### the notion of special or exclusive rights is central to the definition of the scope of this directive , since entities which are neither contracting entities pursuant to article 4 nor public undertakings are subject to its provisions only to the extent that they exercise one of the activities covered on the basis of such rights . it is therefore appropriate to clarify that rights which have been granted by means of a procedure based on objective criteria , notably pursuant to union legislation , and for which adequate publicity has been ensured do not constitute special or exclusive rights for the purposes of this directive . this legislation should include directive 98 / 30 / ec of the european parliament and of the council of 22 june 1998 concerning common rules for the internal market in natural gas5 , directive 96 / 92 / ec of the european parliament and of the council of 19 december 1996 concerning common rules for the internal market in electricity6 , directive 97 / 67 / ec of the european parliament and of the council of 15 december 1997 on common rules for the development of the internal market of community postal services and the improvement of quality of service7 , directive 94 / 22 / ec of the european parliament and of the council of 20 may 1994 on the conditions for granting and using authorisations for the prospection , exploration and production of hydrocarbons8 and regulation no 1370 / 2007of the european parliament and of the council of 23 october 2007 on public passenger transport services by rail and by road and repealing council regulations nos 1191 / 69 and 1107 / 709 . the increasingly diverse forms of public action made it necessary to define more clearly the notion of procurement itself . the union rules on concessions refer to the acquisition of works or services for a consideration consisting in exploitation of those works or services . the notion of acquisition should be understood broadly in the sense of obtaining the benefits of the works or services in question not requiring in all cases a transfer of ownership to contracting authorities or contracting entities . furthermore , the mere financing of an activity , which is frequently linked to the obligation to reimburse the amounts received where they are not used for the purposes intended , does not usually fall under this directive . ### the notion of special or exclusive rights is central to the definition of the scope of this directive , since entities which are neither contracting entities pursuant to article 4 nor public undertakings are subject to these provisions only to the extent that they exercise one of the activities covered on the basis of such rights .


### 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 those services which have a limited cross - border dimension , namely the so - called services to the person . these services are provided within a particular context that varies widely amongst member states , due to different cultural traditions . a lighter regime should therefore be established for concession for these services . an obligation to publish a concession award notice of the award of those concessions which are above the threshold is an adequate way to ensure 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 .


### given the importance of the cultural context and the sensitivity of these services , member states should be given wide discretion to organise the choice of the service providers in the way they consider most appropriate . the rules of this directive do not prevent member states to apply specific quality criteria for the choice of service providers , such as the criteria set out in the voluntary european quality framework for social services of the european union ' s social protection committee . member states and / or public authorities remain free to provide these services themselves or to organise social services in a way that does not entail the conclusion of concessions , for example through the mere financing of such services or by granting licences or authorisations to all economic operators meeting the conditions established beforehand by the contracting authority or contracting entity , without any limits or quotas , provided such system ensures sufficient advertising and complies with the principles of transparency and non - discrimination . ### given the importance of the cultural context and the sensitivity of these services , member states shall have wide discretion to organise the choice of the service providers in the way they consider most appropriate . the rules of this directive do not prevent member states to apply specific quality criteria for the choice of service providers , such as the criteria set out in the voluntary european quality framework for social services of the european union ' s social protection committee . member states and / or public authorities remain free to provide these services themselves or to organise social services in a way that does not entail the conclusion of concessions , for example through the mere financing of such services or by granting licences or authorisations to all economic operators meeting the conditions established beforehand by the contracting authority or contracting entity , provided such system ensures compliance with the principles of transparency and non - discrimination .


### in order to ensure transparency and equal treatment , criteria for the award of concessions should always comply with some general standards . these should be disclosed in advance to all potential tenderers , be related to the subject matter of the contract and should not offer to the contracting authority or contracting entity an unrestricted freedom of choice . they should ensure the possibility of effective competition and be accompanied by requirements that allow the information provided by the tenderers to be effectively verified . in order to comply with these standards while improving legal certainty , member states may provide for the use of the criterion of the most economically advantageous tender . ### in order to ensure transparency and equal treatment , criteria for the award of concessions should always comply with some general standards . these should be disclosed in advance to all tenderers , be linked to the subject matter of the contract and not offer to the contracting authority or contracting entity an unrestricted freedom of choice . they should be accompanied by minimum requirements that allow the information provided by the tenderers to be effectively verified .


### in line with the principles of equal treatment and transparency , the successful tenderer should not be replaced by another economic operator without reopening the concession to competition . however , the successful tenderer performing the concession may undergo certain structural changes during the performance of the concession , such as purely internal reorganisations , mergers and acquisitions or insolvency or be substituted on the basis of a contractual clause known to all tenderers and in line with the principles of equal treatment and transparency . such structural changes should not automatically require new award procedures for all concessions performed by that undertaking . ### in line with the principles of equal treatment and transparency , the successful tenderer should not be replaced by another economic operator without reopening the concession to competition . however , the successful tenderer performing the concession may undergo certain structural changes during the performance of the concession , such as purely internal reorganisations , mergers and acquisitions or insolvency or be substituted on the basis of a contractual clause known to all tenderers and in line with the principles of equal treatment and transparency . such structural changes should not require new award procedures for all concessions performed by that undertaking .


### ‘ services concession’ means a contract for pecuniary interest concluded in writing between one or more economic operators and one or more contracting authorities or contracting entities and having as their object the provision of services other than those referred to in points 2 and 4 where the consideration for the services to be provided consists either solely in the right to exploit the services that are subject of the contract or in that right together with payment . ### ' services concession ' means a contract for pecuniary interest concluded in writing by means of which one or more contracting authorities or contracting entities entrusts the operation of a service for which they are responsible to one or more economic operators , and where the consideration for this delegation consists either solely in the right to exploit the service which is the subject of the contract or in that right together with payment . by contrast , certain state acts such as authorisations , permits or licences , whereby the state or a public authority establishes the conditions for the exercise of an economic activity , having as their object the entitlement to offer social services and / or the right to conclude agreements , by means of which the grantor grants an economic operator the right to exploit certain public domains or resources , or grants rights of way should not be regarded as concessions insofar as they establish only general conditions for their use without turning the public authority into a recipient of specific works or services provided by the contracting partner .


### ' services concession ' means a contract for pecuniary interest concluded in writing between one or more economic operators and one or more contracting authorities or contracting entities and having as their object the provision of services other than those referred to in points 2 and 4 where the consideration for the services to be provided consists either solely in the right to exploit the services that are subject of the contract or in that right together with payment . ### ' services concession ' means a contract for pecuniary interest concluded in writing between one or more economic operators and one or more contracting authorities or contracting entities and having as their object the provision of services other than those referred to in points 2 and 4 where the consideration for the services to be provided consists either solely in the right to exploit the services that are subject of the contract or in that right together with payment , except in the case of simple approvals , in particular approvals on the use of a public good or a public domain .


### this directive shall not apply to concessions which the contracting authority or a contracting entity is obliged to award or organise in accordance with procurement procedures set out in : ### this directive shall not apply to concessions which the contracting authority or a contracting entity is obliged to award or organise in accordance with procedures for the award of services concessions contracts set out in :


### an international agreement concluded in conformity with the treaty between a member state and one or more third countries and covering works , supplies or services intended for the joint implementation or exploitation of a project by the signatory states ; ### an international agreement concluded in conformity with the treaty between a member state and one or more third countries and covering works , or services intended for the joint implementation or exploitation of a project by the signatory states ;


### the acquisition or rental , by whatever financial means , of land , existing buildings or other immovable property or concerning rights thereon ; however financial service concessions awarded at the same time as , before or after the contract of acquisition or rental , in whatever form , shall be subject to this directive ; ### the acquisition or rental , by whatever financial means , of land , existing buildings or other immovable property , including maritime areas , or concerning rights thereon ; however financial service concessions awarded at the same time as , before or after the contract of acquisition or rental , in whatever form , shall be subject to this directive ;


### such an authority or entity exercises over the legal person concerned a control which is similar to that which it exercises over its own departments ; ### such an authority or entity exercises over the legal person concerned a control which is similar to that which it exercises over its own departments ; this shall be deemed to be the case where it exercises a decisive influence over both strategic objectives and significant decisions of the controlled legal person ; with a view to determining whether such control is being exercised , account may also be taken of factors such as the level of representation on administrative , management or supervisory bodies , the relevant provisions of the articles of association or the ownership arrangements ; it is not a mandatory requirement that the controlled legal person be wholly owned by the contracting authority or entity ;


### there is no private participation in the controlled legal person ### there is no private participation in the controlled legal person with the exception of legally enforced forms of private participation .


