### those inspections shall at least cover exports of weee outside the community in accordance with the waste shipment regulation and the operations at treatment facilities in accordance with directive 2008 / xx / ec on waste and annex ii of this directive . ### those inspections shall at least cover exports of weee outside the community in accordance with the waste shipment regulation and the operations at treatment facilities in accordance with directive 2008 / xx / ec on waste and annex ii of this directive . in order to allow a harmonised approach to compliance with the financial guarantee requirements as established in article 12 , the commission shall , no later than 12 months after the entry into force of this directive , establish the minimum requirements and methodology for calculating the level of these guarantees , and establish guidelines for their verification and auditing . these requirements should at least ensure that : the guarantee leads to internalisation of the real end - of - life costs of a producer ' s product , taking into account the treatment and recycling standards , b ) the costs related to a producer’s obligations do not fall on other actors , now or in the future , c ) the guarantee will be available in the future and can be used to resolve the outstanding recycling obligation of a producer in case of insolvency .


### the commission should apply the relevant provisions of regulation no 1025 / 2012 of the european parliament and of the council of 25 october 2012 on european standardisation3 to request the relevant european standardisation organisation to draft a european standard for the semantic data model of the core electronic invoice . in its request to the relevant european standardisation organisation , the commission should require that such european standard is technologically neutral , in order to avoid any distortion of competition . since electronic invoices may contain personal data , the commission should also require that such european standard guarantees personal data protection in accordance with directive 95 / 46 / ec of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data4 . in addition to these minimum requirements , the commission should determine , in its request to the relevant european standardisation organisation , further requirements as to the content of such european standard and a deadline for its adoption . __________________ 3 oj l 316 , 14 . 11 . 2012 , p . 12 . 4 oj l 281 , 23 . 11 . 1995 , p . 31 . ### the commission should apply the relevant provisions of regulation no 1025 / 2012 of the european parliament and of the council of 25 october 2012 on european standardisation3 to request the relevant european standardisation organisation to draft a european standard for the semantic data model of the core electronic invoice . in its request to the relevant european standardisation organisation , the commission should require that such european standard is technologically neutral , in order to avoid any distortion of competition . since electronic invoices may contain personal data , the commission should also require that such european standard guarantees personal data protection in accordance with directive 95 / 46 / ec of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data4 and the principles of data protection by design , proportionality and data minimisation . in addition , s mall and medium - sized enterprises as well as smaller contracting authorities and contracting entities , which have only limited staff and financial resources , should be able to apply the standard without incurring excessive costs . furthermore , the standard should also be suitable for use in commercial transactions between private companies , in order to avoid additional costs . finally , the standard should be compatible with relevant international standards in order to prevent suppliers from third countries encountering technical market access barriers . __________________ 3 oj l 316 , 14 . 11 . 2012 , p . 12 . 4 oj l 281 , 23 . 11 . 1995 , p . 31 .


### “ a summary of the essential information necessary to use the medicine safely and effectively ; ” the following second and third subparagraphs are added : “the information referred to in point of the first subparagraph shall be presented in a box surrounded by a black border . any new or amended text shall for a period of 1 - year be presented in bold text and preceded by the following symbol  and text “new information” . for medicinal products included on the list referred to in article 23 of regulation no 726 / 2004 , the following additional statement shall be included “this medicinal product is under intensive monitoring . all suspected adverse reactions should be reported to &#8221 ; . &#8221 ; ### “ for medicinal products included on the list referred to in article 23 of regulation no 726 / 2004 , a summary including the following statement : ‘ this medicinal product is subject to post - authorisation safety monitoring . all suspected adverse reactions should be reported to your doctor , pharmacist or ' . &#8221 ;


### 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 scientific justification and include the timeframe for submission of the detailed description of the risk - management system .


### the pharmacovigilance risk assessment advisory committee shall assess the matter which has been submitted . for the purposes of that assessment , it may hold a public hearing . ### the pharmacovigilance risk assessment committee shall assess the matter which has been submitted . for the purposes of that assessment , it may hold a public hearing , if objective criteria are met on the basis of scientific data , taking account of the effectiveness and benefits of the product concerned and of earlier risk / benefit assessments conducted by the committee for medicinal products for human use or the coordination group in accordance with the procedure for granting marketing authorisations described in article 107l , which must involve the rapporteur of the committee for medicinal products for human use on the product in question , or the rapporteur of the coordination group . the agency , in consultation with the parties concerned , shall draw up guidelines on the organisation and conduct of public hearings .


### for less developed regions , member states shall concentrate 60 % of the esf allocation to each operational programme on up to four of the investment priorities set out in article 3 . ### for less developed regions , member states shall concentrate at least 60 % of the total amount of the esf resources at the national level to the thematic objectives set out in point 8 , 9 , and 10 in article 9 of the regulation no [ . . . ] / 2012 [ cpr ] .


### the member states and the commission shall promote equal opportunities for all , including accessibility for disabled persons through mainstreaming the principle of non - discrimination , as referred to in article 7 of regulation no [ … ] , and through specific actions within the investment priorities as defined in article 3 , and in particular article 3 . such actions shall target people at risk of discrimination and people with disabilities , with a view to increasing their labour market participation , enhancing their social inclusion , reducing inequalities in terms of educational attainment and health status and facilitating the transition from institutional to community - based care . ### the member states and the commission shall promote equal opportunities for all , without discrimination based on gender , race or ethnic origin , religion or convictions , disability , age or sexual orientation , through mainstreaming the principle of non - discrimination , as referred to in article 7 of regulation no [ … ] . in addition , the esf shall support specific actions within the investment priorities as defined in article 3 of this regulation , and in particular article 3 , which aims to eliminate all forms of discrimination and to improve accessibility for people with disabilities , with a view to reducing inequalities in terms of educational attainment , increasing the labour market participation of people at risk of discrimination and enhancing their social inclusion , including by facilitating the transition from institutional to community - based care .


### to encourage adequate participation of and access by non - governmental organisations to actions supported by the esf , notably in the fields of social inclusion , gender equality and equal opportunities , the managing authorities of an operational programme in a region as defined in article 82 of regulation no [ … ] or in member states eligible for cohesion fund support shall ensure that an appropriate amount of esf resources is allocated to capacity - building for non - governmental organisations . ### to encourage , in accordance with article 5 of regulation no [ . . . ] , adequate participation of and access by non - governmental organisations to actions and to the preparation , implementation , monitoring and assessment of the programmes supported by the esf , in particular by means of effective measures and notably in the fields of social inclusion , gender equality and equal opportunities , the managing authorities of an operational programme in a region as defined in article 82 and of regulation no [ … ] or in member states eligible for cohesion fund support shall ensure that 2 % of esf resources is allocated to capacity - building , in the form of training and networking measures , and to joint measures taken by non - governmental organisations .


### to encourage adequate participation of and access by non - governmental organisations to actions supported by the esf , notably in the fields of social inclusion , gender equality and equal opportunities , the managing authorities of an operational programme in a region as defined in article 82 of regulation no [ … ] or in member states eligible for cohesion fund support shall ensure that an appropriate amount of esf resources is allocated to capacity - building for non - governmental organisations . ### to encourage adequate participation of and access by non - governmental organisations to actions supported by the esf , notably in the fields of social inclusion , gender equality and equal opportunities , the managing authorities of an operational programme in a region as defined in article 82 and of regulation no [ … ] or in member states eligible for cohesion fund support shall ensure that 2 % of esf resources is allocated to capacity - building , to training and networking measures and to joint measures taken by non - governmental organisations .


### the esf shall benefit people , including disadvantaged groups such as the long - term unemployed , people with disabilities , migrants , ethnic minorities , marginalised communities and people facing social exclusion . the esf shall also provide support to enterprises , systems and structures with a view to facilitating their adaptation to new challenges and promoting good governance and the implementation of reforms , in particular in the fields of employment , education and social policies . ### the esf shall benefit people , including disadvantaged groups such as the long - term unemployed , people with disabilities , migrants , ethnic minorities , marginalised communities and people facing or at risk of social exclusion and poverty . the esf shall also provide support to enterprises , systems and structures with a view to facilitating their adaptation to new challenges and promoting good governance and the implementation of reforms , in particular in the fields of employment , education and social policies .


