COUNCIL REGULATION (EU) 2021/2085

of 19 November 2021

establishing the Joint Undertakings under Horizon Europe and repealing Regulations (EC) No 219/2007, (EU) No 557/2014, (EU) No 558/2014, (EU) No 559/2014, (EU) No 560/2014, (EU) No 561/2014 and (EU) No 642/2014

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 187 and the first subparagraph of Article 188 thereof,

Having regard to the proposal from the European Commission,

Having regard to the opinion of the European Parliament (1),

Having regard to the opinion of the European Economic and Social Committee (2),

Whereas:

(1) In order to achieve the greatest possible impact of Union funding and the most effective contribution to the Union’s policy objectives, Regulation (EU) 2021/695 of the European Parliament and of the Council (3) (the ‘Horizon Europe Regulation’) established the policy and legal framework for European partnerships with private or public sector partners. European partnerships are a key element of the policy approach of Horizon Europe – the Framework Programme for Research and Innovation (‘Horizon Europe’). They are set up to deliver on Union priorities targeted by Horizon Europe and ensure a clear impact for the Union and its people, which can be achieved more effectively in partnership, through a strategic vision that is shared and committed to by partners, rather than by the Union alone.

(2) In particular, European partnerships in the ‘Global Challenges and European Industrial Competitiveness’ pillar of Horizon Europe play an important role in achieving strategic objectives such as accelerating the transitions towards sustainable development goals and a green and digital Europe, and should contribute to recovery from the unprecedented crisis brought about by the COVID-19 pandemic. European partnerships address complex cross-border challenges that require an integrated approach. They make it possible to address the transformational, systemic and market failures described in the impact assessments accompanying this Regulation by bringing together a broad range of players across the value chains and ecosystems to work towards a common vision and translating it into concrete roadmaps and coordinated implementation of activities. Furthermore, they enable efforts and resources to be concentrated on common priorities to solve the complex challenges.

(3) To deliver on priorities and impact, European partnerships should be developed through a broad involvement of relevant stakeholders across Europe including industry, research organisations, bodies with a public service mission at local, regional, national or international level, and civil society organisations such as foundations that support or carry out research and innovation. They should also be one of the measures to strengthen cooperation between private or public sector partners at the international level, including by joining up research and innovation programmes and cross-border investment in research and innovation, bringing mutual benefits to people and businesses while ensuring that the Union can uphold its interests in strategic areas.

(4) The interim evaluation of Horizon 2020 established by Regulation (EU) No 1291/2013 of the European Parliament and of the Council (4) revealed that a considerable repertoire of partnership instruments and initiatives have been introduced over time, with seven forms of implementation and close to 120 partnership initiatives running under Horizon 2020. In addition to the complexity generated by the proliferation of instruments and initiatives, it has been assessed that their ability to contribute to related policies at Union and national level as a whole is not sufficient despite the fact that they deliver positive impact in progressing towards their objectives, for example by setting long-term agendas, structuring research and innovation cooperation between otherwise dispersed actors, and leveraging additional investments. The impact assessment of Horizon Europe identifies therefore the need to address and to rationalise the Union research and innovation funding landscape, in particular with respect to partnerships, as well as to re-orient partnerships towards more impact and delivery on Union priorities.

(5) To address such concerns and to achieve the higher ambition for European investments, Horizon Europe should put forward a major simplification and reform for the Commission’s policy on research and innovation partnerships. In order to reflect its systemic nature that aims to contribute to Union-wide ‘transformations’ towards the sustainability objectives, Horizon Europe should make more effective use of those partnerships with a more strategic, coherent and impact-driven approach.

(6) Regulation (EU) 2020/852 of the European Parliament and of the Council (5) establishes the general framework for determining whether an economic activity qualifies as environmentally sustainable for the purposes of defining sustainable investments. It creates a common reference that investors, banks, industry and researchers can use when investing in projects and economic activities that have a substantial positive impact on climate and environment and cause no significant harm to either of them. It is the reference for green investments in the Union.

(7) Where relevant, European partnerships should consider technical screening criteria referred to in Article 3 and the ‘do no significant harm’ principle set out in Article 17 of Regulation (EU) 2020/852 as an instrument to improve their projects’ readiness and access to green financing that will be crucial for market uptake and wider deployment of the innovative technologies and solutions they will deliver. Scientific evidence is at the core of those technical screening criteria. Research and innovation, pursued by European partnerships, should play an important role in helping economic operators to reach or go beyond the standards and thresholds set in that Regulation, and to keep those technical screening criteria up-to-date and consistent with the objectives set out in the Commission Communication of 11 December 2019 on ‘The European Green Deal’.

