### 3. as part of that reporting , the medicines steering group may also provide recommendations on measures , which may be taken by the commission , member states , marketing authorisation holders and other entities to prevent or mitigate potential or actual shortages. in that regard the group shall liaise , as relevant , with the health security committee and , in the case of a public health emergency , the advisory committee on public health emergencies. ### 3. as part of that reporting , the medicines steering group may also provide recommendations on measures , which may be taken by the commission , member states , marketing authorisation holders and other entities , including healthcare professionals or patients , to prevent or mitigate potential or actual shortages. in that regard the group shall liaise , as relevant , with the health security committee and , in the case of a public health emergency , the advisory committee on public health emergencies.


### 3. as part of that reporting , the medicines steering group may also provide recommendations on measures , which may be taken by the commission , member states , marketing authorisation holders and other entities to prevent or mitigate potential or actual shortages. in that regard the group shall liaise , as relevant , with the health security committee and , in the case of a public health emergency , the advisory committee on public health emergencies. ### 3. as part of that reporting , the medicines steering group may also provide recommendations on measures , which may be taken by the commission , member states , marketing authorisation holders and other entities , including healthcare professionals and patients , to prevent or mitigate potential or actual shortages. in that regard the group shall liaise , as relevant , with the health security committee and , in the case of a public health emergency , the advisory committee on public health emergencies.


### 4. the medicines 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 , marketing authorisation holders and other entities to ensure preparedness to deal with potential or actual shortages of medicinal products caused by public health emergencies or major events. ### 4. the medicines 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 , marketing authorisation holders and other entities to ensure preparedness to deal with potential or actual shortages of medicinal products caused by public health emergencies or major events. these recommendations may include measures to minimize unnecessary administrative burdens or facilitate flexible supply chains.


### 5. the medicines steering group may upon request from the commission coordinate measures , where relevant , between the national competent authorities , the marketing authorisation holders and other entities to prevent or mitigate potential or actual shortages in the context of a major event or public health emergency. ### 5. the medicines steering group may upon request from the commission coordinate measures , where relevant , between the national competent authorities , the marketing authorisation holders and other entities , including healthcare professionals , to prevent or mitigate potential or actual shortages in the context of a major event or public health emergency.


### specify the procedures for establishing the critical medicines lists; ### specify the procedures for establishing the critical medicines lists , ensuring adequate consultation with consumers , patients and healthcare professionals and a high level of transparency;


### specify the procedures for establishing the critical medicines lists; ### specify the procedures and criteria for establishing the critical medicines lists;


### specify the procedures for establishing the critical medicines lists; ### specify the procedures for establishing and reviewing the critical medicines lists;


### specify the methods of and criteria for the monitoring , data collection and reporting provided for in articles 4 , 7 and 8; ### specify the methods of and criteria for the monitoring , data collection and reporting through the european union of health digitalized and interoperable early-warning system of shortage of medicines , established in article 2bis(new) , and provided for in articles 4 , 7 and 8;


### develop streamlined electronic monitoring and reporting systems; ### develop streamlined electronic monitoring and reporting systems by implementing and building on existing regulatory infrastructure (eu telematics[1]). this system shall be interoperable with the national shortages reporting to prevent any duplication of the reporting process; the system shall establish a two-way digital communication between the agency and the national competent authorities , as well as a two way communication between the agency and marketing authorisation holders. in case of public health emergency , aggregated information shall be collected by the agency from national competent authority shortages reporting systems in a harmonised and consolidated way , based on national harmonised data fields and definitions across member states. the agency can request additional information directly from the marketing authorisation holders via the industry single point of contact (ispoc) , if this information has not been provided yet to the member states through the system;


### develop streamlined electronic monitoring and reporting systems; ### develop streamlined electronic monitoring and reporting systems , building upon eu telematics regulatory infrastructure , spor , into national shortage reporting interoperable system , based on national harmonised data fields and definitions across member states , preventing reporting duplication , using international standards (iso idmp) and supporting mutual cooperation of the agency and national competent authorities and via ispoc with marketing authorisation holders;


### develop streamlined electronic monitoring and reporting systems; ### develop an interoperable and digitalized platform for monitoring , reporting and notifying;


### develop streamlined electronic monitoring and reporting systems; ### develop streamlined electronic monitoring and reporting systems by implementing and building on existing regulatory infrastructure (eu telematics1a). this system will shall be interoperable with the national shortages reporting to prevent any duplication of the reporting process; the system should establish a two-way digital communication between the agency and the national competent authorities , as well as a two way communication between the agency and marketing authorisation holders. in case of public health emergency , aggregated information should be collected by the ema from national competent authority shortages reporting systems in a harmonised and consolidated way , based on national harmonised data fields across member states. the agency can request additional information directly from the marketing authorisation holders via the industry single point of contact (ispoc) , if this information has not been provided yet to the member states;


### develop streamlined electronic monitoring and reporting systems; ### develop streamlined electronic monitoring and reporting systems , building upon eu telematics regulatory infrastructure , spor , into national shortage reporting interoperable system , preventing reporting duplication , using international standards (iso idmp) and supporting mutual cooperation of the agency and national competent authorities and via ispoc with marketing authorisation holders;


### establish and maintain a list of single points of contact from marketing authorisation holders for all medicinal products for human use authorised in the union , through the database provided for in article 57(1)(l) of regulation 726/2004; ### establish and maintain a list of single points of contact from marketing authorisation holders for all medicinal products for human use authorised in the union , through the database provided for in article 57(1)(l) of regulation 726/2004 after updating it by including the industry single point of contacts (ispoc)maintaining compliance with iso idmp;


### establish and maintain a list of single points of contact from marketing authorisation holders for all medicinal products for human use authorised in the union , through the database provided for in article 57(1)(l) of regulation 726/2004; ### update the article57(1)(l) of regulation 726/2004 database by including the industry single point of contact (ispoc); this database should be digital , regularly updated , and compliant with the international organization for standardization (iso) for the identification of medicinal products (idmp)


### establish and maintain a list of single points of contact from marketing authorisation holders for all medicinal products for human use authorised in the union , through the database provided for in article 57(1)(l) of regulation 726/2004; ### establish and maintain a list of single points of contact from marketing authorisation holders for all medicinal products for human use authorised in the union , through the database provided for in article 57(1)(l) of regulation 726/2004 after updating it by including the industry single point of contacts (ispoc) maintaining compliance with iso idmp;


### establish and maintain a list of single points of contact from marketing authorisation holders for all medicinal products for human use authorised in the union , through the database provided for in article 57(1)(l) of regulation 726/2004; ### update the article 57(1)(l) of regulation 726/2004 database by including the industry single point of contact (ispoc); this database should be digital , regularly updated , and compliant with the international organization for standardization (iso) for the identification of medicinal products (idmp)1a;


### request information from the points of contact included in the sub-network referred to in point (a) and set a deadline for its submission; ### request information , including on the supply of the list of critical medicinal products , from the points of contact included in the sub-network referred to in point (a) and set a deadline for its submission in the platform;


### request information from the single points of contact from member states’ national competent authorities based on the set of information agreed on by the medicines steering group and set a deadline for its submission. ### request information , including on the supply of the list of critical medicinal products , from the single points of contact from member states’ national competent authorities based on the set of information agreed on by the medicines steering group and set a deadline for its submission in the platform.