### the esf should improve employment opportunities , promote education and life - long learning and develop active inclusion policies in accordance with the tasks entrusted to the esf by article 162 of the treaty , and thereby contribute to economic , social and territorial cohesion in accordance with article 174 of the treaty . in accordance with article 9 of the treaty , the esf should take into account requirements linked to the promotion of a high level of employment , the guarantee of adequate social protection , the fight against social exclusion , and a high level of education , training and protection of human health . ### the esf should improve employment opportunities , promote education and life - long learning and develop active inclusion policies and policies to combat poverty in accordance with the tasks entrusted to the esf by article 162 of the treaty , and thereby contribute to economic , social and territorial cohesion in accordance with article 174 of the treaty . in accordance with article 9 of the treaty , the esf should take into account requirements linked to the promotion of a high level of employment , the guarantee of adequate social protection , the fight against social exclusion , and a high level of education , training and protection of human health .


### by way of derogation from article 110 of regulation no [ … ] , the maximum co - financing rate for a priority axis shall be increased by ten percentage points , but not exceeding 100% , where the whole of a priority axis is dedicated to social innovation or to transnational cooperation , or a combination of both . ### by way of derogation from article 110 of regulation no [ . . . ] , the maximum co - financing rate for a priority axis shall be increased by ten percentage points , but not exceeding 100% , where the whole of a priority axis is dedicated to transnational cooperation , or a combination of both .


### for transition regions , member states shall concentrate 70 % of the esf allocation to each operational programme on up to four of the investment priorities set out in article 3 . ### for transition regions , member states shall concentrate at least 70 % of the total amount of the esf resources at the national level to the thematic objectives set out in point 8 , 9 , and 10 in article 9 of the regulation no [ . . . ] / 2012 [ cpr ] .


### the esf may support community - led local development strategies , as referred to in article 28 of regulation no [ &#8230 ; ] , territorial pacts and local initiatives for employment , education and social inclusion , as well as integrated territorial investments as referred to in article 99 of regulation no [ &#8230 ; ] . ### the esf should support community - led local development strategies , as referred to in article 28 of regulation no [ &#8230 ; ] , territorial pacts and local initiatives for employment , education and social inclusion , as well as integrated territorial investments as referred to in article 99 of regulation no [ &#8230 ; ] .


### complementing erdf interventions as referred to in article 7 of regulation no [ erdf ] , the esf may support sustainable urban development through strategies setting out integrated actions to tackle the economic , environmental and social challenges affecting urban areas of cities which are listed in the partnership contract . ### complementing erdf interventions as referred to in article 7 of regulation no [ erdf ] , the esf should support sustainable urban development through strategies setting out integrated actions to tackle the economic , environmental and social challenges affecting urban areas of cities which are listed in the partnership contract . this should include the possibility to designate cities as intermediate bodies .


### the member states and the commission shall promote equal opportunities for all , including accessibility for disabled persons through mainstreaming the principle of non - discrimination , as referred to in article 7 of regulation no [ … ] , and through specific actions within the investment priorities as defined in article 3 , and in particular article 3 . such actions shall target people at risk of discrimination and people with disabilities , with a view to increasing their labour market participation , enhancing their social inclusion , reducing inequalities in terms of educational attainment and health status and facilitating the transition from institutional to community - based care . ### the member states and the commission shall promote equal opportunities for all , without discrimination based on gender , race or ethnic origin , religion or convictions , disability , age or sexual orientation , through mainstreaming the principle of non - discrimination , as referred to in article 7 of regulation no [ . . . ] . in addition , the esf shall support specific actions within the investment priorities as defined in article 3 of this regulation , and in particular article 3 . such actions shall target people at risk of discrimination of all ages and people with disabilities , with a view to increasing their labour market participation , enhancing their social inclusion , reducing inequalities in terms of educational attainment and health status and facilitating the transition from institutional to community - based care .


### member states may select themes for transnational co - operation from a list proposed by the commission and endorsed by the esf committee . ### member states in cooperation with regional , local , urban and other authorities may select themes for transnational co - operation from a list proposed by the commission and endorsed by the esf committee .


### the duration of the concession shall be limited to the time estimated to be necessary for the concessionaire to recoup the investments made in operating the works or services together with a reasonable return on invested capital . ### the duration of the concession shall be limited to the time estimated to be necessary for the concessionaire to recoup the investments made in operating the works or services together with a reasonable return on invested capital and also to the time estimated to reach the performance objectives set by the contracting authority .


### in the light of the results of the evaluation conducted by the commission on the reform of public procurement rules it is appropriate to exclude from the full application of this directive only those services which have a limited cross - border dimension , namely the so - called services to the person such as certain social , health and educational services . these services are provided within a particular context that varies widely amongst member states , due to different cultural traditions . a specific regime should therefore be established for concession for these services which takes into account the fact that they are newly regulated . an obligation to publish a prior information notice and a concession award notice of any concession with a value equal to or greater than thresholds established in this directive is an adequate way to provide information on business opportunities to potential tenderers as well as on the number and type of contracts awarded to all interested parties . furthermore , member states should put in place appropriate measures with reference to the award of concession contracts for these services aimed at ensuring compliance with the principles of transparency and equal treatment of economic operators while allowing contracting authorities and contracting entities to take into account the specificities of the services in question . member states should ensure that contracting authorities and contracting entities may take into account the need to ensure quality , continuity , accessibility , availability and comprehensiveness of the services , the specific needs of different categories of users , the involvement and empowerment of users and innovation . ### in the light of the results of the evaluation conducted by the commission on the reform of public procurement rules it is appropriate to exclude from the full application of this directive only those services which have a limited cross - border dimension , namely the so - called services to the person such as certain educational services . these services are provided within a particular context that varies widely amongst member states , due to different cultural traditions . a specific regime should therefore be established for concession for these services which takes into account the fact that they are newly regulated . an obligation to publish a prior information notice and a concession award notice of any concession with a value equal to or greater than thresholds established in this directive is an adequate way to provide information on business opportunities to potential tenderers as well as on the number and type of contracts awarded to all interested parties . furthermore , member states should put in place appropriate measures with reference to the award of concession contracts for these services aimed at ensuring compliance with the principles of transparency and equal treatment of economic operators while allowing contracting authorities and contracting entities to take into account the specificities of the services in question . member states should ensure that contracting authorities and contracting entities may take into account the need to ensure quality , continuity , accessibility , availability and comprehensiveness of the services , the specific needs of different categories of users , the involvement and empowerment of users and innovation .


### the imposition of the visa requirement on the nationals of dominica , grenada , kiribati , marshall islands , micronesia , nauru , palau , saint lucia , saint vincent and the grenadines , samoa , solomon islands , timor - leste , tonga , trinidad and tobago , tuvalu and vanuatu is no longer justified . these countries do not present any risk of illegal immigration or a threat to public policy for the union in accordance with the criteria set out in recital 5 of regulation n° 539 / 2001 . consequently , nationals of those countries should be exempt from the visa requirement for stays of no more than three months in all and references to those countries should be transferred to annex ii . ### the imposition of the visa requirement on the nationals of dominica , grenada , kiribati , marshall islands , micronesia , nauru , palau , saint lucia , saint vincent and the grenadines , samoa , solomon islands , timor - leste , tonga , trinidad and tobago , tuvalu , the united arab emirates and vanuatu is no longer justified . these countries do not present any risk of illegal immigration or a threat to public policy for the union in accordance with the criteria set out in recital 5 of regulation n° 539 / 2001 . consequently , nationals of those countries should be exempt from the visa requirement for stays of no more than three months in all and references to those countries should be transferred to annex ii .


### exemption from the visa requirement for nationals of dominica , grenada , kiribati , marshall islands , micronesia , nauru , palau , saint lucia , saint vincent and the grenadines , samoa , solomon islands , timor - leste , tonga , trinidad and tobago , tuvalu and vanuatu should not come into force until bilateral agreements on visa waiver between the union and the countries concerned have been concluded in order to ensure full reciprocity . ### exemption from the visa requirement for nationals of dominica , grenada , kiribati , marshall islands , micronesia , nauru , palau , saint lucia , saint vincent and the grenadines , samoa , solomon islands , timor - leste , tonga , trinidad and tobago , tuvalu , the united arab emirates and vanuatu should not come into force until bilateral agreements on visa waiver between the union and the countries concerned have been concluded in order to ensure full reciprocity .


