ISSN 1977-0677 |
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Official Journal of the European Union |
L 79 |
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English edition |
Legislation |
Volume 66 |
Contents |
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I Legislative acts |
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REGULATIONS |
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(1) Text with EEA relevance. |
EN |
Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period. The titles of all other Acts are printed in bold type and preceded by an asterisk. |
I Legislative acts
REGULATIONS
17.3.2023 |
EN |
Official Journal of the European Union |
L 79/1 |
REGULATION (EU) 2023/588 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 15 March 2023
establishing the Union Secure Connectivity Programme for the period 2023-2027
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 189(2) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Acting in accordance with the ordinary legislative procedure (1),
Whereas:
(1) |
The conclusions of the European Council of 19-20 December 2013 welcomed the preparations for the next generation of governmental satellite communications through close cooperation between the Member States, the Commission and the European Space Agency (ESA). Governmental satellite communications have also been identified as one of the elements of the Global Strategy for the European Union’s Foreign and Security Policy of June 2016. Governmental satellite communications are to contribute to the EU response to Hybrid Threats and provide support to the EU Maritime Security Strategy and to the EU Arctic policy. |
(2) |
The conclusions of the European Council of 21-22 March 2019 stressed that the Union needs to go further in developing a competitive, secure, inclusive and ethical digital economy with world-class connectivity. |
(3) |
The Communication of the Commission of 22 February 2021, entitled ‘Action Plan on synergies between civil, defence and space industries’, states that it aims to ‘enable access to high-speed connectivity for everyone in Europe, and provide a resilient connectivity system allowing Europe to remain connected whatever happens’. |
(4) |
‘A Strategic Compass for Security and Defence’ adopted by the Council on 21 March 2022 recognises that the space infrastructure of the Union and of its Member States contributes to our resilience and offers key services that substitute or complement ground infrastructures for telecommunications. It therefore calls for the Union to work on the proposal for a Union space-based global secure communication system. |
(5) |
One of the components of the Union Space Programme established by Regulation (EU) 2021/696 of the European Parliament and of the Council (2) is GOVSATCOM, which aims to ensure the long-term availability of reliable, secure, scalable and cost-effective satellite communications services for GOVSATCOM users. Regulation (EU) 2021/696 envisages that in a first phase of the GOVSATCOM component, until approximately 2025, existing capacity would be pooled and shared through the GOVSATCOM Hub. In that context, the Commission is to procure GOVSATCOM capacities from Member States with national systems and space capacities and from commercial satellite communication or service providers, taking into account the essential security interests of the Union. In that first phase, GOVSATCOM services are to be introduced on the basis of a step-by-step approach, in light of the scaling up of the GOVSATCOM Hub infrastructure capabilities. That approach is also based on the premise that if in the course of the first phase a detailed analysis of future supply and demand reveals that it was insufficient to cover the evolving demand, it will be necessary to move to a second phase and develop additional bespoke space infrastructure or capacities through cooperation with the private sector, for example with Union satellite operators. |
(6) |
On 22 March 2017, the Council’s Political and Security Committee endorsed the High Level Civil Military User Needs for Governmental Satellite Communications (GOVSATCOM), which were prepared by the European External Action Service (EEAS) and with which the military user’s requirements identified by the European Defence Agency in its Common Staff Target adopted in 2013 and the civilian user needs collected by the Commission have been merged. Subsequent analyses by the Commission showed that the Union’s current satellite communication offer, on the basis of capacities from Member States with national systems as well as the private sector, cannot meet certain new needs of the governmental demand which are moving towards higher security solutions, low latency and global coverage. Those needs should be monitored and reassessed regularly. |
(7) |
Recent technical progress has allowed non-geostationary-orbit (NGSO) communications constellations to emerge and gradually offer high-speed and low latency connectivity services. There is therefore a window of opportunity for addressing the evolving needs of government-authorised users by developing and deploying additional infrastructure as filings for the frequencies with the International Telecommunication Union which are necessary to provide the required services are currently available within the Union. If not used, those filings for the frequencies will become obsolete and be attributed to other players. As frequencies and orbital slots are an increasingly scarce resource, the Commission, through an open and transparent process with the Member States, should seize this opportunity to conclude with the Member States providing the filings for the frequencies dedicated licensing agreements for the provision of governmental services based on the governmental infrastructure. The private sector is responsible for obtaining the rights on filings for the frequencies required for the provision of commercial services. |
(8) |
There is growing demand by the Union’s governmental actors for secure and reliable spaced-based satellite communication services, particularly because they are the most viable option in the absence of ground-based communication systems or where they are disrupted or unreliable. Affordable and cost-effective access to satellite communication is also indispensable in areas where there is no terrestrial infrastructure, including over oceans, in airspace, in remote areas and where terrestrial infrastructure faces serious outage or cannot be trusted in crisis situations. Satellite communication can increase the overall resilience of communication networks, for example offering an alternative in the case of physical attacks or cyberattacks on local terrestrial infrastructure, accidents or natural or man-made disasters. |
(9) |
The Union should ensure the provision of resilient, global, secure, protected, uninterrupted, guaranteed and flexible satellite communication solutions for evolving governmental needs and requirements, built on a Union technological and industrial base, in order to increase the resilience of Member States’ and Union institutions’ operations. |
(10) |
Therefore, it is important to establish a new programme, namely the Union Secure Connectivity Programme (the ‘Programme’), to provide for a Union satellite-based, multi-orbital communication infrastructure for governmental use, while integrating and complementing existing and future national and European capacities in the framework of the GOVSATCOM component, and developing further and gradually integrating the European Quantum Communication Infrastructure (EuroQCI) initiative into the secure connectivity system. |
(11) |
The Programme should meet the new governmental needs for higher security solutions, low latency and global coverage. It should ensure the provision and long-term availability of worldwide uninterrupted access to secure, autonomous, reliable and cost-effective satellite governmental communication services, supporting the resilience and protection of critical infrastructure, situational awareness, external actions, crisis management, as well as applications that are critical for the Union’s and Member States’ economy, security and defence, through a dedicated governmental infrastructure which integrates and complements the capacities of GOVSATCOM. Moreover, the Programme should prioritise the delivery of governmental services and allow for the provision of commercial services by the European private sector, taking into account a market survey including consultation of government-authorised users, through a commercial infrastructure. |
(12) |
Decision (EU) 2022/2481 of the European Parliament and of the Council (3) sets a series of objectives and targets to promote the development of resilient, secure, performant and sustainable digital infrastructures in the Union, including a digital target for the Commission and Member States to achieve gigabit connectivity for all by 2030. The Programme should enable connectivity across the Union and around the globe, for citizens and business, including, but not limited to, providing access to affordable high-speed broadband that can help remove communication dead zones and increase cohesion across the Union, including its outermost regions, rural, peripheral, remote and isolated areas and islands. The satellite services cannot currently replace the performance of ground-based networks but can bridge the digital divide and even contribute, where applicable, to the general objectives of Directive (EU) 2018/1972 of the European Parliament and of the Council (4). |
(13) |
The Programme should therefore consist of the definition, design, development, validation and related deployment activities for the construction of the initial space and ground infrastructure, required for the provision of first governmental services. The Programme should then entail gradual deployment activities aimed at completing both the space and ground infrastructure required for the provision of advanced governmental services, which are currently not available and are beyond the state-of-the-art of existing European satellite communication services. Moreover, the Programme should promote the development of user terminals able to exploit the advanced communication services. The exploitation activities should begin as soon as possible with the provision of the first governmental services aimed by 2024, so that the needs of government-authorised users are met as soon as possible. The Programme should then entail activities aiming to complete both the space and ground infrastructure required for a full operational capability by 2027. The provision of governmental services, the operation, maintenance and continuous improvement of the space and ground infrastructure, once deployed, as well as the development of the future generations of the governmental services, should be part of the exploitation activities. |
(14) |
In June 2019, Member States signed the European Quantum Communication Infrastructure (EuroQCI) Declaration (the ‘Declaration’), agreeing to work together, with the Commission and with the support of ESA, towards the development of a quantum communication infrastructure covering the whole Union. In accordance with the Declaration, EuroQCI aims to deploy a certified secure end-to-end quantum communication infrastructure, enabling information and data to be transmitted and stored and to be capable of linking critical public communication assets throughout the Union. The Programme will contribute to meeting the objectives of the Declaration by developing a EuroQCI space and ground infrastructure integrated into the governmental infrastructure of the Programme, as well as by developing and deploying the EuroQCI terrestrial infrastructure, which will be owned by the Member States. The EuroQCI space, ground and terrestrial infrastructure should be developed within the Programme in two main phases, a preliminary validation phase, which may involve the development and validation of several different technologies and communication protocols, and a full-deployment phase including appropriate solutions for inter-satellite connectivity and data relay between satellites, the ground and the terrestrial infrastructure. |
(15) |
One of the main functions of the EuroQCI will be to allow for quantum distribution of cryptographic keys (QKD). To date, QKD technology and products are not sufficiently mature to be used for the protection of EU classified information (EUCI). The main issues concerning QKD security, such as standardisation of QKD protocols, side channel analysis and evaluation methodology, still need to be solved. The Programme should therefore support the EuroQCI and allow for the inclusion of approved cryptographic products in the infrastructure when available. |
(16) |
In order to protect EUCI in a satisfactory secured manner, primary solutions to counter threats posed by quantum computing should be the combination of conventional solutions, post-quantum cryptography and possibly QKD in hybrid approaches. The Programme should therefore use such approaches, for the purpose of ensuring both state-of the-art cryptography and key distribution. |
(17) |
In order to expand Union satellite communication capacities, the Programme infrastructure should be based upon, integrate and complement the infrastructure developed for the purposes of the of the GOVSATCOM component. In particular, the Programme’s ground infrastructure should be based upon the GOVSATCOM Hubs, as progressively scaled up on the basis of user needs through other ground segment assets, including those of the Member States willing to contribute additionally, on the basis of operational and security requirements. |
(18) |
The Programme should improve secure connectivity over geographical areas of strategic interest, such as Africa and the Arctic as well as the Baltic, the Black Sea, Mediterranean regions and the Atlantic. The services provided under the Programme should also contribute to geopolitical resilience by offering additional connectivity in line with policy targets in those regions and with the Joint Communication of the Commission and the High Representative of the Union for Foreign Affairs and Security policy of 1 December 2021 entitled ‘The Global Gateway’. |
(19) |
Without prejudice to the communication services, the satellites built for the purposes of the Programme could be equipped with subsystems, including payloads, that can allow the increase of the capacity and services of the components of the Union Space Programme, enabling thereby the development of additional non-communication services to be decided by the Programme committee meeting in the relevant configuration, as set out in Regulation (EU) 2021/696, and implemented under the conditions set out in this Regulation. If the benefit to the components of the Union Space Programme is duly established, taking into account user needs and budgetary constraints, those subsystems could be developed to offer alternative positioning, navigation and timing services complementing Galileo, to ensure the broadcast of European Geostationary Navigation Overlay Service (EGNOS) messages with a lower latency, to provide space-based sensors for space surveillance and to support the enhancement of current Copernicus capabilities, in particular for emergency and civil security services. Moreover, those subsystems could provide non-communication services to Member States, under the condition that this does not impact the security and budget of the Programme. |
(20) |
Considering the importance for the Programme of its ground governmental infrastructure and the impact thereof on its security, the location of such infrastructure should be determined by the Commission, in line with the general security requirements and following an open and transparent process, with a view to ensuring a balanced distribution among Member States. The deployment of the ground governmental infrastructure of the Programme, which also integrates the infrastructure developed under the GOVSATCOM component, could involve the European Union Agency for the Space Programme (the ‘Agency’) or, where appropriate and within its field of competence, ESA. |
(21) |
It is vital for the security of the Union and its Member States and for ensuring the security and integrity of the governmental services, that the space assets of the Programme are launched from the Union’s territory. In exceptional, duly substantiated circumstances, it should be possible for such launches to take place from the territory of a third country. In addition to heavy and medium launchers, small launchers and microlaunchers could provide additional flexibility to allow for a rapid deployment of the space assets. |
(22) |
It is important that the Union owns all tangible and intangible assets related to governmental infrastructure developed under the Programme, except the EuroQCI terrestrial infrastructure, while ensuring the compliance with the Charter of Fundamental Rights of the European Union, including Article 17 thereof. Despite the ownership by the Union of those assets, it should be possible for the Union, in accordance with this Regulation and, where it is deemed appropriate on a case-by-case assessment, to make those assets available to third parties or to dispose of them. |
(23) |
Union-wide initiatives, such as the secure connectivity initiative, are shaped by the broad participation of innovative small and medium-sized enterprises (SMEs), start-ups and large enterprises from the upstream and downstream space sector throughout the Union. In recent years, some space actors have challenged the space sector, in particular start-ups and SMEs which developed innovative, market-driven space technologies and applications, sometimes with different business models. In order to ensure the competitiveness of the Union space ecosystem, the Programme should maximise the use of innovative and disruptive technologies, as well as novel business models developed by the European space ecosystem, including New Space, in particular by SMEs, mid-cap companies and start-ups that develop market-driven novel space technologies and applications, while covering the whole space value chain encompassing the upstream and downstream segments. |
(24) |
It is essential to encourage private sector investment through appropriate procurement and aggregation of service contracts, thus reducing uncertainty and providing long-term visibility and predictability of public sector services needs. To ensure the competitiveness of the European space industry in the future, the Programme should also contribute to the development of advanced skills in space-related fields and support education and training activities, as well as promoting equal opportunities, gender equality and women’s empowerment, in order to realise the full potential of Union citizens in that area. |
(25) |
In line with the objectives set out in the Commission Communication of 11 December 2019 entitled ‘The European Green Deal’, the Programme should minimise, to the extent possible, its environmental impact. While the space assets do not themselves emit greenhouse gases while in use, their manufacturing and associated ground facilities do have an environmental impact. Measures should be adopted to mitigate that impact. To that end, the procurement referred to under the Programme should include principles and measures on sustainability, such as provisions to minimise and offset the greenhouse gas emissions generated by the development, production and deployment of the infrastructure, and measures to prevent light pollution, such as the impact on ground-based astronomical observations. |
(26) |
Given the growing number of spacecraft and space debris in orbit, the new European constellation should also satisfy space sustainability criteria and be an example of good practices in space traffic management and in space surveillance and tracking (SST), in order to reduce the amount of space debris produced, prevent on-orbit break-ups and on-orbit collision, and provide appropriate end-of-life spacecraft measures. As legitimate concerns on the protection of space environment are being discussed in international fora, such as within the United Nations’ Committee on the Peaceful Uses of Outer Space, it is of the utmost importance that the Union shows leadership in space sustainability. The contracts procured under the Programme should ensure that the technology deployed enables the highest possible standards when it comes to sustainability, as well as energy and resource efficiency. |
(27) |
Operational requirements for the governmental services should be based on the assessment of government-authorised users’ needs, while also taking into account the capabilities of the current market offer. When assessing those requirements the current market capacities should be used to the largest extent possible. From those operational requirements, in combination with the general security requirements and evolving demand of governmental services, the service portfolio for governmental services should be developed. That service portfolio should establish the applicable baseline for the governmental services. It should also identify the categories of service which complement the service portfolio of the GOVSATCOM services established within the framework of Regulation (EU) 2021/696. The Commission should ensure the consistency and coherence of operational and security requirements between the GOVSATCOM component and the Programme. In order to maintain the best possible match between the demand and supply of services, the service portfolio for governmental services should be identified in 2023 and should be able to be regularly updated, after consulting Member States on the basis of those operational and security requirements. |
(28) |
Satellite communications is a finite resource limited by the satellite capacity, frequency and geographical coverage. Hence, in order to be cost-effective and to capitalise on economies of scale, the Programme should optimise the match between the supply and demand of the governmental services and avoid overcapacity. Since the demand and the potential supply both change over time, the Commission should monitor the needs to adjust the portfolio for the governmental services whenever this appears necessary. |
(29) |
Member States, the Council, the Commission and the EEAS, as well as Union agencies and bodies should be able to become Programme participants, insofar as they choose to authorise users of governmental services or provide capacities, sites or facilities. Taking into consideration that it is for the Member States to decide whether to authorise national users of governmental services, Member States should not be obliged to contribute to the Programme or to host the Programme infrastructure. |
(30) |
Each Programme participant should designate a competent secure connectivity authority to monitor whether users, and other national entities that play a role in the Programme, comply with the applicable rules and security procedures, as laid down in the general security requirements. Programme participants may confer the functions of such an authority to an existing authority. |
(31) |
This Regulation lays down a financial envelope for the entire duration of the Programme, which is to constitute the prime reference amount, within the meaning of point 18 of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (5), for the European Parliament and the Council during the annual budgetary procedure. |
(32) |
The objectives of the Programme are consistent and complementary with those of other Union programmes, particularly Horizon Europe, established by Regulation (EU) 2021/695 of the European Parliament and of the Council (6) and Council Decision (EU) 2021/764 (7), the Digital Europe Programme, established by Regulation (EU) 2021/694 of the European Parliament and of the Council (8), the Neighbourhood, Development and International Cooperation Instrument – Global Europe, established by Regulation (EU) 2021/947 of the European Parliament and of the Council (9), the Connecting Europe Facility, established by Regulation (EU) 2021/1153 of the European Parliament and of the Council (10) and, in particular, the Union Space Programme. |
(33) |
Horizon Europe will allocate a dedicated share of its Cluster ‘Digital, Industry and Space’ components to research and innovation activities related to development and validation of the secure connectivity system, including for the potential technologies that would be developed under the space ecosystem, including New Space. The Neighbourhood, Development and International Cooperation Instrument – Global Europe (NDICI) will allocate a dedicated share of its Global Europe funds for activities related to the operation of the secure connectivity system and the worldwide provision of services that will make it possible to offer an array of services to international partners. The Union Space Programme will allocate a dedicated share of the GOVSATCOM component for the activities related to the development of the GOVSATCOM Hub which will form part of the ground infrastructure of the secure connectivity system. The funding stemming from these programmes should be implemented in accordance with the rules of these programmes. |
(34) |
Due to its inherent implications on the security of the Union and its Member States, the Programme also shares objectives and principles with the European Defence Fund, established by Regulation (EU) 2021/697 of the European Parliament and of the Council (11). Therefore, part of the funding from the European Defence Fund should be provided to fund the activities under the Programme, particularly the activities related to the deployment of its infrastructure. |
(35) |
In order to ensure that the Programme is implemented successfully, it is important to ensure that sufficient resources are available. Member States should be able to contribute with their technical competence, know-how and assistance, in particular in the fields of safety and security, or, where appropriate and possible, by making available to the Programme the data, information, services and infrastructure located on their territory. The Programme should be able to receive additional financial contributions or in-kind contributions from third parties, including Union agencies and bodies, Member States, third countries participating in the Programme or international organisations, in line with the relevant agreements. |
(36) |
Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (12) (the ‘Financial Regulation’) applies to the Programme. The Financial Regulation lays down rules on the implementation of the Union budget, including the rules on grants, prizes, procurement, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts. |
(37) |
In accordance with Article 191(3) of the Financial Regulation, in no circumstances are the same costs to be financed twice by the Union budget. |
(38) |
The Commission should be able to have recourse, as required and insofar as necessary, to the technical assistance of certain external parties, insofar as Union security interests are preserved. Other entities involved in the public governance of the Programme should also be able to make use of the same technical assistance in performing tasks entrusted to them under this Regulation. |
(39) |
Public contracts concluded under the Programme for activities financed by the Programme should comply with Union rules. In that context, the Union should also be responsible for defining the objectives to be pursued as regards public procurement. |
(40) |
The Programme relies on complex and constantly changing technologies. The reliance on such technologies results in uncertainty and risk for public contracts concluded under the Programme, insofar as those contracts involve long-term commitments to equipment or services. Specific measures concerning public contracts are therefore required in addition to the rules laid down in the Financial Regulation. It should thus be possible to impose a minimum level of subcontracting. As regards the latter, priority should be given, where possible, to start-ups and SMEs, particularly in order to enable their cross-border participation. |
(41) |
In order to meet the objectives of the Programme, it is important to be able to call, where appropriate, on capacities offered by Union public and private entities active in the space domain and also to be able to work at international level with third countries or international organisations. For that reason, it is necessary to provide for the possibility to use all the relevant tools and management methods provided for by the Treaty on the Functioning of the European Union (TFEU) and the Financial Regulation and joint procurement procedures. |
(42) |
Public-private cooperation is the most appropriate scheme by which to ensure that the objectives of the Programme can be pursued. It should permit building upon the existing Union satellite communication technological and industrial base, including private assets, and providing robust and innovative governmental services, and enabling private partners to complement the Programme infrastructure with additional capabilities to offer commercial services on market conditions through additional own investments. Such a scheme should furthermore optimise deployment and operation costs by sharing development and deployment costs on components common to both governmental and commercial infrastructures, as well as operational costs by allowing a high level of capacity mutualisation. It should also stimulate innovation in the European space ecosystem, including New Space, by enabling the sharing of research and development risks between public and private partners. |
(43) |
For the implementation of the Programme, the concession contracts, supply, service or works contracts or mixed contracts should follow key principles. Such contracts should establish a clear distribution of tasks and responsibilities between the public and private partners, including a clear allocation of risks between them, with a view to ensuring that the contractors assume responsibility for the consequences of any failings for which they are liable. The contracts should ensure that contractors do not receive overcompensation for the provision of governmental services, allow the provision of commercial services to be established by the private sector and ensure an appropriate prioritisation of government-authorised users’ needs. The contracts should ensure that the provision of services based on commercial infrastructure preserves the Union’s essential interests and the Programme’s general and specific objectives. It is therefore important that there are measures in place to ensure that those essential interests and objectives are preserved. In particular, the Commission should be able to take necessary measures to ensure service continuity in the event that the contractor is unable to fulfil its obligations. The contracts should include adequate safeguards to prevent, inter alia, conflicts of interest and potential distortions of competition stemming from the provision of commercial services, undue discrimination or any other hidden indirect advantages. Such safeguards may include separation of accounts between governmental and commercial services, including the setting up of a structurally and legally separate entity from the vertically integrated operator for the provision of governmental services, as well as open, fair, reasonable and non-discriminatory access to infrastructure necessary for the provision of commercial services. Therefore, commercial services should be available to existing terrestrial services providers under transparent and non-discriminatory conditions. The contracts should foster the participation of start-ups and SMEs along the whole value chain and across Member States. |
(44) |
An important objective of the Programme is to ensure the security of the Union and of the Member States and to strengthen the resilience across key technologies and value chains while preserving an open economy. In specific cases, that objective requires conditions for eligibility and participation to be set, in order to ensure the protection of the integrity, security and resilience of the operational systems of the Union. That should not undermine the need for competitiveness and cost-effectiveness. |
(45) |
In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (13) and Council Regulations (EC, Euratom) No 2988/95 (14), (Euratom, EC) No 2185/96 (15) and (EU) 2017/1939 (16), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities including fraud, the recovery of funds lost, wrongly paid or incorrectly used, and, where appropriate, the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013 the European Anti-Fraud Office (OLAF) has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor’s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (17). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation, the EPPO pursuant to Regulation (EU) 2017/1939, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. |
(46) |
In order to ensure the protection of the financial interests of the Union, it is necessary to require third countries to grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. |
(47) |
To optimise the efficiency and impact of the Programme, actions should be taken to promote the use and development of open standards, open source technologies and interoperability in the architecture of the secure connectivity system. A more open conception of that system could enable better synergies with other components of the Union Space Programme or national services and applications, optimise costs by avoiding duplication in the development of the same technology, improve reliability, foster innovation and reap the benefits of wide competition. |
(48) |
Sound public governance of the Programme requires the clear distribution of responsibilities and tasks among the different actors involved to avoid unnecessary overlap and reduce cost overruns and delays. All the actors of the governance should support, within their field of competence and in accordance with their responsibilities, the achievement of the objectives of the Programme. |
(49) |
Member States have long been active in the field of space. They have systems, infrastructure, national agencies and bodies in that field. They are therefore able to make a major contribution to the Programme, especially in its implementation. They might cooperate with the Union to promote the Programme’s services and applications and ensure coherence between the relevant national initiatives and the Programme. The Commission might be able to mobilise the means at Member States’ disposal, benefit from their assistance and, subject to mutually agreed conditions, entrust the Member States with tasks in the implementation of the Programme. Where relevant, Member States should aim to ensure coherence and complementarity of their recovery and resilience plans with the Programme. Moreover, the Member States should take all necessary measures to ensure the protection of the ground infrastructure located on their territories. In addition, Member States should be able to ensure that the frequencies necessary for the Programme are available and protected at the adequate level to allow for the full development and implementation of applications on the basis of the services offered, in compliance with Decision No 243/2012/EU of the European Parliament and of the Council (18). The frequencies made available to the Programme should have no financial impact on the Programme. |
(50) |
In accordance with Article 17 of the Treaty on European Union (TEU) and as a promoter of the Union’s general interest, it is the Commission’s responsibility to implement the Programme, assume overall responsibility and promote its use. In order to optimise the resources and competences of the various stakeholders, the Commission should be able to entrust certain tasks to other entities under justifiable circumstances. The Commission should determine the main technical and operational requirements necessary to implement systems and services evolution. It should do so after consulting Member States’ experts, users and other relevant public or private stakeholders. Finally, in accordance with Article 4(3) TFEU, the exercise of competence by the Union does not result in Member States being prevented from exercising their respective competences. However, to make good use of the Union funds, it is appropriate that the Commission ensures, as far as possible, the consistency of activities performed in the context of the Programme, with those of the Member States, without creating any unnecessary duplication of efforts. |
(51) |
Article 154 of the Financial Regulation provides that, on the basis of the results of an ex-ante assessment, the Commission is to be able to rely on the systems and the procedures of the persons or entities entrusted with the implementation of Union funds. If necessary, specific adjustments to those systems and procedures (supervisory measures), as well as the arrangements for the existing contracts, should be defined in the corresponding contribution agreement. |
(52) |
Given its worldwide coverage, the Programme has a strong international dimension. International partners, their governments and citizens will be recipients of the Programme’s array of services with accrued benefits to the international cooperation of the Union and the Member States with those partners. For matters relating to the Programme, the Commission might coordinate, within its field of competence and on behalf of the Union, the activities on the international scene. |
(53) |
Building on the expertise developed in the past years in management, operation and service provision related to the Galileo and EGNOS components of the Union Space Programme, the Agency is the most appropriate body to implement, under the supervision of the Commission, tasks relating to the operation of the governmental infrastructure and provision of governmental services. It should therefore develop further relevant capacities for that purpose. The Agency should then be entrusted with the provision of governmental services and should be able to be entrusted with all or part of the operational management of the governmental infrastructure. |
(54) |
In relation to security, and given its experience in this area, the Agency should be responsible for ensuring, through its Security Accreditation Board, the security accreditation of the governmental services and infrastructure. Furthermore, subject to the operational readiness of the Agency, notably in terms of adequate levels of human resources, the Agency should perform the tasks entrusted to it by the Commission. Where possible, the Agency should leverage its expertise, for example, throughout the European Global Navigation Satellite System (EGNSS) activities. When entrusting tasks to the Agency, adequate human, administrative and financial resources should be made available to enable the Agency to fully carry out its tasks and missions. |
(55) |
In order to ensure the operation of the governmental infrastructure and facilitate the provision of the governmental services, the Agency should be allowed to entrust, by means of contribution agreements, specific activities to other entities, within their respective fields of competence, under the conditions of indirect management that apply to the Commission as laid down in the Financial Regulation. |
(56) |
ESA is an international organisation with extensive expertise in the space domain, including in satellite communication, and is therefore an important partner in the implementation of the different aspects of the Union’s space policy. In that regard, ESA should be able to provide expertise to the Commission, including for the preparation of specifications and implementation of the technical aspects of the Programme. For that purpose, ESA should be entrusted with the supervision of the development and validation activities of the Programme, and support the evaluation of the contracts concluded in the context of the implementation of the Programme. |
(57) |
Owing to the importance of space-related activities for the Union economy and the lives of Union citizens, achieving and maintaining a high degree of security should be a key priority for the Programme, particularly in order to safeguard the interests of the Union and of the Member States, including in relation to classified and sensitive non-classified information. |
(58) |
Given the specific expertise of the EEAS and its regular contact with authorities of third countries and international organisations, the EEAS should be able to assist the Commission in performing certain tasks relating to the security of the Programme in the field of external relations, in accordance with Council Decision 2010/427/EU (19). |
(59) |
Without prejudice to the sole responsibility of the Member States in the area of national security, as provided for in Article 4(2) TEU, and to the right of the Member States to protect their essential security interests in accordance with Article 346 TFEU, a specific governance of security should be established to ensure a smooth implementation of the Programme. That governance should be based on three key principles. Firstly, it is imperative that Member States’ extensive, unique experience in security matters be taken into consideration to the greatest possible extent. Secondly, in order to prevent conflicts of interest and any shortcomings in applying security rules, operational functions should be segregated from security accreditation functions. Thirdly, the entity in charge of managing all or part of the Programme’s infrastructure is also the best suited to manage the security of the tasks entrusted to it. The security of the Programme would build upon the experience gained in the implementation of the Union Space Programme over the past years. Sound security governance also requires that roles be appropriately distributed among the various players. As it is responsible for the Programme, the Commission, without prejudice to Member States’ prerogatives in the area of national security, should determine together with the Member States the general security requirements applicable to the Programme. In particular in the area of classified information, the security governance of the Programme should reflect the respective roles and fields of competence of the Council and the Member States in the evaluation and approval of cryptographic products for protecting EUCI. |
(60) |
The cybersecurity and physical security of the Programme infrastructure, both ground and space, as well as its physical redundancy, are key to ensuring the continuity of the service and the operations of the system. The need to protect the system and its services against cyberattacks and threats to satellites, including by making use of new technologies, and by supporting response to and recovery from such cyberattacks, should therefore be duly taken into account when establishing general security requirements. |
(61) |
Where appropriate, after the risk and threat analysis, the Commission should identify a security monitoring structure. That security monitoring structure should be the entity responding to instructions developed under the scope of Council Decision (CFSP) 2021/698 (20). |
(62) |
Without prejudice to Member States’ prerogatives in the area of national security, the Commission and the High Representative, each within their respective field of competence, should ensure the security of the Programme in accordance with this Regulation and, where relevant, Decision (CFSP) 2021/698. |
(63) |
The governmental services provided by the Programme will be used by the Union’s governmental actors in security, defence, safety-critical missions and operations, as well as the protection of critical infrastructure. Therefore, such services and infrastructure should be subject to security accreditation. |
(64) |
It is indispensable that security accreditation activities be carried out on the basis of collective responsibility for the security of the Union and its Member States, by endeavouring to build consensus and involving all those concerned with the issue of security, and that a procedure for permanent risk monitoring be put in place. It is also necessary that technical security accreditation activities are conducted by professionals who are duly qualified in the field of accreditation of complex systems and who have an adequate level of security clearance. |
(65) |
Under Article 17 TEU, the Commission is responsible for the management of programmes which, in accordance with rules set out in the Financial Regulation, can be sub-delegated to third parties under indirect management. In that context, it is necessary that the Commission ensure that the tasks performed by third parties to implement the Programme under indirect management do not undermine the security of the Programme in particular as regards the control of classified information. It should therefore be clarified that where the Commission entrusts ESA to carry out tasks under the Programme, the corresponding contribution agreements are to ensure that classified information generated by ESA be considered to be EUCI in accordance with Council Decision 2013/488/EU (21) and Commission Decision (EU, Euratom) 2015/444 (22) and created under the authority of the Commission. |
(66) |
The governmental services of the Programme could be used in security and safety critical missions and operations by Union and Member State actors. Therefore, in order to protect the essential security interests of the Union and its Member States, measures to ensure a necessary level of non-dependence on third parties (third countries and entities from third countries) are needed, covering all Programme elements. Such measures could include space and ground technologies at component, subsystem or system level, manufacturing industries, owners and operators of space systems, and physical location of ground system components. |
(67) |
On the sole basis of an agreement to be concluded in accordance with Article 218 TFEU, Members of the European Free Trade Association (EFTA) which are members of the European Economic Area (EEA), acceding countries, candidate countries and potential candidates as well as the European Neighbourhood Policy countries and other third countries may be allowed to participate in the Programme. |
(68) |
Pursuant to Council Decision (EU) 2021/1764 (23), persons and entities established in overseas countries or territories are eligible for funding subject to the rules and objectives of the Programme and possible arrangements applicable to the Member State to which the relevant overseas country or territory is linked. |
(69) |
Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (24), the Programme should be evaluated on the basis of information collected in accordance with specific monitoring requirements, while avoiding administrative burden, in particular on Member States, and overregulation. Those requirements, where appropriate, should include measurable indicators as a basis for evaluating the effects of the Programme. The evaluation of the Programme should take into account the findings of the evaluation of the Union Space Programme pertaining to the GOVSATCOM component carried out within the framework of Regulation (EU) 2021/696. |
(70) |
In order to ensure the continuing adequacy of the indicators to report on the progress of the Programme, as well as the Programme’s monitoring and evaluation framework, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending the Annex to this Regulation with regard to the indicators, of supplementing this Regulation with provisions on the establishment of a monitoring and evaluation framework and of supplementing this Regulation by specifying the characteristics of a database of the Programme’s space assets, as well as the methodology and the processes to maintain and update it. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. |
(71) |
In the interests of sound public governance and given the synergies between the Programme and the GOVSATCOM component, the Programme committee established within the framework of Regulation (EU) 2021/696 in the GOVSATCOM configuration should also serve as the committee for the purposes of the Programme. For matters pertaining to the security of the Programme, the Programme committee should meet in a dedicated security configuration. |
(72) |
As sound public governance requires uniform management of the Programme, faster decision making and equal access to information, representatives of the entities entrusted with tasks related to the Programme might be able to take part as observers in the work of the Programme committee established in application of Regulation (EU) No 182/2011 of the European Parliament and of the Council (25). For the same reasons, representatives of third countries and international organisations who have concluded an international agreement with the Union, relating to the Programme, might be able to take part in the work of the Programme committee subject to security constraints and as provided for in the terms of such agreement. The representatives of entities entrusted with tasks related to the Programme, third countries and international organisations should not be entitled to take part in the Programme committee voting procedures. The conditions for the participation of observers and ad hoc participants should be laid down in the rules of procedure of the Programme committee. |
(73) |
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission relating to the adoption of: the detailed rules on the provision of governmental services, the operational requirements for governmental services, the service portfolio for governmental services, the contribution decisions regarding the contribution agreements and the work programmes, as well as establishing additional requirements for the participation of third countries and international organisations in the Programme. Those powers should be exercised in accordance with Regulation (EU) No 182/2011. |
(74) |
Governmental services that are based on governmental infrastructure should, as a general rule, be provided free of charge to government-authorised users. However, capacity for those services is limited. If, after analysis, the Commission concludes that there is a shortage of capacities, it should be permitted to adopt a pricing policy, in duly justified cases where demand exceeds the access capacity, as part of those detailed rules on the service provision, to match the supply and demand of services. In order to ensure uniform conditions for the implementation of this Regulation, implementing powers relating to the adoption of such a pricing policy should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011. |
(75) |
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers relating to laying down measures required to determine the location of the centres belonging to the ground governmental infrastructure should be conferred on the Commission. For the selection of such locations, the Commission should be able to take into account the operational and security requirements, as well as the existing infrastructure. Those powers should be exercised in accordance with Regulation (EU) No 182/2011. |
(76) |
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers relating to determining general security requirements should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011. Member States should be able to exert a maximum of control over the Programme’s general security requirements. When adopting implementing acts in the area of security of the Programme, the Commission should be assisted by the Programme committee, meeting in a dedicated security configuration. In view of the sensitivity of security matters, the chair of the Programme committee should endeavour to find solutions which command the widest possible support within the Programme committee. The Commission should not adopt implementing acts determining the general security requirements of the Programme in cases where no opinion is delivered by the Programme committee. Where the involvement of the security configuration of the Programme committee is otherwise provided for, such involvement should take place in accordance with the rules of procedure of the Programme committee. |
(77) |
The Programme complements the existing Union Space Programme by integrating and extending its objectives and actions to create a secure and space-based connectivity system for the Union. The evaluation of the Programme should take this into account. |
(78) |
Since the objectives of this Regulation cannot be sufficiently achieved by the Member States, but can rather, by reason of the scale and effects of the action that go beyond the financial and technical capacities of any single Member State, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. |
(79) |
The Programme should be established for a period of five years to align its duration with that of the multiannual financial framework for the years 2021 to 2027 laid down in Council Regulation (EU, Euratom) 2020/2093 (26) (‘MFF 2021-2027’). |
(80) |
In order to allow for the implementation of this Regulation to start as soon as possible, with a view to reaching its objectives, it should enter into force as a matter of urgency, |
HAVE ADOPTED THIS REGULATION:
CHAPTER I
General provisions
Article 1
Subject matter
This Regulation establishes the Union Secure Connectivity Programme (the ‘Programme’) for the remaining duration of the MFF 2021-2027. It lays down the objectives of the Programme, the budget for the period 2023-2027, the forms of Union funding and the rules for providing such funding, as well as the rules for the implementation of the Programme, taking into account Regulation (EU) 2021/696.
