### in this context , it is necessary to establish the successor programme for education , training , youth and sport of the 2014 - 2020 erasmus + programme established by regulation no 1288 / 2013 of the european parliament and the council27 . the integrated nature of the 2014 - 2020 programme covering learning in all contexts - formal , non - formal and informal , and at all stages of life - should be maintained to boost flexible learning paths allowing individuals to develop those competences that are necessary to face the challenges of the twenty - first century . __________________ 27 regulation no 1288 / 2013 of the european parliament and the council of 11 december 2013 establishing ' erasmus + ' : the union programme for education , training , youth and sport and repealing decisions no 1719 / 2006 / ec , no 1720 / 2006 / ec and no 1298 / 2008 / ec . ### in this context , it is necessary to establish the successor programme for education , training , youth and sport of the 2014 - 2020 erasmus + programme established by regulation no 1288 / 2013 of the european parliament and the council 27 . the integrated nature of the 2014 - 2020 programme covering learning in all contexts - formal , non - formal and informal , and at all stages of life - should be reinforced in order to boost flexible learning paths as well as a lifelong learning approach , allowing individuals to develop those competences that are necessary to develop as individuals and to face the challenges of the twenty - first century . the commission and member states should strongly promote cross - sectoral cooperation with a sufficient budget for implementing also large - scale policy projects as well as by ensuring budget - flexibility for national authorities and project applicants to build common projects on transversal issues , that have a lifelong learning approach and promote flexible pathways . __________________ 27 regulation no 1288 / 2013 of the european parliament and the council of 11 december 2013 establishing ' erasmus + ' : the union programme for education , training , youth and sport and repealing decisions no 1719 / 2006 / ec , no 1720 / 2006 / ec and no 1298 / 2008 / ec .


### in a context of rapid and profound changes induced by technological revolution and globalisation , investing in learning mobility , cooperation and innovative policy development in the fields of education , training , youth and sport is key to building inclusive , cohesive and resilient societies and sustaining the competitiveness of the union , while contributing to strengthening european identity and to a more democratic union . ### in a context of rapid and profound changes , investing in learning mobility , education for democracy and solidarity , cooperation and innovative policy development in the fields of education , training , youth and sport is key to building inclusive , democratic , cohesive and resilient societies and sustaining the competitiveness of and solidarity in the union , while contributing to strengthening european identity and to a more democratic union .


### the commission shall implement information and communication actions relating to the programme , and its actions and results . financial resources allocated to the programme shall also contribute to the corporate communication of the political priorities of the union , as far as they are related to the objectives referred to in article 3 . ### the commission shall set the requirements for the national agency work programme with attention to the inclusive and qualitative nature of this programme . the commission shall not make programme funds available to the national agency until the commission has formally approved the national agency’s work programme .


### the general objective of the programme is to support the educational , professional and personal development of people in education , training , youth and sport , in europe and beyond , thereby contributing to sustainable growth , jobs and social cohesion and to strengthening european identity . as such , the programme shall be a key instrument for building a european education area , supporting the implementation of the european strategic cooperation in the field of education and training , with its underlying sectoral agendas , advancing youth policy cooperation under the union youth strategy 2019 - 2027 and developing the european dimension in sport . ### the general objective of the programme is to support the educational , professional and personal development of people in education , training , youth and sport , in europe and beyond , thereby contributing to sustainable growth , quality jobs and social cohesion and to strengthening european identity . as such , the programme shall be a key instrument for building a european education area , supporting the implementation of the european strategic cooperation in the field of education and training , with its underlying sectoral agendas , advancing youth policy cooperation under the union youth strategy 2019 - 2027 , reinforcing lifelong learning and promoting an innovation - driven approach to education and training as well as a european dimension in sport ;


### policy dialogue and cooperation with relevant key stakeholders , including union - wide networks , european non - governmental organisations , and international organisations in the field of youth , the eu youth dialogue as well as support to the european youth forum ; ### policy dialogue , cooperation with and support for relevant key stakeholders , including union - wide networks , european non - governmental organisations , and international organisations in the field of youth , the structured dialogue as well as structural support to the european youth forum and other european youth organisations ;


### promote non - formal learning mobility and active participation among young people , as well as cooperation , inclusion , creativity and innovation at the level of organisations and policies in the field of youth ; ### promote non - formal and informal learning mobility and active participation among young people , as well as cooperation , inclusion , creativity and innovation at the level of organisations and policies in the field of youth ;


### actions eligible under the programme which have been assessed in a call for proposals under the programme and which comply with the minimum quality requirements of that call for proposals , but which are not financed due to budgetary constraints , may be selected for funding by the european structural and investment funds . in this case the co - financing rates and the eligibility rules based on this regulation shall apply . these actions shall be implemented by the managing authority referred to in article [ 65 ] of regulation xx [ cpr ] in accordance with the rules set out in that regulation and fund specific regulations , including rules on financial corrections . ### actions eligible under the programme which have been assessed in a call for proposals under the programme and which comply with the minimum quality requirements of that call for proposals , but which are not financed due to budgetary constraints , should be provided with a seal of excellence to acknowledge their high quality . this might facilitate their application for funding from other sources and / or enable their selection for funding by the european structural and investment funds , without a new application process . in this case the co - financing rates and the eligibility rules based on this regulation shall apply . these actions shall be implemented by the managing authority referred to in article [ 65 ] of regulation xx [ cpr ] in accordance with the rules set out in that regulation and fund specific regulations , including rules on financial corrections .


### ‘ youth participation activity’ means an out - of - school activity carried out by informal groups of young people and / or youth organisations , and characterised by a non - formal learning approach ; ### ‘ youth participation activity’ means an out - of - school activity carried out by informal groups of young people and / or youth organisations , and characterised by a non - formal or informal learning approach ;


### the programme should also enhance the learning of languages , in particular through widened use of online tools , as e - learning offers additional advantages for language learning in terms of access and flexibility . ### the programme should also enhance the learning of languages , including on - site language courses and widened use of online tools , as e - learning offers additional advantages for language learning in terms of access and flexibility . the erasmus online linguistic support should be tailored to the specific needs of participants of the programme and open to everybody .


### eur 450 000 000 for jean monnet actions referred to in article 7 ; ### 1 , 8% for jean monnet actions referred to in article 7 ;


### reflecting the importance of tackling climate change in line with the union ' s commitments to implement the paris agreement and achieve the united nations ' sustainable development goals , this programme will contribute to mainstream climate action in the union ' s policies and to the achievement of an overall target of 25% of the union budget expenditures supporting climate objectives . relevant actions will be identified during the programme ' s preparation and implementation and reassessed in the context of the relevant evaluations and review process . ### the programme should be in line with the central aim of the paris agreement to strengthen the global response to the threat of climate change by raising awareness of responsible behaviour in order to keep the global temperature rise this century well below 2 degrees celsius . reflecting the importance of tackling climate change in line with the union ' s commitments to implement the paris agreement and achieve the united nations ' sustainable development goals , this programme will contribute to mainstream climate action in the union ' s policies and to the achievement of an overall target of 25% of the union budget expenditures supporting climate objectives . relevant actions will be identified during the programme ' s preparation and implementation and reassessed in the context of the relevant evaluations and review process .


### as a way to ensure cooperation with other union instruments and support to other policies of the union , mobility opportunities should be offered to people in various sectors of activity , such as the public sector , agriculture and enterprise , to have a learning experience abroad allowing them , at any stage of their life , to grow and develop professionally but also personally , in particular by developing an awareness of their european identity and an understanding of european cultural diversity . the programme should offer an entry point for union transnational mobility schemes with a strong learning dimension , simplifying the offer of such schemes for beneficiaries and those taking part in these activities . the scaling - up of erasmus projects should be facilitated ; specific measures should be put in place to help promoters of erasmus projects to apply for grants or develop synergies through the support of the european structural and investment funds and the programmes relating to migration , security , justice and citizenship , health and culture . ### as a way to ensure cooperation with other union instruments and support to other policies of the union , mobility opportunities should be offered to people , including persons with disabilities , in various sectors of activity , such as the public sector , agriculture and enterprise , to have a learning experience abroad allowing them , at any stage of their life , to grow and develop professionally but also personally , in particular by developing an awareness of their european identity and an understanding of european cultural diversity . the programme should offer an entry point for union transnational mobility schemes with a strong learning dimension , simplifying the offer of such schemes for beneficiaries and those taking part in these activities . the scaling - up of erasmus projects should be facilitated ; specific measures should be put in place to help promoters of erasmus projects to apply for grants or develop synergies through the support of the european structural and investment funds and the programmes relating to migration , security , justice and citizenship , health and culture , as well as the european solidarity corps .