### ' tuvalu* ' and ' vanuatu* ' ### ' tuvalu* ' , ' united arab emirates* ' and ' vanuatu* '


### in point 1 , the references to dominica , grenada , kiribati , marshall islands , micronesia , nauru , palau , saint lucia , saint vincent and the grenadines , samoa , solomon islands , timor - leste , tonga , trinidad and tobago , tuvalu and vanuatu are deleted and a reference to south - sudan is inserted ; ### in point 1 , the references to dominica , grenada , kiribati , marshall islands , micronesia , nauru , palau , saint lucia , saint vincent and the grenadines , samoa , solomon islands , timor - leste , tonga , trinidad and tobago , tuvalu , the united arab emirates and vanuatu are deleted and a reference to south - sudan is inserted ;


### establish and manage the emergency response centre , ensuring 24 / 7 operational capacity , and serving the member states and the commission for the purposes of the mechanism ; ### establish and manage the emergency response centre in coordination with the existing national and regional bodies , ensuring 24 / 7 operational capacity , and serving the member states and the commission for the purposes of the mechanism ;


### with respect to disaster response assistance interventions outside the union , the mechanism should facilitate and support actions undertaken by the member states and the union as a whole in order to promote consistency in international civil protection work . the united nations , where present , has an overall coordinating role for relief operations in third countries . assistance provided under the mechanism should be coordinated with the united nations and other relevant international actors to maximise the use of available resources and avoid any unnecessary duplication of effort . enhanced coordination of civil protection assistance through the mechanism is a prerequisite to supporting the overall coordination effort and ensuring a comprehensive union contribution to the overall relief effort . in major disasters where assistance is provided under both the mechanism and council regulation no 1257 / 96 of 20 june 1996 concerning humanitarian aid , the commission shall ensure the effectiveness , coherence and complementarities of the overall union response respecting the european consensus on humanitarian aid . ### with respect to disaster response assistance interventions outside the union , the mechanism should facilitate and support actions undertaken by the member states and the union as a whole in order to promote consistency in international civil protection work . draft funding proposals from third countries should be communicated to member states . the united nations , where present , has an overall coordinating role for relief operations in third countries . assistance provided under the mechanism should be coordinated with the united nations and other relevant international actors to maximise the use of available resources and avoid any unnecessary duplication of effort . enhanced coordination of civil protection assistance through the mechanism is a prerequisite to supporting the overall coordination effort and ensuring a comprehensive union contribution to the overall relief effort . in major disasters where assistance is provided under both the mechanism and council regulation no 1257 / 96 of 20 june 1996 concerning humanitarian aid , the commission shall ensure the effectiveness , coherence and complementarities of the overall union response respecting the european consensus on humanitarian aid .


### the focus of activities shall be to reduce congestion , improve accessibility and match user needs by promoting integrated door - to - door transport and logistics ; to enhance inter - modality and the deployment of smart planning and management solutions ; and to drastically reduce the occurrence of accidents and the impact of security threats . ### the focus of activities shall be to reduce congestion , improve accessibility and match user needs by promoting integrated door - to - door transport and logistics ; to enhance inter - modality and the deployment of smart planning and management solutions ; and to drastically reduce the occurrence of accidents and the impact of security threats . a gender dimension should be integrated in the activities described above and should be preceded by a gender analysis .


### the activities are inherently forward - looking , building skills in the long term , focusing on the next generation of science , technology , researchers and innovations and providing support for emerging talent from across the whole of the union and associated countries , as well as worldwide . in view of their science - driven nature and largely ‘ bottom - up’ , investigator - driven funding arrangements , the european scientific community will play a strong role in determining the avenues of research followed under the programme . ### the activities are inherently forward - looking , building skills in the long term , focusing on the next generation of science , technology , researchers and innovations and providing support for emerging talent from across the whole of the union and associated countries , as well as worldwide , with view to increase the participation of female researchers and use the full potential and scientific excellence of women scientists for the benefit of european economy and society . in view of their science - driven nature and largely ' bottom - up ' , investigator - driven funding arrangements , the european scientific community will play a strong role in determining the avenues of research followed under the programme .


### linkages and interfaces shall be implemented across and within the priorities of horizon 2020 . particular attention shall be paid in this respect to the development and application of key enabling and industrial technologies , to bridging from discovery to market application , to cross - disciplinary research and innovation , to social and economic sciences and humanities , to fostering the functioning and achievement of the era , to cooperation with third countries , to responsible research and innovation including gender , and to enhancing the attractiveness of the research profession and to facilitating cross - border and cross - sector mobility of researchers . ### linkages and interfaces shall be implemented across and within the priorities of horizon 2020 . particular attention shall be paid in this respect to the development and application of key enabling and industrial technologies , to bridging from discovery to market application , to cross - disciplinary research and innovation , to social and economic sciences and humanities , to fostering the functioning and achievement of the era , to cooperation with third countries , to responsible research and innovation including gender , and to achieving gender balance , enhancing the attractiveness of the research profession , especially amongst young women and facilitating cross - border and cross - sector mobility of researchers , with particular attention to female researchers . each work programme shall contain a dedicated section describing the action planned to address gender imbalances and to integrate a gender dimension . this shall be reflected also at a project level within the provisions of grant agreements .


### the commission shall annually monitor the implementation of horizon 2020 , its specific programme and the activities of the european institute of innovation and technology . this shall include information on cross - cutting topics such as sustainability and climate change , including information on the amount of climate related expenditure . ### the commission shall annually monitor the implementation of horizon 2020 , its specific programme and the activities of the european institute of innovation and technology . this shall include information and indicators on cross - cutting topics such as gender , sustainability and climate change , including information on the amount of climate related expenditure .


### marie curie actions shall provide excellent and innovative research training as well as attractive career and knowledge - exchange opportunities through cross - border and cross - sector mobility of researchers to best prepare them to face current and future societal challenges . ### marie curie actions shall provide excellent and innovative research training as well as attractive career and knowledge - exchange opportunities through cross - border and cross - sector mobility of researchers to best prepare them to face current and future societal challenges . mobility programs shall ensure effective equal opportunities between women and men and include specific measures to remove obstacles to the mobility of female researchers .


### the activities are inherently forward - looking , building skills in the long term , focusing on the next generation of science , technology , researchers and innovations and providing support for emerging talent from across the whole of the union and associated countries , as well as worldwide . in view of their science - driven nature and largely ‘ bottom - up’ , investigator - driven funding arrangements , the european scientific community will play a strong role in determining the avenues of research followed under the programme . ### the activities are inherently forward - looking , building skills in the long term , focusing on the next generation of science , technology , researchers and innovations and providing support for emerging talent from across the whole of the union and associated countries , as well as worldwide , with a view to increasing the participation of female research talents . in view of their science - driven nature and largely ' bottom - up ' , investigator - driven funding arrangements , the european scientific community will play a strong role in determining the avenues of research followed under the programme .


### the specific objective ‘ inclusive , innovative and secure societies’ also includes an activity to close the research and innovation divide with specific measures to unlock excellence in less developed regions of the union . ### the specific objective ' inclusive , equal , innovative and secure societies ' shall also include activities aiming at promoting gender balance in research and integration of gender dimension in research and innovation content , and at closing the research and innovation divide with specific measures to unlock excellence in less developed regions of the union .


### the union has the objective of strengthening its scientific and technological bases by achieving a european research area in which researchers , scientific knowledge and technology circulate freely , and encouraging the union to become more competitive , including in its industry . to pursue those objectives the union should carry out activities to implement research , technological development and demonstration , promote international cooperation , disseminate and optimise results and stimulate training and mobility . ### the union has the objective of strengthening its scientific and technological bases by achieving a european research area in which researchers , scientific knowledge and technology circulate freely , and encouraging the union to become more competitive , including in its industry . to pursue those objectives the union should carry out activities to implement research , technological development and demonstration , promote international cooperation , disseminate and optimise results , stimulate training and mobility and take measures to promote gender equality and the gender dimension in research and innovation .


### horizon 2020 shall ensure the effective promotion of gender equality and the gender dimension in research and innovation content . ### horizon 2020 shall ensure the effective promotion and inclusion of gender equality and the gender dimension in research and innovation content and in any and all decision - making bodies . to this end , targets will be set and efficient plans to reach those targets will be developed and implemented .