(8) On the basis of the Horizon Europe Regulation, it should be possible for the European partnerships to be set up using three different forms, namely ‘co-funded’, ‘co-programmed’ and ‘institutionalised’. The setting-up of institutionalised European partnerships that are joint undertakings between private and public sector partners should involve new Union legislation and the establishment of dedicated implementing structures pursuant to Article 187 of the Treaty on the Functioning of the European Union (TFEU).

(9) The Horizon Europe Regulation defines eight priority areas, in which institutionalised European partnerships established under Article 185 or 187 TFEU could be proposed. Across those priority areas, several initiatives for such institutionalised European partnerships are put forward and nine of them are covered by this Regulation.

(10) The research and innovation activities undertaken by joint undertakings should be funded from Horizon Europe as provided in Articles 12 and 13 of the Horizon Europe Regulation. To achieve maximum impact, the joint undertakings should develop close synergies with other Horizon Europe initiatives and other Union programmes and funding instruments, particularly with those supporting the deployment of innovative solutions, education and regional development, in order to increase economic and social cohesion and reduce imbalances.

(11) The new policy approach for European partnerships, and in particular institutionalised European partnerships, calls for a novel way of establishing the legal framework under which they would operate. While the setting-up of joint undertakings on the basis of Article 187 TFEU for the purpose of Horizon 2020 has proven to be effective as far as the implementation is concerned, it is necessary to step it up. Therefore, this Regulation aims to increase the coherence, efficiency, openness, effectiveness and impact-orientation of implementation by translating the Horizon Europe Regulation and the experience gained from programme implementation under Horizon 2020 into common provisions across the joint undertakings in a harmonised way. It aims to facilitate the creation of collaboration and synergies between European partnerships, thereby making full use of their interconnections at the organisational level. Joint undertakings should seek opportunities to involve representatives of other European partnerships in discussions during the drafting of their work programmes, identify the areas in which complementary or joint activities would address the challenges more effectively and efficiently, avoid overlaps, align timing of their activities and ensure access to results and other relevant means of knowledge exchange.

(12) Following the identification of synergies between them, joint undertakings should aim to determine budget shares which should be used for complementary or joint activities between joint undertakings. Moreover, this Regulation aims to improve efficiencies and harmonisation of the rules through intensified operational collaboration and by exploring economies of scale, including the establishment of back office arrangements which should provide horizontal support functions to the joint undertakings. Those back office arrangements should make it easier to achieve greater impact and harmonisation on common points while retaining a certain degree of flexibility to meet the specific needs of each joint undertaking. The structure should be established using service level agreements to be concluded by the joint undertakings. The back office arrangements should cover coordination and administrative support functions in areas where their screening has proved efficient and cost-effective and should take into account as far as possible compliance with the requirement of accountability of each individual authorising officer and harmonisation of the rules, including intellectual property rights. The legal set-up should be designed to best serve the common needs of the joint undertakings, to ensure their close collaboration and to explore all possible synergies among the European partnerships and, as a consequence, between the various parts of Horizon Europe as well as between the other programmes managed by the joint undertakings.

(13) The impact assessments regarding each joint undertaking accompanying the proposal for this Regulation have provided evidence that justifies the implementation of European partnerships in accordance with the Horizon Europe Regulation only where other parts of Horizon Europe, including other forms of European partnership, would not achieve the objectives or would not generate the necessary expected impacts, and whereby such implementation is justified by a long-term perspective and high degree of integration.

(14) Horizon Europe introduces a more strategic, coherent and impact-driven approach to European partnerships, building on the lessons learned from the Horizon 2020 interim evaluation. In line with the new ambition, this Regulation aims to achieve a more effective use of institutionalised European partnerships, in particular by focusing on clear objectives, outcomes and impact that can be achieved by 2030, and by ensuring a clear contribution to the related Union policy priorities and policies. Close collaboration and synergies with other relevant initiatives at Union, national and regional level, in particular with other European partnerships, are key to achieving greater scientific, socioeconomic and environmental impact and ensuring uptake of results. For this purpose, the joint undertakings may apply Horizon Europe provisions enabling different types of synergies, such as alternative, cumulative or combined funding and transfer of resources. In assessing the overall impact, broader investments beyond the contributions from partners and triggered by the joint undertakings that contribute to achieving their objectives should be taken into account to facilitate the acceleration of market uptake of innovative solutions.