Article 2
Definitions
For the purposes of this Regulation, the following definitions apply:
(1) |
‘spacecraft’ means a spacecraft as defined in Article 2, point (1), of Regulation (EU) 2021/696; |
(2) |
‘space debris’ means space debris as defined in Article 2, point (4), of Regulation (EU) 2021/696; |
(3) |
‘payload’ means equipment carried by a spacecraft for the performance of a particular mission in space; |
(4) |
‘ space ecosystem’ means a network of interacting undertakings operating in value chains in the space sector, from the smallest start-ups to the largest undertakings, encompassing the upstream and downstream segments of the space market; |
(5) |
‘European Quantum Communication Infrastructure’ or ‘EuroQCI ’ means an interconnected space, ground and terrestrial infrastructure integrated into the secure connectivity system, using quantum-based technology; |
(6) |
‘GOVSATCOM Hub’ means a GOVSATCOM hub as defined in Article 2, point (23), of Regulation (EU) 2021/696; |
(7) |
‘the Agency’ means the European Union Agency for the Space Programme established by Regulation (EU) 2021/696; |
(8) |
‘EU classified information’ or ‘EUCI’ means EU classified information or EUCI as defined in Article 2, point (25), of Regulation (EU) 2021/696; |
(9) |
‘sensitive non-classified information’ means sensitive non-classified information as defined in Article 2, point (26), of Regulation (EU) 2021/696; |
(10) |
‘blending operation’ means a blending operation as defined in Article 2, point (27), of Regulation (EU) 2021/696. |
Article 3
Programme objectives
1. The general objectives of the Programme shall be to:
(a) |
ensure the provision and long-term availability within the Union’s territory and worldwide uninterrupted access to secure, autonomous, high-quality, reliable and cost-effective satellite governmental communication services to government-authorised users, by establishing a multi-orbital, secure connectivity system under civil control and by supporting the protection of critical infrastructures, within the meaning of Council Directive 2008/114/EC (27), situational awareness, external actions, crisis management and applications that are critical for the economy, the environment, security and defence, thereby increasing the resilience and the autonomy of the Union and the Member States, and reinforcing their satellite communication technological and industrial base, while avoiding excessive reliance on non-Union based solutions, in particular for critical infrastructure and access to space; |
(b) |
enable the provision of commercial services, or services offered to government-authorised users based on commercial infrastructure at market conditions, by the private sector in accordance with the Union’s applicable competition law, in order to facilitate, inter alia, the further development of worldwide high-speed broadband and seamless connectivity as well as removing communication dead zones and increasing cohesion across Member States’ territories, while bridging the digital divide and contributing, where applicable, to the general objectives referred to in Article 3 of Directive (EU) 2018/1972. |
2. The specific objectives of the Programme shall be to:
(a) |
complement and integrate the existing and future capacities of the GOVSATCOM component into the secure connectivity system; |
(b) |
improve the resilience, security and autonomy of the Union’s and Member States’ communication services; |
(c) |
develop further and gradually integrate EuroQCI into the secure connectivity system; |
(d) |
ensure the right of use of orbital slots and relevant frequencies; |
(e) |
increase the robustness of the Union’s and the Member States’ communication services and the cyber resilience of the Union, by developing redundancy, passive, proactive and reactive cyber protection and operational cybersecurity and protective measures against cyber threats and other measures against electromagnetic threats; |
(f) |
enable, where possible, the development of communication and additional non-communication services, in particular by improving components of the Union Space Programme, creating synergies between them and expanding their capabilities and services, as well as the development of non-communication services to be provided to Member States, by hosting additional satellite subsystems, including payloads; |
(g) |
encourage innovation, efficiency, as well as the development and use of disruptive technologies and innovative business models throughout the European space ecosystem, including New Space actors, new entrants, start-ups and SMEs, in order to strengthen the competitiveness of the Union space sector; |
(h) |
improve secure connectivity over geographical areas of strategic interest, such as Africa and the Arctic as well as the Baltic, the Black Sea, Mediterranean regions and the Atlantic; |
(i) |
enhance the safety and sustainability of outer space activities, by implementing appropriate measures to ensure and to promote responsible behaviour in space when implementing the Programme, including through seeking to prevent the proliferation of space debris. |
3. The prioritisation and development of the additional non-communication services referred to in paragraph 2, point (f), of this Article and their respective funding shall comply with the objectives of Regulation (EU) 2021/696 and shall be examined by the Programme committee meeting in the relevant configuration, as set out in Regulation (EU) 2021/696.
Article 4
Programme activities
1. The provision of the governmental services referred to in Article 10(1) shall be ensured through the following phased activities, which shall complement and integrate the GOVSATCOM component into the secure connectivity system:
(a) |
the definition, design, development, validation and related deployment activities for the construction of the space and ground infrastructure required for the provision of the first governmental services by 2024; |
(b) |
gradual deployment activities to complete the space and ground infrastructure required for the provision of advanced governmental services, in order to meet the needs of government-authorised users as soon as possible, aiming to achieve full operational capability by 2027; |
(c) |
the development and deployment of EuroQCI for the purpose of its gradual integration into the secure connectivity system; |
(d) |
exploitation activities providing governmental services, comprising the operation, maintenance, continuous improvement and protection of the space and ground infrastructure, including replenishment and obsolescence management; |
(e) |
the development of future generations of space and ground infrastructure and the evolution of governmental services. |
2. The provision of commercial services shall be ensured by the contractors referred to in Article 19.
Article 5
Infrastructure of the secure connectivity system
1. The secure connectivity system shall be established by defining, designing, developing, building and operating a multi-orbital connectivity infrastructure, adjusted to the evolution of governmental demand for satellite communications and offering low latency. It shall be modular in order to fulfil the objectives referred to in Article 3 and to establish the service portfolio for governmental services laid down in Article 10(1). It shall complement and integrate the existing and future capacities used in the framework of the GOVSATCOM component. It shall consist of a governmental infrastructure, as referred to in paragraph 2 of this Article, and a commercial infrastructure, as referred to in paragraph 4 of this Article.
2. The governmental infrastructure of the secure connectivity system shall include all the related ground and space assets which are required for the provision of the governmental services, as laid down in Article 10(1), points (a) and (b), of this Regulation, including the following assets:
(a) |
either satellites or satellite subsystems, including payloads; |
(b) |
EuroQCI; |
(c) |
infrastructure for monitoring the security of the governmental infrastructure and governmental services; |
(d) |
ground infrastructure for the provision of the services to government-authorised users, including the GOVSATCOM ground segment infrastructure, which is to be scaled up, in particular the GOVSATCOM Hubs referred to in Article 67 of Regulation (EU) 2021/696. |
The governmental infrastructure shall host, where appropriate, additional satellite subsystems, in particular payloads, that may be used as part of the space-based infrastructure of the components of the Union Space Programme referred to in Article 3 of Regulation (EU) 2021/696 under the terms and conditions set out in that Regulation, as well as satellite subsystems used for the provision of non-communication services to Member States.
3. The Commission shall adopt, by means of implementing acts, where necessary, measures required to determine the location of the centres belonging to the ground governmental infrastructure, in accordance with the general security requirements referred to in Article 30(3) of this Regulation, following an open and transparent process. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 47(3) of this Regulation.
For the protection of the security interests of the Union and its Member States the centres referred to in the first subparagraph of this paragraph shall be, where possible, located in the territory of the Member States and governed by a hosting agreement in the form of an administrative agreement between the Union and the Member State concerned.
Where it is not possible to locate the centres in the territory of the Member States, the Commission may determine the location of such centres in the territory of members of EFTA which are members of the EEA or in the territory of another third country, subject to a hosting agreement between the Union and the third country concerned concluded in accordance with Article 218 TFEU.
Notwithstanding the first subparagraph of this paragraph, the location of the GOVSATCOM Hubs shall be determined in accordance with Article 67(2) of Regulation (EU) 2021/696.
4. The commercial infrastructure of the secure connectivity system shall include all space and ground assets other than those being part of the governmental infrastructure. The commercial infrastructure shall not impair the performance or security of the governmental infrastructure. The commercial infrastructure and any related risks shall be entirely financed by the contractors referred to in Article 19, in order to fulfil the objective referred to in Article 3(1), point (b).
5. In order to protect the security interests of the Union, the space assets of the governmental infrastructure shall be launched by existing and future service providers, including those using small launchers and microlaunchers, that comply with the eligibility and participation conditions set out in Article 22 and, only in justified exceptional circumstances, from the territory of a third country.
Article 6
Ownership and use of assets
1. The Union shall be the owner of all tangible and intangible assets which form part of the governmental infrastructure developed under the Programme, as referred to in Articles 5(2) and 19(10), with the exception of the EuroQCI terrestrial infrastructure, which shall be owned by the Member States. To that end, the Commission shall ensure that contracts, agreements and other arrangements concerning activities that may result in the creation or development of such assets contain provisions ensuring the Union’s ownership of those assets.
2. The Commission shall ensure that the Union has the following rights:
(a) |
the right of use of the frequencies required for the transmission of the signals generated by the governmental infrastructure, in accordance with the applicable laws and regulations and the relevant licensing agreements, enabled by the relevant filings for the frequencies provided by the Member States, which remain under the responsibility of the Member States; |
(b) |
the right to prioritise the provision of the governmental services over commercial services, in accordance with the terms and conditions to be established in the contracts referred to in Article 19 and by taking into consideration the needs of government-authorised users referred to in Article 12(1). |
3. The Commission shall seek to conclude contracts, agreements or other arrangements with third parties, including the contractors referred to in Article 19, with regard to:
(a) |
pre-existing ownership rights in respect of tangible and intangible assets which form part of the governmental infrastructure; |
(b) |
the acquisition of the ownership or license rights in respect of other tangible and intangible assets necessary for the implementation of the governmental infrastructure. |
4. Where the assets referred to in paragraphs 1, 2 and 3 consist of intellectual property rights, the Commission shall manage those rights as effectively as possible, taking into account:
(a) |
the need to protect and give value to the assets; |
(b) |
the legitimate interests of all stakeholders concerned; |
(c) |
the need to ensure competitive and well-functioning markets and to develop new technologies; |
(d) |
the need for the continuity of the services provided by the Programme. |
5. The Commission shall, where appropriate, ensure that the relevant contracts, agreements and other arrangements include the possibility of transferring those intellectual property rights to third parties or of granting third-party licences for those rights, including to the creator of the intellectual property, and that such third parties can freely enjoy those rights where necessary for carrying out their tasks under this Regulation.
Article 7
Actions in support of an innovative and competitive Union space ecosystem
1. In accordance with the objective referred to in Article 3(2), point (g), of this Regulation, the Programme shall support an innovative and competitive Union space ecosystem, including New Space, and in particular the activities set out in Article 6 of Regulation (EU) 2021/696.
2. The Commission shall stimulate innovation in the Union space ecosystem, including New Space, throughout the duration of the Programme by:
(a) |
establishing criteria for the award of the contracts referred to in Article 19, ensuring the widest participation of start-ups and SMEs from across the Union and along the whole value chain; |
(b) |
requiring that the contractors referred to in Article 19 provide a plan to maximise, in accordance with Article 21, the integration of new entrants, start-ups and SMEs from across the Union in the activities under the contracts referred to in Article 19; |
(c) |
requiring, through the contracts referred to in Article 19, that new entrants, start-ups, SMEs and mid-cap companies from across the Union are able to deliver their own services to end-users; |
(d) |
promoting the use and development of open standards, open source technologies and interoperability in the architecture of the secure connectivity system, in order to allow synergies, optimise costs, improve reliability, foster innovation and reap the benefits of wide competition; |
(e) |
promoting the development and production in the Union of critical technologies, which are required to exploit governmental services. |
3. The Commission shall also:
(a) |
support the procurement and aggregation of service contracts for the needs of the Programme with the objective of leveraging and stimulating private investments in the long term, including through joint procurement; |
(b) |
promote and encourage stronger participation of women and establish equality and inclusion goals in the tender documentation; |
(c) |
contribute to the development of advanced skills in space-related fields and to training activities. |
Article 8
Environmental and space sustainability
1. The Programme shall be implemented with a view to ensuring environmental and space sustainability. To that end, the contracts and procedures referred to in Article 19 shall include provisions on:
(a) |
the minimisation of greenhouse gas emissions generated by the development, production and deployment of the infrastructure; |
(b) |
the establishment of a scheme to offset the remaining greenhouse gas emissions; |
(c) |
appropriate measures to reduce visible and invisible radiation pollution caused by spacecraft, and that can hamper astronomical observations or any other type of research and observations; |
(d) |
the use of appropriate collision-avoidance technologies for spacecraft; |
(e) |
the submission and implementation of a comprehensive mitigation plan regarding space debris before the deployment phase, including orbital positioning data, in order to ensure the avoidance of space debris by the satellites of the constellation. |
2. The contracts and procedures referred to in Article 19 of this Regulation shall include an obligation to provide data, in particular ephemeris data and planned manoeuvres, to the entities in charge of producing SST information as defined in Article 2, point (10), of Regulation (EU) 2021/696 and SST services as referred to in Article 55 of that Regulation.
3. The Commission shall ensure that a comprehensive database of the Programme’s space assets, containing, in particular, data relating to environmental and space sustainability aspects, is maintained.
4. The Commission shall adopt delegated acts, in accordance with Article 45, in order to supplement this Regulation by specifying the characteristics of, and establishing the methodology and the processes to maintain and update the database referred to in paragraph 3 of this Article.
5. The scope of delegated acts adopted in accordance with paragraph 4 shall be limited to:
(a) |
the space assets owned by the Union, as referred to in Articles 5(2) and 19(10); |
(b) |
the space assets owned by the contractors referred to in Article 19, as referred to in Articles 5(4) and 19(10). |
CHAPTER II
Services and participants
Article 9
Governmental services
1. Governmental services shall be provided to the Programme participants referred to in Article 11(1), (2) and (3).
2. The Commission shall adopt, by means of implementing acts, detailed rules on the provision of governmental services, by taking into account Article 66 of Regulation (EU) 2021/696, on the basis of the consolidated demand of current and anticipated needs for the different services as identified together with the Member States, and dynamic allocation of the resources and prioritisation of the governmental services between different Programme participants according to relevance and criticality of the users’ needs and, where appropriate, cost-efficiency.
3. The governmental services referred to in Article 10(1) shall be provided free of charge to government-authorised users.
4. The Commission shall purchase the services referred to in Article 10(2), under market conditions, in accordance with the applicable provisions of the Financial Regulation with the objective of guaranteeing the provision of those services to all Member States. The precise capacity and budget allocation for those services shall be determined in the implementing act referred to in paragraph 2 of this Article on the basis of input from the Member States.
5. By way of derogation from paragraph 3 of this Article, the Commission shall, in duly justified cases, where strictly necessary to match supply and demand of governmental services, adopt, by means of implementing acts, a pricing policy, which shall be consistent with the pricing policy referred to in Article 63(1) of Regulation (EU) 2021/696.
By adopting a pricing policy, the Commission shall ensure that the provision of the governmental services does not distort competition, that there is no shortage of the governmental services and that the price identified will not result in an overcompensation of the contractors referred to in Article 19.
6. The implementing acts referred to in paragraphs 2 and 5 of this Article shall be adopted in accordance with the examination procedure referred to in Article 47(3).
7. The gradual provision of governmental services shall be ensured as laid down in the service portfolio referred to in Article 10(1), subject to the availability of the infrastructure of the secure connectivity system, following the implementation of the activities set out in Article 4(1), points (a) and (b), and building on and leveraging existing services and capabilities as appropriate.
8. Equal treatment of the Member States shall be ensured when providing governmental services in accordance with their needs as referred to in Article 25(7).
Article 10
Service portfolio for governmental services
1. The service portfolio for governmental services shall be established in accordance with paragraph 4 of this Article. It shall comprise at least the following categories of service and shall complement the portfolio of GOVSATCOM services referred to in Article 63(3) of Regulation (EU) 2021/696:
(a) |
services restricted to government-authorised users based on governmental infrastructure, which require a high level of security and which are not suitable for services referred to in paragraph 2 of this Article, such as robust worldwide low-latency service or robust space data relay; |
(b) |
quantum communication services, such as QKD services. |
2. The service portfolio for governmental services shall also comprise services to government-authorised users based on the commercial infrastructure, such as assured worldwide low latency service or worldwide narrowband service.
3. The service portfolio for the governmental services shall also comprise the technical specifications for each category of service, such as geographical coverage, frequency, bandwidth, user equipment and security features.
4. The Commission shall adopt, by means of implementing acts, the service portfolio for governmental services. Those implementing acts shall be based on the operational requirements referred to in paragraph 5 of this Article, on input from the Member States and on the general security requirements referred to in Article 30(3).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 47(3).
5. The Commission shall adopt, by means of implementing acts, the operational requirements for governmental services, in the form of technical specifications and implementation plans, relating in particular to crisis management, situational awareness, key infrastructure management, including diplomatic and defence communication networks, and other government-authorised users’ needs. Those operational requirements shall be based on the requirements of the Programme users, tailored to cover the confirmed demand, and shall take into account requirements stemming from existing user equipment and networks and operational requirements for GOVSATCOM services adopted in accordance with Article 63(2) of Regulation (EU) 2021/696. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 47(3) of this Regulation.
6. The terms and conditions for the provision of services, and related risks, provided through the commercial infrastructure shall be determined in the contracts referred to in Article 19.
Article 11
Programme participants and competent authorities
1. Member States, the Council, the Commission and the EEAS shall be Programme participants insofar as they authorise the users of the governmental services or provide capacities, sites or facilities.
2. Union agencies and bodies may become Programme participants insofar as necessary to fulfil their tasks and in accordance with detailed rules laid down in an administrative arrangement concluded between the agency or body concerned and the Union institution that supervises it.
3. Third countries and international organisations may become Programme participants in accordance with Article 39.
4. Each Programme participant shall designate one competent secure connectivity authority.
Programme participants shall be deemed to comply with the requirement referred to in the first subparagraph if they satisfy both of the following criteria:
(a) |
they are also GOVSATCOM participants in accordance with Article 68 of Regulation (EU) 2021/696; |
(b) |
they have designated a competent authority in accordance with Article 68(4) of Regulation (EU) 2021/696. |
5. The prioritisation of governmental services between the users authorised by each Programme participant shall be determined and implemented by that Programme participant.
6. A competent secure connectivity authority as referred to in paragraph 4 shall ensure that:
(a) |
the use of governmental services is in compliance with the general security requirements referred to in Article 30(3); |
(b) |
the access rights to the governmental services are determined and managed; |
(c) |
user equipment necessary for the use of the governmental services and associated electronic communication connections and information are used and managed in accordance with the general security requirements referred to in Article 30(3); |
(d) |
a central point of contact is established to assist as necessary in the reporting of security risks and threats, in particular the detection of potentially harmful electromagnetic interference affecting the services under the Programme. |
Article 12
Users of the governmental services
1. The following entities may be authorised as users of governmental services:
(a) |
a Union or Member State public authority or a body entrusted with the exercise of public authority; |
(b) |
a natural or legal person acting on behalf and under the control of an entity referred to in point (a). |
2. The users of governmental services referred to in paragraph 1 of this Article shall be duly authorised by the Programme participants referred to in Article 11 to use the governmental services and shall comply with the general security requirements referred to in Article 30(3).
CHAPTER III
Budgetary contribution and funding mechanisms
Article 13
Budget
1. The financial envelope for the implementation of the Programme for the period from 1 January 2023 to 31 December 2027 and for covering the associated risks shall be EUR 1,65 billion in current prices.
The amount referred to in the first subparagraph shall be distributed indicatively from the MFF 2021-2027 as follows:
(a) |
EUR 1 billion from Heading 1 (Single Market, Innovation and Digital); |
(b) |
EUR 0,5 billion from Heading 5 (Security and Defence); |
(c) |
EUR 0,15 billion from Heading 6 (Neighbourhood and the World). |
2. The Programme shall be complemented by an amount of EUR 0,75 billion implemented under the Horizon Europe Programme, the GOVSATCOM component and the Neighbourhood, Development and International Cooperation Instrument (NDICI) for a maximum indicative amount of EUR 0,38 billion, EUR 0,22 billion and EUR 0,15 billion, respectively. That funding shall be implemented in compliance with the objectives, rules and procedures set out, respectively, in Regulation (EU) 2021/695 and Decision (EU) 2021/764, and Regulations (EU) 2021/696 and (EU) 2021/947.
3. The amount referred to in paragraph 1, first subparagraph, of this Article shall be used to cover all the activities required to fulfil the objectives referred to in Article 3(1), point (a), and to cover the purchase of services referred to in Article 9(4). Such expenditure may also cover:
(a) |
studies and meetings of experts, in particular compliance with its cost and time constraints; |
(b) |
information and communication activities, including corporate communication on the policy priorities of the Union where they are directly linked to the objectives of this Regulation, with a particular view to creating synergies with other Union policies; |
(c) |
the information technology networks whose function it is to process or exchange information, and the administrative management measures implemented by the Commission, including in the field of security; |
(d) |
technical and administrative assistance for the implementation of the Programme, such as preparatory, monitoring, control, audit and evaluation activities including corporate information technology systems. |
4. Actions that receive cumulative funding from different Union programmes shall be audited only once, covering all involved programmes and their respective applicable rules.
5. The budgetary commitments for activities extending over more than one financial year may be broken down over several years into annual instalments.
6. Resources allocated to Member States under shared management may, at the request of the Member State concerned, be transferred to the Programme, subject to the conditions set out in Article 26 of Regulation (EU) 2021/1060 of the European Parliament and of the Council (28). The Commission shall implement those resources directly in accordance with Article 62(1), first subparagraph, point (a), of the Financial Regulation or indirectly in accordance with point (c) of that subparagraph. Those resources shall be used for the benefit of the Member State concerned.
Article 14
Cumulative and alternative funding
An action that has received a contribution from another Union programme, including funds under shared management, may also receive a contribution under the Programme, provided that the contributions do not cover the same costs. The rules of the relevant Union programme shall apply to the corresponding contribution to the action. The cumulative funding shall not exceed the total eligible costs of the action. The support from the different Union programmes may be calculated on a pro-rata basis in accordance with the documents setting out the conditions for support.
Article 15
Additional contributions to the Programme
1. The Programme may receive additional financial contributions or contributions in-kind from any of the following:
(a) |
Union agencies and bodies; |
(b) |
Member States, in accordance with relevant agreements; |
(c) |
third countries participating in the Programme, in accordance with relevant agreements; |
(d) |
international organisations, in accordance with relevant agreements. |
2. The additional financial contribution referred to in paragraph 1 of this Article and revenues pursuant to Article 9(5) of this Regulation shall be treated as external assigned revenue in accordance with Article 21(5) of the Financial Regulation.
Article 16
ESA contribution
ESA, in accordance with its own internal rules and procedures, may contribute through ESA optional programmes to the Programme’s development and validation activities resulting from the procurement approach referred to in Article 19(1), while protecting the essential security interests of the Union and its Member States.
Article 17
Private sector contribution
The contractors referred to in Article 19 shall entirely finance the commercial infrastructure referred to in Article 5 in order to fulfil the objective referred to in Article 3(1), point (b).
Article 18
Implementation and forms of Union funding
1. The Programme shall be implemented under direct management in accordance with the Financial Regulation or under indirect management with bodies referred to in the Article 62(1), first subparagraph, point (c), of the Financial Regulation.
