### 4. the medical devices steering group shall establish its rules of procedure including procedures relating to the working party referred to in paragraph 5 , and on the adoption of lists , sets of information and recommendations. the rules of procedures shall enter into force after receiving a favourable opinion from the commission and the management board of the agency. ### 4. the medical devices steering group shall establish its rules of procedure including procedures relating to the working party referred to in paragraph 5 , and on the adoption of lists , sets of information and recommendations. the rules of procedures shall enter into force after receiving a favourable opinion from the commission and the management board of the agency. agendas and minutes of the steering group as well as the rules of procedure and recommendations should be made available to the public via the agency web-portal.


### 3. the agency shall publish the public health emergency critical devices list and any updates to that list on its web-portal. ### 3. the agency shall publish the public health emergency critical devices list and any updates to that list in a timely manner on its web-portal.


### 1. on the basis of the public health emergency critical devices list and the information and data provided in accordance with articles 24 and 25 , the medical devices steering group shall monitor supply and demand of medical devices included on that list with a view to identifying any potential or actual shortages of those medical devices. as part of that monitoring , the medical devices steering group shall liaise , where relevant , with the health security committee established in article 4 of regulation (eu) 2020/[…]22 and the advisory committee on public health emergencies established pursuant to article 24 of that regulation. ### 1. on the basis of the public health emergency critical devices list and the information and data provided in accordance with articles 24 and 25 , the medical devices steering group shall monitor supply and demand of medical devices included on that list with a view to identifying any potential or actual shortages of those medical devices. as part of that monitoring , the medical devices steering group shall liaise , where relevant , with the health security committee established in article 4 of regulation (eu) 2020/[…]22 and the advisory committee on public health emergencies established pursuant to article 24 of that regulation as well as with union and national entities engaged with stockpiling of medical devices.


### 2. where requested by the commission or the sub-network referred to in article 23(2)(b) , the medical devices steering group shall provide aggregated data and forecasts of demand to support its findings. in that regard , the steering group shall liaise with the european centre for disease prevention and control to obtain epidemiological data to help forecast medical device needs , and with the medicines steering group referred to in article 3 where medical devices included on the public health emergency critical devices list are used to jointly with a medicinal product. ### 2. where requested by the commission or the sub-network referred to in article 23(2)(b) , the medical devices steering group shall provide aggregated data and forecasts of demand to support its findings. in that regard , the steering group shall liaise with the european centre for disease prevention and control to obtain epidemiological data to help forecast medical device needs , and with the medicines steering group referred to in article 3 where medical devices included on the public health emergency critical devices list are used to jointly with a medicinal product as well as with union and national entities engaged with stockpiling of medical devices.


### 4. the medical devices steering group may , on its own initiative or upon request from the commission , provide recommendations on measures which may be taken by the commission , member states , medical device manufacturers , notified bodies and other entities to ensure preparedness to deal with potential or actual shortages of medical devices caused by public health emergencies. ### 4. the medical devices steering group may , on its own initiative or upon request from the commission , provide recommendations on measures which may be taken by the commission , member states , medical device manufacturers , notified bodies and other entities , including healthcare professionals , to ensure preparedness to deal with potential or actual shortages of medical devices caused by public health emergencies.


### 5. the medical devices steering group may , upon request from the commission coordinate measures , where relevant , between the national competent authorities , manufacturers of medical devices , notified bodies , and other entities to prevent or mitigate potential or actual shortages in the context of a public health emergency. ### 5. the medical devices steering group may , upon request from the commission coordinate measures , where relevant , between the national competent authorities , manufacturers of medical devices , notified bodies , and other entities , including healthcare professionals , to prevent or mitigate potential or actual shortages in the context of a public health emergency.


### specify the procedures for establishing the public health emergency critical devices list; ### specify the procedures for establishing the public health emergency critical devices list , ensuring adequate consultation with healthcare professionals , consumers , patients and a high level of transparency indecision-making;


### establish and maintain a list of single points of contact from medical device manufacturers , authorised representatives and notified bodies; ### deleted


### establish and maintain for the duration of the public health emergency , a sub-network of single points of contact from medical device manufacturers and notified bodies based on the medical devices included on the public health emergency critical devices list; ### establish and maintain for the duration of the public health emergency , a sub-network of single points of contact from medical device manufacturers and notified bodies based on the medical devices included on the public health emergency critical devices list based on single points of contact to be included for all medical device manufacturers in the database referred to in article 33 of regulation (eu) 2017/745 and article 30 of regulation (eu) 2017/746;


### mitigation plans including production and supply capacity; ### prevention and mitigation plans including production and supply capacity; such plans shall contain preventative measures that help ensure the continued supply of critical medical devices;


### mitigation plans including production and supply capacity; ### mitigation plans including production and supply capacity , with a view to guarantee continued supply and prevent shortages of medicinal products included on the critical medicines lists;


### consider the need to provide for temporary exemptions at member state level pursuant to article 59(1) of regulation (eu) 2017/745 or article 54(1) of regulation (eu) 2017/746 with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list; ### consider the need to provide for temporary exemptions at member state level pursuant to article 59(1) of regulation (eu) 2017/745 or article 54(1) of regulation (eu) 2017/746 with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list , while at the same time ensuring a high level of patient and product safety;


### consider the need to provide for temporary exemptions at member state level pursuant to article 59(1) of regulation (eu) 2017/745 or article 54(1) of regulation (eu) 2017/746 with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list; ### consider the need to provide for temporary exemptions at member state level pursuant to article 59(1) of regulation (eu) 2017/745 or article 54(1) of regulation (eu) 2017/746 with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list , while at the same time ensuring both patient and product safety;


### consider the need to provide for temporary exemptions at member state level pursuant to article 59(1) of regulation (eu) 2017/745 or article 54(1) of regulation (eu) 2017/746 with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list; ### consider the need to provide for temporary exemptions at member state level pursuant to article 59(1) of regulation (eu) 2017/745 or article 54(1) of regulation (eu) 2017/746 with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list while at the same time ensuring both patient and product safety;


### take all necessary action within the limits of the powers conferred on it , with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list , including , where necessary , granting temporary exemptions at union level pursuant to article 59(3) of regulation (eu) 2017/745 or article 54(3) of regulation (eu) 2017/746; ### take all necessary action within the limits of the powers conferred on it , with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list , including , where necessary , granting temporary exemptions at union level pursuant to article 59(3) of regulation (eu) 2017/745 or article 54(3) of regulation (eu) 2017/746 , while at the same time ensuring a high level of patient and product safety;


### take all necessary action within the limits of the powers conferred on it , with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list , including , where necessary , granting temporary exemptions at union level pursuant to article 59(3) of regulation (eu) 2017/745 or article 54(3) of regulation (eu) 2017/746; ### take all necessary action within the limits of the powers conferred on it , with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list , including , where necessary , granting temporary exemptions at union level pursuant to article 59(3) of regulation (eu) 2017/745 or article 54(3) of regulation (eu) 2017/746 while at the same time ensuring both patient and product safety;


### consider the need for guidelines addressed to member states , medical device manufacturers , notified bodies and other entities; ### consider the need for guidelines addressed to member states , medical device manufacturers , notified bodies , health care professionals and other entities;


### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform the public and relevant interest groups with regard to the work of the medical devices steering group. ### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform the public and relevant interest groups with regard to the work of the medical devices steering group , and ensure adequate consultation with the patients’ and consumers’ working party and the healthcare professionals’ working party. the list of the members of the medical devices steering group , the rules of procedure , agendas and minutes of the meetings and recommendations shall be published on the agency’s web-portal.


### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform the public and relevant interest groups with regard to the work of the medical devices steering group. ### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform without delay the public and relevant interest groups with regard to the work of the medical devices steering group , and respond to disinformation.


### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform the public and relevant interest groups with regard to the work of the medical devices steering group. ### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform the public and relevant interest groups with regard to the work of the medical devices steering group , including the recommendations , opinions and decisions made by the medical devices steering group as well as agendas and minutes of the group’s meetings.


