### (9) as serious cross-border threats to health are not limited to union borders , joint procurement of medical countermeasures should be extended to include european free trade association states and union candidate countries , in accordance with the applicable union legislation. the joint procurement agreement , determining the practical arrangements governing the joint procurement procedure established under article 5 of decision no 1082/2013/eu , should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure , to allow for better coordination within the eu. the commission should ensure coordination and information exchange between the entities organizing any action under different mechanisms established under this regulation and other relevant union structures related to procurement and stockpiling of medical countermeasures , such as the strategic resceu reserve under decision no 1313/2013/eu of the european parliament and of the council16 . ### (9) as serious cross-border threats to health are not limited to union borders , the union should adopt a coordinated approach in fighting against such threats. the joint procurement of medical countermeasures should , therefore , be extended to include european free trade association states and union candidate countries , in accordance with the applicable union legislation. the joint procurement agreement , determining the practical arrangements governing the joint procurement procedure established under article 5 of decision no 1082/2013/eu , should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure , to allow for better coordination within the eu. in times of crisis , the union should also aim to support access to medical countermeasures for eastern partnership and low- and middle-income countries. the commission should ensure coordination and information exchange between the entities organizing any action under different mechanisms established under this regulation and other relevant union structures related to procurement and stockpiling of medical countermeasures , such as the strategic resceu reserve under decision no 1313/2013/eu of the european parliament and of the council16 . the member states should ensure a sufficient reserve of critical medical products at member state level to counter the risk of shortages of critical products.


### (9) as serious cross-border threats to health are not limited to union borders , joint procurement of medical countermeasures should be extended to include european free trade association states and union candidate countries , in accordance with the applicable union legislation. the joint procurement agreement , determining the practical arrangements governing the joint procurement procedure established under article 5 of decision no 1082/2013/eu , should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure , to allow for better coordination within the eu. the commission should ensure coordination and information exchange between the entities organizing any action under different mechanisms established under this regulation and other relevant union structures related to procurement and stockpiling of medical countermeasures , such as the strategic resceu reserve under decision no 1313/2013/eu of the european parliament and of the council16 . ### (9) as serious cross-border threats to health are not limited to union borders , joint procurement of medical countermeasures should be extended to include european free trade association states and union candidate countries , in accordance with the applicable union legislation. the joint procurement agreement , determining the practical arrangements governing the joint procurement procedure established under article 5 of decision no 1082/2013/eu , should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure , to allow for better coordination within the eu. the commission should ensure coordination and information exchange between the entities organizing any action under different mechanisms established under this regulation and other relevant union structures related to procurement and stockpiling of medical countermeasures , such as the strategic resceu reserve under decision no 1313/2013/eu of the european parliament and of the council16 the functioning of the joint procurement agreement and resceu should abide by high standards of transparency , including in relation to the disclosure of the exact amount ordered and provided to each participating country , and the delivery of procured products , and details of the liability of participating countries;


### (10) unlike for communicable diseases , the surveillance of which at union level is carried out on a permanent basis by the ecdc , other potentially serious cross-border threats to health do not currently necessitate monitoring by eu agencies. a risk-based approach , whereby monitoring is carried out by member states and available information is exchanged through ewrs , is therefore more appropriate for such threats. ### (10) unlike for communicable diseases , the surveillance of which at union level is carried out on a permanent basis by the ecdc , other potentially serious cross-border threats to health do not currently necessitate monitoring by eu agencies. a risk-based approach , whereby monitoring is carried out by member states and available information is exchanged through ewrs , is therefore more appropriate for such threats. nevertheless , the ecdc should have the ability to monitor the impact of communicable diseases on non-communicable diseases , including the continuity of screening , diagnosis , monitoring , treatment and care in the healthcare system;


### (11) the commission should strengthen cooperation and activities with the member states , the ecdc , the european medicines agency (‘ema’) , other union agencies , research infrastructures and the who to improve the prevention of communicable diseases , such as vaccine preventable diseases , as well as other health issues , such as antimicrobial resistance. ### (11) the commission should strengthen cooperation and activities with the member states , the ecdc , the european medicines agency (‘ema’) , other union agencies , research infrastructures and the who to improve the prevention of communicable diseases , such as vaccine preventable diseases , as well as other health issues , such as antimicrobial resistance. in times of crisis , particular attention should also be paid to the continuity of screening , diagnosis , monitoring , treatment and care for other diseases and conditions , and to the mental health implications of the crisis and psychosocial needs of the population.


### (12) in case of cross-border health threats due to a communicable disease , the blood and transplant services in the member states can provide a means for rapid testing of the donor population and assessing exposure to and immunity from the disease in the general population. these services in return are dependent on rapid risk assessments by the ecdc to safeguard patients , in need of a therapy from a substance of human origin , from a transmission of such communicable disease. such risk assessment serves then as basis to allow for the appropriate adaptation of measures setting standards for quality and safety of such substances of human origin. the ecdc should therefore set up and operate a network of national blood and transplant services and their authorities to serve this dual purpose. ### (12) in case of cross-border health threats due to a communicable disease , the blood and transplant services in the member states can provide a means for rapid testing of the donor population and , together with pharmacies and other licensed health care establishments , also testing for assessing exposure to and immunity from the disease in the general population. these services in return are dependent on rapid risk assessments by the ecdc to safeguard patients , in need of a therapy from a substance of human origin , from a transmission of such communicable disease. such risk assessment serves then as basis to allow for the appropriate adaptation of measures setting standards for quality and safety of such substances of human origin. the ecdc should therefore set up and operate a network of national blood and transplant services , as well as pharmacy services and other licensed health services and establishments , and their authorities to serve this dual purpose.


### (16) to this effect , the hsc responsible for the coordination of response at union level , should assume additional responsibility for the adoption of opinions and guidance for member states related to the prevention and control of a serious cross border threats to health. furthermore , should the coordination of national public health measures prove insufficient to ensure an adequate union response , the commission should further support member states via the adoption of recommendations on temporary public health measures. ### (16) to this effect , the hsc responsible for the coordination of response at union level , should assume additional responsibility for the adoption of opinions and recommendations for member states related to the prevention and control of a serious cross border threats to health. furthermore , should the coordination of national public health measures prove insufficient to ensure an adequate union response , the commission should further support member states via the adoption of recommendations on temporary public health measures.


### (18) the recognition of public health emergency situations and the legal effects of this recognition provided by decision no 1082/2013/eu should be broadened. to this end , this regulation should allow for the commission to formally recognise a public health emergency at union level. in order to recognise such an emergency situation , the commission should establish an independent advisory committee that will provide expertise on whether a threat constitutes a public health emergency at union level , and advise on public health response measures and on the termination of this emergency recognition. the advisory committee should consist of independent experts , selected by the commission from the fields of expertise and experience most relevant to the specific threat that is occurring , representatives of the ecdc , of the ema , and of other union bodies or agencies as observers. recognition of a public health emergency at union level will provide the basis for introducing operational public health measures for medical products and medical devices , flexible mechanisms to develop , procure , manage and deploy medical countermeasures as well as the activation of support from the ecdc to mobilise and deploy outbreak assistance teams , known as ‘eu health task force’. ### (18) the recognition of public health emergency situations and the legal effects of this recognition provided by decision no 1082/2013/eu should be broadened. to this end , this regulation should allow for the commission to formally recognise a public health emergency at union level. in order to recognise such an emergency situation , the commission should establish an independent advisory committee that will provide expertise on whether a threat constitutes a public health emergency at union level , and advise on public health response measures and on the termination of this emergency recognition. the advisory committee should consist of independent experts and representatives of health and care workers , including nurses and medical doctors , selected by the commission from the fields of expertise and experience most relevant to the specific threat that is occurring , representatives of the ecdc , of the ema , and of other union bodies or agencies as observers. all members of the advisory committee should provide declarations of interest in line with the applicable rules in each case. the advisory committee should work in close cooperation with national advisory bodies. recognition of a public health emergency at union level will provide the basis for introducing operational public health measures for medical products and medical devices , union export control mechanisms , flexible mechanisms to develop , procure , manage and deploy medical countermeasures as well as the activation of support from the ecdc to mobilise and deploy outbreak assistance teams , known as ‘eu health task force’.