2. The Programme may provide funding in any of the forms laid down in the Financial Regulation, in particular grants, prizes and procurement. It may also provide financing in the form of financial instruments within blending operations.
CHAPTER IV
Implementation of the Programme
Article 19
Implementation model
1. The Programme shall be implemented, as appropriate, in a phased approach until the completion of the activities set out in Article 4. The Commission, in coordination with the Member States, shall ensure that the procurement approach allows for the widest competition possible in order to foster appropriate participation of the entire industrial value chain for the contracts related to the provision of the services referred to in Article 10(1) and the contracts related to the purchase of the services referred to in Article 10(2).
2. The activities set out in Article 4 of this Regulation shall be implemented through several contracts awarded in compliance with the Financial Regulation and the principles of procurement under Article 20 of this Regulation and may take the form of concession contracts, supply, service, or works contracts or mixed contracts.
3. The contracts referred to in this Article shall be procured under direct or indirect management and may take the form of an inter-institutional procurement, as referred to in Article 165(1) of the Financial Regulation, between the Commission and the Agency, whereby the Commission shall assume the role of lead contracting authority.
4. The procurement approach referred to in paragraph 1 of this Article and the contracts referred to in this Article shall comply with the implementing acts referred to in Articles 9(2), 10(4) and 10(5).
5. If the result of the procurement approach referred to in paragraph 1 of this Article takes the form of concession contracts, those concession contracts shall set out the architecture of the governmental infrastructure of the secure connectivity system, roles, responsibilities, financial scheme and the allocation of risks between the Union and the contractors, by taking into account the ownership regime under Article 6 and the funding of the Programme under Chapter III.
6. If a concession contract is not awarded, the Commission shall ensure an optimal implementation of the objective referred to in Article 3(1), point (a), by procuring, as appropriate, a supply, service or works contract or a mixed contract.
7. The Commission shall take the necessary measures to ensure continuity of the governmental services if the contractors referred to in this Article are unable to fulfil their obligations.
8. Where appropriate, the procurement procedures for the contracts referred to in this Article may also take the form of joint procurements with Member States, in accordance with Article 165(2) of the Financial Regulation.
9. The contracts referred to in this Article shall in particular ensure that the provision of services based on commercial infrastructure preserves the Union’s essential interests and the Programme’s general and specific objectives referred to in Article 3. Those contracts shall also include adequate safeguards to avoid any overcompensation of the contractors referred to in this Article, distortions of competition, conflicts of interest, undue discrimination or any other hidden indirect advantages. Such safeguards may include the obligation of accounting separation between the provision of governmental services and the provision of commercial services, including the setting up of a structurally and legally separate entity from the vertically integrated operator for the provision of governmental services, and the provision of open, fair, reasonable and non-discriminatory access to the infrastructure necessary for the provision of commercial services. The contracts shall also ensure that the conditions of Article 22 are met throughout their duration.
10. Where the governmental and commercial services rely on common subsystems or interfaces to ensure synergies, the contracts referred to in this Article shall also determine which of those interfaces and common subsystems shall be part of the governmental infrastructure in order to ensure the protection of the security interests of the Union and its Member States.
Article 20
Principles of procurement
1. Public procurement under the Programme shall be carried out in accordance with the rules on procurement laid down in the Financial Regulation.
2. In public procurement procedures for the purpose of the Programme, complementing the principles laid down in the Financial Regulation, the contracting authority shall act in accordance with the following principles:
(a) |
to promote in all Member States across the Union and throughout the supply chain, the widest and most open participation possible by economic operators, in particular new entrants, start-ups and SMEs, including in the case of subcontracting by the tenderers; |
(b) |
to ensure effective competition in the tendering process, and where possible, to avoid reliance on a single provider, in particular for critical equipment and services, while taking into account the objectives of technological independence and continuity of services; |
(c) |
to follow the principles of open access and competition, by tendering on the basis of the provision of transparent and timely information, clear communication of the applicable procurement rules and procedures, selection and award criteria and any other relevant information allowing a level-playing field for all potential tenderers; |
(d) |
to protect the security and public interest of the Union and its Member States, including through a reinforcement of the strategic autonomy of the Union, in particular in technological terms, by performing risk assessments and implementing disruption risk mitigation measures, for instance when only one supplier is available; |
(e) |
to comply with the general security requirements referred to in Article 30(3) and to contribute to the protection of the essential security interests of the Union and its Member States; |
(f) |
by way of derogation from Article 167 of the Financial Regulation, to use, where appropriate, multiple supply sources in order to ensure better overall control of the Programme, its cost and schedule; |
(g) |
to promote service accessibility, continuity and reliability; |
(h) |
to enhance the safety and sustainability of outer space activities, by implementing appropriate measures in accordance with the provisions set out in Article 8; |
(i) |
to ensure the effective promotion of equal opportunities for all, the implementation of gender mainstreaming and of the gender dimension and to aim to address the causes of gender imbalance, paying particular attention to ensure gender balance in evaluation panels. |
Article 21
Subcontracting
1. To encourage new entrants, start-ups and SMEs across the Union and their cross-border participation, and to offer the widest possible geographical coverage while protecting the Union’s autonomy, the contracting authority shall request that the tenderer subcontract part of the contract by competitive tendering at the appropriate levels of subcontracting to companies other than those which belong to the tenderer’s group.
2. For contracts above EUR 10 million, the contracting authority shall ensure that at least 30 % of the value of the contract is subcontracted by competitive tendering at various levels of subcontracting to companies outside the group of the prime tenderer, in particular in order to enable the cross-border participation of SMEs in the space ecosystem.
3. The tenderer shall provide reasons for not fulfilling a request made under paragraph 1 or for deviating from the percentage referred to in paragraph 2.
4. The Commission shall inform the Programme committee referred to in Article 47 of the fulfilment of the objectives referred to in paragraphs 1 and 2 of this Article for contracts signed after 20 March 2023.
Article 22
Eligibility and participation conditions for the preservation of the security, integrity and resilience of operational systems of the Union
Eligibility and participation conditions shall apply to the award procedures carried out in the implementation of the Programme, where necessary and appropriate to preserve the security, integrity and resilience of the operational Union systems as set out in Article 24 of Regulation (EU) 2021/696, taking into account the objective to promote the Union’s strategic autonomy, in particular in terms of technology across key technologies and value chains, while preserving an open economy.
Article 23
Protection of the financial interests of the Union
Where a third country participates in the Programme by means of a decision adopted pursuant to an international agreement or on the basis of any other legal instrument, the third country shall grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. In the case of OLAF, such rights shall include the right to carry out investigations, including on-the-spot checks and inspections, as provided for in Regulation (EU, Euratom) No 883/2013.
CHAPTER V
Governance of the Programme
Article 24
Principles of governance
The governance of the Programme shall be based on the following principles:
(a) |
a clear distribution of tasks and responsibilities between the entities involved in the implementation of the Programme; |
(b) |
ensuring the relevance of the governance structure to the specific needs of the Programme and measures, as appropriate; |
(c) |
strong control of the Programme, including strict adherence to cost, schedule and performance by all the entities, according to their respective roles and the tasks conferred on them, in accordance with this Regulation; |
(d) |
transparent and cost-efficient management; |
(e) |
service continuity and necessary infrastructure continuity, including security monitoring and management, and protection from relevant threats; |
(f) |
systematic and structured consideration of the needs of users of the data, information and services provided by the Programme, as well as of related scientific and technological evolutions; |
(g) |
constant efforts to control and mitigate risks. |
Article 25
Role of the Member States
1. The Member States may contribute with their technical competence, know-how and assistance, in particular in the field of safety and security, or, where appropriate and possible, by making available to the Programme the data, information, services and infrastructure located on their territory.
2. Where possible, the Member States shall aim to ensure coherence and complementarity of the relevant activities and interoperability of their capacities under their recovery and resilience plans under Regulation (EU) 2021/241 of the European Parliament and of the Council (29) with the Programme.
3. The Member States shall take all the necessary measures to ensure the smooth functioning of the Programme.
4. The Member States may help to secure and protect, at the appropriate level, the frequencies required for the Programme.
5. The Member States and the Commission may cooperate to widen the uptake of governmental services provided by the Programme.
6. In the field of security, the Member States shall perform the tasks referred to in Article 42 of Regulation (EU) 2021/696.
7. The Member States shall provide their operational needs in order to consolidate the capacity and further detail the specifications of their governmental services. They shall also advise the Commission on any matter within their respective fields of competence, in particular by providing input for the preparation of the implementing acts.
8. The Commission may entrust, by means of contribution agreements, specific tasks to Member State organisations, where such organisations have been designated by the Member State concerned. The Commission shall adopt the contribution decisions regarding the contribution agreements by means of implementing acts. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 47(2).
Article 26
Role of the Commission
1. The Commission shall have overall responsibility for the implementation of the Programme, including in the field of security, without prejudice to Member States’ prerogatives in the area of national security. The Commission shall, in accordance with this Regulation, determine the priorities and evolution of the Programme, in line with the duly established user requirements, and shall supervise its implementation, without prejudice to other policies of the Union.
2. The Commission shall ensure a clear division of tasks and responsibilities between the various entities involved in the Programme and shall coordinate the activities of those entities. The Commission shall also ensure that all the entrusted entities involved in the implementation of the Programme protect the interests of the Union, guarantee the sound management of the Union’s funds and comply with the Financial Regulation and this Regulation.
3. The Commission shall procure, award and sign the contracts referred to in Article 19.
4. The Commission may entrust tasks concerning the Programme to the Agency and ESA under indirect management, according to their respective roles and responsibilities, as set out under Articles 27 and 28. In order to facilitate the achievement of the objectives referred to in Article 3 and promote the most efficient cooperation between the Commission, the Agency and ESA, the Commission may establish contribution agreements with each entrusted entity.
The Commission shall adopt the contribution decisions regarding the contribution agreements by means of implementing acts. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 47(2).
5. Without prejudice to the tasks of the contractors referred to in Article 19, the Agency or other entrusted entities, the Commission shall ensure the uptake and use of the governmental services. It shall ensure complementarity, consistency, synergies and links between the Programme and other Union actions and programmes.
6. Where appropriate, the Commission shall ensure the coherence of activities performed in the context of the Programme with the activities already carried out in the space domain at Union, national or international level. It shall encourage cooperation between the Member States, facilitate interoperability of their technological capacities and developments in the space domain, and, where relevant to the Programme, aim to ensure coherence of the secure connectivity system with the relevant activities and interoperability of capacities developed under the national recovery and resilience plans.
7. The Commission shall inform the European Parliament and the Programme committee referred to in Article 47(1) of the interim and final results of the evaluation of any procurement procedures and of any contracts, including subcontracts, with public and private entities.
Article 27
Role of the Agency
1. The own task of the Agency shall be to ensure, through its Security Accreditation Board, the security accreditation of the governmental infrastructure and governmental services in accordance with Chapter II of Title V of Regulation (EU) 2021/696.
2. The Commission shall entrust, by means of one or more contribution agreements, subject to the operational readiness of the Agency, in particular in terms of adequate level of human resources, the following tasks to the Agency:
(a) |
all or part of the operational management of the governmental infrastructure of the Programme; |
(b) |
operational security of the governmental infrastructure, including risk and threat analysis, security monitoring, in particular setting technical specifications and operational procedures, and monitoring their compliance with the general security requirements referred to in Article 30(3). |
(c) |
provision of the governmental services, in particular through the GOVSATCOM Hub; |
(d) |
management of the contracts referred to in Article 19, after their award and signature; |
(e) |
overarching coordination of user-related aspects of the governmental services in close collaboration with Member States, relevant Union agencies, the EEAS and other entities; |
(f) |
undertaking activities related to user uptake of services offered by the Programme without affecting the activities performed by the contractors under the contracts referred to in Article 19. |
3. The Commission may entrust, by means of one or more contribution agreements, other tasks to the Agency, on the basis of the needs of the Programme.
4. Where activities are entrusted to the Agency, appropriate financial, human and administrative resources shall be ensured for their implementation. For that purpose, the Commission may allocate part of the budget for the activities entrusted to the Agency for the funding of human resources necessary for their implementation.
5. By way of derogation from Article 62(1) of the Financial Regulation and subject to the Commission’s assessment of the protection of the Union’s interests, the Agency may entrust, by means of contribution agreements, specific activities to other entities, within their respective fields of competence, under the conditions of indirect management applying to the Commission.
Article 28
Role of ESA
1. Provided that the interest of the Union is protected, ESA shall, within the field of its expertise, be entrusted with the following tasks:
(a) |
the supervision of the development, of the validation and of the related deployment activities referred to in Article 4(1), point (a), and of the development and evolution referred to in Article 4(1), point (e), undertaken within the framework of contracts referred to in Article 19, in accordance with terms and conditions to be agreed in the contribution agreements referred to in Article 26(4), ensuring coordination between the tasks and budget entrusted to ESA under this Article and possible contribution by ESA, as referred to in Article 16; |
(b) |
the provision of its expertise to the Commission including for the preparation of specifications and implementation of the technical aspects of the Programme; |
(c) |
the provision of support with regard to the evaluation of contracts concluded under Article 19; |
(d) |
tasks related to the space and related ground segment of the EuroQCI referred to in Article 4(1), point (c). |
2. On the basis of an assessment by the Commission, ESA may be entrusted with other tasks on the basis of the needs of the Programme, provided that those tasks do not duplicate activities performed by another entity in the context of the Programme and that they aim to improve the efficiency of the implementation of the Programme’s activities.
CHAPTER VI
Security of the Programme
Article 29
Principles of security
Article 33 of Regulation (EU) 2021/696 shall apply to the Programme.
Article 30
Governance of security
1. The Commission shall, within its field of competence and with the support of the Agency, ensure a high degree of security, in particular, with regard to:
(a) |
the protection of infrastructure, both ground and space, and of the provision of services, particularly against physical or cyberattacks, including interference with data streams; |
(b) |
the control and management of technology transfers; |
(c) |
the development and preservation within the Union of the competences and know-how acquired; |
(d) |
the protection of sensitive non-classified information and classified information. |
2. The Commission shall consult the Council and the Member States regarding the specification and design of any aspect of the EuroQCI infrastructure, in particular the QKD that relates to the protection of EUCI.
The evaluation and approval of cryptographic products for the protection of EUCI shall be carried out while respecting the respective roles and fields of competence of the Council and the Member States.
The security accreditation authority shall verify within the security accreditation process that only approved cryptographic products are used.
3. For the purposes of paragraph 1 of this Article, the Commission shall ensure that a risk and threat analysis is performed for the governmental infrastructure referred to in Article 5(2). On the basis of that analysis, it shall determine, by means of implementing acts, the general security requirements. In doing so, the Commission shall take account of the impact of those requirements on the smooth functioning of the governmental infrastructure, in particular in terms of cost, risk management and schedule, and shall ensure that the general level of security is not reduced, the functioning of the equipment is not undermined and the cybersecurity risks are taken into account. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 47(3).
4. Article 34(3) to (7) of Regulation (EU) 2021/696 shall apply to the Programme. For the purposes of this Regulation, the term ‘component’ in Article 34 of Regulation (EU) 2021/696 shall be read as ‘governmental infrastructure’, including governmental services, and all the references to Article 34(2) of Regulation (EU) 2021/696 shall be construed as references to paragraph 3 of this Article.
Article 31
Security of the system and services deployed
Whenever the security of the Union or its Member States may be affected by the operation of the system or the provision of the governmental services, Decision (CFSP) 2021/698 shall apply.
Article 32
Security accreditation authority
The Security Accreditation Board established within the Agency under Article 72(1), point (c), of Regulation (EU) 2021/696 shall be the security accreditation authority for the governmental infrastructure and related governmental services of the Programme.
Article 33
General principles of security accreditation
Security accreditation activities related to the Programme shall be conducted in accordance with the principles laid down in Article 37, points (a) to (j), of Regulation (EU) 2021/696. For the purposes of this Regulation, the term ‘component’ in Article 37 of Regulation (EU) 2021/696 shall be read as ‘governmental infrastructure’ and all the references to Article 34(2) of Regulation (EU) 2021/696 shall be construed as references to Article 27(2) of this Regulation.
Article 34
Tasks and composition of the Security Accreditation Board
1. Article 38, with the exception of paragraph 2, points (c) to (f), and of paragraph 3, point (b), and Article 39 of Regulation (EU) 2021/696 shall apply to the Programme.
2. The Security Accreditation Board shall have the following tasks, in addition to those referred to in paragraph 1:
(a) |
examining and, except as regards documents which the Commission is to adopt under Article 30(3), approving all documentation relating to security accreditation; |
(b) |
advising, within its field of competence, the Commission on the production of draft texts for the acts referred to in Article 30(3), including for the establishment of security operating procedures, and providing a statement with its concluding position; |
(c) |
examining and approving the security risk assessment drawn up in accordance with the monitoring process referred to in Article 37, point (h), of Regulation (EU) 2021/696 and the risk and threat analysis drawn up in accordance with Article 30(3) of this Regulation, and cooperating with the Commission to establish risk mitigation measures. |
3. In addition to paragraph 1 and on an exceptional basis, only representatives of the contractors involved in governmental infrastructure and services may be invited to attend the meetings of the Security Accreditation Board, as observers, for matters directly relating to those contractors. The arrangements and conditions for their attendance shall be laid down in the rules of procedure of the Security Accreditation Board.
Article 35
Voting rules of the Security Accreditation Board
Article 40 of Regulation (EU) 2021/696 shall apply with regard to the voting rules of the Security Accreditation Board.
Article 36
Communication and impact of decisions of the Security Accreditation Board
1. Article 41(1) to (4) of Regulation (EU) 2021/696 shall apply to the decisions of the Security Accreditation Board. For the purposes of this Regulation, the term ‘component’ in Article 41 of Regulation (EU) 2021/696 shall be read as ‘governmental infrastructure’.
2. The timetable for the work of the Security Accreditation Board shall not hamper the timetable of activities provided in the work programmes referred to in Article 41(1).
Article 37
Role of the Member States in security accreditation
Article 42 of Regulation (EU) 2021/696 shall apply to the Programme.
Article 38
Protection of classified information
1. Article 43 of Regulation (EU) 2021/696 shall apply to classified information related to the Programme.
2. Subject to the provisions of the agreement on the security and exchange of classified information between the Union institutions and ESA, ESA may generate EUCI with regard to the tasks entrusted to it pursuant to Article 28(1) and (2).
CHAPTER VII
International relations
Article 39
Participation of third countries and international organisations in the Programme
1. In accordance with the conditions laid down in specific agreements concluded in accordance with Article 218 TFEU covering the participation of a third country to any Union programme, the Programme shall be open to the participation of members of EFTA which are members of EEA), as well as of the following third countries:
(a) |
acceding countries, candidate countries and potential candidates, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or in similar agreements, and in accordance with the specific conditions laid down in agreements between the Union and those countries; |
(b) |
European Neighbourhood Policy countries, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or in similar agreements, and in accordance with the specific conditions laid down in agreements between the Union and those countries; |
(c) |
third countries, other than those third countries covered in points (a) and (b). |
2. The Programme shall be open to the participation of an international organisation in accordance with a specific agreement concluded in accordance with Article 218 TFEU.
3. The specific agreement referred to in paragraphs 1 and 2 shall:
(a) |
ensure a fair balance as regards the contributions and benefits of the third country or international organisation participating in the Union programmes; |
(b) |
lay down the conditions of participation in the programmes, including the calculation of financial contributions to individual programmes, and their administrative costs; |
(c) |
not confer on the third country or international organisation any decision-making power in respect of the Union programme; |
(d) |
guarantee the rights of the Union to ensure sound financial management and to protect its financial interests. |
4. Without prejudice to the conditions laid down in paragraphs 1, 2 and 3, and in the interests of security, the Commission may, by means of implementing acts, establish additional requirements for the participation of third countries and international organisations in the Programme, to the extent compatible with the existing agreements referred to in paragraphs 1 and 2.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 47(3).
Article 40
Access to the governmental services by third countries and international organisations
Third countries and international organisations may have access to the governmental services provided that they:
(a) |
conclude an agreement, in accordance with Article 218 TFEU, laying down the terms and conditions for access to governmental services; |
(b) |
comply with Article 43(1) of Regulation (EU) 2021/696. |
For the purposes of this Regulation, the references to ‘the Programme’ in Article 43(1) of Regulation (EU) 2021/696 shall be construed as references to ‘the Programme’ established by this Regulation.
CHAPTER VIII
Programming, monitoring, evaluation and control
Article 41
Programming, monitoring and reporting
1. The Programme shall be implemented by work programmes as referred to in Article 110 of the Financial Regulation. The work programmes shall set out the actions and associated budget required to meet the objectives of the Programme and, where applicable, the overall amount reserved for blending operations. The work programmes shall complement the work programmes for GOVSATCOM component, as referred to in Article 100 of Regulation (EU) 2021/696.
The Commission shall adopt the work programmes by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 47(3).
2. Indicators to report on progress of the Programme towards the achievement of the general and specific objectives referred to in Article 3 are set out in the Annex.
3. The Commission is empowered to adopt delegated acts, in accordance with Article 45, to amend the Annex with regard to the indicators where considered necessary as well as to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework.
4. Where imperative grounds of urgency so require, the procedure provided for in Article 46 shall apply to delegated acts adopted pursuant to this Article.
5. The performance reporting system shall ensure that data for monitoring the implementation and the results of the Programme are collected efficiently, effectively and in a timely manner.
To that end, proportionate reporting requirements shall be imposed on recipients of Union funds and, where appropriate, on Member States.
6. For the purposes of paragraph 2, the recipients of Union funds shall provide appropriate information. The data necessary for the verification of the performance shall be collected in an efficient, effective and timely manner.
Article 42
Evaluation
1. The Commission shall carry out evaluations of the Programme in a timely manner to feed into the decision-making process.
2. By 21 March 2024 and every year thereafter, the Commission shall inform the European Parliament and the Council of the main findings regarding the initial implementation of the Programme, including the completion of definition activities, the consolidation of user needs and implementation plans, as well as the views of relevant stakeholders at Union and national level.
3. By 30 June 2026, the Commission shall evaluate the implementation of the Programme in light of the objectives referred to in Article 3. To that end, the Commission shall assess:
(a) |
the performance of the secure connectivity system and services provided under the Programme, in particular low latency, reliability, autonomy and worldwide access; |
(b) |
the governance and implementation models, and their efficiency; |
(c) |
the evolution of needs of the users of the Programme; |
(d) |
the synergy and complementarity of the Programme with other Union programmes, in particular GOVSATCOM and the other components of the Union Space Programme; |
(e) |
the evolution of available capacities, innovations, and development of new technologies in the space ecosystem; |
(f) |
the participation of start-ups and SMEs throughout the Union; |
(g) |
the environmental impact of the Programme taking account of the criteria set out in Article 8; |
(h) |
any cost overruns, the timeliness in meeting the established project deadlines and the effectiveness of the governance and management of the Programme; |
(i) |
the effectiveness, efficiency, relevance, coherence, and Union added value of the Programme’s activities. |
If appropriate, the evaluation shall be accompanied by an appropriate proposal.
4. The evaluation of the Programme shall take into consideration the results of the evaluation of the GOVSATCOM component pursuant to Article 102 of Regulation (EU) 2021/696.
5. The Commission shall communicate the conclusions of the evaluations accompanied by its observations, to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.
6. The entities involved in the implementation of this Regulation shall provide the Commission with the data and information necessary for the evaluation referred to in paragraph 1.
7. Two years after the full operational capability, and every two years thereafter, the Agency shall issue a market report, after consulting relevant stakeholders, on the impact of the Programme on the Union commercial satellite upstream and downstream industry with a view to ensuring the minimum possible impact on competition and the maintenance of incentives to innovate.
Article 43
Audits
Audits on the use of the Union contribution carried out by persons or entities, including by others than those mandated by the Union institutions or bodies, shall form the basis of the overall assurance pursuant to Article 127 of the Financial Regulation.
Article 44
Personal data and privacy protection
All personal data handled in the context of the tasks and activities provided for in this Regulation, including by the Agency, shall be processed in accordance with the applicable law on personal data protection, in particular Regulations (EU) 2016/679 (30) and (EU) 2018/1725 of the European Parliament and of the Council (31).
CHAPTER IX
Delegated and implementing acts
Article 45
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Articles 8(4) and 41(3) shall be conferred on the Commission until 31 December 2028.
3. The delegation of power referred to in Articles 8(4) and 41(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated act already in force.
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6. A delegated act adopted pursuant to Article 8(4) or Article 41(3) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 46
Urgency procedure
1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure.
2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 45(6). In such a case, the Commission shall repeal the act immediately following the notification of the decision to object by the European Parliament or by the Council.
Article 47
Committee procedure
1. The Commission shall be assisted by the Programme committee established by Article 107 of Regulation (EU) 2021/696, in the GOVSATCOM configuration. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
For the purposes of the adoption of implementing acts referred to in Articles 5(3) and 30(3) of this Regulation, the Programme committee referred to in the first subparagraph of this paragraph shall meet in the security configuration referred to in Article 107(1), point (e), of Regulation (EU) 2021/696.
For the purposes of the adoption of implementing acts referred to in Articles 9(2) and 10(4) of this Regulation, the Programme committee in the security configuration referred to in Article 107(1), point (e), of Regulation (EU) 2021/696 shall be duly involved.
2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
4. Where the Programme committee delivers no opinion on the draft implementing act referred to in Article 30(3) of this Regulation, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph of Regulation (EU) No 182/2011 shall apply.
CHAPTER X
Transitional and final provisions
Article 48
Information, communication and publicity
1. The recipients of Union funding shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public.
2. The Commission shall implement information and communication actions relating to the Programme, to actions taken pursuant to the Programme and to the results obtained.
3. Financial resources allocated to the Programme shall also contribute to the corporate communication of the political priorities of the Union, insofar as those priorities are related to the objectives referred to in Article 3.
Article 49
Continuity of services after 2027
If necessary, appropriations may be entered in the Union budget beyond 2027 to cover the expenses necessary to fulfil the objectives referred to in Article 3, to enable the management of actions not completed by the end of the Programme, and to cover the expenses of critical operational activities and services provision.
Article 50
Entry into force
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 15 March 2023.
For the European Parliament
The President
R. METSOLA
For the Council
The President
J. ROSWALL
(1) Position of the European Parliament of 14 February 2023 (not yet published in the Official Journal) and decision of the Council of 7 March 2023.
(2) Regulation (EU) 2021/696 of the European Parliament and of the Council of 28 April 2021 establishing the Union Space Programme and the European Union Agency for the Space Programme and repealing Regulations (EU) No 912/2010, (EU) No 1285/2013 and (EU) No 377/2014 and Decision No 541/2014/EU (OJ L 170, 12.5.2021, p. 69).
(3) Decision (EU) 2022/2481 of the European Parliament and of the Council of 14 December 2022 establishing the Digital Decade Policy Programme 2030 (OJ L 323, 19.12.2022, p. 4).
(4) Directive (EU) 2018/1972 of the European Parliament and of the Council of 11 December 2018 establishing the European Electronic Communications Code (OJ L 321, 17.12.2018, p. 36).
(5) OJ L 433 I, 22.12.2020, p. 28.
(6) Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, p. 1).
(7) Council Decision (EU) 2021/764 of 10 May 2021 establishing the Specific Programme implementing Horizon Europe – the Framework Programme for Research and Innovation, and repealing Decision 2013/743/EU (OJ L 167 I, 12.5.2021, p. 1).
(8) Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240 (OJ L 166, 11.5.2021, p. 1).
(9) Regulation (EU) 2021/947 of the European Parliament and of the Council of 9 June 2021 establishing the Neighbourhood, Development and International Cooperation Instrument – Global Europe, amending and repealing Decision No 466/2014/EU of the European Parliament and of the Council and repealing Regulation (EU) 2017/1601 of the European Parliament and of the Council and Council Regulation (EC, Euratom) No 480/2009 (OJ L 209, 14.6.2021, p. 1).
(10) Regulation (EU) 2021/1153 of the European Parliament and of the Council of 7 July 2021 establishing the Connecting Europe Facility and repealing Regulations (EU) No 1316/2013 and (EU) No 283/2014 (OJ L 249, 14.7.2021, p. 38).
(11) Regulation (EU) 2021/697 of the European Parliament and of the Council of 29 April 2021 establishing the European Defence Fund and repealing Regulation (EU) 2018/1092 (OJ L 170, 12.5.2021, p. 149).
(12) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
(13) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1).
(14) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1).
(15) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2).
(16) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor’s Office (‘the EPPO’) (OJ L 283, 31.10.2017, p. 1).
(17) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union’s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29).
(18) Decision No 243/2012/EU of the European Parliament and of the Council of 14 March 2012 establishing a multiannual radio spectrum policy programme (OJ L 81, 21.3.2012, p. 7).
(19) Council Decision 2010/427/EU of 26 July 2010 establishing the organisation and functioning of the European External Action Service (OJ L 201, 3.8.2010, p. 30).
(20) Council Decision (CFSP) 2021/698 of 30 April 2021 on the security of systems and services deployed, operated and used under the Union Space Programme which may affect the security of the Union, and repealing Decision 2014/496/CFSP (OJ L 170, 12.5.2021, p. 178).
(21) Council Decision 2013/488/EU of 23 September 2013 on the security rules for protecting EU classified information (OJ L 274, 15.10.2013, p. 1).
(22) Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53).
(23) Council Decision (EU) 2021/1764 of 5 October 2021 on the association of the Overseas Countries and Territories with the European Union including relations between the European Union on the one hand, and Greenland and the Kingdom of Denmark on the other (Decision on the Overseas Association, including Greenland) (OJ L 355, 7.10.2021, p. 6).
(24) OJ L 123, 12.5.2016, p. 1.
(25) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(26) Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433 I, 22.12.2020, p. 11).
(27) Council Directive 2008/114/EC of 8 December 2008 on the identification and designation of European critical infrastructures and the assessment of the need to improve their protection (OJ L 345, 23.12.2008, p. 75).
(28) Regulation (EU) 2021/1060 of the European Parliament and of the Council of 24 June 2021 laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (OJ L 231, 30.6.2021, p. 159).
