### 10. stresses that barriers also derive from limited national administration capabilities to provide services in other languages , and from shortages of skills and infrastructure; ### 10. stresses that barriers may also derive from limited national administration capabilities to provide services in other languages , in addition to the language required by the member state of destination;


### 11. welcomes the significant improvements to the free movement of goods in recent years thanks to regulations such as regulation (eu) 2018/302 (‘geo-blocking regulation) , regulation (eu) 2019/1020 (‘regulation on market surveillance and compliance of products’) , and most importantly thanks to regulation (eu) 2019/515 (‘regulation on mutual recognition of goods’);; believes that thorough application of the principle of mutual recognition would efficiently advance the agenda of the single market , especially in the areas where difficulties remain; ### 11. welcomes the significant improvements to the free movement of goods in recent years thanks to regulations such as regulation (eu) 2018/302 (‘geo-blocking regulation) , regulation (eu) 2019/1020 (‘regulation on market surveillance and compliance of products’) , and most importantly thanks to regulation (eu) 2019/515 (‘regulation on mutual recognition of goods’); recalls that the principle of mutual recognition applies only to non-harmonised goods and stresses the importance of top-down harmonisation in order to ensure a high level of product safety and consumer protection; believes that thorough application of the principle of mutual recognition and the instruments recently defined by regulation (eu) 2019/2015 would benefit the economic operators concerned while preserving the ability of national authorities to act in the public interest; stresses in this connection that the commission published guidelines on application thereof in march 2021 in order to raise awareness of the tools available to businesses and competent authorities;


### 12. considers that mutual recognition of professional qualification is seriously affected by administrative barriers imposed by member states; ### deleted


### 13. is concerned by the insufficient access to information on mobility of services , as well as by the burdensome procedures to obtain essential documents such as the a1 form; underlines that access to information , such as on domestic collective agreements where applicable and relevant , should be improved to facilitate compliance for businesses; ### 13. deplores the insufficient access to information on the conditions for providing services in a country and the applicable obligations and rules; calls for the procedures for obtaining essential documents such as the a1 form to be simplified as much as possible , particularly as part of a strategy for the digitisation of administrative procedures; underlines that access to information , such as on domestic collective agreements and other conventions applicable in the country of origin should be improved to facilitate compliance for businesses;


### 14. recognises that numerous barriers stem from the limited capacity of administrations to deliver high quality services in cross-border settings; believes that digitalisation of public services and fully-fledged egovernment capabilities remain essential to eradicate some of the onerous ntbs; recalls , in this regard , that the key provisions of the single digital gateway had to be in force in all eu member states by 12 december 2020; underlines the importance of the ‘once only’ principle , which will save citizens and businesses time and money , in particular if used more widely; welcomes the proposal to add a single market obstacles tool to the single digital gateway; ### 14. believes that digitisation of public services and fully-fledged egovernment capabilities remain essential to eradicate certain onerous ntbs; stresses the importance of developing and using interoperable and open-source egovernment tools with a view to fostering the development of internationally compatible egovernment procedures; recalls , in this regard , that the key provisions of the single digital gateway had to be in force in all eu member states by 12 december 2020; underlines the importance of the ‘once only’ principle , which will save citizens and businesses time and money , in particular if used more widely; welcomes the proposal to add a single market obstacles tool to the single digital gateway;


### 16. welcomes the commission proposal to make solvit the default tool for single market dispute resolution; ### 16. welcomes the commission proposal to make solvit the default tool for single market dispute resolution; takes the view that this requires greater awareness-raising of the existence of these dispute-resolution instruments;


### 17. stresses that the international road haulage sector is subject to a number of ntbs restricting access to national markets , which limit its competitiveness , discriminate against transport companies from certain member states and increase emissions; calls on commission and member states to abolish unnecessary restrictions on cabotage , and calls for the opening of the freight and passenger transport services sector within the eu; ### deleted


### 19. recalls that so far the commission’s plan to step up enforcement of eu law by means of the smet has only delivered limited results; calls on the commission to present in due time concrete outcomes of the work of smet , including information on barriers that have been abolished as a result of its actions; ### 19. recalls that so far the commission’s plan to step up enforcement of eu law by means of the smet , which met for the first time in april 2020 , has only delivered limited results; calls on the commission to enhance smet's transparency and to present in due time concrete outcomes of the work of smet , including information on barriers that have been abolished as a result of its actions; stresses that smet's work cannot have a purely businesses-based perspective , but must be supplemented by approaches grounded in social and environmental sustainability so as to ensure a holistic understanding of the proper functioning of the internal market;


### 20. calls on the commission to present an annual report on ntbs and establish an open and transparent database compiling specific national ntbs together with ongoing infringement procedures; ### 20. calls on the commission to present a regular report at least every two years on ntbs and establish an open and transparent database compiling specific national ntbs together with ongoing infringement procedures;


### 21. calls on the commission and the member states to consistently , speedily and rigorously assess whether national rules hinder the internal market , and where they do , to assess if they are necessary , proportional and justified; ### 21. calls on the commission and the member states to consistently , speedily and rigorously assess whether national rules are necessary , proportionate and justified , as stipulated by directive (eu) 2015/1535 on the provision of information on technical regulations and directive (eu) 2018/958 on access to regulated professions;


### 22. recalls that throughout the regulatory lifecycle , member states and the commission must share the responsibility of ensuring that single market rules are complied with and that citizens’ rights are enforced; ### 22. recalls that throughout the regulatory lifecycle , member states and the commission must share the responsibility of ensuring that single market rules are complied with and that citizens’ , workers' and consumers' rights are enforced; stresses the need for harmonised rules eu-wide on the frequency and quality of checks and other market surveillance activities , particularly in respect of product safety , and for the promotion of tools for the exchange of information between national authorities with a view to strengthening cooperation in this area;