### national agencies referred to in article 24 shall develop a consistent strategy with regard to the effective outreach as well as dissemination and exploitation of results of activities supported under the actions they manage within the programme , shall assist the commission in its general task of disseminating information concerning the programme , including information in respect of actions and activities managed at national and union level , and its results , and shall inform relevant target groups about the actions and activities undertaken in their country . ### national agencies referred to in article 24 , together with the european commission , shall develop an eu - wide consistent strategy with regard to the effective outreach as well as dissemination and exploitation of results of activities supported under the actions they manage within the programme , including information regarding actions and activities managed at the national and union level , and its results . national agencies shall inform relevant target groups about the actions and activities undertaken in their country , with a view to enhancing outreach across and cooperation with the wide spectrum of stakeholders , and to support a cross - sectoral approach in the programme ' s implementation .


### national agencies referred to in article 24 shall develop a consistent strategy with regard to the effective outreach as well as dissemination and exploitation of results of activities supported under the actions they manage within the programme , shall assist the commission in its general task of disseminating information concerning the programme , including information in respect of actions and activities managed at national and union level , and its results , and shall inform relevant target groups about the actions and activities undertaken in their country . ### national agencies referred to in article 24 shall develop a consistent strategy with regard to the effective outreach as well as dissemination and exploitation of results of activities supported under the actions they manage within the programme , shall assist the commission in its general task of disseminating information concerning the programme , including information in respect of actions and activities managed at national and union level and its results . national agencies shall inform all relevant target groups about the actions and activities undertaken in their country , with a view to enhancing outreach across and cooperation with the wide spectrum of stakeholders and to support a cross - sectoral approach in the programme ' s implementation .


### the general objective of the programme is to support the educational , professional and personal development of people in education , training , youth and sport , in europe and beyond , thereby contributing to sustainable growth , jobs and social cohesion and to strengthening european identity . as such , the programme shall be a key instrument for building a european education area , supporting the implementation of the european strategic cooperation in the field of education and training , with its underlying sectoral agendas , advancing youth policy cooperation under the union youth strategy 2019 - 2027 and developing the european dimension in sport . ### the general objective of the programme is to support the educational , professional and personal development of people in education , training , youth and sport , in europe and beyond , thereby contributing to sustainable growth , jobs and social cohesion , promote active citizenship , participation in democratic life and to strengthening european identity . as such , the programme shall be a key instrument for building a european education area , supporting the implementation of the european strategic cooperation in the field of education and training , with its underlying sectoral agendas , strengthening the youth sector and advancing youth policy cooperation under the union youth strategy 2019 - 2027 and developing the european dimension in sport .


### in compliance with the financial regulation , the commission should adopt work programmes and inform the european parliament and the council thereof . the work programme should set out the measures needed for their implementation in line with the general and specific objectives of the programme , the selection and award criteria for grants , as well as all other elements required . work programmes and any amendments to them should be adopted by implementing acts in accordance with the examination procedure . ### in compliance with the financial regulation , the commission should establish and adopt work programmes in close cooperation with the european parliament and the council , having consulted national agencies and relevant stakeholders . the work programme should set out the measures needed for their implementation in line with the general and specific objectives of the programme , the selection and award criteria for grants , as well as all other elements required . the yearly programme priorities should maintain continuity . nevertheless , a certain degree of flexibility is necessary to respond to emerging challenges . work programmes and any amendments to them should be adopted by means of delegated acts .


### the programme should be more inclusive by improving its outreach to those with fewer opportunities , including through more flexible learning mobility formats , and by fostering participation of small organisations , in particular newcomers and community - based grassroots organisations that work directly with disadvantaged learners of all ages . virtual formats , such as virtual cooperation , blended and virtual mobility , should be promoted to reach more participants , in particular those with fewer opportunities and those for whom moving physically to a country other than their country of residence would be an obstacle . ### the programme should be more inclusive by improving its outreach to those with fewer opportunities , including through more flexible learning mobility formats , simplified administrative procedures , youth - friendly and clear information and communication about the programme and by fostering and supporting the participation of local organisations , in particular newcomers and volunteer - based grassroots organisations that work directly with disadvantaged learners of all ages . simplified procedures , such as accreditation through compliance with quality charters , should be put in place to allow experienced mobility providers to support institutions and organisations with limited resources and capacities , with a view to enhancing outreach , inclusion and quality of learning mobility . virtual formats , such as virtual cooperation , blended and virtual mobility , should be promoted as a complementary aspect of a physical mobility to reach more participants , in particular those with fewer opportunities and those for whom moving physically to a country other than their country of residence would be an obstacle .


### ‘ youth worker’ means a professional or a volunteer involved in non - formal learning who supports young people in their personal socio - educational and professional development ; ### ‘ youth worker’ means a professional or a volunteer involved in non - formal learning who supports young people in their personal socio - educational and professional development and the development of their competences . youth workers together with young people are involved in the planning , steering , coordination , implementation and evaluation of youth work activities and related youth work development .


### appropriate outreach , publicity and dissemination of the opportunities and results of the actions supported by the programme should be ensured at european , national and local level . the outreach , publicity and dissemination activities should rely on all the implementing bodies of the programme , including , when relevant , with the support of other key stakeholders . ### appropriate outreach , publicity and dissemination of the opportunities and results of the actions supported by the programme should be ensured at european , national and local level . the outreach , publicity and dissemination activities should rely on all the implementing bodies of the programme , including , when applicable , with the support of other relevant stakeholders .


### ‘ eu youth dialogue’ means the dialogue with young people and youth organisations which serves as a forum for continuous joint reflection on the priorities , implementation and follow - up of european cooperation in the youth field ; ### ‘ eu youth dialogue’ means the dialogue with young people and youth organisations involving policy - and decision - makers , as well as experts , researchers and other relevant civil society actors . it serves as a forum for continuous joint reflection on the priorities , implementation and follow - up of european cooperation in the all fields of relevance to young people ;


### on 16 september 2016 in bratislava , leaders of twenty - seven member states stressed their determination to provide better opportunities for youth . in the rome declaration signed on 25 march 2017 , leaders of twenty - seven member states and of the european council , the european parliament and the european commission pledged to work towards a union where young people receive the best education and training and can study and find jobs across the union ; a union which preserves our cultural heritage and promotes cultural diversity . ### on 16 september 2016 in bratislava , leaders of twenty - seven member states stressed their determination to provide better opportunities for youth . in the rome declaration signed on 25 march 2017 , leaders of twenty - seven member states and of the european council , the european parliament and the european commission pledged to work towards a union where young people receive the best education and training and can work , learn , exchange , study and find jobs across the union ; a union which preserves our cultural heritage and promotes solidarity , democracy and cultural diversity .


### proposal for a regulation of the european parliament and of the council establishing ' erasmus ' : the union programme for education , training , youth and sport and repealing regulation no 1288 / 2013 ### proposal for a regulation of the european parliament and of the council establishing ' erasmus + ' : the union programme for education , training , youth and sport and repealing regulation no 1288 / 2013


### the programme should also enhance the learning of languages , in particular through widened use of online tools , as e - learning offers additional advantages for language learning in terms of access and flexibility . ### the programme should also enhance the learning of languages , including sign languages , minority and neighbouring languages , in particular through widened use of accessible online tools , as well as traditional classroom language teaching , in order to overcome one of the students ' mobility barriers .


### ' learning mobility ' means moving physically to a country other than the country of residence , in order to undertake study , training or non - formal or informal learning ; it may be accompanied by measures such as language support and training and / or be complemented by online learning and virtual cooperation . in some specific cases , it may take the form of learning through the use of information technology and communications tools ; ### ‘ learning mobility ' means moving physically to country other than the country of residence , in order to undertake study , training or non - formal or informal learning ; it is fully accessible , inclusive and adequately funded and shall be accompanied by measures such as language support , including for national sign languages , and training and / or be complemented by accessible online learning of and virtual cooperation regarding all eu spoken and signed languages . in some specific cases , it may take the form of learning through the use of accessible information technology and accessible communications tools ;


### not for profit sport events aiming at further developing the european dimension of sport . ### not - for - profit sport events , including small - scale events , aimed at further developing the european dimension of sport .