### (18) the recognition of public health emergency situations and the legal effects of this recognition provided by decision no 1082/2013/eu should be broadened. to this end , this regulation should allow for the commission to formally recognise a public health emergency at union level. in order to recognise such an emergency situation , the commission should establish an independent advisory committee that will provide expertise on whether a threat constitutes a public health emergency at union level , and advise on public health response measures and on the termination of this emergency recognition. the advisory committee should consist of independent experts , selected by the commission from the fields of expertise and experience most relevant to the specific threat that is occurring , representatives of the ecdc , of the ema , and of other union bodies or agencies as observers. recognition of a public health emergency at union level will provide the basis for introducing operational public health measures for medical products and medical devices , flexible mechanisms to develop , procure , manage and deploy medical countermeasures as well as the activation of support from the ecdc to mobilise and deploy outbreak assistance teams , known as ‘eu health task force’. ### (18) the recognition of public health emergency situations and the legal effects of this recognition provided by decision no 1082/2013/eu should be broadened. to this end , this regulation should allow for the commission to formally recognise a public health emergency at union level. in order to recognise such an emergency situation , the commission should establish an independent advisory committee that will provide expertise on whether a threat constitutes a public health emergency at union level , and advise on public health response measures and on the termination of this emergency recognition. the advisory committee should consist of independent experts , selected by the commission from the fields of expertise and experience most relevant to the specific threat that is occurring , representatives of the ecdc , of the ema , and of other union bodies or agencies as observers. member states , through their representatives , should also be able to participate in the committee's meetings as observers. recognition of a public health emergency at union level will provide the basis for introducing operational public health measures for medical products and medical devices , flexible mechanisms to develop , procure , manage and deploy medical countermeasures as well as the activation of support from the ecdc to mobilise and deploy outbreak assistance teams , known as ‘eu health task force’.


### (18) the recognition of public health emergency situations and the legal effects of this recognition provided by decision no 1082/2013/eu should be broadened. to this end , this regulation should allow for the commission to formally recognise a public health emergency at union level. in order to recognise such an emergency situation , the commission should establish an independent advisory committee that will provide expertise on whether a threat constitutes a public health emergency at union level , and advise on public health response measures and on the termination of this emergency recognition. the advisory committee should consist of independent experts , selected by the commission from the fields of expertise and experience most relevant to the specific threat that is occurring , representatives of the ecdc , of the ema , and of other union bodies or agencies as observers. recognition of a public health emergency at union level will provide the basis for introducing operational public health measures for medical products and medical devices , flexible mechanisms to develop , procure , manage and deploy medical countermeasures as well as the activation of support from the ecdc to mobilise and deploy outbreak assistance teams , known as ‘eu health task force’. ### (18) the recognition of public health emergency situations and the legal effects of this recognition provided by decision no 1082/2013/eu should be broadened. to this end , this regulation should allow for the commission to formally recognise a public health emergency at union level. in order to recognise such an emergency situation , the commission should establish an independent advisory committee that will provide expertise on whether a threat constitutes a public health emergency at union level , and advise on public health response measures and on the termination of this emergency recognition. the advisory committee should consist of independent experts , selected by the commission from the fields of expertise and experience most relevant to the specific threat that is occurring , representatives of the ecdc , of the ema , and of other union bodies or agencies as observers with close involvement of the relevant industry stakeholders. recognition of a public health emergency at union level will provide the basis for introducing operational public health measures for medical products and medical devices , flexible mechanisms to develop , procure , manage and deploy medical countermeasures as well as the activation of support from the ecdc to mobilise and deploy outbreak assistance teams , known as ‘eu health task force’.


### (21) cooperation with third countries and international organisations in the field of public health should be fostered. it is particularly important to ensure the exchange of information with the who on the measures taken pursuant to this regulation. this reinforced cooperation is also required to contribute to eu’s commitment to strengthening support to health systems and reinforcing partners’ preparedness and response capacity. the union could benefit from concluding international cooperation agreements with third countries or international organisations , including the who , to foster the exchange of relevant information from monitoring and alerting systems on serious cross-border threats to health. within the limits of the union’s competences , such agreements could include , where appropriate , the participation of such third countries or international organisations in the relevant epidemiological surveillance monitoring network and the ewrs , exchange of good practice in the areas of preparedness and response capacity and planning , public health risk-assessment and collaboration on response coordination , including the research response. ### (21) cooperation with third countries and international organisations in the field of public health should be fostered. it is particularly important to ensure the exchange of information with the who on the measures taken pursuant to this regulation. this reinforced cooperation is also required to contribute to eu’s commitment to strengthening support to health systems and reinforcing partners’ preparedness and response capacity. international cooperation agreements should be concluded with third countries or international organisations , including the who , to foster the exchange of relevant information from monitoring and alerting systems on serious cross-border threats to health. such agreements would benefit the union and third countries , and within the limits of the union’s competences , could include , where appropriate , the participation of such third countries or international organisations in the relevant epidemiological surveillance monitoring network and the ewrs , exchange of good practice in the areas of preparedness and response capacity and planning , public health risk-assessment and collaboration on response coordination , including the research response.


### 3. the implementation of this regulation shall be supported by funding from relevant union programmes and instruments. ### 3. in keeping with "one health" and "health in all policies approaches" , the implementation of this regulation shall be supported by funding from relevant union programmes and instruments. the strengthened union health framework addressing serious cross-border health threats shall work in synergy with and in a manner that is complementary to other union policies and funds , such as actions implemented under the esif , horizon europe , the digital europe programme , resceu , esi , esf+ and smp.


### events which may constitute public health emergencies of international concern under the international health regulations (ihr) , provided that they fall under one of the categories of threats set out in points (a) to (d). ### events which may constitute public health emergencies of international concern under the international health regulations (ihr) , provided that they fall under one of the categories of threats set out in points (a) to (d).


### 2. this regulation shall also apply to the epidemiological surveillance of communicable diseases and of related special health issues. ### 2. this regulation shall also apply to the epidemiological surveillance of communicable diseases , the surveillance of the impact of such diseases on non-communicable diseases and of related special health issues , such as mental health impacts of the crisis and the impact of deferred screening , diagnosis , monitoring , treatment and care for other diseases and conditions.


### (2) ‘communicable disease’ means an infectious disease caused by a contagious agent which is transmitted from person to person by direct contact with an infected individual or by indirect means such as exposure to a vector , animal , fomite , product or environment , or exchange of fluid , which is contaminated with the contagious agent; ### 2) ‘communicable disease’ means an infectious disease caused by a contagious agent which is transmitted from person to person by direct contact with an infected individual or by indirect means such as exposure to a vector , animal , fomite , product or environment , or exchange of fluid , which is contaminated with the contagious agent , or from animal to human;


### (7) ‘serious cross-border threat to health’ means a life-threatening or otherwise serious hazard to health of biological , chemical , environmental , climate or unknown origin which spreads or entails a significant risk of spreading across the national borders of member states , and which may necessitate coordination at union level in order to ensure a high level of human health protection; ### (does not affect the english version.)


### adoption of opinions and guidance , including on specific response measures for the member states for the prevention and control of serious cross-border threats to health. ### (does not affect the english version.)


### 4. the hsc shall be chaired by a representative of the commission. the hsc shall meet at regular intervals and whenever the situation requires , on a request from the commission or a member state. ### 4. the hsc shall be chaired by a representative of the commission who shall have no voting rights. the health security committee shall meet when the situation requires , on a request from the commission or a member state , as well as outside those intervals.


### the participation of experts in plenary meetings at high level , the status of possible observers , including from third countries; ### the participation of experts in plenary meetings , the status of possible observers , including from third countries;


### ii preparedness and response planning ### ii prevention , preparedness and response planning


### 2. the union preparedness and response plan shall complement the national preparedness and response plans established in accordance with article 6. ### 2. the union preparedness and response plan shall complement the national preparedness and response plans established in accordance with article 6.