(29) Regulation (EU) 2021/241 of the European Parliament and of the Council of 12 February 2021 establishing the Recovery and Resilience Facility (OJ L 57, 18.2.2021, p. 17).
(30) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (OJ L 119, 4.5.2016, p. 1).
(31) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
ANNEX
INDICATORS FOR THE EVALUATION OF THE PROGRAMME
The Programme will be monitored closely on the basis of a set of indicators intended to measure the extent to which the specific objectives of the Programme have been achieved and with a view to minimising administrative burdens and costs. To that end, data will be collected as regards the following set of key indicators:
1. |
General objective referred to in Article 3(1), point (a):
|
2. |
General objective referred to in Article 3(1), point (b):
|
3. |
Specific objective referred to in Article 3(2), point (a):
|
4. |
Specific objective referred to in Article 3(2), point (b):
|
5. |
Specific objective referred to in Article 3(2), point (c):
|
6. |
Specific objective referred to in Article 3(2), point (d):
|
7. |
Specific objective referred to in Article 3(2), point (e):
|
8. |
Specific objective referred to in Article 3(2), point (f):
|
9. |
Specific objective referred to in Article 3(2), point (g):
|
10. |
Specific objective referred to in Article 3(2), point (h):
|
11. |
Specific objective referred to in Article 3(2), point (i):
|
Two statements have been made with regard to this act and can be found in OJ C 101, 17.3.2023, p. 1 and at the following link[s]: ….
II Non-legislative acts
REGULATIONS
17.3.2023 |
EN |
Official Journal of the European Union |
L 79/40 |
COMMISSION DELEGATED REGULATION (EU) 2023/589
of 10 January 2023
amending Delegated Regulation (EU) 2016/127 as regards the protein requirements for infant and follow-on formula manufactured from protein hydrolysates
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (1), and in particular Article 11(2) thereof,
Whereas:
(1) |
Commission Delegated Regulation (EU) 2016/127 (2) lays down, amongst other things, specific compositional requirements for infant formula and follow-on formula manufactured from protein hydrolysates. It provides that infant formula and follow-on formula manufactured from protein hydrolysates are to comply with the requirements for protein content, protein source, protein processing as well as with the requirements for indispensable and conditionally indispensable amino acids and L-carnitine as set out in point 2.3 of Annex I and point 2.3 of Annex II to that Regulation. |
(2) |
As stated in Delegated Regulation (EU) 2016/127, in its opinion of 24 July 2014 on the essential composition of infant and follow-on formulae (3), the European Food Safety Authority (‘the Authority’) noted that the safety and suitability of each specific formula containing protein hydrolysates has to be established by clinical evaluation in the target population. So far, the Authority has evaluated positively two protein hydrolysates used in infant and follow-on formulae. The composition of those two protein hydrolysates is reflected in the requirements currently set out in Delegated Regulation (EU) 2016/127. However, those requirements may be updated in order to allow the placing on the market of a formula manufactured from protein hydrolysates with a composition different from those already positively assessed, following a case-by-case evaluation by the Authority of their safety and suitability. |
(3) |
On 6 February 2019, the Commission received a request from meyer.science GmbH, on behalf of HIPP-Werk Georg Hipp OHG and Arla Foods Ingredients, for the evaluation by the Authority of the safety and suitability of an infant and follow-on formula manufactured from a protein hydrolysate, the composition of which does not comply with the requirements laid down in point 2.3 of Annex I and point 2.3 of Annex II to Delegated Regulation (EU) 2016/127. |
(4) |
Upon request from the Commission, the Authority issued a scientific opinion on 9 March 2022 on the nutritional safety and suitability of that infant and follow-on formula (4). In that opinion, the Authority concluded that the protein hydrolysate in question is a nutritionally safe and suitable protein source for use in an infant and follow-on formula, as long as the formula in which it is used contains a minimum of 0,45 g/100 kJ (1,9 g/100 kcal) protein and complies with the other compositional criteria set out in Delegated Regulation (EU) 2016/127 and with the amino acid pattern contained in Section A of Annex III to that Regulation. |
(5) |
Taking into account the Authority’s conclusions, it is appropriate to allow the placing on the market of infant and follow-on formula manufactured from the protein hydrolysate in question. Therefore, the requirements for protein hydrolysates set out in Delegated Regulation (EU) 2016/127 should be updated and adapted to include also the requirements for that protein hydrolysate. |
(6) |
Annexes I, II and III to Delegated Regulation (EU) 2016/127 should therefore be amended accordingly. |
(7) |
Delegated Regulation (EU) 2016/127 applies to infant and follow-on formula manufactured from protein hydrolysates as of 22 February 2022. In order to allow the placing on the market of infant and follow-on formula manufactured from hydrolysed protein in accordance with the requirements set out in this Regulation without unnecessary delay, this Regulation should enter into force as a matter of urgency, |
HAS ADOPTED THIS REGULATION:
Article 1
Annexes I, II and III to Delegated Regulation (EU) 2016/127 are amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 January 2023.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 181, 29.6.2013, p. 35.
(2) Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding (OJ L 25, 2.2.2016, p. 1).
(3) EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the essential composition of infant and follow-on formulae. EFSA Journal 2014;12(7):3760.
(4) EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens), 2022. Nutritional safety and suitability of a specific protein hydrolysate derived from whey protein concentrate and used in an infant and follow-on formula manufactured from hydrolysed protein by HIPP-Werk Georg Hipp OHG (dossier submitted by meyer.science GmbH) EFSA Journal 2022;20(3):7141.
ANNEX
Annexes I, II and III to Delegated Regulation (EU) 2016/127 are amended as follows:
(1) |
in Annex I, point 2.3 is replaced by the following:
|
(2) |
in Annex II, point 2.3 is replaced by the following:
|
(3) |
in Annex III, the introductory sentence under section A is replaced by the following: ‘For the purposes of points 2.1, 2.2, 2.3.2 and 2.3.3 of Annexes I and II, the indispensable and conditionally indispensable amino acids in breast milk, expressed in mg per 100 kJ and 100 kcal, are the following:’. |
17.3.2023 |
EN |
Official Journal of the European Union |
L 79/46 |
COMMISSION DELEGATED REGULATION (EU) 2023/590
of 12 January 2023
correcting the Latvian language version of Delegated Regulation (EU) 2019/2035 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for establishments keeping terrestrial animals and hatcheries, and the traceability of certain kept terrestrial animals and hatching eggs
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (1), and in particular Articles 3(5), 87(3), 94(3), 97(2), 101(3), 106(1), Article 118(1) and (2) and Articles 119(1), 122(2), 271(2) and 279(2) thereof,
Whereas:
(1) |
The Latvian language version of Commission Delegated Regulation (EU) 2019/2035 (2) contains errors in its title and in recital (1) as regards rules for establishments keeping terrestrial animals and hatcheries, in recital (2) as regards the approval of hatcheries, in recital (11) as regards hatcheries of captive birds and hatcheries of poultry. That Regulation also contains several errors, which affect the scope of the following provisions: in Article 1(3) as regards hatcheries of captive birds; in Article 1(3), second subparagraph, point (b) as regards hatching eggs from hatcheries; in Article 1(6)(b) as regards the information obligations of the competent authority as regards its registers of hatcheries; in Article 1(9) as regards registered or approved hatcheries; in Part II, Title I, the title of Chapter 2 as regards hatcheries; in Article 7, the title and the introductory phrase as regards the requirements for granting approval of hatcheries from which hatching eggs of poultry or day-old chicks are to be moved to another Member State; in Article 18, the title and the introductory phrase as regards registers of establishments of kept terrestrial animals and hatcheries; in Part II, Title III, the title of Chapter 2 as regards hatcheries; in Article 33, the title, the introductory phrase and point (a) as regards the record-keeping obligations of operators of hatcheries; in Annex I, Part 3, the title as regards the requirements for granting approval of hatcheries; in Annex I, Part 3, point 1, the introductory phrase and points (a) and (b) as regards requirements in relation to biosecurity measures of hatcheries; in Annex I, Part 3, point 2, the introductory phrase and point (b) as regards the requirements in relation to the surveillance of hatcheries; in Annex I, Part 3, point 3, the introductory phrase and points (a), (c) and (f) as regards the requirements in relation to the facilities and equipment of hatcheries; Annex I, part 3, point 5, the introductory phrase and point (a)(i) as regards the requirements in relation to the supervision by the competent authority of hatcheries; in Annex I, Part 4, point 1(a)(ii) as regards the requirements in relation to biosecurity measures of establishments keeping poultry; in Annex I, Part 4, point 2(b) as regards the requirements in relation to surveillance of establishments keeping poultry; in Annex I, Part 4, point 3(b)(iii) and point 3(e) as regards the requirements in relation to the facilities and equipment of establishments keeping poultry; in Annex II, the title as regards microbiological control programme in hatcheries and disease surveillance programmes in establishments keeping poultry and in hatcheries; Annex II, Part 1, the title as regards the microbiological control programme in hatcheries; in Annex II, Part 2, the title as regards diseases surveillance programmes in hatcheries and in establishments keeping poultry; in Annex II, Part 2, point 2.4(b), the introductory phrase and point (iv) as regards the requirements in relation to sampling matrix; in Annex II, Part 2, point 2.5(b), first sentence and points i) and ii) as regards the requirements in relation to sampling frame and frequency of sampling. |
(2) |
The Latvian language version of Delegated Regulation (EU) 2019/2035 should therefore be corrected accordingly. The other language versions are not affected, |
HAS ADOPTED THIS REGULATION:
Article 1
(Does not concern the English language.)
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 12 January 2023.
For the Commission
The President
Ursula VON DER LEYEN
(2) Commission Delegated Regulation (EU) 2019/2035 of 28 June 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for establishments keeping terrestrial animals and hatcheries, and the traceability of certain kept terrestrial animals and hatching eggs (OJ L 314, 5.12.2019, p. 115).
17.3.2023 |
EN |
Official Journal of the European Union |
L 79/49 |
COMMISSION IMPLEMENTING REGULATION (EU) 2023/591
of 16 March 2023
accepting a request for new exporting producer treatment with regard to the definitive anti-dumping measures imposed on imports of electric bicycles originating in the People’s Republic of China and amending Implementing Regulation (EU) 2019/73
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (1),
Having regard to Commission Implementing Regulation (EU) 2019/73 of 17 January 2019 imposing a definitive anti-dumping duty and definitively collecting the provisional duty imposed on imports of electric bicycles originating in the People’s Republic of China (2), and in particular Article 1, paragraph 6, thereof,
Whereas:
1. MEASURES IN FORCE
(1) |
On 17 January 2019, the Commission imposed a definitive anti-dumping duty on imports into the Union of electric bicycles, originating in the People’s Republic of China (‘the PRC’) (‘the product concerned’) by Implementing Regulation (EU) 2019/73 (the original Regulation). |
(2) |
In the original investigation, sampling was applied for investigating the exporting producers in the People’s Republic of China in accordance with Article 17 of Regulation (EU) 2016/1036. |
(3) |
The Commission imposed individual anti-dumping duty rates ranging from 10,3 % to 62,1 % on imports of electric bicycles for the sampled exporting producers from the People’s Republic of China. For the cooperating exporting producers that were not included in the sample (with the exception of the companies subject to the parallel countervailing duty rate for all other companies Commission Implementing Regulation (EU) 2019/72 (3)) a weighted average duty of 24,2 % was imposed. These cooperating exporting producers not included in the sample are listed in Annex I to the original Regulation. A weighted average duty of 16,2 % was imposed on other cooperating companies not included in the sample (subject to the parallel countervailing duty rate for all other companies – Implementing Regulation (EU) 2019/72). These are listed in Annex II to the original Regulation. Furthermore, a country-wide duty rate of 70,1 % was imposed on electric bicycles from companies in People’s Republic of China which either did not make themselves known or did not cooperate with the anti-dumping investigation, but cooperated in the parallel anti-subsidy investigation (listed in Annex III to the original Regulation). |
(4) |
Pursuant to Article 1, paragraph 6, of the original Regulation, paragraph 2 of that Article may be amended by adding the new exporting producer to the appropriate annex with the cooperating companies not included in the sample and thus subject to the appropriate weighted average anti-dumping duty rate, where that new exporting producer in People’s Republic of China provides sufficient evidence to the Commission that:
|
2. REQUEST FOR NEW EXPORTING PRODUCER TREATMENT
(5) |
The company Zhejiang Jollo Technology Co., Ltd (‘the applicant’) submitted a request to the Commission to be granted new exporting producer treatment and hence be subject to the duty rate applicable to the cooperating companies in the People’s Republic of China not included in the sample, subject to the parallel countervailing duty rate for all other companies, i.e. 16,2 % (‘NEPT’), claiming that it met all three conditions set out in Article 1, paragraph 6, of the original Regulation. |
(6) |
In order to determine whether the applicant fulfilled the conditions for being granted NEPT, as set out in Article 1, paragraph 6 of the original Regulation (‘the NEPT conditions’), the Commission first sent a questionnaire to the applicant requesting evidence showing that it met the NEPT conditions. The applicant provided a questionnaire reply. |
(7) |
The Commission sought to verify all information it deemed necessary for the purpose of determining whether the applicant met the NEPT conditions. |
3. ANALYSIS OF THE REQUEST
(8) |
With regard to the condition set out in Article 1, paragraph 6, of the original Regulation that the applicant did not export the product concerned to the Union during the period of investigation on which the measures are based, that is from 1 October 2016 to 30 September 2017 (‘the original investigation period’), during the investigation the Commission established that the applicant could not have exported electric bicycles to the Union during the period of investigation as the applicant provided evidence that it was established in 2021. |
(9) |
With regard to the condition set out in Article 1, paragraph 6, of the original Regulation, that the applicant is not related to any exporters or producers which are subject to the anti-dumping measures imposed by the original Regulation, during the investigation the Commission established that the applicant is not related to any of the exporters or producers in the People’s Republic of China that are subject to the anti-dumping measures imposed by the original Regulation and which could have cooperated in the original investigation. |
(10) |
With regard to the condition set out in Article 1, paragraph 6, of the original Regulation, that the applicant has actually exported the product concerned to the Union after the original investigation period or has entered into an irrevocable contractual obligation to export a significant quantity to the Union, during the investigation the Commission established that based on the documentary evidence provided, the applicant had actually exported electric bicycles to the Union following the investigation period. The applicant provided sales documentations for transactions to Spain (June 2021) and Italy (August 2022). |
(11) |
Consequently, the Commission concluded that the applicant complies with the condition set out in Article 1, paragraph 6, of the original Regulation. |
(12) |
Accordingly, the applicant fulfils all three conditions to be granted NEPT, as set out in Article 1, paragraph 6, of the original Regulation and the request should therefore be accepted. Consequently, the applicant should be subject to an anti-dumping duty of 16,2 % for cooperating companies not included in the sample of the original investigation and subject to the parallel countervailing duty rate for all other companies – Implementing Regulation (EU) 2019/72. |
4. DISCLOSURE
(13) |
The applicant and the Union industry were informed of the essential facts and considerations based on which it was considered appropriate to grant the anti-dumping duty rate applicable to the cooperating companies not included in the sample of the original investigation to Zhejiang Jollo Technology Co., Ltd. |
(14) |
The parties were granted the possibility to submit comments. No comments were received. |
(15) |
The Regulation is in accordance with the opinion of the Committee established by Article 15(1) of Regulation (EU) 2016/1036 of the European Parliament and the Council, |
HAS ADOPTED THIS REGULATION:
Article 1
In Annex II to Implementing Regulation (EU) 2019/73, the following company is added to the list of cooperating companies not included in the sample:
Company |
TARIC additional code |
Zhejiang Jollo Technology Co., Ltd |
899A |
Article 2
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 March 2023.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 176, 30.6.2016, p. 21.
(2) OJ L 16, 18.1.2019, p. 108.
(3) Commission Implementing Regulation (EU) 2019/72 of 17 January 2019 imposing a definitive countervailing duty on imports of electric bicycles originating in the People's Republic of China (OJ L 16, 18.1.2019, p. 5).
17.3.2023 |
EN |
Official Journal of the European Union |
L 79/52 |
COMMISSION IMPLEMENTING REGULATION (EU) 2023/592
of 16 March 2023
amending Implementing Regulation (EU) 2019/244 imposing a definitive countervailing duty on imports of biodiesel originating in Argentina
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2016/1037 of the European Parliament and of the Council of 8 June 2016 on protection against subsidised imports from countries not members of the European Union (1), and in particular Article 24(1) thereof,
Whereas:
(1) |
Imports of biodiesel originating in Argentina are subject to definitive countervailing duties imposed by Commission Implementing Regulation (EU) 2019/244 (2) (the original investigation). |
(2) |
Oleaginosa Moreno Hermanos S.A.C.I.F.I. y A (the applicant), an Argentinian exporting producer, TARIC (3) additional code C497, subject to an individual countervailing duty rate of 25,0 %, informed the Commission on 23 May 2022 that it had changed its name to Viterra Argentina S.A. |
(3) |
The company considered that the change of name does not affect its rights to benefit from the individual countervailing duty rate applied to it under its previous name and requested the Commission to confirm it. |
(4) |
The European Association of biodiesel producers (EBB) did not agree with the applicant arguing that it had undergone more complex structural change affecting its right to continue benefitting from the level of measure established in the original investigation. |
(5) |
The Commission collected information and examined the evidence supplied by the applicant and considered that the change of name was properly registered with the relevant authorities, and did not result in any new relationship with other groups of companies which were not investigated by the Commission in the original investigation. |
(6) |
The evidence in the file confirmed the applicant’s statement that the change of the name has been approved by Public Registry of Commerce of Argentina on 3 May 2022 and the Federal Administration of Public Revenue on 1 July 2022. Accordingly, the Commission concluded that the change of name does not affect the findings of Implementing Regulation (EU) 2019/244 and in particular the countervailing duty rate applicable to it. |
(7) |
Based on the above, the name change should take effect as of the date on which the company was officially operating under the new name, i.e. 1 July 2022. |
(8) |
The Union industry (EBB) in its comments to the disclosure reiterated the arguments initially submitted on the request for a name change. It alleged that the change of name was hiding a more complex structural change, that the applicant increased its biodiesel activities by different acquisitions, changed CEO, became leader in the agricultural sector in Argentina, and that it was, somehow, related to another exporting producer, which had gone bankrupt. |
(9) |
It is recalled that all exporting producers in Argentina are subject to a price undertaking whereby they must respect a minimum import price and export their biodiesel to the Union below a volume threshold, which is annually revised for the whole country. |
(10) |
The Commission examined the above allegations and noted that the industry did not provide sufficient evidence corroborating their claims. The Commission did not find evidence pointing to an impact of the applicant’s activities in the agricultural sector, or its alleged production capacity increase on the measures currently in place. The mere name change will not allow the applicant to export a higher volume to the Union or sell below the minimum price periodically fixed by the Commission and thus cannot affect or undermine the measures currently in force. The claims made by the Union industry could not be taken into account and were therefore rejected. |
(11) |
Given the considerations in the recitals above, the Commission considered it appropriate to amend Implementing Regulation (EU) 2019/244 to reflect the changed name of the company previously attributed to additional TARIC code C497. |
(12) |
The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 15(1) of Regulation (EU) 2016/1036 of the European Parliament and of the Council (4). |
HAS ADOPTED THIS REGULATION:
Article 1
1. Article 1 of Commission Implementing Regulation 2019/244 is amended as follows:
‘Oleaginosa Moreno Hermanos S.A.C.I.F.I. y A |
25,0 % |
C497’ |
is replaced by
‘Viterra Argentina S.A. |
25,0 % |
C497’. |
2. TARIC additional code C497 previously attributed to Oleaginosa Moreno Hermanos S.A.C.I.F.I. y A shall apply to Viterra Argentina S.A., as of 1 July 2022. Any definitive duty paid on imports of products manufactured by Viterra Argentina S.A. in excess of the countervailing duty established in Article 1 of Implementing Regulation (EU) 2019/244 as regards Oleaginosa Moreno Hermanos S.A.C.I.F.I. y A shall be repaid or remitted in accordance with the applicable customs legislation.
Article 2
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 March 2023.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 176, 30.6.2016, p. 55.
(2) Commission Implementing Regulation (EU) 2019/244 of 11 February 2019 imposing a definitive countervailing duty on imports of biodiesel originating in Argentina (OJ L 40, 12.2.2019, p. 1).
(3) The Integrated Tariff of the European Union.
(4) Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (codification) (OJ L 176, 30.6.2016, p. 21).
17.3.2023 |
EN |
Official Journal of the European Union |
L 79/54 |
COMMISSION IMPLEMENTING REGULATION (EU) 2023/593
of 16 March 2023
re-imposing a definitive anti-dumping duty on imports of certain lightweight thermal paper originating in the Republic of Korea as regards the Hansol Group and amending the residual duty
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (1) (‘the basic Regulation’), and in particular Articles 9(4) and 14(1) thereof,
Whereas:
1. PROCEDURE
(1) |
Following an anti-dumping investigation in accordance with Article 5 of the basic Regulation, on 2 May 2017 the Commission adopted Implementing Regulation (EU) 2017/763 (2) imposing a definitive anti-dumping duty on imports into the Union of certain lightweight thermal paper (‘LWTP’) originating in the Republic of Korea (‘the country concerned’) (‘the Regulation at issue’). The measures took the form of fixed duty rates: EUR 104,46 per tonne net for both the Hansol group and for all other companies. |
1.1. The judgments in cases T-383/17 (3) and C-260/20 P (4)
(2) |
The Hansol group (Hansol Paper Co. Ltd. and Hansol Artone Paper Co. Ltd.) (‘Hansol’) challenged the Regulation at issue before the General Court. On 2 April 2020, the General Court issued its judgment in Case T-383/17 annulling Implementing Regulation (EU) 2017/763 insofar as it concerned Hansol. On 11 June 2020, the Commission appealed the judgment of the General Court (Case C-260/20 P). On 12 May 2022, the Court of Justice rejected the appeal. |
(3) |
The General Court found that the Commission had committed an error when establishing normal value for at least one product type sold by Hansol Artone Paper Co. Ltd. (‘Artone’). Absent domestic sales of that product type, the Commission had, pursuant to Article 2(3) of the basic Regulation, constructed normal value for Artone on the basis of Artone’s cost of production. As Hansol Paper Co. Ltd. (‘Hansol Paper’) had representative domestic sales in the ordinary course of trade of that product type, the General Court found that the Commission should have used the domestic sales price of that party as a normal value, pursuant to Article 2(1) of the basic Regulation. |
(4) |
The General Court also found that the Commission had made a manifest error of assessment in the weighting of sales in the European Union of jumbo rolls to independent customers as compared with sales to related converters for conversion into small rolls. The Commission had applied such weighting to properly reflect Hansol’s overall dumping behaviour whereas Hansol, at its request, had been granted an exemption for three of its related converters to complete a questionnaire. The General Court found that, by not accounting for a certain resales volume of Schades Nordic, one of these three related converters in the Union, the Commission had underestimated the weight of Hansol’s sales of jumbo rolls to independent customers which had a significantly lower dumping margin than its sales to related converters for resale in the form of small rolls to independent traders. The Commission had therefore infringed Article 2(11) of the basic Regulation as the calculations made by the Commission did not reflect the full extent of dumping practiced by Hansol. |
(5) |
The General Court finally found that the weighting error described under recital (4) also affected the calculation of the undercutting and injury margin, since the Commission had used the same weighting for those calculations. It therefore found that the Commission had infringed Article 3(2) and 3(3) of the basic Regulation. |
(6) |
These findings were upheld by the Court of Justice (5). |
1.2. Implementation of the judgments
(7) |
According to Article 266 of the Treaty on the Functioning of the European Union (‘TFEU’), the Union institutions are obliged to take the necessary steps to comply with the Union Courts’ judgments. In case of an annulment of an act adopted by the Union institutions in the context of an administrative procedure, such like the anti-dumping investigation in this case, compliance with the General Court’s judgment consists in the replacement of the annulled act by a new act, in which the illegality identified by the General Court is eliminated (6). |
(8) |
According to the case-law of the General Court and the Court of Justice, the procedure for replacing an annulled act may be resumed at the very point at which the illegality occurred (7). That implies, in particular, that in a situation where an act concluding an administrative procedure is annulled, that annulment does not necessarily affect the preparatory acts, such as the initiation of the anti-dumping procedure. For instance, where a regulation imposing definitive anti-dumping measures is annulled, the proceeding remains open because it is only the act concluding the proceeding that has disappeared from the Union legal order (8), except in cases where the illegality occurred at the stage of initiation. The resumption of the administrative procedure with the re-imposition of anti-dumping duties on imports that were made during the period of application of the annulled regulation cannot be considered as contrary to the rule of non-retroactivity (9). |
(9) |
In the present case, the General Court annulled the Regulation at issue as regards Hansol on the grounds mentioned under recitals (3) to (5). |
(10) |
Findings in the Regulation at issue, which were not contested, or which were contested but rejected by the General Court or not examined by the General Court, and therefore did not lead to the annulment of the Regulation at issue, remain fully valid (10). |
(11) |
Following the Court of Justice’s judgment in Case C-260/20 P, the Commission decided to partially re-open the anti-dumping investigation concerning imports of certain lightweight thermal paper that lead to the adoption of the Regulation at issue and to resume the investigation at the point at which the irregularities occurred. A Notice (‘the re-opening Notice’) was published in the Official Journal of the European Union on 30 June 2022 (11). The re-opening was limited in scope to the implementation of the judgment of the Court of Justice with regard to Hansol. |
(12) |
At the same time, the Commission decided to make imports of certain lightweight thermal paper originating in the Republic of Korea and produced by Hansol subject to registration and requested national customs authorities to await the publication of the relevant Commission Implementing Regulation re-imposing the duties before deciding on any claims for repayment and remission of anti-dumping duties insofar as imports concerning Hansol’s products were concerned (12) (‘the registration Regulation’). |
(13) |
The Commission informed interested parties of the re-opening and invited them to comment. |
2. COMMENTS FROM INTERESTED PARTIES UPON REOPENING
(14) |
The Commission received comments from Hansol and the European Thermal Paper Association (‘ETPA’) and its members. |
(15) |
Hansol noted that in the registration Regulation, the Commission had relied on the judgments of the General Court in Cases T-440/20 and T-441/20 (‘Jindal Saw’) (13) for concluding that registration was a tool so that measures may subsequently be applied against imports from the date of registration. Hansol submitted that these judgments were not yet final and that they did not apply to the present situation, as in Case T-383/17 the General Court had stated that the regulation was illegal whereas it had not stated so in Cases T-440/20 and T-441/20. It also argued that in Jindal Saw the company concerned, Jindal Saw, was one of several exporting producers and there were several countries concerned, whereas Hansol is the sole exporting producer in the case at hand which concerns only Korea. On that basis, Hansol submitted that the Commission may therefore not rely on the Jindal Saw judgments to retroactively collect the final liability for the payment of the anti-dumping duties on imports of the product concerned manufactured by Hansol. |
(16) |
Concerning the fact that the Jindal Saw judgment could still be appealed, ETPA submitted that these judgments replicate long-established case-law. ETPA also disputed the differences alleged by Hansol between the judgments in Jindal Saw and that in T-383/17, as in the operative part of the judgments in T-300/16 and T-301/16 (the cases preceding T-440/20 and T-441/20 by which the original regulations in Jindal Saw were annulled), like in T-383/17, the General Court annulled the contested regulation in its entirety, in so far as it concerns the applicant. According to ETPA, the fact that the judgment annulled the Regulation at issue only for Hansol also entails that, contrary to Hansol’s claim, it still forms part of the legal order of the Union. |
(17) |
In this respect, the Commission noted that the fact that the judgment in Case T-440/20 was still not final when the registration regulation was published does not imply that registration was not possible in this case. The General Court in that case endorsed the Commission practice of registering imports when implementing judgments, supporting the fact that the Commission can indeed register imports in such situations. The General Court stated that Article 14 of the basic Regulation, empowering the Commission to require national authorities to take appropriate measures to register imports, is of general application. In particular the General Court noted that ‘Article 14(5) of that regulation is not subject to any restriction as to the circumstances in which the Commission is empowered to require the national customs authorities to register goods’. The General Court further stated that ‘depriving the Commission of the right to resort to registration as part of proceedings for reimposing a definitive anti-dumping duty is liable to undermine the effectiveness of regulations that may lead to such a reimposition’. The judgment in any event became final in the meantime. The claim was therefore rejected. |