### 3. the information referred to in point (b) of paragraph 2 shall include at least: ### 3. the scope of the information referred to in point (b) of paragraph 2 shall be discussed with representatives of the relevant marketing authorisation holders , including to avoid overlaps with information already submitted following directive 2001/83/ec. requested information may include:


### 3. the information referred to in point (b) of paragraph 2 shall include at least: ### 3. the information referred to in point (b) of paragraph 2 , without duplicating information available to the agency via collection of information submitted by industry to the national competent authority shortages systems , shall include at least:


### sales and market share data; ### sales , available stock , where relevant , and market share data;


### details of available alternative medicinal products; ### details of available alternative medicinal products where known by the marketing authorisation holder;


### mitigation plans including production and supply capacity; ### prevention and mitigation plans including information on production and supply capacity; production sites of the finished pharmaceutical product and of active pharmaceutical ingredients , potential alternative production sites , minimum stock levels , etc.;


### mitigation plans including production and supply capacity; ### mitigation plans including production and supply capacity; these plans shall contain preventative measures that help ensure the continued supply of critical medicines , such as diversification of supply chains;


### mitigation plans including production and supply capacity; ### prevention and mitigation plans including production and supply capacity;


### mitigation plans including production and supply capacity; ### mitigation plans;


### 1. in order to facilitate the monitoring referred to in article 7 and following a request from the agency , marketing authorisation holders for medicinal products included on the critical medicines lists shall submit the information referred to in article 9(3) by the deadline set by the agency. they shall submit the information through the points of contact designated in accordance with article 9(2) and using the reporting methods and system established pursuant to article 9(1). they shall provide updates where necessary. ### 1. in order to facilitate the monitoring referred to in article 7 and following a request from the agency , marketing authorisation holders for medicinal products included on the critical medicines lists shall submit upload the additional information referred to in article 9(3) in the harmonised pan-european interoperable and digitalized shortages reporting and notification system by the a reasonable deadline set by the agency in concertation with industry. they shall submit upload the additional information in the harmonised pan-european interoperable and digitalized shortages reporting and notification system through the points of contact designated in accordance with article 9(2) and using the reporting methods and system established pursuant to article 9(1). they shall provide updates where necessary. once uploaded , the information is accessible to the agency and national competent authorities , ensuring transparency and avoiding duplications of reporting at different levels and enabling the two-way communication with industry and entities of the pharmaceutical supply chain .


### 2. marketing authorisation holders of medicinal products authorised in the union shall , within 6 months from the date of application of this regulation , provide the information required pursuant to article 9(1)(e) in the form of an electronic submission in the database referred to in article 57(1)(l) of regulation (ec) no 726/2004. those marketing authorisation holders shall update their submission wherever necessary. ### 2. marketing authorisation holders of medicinal products authorised in the union shall , within 6 months from the date of application of this regulation , provide the information required pursuant to article 9(1)(e) in the form of an electronic submission in the database referred to in article 57(1)(l) of regulation (ec)no 726/2004 and compliant with iso idmp standards for the identification of human medicines. those marketing authorisation holders shall update their submission wherever necessary.


### 3. marketing authorisation holders shall justify the absence of any requested information and any delays in providing it by the deadline set by the agency. ### 3. marketing authorisation holders of medicinal products authorised in the union shall , within 6 months from the date of application of this regulation , provide the information required pursuant to article 9(1)(e) in the form of an electronic submission in the database referred to in article 57(1)(l) of regulation (ec)no 726/2004 and compliant with iso idmp standards for the identification of human medicines. those marketing authorisation holders shall update their submission wherever necessary.


### 4. where marketing authorisation holders for medicinal products included on the critical medicines lists 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 commercially confidential information against unjustified disclosure. ### 4. where marketing authorisation holders for medicinal products included on the critical medicines lists indicate that the submitted information requested by the agency and the national competent authorities 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 commercially confidential information against unjustified disclosure.


### 5. where marketing authorisation holders for medicinal products included on the critical medicines lists are in possession of any additional information , which provides evidence of a potential or actual shortage they shall immediately provide such information to the agency. ### 5. where marketing authorisation holders for medicinal products included on the critical medicines lists and /or other relevant entities of the pharmaceutical supply chain , are in possession of any additional information , which provides evidence of a potential or actual shortage they shall immediately provide such information to the agency.


### inform the medicines steering group of any measures taken and report on the results of those measures , including information on the resolution of the potential or actual shortage. ### inform the medicines steering group of any measures taken and report on the monitoring and results of those measures , including information on the resolution of the potential or actual shortage.


### 1. in order to facilitate the monitoring referred to in article 7 and following a request from the agency , member states shall , by the deadline set by the agency: ### 1. in order to facilitate the monitoring referred to in article 7 and following a request from the agency , member states shall , by the deadline set by the agency , submit the following , if not already available in the harmonised pan-european interoperable and digitalized shortages reporting and notification system :


### 1. in order to facilitate the monitoring referred to in article 7 and following a request from the agency , member states shall , by the deadline set by the agency: ### 1. in order to facilitate the monitoring referred to in article 7 and following a request from the agency , member states or any national competent authority shall , by the deadline set by the agency:


### submit the set of information requested by the agency including available and estimated data on volume of demand , through its designated point of contact and using the reporting methods and system established pursuant to article 9(1); ### submit the set of additional information requested by the agency in chapter 2 article 9 (3) including available and estimated data on volume of demand , through its designated point of contact and using the reporting methods and system established pursuant to article 9(1);


### submit the set of information requested by the agency including available and estimated data on volume of demand , through its designated point of contact and using the reporting methods and system established pursuant to article 9(1); ### submit the set of information requested by the agency including available and estimated data on volume of demand , through its designated point of contact and using the reporting methods , system and platform established pursuant to article 9(1);


### 2. where necessary to fulfil their reporting obligations set out in paragraph 1 , member states , with the support of the agency , shall gather information and data on stock levels from wholesale distributors and other legal entities entitled to supply the public with medicinal products included on the critical medicines lists. ### 2. where necessary to fulfil their reporting obligations set out in paragraph 1 , member states , with the support of the agency , shall gather information and data on stock levels from wholesale distributors and other legal entities entitled to supply the public with medicinal products included on the critical medicines lists , when not yet available or accessible in the harmonised pan-european interoperable and digitalized shortages reporting and notification system


### 2. where necessary to fulfil their reporting obligations set out in paragraph 1 , member states , with the support of the agency , shall gather information and data on stock levels from wholesale distributors and other legal entities entitled to supply the public with medicinal products included on the critical medicines lists. ### 2. where necessary to fulfil their reporting obligations set out in paragraph 1 , member states , with the support of the agency , shall gather information and data on stock levels from marketing authorisation holders , wholesale distributors , community and hospital pharmacies , and other legal entities entitled to supply the public with medicinal products included on the critical medicines lists.


