### the programme should reinforce existing learning mobility opportunities , notably in those sectors where the programme could have the biggest efficiency gains , to broaden its reach and meet the high unmet demand . this should be done notably by increasing and facilitating mobility activities for higher education students , school pupils and learners in vocational education and training . mobility of low - skilled adult learners should be embedded in partnerships for cooperation . mobility opportunities for youth participating in non - formal learning activities should also be extended to reach more young people . mobility of staff in education , training , youth and sport should also be reinforced , considering its leverage effect . in line with the vision of a true european education area , the programme should also boost mobility and exchanges and promote student participation in educational and cultural activities by supporting digitalisation of processes , such as the european student card . this initiative can be an important step in making mobility for all a reality first by enabling higher education institutions to send and receive more exchange students while still enhancing quality in student mobility and also by facilitating students ' access to various services before arriving at the institution abroad . ### the programme should reinforce existing learning mobility opportunities , notably in those sectors where the programme could have the biggest efficiency gains , to broaden its reach and meet the high unmet demand . this should be done notably by increasing and facilitating mobility for groups currently reached less such as learners in vocational education and training , especially for initial vet , school pupils , as well as higher education students . mobility of low - skilled adult learners or people with fewer opportunities should be embedded in partnerships for cooperation . mobility opportunities for youth participating in non - formal learning activities should also be extended to reach more young people . mobility of staff in education , training , youth and sport should also be reinforced , considering its leverage effect . in line with the vision of a true european education area , the programme should also boost mobility and exchanges and promote student participation in educational and cultural activities by supporting digitalisation of processes , such as the european student card . this initiative can be an important step in making mobility for all a reality first by enabling higher education institutions to send and receive more exchange students while still enhancing quality in student mobility and also by facilitating students ' access to various services before arriving at the institution abroad .


### 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 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 .


### to increase the use of virtual cooperation activities , the programme should support a more systematic use of the online platforms such as etwinning , the school education gateway , the electronic platform for adult learning in europe , the european youth portal and the online platform for higher education . ### to increase the use of virtual cooperation activities , the programme should support a more systematic use of the online platforms such as etwinning , the school education gateway , the electronic platform for adult learning in europe , the european youth portal and the online platform for higher education . the online platforms should comply with the requirements laid down in directive 2016 / 2102 on the accessibility of websites and mobile applications of public sector bodies .


### partnerships for excellence , in particular european universities , centres of vocational excellence and joint master degrees ; ### partnerships for excellence , in particular european universities , centres of vocational excellence and erasmus mundus joint master degrees and doctorates ;


### 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 .


### synergies with horizon europe should ensure that combined resources from the programme and the horizon europe programme33 are used to support activities dedicated to strengthening and modernising european higher education institutions . horizon europe will , where appropriate , complement the programme ' s support for the european universities initiative , in particular its research dimension as part of developing new joint and integrated long term and sustainable strategies on education , research and innovation . synergies with horizon europe will help to foster the integration of education and research in higher education institutions . ### synergies with horizon europe should ensure that combined resources from the programme and the horizon europe programme33 are used to support activities dedicated to strengthening and modernising european higher education institutions . horizon europe will , where appropriate , complement the programme ' s support for the european universities initiative , in particular its research dimension as part of developing new joint and integrated long term and sustainable strategies on education , research and innovation . synergies with horizon europe will help to foster the integration of education and research in higher education institutions . the programming of synergies should be coherent and synchronised in all relevant programmes . the simplified procedures for application should be applied for beneficiaries at the implementation level .


### 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 .


### 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 , such as solidarity , amongst the youngest generations . strengthening awareness and understanding of the common european identity and fostering the active participation of individuals in the democratic processes is crucial for the future of europe and our democratic societies , which can become more inclusive , not least through intercultural and , where appropriate , interreligious dialogue . 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 engaging 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 .


### 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 ;


### the programme should encourage youth participation in europe ' s democratic life , including by supporting participation projects for young people to engage and learn to participate in civic society , raising awareness about european common values including fundamental rights , bringing together young people and decision makers at local , national and union level , as well as contributing to the european integration process . ### the programme should encourage youth participation in europe ' s democratic life , with a particular focus on young people from the more remote areas and from migrant backgrounds , including by supporting participation projects for young people to engage and learn to participate in civic society , raising awareness about european common values including fundamental rights , bringing together young people and decision makers at local , regional , national and union level , as well as contributing to the european integration process .


### ' 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 a country other than the country of residence , in order to undertake study , training or non - formal or informal learning , including teaching or professional development activities . 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 communication tools , but not to the exclusion of physical mobility .


### 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 implement information and communication actions relating to the programme , and its actions and results .


### the financial envelope for the implementation of the programme for the period 2021 - 2027 shall be eur 30 000 000 000 in current prices . ### the financial envelope for the implementation of the programme for the period 2021 - 2027 shall be eur 41 097 000 000 in constant prices .


### synergies with horizon europe should ensure that combined resources from the programme and the horizon europe programme33 are used to support activities dedicated to strengthening and modernising european higher education institutions . horizon europe will , where appropriate , complement the programme ' s support for the european universities initiative , in particular its research dimension as part of developing new joint and integrated long term and sustainable strategies on education , research and innovation . synergies with horizon europe will help to foster the integration of education and research in higher education institutions . _________________ 33 com [ ] . ### synergies with horizon europe should ensure that combined resources from the programme and the horizon europe programme33 are used to support activities dedicated to strengthening and modernising european higher education institutions . horizon europe will , where appropriate , complement the programme ' s support for the european universities initiative , in particular its research dimension as part of developing new joint and integrated long term and sustainable strategies on education , research and innovation . synergies with horizon europe will help to foster the integration of education , training and research in higher education institutions . _________________ 33 com [ ] .


