegated acts the european parliament and the council may object to the delegated act within a period of two months from the date of notification . at the initiative of the european parliament or the council this period shall be extended by one month . 2 . if , on expiry of that period , neither the european parliament nor the council has objected to the delegated act it shall be published in the official journal of the european union and shall enter into force at the date stated therein . the delegated act may be published in the official journal of the european union and enter into force before the expiry of that period if the european parliament and the council have both informed the commission of their intention not to raise objections . 3 . if the european parliament or the council objects to a delegated act , it shall not enter into force . the institution which objects shall state the reasons for objecting to the delegated act . ' ### the following article is inserted : ' article 13a exercise of the delegation the power to adopt the delegated acts referred to in article 13 is conferred on the commission subject to the conditions laid down in this article . 1a . the power to adopt delegated acts referred to in article 13 shall be conferred on the commission for an indeterminate period of time from . . . * . 1b . the power to adopt delegated acts referred to in article 13 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . 2 . as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament and to the council . 3 . a delegated act adopted pursuant to article 13 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council . * oj : please insert the date of entry into force of this regulation . '


### by 31 december 2014 , the commission shall evaluate , submit a report to the european parliament and to the council on the use of phosphates and other phosphorous compounds in household automatic dishwasher detergents and , if justified , present a legislative proposal with a view to their gradual phase - out or restriction to specific applications . ” ### by 31 december 2013 , the commission shall evaluate and submit a report to the european parliament and to the council on the use of phosphates and other phosphorous compounds in household automatic dishwasher detergents , based on a life - cycle analysis of those detergents and taking into account the non - toxicity and effectiveness of alternative products . if justified , it shall present a legislative proposal with a view to their gradual phase - out or restriction to specific applications . ”


### article 16 is replaced by the following : ' article 16 report by 31 december 2014 , the commission shall evaluate , submit a report to the european parliament and to the council on the use of phosphates and other phosphorus compounds in household automatic dishwasher detergents and , if justified , present a legislative proposal with a view to their gradual phase - out or restriction to specific applications . ” ### article 16 is replaced by the following : ' article 16 report by 31 december 2016 , the commission shall evaluate , submit a report to the european parliament and to the council on the use of phosphates and other phosphorus compounds in industrial and institutional detergents and , if justified , present a legislative proposal with a view to their gradual phase - out or restriction to specific applications . ”


### the high and rapidly increasing demand for maritime space for different purposes , such as renewable energy installations , maritime shipping and fishing activities , ecosystem conservation and tourism and aquaculture installations , as well as the multiple pressures on coastal resources require an integrated planning and management approach . ### the high and rapidly increasing demand for maritime space for different purposes , such as renewable energy installations , maritime shipping and fishing activities , ecosystem conservation , the extraction of raw materials , tourism and aquaculture installations , as well as the multiple pressures on coastal resources , require an integrated planning and management approach .


### such an approach to ocean management has been developed in the integrated maritime policy for the european union , including , as its environmental pillar , directive 2008 / 56 / ec of the european parliament and of the council of 17 june 2008 establishing a framework for community action in the field of marine environmental policy . the objective of the integrated maritime policy is to support the sustainable development of seas and oceans and to develop coordinated , coherent and transparent decision - making in relation to the union ' s sectoral policies affecting the oceans , seas , islands , coastal and outermost regions and maritime sectors , including through sea - basin strategies or macro - regional strategies . ### such an approach to ocean management and maritime governance has been developed in the integrated maritime policy for the european union , including , as its environmental pillar , directive 2008 / 56 / ec of the european parliament and of the council of 17 june 2008 establishing a framework for community action in the field of marine environmental policy . the objective of the integrated maritime policy is to support the sustainable development of seas and oceans and to develop coordinated , coherent and transparent decision - making in relation to the union ' s sectoral policies affecting the oceans , seas , islands , coastal and outermost regions and maritime sectors , including through sea - basin strategies or macro - regional strategies .


### the integrated maritime policy identifies maritime spatial planning and integrated coastal management as cross - cutting policy tools for public authorities and stakeholders to apply a coordinated , integrated approach . the application of an ecosystem - based approach will contribute to promoting the sustainable growth of the maritime and coastal economies and the sustainable use of marine and coastal resources . ### the integrated maritime policy identifies maritime spatial planning and integrated coastal management as cross - cutting policy tools for public authorities and stakeholders to apply a coordinated , integrated and trans - boundary approach . the application of an ecosystem - based approach will contribute to promoting the sustainable growth of the maritime and coastal economies and the sustainable use of marine and coastal resources .