### in its communication on ' a modern budget for a union that protects , empowers and defends - the multiannual financial framework for 2021 - 2027 ' 26 adopted on 2 may 2018 , the commission called for a stronger “youth” focus in the next financial framework , notably by more than doubling the size of the 2014 - 2020 erasmus + programme , one of the union’s most visible success stories . the focus of the new programme should be on inclusiveness , and to reach more young people with fewer opportunities . this should allow more young people to move to another country to learn or work . ### in its communication on ' a modern budget for a union that protects , empowers and defends - the multiannual financial framework for 2021 - 2027 ' 26adopted on 2 may 2018 , the commission called for a stronger “youth” focus in the next financial framework , notably by more than doubling the size of the 2014 - 2020 erasmus + programme , one of the union’s most visible success stories . in its resolution of 14 march 2018 on the next multiannual financial framework , the european parliament called for the programme’s budget to be tripled on order to maintain its success , achieve its goals including increased inclusiveness , as well as reduce its shortcomings and barriers to participation . the focus of the new programme should be on inclusiveness , and to reach more young people with fewer opportunities . this should allow more young people to move to another country to learn or work .


### at least eur 3 790 000 000 to school education actions referred to in point of article 4 and point of article 5 ; ### at least 18% to school education actions referred to in point of article 4 and point of article 5 ;


### the programme should be coherent with the new european union youth strategy30 , the framework for european cooperation in the youth field for 2019 - 2027 , based on the commission ' s communication of 22 may 2018 on ' engaging , connecting and empowering young people : a new eu youth strategy ' 31 . _________________ 30 [ reference - to be adopted by the council by the end of 2018 ] . 31 com 269 final . ### the programme should be coherent with the new european union youth strategy30 , the framework for european cooperation in the youth field for 2019 - 2027 , based on the commission ' s communication of 22 may 2018 on ' engaging , connecting and empowering young people : a new eu youth strategy’31 , including the strategy’s aspirations to support quality youth work and non - formal and informal learning . this entails attention to mobility , inclusiveness , capacity - building , innovation and recognition of youth work and non - formal or informal learning within the context of the 2012 council recommendation on the validation of non - formal and informal learning . this also calls for the promotion of quality tools and systems that should be used in the training of youth workers and that correspond to the changing circumstances of young people’s lives . these should be embedded in a broader quality approach to empower youth organisations . _________________ 30 [ reference - to be adopted by the council by the end of 2018 ] . 31 com 269 final .


### in its communication on strengthening european identity through education and culture , the commission highlighted the pivotal role of education , culture and sport in promoting active citizenship and common values amongst the youngest generations . strengthening european identity and fostering the active participation of individuals in the democratic processes is crucial for the future of europe and our democratic societies . going abroad to study , learn , train and work or to participate in youth and sport activities contributes to strengthening this european identity in all its diversity and the sense of being part of a cultural community as well as to fostering such active citizenship , among people of all ages . those taking part in mobility activities should get involved in their local communities as well as engage in their host country local communities to share their experience . activities linked to reinforcing all aspects of creativity in education , training and youth and enhancing individual key competencies should be supported . ### in its communication on strengthening european identity through education and culture , the commission highlighted the pivotal role of education , culture and sport in promoting active citizenship and common values amongst the youngest generations . strengthening european identity and fostering the active participation of individuals in the democratic processes and civil society is crucial for the future of europe and our democratic societies . going abroad to study , learn , train and work or to participate in youth and sport activities contributes to strengthening this european identity in all its diversity and the sense of being part of a community as well as to fostering such active citizenship , among people of all ages . those taking part in mobility activities should get involved in their local communities , for example by volunteering in local initiatives , as well as engage in their host country local communities to share their experience . activities linked to reinforcing all aspects of creativity in education , training and youth and enhancing individual key competencies should be supported . the role of civil society organisations , such as youth organisations , is particularly important in achieving this goal through non - formal education and informal learning .


### the amount referred to in paragraph 1 may be used for technical and administrative assistance for the implementation of the programme such as preparatory , monitoring , control , audit and evaluation activities , including corporate information technology systems . ### the amount referred to in paragraph 1 may be used for technical and administrative assistance for the implementation of the programme , such as preparatory , monitoring , control , audit and evaluation activities , including corporate information technology systems and accessibility advice , training and monitoring .


### the general objective of the programme is to support the educational , professional and personal development of people in education , training , youth and sport , in europe and beyond , thereby contributing to sustainable growth , jobs and social cohesion and to strengthening european identity . as such , the programme shall be a key instrument for building a european education area , supporting the implementation of the european strategic cooperation in the field of education and training , with its underlying sectoral agendas , advancing youth policy cooperation under the union youth strategy 2019 - 2027 and developing the european dimension in sport . ### the general objective of the programme is to support the educational , professional and personal development of people in education , training , youth , adult learning and sport , in europe and beyond , thereby contributing to sustainable growth , decent jobs and social cohesion and inclusion , environmental protection , active citizenship , promoting rights and values and participation in democratic life , as well as to strengthening european identity . as such , the programme shall be a key instrument for building an accessible and inclusive european education area , supporting the implementation of the european strategic cooperation in the field of education , training and youth , with its underlying sectoral agendas , advancing youth policy cooperation under the union youth strategy 2019 - 2027 and developing the european dimension in sport .


### as a way to ensure cooperation with other union instruments and support to other policies of the union , mobility opportunities should be offered to people in various sectors of activity , such as the public sector , agriculture and enterprise , to have a learning experience abroad allowing them , at any stage of their life , to grow and develop professionally but also personally , in particular by developing an awareness of their european identity and an understanding of european cultural diversity . the programme should offer an entry point for union transnational mobility schemes with a strong learning dimension , simplifying the offer of such schemes for beneficiaries and those taking part in these activities . the scaling - up of erasmus projects should be facilitated ; specific measures should be put in place to help promoters of erasmus projects to apply for grants or develop synergies through the support of the european structural and investment funds and the programmes relating to migration , security , justice and citizenship , health and culture . ### as a way to ensure cooperation with other union instruments and support to other policies of the union , mobility opportunities should be offered to people in various sectors of activity , to have a learning experience abroad allowing them , at any stage of their life , to grow and develop professionally but also personally , in particular by developing an awareness of their european identity and an understanding of european cultural diversity . the programme should offer an entry point for union transnational mobility schemes with a strong learning dimension , simplifying the offer of such schemes for beneficiaries and those taking part in these activities . the scaling - up of erasmus + projects should be facilitated ; specific measures should be put in place to help promoters of erasmus projects to apply for grants or develop synergies through the support of the european structural and investment funds and the programmes relating to migration , security , justice and citizenship , health and culture , as well as the european solidarity corps .


### promote non - formal learning mobility and active participation among young people , as well as cooperation , inclusion , creativity and innovation at the level of organisations and policies in the field of youth ; ### promote non - formal learning mobility , intercultural learning , critical thinking , volunteering and active participation among young people , as well as cooperation , quality , inclusion , growth , creativity and innovation at the level of organisations and policies in the field of youth ;


### in a context of rapid and profound changes induced by technological revolution and globalisation , investing in learning mobility , cooperation and innovative policy development in the fields of education , training , youth and sport is key to building inclusive , cohesive and resilient societies and sustaining the competitiveness of the union , while contributing to strengthening european identity and to a more democratic union . ### in a context of rapid and profound changes , investing in learning mobility , education for democracy and solidarity , cooperation and innovative policy development in the fields of education , training , youth and sport is key to building inclusive , democratic , cohesive and resilient societies and sustaining the competitiveness of and solidarity in the union , while contributing to strengthening european identity and to a more democratic union .