### 23. points to the importance of surveillance , inspection and sanctioning by relevant authorities of economic operators who do not comply with legislation; ### 23. points to the importance of surveillance , inspection and sanctioning by relevant authorities of economic operators who do not comply with legislation; stresses that not only is it essential to make use of instruments for market surveillance cooperation between national authorities and the commission , but also to develop new ones to give advance warning of non-compliance problems that jeopardise consumer safety , in particular by providing increased supervision at european level;


### 24. stresses the importance of monitoring , and therefore welcomes the single market scoreboard as a performance monitoring tool; emphasises the need for a recurring debate on the outcomes of the scoreboard at the highest political levels , ensuring political commitment to tackling the obstacles identified; ### 24. stresses the importance of monitoring , and therefore welcomes the single market scoreboard as a performance monitoring tool; takes the view that this monitoring tool should include qualitative components in addition to quantitative criteria , in other words it should take environmental and social indicators into account; emphasises the need for a recurring debate on the outcomes of the scoreboard at the highest political levels , ensuring political commitment to tackling the obstacles identified not only from a business perspective , but also with regard to the challenges faced by workers , consumers and citizens , with due account for social and environmental policy considerations;


### 25. recalls that the initial response to the pandemic by member states and the commission did not take into account the needs of the single market , and recalls the serious impact this has had on the free cross-border movement of goods and services; ### 25. recalls that the initial response to the pandemic by member states and the commission did not take into account the needs of the single market since unilateral national measures were taken that restricted the free movement of essential goods , services and people , in particular cross-border workers; recalls the serious impact this has had on the free cross-border movement of goods and services as well as of workers;


### 26. welcomes the nextgenerationeu recovery package , the eu guidelines for border management , transport green lanes , the eu digital covid certificate to facilitate free movement , and further measures which aim to allow the single market to operate normally; ### 26. welcomes the nextgenerationeu recovery package , the eu guidelines for border management and free movement , transport green lanes , the eu digital covid certificate to facilitate free movement , and further measures which aim to allow the single market to operate normally; takes the view that the recovery must be paved by sustainable development , fair transition , social inclusion and the creation of quality jobs


### 27. calls on the commission and member states to proactively use the lessons learned and to develop a response plan for emergencies , which should aim to safeguard as far as possible the free movement of services and goods; ### 27. calls on the commission and member states to proactively use the lessons learned and to develop a response plan for emergencies and ensure a common response , which should aim to safeguard as far as possible the free movement of services , goods and persons , particularly cross-border workers;


### (2) in light of the lessons learnt during the ongoing covid-19 pandemic and in order to facilitate adequate union-wide preparedness and response to all cross-border threats to health , the legal framework for epidemiological surveillance , monitoring , early warning of , and combating serious cross-border threats to health , as set out in decision no 1082/2013/eu , needs to be broadened with regard to additional reporting requirements and analysis on health systems indicators , and cooperation by member states with the european centre for disease prevention and control (ecdc). moreover , in order to ensure effective union response to novel cross- border threats to health , the legal framework to combat serious cross-border threats to health should enable to immediately adopt case definitions for the surveillance of novel threats and should provide for the establishment of a network of eu reference laboratories and a network to support monitoring of disease outbreaks that are relevant to substances of human origin. the capacity for contact tracing should be strengthened via the creation of an automated system , using modern technologies. ### (2) in light of the lessons learnt during the ongoing covid-19 pandemic and in order to facilitate adequate union-wide preparedness and response to all cross-border threats to health , the legal framework for epidemiological surveillance , monitoring , early warning of , and combating serious cross-border threats to health , as set out in decision no 1082/2013/eu , needs to be broadened with regard to additional reporting requirements and analysis on health systems indicators , and cooperation between member states , and union agencies , particularly the european centre for disease prevention and control (ecdc) and the european medicines agency (ema) , and international organisations , namely the world health organization (who). moreover , in order to ensure effective union response to novel cross- border threats to health , the legal framework to combat serious cross-border threats to health should enable to immediately adopt case definitions for the surveillance of novel threats and should provide for the establishment of a network of eu reference laboratories and a network to support monitoring of disease outbreaks that are relevant to substances of human origin.


### (5) this regulation should apply without prejudice to other binding measures concerning specific activities or quality and safety standards for certain goods , which provide for special obligations and tools for monitoring , early warning and combatting specific threats of a cross-border nature. those measures include , in particular , relevant union legislation in the area of common safety concerns in public health matters , covering goods such as pharmaceutical products , medical devices and foodstuffs , substances of human origin (blood , tissues and cells , organs) , and exposure to ionising radiation. ### (5) this regulation should apply without prejudice to other binding measures concerning specific activities or quality and safety standards for certain goods , which provide for special obligations and tools for monitoring , early warning and combatting specific threats of a cross-border nature. those measures include , in particular , relevant union legislation in the area of common safety concerns in public health and environmental matters , covering goods such as pharmaceutical products , medical devices , foodstuffs , substances of human origin (blood , tissues and cells , organs) , and exposure to ionising radiation.


