### as part of multilateral surveillance in accordance with article 121 of the treaty , the council shall monitor the implementation of convergence programmes , on the basis of information provided by member states with a derogation and of assessments by the commission and the economic and financial committee , in particular with a view to identifying actual or expected significant divergences of the budgetary position from the medium - term budgetary objective , or from the appropriate adjustment path towards it , ensuing from deviations from prudent fiscal - policy making . ### as part of multilateral surveillance in accordance with article 121 tfeu , the council shall monitor the implementation of convergence programmes , on the basis of information provided by member states with a derogation and of assessments by the commission , the economic and financial committee , the employment committee and the social protection committee , in particular with a view to identifying actual or expected significant divergences of the budgetary position from the medium - term budgetary objective , or from the appropriate adjustment path towards it , ensuing from deviations from efficient fiscal - policy making .


### in the event of a significant deviation from prudent fiscal - policy making referred in the fourth subparagraph of article 5 of this regulation , and in order to prevent the occurrence of an excessive deficit , the commission , in accordance with article 121 of the treaty may address a warning to the member state concerned . ### in the event of a significant deviation from efficient fiscal - policy making referred in the fourth subparagraph of article 5 of this regulation , and in order to prevent the occurrence of an excessive deficit or surplus , the commission , in accordance with article 121 of the treaty may address a warning to the member state concerned .


### in the event of a significant deviation from prudent fiscal - policy making referred to in the fourth subparagraph of article 9 of this regulation , and in order to prevent the occurrence of an excessive deficit , the commission , in accordance with article 121 of the treaty may address a warning to the member state concerned . ### in the event of a significant deviation from efficient fiscal - policy making referred to in the fourth subparagraph of article 9 of this regulation , and in order to prevent the occurrence of an excessive deficit or surplus , the commission , in accordance with article 121 tfeu may address a warning to the member state concerned .


### a deviation from prudent fiscal policy making shall be considered significant if the following conditions occur : an excess over the expenditure growth consistent with prudent fiscal policy - making , not offset by discretionary revenue - increasing measures ; or discretionary revenue - decreasing measures not offset by reductions in expenditure ; and the deviation has a total impact on the government balance of at least 0 . 5 % of gdp in one single year or of at least 0 . 25 % of gdp on average per year in two consecutive years . ### a deviation from efficient fiscal policy making shall be considered significant if the following conditions occur : an excess over the expenditure growth consistent with efficient fiscal policy - making , not offset by discretionary revenue - increasing measures ; or discretionary revenue - decreasing measures not offset by reductions in expenditure ; and the deviation has a total impact on the government balance of at least 0 , 5 % of gdp in one single year or of at least 0 , 25 % of gdp on average per year in two consecutive years .


### a deviation from prudent fiscal policy making shall be considered significant if the following conditions occur : an excess over the expenditure growth consistent with prudent fiscal policy - making , not offset by discretionary revenue - increasing measures ; or discretionary revenue - decreasing measures not offset by reductions in expenditure ; and the deviation has a total impact on the government balance of at least 0 . 5% of gdp in one single year or of at least 0 . 25% of gdp on average per year in two consecutive years . ### a deviation from efficient fiscal policy making shall be considered significant if the following conditions occur : an excess over the expenditure growth consistent with efficient fiscal policy - making , not offset by discretionary revenue - increasing measures ; or discretionary revenue - decreasing measures not offset by reductions in expenditure ; and the deviation has a total impact on the government balance of at least 0 , 5% of gdp in one single year or of at least 0 , 25% of gdp on average per year in two consecutive years .


### the deviation shall not be considered if the member state concerned has significantly overachieved the medium - term budgetary objective , taking into account the presence of excessive macroeconomic imbalances , and the budgetary plans laid out in the stability programme do not jeopardise this objective over the programme period . ### the deviation shall not be considered if the member state concerned has achieved the medium - term budgetary objective , taking into account the presence of excessive macroeconomic and social imbalances , and the budgetary plans laid out in the stability programme do not jeopardise this objective over the programme period .


### the deviation shall not be considered if the member state concerned has significantly overachieved the medium - term budgetary objective , taking into account the presence of excessive macroeconomic imbalances , and the budgetary plans laid out in the stability programme do not jeopardise this objective over the programme period . ### the deviation shall not be considered if the member state concerned has achieved the medium - term budgetary objective , taking into account the presence of excessive macroeconomic or social imbalances , and the budgetary plans laid out in the stability programme do not jeopardise this objective over the programme period .


### in the event that the significant deviation from prudent fiscal policy making persists or is particularly serious , the council , on a recommendation from the commission , shall address a recommendation to the member state concerned to take the necessary adjustment measures . the council , on a proposal from the commission , shall make the recommendation public . ' ### in the event that the significant deviation from efficient fiscal policy making persists or is particularly serious , the council , on a recommendation from the commission , shall address a recommendation to the member state concerned to take the necessary adjustment measures . the council , on a proposal from the commission , shall make the recommendation public . '


### the council shall furthermore examine whether the contents of the convergence programme facilitate the closer coordination of economic policies and whether the economic policies of the member state concerned are consistent with the broad guidelines of economic policies of the member states and of the union . in addition , for erm2 member states , the council shall examine whether the content of the convergence programme ensure a smooth participation in the exchange rate mechanism . ### the council shall furthermore examine whether the contents of the convergence programme facilitate the closer coordination of economic policies and whether the economic policies of the member state concerned are consistent with article 9 tfeu , in particular with regard to the promotion of a high level of employment , the guarantee of adequate social protection and the fight against social exclusion , the union’s growth and jobs objectives , the broad guidelines of economic policies of the member states and of the union and the guidelines for the employment policies of the member states . in addition , for erm2 member states , the council shall examine whether the content of the convergence programme ensure a smooth participation in the exchange rate mechanism .


### contracting authorities and contracting entities shall indicate in the contract notice , in the invitation to submit tenders or in the concession documents a description of the concession , the award criteria and the minimum requirements to be met . this information must allow to identify the nature and scope of the concession , enabling economic operators to decide whether they request to participate in the concession award procedure . the description , award criteria and minimum requirements shall not be changed in the course of the negotiations . ### contracting authorities and contracting entities shall indicate in the contract notice , in the invitation to submit tenders or in the concession documents a description of the concession , the award criteria and the minimum requirements to be met . this information must allow to identify the nature and scope of the concession , enabling economic operators to decide whether they request to participate in the concession award procedure . contracting authorities may , during the procedure but before tenders are received , adjust the minimum requirements and the award criteria without publishing a general correction , if the change has no impact on the tenderers . contracting authorities should inform the tenderers concerned and should provide for a reasonable extension of the deadline for application .


### in the concession documents , the contracting authority or contracting entity may ask or may be required by a member state to ask the tenderer to indicate in its tender any share of the contract it may intend to subcontract to third parties and any proposed subcontractors . ### in the concession documents , the contracting authority or contracting entity may ask or may be required by a member state to ask the tenderer to indicate in its tender any share of the contract it may intend to subcontract to third parties and any proposed subcontractors . member states shall ensure there is no discrimination , in terms of working conditions and wages , between persons employed by subcontractors and persons employed by tenderers .


### the appearance of alien species , whether animals , plants , fungi or micro - organisms , in new locations is not always a cause for concern . however , a significant subset of alien species can become invasive and have serious adverse impacts on biodiversity and ecosystem services , as well as other economic and social impacts , which should be prevented . some 12&#160 ; 000 species in the environment in the union and other european countries are alien , of which roughly 10 to 15&#160 ; % are estimated to be invasive . ### the appearance of alien species , whether animals , plants , fungi or micro - organisms , in new locations is not always a cause for concern . however , a significant subset of alien species can become invasive and have serious adverse impacts on biodiversity and ecosystem services , as well as other economic and social impacts , which should be prevented . some 12&#160 ; 000 species in the environment in the union and other european countries are alien , of which over 40 % are native to some european countries but have been introduced by humans in the other european countries and of which roughly 10 to 15&#160 ; % are estimated to be invasive .


