### 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. 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 and ensure the respect and enforcement of workers’ rights;


### 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; ### 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;


### 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; ### deleted


### 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; ### deleted


### 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 in line with the paris agreement and the european pillar of social rights and that citizens’ rights , are enforced;


### (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 health and zoonotic 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 or animal origin. the capacity for contact tracing should be strengthened via the creation of an automated system , using modern technologies.


### (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 matters , covering goods such as pharmaceutical products , medical devices and foodstuffs , substances of human or animal origin (blood , tissues and cells , organs) , and exposure to ionising radiation.


### (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 interdisciplinary 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 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) prevention , 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’ prevention , 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. this training should be consistent with the one-health approach in recognition of the interlinks between human health , animal health and the environment. 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. specific considerations should be given to border regions , where joint cross-border exercises should be promoted and familiarity with the public health system structures encouraged. 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) 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 , agriculture , food-chain , natural resources , 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.


### (25) in order to ensure uniform conditions for the implementation of this regulation , implementing powers should be conferred on the commission to adopt implementing acts in relation to: templates to be used when providing the information on preparedness and response planning; organisation of the training activities for health care and public health staff; the establishment and update of a list of communicable diseases and related special health issues subject to the network of epidemiological surveillance and the procedures for the operation of such a network; the adoption of case definitions for those communicable diseases and special health issues covered by the epidemiological surveillance network and , where necessary , for other serious cross-border threats to health subject to ad hoc monitoring; the procedures for the operation of the ewrs; the functioning of the surveillance platform; the designation of eu reference laboratories to provide support to national reference laboratories; the procedures for the information exchange on and the coordination of the responses of the member states; the recognition of situations of public health emergency at union level and the termination of such a recognition and procedures necessary to ensure that the operation of the ewrs and the processing of data are in accordance with the data protection legislation. ### (25) in order to ensure uniform conditions for the implementation of this regulation , implementing powers should be conferred on the commission to adopt implementing acts in relation to: templates to be used when providing the information on preparedness and response planning; organisation of the training activities for health care and public health staff; the establishment and update of a list of communicable diseases and related special health issues subject to the network of epidemiological surveillance and the procedures for the operation of such a network; the adoption of case definitions for those communicable diseases and special health issues covered by the epidemiological surveillance network and , where necessary , for other serious cross-border threats to health subject to ad hoc monitoring; the procedures for the operation of the ewrs; the establishment and updating of a list of relevant health data that the ecdc will have access to pursuant to article 14(2)(a) and (5) and respective role; the functioning of the surveillance platform; the designation of eu reference laboratories to provide support to national reference laboratories; the procedures for the information exchange on and the coordination of the responses of the member states; the recognition of situations of public health emergency at union level and the termination of such a recognition and procedures necessary to ensure that the operation of the ewrs and the processing of data are in accordance with the data protection legislation.


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


### 1. the commission , in cooperation with member states and the relevant union agencies , shall establish a union health crisis and pandemic plan (‘the union preparedness and response plan’) to promote effective and coordinated response to cross-border health threats at union level. ### 1. the commission , in cooperation with member states and the relevant union agencies , shall establish a union health crisis and pandemic plan (‘the union prevention , preparedness and response plan’) to promote effective and coordinated response to cross-border health threats at union level.


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


### 3. the union preparedness and response plan shall , in particular , include arrangements for governance , capacities and resources for: ### 3. the union prevention , preparedness and response plan shall , in particular , include arrangements for governance , capacities and resources for:


### 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 prevention , 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.


### 5. in order to ensure the operation of the union preparedness and response plan , the commission shall conduct stress tests , exercises and in-action and after-action reviews with member states , and update the plan as necessary. ### 5. in order to ensure the operation of the union preparedness and response plan , the commission shall conduct stress tests , exercises and in-action and after-action reviews with member states , and update the plan as necessary. the prevention , preparedness and response plan will take into account health systems data and relevant data to be collected at national level. based on eu health systems data , the european commission should issue recommendations as to ratios of resources in relation to population unit for baseline universal health coverage and emergencies , including the option of pooling resources at union level.


### national preparedness and response plans ### national prevention , preparedness and response plans


### 1. when preparing national preparedness and response plans each member state shall coordinate with the commission in order to reach consistency with the union preparedness and response plan , also inform without delay the commission and the hsc of any substantial revision of the national plan. ### 1. when preparing national prevention , preparedness and response plans each member state shall consult patient's organizations , healthcare professionals organizations and national social partners and coordinate with the commission in order to reach consistency with the union prevention , preparedness and response plan , also inform without delay the commission and the hsc of any substantial revision of the national plan.