(18) |
Concerning Hansol’s claim that the Regulation at issue no longer stands as Hansol, for which it was annulled, was the only exporting producer concerned by that Regulation, the Commission noted that, without entering into the legal relevance of the claim, the claim is factually incorrect. Indeed, the fact that no other producers from the Republic of Korea exporting to the Union in the investigation period had been identified does not mean that Implementing Regulation (EU) 2017/763 only applies to Hansol. Indeed, in the Regulation at issue, the Commission also imposed duties on other exporting producers via the residual duty. (14) Moreover, the General Court annulled the contested Regulation only ‘in so far as it concerns Hansol Paper Co. Ltd.’. The claim was therefore rejected. |
(19) |
Hansol further indicated a concern that the Commission would possibly not correctly understand how to correct the issue of the weighting. Hansol claimed that, according to the judgment of the General Court, the percentage representing the resales of jumbo rolls by Schades Ltd. in the total sales of Jumbo rolls by Hansol Paper, Artone, and its related trader Hansol Europe to its related trader Schades Ltd., should be applied to the quantity of sales of jumbo rolls to its related converters (Schades Nordic, Heipa and R+S) for resales. The resulting quantity should be added to the quantity of sales of jumbo rolls (direct and indirect) used for the dumping margin calculation and deducted from the quantity of sales of jumbo rolls to Schades Nordic, Heipa and R+S for conversion. On that basis, Hansol provided a recalculation of the weighting between the direct and indirect sales of jumbo rolls to independent customers versus the sales to related converters for resales in the form of small rolls to independent customers. ETPA underlined that during the investigation, in addition to Schades Ltd., the only converter related to Hansol that also resold jumbo rolls was Schades Nordic and that therefore only for that reason already such an approach would not be in line with the evidence available to the Commission. It also emphasized that, while the General Court identified certain errors in the approach adopted by the Commission in the original investigation, it did not impose an approach for a revised weighting calculation and clarified that it is up to the Commission to decide what measures are appropriate to ensure compliance with the judgment. |
(20) |
With regard to this issue, the Commission noted that the method proposed by Hansol is fundamentally different from the method used by the Commission in its dumping calculation for the Regulation at issue. In that calculation establishing Hansol’s margins, the Commission quantified the total direct and indirect sales of jumbo rolls to unrelated customers made by the Hansol group as a whole as reported in the questionnaire replies of the different group entities in their sales tables. On that basis the Commission established the weight of such sales as compared to the weight of jumbo rolls for conversion into small rolls. Hansol’s proposal to apply the calculated share of jumbo rolls resales by Schades Ltd. as compared to Schades Ltd’s total purchase volumes to the other three related converters is a fundamentally different and less accurate method, in view of the jumbo roll resales volumes of the three related converters which did not reply to the questionnaire, as reported by Hansol during the proceeding. |
(21) |
The Commission further clarified that, whereas the General Court found that the Commission had erred by not including in the calculation the jumbo rolls resales volumes reported in the proceeding by Schades Nordic (15), it had not disqualified the Commission’s methodology as such. The Commission therefore strictly adhered to the General Court’s ruling by keeping the methodology for establishing the respective weight unchanged, except for the fact that it now added the volumes of jumbo rolls sold by Schades Nordic, Heipa and R+S, as required by the General Court. That calculation was further explained in the limited company-specific disclosure. |
3. RE-EXAMINATION OF THE ISSUES IDENTIFIED BY THE GENERAL COURT AND UPHELD BY THE COURT OF JUSTICE
3.1. Dumping margin
3.1.1. Normal value
(22) |
For two product types exported to the Union by Artone, the Commission had, in its calculating of dumping, constructed normal value in the absence of representative domestic sales of that party. In paragraph 148 and paragraphs 152-158 of the judgment in Case T-383/17 and paragraphs 79 and 85 of the judgment in Case C-260/20 P, the Union Courts found that, according to both the wording and the structure of the first subparagraph of Article 2(1) of the basic Regulation, it was the price actually paid or payable in the ordinary course of trade which must, as a matter of priority, be taken into consideration to establish the normal value. When the exporter does not sell the like product domestically, the normal value is to be established on the basis of prices of other sellers or producers as a matter of priority, and not on the basis of the production costs of the company concerned. |
(23) |
One of the two product types referred to in recital (22) was indeed sold on the domestic market in representative quantities and in the ordinary course of trade by the related company Hansol Paper and, therefore, the General Court found that the Commission had infringed Article 2(1) of the basic Regulation in the context of the calculation of the normal value of Artone. |
(24) |
Thus, the Commission revised the calculation of the normal value for that product type by replacing Artone’s constructed normal value by the normal value of Hansol Paper as regards that product type. |
(25) |
The other product type exported by Artone for which normal value was constructed did not have representative domestic sales by Hansol Paper either. Indeed, Hansol Paper’s domestic sales volumes fell well below the 5 % threshold of Article 2(2) of the basic Regulation. Consequently, and pursuant to Article 2(3) of the basic Regulation, the normal value of that product type had also been constructed for Hansol Paper. In the absence of representative sales prices in the ordinary course of trade of other sellers or producers in the exporting country, the construction of Artone’s normal value for this product type was therefore maintained. |
3.1.2. Weighting
(26) |
In the investigation leading to the Regulation at issue, the Commission had received questionnaire replies from Hansol, Artone, Hansol Europe (a related trader in the Union) and Schades UK Ltd., a related trader/converter located in the Union. Three converters located in the Union and related to the Hansol Group, i.e. Schades Nordic, Heipa and R+S, had requested an exemption to complete the questionnaire for companies related to the exporting producer (Annex I to the questionnaire). These parties converted the product concerned for resale, in small rolls, to independent customers. The Commission accepted their exemption request, which was based on the absence or limited volume of sales of the product concerned by these parties. |
(27) |
As per Article 2(11) of the basic Regulation, the Commission is obliged to take into account all of the export transactions to the Union when calculating the dumping margin. In order to include in its calculation of dumping the significant volume of sales by the Hansol Group to the related converters which had been exempted from completing a questionnaire, the Commission had extended the results of the dumping calculation by applying a weighting of the dumping margins calculated on the basis of the verified questionnaire replies of Hansol Paper, Artone, Hansol Europe and Schades UK Ltd. For that purpose, the Commission attributed a weight of between 15 % and 25 % to the dumping margin established for direct sales and sales of the product concerned through related companies and a weight of between 75 % and 85 % to the dumping margin established for sales to related converters for resale as small rolls to unrelated parties (16). |
(28) |
The General Court and the Court of Justice found that the Commission had infringed Article 2(11) and 9(4) of the basic Regulation. They found that the weighting used was vitiated by a manifest error as a certain volume of product concerned resold by Schades Nordic had been neglected. The volume of direct and indirect sales of the product concerned had thus been understated in the calculation of the weighting and the full extent of the dumping had consequently not been reflected in the calculations (17). |
(29) |
In light of the findings of the Union Courts as summarized in recital (28), the Commission reviewed the weighting calculation. It did so by adding to the volume of direct and indirect sales of the product concerned used for that computation, the volume of Hansol jumbo rolls resales through Schades Nordic as reported by Hansol during the investigation. The weight of Hansol’s direct and indirect sales of the product concerned as compared to its total sales to the Union consequently increased by 0,7 percentage points, whereas the weight of its sales to related converters for resale as small rolls to unrelated parties decreased by the same percentage. |
3.1.3. Dumping margin
(30) |
The Commission recalculated the dumping margin for Hansol, by replacing the constructed normal value of one product type sold by Artone by a normal value based on the domestic sales price of that product type achieved by Hansol Paper, as explained in recital (24), and by revising the weighting of the established dumping margins for the two kinds of sale, as explained in recital (29). |
(31) |
On that basis, the revised definitive weighted average dumping margin of the Hansol Group, expressed as a percentage of the CIF Union frontier price, duty unpaid, was lowered from 10,3 % to 10,2 %. |
3.2. Undercutting margin and impact analysis
(32) |
In the Regulation at issue, the same weighting which had been applied to the dumping margins for direct and indirect sales of the product concerned, on the one hand, and for sales to related converters for resale as small rolls to unrelated parties, on the other, had also been applied to calculate Hansol’s undercutting margin. |
(33) |
The Union Courts found that the error affecting the calculation of the weighting of sales also affected the price undercutting calculation and the assessment of the impact of the dumped imports on like products of the Union industry (18). |
(34) |
With regard to the calculation of undercutting, the Commission implemented the Court of Justice’s judgment by applying the revised weighting rates, as explained under recital (29), also to the undercutting margins for the direct and indirect sales of the product concerned, on the one hand, and for sales to related converters for resale as small rolls to unrelated parties, on the other. |
(35) |
The result of the comparison, expressed as a percentage of the sampled Union producers’ turnover during the investigation period, was a weighted average undercutting margin of 9,3 %. |
(36) |
The undercutting margin found during the investigation leading to the regulation at issue was 9,4 %. In view of the immaterial difference between that margin and the revised undercutting margin, the Commission concluded that that change did not warrant the reassessment of the injury or causation analysis. Therefore, it confirmed the findings in that respect as summarized in sections 4 and 5 of the Regulation imposing provisional measures (19) and recital (102) of the Regulation at issue. |
4. DISCLOSURE
(37) |
On 14 November 2022, the Commission informed all interested parties of the above findings on the basis of which it intended to propose to re-impose the anti-dumping duty on imports of certain lightweight thermal paper originating in the Republic of Korea and manufactured by Hansol and adjust the residual duty, on the basis of the facts collected and submitted relating to the original investigation. Following the final disclosure, comments were received from Hansol, ETPA and the Government of the Republic of Korea (‘GOK’). |
(38) |
The GOK expressed its concerns with regard to the way the Commission had implemented the Union Courts’ judgments as it understood that the revised dumping calculations did not fully rectify the errors identified in these judgments. However, the GOK did not further specify in what sense the Commission would have erred. |
(39) |
ETPA strongly supported the Commission’s intended course of action. |
(40) |
In its comments to the disclosure, Hansol submitted that the Commission had not corrected the mistake with regard to the normal value calculation. Hansol also submitted that the Commission had not rectified the weighting error identified by the General Court and confirmed by the Court of Justice. |
4.1. Normal value
(41) |
Hansol submitted that it agreed to the fact that the Commission had implemented the Union Courts’ judgments by using, for the comparison with Artone’s export price, the domestic sales price of Hansol Paper for a product type which that party had sold on the domestic market in representative quantities and in the ordinary course of trade (see recitals (23) and (24)). However, Hansol disagreed with the fact that the Commission, as explained in recital (25), had not done so for another product type not sold on the domestic market by Artone. |
(42) |
Hansol claimed that the Commission should nevertheless have used Hansol Paper’s sales prices of that product type hereafter also referred to as ‘product type X’ (the actual product type number is confidential). It argued that the General Court had ruled that the Commission should use other parties’ sales prices, if available, ‘as a matter of priority’. In this respect, it claimed that Hansol’s domestic sales of product type X were all profitable and, as a result, Hansol Paper’s constructed normal value for that product type was equal to a normal value based on sales prices. The constructed normal value being equal to the sales price, Hansol claimed that the Commission was under the obligation to use Hansol Paper’s sales price. |
(43) |
The Commission disagreed. First, it clarified that the General Court had confirmed that, pursuant to Article 2(3) of the basic Regulation, first subparagraph, if there are no or insufficient sales of the like product in the ordinary course of trade, the Commission shall derogate from the principle of using sales prices to establish normal value and shall base normal value on the basis of prices of other sellers or producers or, if these are not available, calculate normal value on the basis of cost of production. It specified, in paragraph 150 of the judgment in Case T-383/17, that an insufficiency of sales covers the situation in which sales of the like product in the exporting country constitutes less than 5 % of the sales volume of the product concerned to the Union. The General Court therefore confirmed that in this scenario the Commission shall not use domestic sales prices (20). In this case, Hansol Paper’s domestic sales volumes of product type X constituted less than 1 % of the sales of that product type to the Union, which is well below the 5 % threshold mentioned in Article 2(2) of the basic Regulation, and therefore its normal value of that product type was constructed by the Commission. It also recalled that during the investigation, Hansol never claimed that the Commission should not have constructed normal value of that product type for Hansol Paper. Absent of any other cooperating producer, as the Commission had constructed normal value of product type X for Hansol Paper, as explained above, and no alternative domestic sales price of that product type was therefore available, the Commission constructed normal value of product type X for Artone. |
(44) |
Second, the mere fact that the constructed normal value of a given product type is identical to the sales price thereof does not turn it into a normal value based on sales prices. A normal value established under Article 2(3) of the basic Regulation is a constructed normal value. Therefore, for the purpose of calculating dumping, this constructed normal value cannot be used for a comparison with other parties’ export prices as there is no provision for doing so in the basic Regulation. Hansol’s claim that the Union Courts’ judgments obliged the Commission to use Hansol Paper’s domestic sales price in Artone’s dumping calculation for that particular product type was therefore rejected. |
4.2. Weighting
(45) |
Hansol further submitted that the Commission had not correctly understood the method that it should adopt to correct the weighting error. It invoked paragraph 86 of the judgment in Case T-383/17 and paragraph 64 of the judgment in Case C-260/20 P to claim that the Commission should have reflected the proportion of Schades UK Ltd. sales without conversion in Hansol’s sales to its other related traders and not simply add the volume of Schades Nordic sales without conversion to Hansol’s direct and indirect sales to independent customers. Hansol also brought forward that if the General Court would have considered that the Commission would rectify the weighting error as explained in recital (29), it would, in view of the limited impact, not have reached the conclusion that the weighting error could have affected the price undercutting calculation and the assessment of the impact of the dumped imports on like products of the Union industry. |
(46) |
As a preliminary comment, Hansol’s claim suggests that the Commission had used sampling, i.e. that it had applied Article 17(1) of the basic Regulation where it decided to use Schades UK Ltd.’s data in order to calculate the dumping margin for sales of the product concerned to related converters. The Commission noted that in paragraphs 63 to 69 of the judgment in Case T-383/17, the General Court dismissed the same claim. Indeed, the Commission decided to calculate the dumping margin on Hansol’s sales to the other three related converters on the export price data from Schades UK Ltd, because it was considered the best placed to provide the most accurate figures with regard to the majority of Hansol Group’s sales to related converters in the Union for subsequent resale as small roll to unrelated customers (21). For the purposes of Hansol Group’s dumping calculation, the Commission took the view that Schades UK Ltd. was the only converter related to the Hansol group to have resold the product concerned to independent customers. This conclusion was considered incorrect by the Union Courts in view of the available evidence on file as regards Schades Nordic. |
(47) |
Indeed, the Commission noted that Hansol, in the original investigation, had reported to the Commission that Schades Nordic had resold [170 – 190] tonnes without conversion to independent customers. It also reported that the other two related converters that had been exempted, Heipa and R+S, had no resales without conversion (22). Hansol did not provide any evidence of sales of jumbo rolls by either Heipa or R+S. Therefore, Hansol’s claim was in direct contradiction with the information that it had provided during the investigation. |
(48) |
In the judgment in Case C-260/20 P, the Court of Justice clearly stated that the Commission cannot exclude information provided by interested parties purely on the ground that it was provided other than by responding to the anti-dumping questionnaire (23). The Commission, after having reopened the investigation, complied with that finding as it had taken aboard the information provided by Hansol, in the investigation, on the resales of jumbo rolls by Schades Nordic, Heipa and R+S. As Hansol had reported that Heipa and R+S had no resales of the product concerned, no correction was needed with regard to the volumes established for these parties |
(49) |
Moreover, Hansol based its claim that the Commission should apply the proportion of Schades UK Ltd.’s sales without conversion to Hansol’s three other related traders in particular on the text in paragraph 86 of the judgment in Case T-383/17 which reads: ‘(…) it should be noted that the Commission decided to use Schades (UK Ltd’s) data in order to calculate the dumping margin on the sales made by the applicant to the three other related converters.(…)’. In this respect it also referred to the statement of the Court of Justice in paragraph 64 of the judgment in Case C-260/20 P, as follows: ‘as is apparent from paragraphs 85 and 86 of the judgment under appeal, the Commission had decided to use Schades (UK Ltd’s) data to calculate the dumping margin on Hansol’s sales to the other three related converters. (…) In view of the fact that the Commission knew that Schades (Nordic) had resold certain quantities of the product concerned to independent customers without conversion, the General Court held that that institution should have reflected this in the sales of the product concerned to the other related converters. (…)’. |
(50) |
The Commission considered that Hansol misread the statements made by the Union Courts. Indeed, Schades UK Ltd’s data was used to calculate the dumping margin on Hansol’s sales to the other three related converters as the dumping margin established for Schades UK Ltd.’s sales of jumbo rolls converted into small rolls was applied to the applicable volumes for conversion of Korean origin sold to these other three related converters. In paragraph 64 the Court of Justice noted, however, that the representative nature of Schades UK Ltd.’ data ‘in no way excluded the calculation based on those data from being vitiated by errors, given the failure to take account of all the relevant data in that regard’. In other words, the Court of Justice found that the use of Schades UK Ltd. as representative for Hansol’s sales to the other related converters did not imply that the Commission could disregard the evidence on file as regards sales of jumbo rolls to independent customers reported by Schades Nordic. It did not require the Commission to reflect or extent the same proportion of Schades Ltd’s sales without conversion in Hansol’s sales to its other related traders. That would contradict the actual evidence on file, which has not been contested by Hansol. Through the re-opening of the investigation, and unlike previously done, the Commission fully considered the amounts of jumbo rolls sold to Hansol’s related converters in the Union that resold jumbo rolls without conversion. |
(51) |
It is with regard to the [170 – 190] tonnes of resales of the product concerned to independent customers by Schades Nordic that the General Court and the Court of Justice had established an error as these resales, that had been reported by Hansol in the procedure by other means than through a questionnaire reply, had not been considered by the Commission. This was corrected, as explained in recital (29), by adding to the volume of direct and indirect sales of the product concerned that volume of Hansol’s jumbo rolls resales through Schades Nordic as reported by Hansol during the investigation. No further adjustments needed to be made, as Hansol had reported that the converters Heipa and R+S had not made any resales of the product concerned to independent customers. |
(52) |
Finally, the Commission rejected that the fact that the correction made by the Commission has a small impact only on the undercutting margin and no impact on the injury and causation analysis would demonstrate that the Commission had misunderstood the Union Courts’ judgments. The General Court judgment says that ‘it could not be excluded’ that the Commission’s error could have had an impact and not that it had an impact on the injury and causation analysis. (24) In the same vein, the Court of Justice noted in paragraph 62: ‘The fact that, in light of those data, it was, at the very least, possible that the Commission had given too great a weighting to sales made to related converters for the purposes of conversion into small rolls, thereby increasing the actual dumping practised by Hansol, was sufficient to call in question the reliability and objective nature of the Commission’s assessment of the dumping practised by Hansol’. Therefore, the fact that the correction of the weighing had a small impact on the revised undercutting demonstrates nothing but that the error identified by the General Court was immaterial. Thus, this claim was rejected. |
5. LEVEL OF THE MEASURES
(53) |
The error identified by the General Court and upheld by the Court of Justice on the weighting of sales also affected the calculation of the injury margin. The Commission implemented the Union Courts’ judgments by applying the revised weighting rates, as explained under recital (29), also to the injury margins for the direct and indirect sales of the product concerned, on the one hand, and for sales to related converters for resale as small rolls to unrelated parties, on the other. |
(54) |
The result of the comparison resulted in an injury margin for Hansol of 36,9 %, whereas the injury margin established during the investigation leading to the regulation at issue was 37 % (25). Given that the re-established dumping margin is lower than the injury margin, in accordance with the applicable rules, the anti-dumping duty rate should be set at the level of the dumping rate. Accordingly, the re-imposed anti-dumping duty rate for Hansol is 10,2 %. |
(55) |
The Commission recalled that the anti-dumping duty was imposed as a fixed amount in euro per tonne net. The revised definitive duty rate of 10,2 % represents a fixed duty rate of EUR 103,16 per tonne net. |
(56) |
The Commission also recalled that the level of cooperation in this case was high, as the imports of Hansol constituted the total exports to the Union during the investigation period. Therefore, the residual anti-dumping duty was set at the level of the cooperating company. Consequently, the residual definitive duty rate, applicable to all other companies, was revised to a fixed duty rate of EUR 103,16 per tonne net. |
(57) |
The revised level of anti-dumping duty applies without any temporal interruption since the entry into force or the Regulation at issue (namely, as of 4 May 2017 onwards). Customs authorities are instructed to collect the appropriate amount on imports concerning Hansol’s products and refund any excess amount collected so far in accordance with the applicable customs legislation. |
(58) |
In view of Article 109 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (26), when an amount is to be reimbursed following a judgment of the Court of Justice of the European Union, the interest to be paid should be the rate applied by the European Central Bank to its principal refinancing operations, as published in the C series of the Official Journal of the European Union on the first calendar day of each month. |
6. CONCLUSION
(59) |
On the basis of the above, the Commission considered it appropriate to re-impose the definitive anti-dumping duty on imports of certain lightweight thermal paper weighing 65 g/m2 or less; in rolls of a width of 20 cm or more, a weight of the roll (including the paper) of 50 kg or more and a diameter of the roll (including the paper) of 40 cm or more (‘jumbo rolls’); with or without a base coat on one or both sides; coated with a thermos-sensitive substance on one or both sides; and with or without a top coat, currently falling under CN codes ex 4809 90 00, ex 4811 90 00, ex 4816 90 00 and ex 4823 90 85 (TARIC codes: 4809900010, 4811900010, 4816900010, 4823908520), originating in the Republic of Korea at a fixed duty rate of EUR 103,16 per tonne. |
(60) |
The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 15(1) of Regulation (EU) 2016/1036, |
HAS ADOPTED THIS REGULATION:
Article 1
1. A definitive anti-dumping duty is imposed on imports of certain lightweight thermal paper weighing 65 g/m2 or less; in rolls of a width of 20 cm or more, a weight of the roll (including the paper) of 50 kg or more and a diameter of the roll (including the paper) of 40 cm or more (‘jumbo rolls’); with or without a base coat on one or both sides; coated with a thermos-sensitive substance on one or both sides; and with or without a top coat, currently falling under CN codes ex 4809 90 00, ex 4811 90 00, ex 4816 90 00 and ex 4823 90 85 (TARIC codes: 4809900010, 4811900010, 4816900010, 4823908520), originating in the Republic of Korea, as of 4 May 2017.
2. The rate of the definitive anti-dumping duty applicable to the product described in paragraph 1 shall be a fixed amount of EUR 103,16 per tonne net.
3. Unless otherwise specified, the provisions in force concerning customs duties shall apply.
Article 2
1. Any definitive anti-dumping duty as regards Hansol’s products paid pursuant to Implementing Regulation (EU) 2017/763 in excess of the definitive anti-dumping duty established in Article 1 shall be repaid or remitted.
2. The repayment or remission shall be requested from national customs authorities in accordance with the applicable customs legislation. Any reimbursement that took place following the Court of Justice ruling in Case C-260/20 P Hansol Paper shall be recovered by the authorities which made the reimbursement, up to the amount set out in Article 1(2).
Article 3
The definitive anti-dumping duty imposed by Article 1 shall also be collected on imports registered in accordance with Article 1 of Implementing Regulation (EU) 2022/1041 making imports of certain lightweight thermal paper originating in the Republic of Korea subject to registration following the re-opening of the investigation in order to implement the judgment of the General Court of 2 April 2020 in Case T-383/17, as upheld by the Court of Justice in Case C-260/20 P, with regard to Implementing Regulation (EU) 2017/763.
Article 4
Customs authorities are directed to discontinue the registration of imports, established in accordance with Article 1(1) of Implementing Regulation (EU) 2022/1041, which is hereby repealed.
Article 5
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 March 2023.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 176, 30.6.2016, p. 21.
(2) Commission Implementing Regulation (EU) 2017/763 of 2 May 2017 imposing a definitive anti-dumping duty and collecting definitively the provisional duty imposed on imports of certain lightweight thermal paper originating in the Republic of Korea (OJ L 114, 3.5.2017, p. 3).
(3) ECLI:EU:T:2020:139.
(4) ECLI:EU:C:2022:370.
(5) The Court of Justice found that the General Court had erred in law in holding that the Commission had incorrectly decided to deduct SG&A costs and a profit margin for resales of the product concerned by Schades to independent customers for the purpose of establishing the export prices of that product in the context of the determination of the injury.
(6) Joined Cases 97, 193, 99 and 215/86 Asteris AE and others and Hellenic Republic v Commission [1988] ECR 2181, paragraphs 27 and 28; Case T-440/20, Jindal Saw v European Commission [2022] EU:T:2022:318, paragraphs 77-81.
(7) Case C-415/96 Spain v Commission, ECR I-6993, paragraph 31; Case C-458/98 P Industrie des Poudres Spheriques v Council [2000] ECR I-8147, paragraphs 80 to 85; Case T-301/01 Alitalia v Commission [2008] ECR II-1753, paragraphs 99 and 142; Joined Cases T-267/08 and T-279/08 Region Nord-Pas de Calais v Commission [2011] ECLI:EU:T:2011:209, paragraph 83.
(8) Case C-415/96 Spain v Commission, ECR I-6993, paragraph 31; Case C-458/98 P Industries des Poudres Spheriques v Council [2000] ECR I-8147, paragraphs 80 to 85.
(9) Cases C-256/16 Deichmann SE v Hauptzollamt Duisburg [2018] ECLI:EU:C:2018:187, paragraph 79; C-612/16 C & J Clark International Ltd v Commissioners for Her Majesty’s Revenue & Customs [2019] ECLI:EU:C:2019:508, paragraph 58; and Case T-440/20, Jindal Saw v European Commission [2022] EU:T:2022:318, paragraph 59.
(10) Case T-650/17, Jinan Meide Casting Co. Ltd [2019] ECLI:EU:T:2019:644, paragraphs. 333–342.
(11) Notice of re-opening of the anti-dumping investigation with regard to Commission Implementing Regulation (EU) 2017/763 imposing a definitive anti-dumping duty and collecting definitively the provisional duty imposed on imports of certain lightweight thermal paper originating in the Republic of Korea following the judgment of the General Court of 2 April 2020 in Case T-383/17, as upheld by the Court of Justice in case C-260/20 P (OJ C 248, 30.6.2022, p. 152).
(12) Commission Implementing Regulation (EU) 2022/1041 of 29 June 2022 making imports of certain lightweight thermal paper originating in the Republic of Korea subject to registration following the re-opening of the investigation in order to implement the judgment of the General Court of 2 April 2020 in Case T-383/17, as upheld by the Court of Justice in Case C-260/20 P, with regard to Commission Implementing Regulation (EU) 2017/763 (OJ L 173, 30.6.2022, p. 64).
(13) Case T-440/20, Jindal Saw v European Commission [2022] EU:T:2022:318, paragraphs 154 – 159.
(14) Implementing Regulation (EU) 2017/763, recitals (129) and (133).
(15) Paragraphs 86 and 87 of the General Court’s judgment in case T-383/17, paragraphs 62 – 64 of the Court of Justice’s judgment in case C-260/20 P.
(16) Commission Implementing Regulation (EU) 2016/2005 of 16 November 2016 imposing a provisional anti-dumping duty on imports of certain lightweight thermal paper originating in the Republic of Korea (OJ L 310, 17.11.2016, p. 1), recitals (45) and (46).
(17) Case T-383/17, paragraphs 83 to 87 and 92; and Case C-260/20 P, paragraph 63.
(18) Case T-383/17, paragraphs 211 and 212; and Case C-260/20 P, paragraph 112.
(19) Implementing Regulation (EU) 2016/2005.
(20) Case T-383/17, paragraphs 150 and 152.
(21) Implementing Regulation (EU) 2017/763, recital (32).
(22) Email of Hansol submitted on 19 February 2016, Sherlock number t16.002026.
(23) Case C-260/20 P, paragraphs 50 to 53.
(24) Case T-383/17, paragraph 212.
(25) Implementing Regulation (EU) 2017/763, recital (126).