### to support the achievement of the objectives of directive 2009 / 147 / ec of the european parliament and of the council of 30 november 2009 on the conservation of wild birds7 , council directive 92 / 43 / eec of 21 may 1992 on the conservation of natural habitats and of wild fauna and flora8 , directive 2008 / 56 / ec of the european parliament and of the council of 17 june 2008 establishing a framework for community action in the field of marine environmental policy 9 and directive 2000 / 60 / ec of the european parliament and of the council of 23 october 2000 establishing a framework for community action in the field of water policy10 , the primary objective of this regulation should be to prevent , minimise and mitigate the adverse effects of invasive alien species on biodiversity and ecosystem services , as well as to reduce their economic and social impact . __________________ 7 oj l 20 , 26 . 1 . 2010 , p . 7 . 8 oj l 206 , 22 . 7 . 1992 , p . 7 . 9 oj l 164 , 25 . 6 . 2008 , p . 19 . 10 oj l 327 , 22 . 12 . 2000 , p . 1 . ### to support the achievement of the objectives of directive 2009 / 147 / ec of the european parliament and of the council of 30 november 2009 on the conservation of wild birds7 , council directive 92 / 43 / eec of 21 may 1992 on the conservation of natural habitats and of wild fauna and flora8 , directive 2008 / 56 / ec of the european parliament and of the council of 17 june 2008 establishing a framework for community action in the field of marine environmental policy 9 and directive 2000 / 60 / ec of the european parliament and of the council of 23 october 2000 establishing a framework for community action in the field of water policy10 , the primary objective of this regulation should be to prevent , minimise and mitigate the adverse effects of invasive alien species on biodiversity , ecosystem services , public health and safety , as well as to reduce their economic and social impact . __________________ 7 oj l 20 , 26 . 1 . 2010 , p . 7 . 8 oj l 206 , 22 . 7 . 1992 , p . 7 . 9 oj l 164 , 25 . 6 . 2008 , p . 19 . 10 oj l 327 , 22 . 12 . 2000 , p . 1 .


### at union level , the proposal for a new regulation of the european parliament and the council on animal health11 include provisions on animal diseases , and the new regulation of the european parliament and the council on protective measures against pests of plants12 provides rules for pests of plants , and directive 2001 / 18 / ec of the european parliament and of the council of 12 march 2001 on the deliberate release into the environment of genetically modified organisms and repealing council directive 90 / 220 / eec13 sets out the regime applicable to genetically modified organisms . therefore , the new rules on invasive alien species should align and not overlap with those union acts and shall not apply to the organisms targeted by those acts . __________________ 11 com 260 final . 12 com 267 final . 13 oj l 106 , 17 . 4 . 2001 , p . 1 . ### at union level , the proposal for a new regulation of the european parliament and the council on animal health11 include provisions on disease agents that cause animal diseases , at union level , the proposal for a new regulation of the european parliament and the council on animal health11 include provisions on animal diseases , and the new regulation of the european parliament and the council on protective measures against pests of plants12 provides rules for pests of plants , and directive 2001 / 18 / ec of the european parliament and of the council of 12 march 2001 on the deliberate release into the environment of genetically modified organisms and repealing council directive 90 / 220 / eec13 sets out the regime applicable to genetically modified organisms . therefore , the new rules on invasive alien species should align and not overlap with those union acts and shall not apply to the organisms targeted by those acts . __________________ 11 com 260 final . 12 com 267 final . 13 oj l 106 , 17 . 4 . 2001 , p . 1 .


### in order to ensure compliance with the rules of the world trade organisation and ensure the coherent application of these new rules common criteria should be established to perform the risk assessment . those criteria should use when appropriate existing national and international standards and should encompass different aspects of the characteristics of the species , the risk and modes of entry into the union , the negative economic , social and biodiversity impacts of the species , the potential benefits of uses and the costs of mitigation to weight them against the negative impacts , as well as a quantified forecast of the environmental , economic and social damage costs at union level demonstrating the significance for the union , so as to further justify action . in order to develop the system progressively and build upon the experience gained , the overall approach should be evaluated after five years . ### in order to ensure compliance with the rules of the world trade organisation and ensure the coherent application of these new rules , common criteria should be established to perform the risk assessment . those criteria should use , when appropriate , existing national and international standards and should encompass different aspects of the characteristics of the species , the risk and modes of introduction into the union , the negative economic , social and biodiversity impacts of the species , the potential benefits of uses and the costs of mitigation to weight them against the negative impacts , as well as an approximate quantified forecast of the environmental , economic and social damage costs at union level demonstrating the significance for the union , so as to further justify action . in order to develop the system progressively and build upon the experience gained , the overall approach should be evaluated after five years .


### there may be cases where alien species not yet recognised as invasive alien species of union concern appear at the union borders or are detected in the union territory . member states should therefore be granted the possibility to adopt on the basis of available scientific evidence certain emergency measures . such emergency measures would allow immediate reaction against species which may pose risks related to their introduction , establishment and spread in those countries , while member states assess the effective risks posed by them , in line with the applicable provisions of the agreements of the world trade organisation , in particular with a view to having those species recognised as invasive alien species of union concern . there is a need to couple national emergency measures with the possibility of adopting emergency measures at union level in order to comply with the provisions of the agreements of the world trade organisation . furthermore , union level emergency measures would equip the union with a mechanism to act swiftly in case of presence or imminent danger of entry of a new invasive alien species in accordance with the precautionary principle . ### there may be cases where alien species not yet recognised as invasive alien species of union concern appear at the union borders or are detected in the union territory . member states should therefore be granted the possibility to adopt on the basis of available scientific evidence certain emergency measures . such emergency measures would allow immediate reaction against species which may pose risks related to their introduction , establishment and spread in those countries , while member states assess the effective risks posed by them , in line with the applicable provisions of the agreements of the world trade organisation , in particular with a view to having those species recognised as invasive alien species of union concern . there is a need to couple national emergency measures with the possibility of adopting emergency measures at union level in order to comply with the provisions of the agreements of the world trade organisation . furthermore , union level emergency measures would equip the union with a mechanism to act swiftly in case of presence or imminent danger of entry of a new invasive alien species in accordance with the precautionary principle . in case emergency measures require eradication , control or containment , the welfare of targeted and non - targeted animals should be taken into account . the competent authorities should take the necessary measures to avoid pain , distress and suffering of animals during the process , based insofar as possible on best practices in the field .


### in order to develop an adequate knowledge base to address the problems raised by invasive alien species , it is important that member states undertake research , monitoring and surveillance of such species . as surveillance systems offer the most appropriate means for early detection of new invasive alien species and for the determination of the distribution of already established species , they should include both targeted and general surveys and benefit from the involvement of different sectors and stakeholders , including local communities . surveillance systems should imply paying continuous attention to any new invasive alien species anywhere in the union . in the interest of efficiency and cost - effectiveness , existing systems of border control , surveillance and monitoring already established in union legislation should be applied , in particular those set out directives 2009 / 147 / ec , 92 / 43 / eec , 2008 / 56 / ec and 2000 / 60 / ec . ### in order to develop an adequate knowledge base to address the problems raised by invasive alien species , it is important that member states undertake research , monitoring and surveillance of such species . as surveillance systems offer the most appropriate means for early detection of new invasive alien species and for the determination of the distribution of already established species , they should include both targeted and general surveys and benefit from the involvement of different sectors and stakeholders , including local communities . surveillance systems should imply paying continuous attention to any new invasive alien species anywhere in the union and should aim , in particular , to provide a highly effective and coherent picture at union level . in the interest of efficiency and cost - effectiveness , existing systems of border control , surveillance and monitoring already established in union legislation should be applied , in particular those set out directives 2009 / 147 / ec , 92 / 43 / eec , 2008 / 56 / ec and 2000 / 60 / ec .


### invasive alien species generally cause damage to ecosystems and reduce their resilience . therefore restoration measures are required to strengthen the ecosystems ' resilience towards invasions , to repair the damage caused and to enhance the conservation status of species and their habitats in accordance with article 4 of directive 2009 / 147 / ec and article 6 of directive 92 / 43 / eec , the ecological status of inland surface waters , transitional waters , coastal waters and groundwater in accordance with article 11 of directive 2000 / 60 / ec , and the environmental status of marine waters in accordance with article 13 of directive 2008 / 56 / ec . ### invasive alien species generally cause damage to ecosystems and reduce their resilience . therefore proportionate restoration measures should be undertaken to strengthen the ecosystems ' resilience towards invasions , to repair the damage caused and to enhance the conservation status of species and their habitats in accordance with article 4 of directive 2009 / 147 / ec and article 6 of directive 92 / 43 / eec , the ecological status of inland surface waters , transitional waters , coastal waters and groundwater in accordance with article 11 of directive 2000 / 60 / ec , and the environmental status of marine waters in accordance with article 13 of directive 2008 / 56 / ec .