### 3. where member states are in possession of any additional information on volume of sales and volumes of prescriptions , including data based on article 23a of directive 2001/83/ec , which provides evidence of a potential or actual shortage of a medicinal product included on the critical medicines lists , they shall immediately provide such information to the medicines steering group through their designated points of contact. ### 3. where member states are in possession of any additional information on volume of sales and volumes of prescriptions , including data based on article 23a of directive 2001/83/ec , which provides evidence of a potential or actual shortage of a medicinal product included on the critical medicines lists , they shall immediately provide such information to the medicines steering group through their designated points of contact via the harmonised pan-european interoperable and digitalized shortages reporting and notification system.


### the commission shall take into account the information from and recommendations of the medicines steering group and shall: ### the commission shall take into account the aggregated data from the harmonised pan-european interoperable and digitalized shortages reporting and notification system , as well as information from and recommendations of the medicines steering group and shall:


### consider the need for guidelines addressed to member states , marketing authorisation holders , and other entities; ### consider the need for guidelines addressed to member states , marketing authorisation holders , and other entities , including healthcare professionals to support them in their work and in the communication with patients;


### consider the need for guidelines addressed to member states , marketing authorisation holders , and other entities; ### consider the need for guidelines addressed to member states , marketing authorisation holders , and other entities including from the pharmaceutical supply chain;


### consider the need for guidelines addressed to member states , marketing authorisation holders , and other entities; ### consider the need for guidelines addressed to member states , marketing authorisation holders , and other entities of the pharmaceuticals supply chain


### consider the need for guidelines addressed to member states , marketing authorisation holders , and other entities; ### consider the need for guidelines and recommendations addressed to member states , marketing authorisation holders , and other entities;


### inform the medicines steering group of any measures taken and report on the results; ### inform the medicines steering group and industry of any measures taken and report on the results;


### the agency shall , via its web-portal and other appropriate means , in conjunction with national competent authorities , inform the public and interest groups with regard to the work of the medicines steering group. ### the agency shall , via its web-portal and other appropriate means , in conjunction with national competent authorities , inform the public and interest groups with regard to the work of the medicines steering group , and ensure adequate consultation with the patients’ and consumers’ working party and the healthcare professionals’ working party


### the agency shall , via its web-portal and other appropriate means , in conjunction with national competent authorities , inform the public and interest groups with regard to the work of the medicines steering group. ### the agency shall , via its web-portal and other appropriate means , in conjunction with national competent authorities , inform the public and interest groups with regard to the work , advices and findings of the medicines steering group.


### reviewing clinical trial protocols and providing advice to developers on clinical trials to be conducted in the union for medicinal products intended to treat , prevent , or diagnose the disease causing the public health emergency , in accordance with article 15; ### reviewing clinical trial protocols and providing advice to developers on clinical trials to be conducted in the union , in particular on large multicentre clinical trials , for medicinal products intended to treat , prevent , or diagnose the disease causing the public health emergency , in accordance with article 15;


### providing scientific recommendations with regard to the use of any medicinal product , which may have the potential to address public health emergencies , in accordance with article 16; ### providing scientific recommendations with regard to the use of any medicinal product , and in particular alternative medicinal products , which may have the potential to address public health emergencies , in accordance with article 16;


### providing scientific recommendations with regard to the use of any medicinal product , which may have the potential to address public health emergencies , in accordance with article 16; ### providing scientific recommendations with regard to the use of any human and veterinary medicinal product , which may have the potential to address public health emergencies , in accordance with article 16.


### cooperating with union bodies and agencies , the world health organization , third countries , and international scientific organisations on scientific and technical issues relating to the public health emergency and to medicinal products which may have the potential to address public health emergencies , as necessary. ### cooperating with national and regional competent authorities , union bodies and agencies , the world health organization , third countries , and international scientific organisations on scientific and technical issues relating to the public health emergency and to medicinal products which may have the potential to address public health emergencies , as necessary.


### 3. the emergency task force shall be composed of representatives of the scientific committees , working parties , and staff members of the agency , the coordination group established in accordance with article 27 of directive 2001/83/ec , and the clinical trials coordination and advisory group established in accordance with article 85 of regulation (eu) 536/2014.21 external experts may be appointed and representatives of other union bodies and agencies be invited on an ad hoc basis , as necessary. it shall be chaired by the agency. ### 3. the emergency task force shall be composed of representatives of the scientific committees , working parties , including a representative of the patients’ and consumers’ working party and a representative of the healthcare professionals’ working party , and staff members of the agency , the coordination group established in accordance with article 27 of directive 2001/83/ec , and the clinical trials coordination and advisory group established in accordance with article 85 of regulation (eu) 536/2014.21 external experts may be appointed and representatives of other union bodies and agencies be invited on an ad hoc basis , as necessary. it shall be chaired by the agency.


### 4. the emergency task force shall involve representatives of the member state or states where an application for authorisation of a clinical trial is submitted or is intended to be submitted in the preparation of the scientific advice. ### 4. for the purposes of this article , the emergency task force shall involve representatives of the member state or states where an application for authorisation of a clinical trial is submitted or is intended to be submitted in the preparation of the scientific advice.


### 1. following the recognition of a public health emergency , the emergency task force shall undertake a review of the available scientific data on medicinal products , which may have the potential to be used to address the public health emergency. the review shall be regularly updated during the public health emergency. ### 1. following the recognition of a public health emergency , the emergency task force shall undertake a review of the available scientific data on human and veterinary medicinal products , which may have the potential to be used to address the public health emergency. the review shall be regularly updated and published during the public health emergency.


### 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 emergency task force. ### 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 emergency task force , and ensure adequate consultation with the patients’ and consumers’ working party and the healthcare professionals’ working party.