### the programme should encourage youth participation in europe ' s democratic life , including by supporting participation projects for young people to engage and learn to participate in civic society , raising awareness about european common values including fundamental rights , bringing together young people and decision makers at local , national and union level , as well as contributing to the european integration process . ### the programme should encourage youth participation in europe ' s democratic life , including by supporting participation projects for young people to engage and learn to participate in civic society , raising awareness about european common values including fundamental rights , through a specific module enabling them , from the moment they arrive in the host country , to discover european history , culture and citizenship , bringing together young people and decision makers at local , national and union level , as well as contributing to the european integration process .


### 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 .


### in the field of sport , the programme shall support , under key action 1 , the mobility of sport coaches and staff . ### in the field of sport , the programme shall support , under key action 1 , the mobility of young people involved in grassroots sport as well as the mobility of voluntary sports trainers and other staff in grassroots sports .


### the programme should contribute to strengthening the union ' s innovation capacity notably by supporting mobility and cooperation activities that foster the development of competences in forward - looking study fields or disciplines such as science , technology , engineering and mathematics , climate change , the environment , clean energy , artificial intelligence , robotics , data analysis and arts / design , to help people develop knowledge , skills and competences needed for the future . ### the programme should contribute to strengthening the union ' s innovation capacity notably by supporting mobility and cooperation activities that foster the development of competences in forward - looking study fields or disciplines , to help people develop knowledge , skills and competences needed for the future .


### the programme should contribute to strengthening the union ' s innovation capacity notably by supporting mobility and cooperation activities that foster the development of competences in forward - looking study fields or disciplines such as science , technology , engineering and mathematics , climate change , the environment , clean energy , artificial intelligence , robotics , data analysis and arts / design , to help people develop knowledge , skills and competences needed for the future . ### the programme should contribute to strengthening the union ' s innovation capacity notably by supporting mobility and cooperation activities that foster the development of competences in forward - looking study fields or disciplines such as science , technology , engineering , arts and mathematics , digital skills , climate change , environmental protection , sustainable development , clean energy , artificial intelligence , robotics , data analysis and design and architecture , to help people develop knowledge , skills and competences needed for the future .


### 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 .


### 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 . ### 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 .


### not for profit sport events aiming at further developing the european dimension of sport . ### sport events promoted by not - for - profit organisations aiming at further developing the european dimension of 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 , 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 ;


### ' 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 a country other than the country of residence , in order to undertake study , training or non - formal or informal learning ; learning mobility activities are fully accessible , inclusive and adequately funded and shall 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 ;


### 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 . ### while the learning of european languages contributes to mutual understanding and mobility within and outside the union , language competences constitute crucial skills for learners . the programme should also enhance the learning of languages , including national sign languages , in particular through widened use of online tools , as e - learning offers additional advantages for language learning in terms of access and flexibility . it should also further explore the potential of blended and virtual forms of learning , such as moocs .


### ' 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 ; ### ' structured dialogue ' means the dialogue with young people and youth organisations with policy and decision makers which serves as a forum for continuous joint reflection on the priorities , implementation and follow - up of european cooperation in all fields of relevance to young people ;


### 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 .


### in order to prevent littering and other inappropriate forms of disposal resulting in marine litter containing plastic , consumers need to be properly informed about the most appropriate waste disposal options available and / or waste disposal options to be avoided , best practices with regard to waste disposal and the environmental impact of bad disposal practices as well as about the plastic content in certain single - use plastic products and fishing gear . therefore , member states should be required to take awareness raising measures ensuring that such information is given to the consumers . the information should not contain any promotional content encouraging the use of the single - use plastic products . member states should be able to choose the measures which are most appropriate based on the nature of the product or its use . producers of single - use plastic products and fishing gear containing plastic should cover the costs of the awareness raising measures as part of their extended producer responsibility obligation . ### in order to prevent littering and other inappropriate forms of disposal resulting in marine litter containing plastic , consumers need to be properly informed about the most appropriate waste disposal options available and / or waste disposal options to be avoided , best practices with regard to waste disposal and the environmental impact of bad disposal practices as well as about the plastic content in certain single - use plastic products and fishing gear , and available alternatives already on the market . therefore , member states should be required to take awareness raising measures ensuring that such information is given to the consumers . the information should not contain any promotional content encouraging the use of the single - use plastic products . member states should be able to choose the measures which are most appropriate based on the nature of the product or its use . producers of single - use plastic products and fishing gear containing plastic should cover the costs of the awareness raising measures as part of their extended producer responsibility obligation .


### ‘ fishing gear’ means any item or piece of equipment that is used in fishing and aquaculture to target or capture marine biological resources or that is floating on the sea surface and is deployed with the objective of attracting and capturing such marine biological resources ; ### ‘ fishing gear’ means any item or piece of equipment that is used in fishing and aquaculture to target or capture or retain for farming marine biological resources or that is floating on the sea surface and is deployed with the objective of attracting , capturing or retaining such marine biological resources ;


### 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 or fishing gear containing plastic 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 .


