### member states shall ensure that institutional investors disclose to the public how their equity investment strategy is aligned with the profile and duration of their liabilities and how it contributes to the medium to long - term performance of their assets . the information referred to in the first sentence shall at least be available on the company ' s website as long as it is applicable . ### member states shall ensure that regulated institutional investors report to the relevant supervisory authority how their equity investment strategy is aligned with the profile and duration of their liabilities and how it contributes to the medium to long - term performance of their assets . non - regulated institutional investors shall disclose this information to the public . the information referred to in the first sentence shall at least be available on the company ' s website as long as it is applicable .


### member states shall ensure that proxy advisors adopt and implement adequate measures to guarantee that their voting recommendations are accurate and reliable , based on a thorough analysis of all the information that is available to them . ### member states shall ensure that proxy advisors adopt and implement adequate measures to guarantee that their voting recommendations are accurate and reliable , based on a thorough analysis of all the information that is available to them . the member states shall ensure that proxy advisors prepare their voting recommendations taking into account national or european market , legal , regulatory and company - specific conditions and explain how they take these factors into account in their voting recommendations . the member states shall ensure that proxy advisors , where they intend to a recommend voting against a proposed resolution on an agenda item at a general meeting , notify the company thereof without undue delay . within three days of notification the company may inform the proxy advisor of the reasons underlying the resolution . where the company sends the proxy advisor its reasons in writing , the proxy advisor shall refer to those reasons in its voting recommendation to shareholders , even if it still recommends voting against .


### member states shall ensure that proxy advisors adopt and implement adequate measures to guarantee that their voting recommendations are accurate and reliable , based on a thorough analysis of all the information that is available to them . ### member states shall ensure that proxy advisors make recommendations on the exercise of voting rights available to shareholders in good time . advisors shall be guided by the interests of the shareholder and shall ensure that they are not influenced by their own interests . proxy advisors shall point out that they will exercise their voting rights in accordance with their own proposals if shareholders do not issue different instructions in time . member states shall ensure that proxy advisors adopt adequate measures to guarantee accurate and reliable voting recommendations that are based on a thorough analysis of all the information that is available to them .


### whether they have dialogues with the companies which are the object of their voting recommendations , and , if so , the extent and nature thereof ; ### the nature and extent of their dialogue with the companies which are the object of their voting recommendations ;


### member states shall ensure that shareholders have the right to vote on the remuneration policy as regards directors . companies shall only pay remuneration to their directors in accordance with a remuneration policy that has been approved by shareholders . the policy shall be submitted for approval by the shareholders at least every three years . ### member states shall ensure that companies draw up a remuneration policy for corporate governance . this policy shall ensure that shareholders have the right to vote on the remuneration policy as regards directors . the result of the vote at the general meeting shall be recommendatory in nature . the policy shall be submitted for approval by the shareholders at least every three years .


### any remuneration received by directors of the company from any undertaking belonging to the same group ; ### any remuneration received by or still due to directors of the company from any undertaking belonging to the same group ;


### the number of shares and share options granted or offered , and the main conditions for the exercise of the rights including the exercise price and date and any change thereof ; ### the number of shares and share options granted , and the main conditions for the exercise of the rights including the exercise price and date and any change thereof ;


### member states shall ensure that companies , in case of transactions with related parties that represent more than 1% of their assets , publicly announce such transactions at the time of the conclusion of the transaction , and accompany the announcement by a report from an independent third party assessing whether or not it is on market terms and confirming that the transaction is fair and reasonable from the perspective of the shareholders , including minority shareholders . the announcement shall contain information on the nature of the related party relationship , the name of the related party , the amount of the transaction and any other information necessary to assess the transaction . ### member states shall ensure that companies , in case of material transactions with related parties , publicly announce such transactions at the time of the conclusion of the transaction . the announcement shall contain information on the nature of the related party relationship , the name of the related party , the value of the transaction and any other information necessary to assess the transaction . member states may provide that the announcement published pursuant to paragraph 1 is accompanied by a report assessing whether or not the transaction is fair and reasonable from the perspective of the shareholders who are not related party , in particular minority shareholders . this report is produced by an independent third party or the administrative or the supervisory body of the company or the audit committee or any committee the majority of which is composed by independent directors , provided that the related parties are prevented from having a role in the preparation of the report .


### member states shall ensure that companies , in case of transactions with related parties that represent more than 1% of their assets , publicly announce such transactions at the time of the conclusion of the transaction , and accompany the announcement by a report from an independent third party assessing whether or not it is on market terms and confirming that the transaction is fair and reasonable from the perspective of the shareholders , including minority shareholders . the announcement shall contain information on the nature of the related party relationship , the name of the related party , the amount of the transaction and any other information necessary to assess the transaction . ### member states shall ensure that companies , in case of significant&#160 ; transactions with related parties , publicly announce such transactions at the time of the conclusion of the transaction , and accompany the announcement by a report from the administrative or supervising body assessing whether or not it is on market terms and confirming that the transaction is fair and reasonable from the perspective of the shareholders , including minority shareholders . the announcement shall contain information on the nature of the related party relationship , the name of the related party , the amount of the transaction and any other information necessary to assess the transaction . member states may provide that report may be prepared by an independent third party .


### member states shall ensure that companies , in case of transactions with related parties that represent more than 1% of their assets , publicly announce such transactions at the time of the conclusion of the transaction , and accompany the announcement by a report from an independent third party assessing whether or not it is on market terms and confirming that the transaction is fair and reasonable from the perspective of the shareholders , including minority shareholders . the announcement shall contain information on the nature of the related party relationship , the name of the related party , the amount of the transaction and any other information necessary to assess the transaction . ### member states shall ensure that companies publicly announce transactions with related parties that represent more than 1% of their assets&#160 ; immediately following the approval of the transaction . the announcement shall at least&#160 ; contain information on the nature of the related party relationship , the name of the related party , the value of the transaction and any other information necessary to assess the financial impartiality of the transaction .


### member states shall ensure that companies , in case of transactions with related parties that represent more than 1% of their assets , publicly announce such transactions at the time of the conclusion of the transaction , and accompany the announcement by a report from an independent third party assessing whether or not it is on market terms and confirming that the transaction is fair and reasonable from the perspective of the shareholders , including minority shareholders . the announcement shall contain information on the nature of the related party relationship , the name of the related party , the amount of the transaction and any other information necessary to assess the transaction . ### member states shall ensure that companies publicly announce material transactions with related parties at the latest at the time of the conclusion of the transaction . the announcement shall contain at least information on the nature of the related party relationship , the name of the related party , the date and the value of the transaction and any other information necessary to assess the transaction .


