### 10. stresses that barriers also derive from limited national administration capabilities to provide services in other languages , and from shortages of skills and infrastructure; ### 10. takes note of the assessment of the commission that cross-border activities might be reduced due to limited national administration capabilities to provide services in other languages , and from shortages of relevant training and infrastructure;


### 12. considers that mutual recognition of professional qualification is seriously affected by administrative barriers imposed by member states; ### 12. welcomes again the fact that the harmonisation of qualifications through mutual recognition has already been successful in relation to several professions , but still stresses the need to improve the comparability of levels of professional qualifications; recalls the specific status that regulated professions have within the single market and their role in protecting the public interest , but also underlines that this specific status should not be used to maintain unjustified barriers resulting in the fragmentation of the single market;


### 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 labour mobility of services , as well as by the procedures to obtain essential documents such as the a1 form; underlines that access to information , such as on minimum wages and domestic collective agreements where applicable and relevant , should be improved to facilitate information for workers and compliance for businesses;


### 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. recalls that the international road haulage sector is subject to ntbs restricting access to national markets , which limit its competitiveness;


### 18. welcomes in principle the single market enforcement taskforce (smet) , which aims to assess compliance of national law with single market rules and to prioritise the most pressing barriers; points out that the smet should not just identify problems , but also provide solutions; ### 18. welcomes in principle the single market enforcement taskforce (smet) , which aims to assess compliance of national law with single market rules and to prioritise the most pressing barriers; points out that the smet should not just identify problems , but also propose possible solutions;


### 19. recalls that so far the commission’s plan to step up enforcement of eu law by means of the smet has only delivered limited results; calls on the commission to present in due time concrete outcomes of the work of smet , including information on barriers that have been abolished as a result of its actions; ### 19. recalls that so far the commission’s plan to step up enforcement of eu law by means of the smet has only delivered limited results; calls on the commission to improve the transparency of the smet and present in due time concrete outcomes of the work of smet;


### 20. calls on the commission to present an annual report on ntbs and establish an open and transparent database compiling specific national ntbs together with ongoing infringement procedures; ### 20. calls on the commission to present an annual report on ntbs and to expand the existing single market scoreboard in a transparent manner , to list the infringement procedures and the national regulations suspected to contravene eu law;


### 21. calls on the commission and the member states to consistently , speedily and rigorously assess whether national rules hinder the internal market , and where they do , to assess if they are necessary , proportional and justified; ### 21. calls on the commission and the member states to consistently , speedily and rigorously assess whether national rules hinder the internal market , and where they do , to assess if they are necessary , proportional and justified; recalls that economic freedoms cannot be put on an equal footing with fundamental rights , but rather represent just one of many factors to consider in this assessment;


### 21. calls on the commission and the member states to consistently , speedily and rigorously assess whether national rules hinder the internal market , and where they do , to assess if they are necessary , proportional and justified; ### 21. calls on the commission and the member states to consistently , speedily and rigorously assess whether national rules hinder the internal market , and where they do , to assess if they are necessary , proportional and justified; where these rules are shown to be unnecessary , the commission should encourage member states to dispense with them;


### 24. stresses the importance of monitoring , and therefore welcomes the single market scoreboard as a performance monitoring tool; emphasises the need for a recurring debate on the outcomes of the scoreboard at the highest political levels , ensuring political commitment to tackling the obstacles identified; ### 24. stresses the importance of monitoring , and therefore welcomes the single market scoreboard as a performance monitoring tool; emphasises the need for a recurring debate on the outcomes of the scoreboard at the highest political levels , ensuring political commitment to tackling the obstacles identified , not only from a business perspective , but also with regard to the challenges experienced by workers , consumers and citizens , taking due account of social and environmental policy considerations;


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


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


### (2) in light of the lessons learnt during the ongoing covid-19 pandemic and in order to facilitate adequate union-wide preparedness and response to all cross-border threats to health , the legal framework for epidemiological surveillance , monitoring , early warning of , and combating serious cross-border threats to health , as set out in decision no 1082/2013/eu , needs to be broadened with regard to additional reporting requirements and analysis on health systems indicators , and cooperation 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 prevention , 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.


### (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 , such as the international health regulations (ihr) of the world health organization (who) amongst others. 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.