### the large portion of plastic stemming from abandoned , lost and discarded fishing gear containing plastic in marine litter indicates that the existing legal requirements46 do not provide sufficient incentives to return such fishing gear to shore for collection and treatment . the indirect fee system envisaged under union law on port reception facilities for the delivery of waste from ships takes away the incentive for ships to discharge their waste at sea , and ensures a right of delivery . that system should , however , be supplemented by further financial incentives for fishermen to bring their fishing gear waste on shore to avoid any potential increase in the indirect waste fee to be paid . as plastic components of fishing gear have a high recycling potential , member states should , in line with the polluter pays principle , introduce extended producer responsibility for fishing gear containing plastic to facilitate separate collection of waste fishing gear and to finance sound waste management of such fishing gear , in particular recycling . _________________ 46 council regulation no 1224 / 2009 , directive 2000 / 59 / ec and directive 2008 / 98 / ec . ### the large portion of plastic stemming from abandoned , lost and discarded fishing gear containing plastic in marine litter and in passively fished waste collected during normal fishing operations indicates that the existing legal requirements46 do not provide sufficient incentives to return such fishing gear or such passively fished waste to shore for collection and treatment . under regulation no 1224 / 2009 , if lost fishing gear cannot be retrieved the master of the vessel must inform the competent authority of its flag member state . in order to ensure harmonised monitoring , the data on lost fishing gear shall be collected and recorded by the member states and forwarded annually to the commission . the indirect fee system envisaged under union law on port reception facilities for the delivery of waste from ships takes away the incentive for ships to discharge their waste at sea , and ensures a right of delivery . that system should , however , be supplemented by further financial incentives for fishermen to bring their fishing gear waste and passively fished waste on shore to avoid any potential increase in the indirect waste fee to be paid . the delivery of passively fished waste should not result in additional costs to be borne by fishermen . as plastic components of fishing gear have a high recycling potential , member states should , in line with the polluter pays principle , introduce extended producer responsibility for fishing gear containing plastic to facilitate separate collection of waste fishing gear and to finance sound waste management of such fishing gear , by laying down incentives for those sending these materials for recycling . _________________ 46 council regulation no 1224 / 2009 , directive 2000 / 59 / ec and directive 2008 / 98 / ec .


### directive 2008 / 98 / ec lays down general minimum requirements for extended producer responsibility schemes . those requirements should apply to extended producer responsibility schemes established by this directive . this directive , however , establishes additional extended producer responsibility requirements , for example , the requirement on producers of certain single - use plastic products to cover the costs of clean - up of litter . ### directive 2008 / 98 / ec lays down general minimum requirements for extended producer responsibility schemes . those requirements should apply to extended producer responsibility schemes established by this directive . this directive , however , establishes additional extended producer responsibility requirements , for example , the requirement on producers of certain single - use plastic products to cover the costs of clean - up of litter . with regard to fishing gear , the member states should adopt the measures required to ensure that financial contributions paid by producers of fishing gear containing plastic in fulfilment of their obligations deriving from producer responsibility are adjusted , in particular to take into account the durability , repairability , re - usability and recyclability of such fishing gear placed on the market .


### sufficient scientific and technical progress has been made , and criteria or a standard for biodegradability in the marine environment applicable to single - use plastic products within the scope of this directive and their single - use substitutes have been developed , in order to determine which products no longer need to be subject to the restrictions on placing on the market , where appropriate . ### sufficient scientific and technical progress has been made , and criteria or a standard for biodegradability in the marine environment applicable to single - use plastic products or to fishing gear containing plastic within the scope of this directive and their substitutes have been developed , in order to determine which products no longer need to be subject to the restrictions on placing on the market , where appropriate .


### the objective of this directive is to prevent and reduce the impact of certain plastic products on the environment , in particular the aquatic environment , and on human health as well as to promote the transition to a circular economy with innovative business models , products and materials , thus also contributing to the efficient functioning of the internal market . ### the objective of this directive is for the union to play its part in solving the global problem of marine litter due to plastic , by preventing and reducing the impact of certain plastic products on the environment , in particular the aquatic environment , and on human health as well as by promoting the transition to a circular economy with innovative business models , products and materials , thus also contributing to the efficient functioning of the internal market .


### the presence of plastics in the product . ### the presence of plastics in the product and , if applicable , the existence of alternative products with similar operational characteristics .


### in certain instances , sector - specific union law has been adopted in order to respond to specific needs in that sector , such as the area of international transport . the authority should also deal with the cross - border aspects of the application of such sector - specific union law , in particular regulation no 561 / 2006 of the european parliament and the council49 , directive 2006 / 22 / ec of the european parliament and the council50 , regulation no 1071 / 2009 of the european parliament and the council51 and directive 278 ) 52 . _________________ 49 regulation no 561 / 2006 of the european parliament and of the council of 15 march 2006 on the harmonisation of certain social legislation relating to road transport and amending council regulations no 3821 / 85 and no 2135 / 98 and repealing council regulation no 3820 / 85 . 50 directive 2006 / 22 / ec of the european parliament and of the council of 15 march 2006 on minimum conditions for the implementation of council regulations no 3820 / 85 and no 3821 / 85 concerning social legislation relating to road transport activities and repealing council directive 88 / 599 / eec . 51 regulation no 1071 / 2009 of the european parliament and of the council of 21 october 2009 establishing common rules concerning the conditions to be complied with to pursue the occupation of road transport operator and repealing council directive 96 / 26 / ec . 52 com278 – proposal for a directive of the european parliament and of the council amending directive 2006 / 22 / ec as regards enforcement requirements and laying down specific rules with respect to directive 96 / 71 / ec and directive 2014 / 67 / eu for posting drivers in the road transport sector . ### in certain instances , sector - specific union law has been adopted in order to respond to specific needs in that sector , such as the area of international transport . the authority should also deal with the cross - border aspects of the application of such sector - specific union law , in particular regulation no 561 / 2006 of the european parliament and the council49 , directive 2006 / 22 / ec of the european parliament and the council50 , regulation no 1072 / 2009 , directive no 2002 / 15 , regulation no 1071 / 2009 of the european parliament and the council51 and directive 278 ) 52 , as well as regulation no 1008 / 2008 . _________________ 49 regulation no 561 / 2006 of the european parliament and of the council of 15 march 2006 on the harmonisation of certain social legislation relating to road transport and amending council regulations no 3821 / 85 and no 2135 / 98 and repealing council regulation no 3820 / 85 . 50 directive 2006 / 22 / ec of the european parliament and of the council of 15 march 2006 on minimum conditions for the implementation of council regulations no 3820 / 85 and no 3821 / 85 concerning social legislation relating to road transport activities and repealing council directive 88 / 599 / eec . 51 regulation no 1071 / 2009 of the european parliament and of the council of 21 october 2009 establishing common rules concerning the conditions to be complied with to pursue the occupation of road transport operator and repealing council directive 96 / 26 / ec . 52 com278 – proposal for a directive of the european parliament and of the council amending directive 2006 / 22 / ec as regards enforcement requirements and laying down specific rules with respect to directive 96 / 71 / ec and directive 2014 / 67 / eu for posting drivers in the road transport sector .