### in order to ensure uniform conditions for the application of this regulation , for adopting and updating the list of invasive alien species of union concern , for granting derogations from the obligation of rapid eradication and for the adoption of union emergency measures , implementing powers should be conferred on the commission . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission’s exercise of implementing powers22 . ______________ 22 oj l 55 , 28 . 2 . 2011 , p . 13 . ### in order to ensure uniform conditions for the application of this regulation , for granting specific national derogations and derogations from the obligation of rapid eradication and for the adoption of union emergency measures , implementing powers should be conferred on the commission . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission’s exercise of implementing powers22 . _____________ 22 oj l 55 , 28 . 2 . 2011 , p . 13 .


### in order to take into account the latest scientific developments in the environmental field , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of determining how to conclude that invasive alien species are capable of establishing viable populations and of spreading , as well as for setting out the common elements for the development of risk assessments . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### in order to take into account the latest scientific developments in the environmental field , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of establishing and updating the list of invasive alien species of union concern , determining how to conclude that invasive alien species are capable of establishing viable populations and of spreading , as well as for setting out the common elements for the development of risk assessments . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### in order to enable commercial operators , who may have legitimate expectations , for instance those who have received an authorisation in accordance with regulation no . 708 / 2007 , to exhaust their stock of invasive alien species of union concern when these new rules enter into force , it is justified to allow them two years to slaughter , sell or hand over the specimens to research or ex - situ conservation establishments . ### in order to enable commercial operators , who may have legitimate expectations , for instance those who have received an authorisation in accordance with regulation no . 708 / 2007 , to exhaust their stock of invasive alien species of union concern when these new rules enter into force , it is justified to allow them two years to humanely cull , sell or , where relevant , hand over the specimens to research or ex - situ conservation establishments .


### animal disease regulated as defined in article 4 of regulation no xxx / xxxx [ animal health law - com 260 final ] ; ### disease agents that cause animal diseases regulated as defined in article 4 of regulation no xxx / xxxx [ animal health law - com 260 final ] ;


### ' alien species ' means any live specimens of species , subspecies or lower taxon of animals , plants , fungi or micro - organisms introduced outside its natural past or present distribution ; it includes any part , gametes , seeds , eggs , or propagules of such species , as well as any hybrids , varieties or breeds that might survive and subsequently reproduce ; ### ' alien species ' means any live specimens of species , subspecies or lower taxon of animals , plants , fungi or micro - organisms introduced , deliberately or unintentionally , outside its natural past or present distribution and spread ; it includes any part , gametes , seeds , eggs , or propagules of such species , as well as any feral domestic species , hybrids , varieties or breeds that might survive and subsequently reproduce ;


### ' alien species ' means any live specimens of species , subspecies or lower taxon of animals , plants , fungi or micro - organisms introduced outside its natural past or present distribution ; it includes any part , gametes , seeds , eggs , or propagules of such species , as well as any hybrids , varieties or breeds that might survive and subsequently reproduce ; ### ' alien species ' means any live specimens of species , subspecies or lower taxon of animals , plants , fungi or micro - organisms introduced outside its natural past or present distribution ; it includes any part or developmental stages , gametes , seeds , eggs , or propagules of such species , as well as any feral domestic species , hybrids , varieties , or breeds that might survive and subsequently reproduce ;


### ' eradication ' means the complete and permanent removal of a population of invasive alien species by physical , chemical or biological means ; ### ' eradication ' means the complete and permanent removal of a population of invasive alien species by physical , chemical or biological means ; the eradication of animal species shall be achieved exclusively through the use of non - lethal methods ;


### ‘ eradication’ means the complete and permanent removal of a population of invasive alien species by physical , chemical or biological means ; ### ‘ eradication’ means the complete and permanent removal of a population of invasive alien species by lethal or non - lethal physical , chemical or biological means ;


### ‘ management’ means any physical , chemical or biological action aimed at the eradication , population control or containment of a population of an invasive alien species ; ### ‘ management’ means any lethal or non - lethal physical , chemical or biological action aimed at the eradication , population control or containment of a population of an invasive alien species , while also avoiding impact on non - targeted species and their habitats ;


### ' population control ' means physical , chemical or biological actions applied to a population of invasive alien species with the aim of keeping the number of individuals as low as possible , so that , while not being able to eradicate the species , its invasive capacity and adverse impacts on biodiversity and ecosystem services , or on human health and the economy , are minimised . ### ‘ population control’ means physical , chemical or biological actions applied to a population of invasive alien species with the aim of keeping the number of individuals as low as possible , so that , while not being able to eradicate the species , its invasive capacity and adverse impacts on biodiversity and ecosystem services , or on human health and the economy , are minimised ; in the case of animal species , these actions should provide exclusively for the use of non - lethal methods ;


### ‘ population control’ means physical , chemical or biological actions applied to a population of invasive alien species with the aim of keeping the number of individuals as low as possible , so that , while not being able to eradicate the species , its invasive capacity and adverse impacts on biodiversity and ecosystem services , or on human health and the economy , are minimised . ### ‘ population control’ means lethal or non - lethal physical , chemical or biological actions applied to a population of invasive alien species , while also avoiding impact on non - targeted species and their habitats , with the aim of keeping the number of individuals as low as possible , so that , while not being able to eradicate the species , its invasive capacity and adverse impacts on biodiversity and ecosystem services , or on human health and the economy , are minimised .


### a list of invasive alien species of union concern shall be adopted , and updated , by the commission by means of implementing acts on the basis of the criteria in paragraph 2 . the implementing acts shall be adopted in accordance with the examination procedure referred to in article 22 . ### the commission shall be empowered to adopt delegated acts in accordance with article 23 to establish a list of invasive alien species of union concern on the basis of the criteria laid down in paragraph 2 . the list shall take the form of an annex to this regulation .


### member states may submit to the commission requests for the inclusion of invasive alien species on the list referred to in paragraph 1 . those requests shall include all of the following criteria : ### in addition , member states may at any time submit to the commission requests for the inclusion of invasive alien species on the list referred to in paragraph 1 . those requests shall include all of the following criteria :


### member states may submit to the commission requests for the inclusion of invasive alien species on the list referred to in paragraph 1 . those requests shall include all of the following criteria : ### member states may submit to the commission requests for the inclusion of invasive alien species on the list referred to in paragraph 1 . those requests shall include all of the following data :


### a description of the potential pathways of entry and spread , both intentional and unintentional , including where relevant the commodities with which the species are generally associated ; ### a description of the potential pathways of introduction and spread , both intentional and unintentional , including where relevant the commodities with which the species are generally associated ;


### a thorough assessment of the risk of entry , establishment , spread in relevant biogeographical regions in current conditions and in foreseeable climate change conditions ; ### a thorough assessment of the risk of introduction , establishment , spread in relevant biogeographical regions in current conditions and in foreseeable climate change conditions ;


### a description of the current distribution of the species including whether the species is already present in the union or in neighbouring countries ; ### a description of the current distribution of the species including whether the species is already present in the union as a native or alien species or in neighbouring countries and a projection of its likely future distribution ;


### a description of the negative impact on biodiversity and ecosystem services , including on native species , protected sites , endangered habitats , on human health and the economy including an assessment of the magnitude of future impact ; ### a description , or estimation based on the best available scientific knowledge , of the negative impact on biodiversity and ecosystem services , including on native species , protected sites , endangered habitats , on human health and the economy including an assessment of the magnitude of future impact ;


### a description of the possible uses and benefits deriving from those uses of the species . ### a description of the known and possible uses and benefits deriving from those uses of the species ;


### species included on the list referred to in article 4 which are native in an outermost region shall not be subject to the provisions of articles 7 , 8 , 11 and 13 to 17 in the outermost region where they are native . ### invasive alien species of union concern which are native in an outermost region shall not be subject to the provisions of articles 7 , 8 , 11 and 13 to 17 in the outermost region where they are native .