### member states shall ensure that companies , in case of transactions with related parties that represent more than 1% of their assets , publicly announce such transactions at the time of the conclusion of the transaction , and accompany the announcement by a report from an independent third party assessing whether or not it is on market terms and confirming that the transaction is fair and reasonable from the perspective of the shareholders , including minority shareholders . the announcement shall contain information on the nature of the related party relationship , the name of the related party , the amount of the transaction and any other information necessary to assess the transaction . ### member states shall ensure that companies , in case of significant transactions with related parties , publicly announce such transactions as soon as reasons of confidentiality no longer apply . the announcement shall be accompanied by a report from an independent third party or the administrative or supervisory body assessing whether or not the transaction is fair and reasonable from the perspective of the company . the announcement shall contain information on the nature of the related party relationship , the name of the related party and the main information necessary to assess the transaction .


### the board of supervisors shall adopt , before 30 september of each year , on the basis of a proposal by the executive board , the work programme of the authority for the coming year , and shall transmit it for information to the european parliament , the council and the commission . ; ### the board of supervisors shall adopt , before 30 september of each year , on the basis of a proposal by the management board , the work programme of the authority for the coming year , and shall transmit it for information to the european parliament , the council and the commission . ;


### 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 . ### after submission to the board of supervisors and if no objection is expressed by the board on the shortlist of candidates , 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 .


### decisions by the executive board shall be adopted by simple majority of its members . each member shall have one vote . in the event of a tie , the chairperson shall have a casting vote . ### decisions by the executive board shall be adopted by simple majority of its members . each member shall have one vote . in the event of a tie , or if requested by the chairperson or at least two executive board members , the decision will be referred to the board of supervisors .


### 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 .


### 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 . ; ### the executive director , 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 . ;


### 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 40% of the estimated revenues of the authority ; no 1094 / 2010 and regulation no 1095 / 2010 ) . )


### 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 . ### after submission to the board of supervisors and if no objection is expressed by the board on the shortlist of candidates , 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 .


### ' 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 and anticipate technological innovation , innovative and sustainable business models , and the integration of environmental , social and governance related factors , including monitoring of how financial institutions identify , report , and address risks that environmental , social and governance factors may pose to financial stability , providing guidance on how sustainability considerations can be effectively embodied in relevant eu financial legislation , and promoting coherent implementation of these provisions upon adoption .


### in particular , the current functioning of wholesale roaming markets could affect competition and investments in home operators’ domestic markets due to excessive wholesale roaming charges compared to the domestic retail prices applied to end - users . this applies in particular for smaller or net out - bound operators , thus making rlah structurally unsustainable . ### in particular , the current functioning of wholesale roaming markets could affect competition and investments in home operators’ domestic markets due to excessive wholesale roaming charges compared to the domestic retail prices applied to end - users . this applies in particular for smaller operators or mobile virtual network operators , service providers or net out - bound operators , thus making rlah structurally unsustainable .


### the functioning of the wholesale roaming market should allow that operators recover all costs of providing regulated wholesale roaming services , including joint and common costs . this should preserve incentives to invest in visited networks and avoid any distortion of domestic competition in the visited markets caused by regulatory arbitrage by operators using wholesale roaming access remedies to compete in domestic visited markets . ### however , the functioning of the wholesale roaming market also warrants that operators are allowed to recover all costs of providing regulated wholesale roaming services , including joint and common costs . this fundamental requirement should preserve sufficient incentives for the operators to invest in visited networks and avoid any distortion of domestic competition in the visited markets caused by regulatory arbitrage by operators using wholesale roaming access remedies to compete in domestic visited markets .


### in order to assess the competitive developments in union - wide roaming markets and to report regularly on changes in actual wholesale roaming charges for unbalanced traffic between roaming providers , berec should be given the task of collecting data from national regulatory authorities on the actual charges applied for balanced and unbalanced traffic respectively . it should also collect data on cases where parties to a wholesale agreement have opted out from the application of maximum wholesale roaming charges or have implemented measures at wholesale level that are aimed at preventing permanent roaming or anomalous or abusive use of wholesale roaming access for purposes other than the provision of regulated roaming services to roaming providers’ customers while the latter are periodically travelling within the union . ### in order to assess the competitive developments in union - wide roaming markets and to report regularly on changes in actual wholesale roaming charges for unbalanced traffic between roaming providers , berec should be given the task of collecting data from national regulatory authorities on the actual charges applied for balanced and unbalanced traffic respectively . it should also collect data on cases where parties to a wholesale agreement have opted out from the application of maximum wholesale roaming charges or have implemented measures at wholesale level that are aimed at preventing permanent roaming or anomalous or abusive use of wholesale roaming access for purposes other than the provision of regulated roaming services to roaming providers ' customers while the latter are periodically travelling within the union . in administering the rlah fund , berec should collect financial contributions from the market participants , and review all requests for compensation received from the operators .


### the average wholesale charge that the visited network operator may levy on the roaming provider for the provision of a regulated roaming call originating on that visited network , inclusive , among others , of origination , transit and termination costs , shall not exceed a safeguard limit of eur 0 . 04 per minute as of 15 june 2017 and shall , without prejudice to article 19 , remain at eur 0 . 04 until 30 june 2022 ### as of 15 june 2017 , the average wholesale charge that a visited network operator may levy on a roaming provider for the provision of a regulated roaming call originating on that visited network , inclusive , among others , of origination , transit and termination costs , shall be set based on the principle of reciprocal charging .


### with effect from 15 june 2017 , the average wholesale charge that the visited network operator may levy on the roaming provider for the provision of regulated data roaming services by means of that visited network shall not exceed a safeguard limit of eur 0 . 0085 per megabyte of data transmitted and shall , without prejudice to article 19 , remain at eur 0 . 0085 per megabyte of data transmitted until 30 june 2022 . ### with effect from 15 june 2017 , the average wholesale charge that a visited network operator may levy on a roaming provider for the provision of regulated data roaming services by means of that visited network shall be set based on the principle of reciprocal charging .