### 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 concessions shall be limited . the grantor shall estimate the duration on the basis of the works or services requested . when the cost of investments must be met by the concessionaire , the duration of a concession shall reflect the nature and amount of the investments involved , both initial and further investments during the life of the concession , and should take into consideration the normal amortisation period .


### the need for modification has been brought about by circumstances which a diligent contracting authority or entity could not foresee ### the need for modification has been brought about by circumstances in particular of a technical and / or financial nature which a diligent grantor could not foresee ,


### name and address of the oversight body and the body responsible for review and , where appropriate , mediation procedures . precise information concerning the deadline for review procedures , or if need be , the name , address , telephone number , fax number and email address of the service from which this information may be obtained ### name and address of the body responsible for review and , where appropriate , mediation procedures . precise information concerning the deadline for review procedures , or if need be , the name , address , telephone number , fax number and email address of the service from which this information may be obtained .


### over the past decade , the growth of passenger traffic by rail has been insufficient to increase its modal share in comparison to cars and aviation . the 6&#160 ; % modal share of passenger transport for rail in the european union has remained fairly stable . rail passenger services have not kept pace with evolving needs in terms of offer or quality . ### over the past decade , the european motorway network has grown by 27&#160 ; % , but the railway network in use has shrunk by 2&#160 ; % . furthermore , the growth of passenger traffic by rail has been insufficient to increase its modal share in comparison to cars and aviation . the 6&#160 ; % modal share of passenger transport for rail in the european union has remained fairly stable and rail passenger services have not kept pace with evolving needs in terms of offer or quality .


### the coordination committee shall draw up rules of procedure that include , in particular , rules on participation in and frequency of meetings which shall be at least quarterly . a report of the coordination committee ' s discussions shall be submitted annually to the infrastructure manager , the member state , the regulatory body concerned and the commission with an indication of the respective positions taken by the committee members . ### the coordination committee shall draw up rules of procedure that include , in particular , rules on participation in and frequency of meetings which shall be at least quarterly . a report of the coordination committee ' s discussions shall be submitted annually to the infrastructure manager and , where appropriate , the charging body and the allocation body , as well as to the member state , the regulatory body concerned and the commission with an indication of the respective positions taken by the committee members .


### the coordination committee shall draw up rules of procedure that include , in particular , rules on participation in and frequency of meetings which shall be at least quarterly . a report of the coordination committee’s discussions shall be submitted annually to the infrastructure manager , the member state , the regulatory body concerned and the commission with an indication of the respective positions taken by the committee members . ### the coordination committee shall draw up rules of procedure that include , in particular , rules on participation in and frequency of meetings which shall be at least quarterly . a report of the coordination committee’s discussions shall be submitted annually to the infrastructure manager and , where appropriate , the charging body and the train path allocating body , and to the member state , the regulatory body concerned and the commission with an indication of the respective positions taken by the committee members .


### member states may limit the right of access provided for in article 10 to passenger services between a given place of departure and a given destination when one or more public service contracts cover the same route or an alternative route if the exercise of this right would compromise the economic equilibrium of the public service contract or contracts in question . ### member states may limit the right of access provided for in article 10 to passenger services between a given place of departure and a given destination when one or more public service contracts cover the same route or an alternative route if the exercise of this right would affect the economic equilibrium of the public service contract or contracts in question or compromise the quality of the service provided .


### in case the regulatory body decides that the economic equilibrium of a public contract would be compromised by the intended passenger service referred to in article 38 , it shall indicate possible changes to such service which would ensure that the conditions to grant the right of access provided for in article 10 are met . ### in case the regulatory body decides that the economic equilibrium of a public contract or the quality of the service provided would be affected by the intended passenger service referred to in article 38 , it shall indicate to the extent that this is feasible possible changes to such service which would ensure that the conditions to grant the right of access provided for in article 10 are met .


### in order to promote learning and culture , member states should permit libraries , educational establishments and museums which are publicly accessible , as well as archives , film heritage institutions and public service broadcasting organisations , to make available and reproduce orphan works , provided such use fulfils their public interest missions , notably preservation , restoration and the provision of cultural and educational access to works contained in their collections . film heritage institutions should , for the purposes of this directive , cover organisations designated by member states to collect , catalogue , preserve and restore films forming part of their cultural heritage . ### in order to promote learning and culture , member states should permit libraries , educational establishments and museums which are publicly accessible , as well as archives , film heritage institutions and broadcasting organisations , to communicate , make available and reproduce , within the meaning of directive 2001 / 29 / ec , orphan works , provided such use fulfils their public interest missions and guarantees cultural and educational access to them . film heritage institutions should , for the purposes of this directive , cover organisations designated by member states to collect , catalogue , preserve and restore films forming part of their cultural heritage


### cinematographic or audiovisual works contained in the collections of film heritage institutions , or ### sound recordings or cinematographic or audiovisual works that were first published , exhibited or broadcast in the territory of a member state at least five years earlier , or


### where a work has more than one rightholder , and one of the rightholders has been identified and located , that work shall not be considered an orphan work . ### where a work has more than one rightholder in copyright or related rights , and one of the rightholders has been identified and located , the rights of the other rightholder are not affected by the present directive .


### the sources that are appropriate for each category of works shall be determined by each member state , in consultation with rightholders and users , and include , the sources listed in the annex . ### the sources that are appropriate for each category of works or other protected subject matter shall be the publicly accessible databases determined by each member state , in consultation with rightholders and users , and may include the sources listed in the annex .


### rightholders which put an end to the orphan status of the work , within the meaning of article 5 , are remunerated for the use that has been made of the work by the organisations referred to in article 1 ; ### rightholders which put an end to the orphan status of the work , within the meaning of article 5 , are remunerated according to fixed tariffs determined by the member states for the use that has been made of the work by the organisations referred to in article 1 ;


### rightholders may claim their remuneration under point within a period fixed by member states and which shall not be less than five years from the date of the act giving rise to the claim . ### rightholders may claim their remuneration under point within a period of five years from the date of the act giving rise to the claim .


### the commission shall keep under constant review the development of rights information sources and shall , at the latest one year after the entry into force of this directive , and at annual intervals thereafter , submit a report concerning the possible inclusion in the scope of application of this directive of works or other protected subject matter not currently included in such scope , and in particular phonograms and stand alone photographs and other images . ### the commission shall keep under constant review the development of rights information sources and shall , at the latest one year after the entry into force of this directive , and at annual intervals thereafter , submit a report concerning the possible inclusion in the scope of application of this directive of beneficiaries other than those listed in article 1 , and of works or other protected subject matter not currently included in such scope , and in particular stand alone photographs and other images , as well as unpublished works of all kinds created in europe .


### the objectives of the csf funds shall be pursued in the framework of sustainable development and the union ' s promotion of the aim of protecting and improving the environment , as set out in article 11 of the treaty , taking into account the polluter pays principle . ### the objectives of the csf funds shall be pursued in the framework of integrated sustainable development and the union ' s promotion of the aim of protecting and improving the environment , as set out in articles 11 and 19 of the treaty , taking into account the polluter pays principle and the need to avoid future external costs for the european society .