### to prepare for and support the work of the emergency task force during public health emergencies , the agency shall: ### to prepare for and support the work related to the reporting and notification obligations defined in this regulation , as well as the tasks of the agency bodies established , including of the emergency task force during public health emergencies , the agency shall:


### develop and maintain electronic tools for the submission of information and data , including electronic health data generated outside the scope of clinical studies; ### develop and maintain pan-european interoperable and digitalized electronic tools for the submission of information and data , including electronic health data generated outside the scope of clinical studies , as well as for the harmonised pan-european interoperable and digitalized shortages reporting and notification system , based on iso idmp standards for the identification of human medicines and based on a harmonized data collection model with interoperability with spor data , as well as on the eudamed it platform for medical devices. those platforms shall be accessible to relevant authorities at eu and national level to ensure the transparency needed to take actions to prevent and mitigate cross border shortages , as well as to avoid duplications of reporting at different levels;


### develop and maintain electronic tools for the submission of information and data , including electronic health data generated outside the scope of clinical studies; ### develop and maintain electronic tools , including an interoperable and digitalized platform , for the submission of information and data , including electronic health data generated outside the scope of clinical studies;


### as part of its regulatory tasks , make use of digital infrastructures or tools , to facilitate the rapid access to or analysis of available electronic health data generated outside the scope of clinical studies , and the exchange of such data between member states , the agency , and other union bodies; ### as part of its regulatory tasks , make use of digital infrastructures or tools , as referred to in point (a) , to facilitate the rapid access to or analysis of available electronic health data generated outside the scope of clinical studies , and the exchange of such data between member states , the agency , and other union bodies;


### 2. the medical devices steering group shall be composed of a representative of the agency , a representative of the commission and one senior representative per member state. each member state shall appoint their representative. members may be accompanied by experts in specific scientific or technical fields. ### 2. the medical devices steering group shall be composed of a representative of the agency , a representative of the commission and one senior representative per member state. each member state shall appoint their representative. members may be accompanied by experts in specific scientific or technical fields. the steering group shall also include a representative the patients’ and consumers’ working party and a representative of the healthcare professionals’ working party.


### 3. the medical devices steering group shall be chaired by the agency. the chair may invite third parties , including representatives of medical device interest groups to attend its meetings. ### 3. the medical devices steering group shall be chaired by the agency. the chair may invite third parties , including representatives of medical device interest groups , any other entity in the relevant pharmaceutical supply chain , healthcare professionals and patients’ associations , to attend its meetings to ensure transparent and effective dialogue between all stakeholders in the supply chain and the relevant authorities.


### 3. the medical devices steering group shall be chaired by the agency. the chair may invite third parties , including representatives of medical device interest groups to attend its meetings. ### 3. the medical devices steering group shall be chaired by the agency. the chair may invite third parties , including representatives of medical device interest groups and representatives of patients , consumers and healthcare professionals to attend its meetings.


### 1. immediately following the recognition of a public health emergency and after consultation of its working party , the medical devices steering group shall adopt a list of medical devices which it considers as critical during the public health emergency (‘the public health emergency critical devices list’). the list shall be updated whenever necessary until the termination of the recognition of the public health emergency. ### 1. immediately following the recognition of a public health emergency and after consultation of its working party , the medical devices steering group , in coordination with stakeholders in the sector , shall adopt a list of medical devices which it considers as critical during the public health emergency (‘the public health emergency critical devices list’). the list shall be updated whenever necessary until the termination of the recognition of the 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 consumers , patients and healthcare professionals and a high level of transparency;


### specify the procedures for establishing the public health emergency critical devices list; ### specify the procedures and criteria for establishing the public health emergency critical devices list;


### sales and market share data; ### sales , stock , where relevant , and market share data;


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


### mitigation plans including production and supply capacity; ### prevention and mitigation plans including production and supply capacity;


### 1. in order to facilitate the monitoring referred to in article 21 and following a request from the agency , member states shall , by the deadline set by the agency: ### 1. in order to facilitate the monitoring referred to in article 21 and following a request from the agency , member states or any national competent authority shall , by the deadline set by the agency:


### 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 both patient and product safety;


### 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.


### 3. in agreement with the chairs , joint meetings of the medicines and medical devices steering groups may be held. ### 3. in agreement with the chairs , the medicines and medical devices steering groups shall be maintained and deployed beyond crisis situations for the management of medicines shortage , ensuring proportionality of their actions compared to emergency situations.


### personal data in accordance with article 32; ### personal data in accordance with the definition contained in the article 4 of gdpr and article 3(1) 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 , including intellectual property rights , unless there is an overriding public interest in disclosure.;


### (28) since the objectives of this regulation cannot be sufficiently achieved by the member states alone due to the cross-border dimension of public health emergencies and major events and can , therefore , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union. in accordance with the principle of proportionality , as set out in that article , this regulation does not go beyond what is necessary in order to achieve those objectives. ### (28) as stressed out as well by eu4health programme recently adopted by the eu , since the objectives of this regulation cannot be sufficiently achieved by the member states alone due to the cross-border dimension of public health emergencies and major events and can , therefore , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union. in accordance with the principle of proportionality , as set out in that article , this regulation does not go beyond what is necessary in order to achieve those objectives.


### 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 rapidly publish all 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.


### 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 and awaiting the launch of the clinical trials information system (ctis) in accordance with art. 80 and 81 of regulation (eu) no 536/2014.


### (1) directive 2004/37/ec of the european parliament and the council45 aims to protect workers against risks to their health and safety from exposure to carcinogens or mutagens at the workplace. a consistent level of protection from the risks related to the occupational exposure to carcinogens and mutagens is provided for in that directive by a framework of general principles to enable member states to ensure the consistent application of minimum requirements. the aim of these minimum requirements is to protect workers at union level. more stringent provisions can be set by member states. ### (1) directive 2004/37/ec of the european parliament and the council45 aims to protect workers against risks to their health and safety from exposure to carcinogens or mutagens and reprotoxic substances at the workplace. a consistent level of protection from the risks related to the occupational exposure to carcinogens and mutagens and reprotoxic substances is provided for in that directive by a framework of general principles to enable member states to ensure the consistent application of minimum requirements. the aim of these minimum requirements is to protect workers at union level. more stringent provisions can be set by member states.


### (1) directive 2004/37/ec of the european parliament and the council45aims to protect workers against risks to their health and safety from exposure to carcinogens or mutagens at the workplace. a consistent level of protection from the risks related to the occupational exposure to carcinogens and mutagens is provided for in that directive by a framework of general principles to enable member states to ensure the consistent application of minimum requirements. the aim of these minimum requirements is to protect workers at union level. more stringent provisions can be set by member states. ### (1) directive 2004/37/ec of the european parliament and the council45 aims to protect workers against risks to their health and safety from exposure to carcinogens or mutagens at the workplace. a consistent level of protection from the risks related to the occupational exposure to carcinogens and mutagens is provided for in that directive by a framework of general principles to enable member states to ensure the consistent application of minimum requirements. the aim of these minimum requirements is to protect workers at union level. more stringent provisions can be set by member states that are compatible with the treaties , taking into account also their possible impact on the competitiveness of undertakings.