### national regulatory authorities shall monitor and supervise compliance with this regulation within their territory . ### in article 16 , the first subparagraph is replaced by the following : “1 . national regulatory authorities and berec shall monitor and supervise compliance with this regulation within their territory and across the union , as applicable . ”


### in addition , the commission shall submit a report to the european parliament and the council every two years after 15 june 2017 . ### in addition , after consulting berec , the commission shall submit a report to the european parliament and the council every two years after 15 june 2017 , accompanied , if appropriate , by a legislative proposal to review the level of wholesale caps .


### in order to prevent fraud , the envisioned autonomous trade measures should be subject to compliance by tunisia with the union’s relevant rules regarding the origin of products and the procedures related thereto , as well as to tunisia’s effective administrative cooperation with the union . ### in order to prevent fraud and ensure that consumers are properly protected in accordance with article 169 of the tfeu , the envisioned autonomous trade measures should be subject to compliance by tunisia with the union’s relevant rules regarding the origin of products and the procedures related thereto , as well as to tunisia’s effective administrative cooperation with the union .


### the preservation of the stability of the olive oil market in the union requires that the additional volume generated by the autonomous trade measures is only made available after the exhaustion of the volume of the annual olive oil duty free tariff rate quota laid down in article 3 of protocol 1 to the euro - mediterranean agreement . ### the stability ' s protection of the olive oil market in the union requires that the additional volume created by the autonomous trade measures is only made available after the exhaustion of the volume of the annual olive oil duty free tariff rate quota remarked in article 3 of protocol 1 to the euro - mediterranean agreement .


### the preservation of the stability of the olive oil market in the union requires that the additional volume generated by the autonomous trade measures is only made available after the exhaustion of the volume of the annual olive oil duty free tariff rate quota laid down in article 3 of protocol 1 to the euro - mediterranean agreement . ### the preservation of the stability of the olive oil market in the union requires that the additional volume generated by the autonomous trade measures is only made available after the exhaustion of the volume of the annual olive oil duty free tariff rate quota laid down in article 3 of protocol 1 to the euro - mediterranean agreement . in order to prevent major harm to union production setups , this regulation also provides for safeguard measures so as to preclude market distortions .


### it shall apply from 1 january 2016 until 31 december 2017 . ### it shall apply from 1 january 2016 until 31 december 2016 this regulation may be extended up to december 2017 in accordance with the conditions laid down in article 1 .


### the development of health technologies is a key driver of economic growth and innovation in the union . it forms part of an overall market for healthcare expenditure that accounts for 10% of eu gross domestic product . health technologies encompass medicinal products , medical devices and medical procedures , as well as measures for disease prevention , diagnosis or treatment . ### the development of health technologies is a key to improving health policies through access to more progressive health technologies , and thus achieving a high level of health protection . at the same time , health technologies are an innovative sector of the economy , which forms part of an overall market for healthcare expenditure that accounts for 10% of eu gross domestic product . health technologies encompass medicinal products , medical devices and medical procedures , as well as measures for disease prevention , diagnosis or treatment .


### 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 .


### 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 . ### 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 , while patients have the right to health protection and protection against the financial , social and medical consequences of a disease , as well as unrestrained access to the latest therapeutic discoveries , which should be guaranteed by law in all member states .


### in order to ensure a wide application of harmonised rules on clinical aspects of hta and enable pooling of expertise and resources across hta bodies , it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under regulation no 726 / 2004 of the european parliament and of the council , 11 which incorporate a new active substance , and where those medicinal products are subsequently authorised for a new therapeutic indication . joint clinical assessments should also be carried out on certain medical devices within the meaning of regulation 2017 / 745 of the european parliament and of the council12 which are in the highest risk classes and for which the relevant expert panels have provided their opinions or views . a selection of medical devices for joint clinical assessment should be made based on specific criteria . _________________ 11 regulation no 726 / 2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency . 12 regulation 2017 / 745 of the european parliament and of the council of 5 april 2017 on medical devices , amending directive 2001 / 83 / ec , regulation no 178 / 2002 and regulation no 1223 / 2009 and repealing council directives 90 / 385 / eec and 93 / 42 / eec . ### in order to ensure a wide application of harmonised rules on clinical aspects of hta and enable pooling of expertise and resources across hta bodies , it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under regulation no 726 / 2004 of the european parliament and of the council , 11 which incorporate a new active substance , and where those medicinal products are subsequently authorised for a new therapeutic indication . joint clinical assessments should also be carried out on certain medical devices classified as high risk class iib implantable devices and class iii devices pursuant to article 51 of regulation 2017 / 745 of the european parliament and of the council12 for which the relevant expert panels have provided a scientific opinion in the framework of the clinical evaluation consultation procedure pursuant to article 54 of that regulation and which have already been marketed in at least one member state . _________________ 11 regulation no 726 / 2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency . 12 regulation 2017 / 745 of the european parliament and of the council of 5 april 2017 on medical devices , amending directive 2001 / 83 / ec , regulation no 178 / 2002 and regulation no 1223 / 2009 and repealing council directives 90 / 385 / eec and 93 / 42 / eec .


### in order to ensure that joint clinical assessments carried out on health technologies remain accurate and relevant , it is appropriate to establish conditions for the updating of assessments , in particular where additional data available subsequent to the initial assessment has the potential to increase the accuracy of the assessment . ### to ensure timely patient access to health technologies across the union , in order to ensure that joint clinical assessments carried out on health technologies remain accurate and relevant , and in order to avoid duplications between the regulatory assessments carried out by the european medicines agency and the joint clinical assessments , it is appropriate to establish synergies , and conditions for the updating of assessments , in particular where additional data available subsequent to the initial assessment has the potential to increase the accuracy of the assessment .