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


### (7) preparedness and response planning are essential elements for effective monitoring , early warning of and combatting serious cross-border threats to health. as such , a union health crisis and pandemic preparedness plan needs to be established by the commission and approved by the hsc. this should be coupled with updates to member states’ preparedness and response plans so as to ensure they are compatible within the regional level structures. to support member states in this endeavour , targeted training and knowledge exchange activities for healthcare staff and public health staff should be provided knowledge and necessary skills should be provided by the commission and union agencies. to ensure the putting into operation and the running of these plans , the commission should conduct stress tests , exercises and in-action and after-action reviews with member states. these plans should be coordinated , be functional and updated , and have sufficient resources for their operationalisation. following stress tests and reviews of the plans , corrective actions should be implemented and the commission should be kept informed of all updates. ### (7) preventing , 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. this exercise should be consistent with the one-health approach in recognition of the interlinks between human health , animal health and the environment. 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. 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 prevention , 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 prevention , preparedness , response planning and implementation at union level , including on corrective actions , every year 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.


### (3) an important role in the coordination of preparedness and response planning for serious cross-border threats to health is being played by the health security committee (hsc) , as formally established by decision no 1082/2013/eu. this committee should be given additional responsibilities with regard to the adoption of guidance and opinions to better support member states in the prevention and control of serious cross-border threats to health. ### (3) an important role in the coordination of prevention , preparedness and response planning for serious cross-border threats to health is being played by the health security committee (hsc) , as formally established by decision no 1082/2013/eu. this committee should be given additional responsibilities with regard to the adoption of guidance and opinions to better support member states in the prevention and control of serious cross-border threats to health and support better coordination between member states to address these threats.


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


### (9) as serious cross-border threats to health are not limited to union borders , joint procurement of medical countermeasures should be extended to include european free trade association states and union candidate countries , in accordance with the applicable union legislation. the joint procurement agreement , determining the practical arrangements governing the joint procurement procedure established under article 5 of decision no 1082/2013/eu , should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure , to allow for better coordination within the eu. the commission should ensure coordination and information exchange between the entities organizing any action under different mechanisms established under this regulation and other relevant union structures related to procurement and stockpiling of medical countermeasures , such as the strategic resceu reserve under decision no 1313/2013/eu of the european parliament and of the council16 . ### (9) as serious cross-border threats to health are not limited to union borders , joint procurement of medical countermeasures should be extended to include european free trade association states , union candidate countries and those third countries whose territories lie entirely within a member state , in accordance with the applicable union legislation. the joint procurement agreement , determining the practical arrangements governing the joint procurement procedure established under article 5 of decision no 1082/2013/eu , should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure , to allow for better coordination within the eu. the commission should ensure coordination and information exchange between the entities organizing any action under different mechanisms established under this regulation and other relevant union structures related to procurement and stockpiling of medical countermeasures , such as the strategic resceu reserve under decision no 1313/2013/eu of the european parliament and of the council16 .


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


### (13) a system enabling the notification at union level of alerts related to serious cross-border threats to health has been put in place by decision no 2119/98/ec in order to ensure that competent public health authorities in member states and the commission are duly informed in a timely manner. all serious cross-border threats to health covered by this regulation are covered by the ewrs. the operation of the ewrs should remain within the remit of the ecdc. the notification of an alert should be required only where the scale and severity of the threat concerned are or could become so significant that they affect or could affect more than one member state and require or could require a coordinated response at the union level. to avoid duplication and ensure coordination across union alert systems , the commission and ecdc should ensure that alert notifications under the ewrs and other rapid alert systems at union level are linked to each other to the extent possible so that the competent authorities of the member states can avoid as much as possible notifying the same alert through different systems at union level and can benefit from receiving all-hazard alerts from a single coordinated source. ### (13) a system enabling the notification at union level of alerts related to serious cross-border threats to health has been put in place by decision no 2119/98/ec in order to ensure that competent public health authorities in member states and the commission are duly informed in a timely manner. all serious cross-border threats to health covered by this regulation are covered by the ewrs. the operation of the ewrs should remain within the remit of the ecdc. the notification of an alert should be required only where the scale and severity of the threat concerned are or could become so significant that they affect or could affect more than one member state and require or could require a coordinated response at the union level. to avoid duplication and ensure coordination across union alert systems , the commission and ecdc should ensure that alert notifications under the ewrs and other rapid alert systems at union level are automatically linked to each other to the extent possible so that the competent authorities of the member states can avoid as much as possible notifying the same alert through different systems at union level and can benefit from receiving all-hazard alerts from a single coordinated source.