### supporting the shift towards a low - carbon economy in all sectors ; ### supporting the shift towards an efficient and renewable energy - based economy in all sectors ;


### promoting sustainable transport and removing bottlenecks in key network infrastructures ; ### promoting intermodal sustainable transport and mobility while focusing on removing bottlenecks and completing missing transborder links in sustainable and intermodal transport infrastructures


### enhancing institutional capacity and an efficient public administration . ### enhancing institutional capacity , including capacity building for partners referred to in article 5 , in particular local and regional authorities and civil society organisations , and an efficient and innovative public administration


### a consolidated table of milestones and targets established in programmes for the performance framework referred to in article 19 , together with the methodology and mechanism to ensure consistency across programmes and csf funds ; ### a consolidated table of measurable qualitative and quantitative milestones and targets established in programmes for the performance framework referred to in article 19 , together with the methodology and mechanism to ensure consistency across programmes and csf funds ;


### a description of specific actions to take into account environmental protection requirements , resource efficiency , climate change mitigation and adaptation , disaster resilience and risk prevention and management , in the selection of operations ; ### a description of specific actions to take into account environmental protection requirements , resource efficiency , biodiversity protection , ecosystem - based climate change mitigation and adaptation , disaster resilience and risk prevention and management , in the selection of operations ;


### an analysis of the environmental impact , taking into account climate change adaptation and mitigation needs , and disaster resilience ; ### an analysis of the environmental impact , taking into account climate change adaptation and mitigation needs , resource efficiency , biodiversity protection , and disaster resilience ;


### one of the objectives of the new cap is the enhancement of environmental performance through a mandatory ‘ greening’ component of direct payments which will support agricultural practices beneficial for the climate and the environment applicable throughout the union . for that purpose , member states should use part of their national ceilings for direct payments to grant an annual payment , on top of the basic payment , for compulsory practices to be followed by farmers addressing , as a priority , both climate and environment policy goals . those practises should take the form of simple , generalised , non - contractual and annual actions that go beyond cross - compliance and are linked to agriculture such as crop diversification , maintenance of permanent grassland and ecological focus areas . the compulsory nature of those practises should also concern farmers whose holdings are fully or partly situated in ‘ natura 2000’ areas covered by council directive 92 / 43 / eec of 21 may 1992 on the conservation of natural habitats and of wild fauna and flora and by directive 2009 / 147 / ec of the european parliament and of the council of 30 november 2009 on the conservation of wild birds , as long as these practises are compatible with the objectives of those directives . farmers who fulfil the conditions laid down in council regulation no 834 / 2007 of 28 june 2007 on organic production and labelling of organic products and repealing regulation no 2092 / 91 should benefit from the ‘ greening’ component without fulfilling any further obligation , given the recognised environmental benefits of the organic farming systems . non - respect of the ‘ greening’ component should lead to penalties on the basis of article 65 of regulation no [ … ] [ hzr ] . ### one of the objectives of the new cap is the enhancement of environmental performance through a mandatory ' greening ' component of direct payments which will support agricultural practices beneficial for the climate and the environment applicable throughout the union . for that purpose , member states should use part of their national ceilings for direct payments to grant an annual payment , on top of the basic payment , for compulsory practices to be followed by farmers addressing , as a priority , both climate and environment policy goals . those practises should take the form of simple , generalised , non - contractual and annual actions that go beyond cross - compliance and are linked to agriculture such as diversified crop rotation , maintenance of permanent grassland and ecological focus areas , or production of crops which are beneficial to the climate and the environment , help lower production costs and stimulate local markets in animal feed . the compulsory nature of those practises should also concern farmers whose holdings are fully or partly situated in ' natura 2000 ' areas covered by council directive 92 / 43 / eec of 21 may 1992 on the conservation of natural habitats and of wild fauna and flora and by directive 2009 / 147 / ec of the european parliament and of the council of 30 november 2009 on the conservation of wild birds , as long as these practises are compatible with the objectives of those directives . farmers who fulfil the conditions laid down in council regulation no 834 / 2007 of 28 june 2007 on organic production and labelling of organic products and repealing regulation no 2092 / 91 should benefit from the ' greening ' component without fulfilling any further obligation , given the recognised environmental benefits of the organic farming systems . non - respect of the ' greening ' component should lead to penalties on the basis of article 65 of regulation no [ . . . ] [ hzr ] .


### member states should be allowed to use part of their national ceilings for direct payments for coupled support in certain sectors in clearly defined cases . the resources that may be used for any coupled support should be limited to an appropriate level , while allowing such support to be granted in member states or in their specific regions facing particular situations where specific types of farming or specific agricultural sectors are particularly important for economic , environmental and / or social reasons . member states should be allowed to use up to 5 % of their national ceilings for this support , or 10 % in case their level of coupled support in at least one of the years of the period 2010 - 2013 exceeded 5 % . however , in duly justified cases where certain sensitive needs in a region are demonstrated , and upon approval by the commission , member states should be allowed to use more than 10 % of their national ceiling . coupled support should only be granted to the extent necessary to create an incentive to maintain current levels of production in those regions . this support should also be available to farmers holding , on 31 december 2013 , special payment entitlements allocated under regulation no 1782 / 2003 and regulation no 73 / 2009 and who do not have eligible hectares for the activation of payment entitlements . as regards the approval of voluntary coupled support exceeding 10 % of the annual national ceiling fixed per member state , the commission should further be empowered to adopt implementing acts without applying regulation no 182 / 2011 . ### member states should be allowed to use part of their national ceilings for direct payments for coupled support in certain sectors in clearly defined cases . the resources that may be used for any coupled support should be limited to an appropriate level , while allowing such support to be granted in member states or in their specific regions facing particular situations where specific types of farming or specific agricultural sectors are particularly important for economic , environmental and / or social reasons . member states should be allowed to use up to 5 % of their national ceilings for this support , or 10 % in case their level of coupled support in at least one of the years of the period 2010 - 2013 exceeded 5 % . however , in duly justified cases where certain sensitive needs in a region are demonstrated , and upon approval by the commission , member states should be allowed to use more than 10 % of their national ceiling . coupled support should only be granted to the extent necessary to create an incentive to maintain current levels of production in those regions or increase levels of production in the case of leguminous crops in rotation . this support should also be available to farmers holding , on 31 december 2013 , special payment entitlements allocated under regulation no 1782 / 2003 and regulation no 73 / 2009 and who do not have eligible hectares for the activation of payment entitlements . as regards the approval of voluntary coupled support exceeding 10 % of the annual national ceiling fixed per member state , the commission should further be empowered to adopt implementing acts without applying regulation no 182 / 2011 .


### democracy and human rights are inextricably linked , as recalled in the council conclusions of 18 november 2009 , on democracy support in the eu ' s external relations . the fundamental freedoms of expression and association are the preconditions for political pluralism and democratic processes , whereas democratic control and separation of powers are essential to sustain an independent judiciary and the rule of law which in turn are required for effective protection of human rights . ### democracy and human rights are inextricably linked and mutually reinforcing , as recalled in the council conclusions of 18 november 2009 , on democracy support in the eu ' s external relations . the fundamental freedoms of expression , association and assembly are the preconditions for political pluralism and democratic processes , whereas democratic control , domestic accountability and separation of powers are essential to sustain an independent judiciary and the rule of law which in turn are required for effective protection of human rights .


### the task of building and sustaining a culture of human rights and making democracy work for citizens , though especially urgent and difficult in emerging democracies , is essentially a continuous challenge , belonging first and foremost to the people of the country concerned but without diminishing the commitment of the international community . it also requires a range of institutions , in particular national democratic parliaments that should ensure participation , representation , responsiveness and accountability . ### the task of building and sustaining a culture of human rights as well as of supporting the emergence of an independent civil society , including the enhancement of its role in its country and making democracy work for citizens , though especially urgent and difficult in emerging democracies , is essentially a continuous challenge , belonging first and foremost to the people of the country concerned but without diminishing the commitment of the international community . it requires a range of institutions , in particular national democratic parliaments and local elected assemblies that should ensure participation , representation , responsiveness and accountability . it also requires independent civil society organisations that should take part in national good governance processes , including domestic accountability .


### under this regulation , the union will provide assistance to address global , regional , national and local human rights and democratisation issues in partnership with civil society understood to span all types of social action by individuals or groups that are independent from the state and active in the field of human rights and democracy support . ### under this regulation , the union will provide assistance to address global , regional , national and local human rights and democratisation issues in partnership with civil society ; it ranges from human rights defenders as defined by the un declaration on human rights defenders , to individuals or groups that are independent from the state and that are at risk due to the lack of freedom of expression and of association in their countries and that are active in the field of human rights and democracy support .