### the agency shall , on behalf of the commission , from 1 march 2022 onwards , provide the secretariat of the expert panels designated in accordance with implementing decision (eu) 2019/1396 and provide the support necessary to ensure that those panels can efficiently perform their tasks as set out in article 106(9) and (10) of regulation (eu) 2017/745. the agency shall: ### the agency shall , on behalf of the commission , provide the secretariat of the expert panels designated in accordance with implementing decision (eu) 2019/1396 and provide the support necessary to ensure that those panels can efficiently perform their tasks as set out in article 106(9) and (10) of regulation (eu) 2017/745. the agency shall:


### provide administrative and technical support to the expert panels for the provision of scientific opinions , views and advice; ### provide administrative , scientific and technical support to the expert panels for the provision of scientific opinions , views and advice;


### confidentiality ### confidentiality and data privacy


### 1. unless otherwise provided for in this regulation and without prejudice to regulation (ec) no 1049/200124 and existing national provisions and practices in the member states on confidentiality , all parties involved in the application of this regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following: ### 1. unless otherwise provided for in this regulation and without prejudice to regulation (ec) no 1049/200124 and on the legal protection of persons who report breaches of union law , and existing national provisions and practices in the member states on confidentiality , all parties involved in the application of this regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following:


### personal data in accordance with article 32; ### personal data in accordance with the definitions contained in article 4(1) of regulation (eu) 2016/679 (gdpr) and article3(1) of regulation (eu) 2018/1725 (eudpr);


### commercially confidential information and trade secrets of a natural or legal person , including intellectual property rights; ### commercially confidential information and trade secrets of a natural or legal person in accordance with directive 2016/943 and without prejudice to directive 2019/1937 , as well as intellectual property rights , unless there is an overriding public interest in disclosure;


### 5. the commission , the agency , and member states may exchange commercially confidential information and , where necessary to protect public health , personal data , with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements. ### 5. the commission , the agency , and member states may , in compliance with chapter v of the eudpr , exchange commercially confidential information and , where necessary to protect public health , personal data , with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.


### 5. the commission , the agency , and member states may exchange commercially confidential information and , where necessary to protect public health , personal data , with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements. ### 5. the commission , the agency , and member states may exchange commercially confidential information and , where necessary to protect public health , personal data , with regulatory authorities of third countries with which they have concluded legally binding and enforceable bilateral or multilateral confidentiality arrangements.


### 31 entry into force ### 31 entry into force and date of application


### 31 entry into force ### 31 entry into force and application


### providing scientific support to facilitate clinical trials to be conducted in the union for medicinal products intended to treat , prevent , or diagnose the disease causing the public health emergency. such support shall include advice to sponsors of similar or linked planned clinical trials on the establishment , in their place , of joint clinical trials and may include advice on establishing agreements to act as a sponsor or as co-sponsor in accordance with articles 2(14) and 72 of regulation (eu) 536/2014; ### providing scientific support to facilitate clinical trials to be conducted in the union for medicinal products intended to treat , prevent , or diagnose the disease causing the public health emergency. such support shall include advice to sponsors of similar or linked planned clinical trials on the establishment , in their place , of joint clinical trials and may include advice on establishing agreements to act as a sponsor or as co-sponsor in accordance with articles 2(14) and 72 of regulation (eu) 536/2014 and on developing suitable protocols;


### 9. the agency shall publish information about the medicinal products that the emergency task force considers may have the potential to address public health emergencies and any updates on its web-portal. ### 9. the agency shall publish information about the medicinal products that the emergency task force considers may have the potential to address public health emergencies and any updates on its web-portal. the agency shall also publish clinical trials data on medicines and vaccines reviewed by the emergency task force and clinical trials protocols on which the emergency task force provided advise to developers , in line with the provisions of the regulation (eu) no 536/2014.


### advice on clinical trials ### advice and guidance on clinical trials


### 6. where a developer is the recipient of scientific advice , the developer shall subsequently submit the data resulting from clinical trials to the agency following a request made pursuant to article 16. ### 6. where a developer is the recipient of scientific advice , the developer shall subsequently submit the data resulting from clinical trials to the agency following a request made pursuant to article 16. due to the sensitive nature of this data , it shall be pseudonymised in line with the requirements of article 89 of gdpr.


### where conformity assessments are on-going , the status of the conformity assessment by the concerned notified bodies in relation to medical devices included in the public health emergency critical devices list and possible issues which need to be resolved in order to complete the conformity assessment process. ### where conformity assessments are on-going , the status of the conformity assessment by the concerned notified bodies in relation to medical devices included in the public health emergency critical devices list and possible issues which need to be resolved in order to speedily complete the conformity assessment process.


### 3. where manufacturers of medical devices included on the public health emergency critical devices list and concerned notified bodies indicate that the submitted information contains information of a commercially confidential nature , they shall identify the relevant parts and clarify the reasons for such an indication. the agency shall assess the merits of each request and protect such commercially confidential information against unjustified disclosure. ### 3. where manufacturers of medical devices included on the public health emergency critical devices list and concerned notified bodies indicate that the submitted information contains information of a commercially confidential nature , they shall identify the relevant parts and clarify the reasons for such an indication. the agency shall assess the merits of each request and protect such commercially confidential information against unjustified disclosure unless the information is in the public interest.


### 2. where necessary to fulfil their reporting obligations set out in paragraph 1 , member states shall gather information from manufacturers , importers , distributors and notified bodies on medical devices included on the public health emergency critical devices list. ### 2. where necessary to fulfil their reporting obligations set out in paragraph 1 , member states shall gather information from manufacturers , importers , distributors , health care professionals and notified bodies on medical devices included on the public health emergency critical devices list.


### 1. emphasises the important role of the european medicines agency (‘the ema') in protecting and promoting public and animal health by making independent , science-based recommendations on the quality , safety and efficacy of medicines , and providing scientific advice and incentives to stimulate the development and improve the availability of innovative new medicines; ### 1. emphasises the important role of the european medicines agency (‘the ema') in protecting and promoting human and animal health by making independent , science-based recommendations on the quality , safety and efficacy of medicines , and providing scientific advice and regulatory incentives to stimulate the development and improve the availability of innovative new medicines;


### 2. notes that , owing to the global covid-19 pandemic , 2020 was an extremely challenging year for the ema , requiring a shift in its priorities and extreme agility and resilience to maintain the ema’s activities while supporting global efforts to combat the pandemic in a new and challenging environment; ### 2. notes that , owing to the global covid-19 pandemic , 2020 was an extremely challenging year for the ema , requiring a shift in its priorities and extreme agility and resilience to maintain the ema’s activities while supporting enhanced collaboration between member states to manage the supply of medicines and global efforts to combat the pandemic in a new and challenging environment;


### 2. notes that , despite the difficulties caused by the global pandemic , the agency continued to act in the interests of a functioning single market for human and veterinary medicines , by acting as the hub of the european network of regulatory medicines authorities that implements the applicable union legislative framework for such products; ### 2. notes that , despite the unprecedented difficulties since the start of the global pandemic in 2020 , the agency continued to act in the interests of the public health of all european citizens as they were confronted with covid-19 , by acting as the hub of the european network of regulatory medicines authorities that implements the applicable union legislative framework for such products; highlights the important role the agency played in preparation of the union’s response to the covid-19 pandemic and swift preparatory work related to the certification of the vaccines;


### 10. welcomes the proposal to extend the ema’s mandate but expresses concern that the addition of significant new tasks and its increasing workload over the years has not been accompanied by corresponding increases in the ema's staff and resources , and that such a shortage of staff puts the continuity of its operations under significant pressure; ### 10. welcomes the proposal to extend the ema’s mandate but expresses concern that the addition of significant new tasks and its increasing workload over the years has not been accompanied by sufficient corresponding increases in the ema's staff and resources , and that such a shortage of staff puts the continuity of its operations under significant pressure and threatens the quality of the ema's work;


### 11. acknowledges the revised policy on the handling of competing interests of the management board , which took effect from 1 july 2020 and the practice of systematic ex-ante controls on all declarations of interest submitted by management board members together with the requirement that those members undertake training before their declaration of interest can be submitted; ### 11. welcomes the revised policy on the handling of competing interests of the management board , which took effect from 1 july 2020 and the practice of systematic ex-ante controls on all declarations of interest submitted by management board members together with the requirement that those members undertake training before their declaration of interest can be submitted;


### 14. welcomes the further steps taken in order to enhance the transparency of the agency’s activities by reporting the meetings that the agency’s staff have with external stakeholders , and their availability on the website of the agency; ### 14. welcomes the further steps taken in order to enhance the transparency of the agency’s activities by reporting the meetings that the agency’s staff have with external stakeholders and their availability on the website of the agency; notes the substantial and consistent concerns about the lack of transparency about vaccine contracts with pharmaceutical companies , but emphasises that although the agency approves of these vaccines the commission and not the agency is a party in these contracts;