### 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 objective and at the same time support access to medical innovations , member states should be required to take full account of the results of joint clinical assessments and not repeat those assessments . according to national needs , member states should have the right to complement joint clinical assessments with additional clinical evidence . in addition , this does not prevent member states from carrying out non - clinical assessments on the same health technology , or from drawing conclusions on the clinical 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 time - frame for joint clinical assessments for medicinal products should , in as far as possible , be fixed by reference to the time - frame applicable to the completion of the central marketing authorisation procedure provided for under regulation no 726 / 2004 . such coordination should ensure clinical assessments can effectively facilitate market access and contribute to the timely availability of innovative technologies for patients . as a rule , the process should be completed by the time of the publication of the commission decision granting marketing authorisation . ### the time - frame for joint clinical assessments for medicinal products should , in as far as possible , be fixed by reference to the time - frame applicable to the completion of the central marketing authorisation procedure provided for under regulation no 726 / 2004 . such coordination should ensure clinical assessments can effectively facilitate market access and contribute to the timely availability of innovative technologies for patients . in certain member states , clinical assessments can start even before the marketing authorisation has been granted by the commission . in order to support the objectives of this regulation and to avoid that joint clinical assessments result in delays in those member states compared to the status quo , as a rule , the process should be completed by the time of the publication of the commission decision granting marketing authorisation .


### joint clinical assessments and joint scientific consultations necessitate the sharing of confidential information between health technology developers and hta authorities and bodies . in order to ensure the protection of such information , information provided to the coordination group in the framework of assessments and consultations should only be disclosed to a third party after a confidentiality agreement has been concluded . in addition , it is necessary for any information made public about the results of joint scientific consultations to be presented in an anonymised format with the redaction of any information of a commercially sensitive nature . ### given the sensitive nature of health information and the confidential handling of commercially sensitive data , these hould be safeguarded at all times . joint clinical assessments and joint scientific consultations necessitate the sharing of confidential information between health technology developers and hta authorities and bodies . in order to ensure the protection of such information , information provided to the coordination group in the framework of assessments and consultations should only be disclosed to a third party after a confidentiality agreement has been concluded with the technology developer that has provided the information . in addition , it is necessary for any information made public about the results of joint scientific consultations to be presented in an anonymised format with the redaction of any information of a commercially sensitive nature . it should be clarified that the provisions concerning protection of confidential information do not prevent in any way public disclosure of joint scientific consultations being evaluated . the clinical data employed , the studies , the methodology and the clinical results used should be made public . the highest possible level of public openness in scientific data and assessments should facilitate progress in biomedical research and ensure the highest possible level of confidence in the system .


### 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 , implementing powers should be conferred on the commission to establish , after consulting the coordination group , 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 . the procedural and methodological frameworks should be updated at the frequency deemed necessary by the commission and the coordination group to ensure that those frameworks are adapted to scientific evolution . in developing the methodological framework , the commission , 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 authorisation . 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 high standard of clinical evidence , while preserving the necessary flexibility , 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 observational data , as well as the acceptance of indirect treatment comparators . the methodological rules to be developed should cover the possibilities for improvement of clinical evidence in the cases where further scientific evidence is nevertheless needed . 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 .


### ' clinical assessment ' means a compilation and evaluation of the available scientific evidence on a health technology in comparison with one or more other health technologies based on the following clinical domains of health technology assessment : the description of the health problem addressed by the health technology and the current use of other health technologies addressing that health problem , the description and technical characterisation of the health technology , the relative clinical effectiveness , and the relative safety of the health technology ; ### ' clinical assessment ' means a compilation and analysis of the available scientific evidence on a health technology in comparison with one or more other health technologies based on the following clinical domains of health technology assessment : the description of the health problem addressed by the health technology and the current use of other health technologies addressing that health problem , the description and technical characterisation of the health technology , the relative clinical effectiveness , and the relative safety of the health technology at the time of regulatory approval ;


### 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 that inform decision - making at national level 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 . each member state may appoint to the coordination group at least one authority or body responsible with expertise in the field of medicinal products .


### 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 , their staff and their appointed representatives shall respect the principles of independence , impartiality , and confidentiality . they shall be subject to a duty of professional secrecy under union or member state legislation both during and after their term of office , with regard to any confidential information that has come to their knowledge in the course of the performance of their tasks or exercise of their powers .


### 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 ;


### the joint clinical assessment report shall be accompanied by a summary report and they shall be prepared in accordance with the requirements in this article and the requirements established pursuant to articles 11 , 22 , and 23 . ### the joint clinical assessment report shall be accompanied by a summary report and shall be prepared in accordance with the requirements in this article , the requirements established pursuant to articles 11 , 22 , and 23 , taking into account the results of the work already undertaken in the eunethta joint actions and the eunethta procedures for joint clinical assessments of medicinal products .


### the designated sub - group shall request relevant health technology developers to submit documentation containing the information , data and evidence necessary for the joint clinical assessment . ### the designated sub - group shall meet with relevant health technology developers on the scope of the assessment and on the documentation containing the information , data and evidence necessary for the joint clinical assessment to be submitted . the relationship between evaluators and health technology developers shall be independent and impartial . developers of health technologies may be consulted , but shall not participate actively in the evaluation process .


### the designated sub - group shall appoint , from among its members , an assessor and a co - assessor to conduct the joint clinical assessment . 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 to conduct the joint clinical assessment . the appointments shall take into account the scientific expertise necessary for the assessment and prioritise those assessors with the relevant scientific expertise necessary for the assessment .


### where , at any stage in the preparation of the draft joint clinical assessment report , the assessor considers that additional evidence from the submitting health technology developer is necessary in order to complete the report , it may request the designated sub - group to suspend the time period set for the preparation of the report and to request additional evidence from the health technology developer . having consulted the health technology developer on the time needed to prepare the necessary additional evidence , the request from the assessor shall specify the number of working days for which the preparation shall be suspended . ### where , at any stage in the preparation of the draft joint clinical assessment report , the assessor considers that additional evidence from the submitting health technology developer is necessary in order to complete the report , it may request the designated sub - group to suspend once the time period set for the preparation of the report and to request additional evidence from the health technology developer , provided that such evidence is available in advance of the marketing authorisation . having agreed with the health technology developer on the necessary additional evidence and the time needed to prepare it , the request from the assessor shall specify the number of working days for which the preparation shall be suspended .


### the designated sub - group shall ensure that stakeholders , including patients and clinical experts , are given an opportunity to provide comments during the preparation of the draft joint clinical assessment report and the summary report and set a time - frame in which they may submit comments . ### the designated sub - group shall ensure that all relevant stakeholders , including patient organisations , health professionals and clinical experts , are given an opportunity to provide comments during the preparation of the draft joint clinical assessment report and the summary report and set a time - frame in which they may submit comments .