### reporting on preparedness and response planning ### reporting on prevention , preparedness and response planning


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


### (ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning , information management; access to diagnostic services during emergencies; basic and safe gender-sensitive health and emergency services; risk communications; research development and evaluations to inform and accelerate emergency preparedness; ### (ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning , information management; access to diagnostic services during emergencies; basic and safe gender-sensitive health and emergency services; risk communications; research development and evaluations to inform and accelerate emergency preparedness , adequate stock of personal protective equipment of the highest quality;


### (iii) resources: including financial resources for emergency preparedness and contingency funding for response; logistics mechanisms and essential supplies for health; and dedicated , trained and equipped human resources for emergencies; and ### (iii) resources: including financial resources for emergency preparedness and contingency funding for response; logistics mechanisms and essential supplies for health; and adequate needs-oriented number of dedicated , trained and equipped human resources for emergencies in the health and social services ; and


### 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 prevention , 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.


### auditing on preparedness and response planning ### auditing on prevention , preparedness and response planning


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


### training initiatives; ### initiatives in relation to recruitment and retention of healthcare personnel and training initiatives;


### commission report on preparedness planning ### commission report on prevention , preparedness planning


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


### 2. the commission may adopt recommendations on preparedness and response planning addressed to member states based on the report referred to in paragraph 1. ### 2. the commission may adopt recommendations on preparedness and response planning addressed to member states based on the report referred to in paragraph 1.these recommendations shall include ratios for resources per population unit , developed on the basis of good practice and policy assessments.


### 2. the commission may adopt recommendations on preparedness and response planning addressed to member states based on the report referred to in paragraph 1. ### 2. the commission may adopt recommendations on prevention , preparedness and response planning addressed to member states based on the report referred to in paragraph 1.


### coordination of preparedness and response planning in the hsc ### coordination of prevention , preparedness and response planning in the hsc


### monitoring progress , identifying gaps and actions to strengthen preparedness and response planning , including in the field of research , at national and at union levels. ### monitoring progress , identifying gaps and actions to strengthen prevention , preparedness and response planning , including in the field of research , at national and at union levels.


### 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 may organise training activities for healthcare and social service staff and public health staff in the member states , including preparedness capacities under the international health regulations.


### the commission shall organise those activities in cooperation with the member states concerned. ### the commission shall organise those activities in cooperation with the member states concerned. at border regions , joint cross-border exercises should be promoted and familiarity with public health systems encouraged.


### 3. the training activities referred to in paragraph 1 may be open to staff of the competent authorities of third countries and may be organised outside the union. ### 3. the training activities referred to in paragraph 1 may be open to staff of the competent authorities of third countries and may be organised outside the union in coordination with ecdc activities in this area.


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


### 3. the network of eu reference laboratories shall be operated and coordinated by the ecdc. ### 3. the network of eu reference laboratories shall be operated and coordinated by the ecdc in cooperation with who network laboratories to avoid duplication of activities.


### (4) trade facilitation , and safety and security , concern all authorities involved in the goods clearance process across union borders. the rapid rise in international trade has increased the need for better cooperation and coordination among those authorities. the ongoing process of digitalisation allows this situation to be addressed more efficiently by connecting the systems of customs and partner competent authorities and enabling a systematic automated exchange of information between them. as such , the current framework of regulatory compliance is insufficient to support an effective interaction between customs and partner competent authorities , whose systems and procedures are characterised by fragmentation and redundancy. a fully coordinated and efficient goods clearance process requires a streamlined union regulatory environment for international trade that delivers long-term benefits to the union and its residents in all policy areas. ### (4) trade facilitation , and safety and security , concern all authorities involved in the goods clearance process across union borders. the rapid rise in international trade and e-commerce has increased the need for better cooperation and coordination among those authorities. the ongoing process of digitalisation allows this situation to be addressed more efficiently by connecting the systems of customs and partner competent authorities and enabling a systematic automated exchange of information between them. as such , the current framework of regulatory compliance is insufficient to support an effective interaction between customs and partner competent authorities , whose systems and procedures are characterised by fragmentation and redundancy. in order to adapt to these new challenges , customs offices across the union need the means to review their territorial network , especially in view of storage places of goods traded by e-commerce. a fully coordinated and efficient goods clearance process requires a streamlined union regulatory environment for international trade that delivers long-term benefits to the union and its residents in all policy areas.