### (6) the protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous union policies and activities. in order to achieve a high level of human health protection , and to avoid any overlap of activities , duplication or conflicting actions , the commission , in liaison with the member states , should ensure coordination and exchange of information between the mechanisms and structures established under this regulation , and other mechanisms and structures established at union level and under the treaty establishing the european atomic energy community (the euratom treaty) , the activities of which are relevant to the preparedness and response planning , monitoring , early warning of , and combating serious cross-border threats to health. in particular , the commission should ensure that relevant information from the various rapid alert and information systems at union level and under the euratom treaty is gathered and communicated to the member states through the early warning and response system (‘ewrs’) set up by decision no 2119/98/ec. ### (6) in line with the one health and health in all policies approach , the protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous union policies and activities. in order to achieve a high level of human health protection , and to avoid any overlap of activities , duplication or conflicting actions , the commission , in liaison with the member states , should ensure coordination and exchange of information between the mechanisms and structures established under this regulation , and other mechanisms and structures established at union level and under the treaty establishing the european atomic energy community (the euratom treaty) , the activities of which are relevant to the preparedness and response planning , monitoring , early warning of , and combating serious cross-border threats to health. in particular , the commission should ensure that relevant information from the various rapid alert and information systems at union level and under the euratom treaty is gathered and communicated to the member states through the early warning and response system (‘ewrs’) set up by decision no 2119/98/ec.


### (7) preparedness and response planning are essential elements for effective monitoring , early warning of and combatting serious cross-border threats to health. as such , a union health crisis and pandemic preparedness plan needs to be established by the commission and approved by the hsc. this should be coupled with updates to member states’ preparedness and response plans so as to ensure they are compatible within the regional level structures. to support member states in this endeavour , targeted training and knowledge exchange activities for healthcare staff and public health staff should be provided knowledge and necessary skills should be provided by the commission and union agencies. to ensure the putting into operation and the running of these plans , the commission should conduct stress tests , exercises and in-action and after-action reviews with member states. these plans should be coordinated , be functional and updated , and have sufficient resources for their operationalisation. following stress tests and reviews of the plans , corrective actions should be implemented and the commission should be kept informed of all updates. ### (7) preparedness and response planning are essential elements for effective monitoring , early warning of and combatting serious cross-border threats to health. as such , a union health crisis and pandemic preparedness plan needs to be established by the commission and approved by the hsc. this should be coupled with updates to member states’ preparedness and response plans so as to ensure they are compatible within the regional level structures. to support member states in this endeavour , targeted training and knowledge exchange activities for healthcare staff and public health staff should be provided knowledge and necessary skills should be provided by the commission and union agencies. to ensure the putting into operation and the running of these plans , the commission should conduct stress tests , exercises and in-action and after-action reviews with member states. these plans should include recommendations for policy interventions related to mitigation of the impact of communicable diseases on health services and care , including for non-communicable diseases (ncds). the plans should be coordinated , be functional and updated , and have sufficient resources for their operationalisation. following stress tests and reviews of the plans , corrective actions should be implemented and the commission should be kept informed of all updates.


### (8) to this end , member states should provide the commission with an update on the latest situation with regard to their preparedness and response planning and implementation at national level. information provided by the member states should include the elements that member states are obliged to report to the world health organization (who) in the context of the international health regulations (ihr)15 . in turn , the commission should report to the european parliament and to the council on the state of play and progress with preparedness , response planning and implementation at union level , including on corrective actions , every 2 years to ensure that national preparedness and response plans are adequate. in order to support the assessment of these plans , eu audits in member states should be conducted , in coordination with the ecdc and union agencies. such planning should include in particular adequate preparedness of critical sectors of society , such as energy , transport , communication or civil protection , which rely , in a crisis situation , on well-prepared gender-sensitive public health systems that are also in turn dependent on the functioning of those sectors and on maintenance of essential services at an adequate level. in the event of a serious cross-border threat to health originating from a zoonotic infection , it is important to ensure the interoperability between health and veterinary sectors for preparedness and response planning. ### (8) access to timely and complete data is a precondition for a rapid risk assessments and crisis mitigation. to this end , member states should provide the commission with an update on the latest situation with regard to their preparedness and response planning and implementation at national level. information provided by the member states should include the elements that member states are obliged to report to the world health organization (who) in the context of the international health regulations (ihr)15 . to avoid duplication of efforts and diverging recommendations , standardised definitions and fluid information exchange should take place between union agencies , the who and national agencies. in turn , the commission should report to the european parliament and to the council on the state of play and progress with preparedness , response planning and implementation at union level , including on corrective actions , every 2 years to ensure that national preparedness and response plans are adequate. in order to support the assessment of these plans , eu audits in member states should be conducted , in coordination with the ecdc and union agencies. such planning should include in particular adequate preparedness of critical sectors of society , such as agriculture , energy , transport , communication or civil protection , which rely , in a crisis situation , on well-prepared gender-sensitive public health systems that are also in turn dependent on the functioning of those sectors and on maintenance of essential services at an adequate level. in the event of a serious cross-border threat to health originating from a zoonotic infection , it is important to ensure the interoperability between health and veterinary sectors for preparedness and response planning.


### (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. joint procurement of medical countermeasures will strengthen the purchasing power of participating countries , improve the security of supply and ensure equitable access to medical countermeasures against serious cross-border threats to health. 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. all joint procurement agreements should adhere to the highest level of transparency to allow public scrutiny of the contracts. 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 union should , in a spirit of solidarity , pre-allocate part of jointly procured products to low-and middle-income countries.


### (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 , through the one health approach , the prevention of communicable diseases , such as vaccine preventable diseases , as well as other health issues , such as antimicrobial resistance.