### maritime spatial planning and integrated coastal management will contribute , inter alia , to achieving the aims of directive 2009 / 28 / ec of the european parliament and of the council of 23 april 2009 on the promotion of the use of energy from renewable sources , council regulation 2371 / 2002 of 20 december 2002 on the conservation and sustainable exploitation of fisheries resources under the common fisheries policy , decision 884 / 2004 / ec of the european parliament and of the council amending decision no 1692 / 96 / ec on community guidelines for the development of the trans - european transport network , directive 2000 / 60 / ec of the european parliament and of the council of 23 october 2000 establishing a framework for community action in the field of water policy , directive 2008 / 56 / ec of the european parliament and of the council of 17 june 2008 establishing a framework for community action in the field of marine environmental policy , the eu biodiversity strategy for 2020 , the roadmap towards a resource efficient europe , the eu strategy on adaptation to climate change well as , where appropriate , those of the eu regional policy , including the sea - basin and macro - regional strategies . ### maritime spatial planning and integrated coastal management will contribute , inter alia , to achieving the aims of directive 2009 / 28 / ec of the european parliament and of the council of 23 april 2009 on the promotion of the use of energy from renewable sources , council regulation 2371 / 2002 of 20 december 2002 on the conservation and sustainable exploitation of fisheries resources under the common fisheries policy , decision 884 / 2004 / ec of the european parliament and of the council amending decision no 1692 / 96 / ec on community guidelines for the development of the trans - european transport network , directive 2000 / 60 / ec of the european parliament and of the council of 23 october 2000 establishing a framework for community action in the field of water policy , directive 2008 / 56 / ec of the european parliament and of the council of 17 june 2008 establishing a framework for community action in the field of marine environmental policy , the eu biodiversity strategy for 2020 , the roadmap towards a resource efficient europe , the eu strategy on adaptation to climate change and the commission ' s communication com0008 entitled ' strategic goals and recommendations for the eu ' s maritime transport policy until 2018 ' , as well as , where appropriate , those of the eu regional policy , including the sea - basin and macro - regional strategies .


### the main purpose of maritime spatial planning is to identify and manage spatial uses and conflicts in maritime areas . in order to achieve that purpose , member states need at least to ensure that the planning process or processes result in a comprehensive map identifying the different uses of maritime space , taking into consideration long term changes due to climate change . ### the main purposes of maritime spatial planning are to identify and manage spatial uses , to minimise cross - sectoral conflicts in maritime areas and to enhance sustainable growth in the maritime sector . in order to achieve those purposes , member states need at least to ensure that the planning process or processes result in a comprehensive map identifying the different uses of maritime space , taking into consideration long term changes due to climate change .


### member states should consult and coordinate their plans and strategies with the relevant member state or third country authorities in the marine region or sub - region or coastal zone concerned in conformity with the rights and obligations of these member states and third countries under european and international law . effective cross border cooperation between member states and with neighbouring third countries requires that the competent authorities in each member state are identified . member states therefore need to designate the competent authority or authorities responsible for cooperation with other member states or third countries . given the differences between various marine regions or sub - regions and coastal zones , it is not appropriate to prescribe in detail in this directive how these cooperation mechanisms should look . ### member states should consult and , as far as possible , coordinate their plans and strategies with the relevant member state or third country authorities in the marine region or sub - region or coastal zone concerned in conformity with the rights and obligations of these member states and third countries under european and international law . effective cross border cooperation between member states and with neighbouring third countries requires that the competent authorities in each member state are identified . member states therefore need to designate competent authorities responsible for cooperation with other member states or third countries . given the differences between various marine regions or sub - regions and coastal zones , it is not appropriate to prescribe in detail in this directive how these cooperation mechanisms should look .


### in order to ensure that the establishment of maritime spatial plans and integrated coastal management strategies is based on reliable data and to avoid additional administrative burden , it is essential that member states collect the best available data and information by making use of existing instruments and tools for data collection , such as those developed in the context of the marine knowledge 2020 initiative . ### in order to ensure that the establishment of maritime spatial plans and integrated coastal management strategies is based on reliable data and to avoid any additional administrative burden , it is essential that member states collect and use the best available data and information by encouraging the relevant stakeholders to share their data and information and making use of existing instruments and tools for data collection , such as those developed in the context of the marine knowledge 2020 initiative .


### ' coastal zone ' means the geomorphologic area on both sides of the seashore area with as the seaward limit the external limit of the territorial seas of member states and as the landward limit , the limit as defined by the member states in their integrated coastal management strategies . ### ' coastal zone ' means the seashore and the geomorphologic area on both sides of the seashore area . the landward and the seaward limit shall be defined by the member states and those limits shall not exceed their territorial seas .


### ‘ integrated maritime policy’ means the union policy with the aim to foster coordinated and coherent decision - making to maximise the sustainable development , economic growth and social cohesion of member states , in particular with regard to coastal , insular and outermost regions in the union , as well as maritime sectors , through coherent maritime - related policies and relevant international cooperation . ### ' integrated maritime policy ' means the union policy established to foster a coordinated and coherent cross - sectoral and trans - boundary maritime governance designed to maximise the sustainable development , economic growth and social cohesion of member states , in particular with regard to coastal , insular and outermost regions in the union .


### ‘ public’ means involving one or more natural or legal persons and , in accordance with national legislation or practice , their associations , organisations or groups . ### ' public ' means one or more natural or legal persons and , in accordance with national legislation or practice , their associations , organisations or groups .


### identify the trans - boundary effects of maritime spatial plans and integrated coastal management strategies on the marine waters and coastal zones under the sovereignty or jurisdiction of third countries in the same marine region or sub - region and related coastal zones and deal with them in cooperation with the competent authorities of these countries in accordance with articles 12 and 13 ; ### identify the trans - boundary effects of maritime spatial plans and integrated coastal management strategies on the marine waters and coastal zones under the sovereignty or jurisdiction of third countries in the same marine region or sub - region and related coastal zones and deal with them in cooperation with the competent authorities of those countries in accordance with article 13 ;


### fishing areas ; ### existing and potential fishing areas ;


### when establishing integrated coastal management strategies , member states shall take into consideration , at least , the following activities : ### when establishing integrated coastal management strategies , member states shall take into consideration :


### member states shall establish means for the public participation of all interested parties at an early stage in the development of maritime spatial plans and integrated coastal management strategies . ### member states shall establish means for public participation by informing and consulting the relevant stakeholders and authorities and the public concerned at an early stage in the development of maritime spatial plans and integrated coastal management strategies . member states shall also ensure that those stakeholders and authorities and the public concerned have access to the results once they are finalised .