### (2) principle 10 of the european pillar of social rights46 , jointly proclaimed by the european parliament , the council and the commission at the social summit for fair jobs and growth on 17 november 2017 , provides workers’ right to a high level of protection of their health and safety at work , which includes the protection from the exposure to carcinogens and mutagens at the workplace. ### (2) principle 10 of the european pillar of social rights46 , jointly proclaimed by the european parliament , the council and the commission at the social summit for fair jobs and growth on 17 november 2017 , provides workers’ right to a high level of protection of their health and safety at work , which includes the protection from the exposure to carcinogens , mutagens and reprotoxic substances at the workplace.


### (2) principle 10 of the european pillar of social rights46 , jointly proclaimed by the european parliament , the council and the commission at the social summit for fair jobs and growth on 17 november 2017 , provides workers’ right to a high level of protection of their health and safety at work , which includes the protection from the exposure to carcinogens and mutagens at the workplace. ### (2) principle 10 of the european pillar of social rights46 , jointly proclaimed by the european parliament , the council and the commission at the social summit for fair jobs and growth on 17 november 2017 , provides workers’ right to a safe , healthy and properly adapted working environment , meaning a high level of protection of their health and safety at work , which includes the protection from the exposure to carcinogens and mutagens at the workplace.


### (3) binding occupational exposure limit values are important component of the general arrangements for the protection of workers established by directive 2004/37/ec and must not be exceeded. limit values and other directly related provisions should be established for all those carcinogens or mutagens for which the available information , including scientific and technical data , make this possible. ### (3) binding occupational exposure limit values are important component of the general arrangements for the protection of workers established by directive 2004/37/ec and must not be exceeded. limit values and other directly related provisions should be established for all those carcinogens or mutagens or reprotoxic substances for which the available information , including scientific and technical data , make this possible.


### (3) binding occupational exposure limit values are important component of the general arrangements for the protection of workers established by directive 2004/37/ec and must not be exceeded. limit values and other directly related provisions should be established for all those carcinogens or mutagens for which the available information , including scientific and technical data , make this possible. ### (3) binding occupational exposure limit values are important component of the general arrangements for the protection of workers established by directive 2004/37/ec and must not be exceeded. in view of social , economic and technological developments , limit values and other provisions directly relating to mandatory occupational exposure limit values should be established for all those carcinogens or mutagens for which the available information , including scientific and technical data , make this possible , with a view to stepping up efforts to protect workers and societies from all possible occupational risks.


### (4) compliance with binding occupational exposure limit values is without prejudice to other employers’ obligations pursuant to directive 2004/37/ec , such as the reduction of the use of carcinogens and mutagens at the workplace , the prevention or reduction of workers’ exposure to carcinogens or mutagens and the measures which should be implemented to that effect. those measures should include , as far as it is technically possible , the replacement of the carcinogen or mutagen by a substance , mixture or process which is not dangerous or is less dangerous to workers’ health , the use of a closed system or other measures aiming to reduce the level of workers’ exposure. ### (4) compliance with binding occupational exposure limit values is without prejudice to other employers’ obligations pursuant to directive 2004/37/ec , such as the reduction of the use of carcinogens , mutagens and reprotoxic substances at the workplace , the prevention or reduction of workers’ exposure to carcinogens , mutagens or reprotoxic chemicals and the measures which should be implemented to that effect. those measures should include , as far as it is technically possible , the replacement of the carcinogen , mutagen or reprotoxic substance by a substance , mixture or process which is not dangerous or is less dangerous to workers’ health , the use of a closed system or other measures aiming to reduce the level of workers’ exposure.


### (4) compliance with binding occupational exposure limit values is without prejudice to other employers’ obligations pursuant to directive 2004/37/ec , such as the reduction of the use of carcinogens and mutagens at the workplace , the prevention or reduction of workers’ exposure to carcinogens or mutagens and the measures which should be implemented to that effect. those measures should include , as far as it is technically possible , the replacement of the carcinogen or mutagen by a substance , mixture or process which is not dangerous or is less dangerous to workers’ health , the use of a closed system or other measures aiming to reduce the level of workers’ exposure. ### (4) compliance with binding occupational exposure limit values is without prejudice to other employers’ obligations pursuant to directive 2004/37/ec , such as the reduction of the use of carcinogens and mutagens at the workplace , the prevention or reduction of workers’ exposure to carcinogens or mutagens and the measures which should be implemented to that effect. those measures should include , as far as it is technically feasible and possible , the replacement of the carcinogen or mutagen by a substance , mixture or process which is not dangerous or is less dangerous to workers’ health , the use of a closed system or other measures aiming to reduce the level of workers’ exposure. whilst the protection of workers is a priority , the replacement of carcinogens and mutagens with less dangerous substances should be carried out in proportion with the feasibility and the possibility of that exchange to its economic impact in relation to the improvement of the exchange.


### (5) this directive strengthens the protection of workers’ health and safety at their workplace. new limit values should be set out in directive 2004/37/ec in the light of available information , including new scientific and technical data and should also be based on a thorough assessment of the socioeconomic impact and availability of exposure measurement protocols and techniques at the workplace. that information should , if possible , include data on residual risks to the health of workers , opinions of the committee for risk assessment (rac) of the european chemicals agency (echa) , as well as opinions of the advisory committee on safety and health at work (acsh). information related to residual risk , made publicly available at union level , is valuable for any future work to limit risks from occupational exposure to carcinogens and mutagens. ### (5) this directive strengthens the protection of workers’ health and safety at their workplace. new limit values should be set out in directive 2004/37/ec using a risk-based methodology. all available information should be considered , including new scientific and technical data , a thorough assessment of the socioeconomic impact and the availability of exposure measurement protocols and techniques at the workplace. that information should , if possible , include data on residual risks to the health of workers , opinions of the committee for risk assessment (rac) of the european chemicals agency (echa) , as well as opinions of the advisory committee on safety and health at work (acsh). information related to residual risk , made publicly available at union level , is valuable for any future work to limit risks from occupational exposure to carcinogens , mutagens and reprotoxic substances.


### (5) this directive strengthens the protection of workers’ health and safety at their workplace. new limit values should be set out in directive 2004/37/ec in the light of available information , including new scientific and technical data and should also be based on a thorough assessment of the socioeconomic impact and availability of exposure measurement protocols and techniques at the workplace. that information should , if possible , include data on residual risks to the health of workers , opinions of the committee for risk assessment (rac) of the european chemicals agency (echa) , as well as opinions of the advisory committee on safety and health at work (acsh). information related to residual risk , made publicly available at union level , is valuable for any future work to limit risks from occupational exposure to carcinogens and mutagens. ### (5) this directive strengthens the protection of workers’ health and safety at their workplace. update limit values should be set out in directive 2004/37/ec based on the currently available relevant information , including new scientific and technical data and should also respect thorough assessments of the socioeconomic impact , proportionality and availability of exposure measurement protocols and techniques at the workplace. that information should , if possible , include data on residual risks to the health of workers , opinions of the committee for risk assessment (rac) of the european chemicals agency (echa) , as well as opinions of the advisory committee on safety and health at work (acsh). information related to residual risk , made publicly available at union level , is valuable for any future work to limit risks from occupational exposure to carcinogens and mutagens.


