### there are a number of barriers which hinder the provision of these services to consumers temporarily present in another member state . certain online services include content such as music , games or films which are protected by copyright and / or related rights under union law . in particular , the obstacles to cross - border portability of online content services stem from the fact that the rights for the transmission of content protected by copyright and / or related rights such as audiovisual works are often licensed on a territorial basis as well as from the fact that online service providers may choose to serve specific markets only . ### there are a number of barriers which hinder the provision of these services to consumers temporarily present in another member state . certain online services include content such as music , games or films which are protected by copyright and / or related rights under union law . in particular , the obstacles to cross - border portability of online content services stem from the fact that the rights for the transmission of content protected by copyright and / or related rights such as audiovisual works are often licensed on a territorial basis as well as from the fact that online service providers may choose to serve specific markets only . nonetheless , territorial licences play a key role in the financing and production of cultural content tailored to the eu ' s various markets , especially in the world of tv and cinema , thus making a decisive contribution to european cultural diversity .


### therefore , the objective of this regulation is to adapt the legal framework in order to ensure that the licensing of rights no longer presents barriers to cross - border portability of online content services in the union and that the cross - border portability can be ensured . ### therefore , the objective of this regulation is to adapt the legal framework on copyright and related rights in order to provide and ensure cross - border portability of online content services in the union to subscribers temporarily present in member states other than their member state of residence , without undermining the principle of territoriality as it plays a key role in the financing , production and distribution of european audiovisual content .


### this regulation should , therefore , apply to online content services that a service provider , after having obtained the relevant rights from right holders in a given territory , provides to its subscribers on the basis of a contract , by any means including streaming , downloading or any other technique which allows use of that content . a registration to receive content alerts or a mere acceptance of html cookies should not be regarded as a contract for the provision of online content service for the purposes of this regulation . ### this regulation should , therefore , apply to online content services that a service provider , after having obtained the relevant rights from right holders in a given territory , provides to its subscribers on the basis of a contract , by any means including streaming , downloading or any other technique which allows use of that content . a registration to receive content alerts or a mere acceptance of html cookies should not be regarded as a contract for the provision of online content service for the purposes of this regulation . online content services provided on the basis of pan - european licences under directive 2014 / 26 / eu shall also be excluded from the scope of this regulation .


### this regulation should apply only to online content services which subscribers can effectively access and use in the member state in which they habitually reside without being limited to a specific location , as it is not appropriate to require service providers that do not offer portable services in their home country to do so across borders . ### this regulation should apply only to online content services which subscribers can effectively access and use in the member state in which they habitually reside without being limited to a specific location , as it is not appropriate to require service providers that are not able to offer portable services in their home country to do so across borders . nevertheless , in order for this regulation to have a meaningful and practical impact on the life of end - users , it is important that rights holders increasingly are encouraged to allow service providers to offer portable services at national level .


### in order to ensure the cross - border portability of online content services it is necessary to require that online service providers enable their subscribers to use the service in the member state of their temporary presence by providing them access to the same content on the same range and number of devices , for the same number of users and with the same range of functionalities as those offered in their member state of residence . this obligation is mandatory and therefore the parties may not exclude it , derogate from it or vary its effect . any action by a service provider which would prevent the subscriber from accessing or using the service while temporarily present in a member state , for example restrictions to the functionalities of the service or to the quality of its delivery , would amount to a circumvention of the obligation to enable cross - border portability of online content services and therefore would be contrary to this regulation . ### in order to ensure the cross - border portability of online content services it is necessary to require that online service providers enable their subscribers to use the service in the member state of their temporary presence by providing them access to the same content on the same range and number of devices , for the same number of users and with the same range of functionalities as those offered in their member state of residence . this obligation is mandatory and therefore the parties may not exclude it , derogate from it or vary its effect . any action by a service provider which would prevent the subscriber from accessing or using the service while temporarily present in a member state other than the member state of residence , for example restrictions to the functionalities of the service or to the quality of its delivery , would amount to a circumvention of the obligation to enable cross - border portability of online content services and therefore would be contrary to this regulation .


### in order to ensure that providers of online content services comply with the obligation to provide cross - border portability of their services without acquiring the relevant rights in another member state , it is necessary to stipulate that those service providers which lawfully provide portable online content services in the member state of residence of subscribers are always entitled to provide such services to those subscribers when they are temporarily present in another member state . this should be achieved by establishing that the provision , the access to and the use of such online content service should be deemed to occur in the member state of the subscriber ' s residence . ### in order to ensure that providers of online content services comply with the obligation to provide cross - border portability of their services without acquiring the relevant rights in another member state , it is necessary to stipulate that those service providers which lawfully provide portable online content services in the member state of residence of subscribers are always entitled to provide such services to those subscribers when they are temporarily present in another member state . this should be achieved by establishing that the provision , the access to and the use of such online content service should be deemed to occur in the member state of the subscriber ' s residence . this regulation does not prevent a provider from offering its subscriber who is temporarily present in another member state an online content service that the provider lawfully provides in that member state .


### service providers should ensure that their subscribers are properly informed about the conditions of enjoyment of online content services in member states other than the member state of residence of the subscribers . the regulation enables right holders to require that the service provider make use of effective means in order to verify that the online content service is provided in conformity with this regulation . it is necessary , however , to ensure that the required means are reasonable and do not go beyond what is necessary in order to achieve this purpose . examples of the necessary technical and organisational measures may include sampling of ip address instead of constant monitoring of location , transparent information to the individuals about the methods used for the verification and its purposes , and appropriate security measures . considering that for purposes of the verification what matters is not the location , but rather , in which member state the subscriber is accessing the service , precise location data should not be collected and processed for this purpose . similarly , where authentication of a subscriber is sufficient in order to deliver the service provided , identification of the subscriber should not be required . ### service providers within the scope of this regulation should be obliged to make use of effective means in order to verify the member state of residence of their subscribers . to that effect , the providers should rely on the verification means listed in this regulation . providers and right holders should be allowed to enter into agreements on particular verification means , whether listed or not in this regulation . the use of such means should always be reasonable and should not go beyond what is necessary in order to achieve the purpose of establishing the member state of residence .


### this regulation respects fundamental rights and observes the principles recognised in the charter of fundamental rights of the european union . accordingly , this regulation should be interpreted and applied in accordance with those rights and principles , in particular the right to respect for private and family life , the right to protection of personal data , the freedom of expression and the freedom to conduct a business . any processing of personal data under this regulation should respect fundamental rights , including the right to respect for private and family life and the right to protection of personal data under articles 7 and 8 of the charter of fundamental rights of the european union and must be in compliance with directives 95 / 46 / ec27 and 2002 / 58 / ec28 . in particular , service providers must ensure that any processing of personal data under this regulation must be necessary and proportionate in order to achieve the relevant purpose . _________________ 27 directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data oj l 281 , 23 . 11 . 1995 , p . 31–50 . 28 directive 2002 / 58 / ec of the european parliament and of the council of 12 july 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector , called , as amended by directives 2006 / 24 / ec and 2009 / 136 / ec , the ' e - privacy directive ' . ### this regulation respects fundamental rights and observes the principles recognised in the charter of fundamental rights of the european union . accordingly , this regulation should be interpreted and applied in accordance with those rights and principles , in particular the right to respect for private and family life , the right to protection of personal data , the right to property , including intellectual property rights , the freedom of expression and the freedom to conduct a business . any processing of personal data under this regulation should respect fundamental rights , including the right to respect for private and family life and the right to protection of personal data under articles 7 and 8 of the charter of fundamental rights of the european union and must be in compliance with directives 95 / 46 / ec27 and 2002 / 58 / ec28 . in particular , service providers must ensure that any processing of personal data under this regulation must be necessary and proportionate in order to achieve the relevant purpose . _________________ 27 directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data oj l 281 , 23 . 11 . 1995 , p . 31–50 . 28 directive 2002 / 58 / ec of the european parliament and of the council of 12 july 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector , called , as amended by directives 2006 / 24 / ec and 2009 / 136 / ec , the ' e - privacy directive ' .