### horizon 2020 shall ensure the effective promotion of gender equality and the gender dimension in research and innovation content . ### horizon 2020 shall ensure the effective promotion of gender balance and dimensions in research and innovation content , implementation and evaluation . gender balance shall be promoted in all programmes , in evaluation committees , in expert and advisory groups and decision making bodies created for its implementation . to this end , targets will be developed , and appropriate actions designed to reach those targets .


### the aim is to develop and assess innovative , cost - effective and sustainable adaptation and mitigation measures , targeting both co2 and non - co2 greenhouse gases , and underlining both technological and non - technological green solutions , through the generation of evidence for informed , early and effective action and the networking of the required competences . activities shall focus on : improving the understanding of climate change and the provision of reliable climate projections ; assessing impacts , vulnerabilities and developing innovative cost - effective adaptation and risk prevention measures ; supporting mitigation policies . ### the aim is to develop and assess innovative , cost - effective and sustainable adaptation and mitigation measures , targeting both co2 and non - co2 greenhouse gases , and underlining both technological and non - technological green solutions , through the generation of evidence for informed , early and effective action and the networking of the required competences . activities shall focus on : improving the understanding of climate change and the provision of reliable climate projections ; assessing impacts , vulnerabilities and developing innovative cost - effective adaptation and risk prevention measures ; supporting mitigation policies . a gender dimension should be integrated in the activities described above and should be preceded by a gender analysis .


### for the implementation of horizon 2020 , account shall be taken of advice and inputs provided by : advisory groups of independent , high level experts set up by the commission ; dialogue structures created under international science and technology agreements ; forward looking activities ; targeted public consultations ; and transparent and interactive processes that ensure responsible research and innovation is supported . ### for the implementation of horizon 2020 , account shall be taken of advice and inputs provided by : advisory groups of independent , high level experts set up by the commission ; dialogue structures created under international science and technology agreements ; forward looking activities ; targeted public consultations ; and transparent and interactive processes that ensure responsible research and innovation is supported . the composition of the advisory boards shall seek gender balance .


### for the purposes of this directive , cinematographic , audio and audiovisual works in the archives of public service broadcasting organisations should be understood as including works commissioned by such organisations for their exclusive exploitation . ### for the purposes of this directive , cinematographic , audio and audiovisual works , or contributions to works contained therein , in the archives of broadcasting organisations should be understood as including works commissioned by such organisations for their exclusive exploitation .


### a work shall be considered an orphan work if the rightholder in the work is not identified or , even if identified , is not located after a diligent search for the rightholder has been carried out and recorded in accordance with article 3 . ### a work shall be considered an orphan work if one or more of the holders of the copyright or related rights are not identified or , even if identified , are not located after a good faith and diligent search for the rightholder has been carried out and recorded in accordance with article 3 .


### this directive should be without prejudice to existing arrangements in the member states concerning the management of rights such as extended collective licences . ### this directive should be without prejudice to arrangements in the member states concerning the management of rights such as extended collective licences .


### this directive should be without prejudice to existing arrangements in the member states concerning the management of rights such as extended collective licences . ### this directive should be without prejudice to arrangements by the member states concerning the management of rights such as extended collective licences , legal presumptions of representation or transfer , mandatory collective licensing , or any combination thereof .


### a diligent search is required to be carried out only in the member state of first publication or broadcast . ### a diligent search is required to be carried out only in the member state of first publication or broadcast or fixation .


### the exclusive rights for authors of reproduction and of making available to the public of their works , as harmonised under directive 2001 / 29 / ec of the european parliament and council of 22 may 2001 on the harmonisation of certain aspects of copyright and related rights in the information society , require the consent of the author prior to the digitisation and making available of a work . ### the exclusive rights for rightholders of reproduction and of making available to the public of their works , as harmonised under directive 2001 / 29 / ec of the european parliament and of the council of 22 may 2001 on the harmonisation of certain aspects of copyright and related rights in the information society , require the consent of the rightholder or rightholders prior to the digitisation and making available of a work .


### cinematographic , audio or audiovisual works produced by public service broadcasting organisations before the 31 december 2002 and contained in their archives . ### cinematographic works or works forming a part of audio or audiovisual works produced by broadcasting organisations and contained in their archives .


### the commission has assessed the availability of footprint data and its use as the utility parameter in the formulae in annex i . this data is available and its potential use has been assessed in the impact assessment , on the basis of that assessment it is concluded that the utility parameter used in the formula for 2020 should be mass . nevertheless , the lower cost and merits of a change to footprint as the utility parameter should be considered in the future review . ### the commission has assessed the availability of footprint data and its use as the utility parameter in the formulae in annex i . this data is available and its potential use has been assessed in the impact assessment . on the basis of that assessment it is concluded that the utility parameter used in the formula for 2020 should be mass , since manufacturers have planned their compliance pathways to 2020 on the basis of continuation of the current parameter . nevertheless , the lower cost and merits of footprint would justify its use as the utility parameter from 2025 onwards . therefore , in order to ensure a smooth transition to a future shift from mass to footprint , it is appropriate to introduce a footprint - based formula , which may be used from 2016 onwards by manufacturers as an alternative to the mass - based formula .


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


### by 31 december 2014 , the commission shall review the specific emissions targets , modalities and other aspects of this regulation in order to establish the co2 emission targets for new passenger cars for the period beyond 2020 . ### by 31 december 2014 , the commission shall complete a review of the specific emissions targets , modalities and other aspects of this regulation in order to establish the co2 emissiontargets for new passenger cars for 2025 and beyond . such targets shall be consistent with the cost - effective pathway to achieving the union ' s long - term climate goals for 2050 . the commission shall assess : on the basis of an impact assessment and of technical and economic feasibility the modalities for reaching a long - term 2025 target ; the aspects of the implementation of that target , including the excess emissions premium . on the basis of that review and its impact assessment , which shall include an overall assessment of the impact on the car industry and its dependent industries , the commission shall , if appropriate , make a proposal to amend this regulation , in accordance with the ordinary legislative procedure , in a way which is as neutral as possible from the point of view of competition , and which is socially equitable and sustainable .


### to enable the automotive industry to carry out long - term investments and innovation it is desirable to provide indications of how this regulation should be amended for the period beyond 2020 . these indications should be based on an assessment of the necessary rate of reduction in line with the union ' s long term climate goals and the implications for the development of cost effective co2 reducing technology for cars . it is therefore desirable for these aspects to be reviewed , the commission to make a report on the co2 emission targets for new passenger cars for the period beyond 2020 . ### to enable the automotive industry to carry out long - term investments and innovation it is desirable to provide indications for the period beyond 2020 . this should be done by setting a target for 2025 . that target should be based on the necessary rate of reduction in line with the union ' s long term climate goals and should enhance the development of cost effective co2 reducing technology for cars . it is therefore desirable for the commission to make a report and propose targets which are consistent with the cost - effective pathway to achieving the union ' s long - term climate goals for 2050 and which ensure the european union ' s continued leadership in fuel economy and co2emissions . the report should take into consideration co2 emissions over the whole life cycle of cars .


### from 2020 : specific emissions of co2 = 95 + a × where : m = mass of vehicle in kilograms m0 = the value adopted pursuant to article 13 a = 0 , 0333 . ### ' from 2020 : one of the following formulae should be used : specific emissions of co2 = 95 + a &#215 ; where : m = mass of vehicle in kilograms m0 = the value adopted pursuant to article 13 a = 0 , 0333 . ii ) specific emissions of co2 = 95 + b × where : f = footprint of vehicle in square metres f0 = the value adopted pursuant to article 13 b = 17 , 6 '


### in recognition of the disproportionate impacts on the smallest manufacturers resulting from compliance with specific emissions targets defined on the basis of the utility of the vehicle , high administrative burden of the derogation procedure and only marginal benefit in terms of avoided co2 from the vehicles sold by these manufacturers , producers responsible annually for less than 500 new passenger cars are excluded from the scope of the specific emissions target and the excess emissions premium . ### in recognition of the disproportionate impacts on the smallest manufacturers resulting from compliance with specific emissions targets defined on the basis of the utility of the vehicle , high administrative burden of the derogation procedure and only marginal benefit in terms of avoided co2 from the vehicles sold by these manufacturers , producers responsible annually for less than 1000 new passenger cars are excluded from the scope of the specific emissions target and the excess emissions premium .