### species included on the list referred to in article 4 shall not be intentionally : brought into or transited through the union territory ; permitted to reproduce ; transported , except for the transportation of species to facilities for eradication ; placed on the market ; used or exchanged ; kept or grown , including in contained holding ; released into the environment . ### for species included on the list referred to in article 4 , it shall be prohibited : to bring or convey them through the union territory ; to permit them to reproduce ; to transport them , except for the transportation of species to facilities for eradication ; to place them on the market ; to use or exchange them ; to keep or grow them , including in contained holding ; to release them into the environment .


### ban on invasive alien species of union concern ### restrictions on invasive alien species of union concern


### member states shall prevent the unintentional introduction of invasive alien species of union concern in accordance with the provisions of article 11 and . ### member states shall prevent any other unintentional introduction of invasive alien species of union concern in accordance with the provisions of article 11 and .


### the activity is to be carried out by personnel possessing the scientific and technical qualifications prescribed by the competent authorities ; ### the activity is to be carried out by personnel possessing the scientific or technical qualifications prescribed by the competent authorities ;


### when applying for a permit , the establishment shall provide all necessary evidence to allow the competent authority to assess whether the conditions referred to in paragraphs 2 and 3 are fulfilled . ### when applying for a permit , the applicant shall provide all necessary evidence to allow the competent authority to assess whether the conditions referred to in paragraphs 2 and 3 are fulfilled .


### member states shall , by [ 18 months from the entry into force of this regulation &#8211 ; date to be inserted ] at the latest carry out a comprehensive analysis of the pathways of unintentional introduction and spread of invasive alien species in their territory and identify the pathways which require priority action , because of the volume of species or of the damage caused by the species entering the union through them . in doing so , member states shall in particular focus on an analysis of the pathways of introduction of invasive alien species of union concern . ### member states shall , within two years from the adoption of the list referred to in article 4 carry out a comprehensive analysis of the pathways of unintentional introduction and spread of invasive alien species of union concern in their territory and identify the pathways which require priority action , because of the volume of species or of the damage caused by the species entering the union through them .


### by [ 18 months from the date of entry into force of this regulation &#8211 ; date to be inserted ] at the latest , member states shall have an official surveillance system in place which collects and records data on the occurrence in the environment of invasive alien species by survey , monitoring or other procedures to prevent the spread of invasive alien species into the union . ### within 18 months from the adoption of the list referred to in article 4 , member states shall have an official surveillance system in place which collects and records data on the occurrence in the environment of invasive alien species by survey , monitoring or other procedures to prevent the spread of invasive alien species into the union .


### by [ 12 months from the date of entry into force of this regulation &#8211 ; date to be inserted ] at the latest , member states shall have in place fully functioning structures to perform the official controls on animals and plants including their seeds , eggs , or propagules , brought into the union , necessary to prevent the intentional introduction into the union of invasive alien species of union concern . ### within 12 months from the adoption of the list referred to in article 4 at the latest , member states shall have in place fully functioning structures to perform the official controls on animals and plants including their seeds , eggs , developmental stages or propagules , brought into the union , necessary to prevent the intentional introduction into the union of invasive alien species of union concern .


### when applying eradication measures , member states shall ensure that the methods used are effective in achieving the complete and permanent removal of the population of the invasive alien species concerned , with due regard to human health and the environment , and ensuring that targeted animals are spared any avoidable pain , distress or suffering . ### when applying eradication measures , member states shall ensure that the methods used are effective in achieving the complete and permanent removal of the population of the invasive alien species concerned , with due regard to human health and the environment , and ensuring that targeted and non - targeted animals are spared any avoidable pain , distress or suffering .


### applications for derogations shall be based on sound scientific evidence and only be submitted if the following conditions are met : ### applications for derogations shall be based on sound scientific evidence and only be submitted if at least one of the following conditions are met :


### the management measures shall consist of physical , chemical or biological actions aimed at the eradication , population control or containment of a population of an invasive alien species . where appropriate , management measures shall include actions applied to the receiving ecosystem aimed at increasing its resilience to current and future invasions . ### the management measures shall consist of lethal and non - lethal physical , chemical or biological actions aimed at the eradication , population control or containment of a population of an invasive alien species . where necessary , management measures shall include actions applied to the receiving ecosystem aimed at increasing its resilience to current and future invasions .


### the management measures shall consist of physical , chemical or biological actions aimed at the eradication , population control or containment of a population of an invasive alien species where appropriate , management measures shall include actions applied to the receiving ecosystem aimed at increasing its resilience to current and future invasions . ### the management measures shall consist of physical , chemical or biological actions aimed at the eradication , population control or containment of a population of an invasive alien species . in the case of animal species , the measures to be adopted shall provide for the sole use of non - lethal methods . where appropriate , management measures shall include actions applied to the receiving ecosystem aimed at increasing its resilience to current and future invasions .


### information support mechanism ### information support system


### the commission shall gradually establish an information support mechanism necessary to facilitate the application of this regulation . ### the commission shall , within 12 months from the adoption of the list referred to in article 4 , establish an information support system necessary to facilitate the application of this regulation .


### in an initial phase the system shall include a data support mechanism interconnecting existing data systems on invasive alien species , paying particular attention to information on the invasive alien species of union concern so as to facilitate the reporting pursuant to article 19 . ### the system shall include a data support mechanism interconnecting existing data systems on invasive alien species , paying particular attention to information on the invasive alien species of union concern so as to facilitate the reporting pursuant to article 19 .


### in a second phase , the data support mechanism referred to in paragraph 2 shall become a tool to assist the commission in handling the relevant notifications required in article 14 . ### the data support mechanism referred to in paragraph 2 shall become a tool to assist the commission in handling the relevant notifications required in article 14 .


### in a third phase , the data support mechanism referred to in paragraph 2 shall become a mechanism for exchanging information on other aspects of the application of this regulation . ### the information support system referred to in paragraph 1 shall include a mechanism for exchanging information on other aspects of the application of this regulation , especially with regards to the early detection and rapid eradication of invasive alien species .


### article 23 exercise of the delegation the power to adopt delegated acts is conferred on the commission subject to the conditions laid down in this article . 2 . the delegation of power referred to in article 5 shall be conferred on the commission for an undetermined period of time from the entry into force of this regulation . 3 . the delegation of power referred to in article 5 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated act already in force . 4 . as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament and to the council . 5 . a delegated act adopted pursuant to article 5 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council . ### article 23 exercise of the delegation the power to adopt delegated acts is conferred on the commission subject to the conditions laid down in this article . 2 . the delegation of power referred to in article 4 , article 4 and article 5 shall be conferred on the commission for an undetermined period of time from the entry into force of this regulation . 3 . the delegation of power referred to in article 4 , article 4 and article 5 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated act already in force . 4 . as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament and to the council . 5 . a delegated act adopted pursuant to article 4 , article 4 and article 5 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council .


### by way of derogation from to article 7 and , owners of companion animals not kept for commercial purposes that belong to the species included on the list referred to in article 4 shall be allowed to keep them until the end of the animals ' natural life , provided the following conditions are met : ### by way of derogation from to article 7 and , owners of companion animals not kept for commercial purposes that belong to the species included on the list of invasive alien species of union concern shall be allowed to keep them until the end of the animals ' natural life , provided the following conditions are met :


### in addition , voluntary action by the marketing authorisation holder should not lead to a situation where concerns related to the risks or benefits of a medicinal product authorised in the union are not properly addressed in all member states . therefore , provisions should be made for the marketing authorisation holder to inform competent authorities of the reasons for the withdrawal of a medicinal product , for interrupting the placing on the market of a medicinal product , for requests for revoking a marketing authorisation , or for not renewing a marketing authorisation . ### in addition , voluntary action by the marketing authorisation holder should not lead to a situation where concerns related to the risks or benefits of a medicinal product authorised in the union are not properly addressed in all member states . therefore , provisions should be made for the marketing authorisation holder to inform competent authorities and the agency of the reasons for the withdrawal of a medicinal product , for interrupting the placing on the market of a medicinal product , for requests for revoking a marketing authorisation , or for not renewing a marketing authorisation .