### (7) the exchanges of digital information through eu csw-certex should cover union non-customs formalities laid down in union legislation that customs authorities are entrusted to enforce. those formalities impose different obligations for the import , export or transit of certain goods , and their verification through customs controls is fundamentally important to the effective functioning of the eu single window environment for customs. eu csw-certex should cover digitalised regulatory formalities laid down in union legislation and managed by partner competent authorities in electronic union non-customs systems , storing the relevant information from all member states required for goods clearance. it is therefore appropriate to identify the union non-customs formalities which should be subject to digital cooperation through eu csw-certex. in particular , eu csw-certex should initially cover sanitary and phytosanitary requirements , rules regulating the import of organic products , environmental requirements in relation to fluorinated greenhouse gases and ozone depleting substances , and formalities related to the import of cultural goods. ### (7) the exchanges of digital information through eu csw-certex should cover union non-customs formalities laid down in union legislation that customs authorities are entrusted to enforce. those formalities impose different obligations for the import , export or transit of certain goods , and their verification through customs controls is fundamentally important to the effective functioning of the eu single window environment for customs. eu csw-certex should cover digitalised regulatory formalities laid down in union legislation and managed by partner competent authorities in electronic union non-customs systems , storing the relevant information from all member states required for goods clearance. it is therefore appropriate to identify the union non-customs formalities which should be subject to digital cooperation through eu csw-certex , while in the long term all non-customs systems should be included. in particular , eu csw-certex should initially cover sanitary and phytosanitary requirements , rules regulating the import of organic products , environmental requirements in relation to fluorinated greenhouse gases and ozone depleting substances , and formalities related to the import of cultural goods , rules related to product safety , rules related to forest law enforcement , governance and trade and rules related to the registration , evaluation , authorisation and restriction of chemicals.


### (10) any processing of personal data in eu csw-certex should facilitate information sharing between the national environments for customs and union non-customs systems without any storing of data. it should also transform data , where necessary , to enable information exchange between both digital domains. the information technology facilities used for data transformation should be located in the union. ### (10) any processing of personal data in eu csw-certex should facilitate information sharing between the national environments for customs and union non-customs systems without any storing of data fully respecting regulation (eu) 2016/679. it should also transform data , where necessary , to enable information exchange between both digital domains. the information technology facilities used for data transformation should be located in the union.


### (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. therefore , the relevant it systems should be designed in a cyber-resilient way , allowing interoperability in real time. 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.


### 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.


### 1. processing of personal data may take place in eu csw-certex only for the following purposes: ### 1. processing of personal data may take place in a cyber-resilient way in eu csw-certex , only for the following purposes and without prejudice to regulation (eu) 2016/679:


### 1. the member states shall establish national single window environments for customs. each member state shall be responsible for the development , integration and operation of its single window environment for customs. ### 1. the member states shall establish national single window environments for customs. each member state shall be responsible for the development , integration and operation of its single window environment for customs in a cyber-resilient design , which must be interoperable in real time.


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


### 2. each member state shall bear the costs incurred in relation to the development , integration and operation of its national single window environment for customs and its connection with eu csw-certex. ### 2. each member state shall bear the costs incurred in relation to the development , integration and operation of its national single window environment for customs and its connection with eu csw-certex , including a sufficient number of properly trained staff.


### 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 delegated 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.


### 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.


### (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 protection of the population and the performance of vital societal functions or economic activities. this is due to 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. 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 and on the human wellbeing. the covid-19 pandemic has shown the vulnerability of our increasingly interdependent societies in the face of low-probability risks.


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


### (5) it is therefore necessary to lay down harmonised minimum rules to ensure the provision of essential services in the internal market and enhance the resilience of critical entities. ### (5) it is therefore necessary to lay down harmonised minimum rules to ensure the provision of essential services to the population and enhance the resilience of critical entities.


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


### (24) the risk of employees of critical entities misusing for instance their access rights within the entity’s organisation to harm and cause damage is of increasing concern. that risk is exacerbated by the growing phenomenon of radicalisation leading to violent extremism and terrorism. it is therefore necessary to enable critical entities to request background checks on persons falling within specific categories of its personnel and to ensure that those requests are assessed expeditiously by the relevant authorities , in accordance with the applicable rules of union and national law , including on the protection of personal data. ### deleted


### (25) critical entities should notify , as soon as reasonably possible under the given circumstances , member states’ competent authorities of incidents that significantly disrupt or have the potential to significantly disrupt their operations. the notification should allow the competent authorities to respond to the incidents rapidly and adequately and to have a comprehensive overview of the overall risks that critical entities face. for that purpose , a procedure should be established for the notification of certain incidents and parameters should be provided for to determine when the actual or potential disruption is significant and the incidents should thus be notified. given the potential cross-border impacts of such disruptions , a procedure should be established for member states to inform other affected member states via single points of contacts. ### (25) critical entities should notify , as soon as reasonably possible under the given circumstances , member states’ competent authorities of incidents that disrupt or have the potential to disrupt their operations. the notification should allow the competent authorities to respond to the incidents rapidly and adequately and to have a comprehensive overview of the overall risks that critical entities face. for that purpose , a procedure should be established for the notification of certain incidents and parameters should be provided for to determine when the actual or potential disruption is significant and the incidents should thus be notified. given the potential cross-border impacts of such disruptions , a procedure should be established for member states to inform other affected member states via single points of contacts.