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


### (20) the occurrence of an event that corresponds to serious cross-border threats to health and is likely to have union-wide consequences should require the member states concerned to take particular control or contact-tracing measures in a coordinated manner in order to identify people already contaminated and those persons exposed to risk. such cooperation could require the exchange of personal data through the system , including sensitive information related to health and information about confirmed or suspected human cases of the disease , between those member states directly involved in the contact-tracing measures. the exchange of personal data concerning health by the member states has to comply with article 9(2)(i) of regulation (eu) 2016/679 of the european parliament and of the council18 . ### (20) the occurrence of an event that corresponds to serious cross-border threats to health and is likely to have union-wide consequences should require the member states concerned to take particular control or contact-tracing measures in a coordinated manner in order to identify people already contaminated and those persons exposed to risk. such cooperation could require the exchange of personal data through the system , including sensitive information related to health and information about confirmed or suspected human cases of the disease or infection , between those member states directly involved in the contact-tracing. the exchange of personal data concerning health by the member states has to comply with article 9(2)(i) of regulation (eu) 2016/679 of the european parliament and of the council18 .


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


### (22) the processing of personal data for the purpose of implementing this regulation should comply with regulation (eu) 2016/679 and regulation (eu) 2018/1725 of the european parliament and of the council19 . in particular , the operation of the ewrs should provide for specific safeguards for the safe and lawful exchange of personal data for the purpose of contact tracing measures implemented by member states at national level. in this regard , the ewrs includes a messaging function in which personal data , including contact and health data , can be communicated to relevant authorities involved in contact tracing measures. ### (22) the processing of personal data for the purpose of implementing this regulation should comply with regulation (eu) 2016/679 and regulation (eu) 2018/1725 of the european parliament and of the council19 . in particular , the operation of the ewrs should provide for specific safeguards for the safe and lawful exchange of personal data for the purpose of contact tracing measures implemented by member states at national level. in this regard , the ewrs includes a messaging function in which personal data , including contact and health data , can be communicated to relevant authorities involved in contact tracing.


### (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 update of a list of relevant health data to be automatically collected by digital platform; 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.


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


### (3) ‘contact tracing’ means measures implemented in order to trace persons who have been exposed to a source of a serious cross-border threat to health , and who are in danger of developing or have developed a disease , through manual or other technological means; ### (3) ‘contact tracing’ means measures implemented in order to trace persons who have been exposed to a source of a serious cross-border threat to health , and who are in danger of being infected , being infectious or have developed a disease , through manual or other technological means;


### coordination in liaison with the commission of the preparedness and response planning of the member states in accordance with article 10; ### coordination in liaison with the commission of the prevention , preparedness and response planning of the member states in accordance with article 10;


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


### union preparedness and response plan ### union prevention , preparedness and response plan


### 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.


### the risk and crisis communication; ### the risk and crisis communication , for health professionals and for citizens;


### 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 prevention , 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 or regional 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 preparedness and response plans each member state shall coordinate with the commission in order to reach consistency with the union preparedness and response plan , including disclosing national stockpiling requirements and the management of eu strategic reserves , also inform without delay the commission and the hsc of any substantial revision of the national plan.


### 1. when preparing national preparedness and response plans each member state shall coordinate with the commission in order to reach consistency with the union preparedness and response plan , also inform without delay the commission and the hsc of any substantial revision of the national plan. ### 1. when preparing national prevention , preparedness and response plans each member state shall 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 year thereafter provide the commission with an updated report on their prevention , preparedness and response planning and implementation at national and regional levels.


### that report shall cover the following: ### that report shall be succinct and give an overview of the actions implemented in the member states , and shall cover the following:


### identification of , and update on the status of the implementation of the capacity standards for preparedness and response planning as determined at national level for the health sector , as provided to the who in accordance with the ihr; ### identification of , and update , where necessary , on the status of the implementation of the capacity standards for prevent , preparedness and response planning as determined at national level for the health sector , as provided to the who in accordance with the ihr;


### elements of emergency preparedness , in particular: ### an update , if needed , on the elements of emergency prevention , preparedness and response , in particular:


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


### (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; existing national stockpile of medical countermeasures; 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; ### (ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning , information management; equitable access to diagnostic services during emergencies; equitable , quality , basic and safe gender-sensitive health and emergency services; risk communications; research development and evaluations to inform and accelerate emergency preparedness and response;


### 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 and intersectorial 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. 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 recommendations on the minimum resources needed in relation to population size , developed on the basis of good practice and policy assessments.


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


### 1. the commission and the member states shall work together within the hsc to coordinate their efforts to develop , strengthen and maintain their capacities for the monitoring , early warning and assessment of , and response to serious cross-border threats to health. ### 1. the commission and the member states shall work together within the hsc to coordinate their efforts to develop , strengthen and maintain their capacities for the monitoring , prevention , early warning , and assessment of , and response to serious cross-border threats to health.