### this regulation should not affect the application of the rules of competition , and in particular articles 101 and 102 of the treaty . the rules provided for in this regulation should not be used to restrict competition in a manner contrary to the treaty . ### this regulation should not affect the application of the rules of competition , and in particular articles 101 and 102 of the treaty . the rules provided for in this regulation should not be used to restrict competition in a manner contrary to the treaty . nor shall this regulation apply to online content services for which pan - european licences already exist under directive 2014 / 26 / eu .


### this regulation introduces a common approach to ensuring that subscribers to online content services in the union , when temporarily present in a member state , can access and use these services . ### this regulation introduces a common approach in the union to ensuring that subscribers to portable online content services in their member states of residence can access and use these services when temporarily present in a member state .


### the provider of an online content service shall inform the subscriber of the quality of delivery of the online content service provided in accordance with paragraph 1 . ### the provider and the related holders of copyright of an online content service subject to payment or without payment of money but subject to prior certification of the subscriber ' s country of residence shall not prevent a subscriber who is temporarily present in a member state from accessing and using the online content service .


### member states shall allow intermediaries to charge prices or fees for the service to be provided under this chapter . intermediaries shall publicly disclose prices , fees and any other charges separately for each service referred to in this chapter . ### member states shall allow intermediaries to charge prices or fees for the service to be provided under articles 3b and 3c of this chapter . member states may allow intermediaries to charge prices or fees for the service to be provided under article 3a of this chapter . member states shall ensure that prices and fees for the services to be provided under this chapter are affordable and reasonable . intermediaries shall publicly disclose , separately for each service , prices , fees and any other charges for the services referred to in this chapter .


### the commission shall submit the shortlist to the european parliament for approval . following the approval of that shortlist , the council shall adopt a decision to appoint the full time members of the executive board including the member in charge . the executive board shall be balanced and proportionate and shall reflect the union as a whole . ### the selection committee shall submit the shortlists of candidates for the position of the member of the executive board to the european parliament and the council . the european parliament may invite the selected candidates to in camera public hearings , submit written questions to the candidates , object to the designation of a candidate and recommend its preferred candidate . the european parliament and the council shall adopt a joint decision to appoint the members of the executive board from the shortlists of candidates . the executive board shall be gender - balanced , proportionate and shall reflect the union as a whole .


### one member of the executive board , the representative of the commission and the esrb shall be invited to the meetings of the joint committee , as well as of any sub - committees referred to in article 57 , as observers . ; ### one member of the executive / management board , a representative of the commission and the second chair of the esrb and , where relevant , the chairperson of any sub - committee of the joint committee shall be invited to the meetings of the joint committee , as well as where relevant of any sub - committees referred to in article 57 , as observers .


### a balancing contribution from the union , entered in the general budget of the union which shall not exceed 40% of the estimated revenues of the authority ; ### a balancing contribution from the union , entered in the general budget of the union which shall be at least 35% of the estimated revenues of the authority covering regulatory tasks ;


### when carrying out its tasks in accordance with this regulation , the authority shall take account of technological innovation , innovative and sustainable business models , and the integration of environmental , social and governance related factors ; ### when carrying out its tasks in accordance with this regulation , the authority shall take account of technological and social innovation , innovative and sustainable business models such as cooperatives and mutuals , and the integration of environmental , social and governance related factors ;


### regulation 2015 / 2120 establishes a new retail pricing mechanism for union - wide regulated roaming services in order to abolish retail roaming surcharges without distorting domestic and visited markets . ### regulation 2015 / 2120 establishes a new retail pricing mechanism for union - wide regulated roaming services in order to abolish retail roaming surcharges without distorting domestic and visited markets as there is no justification for roaming charges in a europe without borders ;


### regulation 2015 / 2120 establishes a new retail pricing mechanism for union - wide regulated roaming services in order to abolish retail roaming surcharges without distorting domestic and visited markets . ### regulation 2015 / 2120 establishes a new retail pricing mechanism for union - wide regulated roaming services in order to abolish retail roaming surcharges as of 15 june 2017 without distorting domestic and visited markets .


### it is necessary to monitor and regularly review the functioning of wholesale roaming markets and their interrelationship with the retail roaming market , taking into account competitive and technological developments and traffic flows . in order to properly assess how roaming markets will adapt to rlah rules , sufficient data should be gathered on functioning of these markets after the implementation of these rules . ### it is necessary to monitor and regularly review the functioning of wholesale roaming markets and their interrelationship with the retail roaming market , taking into account competitive and technological developments and traffic flows . this should include both an assessment of any emergence of tariff plans that include only domestic services and exclude roaming services altogether , thus undermining the very objective of rlah and an assessment of any reduction in the availability of flat - rate tariff plans , which could also represent a loss for consumers and undermine the objectives of the digital single market . also , as in its report on the review of the wholesale roaming market of 15 june 2016 , the commission ' s biennial reports should assess the ability of visited network operators to recover all costs of providing regulated wholesale roaming services , and propose correction mechanisms to remedy the situation in the event that this happens . in addition , the commission should assess the ability of domestic network operators to recover their costs of providing regulated roaming services from their revenues from the provision of such services , and the extent to which retail roaming surcharges have been authorised by national regulatory authorities under the sustainability mechanism . in order to properly assess how roaming markets will adapt to rlah rules , sufficient data should be gathered on functioning of these markets after the implementation of these rules .


### health technology assessment is an evidence - based process that allows competent authorities to determine the relative effectiveness of new or existing technologies . hta focuses specifically on the added value of a health technology in comparison with other new or existing health technologies . ### health technology assessment is an evidence - based , multidisciplinary process that allows competent authorities to determine the relative effectiveness of new or existing health technologies and should be carried out in a systematic , independent and transparent manner . hta focuses specifically on the added value of a health technology in comparison with other new or existing health technologies .


### hta covers both clinical and non - clinical aspects of a health technology . the eu co - funded joint actions on hta have identified nine domains by reference to which health technologies are assessed . of these nine domains , four are clinical and five are non - clinical . the four clinical domains of assessment concern the identification of a health problem and current technology , the examination of the technical characteristics of the technology under assessment , its relative safety , and its relative clinical effectiveness . the five non - clinical assessment domains concern cost and economic evaluation of a technology , its ethical , organisational , social , and legal aspects . the clinical domains are therefore more suited to joint assessment at eu - level on their scientific evidence base , while the assessment of non - clinical domains tends to be more closely related to national and regional contexts and approaches . ### hta covers both clinical and non - clinical aspects of a health technology . the eu co - funded joint actions on hta have identified nine domains by reference to which health technologies are assessed . of these nine domains , four are clinical and five are non - clinical . the four clinical domains of assessment concern the identification of a health problem and current technology , the examination of the technical characteristics of the technology under assessment , its relative safety , and its relative clinical effectiveness . the five non - clinical assessment domains concern cost and economic evaluation of a technology , its ethical , organisational , social , and legal aspects . the clinical domains are therefore more suited to joint assessment at eu - level on their scientific evidence base . the assessment of non - clinical domains should closely related to national and regional contexts , approaches and competences .


### the outcome of hta is used to inform decisions concerning the allocation of budgetary resources in the field of health , for example , in relation to establishing the pricing or reimbursement levels of health technologies . hta can therefore assist member states in creating and maintaining sustainable healthcare systems and to stimulate innovation that delivers better outcomes for patients . ### hta can assist member states in creating and maintaining sustainable and comprehensive healthcare systems while stimulating innovation and increasing sector competitiveness , which will ultimately deliver better outcomes for patients .


### the european parliament , in its resolution of 2 march 2017 on eu options for improving access to medicines , 9 called on the commission to propose legislation on a european system for health technology assessment as soon as possible and to harmonise transparent health technology assessment criteria in order to assess the added therapeutic value of medicines . _________________ 9 european parliament resolution of 2 march 2017 on eu options for improving access to medicines – 2016 / 2057 . ### the european parliament , in its resolution of 2 march 2017 on eu options for improving access to medicines , 9 called on the commission to propose legislation on a european system for health technology assessment as soon as possible and to harmonise transparent health technology assessment criteria in order to assess the added therapeutic value of health technologies compared with the best available alternative taking into account the level of innovation and value for the patients . _________________ 9 european parliament resolution of 2 march 2017 on eu options for improving access to medicines – 2016 / 2057 .