### 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 protecting people and 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;


### 4. without prejudice to article 346 tfeu , information that is confidential pursuant to union and national rules , such as rules on business confidentiality , shall be exchanged with the commission and other relevant authorities only where that exchange is necessary for the application of this directive. the information exchanged shall be limited to that which is relevant and proportionate to the purpose of that exchange. the exchange of information shall preserve the confidentiality of that information and protect the security and commercial interests of critical entities. ### 4. without prejudice to article 346 tfeu , information that is confidential pursuant to union and national rules , such as rules on business confidentiality , shall be exchanged with the commission and other relevant authorities only where that exchange is necessary for the application of this directive. the information exchanged shall be limited to that which is relevant and proportionate to the purpose of that exchange. the exchange of information shall preserve the confidentiality of that information and protect the security of critical entities.


### (6) “risk” means any circumstance or event having a potential adverse effect on the resilience of critical entities; ### (6) “risk” means any circumstance or event having a potential adverse effect on the resilience of critical entities;


### (6) “risk” means any circumstance or event having a potential adverse effect on the resilience of critical entities; ### (6) “risk” means any circumstance or event having a potential adverse effect on the provision of essential services by critical entities;


### 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 , antagonistic threats , including terrorist offences pursuant to title ii of the 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 three 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 the provision of essential services to the affected population , economic and societal activities , the environment and public safety;


### 3. by [three years and six months after entry into force of this directive] , and every year thereafter , the single points of contact shall submit a summary report to the commission and to the critical entities resilience group on the notifications received , including the number of notifications , the nature of notified incidents and the actions taken in accordance with article 13(3). ### 3. by [three years and six months after entry into force of this directive] , and every year thereafter , the single points of contact shall submit a summary report to the member states' single point of contact , and to the critical entities resilience group on the notifications received , including the number of notifications , the nature of notified incidents and the actions taken in accordance with article 13(3).


### 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 and ensure that such support is given at all levels of government. 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 ensure that critical entities notify without undue delay the competent authority of incidents that significantly disrupt or have the potential to significantly disrupt their operations. notifications shall include any available information necessary to enable the competent authority to understand the nature , cause and possible consequences of the incident , including so as to determine any cross-border impact of the incident. such notification shall not make the critical entities subject to increased liability. ### 1. member states shall ensure that critical entities notify without undue delay the competent authority of incidents. notifications shall include any available information necessary to enable the competent authority to understand the nature , cause and possible consequences of the incident , including so as to determine any cross-border impact of the incident. such notification shall not make the critical entities subject to increased liability.


### the number of users affected by the disruption or potential disruption; ### deleted


### in so doing , the single points of contact shall , in accordance with union law or national legislation that complies with union law , treat the information in a way that respects its confidentiality and protects the security and commercial interest of the critical entity concerned. ### in so doing , the single points of contact shall , in accordance with union law or national legislation that complies with union law , treat the information in a way that respects its confidentiality and protects the security of the critical entity concerned.


### 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 three member states and has been notified as such to the commission pursuant to article 5(1) and (6) , respectively.


### [...] ### deleted


### upon request of one or more member states or of the commission , the member state where the infrastructure of the critical entity of particular european significance is located shall , together with that entity , inform the commission and the critical entities resilience group of the outcome of the risk assessment carried out pursuant to article 10 and the measures taken in accordance with article 11. ### upon request of one or more member states , the member state where the infrastructure of the critical entity of particular european significance is located shall , together with that entity , inform the commission and the critical entities resilience group of the outcome of the risk assessment carried out pursuant to article 10 and the measures taken in accordance with article 11.


### 1. upon request of one or more member states or of the commission , the member state where the infrastructure of the critical entity of particular european significance is located shall , together with that entity , inform the commission and the critical entities resilience group of the outcome of the risk assessment carried out pursuant to article 10 and the measures taken in accordance with article 11. ### 1. upon request of one or more member states or of the commission , a critical entity of particular european significance shall , inform the critical entities resilience group of the outcome of the risk assessment carried out pursuant to article 10 and the measures taken in accordance with article 11.


### 2. upon request of one or more member states , or at its own initiative , and in agreement with the member state where the infrastructure of the critical entity of particular european significance is located , the commission shall organise an advisory mission to assess the measures that that entity put in place to meet its obligations pursuant to chapter iii. where needed , the advisory missions may request specific expertise in the area of disaster risk management through the emergency response coordination centre. ### 2. upon request of one or more member states , and in agreement with the member state where the infrastructure of the critical entity of particular european significance is located , the commission shall organise an advisory mission to assess the measures that that entity put in place to meet its obligations pursuant to chapter iii. where needed , the advisory missions may request specific expertise in the area of disaster risk management through the emergency response coordination centre.


### 2. upon request of one or more member states , or at its own initiative , and in agreement with the member state where the infrastructure of the critical entity of particular european significance is located , the commission shall organise an advisory mission to assess the measures that that entity put in place to meet its obligations pursuant to chapter iii. where needed , the advisory missions may request specific expertise in the area of disaster risk management through the emergency response coordination centre. ### 2. upon request of one or more member states , the commission shall organise an assessment mission to assess the measures that that entity put in place to meet its obligations pursuant to chapter iii. where needed , the assessment missions may request specific expertise in the area of disaster risk management through the emergency response coordination centre.