### sharing best practice and experience in preparedness and response planning; ### sharing best practice and experience in prevention , preparedness and response planning;


### promoting the interoperability of national preparedness planning and the intersectoral dimension of preparedness and response planning at union level; ### promoting the interoperability of national prevention , preparedness planning and the intersectoral dimension of prevention , preparedness and response planning at union level;


### 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 regional , 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 , supported by the union agencies including ecdc , ema among others , in close cooperation with medical societies and patient organisations , for healthcare staff and public health staff in the member states in particular interdisciplinary one health training , 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 and in articulation with who to avoid duplication of activities , including preparedness capacities under the international health regulations. at border regions , joint cross-border exercises should be promoted and familiarity with public health systems encouraged.


### 2. the training activities referred to in paragraph 1 shall aim to provide staff referred to in that paragraph with knowledge and skills necessary in particular to develop and implement the national preparedness plans referred to in article 6 , implement activities to strengthen crisis preparedness and surveillance capacities including the use of digital tools. ### 2. the training activities referred to in paragraph 1 shall aim to provide staff referred to in that paragraph with knowledge and skills necessary in particular to develop and implement the national preparedness plans referred to in article 6 , implement activities to strengthen crisis preparedness and surveillance capacities including the use of digital tools and consistent with the one-health approach.


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


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


### 1. the network for the epidemiological surveillance of the communicable diseases and of the related special health issues referred to in points (i) and (ii) of point (a) of article 2(1) shall ensure a permanent communication between the commission , the ecdc , and the competent authorities responsible at national level for epidemiological surveillance. ### 1. the network for the epidemiological surveillance of the communicable diseases , including communicable diseases of zoonotic origin , and of the related special health issues referred to in points (i) and (ii) of point (a) of article 2(1) shall ensure a permanent communication between the commission , the ecdc , and the competent authorities responsible at national level for epidemiological surveillance.


### identify risk factors for disease transmission , population groups at risk and in need of targeted prevention measures; ### identify and monitor risk factors for disease transmission , population groups at risk and in need of targeted prevention measures;


### 9. the commission shall , by means of implementing acts , establish and update: ### 9. the commission shall , after consulting with the ecdc , by means of implementing acts , establish and update:


### 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.


### enable the automated collection of surveillance and laboratory data , make use of information from electronic health records , media monitoring , and apply artificial intelligence for data validation , analysis and automated reporting; ### enable the automated collection of surveillance and laboratory data , make use of relevant health data from a previously defined and authorized list from the electronic health records and health databases , media monitoring , and apply artificial intelligence for data validation , analysis and automated reporting;


### 3. member states are responsible for ensuring that the integrated surveillance system is fed on a regular basis with timely and complete information , data and documents transmitted and exchanged through the digital platform. ### 3. member states are responsible for ensuring that the integrated surveillance system is fed on a regular basis with timely and complete information , data and documents transmitted and exchanged through the digital platform. the member states shall promote the automation of this process between the national and the union surveillance system.


### 5. for epidemiological purposes , ecdc shall also have access to relevant health data accessed or made available through digital infrastructures enabling the use of health data for research , policy making and regulatory purposes. ### 5. for epidemiological surveillance purposes , ecdc shall also have access to relevant health data accessed or made available through digital infrastructures enabling the use of health data for research , policy making and regulatory purposes. the access to the health data should be proportionate to specific and concrete purposes that shall be defined previously by ecdc.


### contingency arrangements to be applied in the event of unavailability of any of the functionalities of the platform; ### contingency arrangements and secure data backups to be applied in the event of unavailability of any of the functionalities of the platform;


### 3. the commission shall , by means of implementing acts , adopt , where necessary , the case definitions to be used for ad hoc monitoring , in order to ensure the comparability and compatibility at union level of the collected data. ### 3. the commission , after consulting the ecdc shall , by means of implementing acts , adopt , where necessary , the case definitions to be used for ad hoc monitoring , in order to ensure the comparability and compatibility at union level of the collected data.


### 1. the ewrs shall enable the commission and the competent authorities responsible at national level to be in permanent communication for the purposes of preparedness , early warning and response , alerting , assessing public health risks and determining the measures that may be required to protect public health. ### 1. the ewrs shall enable the commission , the ecdc , and the competent authorities responsible at national level to be in permanent communication for the purposes of preparedness , early warning and response , alerting , assessing public health risks and determining the measures that may be required to protect public health.


### the ecdc shall continuously update the ewrs allowing for the use of modern technologies , such as digital mobile applications , artificial intelligence models , space enabled applications , or other technologies for automated contact tracing , building upon the contact tracing technologies developed by the member states. ### the ecdc shall continuously update the ewrs allowing for the use of modern technologies , such as digital mobile applications , space enabled applications , or other technologies for automated contact tracing , building upon the contact tracing technologies developed by the member states. all contact tracing applications shall use privacy-enhancing technologies and be designed in line with the principles of data minimisation , purpose limitation and storage limitation. any deployment of technological or organisational solutions that involve novel forms of data collection and usage , such as artificial intelligence , shall be carried out only after a data protection impact assessment (dpia).