### member states shall organise the collection of the best available data and the exchange of information necessary for maritime spatial plans and integrated coastal management strategies . ### member states shall organise the collection and use of the best available data and the exchange of information necessary for maritime spatial plans and the implementation of integrated coastal management strategies .


### each member state bordering a coastal zone or maritime area of another member state shall cooperate to ensure that maritime spatial plans and integrated coastal management strategies are coherent and coordinated across the coastal zone or marine region and / or sub - region concerned . such cooperation shall in particular take into account issues of a transnational nature , such as cross - border infrastructure . ### member states bordering the same coastal zone or maritime area shall consult each other and take all necessary steps to cooperate to ensure that maritime spatial plans and integrated coastal management strategies are coherent and coordinated across the coastal zone or marine region and / or sub - region concerned . such cooperation shall in particular take into account issues of a transnational nature , such as cross - border infrastructure .


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


### the commission may , by means of implementing acts , adopt provisions on : ### the commission may without prejudice to specifications on substantive related matter of plans and strategies , by means of implementing acts , adopt provisions on :


### operational specifications for management of data referred in article 10 , provided they have not been established by other eu legislation , such as directive 2007 / 2 / ec or 2008 / 56 / ec , on ### process related specifications for management of data referred in article 10 , provided they have not been established by other eu legislation , such as directive 2007 / 2 / ec or 2008 / 56 / ec , on


### – the sharing of data , and interfacing with existing data management and collection processes ; and ### – the effective sharing of data , and interfacing with existing systems of data management and collection processes ; and


### the operational steps for the establishment and reporting on maritime spatial plans and integrated coastal management strategies concerning : ### the process related steps that contribute to the establishment and reporting on maritime spatial plans and integrated coastal management strategies concerning :


### – cross - border co - operation modalities ; ### – the most effective modalities of cross - border co - operation ;


### where reference is made to paragraph 1 , article 5 of regulation 182 / 2011 shall apply . ### where reference is made to this paragraph , article 5 of regulation no 182 / 2011 shall apply .


### 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 , 54 months following the entry into force of this directive , and every six years thereafter .


### after the granting of a marketing authorisation , the agency may require a marketing authorisation holder to conduct a post - authorisation safety study if there are concerns about the risks of an authorised medicinal product . the requirement shall be made in writing , provide a detailed justification and include the objectives and timeframe for submission and conduct of the study . ### after the granting of a marketing authorisation , the agency may require a marketing authorisation holder to conduct a post - authorisation safety study if there are concerns about the risks of an authorised medicinal product . the requirement shall be made in writing , provide a detailed justification on the basis of scientific arguments and include the objectives and timeframe for submission and conduct of the study .


### once renewed , the marketing authorisation shall be valid for an unlimited period , unless the national competent authority decides , on justified grounds relating to pharmacovigilance or to insufficient exposure to the product , to proceed with one additional five - year renewal in accordance with paragraph 2 . ” ### once renewed , the marketing authorisation shall be valid for an unlimited period , unless the competent authority decides , on justified grounds relating to pharmacovigilance , to proceed with one additional five - year renewal in accordance with paragraph 2 . ”


### the requirement shall be made in writing , provide a detailed justification , and include the timeframe for submission of the detailed description of the risk - management system . ### the requirement shall be made in writing , provide a detailed justification on the basis of scientific arguments and include the timeframe for submission of the detailed description of the risk - management system .


### the opinions and decisions referred to in paragraphs 3 to 5 of this article shall be made public by means of the european medicines safety web - portal referred to in article 26 . ### the final opinions and final decisions referred to in paragraphs 3 to 5 of this article shall be made public by means of the european medicines safety web - portal referred to in article 26 .


### the full traceability of transfers of funds can be a particularly important and valuable tool in the prevention , investigation and detection of money laundering or terrorist financing . it is therefore appropriate , in order to ensure the transmission of information throughout the payment chain , to provide for a system imposing the obligation on payment service providers to have transfers of funds accompanied by information on the payer and the payee . ### the full traceability of transfers of funds can be a particularly important and valuable tool in the prevention , investigation and detection of money laundering or terrorist financing . it is therefore appropriate , in order to ensure the transmission of information throughout the payment chain , to provide for a system imposing the obligation on payment service providers to have transfers of funds accompanied by information on the payer and the payee . this system should also ensure the inclusion of payment service providers situated in developing countries whose financial systems are often abused for these illegal purposes .


### 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 interpreted consistently across the eu , and that this has given rise to situations where the general public is exposed to disguised advertising .


### 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 make information available to patients and the general public result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the community .


### 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 .


### 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 make available , either directly or indirectly through a third party that is acting in the name of the marketing authorization holder , information that has been approved by the competent authorities to the general public or members thereof on authorised medicinal products subject to medical prescription provided that this information and the way it is supplied 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 that acts on behalf of the marketing authorisation holder shall be clearly identified as such .


### 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 shall ensure that misuse is avoided by securing that only the marketing authorisation holder supplies information , and only such information which has been approved by the competent authorities about approved medicines subject to medical prescription , and in the form which has been approved for the dissemination to the general public or members thereof . by way of derogation member states may continue those types of control mechanism which they have been implemented before 31 . 12 . 2008 . the commission verifies and approves these systems .