### the authority shall promote the use of electronic tools and procedures for message exchange between national authorities , including the internal market information system and the electronic exchange of social security information system . ### the authority shall promote the use of electronic tools and procedures for message exchange between national authorities , including the internal market information system and the electronic exchange of social security information system . with the objective of verifying the correct application of and compliance with union law , inspectors responsible for roadside checks shall have direct real - time access , via an electronic application common to all member states , both to the system interconnecting national registers of transport undertakings and activities , erru , and to information on the driver’s posting declaration through the imi . in this context , the authority shall promote this electronic application that will provide direct real - time access to the erru and imi during roadside checks .


### the authority should perform its activities in the areas of cross - border labour mobility and social security coordination , including free movement of workers , posting of workers and highly mobile services . it should also enhance cooperation between member states in tackling undeclared work . in cases where the authority , in the course of the performance of its activities , becomes aware of suspected irregularities , including in areas of union law beyond its scope , such as violations of working conditions , health and safety rules , or the employment of illegally staying third - country nationals , it should be able to report them and cooperate on these matters with the commission , competent union bodies , and national authorities where appropriate . ### the authority should perform its activities in the areas of cross - border labour mobility and social security coordination , including free movement of workers , posting of workers and highly mobile services , such as the transport sector . this sector is particularly affected by existing unfair and exploitative employment practices across all transport modes and the existence of legislative loopholes allow for cross - border wage and social dumping , a downgrading of terms and conditions for workers , poorer - quality services , and the distortion of fair competition . the authority should also enhance cooperation between member states in tackling undeclared work , letter box companies , fraudulent postings and bogus self - employment . . in cases where the authority , in the course of the performance of its activities , becomes aware of suspected irregularities , including in areas of union law beyond its scope , such as violations of working conditions , health and safety rules , or the employment of illegally staying third - country nationals , it should be able to report them and cooperate on these matters with the commission , competent union bodies , and national authorities where appropriate .


### provide relevant information on the rights and obligations of individuals in cross - border labour mobility situations ; ### provide relevant comprehensive information and advisory services on the rights and obligations of individuals in cross - border labour mobility situations ;


### the authority should perform its activities in the areas of cross - border labour mobility and social security coordination , including free movement of workers , posting of workers and highly mobile services . it should also enhance cooperation between member states in tackling undeclared work . in cases where the authority , in the course of the performance of its activities , becomes aware of suspected irregularities , including in areas of union law beyond its scope , such as violations of working conditions , health and safety rules , or the employment of illegally staying third - country nationals , it should be able to report them and cooperate on these matters with the commission , competent union bodies , and national authorities where appropriate . ### the authority should perform its activities in the areas of cross - border labour mobility and social security coordination , including free movement of workers , posting of workers and highly mobile services such as the transport sector . it should also enhance cooperation between member states in tackling undeclared work . in cases where the authority , in the course of the performance of its activities , becomes aware of suspected irregularities , including in areas of union law beyond its scope , such as violations of working conditions , health and safety rules , or the employment of illegally staying third - country nationals , it should be able to report them and cooperate on these matters with the commission , competent union bodies , and national authorities where appropriate .


### 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 , including through social partners , to information on their rights and obligations as well as to relevant services ;


### to guarantee its full autonomy and independence , the authority should be granted an autonomous budget , with revenue coming from the general budget of the union , any voluntary financial contribution from the member states and any contribution from third countries participating in the work of the authority . in exceptional and duly justified cases it should also be in the position to receive delegation agreements or ad hoc grants , and to charge for publications and any service provided by the authority . ### to guarantee its full autonomy and independence , the authority should be granted an autonomous budget , with revenue coming from the general budget of the union and any voluntary financial contribution from the member states participating in the work of the authority . in exceptional and duly justified cases it should also be in the position to receive delegation agreements or ad hoc grants , and to charge for publications and certain services provided by the authority at the request of interested parties .