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


### 2. where the national competent authorities notify the who of events that may constitute public health emergencies of international concern in accordance with article 6 of the ihr , they shall at the latest simultaneously notify an alert in the ewrs , provided that the threat concerned falls within those referred to in article 2(1) of this regulation. ### 2. where the national competent authorities notify the who of events that may constitute public health emergencies of international concern in accordance with article 6 of the ihr , as referred to in point 2b , article 18 , shall be simultaneously notify an alert in the ewrs , provided that the threat concerned falls within those referred to in article 2(1) of this regulation.


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


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


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


### 2. where a member state intends to adopt public health measures to combat a serious cross-border threat to health , it shall , before adopting those measures , inform and consult the other member states and the commission on the nature , purpose and scope of the measures , unless the need to protect public health is so urgent that the immediate adoption of the measures is necessary. ### 2. where a member state intends to adopt or cease public health measures to combat a serious cross-border threat to health , it shall , before adopting or ceasing those measures , inform , consult and coordinate with the other member states , the commission and health security committee on the nature , purpose and scope of the measures , unless the need to protect public health is so urgent that the immediate adoption of the measures is necessary.


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


### be proportionate to the public health risks related to the threat in question , avoiding in particular any unnecessary restriction to the free movement of persons , of goods and of services. ### be proportionate to the public health risks related to the threat in question , avoiding in particular any unnecessary restriction to the free movement of persons , of goods and of services , and promote coordination of measures between member states.


### 1. for the purpose of the formal recognition of a public health emergency at union level , the commission shall establish an advisory committee on public health emergencies (‘advisory committee’) which , at the request of the commission , shall advise the commission by providing its views on: ### 1. for the purpose of the formal recognition of a public health emergency at union level , the commission , with the consultation of the health security committee shall establish an advisory committee on public health emergencies (‘advisory committee’) which , at the request of the commission or the health security committee , shall advise the commission and the health security committee by providing its views on:


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


### 3. the advisory committee shall meet whenever the situation requires , on a request from the commission or a member state. ### 3. the advisory committee shall meet whenever the situation requires , on a request from the commission , the health security committee or a member state.


### 6. the advisory committee shall establish its rules of procedure including on the rules for the declaration and termination of an emergency situation , and adoption of recommendations and voting. the rules of procedures shall enter into force after receiving a favourable opinion from the commission. ### 6. the advisory committee shall establish its rules of procedure including on the rules for the declaration and termination of an emergency situation , and adoption of recommendations and voting. the rules of procedures shall enter into force after receiving a favourable opinion from the commission and the health security committee.


### procedures for the interlinking of the ewrs with contact tracing systems at union level; ### procedures for the interlinking of the ewrs with contact tracing systems at union level and international level;


### (1) the union's international trade is subject to both customs legislation and union non-customs legislation. the latter is applicable to specific goods in policy areas such as health and safety , the environment , agriculture , fisheries , cultural heritage and market surveillance. one of the main tasks assigned to customs authorities in line with regulation (eu) no 952/2013 of the european parliament and of the council30 is to ensure the security and safety of the union and its residents , and the protection of the environment , where appropriate , in close cooperation with other authorities. the authorities responsible for union non-customs regulatory formalities (‘partner competent authorities’) and customs authorities often work in silos , creating complex and burdensome reporting obligations for traders and inefficient goods clearance processes conducive to error and fraud. to address the fragmented interoperability between customs and partner competent authorities in the management of goods clearance processes and to coordinate action in this area , the commission and the member states have taken a number of commitments over the years to develop single window initiatives for the clearance of goods. ### (1) the union's international trade is subject to both customs legislation and union non-customs legislation. the latter is applicable to specific goods in policy areas such as health and safety , the environment , agriculture , fisheries , cultural heritage , and market surveillance , namely product safety and counterfeit. one of the main tasks assigned to customs authorities in line with regulation (eu) no 952/2013 of the european parliament and of the council30 is to ensure the security and safety of the union and its residents , and the protection of the environment , where appropriate , in close cooperation with other authorities. given their extensive mandate , the customs authorities are the leading authorities for the control of goods at the union's external borders. the authorities responsible for union non-customs regulatory formalities (‘partner competent authorities’) and customs authorities often work in silos , creating complex and burdensome reporting obligations for traders and inefficient goods clearance processes conducive to error and fraud. the fragmented interoperability between these authorities is a major obstacle to progress on the digital single market and to achieving an integrated , coordinated customs and border management. to address the fragmented interoperability between customs and partner competent authorities in the management of goods clearance processes and to coordinate action in this area , the commission and the member states have taken a number of commitments over the years to develop single window initiatives for the clearance of goods.