### internet websites registered in accordance with paragraph 1 shall not allow the identification of members of the general public which have access to those websites or the appearance therein of unsolicited material actively distributed to the general public or members thereof . those websites shall not contain web - tv . ### internet websites registered in accordance with paragraph 1 shall not allow the identification of members of the general public which have access to those websites without their explicit prior consent or the appearance therein of unsolicited material actively distributed to the general public or members thereof . internet websites may provide video content if it is useful for the safe and effective use of the medicine . video contents shall only reflect the package leaflet , the summary of the characteristics and the drug - fact - box and hints how to use this medicine safe and effectively . before publication video contents must be approved by the competent authorities .


### if a member state has reasons for doubts as to whether the translation of the reproduced information is correct , it may require a marketing authorisation holder to provide for a certified translation of the information disseminated on the internet website registered with the national competent authority of another member state . ### if a member state has reasons for doubts as to whether the translation of the reproduced information is correct , it may require a marketing authorisation holder to provide for a certified translation of the authority - approved information disseminated on the internet website registered with the national competent authority of another member state .


### if a member state has reasons for doubts as to whether the information disseminated on an internet website registered with the national competent authorities of another member state complies with the requirements of this title , it shall inform that member state of the reasons for its doubts . the member states concerned shall use their best endeavours to reach agreement on the action to be taken . if they fail to reach an agreement within two months , the case shall be referred to the pharmaceutical committee set up by decision 75 / 320 / eec . any necessary measures may only be adopted after an opinion has been delivered by that committee . member states shall take account of opinions delivered by the pharmaceutical committee and shall inform the committee of how its opinion has been taken into account . ### if a member state has reasons for doubts as to whether the authority - approved information disseminated on an internet website registered with the national competent authorities of another member state complies with the requirements of this title , it shall inform that member state of the reasons for its doubts . the member states concerned shall use their best endeavours to reach agreement on the action to be taken . if they fail to reach an agreement within two months , the case shall be referred to the pharmaceutical committee set up by decision 75 / 320 / eec . any necessary measures may only be adopted after an opinion has been delivered by that committee . member states shall take account of opinions delivered by the pharmaceutical committee and shall inform the committee of how its opinion has been taken into account .


### 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 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 .


### 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 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 clearly identify the national competent authority monitoring the website concerned and the marketing authorisation holder responsible for the website . 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 .


### keep available for the authorities or bodies responsible for monitoring information on medicinal products , a sample of all information disseminated in accordance with this title and information on its volume of dissemination , together with a statement indicating the persons to whom it is addressed , the method of dissemination and the date of first dissemination , ### keep available for the competent authorities or bodies responsible for monitoring information on medicinal products that have approved the information in advance , a sample of all information made available in accordance with this title and information on its volume of provision , together with a statement indicating the persons to whom it is addressed , the method of provision and the date of first provision ,


### by [ insert specific date five years from the entry into force of amending directive ] at the latest , the commission shall publish a report on the experience acquired in the implementation of this title and shall also assess the need for a review thereof . the commission shall submit this report to the european parliament and to the council . ### by [ insert specific date five years from the entry into force of amending directive ] at the latest , the commission shall publish a report on the experience acquired in the implementation of this title after consulting the patient organisations and the members of health care professions and shall also assess the need for a review thereof . the commission shall submit this report to the european parliament and to the council .


### 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 .


### ' member states may exchange electronic data between their computerised databases from the date when the commission recognises the full operability of the data exchange system . ### ' member states may exchange electronic data between their computerised databases from the date when the commission recognises the full operability of the data exchange system . this must be done in such a way that data protection is guaranteed and any abuse prevented in order to protect the interests of the holding .


### 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 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 . the pilot phase of this initiative will redirect some eu budget spending towards growth - enhancing areas – particularly transport , energy and telecommunications infrastructure – taking into account the union’s budgetary discipline and the ceilings under the current multiannual financial framework .


### it will be the first financial instrument benefiting infrastructure projects with similar financing needs across several sectors and will as such produce higher benefits in terms of market impact , administrative efficiency and resource utilisation . it will provide a coherent instrument to infrastructure stakeholders such as financiers , public authorities , construction companies and operators . ### it will be the first financial instrument benefiting infrastructure projects with similar financing needs across several sectors and will as such produce higher benefits in terms of market impact , administrative efficiency and resource utilisation , thanks to the possible synergies between the transport , energy and ict sectors . it will provide a coherent instrument to infrastructure stakeholders such as financiers , public authorities , construction companies and operators .


### the union support should mitigate the risk inherent in project bonds to the extent that capital market participants are willing to invest in a larger volume infrastructure project bonds than would be possible without union support . ### the union support provided by means of this regulation should mitigate the risk inherent in project bonds to the extent that capital market participants are willing to invest in a larger volume infrastructure project bonds than would be possible without union support .


### europe ' s economic recovery should not be compromised by growing transport congestion , missing energy links and a slowing down of broadband penetration due to infrastructure projects ' difficulties in gaining access to long - term private finance or public funding . ### europe ' s economic recovery should not be compromised by deteriorating performance on the part of transport , missing energy links and a slowing down of broadband penetration due to infrastructure projects ' difficulties in gaining access to long - term private finance or public funding .


### in light of the eib ' s long - standing expertise and as the major financier of infrastructure projects and given its nature as the eu financial body established by the treaty , the commission should involve the eib in the implementation of this pilot phase . the specific terms and conditions of the co - operation including risk - sharing and remuneration of the eib , should be laid down in an agreement between the commission and the eib . ### in light of the eib ' s long - standing expertise and as the major financier of infrastructure projects and given its nature as the eu financial body established by the treaty , the commission should involve the eib in the implementation of this pilot phase . it is necessary to lay down the specific terms and conditions of the co - operation , including risk - sharing and remuneration of the eib , in an agreement between the commission and the eib .