### the critical entities resilience group shall analyse the report and , where necessary , shall advise the commission on whether the critical entity of particular european significance concerned complies with its obligations pursuant to chapter iii and , where appropriate , which measures could be taken to improve the resilience of that entity. ### the critical entities resilience group shall analyse the report and , where necessary , shall advise the member states and the commission on whether the critical entity of particular european significance concerned complies with its obligations pursuant to chapter iii and , where appropriate , which measures could be taken to improve the resilience of that entity.


### each advisory mission shall consist of experts from member states and of commission representatives. member states may propose candidates to be part of an advisory mission. the commission shall select and appoint the members of each advisory mission according to their professional capacity and ensuring a geographically balanced representation among member states. the commission shall bear the costs related to the participation in the advisory mission. ### each advisory mission shall consist of experts from member states and of commission representatives. member states may propose candidates to be part of an advisory mission. the commission shall select and appoint the members of each advisory mission according to their professional capacity and ensuring a geographically balanced representation among member states , including at least one from the member state in which the critical entity is located. the commission shall bear the costs related to the participation in the advisory mission.


### 4. each advisory mission shall consist of experts from member states and of commission representatives. member states may propose candidates to be part of an advisory mission. the commission shall select and appoint the members of each advisory mission according to their professional capacity and ensuring a geographically balanced representation among member states. the commission shall bear the costs related to the participation in the advisory mission. ### 4. each assessment mission shall consist of experts from member states and the commission. member states shall nominate candidates to be part of an assessment mission. the commission shall select and appoint the members of each advisory mission according to their professional capacity and ensuring a geographically balanced representation among member states. the commission shall bear the costs related to the participation in the assessment mission.


### 2. the critical entities resilience group shall be composed of representatives of the member states and the commission. where relevant for the performance of its tasks , the critical entities resilience group may invite representatives of interested parties to participate in its work. ### 2. the critical entities resilience group shall be composed of representatives of the member states and the commission. where relevant for the performance of its tasks , the critical entities resilience group shall invite representatives of interested parties , such as academia , civil society and critical entities , to participate in its work.


### (9) where provisions of other acts of union law require critical entities to assess relevant risks , take measures to ensure their resilience or notify incidents , and those requirements are at least equivalent to the corresponding obligations laid down in this directive , the relevant provisions of this directive should not apply , so as to avoid duplication and unnecessary burdens. in that case , the relevant provisions of such other acts should apply. where the relevant provisions of this directive do not apply , its provisions on supervision and enforcement should not be applicable either. member states should nevertheless include all the sectors listed in the annex in their strategy for reinforcing the resilience of critical entities , the risk assessment and the support measures pursuant to chapter ii and be able to identify critical entities in those sectors where the applicable conditions have been met , taking into account the particular regime for entities in the banking , financial market infrastructure and digital infrastructure sector. ### deleted


### (15) the eu financial services acquis establishes comprehensive requirements on financial entities to manage all risks they face , including operational risks and ensure business continuity. this includes regulation (eu) no 648/2012 of the european parliament and of the council22 , directive 2014/65/eu of the european parliament and of the council23 and regulation (eu) no 600/2014 of the european parliament and of the council24 as well as regulation (eu) no 575/2013 of the european parliament and of the council25 and directive 2013/36/eu of the european parliament and of the council26 . the commission has recently proposed to complement this framework with regulation xx/yyyy of the european parliament and of the council [proposed regulation on digital operational resilience for the financial sector (hereafter “dora regulation”)27 ] , which lays down requirements for financial firms to manage ict risks , including the protection of physical ict infrastructures. since the resilience of entities listed in points 3 and 4 of the annex is comprehensively covered by the eu financial services acquis , those entities should also be treated as equivalent to critical entities for the purposes of chapter ii of this directive only. to ensure a consistent application of the operational risk and digital resilience rules in the financial sector , member states’ support to enhancing the overall resilience of financial entities equivalent to critical entities should be ensured by the authorities designated pursuant to article 41 of [dora regulation] , and subject to the procedures set out in that legislation in a fully harmonised manner. ### deleted


### (26) while critical entities generally operate as part of an increasingly interconnected network of service provision and infrastructures and often provide essential services in more than one member state , some of those entities are of particular significance for the union because they provide essential services to a large number of member states , and therefore require specific oversight at union level. rules on the specific oversight in respect of such critical entities of particular european significance should therefore be established. those rules are without prejudice to the rules on supervision and enforcement set out in this directive. ### (26) while critical entities generally operate as part of an increasingly interconnected network of service provision and infrastructures and often provide essential services in more than one member state , some of those entities are of particular significance for the union because they provide essential services to a number of member states , and therefore require specific oversight at union level. rules on the specific oversight in respect of such critical entities of particular european significance should therefore be established. those rules are without prejudice to the rules on supervision and enforcement set out in this directive.