### the designated sub - group shall ensure that stakeholders , including patients , and clinical experts are given an opportunity to provide comments during the preparation of the draft joint scientific consultation report and set a time - frame in which they may submit comments . ### the designated sub - group shall ensure that all relevant stakeholders , including patient organisations , health professionals and clinical experts are given an opportunity to provide comments during the preparation of the draft joint scientific consultation report and set a time - frame in which they may submit comments .


### determining the detailed procedural steps and their timing , and the overall duration of joint clinical assessments ; ### determining the detailed procedural steps and their timing , and the overall duration of joint clinical assessments , including for appeal mechanisms for health technology developers ;


### 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 request the health technology developer to submit the documentation containing the information , data and evidence necessary for the joint scientific consultation . ### the designated sub - group shall request the health technology developer to submit the documentation containing the information , data and evidence necessary for the joint scientific consultation . all relevant data and information shall be made publicly available .


### the rules for determining the stakeholders to be consulted for the purpose of this section . ### the rules for determining the stakeholders to be consulted for the purpose of this section , including on the prevention of conflicts of interest .


### the mechanisms for the interaction between health technology bodies and health technology developers during clinical assessments ; ### the mechanisms for the interaction between health technology bodies and health technology developers during clinical assessments including as regards to the protection of developer ' s confidential information ;


### the delegation of power referred to in articles 17 and 23 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . ### the delegation of power referred to in articles 17 , 22 , 23 and 27a may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force .


### member states may carry out a clinical assessment using means other than the rules provided for in chapter iii of this regulation , on grounds related to the need to protect public health in the member state concerned and provided the measure is justified , necessary and proportionate as regards achieving that aim . ### member states may carry out a clinical assessment as a provisional measure using means other than the rules provided for in chapter iii of this regulation , namely on grounds related to the need to protect public health in the member state concerned and provided the measure is justified , necessary and proportionate as regards achieving that aim .


### 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 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 established high functionality and&#160 ; relatively low cost of plastic means that this material is increasingly&#160 ; ubiquitous in everyday life . its growing use in short - lived applications , &#160 ; which are not designed for re - use or cost - effective recycling means that&#160 ; related production and consumption patterns have become increasingly&#160 ; inefficient and linear . therefore , in the context of the circular economy&#160 ; action plan32 , the commission concluded in the european strategy&#160 ; for plastics33 that the steady increase in plastic waste&#160 ; generation and its leakage into our environment , in particular into the&#160 ; marine environment , must be tackled in order to achieve a truly circular&#160 ; 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 ) .


### 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 unfortunately bereft of any effective channels of recycling or re - use and 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 .


### single use plastic products can be manufactured from a wide range of plastics . plastics are usually defined as polymeric materials to which additives may have been added . however , this definition would cover certain natural polymers . unmodified natural polymers should not be covered as they occur naturally in the environment . therefore , the definition of polymer in article 3 of regulation no 1907 / 2006 of the european parliament and of the council43should be adapted and a separate definition should be introduced for the purposes of this directive . plastics manufactured with modified natural polymers , or plastics manufactured from bio - based , fossil or synthetic starting substances are not naturally occurring and should therefore be addressed by this directive . the adapted definition of plastics should therefore cover polymer - based rubber items and bio - based and biodegradable plastics regardless of whether they are derived from biomass and / or intended to biodegrade over time . certain polymeric materials are not capable of functioning as a main structural component of final materials and products , such as polymeric coatings , paints , inks , and adhesives . those materials should not be addressed by this directive and should therefore not be covered by the definition . _________________ 43 regulation no 1907 / 2006 of the european parliament and of the council of 18 december 2006 concerning the registration , evaluation , authorisation and restriction of chemicals , establishing a european chemicals agency , amending directive 1999 / 45 / ec and repealing council regulation no 793 / 93 and commission regulation no 1488 / 94 as well as council directive 76 / 769 / eec and commission directives 91 / 155 / eec , 93 / 67 / eec , 93 / 105 / ec and 2000 / 21 / ec . ### single - use plastic products can be manufactured from a wide range of plastics . plastics are usually defined as polymeric materials to which additives may have been added . however , this definition would cover certain natural polymers . unmodified natural polymers should not be covered as they occur naturally in the environment . therefore , the definition of polymer in article 3 of regulation no 1907 / 2006 of the european parliament and of the council43 should be adapted and a separate definition should be introduced for the purposes of this directive . certain polymeric materials are not capable of functioning as a main structural component of final materials and products , such as polymeric coatings , paints , inks , and adhesives . those materials should not be addressed by this directive and should therefore not be covered by the definition . _________________ 43 regulation no 1907 / 2006 of the european parliament and of the council of 18 december 2006 concerning the registration , evaluation , authorisation and restriction of chemicals , establishing a european chemicals agency , amending directive 1999 / 45 / ec and repealing council regulation no 793 / 93 and commission regulation no 1488 / 94 as well as council directive 76 / 769 / eec and commission directives 91 / 155 / eec , 93 / 67 / eec , 93 / 105 / ec and 2000 / 21 / ec .


### single use plastic products can be manufactured from a wide range of plastics . plastics are usually defined as polymeric materials to which additives may have been added . however , this definition would cover certain natural polymers . unmodified natural polymers should not be covered as they occur naturally in the environment . therefore , the definition of polymer in article 3 of regulation no 1907 / 2006 of the european parliament and of the council43 should be adapted and a separate definition should be introduced for the purposes of this directive . plastics manufactured with modified natural polymers , or plastics manufactured from bio - based , fossil or synthetic starting substances are not naturally occurring and should therefore be addressed by this directive . the adapted definition of plastics should therefore cover polymer - based rubber items and bio - based and biodegradable plastics regardless of whether they are derived from biomass and / or intended to biodegrade over time . certain polymeric materials are not capable of functioning as a main structural component of final materials and products , such as polymeric coatings , paints , inks , and adhesives . those materials should not be addressed by this directive and should therefore not be covered by the definition . _________________ 43 regulation no 1907 / 2006 of the european parliament and of the council of 18 december 2006 concerning the registration , evaluation , authorisation and restriction of chemicals , establishing a european chemicals agency , amending directive 1999 / 45 / ec and repealing council regulation no 793 / 93 and commission regulation no 1488 / 94 as well as council directive 76 / 769 / eec and commission directives 91 / 155 / eec , 93 / 67 / eec , 93 / 105 / ec and 2000 / 21 / ec . ### single use plastic products can be manufactured from a wide range of plastics . plastics are usually defined as polymeric materials to which additives may have been added . however , this definition would cover certain natural polymers . unmodified natural polymers should not be covered as they occur naturally in the environment . therefore , the definition of polymer in article 3 of regulation no 1907 / 2006 of the european parliament and of the council43 should be adapted and a separate definition should be introduced for the purposes of this directive . plastics manufactured with modified natural polymers , or plastics manufactured from bio - based , fossil or synthetic starting substances are not naturally occurring and should therefore be addressed by this directive . the adapted definition of plastics should therefore cover polymer - based rubber items and bio - based and biodegradable plastics regardless of whether they are derived from biomass and / or intended to biodegrade over time . certain polymeric materials are not capable of functioning as a main structural component of final materials and products , such as polymeric coatings , linings or layers , paints , inks , and adhesives . those materials should not be addressed by this directive and should therefore not be covered by the definition . _________________ 43 regulation no 1907 / 2006 of the european parliament and of the council of 18 december 2006 concerning the registration , evaluation , authorisation and restriction of chemicals , establishing a european chemicals agency , amending directive 1999 / 45 / ec and repealing council regulation no 793 / 93 and commission regulation no 1488 / 94 as well as council directive 76 / 769 / eec and commission directives 91 / 155 / eec , 93 / 67 / eec , 93 / 105 / ec and 2000 / 21 / ec .