### furthermore , whilst democracy and human rights objectives must be increasingly mainstreamed in all external assistance financing instruments , union assistance under this regulation will have a specific complementary and additional role by virtue of its global nature and its independence of action from the consent of third country governments and other public authorities . this will allow for cooperation with civil society on sensitive human rights and democracy issues possible , providing the flexibility to respond to changing circumstances . it should also provide union capacity to articulate and support specific objectives and measures at international level which are neither geographically linked nor crisis related and which may require a transnational approach or involve operations both within the union and in a range of third countries . moreover , it will provide the necessary framework for operations , such as support for independent european union election observation missions requiring policy coherence , a unified management system and common operating standards . ### furthermore , whilst democracy and human rights objectives must be increasingly mainstreamed in all external assistance financing instruments , union assistance under this regulation will have a specific complementary and additional role by virtue of its global nature and its independence of action from the consent of third country governments and other public authorities . this will allow for cooperation and partnership with civil society on sensitive human rights and democracy issues possible , providing the flexibility to respond to changing circumstances . it may also provide union capacity to articulate and support specific objectives and measures at international level which are neither geographically linked nor crisis related and which may require a transnational approach such as the establishment of shelter cities dedicated to human rights defenders or involve operations both within the union and in a range of third countries while privileging the use of geographic instruments over this instrument to finance worldwide campaigns promoting fundamental rights . moreover , it will provide the necessary framework for operations , such as support for independent european union election observation missions requiring policy coherence , a unified management system and common operating standards .


### supporting and consolidating democratic reforms in third countries , by enhancing participatory and representative democracy , strengthening the overall democratic cycle , and improving the reliability of electoral processes , in particular by means of election observation missions . ### supporting and consolidating democratic reforms in third countries , by enhancing participatory and representative democracy , strengthening the overall democratic cycle , and improving the reliability of electoral processes , also by means of election observation missions .


### supporting reforms to achieve effective and transparent democratic accountability and oversight , including that of the security and justice sectors , and encouraging measures against corruption ; ### supporting reforms to achieve effective and transparent democratic and domestic accountability and oversight , including that of the security and justice sectors , and encouraging measures against corruption ;


### building confidence in and enhancing the reliability and transparency of democratic electoral processes , while contributing to the efficiency and consistency of the whole electoral cycle , in particular , ### building confidence in and enhancing the reliability and transparency of democratic electoral processes , while contributing to the efficiency and consistency of the whole electoral cycle , which should not exceed more than 25% of the total budget of the instrument and in particular ,


### by contributing to the development of the electoral observation capacity of civil society organisations at regional and local levels , and supporting their initiatives to enhance participation in , and the follow - up to , the electoral process ; ### by contributing to the development of the electoral observation capacity of civil society organisations at regional and local levels , and supporting domestic election observation and their initiatives to enhance participation in , and the follow - up to , the electoral process ;


### the scope of this regulation should extend to proceedings which promote the rescue of an economically viable debtor in order to help sound businesses to survive and give a second chance to entrepreneurs . it should notably extend to proceedings which provide for the restructuring of a debtor at a pre - insolvency stage , proceedings which leave the existing management in place and proceedings providing for a debt discharge of consumers and self - employed persons . since these proceedings do not necessarily entail the appointment of a liquidator , they should be covered by this regulation if they take place under the control or supervision of a court . in this context , the term “control” should include situations where the court only intervenes on appeal by a creditor or interested party . ### the scope of this regulation should extend to proceedings which promote the rescue of an economically viable debtor in order to help sound businesses to survive and give a second chance to entrepreneurs . it should notably extend to proceedings which provide for the restructuring of a debtor at a pre - insolvency stage , proceedings which leave the existing management in place and proceedings providing for a debt discharge of consumers and self - employed persons . these proceedings should entail the appointment of a liquidator , they should be covered by this regulation if they take place under the control or supervision of a court .


### secondary proceedings may also hamper the efficient administration of the estate . therefore , the court opening secondary proceedings should be able , on request of the liquidator , to postpone or refuse the opening if these proceedings are not necessary to protect the interests of local creditors . this should notably be the case if the liquidator , by an undertaking binding on the estate , agrees to treat local creditors as if secondary proceedings had been opened and to apply the rules of ranking of the member state where the opening of secondary proceedings has been requested when distributing the assets located in that member state . this regulation should confer on the liquidator the possibility to give such undertakings . ### secondary proceedings may also hamper the efficient administration of the estate . therefore , the court opening secondary proceedings should be able , on request of the liquidator , to postpone or refuse the opening if these proceedings are not necessary to protect the interests of local creditors . this should notably be the case if the liquidator , by an undertaking binding on the estate , agrees to treat local creditors as if secondary proceedings had been opened and to apply the rules of ranking of the member state where the opening of secondary proceedings has been requested when distributing the assets located in that member state . this regulation should confer on the liquidator the possibility to give such undertakings and to lay down objective criteria which such undertakings need to meet .


### this regulation shall apply to collective judicial or administrative proceedings , including interim proceedings , which are based on a law relating to insolvency or adjustment of debt and in which , for the purpose of rescue , adjustment of debt , reorganisation or liquidation , ### this regulation shall apply to collective judicial or administrative proceedings , including interim proceedings , which are based on a law relating to insolvency or adjustment of debt for the purpose of avoidance of liquidation , adjustment of debt , reorganisation or liquidation ,


### credit institutions , ### any credit institutions , including institutions defined in article 2 of directive 2013 / 36 / eu ,


### investment firms to the extent these are covered by directive 2001 / 24 / ec as amended , and ### investment firms to the extent these are covered by directive 2001 / 24 / ec as amended , and institutions subject to directive 2011 / 61 / eu ,


### article 176 of the treaty provides that the european regional development fund is intended to help to redress the main regional imbalances in the union . the erdf therefore contributes to reducing the gap between the levels of development of the various regions and the extent to which the least favoured regions , including rural and urban areas , declining industrial regions , areas with severe and permanent natural and demographic handicaps , such as islands , mountainous areas , sparsely populated areas and border regions , are lagging behind . ### article 176 of the treaty provides that the european regional development fund is intended to help to redress the main regional imbalances in the union and thus enhance the principle of territorial cohesion . the erdf therefore contributes to reducing the gap between the levels of development of the various regions and the extent to which the least favoured regions , including rural and urban areas , declining industrial regions , areas with severe and permanent natural and demographic handicaps , such as islands , mountainous areas , sparsely populated areas and border regions , are lagging behind .


### the erdf should contribute to the europe 2020 strategy , thus ensuring greater concentration of erdf support on the priorities of the union . according to the category of regions supported , the support from the erdf should be concentrated on research and innovation , small and medium - sized enterprises and climate change mitigation . the degree of concentration should take into account the level of development of the region as well as the specific needs of regions whose gdp per capita for the 2007 - 13 period was less than 75% of the average gdp of the eu - 25 for the reference period . ### the erdf should contribute to the europe 2020 strategy for smart , sustainable and inclusive growth , thus ensuring greater concentration of erdf support on the priorities of the union . according to the category of regions supported , the support from the erdf under the investment for growth and jobs goal should be concentrated on research and innovation , information and communication technologies , small and medium - sized enterprises and promoting a low carbon economy . this concentration should be attained at national level allowing for flexibility at the level of operational programmes and in different categories of regions and should be adjusted , if appropriate , to take into account cohesion fund resources allocated to supporting the investment priorities referred to in article 3 of regulation no [ . . . ] / 2013 [ cf ] . the degree of concentration should take into account the level of development of the region , the contribution of cohesion fund resources if applicable , as well as the specific needs of regions whose gdp per capita for the 2007 - 13 period was less than 75% of the average gdp of the eu - 25 for the reference period , regions designated with the phasing - out status in the 2007 - 2013 period and nuts 2 level regions consisting solely of islands which are situated in member states which receive support from the cohesion fund or which are outermost regions .