### in certain instances , sector - specific union law has been adopted in order to respond to specific needs in that sector , such as the area of international transport . the authority should also deal with the cross - border aspects of the application of such sector - specific union law , in particular regulation no 561 / 2006 of the european parliament and the council49 , directive 2006 / 22 / ec of the european parliament and the council50 , regulation no 1071 / 2009 of the european parliament and the council51 and directive 278 ) 52 . __________________ 49 regulation no 561 / 2006 of the european parliament and of the council of 15 march 2006 on the harmonisation of certain social legislation relating to road transport and amending council regulations no 3821 / 85 and no 2135 / 98 and repealing council regulation no 3820 / 85 . 50 directive 2006 / 22 / ec of the european parliament and of the council of 15 march 2006 on minimum conditions for the implementation of council regulations no 3820 / 85 and no 3821 / 85 concerning social legislation relating to road transport activities and repealing council directive 88 / 599 / eec . 51 regulation no 1071 / 2009 of the european parliament and of the council of 21 october 2009 establishing common rules concerning the conditions to be complied with to pursue the occupation of road transport operator and repealing council directive 96 / 26 / ec . 52 com278 – proposal for a directive of the european parliament and of the council amending directive 2006 / 22 / ec as regards enforcement requirements and laying down specific rules with respect to directive 96 / 71 / ec and directive 2014 / 67 / eu for posting drivers in the road transport sector . ### in certain instances , sector - specific union law has been adopted in order to respond to specific needs in that sector , such as the area of international transport . the authority should also deal with the cross - border aspects of the application of such sector - specific union law , in particular regulation no 561 / 2006 of the european parliament and the council49 , directive 2006 / 22 / ec of the european parliament and the council50 , regulation no 1071 / 2009 of the european parliament and the council51 , directive 278 ) 52 and regulation no 1008 / 2008 of the european parliament and the council52a . __________________ 49 regulation no 561 / 2006 of the european parliament and of the council of 15 march 2006 on the harmonisation of certain social legislation relating to road transport and amending council regulations no 3821 / 85 and no 2135 / 98 and repealing council regulation no 3820 / 85 . 50 directive 2006 / 22 / ec of the european parliament and of the council of 15 march 2006 on minimum conditions for the implementation of council regulations no 3820 / 85 and no 3821 / 85 concerning social legislation relating to road transport activities and repealing council directive 88 / 599 / eec . 51 regulation no 1071 / 2009 of the european parliament and of the council of 21 october 2009 establishing common rules concerning the conditions to be complied with to pursue the occupation of road transport operator and repealing council directive 96 / 26 / ec . 52 com278 – proposal for a directive of the european parliament and of the council amending directive 2006 / 22 / ec as regards enforcement requirements and laying down specific rules with respect to directive 96 / 71 / ec and directive 2014 / 67 / eu for posting drivers in the road transport sector . 52a regulation no 1008 / 2008 of the european parliament and of the council of 24 september 2008 on common rules for the operation of air services in the community , oj l 293 , 31 . 10 . 2008


### 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 , or of social partners ' organisations or on the initiative of the authority , member states shall work towards concluding an agreement between them and the authority for concerted or joint inspections in the areas under the scope of the authority ' s competences .


### a european labour authority should be established in order to help strengthen fairness and trust in the single market . to that effect , the authority should support the member states and the commission in strengthening access to information for individuals and employers about their rights and obligations in cross - border labour mobility situations as well as access to relevant services , support compliance and cooperation between the member states to ensure the effective application of the union law in these areas , and mediate and facilitate a solution in case of cross - border disputes or labour market disruptions . ### a european labour authority should be established in order to help strengthen fairness and trust in the single market , while respecting the principles of proportionality and subsidiarity . to that effect , the authority should support the member states and the commission in strengthening access to information for individuals and employers about their rights and obligations in cross - border labour mobility situations as well as access to relevant services , support compliance and cooperation between the member states to ensure the effective application of the union law in these areas , and mediate and facilitate a solution in case of cross - border disputes or labour market disruptions .


### 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&#160 ; agency may participate in&#160 ; concerted or joint inspections in the areas under the scope of the authority ' s competences .


### the authority should perform its activities in the areas of cross - border labour mobility and social security coordination , including free movement of workers , posting of workers and highly mobile services . it should also enhance cooperation between member states in tackling undeclared work . in cases where the authority , in the course of the performance of its activities , becomes aware of suspected irregularities , including in areas of union law beyond its scope , such as violations of working conditions , health and safety rules , or the employment of illegally staying third - country nationals , it should be able to report them and cooperate on these matters with the commission , competent union bodies , and national authorities where appropriate . ### the authority should perform its activities in the areas of cross - border labour mobility and social security coordination , including free movement of workers , posting of workers and cross - border provision of services . it should also oblige cooperation between member states in tackling undeclared work . in cases where the authority , in the course of the performance of its activities , becomes aware of suspected irregularities , including in areas of union law beyond its scope , such as violations of working conditions , health and safety rules , or the employment of illegally staying third - country nationals , it should be able to report them and cooperate on these matters with the commission , competent union bodies , and national authorities where appropriate . the authority should support member states in fulfilling their responsibilities and thereby help them to exploit any synergy effects in order to work as efficient as possible .


### to increase member states ' capacity to tackle irregularities with a cross - border dimension in relation to union law within its scope , the authority should support the national authorities in carrying out concerted and joint inspections , including by facilitating the implementation of the inspections in accordance with article 10 of directive 2014 / 67 / eu . these should take place at the request of member states or upon their agreement to the authority ' s suggestion . the authority should provide strategic , logistical , and technical support to member states participating in the concerted or joint inspections in full respect of confidentiality requirements . inspections should be carried out in agreement with the member states concerned and take place fully within the legal framework of national law of member states concerned , which should follow up on the outcomes of the concerted and joint inspections according to national law . ### to increase member states ' capacity to tackle irregularities with a cross - border dimension in relation to union law within its scope , the authority should support the national authorities in carrying out concerted and joint inspections and checks , including by facilitating the implementation of the inspections in accordance with article 10 of directive 2014 / 67 / eu . these should take place at the request of member states or upon their agreement to the authority ' s suggestion . the authority should provide strategic , logistical , and technical support to member states participating in the concerted or joint inspections in full respect of confidentiality requirements . inspections should be carried out in agreement with the member states concerned and take place fully within the legal framework of national law of member states concerned , which should follow up on the outcomes of the concerted and joint inspections according to national law .