### 5. notes that , on 31 december 2020 , the establishment plan was 100 ,00 % implemented , with 596 temporary agents appointed out of 596 temporary agents authorised under the union budget (compared to 591 authorised posts in 2019); notes that , in addition , 197 contract agents and 32 seconded national experts worked for the agency in 2020; ### 5. welcomes that , on 31 december 2020 , the establishment plan was 100 ,00 % implemented , with 596 temporary agents appointed out of 596 temporary agents authorised under the union budget (compared to 591 authorised posts in 2019); notes that , in addition , 197 contract agents and 32 seconded national experts worked for the agency in 2020;


### 9. notes that the covid-19 pandemic dominated the agency’s activities in 2020 which resulted in substantial resources being allocated to respond to the public health crisis; notes that , as a consequence , the scope of the agency’s 2020 work programme had to be reduced , with important public health activities either delayed or suspended , in line with the business continuity plan , such as clinical data publication for non-covid-19 related products , development of guidelines for and provision of support to scientific working parties; notes that the granting of 40 temporary agent posts by the budgetary authority helped the agency to respond to the exceptional workload; further notes the agency´s statement that those positions were only granted in november 2020 , when it was operationally too late to significantly mitigate the covid-19 related workload of the year; ### 9. notes that the covid-19 pandemic dominated the agency’s activities in 2020 which resulted in substantial resources being allocated to respond to the public health crisis; notes that , as a consequence , the scope of the agency’s 2020 work programme had to be reduced , with important public health activities either delayed or suspended , in line with the business continuity plan , such as clinical data publication for non-covid-19 related products , development of guidelines for and provision of support to scientific working parties; notes with concern the words of the former executive director of the agency stating that he was ‘very concerned’ about the redeployment of the agency’s staff , emphasising that the pressure under which his staff operated could not last forever; notes that the granting of 40 temporary agent posts by the budgetary authority helped the agency to respond to the exceptional workload; further notes the agency´s statement that those positions were only granted in november 2020 , when it was operationally too late to significantly mitigate the covid-19 related workload of the year;


### 13. notes that in 2020 no case of conflict of interest was reported by the agency and that the agency published the conflicts of interest declarations of its management board members and its senior management; notes with satisfaction that the agency published the cvs of its management board members , senior management and of its external and in-house experts; ### 13. notes with satisfaction that in 2020 no case of conflict of interest was reported by the agency and that the agency published the conflicts of interest declarations of its management board members and its senior management; notes with satisfaction that the agency published the cvs of its management board members , senior management and of its external and in-house experts;


### 8. welcomes the improvement in the percentage of management board members , advisory forum members and their alternates submitting the required annual declarations of interest in 2020 compared to the figures for 2019; calls on the centre to ensure that this level of compliance is maintained; ### 8. welcomes the improvement in the percentage of management board members , advisory forum members and their alternates submitting the required annual declarations of interest in 2020 compared to the figures for 2019; calls on the centre to ensure that appropriate experts are engaged in the centre’s work and that a high level of compliance with conflict of interest rules is maintained;


### 9. notes that the centre has adopted a policy on protecting the dignity of the person and preventing harassment; takes note that two cases of alleged harassment have been reported and one case was brought to the court of justice of the european union in 2020; ### 9. notes that the centre has adopted a policy on protecting the dignity of the person and preventing harassment; takes note that two cases of alleged harassment have been reported and one case was brought to the court of justice of the european union in 2020; calls on the centre to inform the discharge authority about the status of that case; calls on the centre to ensure continuous measures aiming at strengthening ethical framework at the workplace , preventing burnout and harassment;


### (2) regulation (ec) no 1367/2006 of the european parliament and of the council4 was adopted in order to contribute to the implementation of the obligations arising under the aarhus convention by laying down rules on its application to union institutions and bodies. ### (2) regulation (ec) no 1367/2006 of the european parliament and of the council4 was adopted in order to contribute to the implementation of the obligations arising under the aarhus convention by laying down rules on its application to union institutions and bodies. this regulation therefore amends the regulation (ec) no 1367/2006 in order to implement article 9(3) and 9(4) of the convention.


### (3) in its communication to the european parliament , the european council , the council , the european economic and social committee and the committee of the regions of 11 december 2019 , entitled ‘the european green deal’ the commission committed itself to consider revising regulation (ec) no 1367/2006 to improve access to administrative and judicial review at union level for citizens and environmental non-governmental organisations who have concerns about the compatibility with environmental law of decisions with effects on the environment. the commission also committed to take action to improve their access to justice before national courts in all member states; to this end , it issued a communication on ‘improving access to justice in environmental matters in the eu and its member states’. ### (3) in its communication to the european parliament , the european council , the council , the european economic and social committee and the committee of the regions of 11 december 2019 , entitled ‘the european green deal’ the commission committed itself to consider revising regulation (ec) no 1367/2006 to improve access to administrative and judicial review at union level for citizens and environmental non-governmental organisations who have concerns about the compatibility with environmental law of decisions with effects on the environment. the commission also committed to take action to improve the right of citizens to have access to justice before national courts in all member states; to this end , it issued a communication on ‘improving access to justice in environmental matters in the eu and its member states’ in which it affirms that “access to justice in environmental matters both via the court of the justice of the eu (cjeu) and the national courts as union courts , is an important support measure to help deliver the european green deal transition and a way to strengthen the role which civil society can play as watchdog in the democratic space”.


### (3) in its communication to the european parliament , the european council , the council , the european economic and social committee and the committee of the regions of 11 december 2019 , entitled ‘the european green deal’ the commission committed itself to consider revising regulation (ec) no 1367/2006 to improve access to administrative and judicial review at union level for citizens and environmental non-governmental organisations who have concerns about the compatibility with environmental law of decisions with effects on the environment. the commission also committed to take action to improve their access to justice before national courts in all member states; to this end , it issued a communication on ‘improving access to justice in environmental matters in the eu and its member states’. ### (3) in its communication to the european parliament , the european council , the council , the european economic and social committee and the committee of the regions of 11 december 2019 , entitled ‘the european green deal’ the commission committed itself to consider revising regulation (ec) no 1367/2006 to improve access to administrative and judicial review at union level for citizens and environmental non-governmental organisations who have concerns about the compatibility with environmental law of decisions with effects on the environment. the commission also committed to take action to improve the right of citizens to have access to justice before national courts in all member states; to this end , it issued a communication on ‘improving access to justice in environmental matters in the eu and its member states’ in which it recalls that ‘access to justice in environmental matters (...) is an important support measure to help deliver the european green deal transition and a way to strengthen the role which civil society can play as watchdog in the democratic space’.


### (4) taking into account the provisions of article 9(3) of the aarhus convention , as well as concerns expressed by the aarhus convention compliance committee5 , union law should be brought into compliance with the provisions of the aarhus convention on access to justice in environmental matters in a way that is compatible with the fundamental principles of union law and with its system of judicial review. ### (4) taking into account the provisions of article 9(3) and (4) of the aarhus convention , union law should be brought into compliance with the provisions of the aarhus convention on access to justice in environmental matters , the findings5 and the advice5a of the aarhus convention compliance committee , as the main body for the review of compliance with the aarhus convention5b , in a way that is compatible with the fundamental principles of union law and with its system of judicial review. this regulation therefore amends regulation (ec) no 1367/2006 in order to fulfil the union’s obligations under international law to implement article 9(3) and (4) of the aarhus convention as regards the union’s institutions and bodies.


### (4) taking into account the provisions of article 9(3) of the aarhus convention , as well as concerns expressed by the aarhus convention compliance committee5 , union law should be brought into compliance with the provisions of the aarhus convention on access to justice in environmental matters in a way that is compatible with the fundamental principles of union law and with its system of judicial review. ### (4) taking into account the provisions of article 9(3) of the aarhus convention , union law should be brought into compliance with the provisions of the aarhus convention on access to justice in environmental matters and the recommendations and findings of the aarhus convention compliance committee , including in cases accc/c/2008/32 and accc/c/2015/128 ,5 in a way that is compatible with the fundamental principles of union law and with its system of judicial review.


### (4) taking into account the provisions of article 9(3) of the aarhus convention , as well as concerns expressed by the aarhus convention compliance committee62 , union law should be brought into compliance with the provisions of the aarhus convention on access to justice in environmental matters in a way that is compatible with the fundamental principles of union law and with its system of judicial review. ### (4) taking into account the provisions of article 9(3) of the aarhus convention , union law should be brought into compliance with the provisions of the aarhus convention on access to justice in environmental matters and the findings of the aarhus convention compliance committee62 in a way that is compatible with the fundamental principles of union law and with its system of judicial review.