### (6) in accordance with the recommendations of the rac and the acsh , where possible , limit values for the inhalation route of exposure are established in relation to a reference period of eight hours time-weighted average (long-term exposure limit values) and , for certain carcinogens or mutagens to a shorter reference period , in general fifteen minutes time-weighted average (short-term exposure limit values) , in order to limit , to the extent possible , the effects arising from short-term exposure. ### (6) in accordance with the recommendations of the rac and the acsh , where possible , limit values for the inhalation route of exposure are established in relation to a reference period of eight hours time-weighted average (long-term exposure limit values) and , for certain carcinogens , mutagens or reprotoxic chemicals to a shorter reference period , in general fifteen minutes time-weighted average (short-term exposure limit values) , in order to limit , to the extent possible , the effects arising from short-term exposure.


### (7) it is also necessary to consider other absorption pathways than inhalation of all carcinogens and mutagens , including the possibility of uptake through the skin , in order to ensure the best possible level of protection. ### (7) it is also necessary to consider other absorption pathways than inhalation of all carcinogens , mutagens and reprotoxic substances , including the possibility of uptake through the skin , in order to ensure the best possible level of protection.


### (7) it is also necessary to consider other absorption pathways than inhalation of all carcinogens and mutagens , including the possibility of uptake through the skin , in order to ensure the best possible level of protection. ### (7) it is also necessary to consider other relevant absorption pathways than inhalation of all carcinogens and mutagens , including the possibility of uptake through the skin , in order to ensure the best possible level of protection.


### (10) with regard to acrylonitrile , a limit value of 1 mg/m³ (0.45 ppm) and a short-term limit value of 4 mg/m³ (1.8 ppm) may be difficult to be complied with in the short term. a transitional period of four years after entry into force of this directive should be introduced from which these occupational exposure limit (oel) values shall apply. ### (10) with regard to the newly added acrylonitrile , a limit value of 1 mg/m³ (0.45 ppm) and a short-term limit value of 4 mg/m³ (1.8 ppm) may be difficult to be complied with in the short term. a transitional period of four years after entry into force of this directive should be introduced from which these occupational exposure limit (oel) values should apply.


### (12) with regard to nickel compounds , limit values of 0.01 mg/m³ for the respirable fraction and 0.05 mg/m³ for the inhalable fraction may be difficult to be complied with in a number of sectors or processes , including specifically smelting , refineries and welding. furthermore , since identical risk management measures can be used both for chromium (vi) and nickel compounds , the transitional measures aiming to reduce the exposure to these two groups of carcinogens should be aligned. therefore , a transitional period until 17 january 2025 inclusive should be introduced during which a limit value of 0.1 mg/m³ for the inhalable fraction of the nickel compounds should apply. this transitional period would ensure alignment with the date of application of the oel for chromium (vi) compounds adopted in directive 2017/2398/eu48 . ### (12) with regard to the newly added nickel compounds , limit values of 0.01 mg/m³ for the respirable fraction and 0.05 mg/m³ for the inhalable fraction may be difficult to be complied with in a number of sectors or processes , including specifically smelting , refineries and welding. furthermore , since identical risk management measures can be used both for chromium (vi) and nickel compounds , the transitional measures aiming to reduce the exposure to these two groups of carcinogens should be aligned. therefore , a transitional period until 17 january 2025 inclusive should be introduced during which a limit value of 0.1 mg/m³ for the inhalable fraction of the nickel compounds should apply. this transitional period would ensure alignment with the date of application of the oel for chromium (vi) compounds adopted in directive 2017/2398/eu48 .


### (13) benzene meets the criteria for classification as carcinogenic (category 1a) in accordance with regulation (ec) no 1272/2008 and is therefore carcinogen within the meaning of directive 2004/37/ec. benzene can also be absorbed through the skin. the limit value set out in annex iii to directive 2004/37/ec for benzene should be revised in the light of more recent scientific data and it is appropriate to keep the skin notation. the acsh , based on the rac opinion , agreed on the usefulness of the biomonitoring for benzene. this should be considered when developing guidance on the practical use of biomonitoring. ### (13) benzene meets the criteria for classification as carcinogenic (category 1a) in accordance with regulation (ec) no 1272/2008 and is therefore carcinogen within the meaning of directive 2004/37/ec. benzene can also be absorbed through the skin. the limit value set out in annex iii to directive 2004/37/ec for benzene should be revised in the light of more recent scientific data no later than 1 january 2030 in accordance with the acsh opinion and it is appropriate to keep the skin notation. the acsh , based on the rac opinion , also agreed on the usefulness of the biomonitoring for benzene. this should be considered when developing guidance on the practical use of biomonitoring.


### (13) benzene meets the criteria for classification as carcinogenic (category 1a) in accordance with regulation (ec) no 1272/2008 and is therefore carcinogen within the meaning of directive 2004/37/ec. benzene can also be absorbed through the skin. the limit value set out in annex iii to directive 2004/37/ec for benzene should be revised in the light of more recent scientific data and it is appropriate to keep the skin notation. the acsh , based on the rac opinion , agreed on the usefulness of the biomonitoring for benzene. this should be considered when developing guidance on the practical use of biomonitoring. ### (13) benzene meets the criteria for classification as carcinogenic (category 1a) in accordance with regulation (ec) no 1272/2008 and is therefore carcinogen within the meaning of directive 2004/37/ec. benzene can also be absorbed through the skin. the limit value set out in annex iii to directive 2004/37/ec for benzene should be carefully revised in the light of currently available relevant scientific data and it is appropriate to keep the skin notation. the acsh , based on the rac opinion , agreed on the usefulness of the biomonitoring for benzene. this should be considered when developing guidance on the practical use of biomonitoring.


### (14) with regard to benzene , a revised limit value of 0.2 ppm (0.66 mg/m³) may be difficult to be complied with in some sectors in the short term. a transitional period of 4 years after entry into force of this directive should be introduced. from two years up to four years after entry into force , a transitional limit value of 0.5 ppm (1.65 mg/m³) should apply. ### (14) with regard to benzene , a revised limit value of 0.2 ppm (0.66 mg/m³) from previously 1 ppm (3 ,25mg/m3) may be difficult to be complied with in some sectors and by some undertakings , in particular microentreprises and smes , in the short term. a transitional period of 4 years after entry into force of this directive should therefore be introduced. from two years up to four years after entry into force , a transitional limit value of 0.5 ppm (1.65 mg/m³) should apply.