### article 4 , article 8 and , article 9 and article 10 and shall not apply to a manufacturer which is responsible together with all of its connected undertakings for less than 500 new passenger cars registered in the eu in the previous calendar year . ### article 4 , article 8 and , article 9 and article 10 and shall not apply to a manufacturer which is responsible together with all of its connected undertakings for less than 1000 new passenger cars registered in the eu in the previous calendar year .


### the procedure to grant derogations to niche manufacturers should be continued for 2020 . however , in order to ensure that the reduction effort required by niche manufacturers is consistent with that of large volume manufacturers , a target 45 % lower than the average specific emissions of niche manufacturers in 2007 should therefore apply from 2020 . ### the procedure to grant derogations to niche manufacturers should be continued for 2020 . however , in order to ensure that the reduction effort required by niche manufacturers is consistent with that of large volume manufacturers , a target 45 % lower than the average specific emissions of niche manufacturers in 2007 should therefore apply from 2020 . equivalent targets should be established for 2025 .


### the second subparagraph of paragraph 3 is deleted . ### the first subparagraph of paragraph 3 is replaced by the following : ' 3 . from 2012 , the commission shall carry out an impact assessment in order to review by 2014 , as provided for in article 14 , of regulation no 715 / 2007 , the procedures for measuring co2 emissions pursuant to that regulation with a view to applying a revised measuring procedure as soon as feasible . the commission shall , in particular , make appropriate proposals to adapt those procedures to reflect adequately the real co2 emissions behaviour of cars and to include the approved innovative technologies as defined in article 12 that could be reflected in the test cycle . the commission shall ensure that those procedures are subsequently reviewed on a regular basis . '


### in recognition of the high research and development and unit production costs of early generations of ultra - low carbon vehicles it is appropriate to accelerate and facilitate , on an interim basis and to a limited extent , the process of their introduction into the union market at their initial stages of commercialization . ### in recognition of the high research and development and unit production costs of early generations of ultra - low carbon vehicles it is appropriate to accelerate and facilitate , on an interim basis and to a limited extent , the process of their introduction into the union market at their initial stages of commercialization . the commission , member states and regional and local authorities should work to identify and disseminate best practice in stimulating demand for ultra - low emission vehicles so that the healthy growth in sales in some european countries is replicated in all member states .


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


### the regulation requires the commission to carry out an impact assessment in order to review the test procedures to reflect adequately the real co2 emissions behaviour of cars . this work is proceeding through the development of a world light duty test procedure in the framework of the united nations economic commission for europe but is not yet complete . in view of this , annex i to regulation no 443 / 2009 establishes emission limits for 2020 as measured according to regulation no 715 / 2007 and annex xii to regulation no 692 / 2008 . when the test procedures are amended , the limits set in annex i should be adjusted to ensure comparable stringency for manufacturers and classes of vehicles . ### the regulation requires the commission to carry out an impact assessment in order to review the test procedures to reflect adequately the real co2 emissions behaviour of cars . this work is proceeding through the development of a world light duty test procedure in the framework of the united nations economic commission for europe but is not yet complete . in view of this , annex i to regulation no 443 / 2009 establishes emission limits for 2020 as measured according to regulation no 715 / 2007 and annex xii to regulation no 692 / 2008 . in order to ensure that this regulation delivers the anticipated reduction in emissions , the test procedure should be changed from 1 january 2016 to the wltp . when the wltp is applied in 2016 for the purposes of this regulation , the limits set in annex i should be adjusted to ensure comparable stringency for manufacturers and classes of vehicles .


### m0 = the value adopted pursuant to article 13 ### f0 = the value adopted pursuant to article 13


### in order to increase the competitiveness and economic performance of fishing activities it is vital to stimulate innovation and entrepreneurship . therefore the emff should support innovative operations and business development . ### in order to increase the competitiveness and economic performance of fishing activities it is vital to stimulate innovation and entrepreneurship . eco - innovation shall aim to improve the long term ecological sustainability of fishing operations and reduce the impact of fisheries on the marine ecosystems . therefore the emff should support innovative operations and business development that are environmentally sustainable and apply the precautionary principle and adhere to the ecosystem based approach .


### member states shall ensure that victims and their family members , in accordance with their needs , have access to free of charge , confidential victim support services . ### member states shall ensure that victims and their family members have access to free of charge , confidential victim support services from the moment the victims suffer harm , during and after the conclusion of criminal proceedings and regardless of where the crime took place .


### member states shall progressively establish the necessary conditions to enable avoidance of contact between victims and accused or suspected persons in any venue where victims may have personal contact with public authorities due to their being a victim and in particular venues where criminal proceedings are conducted . ### member states shall establish the necessary conditions to enable avoidance of contact between victims and their family members and accused or suspected persons or offenders in any venue where victims may have personal contact with competent authorities due to their being a victim and in particular venues where criminal proceedings are conducted , unless criminal proceedings require such contact or the victims request otherwise .


### support , whether provided by governmental or non - governmental organisations , should be made available from the moment a crime takes place as well as throughout criminal proceedings and after such proceedings in accordance with the needs of the victim . support should be provided through a variety of means , without excessive formalities and through a sufficient geographical distribution to allow all victims the opportunity to access such services . certain groups of victims such as victims of sexual violence , gender , race hate or other bias crimes or victims of terrorism may require specialist support services due to the particular characteristics of the crime they have fallen victim to . ### support , whether provided by governmental or non - governmental organisations , should be made available from the moment a crime takes place as well as throughout criminal proceedings and after such proceedings in accordance with the needs of the victim . support should be provided through a variety of means , without excessive formalities and through a sufficient geographical distribution to allow all victims the opportunity to access such services . certain groups of victims such as victims of sexual violence , gender , race hate or other bias crimes or victims of terrorism may require specialist support services due to the particular characteristics of the crime they have fallen victim to . member states should provide the necessary resources for the support , assistance and protection of victims .


### member states shall ensure that victims are offered the opportunity to be notified when the person prosecuted or sentenced for offences concerning them is released from detention . victims shall receive this information where they have expressed such a wish . ### member states shall ensure that victims are offered the opportunity to be notified , without unnecessary delay , when the person arrested , remanded in custody , prosecuted or sentenced for offences concerning them is released from or has escaped detention . victims shall also be informed of any measures taken for the protection of victims such as restraining orders or no - contact orders . member states shall ensure that victims are provided with effective support and assistance when receiving that information .


### member states shall ensure that victims are offered the opportunity to be notified when the person prosecuted or sentenced for offences concerning them is released from detention . victims shall receive this information where they have expressed such a wish . ### member states shall ensure that victims are offered the opportunity to be notified , without unnecessary delay , when the person arrested , remanded in custody , prosecuted or sentenced for offences concerning them is released from or has escaped detention . member states shall ensure that victims are provided with effective support and assistance when receiving that information . victims shall receive that information unless the competent authority is aware that notification of release is likely to result in harm to the offender .


### member states shall ensure that police , prosecutors and court staff receive both general and specialist training to a level appropriate to their contact with victims to sensitise them to the needs of victims and to deal with them in an impartial , respectful and professional manner . ### member states shall ensure that police , prosecutors and court staff receive both general and specialist training to a level appropriate to their contact with victims to sensitise them to the needs of victims and to deal with them in an impartial , respectful and professional manner , and ensure that they know to refer them to support services , preferably via a one - stop shop providing specific guidance for victims and helping them cope with complex administrative formalities .


### member states shall ensure that police , prosecutors and court staff receive both general and specialist training to a level appropriate to their contact with victims to sensitise them to the needs of victims and to deal with them in an impartial , respectful and professional manner . ### member states shall ensure that police , prosecutors , court staff , lawyers and any other officials likely to come into contact with victims receive both general and specialist training to a level appropriate to their contact with victims to sensitise them to the needs of victims and to deal with them in an impartial , respectful and professional manner .