### the pilot phase of the europe 2020 project bond initiative should be launched in preparation of the proposed connecting europe facility . this pilot phase will help to pave the way for the risk - sharing financial instrument under the connecting europe facility . ### it is important that the pilot phase of the europe 2020 project bond initiative should be launched in preparation of the proposed connecting europe facility , which will help to pave the way for the risk - sharing financial instrument under this facility .


### budgetary funds should be requested by the eib on the basis of a range of projects , which the eib would deem suitable and likely to be realised . any such requests should be made prior to 31 december 2013 . due to the complexity of large infrastructure projects , the actual approval might take place at a later date , but no later than 31 december 2014 . ### budgetary funds should be requested by the eib on the basis of a range of projects , which the eib and the commission would deem suitable and likely to be realised . any such requests should be made prior to 31 december 2013 . due to the complexity of large infrastructure projects , the actual approval might take place at a later date , but no later than 31 december 2014 .


### is used only for projects whose financial viability is based on project revenues . ### is used only for projects whose financial viability is based on project revenues and whose commercial potential is not sufficient to ensure financing by market mechanisms alone .


### 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 . ### 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 , during the term of those bonds , 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 . interest and other revenue generated by the risk - sharing instrument for project bonds in the form of commission paid by the beneficiaries which is received before 31 december 2013 may be reused for new loans and guarantees . after 1 january 2014 , the revenues shall be returned to the union budget .


### ‘ postal services’ means services consisting of the clearance , sorting , routing and delivery of postal items . this shall include both services falling within as well as services falling outside the scope of the universal service set up in conformity with directive 97 / 67 / ec ; ### ‘ postal services’ means services consisting of the clearance , sorting , routing and delivery of domestic postal items and services falling within the scope of the universal service set up in conformity with directive 97 / 67 / ec ;


### contracts intended to enable an activity mentioned in articles 5 to 11 to be carried out shall not be subject to this directive if the member state or the contracting entities having introduced the request pursuant to article 28 can demonstrate that , in the member state in which it is performed , the activity is directly exposed to competition on markets to which access is not restricted ; nor shall design contests that are organised for the pursuit of such an activity in that geographic area be subject to this directive . such competition assessment , which will be made in the light of the information available to the commission and for the purposes of this directive , is without prejudice to the application of competition law . ### contracts intended to enable an activity mentioned in articles 5 to 11 to be carried out shall not be subject to this directive if the member state or the contracting entities having introduced the request pursuant to article 28 can demonstrate that , in the member state in which it is performed , the activity , or its specific sectors or segments , is directly exposed to competition on markets to which access is not restricted ; nor shall design contests that are organised for the pursuit of such an activity in that geographic area be subject to this directive . such competition assessment , which will be made in the light of the information available to the commission and for the purposes of this directive , is without prejudice to the application of competition law .


### for the purposes of paragraph 1 , access to a market shall be deemed not to be restricted if the member state has implemented and applied the union legislation listed in annex iii . ### for the purposes of paragraph 1 , access to a market shall be deemed not to be restricted if the member state has implemented and applied the union legislation listed in annex iii or if the member state has extended to the market in question the application of principles established by this legislation .


### where a member state or , where the legislation of the member state concerned provides for it , a contracting entity considers that , on the basis of the criteria set out in article 27 and , a given activity is directly exposed to competition on markets to which access is not restricted , it may submit a request to establish that this directive does not apply to the award of contracts or the organisation of design contests for the pursuit of that activity . ### where a member state or , where the legislation of the member state concerned provides for it , a contracting entity considers that , on the basis of the criteria set out in article 27 and , a given activity is completely or partially , even with regard to single sectors or segments of it , directly exposed to competition on markets to which access is not restricted , it may submit a request to establish that this directive does not apply to the award of contracts or the organisation of design contests for the pursuit of that activity or of a single sector or segment of it .


### requests shall be accompanied by a reasoned and substantiated position adopted by an independent national authority that is competent in relation to the activity concerned . this position shall thoroughly analyse the conditions for the possible applicability of article 27 to the activity concerned in accordance with its paragraphs 2 and 3 . ### requests shall be accompanied by a reasoned and substantiated position adopted by an independent national authority that is competent in relation to the activity concerned or a single sector or segment of it . this position shall thoroughly analyse the conditions for the possible applicability of article 27 to the activity concerned in accordance with its paragraphs 2 and 3 .


### upon request submitted in accordance with paragraph 1 of this article , the commission may , by way of an implementing decision adopted within the periods set out in paragraph 4 of this article , establish whether an activity referred to in articles 5 to 11 is directly exposed to competition on the basis of the criteria set out in article 27 . those implementing decisions shall be adopted in accordance with the advisory procedure referred to in article 100 . ### upon request submitted in accordance with paragraph 1 of this article , the commission may , by way of an implementing decision adopted within the periods set out in paragraph 4 of this article , establish whether an activity , or a single sector or segment of it , referred to in articles 5 to 11 is directly exposed to competition on the basis of the criteria set out in article 27 . those implementing decisions shall be adopted in accordance with the advisory procedure referred to in article 100 .