### (33) since the objectives of this directive , namely to ensure the provision in the internal market of services essential for the maintenance of vital societal functions or economic activities and to enhance the resilience of critical entities providing such services , cannot be sufficiently achieved by the member states , but can rather , by reason of the effects of the action , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on the european union. in accordance with the principle of proportionality as set out in that article 5 , this directive does not go beyond what is necessary in order to achieve those objectives. ### (33) since the objectives of this directive , namely to ensure the provision to the population of services essential for the maintenance of vital societal functions or economic activities and to enhance the resilience of critical entities providing such services , cannot be sufficiently achieved by the member states , but can rather , by reason of the effects of the action , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on the european union. in accordance with the principle of proportionality as set out in that article 5 , this directive does not go beyond what is necessary in order to achieve those objectives.


### 1. by [three years and three months after entry into force of this directive] member states shall identify for each sector and subsector referred to in the annex , other than points 3 , 4 and 8 thereof , the critical entities. ### 1. by [three years and three months after entry into force of this directive] member states shall identify for each sector and subsector referred to in the annex , other than points 8 and 9 thereof , the critical entities.


### 5. following the notification referred in paragraph 3 , member states shall ensure that critical entities provide information to their competent authorities designated pursuant to article 8 of this directive on whether they have been identified as a critical entity in one or more other member states. where an entity has been identified as critical by two or more member states , these member states shall engage in consultation with each other with a view to reduce the burden on the critical entity in regard to the obligations pursuant to chapter iii. ### 5. member states shall ensure that critical entities provide information to their competent authorities designated pursuant to article 8 of this directive on whether they have been identified as a critical entity in one or more other member states. where an entity has been identified as critical by two or more member states , these member states shall engage in consultation with each other with a view to reduce the burden on the critical entity in regard to the obligations pursuant to chapter iii and to achieve a comparable level of resilience across the border.


### the number of users relying on the service provided by the entity; ### the number of persons relying on the service provided by the entity;


### 1. as regards the sectors referred to in points 3 , 4 and 8 of the annex , member states shall , by [three years and three months after entry into force of this directive] , identify the entities that shall be treated as equivalent to critical entities for the purposes of this chapter. they shall apply the provisions of articles 3 , 4 , 5(1) to (4) and (7) , and 9 in respect of those entities. ### 1. as regards the sectors referred to in points 8 and 9 of the annex , member states shall , by [three years and three months after entry into force of this directive] , identify the entities that shall be treated as equivalent to critical entities for the purposes of this chapter. they shall apply the provisions of articles 3 , 4 , 5(1) to (4) and (7) , and 9 in respect of those entities.


### 2. in respect of the entities in the sectors referred to in points 3 and 4 of the annex identified pursuant to paragraph 1 , member states shall ensure that , for the purposes of the application of article 8(1) , the authorities designated as competent authorities are the competent authorities designated pursuant to article 41 of [dora regulation]. ### deleted


### 1. each member state shall designate one or more competent authorities responsible for the correct application , and where necessary enforcement , of the rules of this directive at national level (‘competent authority’). member states may designate an existing authority or authorities. ### 1. each member state shall designate one or more competent authorities responsible for the correct application , and where necessary enforcement , of the rules of this directive (‘competent authority’). member states may designate an existing authority or authorities.


### where they designate more than one authority , they shall clearly set out the respective tasks of the authorities concerned and ensure that they cooperate effectively to fulfil their tasks under this directive , including with regard to the designation and activities of the single point of contact referred to in paragraph 2. ### where they designate more than one authority , they shall clearly set out the territorial delineation of competences and the respective tasks of the authorities concerned and ensure that they cooperate effectively to fulfil their tasks under this directive , including with regard to the designation and activities of the single point of contact referred to in paragraph 2.


### 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 and protection of personal data , as well as with relevant interested parties , including academia , civil society and critical entities.


### 6. member states shall ensure that their competent authorities designated pursuant to this article cooperate with competent authorities designated pursuant to [the nis 2 directive] on cybersecurity risks and cyber incidents affecting critical entities , as well as the measures taken by competent authorities designated under [the nis 2 directive] relevant for critical entities. ### 6. member states shall ensure that their competent authorities designated pursuant to this article cooperate with competent authorities designated pursuant to [the nis 2 directive] on risks and incidents affecting critical entities , as well as the measures taken by competent authorities designated under [the nis 2 directive] relevant for critical entities.


### 7. each member state shall notify the commission of the designation of the competent authority and single point of contact within three months from that designation , including their precise tasks and responsibilities under this directive , their contact details and any subsequent change thereto. each member state shall make public its designation of the competent authority and single point of contact. ### 7. each member state shall notify the commission of the designation of the competent authority and single point of contact within one month from that designation , including their precise tasks and responsibilities under this directive , their contact details and any subsequent change thereto. each member state shall make public its designation of the competent authority and single point of contact.