### (14) in order to ensure that the assessment of risks to public health at the union level from serious cross-border threats to health is consistent as well as comprehensive from a public health perspective , the available scientific expertise should be mobilised in a coordinated manner , through appropriate channels or structures depending on the type of threat concerned. that assessment of risks to public health should be developed by means of a fully transparent process and should be based on principles of excellence , independence , impartiality and transparency. the involvement of union agencies in these risk assessments needs to be broadened according to their speciality in order to ensure an all hazard approach , via a permanent network of agencies and relevant commission services to support the preparation of risk assessments. ### (14) in order to ensure that the assessment of risks to public health at the union level from serious cross-border threats to health is consistent as well as comprehensive from a public health perspective , the available scientific expertise should be mobilised in a coordinated and multidisciplinary manner , through appropriate channels or structures depending on the type of threat concerned. that assessment of risks to public health should be developed by means of a fully transparent process and should be based on principles of science , excellence , independence , impartiality and transparency. the involvement of union agencies in these risk assessments needs to be broadened according to their speciality in order to ensure an all hazard approach , via a permanent network of agencies and relevant commission services to support the preparation of risk assessments.


### (17) inconsistent communication with the public and stakeholders such as healthcare professionals can have a negative impact on the effectiveness of the response from a public health perspective as well as on economic operators. the coordination of the response within the hsc , assisted by relevant subgroups , should , therefore , encompass rapid information exchange concerning communication messages and strategies and addressing communication challenges with a view to coordinating risk and crisis communication , based on robust and independent evaluation of public health risks , to be adapted to national needs and circumstances. such exchanges of information are intended to facilitate the monitoring of the clarity and coherence of messages to the public and to healthcare professionals. given the cross-sectoral nature of this type of crises , coordination should also be ensured with other relevant constituencies , such as the union civil protection mechanism established by decision (eu) 2019/420 of the european parliament and of the council17 . ### (17) inconsistent communication with the public and stakeholders such as healthcare professionals can have a negative impact on the effectiveness of the response from a public health perspective as well as on economic operators. in addition to the recommendations targeted at member states and healthcare professionals , the ecdc should broaden its communication activities to provide key information available in all eu languages to the general public and serve as a point of reference and reliable source of information. the coordination of the response within the hsc , assisted by relevant subgroups , should , therefore , encompass rapid information exchange concerning communication messages and strategies and addressing communication challenges with a view to coordinating risk and crisis communication , based on robust and independent evaluation of public health risks , to be adapted to national needs and circumstances. such exchanges of information are intended to facilitate the monitoring of the clarity and coherence of messages to the public and to healthcare professionals. given the cross-sectoral nature of this type of crises , coordination should also be ensured with other relevant constituencies , such as the union civil protection mechanism established by decision (eu) 2019/420 of the european parliament and of the council17 .


### (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 civil society , 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’.


### (22) the processing of personal data for the purpose of implementing this regulation should comply with regulation (eu) 2016/679 and regulation (eu) 2018/1725 of the european parliament and of the council19 . in particular , the operation of the ewrs should provide for specific safeguards for the safe and lawful exchange of personal data for the purpose of contact tracing measures implemented by member states at national level. in this regard , the ewrs includes a messaging function in which personal data , including contact and health data , can be communicated to relevant authorities involved in contact tracing measures. ### (22) due to the sensitive nature of the health data , member states , the commission and union agencies should safeguard and guarantee that their processing operations respect the data protection principles of lawfulness , fairness , transparency , purpose limitation , data minimisation , accuracy , storage limitation , integrity and confidentiality. the processing of personal data for the purpose of implementing this regulation should comply with regulation (eu) 2016/679 and regulation (eu) 2018/1725 of the european parliament and of the council19 . in particular , the operation of the ewrs should provide for specific safeguards for the safe and lawful exchange of personal data for the purpose of contact tracing measures implemented by member states at national level. in this regard , the ewrs includes a messaging function in which personal data , including contact and health data , can be communicated to relevant authorities involved in contact tracing measures. article 27 of regulation (eu) 2018/1725 eudpr should be strictly respected and appropriate technical and organisational security measures in accordance with article 33 eudpr should be put in place.


### communicable diseases; ### communicable diseases , including of zoonotic origin;


### coordination in liaison with the commission of the preparedness and response planning of the member states in accordance with article 10; ### coordination in liaison with the commission and relevant union agencies of the preparedness and response planning of the member states in accordance with article 10;


### coordination in liaison with the commission of the risk and crisis communication and responses of the member states to serious cross-border threats to health , in accordance with article 21; ### coordination in liaison with the commission and relevant union agencies of the risk and crisis communication and responses of the member states to serious cross-border threats to health , in accordance with article 21;


### 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 should include recommendations for policy interventions related to mitigation of the impact of communicable diseases on health services and care , including for non-communicable diseases (ncds). the plans shall include preparedness and response means to address the situation of those citizens with higher risks.


### that report shall cover the following: ### that report shall be based on set indicators and cover the following:


### 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. ### 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. union or national entities that are engaged in stockpiling of medical products shall engage with the commission and member states in reporting of available stocks and taken into account in both union and national preparedness and response planning.


### the recommendations of the report shall be published on at the website of the commission. ### the recommendations of the report shall be published on the websites of the commission and the ecdc.


### 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 2 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 based on a set of agreed indicators and 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. the commission and the member states shall work together within the hsc to coordinate their efforts to develop , strengthen and maintain their capacities for the monitoring , early warning and assessment of , and response to serious cross-border threats to health. ### 1. the commission , relevant union agencies and the member states shall work together within the hsc to coordinate their efforts to develop , strengthen and maintain their capacities for the monitoring , early warning and assessment of , and response to serious cross-border threats to health.