### contracts intended to enable the activity concerned to be carried out and design contests that are organised for the pursuit of such an activity shall cease to be subject to this directive in any of the following cases : ### contracts intended to enable the activity concerned , or a single sector or segment of it , to be carried out and design contests that are organised for the pursuit of such an activity , or a single sector or segment of it , shall cease to be subject to this directive in any of the following cases :


### the term of a framework agreement shall not exceed four years , save in exceptional cases duly justified , in particular by the subject of the framework agreement . ### the term of a framework agreement shall not exceed six years , save in exceptional cases duly justified , in particular by the subject of the framework agreement .


### contracting entities shall document the progress of all procurement procedures , whether or not the procedures are conducted by electronic means . to that end , they shall document all stages in the procurement procedure , including all communications with economic operators and internal deliberations , preparation of the tenders , dialogue or negotiation if any , selection and award of the contract . ### contracting entities shall document the progress of all procurement procedures , whether or not the procedures are conducted by electronic means . to that end , they shall document all stages in the procurement procedure , including all communications with economic operators , preparation of the tenders , dialogue or negotiation if any , selection and award of the contract .


### undertake a review of the operation of this directive and submit a report to the european parliament and the council within four years after the date mentioned in article 15 . such review shall cover all the elements of this directive , with special attention to the compliance with standard of protection of personal data , the length of the data retention period and the quality of the assessments . it shall also contain the statistical information gathered pursuant to article 18 . ### undertake a review of the operation of this directive and submit a report to the european parliament and the council within four years after the date mentioned in article 15 . such review shall cover all the elements of this directive , with special attention to the compliance with standard of protection of personal data , including in cases of transfers of data to third countries , the length of the data retention period and the quality of the assessments . it shall also contain a review of the transitional provisions in article 16 and advice on any problems regarding air carriers’ provision of pnr data according to the push method , including the impact on third - country carriers and their flag states , and the statistical information gathered pursuant to article 18 .


### undertake a review of the operation of this directive and submit a report to the european parliament and the council within four years after the date mentioned in article 15 . such review shall cover all the elements of this directive , with special attention to the compliance with standard of protection of personal data , the length of the data retention period and the quality of the assessments . it shall also contain the statistical information gathered pursuant to article 18 . ### undertake a review of the operation of this directive and submit a report to the european parliament and the council within four years after the date mentioned in article 15 . such review shall cover all the elements of this directive , with special attention to the compliance with standard of protection of personal data , the necessity of the collection and processing of pnr data for each of the stated purposes , the length of the data retention period and the quality of the assessments . it shall also contain the statistical information gathered pursuant to article 18 .


### ' withdrawal of a registration ' : shall mean a limited period of time in which the vehicle is not authorised to be used in road traffic , not involving a new process of registration ; ### ' withdrawal of a registration ' : shall mean banning the vehicle temporarily from public roads . the directive sets out the circumstances in which a new process of registration is required


### ' cancellation of a registration ' : shall mean a permanent cancellation of the authorisation for the vehicle to be used in road traffic , involving a new process of registration . ### ' cancellation of a registration ' : shall mean a permanent cancellation of the authorisation for the vehicle to be used in road traffic by the competent authority or by the person named as its owner in the registration certificate , necessitating – if the vehicle is to be used again in road traffic – a new process of registration .


### member states shall keep the data on all vehicles registered on their territory in an electronic register . the data in this register shall contain all elements in accordance with annex i as well as the results of mandatory roadworthiness tests in accordance with regulation xx / xx / xx [ on periodic roadworthiness tests ] . they shall make the technical data on vehicles available to the competent authorities or testing centres involved in roadworthiness testing . ### member states shall keep the data on all vehicles registered on their territory in an electronic register . the data in this register shall contain the data specified in point 5 of annex i as well as any information on the condition of the vehicle on the basis of the results of periodic roadworthiness tests in accordance with regulation xx / xx / xx [ on periodic roadworthiness tests ] . they shall make the technical data on vehicles available to the competent authorities or testing centres involved in periodic roadworthiness testing .


### the withdrawal shall be effective until the vehicle has passed a new roadworthiness test . on successful completion of the roadworthiness test , the registration authority shall without delay re - authorise the use of the vehicle in road traffic . ### the withdrawal shall be effective until the vehicle has passed a new roadworthiness test . on successful completion of the roadworthiness test , the registration authority shall without delay re - authorise the use of the vehicle in road traffic ; no new process of registration shall be necessary .


### in case that a member state registration authority receives a notification that a vehicle has been treated as an end - of - life vehicle in accordance with directive 2000 / 53 / ec the registration shall be cancelled and this information shall be added to its electronic register . ### in case that a member state registration authority receives a notification that a vehicle has been treated as an end - of - life vehicle in accordance with directive 2000 / 53 / ec the registration shall be cancelled and this information shall be added to its electronic register . this cancellation shall not involve a new process of registration .


### the following paragraph is added to article 5 : ' 3 . in case that a member state receives a notification that a vehicle has been re - registered in another member state , it shall cancel the registration of this vehicle on its territory . ' ### the following paragraphs are added to article 5 : ' 3 . in the event that a member state receives a notification that a vehicle has been re - registered in another member state , it shall cancel the registration of that vehicle on its territory . 3a . in the event that a vehicle is re - registered in another member state and the proof of the last roadworthiness test together with the date for the next roadworthiness test appear on the registration certificate , the member state in which the vehicle is re - registered , when issuing the new registration certificate , shall recognise the validity of the roadworthiness certificate and , provided the certificate is valid in terms of the testing intervals applied in the member state of re - registration , shall include a statement to that effect on the new registration certificate . 3b . in the event that the ownership of the vehicle changes and the proof of the last roadworthiness test together with the date for the next roadworthiness test appear on the registration certificate , the member state concerned , when issuing the new registration certificate to the new owner , shall recognise the validity of the roadworthiness certificate and shall include a statement to that effect on the new registration certificate . '


### the delegation of power referred to in article 6 shall be conferred for an indeterminate period of time from the date of entry into force of this regulation . ### the power to adopt delegated acts referred to in article 6 shall be conferred on the commission for a period of five years from the date of entry into force of this directive . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five - year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period .