### 3. member states shall establish information sharing tools to support voluntary information sharing between critical entities in relation to matters covered by this directive , in accordance with union and national law on , in particular , competition and protection of personal data. ### 3. member states shall establish information sharing tools to support voluntary sharing of information that is not personal data between critical entities in relation to matters covered by this directive , in accordance with union and national law.


### recover from incidents , including business continuity measures and the identification of alternative supply chains; ### recover from incidents , including business continuity measures and the identification of alternative supply chains to ensure the continuation of the essential service;


### 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 , the commission shall organise assessment missions , in accordance with the arrangements set out in article 15(4) , (5) , (7) and (8) , to assess compliance of the critical entity concerned with its obligations pursuant to chapter iii. the assessment mission shall report its findings to the commission , that member state and the critical entity concerned.


### 3. in accordance with applicable union and national law , including regulation (eu) 2016/679 , each member state shall ensure that a background check as referred to in paragraph 1 may also be extended , on the basis of a duly justified request of the critical entity , to draw upon intelligence and any other objective information available that may be necessary to determining the suitability of the person concerned to work in the position in relation to which the critical entity has requested an extended background check. ### deleted


### 2. in order to determine the significance of the disruption or the potential disruption to the critical entity’s operations resulting from an incident , the following parameters shall , in particular , be taken into account: ### deleted


### the duration of the disruption or anticipated duration of a potential disruption; ### deleted


### the geographical area affected by the disruption or potential disruption. ### deleted


### 3. on the basis of the information provided in the notification by the critical entity , the competent authority , via its single point of contact , shall inform the single point of contact of other affected member states if the incident has , or may have , a significant impact on critical entities and the continuity of the provision of essential services in one or more other member states. ### 3. on the basis of the information provided in the notification by the critical entity , the competent authority , via its single point of contact , shall inform the single point of contact of other affected member states if the incident has , or may have , an impact on critical entities and the continuity of the provision of essential services in one or more other member states.


### that member state shall also inform , without undue delay , the commission and the critical entities resilience group of any supervisory or enforcement actions , including any assessments of compliance or orders issued , that its competent authority has undertaken pursuant to articles 18 and 19 in respect of that entity. ### that entity shall also inform , without undue delay , the critical entities resilience group of any supervisory or enforcement actions , including any assessments of compliance or orders issued pursuant to articles 18 and 19 in respect of that entity.


### 3. the advisory mission shall report its findings to the commission , the critical entities resilience group and the critical entity of particular european significance concerned within a period of three months after the conclusion of the advisory mission. ### 3. the assessment mission shall report its findings to the critical entities resilience group and the critical entity of particular european significance concerned within a period of three months after the conclusion of the advisory mission.


### the commission shall , based on that advice , communicate its views to the member state where the infrastructure of that entity is located , the critical entities resilience group and that entity on whether that entity complies with its obligations pursuant to chapter iii and , where appropriate , which measures could be taken to improve the resilience of that entity. ### the commission shall communicate the advice to the member states where that entity operates , the critical entities resilience group and that entity on whether that entity complies with its obligations pursuant to chapter iii and , where appropriate , which measures could be taken to improve the resilience of that entity.


### that member state shall take due account of those views and provide information to the commission and the critical entities resilience group on any measures it has taken pursuant to the communication. ### the member states shall take due account of those views and provide information to the commission and the critical entities resilience group on any measures they have taken pursuant to the communication.


### the commission shall organise the programme of an advisory mission , in consultation with the members of the specific advisory mission and in agreement with the member state where the infrastructure of the critical entity or the critical entity of european significance concerned is located. ### the commission shall organise the programme of an assessment mission , in consultation with the members of the specific advisory mission.


### 5. the commission shall adopt an implementing act laying down rules on the procedural arrangements for the conduct and reports of advisory missions. this implementing act shall be adopted in accordance with the examination procedure referred to in article 20(2). ### 5. the commission shall adopt an implementing act laying down rules on the procedural arrangements for the conduct and reports of assessment missions. this implementing act shall be adopted in accordance with the examination procedure referred to in article 20(2).


### 6. member states shall ensure that the critical entity of particular european significance concerned provides the advisory mission with access to all information , systems and facilities relating to the provision of its essential services necessary for the performance of its tasks. ### 6. member states shall ensure that the critical entity of particular european significance concerned provides the assessment mission with access to all information , systems and facilities relating to the provision of its essential services necessary for the performance of its tasks.


### 7. the advisory mission shall be carried out in compliance with the applicable national law of the member state where that infrastructure is located. ### 7. the assessment mission shall be carried out in compliance with the applicable national law of the member state where that infrastructure is located.