### 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. ### 1. the commission or relevant union agencies may organise training activities for healthcare staff and public health staff in the member states , including preparedness capacities under the international health regulations.


### 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 as contracting parties 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.


### 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 health systems , care delivery , including for non-communicable diseases (ncds) , and the population using such data as disease prevalence , complications , hospitalisation and mortality;


### enable the automated collection of surveillance and laboratory data , make use of information from electronic health records , media monitoring , and apply artificial intelligence for data validation , analysis and automated reporting; ### enable the automated collection of surveillance and laboratory data , make use of information from electronic health records , media monitoring , and apply artificial intelligence for data validation , analysis and statistical reporting in accordance to article 22 of the gdpr;


### 1. a network of member states’ services supporting transfusion , transplantation and medically assisted reproduction is established to allow for the continuous and rapid access to sero-epidemiological data , including assessment of donor population exposure and immunity , and to monitor , assess and help address disease outbreaks that are relevant to substances of human origin. ### 1. a network of member states’ services supporting transfusion and transplantation is established to allow for the continuous and rapid access to sero-epidemiological data , including assessment of donor population exposure and immunity , and to monitor , assess and help address disease outbreaks that are relevant to substances of human origin.


### 3. each member state shall designate the competent authorities responsible within their territory for the services supporting transfusion , transplantation and medically assisted reproduction as referred to in paragraph 1. ### 3. each member state shall designate the competent authorities responsible within their territory for the services supporting transfusion and transplantation as referred to in paragraph 1.


### 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 taking into account lessons learned by the member states.


### the risk assessment shall take into account , if available , relevant information provided by other entities , in particular by the who in the case of a public health emergency of international concern. ### the risk assessment shall take into account , if available , relevant information provided by public health experts and other entities , in particular by the who in the case of a public health emergency of international concern.


### (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 , stability of supply chains and production capacity of medical countermeasures and public health research needs;


### 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 and of the ema take an active part 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.


### (13) the increased digitalisation of customs and union non-customs regulatory formalities applicable to international trade has opened up new opportunities for member states to improve the digital cooperation between customs and partner competent authorities. in pursuit of those priorities , several member states have started to develop frameworks for national single window environments for customs. those initiatives differ substantially depending on the level of existing customs information technology architecture , priorities and cost structures. it is therefore necessary to require member states to establish and operate national single window environments for customs for union non-customs formalities covered by eu csw-certex. those environments should constitute the national components of the eu single window environment for customs , enabling electronic information sharing and collaboration between customs , partner competent authorities and economic operators to ensure compliance with and efficient enforcement of customs legislation and union non-customs formalities covered by eu csw-certex. in line with this objective , the national single window environments for customs should enable the automated verification by customs authorities of formalities in respect of which data is transmitted from the respective union non-customs system through eu csw-certex. the national single window environments for customs should also allow partner competent authorities to monitor and control the quantities of authorised goods (‘quantity management’) that have been released by customs through the union. this should be ensured by providing the necessary clearance information to the union non-customs systems through eu csw-certex. in practical terms , quantity management at union level is necessary to enable a better enforcement of non-customs regulatory formalities by automatically and consistently monitoring the consumption of authorised quantities for the release of goods , avoiding their overuse or mishandling. ### (13) the increased digitalisation of customs and union non-customs regulatory formalities applicable to international trade has opened up new opportunities for member states to improve the digital cooperation between customs and partner competent authorities. in pursuit of those priorities , several member states have started to develop frameworks for national single window environments for customs. those initiatives differ substantially depending on the level of existing customs information technology architecture , priorities and cost structures. it is therefore necessary to require member states to establish and operate national single window environments for customs for union non-customs formalities covered by eu csw-certex. those environments should constitute the national components of the eu single window environment for customs , enabling electronic information sharing and collaboration between customs , partner competent authorities and economic operators to ensure compliance with and efficient enforcement of customs legislation and union non-customs formalities covered by eu csw-certex. in line with this objective , the national single window environments for customs should enable the automated verification by customs authorities of formalities in respect of which data is transmitted from the respective union non-customs system through eu csw-certex. the national single window environments for customs should also allow partner competent authorities to monitor and control the quantities of authorised goods (‘quantity management’) that have been released by customs through the union. this should be ensured by providing the necessary clearance information to the union non-customs systems through eu csw-certex. in practical terms , quantity management at union level is necessary to enable a better enforcement of non-customs regulatory formalities by automatically and consistently monitoring the consumption of authorised quantities for the release of goods , avoiding their overuse or mishandling. the relevant non-customs systems listed in annex i should be developed and integrated by each member state in its single window environment for customs and should be conducted within a safe and secure environment , protected from cyber threats and using the best available cybersecurity tools , and on the basis of uniform technical specifications provided by the commission. those uniform technical specifications should provide common data sets for all applications , declarations and notifications in order to create an interoperable common it interface solution.


### 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


### the commission shall , by means of implementing acts , adopt a work programme to support the implementation of the provisions of this regulation related to the connection of the union non-customs systems referred to in the annex to eu csw-certex and the integration of the respective union non-customs formalities. the work programme shall be kept up to date. those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 22(2). ### the commission shall , by means of implementing acts , adopt a work programme to support the implementation of the provisions of this regulation related to the connection of the union non-customs systems referred to in the annex to eu csw-certex and the integration of the respective union non-customs formalities. the work programme shall also include training support for national competent authorities including issuance of guidelines to ensure harmonized implementation across member states. the work programme shall be kept up to date. those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 22(2).