### 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 with combinations of vehicles not exceeding that limit should have a minimum level of financial standing , to ensure that they have the means to carry out operations on a stable and long - lasting basis . however , since the operations concerned are generally of a limited size , the corresponding requirements should be less demanding than those applicable to operators using vehicles or combinations of vehicles above that limit . ### undertakings engaged in the occupation of road haulage operator solely by means of motor vehicles or combinations of vehicles with a permissible laden mass exceeding 2 . 5 tonnes and less than 3 . 5 tonnes should have a minimum level of financial standing , to ensure that they have the means to carry out operations on a stable and long - lasting basis . however , since the operations concerned are generally of a limited size , the corresponding requirements should be less demanding than those applicable to operators using vehicles or combinations of vehicles above that limit .


### have premises in which it keeps its core business documents , in particular its commercial contracts , accounting documents , personnel management documents , labour contracts , documents containing data relating to driving time and rest and any other document to which the competent authority must have access in order to verify compliance with the conditions laid down in this regulation ; ; ### have premises in which it keeps its original business documents , or ensure access to the documents electronically , in particular its transport contracts , accounting documents , personnel management documents , labour contracts , social security documents , documents relating to collective agreements , where appropriate , documents containing data relating to driving time and rest and any other document to which the competent authority must have access in order to verify compliance with the conditions laid down in this regulation ;


### the information about transport operators contained in the national electronic registers should be as complete as possible to allow national authorities in charge of enforcing the relevant rules to have a sufficient overview of the operators being investigated . in particular , information regarding the registration number of the vehicles at the disposal of operators , the number of employees they hire , their risk rating and their basic financial information should allow a better national and cross - border enforcement of the provisions of regulations no 1071 / 2009 and no 1072 / 2009 . the rules on the national electronic register should therefore be amended accordingly . ### the information about transport operators contained in the national electronic registers should be as complete and up - to - date as possible to allow national authorities in charge of enforcing the relevant rules to have a sufficient overview of the operators being investigated . in particular , information regarding the registration number of the vehicles at the disposal of operators , the number of employees they hire , their risk rating and their basic financial information should allow a better national and cross - border enforcement of the provisions of regulations no 1071 / 2009 and no 1072 / 2009 . national electronic registers should become interoperable in order for data to be accessible for enforcement authorities from all member states . the rules on the national electronic register should therefore be amended accordingly .


### in view of their potential to considerably affect the road haulage market , as well as the social protection of workers , serious infringements of union rules on the posting of workers and the law applicable to contractual obligations should be added to the items relevant to the assessment of good repute . ### in view of their potential to considerably affect the road haulage market , as well as the social protection of workers , serious infringements of union rules on the posting of workers , cabotage and the law applicable to contractual obligations should be added to the items relevant to the assessment of good repute .


### conduct effectively and continuously its administrative and commercial activities with the appropriate administrative equipment and facilities at premises situated in that member state ; ; ### conduct effectively and continuously its administrative and commercial activities at premises situated in that member state and carry out its transport operations with the vehicles referred to in point with the appropriate technical equipment situated in that member state ;


### 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 with combinations of vehicles not exceeding that limit should have a minimum level of financial standing , to ensure that they have the means to carry out operations on a stable and long - lasting basis . however , since the operations concerned are generally of a limited size , the corresponding requirements should be less demanding than those applicable to operators using vehicles or combinations of vehicles above that limit . ### undertakings engaged in the occupation of road haulage operator engaged in international transport by means of motor vehicles , or with combinations of vehicles , intended solely for the transport of goods and with a permissible laden mass of 2 . 5 to 3 . 5 tonnes should have a minimum level of financial standing , to ensure that they have the means to carry out operations on a stable and long - lasting basis . however , since the operations carried out with such vehicles are generally of a limited size , the corresponding requirements should be less demanding than those applicable to operators using vehicles above that limit .


### 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 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 legal harmonisation and a greater level of professionalisation of the sector , it is necessary to apply common rules also to vehicles with a permissible laden mass of 2 . 5 to 3 . 5 tonnes .


### the means by which road transport operators can prove compliance with the rules for cabotage operations should be clarified . the use and transmission of electronic transport information should be recognised as such means , which should simplify the provision of relevant evidence and its treatment by the competent authorities . the format used for that purpose should ensure reliability and authenticity . considering the increasing use of efficient electronic exchange of information in transport and logistics , it is important to ensure coherence in the regulatory frameworks and provisions addressing the simplification of administrative procedures . ### effective and efficient enforcement of the rules is a prerequisite for fair competition in the internal market and to ensure that the rights of workers are protected . further digitalisation of enforcement is essential in order to free up enforcement capacity , reduce unnecessary administrative burden and better target high - risk transport operators . the rapid update and use of smart tachographs and electronic transport documents is necessary . the means by which road transport operators can prove compliance with the rules for cabotage operations should be clarified . the use and transmission of electronic transport information should be recognised as such means , which should simplify the provision of relevant evidence and its treatment by the competent authorities . the format used for that purpose should ensure reliability and authenticity . considering the increasing use of efficient electronic exchange of information in transport and logistics , it is important to ensure coherence in the regulatory frameworks and provisions addressing the simplification of administrative procedures .


### the information about transport operators contained in the national electronic registers should be as complete as possible to allow national authorities in charge of enforcing the relevant rules to have a sufficient overview of the operators being investigated . in particular , information regarding the registration number of the vehicles at the disposal of operators , the number of employees they hire , their risk rating and their basic financial information should allow a better national and cross - border enforcement of the provisions of regulations no 1071 / 2009 and no 1072 / 2009 . the rules on the national electronic register should therefore be amended accordingly . ### the information about transport operators contained in the national electronic registers should be as complete as possible to allow national authorities in charge of enforcing the relevant rules to have a sufficient overview of the operators being investigated . in particular , information regarding the number of vehicles at the disposal of operators , the number of drivers and their risk rating , which should allow a better national and cross - border enforcement of the provisions of regulations no 1071 / 2009 and no 1072 / 2009 . the rules on the national electronic register should therefore be amended accordingly .