### (6) the definition of an administrative act for the purposes of regulation (ec) no 1367/2006 should include non-legislative acts. however , a non legislative act might entail implementing measures at national level against which environmental non-governmental organisations can obtain judicial protection , including before the court of justice of the european union (cjeu) through a procedure for preliminary ruling under article 267 tfeu. therefore , it is appropriate to exclude from the scope of the internal review those provisions of such non-legislative acts for which union law requires implementing measures at national level. ### (6) the definition of an administrative act for the purposes of regulation (ec) no 1367/2006 should include non-legislative acts.


### — having regard to articles 192 and 194 of the treaty on the functioning of the european union (tfeu) , ### — having regard to article 192 of the treaty on the functioning of the european union (tfeu) ,


### b. whereas the european climate law commits the eu to reaching climate neutrality by 2050 with increased emission reductions by 2030; whereas addressing energy-related methane emissions is a key component of the european green deal , as are measures in the agriculture and waste sectors; whereas the eu strategy to reduce methane emissions notes that the eu should also play a role in ensuring methane emission reductions at global level , as the largest global importer of fossil fuels and a significant player in the agriculture sector; ### b. whereas the european climate law commits the eu to reaching a balance between all anthropogenic ghg emissions by sources and removals by sinks (‘climate neutrality’) by 2050 at the latest with increased emission reductions by 2030; whereas urgently reducing methane emissions in the energy , agricultural , waste , water , and petrochemical sectors is a necessary condition for achieving the eu’s climate targets; whereas the eu strategy to reduce methane emissions notes that the eu should also play a role in ensuring methane emission reductions at global level , as the largest global importer of fossil fuels and a significant player in the agriculture sector;


### d. whereas cutting methane emissions can have a quicker impact on slowing the rate of global warming than reducing co2 emissions , since methane does not stay in the atmosphere for as long , and it could therefore be one of the most cost-effective strategies to rapidly reduce the rate of warming and avoid some tipping points for global warming; ### d. whereas cutting methane emissions has an important short-term impact on slowing the rate of global warming , since methane is a short-lived climate forcer with an atmospheric lifetime of about 12 years before being ultimately degraded to co2 in the atmosphere , and whereas cutting methane emissions is therefore one of the most cost-effective strategies to rapidly reduce the rate of warming and avoid some tipping points for global warming;


### 1. welcomes the cross-sectoral approach outlined in the eu strategy to reduce methane emissions and fully supports a fair framework covering the agriculture , waste and energy sectors; ### 1. welcomes the cross-sectoral approach outlined in the eu strategy to reduce methane emissions and calls on the commission to pursue such an approach when proposing legislation; calls on the commission to propose a legislative framework that establishes binding union and national methane emissions reduction targets covering the agriculture , waste , energy , water , and petrochemical sectors;


### 1. welcomes the eu strategy to reduce methane emissions; supports a clear pathway and framework to address methane emissions in a more comprehensive fashion across europe , by fostering synergies between sectors to strengthen the business case for capturing methane emissions; ### 1. welcomes the eu strategy to reduce methane emissions; notes that methane is the second biggest contributor to the eu’s greenhouse gas emissions; recalls that the ipcc 1.5°c special report (sr) concluded that ‘[t]hough co2 dominates long-term warming , the reduction of warming short-lived climate forcers (slcfs) , such as methane and black carbon , can in the short term contribute significantly to limiting warming to 1.5°c above pre-industrial levels'; highlights the importance of immediate and rapid reductions in methane emissions this decade as one of the most effective measures for eu climate action; notes that methane emission reductions complement the necessary reductions in carbon dioxide emissions and that 15% of the required emissions cuts by the paris agreement could already be eliminated with low-cost and technically feasible methane mitigation; highlights that methane reduction brings enormous benefits not only in reduced climate impacts but also from improved air quality; supports a clear legislative framework to address methane emissions in a more comprehensive fashion across all sectors , including agriculture , waste , energy and the petrochemical sector , by establishing binding union and national methane emissions reduction targets;


### 1. regrets the lack of a comprehensive eu monitoring framework for methane emissions; calls on the commission , therefore , to improve the measurement , reporting and verification of methane emissions in the agricultural sector; ### 1. welcomes the commission efforts to develop a more comprehensive eu monitoring framework for methane emissions in the agriculture sector , which will be of interest to encourage individual action within national frameworks; recalls that the existing monitoring system already allows us to take action , as tier 2 methodology is used for reporting and monitoring , e.g. to report under the nec directive;


### 2. underlines the importance of improving measurement , reporting and verification (mrv) as well as leak detection and repair (ldar) standards; ### 2. recalls the 2016 declaration by the commission on the review of methane emissions as part of the adoption of directive (eu) 2016/2284 on the reduction of national emissions of certain atmospheric pollutants (nec)1b; deplores that since then the commission has not lived up to their declaration , failing to come back to the eu legislators with measures for effectively reducing methane emissions in order to achieve the objectives set out in article 1 , paragraph 2 of the nec directive , including enhanced synergies between the union's air quality policy and other relevant union policies , in particular climate and energy policies; regrets the absence of any methane reduction emission objective in the zero pollution action plan; deeply regrets the time wasted by the commission to establish a binding measurement , reporting and verification (mrv) and leak detection and repair (ldar) system and the delay of action against methane emissions on the pretext of missing data;


### 3. underscores the need to revise eu climate and environmental legislation in a coherent manner; takes the view that the binding emissions reduction targets for member states in the effort sharing regulation5 should remain the main legislative tool to reduce methane emissions , while the industrial emissions directive6 and other legislation could serve as a complementary tool; ### 3. underscores the need to revise eu climate and environmental legislation in a coherent manner; in light of the urgency to mitigate methane emissions , calls on the commission to propose an overarching legislative framework setting 2030 binding european and national methane reduction targets of at least 45% compared to today’s emissions covering all the relevant emitting sectors , complemented with an extended nec directive , the inclusion of methane in the industrial emissions directive , and new energy and petrochemical specific legislation and revised water and waste legislation;


### 4. stresses the importance of developing an inventory of best practices and available technologies to promote the wider uptake of innovative mitigating actions; ### 4. stresses the importance of developing an inventory of best practices and available technologies to promote the wider uptake of scientifically peer-reviewed innovative mitigating actions;


### 5. stresses that the upcoming methane regulatory measures should strive to achieve emissions reductions as cost-effectively as possible and provide flexibility for companies to achieve performance standards in an optimal , technologically neutral manner , and at the lowest possible cost; ### 5. draws attention to the fact that the 2021 unep methane global assessment states that 60% of targeted measures in the energy , waste and agriculture sectors are low cost and 50% have negative costs , meaning that companies can make money from taking action; stresses therefore the potential for the eu to adopt ambitious regulatory measures to reduce methane emissions in a cost-effective way;


### 6. recognises the importance of voluntary industry initiatives aimed at reducing methane emissions and considers that any regulatory initiatives should build upon best practices from existing voluntary actions and must be duly preceded by thorough impact assessments; ### 6. notes that voluntary industry initiatives aimed at reducing methane emissions exist , but considers that these initiatives are not enough to achieve the swift and ambitious methane mitigation levels needed to meet the 1.5°c scenario; calls on the commission to rather propose regulatory initiatives , which might build on best practices from existing voluntary actions; believes that thorough impact assessments preceding such regulatory measures must take into account the economic , social and environmental costs of both action and non-action;


### energy ### energy and petrochemicals


### 7. welcomes the upcoming legislative proposal on compulsory mrv for all energy-related methane emissions; ### 7. welcomes the commission commitment to come forward with a legislative proposal on compulsory mrv and ldar; believes that such legislative proposal should not be limited to compulsory mrv and ldar for all energy-related methane emissions as anticipated by the commission , but should apply to all methane emitting sectors and contain binding targets as well as other regulatory measures in order to rapidly reduce all methane emissions;


### 8. welcomes the commission’s proposal to consider legislation on venting and flaring in the energy sector covering , if feasible , the full supply chain; considers that existing national legislation addressing routine venting and flaring , taking into account complex safety and environmental aspects , must be taken into consideration when developing eu legislation; ### 8. looks forward to the commission’s proposed legislation to ban venting and flaring in the energy sector covering the full supply chain;


### 9. acknowledges that imports comprise over four fifths of the oil and gas consumed in the eu and that most methane emissions associated with oil and gas occur outside eu borders; calls on the commission to explore regulatory tools for fossil energy imports , including extending forthcoming obligations on mrv , ldar , venting and flaring to imports; ### 9. calls on the commission to extend requirements on mrv , ldar and routine venting and flaring to all actors of the oil and gas value chain to cover all oil and gas consumed in the eu , including actors from outside of the eu; calls for these obligations to be implemented as soon as possible but no later than 1 january 2023;