### in accordance with article 168 of the treaty on the functioning of the european union , the member states remain responsible for the organisation and delivery of their healthcare . as such , it is appropriate to limit the scope of union rules to those aspects of hta that relate to the clinical assessment of a health technology , and in particular , to ensure that the assessment conclusions are confined to findings relating to the comparative effectiveness of a health technology . the outcome of such assessments should not therefore affect the discretion of member states in relation to subsequent decisions on pricing and reimbursement of health technologies , including the fixing of criteria for such pricing and reimbursement which may depend on both clinical and non - clinical considerations , and which remain solely a matter of national competence . ### in accordance with article 168 of the treaty on the functioning of the european union , the member states remain responsible for the organisation and delivery of their healthcare . as such , it is appropriate to limit the scope of union rules to those aspects of hta that relate to the clinical assessment of a health technology . in this connection , the joint clinical assessment provided for by this regulation constitutes a scientific analysis of the relative effects of health technology on clinical outcomes , evaluated in relation to the chosen comparative indicators and chosen groups or subgroups of patients , taking into account the hta core model criteria . this will include consideration of the degree of certainty on the relative outcomes , based on the available evidence . the outcome of such joint clinical assessments should not therefore affect the discretion of member states in relation to subsequent decisions on pricing and reimbursement of health technologies , including the fixing of criteria for such pricing and reimbursement which may depend on both clinical and non - clinical considerations , and which remain solely a matter of national competence . the assessment conducted by each member state as part of its national appraisal should therefore fall outside the scope of this proposal .


### a coordination group composed of representatives from member states ' health technology assessment authorities and bodies should be established with responsibility for overseeing the carrying out of joint clinical assessments and other joint work . ### a coordination group composed of representatives from member states ' health technology assessment of national and regional authorities and bodies should be established with responsibility for overseeing the carrying out of joint clinical assessments and other joint work .


### in order to ensure a member - state led approach to joint clinical assessments and scientific consultations , member states should designate national hta authorities and bodies which inform decision - making as members of the coordination group . the designated authorities and bodies should ensure an appropriately high level of representation in the coordination group and technical expertise in its sub - groups , taking into account the need to provide expertise on the hta of medicinal products and medical devices . ### in order to ensure a member - state led approach to joint clinical assessments and scientific consultations , member states should designate national hta authorities and bodies which inform decision - making as members of the coordination group . the designated authorities and research bodies should ensure an appropriately high level of representation in the coordination group and technical expertise in its sub - groups , taking into account the need to provide expertise on the hta of medicinal products and medical devices .


### in order that the harmonised procedures fulfil their internal market objective , member states should be required to take full account of the results of joint clinical assessments and not repeat those assessments . compliance with this obligation does not prevent member states from carrying out non - clinical assessments on the same health technology , or from drawing conclusions on the added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as non - clinical data and criteria . it also does not prevent member states from forming their own recommendations or decisions on pricing or reimbursement . ### in order that the harmonised procedures fulfil their internal market objectives , increase the efficiency of clinical evaluations , contribute to the sustainability of healthcare systems and maximise innovation , member states should be required to take full account of the joint clinical assessment results . compliance with this obligation does not prevent member states from carrying out additional clinical analyses to the extent that they are missing from the joint clinical assessment and are deemed necessary within the national health technology assessment context . member states remain free to carry out non - clinical assessments on the same health technology , or from drawing conclusions on the added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as non - clinical data and criteria . it also does not prevent member states from forming their own recommendations or decisions on pricing or reimbursement .


### the establishment of a time - frame for the joint clinical assessments for medical devices should take into account the highly decentralised market access pathway for medical devices and the availability of appropriate evidence data required to carry out a joint clinical assessment . as the required evidence may only become available after a medical device has been placed on the market and in order to allow for the selection of medical devices for joint clinical assessment at an appropriate time , it should be possible for assessments of such devices to take place following market launch of medical devices . ### the establishment of a time - frame for the joint clinical assessments for medical devices should take into account the highly decentralised market access pathway for medical devices and the availability of appropriate evidence data required to carry out a joint clinical assessment . as the required evidence may only become available after a medical device has been placed on the market and in order to allow for the selection of medical devices for joint clinical assessment at an appropriate time , it should be possible for assessments of such devices to take place following market launch of medical devices and , if possible , in the presence of producers .


### in order to ensure a uniform approach to the joint work provided for in this regulation , implementing powers should be conferred on the commission to establish a common procedural and methodological framework for clinical assessments , procedures for joint clinical assessments and procedures for joint scientific consultations . where appropriate , distinct rules should be developed for medicinal products and medical devices . in the development of such rules , the commission should take into account the results of the work already undertaken in the eunethta joint actions . it should also take into account initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta such as the beneluxa and valletta declaration initiatives . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council . 13 __________________ 13 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers . ### in order to ensure a uniform approach to the joint work provided for in this regulation , the coordination group together with the commission should establish a common procedural and methodological framework for clinical assessments , procedures for joint clinical assessments and procedures for joint scientific consultations . where appropriate , distinct rules should be developed for medicinal products and medical devices . in the development of such rules , the commission and the coordination group should take into account the results of the work already undertaken in the eunethta joint actions and in particular the methodological guidelines and evidence submission template . it should also take into account initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta such as the beneluxa and valletta declaration initiatives . in order to ensure uniform conditions for the implementation of this regulation , implementing powers should be conferred on the commission to establish procedures for joint clinical assessments and procedures for joint scientific consultations . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council . 13 the procedural and methodological framework are updated at the frequency deemed necessary by the commission and the coordination group to ensure that they should be adapted to the evolution of science . in developing the methodological framework , the commission and in collaboration with the coordination group should consider the specificity and corresponding challenges of certain types of health technologies , advanced therapies or life - prolonging therapies where innovative clinical study designs may be required . these may result in evidential uncertainty at the time of the marketing authorization . as such innovative clinical study designs are often accepted for the purposes of regulatory assessments , the methodology for joint clinical assessments should not prevent these health technologies from reaching patients . the commission and the coordination group should therefore ensure that the methodology provides for a sufficient level of clinical evidence to enable an adequate assessment of such health technologies . such clinical evidence should include the acceptance of the best available scientific evidence at the time of the submission , including , for instance , data from case control studies , real world evidence , as well as the acceptance of indirect treatment comparators . __________________ 13 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers .


### in order to ensure that this regulation is fully operational and to adapt it to technical and scientific development , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the contents of documents to be submitted , reports , and summary reports of clinical assessments , the contents of documents for requests , and reports of joint scientific consultations , and the rules for selecting stakeholders . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law - making of 13 april 2016 . 14 in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council should receive all documents at the same time as member states ' experts , and their experts systematically should be granted access to meetings of commission expert groups dealing with the preparation of delegated acts . __________________ 14 interinstitutional agreement between the european parliament , the council of the european union and the european commission of 13 april 2016 on better law - making . ### in order to ensure that this regulation is fully operational and to adapt it to technical and scientific development , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the contents of documents to be submitted , reports , and summary reports of clinical assessments , the contents of documents for requests , and reports of joint scientific consultations , and the rules for selecting stakeholders , but with the obligation to periodically inform the european parliament and the council of these documents and reports . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law - making of 13 april 2016 . 14 in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council should receive all documents at the same time as member states ' experts , and their experts systematically should be granted access to meetings of commission expert groups dealing with the preparation of delegated acts . __________________ 14 interinstitutional agreement between the european parliament , the council of the european union and the european commission of 13 april 2016 on better law - making .


### member states shall designate their national authorities and bodies responsible for health technology assessment as members of the coordination group and its sub - groups and inform the commission thereof and of any subsequent changes . member states may designate more than one authority or body responsible for health technology assessment as members of the coordination group and one or more of its sub - groups . ### member states shall designate their national authorities and bodies responsible for health technology assessment which inform decision - making as members of the coordination group and its sub - groups and inform the commission thereof and of any subsequent changes . member states shall designate more than one authority or body responsible for health technology assessment which inform decision - making at national level as members of the coordination group and one or more of its sub - groups .