### the marketing authorization holder shall be obliged to notify member states forthwith of any action taken by him to suspend the marketing of a medicinal product , to withdraw a medicinal product from the market , to request the withdrawal of a marketing authorisation or not to apply for the renewal of a marketing authorisation , together with the reasons for such action . the marketing authorisation holder shall in particular declare if such action is linked to any of the grounds set out in articles 116 and 117 . in such case , member states shall ensure that this information is brought to the attention of the agency . ### the marketing authorization holder shall be obliged to notify member states and the agency forthwith of any action taken by him to suspend the marketing of a medicinal product , to withdraw a medicinal product from the market , to request the withdrawal of a marketing authorisation or not to apply for the renewal of a marketing authorisation , together with the reasons for such action . the marketing authorisation holder shall in particular declare if such action is linked to any of the grounds set out in articles 116 and 117 .


### in line with the obligations under the un convention on the rights of persons with disabilities that has entered into force in the eu , persons with disabilities should be able to use trust services and end user products used in the provision of those services on equal bases with other consumers . ### in line with the obligations under the un convention on the rights of persons with disabilities that has entered into force in the eu and in line the commission proposal on the accessibility of public sector bodies ' websites1 , persons with disabilities should be able to use trust services and end user products used in the provision of those services on equal bases with other consumers . __________________ 1proposal for a directive of the european parliament and of the council on the accessibility of public sector bodies ' websites 2012 / 0340 . com 721 final .


### trust service providers shall guarantee the confidentiality and integrity of data related to a person to whom the trust service is provided . ### trust service providers shall guarantee the confidentiality and integrity of data related to a person to whom the trust service is provided . pseudonyms shall nevertheless remain personal data and shall be treated as such .


### trust services provided and end user products used in the provision of those services shall be made accessible for persons with disabilities whenever possible . ### trust services provided and end user products used in the provision of those services shall be made accessible for persons with disabilities .


### the commission shall , where appropriate , adapt the timetable for each period so as to ensure an orderly functioning of the market . ### the commission may , in exceptional circumstances , adapt the timetable for the period referred to in article 13 beginning on 1 january 2013 so as to ensure an orderly functioning of the market . the commission shall make no more than one such adaptation .


### article 174 of the treaty provides that the union should develop and pursue its actions leading to the strengthening of its economic , social and territorial cohesion . the cohesion fund should therefore provide a financial contribution to projects in the field of the environment and to trans - european networks in the area of transport infrastructure . ### article 174 of the treaty provides that the union should develop and pursue its actions leading to the strengthening of its economic , social and territorial cohesion . the cohesion fund should therefore provide a financial contribution to projects in the field of the environment and to trans - european networks in the area of transport infrastructure and in areas related to sustainable development which clearly offer environmental benefits , such as energy efficiency and renewable energy .


### article 174 of the treaty provides that the union should develop and pursue its actions leading to the strengthening of its economic , social and territorial cohesion . the cohesion fund should therefore provide a financial contribution to projects in the field of the environment and to trans - european networks in the area of transport infrastructure . ### article 174 of the treaty on the functioning of the european union provides that the union is to develop and pursue its actions leading to the strengthening of its economic , social and territorial cohesion . the cohesion fund which is established by this regulation should therefore provide a financial contribution to projects in the field of the environment and to trans - european networks in the area of transport infrastructure .


### regulation no [ … ] / 2012 of [ … ] laying down common provisions on the european regional development fund , the european social fund , the cohesion fund , the european agricultural fund for rural development and the european maritime and fisheries fund covered by the common strategic framework and laying down general provisions on the european regional development fund , the european social fund and the cohesion fund and repealing regulation no 1083 / 2006 [ common provisions regulation - cpr ] establishes a new framework for the action of the structural funds and the cohesion fund . it is necessary to specify the objectives of the cohesion fund in relation to the new framework for its action and in relation to the purpose assigned to it in the treaty . ### regulation no [ … ] / 2012 of [ … ] laying down common provisions on the european regional development fund , the european social fund , the cohesion fund , the european agricultural fund for rural development and the european maritime and fisheries fund covered by the common strategic framework and laying down general provisions on the european regional development fund , the european social fund and the cohesion fund and repealing regulation no 1083 / 2006 [ common provisions regulation - cpr ] establishes a new framework for the action of the structural funds and the cohesion fund . it is necessary to specify the objectives of the cohesion fund in relation to the new framework for its action and in relation to the purpose assigned to it in the treaty . synergies should also be fostered between the cohesion fund and other eu instruments and programmes , relevant to transport , energy , climate , and environmental policy


### regulation no [ … ] / 2012 of [ … ] laying down common provisions on the european regional development fund , the european social fund , the cohesion fund , the european agricultural fund for rural development and the european maritime and fisheries fund covered by the common strategic framework and laying down general provisions on the european regional development fund , the european social fund and the cohesion fund and repealing regulation no 1083 / 2006 [ common provisions regulation - cpr ] establishes a new framework for the action of the structural funds and the cohesion fund . it is necessary to specify the objectives of the cohesion fund in relation to the new framework for its action and in relation to the purpose assigned to it in the treaty . ### the provisions common to the european regional development fund , the european social fund and the cohesion fund are set out in regulation no [ … ] / 2013 of [ … ] laying down common provisions on the european regional development fund , the european social fund , the cohesion fund , the european agricultural fund for rural development and the european maritime and fisheries fund covered by the common strategic framework and laying down general provisions on the european regional development fund , the european social fund and the cohesion fund and repealing regulation no 1083 / 2006 [ common provisions regulation - cpr ] . the cpr establishes a new framework for the action of the european structural and investment funds including the cohesion fund . it is necessary therefore to specify the objectives of the cohesion fund in relation to the new framework for its action and in relation to the purpose assigned to it in the treaty on the functioning of the european union .


### the union may , through the cohesion fund , contribute to actions in pursuit of the union ' s environmental objectives specified in articles 11 and 191 of the treaty . ### the union should , through the cohesion fund , also contribute to actions in pursuit of the union ' s environmental objectives specified in articles 11 and 191 of the treaty .


### the union may , through the cohesion fund , contribute to actions in pursuit of the union ' s environmental objectives specified in articles 11 and 191 of the treaty . ### the union may , through the cohesion fund , contribute to actions in pursuit of the union’s environmental objectives specified in articles 11 and 191 of the tfeu , namely energy efficiency and renewable energy and , in the transport sector outside the trans - european networks , rail , river and sea transport , intermodal transport systems and their interoperability , management of road , sea and air traffic , clean urban transport and public transport .


### specific provisions concerning the type of activities which may be supported by the cohesion fund under the thematic objectives defined in regulation no [ … ] / 2012 [ cpr ] should be laid down . at the same time , expenditure outside the scope of the cohesion fund should be defined and clarified , including as regards the reduction of greenhouse gas emissions in installations falling under directive 2003 / 87 / ec of the european parliament and of the council of 13 october 2003 establishing a scheme for greenhouse gas emission allowance trading within the community and amending council directive 96 / 61 / ec . ### specific provisions concerning the type of activities which may be supported by the cohesion fund under the thematic objectives defined in regulation no [ … ] / 2013 [ cpr ] should be laid down .


### a common set of indicators to assess progress of programme implementation should be set out before the member states draft their operational programmes . these indicators should be complemented by programme - specific indicators . ### in order to assess progress of programme implementation , implementing powers should be conferred on the commission in respect of a common set of indicators . those 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 powers1 . common indicators should be complemented by programme - specific indicators . _________________ 1 oj l 55 , 28 . 2 . 2011 , p . 13 .


### this regulation replaces council regulation no 1084 / 2006 of 11 july 2006 establishing the cohesion fund and repealing regulation no 1164 / 94 . in the interest of clarity , regulation no 1084 / 2006 should therefore be repealed . ### this regulation replaces council regulation no 1084 / 2006 of 11 july 2006 establishing the cohesion fund . that regulation should therefore be repealed . nevertheless , this regulation should not affect either the continuation or modification of assistance approved by the commission on the basis of regulation no 1084 / 2006 or any other legislation applying to that assistance on 31 december 2013 , which should consequently apply thereafter to that assistance or the projects concerned until their closure . applications to receive assistance made or approved under regulation no 1084 / 2006 should therefore remain valid .


### this regulation establishes the tasks of the cohesion fund and the scope of its support with regard to the investment for growth and jobs goal referred to in article 81 of regulation no [ ] / 2012 [ cpr ] . ### a cohesion fund is hereby established for the purpose of strengthening the economic , social and territorial cohesion of the union in the interests of promoting sustainable development . this regulation establishes the tasks of the cohesion fund and the scope of its support with regard to the investment for growth and jobs goal referred to in article 81 of regulation no [ ] / 2013 [ cpr ] .