### the health preparedness and response and intersectoral collaboration; ### the health preparedness and response and intersectoral collaboration , including between the health and veterinary sectors in cases of cross-border zoonotic health threats;


### 4. the union preparedness and response plan shall include interregional preparedness elements to establish coherent , multi-sectoral , cross-border public health measures , in particular considering capacities for testing , contact tracing , laboratories , and specialised treatment or intensive care across neighbouring regions. the plans shall include preparedness and response means to address the situation of those citizens with higher risks. ### 4. the union preparedness and response plan shall include interregional preparedness elements to establish coherent , multi-sectoral , cross-border public health measures , in particular considering capacities for testing , contact tracing , laboratories , and specialised treatment or intensive care across neighbouring regions. the plans shall include preparedness and response means to address the situation of those citizens with higher risks , as well as to ensure the continuity of critical long-term healthcare services for time sensitive , chronic , degenerative and other life-threatening diseases.


### 4. the union preparedness and response plan shall include interregional preparedness elements to establish coherent , multi-sectoral , cross-border public health measures , in particular considering capacities for testing , contact tracing , laboratories , and specialised treatment or intensive care across neighbouring regions. the plans shall include preparedness and response means to address the situation of those citizens with higher risks. ### 4. the union preparedness and response plan shall include cross-border and interregional preparedness plans to establish coherent , multi-sectoral , cross-border public health measures , in particular considering capacities for testing , contact tracing , laboratories , training of healthcare staff and specialised treatment or intensive care across neighbouring regions. the plans shall include preparedness and response means to address the situation of those citizens with higher risks.


### 4. the union preparedness and response plan shall include interregional preparedness elements to establish coherent , multi-sectoral , cross-border public health measures , in particular considering capacities for testing , contact tracing , laboratories , and specialised treatment or intensive care across neighbouring regions. the plans shall include preparedness and response means to address the situation of those citizens with higher risks. ### 4. the union preparedness and response plan shall include interregional preparedness elements to establish coherent , multi-sectoral , cross-border public health measures , in particular considering capacities for testing , contact tracing , laboratories , and specialised treatment or intensive care across neighbouring regions. the plan shall include preparedness and response means to address the situation of those citizens with higher risks.


### 1. when preparing national preparedness and response plans each member state shall coordinate with the commission in order to reach consistency with the union preparedness and response plan , also inform without delay the commission and the hsc of any substantial revision of the national plan. ### 1. when preparing national preparedness and response plans each member state shall coordinate with the commission in order to reach consistency with the union preparedness and response plan , also inform without delay the commission and the hsc of any substantial revision of the national plan. coordination , dialogue and exchange of information with industry and supply chain stakeholders should also be considered.


### 1. when preparing national preparedness and response plans each member state shall coordinate with the commission in order to reach consistency with the union preparedness and response plan , also inform without delay the commission and the hsc of any substantial revision of the national plan. ### 1. member states shall prepare national preparedness and response plans for cross-border health threats. when preparing them , each member state shall coordinate with the commission in order to reach consistency with the union preparedness and response plan , also inform without delay the commission and the hsc of any substantial revision of the national plan.


### 1. member states shall by the end of november 2021 and every 2 years thereafter provide the commission with a report on their preparedness and response planning and implementation at national level. ### 1. member states shall by the end of november 2021 and every 2 years thereafter provide the commission with a report on their preparedness and response planning and implementation at national and , where appropriate , regional and cross-border levels.


### 1. member states shall by the end of november 2021 and every 2 years thereafter provide the commission with a report on their preparedness and response planning and implementation at national level. ### 1. member states shall , within 6 months of the entry into force of this regulation and every 2 years thereafter , provide the commission with a report on their preparedness and response planning and implementation at national level.


### identification of , and update on the status of the implementation of the capacity standards for preparedness and response planning as determined at national level for the health sector , as provided to the who in accordance with the ihr; ### (does not affect the english version.)


### governance: including national policies and legislation that integrate emergency preparedness; plans for emergency preparedness , response and recovery; coordination mechanisms; ### governance: including national policies and legislation that integrate emergency preparedness; plans for emergency preparedness , response and recovery at national and , where relevant , regional and cross-border levels; coordination mechanisms;


### governance: including national policies and legislation that integrate emergency preparedness; plans for emergency preparedness , response and recovery; coordination mechanisms; ### governance: including national policies and legislation that integrate emergency preparedness; plans for emergency preparedness , response and recovery; continuity of critical long-term healthcare; coordination mechanisms;


### governance: including national policies and legislation that integrate emergency preparedness; plans for emergency preparedness , response and recovery; coordination mechanisms; ### governance: including national policies and legislation that integrate emergency preparedness; plans for emergency preparedness , response and recovery; coordination mechanisms of the competent authorities;


### (ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning , information management; access to diagnostic services during emergencies; basic and safe gender-sensitive health and emergency services; risk communications; research development and evaluations to inform and accelerate emergency preparedness; ### (ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning , information management; information relevant for the internal market and union strategic reserves of medical products , including national stockpiles and capacities to contribute to the security of supply of critical medical products at union level; equal access to diagnostic services and tools and medical products during emergencies; the continuity of screening , diagnosis , monitoring , treatment and care for other diseases and conditions during emergencies; basic and safe gender-sensitive health and emergency services; risk communications; research development and evaluations to inform and accelerate emergency preparedness;


### (ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning , information management; access to diagnostic services during emergencies; basic and safe gender-sensitive health and emergency services; risk communications; research development and evaluations to inform and accelerate emergency preparedness; ### (ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning , information management; access to diagnostic services during emergencies; basic and safe gender-sensitive health and emergency services that take account of the needs of populations with higher risks; risk communications; research development and evaluations to inform and accelerate emergency preparedness;


### (ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning , information management; access to diagnostic services during emergencies; basic and safe gender-sensitive health and emergency services; risk communications; research development and evaluations to inform and accelerate emergency preparedness; ### (ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning , information management; access to diagnostic services during emergencies; basic and safe gender-sensitive health and emergency services; continuity of critical long-term healthcare; risk communications; research development and evaluations to inform and accelerate emergency preparedness;


### (iii) resources: including financial resources for emergency preparedness and contingency funding for response; logistics mechanisms and essential supplies for health; and dedicated , trained and equipped human resources for emergencies; and ### (iii) resources: including financial resources for emergency preparedness and contingency funding for response; health logistics mechanisms that meet the specific legal requirements of directive 2001/83/ec of the european parliament and of the council of 6 november 2001 and regulation (eu) 2017/745 of the european parliament and of the council of 5 april 2017; essential supplies for health; and dedicated , trained and equipped human resources for emergencies; and


### (iii) resources: including financial resources for emergency preparedness and contingency funding for response; logistics mechanisms and essential supplies for health; and dedicated , trained and equipped human resources for emergencies; and ### (iii) resources: including financial resources for emergency preparedness and contingency funding for response; logistics mechanisms and essential supplies for health; a reserve of critical medical products at member state level; and dedicated , trained and equipped human resources for emergencies; and


### (iii) resources: including financial resources for emergency preparedness and contingency funding for response; logistics mechanisms and essential supplies for health; and dedicated , trained and equipped human resources for emergencies; and ### (iii) resources: including financial resources for emergency preparedness and contingency funding for response; logistics mechanisms and essential supplies for health; and dedicated , trained and equipped human resources for emergencies; continuity of critical long-term healthcare; and


### (iii) resources: including financial resources for emergency preparedness and contingency funding for response; logistics mechanisms and essential supplies for health; and dedicated , trained and equipped human resources for emergencies; and ### (iii) resources: including financial resources for emergency preparedness and contingency funding for response; logistical mechanisms and essential health supplies; and dedicated , trained and equipped human resources for emergencies; and


### implementation of national response plans , including where relevant implementation at the regional and local levels , covering epidemic response; antimicrobial resistance , health care associated infection , and other specific issues. ### implementation of national response plans , including where relevant implementation at the regional and local levels , covering epidemic response; antimicrobial resistance , health care associated infection , mental health impacts , the continuity of screening , diagnosis , monitoring , treatment and care for other diseases and conditions , and other specific issues.


### the report shall include , whenever relevant , interregional preparedness and response elements in line with the union and national plans , covering in particular the existing capacities , resources and coordination mechanisms across neighbouring regions. ### for member states sharing a border with at least one other member state , the report shall include cross-border and interregional preparedness and response plans with neighbouring regions including coordination mechanisms for all elements under paragraphs 1 (a) , (b) and (c) , cross-border training and sharing of best practices for healthcare staff and public health staff and coordination mechanisms for the medical transfer of patients.