### the erdf should contribute to the europe 2020 strategy , thus ensuring greater concentration of erdf support on the priorities of the union . according to the category of regions supported , the support from the erdf should be concentrated on research and innovation , small and medium - sized enterprises and climate change mitigation . the degree of concentration should take into account the level of development of the region as well as the specific needs of regions whose gdp per capita for the 2007 - 13 period was less than 75% of the average gdp of the eu - 25 for the reference period . ### the erdf should contribute to the europe 2020 strategy , thus ensuring greater concentration of erdf support on the priorities of the union . according to the category of regions supported , the support from the erdf should be primarily concentrated on research and innovation , small and medium - sized enterprises , the minimisation of external costs , climate change mitigation and sustainable transport infrastructure development . the degree of concentration should take into account the level of development of the region as well as the specific needs of regions whose gdp per capita for the 2007 - 13 period was less than 75% of the average gdp of the eu - 25 for the reference period .


### in order to identify or test new solutions to issues relating to sustainable urban development which are of relevance at union level , the erdf should support innovative actions in the field of sustainable urban development . ### in order to identify or test new solutions to issues relating to sustainable urban development which are of relevance at union level , the erdf should support innovative actions and technologies in the field of sustainable urban development , including innovative traffic management systems , placing the emphasis , in particular , on environmentally sound transport , intermodality and sustainable mobility between towns and cities and peri - urban and rural areas .


### the erdf shall contribute to the financing of support which aims to reinforce economic , social and territorial cohesion by redressing the main regional imbalances through support for the development and structural adjustment of regional economies , including the conversion of declining industrial regions and regions lagging behind . ### the erdf shall contribute to the financing of support which aims to reinforce economic , social and territorial cohesion by redressing the main regional imbalances through support for the development and structural adjustment of regional economies , including the conversion of declining industrial regions and regions lagging behind , taking into account the difficulties affecting areas with permanent serious natural or demographic handicaps .


### support to public research and innovation bodies and investment in technology and applied research in enterprises ; ### support to public research and innovation bodies and investment in technology , transport safety , technological innovation in transport and mobility as well as applied research in enterprises ;


### networking , cooperation and exchange of experience between regions , towns , and relevant social , economic and environmental actors ; ### networking , cooperation and exchange of experience and best practices between regions , towns , and relevant social , economic and environmental actors ;


### promoting energy efficiency and renewable energy use in smes ; ### increasing energy efficiency and renewable energy use in smes ;


### promoting climate change adaptation , risk prevention and management : ### promoting eco - system based climate change adaptation , risk prevention and management :


### promoting investment to address specific risks , ensuring disaster resilience and developing disaster management systems ; ### promoting investment to address specific risks , ensuring eco - system based disaster resilience and developing eco - system based disaster management systems ;


### supporting a multimodal single european transport area by investing in the trans - european transport network network ; ### supporting a sustainable , safe and efficient co - modal single european transport area by investing in the trans - european transport network while focusing on the integration of the member states which acceded to the european union on or after 1 may 2004 and their infrastructure needs based on solidarity and territorial cohesion , while focusing on the eco - efficiency of modernising existing infrastructure in the short term and avoiding the reliance on the long term realisation of very large projects ;


### investing in health and social infrastructure which contribute to national , regional and local development , reducing inequalities in terms of health status , and transition from institutional to community - based services ; ### investing in health and social infrastructure which contribute to national , regional and local development , reducing gender - based inequalities and inequalities in terms of health status , and transition from institutional to community - based services ;


### support for social enterprises ; ### support for the social economy and social enterprises , the socio - cultural and creative sectors and non - governmental and cooperative organisations ;


### enhancing institutional capacity and an efficient public administration by strengthening of institutional capacity and the efficiency of public administrations and public services related to implementation of the erdf , and in support of actions in institutional capacity and in the efficiency of public administration supported by the esf . ### enhancing institutional capacity and an efficient and participative public administration by strengthening of institutional capacity and the efficiency of public administrations and public services , and promoting capacity building for social partners , non - governmental organisations , regional and local authorities and other stakeholders , in particular the partners referred to in article 5 of regulation no [ . . . ] / 2012 [ cpr ] , related to the implementation of the erdf , and in support of actions in institutional capacity and in the efficiency of public administration supported by the esf .


### for programme - specific result indicators , baselines shall use the latest available data and targets shall be fixed for 2022 , but may be expressed in quantitative or qualitative terms . ### for programme - specific result indicators , baselines shall use the latest available data and targets shall be fixed for 2022 , and shall be expressed in both quantitative and qualitative terms .


### at the initiative of the commission , the erdf may support innovative actions in the field of sustainable urban development , subject to a ceiling of 0 , 2% of the total annual erdf allocation . they shall include studies and pilot projects to identify or test new solutions to issues relating to sustainable urban development which are of relevance at union level . ### at the initiative of the commission , the erdf shall support innovative actions in the field of sustainable urban development , including the development of peri - urban areas and , where appropriate , corresponding to actions supported by other csf funds , in particular the esf , subject to a ceiling of 0 , 5% of the total annual erdf allocation . they shall include pilot projects , including bottom - up participative solutions , and studies to identify or test new solutions to structural challenges relating to sustainable and inclusive urban development which are of relevance at union level , such as the revitalisation of deprived urban neighbourhoods . the commission shall ensure the close involvement of the partners referred to in article 5 of the regulation no [ . . . ] / 2012 [ cpr ] , including local , regional and civil society partners into all stages of the preparation and implementation of the actions .


### in its report to the european parliament and the council on the experience acquired in the application of the regulation no 91 / 2003 , the commission mentions that long term developments will probably mean the suppression or simplification of the data already collected under the regulation , and that the intention is to reduce the data transmission period for annual data on rail passengers . ### in its report to the european parliament and the council on the experience acquired in the application of the regulation no 91 / 2003 , the commission mentions that long - term developments will probably mean the suppression or simplification of the data already collected under the regulation , and that the intention is to reduce the data transmission period for annual data on rail passengers . the commission should continue to provide reports at regular intervals on the way in which this regulation is implemented .


### in order to ensure uniform conditions for implementation of regulation no 91 / 2003 , implementing powers should be conferred on the commission as regards the specification of information to be supplied for the reports on the quality and comparability of the results . these powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission ' s exercise of implementing powers4 . __________________ 4 oj l 55 , 28 . 2 . 2011 , p . 13 . ### in order to ensure uniform conditions for implementation of regulation no 91 / 2003 , implementing powers should be conferred on the commission as regards the specification of information to be supplied for the reports on the quality and comparability of the results , and on arrangements for the dissemination of results by the commission . these powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission ' s exercise of implementing powers4 . the examination procedure should be used for the adoption of those acts , given their general scope . __________________ 4 oj l 55 , 28 . 2 . 2011 , p . 13 .


### in paragraph 1 , points b , d and h are deleted . ### in paragraph 1 , points b and d are deleted .


### the commission shall be empowered to adopt delegated acts , in accordance with article 10 , concerning the adaptation of the contents of the annexes and the thresholds for reporting as referred to in paragraphs 1 and 3 , in order to take account of economic and technical developments . ### the commission shall be empowered to adopt delegated acts , in accordance with article 10 , concerning the adaptation of the contents of the annexes and the thresholds for reporting as referred to in paragraphs 1 and 3 , in order to take account of technical developments .


### statistics based on the data specified in annexes a , c , e , f , g and l shall be disseminated by the commission . ### statistics based on the data specified in annexes a , c , e , f , g , ga , h and l shall be disseminated by the commission no later than 12 months after the end of the period to which the results relate . the arrangements for the dissemination of results shall be adopted by the commission in accordance with the examination procedure referred to in article 11 .


### article 9 is deleted . ### article 9 is replaced by the following : ' article 9 report by [ dd / mm / yyyy ] [ three years after the date of entry into force of this regulation ] and every three years thereafter , the commission , after consulting the statistical programme committee , shall submit a report to the european parliament and the council on the implementation of this regulation . in particular , that report shall : assess the benefits accruing to the union , the member states and the providers and users of statistical information of the statistics produced , in relation to their costs ; assess the quality of the statistics produced ; identify areas for potential improvement and any amendments considered necessary in the light of the results obtained . ' .