### 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 operations of the critical entity. such disruption could negatively impact the functioning of the internal market and of essential social services.


### (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 the free movement and safety of citizens. 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 often not recognised consistently as critical in all member states which can mean a lack of adequate coordination between member states in the protection of important cross-border and intersectoral critical infrastructures such as those in the transport and energy sectors.


### (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 landscape with growing interdependencies between infrastructures and sectors , as well as an increased physical risk due to natural disasters. the climate crisis also severely 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. therefore , fighting climate change should be considered an essential contribution to the resilience of our societies , which implies that more urgent and more ambitious action needs to be taken also outside the scope of this directive. 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. this is due to a dynamic threat landscape with an evolving threat by hostile states and non-state actors 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 , 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 but which are also of relevance for the common security and defence policy (csdp). 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. the resilience of critical entities gives investors and companies reliability and trust , something that are cornerstones of a well-working internal market. it also ensures that essential social services are not interrupted , thereby contributing to protecting the weakest in society. 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.


### (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 , various effects of climate change , public health emergencies such as pandemics , hybrid threats 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. this directive addresses the need to ensure continuity of the services essential for the maintenance of vital societal functions or economic activities , without prejudice to national competence in organising and delivering public services. 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.


### (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) 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. member states should pay particular attention when transposing this directive and the nis 2 directive in order to ensure that the obligations imposed by each instrument are complementary and that entities can benefit from simplified enforcement conditions and reporting obligations.


### (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) 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. in particular member states , in the transposition acts for nis 2 directive and this directive , should provide measures to avoid double reporting and control , to ensure strategies and requirements are complementary and that entities can benefit from simplified enforcement and reporting conditions.


### (19) member states should support critical entities in strengthening their resilience , in compliance with their obligations under this directive , without prejudice to the entities’ own legal responsibility to ensure such compliance. member states could in particular develop guidance materials and methodologies , support the organisation of exercises to test their resilience and provide training to personnel of critical entities. moreover , given the interdependencies between entities and sectors , member states should establish information sharing tools to support voluntary information sharing between critical entities , without prejudice to the application of competition rules laid down in the treaty on the functioning of the european union. ### (19) member states should support critical entities in strengthening their resilience , in compliance with their obligations under this directive , without prejudice to the entities’ own legal responsibility to ensure such compliance. member states could in particular develop guidance materials and methodologies and should support the organisation of exercises to test their resilience and provide training to personnel of critical entities. moreover , given the interdependencies between entities and sectors , member states should establish information sharing tools to support voluntary information sharing between critical entities , without prejudice to the application of competition rules laid down in the treaty on the functioning of the european union.


### (19) member states should support critical entities in strengthening their resilience , in compliance with their obligations under this directive , without prejudice to the entities’ own legal responsibility to ensure such compliance. member states could in particular develop guidance materials and methodologies , support the organisation of exercises to test their resilience and provide training to personnel of critical entities. moreover , given the interdependencies between entities and sectors , member states should establish information sharing tools to support voluntary information sharing between critical entities , without prejudice to the application of competition rules laid down in the treaty on the functioning of the european union. ### (19) member states should support critical entities in strengthening their resilience , in compliance with their obligations under this directive , without prejudice to the entities’ own legal responsibility to ensure such compliance. member states should in particular develop guidance materials and methodologies , support the organisation of exercises to test their resilience and provide training to personnel of critical entities. moreover , given the interdependencies between entities and sectors , member states should establish information sharing tools to support voluntary information sharing between critical entities , without prejudice to the application of competition rules laid down in the treaty on the functioning of the european union.


### 1. this directive: ### 1. this directive lays down measures with a view to achieving a high level of resilience of critical entities in order to ensure the provision of essential services within the union , and by doing so , ensuring the functioning of the internal market and the provision of essential social services.


### 1. this directive: ### 1. this directive lays down measures with a view to achieve a high level of resilience of critical entities in order to ensure the provision of essential services within the union , and by doing so , ensuring the functioning of the internal market and the provisioning of essential social services.


### lays down obligations for member states to take certain measures aimed at ensuring the provision in the internal market of services essential for the maintenance of vital societal functions or economic activities , in particular to identify critical entities and entities to be treated as equivalent in certain respects , and to enable them to meet their obligations; ### lays down obligations for member states to take certain measures aimed at ensuring the continuous provision in the internal market of services essential for the maintenance of vital societal functions or economic activities , in particular to identify critical entities and entities to be treated as equivalent in certain respects , and to enable them to meet their obligations;


### 2. this directive shall not apply to matters covered by directive (eu) xx/yy [proposed directive on measures for a high common level of cybersecurity across the union; (‘nis 2 directive’)] , without prejudice to article 7. ### 2. this directive shall not apply to matters covered by directive (eu) xx/yy [proposed directive on measures for a high common level of cybersecurity across the union; (‘nis 2 directive’)] , without prejudice to article 7. a coherent approach shall be ensured between these acts , such as by ensuring that entities under nis 2 susceptible to being subject to obligations under this directive , where possible , benefit from a single point of contact and a common set of rules.


### 2. this directive shall not apply to matters covered by directive (eu) xx/yy [proposed directive on measures for a high common level of cybersecurity across the union; (‘nis 2 directive’)] , without prejudice to article 7. ### 2. this directive shall not apply to matters covered by directive (eu) xx/yy [proposed directive on measures for a high common level of cybersecurity across the union; (‘nis 2 directive’)] , and regulation [xx/yy] on digital operational resilience for the financial sector , without prejudice to article 7. entities covered by the nis 2 directive that are subject to obligations under this directive , shall benefit from a single point of contact and common set of rules provided that all the other conditions are met.