### the types of financing and the methods of implementation under this regulation should be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver results , taking into account , in particular , the costs of controls , the administrative burden , and the expected risk of non - compliance . this should include consideration of the use of lump sums , flat rates and unit costs , as well as financing not linked to costs as referred to in article [ 125 ] of the financial regulation . ### the types of financing and the methods of implementation under this regulation should be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver results , taking into account , in particular , the costs of controls , the administrative burden , and the expected risk of non - compliance . this should include consideration of the use of lump sums , flat rates and unit costs , as well as financing not linked to costs as referred to in article [ 125 ] of the financial regulation . targeted financial support for people with fewer opportunities is of paramount importance to the programme’s inclusiveness . therefore , pre - financing options should be put in place .


### not for profit sport events aiming at further developing the european dimension of sport . ### not for profit and grassroots sport events aiming at further developing the european dimension of sport .


### third countries which are members of the european economic area may participate in the programme in the framework of the cooperation established under the european economic area agreement , which provides for the implementation of union programmes by a decision under that agreement . third countries may also participate on the basis of other legal instruments . this regulation should grant the necessary rights for and access to the authorising officer responsible , the european anti - fraud office as well as the european court of auditors to comprehensively exert their respective competences . the full participation of third countries in the programme should be subject to the conditions laid down in specific agreements covering the participation of the third country concerned to the programme . full participation entails , moreover , the obligation to set up a national agency and managing some of the actions of the programme at decentralised level . individuals and entities from third countries that are not associated to the programme should be able to participate in some of the actions of the programme , as defined in the work programme and the calls for proposals published by the commission . when implementing the programme , specific arrangements could be taken into account with regard to individuals and entities from european microstates . ### third countries which are members of the european economic area may participate in the programme in the framework of the cooperation established under the european economic area agreement , which provides for the implementation of union programmes by a decision under that agreement . third countries may also participate on the basis of other legal instruments . this regulation should grant the necessary rights for and access to the authorising officer responsible , the european anti - fraud office as well as the european court of auditors to comprehensively exert their respective competences . the full participation of third countries in the programme should be subject to the conditions laid down in specific agreements covering the participation of the third country concerned to the programme . full participation entails , moreover , the obligation to set up a national agency and managing some of the actions of the programme at decentralised level . individuals and entities from third countries that are not associated to the programme should be able to participate in some of the actions of the programme , as defined in the work programme and the calls for proposals published by the commission . this includes sub - state governments who wish to participate in the programme and that fulfil the obligations laid down in this regulation . when implementing the programme , specific arrangements could be taken into account with regard to individuals and entities from european microstates .


### the programme should be more inclusive by improving its outreach to those with fewer opportunities , including through more flexible learning mobility formats , and by fostering participation of small organisations , in particular newcomers and community - based grassroots organisations that work directly with disadvantaged learners of all ages . virtual formats , such as virtual cooperation , blended and virtual mobility , should be promoted to reach more participants , in particular those with fewer opportunities and those for whom moving physically to a country other than their country of residence would be an obstacle . ### the programme should be more inclusive by improving its outreach to those with fewer opportunities , including through more flexible mobility formats , simplified administrative procedures , targeting of beneficiary organisations working with groups under - represented in erasmus + , youth - friendly and clear information and communication about the programme and by fostering and supporting the participation of local organisations and small organisations , in particular newcomers , youth organisations , volunteer - based and community - based grassroots organisations that work directly with learners with fewer opportunities of all ages , and organisations working with and supporting people from marginalised groups , such as people with an ethnic minority background , people with disabilities and lgbti people . virtual formats , such as virtual cooperation , blended and virtual mobility , should be promoted to reach more participants and complement the mobility experience .


### policy dialogue and cooperation with relevant key stakeholders , including union - wide networks , european non - governmental organisations , and international organisations in the field of youth , the eu youth dialogue as well as support to the european youth forum ; ### policy dialogue , support and cooperation with relevant key stakeholders , including union - wide networks , european non - governmental organisations , and international organisations in the field of youth , the eu youth dialogue as well as support to the european youth forum ;


### policy dialogue and cooperation with relevant key stakeholders , including union - wide networks , european non - governmental organisations , and international organisations in the field of youth , the eu youth dialogue as well as support to the european youth forum ; ### policy dialogue , cooperation with and support for relevant key stakeholders , including union - wide networks , european non - governmental organisations , and international organisations in the field of youth , the structured dialogue as well as structural support to the european youth forum and other european youth organisations ;


### policy dialogue and cooperation with key stakeholders , including union - wide networks , european non - governmental organisations and international organisations in the field of education and training ; ### policy dialogue and cooperation with key stakeholders , including union - wide networks , european , national , sub - state and local non - governmental organisations and international organisations in the field of education and training ;


### actions eligible under the programme which have been assessed in a call for proposals under the programme and which comply with the minimum quality requirements of that call for proposals , but which are not financed due to budgetary constraints , may be selected for funding by the european structural and investment funds . in this case the co - financing rates and the eligibility rules based on this regulation shall apply . these actions shall be implemented by the managing authority referred to in article [ 65 ] of regulation xx [ cpr ] in accordance with the rules set out in that regulation and fund specific regulations , including rules on financial corrections . ### actions eligible under the programme which have been assessed in a call for proposals under the programme and which comply with the minimum quality requirements of that call for proposals , but which are not financed due to budgetary constraints , should be provided with a seal of excellence to acknowledge their high quality . this might facilitate their application for funding from other sources and / or enable their selection for funding by the european structural and investment funds , without a new application process . in this case the co - financing rates and the eligibility rules based on this regulation shall apply . these actions shall be implemented by the managing authority referred to in article [ 65 ] of regulation xx [ cpr ] in accordance with the rules set out in that regulation and fund specific regulations , including rules on financial corrections .


### the negative environmental impacts of littering or other inappropriate waste disposal of the products , or ### the negative environmental impacts of littering or other inappropriate waste disposal of the products , and


### pursuant to paragraph 22 of the interinstitutional agreement between the european parliament , the council of the european union and the european commission on better law - making of 13 april 201648 , the commission should carry out an evaluation of this directive . that evaluation should be based on experience gathered and data collected during the implementation of this directive and data collected under directive 2008 / 56 / ec or directive 2008 / 98 / ec . the evaluation should provide the basis for an assessment of possible further measures and an assessment whether , in view of monitoring of marine litter in the union , the annex listing single - use plastic products needs to be reviewed . the evaluation should also consider whether scientific and technical progress that has taken place in the meantime , including the development of biodegradable materials and the development of criteria or a standard for biodegradability of plastics in the marine environment , as foreseen in the european plastics strategy , allows the setting of a standard for biodegradation of certain single - use plastic products in the marine environment . that standard would include a standard to test if , as a result of physical and biological decomposition in the marine environment , plastics would fully decompose into carbon dioxide , biomass and water within a timescale short enough for the plastics not to be harmful for marine life and not lead to an accumulation of plastics in the environment . if that is the case , single - use plastic products that meet such a standard could be exempted from the prohibition on placing on the market . while the european strategy for plastics already envisages action in this area , it also recognises the challenges in relation to determining a regulatory framework for plastics with biodegradable properties due to different marine conditions across seas . _________________ 48 oj l 123 , 12 . 5 . 2016 , p . 1 . ### pursuant to paragraph 22 of the interinstitutional agreement between the european parliament , the council of the european union and the european commission on better law - making of 13 april 201648 , the commission should carry out an evaluation of this directive . that evaluation should be based on experience gathered and data collected during the implementation of this directive and data collected under directive 2008 / 56 / ec or directive 2008 / 98 / ec . the evaluation should provide the basis for an assessment of possible further measures and an assessment whether , in view of monitoring of marine litter in the union , the annex listing single - use plastic products needs to be reviewed . the evaluation should also consider whether scientific and technical progress that has taken place in the meantime , including the development of biodegradable materials and the development of criteria or a standard for biodegradability of plastics in the marine environment , as foreseen in the european plastics strategy , allows the setting of a standard for biodegradation of certain single - use plastic products in the marine environment . that standard would include a standard to test if , as a result of physical and biological decomposition conditions existing in the marine environment , plastics would fully decompose into carbon dioxide , biomass and water within a timescale short enough for the plastics not to be harmful for marine life and not lead to an accumulation of plastics in the environment . if that is the case , single - use plastic products that meet such a standard could be exempted from the prohibition on placing on the market . while the european strategy for plastics already envisages action in this area , it also recognises the challenges in relation to determining a regulatory framework for plastics with biodegradable properties due to different marine conditions across seas . _________________ 48 oj l 123 , 12 . 5 . 2016 , p . 1 .