### in order to clearly define the scope of this directive the term single - use plastic product should be defined . the definition should exclude plastic products that are conceived , designed and placed on the market to accomplish within their lifecycle multiple trips or rotations by being refilled or reused for the same purpose for which they are conceived . ### in order to clearly define the scope of this directive , the term ‘ single - use plastic product’ should be defined as a product that is conceived and placed on the market to be used just once over a short period of time . the definition should exclude plastic products that are conceived , designed and placed on the market to accomplish within their lifecycle multiple trips or rotations by being refilled or reused for the same purpose for which they are conceived .


### 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 should be addressed by one or several measures , depending on various factors , such as the availability of suitable and more sustainable alternatives , methods of managing and recycling plastic wrapping , the feasibility to change consumption patterns , promotion of exchanges of good practices and the extent to which they are already covered by existing union legislation .


### 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 . 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 . at the same time , labelling content should raise consumer awareness of the environmental dangers of plastic waste . 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 .


### beverage bottles that are single - use plastic products are one of the most found marine litter items on the beaches in the union . this is due to ineffective separate collection systems and low participation in those systems by the consumers . it is necessary to promote more efficient separate collection systems and therefore , a minimum separate collection target should be established for beverage bottles that are single - use plastic products . member states should be able to achieve that minimum target by setting separate collection targets for beverage bottles that are single - use plastic products in the framework of the extended producer responsibility schemes or by establishing deposit refund schemes or by any other measure that they find appropriate . this will have a direct , positive impact on the collection rate , the quality of the collected material and the quality of the recyclates , offering opportunities for the recycling business and the market for the recyclate . ### beverage bottles that are single - use plastic products are one of the most found marine litter items on the beaches in the union . this is due to ineffective separate collection systems and low participation in those systems by the consumers . it is necessary to promote more efficient separate collection systems and therefore , a minimum separate collection target should be established for beverage bottles that are single - use plastic products . member states should be able to achieve that minimum target by setting separate collection targets for beverage bottles that are single - use plastic products in the framework of the extended producer responsibility schemes or by establishing deposit refund schemes or by any other measure that they find appropriate , including awareness campaigns to encourage consumers to collect plastic drinks packaging . this will have a direct , positive impact on the collection rate , the quality of the collected material and the quality of the recyclates , offering opportunities for the recycling business and the market for the recyclate .


### 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 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 , encouraging good practices for the reduction of plastic waste and contributing to the efficient functioning of the internal market .


### ' plastic ' means a material consisting of a polymer within the meaning of article 3 of regulation no 1907 / 2006 , to which additives or other substances may have been added , and which can function as a main structural component of final products , with the exception of natural polymers that have not been chemically modified ; ### ' plastic ' means a material consisting of a polymer within the meaning of article 3 of regulation no 1907 / 2006 , to which additives or other substances may have been added , and which functions as the main structural component of final products , with the exception of natural polymers that have not been chemically modified and polymeric coatings , paints , inks and adhesives which are not capable of functioning as a main structural component of final articles and products ;


### 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 , measures ensuring that reusable or recyclable 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 waste collection system in place , in so far it guarantees that a product listed in part a of the annex once placed on the market is collected and recycled , and the environmental impact of the products referred to in the first subparagraph .


### —cutlery ### —cutlery , except in well controlled closed systems , where separate collection and recycling is ensured ;


### —plates ### —plates , except in well controlled closed systems , where separate collection and recycling is ensured ;


### —straws , except for straws intended and used for medical purposes ### —straws , except for straws intended and used for medical purposes , and straws that are attached to drinks containers .


### 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 , the external lending mandate and the guarantee fund for external actions . the external action guarantee should support the efsd + and elm + 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 .


### 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 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 elm + is established as a budgetary guarantee managed indirectly by the eib , providing commercial and political risk cover for financially sustainable projects in the public sector and political risk cover for financially sustainable projects in the private sector , each worldwide outside the union . the support of the elm + shall not be extended to sovereign investment operations that involve on - lending to the private sector or lending to , or for the benefit of , sub - sovereign entities that can access sub - sovereign financing without sovereign guarantees .


### 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 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 . the elm + is established as a budgetary guarantee managed indirectly by the eib group , providing commercial and political risk cover for financially sustainable projects in the public sector and political risk cover for financially sustainable projects in the private sector , each worldwide outside the union . special attention shall be given to countries identified as experiencing fragility or conflict , least developed countries and heavily indebted poor countries .