### members of the coordination group , and their appointed representatives shall respect the principles of independence , impartiality , and confidentiality . ### members of the coordination group , and their appointed representatives shall respect the principles of transparency , independence , impartiality , and confidentiality of specific information .


### ensure cooperation with relevant union level bodies to facilitate additional evidence generation necessary for its work ; ### ensure cooperation with all relevant union level bodies to facilitate additional evidence generation necessary for its work ;


### cooperation with the notified bodies and expert panels on the preparation and update of joint clinical assessments of medical devices . ### cooperation between the european medicines agency and the coordination group on the preparation and update of joint clinical assessments of medicinal products . this cooperation shall take into account that the coordination group , due to its competences in clinical aspects , is the competent body to detect and prioritise the emerging technologies based on impact on health .


### the designated sub - group shall appoint from among its members , an assessor and a co - assessor , with responsibility for conducting the joint scientific consultation . the appointments shall take into account the scientific expertise necessary for the assessment . ### the designated sub - group shall appoint from among its members , an assessor and a co - assessor , from different member states , with responsibility for conducting the joint scientific consultation . the appointments shall take into account the scientific expertise necessary for the assessment .


### the commission shall organise ad - hoc meetings between the stakeholder network and the coordination group in order to : ### the commission shall organise meetings on a regular basis between the stakeholder network and the coordination group in order to :


### update stakeholders on the work of the group ; ### update stakeholders on the work of the group ; all members of the stakeholder network shall have access to all relevant data and information ;


### provide for an exchange of information on the work of the coordination group . ### provide for an exchange of information between the coordination group and the stakeholder network .


### the high functionality and relatively low cost of plastic means that this material is increasingly ubiquitous in everyday life . its growing use in short - lived applications , which are not designed for re - use or cost - effective recycling means that related production and consumption patterns have become increasingly inefficient and linear . therefore , in the context of the circular economy action plan32 , the commission concluded in the european strategy for plastics33that the steady increase in plastic waste generation and its leakage into our environment , in particular into the marine environment , must be tackled in order to achieve a truly circular lifecycle for plastics . _________________ 32 communication from the commission to the european parliament , the council , the european economic and social committee and the committee of the regions ' closing the loop – an eu action plan for the circular economy ' 0614 final ) . 33 communication from the commission to the european parliament , the council , the european economic and social committee and the committee of the regions ' a european strategy for plastics in a circular economy ' 28 final ) . ### the high functionality and relatively low cost of plastic means that this material is increasingly ubiquitous in everyday life . its growing use in short - lived applications , which are not designed for re - use or cost - effective recycling means that related production and consumption patterns have become increasingly inefficient and linear . therefore , in the context of the circular economy action plan32 , the commission concluded in the european strategy for plastics33 that the steady increase in plastic waste generation and its leakage into our environment , in particular waste which , even if not consumed or used near the sea or the ocean , adversely affects the marine environment , must be tackled in order to achieve a truly circular lifecycle for plastics . _________________ 32 communication from the commission to the european parliament , the council , the european economic and social committee and the committee of the regions : closing the loop - an eu action plan for the circular economy 0614 final ) . 33 communication from the commission to the european parliament , the council , the european economic and social committee and the committee of the regions ' a european strategy for plastics in a circular economy ' 28 final ) .


### marine litter is of a transboundary nature and is recognized as a global problem . reducing marine litter is a key action for the achievement of united nations sustainable development goal 14 which calls to conserve and sustainably use the oceans , seas and marine resources for sustainable development . 36the union must play its part in tackling marine litter and aim to be a standard setter for the world . in this context , the union is working with partners in many international fora such as g20 , g7 and united nations to promote concerted action . this initiative is part of the union efforts in this regard . _________________ 36 the 2030 agenda for sustainable development adopted by the united nations general assembly on 25 september 2015 . ### marine litter is of a transboundary nature and is recognized as a global problem . increasing amounts of waste are reaching the oceans around the world and affecting the health of ecosystems , killing animals and endangering human health . reducing marine litter is a key action for the achievement of united nations sustainable development goal 14 which calls to conserve and sustainably use the oceans , seas and marine resources for sustainable development36 . the union must play its part in tackling and preventing the production of litter and managing marine litter more effectively and aim to be a standard setter for the world . in this context , the union is working with partners in many international fora such as g20 , g7 and united nations to promote concerted action . this initiative is part of the union efforts in this regard .


### in the union , 80 to 85 % of marine litter , measured as beach litter counts , is plastic , with single - use plastic items representing 50 % and fishing - related items representing 27 % . single - use plastics products include a diverse range of commonly used fast - moving consumer products that are discarded after having been used once for the purpose for which they were provided , are rarely recycled , and are prone to littering . a significant proportion of the fishing gear placed on the market is not collected for treatment . single - use plastic products and fishing gear containing plastic are therefore a particularly serious problem in the context of marine litter and pose a severe risk to marine ecosystems , biodiversity and , potentially , to human health and are damaging activities such as tourism , fisheries and shipping . ### in the union , 80 to 85 % of marine litter , measured as beach litter counts , is plastic , with single - use plastic items representing 50 % and fishing - related items representing 27 % . single - use plastics products include a diverse range of commonly used fast - moving consumer products that are discarded after having been used once for the purpose for which they were provided , are rarely recycled , and are prone to littering . a significant proportion of the fishing gear placed on the market is not collected for treatment . single - use plastic products and fishing gear containing plastic are therefore a particularly serious problem in the context of marine litter and pose a severe risk to marine ecosystems , biodiversity and , potentially , to human health and are damaging activities such as tourism , fisheries and shipping . it should nonetheless be emphasised that the use of plastics in food containers for human consumption is highly regulated in the eu .


### the single - use plastic products should be addressed by one or several measures , depending on various factors , such as the availability of suitable and more sustainable alternatives , the feasibility to change consumption patterns , and the extent to which they are already covered by existing union legislation . ### the single - use plastic products must be addressed by one or several measures , depending on various factors , such as the availability of suitable and more sustainable alternatives , the feasibility to change consumption patterns , and the extent to which they are already covered by existing union legislation , bearing in mind inter alia the environmental and economic impact of the choice of alternative materials , particularly in farming .


### certain single - use plastic products end up in the environment as a result of inappropriate disposal through sewers or other inappropriate release into the environment . therefore , single - use plastic products that are frequently disposed of through sewers otherwise inappropriately disposed of should be subject to marking requirements . the marking should inform consumers about appropriate waste disposal options and / or waste disposal options to be avoided and / or about the negative environmental impacts of litter as a result of inappropriate disposal . the commission should be empowered to establish a harmonised format for the marking and when doing so should , where appropriate , test the perception of the proposed marking with representative groups of consumers to ensure that it is effective and clearly understandable . ### certain single - use plastic products end up in the environment as a result of inappropriate disposal through sewers or other inappropriate release into the environment . given their nature , these products are covered by directive 91 / 271 / eec on urban waste water treatment , but remain a primary cause of the problems of pollution and incorrect disposal in waste water , as well as rainwater run - off . therefore , single - use plastic products that are frequently disposed of through sewers otherwise inappropriately disposed of should be subject to marking requirements . the marking should inform consumers about appropriate waste disposal options and / or waste disposal options to be avoided and / or about the negative environmental impacts of litter as a result of inappropriate disposal . the commission should be empowered to establish a harmonised format for the marking and when doing so should , where appropriate , test the perception of the proposed marking with representative groups of consumers to ensure that it is effective and clearly understandable .