### the power to adopt delegated acts referred to in articles 3 and 4 shall be conferred on the commission for an indeterminate period of time from [ publications office : please insert the exact date of the entry into force of the amending regulation ] . ### the power to adopt delegated acts referred to in articles 3 and 4 shall be conferred on the commission for a period of five years from [ publications office : please insert the exact date of the entry into force of the amending regulation ] . the commission shall draw up a report in respect of the delegation of power no later than nine months before the end of the five - year period . the delegation of power shall be tacitly extended for periods of an identical duration unless the european parliament or the council opposes such extension no later than three months before the end of each period .


### annexes b , d , h and i are deleted . ### annexes b , d and i are deleted .


### annex l is added as set out in the annex to this regulation . ### annexes g a and l are added as set out in the annex to this regulation .


### this directive supplements the general community waste management legislation , such as directive 2008 / [ … ] / ec of the european parliament and of the council on waste . ### this directive supplements the general community waste management legislation , such as directive 2008 / [ … ] / ec of the european parliament and of the council on waste as well as regulation no 1907 / 2006 of the european parliament and of the council of 18 december 2006 concerning the registration , evaluation , authorisation and restriction of chemicals 1 . 1 oj l 396 , 30 . 12 . 2006 , p . 1 .


### the technical development of electrical and electronic equipment without heavy metals , pbde and pbb should be taken into account . ### the technical development of electrical and electronic equipment without heavy metals , brominated flame retardants , chlorinated flame retardants , pvc and its hazardous plasticisers should be taken into account .


### exemptions from the substitution requirement should be permitted if substitution is not possible from the scientific and technical point of view , taking specific account of the situation of smes or if the negative environmental , health or socio - economic impacts caused by substitution are likely to outweigh the health , environmental or socio - economic benefits of the substitution or the availability and reliability of substitutes is not ensured . substitution of the hazardous substances in electrical and electronic equipment should also be carried out in a way so as to be compatible with the health and safety of users of electrical and electronic equipment . the placing on the market of medical devices requires a conformity assessment procedure , according to directives 93 / 42 / ec and 98 / 79 / ec , which could require the involvement of a notified body designated by competent authorities of member states . if such a notified body certifies that the safety of the potential substitute for the intended use in medical devices or in vitro medical devices is not demonstrated , this will be viewed as a clear negative socio - economic , health and consumer safety impact . it should be possible to apply for exemptions of equipment coming under the scope of this directive from the date of its entry into force , even when that is before the actual inclusion in the scope of that equipment . ### exemptions from the substitution requirement should be permitted if substitution is not possible from the scientific and technical point of view , taking specific account of the situation of smes or if the negative environmental and health impacts caused by substitution are likely to outweigh the health and environmental benefits of the substitution . substitution of the hazardous substances in electrical and electronic equipment should also be carried out in a way so as to be compatible with the health and safety of users of electrical and electronic equipment . socio - economic considerations should be taken into account when deciding on the duration of an exemption . it should be possible to grant a grace period after expiry of an exemption to allow for regulatory certification or for the supply of safer substitutes to be scaled up to the necessary requirements . the placing on the market of medical devices requires a conformity assessment procedure , according to directives 93 / 42 / ec and 98 / 79 / ec , which could require the involvement of a notified body designated by competent authorities of member states . if such a notified body certifies that the safety of the potential substitute for the intended use in medical devices or in vitro medical devices is not demonstrated , this will be viewed as a clear negative socio - economic , health and consumer safety impact . it should be possible to apply for exemptions of equipment coming under the scope of this directive from the date of its entry into force , even when that is before the actual inclusion in the scope of that equipment .


### in particular the commission should be empowered to adapt annexes ii , iii , iv , v and vi to technical and scientific progress and to adopt other necessary implementing measures . since those measures are of general scope and are designed to amend non - essential elements of directive 2002 / 95 / ec , they must be adopted in accordance with the regulatory procedure with scrutiny provided for in article 5a of decision 1999 / 468 / ec . ### in order to allow the provisions of this directive to be adapted to technical and scientific progress and to adopt other necessary measures , the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty in respect of the adaptation of annexes v , vi , via and vib , the applicability of annex v for industrial monitoring and control instruments , detailed rules for compliance with maximum concentration values and the application of the labelling of nanomaterials in electrical and electronic equipment , and adaptions to reach .


### this directive lays down rules on the restriction of use of hazardous substances in electric and electronic equipment with a view to contribute to the protection of human health and the environmentally sound recovery and disposal of waste electrical and electronic equipment . ### this directive lays down rules on the restriction of use of hazardous substances in electric and electronic equipment with a view to contribute to the protection of human health , the environment , and the environmentally sound recovery and disposal of waste electrical and electronic equipment .


### ' manufacturer” means any natural or legal person who manufactures an eee or who has an eee designed or manufactured under his name or trademark ; ### ' manufacturer ' means any natural or legal person who manufactures eee or who has eee designed or manufactured , and markets it under his name or trademark ;


### “homogeneous material” means a material of uniform composition throughout that can not be mechanically disjointed into different materials , meaning that the materials can not , in principle , be separated by mechanical actions such as unscrewing , cutting , crushing , grinding and abrasive processes ; ### “homogeneous material” means either : - a material that consists of only one material throughout ; - a combination of multiple materials that can not be mechanically disjointed into different materials , excluding surface coatings ; or - a surface coating .


### ”industrial monitoring and control instruments” mean monitoring and control instruments designed for exclusively industrial or professional use . ### ”industrial monitoring and control instruments” mean monitoring and control instruments designed for exclusively industrial use .


### paragraph 1 shall not apply to the applications listed in annexes v and vi . ### paragraph 1 and 1a shall not apply to the applications listed in annexes v , vi and via .


### the commission shall , for the purposes of adapting the annexes to scientific and technical progress , adopt the following measures : ### the commission shall , for the purposes of adapting annexes v , vi and via to scientific and technical progress , adopt the following measures :


### include materials and components of eee in annexes v and vi where either of the following conditions is fulfilled : ### include materials and components of eee for specific applications in annexes v , vi and via where either of the following conditions is fulfilled :


### those measures designed to amend non essential elements of this directive shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 18 . ### those measures designed to amend non essential elements of this directive shall be adopted individually and in accordance with the regulatory procedure with scrutiny referred to in article 18 .


### before annexes are amended , the commission shall inter alia consult producers of electrical and electronic equipment , recyclers , treatment operators , environmental organisations and employee and consumer associations . ### before annexes v , vi and via are amended , the commission shall inter alia consult economic operators , recyclers , treatment operators , environmental organisations and employee and consumer associations . comments received by the commission in the context of such consultations shall be made publicly available and forwarded to the committee referred to in article 18 . the commission shall provide an account of the information it receives and make it publicly available .


### the commission shall adopt detailed rules for : ### no later than [ . . . * ] , the commission shall adopt detailed rules for : * insert date eighteen months after entry into force of this directive .


### - applications for the exemption including a format and types of information to be provided when introducing those applications , including analysis of the alternatives and , if suitable alternatives are available , substitution plans as referred to in regulation 1907 / 2006 . ### - applications for the exemption including a format and types of verifiable information to be provided and comprehensive guidance when introducing those applications , including analysis of the alternatives on a life - cycle basis and , if suitable alternatives are available , substitution plans as referred to in regulation 1907 / 2006 , including transition times necessary for regulatory certification and sufficient supply of suitable alternatives .


### - complying with the maximum concentration values of article ### - complying with the maximum concentration values of article , inter alia by defining a de minimis volume , and specific rules for surface coatings . verification procedures for the prohibition of chlorinated and brominated substances shall be based on existing international industry standards referring to bromine and / or chlorine content .


### manufacturers shall draw up the required technical documentation and carry out the internal production control procedure set out in module a of annex ii to decision no 768 / 2008 / ec or have it carried out . where compliance of an eee with the applicable requirements has been demonstrated by that procedure , manufacturers shall draw up an ec declaration of conformity and affix the ce marking . ### manufacturers draw up the required technical documentation and carry out the internal production control procedure set out in module a of annex ii to decision no 768 / 2008 / ec or have it carried out , unless specific legislation requires technical documentation and internal control procedures that are at least as strict as the procedure set out in that module . where compliance of an eee with the applicable requirements has been demonstrated by those procedures , manufacturers draw up an ec declaration of conformity and affix the ce marking .