### some victims are particularly vulnerable during criminal proceedings to secondary and repeat victimisation and to intimidation by the offender or his associates . such vulnerability can broadly be identified from the personal characteristics of the victim and the type or nature of the crime . on this basis some victims such as children , persons with disabilities , victims of sexual violence and victims of human trafficking are in most cases vulnerable to further victimisation and in need of special protection measures . only in exceptional circumstances , such as balancing the fundamental rights of the accused or suspected person , or where the victim so wishes , should access to such protection measures be limited . in the case of victims of human trafficking and victims of child sexual abuse , sexual exploitation and child pornography , where specific and more detailed provisions are already included in separate instruments adopted or in course of negotiation this directive does not deal with those same matters . ### some victims are particularly vulnerable during criminal proceedings to secondary and repeat victimisation and to intimidation by the offender or his associates . such vulnerability can broadly be identified from the personal characteristics of the victim and the type or nature of the crime . on this basis some victims such as children , persons with disabilities , asylum seekers , victims of sexual violence , victims of human trafficking victims of torture and victims of inhuman or degrading treatment are in most cases vulnerable to further victimisation and in need of special protection measures . only in exceptional circumstances , such as balancing the fundamental rights of the accused or suspected person , or where the victim so wishes , should access to such protection measures be limited . in the case of victims of human trafficking and victims of child sexual abuse , sexual exploitation and child pornography , where specific and more detailed provisions are already included in separate instruments adopted or in course of negotiation this directive does not deal with those same matters .


### any officials in criminal proceedings likely to come into contact with victims should be trained to identify and meet the needs of victims both through initial and ongoing training and to a level appropriate to their contact with victims . this should include specialist training as appropriate . ### any officials in criminal proceedings likely to come into contact with victims should be trained to identify and meet the needs of victims both through initial and ongoing training and to a level appropriate to their contact with victims . this should include specialist training as appropriate . police , prosecutors and other personnel involved in cases of gender - based violence should be trained in appropriate methods to deal with victims of such violence in a gender - sensitive manner . such training should be institutionalised and standardised across member states and should be carried out in close consultation with non - governmental organisations and service providers for victims of gender - based violence .


### member states shall ensure that police , prosecutors and court staff receive both general and specialist training to a level appropriate to their contact with victims to sensitise them to the needs of victims and to deal with them in an impartial , respectful and professional manner . ### member states shall ensure that police , prosecutors , court staff , lawyers and any other officials likely to come into contact with victims receive both general and specialist training to a level appropriate to their contact with victims to sensitise them to the needs of victims and to deal with them in an impartial , respectful and professional manner . these training schemes shall include the respective contribution of all officials to the identification of victims with special needs provided for in article 18 .


### the agency , in collaboration with the member states , shall develop standard web - based structured forms for the reporting of suspected adverse reactions by health - care professionals and patients . ### the agency , in collaboration with the member states and relevant stakeholders , shall develop standard content , formats and procedures for the reporting of suspected adverse reactions by health - care professionals and patients and the traceability of biological medicinal products prescribed , dispensed , or sold on eu territory .


### accelerating the refurbishment of existing and deployment of new energy infrastructure is vital to achieve the union ' s energy and climate policy objectives , consisting in completing the internal market in energy , guaranteeing security of supply , notably for gas and oil , reducing greenhouse gas emissions by 20% , increasing the share of renewable energy in the final energy consumption to 20% and achieving a 20% increase in energy efficiency by 2020 . at the same time , the union has to prepare its infrastructure for further decarbonisation of its energy system in the longer term towards 2050 . ### accelerating the refurbishment of existing and deployment of new energy infrastructure is vital to achieve the union ' s energy and climate policy objectives , consisting in completing the internal market in energy , guaranteeing security of supply , notably for gas and oil , reducing greenhouse gas emissions by 20% , increasing the share of renewable energy in the final energy consumption to 20% and achieving a 20% increase in energy efficiency by 2020 . at the same time , the union has to prepare its infrastructure for further decarbonisation of its energy system in the longer term towards 2050 , and within the same time - frame to prepare it for connecting regions which have high renewable energy production capacity and electricity storage potential .


### projects of common interest should be given ‘ priority status’ at national level to ensure rapid administrative treatment . projects of common interest shall be considered by competent authorities as being in public interest . authorisation should be given to projects which have an adverse impact on the environment , for reasons of overriding public interest , when all the conditions provided for under directives 92 / 43 / ec and 2000 / 60 / ec are met . ### projects of common interest should be given ' priority status ' at national level to ensure rapid administrative treatment . projects of common interest shall be considered by competent authorities as being in public interest . authorisation should be given to projects which have an adverse impact on the environment , for reasons of overriding public interest , only when all the conditions provided for under directives 92 / 43 / ec and 2000 / 60 / ec are met . the cases where infrastructure could be minimised through energy efficiency policies , where existing national and cross - border infrastructure can be upgraded or modernised and where new infrastructure is needed and can be built alongside existing energy or transport infrastructure should be identified , according to a hierarchy of importance and in the interest of cost - effectiveness .


### each group shall draw up its proposed list of projects of common interest according to the process set out in section 2 of annex iii , according to the contribution of each project to implementing the energy infrastructure priority corridors and areas set out in annex i and according to their fulfilment of the criteria set out in article 4 . each individual proposal for a project shall require the approval of the member state , to the territory of which the project relates . ### each group shall draw up its proposed list of projects of common interest according to the process set out in section 2 of annex iii , according to the contribution of each project to implementing the energy infrastructure priority corridors and areas set out in annex i and according to their fulfilment of the criteria set out in article 4 . each individual proposal for a project shall require the approval only of the member state to the territory of which the project relates . in the case of proposals for cross - border projects which meet the relevant criteria set out in this regulation but are supported only by one of the member states involved , the power of decision - making shall be delegated to the commission , which shall act in consultation with the agency and shall secure the involvement of the member states and stakeholders concerned .


### projects of common interest falling under the categories set out in points 1 , 2 and 4 of annex ii are eligible for union financial support in the form of grants for studies and financial instruments in accordance with the provisions of [ regulation of the european parliament and the council establishing the connecting europe facility ] . ### projects of common interest falling under the categories set out in points 1 , 2 and 4 of annex ii are eligible for union financial support in the form of grants for studies and financial instruments in accordance with the provisions of regulation no &#8230 ; / . . . of the european parliament and the council establishing the connecting europe facility , taking into consideration : - the need to avoid any distortion of competition , in particular between projects contributing to the achievement of the same union priority corridor ; - the fact that private financing , or financing by the economic operators concerned , will be the main source of financing . the choice of financial instruments shall be determined by the nature of the projects . not every form of financing shall necessarily be applicable to every project .


### in electricity : scenarios for demand , generation capacities by fuel type and their geographical location , fuel prices , carbon dioxide prices , the composition of the transmission and , if relevant , the distribution network , and its evolution , taking into account all new significant generation , storage and transmission projects for which a final investment decision has been taken and that are due to be commissioned by the end of year n + 5 ; ### in electricity : scenarios for demand , generation capacities by fuel type and their geographical location , fuel prices , carbon dioxide prices , the composition of the transmission and , if relevant , the distribution network , and its evolution , taking into account all new significant generation , storage potential and storage and transmission projects for which a final investment decision has been taken and that are due to be commissioned by the end of year n + 5 ;


### electricity highways : first electricity highways by 2020 , in view of building an electricity highways system across the union ; ### electricity highways : first electricity highways by 2020 , in view of building an electricity highways system across the union , especially connecting regions which have high renewable energy production capacity and storage potential ;


### the commission shall , within three months of the entry into force of this regulation , issue guidance to support member states in defining adequate measures and to ensure the coherent application of environmental assessment procedures required under eu legislation for projects of common interest . ### the commission shall , within three months of the entry into force of this regulation , issue guidance to support member states in defining and implementing adequate measures and to ensure the coherent application of environmental assessment procedures required under eu legislation for projects of common interest , and shall monitor its application .


### – market integration , interoperability and system flexibility ; ### – market integration , inter alia through alleviating the effects of the isolation of regions in the union ; interoperability and system flexibility ;


### – interoperability and secure system operation ; ### – security of supply , inter alia through interoperability and secure system operation ;


### for electricity storage , the project provides storage capacity allowing a net annual electricity generation of at least 500 gigawatt - hours ; ### for electricity storage , the project provides storage capacity allowing a net annual electricity generation of at least 250mw capacity and 250 gigawatt - hours / year ;


### on request , economic operators and , where applicable , conformity assessment bodies , shall make available to market surveillance authorities any documentation and information that those authorities require for the purpose of carrying out their activities , in a language which can be easily understood by them . ### further to a reasoned request , economic operators shall , according to their respective role in the supply chain and , where applicable , including conformity assessment bodies , make available to market surveillance authorities any documentation and information that those authorities require for the purpose of carrying out their activities .