### certain single - use plastic products end up in the environment as a result of inappropriate disposal through sewers or other inappropriate release into the environment . therefore , single - use plastic products that are frequently disposed of through sewers otherwise inappropriately disposed of should be subject to marking requirements . the marking should inform consumers about appropriate waste disposal options and / or waste disposal options to be avoided and / or about the negative environmental impacts of litter as a result of inappropriate disposal . the commission should be empowered to establish a harmonised format for the marking and when doing so should , where appropriate , test the perception of the proposed marking with representative groups of consumers to ensure that it is effective and clearly understandable . ### certain single - use plastic products end up in the environment as people are unaware of their presence or the consequences of using them , or as a result of their inappropriate disposal through sewers or other inappropriate release into the environment . therefore , single - use plastic products that are frequently disposed of through sewers otherwise inappropriately disposed of should be subject to marking requirements . the marking should inform consumers about appropriate waste disposal options and / or waste disposal options to be avoided and / or about the negative environmental impacts of litter as a result of inappropriate disposal . the commission should be empowered to establish a harmonised format for the marking and when doing so should , where appropriate , test the perception of the proposed marking with representative groups of consumers to ensure that it is effective and clearly understandable .


### 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 to prevent and reduce the impact and presence of certain plastic products in and 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 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 to prevent and reduce the impact of plastic products on the environment , in particular the aquatic and land environment , and on human health and the ecosystem , 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 .


### member states shall take the necessary measures to achieve a significant reduction in the consumption of the single - use plastic products listed in part a of the annex on their territory by … [ six years after the end - date for transposition of this directive ] . ### member states shall take the necessary measures to achieve a significant reduction in the supply and consumption of the single - use plastic products listed in part a of the annex on their territory by … [ six years after the end - date for transposition of this directive ] .


### those measures may include national consumption reduction targets , measures ensuring that reusable alternatives to those products are made available at the point of sale to the final consumer , economic instruments such as ensuring that single - use plastic products are not provided free of charge at the point of sale to the final consumer . those measures may vary depending on the environmental impact of the products referred to in the first subparagraph . ### those measures may include national consumption reduction targets , assessment of the impact of using alternative materials , with particular reference to those that are recyclable and are derived from agricultural and food products , measures ensuring that reusable alternatives to those products are made available at the point of sale to the final consumer , economic instruments such as ensuring that single - use plastic products are not provided free of charge at the point of sale to the final consumer . those measures may vary depending on the environmental impact of the products referred to in the first subparagraph .


### the commission may adopt an implementing act laying down the methodology for the calculation and verification of the significant reduction in the consumption of the single - use plastic products referred to in paragraph 1 . that implementing act shall be adopted in accordance with the examination procedure referred to in article 16 . ### the commission may adopt an implementing act laying down the methodology for the calculation and verification of the significant reduction in the supply and consumption of the single - use plastic products referred to in paragraph 1 . that implementing act shall be adopted in accordance with the examination procedure referred to in article 16 .


### member states shall ensure that each single - use plastic product listed in part d of the annex placed on the market bears a conspicuous , clearly legible and indelible marking informing consumers of one or more of the following : ### member states shall ensure that each single - use plastic product listed in part d of the annex placed on the market bears a conspicuous , clearly legible and indelible marking informing consumers at least of one or more of the following :


### member states shall ensure that extended producer responsibility schemes are established for all single - use plastic products listed in part e of the annex placed on the union market , in accordance with the provisions on extended producer responsibility in directive 2008 / 98 / ec . ### member states shall ensure that extended producer responsibility schemes or measures are established for all single - use plastic products listed in part e of the annex placed on the union market , in accordance with the provisions on extended producer responsibility in directive 2008 / 98 / ec .


### member states shall take the necessary measures to collect separately , by 2025 , an amount of waste single - use plastic products listed in part f of the annex equal to 90% of such single - use plastic products placed on the market in a given year by weight . in order to achieve that objective member states may inter alia : ### member states shall take the necessary measures to collect separately , by 2025 , an amount of waste single - use plastic products listed in part f of the annex equal to 90% of such single - use plastic products placed on the market in a given year by weight . for the products in point ba ) the amount of the single - use plastic products collected as % of placed on the market the given year is proportionate to the standard life - span of the product . in order to achieve that objective member states may inter alia :


### member states shall take measures to inform consumers of the single - use plastic products listed in part g of the annex and fishing gear containing plastic about the following : ### member states shall take measures to inform consumers of the single - use plastic products with which this directive is concerned and fishing gear containing plastic about the following :


### the data referred to in point of the first subparagraph shall be updated annually within 12 months from the end of the reference year for which it is collected . where possible , spatial data services as defined in article 3 of directive 2007 / 2 / ec shall be used to present those data sets . ### the data referred to in point of the first subparagraph shall be updated annually within 6 months from the end of the reference year for which it is collected . where possible , spatial data services as defined in article 3 of directive 2007 / 2 / ec shall be used to present those data sets .


### the european environment agency shall publish and update a union - wide overview on the basis of the data collected by the member states , on a regular basis . the union - wide overview shall include , as appropriate , indicators for outputs , results and impacts of this directive , union - wide overview maps and member state overview reports . ### the european environment agency shall publish and update a union - wide overview on the basis of the data collected by the member states , on a regular basis . the union - wide overview shall include , as appropriate , indicators for outputs for each member state , results and impacts of this directive , union - wide overview maps and member state overview reports .


### the commission shall carry out an evaluation of this directive by &#8230 ; [ six years after the end - date for transposition of this directive ] . the evaluation shall be based on the information available in accordance with article 13 . member states shall provide the commission with any additional information necessary for the purposes of the evaluation and the preparation of the report referred to in paragraph 2 . ### the commission shall carry out an evaluation of this directive by &#8230 ; [ four years after the end - date for transposition of this directive ] . this evaluation shall include an assessment of the technological developments and the trends of&#160 ; the materials used in the products . this should include a direct and indirect environmental life cycle analysis of these materials and the resulting alternatives . it shall review the alternative materials are on the market and evaluate their environmental impact compared to single use plastic materials . the evaluation shall be based on the information available in accordance with article 13 . member states shall provide the commission with any additional information necessary for the purposes of the evaluation and the preparation of the report referred to in paragraph 2 .


### —food containers , i . e . receptacles such as boxes , with or without a cover , used to contain food that is intended for immediate consumption from the receptacle either on - the - spot or take - away without any further preparation , such as food containers used for fast food , except beverage containers , plates and packets and wrappers containing food ### —food containers , i . e . receptacles such as boxes , with or without a cover , used to contain food that is intended for immediate consumption from the receptacle either on - the - spot or take - away without any further preparation , such as food containers used for fast food , except beverage containers , plates and packets and single - use wrappers containing fresh agrofood products and meat for domestic use .


### —beverage containers , i . e . receptacles used to contain liquid such as beverage bottles including their caps and lids ### —beverage containers , i . e . receptacles used to contain liquid such as beverage bottles including their labels , caps and lids


### reflecting the importance of tackling climate change in line with the union commitments to implement the paris agreement and the united nations sustainable development goals , this regulation should contribute to mainstream climate action in the union policies and to the achievement of an overall target of 25 % of the union budget expenditures supporting climate objectives . actions under this regulation are expected to contribute 25% of its overall financial envelope to climate objectives . relevant actions will be identified during the implementation of this regulation , and the overall contribution from this regulation should be part of relevant evaluations and review processes . ### reflecting the importance of tackling climate change in line with the union commitments to implement the paris agreement and the united nations sustainable development goals , this regulation should contribute to mainstream climate action in the union policies and to the achievement of an overall target of at least 25 % of the union budget expenditures supporting climate objectives over the 2021 - 2027 period , and 30 % as soon as possible , at the latest by 2027 . actions under this regulation are expected to contribute 35% of its overall financial envelope to climate objectives . relevant actions will be identified during the implementation of this regulation , and the overall contribution from this regulation should be part of relevant evaluations and review processes .