### in accordance with article 16 of regulation no [ … ] / 2012 [ cpr ] , the cohesion fund shall support the following investment priorities within the thematic objectives set out in article 9 of regulation no [ … ] / 2012 [ cpr ] : ### in accordance with article 16 of regulation no [ . . . ] / 2013 [ cpr ] , the cohesion fund shall support the following investment priorities within the thematic objectives set out in article 9 of regulation no [ . . . ] / 2013 [ cpr ] taking into account the needs and potentials described in the partnership agreement referred to in article 14 of that regulation :


### supporting energy efficiency and renewable energy use in public infrastructures ; ### supporting energy efficiency , smart energy management and renewable energy use in public infrastructures , including in public buildings , and in the housing sector ;


### developing smart distribution systems at low voltage levels ; ### developing and implementing smart distribution systems at low and medium voltage levels ;


### promoting low - carbon strategies for urban areas ; ### promoting low - carbon strategies for all types of territories , in particular urban areas , including the promotion of sustainable urban mobility , clean public transport and mitigation relevant adaptation measures ;


### promoting low - carbon strategies for urban areas ; ### promoting low - carbon strategies for all types of territories , in particular for urban areas , including the promotion of sustainable multi - modal urban mobility and mitigation relevant adaptation measures ;


### promoting climate change adaptation , risk prevention and management by : ### promoting climate change adaptation , risk prevention and management through :


### supporting dedicated investment for adaptation to climate change ; ### supporting investment for adaptation to climate change including eco - system based approaches ;


### addressing the significant needs for investment in the waste sector to meet the requirements of the union ' s environmental acquis ; ### investing in the waste sector to meet the requirements of the union ' s environmental acquis and to address needs identified by the member states for investment going beyond those requirements ;


### addressing the significant needs for investment in the water sector to meet the requirements of the union ' s environmental acquis ; ### investing in the water sector to meet the requirements of the union’s environmental acquis and to address needs identified by the member states for investment going beyond those requirements ;


### protecting and restoring biodiversity , including through green infrastructures ; ### protecting and restoring biodiversity , soil protection and restoration and promoting ecosystem services including through natura 2000 and green infrastructures ;


### improving the urban environment , including regeneration of brownfield sites and reduction of air pollution ; ### action to improve the urban environment , revitalisation of cities , regeneration and decontamination of brownfield sites , reduction of air pollution and promotion of noise - reduction measures ;


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


### 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 cohesion fund . ### enhancing institutional capacity of public authorities and stakeholders and an efficient public administration by strengthening of institutional capacity and the efficiency of public administrations and public services related to implementation of the cohesion fund .


### common indicators , as set out in the annex to this regulation , shall be used where relevant and in accordance with article 24 of regulation no [ &#8230 ; ] / 2012 [ cpr ] . for common indicators , baselines shall be set at zero and cumulative targets shall be set for 2022 . ### the commission shall adopt a list of common indicators as referred to in article 24 of regulation no [ . . . ] / 2012 [ cpr ] by means of implementing acts . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 5 a . for common indicators , baselines shall be set at zero and cumulative targets shall be set for 2022 .


### common indicators , as set out in the annex to this regulation , shall be used where relevant and in accordance with article 24 of regulation no [ &#8230 ; ] / 2012 [ cpr ] . for common indicators , baselines shall be set at zero and cumulative targets shall be set for 2022 . 2 . for programme - specific output indicators , baselines shall be set at zero and cumulative targets shall be fixed for 2022 . 3 . 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 . ### common output indicators , as set out in the annex to this regulation , programme - specific result indicators and , where relevant , programme - specific output indicators shall be used in accordance with article 24 and article 87 and of regulation no [ &#8230 ; ] / 2013 [ cpr ] . 2 . for common and programme - specific output indicators , baselines shall be set at zero . cumulative quantified target values for these indicators shall be fixed for 2022 . 3 . for programme - specific result indicators , which relate to investment priorities , baselines shall use the latest available data and targets shall be fixed for 2022 . targets may be expressed in quantitative or qualitative terms . 3a . the commission shall be empowered to adopt a delegated act in accordance with article 5a to amend the list of common output indicators in the annex to this regulation , in order to make adjustments , where justified to ensure effective assessment of progress in programme implementation .


### applications to receive assistance made under regulation no 1084 / 2006 shall remain valid . ### applications to receive assistance made or approved under regulation no 1084 / 2006 shall remain valid .


### regulation no 1084 / 2006 is hereby repealed . references to the repealed regulation shall be construed as references to this regulation . ### without prejudice to the provisions laid down in article 5 , regulation no 1084 / 2006 is hereby repealed with effect from 1 january 2014 . references to the repealed regulation shall be construed as references to this regulation and shall be read in accordance with the correlation table set out in annex x .


### the european parliament and the council shall review this regulation by 31 december 2022 , in accordance with article 177 of the treaty . ### the european parliament and the council shall review this regulation by 31 december 2020 in accordance with article 177 of the treaty on the functioning of the european union .


### the internal market comprises an area without internal frontiers in which the free movement of goods , persons , services and capital must be ensured . to that end a comprehensive union type approval system for motor vehicles is in place . the technical requirements for the type approval of motor vehicles and their exhaust systems with regard to permissible sound levels should be harmonised to avoid the adoption of requirements that differ from one member state to another and to ensure the proper functioning of the internal market while , at the same time , providing for a high level of environmental protection and public safety . ### the internal market comprises an area without internal frontiers in which the free movement of goods , persons , services and capital must be ensured . to that end a comprehensive union type - approval system for motor vehicles is in place , as road vehicles are the biggest source of noise within the transport sector . the technical requirements for the type - approval of motor vehicles and their exhaust systems with regard to permissible sound levels should be harmonised to avoid the adoption of requirements that differ from one member state to another and to ensure the proper functioning of the internal market while , at the same time , providing for a high level of environmental protection and public safety and a better quality of life and health .


### in order to enable the commission to replace the technical requirements of this regulation with a direct reference to unece regulations no 51 and no 59 once the limit values relating to the new test method are laid down in those regulations , or to adapt those requirements to technical and scientific developments , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the amendment of the provisions in annexes to this regulation related to the test methods and sound levels . it is of particular importance that the commission carry out appropriate consultations during its preparatory work . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### in order to enable the commission to replace the technical requirements of this regulation with a direct reference to unece regulations no 51 and no 59 once the limit values relating to the new test method are laid down in those regulations , or to adapt those requirements to technical and scientific developments , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the amendment of the provisions in annexes to this regulation related to the test methods and sound levels . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including consultation of experts . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### for the purposes of this regulation , the following definitions shall apply : ' vehicle type ' means a set of vehicles as defined in annex ii part b to directive 2007 / 46 / ec . ### for the purposes of this regulation , the following definitions shall apply : ‘ vehicle type’ means : for vehicles tested according to annex ii , paragraph 4 . 1 . 2 . 1 , a set of vehicles as defined in annex ii part b to directive 2007 / 46 / ec . for vehicles tested according to annex ii , paragraph 4 . 1 . 2 . 2 , a set of vehicles which do not essentially differ in such respects as : the shape or materials of the bodywork ; the type of engine , number and capacity of cylinders , type of injection system , arrangement of valves , rated engine speed , or the type of electric motor ; vehicles having the same type of engine and / or different overall gear ratios , may be regarded as vehicles of the same type . however , if the above differences provide for a different test method , these differences are to be considered as a change of type .


### manufacturers shall ensure that the noise reduction system is designed , constructed and assembled so as to be able to reasonably resist the corrosive phenomena to which it is exposed having regard to the conditions of use of the vehicle . ### manufacturers shall ensure that the noise reduction system is designed , constructed and assembled so as to be able to reasonably resist the corrosive phenomena to which it is exposed having regard to the conditions of use of the vehicle and to regional climate differences .


### within three years following the date referred to in annex iii , third column , phase 1 , to this regulation , the commission shall carry out a detailed study to ascertain whether the noise limits prove to be appropriate . on the basis of the conclusions of the study , the commission may , where appropriate , present proposals for amendment to this regulation . ### within three years following the date referred to in annex iii , third column , phase 1 , to this regulation , the commission shall carry out a detailed study to ascertain whether the noise limits prove to be appropriate and whether there have been no detrimental effects on road safety . on the basis of the conclusions of the study , the commission may , where justified , present proposals for amendment to this regulation that relate to the noise limits . the results of the study shall be communicated to the european parliament .