### 8. when organising the advisory missions , the commission shall take into account the reports of any inspections carried out by the commission under regulation (ec) 300/2008 and regulation (ec) 725/2004 and of the reports of any monitoring carried out by the commission under directive 2005/65/ec in respect of the critical entity or the critical entity of particular european significance , as appropriate. ### 8. when organising the assessment missions , the commission shall take into account the reports of any inspections carried out by the commission under regulation (ec) 300/2008 and regulation (ec) 725/2004 and of the reports of any monitoring carried out by the commission under directive 2005/65/ec in respect of the critical entity or the critical entity of particular european significance , as appropriate.


### the commission’s representative shall chair the critical entities resilience group. ### the chair of the critical entities resilience group shall be elected by the critical entities resilience group.


### conduct on-site inspections of the premises that the critical entity uses to provide its essential services , and off-site supervision of critical entities’ measures pursuant to article 11; ### conduct unannounced on-site inspections of the premises that the critical entity uses to provide its essential services , and off-site supervision of critical entities’ measures pursuant to article 11;


### conduct or order audits in respect of those entities. ### conduct audits in respect of those entities.


### (4) as regulation (eu) no 531/2012 expires on 30 june 2022 , the aim of this regulation is to recast it while introducing new measures to increase transparency , including on the use of value added services in roaming and ensure a genuine rlah experience in terms of quality of service and access to emergency services while roaming. the duration of this new regulation is set for 10 years , until 2032 , to provide certainty in the market and minimise regulatory burden while introducing a mechanism for intervening at wholesale level in the interim if market developments so require. ### (4) as regulation (eu) no 531/2012 expires on 30 june 2022 , the aim of this regulation is to extend the abolition of roaming charges and recast it while introducing new measures to increase openness , transparency , clear information and consumer protection including on the use of value added services in roaming and ensure a genuine rlah experience in terms of quality of service and access to emergency services while roaming. the duration of this new regulation is extended , with review periods of two years , to provide certainty in the market , while ensuring a legislative proposal will accompany the reviews if market developments so require.


### (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 a decisive criterion 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 or negatively affect customer's roam-like-at-home experience in particular considering that the deployment of new technologies , 5g 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) given that the union is a party to the united nations convention on the rights of persons with disabilities (un crpd) , the provisions of the convention are an integral part of the union law and are binding upon the union and its member states. the un crpd requires its parties to take appropriate measures to ensure that persons with disabilities have access , on an equal basis with others , to information and communications technologies and systems. to that end , directive (eu) 2018/1972 aims to: “ensure the provision throughout the union of good quality , affordable , publicly available services through effective competition and choice , to deal with circumstances in which the needs of end-users , including those with disabilities in order to access the services on an equal basis with others , are not satisfactorily met by the market and to lay down the necessary end-user rights.”. 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. importantly , pursuant to that directive: “emergency communications are a means of communication that includes not only voice communications services , but also sms , messaging , video or other types of communications , for example real time text , total conversation and relay services.” 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.


### (29) roaming providers should be able to apply a ‘fair use policy’ to the consumption of regulated retail roaming services provided at the applicable domestic retail price. the ‘fair use policy’ is intended to prevent abusive or anomalous usage of regulated retail roaming services by roaming customers , such as the use of such services by roaming customers in a member state other than that of their domestic provider for purposes other than periodic travel. roaming providers should , in cases of force majeure caused by circumstances such as pandemics or natural catastrophes which involuntarily extend the period of temporary stay of the roaming customer in another member state , consider extending the applicable fair use allowance for an appropriate period , upon a justified request by the roaming customer . any fair use policy should enable the roaming provider’s customers to consume volumes of regulated retail roaming services at the applicable domestic retail price that are consistent with their respective tariff plans. ### (29) roaming providers should be able to apply a ‘fair use policy’ to the consumption of regulated retail roaming services provided at the applicable domestic retail price. the ‘fair use policy’ is intended to prevent abusive or anomalous usage of regulated retail roaming services by roaming customers , such as the use of such services by roaming customers in a member state other than that of their domestic provider for purposes other than periodic travel. roaming providers must , in cases of force majeure caused by circumstances such as pandemics or natural catastrophes which involuntarily extend the period of temporary stay of the roaming customer in another member state , extend the applicable fair use allowance for a period which covers at least the duration of the extended stay due to the exceptional circumstances , upon a justified request by the roaming customer. any fair use policy should enable the roaming provider’s customers to consume volumes of regulated retail roaming services at the applicable domestic retail price that are consistent with their respective tariff plans.


### (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. these specifications should include clear and comprehensible information on the level of quality of the service , including information on the transfer rate and the available access technologies of each visited operator in each member state. the provider should also be obliged to provide all relevant information on the factors which might have a greater impact on the quality of service , such as coverage or variation due to external factors such as topography. the specifications and information should be provided in line with berec’s data roaming retail service guidelines.