### (17) since the objective of this directive , namely to protect workers against risks to their health and safety , including the prevention of such risks , arising or likely to arise from exposure to carcinogens or mutagens at work , cannot be sufficiently achieved by the member states , but can rather , by reason of its scale and effects , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union. in accordance with the principle of proportionality , as set out in that article , this directive does not go beyond what is necessary in order to achieve that objective. ### (17) since the objective of this directive , namely to protect workers against risks to their health and safety , including the prevention of such risks , arising or likely to arise from exposure to carcinogens , mutagens or reprotoxic substances at work , cannot be sufficiently achieved by the member states , but can rather , by reason of its scale and effects , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union. in accordance with the principle of proportionality , as set out in that article , this directive does not go beyond what is necessary in order to achieve that objective.


### directive 2004/37/ec of the european parliament and of the council of 29 april 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (sixth individual directive within the meaning of article 16(1) of council directive 89/391/eec) ### directive 2004/37/ec of the european parliament and of the council of 29 april 2004 on the protection of workers from the risks related to exposure to carcinogens , mutagens or reprotoxic substances at work (sixth individual directive within the meaning of article 16(1) of council directive 89/391/eec)


### name of agent ### limit values / 8 hours


### (9) acrylonitrile meets the criteria for classification as carcinogenic (category 1b) in accordance with regulation (ec) no 1272/2008 of the european parliament and the council47 and is therefore carcinogen within the meaning of directive 2004/37/ec. it is possible , on the basis of the available information , including scientific and technical data , to set a long- and short-term limit value for that carcinogen. acrylonitrile can also be absorbed through the skin. it is therefore appropriate to establish a limit value for acrylonitrile under the scope of directive 2004/37/ec and to assign a skin notation to it. the acsh , based on the rac opinion , agreed on the usefulness of the biomonitoring for acrylonitrile. this should be considered when developing guidance on the practical use of biomonitoring. ### (9) acrylonitrile meets the criteria for classification as carcinogenic (category 1b) in accordance with regulation (ec) no 1272/2008 of the european parliament and the council47 and is therefore carcinogen within the meaning of directive 2004/37/ec. it is possible , on the basis of the currently available relevant information , including scientific and technical data , to set a long- and short-term limit value for that carcinogen. acrylonitrile can also be absorbed through the skin. it is therefore appropriate to establish a limit value for acrylonitrile under the scope of directive 2004/37/ec and to assign a skin notation to it. the acsh , based on the rac opinion , agreed on the usefulness of the biomonitoring for acrylonitrile. this should be considered when developing guidance on the practical use of biomonitoring.


### (11) nickel compounds meet the criteria for classification as carcinogenic (category 1a) in accordance with regulation (ec) no 1272/2008 and are therefore carcinogens within the meaning of directive 2004/37/ec. it is possible , on the basis of the available information , including scientific and technical data , to set limit values for that group of carcinogens. exposure to nickel compounds at workplaces may also result in dermal sensitisation and sensitisation of the respiratory tract. it is therefore appropriate to establish two limit values for both the inhalable and respirable fractions of the nickel compounds under the scope of directive 2004/37/ec and to assign a notation for dermal and respiratory sensitisation. ### (11) nickel compounds meet the criteria for classification as carcinogenic (category 1a) in accordance with regulation (ec) no 1272/2008 and are therefore carcinogens within the meaning of directive 2004/37/ec. it is possible , on the basis of the currently available relevant information , including scientific and technical data , to set limit values for that group of carcinogens. exposure to nickel compounds at workplaces may also result in dermal sensitisation and sensitisation of the respiratory tract. it is therefore appropriate to establish two limit values for both the inhalable and respirable fractions of the nickel compounds under the scope of directive 2004/37/ec and to assign a notation for dermal and respiratory sensitisation.


### (16) the limit values established in this directive are to be kept under regular scrutiny and review to ensure consistency with regulation (ec) no 1907/200649. ### (16) the limit values established in this directive are to be kept under regular scrutiny and review to ensure consistency with regulation (ec) no 1907/200649 and with social , economic and technological developments.


### (16) the limit values established in this directive are to be kept under regular scrutiny and review to ensure consistency with regulation (ec) no 1907/200649 . ### (16) the limit values established in this directive are to be kept under regular scrutiny and review to ensure ongoing consistency with regulation (ec) no 1907/200649 .


### 2. highlights the 24 covid-19 related risk assessments carried out by the centre , the 159 covid-19 formal scientific requests from the commission and members of the european parliament , and the more than 100 formal scientific requests from member states; ### 2. highlights the significant volume of outputs produced in the context of the ongoing covid-19 pandemic: in relation to which 24 risk assessments were carried out and 159 formal scientific requests from the commission and members of the european parliament , as well as the more than 100 formal scientific requests from member states , were handled;


### (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 declared it would consider revising regulation (ec) no 1367/2006 to improve access to administrative and judicial review at european union level for citizens and environmental non-governmental organisations who have concrete concerns about the legality of decisions with effects on the environment. the commission also announced to take action to improve their entitled 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’.


### (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 , as well as observations by the aarhus convention compliance committee62 on eu failure to fully meet its obligations under the provisions of the convention on access to justice in environmental matters , 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 law.


### (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 , european union law should be brought into compliance with its provisions 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.


### (5) the limitation of the internal review provided for in regulation (ec) no 1367/2006 to administrative acts of individual scope is the main obstacle for environmental non-governmental organisations seeking to have recourse to internal review under article 10 of that regulation also as regards administrative acts that have a wider scope. it is therefore necessary to broaden the scope of the internal review procedure laid down in that regulation to include non-legislative acts of a general scope. ### deleted


### (5) the limitation of the internal review provided for in regulation (ec) no 1367/2006 to administrative acts of individual scope is the main obstacle for environmental non-governmental organisations seeking to have recourse to internal review under article 10 of that regulation also as regards administrative acts that have a wider scope. it is therefore necessary to broaden the scope of the internal review procedure laid down in that regulation to include non-legislative acts of a general scope. ### (5) the limitation of the internal review provided for in regulation (ec) no 1367/2006 to administrative acts of individual scope could be an obstacle for environmental non-governmental organisations seeking to have justified recourse to internal review under article 10 of that regulation.


### (5) the limitation of the internal review provided for in regulation (ec) no 1367/2006 to administrative acts of individual scope is the main obstacle for environmental non-governmental organisations seeking to have recourse to internal review under article 10 of that regulation also as regards administrative acts that have a wider scope. it is therefore necessary to broaden the scope of the internal review procedure laid down in that regulation to include non-legislative acts of a general scope. ### (5) the limitation of the internal review provided for in regulation (ec) no 1367/2006 to administrative acts of individual scope could effectively be the main obstacle for environmental non-governmental organisations seeking to have recourse to internal review under article 10 of that regulation also as regards administrative acts that have a wider scope. it is therefore appropriate to broaden the scope of the internal review procedure laid down in that regulation to include non-legislative acts of a general scope that effectively contravene environmental law.