### an external action guarantee should be established building on the existing efsd guarantee and the guarantee fund for external actions . the external action guarantee should support the efsd + operations covered by budgetary guarantees , macro - financial assistance and loans to third countries on the basis of council decision 77 / 270 / euratom71 . these operations should be supported by appropriations under this regulation , together with those under regulation no … / … and regulation no … / … , which should also cover the provisioning and liabilities arising from macro - financial assistance loans and loans to third countries referred to in article 10 of regulation eins , respectively . when funding efsd + operations , priority should be given to those which have a high impact on job creation and whose cost - benefit ratio enhances the sustainability of investment . the operations supported with the external action guarantee should be accompanied by an in - depth ex ante assessment of environmental , financial and social aspects , as appropriate and in line with the better regulation requirements . the external action guarantee should not be used to provide essential public services , which remains a government responsibility . __________________ 71 council decision 77 / 270 / euratom of 29 march 1977 empowering the commission to issue euratom loans for the purpose of contributing to the financing of nuclear power stations . ### an external action guarantee should be established building on the existing efsd guarantee and the guarantee fund for external actions . the external action guarantee should support the efsd + operations covered by budgetary guarantees , macro - financial assistance and loans to third countries on the basis of council decision 77 / 270 / euratom71 . these operations should be supported by appropriations under this regulation , together with those under regulation no … / … and regulation no … / … , which should also cover the provisioning and liabilities arising from macro - financial assistance loans and loans to third countries referred to in article 10 of regulation eins , respectively . when funding efsd + operations , priority should be given to those which have a high impact on job creation and whose cost - benefit ratio enhances the sustainability of investment . the operations supported with the external action guarantee should be accompanied by an in - depth ex ante assessment of environmental , financial and social aspects and in line with the better regulation requirements . the external action guarantee should not be used to provide essential public services , which remains a government responsibility . __________________ 71 council decision 77 / 270 / euratom of 29 march 1977 empowering the commission to issue euratom loans for the purpose of contributing to the financing of nuclear power stations .


### the financial envelope for the implementation of this regulation for the period 2021 &#8211 ; 2027 shall be eur 89 200 million in current prices . ### the financial envelope for the implementation of this regulation for the period 2021 &#8211 ; 2027 shall be eur 82 451 000 000 in 2018 prices .


### –neighbourhood at least eur 22 000 million , ### –neighbourhood at least eur 20 572 million in 2018 prices ,


### –asia and the pacific eur 10 000 million , ### –asia and the pacific eur 8 851 million in 2018 prices ,


### –americas and the caribbean eur 4 000 million , ### –americas and the caribbean eur 3 540 million in 2018 prices ,


### eur 7 000 million for thematic programmes : ### eur 6 196 million in 2018 prices for thematic programmes :


### the commission shall adopt multiannual indicative programmes referred to in articles 12 and 13 by means of implementing acts . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 35 . this procedure shall also apply to reviews referred to in paragraphs 3 , 4 and 5 of this article , which have the effect of significantly modifying the content of the multiannual indicative programme . ### the commission shall adopt multiannual indicative programmes referred to in articles 12 and 13 by means of delegated acts .


### multiannual indicative programmes for geographic programmes may be reviewed where necessary for effective implementation , in particular where there are substantive changes in the policy framework referred to in article 7 or following a crisis or post - crisis situation . ### multiannual indicative programmes for geographic programmes shall be reviewed at mid - term and , if necessary , for effective implementation at any moment , in particular in the event of substantive changes in the policy framework referred to in article 7 or following a crisis or post - crisis situation .


### the use of these funds shall be decided in accordance with the procedures established in articles 14 and 21 . ### the geographic or thematic allocation of these funds shall be decided in the framework of the annual budgetary procedure or budgetary transfers , and in accordance with the procedures established in articles 14 and 21 .


### action plans and measures shall be adopted by means of implementing acts adopted in accordance with the examination procedure referred to in article 35 . ### the commission shall be empowered to adopt action plans and measures by means of delegated acts in accordance with article 34 .


### the commission shall inform the european parliament and the council of carried over commitment appropriations in line with article 12 of the financial regulation . ### the commission shall submit to the european parliament and to the council information on appropriations which were automatically carried over , including the amounts involved , in line with article 12 of the financial regulation .


### the financial envelope referred to in article shall finance the european fund for sustainable development plus and the external action guarantee . ### the european fund for sustainable development plus and the external action guarantee shall be financed through the financial envelopes for geographic programmes referred to in article 6 . this shall not go to the detriment of other actions financed under the geographic programmes .


### the purpose of the efsd + as an integrated financial package supplying financial capacity drawing on the methods of implementation set up in article 23 , , and , shall be to support investments and increase access to financing , in order to foster sustainable and inclusive economic and social development and promote the socio - economic resilience in partner countries with a particular focus on the , eradication of poverty , sustainable and inclusive growth , the creation of decent jobs , economic opportunities , skills and entrepreneurship , socioeconomic sectors , micro , small and medium - sized enterprises as well as addressing specific socioeconomic root causes of irregular migration , in accordance with the relevant indicative programming documents . special attention shall be given to countries identified as experiencing fragility or conflict , least developed countries and heavily indebted poor countries . ### the purpose of the efsd + as an integrated financial package supplying financial capacity in the form of grants , guarantees and other financial instruments as set out in article 23 shall be to support investments and increase access to financing , in order to foster sustainable and inclusive economic and social development and promote the socio - economic resilience of partner countries with a particular focus on the eradication of poverty , sustainable and inclusive growth , the creation of decent jobs , economic opportunities , skills and entrepreneurship , socioeconomic sectors , micro , small and medium - sized enterprises as well as addressing specific root causes of migration , as well as climate action and environmental protection and management , while maximising additionality , delivering innovative products and crowding in private sector funds . 30% of the financing shall be progressively allocated to investments that contribute to climat action , renewable energy and resource efficiency . a geographical balance shall be ensured , in line with eu external action and development priorities . special attention shall be given to countries identified as experiencing fragility or conflict , least developed countries and heavily indebted poor countries .


### the provisioning rates shall be reviewed every three years from the date of application of this regulation laid down in article 40 . the commission shall be empowered to adopt delegated acts in accordance with article 34 to supplement or amend these rates . ### the provisioning rates shall be reviewed every two years starting from the date of application of this regulation laid down in article 40 . the commission shall be empowered to adopt delegated acts in accordance with article 34 to supplement or amend these rates , and the financial amounts involved .


### the external action guarantee shall support financing and investment operations compliant with the conditions set out in points to of article 209 of the financial regulation and that : ### the external action guarantee shall support financing and investment operations which address market failures or sub - optimal investment situations . operations shall also be compliant with the conditions set out in points to of article 209 of the financial regulation and that :


### eligible counterparts shall comply with the rules and conditions provided for in article 62 of the financial regulation . in the case of bodies governed by the private law of a member state or a third country which have contributed to the external action guarantee in accordance with article 28 of this regulation , preference shall be given to those bodies that disclose information related to environment , social and corporate governance criteria . ### eligible counterparts shall comply with the rules and conditions provided for in article 62 of the financial regulation . in the case of bodies governed by the private law of a member state or a third country which have contributed to the external action guarantee in accordance with article 28 of this regulation , preference shall be given to those bodies that disclose information related to environment , social , tax and corporate governance criteria .


### the annual report prepared in 2021 shall contain consolidated information from annual reports concerning the period from 2014 to 2020 on all funding from the regulations referred to in article 40 , including external assigned revenues and contributions to trust funds , and offering a breakdown of spending by country , use of financial instruments , commitments and payments . the report shall reflect the main lessons learnt and the follow - up to the recommendations of the external evaluative exercises carried out in previous years . ### the commission shall also present to the european parliament an annual report on financing and investment operations covered by the external action guarantee . that report shall be made public . it shall include the following information : an assessment of the results contributing to the purpose and objectives of this regulation ; an assessment of the financing and investment operations in operation and covered by the external action guarantee at sector , country and regional levels and their compliance with this regulation , including the risk measures and their impact on the financial and economic stability of the partners ; an assessment of the additionality and added value , the mobilisation of private sector resources , the estimated and actual outputs and the outcomes and impact of the financing and investment operations covered by the external action guarantee on an aggregated basis , including the impact on decent job creation , the eradication of poverty and on the way in which the root causes of migration are addressed ; that assessment shall include a gender analysis of the operations covered based on evidence and data broken down by gender , where possible ; an assessment of the compliance with the requirements concerning the use of the external action guarantee and of the achievement of key performance indicators established for each proposal submitted ; an assessment of the leverage effect achieved by the operations covered by the efsd plus and the external action guarantee ; the financial amount transferred to beneficiaries and an assessment of financing and investment operations by each eligible counterpart on an aggregated basis ; an assessment of the additionality and added value of financing and investment operations of the eligible counterparts , and of the aggregate risk associated with those operations ; detailed information on calls on the external action guarantee , losses , returns , amounts recovered and any other payments received , as well as overall risk exposure ; the financial reports on financing and investment operations of the eligible counterparts covered by this regulation , audited by an independent external auditor ; an assessment of the synergies and complementarity between operations covered by the external action guarantee and the second and third pillars of the eip based on relevant existing reports , with particular regard to progress made on good governance , including in the fight against corruption and illicit financial flows , respect for human rights , the rule of law and gender - responsive policies , as well as the boosting of entrepreneurship , the local business environment and local financial markets ; an assessment of the compliance of efsd guarantee operations with the internationally agreed development effectiveness principles ; an assessment of the remuneration of the guarantees ; m ) an assessment of the implementation of provisions on excluded activities and non - cooperative jurisdictions .