(15) In order to ensure a coherent approach and capture the scientific, technological, economic, societal and environmental impacts of European partnerships in relation to the objectives of Horizon Europe and Union priorities, this Regulation should set out collective general and common specific objectives that should be delivered by all joint undertakings. All joint undertakings contribute collectively to achieving those objectives by reaching their individual objectives. In addition, the common parts of this Regulation define common operational objectives derived from the objectives set for the Specific Programme implementing Horizon Europe, established by Council Decision (EU) 2021/764 (6) (the ‘Specific Programme implementing Horizon Europe’). All joint undertakings should carry out their tasks in order to fulfil the principles and criteria set out for European partnerships in the Horizon Europe Regulation (Article 10 and Annex III) and deliver European added value compared to calls under the main Horizon Europe work programme. The objectives and tasks of the joint undertakings are complemented by additional ones specific to each joint undertaking. While taking into account their specificities and policy contexts, the alignment of the intervention logics of individual joint undertakings with Horizon Europe should support the coordinated assessment of progress of the joint undertakings as part of Horizon Europe monitoring and evaluation activities.

(16) This Regulation is based on the principles and criteria set out in the Horizon Europe Regulation, including openness and transparency, a strong leverage effect and long-term commitments of all the involved parties. One of the objectives of this Regulation is to ensure the openness of the joint undertakings and their actions to a broad range of entities, including newcomers who will be monitored also within the framework of the strategic coordinating process for European partnerships provided under Article 6(5) of the Specific Programme implementing Horizon Europe. Such partnerships should be open to any entity that is willing and able to work towards the common goal, should promote broad and active participation of stakeholders in their activities, membership and governance, and should ensure that the results would be for the benefit of all Europeans, in particular through a broad dissemination of results and pre-deployment activities across the Union. As regards private members and their constituent or affiliated entities established in third countries, the interests of the Union and the joint undertaking on the grounds of security or public order should be safeguarded. To that end, the Commission should be able to request private members to take appropriate measures. Such measures could include the appropriate handling of confidential information or limitation of certain entities in specific operational activities of the private member.

(17) To ensure the coherent application of Article 22(5) of the Horizon Europe Regulation, the joint undertakings should ensure coherence with the approach taken for actions funded under the Horizon Europe work programme regarding the application of that Article, as well as Union legislation and guidance relevant for its application in similar topics in the work programme of the joint undertaking concerned.

(18) Where the Commission or the Member States consider limiting participation in specific actions of the joint undertaking in accordance with Article 22(5) of the Horizon Europe Regulation, the Commission and the Member States in the states’ representatives group should seek an agreed position on a case-by-case basis before the adoption of the work programme. In the case of joint undertakings with a Public Authorities Board, the application of that Article should be approved by the Public Authorities Board, following the request by the Commission, before the adoption of the work programme. Furthermore, following an invitation from the Chair, the Executive Director should inform regularly the relevant configuration of the Horizon Europe Programme Committee, further to the Commission’s responsibility to inform the Programme Committee under Article 14(7) and Annex III of the Specific Programme implementing Horizon Europe, and in particular before the adoption of the work programme of the joint undertaking concerned, in relation to the application of Article 22(5) of the Horizon Europe Regulation.

(19) Annex III of the Horizon Europe Regulation requires that the financial or in-kind contributions from members other than the Union should be at least equal to 50 % and may reach up to 75 % of the aggregated joint undertaking budgetary commitments. Conversely, the Union contribution, including any additional funds from associated countries, should not exceed 50 % of the aggregated budgetary commitments of each joint undertaking. Consequently, this Regulation should set the required contribution from members other than the Union at the same level or higher than the Union contribution. The Union should be in a position to reduce its contribution if members other than the Union fail to fulfil their commitments.