### 1. every 3 years , the ecdc shall conduct audits in the member states aimed at ascertaining the state of implementation of the national plans and their coherence with the union plan. such audits shall be implemented with the relevant union agencies , aiming at the assessment of preparedness and response planning at national level with regard to the information referred to in article 7(1). ### 1. every 3 years , the ecdc shall conduct audits in the member states aimed at ascertaining the state of implementation of the national plans and their coherence with the union plan. such audits shall be implemented in cooperation with the relevant union agencies , aiming at the assessment of preparedness and response planning at national level with regard to the information referred to in article 7(1).


### 2. member states shall present an action plan addressing the proposed recommendations of the audit and the corresponding corrective actions and milestones. ### 2. should the audit identifies deficiencies , the member state shall , within six months of receipt of its conclusions , present an action plan addressing the proposed recommendations of the audit and setting out the corresponding corrective actions and milestones.


### overview reports of audits series , which present cases of good practice. ### overview reports of audits carried out which contain good practices.


### 1. on the basis of the information provided by the member states in accordance with article 7 , and of the results of the audits referred to in article 8 , the commission shall by july 2022 and every 2 years afterwards , transmit to the european parliament and to the council a report on the state of play and progress on preparedness and response planning at union level. ### 1. on the basis of the information provided by the member states in accordance with article 7 , and of the results of the audits referred to in article 8 , the commission shall , within 2 years of the entry into force of this regulation and every 2 years afterwards , transmit to the european parliament and to the council a report on the state of play and progress on preparedness and response planning at union level.


### supporting the implementation of capacity requirements for surveillance and response as referred to in the ihr; ### (does not affect the english version.)


### developing the preparedness plans referred to in articles 5 and 6; ### supporting the development of the preparedness plans referred to in articles 5 and 6;


### 1. the commission may organise training activities for healthcare staff and public health staff in the member states , including preparedness capacities under the international health regulations. ### (does not affect the english version.)


### the commission shall organise those activities in cooperation with the member states concerned. ### the commission shall organise those activities in cooperation with the member states concerned or potentially concerned.


### 2. the training activities referred to in paragraph 1 shall aim to provide staff referred to in that paragraph with knowledge and skills necessary in particular to develop and implement the national preparedness plans referred to in article 6 , implement activities to strengthen crisis preparedness and surveillance capacities including the use of digital tools. ### 2. the training activities referred to in paragraph 1 shall aim to provide staff referred to in that paragraph with knowledge and skills necessary in particular to develop and implement the national preparedness plans referred to in article 6 , implement activities to strengthen crisis preparedness and surveillance capacities including the use of digital tools , and to ensure the continuity of critical long-term healthcare services.


### 3. the training activities referred to in paragraph 1 may be open to staff of the competent authorities of third countries and may be organised outside the union. ### 3. the training activities referred to in paragraph 1 may be open to staff of the competent authorities of third countries and may , in justified cases , be organised outside the union.


### 1. the commission and any member states which so desire may engage in a joint procurement procedure conducted pursuant to article 165(2) of regulation (eu , euratom) 2018/1046 of the european parliament and of the council29 with a view to the advance purchase of medical countermeasures for serious cross-border threats to health. ### 1. during extraordinary emergencies , where purchase of countermeasures cannot efficiently be ensured by other means , the commission and any member states which so desire may engage in a joint procurement procedure conducted pursuant to article 165(2) of regulation (eu , euratom) 2018/1046 of the european parliament and of the council29 with a view to the advance purchase of medical countermeasures for serious cross-border threats to health.


### 1. the commission and any member states which so desire may engage in a joint procurement procedure conducted pursuant to article 165(2) of regulation (eu , euratom) 2018/1046 of the european parliament and of the council29 with a view to the advance purchase of medical countermeasures for serious cross-border threats to health. ### 1. the commission and any member states which so desire may engage in a joint procurement procedure conducted pursuant to article 165(2) of regulation (eu , euratom) 2018/1046 of the european parliament and of the council29 with a view to the advance purchase of medical countermeasures for serious cross-border threats to health within a reasonable time frame.


### 1. the commission and any member states which so desire may engage in a joint procurement procedure conducted pursuant to article 165(2) of regulation (eu , euratom) 2018/1046 of the european parliament and of the council29with a view to the advance purchase of medical countermeasures for serious cross-border threats to health. ### 1. the commission and any member states which so desire may engage in a joint procurement procedure conducted pursuant to article 165(2) of regulation (eu , euratom) 2018/1046 of the european parliament and of the council29 with a view to the advance purchase of health countermeasures for serious cross-border threats to health.


### participation in the joint procurement procedure shall be open to all members states , european free trade association (efta) states and union candidate countries in accordance with article 165(2) of regulation (eu , euratom) 2018/1046; ### participation in the joint procurement procedure shall be open to all members states , european free trade association (efta) states , union candidate countries in accordance with article 165(2) of regulation (eu , euratom) 2018/1046 , as well as andorra , san marino and monaco;


### member states , efta states and union candidate countries participating in a joint procurement shall procure the medical countermeasure in question through that procedure and not through other channels , and shall not run parallel negotiation processes for that product; ### member states , efta states , union candidate countries , as well as andorra , san marino and monaco , when participating in a joint procurement shall procure the medical countermeasure in question through that procedure and not through other channels , and shall not run parallel negotiation processes for that product;


### 3. the commission shall , in liaison with the member states , ensure coordination and information exchange between the entities organizing any action , including , but not limited to joint procurement procedures , stockpiling and donation of medical countermeasures under different mechanisms established at union level , in particular under: ### 3. the commission shall , in liaison with the member states , ensure coordination and information exchange between the entities organizing any action , including , but not limited to joint procurement procedures , stockpiling in facilities that meet the specific legal requirements for the storage of medical countermeasures and with the greatest proximity and accessibility to the greatest number of population centres and donation of medical countermeasures under different mechanisms established at union level , in particular under:


### 3. the commission shall , in liaison with the member states , ensure coordination and information exchange between the entities organizing any action , including , but not limited to joint procurement procedures , stockpiling and donation of medical countermeasures under different mechanisms established at union level , in particular under: ### 3. during extraordinary emergencies , the commission shall , in liaison with the member states , ensure coordination and information exchange between the entities organizing any action , including , but not limited to joint procurement procedures , stockpiling and donation of medical countermeasures under different mechanisms established at union level , in particular under:


### stockpiling under the resceu referred to in article 12 of decision no 1313/2013/eu; ### stockpiling under the resceu referred to in article 23 of decision no 1313/2013/eu;


### contribute to the assessment of the burden of communicable diseases on the population using such data as disease prevalence , complications , hospitalisation and mortality; ### contribute to the assessment of the burden of communicable diseases on the population using such data as disease prevalence , complications , hospitalisation and mortality , the mental health impact and deferred screening , diagnosis , monitoring , treatment and care for other diseases and conditions;


### contribute to the assessment of the burden of communicable diseases on the population using such data as disease prevalence , complications , hospitalisation and mortality; ### contribute to the assessment of the burden of communicable diseases on the population using such data as disease prevalence , complications , the need for hospitalisation and mortality;


### 3. the national competent authorities referred to in paragraph 1 shall communicate the following information to the participating authorities of the epidemiological surveillance network: ### 3. the national competent authorities referred to in paragraph 1 shall notify the following information to the participating authorities of the epidemiological surveillance network:


### relevant information concerning the progression of epidemic situations , including for modelling and scenario development; ### relevant information concerning the progression of epidemic situations , including for modelling and scenario development , for response;


### 4. when reporting information on epidemiological surveillance , the national competent authorities shall , where available , use the case definitions adopted in accordance with paragraph 9 for each communicable disease and related special health issue referred to in paragraph 1. ### 4. when notifying information on epidemiological surveillance , the national competent authorities shall , where available , use the case definitions adopted in accordance with paragraph 9 for each communicable disease and related special health issue referred to in paragraph 1.