### 10. calls on the commission to support the establishment of an independent international methane emissions observatory , in partnership with the united nations environmental programme , the climate and clean air coalition and the international energy agency , tasked with collecting , reconciling , verifying and publishing anthropogenic methane emissions data at a global level; ### 10. calls on the commission to support the establishment of an independent international methane emissions observatory , in partnership with the united nations environmental programme , the climate and clean air coalition and the international energy agency , tasked with collecting , reconciling , verifying and publishing anthropogenic methane emissions data at a global level; believes that such an observatory should look at methane emissions across all sectors , not only energy , with a view in particular to identifying global super-emitters in all sectors;


### 11. welcomes the commission’s initiatives on the utilisation and mitigation of methane from coal mines; expresses its strong support for mandatory mrv for coal mine methane emissions , including the requirement for companies that own closed sites or member states (for abandoned mines where no existing owner is liable) to adopt the same mrv and ldar measures as for operating sites; ### 11. welcomes the commission’s intention to address methane emissions from coal mines , including closed and abandoned sites; stresses that coal has no future in the eu energy mix and should be fully phased out by 2030 at the latest; expresses its strong support for mandatory mrv and ldar for coal mine methane emissions , including the requirement for companies that own closed sites or member states (for abandoned mines where no existing owner is liable) to effectively close and seal all closed and abandoned sites in the eu by 2025 at the latest; appeals to the commission to require member states to address the ownership of abandoned sites to support coal mine methane mitigation measures;


### 12. stresses that technologies and practices to limit methane emissions from agriculture are developing at a fast pace; calls on the commission to ensure that proven effective and cost-efficient innovations are quickly implemented in the eu and integrated into eu agriculture policies; ### 12. stresses that technologies and practices to limit methane emissions from agriculture already exist; recalls , however , that , as underlined in an iiasa study on methane1c , technical solutions only have limited impact on the reduction of methane emissions from the agriculture sector and must be complemented with a shift in livestock farming practices;


### 13. underlines the key role that the eu should play in supporting research , innovation and development , as well as in scaling up new technologies to help address methane emissions from livestock agriculture , while protecting animal health and welfare; points especially to the need for multigenerational studies on feed additives; ### 13. underlines the existence of eu funding for research , innovation and development , as well as in scaling up new technologies and practices to help address methane emissions from livestock agriculture; stresses that such funding should be limited to projects that guarantee the protection of animal health and welfare and do not incentivise large-scale industrial farming; recalls that methane mitigation measures must be developed for grazing animals as methane mitigation should not come at the expense of animal welfare; points especially to the need for multigenerational studies on feed additives;


### 14. calls on the commission to revise the sewage sludge directive7 and the urban waste water treatment directive8 in 2022; calls on the commission furthermore to be ambitious and to integrate a strong focus on methane emissions in the 2024 review of the landfill directive9 ; highlights the need for measures to require landfill sites to use the bio-methane they produce until its energy content drops below a useful value; ### 14. calls on the commission to further analyse methane emissions from sludge and waste water and to revise the sewage sludge directive7 and the urban waste water treatment directive8 in 2022 to add air pollutant and greenhouse gas emissions to the current focus on water and soil pollution;


### 15. calls on the member states to fully comply with the existing requirements of the landfill directive , including the objective for 2035 , by which date the amount of municipal waste landfilled is to be reduced to 10 % or less of the total amount of municipal waste generated , by weight; calls on the commission to develop a comprehensive strategy to ensure that member states that are likely to miss that target take corrective measures and actions; ### 15. calls on the member states to fully comply with the existing requirements of the landfill directive; highlights with concern that in 2017 , 15 member states were not fully meeting the obligation laid down in the directive to treat waste before landfilling , and that a number of facilities are still not in line with the requirements of the directive; recalls the objective for 2035 , by which date the amount of biodegradable municipal waste going to landfills is to be reduced to 35% or less of the total amount of biodegradable municipal waste generated , by weight; is concerned by the great disparities in landfilling percentages across the eu , with 10 member states having landfilled over 50 % , and 5 having landfilled above 70 % of municipal waste in 2015; calls on the commission to develop a comprehensive strategy to ensure that member states that are not in compliance with the landfill directive and/or that are likely to miss the 35% target take corrective measures and actions;


### 16. emphasises that closure and after-care procedures for landfill cells are key to reducing leakages , taking into account the entire life cycle of landfill sites; calls on the commission to provide specific incentives suited to the conditions of each member state in order to ensure , to the greatest extent possible , separate collection of bio-waste , including by encouraging cooperation between the public and private sectors to secure a high degree of separate collection , recycling and recovery of biodegradable waste , leading to efficient diversion from landfill; ### 16. emphasises that closure and after-care procedures for landfill cells are key to reducing leakages , taking into account the entire life cycle of landfill sites; calls on the commission to provide specific support suited to the conditions of each member state in order to ensure the achievement of the 31 december 2023 target for source separation and separate collection of bio-waste , including by encouraging cooperation between the public and private sectors to secure separate collection , recycling and recovery of biodegradable waste , leading to efficient diversion from landfill; highlights that there must always be a feasible biological treatment (composting or anaerobic digestion) option; in that regard , acknowledges the potential of anaerobic digestion from bio-degradable waste which allows the production of biomethane; recalls that the final step after anaerobic digestion should be composting as a way to prevent fugitive emissions of methane and create a quality soil amendment; believes that incineration of waste is at odds with a fully circular economy; calls , therefore , on member states to end support schemes for incineration facilities and to plan their progressive decommissioning , starting with the least efficient ones;


### 1. welcomes the contribution of the european food safety authority (the 'authority') to the safety of the union food and feed chain , and its considerable efforts in providing risk managers with comprehensive , independent and up-to-date scientific advice on questions linked to the food chain , communicating clearly to the public on its outputs and the information on which they are based , and cooperating with interested parties and institutional partners to promote coherence and trust in the food safety system; ### 1. welcomes the contribution of the european food safety authority (the 'authority') to the safety of the union food and feed chain , believes that the authority should increase its efforts in providing risk managers with comprehensive , independent and up-to-date scientific advice on questions linked to the food chain , communicating clearly to the public on its outputs and the information on which they are based , and cooperating with interested parties and institutional partners to promote coherence and trust in the food safety system;


### 5. recalls that , in 2020 , parliament adopted nine objections to the import of genetically modified crops for food and feed; highlights that one reason for these objections are gaps in the risk assessment undertaken by the authority's panel on genetically modified organisms; urges the authority to address and close these gaps as a matter of urgency; ### 5. recalls that , in 2020 , parliament adopted nine objections to the import of genetically modified crops for food and feed; highlights that one reason for these objections are gaps in the risk assessment undertaken by the authority's panel on genetically modified organisms; urges the authority to address and close these gaps as a matter of urgency; highlights , furthermore , that the parliament adopted numerous objections related to the renewal of active substances and to the extension of approvals of active substances; stresses that these objections have very regularly questioned the scientific conclusions of the authority on the active substances concerned;


### 6. invites the commission to grant the authority , in duly justified cases , the option of hiring contract agents in excess of the establishment plans , for a limited period of time and without exceeding the authority’s agreed annual budget envelope; considers that such flexibility would speed up the reduction of the cumulated backlog of work that has arisen owing to a lack of human resources; ### 6. invites the commission to grant the authority , in duly justified cases , the option of hiring contract agents in excess of the establishment plans , for a limited period of time and without exceeding the authority’s agreed annual budget envelope; considers that such flexibility would speed up the reduction of the cumulated backlog of work that has arisen owing to a lack of human resources; insists that those contract agents obviously need to comply with the authority’s independence rules;


### 11. recommends , based on the facts available , that discharge be granted to the executive director of the european food safety authority in respect of the implementation of the authority's budget for the financial year 2020. ### 11. conditions , based on the facts available , the grant of discharge to the executive director of the european food safety authority in respect of the implementation of the authority's budget for the financial year 2020 , to new commitments in terms of independence policy and management of conflict of interests.