### (1) the union’s international trade is subject to both customs legislation and union non-customs legislation. the latter is applicable to specific goods in policy areas such as health and safety , the environment , agriculture , fisheries , cultural heritage and market surveillance. one of the main tasks assigned to customs authorities in line with regulation (eu) no 952/2013 of the european parliament and of the council30 is to ensure the security and safety of the union and its residents , and the protection of the environment , where appropriate , in close cooperation with other authorities. the authorities responsible for union non-customs regulatory formalities (‘partner competent authorities’) and customs authorities often work in silos , creating complex and burdensome reporting obligations for traders and inefficient goods clearance processes conducive to error and fraud. to address the fragmented interoperability between customs and partner competent authorities in the management of goods clearance processes and to coordinate action in this area , the commission and the member states have taken a number of commitments over the years to develop single window initiatives for the clearance of goods. ### (1) the union’s international trade is subject to both customs legislation and union non-customs legislation. the latter is applicable to specific goods in policy areas such as health and safety , the environment , agriculture , fisheries , cultural heritage and market surveillance. one of the main tasks assigned to customs authorities in line with regulation (eu) no 952/2013 of the european parliament and of the council30 is to ensure the security and safety of the union and its residents , and the protection of the environment , where appropriate , in close cooperation with other authorities. the authorities responsible for union non-customs regulatory formalities (‘partner competent authorities’) and customs authorities often work in silos , creating complex and burdensome reporting obligations for traders and inefficient goods clearance processes conducive to error , fraud and additional costs for economic operators. to address the fragmented interoperability between customs and partner competent authorities in the management of goods clearance processes and to coordinate action in this area , the commission and the member states have taken a number of commitments over the years to develop single window initiatives for the clearance of goods.


### (2) in accordance with article 4(6) of decision no 70/2008/ec of the european parliament and of the council31 , the member states and the commission are to endeavour to establish and make operational a framework of single window services. as stated in the final report on evaluation of the electronic customs implementation in the eu of 21 january 201532 , while certain elements of that decision remain highly relevant , other parts either have been superseded or are not concrete enough to encourage and incentivise further advances , in particular on the single window initiative. following up on this , the council conclusions of 17 december 2014 on electronic customs and single window implementation in the european union33 endorsed the venice declaration of 15 october 201434 and invited the commission to present a proposal for the revision of decision no 70/2008/ec. ### (2) in accordance with article 4(6) of decision no 70/2008/ec of the european parliament and of the council31 , the member states and the commission are to endeavour to establish and make operational a framework of single window services and ,in accordance with article 9(1) of that regulation , ensure appropriate funding for it. as stated in the final report on evaluation of the electronic customs implementation in the eu of 21 january 201532 , while certain elements of that decision remain highly relevant , other parts either have been superseded or are not concrete enough to encourage and incentivise further advances , in particular on the single window initiative. following up on this , the council conclusions of 17 december 2014 on electronic customs and single window implementation in the european union33 endorsed the venice declaration of 15 october 201434 and invited the commission to present a proposal for the revision of decision no 70/2008/ec.


### (5) the eu egovernment action plan 2016-2020 set out in commission communication of 19 april 201636 seeks to increase the efficiency of public services by removing existing digital barriers , reducing the administrative burden and improving the quality of interactions between national administrations. in line with this vision and the wider efforts to simplify and digitalise reporting processes for the international trade in goods , the commission developed a voluntary pilot project called european union customs single window certificates exchange. this project allows customs authorities to automatically verify compliance with a limited number of non-customs formalities , enabling information to be exchanged between the customs systems of participating member states and the respective union non-customs systems managing non-customs formalities. while the project has improved clearance procedures , its voluntary nature clearly limits its potential to generate substantial benefits for customs authorities , partner competent authorities and economic operators. ### (5) the eu egovernment action plan 2016-2020 set out in commission communication of 19 april 201636 seeks to increase the efficiency of public services by removing existing digital barriers , reducing the administrative burden and improving the quality of interactions between national administrations. in particular , that plan encompasses principles such as a digital-by-default service standard , reporting only once , cross-border by default activities to facilitate mobility within the digital single market , interoperability by default to work seamlessly across the single market , and trustworthiness of personal data and it security.