### 5. the commission and the member states shall work together to define disease-specific european surveillance standards based on the proposal of the ecdc , in consultation with the relevant surveillance networks. ### 5. the commission and the member states shall work together to define disease-specific european surveillance standards based on the proposal of the ecdc , in consultation with other bodies connected to the epidemiological surveillance network.


### 1. the ecdc shall ensure the further development of the digital platform through which data are managed and automatically exchanged , to establish integrated and interoperable surveillance systems enabling real-time surveillance where appropriate , for the purpose of supporting communicable disease prevention and control. ### 1. the ecdc shall ensure the further development of the digital platform through which data are managed and automatically exchanged , to establish integrated and interoperable surveillance systems enabling real-time surveillance where appropriate , for the purpose of supporting communicable disease prevention and control. human oversight should be ensured.


### 1. the ecdc shall ensure the further development of the digital platform through which data are managed and automatically exchanged , to establish integrated and interoperable surveillance systems enabling real-time surveillance where appropriate , for the purpose of supporting communicable disease prevention and control. ### 1. the ecdc shall ensure the further development of the digital platform through which data are managed and automatically exchanged , to establish an integrated and interoperable surveillance system enabling real-time surveillance where appropriate , for the purpose of supporting communicable disease prevention and control.


### 1. in the area of public health or for specific areas of public health relevant for the implementation of this regulation or of the national plans referred to in article 6 , the commission may , by means of implementing acts , designate eu reference laboratories to provide support to national reference laboratories to promote good practice and alignment by member states on a voluntary basis on diagnostics , testing methods , use of certain tests for the uniform surveillance , notification and reporting of diseases by member states. ### 1. in the area of public health or for specific areas of public health relevant for the implementation of this regulation or of the national plans referred to in article 6 , the commission may , by means of implementing acts , designate eu reference laboratories to provide support to national reference laboratories to promote good practice and alignment by member states on diagnostics , testing methods , use of certain tests for the uniform surveillance , notification and reporting of diseases by member states.


### 2. the eu reference laboratories shall be responsible in particular for the following tasks to coordinate the network of national reference laboratories , in particular , in the following areas: ### 2. the eu reference laboratories shall fulfil in particular the following tasks to coordinate the network of national reference laboratories:


### 3. the network of eu reference laboratories shall be operated and coordinated by the ecdc. ### (does not affect the english version.)


### 4. the designations provided for in paragraph 1 shall follow a public selection process , be limited in time , with a minimum period of 5 years , and be reviewed regularly. designations shall establish the responsibilities and tasks of the designated laboratories. ### (does not affect the english version.)


### 6. grants may be awarded to the laboratories referred to in paragraph 1 for the costs that they incur in implementing annual or multiannual work programmes that have been established in conformity with the objectives and priorities of the work programmes adopted by the commission in accordance with the eu4health programme established by regulation (eu) …/… of the european parliament and of the council33. ### (does not affect the english version.)


### 2. the network shall be operated and coordinated by the ecdc. ### 2. the ecdc shall assure and coordinate the operations of the network.


### the ecdc shall continuously update the ewrs allowing for the use of modern technologies , such as digital mobile applications , artificial intelligence models , space enabled applications , or other technologies for automated contact tracing , building upon the contact tracing technologies developed by the member states. ### the ecdc shall continuously update the ewrs allowing for the use of modern technologies , such as digital mobile applications , artificial intelligence models , applications using satellite navigation , or other technologies for automated contact tracing , building upon the contact tracing technologies developed by the member states.


### 2. where the national competent authorities notify the who of events that may constitute public health emergencies of international concern in accordance with article 6 of the ihr , they shall at the latest simultaneously notify an alert in the ewrs , provided that the threat concerned falls within those referred to in article 2(1) of this regulation. ### (does not affect the english version.)


### 3. when notifying an alert , the national competent authorities and the commission shall promptly communicate through the ewrs any available relevant information in their possession that may be useful for coordinating the response such as: ### 3. when notifying an alert , the national competent authorities and the commission shall promptly communicate through the ewrs , as well as to relevant third party stakeholders , including manufacturers of relevant medical countermeasures , any available relevant information in their possession that may be useful for coordinating the response such as:


### requests and offers for cross-border emergency assistance; ### requests and offers for cross-border emergency assistance , such as the medical transfer of patients or provision of healthcare staff by one member state to another , in particular in cross-border areas in neighbouring regions;


### 1. where an alert is notified pursuant to article 19 , the commission shall , where necessary for the coordination of the response at union level or upon request of the hsc referred to in article 21 or on its own initiative , make promptly available to the national competent authorities and to the hsc , through the ewrs , a risk assessment of the potential severity of the threat to public health , including possible public health measures. that risk assessment shall be carried out by: ### 1. where an alert is notified pursuant to article 19 , the commission shall , where necessary for the coordination of the response at union level or upon request of the hsc referred to in article 21 or on its own initiative , make promptly available to the national competent authorities and to the hsc , through the ewrs , a risk assessment of the potential severity of the threat to public health , including possible public health measures. that risk assessment shall be carried out on their own initiative or at the request of the commission by:


### the ecdc in accordance with article 8a of regulation (eu) …/… [oj: please insert the number of regulation ecdc [isc/2020/ 12527]] in the case of a threat referred to in points (i) and (ii) of point (a) of article 2(1) including substances of human origin: blood , organs , tissues and cells potentially impacted by communicable diseases; or point (d) of article 2(1); and/or ### the ecdc in accordance with article 8a of regulation (eu) …/… [oj: please insert the number of regulation ecdc [isc/2020/ 12527]] in the case of a threat referred to in points (i) and (ii) of point (a) of article 2(1) including substances of human origin , such as blood , organs , tissues and cells potentially impacted by communicable diseases; or point (d) of article 2(1); and/or


### national responses , including research needs , to the serious cross-border threat to health , including where a public health emergency of international concern is declared in accordance with the ihr and falls within article 2 of this regulation; ### (does not affect the english version.)


### risk and crisis communication , to be adapted to member state needs and circumstances , aimed at providing consistent and coordinated information in the union to the public and to healthcare professionals; ### risk and crisis communication , to be adapted to member state needs and circumstances , aimed at providing consistent and coordinated information in the union to the public and to healthcare professionals. in addition , the commission shall broaden its communication activity to cover the general public by establishing and managing a portal to share verified information and fight against disinformation;


### risk and crisis communication , to be adapted to member state needs and circumstances , aimed at providing consistent and coordinated information in the union to the public and to healthcare professionals; ### risk and crisis communication , to be adapted to member state needs and circumstances , aimed at providing easy-to-understand , consistent and coordinated information in the union to the public and to healthcare professionals;


### adoption of opinions and guidance , including on specific response measures for the member states for the prevention and control of a serious cross-border threat to health. ### adoption of opinions and recommendations , including on specific response measures for the member states for the prevention and control of a serious cross-border threat to health.


### 3. where a member state has to adopt , as a matter of urgency , public health measures in response to the appearance or resurgence of a serious cross-border threat to health , it shall , immediately upon adoption , inform the other member states and the commission on the nature , purpose and scope of those measures. ### 3. where a member state has to adopt , as a matter of urgency , public health measures in response to the appearance or resurgence of a serious cross-border threat to health , it shall , immediately upon adoption , inform the other member states and relevant regional authorities and the commission on the nature , purpose and scope of those measures , especially in cross-border regions.


### 3. where a member state has to adopt , as a matter of urgency , public health measures in response to the appearance or resurgence of a serious cross-border threat to health , it shall , immediately upon adoption , inform the other member states and the commission on the nature , purpose and scope of those measures. ### 3. where a member state has to immediately adopt , as a matter of urgency , public health measures in response to the appearance or resurgence of a serious cross-border threat to health , it shall , directly upon adoption , inform the other member states and the commission on the nature , purpose and scope of those measures.


### 1. the commission may complement the action of the member states through the adoption of recommendations on common temporary public health measures for member states. ### 1. the commission may complement the action of the member states through the adoption of recommendations on common temporary public health measures for member states. in particular it may adopt recommendations on travel restrictions and other restrictions on movement and the gathering of people , as well as quarantine requirements and supervision of quarantines per recommendation of the ecdc. it may also adopt recommendations on common indicators and on actions to be taken in case of serious health hazards , epidemics or pandemics , including in relation to infection rates based on reproduction (r) numbers , in the case of infectious diseases , as a basis for restrictive actions , the harmonised collection of epidemic , diagnostic and mortality data , the use of testing methodologies , quarantines and other restrictions on mobility , and travel and patient isolation requirements. those common indicators shall also cover other health hazards , including chemicals and microplastics in drinking water.