### 67. reiterates the need for targeted action , through a harmonised eu legal framework , against the spread of disinformation and hate speech on issues related to gender , lgbtiq+ people , minorities and refugees; reiterates its call on the commission to develop and implement strategies to hinder the financing of individuals and groups that actively spread or participate in information manipulation frequently targeted on the lgbtiq+ people , minorities and refugees and issues concerning them , in order to divide society; ### 67. reiterates the need for targeted action , through a harmonised eu legal framework , against the spread of disinformation and hate speech on issues related to gender , lgbtiq+ people , minorities , immigrants and refugees; reiterates its call on the commission to develop and implement strategies to hinder the financing of individuals and groups that actively spread or participate in information manipulation frequently targeted on the lgbtiq+ people , minorities , immigrants and refugees and issues concerning them , in order to divide society;


### interference through global actors via elite capture , national diasporas , universities and cultural events ### deleted


### 68. denounces in the strongest terms the alleged attempts by qatar to influence members , former members and staff of the european parliament through acts of corruption , which constitute serious foreign interference in the eu’s democratic processes; underlines the need to step up efforts aimed at combating corruption and influence campaigns; reiterates its call for updated transparency rules , mapping foreign funding for eu-related lobbying , including funding for non-profit organisations and proper regulation and monitoring of friendship groups; ### 68. denounces in the strongest terms the attempts by foreign countries , including qatar and morrocco , to influence members , former members and staff of the european parliament through acts of corruption , which constitute serious foreign interference in the eu’s democratic processes; underlines the need to step up efforts aimed at enhancing transparency and integrity of eu institutions among other measures through reinforcing the use of the transparency register , combating corruption and influence campaigns; reiterates its call for updated transparency and ethics rules , mapping foreign funding for eu-related lobbying , ensuring funding for non-profit organisations working on transparency and integrity and ensuring proper regulation and monitoring of friendship groups; reiterates the need to immediately suspend all work on legislative files relating to qatar and morocco as well as for the access badges of representatives of interests of both countries to be suspended until the judicial investigations provide relevant information and clarification;


### 14. underlines the need for public administrations , at all levels , to have specific training aimed at identifying and countering act of information manipulation and interference; reiterates the call on euibas and on national authorities , to continue and strengthen similar training and situational awareness actions as hybrid threats are persistent and widespread and increasingly aimed at influencing eu policies and legislation; calls on euibas to set up interinstitutional training to promote the overall resilience of euibas as a whole; ### 14. underlines the need for public administrations , at all levels , to have specific training aimed at identifying and countering act of information manipulation and interference , while underlining that these trainings should be gender-sensitive; reiterates the call on eu institutions , bodies and agencies (euibas) and on national authorities , to continue and strengthen similar training and situational awareness actions as hybrid threats are persistent and widespread and increasingly aimed at influencing eu policies and legislation; calls on euibas to set up interinstitutional training to promote the overall resilience of euibas as a whole;


### 26. recalls that , while under the current legislation , the submission of contingency plans in the event of emergencies is a legal requirement to obtain transporter authorisations for long journeys , this is not the case for each journey and the possible specific needs thereof; observes with concern that few competent authorities , road transporters and transport organisers have feasible contingency plans to respond to emergency situations; ### 26. recalls that , while under the current legislation , the submission of contingency plans in the event of emergencies is a legal requirement to obtain transporter authorisations for long journeys , this is not implemented for each journey and the possible specific needs thereof; observes with concern that , when contingency plans are available , they do not cover a broad enough range of scenarios and only a few of them are actually feasible and able to respond to emergency situations; notes that the crew’s knowledge of contingency plans is not verified;


### 31. takes note of the modifications to traces in place since january 2020 , allowing member states to see all journeys of the transports they have authorised and all journeys stopping at control posts located in their country; ### 31. highlights the importance of widespread access to the traces system , for interested stakeholders , such as actors cooperating with the competent authorities during official controls; takes note of the modifications to traces in place since january 2020 , allowing member states to see all journeys of the transports they have authorised and all journeys stopping at control posts located in their country; notes that traces update is not enabling monitoring of journeys passing through member states territories;


### 32. notes that further improvements to data collection systems and to traces can be made in the current legislative framework , to help harmonise procedures between member states’ competent authorities; ### 32. notes that further improvements to data collection systems and to traces can be made in the current legislative framework , to help harmonise procedures between member states’ competent authorities; recalls that the development of software for competent authorities to handle long and cross-border transports is still ongoing , but could , if applied eu-wide , largely harmonise clearance and the underlying plausibility check to verify route planning and weather conditions; reminds that any of the aspects to be monitored for the plausibility check can be digitalised or are already available in digitized form;


### 33. expresses concern that the member states are not required to record data on the transport of animals directly exported from their territories to outside the eu in traces; ### 33. expresses concern that the member states are not required to record data on the transport of animals directly exported from their territories to outside the eu in traces; expresses concern over the absence of eu-wide data collection of transport data , leading to a lack of data in member states as well as the european commission; regrets that the collected data in the member states and in the traces system has not yet been centralised making it impossible to follow up on systemic breaches of regulation (ec) no 1/2005; regrets that no progress has been made on a harmonised system of sanctions , nor on a list of bad conduct of operators perpetrating repeated breaches of the regulation , despite the parliament’s call to the commission in its 2019 resolution;


### 34. is aware that , despite the high level of non-compliance during animal transport , reporting of infringements between the member states is poor and that effective and dissuasive sanctions against those who violate the regulation are lacking; ### 34. is aware that , despite the high level of non-compliance during animal transport , reporting of infringements between the member states is poor which makes monitoring of intra-eu cross-border transport very difficult; points out that effective , proportionate and dissuasive sanctions against those who breach the regulation are still lacking , recalls that there is no eu-wide standard existing for the control and monitoring of long and cross-border animal transport by the competent authorities , especially outside eu borders;


### a. whereas , following the entry into force of the multiannual financial framework (mff) for 2021-2027 , the commission published a roadmap and launched a public consultation with a view to aligning the financial regulation , where appropriate , with the rules agreed by the legislator as part of the mff 2021-2027 package , and to proposing limited and targeted improvements required by the evolving situation , for instance following the covid-19 crisis or in the context of the growing opportunities for digitalisation; ### a. whereas , following the entry into force of the multiannual financial framework (mff) for 2021-2027 , the commission published a roadmap and launched a public consultation with a view to aligning the financial regulation , where appropriate , with the rules agreed by the legislator as part of the mff 2021-2027 package , and to proposing limited and targeted improvements required by the evolving situation , for instance following the covid-19 crisis or in the context of the growing opportunities for digitalisation , as well as improvements regarding crisis management , administrative simplifications for eu funds recipients , and protection of eu financial interests in accordance with the general principles embedded in the union treaties , in particular the values laid down in article 2 teu , as well as in accordance with the principle of sound financial management enshrined in article 317 tfeu and in the rule of law conditionality regulation;


### 1. notes that the upcoming revision of the financial regulation is needed as a consequence of the entry into force of the mff 2021-2027 package , including ngeu , which not only updates legal provisions but also contains significant innovations within the budgetary system; ### 1. notes that the upcoming revision of the financial regulation is needed as a consequence of the entry into force of the mff 2021-2027 package , including ngeu , as well as to ensure the proper implementation of the inter-institutional agreement on budgetary discipline , on cooperation in budgetary matters and on sound financial management , as well as on new own resources , including a roadmap for the introduction of new own resources , which not only updates legal provisions but also contains significant innovations within the budgetary system;


### 2. believes that the revision should seek to modernise the rules applicable to the eu budget in line with its latest evolutions and in line with the budgetary principles , and to increase parliamentary oversight , democratic accountability and the ability to respond to citizens’ needs; ### 2. believes that the revision should seek to modernise the rules applicable to the eu budget in line with its latest evolutions and in line with the budgetary principles , and to strengthen public procurement rules avoiding any potential conflict of interests , including professional conflict of interests , whether immediately apparent or not and to increase parliamentary oversight , democratic accountability and the ability to respond to citizens’ needs;


### 2. believes that the revision should seek to modernise the rules applicable to the eu budget in line with its latest evolutions and in line with the budgetary principles , and to increase parliamentary oversight , democratic accountability and the ability to respond to citizens’ needs; ### 2. believes that the revision should seek to modernise the rules applicable to the eu budget in line with its latest evolutions and in line with the budgetary principles , and to increase respect of the eu values , protection of the financial interests of the eu , parliamentary oversight , democratic accountability and the ability to respond to citizens’ needs quickly , particularly in times of crises;


### 2. believes that the revision should seek to modernise the rules applicable to the eu budget in line with its latest evolutions and in line with the budgetary principles , and to increase parliamentary oversight , democratic accountability and the ability to respond to citizens’ needs; ### 2. believes that the revision should seek to modernise the rules applicable to the eu budget in line with its latest evolutions and in line with the budgetary principles , and to increase parliamentary oversight , transparency , democratic accountability , civic engagement and the ability to respond to citizens’ needs;