### the annual report prepared in 2021 shall contain consolidated information from annual reports concerning the period from 2014 to 2020 on all funding from the regulations referred to in article 40 , including external assigned revenues and contributions to trust funds , and offering a breakdown of spending by country , use of financial instruments , commitments and payments . the report shall reflect the main lessons learnt and the follow - up to the recommendations of the external evaluative exercises carried out in previous years . ### the annual report prepared in 2021 shall contain consolidated information from annual reports concerning the period from 2014 to 2020 on all funding from the regulations referred to in article 40 , including external assigned revenues and contributions to trust funds , and offering a breakdown of spending by country , use of financial instruments , commitments and payments . the report shall reflect the main lessons learnt and the follow - up to the recommendations of the independent external evaluative exercises carried out in previous years .


### evaluation ### mid - term review and evaluation


### an interim evaluation of this regulation shall be performed once there is sufficient information available about its implementation , but no later than four years after the start of the implementation of the instrument . ### no later than 31 december 2024 , a mid - term review report shall be submitted by the commission on the implementation of this regulation . it shall cover the period from 1 january 2021 to 30 june 2024 and shall focus on the achievement of the objectives of this regulation by means of indicators measuring the results delivered and the efficiency of all instruments covered under this instrument , including the european fund for sustainable development plus and the external action guarantee . this report shall in addition address the added value , the scope for simplification , the complementarity and synergies between the instruments covered by this regulation , the continued relevance of all objectives , and the contribution of the measures to consistent union external action . it shall also contain information about the leverage effect achieved by investment operations financed under the european fund for sustainable development plus .


### where appropriate evaluations shall make use of the good practise principles of the development assistance committee of the organisation for economic cooperation and development , seeking to ascertain whether the objectives have been met and to formulate recommendations with a view to improving future actions . ### the mid - term review report referred to in the first subparagraph of paragraph 1 shall be submitted to the european parliament and to the council , and shall be accompanied , if appropriate , by legislative proposals introducing the necessary modifications to this regulation . the evaluations shall also make use of the good practise principles of the development assistance committee of the organisation for economic cooperation and development , seeking to ascertain whether the objectives have been met and to formulate recommendations with a view to improving future actions .


### information , communication and publicity ### transparency , communication and public disclosure of information


### the common fisheries policy has been reformed by regulation no 1380 / 2013 of the european parliament and of the council21 . the objectives of the common fisheries policy and the requirements for data collection in the fisheries sector are set out in articles 2 and 25 of that regulation . furthermore , regulation no 508 / 2014 of the european parliament and of the council22 has reformed the structure of financial support to member states ' data collection activities . __________________ 21 regulation no 1380 / 2013 of the european parliament and of the council of 11 december 2013 on the common fisheries policy , amending council regulations no 1954 / 2003 and no 1224 / 2009 and repealing council regulations no 2371 / 2002 and no 639 / 2004 and council decision 2004 / 585 / ec . 22 regulation no 508 / 2014 of the european parliament and of the council of 15 may 2014 on the european maritime and fisheries fund and repealing council regulations no 2328 / 2003 , no 861 / 2006 , no 1198 / 2006 and no 791 / 2007 and regulation no 1255 / 2011 of the european parliament and of the council . ### the common fisheries policy has been reformed by regulation no 1380 / 2013 of the european parliament and of the council21 . the objectives of the common fisheries policy and the requirements for data collection in the fisheries sector are set out in articles 2 and 25 of that regulation . furthermore , regulation no 508 / 2014 of the european parliament and of the council22 has reformed the structure of financial support to member states ' fisheries data collection activities . __________________ 21 regulation no 1380 / 2013 of the european parliament and of the council of 11 december 2013 on the common fisheries policy , amending council regulations no 1954 / 2003 and no 1224 / 2009 and repealing council regulations no 2371 / 2002 and no 639 / 2004 and council decision 2004 / 585 / ec . 22 regulation no 508 / 2014 of the european parliament and of the council of 15 may 2014 on the european maritime and fisheries fund and repealing council regulations no 2328 / 2003 , no 861 / 2006 , no 1198 / 2006 and no 791 / 2007 and regulation no 1255 / 2011 of the european parliament and of the council .


### the definition of ' recreational fisheries ' should include all non - commercial fisheries , irrespective of their specific purpose , in order to cover all forms of fisheries that may affect fish stocks . ### the definition of ' recreational fisheries ' should include all non - commercial fisheries , irrespective of their specific purpose , in order to cover all forms of fisheries that may affect fish stocks and ecosystems , to ensure the impact and socio - economic value of such fishing is fully taken into consideration when managing fisheries .


### the definition of ' end - users ' should be aligned with the definition of ' end - users of scientific data ' appearing in regulation no 1380 / 2013 and cover also scientific bodies with an interest in the environmental aspects of fisheries management . ### the definition of ' end - users ' should be aligned with the definition of ' end - users of scientific data ' appearing in regulation no 1380 / 2013 and cover also scientific bodies and not - for - profit organisations with an interest in the environmental aspects of fisheries management .


### data needs by end - users should be identified and it should be specified which data have to be collected under this regulation . those data should include ecosystem data related to the impact of fisheries and data on the sustainability of aquaculture . to minimise administrative burden , it is also necessary to ensure that data collected under this regulation are not also collected under other eu legislation . ### data needs by end - users should be identified and it should be specified which data have to be collected under this regulation . those data should include ecosystem data related to the impact of fisheries and data on the sustainability of aquaculture , as well as socioeconomic data on fisheries and aquaculture . to minimise administrative burden , it is also necessary to ensure that data collected under this regulation are not also collected under other eu legislation .


### data needs by end - users should be identified and it should be specified which data have to be collected under this regulation . those data should include ecosystem data related to the impact of fisheries and data on the sustainability of aquaculture . to minimise administrative burden , it is also necessary to ensure that data collected under this regulation are not also collected under other eu legislation . ### data needs by end - users should be identified and it should be specified which data have to be collected under this regulation . those data should include ecosystem data related to the impact of fisheries and data on the sustainability of aquaculture . to simplify and minimise the administrative burden , it is also necessary to ensure that data collected under this regulation are not also collected under other eu legislation .


### for the purpose of verification of the implementation of data collection activities by the member states , there is a need for reporting by the member states to the commission in a specified format . ### for the purpose of verification of the implementation of data collection activities by the member states , there is a need for reporting by the member states to the commission in a clearly defined , standardised format that reduces the administrative burden .


### in view of the objective of the common fisheries policy to give more responsibility to member states and to better involve end - users in data collection , regional co - ordination should be expanded from one single meeting into a continuous process coordinated by regional co - ordination groups for each marine region . ### given that the common fisheries policy attaches particular importance to the collection and transmission of data so that fisheries management can be based on the best available scientific knowledge , it is vital that clear , reliable , accurate data be collected on fleets and their fishing activities , their environmental impact and their discards , in line with proper standardised statistical principles , and so that firms in the fisheries sector can be analysed from an economic standpoint .