### be based on in particular recommendations of the ecdc in particular , other relevant agencies or bodies , or the advisory committee referred to in article 24; ### be based on in particular recommendations of the ecdc , other relevant agencies or bodies , or the advisory committee referred to in article 24;


### be proportionate to the public health risks related to the threat in question , avoiding in particular any unnecessary restriction to the free movement of persons , of goods and of services. ### be proportionate to the public health risks related to the threat in question , must not create any unnecessary restriction to the free movement of persons , of goods and of services.


### 2. the commission shall terminate the recognition referred to in paragraph 1 as soon as one of the applicable conditions laid down therein is no longer met. ### 2. the commission shall terminate the recognition referred to in paragraph 1 as soon as one of the applicable conditions laid down therein is no longer fulfilled.


### 3. before recognising a situation of public health emergency at union level , the commission should liaise with the who in order to share the commission’s analysis of the situation of the outbreak and to inform the who of its intention to adopt such a decision. ### 3. before recognising a situation of public health emergency at union level , the commission shall liaise with the who in order to share the commission’s analysis of the situation of the outbreak and to inform the who of its intention to adopt such a decision.


### 1. for the purpose of the formal recognition of a public health emergency at union level , the commission shall establish an advisory committee on public health emergencies (‘advisory committee’) which , at the request of the commission , shall advise the commission by providing its views on: ### 1. for the purpose of the formal recognition of a public health emergency at union level , the commission shall establish , in response to a specific arising threat , an ad hoc advisory committee on public health emergencies (‘advisory committee’) which , at the request of the commission , shall advise the commission by providing its views on:


### whether a threat constitutes a public health emergency at union level; ### whether a threat constitutes a public health emergency at union level after consulting the ecdc on the matter;


### the termination of a public health emergency at union level; and ### (does not affect the english version.)


### (ii) identification and mitigation of significant gaps , inconsistencies or inadequacies in measures taken or to be taken to contain and manage the specific threat and overcome its impact , including in clinical management and treatment , non-pharmaceutical countermeasures and public health research needs; ### (ii) identification and mitigation of significant gaps , inconsistencies or inadequacies in measures taken or to be taken to contain and manage the specific threat and overcome its impact , including in clinical management and treatment , non-pharmaceutical countermeasures , global supply chain involved in the production and manufacturing of medical countermeasures needed for the prevention , diagnosis , treatment and follow-up of the disease concerned and public health research needs;


### (iii) prioritisation of health care , civil protection and other resources as well as support measures to be organised or coordinated at union level; ### (does not affect the english version.)


### 2. the advisory committee shall be composed of independent experts , selected by the commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. the committee should have multidisciplinary membership so it can advise on biomedical , behavioural , social , economic , cultural and international aspects. the representatives of the ecdc and of the ema participate as observers in the advisory committee. the representatives of other union bodies or agencies relevant to the specific threat shall participate as observers in this committee as necessary. the commission may invite experts with specific expertise with respect to a subject matter on the agenda to take part in the work of the advisory committee on an ad-hoc basis. ### 2. the advisory committee shall be composed of independent experts and representatives of health and care workers , selected by the commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. the committee should have multidisciplinary membership so it can advise on sanitary , biomedical , behavioural , social , economic , cultural and international aspects. the representatives of the ecdc and of the ema participate as observers in the advisory committee. the representatives of other union bodies or agencies relevant to the specific threat shall participate as observers in this committee as necessary. the commission may invite experts with specific expertise with respect to a subject matter on the agenda to take part in the work of the advisory committee on an ad-hoc basis.


### 2. the advisory committee shall be composed of independent experts , selected by the commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. the committee should have multidisciplinary membership so it can advise on biomedical , behavioural , social , economic , cultural and international aspects. the representatives of the ecdc and of the ema participate as observers in the advisory committee. the representatives of other union bodies or agencies relevant to the specific threat shall participate as observers in this committee as necessary. the commission may invite experts with specific expertise with respect to a subject matter on the agenda to take part in the work of the advisory committee on an ad-hoc basis. ### 2. the advisory committee shall be composed of independent experts , selected by the commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. the committee should have multidisciplinary membership so it can advise on biomedical , behavioural , social , economic , manufacturing , research , development , cultural and international aspects. the representatives of the ecdc and of the ema participate as observers in the advisory committee. the representatives of other union bodies or agencies relevant to the specific threat shall participate as observers in this committee as necessary. the commission may invite experts and stakeholders with specific expertise with respect to a subject matter on the agenda to take part in the work of the advisory committee on an ad-hoc basis.


### 2. the advisory committee shall be composed of independent experts , selected by the commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. the committee should have multidisciplinary membership so it can advise on biomedical , behavioural , social , economic , cultural and international aspects. the representatives of the ecdc and of the ema participate as observers in the advisory committee. the representatives of other union bodies or agencies relevant to the specific threat shall participate as observers in this committee as necessary. the commission may invite experts with specific expertise with respect to a subject matter on the agenda to take part in the work of the advisory committee on an ad-hoc basis. ### 2. the advisory committee shall be composed of independent experts selected by the commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. the committee should have multidisciplinary membership so it can advise on biomedical , behavioural , social , economic , cultural and international aspects. the representatives of the ecdc , the ema and the member states participate as observers in the advisory committee. the representatives of other union bodies or agencies relevant to the specific threat shall participate as observers in this committee as necessary. the commission may invite experts with specific expertise with respect to a subject matter on the agenda to take part in the work of the advisory committee on an ad-hoc basis.


### 3. the advisory committee shall meet whenever the situation requires , on a request from the commission or a member state. ### 3. the advisory committee shall meet when the situation requires , on a request from the commission or a member state , as well as outside those intervals.


### 4. the advisory committee shall be chaired by a representative of the commission. ### 4. the advisory committee shall be chaired by a representative of the commission. the chair shall have no voting rights.


### mechanisms to monitor shortages of , develop , procure , manage and deploy medical countermeasures; ### mechanisms to monitor shortages of , develop , procure , ensure security of supply , manage and deploy medical countermeasures;


### 5. personal data may also be exchanged in the context of automated contact tracing , using contact tracing applications. ### 5. personal data may also be exchanged in the context of automated contact tracing , using contact tracing applications , in full compliance with the regulation (eu) 20176/679 ('gdpr').


### this regulation establishes a european union single window environment for customs that provides an integrated set of interoperable electronic services at union and national level through the european union customs single window certificates exchange system to support interaction and information exchange between the national single window environments for customs and the union non-customs systems referred to in the annex. ### this regulation establishes a european union single window environment for customs that provides an integrated set of interoperable electronic services at union and national level through the european union customs single window certificates exchange system to support interaction and information exchange between the national single window environments for customs and the union non-customs systems referred to in part a and part b of annex i.


### a european union single window environment for customs is hereby established. it shall include the european union customs single window certificates exchange system , national single window environments for customs and the union non-customs systems referred to in the annex. ### a european union single window environment for customs is hereby established. it shall include the european union customs single window certificates exchange system , national single window environments for customs and the union non-customs systems referred to in part a of annex i.


### costs of eu csw-certex , work programme , and monitoring and reporting ### costs of eu csw-certex , work programme , and monitoring , reviewing and reporting


### monitoring and reporting ### monitoring , reviewing and reporting


### 1. the commission shall regularly monitor the functioning of the european union single window environment for customs. ### 1. the commission shall regularly monitor the functioning of the european union single window environment for customs. the commission shall regularly review the status of the systems listed in parts b and c of annex i with a view to assessing their progress towards compliance with the rules laid down in articles 10 to 15. if the commission concludes that a system listed in parts b or c of annex i complies with the applicable rules laid down in articles 10 to 15 , it shall adopt a delegated act as mentioned in article 3(1a) integrating the system into part a of annex i.