### the sound emission of the vehicle under typical on - road driving conditions , which are different from those under which the type - approval test set out in annex ii was carried out , shall not deviate from the test result in an unreasonable manner . ### the sound emission of the vehicle under typical on - road driving conditions , which are different from those under which the type - approval test set out in annex ii was carried out , shall not deviate from the test result .


### the vehicle manufacturer shall not intentionally alter , adjust , or introduce any mechanical , electrical , thermal , or other device or procedure solely for the purpose of fulfilling the noise emission requirements under this regulation which is not operational during typical on - road operation under conditions applicable to asep . ### neither the vehicle manufacturer , vehicle owner nor vehicle user shall alter , adjust , or introduce any device or procedure for the purpose of fulfilling the noise emission requirements under this regulation which is not operational during on - road and off - road operation under conditions applicable to asep .


### where manufacturers choose to install an avas in vehicles , the requirements of annex x shall be fulfilled . ### where manufacturers install an avas in vehicles , the requirements of annex x shall be fulfilled .


### when the limit values relating to the test method are laid down in unece regulation no 51 , the commission shall consider replacing the technical requirements laid down in annex iii with a direct reference to the corresponding requirements of unece regulations no 51 and no 59 . ### when the noise limit values relating to the test method used to measure the noise level of motor vehicles are laid down in unece regulation no 51 , the commission shall consider replacing the technical requirements laid down in annex iii with a direct reference to the corresponding requirements of unece regulations no 51 and no 59 .


### 2 . 2 . tyre rolling sound emissions are laid down in regulation no 661 / 2009 on the general safety of motor vehicles . the tyres to be used for the test shall be representative for the vehicle and shall be selected by the vehicle manufacturer and recorded in appendix 3 to annex i of this regulation . they shall correspond to one of the tyre sizes designated for the vehicle as original equipment . the tyre is or will be commercially available on the market at the same time as the vehicle . 2 / the tyres shall be inflated to the pressure recommended by the vehicle manufacturer for the test mass of the vehicle . the tyres shall have at least legal tread depth . 2 / given that the tyre contribution for overall sound emission is significant , regard must be had for existing regulatory provisions concerning tyre / road sound emissions . traction tyres , snow tyres and special - use tyres shall be excluded during type - approval - and conformity of production measurements at the request of the manufacturer in accordance with unece regulation no . 117 . ### 2 . 2 . tyre rolling sound emissions are laid down in regulation no 661 / 2009 on the general safety of motor vehicles . the tyres to be used for the test shall be representative for the vehicle and shall be selected by the vehicle manufacturer and recorded in appendix 3 to annex i of this regulation . they shall correspond to one of the tyre sizes designated for the vehicle as original equipment . the tyre is or will be commercially available on the market at the same time as the vehicle . 2 / the tyres shall be inflated to the pressure recommended by the vehicle manufacturer for the test mass of the vehicle . the tyres shall have at least legal tread depth . 2 / given that the tyre contribution for overall sound emission is significant , regard must be had for existing regulatory provisions concerning tyre / road sound emissions . traction tyres , snow tyres and special - use tyres shall be excluded during type - approval - and conformity of production measurements at the request of the manufacturer in accordance with the latest amendments to ece r117 .


### major accidents can have consequences beyond frontiers , and the ecological and economic cost of an accident is borne not only by the establishment affected but also by the member state concerned . it is therefore necessary to take measures ensuring a high level of protection throughout the union . ### major accidents can have consequences beyond frontiers , and the ecological and economic cost of an accident is borne not only by the establishment affected but also by the member state concerned . it is therefore necessary to take measures ensuring a high level of protection throughout the union and to strengthen cooperation between the member states and , for that reason , between the regional and local authorities , so as to prevent cross - border accidents and ensure coordinated response to major accidents .


### member states shall ensure that the information referred to in annex v is permanently available to the public , including in an electronic format . the information shall be reviewed and where necessary updated at least once a year . ### member states shall ensure that the information referred to in annex v is intelligible and clearly worded , and permanently available to the public , including in an electronic format . the information shall be reviewed and where necessary updated at least once a year .


### all persons liable to be affected by a major accident receive regularly and in the most appropriate form , without their having to request it , information on safety measures and requisite behaviour in the event of an accident ; ### all persons liable to be affected by a major accident receive regularly and in the most appropriate form , without their having to request it , intelligible and clearly worded information on safety measures and requisite behaviour in the event of an accident ;


### the safety report is made available to the public upon request subject to article 21 ; where article 21 applies , an amended report in the form of a non - technical summary , which shall include at least general information on major - accident hazards , potential effects and the requisite behaviour in the event of an accident , shall be made available ; ### the safety report is made available to the public upon request subject to article 21 ; where article 21 applies , an amended report in the form of a non - technical summary , which shall include at least general information on major - accident hazards , potential effects on human health and the environment and the requisite behaviour in the event of an accident , shall be made available ;


### in order to ensure coherence and transparency in relation to proposed citizens ' initiatives , it should be mandatory to register such initiatives on a website made available by the commission prior to collecting the necessary statements of support from citizens ; proposals that are abusive or devoid of seriousness should not be registered and the commission should reject the registration of proposals which would be manifestly against the values of the union . the commission should deal with registration in accordance with the general principles of good administration . ### in order to ensure coherence and transparency in relation to proposed citizens ' initiatives and to avoid a situation in which signatures are collected for a proposal which does not fall within the scope of this regulation , it should be mandatory to register such initiatives on a website made available by the commission prior to collecting the necessary statements of support from citizens . proposals that are not citizens ' initiatives within the meaning of this regulation should not be registered . registration is an administrative procedure aimed at selecting those initiatives that fall within the scope of this regulation ; therefore any refusal of registration should be based only on legal grounds and not , on any account , on grounds of political expediency . the commission should deal with registration in accordance with the general principles of good administration , and should therefore be obliged to inform the organisers of an initiative of the reasons for any refusal to register that initiative and of all possible judicial and extrajudicial remedies available to them . it should also be made clear by the commission that registration and the collection of the required number of statements of support will not necessarily result in the commission adopting a proposal for a legal act and that the registration of an initiative does not constitute a formal decision on competence issues .


### in order to ensure coherence and transparency in relation to proposed citizens ' initiatives , it should be mandatory to register such initiatives on a website made available by the commission prior to collecting the necessary statements of support from citizens ; proposals that are abusive or devoid of seriousness should not be registered and the commission should reject the registration of proposals which would be manifestly against the values of the union . the commission should deal with registration in accordance with the general principles of good administration . ### in order to ensure coherence and transparency in relation to proposed citizens ' initiatives , and to avoid a situation in which signatures are collected for a proposal which does not fall within the scope of this regulation , it should be mandatory to register such initiatives on a website made available by the commission prior to collecting the necessary statements of support from citizens ; proposals that are not citizens ' initiatives in accordance with this regulation should not be registered and the commission should reject the registration of proposals which would be manifestly against the values of the union , as set out in article 2 of the treaty on european union . registration is an administrative procedure aimed at selecting those initiatives that fall within the scope of this regulation ; therefore any refusal of registration should be based only on legal grounds and not , on any account , on grounds of political expediency . the commission should deal with registration in accordance with the general principles of good administration , and should therefore be obliged to inform the organisers of an initiative of the reasons for any refusal to register an initiative and of the legal remedies available to them in that event . it should also be made clear by the commission that registration and the collection of the required number of statements of support will not necessarily result in the commission adopting a proposal for a legal act and that the registration of an initiative does not constitute a formal decision on competence issues .


### it is appropriate to provide for statements of support to be collected in paper form as well as online . online collection systems should have adequate security features in place in order to ensure , inter alia , that the person can be identified and that the data are securely stored . for this purpose , the commission should be required to set out detailed technical specifications for online collection systems . ### it is appropriate to provide for statements of support to be collected in paper form as well as online . online collection systems should have adequate security features in place in order to ensure , inter alia , that the person can be identified and that the data are securely collected and stored . for this purpose , the commission should be required to set out detailed technical specifications for online collection systems .