### member states should determine the way they collect data , but in order to be able to combine data on a regional level , minimum requirements for data quality , coverage and compatibility should be agreed by member states at regional level . when there is general agreement on the methods at regional level , regional co - ordination groups should submit a regional work plan for adoption by commission . ### member states should determine the way they collect data , but in order to be able to combine data on a regional level , minimum requirements for data quality , coverage and compatibility should be agreed by member states at regional level . when there is general agreement on the methods at regional level , regional co - ordination groups should submit a regional work plan for adoption by commission . with that aim in view , the objectives , role and powers of the proposed regional coordination bodies and the role of the authorities with responsibility for taking the necessary measures must be clearly defined .


### member states should determine the way they collect data , but in order to be able to combine data on a regional level , minimum requirements for data quality , coverage and compatibility should be agreed by member states at regional level . when there is general agreement on the methods at regional level , regional co - ordination groups should submit a regional work plan for adoption by commission . ### member states should determine the way they collect data , but in order to be able to combine data on a regional level in a meaningful way , minimum requirements for data quality , coverage and compatibility should be agreed by member states at union level . when there is general agreement on the methods at union level , regional co - ordination groups should submit a regional work plan on the basis of that agreement for adoption by commission .


### union legislation should no longer determine the details of methodologies to be applied in collecting data . provisions on particular methods of data collection should therefore be replaced by the description of the process by which they will be determined . that process should essentially include cooperation between member states and data users in regional co - ordination groups , and validation by the commission through work plans submitted by member states . ### union legislation should no longer determine the precise details of methodologies to be applied in collecting data . provisions on particular methods of data collection should therefore be replaced by the description of the process by which they will be determined . that process should be in accordance to union minimum requirements for data quality , coverage and compatibility and essentially include cooperation between member states and data users in regional co - ordination groups , and validation by the commission through work plans submitted by member states .


### the data referred to in this regulation should be put into national computerised databases so that they are accessible to the commission and can be made available to data users . it is in the interest of all data user that data which does not allow for personal identification should be available without restrictions to any party who has an interest in its analysis . ### the data referred to in this regulation should be put into publicly available national computerised databases so that they are accessible to the commission and can be made available to data users . it is in the interest of all data user that data which does not allow for personal identification should be available without restrictions to any party who has an interest in its analysis .


### there is a need to ensure that end - users are provided with data within relatively short deadlines , as they need to provide timely advice to enable sustainable fisheries . other interested parties should also be assured to receive data within a certain deadline . ### there is a need to ensure that end - users are provided with data quickly and in a standardised form , with clear codification systems , so that they can send a rapid response as they need to provide timely advice to enable sustainable fisheries . other interested parties should also be assured to receive data within a certain deadline .


### in accordance with the principle of proportionality , it is necessary and appropriate , for the achievement of the basic objective of improving data quality , access and availability in the fisheries sector , to establish a framework for data collection , management and use . this regulation does not go beyond what is necessary in order to achieve the objectives pursued , in accordance with article 5 of the treaty on european union , ### in accordance with the principle of proportionality , it is necessary and appropriate , for the achievement of the basic objective of improving data quality , access and availability in the fisheries sector , to establish a framework and general guidelines for data collection , management and use with enough flexibility in the methods for its implementation to take account of the specifics of each case . this regulation does not go beyond what is necessary in order to achieve the objectives pursued , in accordance with article 5 of the treaty on european union ,


### for data which are to be collected under legal acts other than this one , this regulation defines only rules for use of these data ### for data which are to be collected under other legal acts relating to fisheries management , this regulation defines only rules for use of these data .


### existing time - series , ### existing time - series and the need to avoid any interruption in the chronology of data ,


### biological data on all stocks caught or by - caught by union commercial and , where appropriate , recreational fisheries in union and external waters to enable ecosystem based management and conservation as necessary for the operation of the common fisheries policy ; ### biological data on all stocks caught or by - caught by union commercial and , where appropriate , recreational fisheries in union and external waters and by commercial and recreational eel and salmon fisheries in inland waters to enable ecosystem based management and conservation as necessary for the operation of the common fisheries policy ;


### biological data on all stocks caught or by - caught by union commercial and , where appropriate , recreational fisheries in union and external waters to enable ecosystem based management and conservation as necessary for the operation of the common fisheries policy ; ### biological data on all stocks caught or by - caught , including discards , by union commercial and , where appropriate , recreational fisheries in union and external waters to enable ecosystem based management and conservation as necessary for the operation of the common fisheries policy ;


### ecosystem data to assess the impact of union fisheries on the marine ecosystem in union and external waters , including data on by - catch of non - target species , in particular species protected under international or union law , data on impacts of fisheries on marine habitats and data on impacts of fisheries on food webs ; ### subject to the limits of the spatial resolution applied to fisheries observation , ecosystem data to assess the impact of union fisheries on the marine ecosystem in union and external waters , including data on by - catch of non - target species , in particular species protected under international or union law , data on impacts of fisheries on marine habitats and data on impacts of fisheries on food webs , obtained by analysing catches ;


### data on the activity of union vessels in union and external waters , including levels of fishing and of effort and capacity of the union fleet ; ### data on union fleets and their activity in union and external waters , including levels of fishing and of effort and capacity of the union fleet ;


### avoidance of disrupting the history of survey data . ### avoidance of disrupting the history of survey data , and the need to maintain reliable time series .


### regional co - ordination groups shall consist of experts from member states , the commission , and relevant end - users of data . ### regional co - ordination groups shall consist of experts from member states , the commission , and relevant end - users of data , as well as representatives of the local authorities which have legal or economic powers in relation to fisheries .


### regional co - ordination groups shall coordinate with each other and with the commission where issues affect several regions . ### regional co - ordination groups shall coordinate with each other and with the commission where issues affect several marine regions as referred to in article 3 of this regulation .


### regional co - ordination groups may prepare joint recommendations in the form of a draft of a regional work plan regarding procedures , methods , quality assurance and quality control for collecting and processing of data as referred to in paragraph 2 and and paragraph 4 of article 5 , and regionally coordinated sampling strategies . in doing so , the regional co - ordination groups shall take into account the opinion of stecf when relevant . those recommendations shall be submitted to the commission , which shall verify whether the draft joint recommendations are compatible with the provisions of this regulation and with the union ' s multiannual programme and , if so , approve the regional work plan by way of implementing acts . ### regional co - ordination groups shall prepare joint recommendations in the form of a draft of a regional work plan regarding procedures , methods , quality assurance and quality control for collecting and processing of data as referred to in paragraph 2 and and paragraph 4 of article 5 , and regionally coordinated sampling strategies . in doing so , the regional co - ordination groups shall take into account the opinion of stecf , ices and the rfmos . those recommendations shall be submitted to the advisory council concerned for an opinion . the commission , which shall verify whether the draft joint recommendations are compatible with the provisions of this regulation and with the union ' s multiannual programme and , if so , approve the regional work plan by way of implementing acts .


### member states shall set up adequate processes and electronic technologies to ensure an effective application of article 25 of regulation no 1380 / 2013 , and shall refrain from any unnecessary restrictions to the widest possible dissemination of detailed and aggregated data . ### member states shall set up adequate processes and publicly accessible electronic technologies to ensure an effective application of article 25 of regulation no 1380 / 2013 , and shall refrain from any unnecessary restrictions to the widest possible dissemination of detailed and aggregated data .


### in order to maintain a high level of maritime safety and pollution prevention at sea , it is essential to improve the level of knowledge and skills of the union seafarers by developing maritime training and certification in line with the international rules . ### in order to maintain a high level of maritime safety and pollution prevention at sea , it is essential to improve the level of knowledge and skills of the union seafarers by developing maritime training and certification in line with commonly agreed international rules as adapted to technological change .


### in order to maintain a high level of maritime safety and pollution prevention at sea , it is essential to improve the level of knowledge and skills of the union seafarers by developing maritime training and certification in line with the international rules . ### in order to maintain a high level of maritime safety and pollution prevention at sea , it is essential to improve the level of knowledge and skills of the union seafarers by developing maritime training , re - training&#160 ; and certification in line with the international rules .