### (9) the commission , in collaboration with the member states , should develop , integrate , deploy and maintain eu csw-certex. to deliver appropriate and harmonised single window services at union level for union non-customs formalities , the commission should connect the respective union non-customs systems with eu csw-certex. member states should be responsible for connecting their national single window environments for customs with eu csw-certex. ### (9) the commission , in collaboration with the member states , should develop , integrate , deploy and maintain eu csw-certex. to deliver appropriate and harmonised single window services at union level for union non-customs formalities , the commission should connect the respective union non-customs systems with eu csw-certex. member states should be responsible for connecting their national single window environments for customs with eu csw-certex , with assistance from the commission.


### (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 and non-personal data in eu csw-certex must comply with regulation (eu) 2016/679 of the european parliament and of the council (the “gdpr”) and the principles laid down in regulation (eu) 2018/1807 of the european parliament and of the council (the “regulation on the free flow of non-personal data”). moreover , any processing of personal and non-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.


### (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 have equivalent characteristics and 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 and combating fraud. the alignment of national single window environments and the mandatory connection to eu csw-certex is a necessary condition for quantity management at union level.


### (14) to further simplify goods clearance processes for economic operators , the national single window environments for customs should become a single channel to communicate with customs and partner competent authorities. the union non-customs formalities subject to this additional facilitation measure are a subset of the overarching formalities covered by eu csw-certex. the commission should identify those formalities progressively by assessing the fulfilment of a set of criteria relevant to trade facilitation , taking into account their legal and technical feasibility. in order to further enhance trade facilitation , it should be possible to use the national single window environments for customs as a platform for coordinating controls between customs authorities and partner competent authorities in line with article 47(1) of regulation (eu) no 952/2013. ### (14) to further simplify goods clearance processes for economic operators , the national single window environments for customs should become a single channel to communicate with customs and partner competent authorities. the union non-customs formalities subject to this additional facilitation measure are a subset of the overarching formalities covered by eu csw-certex. the commission should identify those formalities progressively by assessing the fulfilment of a set of criteria relevant to trade facilitation , taking into account their legal and technical feasibility. in order to further enhance trade facilitation and improve the efficiency of controls , it should be possible to use the national single window environments for customs as a platform for coordinating controls between customs authorities and partner competent authorities in line with article 47(1) of regulation (eu) no 952/2013.


### (15) each member state should be the sole controller of the data processing operations performed within its national single window environment for customs. the data processing operations should be performed in accordance with regulation (eu) 2016/679. given that some of the data originating from the national single window environment for customs is to be exchanged with union non-customs systems through eu csw-certex , each member state should be required to notify the commission in case of any personal data breach compromising the security , confidentiality , availability or integrity of the personal data processed within its environment. ### (15) each member state should be the sole controller of the data processing operations performed within its national single window environment for customs. the data processing operations should be performed in accordance with regulation (eu) 2016/679. given that some of the data originating from the national single window environment for customs is to be exchanged with union non-customs systems through eu csw-certex , each member state should be required to immediately notify the commission in case of any personal data breach compromising the security , confidentiality , availability , accessibility or integrity of the personal data processed within its environment.


### (16) a fully coordinated goods clearance process requires procedures that support digital cooperation and information sharing between customs authorities , partner competent authorities and economic operators to fulfil and enforce union non-customs formalities covered by eu csw-certex. interoperability means the capability to run these processes seamlessly across customs and non-customs systems and domains without losing the context or meaning of the data exchanged. to enable a fully automated verification of union non-customs formalities , eu csw-certex should ensure technical interoperability as well as consistent meaning. it is important to align customs and non-customs terminology to ensure that the exchanged data and information is preserved and understood throughout the exchanges between union non-customs systems and national single window environments for customs. in addition , to ensure a harmonised enforcement of union non-customs formalities across the union , eu csw-certex should identify the customs procedures for which the supporting documents can be used based on the administrative decisions indicated by the partner competent authority in the supporting documents. from a technical perspective , eu csw-certex should make customs and non-customs data compatible by converting their format or structure where necessary , without changing their content. ### (16) a fully coordinated goods clearance process requires procedures that support digital cooperation and information sharing between customs authorities , partner competent authorities and economic operators to fulfil and enforce union non-customs formalities covered by eu csw-certex. interoperability means the capability to run these processes seamlessly across customs and non-customs systems and domains without losing the context or meaning of the data exchanged. to enable a fully automated verification of union non-customs formalities , eu csw-certex should ensure technical interoperability as well as consistent meaning. it is important to align customs and non-customs terminology to ensure that the exchanged data and information is preserved and understood throughout the exchanges between union non-customs systems and national single window environments for customs. in addition , to ensure a harmonised enforcement of union non-customs formalities across the union , eu csw-certex should identify the customs procedures for which the supporting documents can be used based on the administrative decisions indicated by the partner competent authority in the supporting documents. from a technical perspective , eu csw-certex should make customs and non-customs data compatible by converting their format or structure where necessary , without changing their content. eu csw-certex and the national single window environments should be aligned with the recommendations for interoperability in public services set out in the european interoperability framework – implementation strategy