### when deemed appropriate with regard to the risks presented by a product , manufacturers shall , to protect the health and safety of consumers , carry out sample testing of marketed eee , investigate , and , if necessary , keep a register of complaints , of non - conforming eee and product recalls , and shall keep distributors informed of any such monitoring . ### when deemed appropriate with regard to the risks to human health , the environment or environmentally sound recovery and disposal presented by a product , manufacturers carry out sample testing of marketed eee , investigate , and , if necessary , keep a register of complaints , of non - conforming eee and product recalls , and keep distributors informed of any such monitoring .


### manufacturers shall indicate their name , registered trade name or registered trade mark and the address at which they can be contacted on the eee or , where that is not possible , on its packaging or in a document accompanying the eee . the address must indicate a single point at which the manufacturer can be contacted . ### manufacturers indicate their name , registered trade name or registered trade mark and the address at which they can be contacted on the eee or , where that is not possible , on its packaging or in a document accompanying the eee . where specific applicable legislation already sets out such requirements , the requirements in that legislation shall apply instead . the address must indicate a single point at which the manufacturer can be contacted .


### manufacturers who consider or have reason to believe that an eee which they have placed on the market is not in conformity with the applicable community harmonisation legislation shall immediately take the necessary corrective measures to bring that eee into conformity , to withdraw it or recall it , if appropriate . furthermore , where the eee presents a risk , manufacturers shall immediately inform the competent national authorities of the member states in which they made the eee available to that effect , giving details , in particular , of the non - compliance and of any corrective measures taken . ### manufacturers who consider or have reason to believe that an eee which they have placed on the market is not in conformity with this directive immediately take the necessary corrective measures to bring that eee into conformity , to withdraw it or recall it , if appropriate . furthermore , where the eee presents a risk , manufacturers immediately inform the competent national authorities of the member states in which they made the eee available to that effect , giving details , in particular , of the non - compliance and of any corrective measures taken .


### the reasons for putting research , education and innovation at centre stage are straightforward . in a context of increasing global competition and facing a demographic challenge at home , europe ' s future economic growth and jobs will increasingly come from innovation breakthroughs in products , services and business models as well as from its ability to nurture , attract and retain talent . while there are individual success stories across europe , eu member states on average underperform in comparison with global innovation leaders . moreover , the eu is facing increased competition for talent from new centres of excellence in emerging economies . ### the reasons for putting research , education and innovation at centre stage are straightforward . in the context of the knowledge economy and increasing global competition and facing a demographic challenge at home , europe ' s future economic growth and jobs will increasingly come from innovation breakthroughs in products , services and business models as well as from its ability to nurture , attract and retain talent , while allowing european citizens not only to benefit from these innovations but also to contribute , particularly by means of new technologies , to their emergence . while there are individual success stories across europe , eu member states on average underperform in comparison with global innovation leaders . moreover , the eu is facing increased competition for talent from new centres of excellence in emerging economies .


### a genuine change in our innovation systems and paradigms is therefore necessary . still too often , excellence in higher education , research and innovation , while clearly existing across the eu , remains fragmented . europe needs to overcome this lack of strategic co - operation across boundaries – countries , sectors and disciplines . moreover , europe needs to embrace a true entrepreneurial culture , which is essential for capturing the value of research and innovation , for setting - up new ventures and actual market deployment of innovations in potential high - growth sectors . europe needs to foster the role of higher education institutions as engines of innovation , as talented people need to be equipped with the right skills , knowledge and attitudes in order to drive innovation forward . ### a genuine change in our innovation systems and paradigms is therefore necessary , which requires the adoption of new principles and practices based , in particular , on open and inclusive research and on the development of tools for managing intellectual property rights which promote transparency and exchange , and the development of new financing tools to ensure that research efforts are targeted , effectively and as a matter of priority , at issues of major public interest . still too often , excellence in higher education , research and innovation , while clearly existing across the eu , remains fragmented . europe needs to overcome this lack of strategic co - operation across boundaries – countries , sectors and disciplines . moreover , europe needs to embrace a true entrepreneurial culture , which is essential for capturing the value of research and innovation , for setting - up new ventures and actual market deployment of innovations in potential high - growth sectors . europe needs to foster the role of higher education institutions as engines of innovation , as talented people need to be equipped with the right skills , knowledge and attitudes in order to drive innovation forward .


###  enhancing the impact of investments on education , research and innovation and testing new ways for innovation governance : the eit acts as a catalyst , adding value to the existing research base , by accelerating the take - up and exploitation of technologies and research outcomes . innovation activities contribute in turn to align and leverage research investments and to make education and training activities more responsive to business needs . to this end , the eit has been equipped with a substantial degree of flexibility to test out new innovation models , allowing for true differentiation in the kics ' governance and funding models and quick adaptation to better cope with emerging opportunities . ###  enhancing the impact of investments on education , research and innovation and testing new ways for innovation governance : the eit acts as a catalyst , adding value to the existing research base , by accelerating the take - up and exploitation of technologies and research outcomes . innovation activities contribute in turn to align and leverage research investments and to make education and training activities more responsive to business needs . to this end , the eit has been equipped with a substantial degree of flexibility to test out new innovation models , allowing for true differentiation in the kics ' governance and funding models and quick adaptation to better cope with emerging opportunities . the eit also has the potential to develop new financing models , such as innovation prizes , allowing to maximise the public returns of the financing of research , ensuring that innovation not only tackles the most urgent needs of society but also can benefit rapidly to european citizens .


### the eit will strongly contribute to the objectives set out in horizon 2020 , in particular by addressing societal challenges in a complementary way to other initiatives in these areas . within horizon 2020 , the eit will be part of the ‘ tackling societal challenges’ objective but following the approach of seamless interaction across objectives , it will also contribute to ‘ industrial leadership and competitive frameworks’ by stimulating results - driven research and fostering the creation of high growth innovative smes . finally , it will contribute to the creation of an ‘ excellent science base’ by fostering mobility across boundaries – of disciplines , sectors and countries – and by embedding entrepreneurship and a risk - taking culture in innovative post - graduates degrees . the eit will thereby significantly contribute to promoting the framework conditions that are needed to realise the innovative potential of eu research and to promote the completion of the european research area . ### the eit will strongly contribute to the objectives set out in horizon 2020 , in particular by addressing societal challenges in a complementary way to other initiatives in these areas . within horizon 2020 , the eit will be part of the ‘ tackling societal challenges’ objective but following the approach of seamless interaction across objectives , it will also contribute to ‘ industrial leadership and competitive frameworks’ by stimulating results - driven research and fostering the creation of open and inclusive innovation models among high growth innovative smes . finally , it will contribute to the creation of an ‘ excellent science base’ by fostering mobility across boundaries – of disciplines , sectors and countries – and by embedding entrepreneurship and a risk - taking culture in innovative post - graduates degrees . the eit will thereby significantly contribute to promoting the framework conditions that are needed to realise the innovative potential of eu research and to promote the completion of the european research area .


### joint programming initiatives , a key instrument for addressing fragmentation in research , should provide the nucleus of the pan - european kic research base . in turn , kics can speed up and foster the exploitation of excellent public research pooled together by the jpis , thereby addressing fragmentation in innovation . the joint technology initiatives and the newly established public and private partnerships provide platforms for promotion of large - scale industry - driven research and enhance the development of major technologies . kics can help catalysing these major research investments to boost technology transfer and commercialisation and to develop new ventures within existing business via entrepreneurial talent . through its knowledge triangle approach , the eit will complement investment of the european research council on world - class frontier research by addressing the whole innovation chain from ideas to application and exploitation and provide additional opportunities in innovation and exposure to entrepreneurship to ' marie curie ' researchers and ' erasmus for all ' students . ### joint programming initiatives , a key instrument for addressing fragmentation in research , should provide the nucleus of the pan - european kic research base . in turn , kics can speed up and foster the exploitation of excellent public research pooled together by the jpis , thereby addressing fragmentation in innovation . the joint technology initiatives and the newly established public and private partnerships provide platforms for promotion of large - scale industry - driven research and enhance the development of major technologies . the establishment of ‘ patent pools’ in certain areas and open research will encourage the opening - up of research and act as a catalyst for efforts by both the public and private sectors . kics can help in catalysing these major research investments to boost technology transfer and commercialisation and to develop new ventures within existing business via entrepreneurial talent . through its knowledge triangle approach , the eit will complement investment of the european research council on world - class frontier research by addressing the whole innovation chain from ideas to application and exploitation and provide additional opportunities in innovation and exposure to entrepreneurship for ' marie curie ' researchers and ' erasmus for all ' students .