### on request , economic operators and , where applicable , conformity assessment bodies , shall make available to market surveillance authorities any documentation and information that those authorities require for the purpose of carrying out their activities , in a language which can be easily understood by them . ### further to a reasoned request , economic operators and , where applicable , conformity assessment bodies , shall make available to market surveillance authorities all the documentation and information that those authorities require for the purpose of carrying out their activities , in electronic or physical format and in a language which can be easily understood by them . such information shall include information that enables the precise identification of the product and facilitates the tracing of the product , as appropriate .


### risk assessment shall be based on available scientific or technical evidence . ### risk assessment shall be based on available scientific or technical evidence and shall be carried out in accordance with the general risk assessment methodology developed by the commission in accordance with the previous paragraph and , where relevant , according to the guidelines on the application of thereof to specific categories of products .


### ‘ product presenting a risk’ means a product having the potential to affect adversely health and safety of persons in general , health and safety in the workplace , consumer protection , the environment and public security as well as other public interests to a degree which goes beyond that considered reasonable and acceptable under the normal or reasonably foreseeable conditions of use of the product concerned , including the duration of use and , where applicable , its putting into service , installation and maintenance requirements ; ### ‘ product presenting a risk’ means a product having the potential to affect adversely health and safety of persons in general , health and safety in the workplace , consumer protection , the environment and public security to a degree which goes beyond that considered reasonable and acceptable under the normal or reasonably foreseeable conditions of use of the product concerned , including the duration of use and , where applicable , its putting into service , installation and maintenance requirements ;


### market surveillance authorities may destroy or otherwise render inoperable a product presenting a risk where they deem it necessary and proportionate . they may require the relevant economic operator to bear the cost of such action . ### market surveillance authorities may destroy or otherwise render inoperable a product presenting a risk where they deem it necessary and proportionate . where the relevant economic operator has been identified , he shall bear the entire cost of such action .


### the penalties referred to in the first subparagraph shall have regard to the size of the undertakings and in particular to the situation of small and medium - sized enterprises . the penalties may be increased if the relevant economic operator has previously committed a similar infringement and may include criminal sanctions for serious infringements . ### the level of the penalties referred to in the first subparagraph shall be established as a proportion of the value of sales of the products concerned during the last full year of the infringement , depending on its seriousness , duration and intentional character . the penalties may be increased if the relevant economic operator has previously committed a similar infringement and may include criminal sanctions for serious infringements . in any case , the penalties shall not exceed 10% of the company ' s total turnover in the preceding business year .


### it is necessary to lay down methods for the sampling and analysis of textile products in order to exclude any possibility of objections to the methods used . the methods used for official tests carried out in the member states to determine the fibre composition of textile products composed of binary and ternary fibre mixtures should be uniform , as regards both the pre - treatment of the sample and its quantitative analysis . it is appropriate that the methods set out to that end in this regulation be turned into harmonised standards . therefore , the commission should manage the transition from the current system , which is based on the methods set out in this regulation , to a harmonised standard - based system . the use of uniform methods of analysis of textile products composed of binary and ternary fibre mixtures will facilitate the free movement of those products , and thereby improve the functioning of the internal market . ### it is necessary to lay down methods for the sampling and analysis of textile products in order to exclude any possibility of objections to the methods used . the methods used for official tests carried out in the member states to determine the fibre composition of textile products composed of binary and ternary fibre mixtures should be uniform , as regards both the pre - treatment of the sample and its quantitative analysis . in order to simplify this regulation and adapt the uniform methods set out therein to technical progress , it is appropriate that those methods be turned into harmonised standards . to that end , the commission should manage the transition from the current system , which is based on the methods set out in this regulation , to a harmonised standard - based system . the use of uniform methods of analysis of textile products composed of binary and ternary fibre mixtures will facilitate the free movement of those products , and thereby improve the functioning of the internal market .


### member states shall ensure that final customers for electricity , natural gas , district heating or cooling and district - supplied domestic hot water are provided with individual meters that accurately measure and allow to make available their actual energy consumption and provide information on actual time of use , in accordance with annex vi . ### member states shall ensure that if , where it is technically feasible and cost - effective , final customers for electricity , natural gas , district heating or cooling and district - supplied domestic hot water are provided with individual meters , these will accurately measure , and allow readings to be taken of , their actual energy consumption and provide information on actual time of use , in accordance with annex vi .


### by 1 january 2014 , member states shall establish and notify to the commission a national heating and cooling plan for developing the potential for the application of high - efficiency cogeneration and efficient district heating and cooling , containing the information set out in annex vii . the plans shall be updated and notified to the commission every five years . member states shall ensure by means of their regulatory framework that national heating and cooling plans are taken into account in local and regional development plans , including urban and rural spatial plans , and fulfil the design criteria in annex vii . ### by 1 january 2014 , member states shall analyse the potential for the application of high - efficiency cogeneration and efficient district heating and cooling and supply information on the subject to the commission , including the information set out in annex vii and a cost - benefit analysis . the analyses shall be updated in close cooperation with local authorities and notified to the commission every five years . member states shall ensure by means of their regulatory framework that national heating and cooling plans are taken into account in local and regional development plans , including urban and rural spatial plans , and fulfil the design criteria in annex vii .


### member states shall adopt authorisation or equivalent permitting criteria to ensure that industrial installations with a total thermal input exceeding 20 mw generating waste heat that are built or substantially refurbished after [ the entry into force of this directive ] capture and make use of their waste heat . ### does not affect english text .


### the commission shall evaluate the annual reports and supplementary reports and assess the extent to which member states have made progress towards the achievement of the national energy efficiency targets required by article 3 and towards the implementation of this directive . the commission shall send its assessment to the european parliament and the council . based on its assessment of the reports the commission may issue recommendations to member states . ### the commission shall evaluate the annual reports and supplementary information and assess the extent to which member states have made progress towards the achievement of the national energy efficiency targets required by article 3 , and towards the implementation of this directive . the commission shall send its assessment to the european parliament and the council . based on its assessment of the reports the commission may issue recommendations or suggest modifications to the instruments applied by member states . if the assessment shows that a member state is not on track to achieve the national energy efficiency target , the member state shall , on request of the commission , revise its national energy efficiency plan referred to in paragraph 2 of this article .


### ‘ energy performance contracting’ means a contractual arrangement between the beneficiary and the provider of an energy efficiency improvement measure , according to which the payment for the investment made by the provider is in relation to a contractually agreed level of energy efficiency improvement or other agreed energy performance criterion , such as financial savings ; ### ' energy performance contracting ' means a contractual arrangement between the beneficiary and the provider of an energy efficiency improvement measure , verified and monitored during the whole term of the contract , where investments in that measure are paid for in relation to a contractually agreed level of energy efficiency improvement or other agreed energy performance criterion .


### an assessment of the possibility of establishing a ‘ white certificate’ scheme at union level has shown that , in the current situation , such a system would create excessive administrative costs and that there is a risk that energy savings would be concentrated in a number of member states and not introduced across the union . the latter objective can better be achieved , at least at this stage , by means of national energy efficiency obligation schemes or other alternative measures that achieve the same amount of energy savings . the commission should however define , by a delegated act , the conditions under which a member state could in future recognise the energy savings achieved in another member state . it is appropriate for the level of ambition of such schemes to be established in a common framework at union level while providing significant flexibility to member states to take full account of the national organisation of market actors , the specific context of the energy sector and final customers ' habits . the common framework should give energy utilities the option of offering energy services to all final customers , not only to those to whom they sell energy . this increases competition in the energy market because energy utilities can differentiate their product by providing complementary energy services . the common framework should allow member states to include requirements in their national scheme that pursue a social aim , notably in order to ensure that vulnerable customers have access to the benefits of higher energy efficiency . it should also allow member states to exempt small companies from the energy efficiency obligation . the commission communication ‘ small business act’ sets out principles that should be taken into account by member states that decide to abstain from applying this possibility . ### an assessment of the possibility of establishing a ' white certificate ' scheme at union level has shown that , in the current situation , such a system would create excessive administrative costs and that there is a risk that energy savings would be concentrated in a number of member states and not introduced across the union . the latter objective can better be achieved , at least at this stage , by means of national energy efficiency obligation schemes . the commission should however define , by a delegated act , the conditions under which a member state could in future recognise the energy savings achieved in another member state . it is appropriate for the level of ambition of such schemes to be established in a common framework at union level while providing significant flexibility to member states to take full account of the national organisation of market actors , the specific context of the energy sector and final customers ' habits . the common framework should give energy utilities the option of offering energy services to all final customers , not only to those to whom they sell energy . this increases competition in the energy market because energy utilities can differentiate their product by providing complementary energy services . the common framework should allow member states to include requirements in their national scheme that pursue a social aim , notably in order to ensure that vulnerable customers have access to the benefits of higher energy efficiency . it should also allow member states to exempt small companies from the energy efficiency obligation . the commission communication ‘ small business act’ sets out principles that should be taken into account by member states that decide to abstain from applying this possibility .