### (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. ### deleted


### c. whereas reducing methane emissions is indispensable in the fight against climate change , in line with the goals of the paris agreement; whereas methane emissions contribute to air pollution and it is therefore necessary to tackle these emissions in order to protect the health of eu citizens; ### c. whereas reducing methane emissions is indispensable in the fight against climate change , in line with the goals of the paris agreement; whereas methane emissions contribute to air pollution and the formation of ground-level ozone , another greenhouse gas with negative effects on human health , crops and the stability of ecosystems , and it is therefore necessary to tackle these emissions in order to protect the health of eu citizens;


### 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 methane is a short-lived climate gas that is degraded into water and co2 in the atmosphere within 12 years , and whereas biogenic methane sources do not add new co2 to the atmosphere after their degradation , but that the resulting co2 is removed from the atmosphere by means of photosynthesis through plant growth and therefore is cyclical in principle , while methane from fossil sources adds co2 to the atmosphere , so that fossil and biogenic methane sources should be accorded different weightings.


### 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 fully supports a fair framework covering the energy , agriculture and waste sectors;


### 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. 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; supports the establishment of an international methane emissions observatory in which the commission , in partnership with the united nations environment programme (unep) , the climate and clean air coalition and the international energy agency (iea) , would be responsible for collecting , reconciling , verifying and publishing data on anthropogenic methane emissions;


### 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. 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 while taking into account the specific nature of enteric methane emissions linked to the valorisation of grass by ruminants and distinguishing short-cycle biogenic carbon from long-cycle carbon from fossil resource extraction in the light of recent research;


### 2. underlines the importance of improving measurement , reporting and verification (mrv) as well as leak detection and repair (ldar) standards; ### 2. underlines the importance of improving standards and methodologies for the measurement , reporting and verification (mrv) of methane emissions; calls on the commission to seek effective tools to improve the quality of measurement and reporting of these emissions in all sectors concerned;


### 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; 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; takes the view that the requirements of the effort sharing regulation as regards methane emissions must be designed with full regard for the higher short term climate impact of methane and the potential of a reduction of methane in the atmosphere to contribute to climate neutrality by 2050;


### 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; stresses the importance of binding emissions reduction targets for member states in the effort sharing regulation5 , but also considers that this legislative instrument should be complemented by other instruments targeting methane-emitting sectors , and welcomes in this respect the commission's consideration of strengthening the role of the industrial emissions directive6 and other legislation in the prevention and management of methane emissions;


### 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 innovative mitigating actions; considers that the best available technologies to reduce methane emissions should become part of the best available techniques conclusions of the brefs;


### 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. 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; stresses that this flexibility must not mean the transfer of methane emissions to other sectors or activities;


### 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. stresses that the upcoming methane regulatory measures should strive to achieve emissions reductions as cost-effectively and efficiently as possible and provide flexibility for companies to achieve performance standards in an optimal , technologically neutral manner , and at the lowest possible cost;


### 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. recognises the importance of voluntary industry initiatives aimed at reducing methane emissions and considers that any regulatory initiatives should make use of the best practices from existing voluntary actions , but not be limited to them , and must be duly preceded by thorough impact assessments;


### 7. welcomes the upcoming legislative proposal on compulsory mrv for all energy-related methane emissions; ### 7. welcomes the upcoming legislative proposal concerning compulsory mrv for all energy-related methane emissions , as well as the introduction of an obligation to improve leak detection and repair procedures on all fossil gas infrastructure , as well as on other infrastructure that produces , transports or uses fossil gas;


### 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. welcomes the commission’s proposal to consider legislation to ensure the elimination of routine venting and flaring in the energy sector covering , if feasible , the full supply chain , in accordance with the targets set out in the world bank’s ‘zero routine flaring by 2030’ initiative; 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;


### 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. 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; draws attention in this context to the possibility of adopting a number of measures , which have either zero or near-zero costs , to reduce methane emissions from basic mining operations; calls on the commission to explore regulatory tools for fossil energy imports , including extending forthcoming obligations on mrv , ldar , venting and flaring to imports;


### 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 , and with developing a methane supply index based on these data in order to increase transparency on global methane emissions;


### 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 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; stresses the importance of clean-up works aimed at preventing and eventually eliminating methane emissions from closed coal mines in coal regions undergoing transition , and calls on the commission to ensure that they are effectively supported;


### 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 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; calls on the commission to adopt measurement equipment standards and impose a measuring requirement for mines assumed to be non-methane;


### 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 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; stresses that farmers need a rapid implementation and use of new and existing methane-reducing technologies , as well as continuous training and exchange of best practices;


### 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 are developing at a fast pace; calls on the commission to ensure that proven effective and cost-efficient innovations , supported by appropriate incentive schemes and advisory services , are quickly implemented in the eu and integrated into eu agriculture policies following a proper impact assessment;


### 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 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 , e.g. through feed additives for ruminants and improved processing of manure , while protecting animal health and welfare; points especially to the need for multigenerational studies on feed additives; points in particular to the need for multi-generation studies of feed additives;


### 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 that one of the key roles that the eu should play is 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 , inter alia , to the need for multigenerational studies on feed additives;


### 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 key role that the eu should play in supporting research , innovation and development , as well as in scaling up new technologies to help reduce methane emissions from livestock agriculture , while protecting animal health and 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 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 and , once no longer viable to use the biomethane produced at a landfill site , the use of bio-oxidation and other technologies in hot spots to reduce the remaining methane emissions;


### 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 revise the sewage sludge directive7 and the urban waste water treatment directive8 in 2022 , with a view , inter alia , to reducing emissions of greenhouse gases , including methane , from waste water treatment and sewage sludge; 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;


### 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 , 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 support member states in their efforts to move away from landfills and to ensure that member states that are likely to miss that target take corrective measures and actions; underlines the importance of setting more ambitious targets on commercial and industrial waste for which no legally binding targets to reduce landfilling are set yet;


### 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 incentives suited to the conditions of each member state in order to ensure , to the greatest extent possible , waste prevention and 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 , including - when waste cannot be recycled - energy recovery in advanced waste-to-energy facilities with a high energy efficiency and low emissions , leading to efficient diversion from landfill; 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 , the treatment of the bio-degradable part of residual , non-recyclable waste left after separate collection , according to the waste hierarchy;


### 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 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; 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 , the treatment of the bio-degradable part of residual , non-recyclable waste left after separate collection , according to the waste hierarchy.


### 4. highlights that , in 2020 , the authority finalised 697 questions through scientific opinions , technical reports and supporting publications; ### 4. highlights that , in 2020 , the authority finalised 697 questions through scientific opinions , technical reports and supporting publications; notes that , although there were 83 fewer questions than planned , in the context of the difficult conditions and the plan updated in october to complete 710 questions , the authority worked efficiently;


### — having regard to the treaty on the functioning of the european union , and in particular article 191 thereof , ### — having regard to the treaty on the functioning of the european union , and in particular articles 2 and 191 thereof ,