### mediate in disputes between member states ' authorities on the application of relevant union law , in accordance with article 13 ; ### mediate in disputes between member states ' authorities and between persons and member states ' authorities on the application of relevant union law ,


### facilitate access for individuals and employers to information on their rights and obligations as well as to relevant services ; ### facilitate access for individuals and employers to information , support and counselling on their rights and obligations as well as to all relevant services ;


### the authority shall assist member states and the commission in matters relating to cross - border labour mobility and the coordination of social security systems within the union . ### the authority shall contribute to the consistent , efficient and effective application of european labour and social law and shall assist with the coordination of social security systems within the union


### at the request of one or several member states , the authority shall coordinate concerted or joint inspections in the areas under the scope of the authority ' s competences . the request may be submitted by one or several member states . the authority may also suggest to the authorities of the member states concerned that they perform a concerted or joint inspection . ### at the request of one or several member states , the social partners or its own initiative , the authority shall facilitate concerted or joint inspections in the areas under the scope of the authority ' s competences . the request may be submitted by one or several member states or the social partners . the authority shall also suggest to the authorities of the member states concerned that they perform a concerted or joint inspection .


### an agreement for setting up a joint inspection between the participating member states and the authority shall set out the conditions for carrying out such an exercise . the joint inspection agreement may include provisions which enable joint inspections , once agreed and planned , to take place at short notice . the authority shall establish a model agreement . ### the authority shall develop binding guidelines for concerted and joint inspections .


### manage the transport operations carried out with the vehicles referred to in point with the appropriate technical equiment situated in that member state ; ; ### manage the transport operations carried out with the vehicles referred to in point as well as the routine maintenance of the vehicles of the fleet with the appropriate technical equiment situated in that member state ; ;


### so far , and unless otherwise provided for in national law , the rules on access to the occupation of road transport operator do not apply to undertakings engaged in the occupation of road haulage operator solely by means of motor vehicles with a permissible laden mass not exceeding 3 . 5 tonnes or combinations of vehicles not exceeding that limit . the number of such undertakings which are active in both national and international transport operations has been increasing . as a result , several member states have decided to apply the rules on access to the occupation of road transport operator , provided for in regulation no 1071 / 2009 , to those undertakings . to ensure a minimum level of professionalisation of the sector using vehicles with a permissible laden mass not exceeding 3 . 5 tonnes by way of common rules , and thus to approximate competitive conditions between all operators , this provision should be deleted , whereas the requirements regarding effective and stable establishment and appropriate financial standing should be rendered mandatory . ### so far , and unless otherwise provided for in national law , the rules on access to the occupation of road transport operator do not apply to undertakings engaged in the occupation of road haulage operator solely by means of motor vehicles with a permissible laden mass not exceeding 3 . 5 tonnes or combinations of vehicles not exceeding that limit . the number of such undertakings which are active in both national and international transport operations has been increasing . as a result , several member states have decided to apply the rules on access to the occupation of road transport operator , provided for in regulation no 1071 / 2009 , to those undertakings . to clarify the scope of that regulation and avoid loopholes , to ensure a minimum level of professionalisation of the sector using vehicles with a permissible laden mass not exceeding 3 . 5 tonnes by way of common rules , and thus to approximate competitive conditions between all operators , this provision should be deleted , whereas the requirements regarding effective and stable establishment and appropriate financial standing should be rendered mandatory .


### it is necessary to ensure that road transport operators established in a member state have a real and continuous presence in that member state and conduct their business from there . therefore , and in light of experience , it is necessary to clarify the provisions regarding the existence of an effective and stable establishment . ### it is necessary to ensure that road transport operators established in a member state have a real and continuous presence in that member state and conduct their business from there . therefore , and in light of experience , it is necessary to clarify the provisions regarding the existence of an effective and stable establishment . to that end , the relevant provisions in this regulation should be aligned with those in other legislative acts that refer to an effective and stable establishment , such as article 4 of directive 2014 / 67 / ec .


### by way of derogation from article 69 , veterinary medicinal products authorised before 20 july 2000 as well as veterinary medicinal products authorised after that date but which were identified as potentially harmful to the environment in the course of the environmental risk assessment shall be reassessed before a harmonised summary of the product characteristics is prepared . ### by way of derogation from article 69 , veterinary medicinal products authorised before 20 july 2000 as well as veterinary medicinal products authorised after that date but which were identified as potentially harmful to the environment in the course of the environmental risk assessment , or have no environmental risk assessments or incomplete ones , shall be reassessed in accordance with annex ii before a harmonised summary of the product characteristics is prepared .


### special conditions for use , including restrictions on the use of antimicrobials in order to limit the risk of development of antimicrobial resistance , ### special conditions for use , including restrictions on the use of antimicrobials in order to limit the risk of development of antimicrobial resistance and the prohibition of off - label use ,


### 14 years for antimicrobial veterinary medicinal products for cattle , sheep , pigs , chickens , dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the union on the date of the submission of the application ; ### 10 years for antimicrobial veterinary medicinal products for cattle , sheep , pigs , chickens , dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the union on the date of the submission of the application ;


### member states shall collect relevant and comparable data on the volume of sales and the use of veterinary antimicrobial medicinal products . ### member states shall collect relevant and comparable data on the volume of sales and the use of veterinary antimicrobial medicinal products on a yearly basis . these data shall include : the volume of sales in terms of weight and monetary value for each antimicrobial type at national level ; the quantity of antimicrobials used , the species treated , the disease or infection being treated , and method of treatment , at per farm - level .


### scientific name or other name given in a pharmacopoeia of the homeopathic stock or stocks , together with a statement of the various routes of administration , pharmaceutical forms and degree of dilution to be registered ; ### scientific name or other name given in a pharmacopoeia or documented in a monograph of the homeopathic stock or stocks , together with a statement of the various routes of administration , pharmaceutical forms and degree of dilution to be registered ;


### documentation on the direct or indirect risks to public or animal health of use of the antimicrobial veterinary medicinal product in animals , ### documentation on the direct or indirect risks to public or animal health or the environment of use of the antimicrobial veterinary medicinal product in animals ,


### if necessary , the inspections may be carried out unannounced . ### all inspections shall be carried out unannounced .


### veterinary medicinal products shall be used in accordance with the terms of the marketing authorisation . ### veterinary medicinal products shall be used in accordance with the terms of marketing authorisation or registration .


### in order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans , it may be necessary to reserve those antimicrobials for humans only . therefore it should be possible to decide that certain antimicrobials , following the scientific recommendations of the agency , should not be available on the market in the veterinary sector . ### in order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans , it is necessary to reserve those antimicrobials for humans only . as a baseline , this should apply for the highest priority critically important antimicrobials identified by the who . moreover , it should be possible to decide that other critically important antimicrobials , following the scientific recommendations of the agency , should not be available on the market in the veterinary sector .


### any environmental incidents observed following administration of a veterinary medicinal product to an animal ; ### any adverse or unintended reaction observed in the environment following administration of a veterinary medicinal product to an animal ;


### antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the union and worldwide . many of the antimicrobials used in animals are also used in humans . some of those antimicrobials are critical for preventing or treating life - threatening infections in humans . in order to fight antimicrobial resistance a number of measures should be taken . it needs to be ensured that appropriate warnings and guidance are included on the labels of veterinary antimicrobials . use not covered by the terms of the marketing authorisation of certain new or critically important antimicrobials for humans should be restricted in the veterinary sector . the rules for advertising veterinary antimicrobials should be tightened , and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products . ### antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the union and worldwide . many of the antimicrobials used in animals are also used in humans . some of those antimicrobials are critical for preventing or treating life - threatening infections in humans . in order to fight antimicrobial resistance a number of measures should be taken . it needs to be ensured that appropriate warnings and guidance are included on the labels of veterinary antimicrobials . use of certain new or critically important antimicrobials for humans should be prohibited in the veterinary sector . the rules for advertising veterinary antimicrobials should be tightened , and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products .