### ‘ energy audit’ means a systematic procedure to obtain adequate knowledge of the existing energy consumption profile of a building or group of buildings , an industrial or commercial operation or installation or a private or public service , identify and quantify cost - effective energy savings opportunities , and report the findings ; ### ‘ energy audit’ means a systematic procedure to obtain adequate knowledge of the existing energy consumption profile of a building or group of buildings , an industrial or commercial operation or installation or a private or public service , identify and quantify cost - effective energy savings opportunities , taking into account health impacts , and report the findings ;


### network regulation and tariffs shall allow network operators to offer system services and system tariffs for demand response measures , demand management and distributed generation on organised electricity markets , in particular : ### network regulation and tariffs shall encourage network operators to promote system services and system tariffs for demand response measures , demand management and distributed generation on organized electricity markets , subject to a cost - effectiveness impact per types of targeted customers . systems services include :


### member states shall make publicly available the certification schemes or equivalent qualification schemes referred to in paragraph 1 and shall cooperate among themselves and with the commission on comparisons between and recognition of the schemes . ### member states shall make publicly available the qualification schemes referred to in paragraph 1 and shall work on comparisons between and recognition of the schemes . this shall be without prejudice to directive 2005 / 36 / ec .


### member states shall set a national energy efficiency target expressed as an absolute level of primary energy consumption in 2020 . when setting these targets , they shall take into account the union ' s target of 20&#160 ; % energy savings , the measures provided for in this directive , the measures adopted to reach the national energy saving targets adopted pursuant to article 4 of directive 2006 / 32 / ec and other measures to promote energy efficiency within member states and at union level . ### each member state shall ensure that its national absolute level of primary energy consumption in 2020 is at least below its target as set out in the left column of the table of annex - i - part a . such mandatory national targets are consistent with the union ' s target of at least 20&#160 ; % energy savings referred to in article 1 which requires a reduction of eu primary energy consumption of at least 368 mtoe in 2020 as compared to projections .


### directive 2006 / 32 / ec requires member states to adopt and aim to achieve an overall national indicative energy savings target of 9% by 2016 , to be reached by deploying energy services and other energy efficiency improvement measures . that directive states that the second energy efficiency plan adopted by the member states shall be followed , as appropriate and where necessary , by commission proposals for additional measures , including extending the period of application of targets . if a report concludes that insufficient progress has been made towards achieving the indicative national targets laid down by that directive , these proposals are to address the level and nature of the targets . the impact assessment accompanying this directive finds that the member states are on track to achieve the 9% target , which is substantially less ambitious than the subsequently adopted 20% energy saving target for 2020 , and therefore there is no need to address the level of the targets . ### directive 2006 / 32 / ec requires member states to adopt and achieve an overall national indicative energy savings target of 9 % by 2016 , to be reached by deploying energy services and other energy efficiency improvement measures . that directive states the second energy efficiency plan adopted by the member states shall be followed by commission proposals for additional measures . the impact assessment accompanying the directive finds that the member states are on track to achieve the 9 % target , which is substantially less ambitious than the subsequently adopted 20 % energy saving target for 2020 and that therefore there is need to address the level of the individual national targets as quickly as possible .


### a sufficient number of reliable professionals competent in the field of energy efficiency should be available to ensure the effective and timely implementation of this directive , for instance as regards compliance with the requirements on energy audits and implementation of energy efficiency obligation schemes . member states should therefore put in place certification schemes for the providers of energy services , energy audits and other energy efficiency improvement measures . ### a sufficient number of reliable qualified professionals competent in the field of energy efficiency should be available to ensure the effective and timely implementation of this directive , for instance as regards compliance with the requirements on energy audits and implementation of energy efficiency obligation schemes . member states should therefore put in place certification schemes for the providers of energy services , energy audits and other energy efficiency improvement measures .


### member states shall ensure that enterprises not included in the second subparagraph of paragraph 1 are subject to an energy audit carried out in an independent and cost - effective manner by qualified or accredited experts at the latest by 30 june 2014 and every three years from the date of the previous energy audit . ### member states shall ensure that enterprises not included in the second subparagraph of paragraph 1 are subject to an energy audit carried out in an independent and cost - effective manner by qualified and / or accredited experts at the latest by 30 june 2014 and every three years from the date of the previous energy audit . audits may be carried out by in - house experts , provided that these are qualified and accredited , that they are not directly engaged in the activity audited , and that the member state has put in place a scheme to assure and check their quality .


### by 1 january 2014 , member states shall establish and notify to the commission a national heating and cooling plan for developing the potential for the application of high - efficiency cogeneration and efficient district heating and cooling , containing the information set out in annex vii . the plans shall be updated and notified to the commission every five years . member states shall ensure by means of their regulatory framework that national heating and cooling plans are taken into account in local and regional development plans , including urban and rural spatial plans , and fulfil the design criteria in annex vii . ### by 1 january 2014 , member states shall analyse and notify to the commission a comprehensive assessment of the potential for the application of high - efficiency cogeneration . the assessments shall be updated and notified to the commission every five years .


### member states shall ensure that enterprises not included in the second subparagraph of paragraph 1 are subject to an energy audit carried out in an independent and cost - effective manner by qualified or accredited experts at the latest by 30 june 2014 and every three years from the date of the previous energy audit . ### member states shall ensure that enterprises not included in the second subparagraph of paragraph 1 are subject to an energy audit carried out in an independent and cost - effective manner by qualified and / or accredited experts at the latest by 30 june 2014 and every three years from the date of the previous energy audit .


### within the energy efficiency obligation scheme , member states may : ### within the energy saving obligation scheme , member states shall :


### member states shall ensure that final customers for electricity , natural gas , district heating or cooling and district - supplied domestic hot water are provided with individual meters that accurately measure and allow to make available their actual energy consumption and provide information on actual time of use , in accordance with annex vi . ### member states shall propose that final customers for electricity , natural gas , district heating or cooling and district - supplied domestic hot water are provided with individual meters that accurately measure , and allow readings to be taken of , their actual energy consumption and provide information on actual time of use , in accordance with annex vi .


### member states shall set a national energy efficiency target expressed as an absolute level of primary energy consumption in 2020 . when setting these targets , they shall take into account the union ' s target of 20&#160 ; % energy savings , the measures provided for in this directive , the measures adopted to reach the national energy saving targets adopted pursuant to article 4 of directive 2006 / 32 / ec and other measures to promote energy efficiency within member states and at union level . ### member states shall set a national energy efficiency target expressed as an absolute level of both final and primary energy consumption in 2020 . when setting these targets , they shall take into account the union ' s target of 20&#160 ; % energy savings , the measures provided for in this directive , the measures adopted to reach the national energy saving targets adopted pursuant to article 4 of directive 2006 / 32 / ec and other measures to promote energy efficiency within member states and at union level . account shall also be taken of measures to reduce greenhouse gas emissions and increase the use of renewable energy .


### where a product is covered by a delegated act adopted under directive 2010 / 30 / eu or commission directive implementing directive 92 / 75 / eec , purchase only the products that comply with the criterion of belonging to the highest energy efficiency class while taking into account cost - effectiveness , economical feasibility and technical suitability , as well as sufficient competition ; ### where a product is covered by a delegated act adopted under directive 2010 / 30 / eu or commission directive implementing directive 92 / 75 / eec , purchase only the products that comply with the criterion of belonging to the highest energy efficiency class while taking into account cost - effectiveness , health impact , economical feasibility and technical suitability , as well as sufficient competition ;