(26) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
17.3.2023 |
EN |
Official Journal of the European Union |
L 79/65 |
COMMISSION IMPLEMENTING REGULATION (EU) 2023/594
of 16 March 2023
laying down special disease control measures for African swine fever and repealing Implementing Regulation (EU) 2021/605
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (1), and in particular Articles 71(3) and 259(1) thereof,
Whereas:
(1) |
African swine fever is an infectious viral disease affecting kept and wild porcine animals and can have a severe impact on the concerned animal population and the profitability of farming causing disturbance to movements of consignments of those animals and products thereof within the Union and exports to third countries. |
(2) |
Regulation (EU) 2016/429 establishes a legislative framework for the prevention and control of diseases, which are transmissible to animals or humans. African swine fever falls within the definition of a listed disease in that Regulation, and it is subject to the disease prevention and control rules laid down therein. In addition, the Annex to Commission Implementing Regulation (EU) 2018/1882 (2) lists African swine fever as a category A, D and E disease affecting Suidae, while Commission Delegated Regulation (EU) 2020/687 (3) supplements the rules for the control of category A, B and C diseases laid down in Regulation (EU) 2016/429, including disease control measures for African swine fever. |
(3) |
Regulation (EC) No 1069/2009 of the European Parliament and of the Council (4) lays down animal health rules for animal by-products in order to prevent and minimise risks to animal health arising from those by-products. In addition, Commission Regulation (EU) No 142/2011 (5) lays down certain animal health rules for animal by-products falling within the scope of Regulation (EC) No 1069/2009, including rules regarding the certification requirements for movements of consignments of those by-products in the Union. Those Regulations do not cover all the specific details and aspects in relation to the risk of the spread of African swine fever through animal by-products obtained from porcine animals kept in restricted zones II and III and animal by-products obtained from wild porcine animals from restricted zones I, II and III. It is therefore appropriate to lay down in this Regulation special disease control measures related to those animal by-products and movements of consignments of such animal by-products from restricted zones I, II and III. |
(4) |
Commission Implementing Regulation (EU) 2021/605 (6) was adopted within the framework of Regulation (EU) 2016/429, and it lays down special disease control measures regarding African swine fever to be applied for a limited period of time by the Member States listed in Annex I thereto, in restricted zones I, II and III, as listed in that Annex. The rules laid down in that Implementing Regulation were aligned, as much as possible with international standards such as those set out in Chapter 15.1 ‘Infection with African swine fever virus’ of the Terrestrial Animal Health Code of the World Organization for Animal Health (7) (WOAH Code). |
(5) |
This Regulation should also provide for a regionalisation approach, which should apply in addition to the disease control measures laid down in Delegated Regulation (EU) 2020/687 and it should list the restricted zones of Member States affected by outbreaks of African swine fever or at risk due to their proximity to such outbreaks (the Member States concerned). Those restricted zones should be differentiated by the epidemiological situation of African swine fever and the level of risk and classed as restricted zones I, II and III, with restricted zone III listing the areas with the highest level of risk for the spread of that disease and the most dynamic disease situation in kept porcine animals. In addition, those restricted zones should be listed in Annex I to this Regulation taking account of the information provided by the competent authorities of the Member States concerned as regards the disease situation, scientifically based principles and criteria for geographically defining regionalisation due to African swine fever, and the Union’s guidelines on African swine fever agreed with the Member States within the Standing Committee on Plants, Animals, Food and Feed and publicly available on the Commission’s website (8), as well as the level of risk for the spread of African swine fever and the overall epidemiological situation of African swine fever in the Member State concerned and in the neighbouring Member States or third countries, where relevant. Furthermore, any subsequent amendments of the boundaries of the restricted zones I, II and III in Annex I to this Regulation should be based on similar considerations as were used for listing and should take account of international standards, such as WOAH Code, indicating the absence of the disease for a period of at least twelve months in the zone or a country. In certain situations, taking account of the justification provided by the competent authority of the Member State concerned and scientifically based principles and criteria for geographically defining regionalisation due to African swine fever and guidelines available at Union level, that period should be reduced to three months. |
(6) |
Since the date of adoption of Implementing Regulation (EU) 2021/605, the epidemiological situation in the Union has evolved and new experience and knowledge on the epidemiology of African swine fever has been gathered in the Member States. Therefore, it is appropriate to review and adapt the current special disease control measures for African swine fever laid down in that Implementing Regulation taking account of those developments and in order to prevent the spread of that disease in the Union. Accordingly, the special disease control measures laid down in this Regulation should take account of the experience gained in the application of Implementing Regulation (EU) 2021/605. |
(7) |
Implementing Regulation (EU) 2021/605 lays down special disease control measures for African swine fever that, in general, apply to movements from restricted zones I, II and III of consignments of porcine animals kept in those restricted zones and products thereof. However, the movements of consignments of porcine animals kept in restricted zones I, II and III and products thereof within the restricted zones also present risks in relation to the spread of that disease and contribute to the lengthy persistence of the disease in those restricted zones. Therefore, taking account of the epidemiological situation of African swine fever in the Member States concerned, it is appropriate to lay down specific prohibitions and risk mitigating measures for the movements of consignments of kept porcine animals within those restricted zones and expand the scope of the current special disease control measures laid down in Union rules accordingly. |
(8) |
In the past, to ensure an effective and quick reaction to emerging risks, such as confirmation of an outbreak of African swine fever in a previously disease-free Member State or zone, individual Commission Implementing Decisions were adopted, where relevant, to rapidly identify at Union level the restricted zone for outbreaks of African swine fever in kept porcine animals, which comprised protection and surveillance zones, or the infected zone in the case of an outbreak of that disease in wild porcine animals, as provided for in Delegated Regulation (EU) 2020/687. In order to ensure clarity and transparency of Union rules, it is appropriate that following confirmation of an outbreak of African swine fever in kept or wild porcine animals in a previously disease-free Member State or zone, the concerned areas are identified at Union level as protection and surveillance zones or, in the case of wild porcine animals, as an infected zone and listed in Annex II to this Regulation with the duration of that regionalisation. In order to ensure a territorial continuity of restricted zones for kept or wild porcine animals, in specific situations and taking account of the risk assessment, where relevant, it should also be possible to list previously disease-free zones after the confirmation of an outbreak of African swine fever as restricted zones II or III in Annex I to this Regulation instead of listing these zones in Annex II hereto. |
(9) |
Taking account of the evolving epidemiological situation of African swine fever in wild porcine animals in the Union, the special disease control measures, including relevant derogations, applicable to restricted zones II laid down in this Regulation should also apply in the infected zones listed in Annex II hereto, in addition to the measures laid down in Articles 63 to 66 of Delegated Regulation (EU) 2020/687. However, due to the immediate risk of the further spread of that disease detected in wild porcine animals, movements of consignments of kept porcine animals and products thereof to other Member States and to third countries should not be authorised from the infected zones listed in Annex II hereto. |
(10) |
Article 16(2) of Implementing Regulation (EU) 2021/605 provides for a derogation from the requirement for stock-proof fencing for certain establishments of kept porcine animals for a period of three months after the confirmation of a first outbreak of African swine fever in the Member State subject to certain conditions. Taking account of the specific situation in the Member States when such stock-proof fences cannot be built within a short period of time for technical and administrative reasons, it is appropriate to provide for an extended period of six months in this Regulation, in order to ensure the proper implementation of the special disease control rules for African swine fever in a previously disease-free Member State or zone. |
(11) |
Articles 166 and 167 of Regulation (EU) 2016/429 require that consignments of products of animal origin from terrestrial animals produced or processed in establishments, food businesses or zones subject to emergency measures or movement restrictions, must be accompanied by the relevant animal health certificates. Article 19 of Implementing Regulation (EU) 2021/605 lays down operators obligations with regard to animal health certificates for movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals from restricted zones I, II and III and lists the consignments for which the health or identification mark may substitute the animal health certificate for movements of certain consignments from those restricted zones. In order to ensure the implementation of the special disease control rules for African swine fever, it is necessary to lay down adapted provisions in this Regulation related to the list of establishments for which the competent authority of the Member State concerned may substitute the animal health certificate with the health or identification mark for movements of certain consignments. |
(12) |
Article 10 of Implementing Regulation (EU) 2021/605 lays down specific prohibitions in relation to movements of consignments of germinal products obtained from porcine animals kept in restricted zones II and III outside those restricted zones. In addition, Article 31 of that Implementing Regulation lays down for specific conditions for derogations authorising movements of consignments of germinal products obtained from porcine animals kept in a restricted zone II from that restricted zone in the territory of the same Member State. Taking account of the high level of biosecurity measures in place in approved germinal product establishments, specific conditions for derogations authorising movements of consignments of germinal products obtained from porcine animals kept in a restricted zone III from that restricted zone in the territory of the same Member State should be laid down in this Regulation. Amongst other conditions, such movements should only be authorised by the competent authority of the Member State concerned if donor males and donor females were kept at approved germinal product establishments since birth or for a period of at least three months prior to the collection of the germinal products as provided for in the WOAH Code. Based on the WOAH Code, it is appropriate to lay down also the obligation to test, at least annually, for African swine fever all kept porcine animals in approved germinal product establishments that are authorised for movements of consignments of germinal products from restricted zone III. |
(13) |
Article 14 of Implementing Regulation (EU) 2021/605 lays down the general conditions for derogations from specific prohibitions in relation to movements of consignments of porcine animals kept in restricted zones I, II and III outside those zones. Article 14(1), point (a), of that Regulation refers to a general condition laid down in Article 28(2), point (a), of Delegated Regulation (EU) 2020/687, that requires all authorised movements in the protection zone to be performed exclusively via designated routes. Taking account of other risk-mitigating measures in place for the movements of consignments of porcine animals kept in restricted zones I, II and III provided for in this Regulation and in order to avoid unnecessary restrictions, a reference to the general conditions to grant derogations from prohibitions in the protection zone of Article 28 of Delegated Regulation (EU) 2020/687 should be replaced by a reference to the general conditions for granting derogations from prohibitions relevant to the surveillance zone of Article 43 of that Delegated Regulation, that requires, among other, that all authorised movements are performed prioritising major highways or mainline railways. |
(14) |
Article 35 of Implementing Regulation (EU) 2021/605 lays down specific conditions for authorising movements of consignments of category 3 materials obtained from porcine animals kept in restricted zones II outside those restricted zones within the same Member State for the purpose of the processing of animal by-products by pressure sterilisation or certain alternative methods, manufacturing of pet food and for the transformation of animal by-products and derived products into biogas or compost as provided for in Regulation (EC) No 1069/2009. Taking account of the effectiveness of the relevant processing methods to mitigate risks of African swine fever, it is appropriate also to lay down in this Regulation specific conditions for authorising movements of consignments of Category 3 materials obtained from porcine animals kept in a restricted zone III outside that restricted zone within the same Member State for the purpose of the processing of animal by-products by pressure sterilisation or certain alternative methods, the manufacturing of pet food and for the transformation of animal by-products and derived products into biogas or compost. |
(15) |
Article 44 of Implementing Regulation (EU) 2021/605 provides for special health or, where relevant, identification marks for certain products of animal origin. These products should be marked with a special health mark or, where relevant, an identification mark that is not oval and cannot be confused with the health mark or identification mark provided for in Article 5(1) of Regulation (EC) No 853/2004 of the European Parliament and of the Council (9). Taking account of the rules laid down in that Regulation and for the effective application of the special disease control rules for African swine fever concerning movements within or from restricted zones of certain consignments of fresh meat and meat products obtained from kept or wild porcine animals and in the interests of clarity, a concrete shape of special marks should be laid down in this Regulation, which provides a comprehensive set of technical measures for the control of that disease. In addition, a transitional period for a harmonised shape of such special marks should be introduced to take account of the specific situation of competent authorities and food business operators in Member States affected by African swine fever that need to make the necessary arrangements to ensure compliance with this Regulation. |
(16) |
The experience gained in the fight against African swine fever in the Union shows that certain risk mitigation and reinforced biosecurity measures are necessary in order to prevent the spread of that disease in establishments of kept porcine animals. These measures should be laid down in the Annex III to this Regulation and should cover establishments subject to derogations laid down for movements of consignments of porcine animals kept in the restricted zones I, II and III. |
(17) |
Since the date of adoption of Implementing Regulation (EU) 2021/605, the epidemiological situation in the Union has further evolved with respect to African swine fever in several Member States, in particular in populations of wild porcine animals, which have played a major role in the transmission and persistence of the virus in the Union. Despite the disease control measures taken by the Member States in accordance with Union rules, wild porcine animals continue to be a major source of transmission and persistence of the presence of that disease in the Union. The outbreaks of that disease in porcine animals present a risk also to the disease-free Member States due to the movements of wild porcine animals or as part of human mediated spread through infected materials. Taking into account the current epidemiological situation in the Union as regards African swine fever, well-co-ordinated and consistent control measures should be taken by the Member States. The application of special disease control measures before the introduction of African swine fever have been also recommended through the scientific advice provided by the European Food Safety Authority (EFSA) in its Scientific Opinion of 12 June 2018 on African swine fever in wild boar (10) and in the Scientific Report of 18 December 2019 on Epidemiological analyses of African swine fever in the European Union (11). |
(18) |
Accordingly, in order to avoid the spread of African swine fever by wild porcine animals, well-coordinated measures by the Member States are crucial to circumvent a duplication of efforts. This Regulation should therefore provide for an obligation on the Member States to establish National action plans for wild porcine animals in order to avoid the spread of African swine fever in the Union, by ensuring a coordinated and consistent approach across the Member States (national action plans). Minimum requirements for the national action plans should take account of scientific advice provided by EFSA, in particular on preventive measures to reduce and stabilise wild boar density before the introduction of that disease, passive surveillance, biosecurity measures during the hunting of wild porcine animals, in order to provide for a harmonised approach in the Member States. These national action plans and the annual results of their implementation should be presented to the Commission and to the other Member States. |
(19) |
The wild porcine animals management measures taken in the context of the national action plans should be compatible, where relevant, with Union environmental rules, including the nature protection requirements, laid down in Directive 2009/147/EC of the European Parliament and of the Council (12) and Council Directive 92/43/EEC (13). |
(20) |
In order to take account of the recent developments in the epidemiological situation of African swine fever in the Union, new experience and knowledge gathered in the Union, and in order to combat the risks associated with the spread of that disease in a proactive manner, revised and extended special disease control rules should be laid down in this Regulation. Accordingly, Implementing Regulation (EU) 2021/605 should be repealed and replaced by this Regulation. |
(21) |
Implementing Regulation (EU) 2021/605 applies until 20 April 2028. Taking account of the current epidemiological situation of African swine fever in the Union, it is necessary to maintain the special disease control measures laid down in this Regulation until that date. |
(22) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
CHAPTER I
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
Subject matter and scope
1. This Regulation lays down rules on:
(a) |
special disease control measures regarding African swine fever to be applied for a limited period of time by the Member States (14) which are listed or which have areas listed in Annex I and II (the Member States concerned). Those special disease control measures apply to kept and wild porcine animals and to products obtained from porcine animals in addition to the measures applicable in the protection, surveillance, further restricted and infected zones established by the competent authorities of those Member States in accordance with Article 21(1) and Article 63 of Delegated Regulation (EU) 2020/687. |
(b) |
listing at Union level in Annex I of restricted zones I, II and III following outbreaks of African swine fever; |
(c) |
listing at Union level in Annex II, following an outbreak of African swine fever in a previously disease-free Member State or zone:
|
2. This Regulation also lays down rules on special disease control measures regarding African swine fever to be applied for a limited period of time by all Member States.
3. This Regulation applies to:
(a) |
the movements of consignments of:
|
(b) |
the movements of:
|
(c) |
food business operators handling the consignments referred to in points (a) and (b); |
(d) |
all Member States concerning awareness raising on African swine fever; |
(e) |
all Member States concerning the establishment of national action plans for wild porcine animals in order to avoid the spread of African swine fever in the Union. |
Article 2
Definitions
For the purposes of this Regulation, the definitions laid down in Delegated Regulation (EU) 2020/687 shall apply.
In addition, the following definitions shall apply:
(a) |
‘porcine animal’ means an animal of the species of ungulates of the family Suidae listed in Annex III to Regulation (EU) 2016/429; |
(b) |
‘germinal products’ means porcine semen, oocytes and embryos obtained from kept porcine animals for artificial reproduction; |
(c) |
‘restricted zone I’ means an area of a Member State listed in Part I of Annex I with a precise geographical delimitation subject to special disease control measures and bordering restricted zones II or III; |
(d) |
‘restricted zone II’ means an area of a Member State listed in Part II of Annex I due to an outbreak of African swine fever in a wild porcine animal with a precise geographical delimitation subject to special disease control measures; |
(e) |
‘restricted zone III’ means an area of a Member State listed in Part III of Annex I due to an outbreak of African swine fever in a kept porcine animal with a precise geographical delimitation subject to special disease control measures; |
(f) |
‘previously disease-free Member State or zone’ means a Member State or zone of a Member State, where African swine fever has not been confirmed either in kept or in wild porcine animals during the preceding period of twelve months; |
(g) |
‘area listed in Annex II’ means an area of a Member State listed in Annex II:
|
(h) |
‘Category 2 materials’ means animal by-products referred to in Article 9 of Regulation (EC) No 1069/2009 obtained from kept porcine animals; |
(i) |
‘Category 3 materials’ means animal by-products referred to in Article 10 of Regulation (EC) No 1069/2009 obtained from kept porcine animals; |
(j) |
‘animal by-products approved plant’ means a plant approved by the competent authority in accordance with Article 24 of Regulation (EC) No 1069/2009; |
(k) |
‘approved germinal product establishment’ means an establishment defined in Article 2, point (2), of Commission Delegated Regulation (EU) 2020/686 (15); |
(l) |
‘registered germinal product establishment’ means an establishment defined in Article 2, point (1), of Delegated Regulation (EU) 2020/686. |
CHAPTER II
SPECIAL RULES FOR THE ESTABLISHMENT OF RESTRICTED AND INFECTED ZONES IN THE EVENT OF AN OUTBREAK OF AFRICAN SWINE FEVER
Article 3
Special rules for the immediate establishment of restricted and infected zones in the event of an outbreak of African swine fever in kept or wild porcine animals
In the event of an outbreak of African swine fever in kept or wild porcine animals, the competent authority of the Member State shall immediately establish either:
(a) |
in the case of an outbreak in kept porcine animals, a restricted zone in accordance with Article 21(1) of Delegated Regulation (EU) 2020/687 and subject to the conditions laid down in that Article; or |
(b) |
in the case of an outbreak in wild porcine animals, an infected zone in accordance with Article 63 of Delegated Regulation (EU) 2020/687. |
Article 4
Special rules for the establishment of an additional restricted zone in the event of an outbreak of African swine fever in kept or wild porcine animals
1. In the event of an outbreak of African swine fever in kept or wild porcine animals, the competent authority of the Member State may establish, on the basis of the criteria and principles for the geographical demarcation of restricted zones laid down in Article 64(1) of Regulation (EU) 2016/429, an additional restricted zone bordering the established restricted zone or infected zone referred to in Article 3 of this Regulation in order to demarcate the restricted zone or infected zone from non-restricted areas.
2. The competent authority of the Member State concerned shall ensure that the additional restricted zone referred to in paragraph 1 of this Article corresponds to the restricted zone I listed in Part I of Annex I in accordance with Article 5.
Article 5
Special rules for the listing of restricted zones I in the event of an outbreak of African swine fever in kept or wild porcine animals in an area of a Member State bordering an area where no outbreak of African swine fever has been officially confirmed
1. Following an outbreak of African swine fever in kept or wild porcine animals in an area of a Member State, bordering an area where no outbreak of African swine fever has been officially confirmed in kept or wild porcine animals, that area where no outbreak has been confirmed shall be listed, where necessary, in Part I of Annex I as a restricted zone I.
2. The competent authority of the Member State concerned shall ensure that after the listing of an area in Part I of Annex I to this Regulation as a restricted zone I, an additional restricted zone established in accordance with Article 64(1) of Regulation (EU) 2016/429 is adjusted without delay to comprise at least of the relevant restricted zone I listed in Annex I to this Regulation for that Member State.
3. The competent authority of the Member State shall establish without delay the relevant additional restricted zone in accordance with Article 64(1) of Regulation (EU) 2016/429, if the restricted zone I has been listed in Annex I to this Regulation.
Article 6
Special rules for the listing of restricted zones II or infected zones in the event of an outbreak of African swine fever in wild porcine animals in a Member State
1. Following an outbreak of African swine fever in wild porcine animals in an area of a Member State, that area shall be listed as a restricted zone II in Part II of Annex I to this Regulation, except where that area is subject to listing in accordance with paragraph 2 of this Article.
2. Following an outbreak of African swine fever in wild porcine animals in a previously disease-free Member State or zone, that area shall be listed as an infected zone in Part A of Annex II, except where, due to the proximity of a restricted zone II and in order to ensure territorial continuity of that restricted zone II, that area is subject to listing as a restricted zone II in accordance with paragraph 1 of this Article.
3. The competent authority of the Member State concerned shall ensure that the infected zone established in accordance with Article 63 of Delegated Regulation (EU) 2020/687 is adjusted without delay to comprise, at least for that Member State, the relevant:
(a) |
restricted zone II listed in Annex I to this Regulation for that Member State; or |
(b) |
infected zone listed in Part A of Annex II to this Regulation. |
Article 7
Special rules for the listing of restricted zones in the event of an outbreak of African swine fever in kept porcine animals in a Member State
1. Following an outbreak of African swine fever in kept porcine animals in an area of a Member State, that area shall be listed as a restricted zone III in Part III of Annex I, except where that area is subject to listing in accordance with paragraph 2 of this Article.
2. Following a first and single outbreak of African swine fever in kept porcine animals in a previously disease-free Member State or zone, that area shall be listed as a restricted zone, which comprises protection and surveillance zones, in Part B of Annex II, except when, due to the proximity of a restricted zone III and in order to ensure territorial continuity of that restricted zone III, that area is subject to listing as a restricted zone III in accordance with paragraph 1 of this Article.
3. The competent authority of the Member State concerned shall ensure that the restricted zone established in accordance with Article 21(1) of Delegated Regulation (EU) 2020/687 is adjusted without delay to comprise, at least for that Member State, the relevant:
(a) |
restricted zone III listed in Annex I to this Regulation for that Member State; or |
(b) |
a restricted zone, which comprises protection and surveillance zones, listed in Part B of Annex II to this Regulation. |
Article 8
General and specific application of special disease control measures in restricted zones I, II and III and in infected zones listed in Annex II
1. The Member States concerned shall apply the special disease control measures laid down in this Regulation in restricted zones I, II and III in addition to the disease control measures required to be applied in accordance with Delegated Regulation (EU) 2020/687 in:
(a) |
restricted zones established in accordance with Article 21(1) of Delegated Regulation (EU) 2020/687; |
(b) |
infected zones established in accordance with Article 63 of Delegated Regulation (EU) 2020/687. |
2. The Member States concerned shall apply the special disease control measures laid down in this Regulation applicable to restricted zones II also in the areas listed as infected zones in Part A of Annex II to this Regulation, in addition to the measures laid down in Articles 63 to 66 of Delegated Regulation (EU) 2020/687.
3. The competent authority of the Member State concerned shall prohibit the movements of consignments of kept porcine animals and products thereof to other Member States and to third countries from the infected zone of that Member State concerned listed in Part A of Annex II.
4. The competent authority of the Member State concerned may decide that the prohibition provided for in paragraph 3 shall not apply to the movements of consignments of meat products, including casings, obtained from porcine animals kept in the infected zone listed in Part A of Annex II, which have undergone the relevant risk-mitigating treatment in accordance with Annex VII to Delegated Regulation (EU) 2020/687.
CHAPTER III
SPECIAL DISEASE CONTROL MEASURES APPLICABLE TO CONSIGNMENTS OF PORCINE ANIMALS KEPT IN RESTRICTED ZONES I, II AND III AND PRODUCTS OBTAINED THEREOF IN THE MEMBER STATES CONCERNED
SECTION 1
Application of specific prohibitions on movements of consignments of kept porcine animals and products thereof in the member states concerned
Article 9
Specific prohibitions on movements of consignments of porcine animals kept in restricted zones I, II and III within and outside those restricted zones
1. The competent authority of the Member State concerned shall prohibit movements of consignments of porcine animals kept in restricted zones I, II and III within and outside those restricted zones.
2. The competent authority of the Member State concerned may decide that the prohibition provided for in paragraph 1 shall not apply to:
(a) |
movements of consignments of porcine animals kept in a restricted zone I to establishments located in the same or other restricted zones I, to restricted zones II and III or outside those restricted zones provided that the establishment of destination is located in the territory of the same Member State concerned; |
(b) |
movements of consignments of porcine animals kept in confined establishments located in restricted zones I, II and III provided that:
|
3. By way of derogation from the prohibitions provided for in paragraph 1 of this Article, the competent authority of the Member State concerned may authorise movements of consignments of porcine animals kept in restricted zones I, II and III within and outside those restricted zones in the cases covered by Articles 22 to 31 subject to compliance with the specific conditions laid down in those Articles.
Article 10
Specific prohibitions on movements of consignments of germinal products obtained from porcine animals kept in restricted zones II and III outside those restricted zones
1. The competent authority of the Member State concerned shall prohibit movements of consignments of germinal products obtained from porcine animals kept in restricted zones II and III outside those restricted zones.
2. The competent authority of the Member State concerned may decide that the prohibition provided for in paragraph 1 shall not apply to movements of consignments of germinal products of porcine animals kept in confined establishments located in restricted zones II and III provided that:
(a) |
the competent authority of the Member State concerned assessed the risks arising from such movements and that assessment indicated that the risk of the spread of African swine fever is negligible; |
(b) |
the germinal products are only moved to another confined establishment located in the same Member State concerned. |
3. By way of derogation from the prohibitions provided for in paragraph 1 of this Article, the competent authority of the Member State concerned may authorise movements of consignments of germinal products obtained from porcine animals kept in restricted zones II and III outside those restricted zones in the cases covered by Articles 32, 33 and 34 subject to compliance with the specific conditions laid down in those Articles.
Article 11
Specific prohibitions on movements of consignments of animal by-products obtained from porcine animals kept in restricted zones II and III outside those restricted zones
1. The competent authority of the Member State concerned shall prohibit movements of consignments of animal by-products obtained from porcine animals kept in restricted zones II and III outside those restricted zones.
2. The competent authority of the Member State concerned may decide that the prohibition provided for in paragraph 1 shall not apply to movements of consignments of animal by-products obtained from porcine animals kept outside restricted zones II and III and slaughtered in slaughterhouses located in restricted zones II and III, provided that there is a clear separation of those animal by-products in establishments and during transport from animal by-products obtained from porcine animals kept in restricted zones II and III.
3. By way of derogation from the prohibitions provided for in paragraph 1 of this Article, the competent authority of the Member State concerned may authorise movements of consignments of animal by-products obtained from porcine animals kept in restricted zones II and III outside those restricted zones in the cases covered by Articles 35 to 40 subject to compliance with the specific conditions laid down in those Articles.
Article 12
Specific prohibitions on movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zones II and III outside those restricted zones
1. The competent authority of the Member State concerned shall prohibit movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zones II and III outside those restricted zones.
2. The competent authority of the Member State concerned may decide that the prohibition provided for in paragraph 1 of this Article shall not apply to movements of consignments of meat products, including casings, obtained from porcine animals kept in restricted zones II and III, which have undergone the relevant risk-mitigating treatment in accordance with Annex VII to Delegated Regulation (EU) 2020/687, as regards African swine fever, in establishments designated in accordance with Article 44(1) of this Regulation.
3. By way of derogation from the prohibitions provided for in paragraph 1 of this Article, the competent authority of the Member State concerned may authorise movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zones II and III outside those restricted zones in the cases covered by Articles 41, 42 and 43 subject to compliance with the specific conditions laid down in those Articles.
Article 13
General prohibitions on movements of consignments of kept porcine animals and products thereof considered a risk for the spread of African swine fever
The competent authority of the Member State concerned may prohibit, within the territory of the same Member State, the movements of consignments of kept porcine animals and products obtained from kept porcine animals if the competent authority considers that there is a risk for the spread of African swine fever to, from or through those kept porcine animals or products thereof.
SECTION 2
General and specific conditions for derogations authorising movements of consignments of porcine animals kept in restricted zones i, ii and iii outside those restricted zones
Article 14
General conditions for derogations from specific prohibitions on movements of consignments of porcine animals kept in restricted zones I, II and III within and outside those restricted zones
1. By way of derogation from the specific prohibitions on movements of consignments of porcine animals kept in restricted zones I, II and III within and outside those restricted zones laid down in Article 9(1), the competent authority of the Member State concerned may authorise such movements in the cases covered by Articles 22 to 25 and Articles 28, 29 and 30 subject to compliance with the specific conditions laid down in those Articles, and the following conditions:
(a) |
the general conditions laid down Article 43(2) to (7) of Delegated Regulation (EU) 2020/687; and |
(b) |
the additional general conditions concerning:
|
2. Prior to granting authorisations provided for in Articles 22 to 25 and Articles 28 to 31, the competent authority of the Member State concerned shall assess the risks arising from such authorisations and that assessment must indicate that the risk of the spread of African swine fever is negligible.
3. The competent authority of the Member State concerned may decide that the additional general conditions laid down in Articles 15 and 16 shall not apply to movements of consignments of porcine animals kept in slaughterhouses located in the restricted zones I, II and III provided that:
(a) |
the kept porcine animals need to be moved to another slaughterhouse due to exceptional circumstances, such as a major breakdown in the slaughterhouse; |
(b) |
the slaughterhouse of destination is located either:
|
(c) |
the movement is authorised by the competent authority of the Member State concerned. |
Article 15
Additional general conditions on movements of consignments of porcine animals kept and germinal products collected in restricted zones I, II and III within and outside those restricted zones
1. The competent authority of the Member State concerned shall authorise movements of consignments of porcine animals kept in restricted zones I, II and III or germinal products of those animals collected in restricted zones II and III within and outside those restricted zones in the cases covered by Articles 22 to 25 and Articles 28 to 34 subject to compliance with the specific conditions laid down in those Articles and the following additional general conditions:
(a) |
the porcine animals have been kept in and have not been moved from the establishment of dispatch for a period of at least 30 days prior to the date of movement, or since birth, if they are younger than 30 days of age, and during that period no other kept porcine animals have been introduced from establishments located in restricted zones II that do not comply with the additional general conditions laid down in this Article and in Article 16 and from establishments located in restricted zones III into either:
|
(b) |
a clinical examination has been carried out on the porcine animals kept in the establishment of dispatch, including those animals to be moved or used for the collection of germinal products, with favourable results concerning African swine fever:
|
(c) |
if necessary, following the instructions of the competent authority, pathogen identification tests have been carried out prior to the date of the movement of those consignments from the establishment of dispatch or prior to the date of the collection of germinal products:
|
2. The competent authority of the Member State concerned shall obtain, where relevant, negative results of pathogen identification tests referred to in paragraph 1, point (c), before authorising the movement of the consignments of porcine animals or prior to the date of the collection of germinal products.
3. The competent authority of the Member State concerned may decide that, in the case of movements of consignments of kept porcine animals from establishments of dispatch located in restricted zones I and II within and outside those restricted zones to establishments located within the same Member State concerned, the clinical examination referred to in paragraph 1, point (b):
(a) |
shall be carried out only for porcine animals to be moved; or |
(b) |
shall not be required to be carried out, provided that:
|
4. The competent authority of the Member State concerned may decide that, in the case of movements of consignments of kept porcine animals from an establishment of dispatch located in a restricted zone III to establishments located within that restricted zone III or within restricted zones I or II in the same Member State concerned, the clinical examination referred to in paragraph 1, point (b):
(a) |
shall be carried out only for the porcine animals to be moved; or |
(b) |
shall not be required to be carried out, provided that:
|
5. The competent authority of the Member State concerned may decide that, in the case of movements of consignments of germinal products collected in restricted zones II and III to establishments located within the same Member State concerned or in other Member States, the clinical examination referred to in paragraph 1, point (b), shall not be required to be carried out, provided that:
(a) |
the establishment of dispatch has been visited by an official veterinarian with a frequency rate referred to in Article 16(1), point (a)(ii), and with a favourable outcome for all the visits by an official veterinarian during a period of at least twelve months prior to the date of the collection of germinal products, indicating that:
|
Article 16
Additional general conditions for establishments of kept porcine animals located in restricted zones I, II and III
1. The competent authority of the Member State concerned shall only authorise movements of consignments of porcine animals kept in establishments located in restricted zones I, II or III or consignments of germinal products collected in restricted zones II or III within and outside those restricted zones, in the cases covered by Articles 22 to 25 and Articles 28 to 34 subject to compliance with the specific conditions laid down in those Articles and the following additional general conditions:
(a) |
the establishment of dispatch has been visited by an official veterinarian at least once after the listing of the restricted zones I, II and III in Annex I to this Regulation or during the period of three months prior to the date of movement of the consignment, and is subject to regular visits by official veterinarians as provided for in Article 26(2) of Delegated Regulation (EU) 2020/687 as follows:
|
(b) |
the establishment of dispatch implements biosecurity requirements for African swine fever:
|
(c) |
continuous surveillance by means of testing with pathogen identification tests for African swine fever is carried out in the establishment of dispatch:
|
2. The competent authority may decide to carry out visits to the establishment of dispatch in a restricted zone III referred to in paragraph 1, point (a)(ii), with a frequency rate referred to in paragraph 1, point (a)(i), based on a favourable outcome of the last visit after the listing of the restricted zones I, II and III in Annex I or during the period of three months prior to the date of movement of the consignment indicating that:
(a) |
the biosecurity requirements referred to in paragraph 1, point (b), are implemented, and |
(b) |
the continuous surveillance referred to in paragraph 1, point (c), is in place in that establishment. |
3. The competent authority of the Member State concerned may decide that the stock-proof fencing provided for in point (2)(h) of Annex III and referred to in paragraph 1, point(b)(i), of this Article shall not be required either:
(a) |
for establishments of kept porcine animals for a period of six months from the date of confirmation of the first outbreak of African swine fever in a previously disease-free Member State or zone provided that:
|
(b) |
if the appropriate and continuous surveillance has demonstrated no evidence of the permanent presence of wild porcine animals in that Member State; or |
(c) |
for establishments of kept porcine animals for a period of six months following the date of publication of this Regulation, if consignments of porcine animals kept in restricted zones I, II and III and products thereof are only moved within those restricted zones in accordance with Articles 22, 23, 24, 28 or 30 of this Regulation. |
Article 17
Additional general conditions concerning the means of transport used for the transportation of porcine animals kept in restricted zones I, II and III within and outside those restricted zones
The competent authority of the Member State concerned shall only authorise movements of consignments of porcine animals kept in restricted zones I, II and III within and outside those restricted zones if the means of transport used for the transportation of those consignments:
(a) |
comply with requirements laid down in Article 24(1) of Delegated Regulation (EU) 2020/687; and |
(b) |
are cleaned and disinfected in accordance with Article 24(2) of Delegated Regulation (EU) 2020/687 under the control or supervision of the competent authority of the Member State concerned. |
SECTION 3
Operators’ obligations with regard to animal health certificates
Article 18
Operators’ obligations with regard to animal health certificates for movements of consignments of porcine animals kept in restricted zones I, II and III outside those restricted zones
Operators shall only move consignments of porcine animals kept in restricted zones I, II and III outside those restricted zones within the Member State concerned or to another Member State in the cases covered by Articles 22 to 25 and Articles 28 to 31 of this Regulation if those consignments are accompanied by an animal health certificate as provided for in Article 143(2) of Regulation (EU) 2016/429 that contains at least one of the following attestations of compliance with the requirements laid down in this Regulation:
(a) |
‘Porcine animals kept in a restricted zone I in compliance with the special disease control measures relating to African swine fever laid down in Commission Implementing Regulation (EU) 2023/594’; |
(b) |
‘Porcine animals kept in a restricted zone II in compliance with the special disease control measures relating to African swine fever laid down in Commission Implementing Regulation (EU) 2023/594’; |
(c) |
‘Porcine animals kept in a restricted zone III in compliance with the special disease control measures relating to African swine fever laid down in Commission Implementing Regulation (EU) 2023/594’. |
However, in the case of movements of such consignments within the same Member State concerned, the competent authority may decide that an animal health certificate does not have to be issued as referred to in Article 143(2), second subparagraph, of Regulation (EU) 2016/429.