### inspection reports shall be uploaded to the appropriate database , with continuous access for all competent authorities . ### inspection reports shall be uploaded to the appropriate database , with continuous access for all competent authorities . a summary of the inspection results shall be made publicly available .


### antimicrobial medicinal products shall only be used in accordance with articles 115 and 116 to treat conditions for which there is no other treatment available , and the use of which would not present a risk to public or animal health . ### antimicrobial medicinal products shall only be used in accordance with articles 115 and 116 to treat conditions for which there is no other treatment available , provided that the measures referred to in annex iiia have been taken for food - producing animals , and the use of which would not present a risk to public or animal health and the environment . prophylactic use , as well as control treatment without any diagnosis of disease , shall not be allowed .


### persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their care , and only in the amount required for the treatment concerned . ### persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their care , subject to a veterinary diagnosis based on clinical examination of the animal concerned , and only in the amount required for the treatment concerned .


### the product is an antimicrobial veterinary medicinal product presented for use as performance enhancer in order to promote the growth of treated animals or to increase yields from treated animals ; ### the product is an antimicrobial veterinary medicinal product presented for use as performance enhancer in order to promote the growth of treated animals , or to increase yields from treated animals , or as a routine prophylactic in food producing animals , or to be added to feed or water for mass medication when no disease has been diagnosed in any of the animals ;


### competent authorities , the agency and marketing authorisation holders shall make available to healthcare professionals and animal holders different means of reporting to them the following events whether or not the event is considered to be product - related : ### competent authorities , the agency and marketing authorisation holders shall make available to healthcare professionals , animal holders and environmental authorities different means of reporting to them the following events whether or not the event is considered to be product - related :


### the quantitative particulars of the active substances ; ### the quantitative particulars of the active substances , unless the product exists in only one concentration or the concentration is reflected in the brand name ;


### where a medicinal product has been granted a marketing authorisation in accordance with this article , the summary of product characteristics shall clearly state that only a limited assessment of quality and / or efficacy has been conducted due to the lack of comprehensive efficacy and / or quality data . ### where a medicinal product has been granted a marketing authorisation in accordance with this article , the summary of product characteristics shall clearly state that only a limited assessment of quality and / or efficacy has been conducted due to the lack of comprehensive efficacy and / or quality data . the packaging shall bear a warning with the same information .


### competent authorities may , on their own initiative or on request from the agency , request the marketing authorisation holder to collect specific pharmacovigilance data , in particular regarding the use of a veterinary medicinal product in specified animal species , in the context of public and animal health , safety of the persons administering the product , and the protection of the environment . the authority shall state in detail the reasons for the request and inform other competent authorities and the agency thereof . ### competent authorities shall , on their own initiative or on request from the agency , request the marketing authorisation holder to collect specific pharmacovigilance data , in particular regarding the use of a veterinary medicinal product in specified animal species , in the context of public and animal health , safety of the persons administering the product , and the protection of the environment .


### ' pre - clinical study ' means a study not covered by the definition of clinical trial which aims to investigate the safety or efficacy of a veterinary medicinal product for the purpose of obtaining a marketing authorisation or a change thereof ; ### ' pre - clinical study ' means a study not covered by the definition of clinical trial


### a competent authority or the agency may require the applicant to provide safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment in case the marketing authorisation for the reference veterinary medicinal product was granted before 20 july 2000 or in case the second phase environmental risk assessment was required for the reference veterinary medicinal product . ### the application shall contain safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment in case the marketing authorisation for the reference veterinary medicinal product was granted before 30 october 2005 or in case the second phase environmental risk assessment was required for the reference veterinary medicinal product .


### a competent authority or the agency may require the applicant to provide safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment in case the marketing authorisation for the reference veterinary medicinal product was granted before 20 july 2000 or in case the second phase environmental risk assessment was required for the reference veterinary medicinal product . ### the applicant shall submit to the competent authority or the agency safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment if a potential environmental risk has been identified for that product .


### a marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period of time . ### an initial marketing authorisation for a veterinary medicinal product shall be valid for five years .


### it is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit - risk balance of certain veterinary antimicrobials in the union . any measure restricting the use of those products may affect the trade of products of animal origin or the competitiveness of certain animal production sectors in the union . moreover , antimicrobial resistant organisms can spread to humans and animals in the union through consumption of products of animal origin imported from third countries , from direct contact with animals or humans in third countries or by other means . therefore , measures restricting the use of veterinary antimicrobials in the union should be based on scientific advice and should be considered in the context of cooperation with third countries and international organisations addressing antimicrobial resistance in order the ensure consistency with their activities and policies . ### it is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit - risk balance of certain veterinary antimicrobials in the union . antimicrobial resistant organisms can spread to humans and animals in the union through consumption of products of animal origin imported from third countries , from direct contact with animals or humans in third countries or by other means . therefore , the eu should be active advocating the creation of an international strategy to combat antimicrobial resistance , in line with the recent global action plan adopted by the world health organisation .


### where the application concerns an antimicrobial veterinary medicinal product , the competent authority or the commission may require the marketing authorisation holder to conduct post - authorisation studies in order to ensure that the benefit - risk balance remains positive with a view to the possible development of antimicrobial resistance . ### where the application concerns an antimicrobial veterinary medicinal product , the competent authority or the commission shall require the marketing authorisation holder to conduct post - authorisation studies in order to ensure that the benefit - risk balance remains positive with a view to the possible development of antimicrobial resistance .


### the verification of compliance with the legal requirements through controls is of fundamental importance to ensure that the objectives of the regulation are effectively achieved across the union . therefore the competent authorities of the member states should have the power to perform inspections at all stages of production , distribution and use of veterinary medicinal products . in order to preserve the effectiveness of the inspections , authorities should have the possibility to perform unannounced inspections . ### the verification of compliance with the legal requirements through controls is of fundamental importance to ensure that the objectives of the regulation are effectively achieved across the union . therefore the competent authorities of the member states should have the power to perform inspections at all stages of production , distribution and use of veterinary medicinal products and should publish annual control reports . in order to preserve the effectiveness of the inspections , authorities should perform a certain percentage of unannounced inspections , to be determined by a delegated act .


### there is a sufficient degree of dilution to guarantee the safety of the medicinal product ; in particular , the medicinal product shall not contain more than one part per 10 000 of the mother tincture ; ### there is a sufficient degree of dilution to guarantee the safety of the medicinal product ; in particular , the medicinal product shall not contain more than one part per 10 000 of the mother tincture , unless the ingredients of the medicinal product are included in table 1 of regulation no . 37 / 2010 with the comment ' no maximum residue level required ' .


### if necessary , the inspections may be carried out unannounced . ### all inspections shall be carried out unannounced .


### it is necessary , in specific cases , or from a public health and animal health perspective , to complement the safety and efficacy data available at the time of authorisation with additional information following the placing of the product on the market . therefore the obligation to conduct post - authorisation studies should be imposed on the marketing authorisation holder . ### in specific cases it is necessary , from a public health , animal health or environmental perspective , to complement the safety and efficacy data available at the time of authorisation with additional information following the placing of the product on the market . therefore the obligation to conduct post - authorisation studies should be imposed on the marketing authorisation holder .


### a marketing authorisation for an antimicrobial veterinary medicinal product shall be refused if the antimicrobial is reserved for treatment of certain infections in humans . ### a marketing authorisation for an antimicrobial veterinary medicinal product shall be refused if the antimicrobial is reserved for treatment of certain infections in humans . fluoroquinolones , 3rd and 4th generation cephalosporins , macrolides and glycopeptides shall be considered as reserved for treatment of certain infections in humans . member states may consider further antimicrobials as reserved for treatment of certain infections in humans .


### ‘ homeopathic veterinary medicinal product ' means a veterinary medicinal product prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the european pharmacopoeia or , in the absence thereof , by the pharmacopoeias used officially in member states ; ### ‘ homeopathic veterinary medicinal product ' means a veterinary medicinal product prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the european pharmacopoeia or , in the absence thereof , by the pharmacopoeias used officially in member states ; a homeopathic veterinary medicinal product may contain a number of principles .


### member states should be able to allow exceptional use of veterinary medicinal products without a marketing authorisation where it is necessary to respond to union listed diseases and where the health situation in a member state so requires . ### member states should be able to temporarily allow exceptional use of veterinary medicinal products without a marketing authorisation where it is necessary to respond to union listed diseases and where the health situation in a member state so requires .