### (1) council directive 2008/114/ec17 provides for a procedure for designating european critical infrastructures in the energy and transport sectors , the disruption or destruction of which would have significant cross-border impact on at least two member states. that directive focused exclusively on the protection of such infrastructures. however , the evaluation of directive 2008/114/ec conducted in 201918 found that due to the increasingly interconnected and cross-border nature of operations using critical infrastructure , protective measures relating to individual assets alone are insufficient to prevent all disruptions from taking place. therefore , it is necessary to shift the approach towards ensuring the resilience of critical entities , that is , their ability to mitigate , absorb , accommodate to and recover from incidents that have the potential to disrupt the operations of the critical entity. ### (1) council directive 2008/114/ec17 provides for a procedure for designating european critical infrastructures in the energy and transport sectors , the disruption or destruction of which would have significant cross-border impact on at least two member states. that directive focused exclusively on the protection of such infrastructures. however , the evaluation of directive 2008/114/ec conducted in 201918 found that due to the increasingly interconnected and cross-border nature of operations using critical infrastructure , protective measures relating to individual assets alone are insufficient to prevent all disruptions from taking place. therefore , it is necessary to shift the approach towards ensuring the resilience of critical entities , that is , their ability to mitigate , absorb , accommodate to and recover from incidents that have the potential to disrupt the provision of essential services by the critical entity.


### (2) despite existing measures at union19 and national level aimed at supporting the protection of critical infrastructures in the union , the entities operating those infrastructures are not adequately equipped to address current and anticipated future risks to their operations that may result in disruptions of the provision of services that are essential for the performance of vital societal functions or economic activities. this is due to a dynamic threat landscape with an evolving terrorist threat and growing interdependencies between infrastructures and sectors , as well as an increased physical risk due to natural disasters and climate change , which increases the frequency and scale of extreme weather events and brings long-term changes in average climate that can reduce the capacity and efficiency of certain infrastructure types if resilience or climate adaptation measures are not in place. moreover , relevant sectors and types of entities are not recognised consistently as critical in all member states. ### (2) despite existing measures at union19 and national level aimed at supporting the protection of critical infrastructures in the union , the entities operating those infrastructures are not adequately equipped to address current and anticipated future risks to their operations that may result in disruptions of the provision of services that are essential for the performance of vital societal functions or economic activities. this is due to a dynamic threat landscape with an evolving terrorist threat , criminal infiltration , foreign interference , and growing interdependencies between infrastructures and sectors , as well as an increased physical risk due to natural disasters and climate change , which increases the frequency and scale of extreme weather events and brings long-term changes in average climate that can reduce the capacity and efficiency of certain infrastructure types if resilience or climate adaptation measures are not in place. moreover , relevant sectors and types of entities are not recognised consistently as critical in all member states.


### (2) despite existing measures at union19 and national level aimed at supporting the protection of critical infrastructures in the union , the entities operating those infrastructures are not adequately equipped to address current and anticipated future risks to their operations that may result in disruptions of the provision of services that are essential for the performance of vital societal functions or economic activities. this is due to a dynamic threat landscape with an evolving terrorist threat and growing interdependencies between infrastructures and sectors , as well as an increased physical risk due to natural disasters and climate change , which increases the frequency and scale of extreme weather events and brings long-term changes in average climate that can reduce the capacity and efficiency of certain infrastructure types if resilience or climate adaptation measures are not in place. moreover , relevant sectors and types of entities are not recognised consistently as critical in all member states. ### (2) despite existing measures at union19 and national level aimed at supporting the protection of critical infrastructures in the union , the entities operating those infrastructures are not adequately equipped to address current and anticipated future risks to their operations that may result in disruptions of the provision of services that are essential for the performance of vital societal functions or economic activities , as well as security , including cyber-security. this is due to a dynamic threat landscape with an evolving terrorist threat and growing interdependencies between infrastructures and sectors , as well as an increased physical risk due to natural disasters and climate change , which increases the frequency and scale of extreme weather events and brings long-term changes in average climate that can reduce the capacity and efficiency of certain infrastructure types if resilience or climate adaptation measures are not in place. moreover , relevant sectors and types of entities are not recognised consistently as critical in all member states.


### (3) those growing interdependencies are the result of an increasingly cross-border and interdependent network of service provision using key infrastructures across the union in the sectors of energy , transport , banking , financial market infrastructure , digital infrastructure , drinking and waste water , health , certain aspects of public administration , as well as space in as far as the provision of certain services depending on ground-based infrastructures that are owned , managed and operated either by member states or by private parties is concerned , therefore not covering infrastructures owned , managed or operated by or on behalf of the union as part of its space programmes. these interdependencies mean that any disruption , even one initially confined to one entity or one sector , can have cascading effects more broadly , potentially resulting in far-reaching and long-lasting negative impacts in the delivery of services across the internal market. the covid-19 pandemic has shown the vulnerability of our increasingly interdependent societies in the face of low-probability risks. ### (3) those growing interdependencies are the result of an increasingly cross-border and interdependent network of service provision using key infrastructures across the union in the sectors of energy , transport , banking , financial market infrastructure , digital infrastructure , drinking and waste water , food production , processing and delivery , health , certain aspects of public administration , as well as space in as far as the provision of certain services depending on ground-based infrastructures that are owned , managed and operated either by member states or by private parties is concerned , therefore not covering infrastructures owned , managed or operated by or on behalf of the union as part of its space programmes. these interdependencies mean that any disruption , even one initially confined to one entity or one sector , can have cascading effects more broadly , potentially resulting in far-reaching and long-lasting negative impacts in the delivery of services across the internal market. the covid-19 pandemic has shown the vulnerability of our increasingly interdependent societies in the face of low-probability risks.


### (3) those growing interdependencies are the result of an increasingly cross-border and interdependent network of service provision using key infrastructures across the union in the sectors of energy , transport , banking , financial market infrastructure , digital infrastructure , drinking and waste water , health , certain aspects of public administration , as well as space in as far as the provision of certain services depending on ground-based infrastructures that are owned , managed and operated either by member states or by private parties is concerned , therefore not covering infrastructures owned , managed or operated by or on behalf of the union as part of its space programmes. these interdependencies mean that any disruption , even one initially confined to one entity or one sector , can have cascading effects more broadly , potentially resulting in far-reaching and long-lasting negative impacts in the delivery of services across the internal market. the covid-19 pandemic has shown the vulnerability of our increasingly interdependent societies in the face of low-probability risks. ### (3) those growing interdependencies are the result of an increasingly cross-border and interdependent network of service provision using key infrastructures across the union in the sectors of energy , transport , banking , financial market infrastructure , digital infrastructure , drinking and waste water , health , agri-food , certain aspects of public administration , as well as space in as far as the provision of certain services depending on ground-based infrastructures that are owned , managed and operated either by member states or by private parties is concerned , therefore not covering infrastructures owned , managed or operated by or on behalf of the union as part of its space programmes. these interdependencies mean that any disruption , even one initially confined to one entity or one sector , can have cascading effects more broadly , potentially resulting in far-reaching and long-lasting negative impacts in the delivery of services across the internal market. the covid-19 pandemic has shown the vulnerability of our increasingly interdependent societies in the face of low-probability risks.


### (4) the entities involved in the provision of essential services are increasingly subject to diverging requirements imposed under the laws of the member states. the fact that some member states have less stringent security requirements on these entities not only risks impacting negatively on the maintenance of vital societal functions or economic activities across the union , it also leads to obstacles to the proper functioning of the internal market. similar types of entities are considered as critical in some member states but not in others , and those which are identified as critical are subject to divergent requirements in different member states. this results in additional and unnecessary administrative burdens for companies operating across borders , notably for companies active in member states with more stringent requirements. ### (4) the entities involved in the provision of essential services are increasingly subject to diverging requirements imposed under the laws of the member states. the fact that some member states have less stringent security requirements on these entities not only risks impacting negatively on the maintenance of vital societal functions or economic activities across the union , it also leads to obstacles to the proper functioning of the internal market. similar types of entities are considered as critical in some member states but not in others , and those which are identified as critical are subject to divergent requirements in different member states. this results in additional and unnecessary administrative burdens for companies operating across borders , notably for companies active in member states with more stringent requirements. thus , the member states and the commission should aim at reaching a common understanding of classifications with a view to achieving the highest possible level of protection of critical entities across the union.