(20) In accordance with Article 10(1), point (c), of the Horizon Europe Regulation, the joint undertakings are to implement a central management of all financial contributions through a coordinated approach. Accordingly, each participating state should conclude one or more administrative agreements with the joint undertaking laying down the coordination mechanism for the payment of and reporting on contributions to applicants established in that participating state. In order to ensure coherence with their national strategic priorities, participating states should be provided with a right of veto over the use of their national financial contributions for applicants established in those participating states. In order to minimise the administrative burden for beneficiaries, achieve simplification and ensure a more efficient implementation, each participating state should strive to synchronise its payment schedule, reporting and audits with those of the joint undertakings and to converge its cost eligibility with the Horizon Europe Regulation. Beneficiaries established in participating states that entrusted the payment activities to the joint undertaking should sign a single grant agreement with the joint undertaking following Horizon Europe Regulation.

(21) In line with the ambitions set out in the Horizon Europe Regulation, one of the preconditions of setting up institutionalised European partnerships is ensuring partners’ contributions throughout the lifetime of the joint undertakings. In this context, private partners should deliver a significant part of their contributions in the form of in-kind contributions to operational costs of the joint undertaking. Joint undertakings should be able to identify measures to facilitate those contributions through their work programmes, in particular by reducing funding rates. Those measures should be based on the specific needs of a joint undertaking and the underlying activities. In duly justified cases, it should be possible to introduce additional conditions that require the participation of a member of the joint undertaking or their constituent or affiliated entities, targeting activities where the industrial partners of the joint undertaking can play a key role such as large-scale demonstrations and flagship projects closer to the market, and contribute more via lower funding rates. The level of participation of members should be monitored by the executive director in order to empower the governing board to take appropriate actions, ensuring a balance between commitment from partners and openness. In duly justified cases, the capital expenditure for, for example, large-scale demonstrations or flagship projects may be considered as an eligible cost in line with the applicable legal framework.

(22) It should be possible that, in accordance with Article 15(3) of the Horizon Europe Regulation, contributions from programmes co-financed by the European Regional Development Fund established by Regulation (EU) 2021/1058 of the European Parliament and of the Council (7) (ERDF), the European Social Fund Plus established by Regulation (EU) 2021/1057 of the European Parliament and of the Council (8) (ESF+), the European Maritime, Fisheries and Aquaculture Fund established by Regulation (EU) 2021/1139 of the European Parliament and of the Council (9) (EMFAF) and the European Agricultural Fund for Rural Development established by Regulation (EU) No 1306/2013 of the European Parliament and of the Council (10) (EAFRD) be considered to be a contribution of the participating states that are Member States to the joint undertakings, provided that Regulation (EU) 2021/1060 of the European Parliament and of the Council (11) and the fund-specific regulations are complied with. In addition, it should be possible that contributions from the Recovery and Resilience Facility established by Regulation (EU) 2021/241 of the European Parliament and of the Council (12) (the ‘Facility’) be considered to be a contribution of the Member States that are participating states to the joint undertakings, provided that the provisions of the Facility and commitments set in the national recovery and resilience plans are complied with.

(23) In line with the principle of fair sharing of contributions among the members of joint undertakings, financial contributions to the administrative costs of the joint undertakings should be divided equally between the Union and the members other than the Union. Deviations from that principle should only be considered in exceptional and duly justified cases such as where the size or the membership structure of a member of the joint undertaking other than the Union would result in contributions per constituent or affiliated entity, in particular small and medium-sized enterprises (SMEs), of such a high level as to seriously jeopardise the incentive to become or remain a constituent or affiliated entity of the member of the joint undertaking. In such cases, the minimum percentage of annual financial contribution to the administrative costs of the joint undertaking from members other than the Union should be 20 % of the total annual administrative costs and the contributions from SMEs should be significantly lower than those from larger constituent or affiliated entities. Once a critical mass of membership that allows for a contribution higher than 20 % of the total annual administrative costs is reached, annual contributions per constituent or affiliated entity should be maintained or increased with the aim of gradually increasing the share of the members other than Union in the overall contribution to the annual administrative costs of the joint undertaking. The members of the joint undertaking other than the Union should endeavour to increase the number of constituent or affiliated entities in order to increase their contribution to 50 % of the administrative costs of the joint undertaking over its lifetime.

(24) The Horizon Europe Regulation requires the partners to show their long term commitment, including through a minimum share of public or private investments. Consequently, it is necessary for the Union to identify in this Regulation founding members established in the Member States, countries associated to Horizon Europe or international organisations. However, where necessary it should be possible to expand the membership base of joint undertakings after they are established with associated members selected following open and transparent procedures, taking into account in particular the new technological developments or the association of additional countries to Horizon Europe.