### long - term finance is a crucial enabling tool for putting the european economy on a path of sustainable , smart and inclusive growth and for building tomorrow ' s economy in a way that is less prone to systemic risks and is more resilient . european long - term investment funds provide finance to various infrastructure projects or unlisted companies of lasting duration that issue equity or debt instruments for which there is no readily identifiable buyer . by providing finance to such projects , eltifs contribute to the financing of the union economies . ### long - term finance is a crucial enabling tool for putting the european economy on a path of sustainable , smart and inclusive growth in line with the europe 2020 strategy and for building tomorrow ' s economy in a way that is less prone to systemic risks and is more resilient . european long - term investment funds provide finance to various infrastructure projects or unlisted companies of lasting duration that issue equity or debt instruments for which there is no readily identifiable buyer . by providing finance to such projects , eltifs contribute to the financing of the union ' s real economy and the implementation of its policies .


### financing for projects , regarding transport infrastructure , sustainable energy generation or distribution , social infrastructure , roll - out of new technologies and systems that reduce use of resources and energy or the further growth of smes , can be scarce . as the financial crisis has shown , complementing bank financing with a wider variety of financing sources that better mobilise capital markets could help tackle financing gaps . eltifs can play a crucial role in this respect . ### financing for projects , regarding transport infrastructure , sustainable energy generation or distribution , social infrastructure , roll - out of new technologies and systems that reduce use of resources and energy or the further growth of smes , can be scarce . as the financial crisis has shown , complementing bank financing with a wider variety of financing sources that better mobilise capital markets could help tackle financing gaps . eltifs can play a crucial role in this respect . for certain projects they could make use of resources such as innovative financial instruments to supplement public funding eroded by the sovereign debt crisis .


### in the absence of a regulation setting out rules on eltifs , diverging measures might be adopted at national level , which are likely to cause distortions of competition resulting from differences in investment protection measures . diverging requirements on portfolio composition , diversification and eligible assets , in particular the investment in commodities , create obstacles to the cross - border marketing of funds that focus on non - listed undertakings and real assets because investors cannot easily compare the different investment propositions offered to them . divergent national requirements also lead to different levels of investor protection . furthermore , different national requirements pertaining to investment techniques , such as the permitted levels of borrowing , use of derivative financial instruments , rules applicable to short selling or securities financing transactions lead to discrepancies in the level of investor protection . in addition , different requirements on redemption and / or holding periods impede the cross - border selling of funds investing in non - listed assets . those divergences can undermine the confidence of investors when considering investments in such funds , and reduce the scope for investors to choose effectively between various long - term investment opportunities . consequently , the appropriate legal basis for this regulation is article 114 of the treaty , as interpreted by consistent case law of the court of justice of the european union . ### in the absence of a regulation setting out rules on eltifs , diverging measures might be adopted at national level , which are likely to cause distortions of competition resulting from differences in investment protection measures . diverging requirements on portfolio composition , diversification and eligible assets , in particular the investment in commodities , create obstacles to the cross - border marketing of funds that focus on non - listed undertakings and real assets because investors cannot easily compare the different investment propositions offered to them . divergent national requirements also lead to different levels of investor protection . furthermore , different national requirements pertaining to investment techniques , such as the permitted levels of borrowing , use of derivative financial instruments , rules applicable to short selling or securities financing transactions lead to discrepancies in the level of investor protection . in addition , different requirements on redemption and / or holding periods impede the cross - border selling of funds investing in non - listed assets . by increasing legal uncertainty , those divergences can undermine the confidence of investors when considering investments in such funds , and reduce the scope for investors to choose effectively between various long - term investment opportunities . member states should accordingly not be allowed to stipulate additional requirements in the area covered by this regulation and the appropriate legal basis for this regulation should be article 114 of the treaty , as interpreted by consistent case law of the court of justice of the european union .


### the definition of what constitutes a long - term investment is broad . without necessarily requiring long - term holding periods for the eltif manager , eligible investment assets are generally illiquid , require commitments for a certain period of time , and have an economic profile of a long - term nature . eligible investment assets are non - transferable securities and therefore do not have access to the liquidity of secondary markets . they often require fixed term commitments which restrict their marketability . the economic cycle of the investment sought by eltifs is essentially of a long - term nature due to the high capital commitments and the length of time required to produce returns . as a result such assets do not suit investments with redemption rights . ### the definition of what constitutes a long - term investment is broad . without necessarily requiring long - term holding periods for the eltif manager , eligible investment assets are generally illiquid , require commitments for a certain period of time , and have an economic profile of a long - term nature . eligible investment assets are non - transferable securities and therefore do not have access to the liquidity of secondary markets . they often require fixed term commitments which restrict their marketability . the economic cycle of the investment sought by eltifs is essentially of a long - term nature due to the high capital commitments and the length of time required to produce returns . as a result such assets do not suit investments with redemption rights . if it emerges that the duration of the eltif is no longer adapted to asset life cycles or the profitability of the projects concerned by it , the eltif manager should have the option of increasing or reducing its life cycle .