### 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 has been increasing particularly on the national transport market , because of the use of light commercial vehicles in towns and on shorter routes . 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 , prevent the use of loopholes and create fairer competition on the internal market without imposing unnecessary administrative and financial burdens on transport undertakings , particularly smes , the requirements for engagement in the occupation of road transport operator should apply equally for undertakings using vehicles or combinations of vehicles with a permissible laden mass not exceeding 3 . 5 tonnes involved in international transport and cabotage operations .


### the information about transport operators contained in the national electronic registers should be as complete as possible to allow national authorities in charge of enforcing the relevant rules to have a sufficient overview of the operators being investigated . in particular , information regarding the registration number of the vehicles at the disposal of operators , the number of employees they hire , their risk rating and their basic financial information should allow a better national and cross - border enforcement of the provisions of regulations no 1071 / 2009 and no 1072 / 2009 . the rules on the national electronic register should therefore be amended accordingly . ### the information about transport operators contained in the national electronic registers should be as complete as possible to allow national authorities in charge of enforcing the relevant rules to have a sufficient overview of the operators being investigated . in particular , information regarding the number of the vehicles at the disposal of operators , the number of drivers they hire , their risk rating and their basic financial information should allow a better national and cross - border enforcement of the provisions of regulations no 1071 / 2009 and no 1072 / 2009 . the rules on the national electronic register should therefore be amended accordingly .


### use of antimicrobial veterinary medicinal products for species or indications outside the terms of the marketing authorisation ### use of antimicrobial substances for species or indications outside the terms of the marketing authorisation


### 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 ;


### the conditions governing the supply of veterinary medicinal products to the public should be harmonised in the union . veterinary medicinal products should only be supplied by persons authorised to do so by the member state where they are established . at the same time , in order to improve access to veterinary medicinal products in the union , retailers that are authorised to supply veterinary medicinal products by the competent authority in the member state where they are established should be allowed to sell prescription and non - prescription veterinary medicinal products via the internet to buyers in other member states . ### the conditions governing the supply of veterinary medicinal products to the public should be harmonised in the union . veterinary medicinal products should only be supplied by persons authorised to do so by the member state where they are established . at the same time , in order to improve access to veterinary medicinal products in the union , retailers that are authorised to supply veterinary medicinal products by the competent authority in the member state where they are established should be allowed to sell prescription and non - prescription veterinary medicinal products , except for antimicrobials , via the internet to buyers in their own or other member states .


### applications shall be submitted electronically . for applications submitted in accordance with the centralised marketing authorisation procedure , the formats made available by the agency shall be used . ### applications shall be submitted electronically or saved in exceptional circumstances and following agreement with a competent authority , or , in case of central application , with the agency . the commission , in collaboration with the member states and with the agency shall adopt detailed guidelines for the format of electronic applications .


### 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 . ### veterinarians shall retail veterinary medicinal products that are subject to medical prescription , particularly antimicrobial products , only for animals which are under their care , subject to a veterinary diagnosis based on clinical examination of the animal concerned or , exceptionally , permanent monitoring of its health , 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 , and only in the amount required for the treatment concerned . ### veterinarians qualified to prescribe veterinary medicinal products in accordance with applicable national law shall not retail antimicrobial products and shall only be allowed to provide an emergency doses after a proper diagnosis for the treatment of animals only for animals under their immediate care , and only in the amount required for the treatment concerned .


### member states shall send data on the volume of sales and the use of veterinary antimicrobial medicinal products to the agency . the agency shall analyse the data and publish an annual report . ### member states shall send to the agency data on the volume of sales and the use of veterinary antimicrobial medicinal products to the agency . the agency shall analyse the data and publish an annual report which shall contain guidelines and recommendations as appropriate .


### 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 limited information on its quality and efficacy has been submitted .


### ‘ clinical trial ' means a study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product or both under normal conditions of animal husbandry or as part of normal veterinary practice for the purpose of obtaining a marketing authorisation or a change thereof ; ### ‘ clinical trial ' means a scientific study not falling under the scope of directive 2010 / 63 / eu , conducted in a target species in accordance with good clinical practice under field conditions to test at least one hypothesis relevant to efficacy claim or to in - use safety in the target animal for a veterinary medicinal product under investigation for the purpose of obtaining a marketing authorisation for the veterinary medicinal product concerned or variation thereof ; in case of immunological veterinary medicinal product the study is a ' field trial ' ;


### there is no risk to public or animal health as regards the development of resistance to anthelmintic substances even where the veterinary medicinal products containing those substances are used incorrectly . ### there is no risk to public or animal health as regards the development of antimicrobial or antiparasitic resistance even where the veterinary medicinal products containing those substances are used incorrectly


### by way of derogation from article 9 , small immediate packaging units shall contain only the following information : ### by way of derogation from article 9 , small immediate packaging units shall contain only the following information . in exceptional cases , the applicant or the competent authority may request additional text to be included where this is justified to ensure the safe and correct administration of the 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 . ### if there is evidence that a constituent of a medicinal product is a hazard for the environment , a competent authority or the agency shall require the safety data concerning the potential risks simultaneously to all the marketing authorisation holders 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 , 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 commission shall be empowered to adopt delegated acts in accordance with article 146 in order to establish rules for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of certain active substances in humans . ### the commission shall be empowered to adopt delegated acts in accordance with article 146 and taking into consideration the scientific advice of the agency in order to establish rules for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of certain active substances in humans . the commission , when establishing these rules , shall make decisions on appropriate risk management measures at the class , substance or even the indication level and shall consider also the route of administration .