### data requirements to achieve the objectives of article 25 of regulation no 1380 / 2013 ; ### data requirements to achieve the objectives of articles 6 , 9 and 25 of regulation no 1380 / 2013 ;


### socio - economic data and sustainability data on aquaculture to enable the assessment of the socio - economic performance and the sustainability of the union aquaculture sector , including its environmental impact ; ### socio - economic data and sustainability data on aquaculture of marine and diadromous species to enable the assessment of the socio - economic performance of the union aquaculture sector ;


### directive 2008 / 106 / ec also contains a centralised mechanism for the recognition of seafarers ' certificates issued by third countries . the regulatory fitness programme evaluation14 showed that significant cost savings for the member states were achieved since the introduction of the centralised mechanism . however , the evaluation also revealed that , with regard to some of the recognised third countries , only a very limited number of seafarers was subsequently employed in union vessels . therefore , in order to use the available human and financial resources in a more efficient way , the procedure for the recognition of third countries should be based on an analysis of the need for such recognition , including an estimation of the number of masters and officers originating from that country who are likely to be employed in union vessels . _______________________________ 14 swd19 ### directive 2008 / 106 / ec also contains a centralised mechanism for the recognition of seafarers ' certificates issued by third countries . the regulatory fitness programme evaluation14 showed that significant cost savings for the member states were achieved since the introduction of the centralised mechanism . however , the evaluation also revealed that , with regard to some of the recognised third countries , only a very limited number of endorsements attesting to the recognition of certificates were issued by member states in relation to certificates of competency or certificates of proficiency issued by those third countries . _________________________________ 14 swd19


### directive 2008 / 106 / ec also contains a centralised mechanism for the recognition of seafarers ' certificates issued by third countries . the regulatory fitness programme 14 evaluation showed that significant cost savings for the member states were achieved since the introduction of the centralised mechanism . however , the evaluation also revealed that , with regard to some of the recognised third countries , only a very limited number of seafarers was subsequently employed in union vessels . therefore , in order to use the available human and financial resources in a more efficient way , the procedure for the recognition of third countries should be based on an analysis of the need for such recognition , including an estimation of the number of masters and officers originating from that country who are likely to be employed in union vessels . _________________ 14 swd19 . ### directive 2008 / 106 / ec also contains a centralised mechanism for the recognition of seafarers ' certificates issued by third countries . the regulatory fitness programme 14 evaluation showed that significant cost savings for the member states were achieved since the introduction of the centralised mechanism . however , the evaluation also revealed that , with regard to some of the recognised third countries , only a very limited number of visas attesting to the recognition of certificates were issued by member states in relation to certificates of competency or certificates of proficiency issued by these third countries . _________________ 14 swd19 .


### directive 2008 / 106 / ec also contains a centralised mechanism for the recognition of seafarers ' certificates issued by third countries . the regulatory fitness programme evaluation14 showed that significant cost savings for the member states were achieved since the introduction of the centralised mechanism . however , the evaluation also revealed that , with regard to some of the recognised third countries , only a very limited number of seafarers was subsequently employed in union vessels . therefore , in order to use the available human and financial resources in a more efficient way , the procedure for the recognition of third countries should be based on an analysis of the need for such recognition , including an estimation of the number of masters and officers originating from that country who are likely to be employed in union vessels . _________________ 14 swd19 . ### directive 2008 / 106 / ec also contains a centralised mechanism for the recognition of seafarers ' certificates issued by third countries . the regulatory fitness programme evaluation14 showed that significant cost savings for the member states were achieved since the introduction of the centralised mechanism . however , the evaluation also revealed that , with regard to some of the recognised third countries , only a very limited number of endorsements attesting to the recognition of certificates were issued by member states in relation to certificates of competency or certificates of proficiency issued by these third countries . _________________ 14 swd19 .


### in order to further increase the efficiency of the centralised system for the recognition of third countries , the reassessment of third countries which provide low number of seafarers in the union fleet should be performed in longer intervals which should be increased to ten years . however , this longer period of reassessment of the system of such third countries should be combined with priority criteria which take into account safety concerns , balancing the need for efficiency with an effective safeguard mechanism in case of deterioration of the quality of seafarers ' training provided in the relevant third countries . ### in order to further increase the efficiency of the centralised system for the recognition of third countries , the reassessment of third countries which provide low number of seafarers in the union fleet should be performed in longer intervals which should be increased to ten years . the aptitude of those seafarers should also be assessed by the member states and , if necessary , they should undergo training . however , this longer period of reassessment of the system of such third countries should be combined with priority criteria which take into account safety concerns , balancing the need for efficiency with an effective safeguard mechanism in case of deterioration of the quality of seafarers ' training provided in the relevant third countries .


### information on the seafarers employed from third countries has become available at union level through the communication by the member states of the relevant information kept in their national registers regarding issued certificates and endorsements . this information should be used not only for statistical and policy making purposes but also for the purpose of improving the efficiency of the centralised system recognising third countries . based on the information communicated by the member states , recognised third countries which have not provided the union fleet with seafarers for a period of at least five years shall be withdrawn from the list of recognised third countries . in addition , this information shall be also used in order to prioritise the reassessment of the recognised third countries . ### information on the seafarers employed from third countries has become available at union level through the communication by the member states of the relevant information kept in their national registers regarding issued certificates and endorsements . this information should be used not only for statistical and policy making purposes but also for the purpose of improving the efficiency of the centralised system recognising third countries . based on the information communicated by the member states , the recognition of third countries which have not provided the union fleet with seafarers for a period of at least ten years should be re - examined . the re - examination process should cover the possibility of retaining or withdrawing the recognition of the relevant third country , in accordance with the examination procedure .


### to meet the standards of medical fitness prescribed by article 11 ; and ### to meet the standards of medical fitness prescribed by article 11 , physical as well as mental ; and


### when a positive decision for initiating the recognition procedure has been adopted , the commission , assisted by the european maritime safety agency and with the possible involvement of the member state submitting the request , shall collect the information referred to in annex ii and shall carry out an assessment of the training and certification systems in the third country for which the request for recognition was submitted , in order to verify whether the country concerned meets all the requirements of the stcw convention and whether appropriate measures have been taken to prevent issuance of fraudulent certificates . ' ### the commission , assisted by the european maritime safety agency and with the possible involvement of the member state submitting the request , shall collect the information referred to in annex ii and shall carry out an assessment of the training and certification systems in the third country for which the request for recognition was submitted , in order to verify whether the country concerned meets all the requirements of the stcw convention and whether appropriate measures have been taken to prevent issuance of fraudulent certificates .