### (5) “essential service” means a service which is essential for the maintenance of vital societal functions or economic activities; ### (5) “essential service” means a service which is essential for the maintenance of vital societal functions or economic activities , public safety , the environment , the rule of law or fundamental rights;


### (5) “essential service” means a service which is essential for the maintenance of vital societal functions or economic activities; ### (5) “essential service” means a service which is essential for the maintenance of vital societal functions or economic activities , public safety , the environment , the rule of law and fundamental rights;


### strategic objectives and priorities for the purposes of enhancing the overall resilience of critical entities taking into account cross-border and cross-sectoral interdependencies; ### strategic objectives and priorities for the purposes of enhancing the overall resilience of critical entities taking into account cross-border and cross-sectoral interdependencies , also in the event of a hybrid threat;


### the risk assessment shall account for all relevant natural and man-made risks , including accidents , natural disasters , public health emergencies , antagonistic threats , including terrorist offences pursuant to directive (eu) 2017/541 of the european parliament and of the council34 . ### the risk assessment shall account for all relevant natural and man-made risks , including accidents , natural disasters , public health emergencies , hybrid threats and large-scale incidents , antagonistic threats , including terrorist offences pursuant to directive (eu) 2017/541 of the european parliament and of the council34 .


### 6. for the purposes of chapter iv , member states shall ensure that critical entities , following the notification referred in paragraph 3 , provide information to their competent authorities designated pursuant to article 8 of this directive on whether they provide essential services to or in more than one third of member states. where that is so , the member state concerned shall notify , without undue delay , to the commission the identity of those critical entities. ### 6. for the purposes of chapter iv , member states shall ensure that critical entities , following the notification referred in paragraph 3 , provide information to their competent authorities designated pursuant to article 8 of this directive on whether they provide essential services to or in more than one fifth of member states. where that is so , the member state concerned shall notify , without undue delay , to the commission the identity of those critical entities.


### the impacts that incidents could have , in terms of degree and duration , on economic and societal activities , the environment and public safety; ### the impacts that incidents could have , in terms of degree and duration , on economic and societal activities , the environment , public safety , the rule of law and fundamental rights;


### the impacts that incidents could have , in terms of degree and duration , on economic and societal activities , the environment and public safety; ### the impacts that incidents could have , in terms of degree and duration , on economic and societal activities , the environment and public safety , the rule of law and fundamental rights;


### 1. member states shall support critical entities in enhancing their resilience. that support may include developing guidance materials and methodologies , supporting the organisation of exercises to test their resilience and providing training to personnel of critical entities. ### 1. member states shall support critical entities in enhancing their resilience. that support shall include , among others , developing guidance materials and methodologies , supporting the organisation of exercises to test their resilience and providing training to personnel of critical entities.


### prevent incidents from occurring , including through disaster risk reduction and climate adaptation measures; ### prevent incidents from occurring , including through disaster risk reduction and climate adaptation measures , and measures contributing to the fight against climate change;


### prevent incidents from occurring , including through disaster risk reduction and climate adaptation measures; ### prevent incidents from occurring , including through disaster risk reduction and climate adaptation measures and measures contributing to the fight against climate change;


### ensure adequate employee security management , including by setting out categories of personnel exercising critical functions , establishing access rights to sensitive areas , facilities and other infrastructure , and to sensitive information as well as identifying specific categories of personnel in view of article 12; ### ensure adequate employee security management , including by setting out categories of personnel exercising critical functions , establishing access rights to sensitive areas , facilities and other infrastructure , and to sensitive information as well as identifying specific categories of personnel in view of article 12. where external providers are involved in security management , critical entities should ensure their compliance with generally accepted standards and specifications;


### raise awareness about the measures referred to in points (a) to (e) among relevant personnel. ### raise awareness about the measures referred to in points (a) to (e) among relevant personnel , including laying down appropriate training requirements and qualifications.


### 1. member states shall ensure that critical entities may submit requests for background checks on persons who fall within certain specific categories of their personnel , including persons being considered for recruitment to positions falling within those categories , and that those requests are assessed expeditiously by the authorities competent to carry out such background checks. ### 1. member states shall ensure that critical entities may submit requests for background checks on persons who fall within certain specific categories of their personnel , including persons being considered for recruitment to positions falling within those categories , and that those requests are assessed expeditiously by the authorities competent to carry out such background checks. those persons shall be informed in advance about the checks , including general information about how , when and by whom the checks will be carried out.


### cover previous employments , education and any gaps in education or employment in the person’s resume during at least the preceding five years and for a maximum of ten years. ### in exceptional cases , when deemed necessary by member states , cover previous employments , education and any gaps in education or employment in the person’s resume during a maximum of the ten preceding years.


### the number of users affected by the disruption or potential disruption; ### the number of individual and business users affected by the disruption or potential disruption;


### 2. an entity shall be considered a critical entity of particular european significance when it has been identified as a critical entity and it provides essential services to or in more than one third of member states and has been notified as such to the commission pursuant to article 5(1) and (6) , respectively. ### 2. an entity shall be considered a critical entity of particular european significance when it has been identified as a critical entity and it provides essential services to or in more than one fifth of member states and has been notified as such to the commission pursuant to article 5(1) and (6) , respectively.