(25) Legal entities interested in supporting the joint undertakings’ objectives in their specific areas of research, without becoming a member, should also be offered the possibility to become contributing partners of those joint undertakings.

(26) In accordance with Article 16(5) of the Horizon Europe Regulation, the allocation of the financial contributions from third countries associated to Horizon Europe should take into account the level of participation of the legal entities of the associated third countries. Accordingly, the Union contribution to the joint undertakings may be increased with contributions from third countries associated to Horizon Europe, taking into account the level of participation of such legal entities and provided that the total amount by which the Union contribution is increased is at least matched by the contribution of members other than the Union, or their constituent or affiliated entities.

(27) The establishment of a joint undertaking ensures a mutually beneficial public-private partnership for the members involved, including by promoting certainty on major budget allocations for the relevant industries over a period of seven years. Becoming a founding member or associated member, or one of their constituent or affiliated entities, enables members to gain influence, either directly or through the industry representatives, in the governing board of the joint undertaking. The governing board is the decision-making body of the joint undertaking that decides on the long-term strategic orientation of the partnership, as well as its annual priorities. The Union, the participating states where relevant, the founding members and associated members should therefore be able to contribute to the joint undertaking’s agenda and priority-setting through the adoption and possible amendment of the Strategic Research and Innovation Agenda, as well as the adoption of the annual work programme, including the content of the calls for proposals, the applicable funding rate per call topic, and the related rules for submission, evaluation, selection, award and review procedures.

(28) It is appropriate that the members other than the Union commit to the implementation of this Regulation by means of a letter of commitment, or a joint letter of commitment indicating the total amount of their contributions where appropriate, without imposing conditions regarding their accession. Such letters of commitment should be legally valid throughout the lifetime of the joint undertaking and closely monitored by the joint undertaking and the Commission. Joint undertakings should create a legal and organisational environment that enables members to deliver on their commitments, while ensuring attractiveness for all stakeholders, continuous openness of the joint undertakings and transparency during their implementation, in particular for priority setting and for participation in calls for proposals.

(29) Further simplification is a cornerstone of Horizon Europe. In that context, there should be a simplified reporting mechanism for partners, who are no longer required to report on non-eligible costs. In-kind contributions to operational activities should be accounted for solely on the basis of eligible costs and should be reported and audited in accordance with the mechanism applicable to the specific grant agreement. Such accounting on the basis of eligible costs only allows for the automated calculation of in-kind contributions to operational activities via the Horizon Europe IT tools, lowers the administrative burden for partners and makes the reporting mechanism for contributions more effective. In-kind contributions to operational activities should be closely monitored by the joint undertakings and regular reports should be prepared and made public by the executive director in order to establish whether the progress towards reaching the in-kind contributions targets is sufficiently satisfactory. The governing board should assess both the efforts made and the results achieved by the members contributing to operational activities, as well as other factors such as the level of participation of SMEs and attractiveness of the joint undertakings to newcomers. Where necessary it should take appropriate remedial and corrective measures, taking into account the principles of openness and transparency.

(30) The joint undertakings should provide a systematic opportunity and incentive for members other than the Union to combine their research and innovation activities with those of the joint undertaking. Additional activities should not receive financial support from the joint undertaking. However, they can be accounted for as members’ in-kind contributions to additional activities when they contribute to the objectives of the joint undertaking and are directly linked to its activities, including non-eligible costs of indirect actions funded by the joint undertaking where this is provided for in the annual additional activities plan. That link can be established through the uptake of results from indirect actions funded by the joint undertaking or its preceding initiatives, or by demonstrating a significant Union added value. The respective costs should be certified by an independent audit body appointed by the entity concerned subject to the valuation method being open to verification by the joint undertaking in the event of uncertainty. This Regulation should lay down more specific provisions concerning the scope of additional activities for each joint undertaking, to the extent that it is necessary to achieve the desired directionality and impact. It should be further decided by joint undertakings’ governing boards whether, for the purposes of valuing these contributions, the use of simplifying methods such as lump sums or unit costs is necessary to achieve simplification, cost effectiveness and an appropriate level of protection of confidential commercial data.