### (4) the entities involved in the provision of essential services are increasingly subject to diverging requirements imposed under the laws of the member states. the fact that some member states have less stringent security requirements on these entities not only risks impacting negatively on the maintenance of vital societal functions or economic activities across the union , it also leads to obstacles to the proper functioning of the internal market. similar types of entities are considered as critical in some member states but not in others , and those which are identified as critical are subject to divergent requirements in different member states. this results in additional and unnecessary administrative burdens for companies operating across borders , notably for companies active in member states with more stringent requirements. ### (4) the entities involved in the provision of essential services are increasingly subject to diverging requirements imposed under the laws of the member states. the fact that some member states have less stringent security requirements on these entities not only risks impacting negatively on the maintenance of vital societal functions or economic activities across the union , it also leads to obstacles to the proper functioning of the internal market. the resilience of critical entities is of great importance for the functioning of the internal market and the security of the union , however , this directive should not limit the responsibility of member states to protect national security. similar types of entities are considered as critical in some member states but not in others , and those which are identified as critical are subject to divergent requirements in different member states. this results in additional and unnecessary administrative burdens for companies operating across borders , notably for companies active in member states with more stringent requirements.


### (5) it is therefore necessary to lay down harmonised minimum rules to ensure the provision of essential services in the internal market and enhance the resilience of critical entities. ### (5) since it is not practical to expect full and continuous critical infrastructure protection , the aim of this directive should be to make critical infrastructures resilient thereby furthering their capacity to ensure continuous provision of essential services or essential infrastructure or at least to swiftly restore performance after an incident has taken place. operators of critical infrastructures delivering essential services across the internal market in various sectors necessary for vital societal functions and economic activities , should become resilient against a range of natural and man-made , intentional or unintentional , current and anticipated future risks. it is therefore necessary to lay down harmonised minimum rules to ensure the provision of essential services in the internal market and enhance the resilience of critical entities.


### (5) it is therefore necessary to lay down harmonised minimum rules to ensure the provision of essential services in the internal market and enhance the resilience of critical entities. ### (5) it is therefore necessary to lay down harmonised minimum rules to ensure the provision of essential services in the internal market , enhance the resilience of critical entities , and improve in particular cross-border cooperation of competent authorities.


### (5) it is therefore necessary to lay down harmonised minimum rules to ensure the provision of essential services in the internal market and enhance the resilience of critical entities. ### (5) it is therefore necessary to lay down harmonised minimum rules to ensure the provision of essential services in the internal market and enhance the resilience of critical entities , while maintaining the responsibilities of member states’ for national security.


### (11) the actions of member states to identify and help ensure the resilience of critical entities should follow a risk-based approach that targets efforts to the entities most relevant for the performance of vital societal functions or economic activities. in order to ensure such a targeted approach , each member state should carry out , within a harmonised framework , an assessment of all relevant natural and man-made risks that may affect the provision of essential services , including accidents , natural disasters , public health emergencies such as pandemics , and antagonistic threats , including terrorist offences. when carrying out those risk assessments , member states should take into account other general or sector-specific risk assessment carried out pursuant to other acts of union law and should consider the dependencies between sectors , including from other member states and third countries. the outcomes of the risk assessment should be used in the process of identification of critical entities and to assist those entities in meeting the resilience requirements of this directive. ### (11) the actions of member states to identify and help ensure the resilience of critical entities should follow a risk-based approach that targets efforts to the entities most relevant for the performance of vital societal functions or economic activities. in order to ensure such a targeted approach , each member state should carry out , within a harmonised framework , an assessment of all relevant natural and man-made risks that may affect the provision of essential services , including accidents , natural disasters , public health emergencies such as pandemics , criminal infiltration , and antagonistic threats , including terrorist offences. when carrying out those risk assessments , member states should take into account other general or sector-specific risk assessment carried out pursuant to other acts of union law and should consider the dependencies between sectors , including from other member states and third countries. the outcomes of the risk assessment should be used in the process of identification of critical entities and to assist those entities in meeting the resilience requirements of this directive.


### (12) in order to ensure that all relevant entities are subject to those requirements and to reduce divergences in this respect , it is important to lay down harmonised rules allowing for a consistent identification of critical entities across the union , while also allowing member states to reflect national specificities. therefore , criteria to identify critical entities should be laid down. in the interest of effectiveness , efficiency , consistency and legal certainty , appropriate rules should also be set on notification and cooperation relating to , as well as the legal consequences of , such identification. in order to enable the commission to assess the correct application of this directive , member states should submit to the commission , in a manner that is as detailed and specific as possible , relevant information and , in any event , the list of essential services , the number of critical entities identified for each sector and subsector referred to in the annex and the essential service or services that each entity provides and any thresholds applied. ### (12) in order to ensure that all relevant entities are subject to those requirements and to reduce divergences in this respect , it is important to lay down harmonised rules allowing for a consistent identification of critical entities across the union , while also allowing member states to reflect national specificities. therefore , criteria to identify critical entities should be laid down in a transparent manner. in the interest of effectiveness , efficiency , consistency and legal certainty , appropriate rules should also be set on notification and cooperation relating to , as well as the legal consequences of , such identification. in order to enable the commission to assess the correct application of this directive , member states should submit to the commission , in a manner that is as detailed and specific as possible , relevant information and , in any event , the list of essential services , the number of critical entities identified for each sector and subsector referred to in the annex and the essential service or services that each entity provides and any thresholds applied.


### (16) member states should designate authorities competent to supervise the application of and , where necessary , enforce the rules of this directive and ensure that those authorities are adequately empowered and resourced. in view of the differences in national governance structures and in order to safeguard already existing sectoral arrangements or union supervisory and regulatory bodies , and to avoid duplication , member states should be able to designate more than one competent authority. in that case , they should however clearly delineate the respective tasks of the authorities concerned and ensure that they cooperate smoothly and effectively. all competent authorities should also cooperate more generally with other relevant authorities , both at national and union level. ### (16) member states should designate authorities competent to supervise the application of and , where necessary , enforce the rules of this directive and ensure that those authorities are adequately empowered and resourced. in view of the differences in national governance structures and in order to safeguard already existing sectoral arrangements or union supervisory and regulatory bodies , and to avoid duplication , member states should be able to designate more than one competent authority. in that case , they should however clearly delineate the respective tasks of the authorities concerned and ensure that they cooperate smoothly and effectively. all competent authorities should also cooperate more generally with other relevant authorities , both at national and union level , including with competent authorities of other member states.


### (16) member states should designate authorities competent to supervise the application of and , where necessary , enforce the rules of this directive and ensure that those authorities are adequately empowered and resourced. in view of the differences in national governance structures and in order to safeguard already existing sectoral arrangements or union supervisory and regulatory bodies , and to avoid duplication , member states should be able to designate more than one competent authority. in that case , they should however clearly delineate the respective tasks of the authorities concerned and ensure that they cooperate smoothly and effectively. all competent authorities should also cooperate more generally with other relevant authorities , both at national and union level. ### (16) member states should designate authorities competent to supervise the application of and , where necessary , enforce the rules of this directive and ensure that those authorities are adequately empowered and resourced. in view of the differences in national governance structures and in order to safeguard already existing national or union-based sector-specific arrangements or union supervisory and regulatory bodies , and to avoid duplication , member states should be able to designate more than one competent authority. in that case , they should however clearly delineate the respective tasks of the authorities concerned and ensure that they cooperate smoothly and effectively. all competent authorities should also cooperate more generally with other relevant authorities , both at national and union level.


### (18) given that under the nis 2 directive entities identified as critical entities , as well as identified entities in the digital infrastructure sector that are to be treated as equivalent under the present directive are subject to the cybersecurity requirements of the nis 2 directive , the competent authorities designated under the two directives should cooperate , particularly in relation to cybersecurity risks and incidents affecting those entities. ### (18) entities identified as critical entities under this directive , as well as identified entities in the digital infrastructure sector that are to be treated as equivalent under the present directive are subject to the cybersecurity requirements of the nis 2 directive. for this reason , the competent authorities designated under the two directives should cooperate , particularly in relation to cybersecurity and physical security risks and incidents affecting those entities.