### by way of derogation from article 7 , a marketing authorisation for a veterinary medicinal product intended for a limited market shall be granted although the quality and / or efficacy documentation required in accordance with annex ii has not been provided , if all the following conditions are met : ### by way of derogation from article 7 , in exceptional circumstances related to animal or public health , including unmet needs with respect to animal health , where the applicant has demonstrated that for objective , verifiable reasons he is unable to provide the quality , safety and / or efficacy documentation required in accordance with part 1 , part 2 and part 3 of annex ii , a marketing authorisation may be granted subject to any of the following :


### the immediate packaging of a veterinary medicinal product shall contain only the following information : ### the immediate packaging of a veterinary medicinal product shall contain at least the following information :


### the competent authority shall ascertain that the manufacturers of veterinary medicinal products from third countries are able to manufacture the veterinary medicinal product concerned and / or carry out control tests in accordance with the methods described in the documentation submitted in support of the application in accordance with article 7 . ### the competent authority shall ascertain that the manufacturers of veterinary medicinal products from third countries comply with eu legislation applicable , are able to manufacture the veterinary medicinal product concerned and / or carry out control tests in accordance with the methods described in the documentation submitted in support of the application in accordance with article 7 .


### 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 :


### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting a food - producing animal of a non - aquatic species , the veterinarian responsible may , under his direct personal responsibility and in particular to avoid causing unacceptable suffering , exceptionally treat the animal concerned with any of the following : ### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting a food - producing animal of a non - aquatic species , the veterinarian responsible may , under his direct personal responsibility and in particular to avoid causing unacceptable suffering , exceptionally treat the animal concerned with any of the following , excepting antimicrobial products used as a routine preventative measure :


### its purpose is to be used in or administered to animals with a view to restoring , correcting or modifying physiological functions by exerting a pharmacological , immunological or metabolic action , or to making a medical diagnosis ; ### it may be used in , or administered to , animals with a view either to restoring , correcting or modifying physiological functions by exerting a pharmacological , immunological or metabolic action , or to making a medical diagnosis ;


### the agency shall establish and maintain a union database on pharmacovigilance of veterinary medicinal products . ### the agency shall establish and maintain a union database on pharmacovigilance of veterinary medicinal products that is linked with the product database .


### where a variation is approved in accordance with article 65 extending the marketing authorisation to another species listed in article 34 , the period of the protection provided for in that article shall be prolonged by 1 year for each additional target species , provided that the variation has been submitted at least 3 years before the expiration of the protection period laid down in article 34 . ### where the first marketing authorisation is granted for more than one species or a variation is approved in accordance with article 65 extending the marketing authorisation to another species listed in article 34 , the period of the protection provided for in article 34 shall be prolonged by two years for each additional target species , provided that the variation has been submitted at least 3 years before the expiration of the protection period laid down in article 34 .


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


### 10 years for the veterinary medicinal products for cattle , sheep , pigs , chickens , dogs and cats ; ### 10 years for the veterinary medicinal products for cattle , sheep reared for meat , pigs , chickens , dogs and cats .


### a harmonised summary of product characteristics shall be prepared in accordance with the procedure laid down in article 69 for veterinary medicinal products , other than homeopathic veterinary medicinal products , which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and for which national marketing authorisations have been granted in different member states before 1 january 2004 . ### a harmonised summary of product characteristics including key elements of the application as defined in article 7 relating to the quality of the product shall be prepared in accordance with the procedure laid down in article 69 for groups of similar veterinary medicinal products , other than homeopathic veterinary medicinal products , which have the same qualitative and quantitative composition of their active substances , the same pharmaceutical form and for which national marketing authorisations have been granted in different member states .


### if an antimicrobial is administered and used incorrectly , this presents a risk to public or animal health . therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription . persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials and consequently they should not be influenced , directly or indirectly , by economic incentives when prescribing those products . therefore the supply of veterinary antimicrobials by those health professionals should be restricted to the amount required for treatment of the animals under their care . ### if an antimicrobial is administered and used incorrectly , this presents a risk to public or animal health . therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription . veterinarians are the only professional authorised to prescribe medicinal products to animals , have a key role in ensuring prudent use of antimicrobials and consequently they should not be influenced , directly or indirectly , by economic incentives when prescribing those products . therefore the supply of veterinary antimicrobials by veterinarians should be restricted to the amount required to continue the treatment until the medicinal product prescribed by the veterinarian is obtained by the farmer or by the owner and only for treatment of the animals under their care .


### 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 , and the use of which would not present a risk to public or animal health . antimicrobial products shall not be used as a routine preventive measure .


### where a veterinary medicinal product is supplied on prescription , the quantity prescribed and supplied shall be restricted to the amount required for the treatment or therapy concerned . ### where a veterinary medicinal product is supplied on prescription , the quantity prescribed and supplied shall be restricted to the amount required for the treatment or therapy concerned . the maximum quantity of veterinary medicinal products supplied at one time may not , however , exceed one month ' s treatment . for chronic diseases and for periodic treatments the maximum quantity should not exceed three month ' s treatment .


### 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 . ### if there is evidence that a constituent of a medicinal product is a hazard for the environment , a competent authority or the agency shall require the safety data concerning the potential risks simultaneously to all the marketing authorisation holders concerned .


### 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 , the use of which would not present a risk to public or animal health , and not as a routine preventative measure .


### 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 .