Article 19
Operators’ obligations with regard to animal health certificates for movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals from restricted zones I, II and III
1. Operators shall only move, from restricted zones I and II within the same Member State concerned or to another Member State, consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zones I or II in the cases covered by Articles 41 and 42 of this Regulation, if those consignments are accompanied by an animal health certificate as provided for in Article 167(1) of Regulation (EU) 2016/429 that contains:
(a) |
the information required in accordance with Article 3 of Commission Delegated Regulation (EU) 2020/2154 (16); and |
(b) |
one of the following attestations of compliance with the requirements laid down in this Regulation:
|
2. Operators shall only move, from restricted zones I, II and III within the same Member State concerned or to another Member State, consignments of meat products, including casings, that have undergone the relevant risk-mitigating treatment, obtained from porcine animals kept in restricted zones I, II or III subject to compliance with the following conditions:
(a) |
the meat products, including casings, have undergone the relevant risk-mitigating treatment set out in Annex VII to Delegated Regulation (EU) 2020/687; |
(b) |
those consignments are accompanied by an animal health certificate as provided for in Article 167(1) of Regulation (EU) 2016/429 that contains:
|
3. Operators shall only move, from restricted zones I, II and III within the same Member State concerned or to another Member State, consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in areas outside restricted zones I, II and III and slaughtered either in slaughterhouses located in restricted zones I, II or III or in slaughterhouses located outside those restricted zones, if those consignments are accompanied by:
(a) |
an animal health certificate as provided for in Article 167(1) of Regulation (EU) 2016/429 that contains the information required in accordance with Article 3 of Delegated Regulation (EU) 2020/2154; and |
(b) |
one of the following attestations of compliance with the requirements laid down in this Regulation:
|
4. In the cases of movements of consignments referred to in paragraphs 1, 2 and 3 of this Article within the same Member State concerned, the competent authority may decide that an animal health certificate does not have to be issued as referred to in Article 167(1), first subparagraph, of Regulation (EU) 2016/429.
5. The competent authority of the Member State concerned may decide that, in the cases not covered by Article 167(1), first subparagraph, of Regulation (EU) 2016/429, a health mark or, where relevant, an identification mark provided for in Article 5(1), point (b), of Regulation (EC) No 853/2004 applied on the fresh meat or meat products, including casings, may substitute the animal health certificate for movements of consignments to other Member States provided that:
(a) |
a health mark or, where relevant, an identification mark is applied on the fresh meat or meat products, including casings, in either:
|
(b) |
the animal health certificate is only substituted for the following consignments:
|
(c) |
the competent authority of the Member State concerned ensures that an alternative system is in place ensuring that consignments referred to in point (b) are traceable and that those consignments fulfil the special disease control measures related to African swine fever laid down in this Regulation. |
6. The competent authority of the Member State concerned shall:
(a) |
provide the Commission and other Member States with a link to the website of the competent authority with a list of establishments located in restricted zones I, II and III:
|
(b) |
keep the list provided for in point (a) updated. |
Article 20
Operators’ obligations with regard to animal health certificates for movements of consignments of germinal products obtained from porcine animals kept in establishments located in restricted zones II or III outside those restricted zones
Operators shall only move consignments of germinal products obtained from porcine animals kept in restricted zones II or III outside those restricted zones within the same Member State concerned or to another Member State in the cases covered by Articles 32, 33 and 34 of this Regulation, if those consignments are accompanied by an animal health certificate as provided for in Article 161(1) of Regulation (EU) 2016/429 that contains at least one of the following attestations of compliance with the requirements laid down for in this Regulation:
(a) |
‘Germinal products obtained from porcine animals kept in restricted zones II in compliance with the special disease control measures relating to African swine fever laid down in Commission Implementing Regulation (EU) 2023/594’; |
(b) |
‘Germinal products obtained from porcine animals kept in restricted zone III in compliance with the special disease control measures relating to African swine fever laid down in Commission Implementing Regulation (EU) 2023/594’. |
However, in the case of movements of consignments within the same Member State concerned, the competent authority may decide that an animal health certificate does not have to be issued as referred to in Article 161(2), second subparagraph, of Regulation (EU) 2016/429.
Article 21
Operators’ obligations with regard to animal health certificates for movements of consignments of Category 2 and 3 materials obtained from porcine animals kept in restricted zones II or III outside those restricted zones
Operators shall only move consignments of Category 2 and 3 materials obtained from porcine animals kept in restricted zones II or III outside those restricted zones within the same Member State concerned or to another Member State in the cases covered by Articles 35 to 40, if those consignments are accompanied by:
(a) |
the commercial document referred to in Chapter III of Annex VIII to Regulation (EU) No 142/2011; and |
(b) |
an animal health certificate referred to in Article 22(5) of Delegated Regulation (EU) 2020/687 and set out in Annex VIII to Regulation (EU) No 142/2011. |
However, in the case of movements within the same Member State concerned, the competent authority may decide that an animal health certificate shall not be issued as referred to in Article 22(6) of Delegated Regulation (EU) 2020/687.
SECTION 4
Specific conditions for derogations authorising movements of consignments of porcine animals kept in a restricted zone I within and outside that restricted zone
Article 22
Specific conditions for derogations authorising movements of consignments of porcine animals kept in a restricted zone I within and outside that restricted zone
1. By way of derogation from the prohibition provided for in Article 9(1), the competent authority of the Member State concerned may authorise movements of consignments of porcine animals kept in a restricted zone I within and outside that restricted zone to:
(a) |
an establishment located in the territory of the same Member State concerned:
|
(b) |
an establishment located in the territory of another Member State; |
(c) |
third countries. |
2. The competent authority shall only grant the authorisations provided for in paragraph 1 subject to compliance with:
(a) |
the general conditions laid down in Article 43(2) to (7) of Delegated Regulation (EU) 2020/687; |
(b) |
the additional general conditions laid down in Article 14(2), Article 15(1), points (b) and (c), Article 15(2) and (3), and Articles 16 and 17. |
SECTION 5
Specific conditions for derogations authorising movements of consignments of porcine animals kept in a restricted zone II within and outside that restricted zone
Article 23
Specific conditions for derogations authorising movements of consignments of porcine animals kept in a restricted zone II within and outside that restricted zone in the territory of the same Member State concerned
1. By way of derogation from the prohibition provided for in Article 9(1), the competent authority of the Member State concerned may authorise movements of consignments of porcine animals kept in a restricted zone II within and outside that restricted zone to an establishment located in the territory of the same Member State concerned:
(a) |
in the same or another restricted zone II; |
(b) |
in restricted zones I or III; |
(c) |
outside the restricted zones I, II and III. |
2. The competent authority shall only grant the authorisations provided for in paragraph 1 subject to compliance with:
(a) |
the general conditions laid down in Article 43(2) to (7) of Delegated Regulation (EU) 2020/687; |
(b) |
the additional general conditions laid down in Article 14(2) and Articles 15, 16 and 17. |
3. The competent authority of the Member State concerned shall ensure that porcine animals subject to an authorised movement referred to in paragraph 1 of this Article remain in the establishment of destination for at least the monitoring period for African swine fever set out in Annex II to Delegated Regulation (EU) 2020/687.
Article 24
Specific conditions for derogations authorising movements of consignments of porcine animals kept in a restricted zone II within and outside that restricted zone to a slaughterhouse located in the territory of the same Member State concerned for the purpose of immediate slaughter
1. By way of derogation from the prohibition provided for in Article 9(1), the competent authority of the Member State concerned may authorise movements of consignments of porcine animals kept in a restricted zone II within and outside that restricted zone to a slaughterhouse located in the territory of the same Member State concerned, provided that:
(a) |
the kept porcine animals are moved for the purpose of immediate slaughter; |
(b) |
the slaughterhouse of destination is designated in accordance with Article 44(1). |
2. The competent authority shall only grant the authorisations provided for in paragraph 1 subject to compliance with:
(a) |
the general conditions laid down in Article 43(2) to (7) of Delegated Regulation (EU) 2020/687; |
(b) |
the additional general conditions laid down in Article 14(2), Article 15(1), points (b) and (c), Article 15(2) and (3), and Articles 16 and 17. |
3. By way of derogation from the prohibition provided for in Article 9(1), when the movements referred to in paragraph 1 of this Article do not comply with the conditions provided for in paragraph 2 of this Article, the competent authority of the Member State concerned may authorise movements of consignments of porcine animals kept in a restricted zone II within or outside that restricted zone, provided that:
(a) |
prior to granting the authorisation, the competent authority of the Member State concerned assessed the risks arising from such authorisation and that assessment indicated that the risk of the spread of African swine fever is negligible; |
(b) |
the kept porcine animals are moved for the purpose of immediate slaughter and in accordance with Article 28(2), Article 29(2), point (a), and Article 29(2), point (b)(i) to (v), of Delegated Regulation (EU) 2020/687; |
(c) |
the slaughterhouse of destination is designated in accordance with Article 44(1) and is located:
|
(d) |
the animal by-products obtained from porcine animals kept in a restricted zone II are processed or disposed in accordance with Articles 35 and 39; |
(e) |
the fresh meat and meat products, including casings, obtained from porcine animals kept in a restricted zone II are only moved from a slaughterhouse within the same Member State in accordance with Article 41(2), point (b). |
Article 25
Specific conditions for derogations authorising movements of consignments of porcine animals kept in a restricted zone II outside that restricted zone to restricted zones II or III in another Member State
1. By way of derogation from the prohibition provided for in Article 9(1), the competent authority of the Member State concerned may authorise movements of consignments of porcine animals kept in a restricted zone II outside that restricted zone to an establishment located in restricted zones II or III in another Member State.
2. The competent authority of the Member State concerned shall only grant the authorisations provided for in paragraph 1 where:
(a) |
the general conditions laid down in Article 43(2) to (7) of Delegated Regulation (EU) 2020/687 are met; |
(b) |
the additional general conditions laid down in Article 14(2) and Articles 15, 16 and 17 are met; |
(c) |
a channelling procedure has been set up in accordance with Article 26; |
(d) |
the kept porcine animals comply with any other additional appropriate guarantees related to African swine fever based on a positive outcome of a risk assessment of the measures against the spread of that disease:
|
(e) |
no outbreak of African swine fever has been officially confirmed in kept porcine animals in accordance with Article 11 of Delegated Regulation (EU) 2020/687 in the establishment of dispatch during the period of at least twelve months prior to the date of the movement of the consignment of kept porcine animals; |
(f) |
the operator has notified the competent authority in advance of the intention to move the consignment of kept porcine animals in accordance with Article 152, point (b), of Regulation (EU) 2016/429 and Article 96 of Commission Delegated Regulation (EU) 2020/688 (17). |
3. The competent authority of the Member State concerned shall:
(a) |
draw up a list of establishments that comply with the guarantees referred to in paragraph 2, point (d); |
(b) |
inform, in the framework of the Standing Committee on Plants, Animals, Food and Feed, the Commission and the other Member States of the guarantees provided for in accordance with paragraph 2, point (d), and of the approval by the competent authorities provided for in accordance with the paragraph 2, point (d)(ii). |
4. The approval provided for in paragraph 2, point (d)(ii), of this Article and the obligation of information provided for in paragraph 3, point (b), of this Article shall not be required when the establishment of dispatch, places of passage and the establishment of destination are all located in restricted zones I, II or III and those restricted zones are continuous, thereby ensuring that the consignment of kept porcine animals is only moved through those restricted zones I, II or III in accordance with specific conditions provided for in Article 22(4) of Delegated Regulation (EU) 2020/687.
Article 26
Specific channelling procedure for granting derogations for movements of consignments of porcine animals kept in a restricted zone II outside that restricted zone to restricted zones II or III in another Member State
1. The competent authority of the Member State concerned shall set up a channelling procedure as provided for in Article 25(2), point (c), for movements of consignments of porcine animals kept in a restricted zone II outside that restricted zone to an establishment located in restricted zones II or III in another Member State under the control of the competent authorities of:
(a) |
the establishment of dispatch; |
(b) |
the Member States of passage; |
(c) |
the establishment of destination. |
2. The competent authority of the establishment of dispatch shall:
(a) |
ensure that each means of transport used for the movements of the consignments of kept porcine animals referred to in paragraph 1 are:
|
(b) |
inform in advance the competent authority of the place of the establishment of destination and, where relevant, the competent authority of the Member State of passage, of the intention to send the consignment of kept porcine animals; |
(c) |
set up a system whereby operators are required to immediately notify the competent authority of the place of the establishment of dispatch of any accident or breakdown of any means of transport used for the transportation of the consignment of kept porcine animals; |
(d) |
ensure the establishment of an emergency plan, the chain of command and the necessary arrangements for cooperation between the competent authorities referred to in paragraph 1, points (a), (b) and (c), in the event of possible accidents during the transport, any major breakdown or any fraudulent action by operators. |
Article 27
Obligations on the competent authority of the Member State concerned of the place of the establishment of destination for consignments of porcine animals kept in a restricted zone II of another Member State
The competent authority of the Member State concerned of the place of the establishment of destination for consignments of porcine animals kept in a restricted zone II of another Member State shall:
(a) |
notify without undue delay the competent authority of the establishment of dispatch of the arrival of the consignment; |
(b) |
ensure that kept porcine animals either:
|
SECTION 6
Specific conditions for derogations authorising movements of consignments of porcine animals kept in a restricted zone III within and outside that restricted zone
Article 28
Specific conditions for derogations authorising movements of consignments of porcine animals kept in a restricted zone III within that zone and outside that restricted zone to a restricted zone I or II in the same Member State concerned
1. By way of derogation from the prohibition provided for in Article 9(1), in exceptional circumstances, where as a result of that prohibition animal welfare problems arise in an establishment where porcine animals are kept, the competent authority of the Member State concerned may authorise movements of consignments of porcine animals kept in a restricted zone III outside that restricted zone to an establishment located in a restricted zone II, or, in the absence of such a restricted zone II in that Member State, in a restricted zone I, in the territory of the same Member State provided that:
(a) |
the general conditions laid down in Article 43(2) to (7) of Delegated Regulation (EU) 2020/687 are met; |
(b) |
the additional general conditions laid down in Article 14(2), Article 15(1), (2) and (4), and Articles 16 and 17 are met; |
(c) |
the establishment of destination belongs to the same supply chain and the kept porcine animals are to be moved to complete the production cycle. |
2. By way of derogation from the prohibition provided for in Article 9(1), the competent authority of the Member State concerned may authorise movements of consignments of porcine animals kept in a restricted zone III to an establishment located within that restricted zone in the territory of the same Member State concerned, subject to compliance with:
(a) |
the general conditions laid down in Article 43(2) to (7) of Delegated Regulation (EU) 2020/687; |
(b) |
the additional general conditions laid down in Article 14(2), Article 15(1), (2) and (4), and Articles 16 and 17. |
3. The competent authority of the Member State concerned shall ensure that kept porcine animals are not moved from the establishment of destination located in the restricted zone I, II or III during at least the monitoring period for African swine fever set out in Annex II to Delegated Regulation (EU) 2020/687.
Article 29
Specific conditions for derogations authorising movements of consignments of porcine animals kept in a restricted zone III outside that restricted zone for the purpose of immediate slaughter in the same Member State concerned
1. By way of derogation from the prohibition provided for in Article 9(1), in exceptional circumstances, where as a result of that prohibition animal welfare problems arise in an establishment where porcine animals are kept, and in the case of logistic limitations in the slaughter capacity of the slaughterhouses located in the restricted zone III and designated in accordance with Article 44(1) or in the absence of a designated slaughterhouse in the restricted zone III, the competent authority of the Member State concerned may authorise for the purpose of immediate slaughter movements of porcine animals kept in a restricted zone III outside that restricted zone to a slaughterhouse designated in accordance with Article 44(1) in the same Member State as near as possible to the establishment of dispatch located:
(a) |
in a restricted zone II; |
(b) |
in a restricted zone I, where it is not possible to slaughter the animals in the restricted zone II; |
(c) |
outside of restricted zones I, II and III, where it is not possible to slaughter the animals in those restricted zones. |
2. The competent authority of the Member State concerned shall only grant an authorisation provided for in paragraph 1 where:
(a) |
the general conditions laid down in Article 43(2) to (7) of Delegated Regulation (EU) 2020/687 are met; |
(b) |
the additional general conditions laid down in Article 14(2), Article 15(1), points (b) and (c), Article 15(2), and Articles 16 and 17 are met; |
3. The competent authority of the Member State concerned shall ensure that:
(a) |
the kept porcine animals are destined for the purpose of immediate slaughter directly to a slaughterhouse designated in accordance with Article 44(1); |
(b) |
on arrival at the designated slaughterhouse, the porcine animals from the restricted zone III are kept separately from other porcine animals and are slaughtered either:
|
(c) |
after the slaughtering of the porcine animals from the restricted zone III, and before the slaughtering of other kept porcine animals starts, the slaughterhouse is cleaned and disinfected in accordance with the instructions of the competent authority of the Member State concerned. |
4. The competent authority of the Member State concerned shall ensure that:
(a) |
animal by-products obtained from porcine animals kept in the restricted zone III and moved outside that restricted zone are processed or disposed in accordance with Articles 35 and 40; |
(b) |
fresh meat and meat products, including casings, obtained from porcine animals kept in the restricted zone III and moved outside the restricted zone III are processed and stored in accordance with Article 43, point (d). |
5. By way of derogation from the prohibition provided for in Article 9(1), when the movements referred to in paragraph 1 of this Article do not comply with the conditions laid down in paragraph 2 of this Article, the competent authority of the Member State concerned may authorise movements of consignments of porcine animals kept in a restricted zone III outside that restricted zone, provided that:
(a) |
prior to granting the authorisation, the competent authority of the Member State concerned assessed the risks arising from such authorisation and that assessment indicated that the risk of the spread of African swine fever is negligible; |
(b) |
the kept porcine animals are moved for the purpose of immediate slaughter under conditions provided for in Article 29(3), points (b) and (c), and in accordance with Article 28(2) and Article 29(2) of Delegated Regulation (EU) 2020/687; |
(c) |
the slaughterhouse of destination is designated in accordance with Article 44(1) and is located:
|
(d) |
the animal by-products obtained from porcine animals kept in a restricted zone III are processed or disposed in accordance with Articles 35, 38 and 40; |
(e) |
the fresh meat and meat products, including casings, obtained from porcine animals kept in a restricted zone III are only moved from a slaughterhouse within the same Member State in accordance with Article 41(2), point (b)(i). |
Article 30
Specific conditions for derogations authorising movements of consignments of porcine animals kept in a restricted zone III within that restricted zone to a slaughterhouse located in the territory of the same Member State concerned for the purpose of immediate slaughter
1. By way of derogation from the prohibition provided for in Article 9(1), the competent authority of the Member State concerned may authorise movements of consignments of porcine animals kept in a restricted zone III to a slaughterhouse located within that restricted zone in the territory of the same Member State concerned, provided that:
(a) |
the kept porcine animals are moved for the purpose of immediate slaughter; |
(b) |
the slaughterhouse of destination is:
|
(c) |
the animal by-products obtained from porcine animals kept in a restricted zone III are processed or disposed in accordance with Articles 35, 38 and 40; |
(d) |
fresh meat and meat products, including casings, obtained from porcine animals kept in a restricted zone III are only moved from a slaughterhouse within the same Member State in accordance with Article 43, point (d). |
2. The competent authority shall only grant the authorisations provided for in paragraph 1 subject to compliance with:
(a) |
the general conditions laid down in Article 43(2) to (7) of Delegated Regulation (EU) 2020/687; |
(b) |
the additional general conditions laid down in Article 14(2), Article 15(1), points (b) and (c), Article 15(2) and (4), and Articles 16 and 17. |
3. By way of derogation from the prohibition provided for in Article 9(1), when the movements of consignments of kept porcine animals referred to in paragraph 1 of this Article do not comply with the conditions provided for in paragraph 2 of this Article, the competent authority of the Member State concerned may authorise movements of consignments of porcine animals kept in restricted zone III to a slaughterhouse within that restricted zone, provided that:
(a) |
prior to granting the authorisation the competent authority of the Member State concerned assessed the risks arising from such authorisation and that assessment indicated that the risk of the spread of African swine fever is negligible; |
(b) |
the kept porcine animals are moved for the purpose of immediate slaughter; |
(c) |
the slaughterhouse of destination is:
|
(d) |
animal by-products obtained from porcine animals kept in a restricted zone III are processed or disposed in accordance with Articles 35, 38 and 40; |
(e) |
fresh meat obtained from the porcine animals kept in a restricted zone III is marked and moved in accordance with the specific conditions for authorising movements of consignments of fresh meat obtained from kept animals of listed species from certain establishments laid down in Article 33(2) of Delegated Regulation (EU) 2020/687 to a processing establishment to undergo one of the relevant risk-mitigating treatments set out in Annex VII thereto. |
SECTION 7
Specific conditions for derogations authorising movements of consignments of porcine animals kept in restricted zones i, ii and iii outside those restricted zones to an animal by-products approved plant
Article 31
Specific conditions for derogations authorising movements of consignments of porcine animals kept in restricted zones I, II or III to an animal by-products approved plant located within or outside restricted zones I, II and III situated within the same Member State concerned
1. By way of derogation from the prohibitions provided for in Article 9(1), the competent authority of the Member State concerned may authorise movements of consignments of porcine animals kept in restricted zones I, II or III to an animal by-products approved plant located within or outside restricted zones I, II and III situated within the same Member State concerned in which:
(a) |
the kept porcine animals are immediately killed; and |
(b) |
the resulting animal by-products are disposed of in accordance with Regulation (EC) No 1069/2009. |
2. The competent authority of the Member State concerned shall only grant an authorisation provided for in paragraph 1 where:
(a) |
the general conditions laid down in Article 43(2) to (7) of Delegated Regulation (EU) 2020/687 are met; |
(b) |
the additional general conditions laid down in Article 14(2) and Article 17 are met. |
SECTION 8
Specific conditions for authorising movements of consignments of germinal products obtained from porcine animals kept in a restricted zone II outside that restricted zone
Article 32
Specific conditions for derogations authorising movements of consignments of germinal products obtained from porcine animals kept in a restricted zone II from that restricted zone in the territory of the same Member State concerned
By way of derogation from the prohibition provided for in Article 10(1), the competent authority of the Member State concerned may authorise movements of consignments of germinal products from a registered or approved germinal product establishment located in a restricted zone II to another restricted zone II or restricted zones I or III or to areas outside restricted zones I, II and III in the territory of the same Member State provided that:
(a) |
the germinal products were collected or produced, processed and stored in establishments and were obtained from kept porcine animals that comply with the conditions laid down in Article 15(1), points (b) and (c), Article 15(2) and (5), and Article 16; |
(b) |
the donor males and donor females of the porcine animals were kept at germinal product establishments where no other kept porcine animals were introduced from establishments located in restricted zones II that do not comply with the additional general conditions laid down in Articles 15 and 16 and from establishments located in restricted zones III during a period of at least 30 days prior to the date of the collection or production of the germinal products. |
Article 33
Specific conditions for derogations authorising movements of consignments of germinal products obtained from porcine animals kept in a restricted zone III from that restricted zone in the territory of the same Member State concerned
By way of derogation from the prohibition provided for in Article 10(1), the competent authority of the Member State concerned may authorise movements of consignments of germinal products from an approved germinal product establishment located in a restricted zone III to another restricted zone III or restricted zones I or II or to areas outside restricted zones I, II and III in the territory of the same Member State provided that:
(a) |
the germinal products were collected or produced, processed and stored in establishments and were obtained from kept porcine animals that comply with the conditions laid down in Article 15(1), points (b) and (c), Article 15(2) and (5), and Article 16; |
(b) |
the donor males and donor females of the porcine animals were kept at approved germinal product establishments:
|
(c) |
all kept porcine animals in the approved germinal product establishment have been subjected with favourable results to a laboratory examination for African swine fever at least annually. |
Article 34
Specific conditions for derogations authorising movements of consignments of germinal products obtained from porcine animals kept in a restricted zone II from that restricted zone to restricted zones II or III in another Member State
1. By way of derogation from the prohibition provided for in Article 10(1), the competent authority of the Member State concerned may authorise movements of consignments of the germinal products obtained from porcine animals kept in a restricted zone II from an approved germinal product establishment located in a restricted zone II to restricted zones II or III in the territory of another Member State concerned provided that:
(a) |
the germinal products were collected or produced, processed and stored at germinal product establishments in accordance with the conditions laid down in Article 15(1), points (b) and (c), Article 15(2), and Article 16; |
(b) |
the donor males and donor females of the porcine animals were kept in approved germinal product establishments:
|
(c) |
the consignments of germinal products comply with any other appropriate animal health guarantees based on a positive outcome of a risk assessment of measures against the spread of African swine fever:
|
(d) |
all kept porcine animals in the approved germinal product establishment of dispatch are subjected with favourable results to a laboratory examination for African swine fever at least annually. |
2. The competent authority of the Member State concerned shall:
(a) |
draw up a list of approved germinal product establishments that comply with the conditions laid down in paragraph 1 of this Article and which are authorised for movements of consignments of germinal products from a restricted zone II in that Member State concerned to restricted zones II and III in another Member State concerned; that list shall contain the information required to be kept by the competent authority of the Member State concerned on approved germinal product establishments for porcine animals as laid down in Article 7 of Delegated Regulation (EU) 2020/686; |
(b) |
make the list provided for in point (a) available to the public on its website and keep it up-to-date; |
(c) |
provide the Commission and the other Member States with the link to the website referred to in point (b). |
SECTION 9
Specific conditions for derogations authorising movements of consignments of animal by-products obtained from porcine animals kept in restricted zones II and III outside those restricted zones
Article 35
Specific conditions for derogations authorising movements of consignments of animal by-products obtained from porcine animals kept in restricted zones II and III outside those restricted zones within the same Member State for the purpose of processing or disposal
1. By way of derogation from Article 11(1) of this Regulation, the competent authority of the Member State concerned may authorise movements of consignments of animal by-products obtained from porcine animals kept in restricted zones II and III outside those restricted zones to a plant or establishment approved by the competent authority for the purposes of processing, disposal as waste by incineration or disposal or recovery by co-incineration of animal by-products referred to in Article 24(1), points (a), (b) and (c) of Regulation (EC) No 1069/2009, located outside restricted zones II or III situated within the same Member State provided that the means of transport are individually equipped with a satellite navigation system to determine, transmit and record its real time location.
2. The transport operator responsible for the movements of consignments of animal by-products referred to in paragraph 1 shall:
(a) |
enable the competent authority to control, by means of a satellite navigation system, the real time movement of the means of transport; |
(b) |
keep the electronic records of that movement for a period of at least two months from the date of the movement of the consignment. |
3. The competent authority may decide that the satellite navigation system referred to in paragraph 1 shall be replaced by an individual sealing of the means of transport provided that:
(a) |
the consignments of animal by-products obtained from porcine animals kept in restricted zones II and III are only moved within the same Member State for the purposes referred to in paragraph 1; |
(b) |
each means of transport is sealed by an official veterinarian immediately after the loading of the consignment of animal by-products; only an official veterinarian or enforcement authority of the Member State, as agreed with the competent authority of the Member State concerned, may break the seal and replace it with a new one, where relevant. |
4. By way of derogation from Article 11(1), the competent authority of the Member State concerned may decide to authorize movements of consignments of animal by-products referred to in paragraph 1 of this Article through a temporary collection plant approved in accordance with Art 24(1), point (i), of Regulation (EC) No 1069/2009 provided that:
(a) |
the competent authority of the Member State concerned assessed the risks arising from such movements and that assessment indicated that the risk of the spread of African swine fever is negligible; |
(b) |
the animal by-products are only moved to an approved temporary collection plant located as near as possible to the establishment of dispatch in the same Member State concerned. |
Article 36
Specific conditions for derogations authorising movements of consignments of manure obtained from porcine animals kept in restricted zones II and III outside those restricted zones within the same Member State
1. By way of derogation from Article 11(1) of this Regulation, the competent authority of the Member State concerned may authorise movements of consignments of manure, including litter and used bedding, obtained from porcine animals kept in restricted zones II and III to a landfill located outside those restricted zones within the same Member State in accordance with the specific conditions laid down in Article 51 of Delegated Regulation (EU) 2020/687.