### it is appropriate to provide for statements of support to be collected in paper form as well as online . online collection systems should have adequate security features in place in order to ensure , inter alia , that the person can be identified and that the data are securely stored . for this purpose , the commission should be required to set out detailed technical specifications for online collection systems . ### in order to put modern technology to good use as a tool of participatory democracy , it is appropriate to provide for statements of support to be collected online as well as in paper form . online collection systems should have adequate security features in place in order to ensure , inter alia , that the person signs only once and that the data are securely stored . the detailed technical specifications should be worked out at an expert level and be regularly adapted to technical developments ; the power to adopt detailed technical specifications for online collection systems should therefore be delegated to the commission .


### it is appropriate to provide for statements of support to be collected in paper form as well as online . online collection systems should have adequate security features in place in order to ensure , inter alia , that the person can be identified and that the data are securely stored . for this purpose , the commission should be required to set out detailed technical specifications for online collection systems . ### in order to put modern technology to good use as a tool of participatory democracy , it is appropriate to provide for statements of support to be collected online as well as in paper form . online collection systems should have adequate security features in place in order to ensure , inter alia , that the person is eligible to sign and signs only once , and that the data are securely stored . the detailed technical specifications should be worked out at an expert level and be regularly adapted to technical developments . he power to adopt detailed technical specifications for online collection systems should therefore be delegated to the commission .


### directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data is fully applicable to the processing of personal data carried out in application of this regulation . in this respect , it is appropriate to clarify that the organiser of a citizens ' initiative and the competent authorities of the member states are the data controllers within the meaning of directive 95 / 46 / ec and to specify the maximum period within which the personal data collected for the purposes of a citizens ' initiative may be retained . in their capacity as data controllers , organisers need to take all the appropriate measures to comply with the obligations imposed by directive 95 / 46 / ec , in particular those relating to the lawfulness of the processing , the security of the processing activities and the provision of information and the rights of data subject to access to his / her personal data as well as the correction and erasure of his / her personal data . ### directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data is fully applicable to the processing of personal data carried out in application of this regulation . in this respect , it is appropriate to clarify that in the event of paper - based collection the organiser of a citizens ' initiative and the competent authorities of the member states are the data controllers within the meaning of directive 95 / 46 / ec and to specify the maximum period within which the personal data collected for the purposes of a citizens ' initiative may be retained . in the event of online collection , in its capacity as data controller , the commission needs to take all the appropriate measures to comply with the obligations imposed by directive 95 / 46 / ec , in particular those relating to the lawfulness of the processing , the security of the processing activities and the provision of information and the rights of data subject to access to his / her personal data as well as the correction and erasure of his / her personal data .


### “organiser” means a natural or legal person or organisation responsible for the preparation and submission of a citizens’ initiative to the commission . ### ' organisers ' means natural or legal persons forming an organising committee responsible for the preparation and submission of a citizens ' initiative to the commission .


### prior to initiating the collection of statements of support from signatories for a proposed citizens ' initiative , the organiser shall be required to register it with the commission , providing the information set out in annex ii , in particular on the subject - matter and objectives as well as on the sources of funding and support for the proposed citizens ' initiative . this information shall be provided in one of the official languages of the union , in an online register made available for that purpose by the commission . ### prior to initiating the collection of statements of support from signatories for a proposed citizens ' initiative , the organisers shall be required to register it with the commission , providing the information set out in annex ii , in particular on the subject - matter and objectives of the proposed citizens ' initiative . the organisers shall provide , for the register defined in the third subparagraph and where appropriate on their website , regularly updated information on the sources of support and funding for the initiative . this information shall be provided in one or more official languages of the union , in an online register made available for that purpose by the commission . information in an official language other the language in which it was originally provided may be provided subsequently for entry in the register . the translation of the initiative into other official languages of the union shall be the responsibility of the organisers .


### proposed citizens ' initiatives which can be reasonably regarded as improper because they are abusive or devoid of seriousness will not be registered . ### the commission shall register a proposed initiative within two months from its receipt when the following conditions are fulfilled : the citizens ' committee has been formed and the contact persons have been designated ; there are no manifest , significant inconsistencies between the linguistic versions of the title , subject - matter and objectives of the proposed initiative ; the initiative does not manifestly fall outside the scope of the commission’s power under the treaties to submit a proposal for the requested legal act ; the proposed initiative is not manifestly abusive , frivolous or vexatious ; the proposed initiative is not manifestly contrary to the values of the union as set out in article 2 of the treaty on european union .


### the data provided online is securely stored , in order to ensure , inter alia , that it may not be modified or used for any other purpose than its indicated support of the given citizens ' initiative and to protect personal data against accidental or unlawful destruction or accidental loss , alteration or unauthorized disclosure or access . ### the data provided online is securely collected and stored , in order to ensure , inter alia , that it may not be modified or used for any other purpose than its indicated support of the given citizens ' initiative and to protect personal data against accidental or unlawful destruction or accidental loss , alteration or unauthorized disclosure or access .


### within 12 months following the entry into force of this regulation , the commission shall adopt technical specifications for the implementation of paragraph 4 , in accordance with the regulatory procedure laid down in article 19 . ### within the 12 months following the entry into force of this regulation , the commission shall undertake in conjunction with the european data protection supervisor an evaluation enabling it to adopt technical specifications for the implementation of paragraph 4 , in accordance with the regulatory procedure laid down in article 19 . that evaluation shall be forwarded to the european parliament , together with the proposals .


### the competent authorities shall , within a period that shall not exceed three months , verify the statements of support provided on the basis of appropriate checks , and deliver to the organiser a certificate in accordance with the model set out in annex vii , certifying the number of valid statements of support for that member state . ### the competent authorities shall , within a period that shall not exceed three months , verify the statements of support provided on the basis of sample checks , and deliver to the organiser a certificate in accordance with the model set out in annex vii , certifying the number of valid statements of support for that member state . the percentage of invalid signatures in the sample will be deducted from the overall number of statements of support . a certificate will only be issued if the remaining number of statements of support exceeds one million .


### where the commission receives a citizens ' initiative in accordance with article 10 it shall : publish the citizens ' initiative without delay on its website ; b . examine the citizens ' initiative and , within 4 months , set out in a communication its conclusions on the initiative , the action it intends to take , if any , and its reasons for doing so ### where the commission receives a citizens ' initiative in accordance with article 10 it shall : publish the citizens ' initiative without delay on its website ; ab . receive the organisers at an appropriate level to allow them to explain in detail the matters raised by the initiative and organise a public hearing on the subject - matter of the initiative , if appropriate jointly with other institutions or bodies of the eu ; b . within three months , set out in a communication its final legal and political conclusions on the initiative , the action it intends to take , if any , and its reasons for doing or not doing so .


### publish the citizens ' initiative without delay on its website ; ### publish the citizens ' initiative without delay on its website , in all the official languages of the union ;


### the communication referred to in paragraph 1 shall be notified to the organiser of the citizens ' initiative as well as to the european parliament and the council and shall be made public . ### the list of citizens ' initiatives tabled , as well as the communication referred to in paragraph 1 , shall be notified to the organiser of the citizens ' initiative as well as to the european parliament and the council and shall be made public .


### the competent authority shall destroy all statements of support and copies thereof that it has received for the purpose of carrying out the verification in accordance with article 9 , at the latest one month after issuing the certificate referred to therein . ### the competent authority shall destroy all statements of support and copies thereof that it has received for the purpose of carrying out the verification in accordance with article 9 , at the latest two months after issuing the certificate referred to therein . in the event of litigation they shall be destroyed one month after the conclusion of the litigation .


### the delegated act may be published in the official journal of the european union and enter into force before the expiry of that period if the european parliament and the council have both informed the commission of their intention not to raise objections . ### the delegated act shall be published in the official journal of the european union and enter into force before the expiry of that period if the european parliament and the council have both informed the commission of their intention not to raise objections .


### the commission shall inform the other member states thereof . ### the commission shall inform the other member states and the european parliament thereof .


### five years after the entry into force of this regulation , the commission shall present a report to the european parliament and the council on the implementation of this regulation . ### three years after the entry into force of this regulation , and every three years thereafter , the commission shall present a report to the european parliament and the council on the implementation of this regulation , with special emphasis on online collection systems and the application of transparency requirements concerning the funding of initiatives , together , if appropriate , with a legislative proposal for amendment of this regulation .