(31) The governance of joint undertakings should ensure that their decision-making processes are fit to keep pace with a fast-changing socioeconomic and technological environment and global challenges. Joint undertakings should benefit from expertise, advice and support from all relevant stakeholders, in order to effectively implement their tasks and ensure synergies at Union and national level. Therefore, joint undertakings should be empowered to set up advisory bodies with a view to providing them with expert advice and carrying out any other task of an advisory nature that is necessary for the achievement of the joint undertakings’ objectives. In setting up the advisory bodies, joint undertakings should ensure a balanced representation of experts within the scope of the activities of the joint undertaking, including with respect to gender balance. The advice provided by those bodies should bring in scientific perspectives, as well as those of national and regional authorities and of other stakeholders of joint undertakings.

(32) Joint undertakings should ensure that Member States are sufficiently informed of the joint undertakings’ activities, can provide timely information on activities undertaken in the Member States and have the opportunity to contribute to the preparatory and decision-making processes. Such dialogue with Member States is particularly important in the context of synergies and the need to ensure the alignment of efforts and activities at national, regional, Union and European level to create more impact. Joint undertakings without the direct or indirect involvement of Member States as members or constituent entities should establish a state representatives group with the aim of aligning the joint undertakings’ activities with the policies and actions taken at national and regional level.

(33) Joint undertakings should be able to set up an advisory body with a scientific advisory function. That body or its members should be in a position to provide independent scientific advice and support to the respective joint undertaking. The scientific advice should concern, in particular, annual work programmes and additional activities, as well as any other aspect of the joint undertakings’ tasks, as necessary.

(34) With a view to ensuring that joint undertakings are aware of the positions and views of stakeholders from the entire value chain in their respective fields, joint undertakings should be able to set up their respective advisory stakeholders groups, to be consulted on horizontal issues or specific questions, as per the needs of each joint undertaking. Such groups should be open to public and private stakeholders, including organised interest groups and international interest groups from the Member States, associated countries or other countries, active in the field of the joint undertaking.

(35) The joint undertakings should operate in an open and transparent way, providing all relevant information in a regular and timely manner to their appropriate bodies as well as promoting their activities, including information and dissemination activities, to the wider public. This includes timely information, subject to confidentiality rules and broken down by country on the application and participation in indirect actions funded by the joint undertaking, on the evaluation results of each call for proposals and project implementation, on synergies with other relevant Union programmes and other European partnerships, on additional activities, on committed and actually provided financial and in-kind contributions, on the execution of the budget of the joint undertaking, and on the link between the objectives of the joint undertaking and in-kind contributions to additional activities.

(36) The joint undertakings should be implemented using a structure and rules that enhance efficiency and ensure simplification. To that effect, the joint undertakings should adopt financial rules specific to their needs in accordance with Article 71 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (13).

(37) The implementation of the joint undertakings should be based on the criteria set out for institutionalised European partnerships in the Horizon Europe Regulation. It should be supported by the use of electronic means managed by the Commission. Information related to indirect actions funded by the joint undertakings, including results, is essential for the purposes of developing, implementing, monitoring and evaluating Union policies or programmes. Therefore, joint undertakings should ensure that Union institutions and Union bodies, offices or agencies have access to all information related to the indirect actions they fund, including contributions and results of beneficiaries participating in indirect actions. Such access rights should be limited to non-commercial and non-competitive use and should comply with applicable confidentiality rules. Staff of the Union institutions and Union bodies, offices or agencies should be granted access to this information subject to adequate IT security and information security standards and in accordance with the principles of necessity and proportionality.

(38) Participation in indirect actions funded by the joint undertakings under Horizon Europe should comply with the rules set out in the Horizon Europe Regulation. The joint undertakings should ensure consistent application of those rules based on relevant measures adopted by the Commission. The joint undertakings should use the corporate model grant agreement prepared by the Commission. In relation to the period to object to transfers of ownership of results referred to in Article 40(4) of the Horizon Europe Regulation, the duration of innovation cycles in the areas covered by the respective joint undertakings should be taken into account.

(39) One of the main purposes of joint undertakings is to foster the Union’s economic capacities and in particular its scientific and technological leadership. Moreover, the post-COVID-19 recovery highlights the need to invest in key technologies such as 5G, artificial intelligence (AI), cloud, cybersecurity and green tech and to valorise those technologies in the Union. The joint undertakings should contribute to fostering open science in accordance with Articles 14 and 39 of the Horizon Europe Regulation. Results generated by all participants will play an important role in this respect and all participants will benefit from Union funding through the results generated in the project and access rights thereto, even those participants not having received Union funding. Therefore, to protect Union interests, the right for joint undertakings to object to transfers of ownership of results or to grants of an exclusive licence regarding results should also apply to participants not having received Union funding. In exercising this right to object and in accordance with the principle of proportionality, the joint undertaking should strike a fair balance between Union interests and protection of fundamental rights as regards the results of the participants not having received Union funding, taking into account that those participants did not receive any Union funding for the action from which the results were generated.