### (17) in view of the union non-customs formalities covered , eu csw-certex should serve several purposes. it should make available the relevant data to customs authorities to better enforce union non-customs regulatory policies through the automated verification of those formalities. it should provide the relevant data to partner competent authorities to monitor and determine the remaining quantity of authorised goods not written off by customs in the clearance of other consignments. it should also support the implementation of the ‘one-stop shop’ principle for the performance of controls referred to in article 47(1) of regulation (eu) no 952/2013 , by facilitating the integration of customs and union non-customs procedures for a fully automated goods clearance process. some legal acts of the union may require data transfers between national customs systems and the information and communication system established in the relevant act. eu csw-certex should therefore enable automated data sharing between customs authorities and partner competent authorities where required by those acts. ### (17) in view of the union non-customs formalities covered , eu csw-certex should serve several purposes. it should make available the relevant data to customs authorities to better enforce union non-customs regulatory policies through the automated verification of those formalities. it should provide the relevant data to partner competent authorities to monitor and determine the remaining quantity of authorised goods not written off by customs in the clearance of other consignments. it should also support the implementation of the ‘one-stop shop’ principle for the performance of controls referred to in article 47(1) of regulation (eu) no 952/2013 , by facilitating the integration of customs and union non-customs procedures for a fully automated and intelligence-assisted goods clearance process. some legal acts of the union may require data transfers between national customs systems and the information and communication system established in the relevant act. eu csw-certex should therefore enable automated data sharing between customs authorities and partner competent authorities where required by those acts.


### (19) there is a significant overlap between the data included in the customs declaration and the data included in the application for supporting documents. to enable the re-use of data so that economic operators do not need to provide the same data more than once , it is necessary to reconcile and rationalise the data requirements for customs and the union non-customs formalities covered by eu csw-certex. the commission should therefore identify the data elements included in both the customs declaration and the application for supporting documents. the commission should also identify the data elements that are required only by union non-customs legislation (‘partner competent authority (pca) data set(s)’). the customs declaration data and the pca data set(s) should constitute an integrated declaration including all clearance related information needed to fulfil the customs and union non-customs formalities covered by eu csw-certex. ### (19) there is a significant overlap between the data included in the customs declaration and the data included in the application for supporting documents , which makes the clearance process more laborious. to enable the re-use of data so that economic operators do not need to provide the same data more than once , it is necessary to reconcile and rationalise the data requirements for customs and the union non-customs formalities covered by eu csw-certex. the commission should therefore identify the data elements included in both the customs declaration and the application for supporting documents. the commission should also identify the data elements that are required only by union non-customs legislation (‘partner competent authority (pca) data set(s)’). the customs declaration data and the pca data set(s) should constitute an integrated declaration including all clearance related information needed to fulfil the customs and union non-customs formalities covered by eu csw-certex.


### (20) to allow economic operators to fulfil customs and non-customs formalities affecting the same goods movements , the national single window environments for customs should enable them to submit all data required by multiple regulatory authorities for placing the goods under customs procedures through an integrated declaration. it should be possible to submit such data together with the customs declaration lodged prior to the expected presentation of the goods to customs , in accordance with article 171 of regulation (eu) no 952/2013. ### (20) to allow economic operators to fulfil customs and non-customs formalities affecting the same goods movements , the national single window environments for customs should enable them to submit all data required by multiple regulatory authorities for placing the goods under customs procedures through an integrated declaration. it should be possible to submit such data together with the customs declaration lodged prior to the expected presentation of the goods to customs , in accordance with article 171 of regulation (eu) no 952/2013. such submissions should enable the fulfilment of the once-only principle


### (25) detailed planning is required to progressively integrate various union non-customs formalities from diverse policy areas into eu csw-certex. to that end , the commission should prepare a work programme to incorporate those formalities into eu csw-certex and to develop connections between the union non-customs systems processing those formalities and eu csw-certex. the main objective of the work programme should be to support the operational requirements and implementation timeline of these activities. the work programme should be reviewed regularly to assess overall progress in applying the provisions of this regulation. ### (25) detailed planning is required to progressively integrate various union non-customs formalities from diverse policy areas into eu csw-certex. to that end , the commission should prepare a work programme to incorporate those formalities into eu csw-certex and to develop connections between the union non-customs systems processing those formalities and eu csw-certex. the main objective of the work programme should be to support the operational requirements and implementation timeline of these activities. the work programme should be reviewed and updated regularly to assess and improve overall progress in applying the provisions of this regulation.