### in certain cases failures in member states’ control system can substantially hinder the achievement of the objectives of this regulation and may lead to the emergence of risks to public and animal health and the environment . to ensure a harmonised approach to inspections throughout the union , the commission should be able to carry out audits in the member states to verify the functioning of national control systems . ### in certain cases failures in member states’ control system can substantially hinder the achievement of the objectives of this regulation and may lead to the emergence of risks to public and animal health and the environment . the commission should ensure a harmonised approach to inspections throughout the union , and should be able to carry out audits in the member states to verify the functioning of national control systems .


### where a variation is approved in accordance with article 65 extending the marketing authorisation to a another species not listed in article 34 , the period of the protection provided for in article 34 shall be prolonged by 4 years . ### where a variation is approved in accordance with article 65 extending the marketing authorisation to a another species not listed in article 34 , the period of the protection provided for in article 34 shall be prolonged by 2 years .


### requirement to use take - back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and , if appropriate , additional precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products ; ### requirement to use take - back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products ;


### the general public shall have access to information in the product database as regards the list of the authorised veterinary medicinal products , their summaries of product characteristics and package leaflets . ### the general public shall have access to information in the product database as regards the list of the authorised veterinary medicinal products , their summaries of product characteristics and package leaflets , and all safety information .


### competent authorities may , on their own initiative or on request from the agency , request the marketing authorisation holder to collect specific pharmacovigilance data , in particular regarding the use of a veterinary medicinal product in specified animal species , in the context of public and animal health , safety of the persons administering the product , and the protection of the environment . the authority shall state in detail the reasons for the request and inform other competent authorities and the agency thereof . ### competent authorities shall , on their own initiative or on request from the agency , request the marketing authorisation holder to collect specific pharmacovigilance data , in particular regarding the use of a veterinary medicinal product in specified animal species , in the context of public and animal health , safety of the persons administering the product , and the protection of the environment .


### asylum and managed migration statistics are fundamental for the study , definition and evaluation of a wide range of policies , particularly as regards responses to the arrival of persons seeking protection in europe . ### asylum and managed migration statistics are fundamental for the study , definition and evaluation of a wide range of policies , particularly as regards responses to the arrival of persons seeking protection in europe and to acknowledge the specific needs and including needs for services that particular groups or persons might have , specially those facing multiple forms of discrimination and who might be more vulnerable during the migration and asylum process such as women , pregnant women , children , unaccompanied minors , elderly , persons with disabilities , lgtbi + , victims of gender based violence , among others .


### the individual assessment shall take place at an appropriate stage of the proceedings and in any event before indictment . ### the individual assessment shall take place at the earliest appropriate stage of the proceedings and in any event before indictment or the imposition of measures involving deprivation of liberty , except where this is impossible .


### “cloning” means asexual reproduction of animals with a technique whereby the nucleus of a cell of an individual animal is transferred into an oocyte from which the nucleus has been removed to create genetically identical individual embryos , that can subsequently be implanted into surrogate mothers in order to produce populations of genetically identical animals ; ### “cloning” means asexual reproduction of animals with a technique aimed at producing a genetically identical or nearly identical copy of an individual animal ;


### animals &#8220 ; kept and reproduced for farming purposes&#8221 ; means animals kept and reproduced for the production of food , wool , skin or fur or for other farming purposes . it shall not include animals kept and reproduced exclusively for other purposes such as research , the production of medicinal products and medical devices , the preservation of rare breeds or endangered species , sporting and cultural events ; ### animals &#8220 ; kept and reproduced for farming purposes&#8221 ; means animals kept and reproduced for the production of food , wool , skin or fur or for other farming purposes , such as the preservation of rare breeds . it shall not include animals kept and reproduced exclusively for research purposes ;


### the european food safety authority has confirmed that surrogate dams used in cloning suffer in particular from placenta dysfunctions contributing to increased levels of miscarriages21 . this contributes , amongst other things , to the low efficiency of the technique , 6 to 15 % for bovine and 6 % for porcine species , and the need to implant embryo clones into several dams to obtain one clone . in addition , clone abnormalities and unusually large offspring result in difficult births and neonatal deaths . __________________ 21 scientific opinion of the scientific committee on food safety , animal health and welfare and environmental impact of animals derived from cloning by somatic cell nucleus transfer and their offspring and products obtained from those animals http : / / www . efsa . europa . eu / en / topics / topic / cloning . htm ? wtrl=01 ### the european food safety authority concluded , in its 2008 opinion on animal cloning20a , that ' the health and welfare of a significant proportion of clones have been found to be adversely affected , often severely and with a fatal outcome ' . more specifically , efsa has confirmed that surrogate dams used in cloning suffer in particular from placenta dysfunctions contributing to increased levels of miscarriages21 . this contributes , amongst other things , to the low efficiency of the technique , 6 to 15 % for bovine and 6 % for porcine species , and the need to implant embryo clones into several dams to obtain one clone . in addition , clone abnormalities and unusually large offspring result in difficult births and neonatal deaths . high mortality rates at all development stages are characteristic of the cloning technique21a . __________________ 20a http : / / www . efsa . europa . eu / en / efsajournal / doc / 767 . pdf 21 scientific opinion of the scientific committee on food safety , animal health and welfare and environmental impact of animals derived from cloning by somatic cell nucleus transfer and their offspring and products obtained from those animals http : / / www . efsa . europa . eu / en / topics / topic / cloning . htm ? wtrl=01 21a http : / / www . efsa . europa . eu / en / efsajournal / doc / 2794 . pdf


### member states shall adopt and publish , by 1 april 2019 at the latest , the laws , regulations and administrative provisions necessary to comply with this directive . they shall forthwith communicate to the commission the text of those provisions . ### member states shall adopt and publish , by 1 april 2020 at the latest , the laws , regulations and administrative provisions necessary to comply with this directive . they shall forthwith communicate to the commission the text of those provisions .


### they shall apply those provisions from 1 april 2019 . ### they shall apply those provisions from 1 april 2020 .


### directive 2000 / 84 / ec is repealed with effect from 1 april 2019 . ### directive 2000 / 84 / ec is repealed with effect from 1 april 2020 .


### this directive should apply from 1 april 2019 , so that the last summer - time period subject to the rules of directive 2000 / 84 / ec should start , in every member state , at 1 . 00 a . m . , coordinated universal time , on 31 march 2019 . member states that , after that summer - time period , intend to adopt a standard time corresponding to the time applied during the winter season in accordance with directive 2000 / 84 / ec should change their standard time at 1 . 00 a . m . , coordinated universal time , on 27 october 2019 , so that similar and lasting changes occurring in different member states take place simultaneously . it is desirable that member states take the decisions on the standard time that each of them will apply as from 2019 in a concerted manner . ### this directive should apply from 1 april 2020 , so that the last summer - time period subject to the rules of directive 2000 / 84 / ec should start , in every member state , at 1 . 00 a . m . , coordinated universal time , on 29 march 2020 . member states that , after that summer - time period , intend to adopt a standard time corresponding to the time applied during the winter season in accordance with directive 2000 / 84 / ec should change their standard time at 1 . 00 a . m . , coordinated universal time , on 01 november 2020 , so that similar and lasting changes occurring in different member states take place simultaneously . it is a prerequisite for the implementation of this scheme that member states take the decisions on the standard time that each of them will apply as from 2020 in a concerted and consensual manner , taking account of their need to remain in their current time zone .


### vehicle manufacturers shall make public data which are needed for the purpose of compliance verification testing by third parties . the commission shall adopt implementing acts in order to define the data to be made public and the conditions for such publication , subject to the protection of commercial secrets and the preservation of personal data pursuant to union and national legislation . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 87 . ### vehicle manufacturers shall make public data which are needed for the purpose of compliance verification testing by third parties . the european authority shall list the data that are to be made available to be public and the conditions for such publication , subject to the protection of commercial secrets and the preservation of personal data pursuant to union and national legislation . those lists shall be adopted in accordance with the examination procedure referred to in article 87 .