### 3. is of the opinion that , while a global overhaul of the rules applicable to the budget is not needed at this time , the financial regulation must be subject to targeted improvements and simplifications , in particular where they increase transparency and democratic scrutiny; ### 3. is of the opinion that , while a global overhaul of the rules applicable to the budget is not needed at this time , the financial regulation must be subject to targeted improvements; red tape reduction and simplifications , in particular where they increase transparency and democratic scrutiny; increase the accessibility to the eu funding for the citizens , smes , local and regional authorities;


### 3. is of the opinion that , while a global overhaul of the rules applicable to the budget is not needed at this time , the financial regulation must be subject to targeted improvements and simplifications , in particular where they increase transparency and democratic scrutiny; ### 3. is of the opinion that , while a global overhaul of the rules applicable to the budget is not needed at this time , the financial regulation must be subject to targeted improvements and simplifications , in particular where they increase transparency and democratic scrutiny as well as provide for a better implementation of the eu budget;


### 3. is of the opinion that , while a global overhaul of the rules applicable to the budget is not needed at this time , the financial regulation must be subject to targeted improvements and simplifications , in particular where they increase transparency and democratic scrutiny; ### 3. is of the opinion that , while a global overhaul of the rules applicable to the budget is not needed at this time , the financial regulation must be subject to targeted improvements and simplifications , in particular where they increase rule of law , transparency and democratic scrutiny;


### 4. notes that the number and scope of off-budget instruments have grown significantly in the past decade , and that ngeu has taken this practice to the next level , by greatly , if temporarily , increasing the magnitude of the eu budget in the form of external assigned revenue , and creating liabilities until 2058 through borrowing for lending and borrowing for direct eu expenditure; warns that these developments put at risk central budgetary principles such as unity and budgetary accuracy , equilibrium and universality; ### 4. notes that the number and scope of off-budget instruments have grown significantly in the past decade , and that ngeu has taken this practice to the next level , increasing the magnitude of the eu budget in the form of external assigned revenue; notes that ngeu , financed through the eu budget is the largest amount the eu has ever proposed to redress its economy after the impact of covid-19 pandemic; expresses its confidence that in crises , innovative instruments like ngeu will be used in order to enable the european union to act and support its member states; invites the commission to propose a more transparent system of governance for the off-budget instruments , that involves both arms of budgetary authority , the european parliament and the council; warns that the risks of fraud and misuse of these funds is significant; calls that the modifications of the financial regulation should reinforce the link between ngeu-funded recovery measures and the eu's objectives and values;


### 4. notes that the number and scope of off-budget instruments have grown significantly in the past decade , and that ngeu has taken this practice to the next level , by greatly , if temporarily , increasing the magnitude of the eu budget in the form of external assigned revenue , and creating liabilities until 2058 through borrowing for lending and borrowing for direct eu expenditure; warns that these developments put at risk central budgetary principles such as unity and budgetary accuracy , equilibrium and universality; ### 4. welcomes that ngeu has greatly increased the magnitude of the eu budget allowing the union to face one of its greatest challenges of its existence; notes that it has created liabilities until 2058 through borrowing for lending and borrowing for direct eu expenditure;


### 4. notes that the number and scope of off-budget instruments have grown significantly in the past decade , and that ngeu has taken this practice to the next level , by greatly , if temporarily , increasing the magnitude of the eu budget in the form of external assigned revenue , and creating liabilities until 2058 through borrowing for lending and borrowing for direct eu expenditure; warns that these developments put at risk central budgetary principles such as unity and budgetary accuracy , equilibrium and universality; ### 4. notes that the number and scope of off-budget instruments have grown significantly in the past decade , and that ngeu has taken this practice to the next level , increasing the magnitude of the eu budget in the form of external assigned revenue , and creating liabilities until 2058 through borrowing for lending and borrowing for direct eu expenditure; warns that these developments put at risk central budgetary principles such as unity and budgetary accuracy , equilibrium and universality;


### 5. is concerned that these mechanisms pose a serious challenge to the ability of the parliament to fulfil its decision-making , scrutiny and discharge functions; strongly believes that eu financial rules must be updated as regards the role of the budgetary authority in relation to these mechanisms , in order to bring them closer to the principles and responsibilities set out in the treaties; ### 5. notes that the number and scope of off-budget instruments have grown significantly in the past decade; believes that off-budget instruments funded by external assigned revenues limit the ability of the parliament to fulfil its decision-making , scrutiny and discharge functions; strongly believes that eu financial rules must be updated as regards the role of the budgetary authority in relation to these mechanisms , in order to bring them closer to the principles and responsibilities set out in the treaties;


### 5. is concerned that these mechanisms pose a serious challenge to the ability of the parliament to fulfil its decision-making , scrutiny and discharge functions; strongly believes that eu financial rules must be updated as regards the role of the budgetary authority in relation to these mechanisms , in order to bring them closer to the principles and responsibilities set out in the treaties; ### 5. is concerned that using externally assigned revenues pose a serious challenge to the ability of the parliament to fulfil its decision-making , scrutiny and discharge functions; reminds of the joint declaration and reaffirms that it expects eu financial rules to be updated as regards the role of the budgetary authority , in order to bring them closer to the principles and responsibilities set out in the treaties;


### 6. believes that parliament , as one arm of the budgetary authority , should be able to scrutinise and authorise as appropriate the commission’s plans with respect to the management of external assigned revenue and of its borrowing and lending operations; suggests that relevant articles of the financial regulation , including articles 7 , 46 and 56 , be revised to clarify that assets and liabilities linked to borrowing and lending operations are included in the eu budget; ### 6. believes that parliament , as one arm of the budgetary authority , should be able to scrutinise and authorise as appropriate the commission’s plans with respect to the management of external assigned revenue and of its borrowing and lending operations; suggests that relevant articles of the financial regulation , including articles 7 , 46 and 56 , be revised to clarify that assets and liabilities linked to borrowing and lending operations are included in the eu budget , thus fully under the control and reporting of the european court of auditors;


### 8. calls for the revision of reporting requirements on the commission’s debt management strategy , including maturity and schedule of payments , to adapt them to the increased complexity and risk of borrowing and lending operations; ### 8. calls for the revision of reporting requirements on the commission’s debt management strategy , including maturity and schedule of payments and including the role of new own resources in the repayment of the debt , to adapt them to the increased complexity and risk of borrowing and lending operations;


### 9. emphasises the clear link between respect for the rule of law and the efficient implementation of the union budget in accordance with the principles of sound financial management: economy , efficiency and effectiveness , as laid down in the financial regulation; recalls that , upon adoption of the conditionality regulation , parliament , the council and the commission agreed to consider including the content of the conditionality regulation into the financial regulation upon its next revision; calls on the commission to examine possibilities to strengthen coherence between the two instruments; ### 9. emphasises the clear relationship between respect for the rule of law and the efficient implementation of the union budget in accordance with the principles of sound financial management: economy , efficiency and effectiveness , as laid down in the financial regulation; highlights in this regard that fraudulent and corrupt practices by definition violate sound financial management as defined in article 33 (1) of the financial regulation with regard to economy and efficiency given that such practices are directly at odds with assuring the best quantity , quality at the best price , and with achieving the optimal relationship between resources employed and objectives achieved; recalls that , upon adoption of the conditionality regulation , parliament , the council and the commission agreed to consider including the content of the conditionality regulation into the financial regulation upon its next revision , and calls on the commission to include this in the revision linked to the 2021-2027 mff; calls on the commission to examine possibilities to further strengthen coherence between the two instruments in particular , to ensure sound financial management; believes that the commission should pay particular attention to the effects of member states not fulfilling their duties as laid down in article 63(2) with a particular focus on preventive ex-ante measures;


### 9. emphasises the clear link between respect for the rule of law and the efficient implementation of the union budget in accordance with the principles of sound financial management: economy , efficiency and effectiveness , as laid down in the financial regulation; recalls that , upon adoption of the conditionality regulation , parliament , the council and the commission agreed to consider including the content of the conditionality regulation into the financial regulation upon its next revision; calls on the commission to examine possibilities to strengthen coherence between the two instruments; ### 9. emphasises the clear link between respect for the rule of law and the efficient implementation of the union budget in accordance with the article 2 teu and the principles of sound financial management: economy , efficiency and effectiveness , as laid down in the financial regulation; recalls that , upon adoption of the conditionality regulation , parliament , the council and the commission agreed to consider including the content of the conditionality regulation into the financial regulation upon its next revision and urges the commission to make this proposal; calls on the commission to examine possibilities to strengthen coherence between all eu instruments that allow the protection of the financial interests of the union , the respect of the eu values and rule of law , including the recommendations from the rule of law reports;