### kics not only build on their partners ' existing excellent research base , but are also the frontrunners for promoting and implementing the eit ' s educational mission . the objective is to educate and train talented people with the skills , knowledge and mindset needed in a global knowledge economy . to this end , the eit actively promotes , inter alia , the eit - labelled degrees by monitoring their quality and coherent implementation across kics . in this endeavour they will make extensive use of peer and expert evaluations , and establish a dialogue with national and quality assurance bodies . this will enhance the national and international recognition of the eit labelled qualifications and raise their attractiveness globally , while providing a platform for collaboration at international level . in the future , kics will be encouraged to expand their educational activities beyond post - graduate education to a greater variety of study modes to cater for a wider range of innovative , professional development activities , involving executive education , tailor - made training courses and summer schools . to enhance the impact of kics ' educational activities and to reach out to a wider audience , kics may envisage the design , on an experimental basis , of modules for undergraduate courses or packages targeted to school education . ### kics not only build on their partners ' existing excellent research base , but are also the front - runners for promoting and implementing the eit ' s educational mission . the objective is to educate and train talented people with the skills , knowledge and mindset needed in a global knowledge economy . to this end , the eit actively promotes , inter alia , the eit - labelled degrees by monitoring their quality and coherent implementation across kics . in this endeavour a series of quality criteria will be applied by kics for eit - labelled degrees , to ensure the upholding of high academic standards and the reputation of european universities . they will also make extensive use of peer and expert evaluations , and establish a dialogue with national and quality assurance bodies . this will enhance the national and international recognition of the eit labelled qualifications and raise their attractiveness globally , while providing a platform for collaboration at international level . in the future , kics will be encouraged to expand their educational activities beyond post - graduate education to a greater variety of study modes to cater for a wider range of innovative , professional development activities , involving executive education , tailor - made training courses and summer schools . to enhance the impact of kics ' educational activities and to reach out to a wider audience , kics may envisage the design , on an experimental basis , of modules for undergraduate courses or packages targeted at school education .


### the assessment of the themes proposed in the eit draft as well as by the wider stakeholder community clearly showed a certain degree of variation regarding potential impact the establishment of a kic would offer . as a result , a number of themes were discarded entirely ; others were redefined in order to better respond to the specificities of the european and global context in this area . ### the assessment of the themes proposed in the eit draft as well as by the wider stakeholder community clearly showed a certain degree of variation regarding potential impact the establishment of a kic would offer . as a result , a number of themes were discarded entirely ; others were redefined in order to better respond to the specificities of the european and global context in this area . the regular assessment of the evolution of research potentials and the possible emergence of new innovation dynamics should be taken into consideration for future kics in sectors that are not yet considered but fulfil the given criteria .


### in the initial period , the eit has mainly focused its efforts on establishing the kics . while it is a clear goal for the eit to strengthen existing centres of excellence , the eit will need to ensure it also delivers benefits to areas of the union which are not directly participating in kics . it is therefore mission critical for the eit to actively promote the dissemination of good practices for the integration of the knowledge triangle in order to develop a common innovation and knowledge sharing culture . ### in the initial period , the eit has mainly focused its efforts on establishing the kics . while it is a clear goal for the eit to strengthen existing centres of excellence , the eit will need to ensure it also delivers benefits to areas of the union which are not directly participating in kics . it is therefore mission critical for the eit to actively promote the dissemination of good practices , such as open research and the open publication of results , for the integration of the knowledge triangle in order to develop a common innovation and knowledge sharing culture .


### in the future , the eit must work to make the kic experience understandable and replicable and build it into a culture that can act as a role model in europe and beyond . by identifying , analysing and sharing good practices , as well as new governance and funding models from the kics , the eit seeks to ensure that knowledge generated within the eit and its kics is disseminated and capitalised upon for the benefit of people and institutions , including those not directly participating in the kics . ### in the future , the eit must work to make the kic experience understandable and replicable and build it into a culture that can act as a role model in europe and beyond . by identifying , analysing and sharing good practices , as well as new governance and funding models from the kics , the eit seeks to ensure that knowledge generated within the eit and its kics is disseminated and capitalised upon for the benefit of the citizens , private entities and institutions , including those not directly participating in the kics .


### moreover , the eit has a clear role to play in attracting talent from outside the eu . by creating a strong brand and forging strategic relations with key partners from around the globe , the eit can add to the attractiveness of the partners within the kics . in close cooperation with the kics , the eit should develop a strong international strategy , identifying and liaising relevant interlocutors and potential partners . in this context the eit and its kics should take full advantage of existing eu initiatives in the area , such as the ' erasmus for all ' programme and the marie curie actions . in addition , the eit can foster knowledge sharing , mentoring and networking by encouraging the setting up of an eit alumni network . ### moreover , the eit has a clear role to play in attracting talent from outside the eu . by creating a strong brand and forging strategic relations with key partners from around the globe , the eit can add to the attractiveness of the partners within the kics . in close cooperation with the kics , the eit should develop a strong international strategy , identifying and liaising relevant interlocutors and potential partners . in this context the eit and its kics should take full advantage of existing eu initiatives in the area , such as the union’s research , education , training and youth programmes . in addition , the eit can foster open access , inclusive innovation , knowledge sharing , mentoring and networking by encouraging the setting up of an eit alumni network .


###  make lessons learned and successes from kics systematically accessible to the wider eu innovation community and beyond . this may include the development of a repository of open course ware from the eit ' s and kics ' educational and training activities . ###  make lessons learned and successes from kics systematically accessible to the wider eu innovation community and beyond . this will include , in particular , the development of a repository of open course ware from the eit ' s and kics ' educational and training activities which is accessible to all .


### moving away from a merely administrator role , the eit headquarters will optimise their operational functions to steer the kics to maximum performance and make good results widely available . there are efficiency gains to be achieved from providing a number of centralised services and functions , rather than at individual kic level . while all kics work on specific themes , a number of elements are of a cross - cutting nature and it is precisely there where the eit can provide tangible added value . such knowledge provider functions can relate notably to the eit headquarters becoming an information broker and resourceful interlocutor , e . g . in fostering cross - kic exchange and mutual learning , facilitating relations with the eu institutions and other key organisations , such as the organisation for economic co - operation and development , or on specific cross - cutting issues , such as counselling on ip , technology and knowledge transfer , benchmarking against international best practices , or undertaking anticipation and foresight studies to identify future directions for the eit and the kics . the eit and kics should decide together where these tasks can be most effectively dealt with . in this regard , it will be of crucial importance for the eit and the kics to establish viable mechanisms for systematic collaboration around cross - cutting issues . ### moving away from a merely administrator role , the eit headquarters will optimise their operational functions to steer the kics to maximum performance and make good results widely available . there are efficiency gains to be achieved from providing a number of centralised services and functions , rather than at individual kic level . while all kics work on specific themes , a number of elements are of a cross - cutting nature and it is precisely there where the eit can provide tangible added value . such knowledge provider functions can relate notably to the eit headquarters becoming an information broker and resourceful interlocutor , e . g . in fostering cross - kic exchange , transparency , information provision , and developing mutual learning , facilitating relations with the eu institutions and other key organisations such as the organisation for economic co - operation and development . it can thus focus on specific cross - cutting issues , such as counselling on open research , collaborative research , ip and competition law , and technology and knowledge transfer , benchmarking against international best practices , or undertaking anticipation and foresight studies to identify future directions for the eit and the kics . the eit and kics should decide together where these tasks can be most effectively dealt with . in this regard , it will be of crucial importance for the eit and the kics to establish viable mechanisms for systematic collaboration around cross - cutting issues .