### the approval authority and technical services shall have access to the software and algorithms of the vehicle . ### the approval authority and technical services shall have access to safety and emissions - related software and hardware as well as algorithms of the vehicle . manufacturers shall communicate to the approval authorities and the technical service , in a standardised form , the safety and emissions - related software at the time of the application in order to detect subsequent unlawful changes to the software .


### obligations of distributors concerning their vehicles , systems , components or separate technical units that are not in conformity or concerning their vehicles , systems , components , separate technical units , parts or equipment that present a serious risk ### obligations of distributors concerning their vehicles , systems , components or separate technical units that are not in conformity or concerning their vehicles , systems , components , separate technical units , parts or equipment that present a risk for the environment , health and safety


### the commission shall establish and chair a forum for exchange of information on enforcement . ### the european authority shall establish , chair and oversee a forum for exchange of information on , and evaluation of , enforcement .


### the member states shall periodically review and assess the functioning of their surveillance activities . such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other member states and the commission . the member state concerned shall make a summary of the results accessible to the public . ### the member states shall periodically review and assess the functioning of their surveillance activities . such reviews and assessments shall be carried out at least every two years and the results thereof shall be communicated to the other member states and to the european authority . throughout the review , member states shall pay particular attention to the level of independence of market surveillance activities and to the technological level of the tests performed . the member state concerned shall make a summary of the results accessible to the general public , in particular as regards the number of vehicles , systems , components or separate technical units that are found not to be in compliance with this regulation , together with the identity of the corresponding manufacturers .


### manufacturers holding type - approvals or the economic operators shall , upon request , supply to the commission a statistically relevant number of production vehicles , systems , components and separate technical units selected by the commission that are representative for the vehicles , systems , components and separate technical units available for placing on the market under that type - approval . those vehicles , systems , components and separate technical units shall be supplied for testing at the time and place and for the period the commission may require . ### manufacturers holding type - approvals or the economic operators shall , upon request , supply to the european authority a statistically relevant number of production vehicles , systems , components and separate technical units selected by the european authority that are representative for the vehicles , systems , components and separate technical units available for placing on the market under that type - approval . those vehicles , systems , components and separate technical units shall be supplied for testing at the time and place and for the period the european authority may require .


### compliant vehicles , systems , components or separate technical units that present a serious risk to safety or serious harm to health and the environment ### compliant vehicles , systems , components or separate technical units that present a serious risk to the environment , health and safety


### the manufacturer shall provide the approval authority with the vehicles , systems , components or separate technical units that are required under the relevant acts listed in annex iv for the performance of the required tests . ### the manufacturer shall provide the technical service with the vehicles , systems , components or separate technical units that are required under the relevant acts listed in annex iv for the performance of the required tests .


### market surveillance authorities shall perform regular checks to verify compliance of vehicles , systems , components and separate technical units with the requirements set out in this regulation as well as with the correctness of the type approvals . those checks shall be performed on an adequate scale , by means of documentary checks and real - drive and laboratory tests on the basis of statistically relevant samples . when doing so , market surveillance authorities shall take account of established principles of risk assessment , complaints and other information . ### market surveillance authorities shall perform regular checks to verify compliance of vehicles , systems , components and separate technical units with the requirements set out in this regulation as well as with the correctness of the type approvals , and shall pay equal attention to safety and to environment standards . those checks shall be performed by means of documentary checks and real - drive and laboratory tests on the basis of a statistically significant sample . when doing so , market surveillance authorities shall take account of established principles of risk assessment , third - party test results , complaints and other information coming from their own country as well as information provided by other member states . in the case of vehicles , market surveillance authorities shall aim to cover 20% of the new models placed on the union market each year to verify whether the vehicles concerned comply with the union safety and environmental legislation . when technical services are designated for the purposes of this article , market surveillance authorities shall ensure that a different technical service is used from that performing tests relating to the original type - approval .


### ‘ market surveillance’ means the activities carried out and measures taken by the market surveillance authorities to ensure that vehicles , systems , components or separate technical units as well as parts and equipment made available on the market comply with the requirements set out in the relevant union legislation and do not endanger health , safety or any other aspect of public interest protection ; ### ‘ market surveillance’ means the activities carried out and measures taken by the market surveillance authorities to ensure that vehicles , systems , components or separate technical units as well as parts and equipment made available on the market comply with the requirements set out in the relevant union legislation and do not endanger the environment , health , safety or any other aspect of public interest protection ;


### member states shall establish a national fee structure to cover the costs for their type - approvals and market surveillance activities as well as for the type - approval testing and conformity of production testing and inspections carried out by the technical services they have designated . ### the european authority , together with the forum , shall establish a union - wide fee structure to cover the costs for its type - approval and market surveillance activities , in order to have a consistent fee structure across the union adapted to the type - approval testing and conformity of production testing and inspections carried out by the technical services it has designated .


### the member state may refuse to register such vehicles until the economic operator has taken all appropriate corrective measures . ### the member state shall refuse to register such vehicles until the economic operator has taken all appropriate corrective measures .


### where information society service providers store and provide access to the public to copyright protected works or other subject - matter uploaded by their users , thereby going beyond the mere provision of physical facilities and performing an act of communication to the public , they are obliged to conclude licensing agreements with rightholders , unless they are eligible for the liability exemption provided in article 14 of directive 2000 / 31 / ec of the european parliament and of the council34 . __________________ 34 directive 2000 / 31 / ec of the european parliament and of the council of 8 june 2000 on certain legal aspects of information society services , in particular electronic commerce , in the internal market . ### where information society service providers offer users content storage services and provide the public with access to content and where such activity constitutes an act of communication to the public and is not of a merely technical , automatic and passive nature , they should be obliged to conclude licensing agreements with rightholders as regards copyright protected works or other subject - matter , unless they are eligible for the liability exemptions provided in directive 2000 / 31 / ec of the european parliament and of the council34 . __________________ 34 directive 2000 / 31 / ec of the european parliament and of the council of 8 june 2000 on certain legal aspects of information society services , in particular electronic commerce , in the internal market .


### information society service providers that store and provide to the public access to large amounts of works or other subject - matter uploaded by their users shall , in cooperation with rightholders , take measures to ensure the functioning of agreements concluded with rightholders for the use of their works or other subject - matter or to prevent the availability on their services of works or other subject - matter identified by rightholders through the cooperation with the service providers . those measures , such as the use of effective content recognition technologies , shall be appropriate and proportionate . the service providers shall provide rightholders with adequate information on the functioning and the deployment of the measures , as well as , when relevant , adequate reporting on the recognition and use of the works and other subject - matter . ### where information society service providers offer users content storage services and provide the public with access to content and where such activity is not eligible for the liability exemptions provided for in directive 2000 / 31 / ec , they shall take appropriate and proportionate measures to ensure the functioning of licensing agreements concluded with rightholders . the implementation of such agreements shall respect the fundamental rights of users and shall not impose a general obligation on information society service providers to monitor the information which they transmit or store , in accordance with article 15 of directive 2000 / 31 / ec .


### prohibiting or limiting fishing in specific areas or time periods to protect vulnerable ecosystems and species ; ### prohibiting or limiting fishing in specific areas or time periods to protect vulnerable ecosystems and species , and to minimise the negative impact of fishing operations on the ecosystem ;


### prohibiting or limiting fishing in specific areas or time periods to protect spawning and juvenile fish , fish below the minimum conservation reference size or non - target fish species ; ### prohibiting or limiting fishing in specific areas or time periods to protect spawning and juvenile fish , fish below the minimum conservation reference size or non - target fish species , and to minimise the negative impact of fishing operations on the ecosystem ;


### pursuant to articles 9 and 10 of regulation no 1380 / 2013 , multi - annual plans are to be based on scientific , technical and economic advice . in accordance with those provisions , the multi - annual plan provided for in this regulation should contain objectives , quantifiable targets with clear timeframes , conservation reference points , safeguards and technical measures designed to avoid and reduce unwanted catches . ### pursuant to articles 9 and 10 of regulation no 1380 / 2013 , multi - annual plans are to be based on scientific , technical and economic advice . in accordance with those provisions , the multi - annual plan provided for in this regulation should contain objectives , quantifiable targets with clear timeframes , conservation reference points , safeguards and technical measures designed to avoid and reduce unwanted catches and minimise the impact on the marine environment .