2. By way of derogation from Article 11(1) of this Regulation, the competent authority of the Member State concerned may authorise movements of consignments of manure, including litter and used bedding, obtained from porcine animals kept in a restricted zone II for processing or disposal in accordance with Regulation (EC) No 1069/2009 in a plant approved for those purposes within the territory of the same Member State.
3. The transport operator responsible for the movements of consignments of manure, including litter and used bedding, referred to in paragraphs 1 and 2 shall:
(a) |
enable the competent authority to control, by means of a satellite navigation system, the real time movement of the means of transport; |
(b) |
keep the electronic records of that movement for a period of at least two months from the date of movement of the consignment. |
4. The competent authority of the Member State concerned may decide that the satellite navigation system referred to in paragraph 3, point (a), shall be replaced by an individual sealing of the means of transport provided that each means of transport is sealed by an official veterinarian immediately after the loading of the consignment of manure, including litter and used bedding, referred to in paragraphs 1 and 2.
Only an official veterinarian or enforcement authority of the Member State concerned, as agreed with that competent authority, may break that seal and replace it with a new one, where relevant.
Article 37
Specific conditions for authorising movements of consignments of Category 3 materials obtained from porcine animals kept in restricted zones II outside those restricted zones within the same Member State for the purposes of the processing of animal by-products referred to in Article 24(1), points (a), (e) and (g), of Regulation (EC) No 1069/2009
1. By way of derogation from Article 11(1) of this Regulation, the competent authority of the Member State concerned may authorise movements of consignments of Category 3 materials obtained from porcine animals kept in a restricted zone II outside that restricted zone to a plant or establishment approved by the competent authority for the purposes of further processing into processed feed, for the manufacturing of processed pet food and derived products intended for uses outside the feed chain, or transformation of animal by-products into biogas or compost as referred to in Article 24(1), points (a), (e) and (g), of Regulation (EC) No 1069/2009 located outside the restricted zone II situated within the same Member States provided that:
(a) |
the general conditions laid down in Article 43(2) to (7) of Delegated Regulation (EU) 2020/687 are met; |
(b) |
the additional general conditions laid down in Articles 14(2) are met; |
(c) |
the Category 3 materials originate from kept porcine animals and establishments that comply with the general conditions laid down in Article 15(1), points (b) and (c), Article 15(2) and (3), and Article 16; |
(d) |
the Category 3 materials are obtained from porcine animals kept in a restricted zone II and slaughtered either:
|
(e) |
the means of transport is individually equipped with a satellite navigation system to determine, transmit and record its real time location; |
(f) |
the consignments of Category 3 materials are moved from the slaughterhouse or other establishments of food business operators designated in accordance with Article 44(1) directly to:
|
2. The transport operator responsible for the movements of consignments of Category 3 materials referred to in paragraph 1 shall:
(a) |
enable the competent authority to control, by means of a satellite navigation system, the real time movement of the means of transport; |
(b) |
keep the electronic records of that movement for a period of at least two months from the date of the movement of the consignment. |
3. The competent authority of the Member State concerned may decide that the satellite navigation system referred to in paragraph 1, point (e), shall be replaced by an individual sealing of the means of transport, provided that:
(a) |
the Category 3 materials:
|
(b) |
each means of transport is sealed by an official veterinarian immediately after the loading of the consignment of Category 3 materials referred to in paragraph 1. |
Only an official veterinarian or enforcement authority of the Member State concerned, as agreed with the competent authority of that Member State, may break that seal and replace it with a new one, where relevant.
Article 38
Specific conditions for derogations authorising movements of consignments of Category 2 materials obtained from porcine animals kept in restricted zones II and III outside those restricted zones for the purposes of processing and disposal in another Member State
1. By way of derogation from Article 11(1) of this Regulation, the competent authority of the Member State concerned may authorise movements of consignments of animal by-products of Category 2 materials, other than manure, including litter and used bedding, referred to in Article 36 of this Regulation, obtained from porcine animals kept in restricted zones II and III to a processing plant to be processed by methods 1 to 5, as set out in Chapter III of Annex IV to Regulation (EU) No 142/2011, or to an incineration or co-incineration plant, as referred to in Article 24(1), points (a),(b) and (c), of Regulation (EC) No 1069/2009, located in another Member State, provided that:
(a) |
the general conditions laid down in Article 43(2) to (7) of Delegated Regulation (EU) 2020/687 are met; |
(b) |
the additional general conditions laid down in Articles 14(2) are met; |
(c) |
the means of transport is individually equipped with a satellite navigation system to determine, transmit and record its real time location; |
2. The transport operator responsible for movements of consignments of Category 2 materials referred to in paragraph 1 of this Article, other than manure, including litter and used bedding, referred to in Article 36, shall:
(a) |
enable the competent authority of the Member State concerned to control, by means of a satellite navigation system, the real time movement of the means of transport; and |
(b) |
keep the electronic records of that movement for a period of at least two months from the date of movement of the consignment. |
3. The competent authorities of the Member States of dispatch and of destination of the consignment of Category 2 materials referred to in paragraph 1 of this Article, other than manure, including litter and used bedding, referred to in Article 36 of this Regulation, shall ensure the controls of that consignment in accordance with Article 48of Regulation (EC) No 1069/2009.
Article 39
Specific conditions for derogations authorising movements of consignments of Category 3 materials obtained from porcine animals kept in a restricted zone II outside that restricted zone for further processing or transformation in another Member State
1. By way of derogation from Article 11(1) of this Regulation, the competent authority of the Member State concerned may authorise movements of consignments of Category 3 materials obtained from porcine animals kept in a restricted zone II outside that restricted zone to a plant or establishment approved by the competent authority for the processing of Category 3 materials into processed feed, processed pet food, derived products intended for uses outside the feed chain, or the transformation of Category 3 materials into biogas or compost as referred to in Article 24(1), points (a), (e) and (g), of Regulation (EC) No 1069/2009, located in another Member State, provided that:
(a) |
the general conditions laid down in Article 43(2) to (7) of Delegated Regulation (EU) 2020/687 are met; |
(b) |
the additional general conditions laid down in Article 14(2) are met; |
(c) |
the Category 3 materials originate from kept porcine animals and establishments that comply with the general conditions laid down in Article 15(1), points (b) and (c), Article 15(2) and (3), and Article 16; |
(d) |
the Category 3 materials referred to in paragraph 1 are obtained from porcine animals kept in a restricted zone II and slaughtered either:
|
(e) |
the means of transport is individually equipped with a satellite navigation system to determine, transmit and record its real time location; |
(f) |
the animal by-products are moved directly from the slaughterhouse or other establishments of food business operators designated in accordance with Article 44(1) to:
|
2. The transport operator responsible for movements of consignments of Category 3 materials shall:
(a) |
enable the competent authority to control, by means of a satellite navigation system, the real time movement of the means of transport; and |
(b) |
keep the electronic records of that movement for a period of at least two months from the date of the movement of the consignment. |
Article 40
Specific conditions for authorising movements of consignments of Category 3 materials obtained from porcine animals kept in restricted zones III outside that restricted zone within the same Member State for the purpose of the processing of animal by-products referred to in Article 24(1), points (a), (e) and (g), of Regulation (EC) No 1069/2009
1. By way of derogation from Article 11(1) of this Regulation, the competent authority of the Member State concerned may authorise movements of consignments of Category 3 materials obtained from porcine animals kept in a restricted zone III outside that restricted zone to a plant or establishment approved by the competent authority for the manufacturing of processed pet food, derived products intended for uses outside the feed chain, or the transformation of Category 3 materials into biogas or compost, as referred to in Article 24(1), points (a), (e) and (g), of Regulation (EC) No 1069/2009, located outside the restricted zone III situated within the same Member States provided that:
(a) |
the general conditions laid down in Article 43(2) to (7) of Delegated Regulation (EU) 2020/687 are met; |
(b) |
the additional general conditions laid down in Articles 14(2) are met; |
(c) |
the Category 3 materials originate from kept porcine animals and establishments that comply with the general conditions laid down in Article 15(1), points (b) and (c), Article 15(2) and (3), and Article 16; |
(d) |
the Category 3 materials are obtained from porcine animals kept in a restricted zone III and slaughtered in accordance with Article 29 or 30; |
(e) |
the means of transport is individually equipped with a satellite navigation system to determine, transmit and record its real time location; |
(f) |
the consignments of Category 3 materials are moved directly from the slaughterhouse or other establishments of food business operators designated in accordance with Article 44(1) to:
|
2. The transport operator responsible for the movements of consignments of Category 3 materials referred to in paragraph 1 shall:
(a) |
enable the competent authority to control by means of a satellite navigation system the real time movement of the means of transport; |
(b) |
keep the electronic records of that movement for a period of at least two months from the date of movement of the consignment. |
3. The competent authority of the Member State concerned may decide that the satellite navigation system referred to in paragraph 1, point (e), shall be replaced by an individual sealing of the means of transport provided that:
(a) |
the Category 3 materials are only moved within the same Member State for the purposes referred to in paragraph 1; |
(b) |
each means of transport is sealed by an official veterinarian immediately after the loading of the consignment of Category 3 materials referred to in paragraph 1. |
Only an official veterinarian or enforcement authority of the Member State concerned, as agreed with the competent authority of that Member State, may break that seal and replace it with a new one, where relevant.
SECTION 10
Specific conditions for derogations authorising movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zones II and III outside those restricted zones
Article 41
Specific conditions for authorising movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in a restricted zone II outside that restricted zone in the territory of the same Member State concerned
1. By way of derogation from the prohibitions provided for in Article 12(1), the competent authority of the Member State concerned may authorise movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in a restricted zone II outside that restricted zone in the territory of the same Member State concerned, provided that:
(a) |
the general conditions laid down in Article 43(2) to (7) of Delegated Regulation (EU) 2020/687 are met; |
(b) |
the fresh meat and meat products, including casings, are obtained from porcine animals kept in establishments that comply with the additional general conditions laid down in Article 14(2), Article 15(1), points (b) and (c), Article 15(2) and (3), and Article 16; |
(c) |
the fresh meat and meat products, including casings, have been produced in establishments designated in accordance with Article 44(1). |
2. By way of derogation from the prohibitions provided for in Article 12(1), where the conditions laid down in paragraph 1 of this Article are not met, the competent authority of the Member State concerned may authorise movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in a restricted zone II outside that restricted zone in the territory of the same Member State concerned, provided that:
(a) |
the fresh meat and meat products, including casings, have been produced in establishments designated in accordance with Article 44(1); |
(b) |
the fresh meat and meat products, including casings, either
|
Article 42
Specific conditions for derogations authorising movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in a restricted zone II outside that restricted zone to other Member States and to third countries
By way of derogation from the prohibitions provided for in Article 12(1), the competent authority of the Member State concerned may authorise movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in a restricted zone II outside that restricted zone to other Member States and to third countries, provided that:
(a) |
the general conditions laid down in Article 43(2) to (7) of Delegated Regulation (EU) 2020/687 are met; |
(b) |
the additional general conditions laid down in Article 14(2) are met; |
(c) |
the fresh meat and meat products, including casings, have been obtained from porcine animals kept in establishments that comply with the general conditions laid down in:
|
(d) |
the fresh meat and meat products, including casings, have been produced in establishments designated in accordance with Article 44(1). |
Article 43
Specific conditions for derogations authorising movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in a restricted zone III to other restricted zones I, II and III or areas outside restricted zones I, II and III in the territory of the same Member State
By way of derogation from the prohibitions provided for in Article 12(1), the competent authority of the Member State concerned may authorise movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in a restricted zone III to other restricted zones I, II and III or areas outside restricted zones I, II and III in the territory of the same Member State, provided that:
(a) |
the general conditions laid down in Article 43(2) to (7) of Delegated Regulation (EU) 2020/687 are met; |
(b) |
the additional general conditions laid down in Article 14(2) are met; |
(c) |
the fresh meat and meat products, including casings, have been obtained from porcine animals:
|
(d) |
the fresh meat and meat products, including casings, have been produced in establishments designated in accordance with Article 44(1); and either
|
CHAPTER IV
SPECIAL RISK-MITIGATING MEASURES CONCERNING AFRICAN SWINE FEVER FOR FOOD BUSINESSES IN THE MEMBER STATES CONCERNED
Article 44
Special designation of slaughterhouses and cutting plants, cold stores, meat processing and game handling establishments
1. The competent authority of the Member State concerned shall, following an application by a food business operator, designate establishments for:
(a) |
the immediate slaughter of kept porcine animals from restricted zones II and III:
|
(b) |
the cutting, processing and storage of the fresh meat and meat products, including casings, from porcine animals kept in restricted zones II or III as referred to in Articles 41, 42 and 43; |
(c) |
the preparation of game meat as referred to in point 1(1.18) of Annex I to Regulation (EC) No 853/2004 and the processing and storage of the fresh meat and meat products from wild porcine animals obtained in restricted zones I, II or III as provided for in Articles 51 and 52 of this Regulation; |
(d) |
the preparation of game meat as referred to in point 1(1.18) of Annex I to Regulation (EC) No 853/2004 and the processing and storage of the fresh meat and meat products from wild porcine animals, where those establishments are located in restricted zones I, II or III as provided for in Articles 51 and 52 of this Regulation. |
2. The competent authority may decide that the designation referred to in paragraph 1 shall not be required for establishments processing, cutting and storing fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zones II or III and from wild porcine animals obtained in the restricted zones I, II or III, and establishment referred to in paragraph 1, point (d), provided that:
(a) |
the fresh meat and meat products, including casings, of porcine origin are marked with a special health mark or, where relevant, an identification mark referred to in Article 47 in those establishments; |
(b) |
the fresh meat and meat products, including casings, of porcine origin from those establishments are only intended for the same Member State concerned; |
(c) |
the animal by-products of porcine origin from those establishments are only processed or disposed of in accordance with Article 35 within the same Member State. |
3. The competent authority of the Member State concerned shall:
(a) |
provide the Commission and other Member States with a link to the website of the competent authority with a list of designated establishments and their activities referred to in paragraph 1; |
(b) |
keep the list provided for in point (a) updated. |
Article 45
Special conditions for the designation of establishments for the immediate slaughter of porcine animals kept in restricted zones II or III
The competent authority of the Member State concerned shall only designate establishments for the immediate slaughter of porcine animals kept in restricted zones II or III, subject to compliance with the following conditions:
(a) |
the slaughtering of porcine animals kept outside restricted zones II and III and of porcine animals kept in the restricted zones II or III that are subject to authorised movements provided for in Articles 24, 29 and 30 and the production and storage of products thereof are carried out separately from the slaughtering of porcine animals kept in restricted zones I, II or III and from the production and storage of products thereof that do not comply with the relevant:
|
(b) |
the operator of the establishment has in place documented instructions or procedures approved by the competent authority of the Member State concerned to ensure that the conditions laid down in point (a) are met. |
Article 46
Special conditions for the designation of establishments for the cutting, processing and storing of the fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zones II and III
The competent authority of the Member State concerned shall only designate establishments for the cutting, processing and storing of the fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zones II and III, subject to compliance with the following conditions:
(a) |
the cutting, processing and storing of the fresh meat and meat products, including casings, obtained from porcine animals kept outside restricted zones II and III and from porcine animals kept in restricted zones II and III are carried out separately from fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zones II and III that do not comply with the relevant:
|
(b) |
the operator of the establishment has in place documented instructions or procedures approved by the competent authority of the Member State concerned to ensure that the conditions laid down in point (a) are met. |
Article 47
Special health or identification marks
1. The competent authority of the Member State concerned shall ensure that the following products of animal origin are marked in accordance with paragraph 2:
(a) |
the fresh meat and meat products, including casings, obtained from porcine animals kept in a restricted zone III, as provided for in Article 43, point (d)(ii); |
(b) |
the fresh meat and meat products, including casings, obtained from porcine animals kept in a restricted zone II, where the specific conditions for authorising movements of consignments of those commodities outside the restricted zone II provided for in Article 41(1) are not met, as provided for in Articles 24(3), point (e), and 41(2), point (b)(ii); |
(c) |
the fresh meat and meat products from wild porcine animals moved within a restricted zone I or outside that restricted zone from the establishment designated in accordance with Article 44(1), as provided for in Article 52(1), point (c)(iii), first indent. |
2. The competent authority of the Member State concerned and, where relevant, food business operators shall ensure that:
(a) |
a health mark or, where relevant, an identification mark as provided for in Article 5(1) of Regulation (EC) No 853/2004 with two additional diagonal parallel lines is applied to products of animal origin referred to in paragraph 1 of this Article and intended for movement only within the same Member State concerned; |
(b) |
following the marking of the products of animals origin as provided for in paragraph 2, point (a), of this Article the information required for a health mark or, where relevant, an identification mark provided for in Article 5(1) of Regulation (EC) No 853/2004 remains in perfectly legible characters. |
3. By way of derogation from paragraph 2 of this Article, the competent authority of the Member State concerned may authorise the use of another form of special health mark or, where relevant, an identification mark that is not oval and cannot be confused with the health mark or identification mark provided for in Article 5(1) of Regulation (EC) No 853/2004 for a period of twelve months following the date of publication of this Regulation.
CHAPTER V
SPECIAL DISEASE CONTROL MEASURES APPLICABLE TO WILD PORCINE ANIMALS IN THE MEMBER STATES
Article 48
Specific prohibitions on movements of consignments of wild porcine animals by operators
The competent authorities of the Member States shall prohibit movements of consignments wild porcine animals by operators as provided for in Article 101 of Delegated Regulation (EU) 2020/688:
(a) |
within the whole territory of the Member State; |
(b) |
from the whole territory of the Member State to:
|
Article 49
Specific prohibitions on movements within restricted zones I, II and III and from those restricted zones of fresh meat, meat products and any other products of animal origin, animal by-products and derived products obtained from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption
1. The competent authorities of the Member States concerned shall prohibit movements within and from restricted zones I, II and III of consignments of fresh meat, meat products and any other products of animal origin, animal by-products and derived products obtained from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption.
2. The competent authorities of the Member States concerned shall prohibit movements within and from restricted zones I, II and III of fresh meat, meat products and any other products of animal origin, animal by-products and derived products obtained from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption:
(a) |
for private domestic use; |
(b) |
by hunters for the supply of small quantities of wild porcine game or wild game meat of porcine origin directly to the final consumer or to local retail establishments directly supplying the final consumer, as provided for in Article 1(3), point (e), of Regulation (EC) No 853/2004. |
Article 50
General prohibitions on movements of consignments of products obtained from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption, considered as a risk for the spread of African swine fever
The competent authority of the Member State concerned may prohibit within the territory of the same Member State the movements of consignments of fresh meat, meat products and any other products obtained from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption, if the competent authority considers that there is a risk for the spread of African swine fever to, from or through those wild porcine animals or products thereof.
Article 51
Specific conditions for derogations authorising movements within restricted zones I, II and III and from those restricted zones of consignments of meat products obtained from wild porcine animals
1. By way of derogation from the prohibition provided for in Article 49(1), the competent authority of the Member State concerned may authorise movements within and from restricted zones I, II or III of consignments of meat products obtained from wild porcine animals from establishments located in restricted zones I, II or III to:
(a) |
other restricted zones I, II or III situated in the same Member State concerned; |
(b) |
areas outside restricted zones I, II and III of the same Member State concerned; and |
(c) |
other Member States and to third countries. |
2. The competent authority of the Member State concerned shall only authorise movements of consignments of meat products obtained from wild porcine animals from establishments located in a restricted zone I, II or III referred to in paragraph 1 subject to compliance with the following conditions:
(a) |
pathogen identification tests for African swine fever have been carried out for each wild porcine animal used for the production and processing of the meat products in the restricted zones I, II and III; |
(b) |
the competent authority obtained negative results of the pathogen identification tests for African swine fever referred to in point (a) before the treatment referred to in point (c)(ii); |
(c) |
the meat products from wild porcine animals:
|
Article 52
Specific conditions for derogations authorising movements within restricted zones I, II and III and from restricted zone I of fresh meat, meat products and any other products of animal origin obtained from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption
1. By way of derogation from the prohibitions provided for in Article 49(1) and (2), the competent authority of the Member State concerned may authorise movements within a restricted zone I and from that restricted zone of consignments of the fresh meat, meat products and any other products of animal origin obtained from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption, to other restricted zones I, II and III or to areas outside restricted zones I, II and III of the same Member State, provided that:
(a) |
pathogen identification tests for African swine fever have been carried out for every wild porcine animal before the movement of consignment of the fresh meat, meat products and any other products of animal origin from that wild porcine animal; |
(b) |
the competent authority of the Member State concerned obtained negative results for the pathogen identification tests for African swine fever referred to in point (a) before the movement of the consignment; |
(c) |
the fresh meat, meat products and any other products of animal origin from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption, are moved within or outside restricted zone I within the same Member State:
|
2. By way of derogation from the prohibitions provided for in Article 49(1) and (2), the competent authority of the Member State concerned may authorise movements of consignments of the fresh meat, meat products and any other products of animal origin from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption, within restricted zones II and III of the same Member State, provided that:
(a) |
pathogen identification tests for African swine fever have been carried out for every wild porcine animal before the movement of the consignment of the fresh meat, meat products and any other products of animal origin from that wild porcine or body of that wild porcine animal, which is intended for human consumption; |
(b) |
the competent authority of the Member State concerned obtained negative results for the pathogen identification tests for African swine fever referred to in point (a) before the movement of the consignment; |
(c) |
the fresh meat, meat products and any other products of animal origin from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption, are moved within restricted zones II and III within the same Member State either for:
|
3. The competent authority of the Member State concerned may decide that pathogen identification tests referred to in paragraph 1, point a, and paragraph 2, point a, shall not be required in restricted zone I, II or III provided that:
(a) |
the competent authority of the Member State concerned assessed, on the basis of appropriate and continuous surveillance, the specific epidemiological situation of African swine fever and the related risks in the particular restricted zone or in the part of it that restricted zone and that assessment indicated that the risk of the spread of African swine fever is negligible; |
(b) |
the assessment referred to in point (a) is reviewed on a regular basis:
|
(c) |
the consignment of the fresh meat, meat products and any other products of animal origin from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption, are only moved:
|
Article 53
Operators’ obligations with regard to animal health certificates for consignments of fresh meat, meat products and any other products of animal origin, obtained from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption, for movements from restricted zones I, II and III
Operators shall only move consignments of fresh meat, meat products, and any other products of animal origin obtained from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption, from restricted zones I, II and III:
(a) |
in the cases covered by Articles 51 and 52; and |
(b) |
if those consignments are accompanied by an animal health certificate as provided for in Article 167(1) of Delegated Regulation (EU) 2016/429 that contains:
|
However, in the case of movements of such consignments within the same Member State concerned, the competent authority may decide that an animal health certificate does not have to be issued as referred to in Article 167(1), first subparagraph, of Regulation (EU) 2016/429.
Article 54
Specific conditions for authorising movements within restricted zones I, II and III and outside those restricted zones of consignments of animal by-products and derived products from wild porcine animals
1. By way of derogation from the prohibitions provided for in Article 49(1) and (2), the competent authority of the Member State concerned may authorise movements within restricted zones I, II and III and outside those restricted zones of consignments of derived products obtained from wild porcine animals to other restricted zones I, II and III or to areas outside restricted zones I, II and III of the same Member State and to other Member States provided that they have been subjected to a risk-mitigating treatment which ensures that the derived products pose no risks for the spread of African swine fever.
2. By way of derogation from the prohibitions provided for in Article 49(1), the competent authority of the Member State concerned may authorise movements within restricted zones I, II and III and outside those restricted zones of consignments of animal by-products from wild porcine animals to other restricted zones I, II and III and to areas outside restricted zones I, II and III of the same Member State provided that:
(a) |
the animal by-products are collected, transported and disposed of in accordance with Regulation (EC) No 1069/2009; |
(b) |
for the movements outside restricted zones I, II and III, the means of transport are individually equipped with a satellite navigation system to determine, transmit and record its real time location; the transport operator shall enable the competent authority to control the real time movement of the means of transport and keep the electronic records of the movement for a period of at least two months from the time of the movement of the consignment. |
Article 55
Operators’ obligations with regard to animal health certificates for movements of consignments of animal by-products from wild porcine animals outside restricted zones I, II and III in the territory of the same Member State concerned
Operators shall only move consignments of animal by-products from wild porcine animals outside restricted zones I, II and III within the same Member State concerned in the case referred to in Article 54(2), if those consignments are accompanied by:
(a) |
a commercial document referred to in Chapter III of Annex VIII to Regulation (EU) No 142/2011; and |
(b) |
an animal health certificate referred to in Article 22(5) of Delegated Regulation (EU) 2020/687; |
However, the competent authority of the Member State concerned may decide that an animal health certificate shall not be issued as referred to in Article 22(6) of Delegated Regulation (EU) 2020/687.
Article 56
National action plans for wild porcine animals in order to avoid the spread of African swine fever in the Union
1. All Member States shall establish national action plans covering populations of wild porcine animals on their territory in order to avoid the spread of African swine fever in the Union (national action plans) within a period of six months from the date of publication of this Regulation in the Official Journal of the European Union, in order to ensure:
(a) |
a high level of disease awareness and preparedness with regard to the risks associated with the spread of African swine fever through wild porcine animals; |
(b) |
the prevention, containment, control and eradication of African swine fever; |
(c) |
coordinated actions covering wild porcine animals to take account of the risks posed by those animals with regard to the spread of African swine fever. |
2. The national action plans shall be established in accordance with the minimum requirements laid down in Annex IV.
3. A Member State may decide not to draw up a national action plan if appropriate and continuous surveillance has demonstrated no evidence of the permanent presence of wild porcine animals in that Member State.
4. The measures taken by the Member States in the framework of national action plans shall be compatible, where relevant, with Union environmental rules, including nature protection requirements, laid down in Directives 2009/147/EC and 92/43/EEC.
5. The Member States shall present their national action plans and the annual results of their implementation to the Commission and to the other Member States.
CHAPTER VI
SPECIAL INFORMATION AND TRAINING OBLIGATIONS IN THE MEMBER STATES
Article 57
Special information obligations of the Member States concerned
1. The Member States concerned shall ensure that at least railway, coach, airport and port operators, travel agencies, hunting trip organisers and postal services operators are required to draw the attention of their customers to the special disease control measures laid down in this Regulation, by providing information at least on the main prohibitions laid down in Articles 9, 11, 12, 48 and 49 to travellers moving from restricted zones I, II and III and customers of postal services in an appropriate way.
For that purpose, the Member States concerned shall organise and carry out regular public awareness campaigns to promote and spread information on the special disease control measures laid down in this Regulation.
2. The Member States concerned shall inform the Commission and the other Member States within the framework of the Standing Committee on Plants, Animals, Food and Feed, of the following:
(a) |
changes in the epidemiological situation as regards African swine fever in their territory; |
(b) |
results of surveillance for African swine fever in kept and wild porcine animals carried out in restricted zones I, II and III and areas outside those restricted zones; |
(c) |
the results of surveillance for African swine fever in kept and wild porcine animals carried out in areas listed in Annex II; |
(d) |
other measures and initiatives taken to prevent, control and eradicate African swine fever. |
Article 58
Special trainings obligations of the Member States concerned
The Member States concerned shall organise and carry out regularly or at appropriate intervals specific trainings concerning the risks of African swine fever and possible prevention, control and eradication measures for at least the following targeted groups:
(a) |
veterinarians; |
(b) |
farmers keeping porcine animals and other relevant operators and transporters; |
(c) |
hunters. |
Article 59
Special information obligations of all Member States
1. All Member States shall ensure that:
(a) |
on major land infrastructure routes, such as international communication roads and railways, and related land transport networks, appropriate information on the risks of the transmission of African swine fever and on the special disease control measures laid down in this Regulation are brought to the attention of travellers:
|
(b) |
the necessary measures are in place to raise awareness among stakeholders active in the kept porcine animals sector including small-size establishments of the risks for the introduction and spread of the African swine fever virus and to provide them with the most appropriate information on reinforced biosecurity measures for establishments of kept porcine animals located in the restricted zones I, II or III as provided for in Annex III, in particular the measures to be enforced in restricted zones I, II and III, by the means best suited to bring such information to their attention. |
2. All Member States shall raise awareness on African swine fever among the following:
(a) |
the public as provided for in Article 15 of Regulation (EU) 2016/429; |
(b) |
veterinarians, farmers, other relevant operators and transporters and hunters. |
3. All Member States shall provide the public and professionals listed in paragraph 2 with the most appropriate information on risk mitigation and reinforced biosecurity measures as set out in:
(a) |
Annex III; |
(b) |
The Union’s guidelines on African swine fever as agreed with the Member States at the Standing Committee on Plants, Animals, Food and Feed; |
(c) |
available scientific evidence provided by the European Food Safety Authority; |
(d) |
the Terrestrial Animal Health Code of the World Organisation for Animal Health. |
CHAPTER VII
FINAL PROVISIONS
Article 60
Repeal of Implementing Regulation (EU) 2021/605
Implementing Regulation (EU) 2021/605 is repealed from 21 April 2023.
Article 61
Entry into force and application
This Regulation shall enter into force on the thirtieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 21 April 2023 until 20 April 2028.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 March 2023.
For the Commission
The President
Ursula VON DER LEYEN
(2) Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and groups of species posing a considerable risk for the spread of those listed diseases (OJ L 308, 4.12.2018, p. 21).
(3) Commission Delegated Regulation (EU) 2020/687 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council, as regards rules for the prevention and control of certain listed diseases (OJ L 174, 3.6.2020, p. 64).
(4) Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1).
(5) Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1).
(6) Commission Implementing Regulation (EU) 2021/605 of 7 April 2021 laying down special control measures for African swine fever (OJ L 129, 15.4.2021, p. 1).
(7) Terrestrial Animal Health Code of the World Organisation for Animal Health (2022).
(8) https://ec.europa.eu/food/animals/animal-diseases/control-measures/asf_en
(9) Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55).
(10) EFSA Journal 2018;16(7):5344.
(11) EFSA Journal 2020;18(1):5996.
(12) Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7).
(13) Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7).
(14) In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protoc