### 10. stresses that it is important to know who benefits from eu funds in order to protect the financial interests of the eu and to detect fraud , corruption and conflicts of interest in particular; notes that data for identifying economic operators and their beneficial owners is not easily , or not at all , accessible12 ; considers that the centralisation of the information in a single , interoperable eu database with information on direct and ultimate beneficiaries would overcome the identified fragmentation and lack of transparency; ### 10. stresses that it is important to know how eu funds are spent and who truly benefits from eu funds in order to protect the financial interests of the eu and to detect fraud , corruption and conflicts of interest in particular; notes that data for identifying economic operators and their beneficial owners is not easily , or not at all , accessible12; considers that the centralisation of the information in a single , interoperable and user friendly public eu database with information on direct and ultimate beneficiaries , with data accessible in a machine readable format , would overcome the identified fragmentation and lack of transparency as well as enhance public scrutiny and trust in eu public spending; stresses the urgency in establishing transparency for beneficial owners in light of the pandora papers;


### 10. stresses that it is important to know who benefits from eu funds in order to protect the financial interests of the eu and to detect fraud , corruption and conflicts of interest in particular; notes that data for identifying economic operators and their beneficial owners is not easily , or not at all , accessible12 ; considers that the centralisation of the information in a single , interoperable eu database with information on direct and ultimate beneficiaries would overcome the identified fragmentation and lack of transparency; ### 10. stresses that it is important to know who benefits from eu funds in order to protect the financial interests of the eu and to detect fraud , corruption and conflicts of interest in particular; notes that data for identifying economic operators and their beneficial owners is not easily , or not at all , accessible12 ; considers that the centralisation of the information in a single , interoperable eu database with information on direct and ultimate beneficiaries would overcome the identified fragmentation and lack of transparency; notes that digitalisation of the management of eu funds coupled with a comprehensive definition of conflict of interest at the european level will increase the efficiency for the protection of the financial interests of the eu;


### 11. emphasises that the financial regulation should include provisions that require the responsible actors to gather and keep uniform records of economic operators and beneficial owners in order to allow identification across eu programmes , regardless of who implements these programmes and of management mode; considers that these requirements should be balanced to reflect strictly relevant information items; underlines that data may only be published in line with data protection requirements and the standing jurisprudence of the court of justice of the european union; considers that compulsory information items collected for audit and control purposes need to include as a minimum the registration number of legal entities , national identification number for natural persons , an indication of the type of beneficiary , sub-contractors , beneficial owners , whether the beneficiary also receives state aid and contact information; underlines that the system needs to facilitate the aggregation of individual amounts concerning the same direct or ultimate beneficiary; considers that publicly accessible systems should facilitate both individual searches through a web-based tool and systemic analysis through bulk downloads; ### 11. emphasises that the financial regulation should include provisions that require the responsible actors to gather and keep uniform records of economic operators and beneficial owners in order to allow identification across eu programmes , regardless of who implements these programmes and of management mode; considers that these requirements should reflect all relevant information items to enhance the commission’s capability and capacity to detect fraud;


### 12. considers that article 63 of the financial regulation should be modified to include arachne as a compulsory risk scoring tool made available by the commission to member states and other implementing partners; considers that the financial regulation should also indicate which indicators arachne uses to determine the risk score of economic operators; considers that any additional administrative burden , from inserting information multiple times in various it systems , including arachne , must be avoided; ### 12. considers that article 63 of the financial regulation should be modified to include arachne as a compulsory risk scoring tool made available by the commission to member states and other implementing partners and to oblige implementing partners to feed information into it; considers that the financial regulation should also indicate which indicators arachne uses to determine the risk score of economic operators; calls for maximum interoperability between arachne and the different implementing software used; stresses the importance of the full ownership and operational rights of arachne tool and calls on the commission to consider moving the tool’s management fully in-house;


### 13. calls for the use of the early detection and exclusion system (edes) to be made compulsory under shared management; further notes that edes does not distinguish between subsidiaries of larger corporations; calls on the commission to make this distinction and to specify in the rules for early detection and for exclusion which entity of a multi-national or multi-company corporation is registered for early detection or exclusion; ### 13. recalls that a high-level panel has been established to assess this in 2018 and calls for its findings to be presented to the parliament before the commission makes a proposal to update the financial regulation; insists for the use of the early detection and exclusion system (edes) to be made compulsory also under shared management; further notes that edes does not distinguish between subsidiaries of larger corporations; calls on the commission to make this distinction and to specify in the rules for early detection and for exclusion which entity of a multi-national or multi-company corporation is registered for early detection or exclusion; calls for the obligation to update edes once fraud or other relevant facts have been established by actors involved in the implementation; believes that legal entities or natural persons disqualified through edes could no longer be a final recipient or beneficiary to whom any payments from the eu budget are owned; further calls on the commission to encourage the member states that these entities or natural persons are also excluded from any contributions from national-budgets;


### 15. suggests that the re-use of decommitted appropriations as a result of full or partial non-implementation of projects pursuant to article 15(3) of the financial regulation should be extended beyond research and innovation , to include appropriations that support social policies , youth and humanitarian aid; believes that decommitted appropriations should be made available in their entirety the year following that of their decommitment; ### 15. suggests that the re-use of decommitted appropriations as a result of full or partial non-implementation of projects pursuant to article 15(3) of the financial regulation should be extended beyond research and innovation , to include all appropriations; believes that decommitted appropriations should be made available in their entirety the year following that of their decommitment;


### 16. suggests that the financial regulation be revised to guarantee the appropriate role of parliament in the setting up and scrutiny of any new trust fund , including in the drawing up of the constitutive agreement and the mobilisation of the union’s contribution , the implementation , continuation and possible liquidation; ### 16. insists that the financial regulation be revised to guarantee the appropriate role of parliament in the setting up , supervision and scrutiny of any new trust fund , including in the drawing up of the constitutive agreement and the mobilisation of the union’s contribution , the implementation , continuation and possible liquidation; reiterates that parliament should be involved as observer , and able to monitor the activities of the governing bodies of a trust fund; stresses that timely , regular and figure-based information on the implementation of a trust fund is essential to allow parliament to exercise its democratic oversight and scrutiny role;


### 16. suggests that the financial regulation be revised to guarantee the appropriate role of parliament in the setting up and scrutiny of any new trust fund , including in the drawing up of the constitutive agreement and the mobilisation of the union’s contribution , the implementation , continuation and possible liquidation; ### 16. suggests that the financial regulation be revised to guarantee the appropriate role of parliament in the setting up and scrutiny of trust funds , including in the drawing up of the constitutive agreement and the mobilisation of the union’s contribution , the implementation , continuation and possible liquidation;


### 17. notes that the commission’s vademecum on public procurement was last updated in january 2020; notes that the current definition of ‘professional conflict of interest’ is limited to a conflicting interest that affects the capacity of an economic operator to perform a contract; calls on the commission to provide for a more explicit definition and to ensure that its implementation rules on public procurement do not permit the awarding of policy-related service contracts to undertakings that are under the economic control of a parent company or a group that owns shares related to activities that are not in line with the eu’s environmental , social and green deal objectives; ### 17. notes that the current definition of ‘professional conflict of interest’ is limited to a conflicting interest that affects the capacity of an economic operator to perform a contract; calls on the commission to provide for a more explicit definition and to ensure that its implementation rules on public procurement do not permit the awarding of policy-related service contracts to undertakings that are under the economic control of a parent company or a group that owns shares related to activities that are not in line with the eu’s environmental , social and green deal objectives; believes that such a revised definition should take into account the risk of conflict of interests of a performer that is developing sectoral guidelines it will have to comply with , with particular scrutiny when it comes to policy-related projects and studies;


### 17. notes that the commission’s vademecum on public procurement was last updated in january 2020; notes that the current definition of ‘professional conflict of interest’ is limited to a conflicting interest that affects the capacity of an economic operator to perform a contract; calls on the commission to provide for a more explicit definition and to ensure that its implementation rules on public procurement do not permit the awarding of policy-related service contracts to undertakings that are under the economic control of a parent company or a group that owns shares related to activities that are not in line with the eu’s environmental , social and green deal objectives; ### 17. notes that the commission’s vademecum on public procurement was last updated in january 2020; notes that the current definition of ‘professional conflict of interest’ is limited to a conflicting interest that affects the capacity of an economic operator to perform a contract; calls on the commission to provide for a more explicit definition and to ensure that its implementation rules on public procurement do not permit the awarding of policy-related service contracts to undertakings that are under the economic control of a parent company or a group that owns shares related to activities that are not in line with the eu’s environmental , social and green deal objectives; calls for including the safeguards in public procurement to reject companies whose activities contradict social and environmental objectives of the european union;