### the dependency of other sectors referred to in the annex on that service; ### the dependency of other sectors referred to in the annex on that service , including sectors providing infrastructures and services for institutions in charge of security and defence;


### 5. member states shall ensure that their competent authorities , whenever appropriate , and in accordance with union and national law , consult and cooperate with other relevant national authorities , in particular those in charge of civil protection , law enforcement and protection of personal data , as well as with relevant interested parties , including critical entities. ### 5. member states shall ensure that their competent authorities , whenever appropriate , and in accordance with union and national law , consult and cooperate with other relevant national authorities , in particular those in charge of civil protection , law enforcement , security and defence and protection of personal data , as well as with relevant interested parties , including critical entities.


### 3. upon request of the member state that identified the critical entity and with the agreement of the critical entity concerned , the commission shall organise advisory missions , in accordance with the arrangements set out in article 15(4) , (5) , (7) and (8) , to provide advice to the critical entity concerned in meeting its obligations pursuant to chapter iii. the advisory mission shall report its findings to the commission , that member state and the critical entity concerned. ### 3. upon request of the member state that identified the critical entity and with the agreement of the critical entity concerned , the commission shall organise advisory missions , in accordance with the arrangements set out in article 15(4) , (5) , (7) and (8) , to provide advice to the critical entity concerned in meeting its obligations pursuant to chapter iii. the advisory mission shall report its findings to the commission , that member state and the critical entity concerned. where necessary and appropriate , the commission may mobilise financial support for that member state and the relevant critical entity , including from the internal security fund , without prejudice to applicable budgetary procedures and controls.


### (8) a common , harmonised approach should be employed for ensuring that users of terrestrial public mobile communication networks when travelling within the union do not pay excessive prices for union-wide roaming services , thereby enhancing competition concerning roaming services between roaming providers , achieving a high level of consumer protection and preserving both incentives for innovation and consumer choice. in view of the cross-border nature of the services concerned , this common approach is needed so that roaming providers can operate within a single coherent regulatory framework based on objectively established criteria. ### (8) a common , harmonised approach should be employed for ensuring that users of public mobile communication networks when travelling within the union do not pay excessive prices for union-wide roaming services , thereby enhancing competition concerning roaming services between roaming providers , achieving a high level of consumer protection and preserving both incentives for innovation and consumer choice. in view of the cross-border nature of the services concerned , this common approach is needed so that roaming providers can operate within a single coherent regulatory framework based on objectively established criteria.


### (9) the widespread use of internet-enabled mobile devices means that data roaming is of great economic significance. this is relevant for both users and providers of applications and content. in order to stimulate the development of this market , charges for data transport should not impede growth , in particular considering that the deployment of 5g networks and services is expected to grow steadily . ### (9) the widespread use of internet-enabled mobile devices means that data roaming is of great economic significance. this is relevant for both users and providers of applications and content. in order to stimulate the development of this market , charges for data transport should not impede growth , in particular considering that the deployment of next generation , high speed networks and services is expected to grow steadily.


### (19) in accordance with article 109 of directive (eu) 2018/1972 , all end-users should have access to emergency services , free of charge , through emergency communications to the most appropriate public safety answering point (psap). member states are also required to ensure that access for end-users with disabilities to emergency services is available through emergency communications and is equivalent to that enjoyed by other end-users. it is for the member states to determine the type of emergency communications that are technically feasible to ensure roaming customers access to emergency services. in order to ensure that roaming customers have access to emergency communications under the conditions laid down in article 109 of directive (eu) 2018/1972 , visited network operators should inform the roaming provider through the wholesale roaming agreement about what type of emergency communications are mandated under national measures in the visited member state. in addition , wholesale roaming agreements should include information on the technical parameters for ensuring access to emergency services , including for roaming customers with disabilities , as well as for ensuring the transmission of caller location information to the most appropriate psap in the visited member state. such information should allow the roaming provider to identify and provide the emergency communication and the transmission of caller location free of charge. ### (19) the united nations convention on the rights of persons with disabilities requires to take appropriate measures to ensure that persons with disabilities have access to communications technologies and systems on an equal basis with others. in addition , article 109 of directive (eu) 2018/1972 establishes that all end-users should have access to emergency services , free of charge , through emergency communications to the most appropriate public safety answering point (psap). emergency communications include voice communications services , sms , messaging , video and other type of communications , such as real time text , total conversation and relay services. member states are also required to ensure that access for end-users with disabilities to emergency services is available through emergency communications and is equivalent to that enjoyed by other end-users. it is for the member states to determine the type of emergency communications that are technically feasible to ensure roaming customers access to emergency services. in order to ensure that roaming customers have access to emergency communications under the conditions laid down in article 109 of directive (eu) 2018/1972 , visited network operators should inform the roaming provider through the wholesale roaming agreement about what type of emergency communications are mandated under national measures in the visited member state. in addition , wholesale roaming agreements should include information on the technical parameters for ensuring access to emergency services , including for roaming customers with disabilities , as well as for ensuring the transmission of caller location information to the most appropriate psap in the visited member state. such information should allow the roaming provider to identify and provide the emergency communication and the transmission of caller location free of charge.


### (35) a contract which includes any type of regulated retail roaming service should specify the characteristics of that regulated retail roaming service , including the expected level of quality of service. the provider should make available information on relevant factors that can affect the quality of service , such as availability of certain technologies , coverage or variation due to external factors such as topography. ### (35) a contract which includes any type of regulated retail roaming service should specify the characteristics of that regulated retail roaming service , including the expected level of quality of service. the provider should ensure the highest quality of service available in the country and should make available information on relevant factors that can affect it , such as availability of certain technologies , coverage or variation due to external factors such as topography.