### most customs control equipment may be equally or incidentally fit for controls of compliance with other legislation , such as provisions on border management , visa or police cooperation . the integrated border management fund has therefore been conceived as two complementary instruments with distinct but coherent scopes for the purchase of equipment . on the one hand , the instrument for border management and visa established by regulation [ 2018 / xxx ] 25 will exclude equipment that can be used for both border management and customs control . on the other hand , the instrument for financial support for customs control equipment established by this regulation will not only support financially equipment with customs controls as the main purpose but will also allow its use as well for additional purposes such as border controls and security . this distribution of roles will foster inter - agency cooperation as a component of the european integrated border management approach , as referred to in article 4 of regulation 2016 / 162426 , thereby enabling customs and border authorities to work together and maximising the impact of the union budget through co - sharing and inter - operability of control equipment . __________________ 25 com 473 . 26 regulation 2016 / 1624 of the european parliament and of the council of 14 september 2016 on the european border and coast guard and amending regulation 2016 / 399 of the european parliament and of the council and repealing regulation no 863 / 2007 of the european parliament and of the council , council regulation no 2007 / 2004 and council decision 2005 / 267 / ec . ### most customs control equipment may be equally or incidentally fit for controls of compliance with other legislation , such as provisions on border management , visa or police cooperation . the integrated border management fund has therefore been conceived as two complementary instruments with coherent general objectives but distinct and separate specific objectives for the purchase of equipment . on the one hand , the instrument for border management and visa established by regulation [ 2018 / xxx ] 25 will exclude equipment that can be used for both border management and customs control . on the other hand , the instrument for financial support for customs control equipment established by this regulation will not only support financially equipment with customs controls as the main purpose but will also allow its use as well for additional purposes such as border controls and security . this distribution of roles will foster inter - agency cooperation as a component of the european integrated border management approach , as referred to in article 4 of regulation 2016 / 162426 , thereby enabling customs and border authorities to work together and maximising the impact of the union budget through co - sharing and inter - operability of control equipment . __________________ 25 com 473 . 26 regulation 2016 / 1624 of the european parliament and of the council of 14 september 2016 on the european border and coast guard and amending regulation 2016 / 399 of the european parliament and of the council and repealing regulation no 863 / 2007 of the european parliament and of the council , council regulation no 2007 / 2004 and council decision 2005 / 267 / ec .


### the amount referred to in paragraph 1 may also cover expenses for preparation , monitoring , control , audit , evaluation and other activities for managing the instrument and evaluating the achievement of its objectives . it may moreover cover expenses relating to the studies , meetings of experts , information and communication actions , in so far as they are related to the objectives of the instrument , as well as expenses linked to information technology networks focusing on information processing and exchange , including corporate information technology tools and other technical and administrative assistance needed in connection with the management of the instrument . ### the amount referred to in paragraph 1 may also cover expenses for preparation , monitoring , control , audit , evaluation and other activities for managing the instrument and evaluating the achievement of its objectives . it may moreover cover expenses relating to the studies , meetings of experts , information and communication actions , in so far as they are related to the specific objectives of the instrument in support of the general objective , as well as expenses linked to information technology networks focusing on information processing and exchange , including corporate information technology tools and other technical and administrative assistance needed in connection with the management of the instrument .


### when the action supported involves the purchase or upgrade of equipment , the commission shall set up a coordination mechanism ensuring efficiency and interoperability between all the equipment purchased with the support of union programmes and instruments . ### when the action supported involves the purchase or upgrade of equipment , the commission shall set up a coordination mechanism ensuring efficiency and interoperability between all the equipment purchased with the support of union programmes and instruments . the coordination mechanism shall include the participation and consultation of the european border and coast guard agency to maximise the union added value in the field of border management .


### a common policy on asylum , including a common european asylum system which is based on the full and inclusive application of the geneva convention relating to the status of refugees of 28 july 1951 , as amended by the new york protocol of 31 january 1967 , is a constituent part of the european union’s objective of establishing progressively an area of freedom , security and justice open to those who , forced by circumstances , legitimately seek protection in the union . such a policy should be governed by the principle of solidarity and fair sharing of responsibility , including its financial implications , between the member states . ### a common policy on asylum , including a common european asylum system which is based on the full and inclusive application of the geneva convention relating to the status of refugees of 28 july 1951 , as amended by the new york protocol of 31 january 1967 , is a constituent part of the european union’s objective of establishing progressively an area of freedom , security and justice open to those who , forced by circumstances , legitimately seek protection in the union . such a policy should be governed by the principle of solidarity and fair sharing of responsibility between the member states .


### the main objective of this regulation is , on the one hand , to ensure that member states apply common criteria for the identification of persons genuinely in need of international protection and , on the other hand , to ensure that a common set of rights is available for those persons in all member states . ### the main objective of this regulation is , on the one hand , to ensure that member states apply a set of basic criteria for the identification of persons genuinely in need of international protection and , on the other hand , to ensure that a set of basic rights is available for those persons in all member states .


### the resources of the asylum , migration and refugee fund should be used to provide adequate support to member states’ efforts in implementing the standards set by the regulation , in particular to those member states which are faced with specific and disproportionate pressure on their asylum systems , due in particular to their geographical or demographic situation . ### the resources of the asylum , migration and refugee fund should be used to provide adequate support to member states’ efforts in implementing the standards set by the regulation , in particular to those member states which are faced with specific and disproportionate pressure on their asylum systems , due in particular to their geographical situation .


### the resources of the asylum , migration and refugee fund should be used to provide adequate support to member states’ efforts in implementing the standards set by the regulation , in particular to those member states which are faced with specific and disproportionate pressure on their asylum systems , due in particular to their geographical or demographic situation . ### the resources of the asylum , migration and integration fund should be used to provide adequate support to member states ' efforts in implementing the standards set by this regulation , in particular in relation to promoting sustainable integration of beneficiaries of international protection and to providing support to those member states which are facing challenges as part of their asylum systems , due in particular to their social , geographical or demographic situation . to that end , adequate funding should be made available to local and regional authorities and international and civil society organisations , including through the possibility for local and regional authorities to access the asylum migration and integration fund and other funds for actions that fall directly under their responsibilities in a more direct and efficient manner .


### ' guardian ' means a person or an organisation appointed by the competent bodies in order to assist and represent an unaccompanied minor in procedures provided for in this regulation with a view to ensuring the best interests of the child and exercising legal capacity for the minor where necessary . ### ' guardian ' means a person or an organisation appointed to assist and represent an unaccompanied minor with a view to safeguarding the best interests of the child and his or her general well - being in procedures provided for in this regulation and exercising legal capacity for the minor where necessary ;