### notwithstanding the fact that eltifs do not offer redemption rights before the end of life of the eltif , nothing should prevent an eltif from seeking admission of these shares or units to a regulated market as defined in article 4 of directive 2004 / 39 / ec of the european parliament and of the council of 21 april 2004 on markets in financial instruments , 10 to a multilateral trading facility as defined in article 4 of directive 2004 / 39 / ec , or to an organised trading facility as defined in point of regulation , thus providing investors with an opportunity to sell their units or shares before the end of life of the eltif . the rules or instruments of incorporation of an eltif should therefore not prevent units or shares from being admitted to or from being dealt in regulated markets , nor should they prevent investors from freely transferring their shares or units to third parties who wish to purchase those shares or units . __________________ 10 oj l 145 , 30 . 4 . 2004 , p . 1 . ### notwithstanding the fact that eltifs do not offer redemption rights before the end of life of the eltif , nothing should prevent an eltif from seeking admission of these shares or units to a regulated market as defined in article 4 of directive 2004 / 39 / ec of the european parliament and of the council of 21 april 2004 on markets in financial instruments , 10 to a multilateral trading facility as defined in article 4 of directive 2004 / 39 / ec , or to an organised trading facility as defined in point of regulation , thus providing investors with an opportunity to sell their units or shares before the end of life of the eltif . the rules or instruments of incorporation of an eltif should therefore not prevent units or shares from being admitted to or from being dealt in regulated markets , nor should they prevent investors from freely transferring their shares or units to third parties who wish to purchase those shares or units . however , eltif activities on these markets should be regulated and should , for example , be excluded from the composition of derivatives . __________________ 10 jo l 145 du 30 . 4 . 2004 , p . 1 .


### the life of the eltif shall be sufficient in length to cover the life - cycle of each of the individual assets of the eltif , measured according to the illiquidity profile and economic life - cycle of the asset , and the stated investment objective of the eltif . ### the life of the eltif shall be sufficient in length to cover the life - cycle of each of the individual assets of the eltif , measured according to the illiquidity profile and economic life - cycle of the asset , and the stated investment objective of the eltif . in this connection , if it emerges that the duration of the eltif is no longer adapted to asset life cycles or the profitability of the projects concerned by it , the eltif manager may , exceptionally , increase or reduce its life cycle . he shall , within a reasonable period , inform investors of the new eltif expiry date .


### investors shall always have the option to be repaid in cash . ### investors shall always have the option to be repaid in cash , subject to any restrictions applicable to cash payments in the various member states .


### at company level , it is widely acknowledged that the presence of women on boards improves corporate governance , because team performance and the quality of decision - making are enhanced due to a more diverse and collective mind - set incorporating a wider range of perspectives and therefore reaching more balanced decisions . numerous studies have also shown that there is a positive relationship between gender diversity at top management level and a company ' s financial performance and profitability . enhancing female representation on the boards of publicly listed companies in the union can therefore have a positive impact on the performance of companies concerned . ### at company level , it is widely acknowledged that the presence of women on boards improves corporate governance , because team performance and the quality of decision - making are enhanced due to a more diverse and collective mind - set incorporating a wider range of perspectives and therefore reaching more balanced decisions . numerous studies have also shown that there is a positive relationship between gender diversity at top management level and a company ' s financial performance and profitability . enhancing female representation on the boards of publicly listed companies in the union can therefore have a positive impact on the organisational and financial performance of companies concerned .


### despite the existing union legislation aimed at preventing and combating sex discrimination , the council recommendations aimed specifically at increasing the presence of women in economic decision - making and union - level actions encouraging self - regulation , women continue to be strongly outnumbered by men in the highest decision - making bodies of companies throughout the union . in the private sector and especially in listed companies this gender imbalance is particularly significant and acute . the commission ' s key indicator of gender representation on corporate boards shows that the proportion of women involved in top - level business decision - making remains very low . in january 2012 , women occupied on average just 13 . 7 per cent of board seats in the largest publicly listed companies in member states . among non - executive directors only 15 per cent were women . ### despite the existing union legislation aimed at preventing and combating sex discrimination , the council recommendations aimed specifically at increasing the presence of women in economic decision - making and union - level actions encouraging self - regulation , women continue to be strongly outnumbered by men in the highest decision - making bodies of companies throughout the union . in the private sector this gender imbalance is particularly significant and acute , although certain eu institutions and agencies , such as the european central bank , also display a deeply problematic gender imbalance . the commission ' s key indicator of gender representation on corporate boards shows that the proportion of women involved in top - level business decision - making remains very low . in january 2012 , women occupied on average just 13 . 7 per cent of board seats in the largest publicly listed companies in member states . among non - executive directors only 15 per cent were women .


### while this directive does not aim to harmonise national laws on the selection procedures and qualification criteria for board positions in detail , the introduction of certain minimum standards as regards the requirement for listed companies without balanced gender representation to take appointment decisions for non - executive directors on the basis of an objective comparative assessment of the qualifications of candidates in terms of suitability , competence and professional performance is necessary in order to attain gender balance among non - executives directors . only an eu - level measure can effectively help to ensure a competitive level - playing field throughout the union and avoid practical complications in business life . ### this directive does not aim to harmonise national laws on the selection procedures and qualification criteria for board positions in detail . member states are encouraged to respect articles 2 , 3 and 8 in the teu , as well as article 21 in the charter of fundamental rights instead .