(40) The Union financial contribution should be managed in accordance with the principle of sound financial management and with the rules on indirect management set out in Regulation (EU, Euratom) 2018/1046.

(41) For the purpose of simplification, the administrative burden should be reduced for all parties. Double audits and disproportionate amounts of documentation and reporting should be avoided. Audits of recipients of Union funds under this Regulation should be carried out in compliance with the Horizon Europe Regulation and other relevant Union funding programmes.

(42) The financial interests of the Union and of the other members of the joint undertakings should be protected through proportionate measures throughout the expenditure cycle, including the prevention, detection and investigation of irregularities, the recovery of funds lost, wrongly paid or incorrectly used and, where appropriate, administrative and financial penalties in accordance with Regulation (EU, Euratom) 2018/1046. In view of the specific nature of the actions implemented by some of the joint undertakings requiring them to be phased out over several years, it should be possible to split multiannual budgetary commitments by the Commission and the relevant joint undertaking into annual instalments. In this respect, budgetary commitments of the Clean Aviation Joint Undertaking, of the Europe’s Rail Joint Undertaking and of the Single European Sky ATM Research 3 Joint Undertaking may be divided into annual instalments. Until 31 December 2024, the cumulative amount of those budgetary commitments should not exceed 50 % of the respective maximum Union contribution. From 1 January 2025, at least 20 % of the cumulative budget of the residual years should not be covered by annual instalments.

(43) In view of the specific nature and the current status of the joint undertakings, they should continue to be subject to a separate discharge. The auditing of accounts and of the legality and regularity of the underlying transactions should be undertaken by the Court of Auditors.

(44) In accordance with Article 10(2), point (c), of the Horizon Europe Regulation, joint undertakings should have a clear life cycle approach. In order to adequately protect the financial interests of the Union, joint undertakings should be set up for a period ending 31 December 2031 to allow them to exercise their responsibilities with regard to grant implementation until the last indirect actions launched have been completed. The joint undertakings should be financed by the Union programmes under the multiannual financial framework for 2021-2027 (‘MFF 2021-2027’). The joint undertakings should be able to launch calls for proposals by 31 December 2028, in duly justified cases related to availability of remaining budget stemming from the MFF 2021-2027.

(45) In the context of the Commission’s priority of the European Green Deal supported by the communications from the Commission of 11 October 2018 on A sustainable Union Bioeconomy for Europe: Strengthening the connection between economy, society and the environment, of 28 November 2018 on A Clean Planet for All: A European strategic long-term vision for a prosperous, modern, competitive and climate neutral economy, of 11 March 2020 on A new Circular Economy Action Plan: For a cleaner and more competitive Europe, of 20 May 2020 on EU Biodiversity Strategy for 2030: Bringing nature back into our lives, of 20 May 2020 on A Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system and of 17 October 2020 on the Chemicals Strategy for Sustainability: Towards a Toxic-Free Environment, the European bio-based sector, including SMEs, regions and primary producers, should become climate neutral, more circular and more sustainable while remaining competitive on the global scale. A strong, resource-efficient and competitive bio-based innovation ecosystem can decrease dependency on and accelerate the substitution of non-renewable fossil raw materials and mineral resources. It can develop renewable bio-based products, materials, processes and nutrients from waste and biomass through sustainability and circularity-driven innovation. Such ecosystem can also create value from local feedstock, including waste, residues and side-streams, to deliver jobs, economic growth and development throughout the Union, not only in urban areas but also in rural and coastal territories where biomass is produced and which are often peripheral regions that rarely benefit from industrial development.

(46) The Bio-based Industries Joint Undertaking established under Horizon 2020 has focused on sustainable resource use, especially in resource-intensive and high-impact sectors such as agriculture, textiles manufacturing and construction, in particular aiming at local operators, manufacturers, plants and factories. Its interim evaluation published in October 2017 included a strong set of 34 recommendations that are reflected in the design of the Circular Bio-based Europe Joint Undertaking established by this Regulation. The Circular Bio-based Europe Joint Undertaking is not a direct continuation of the Bio-Based Industries Joint Undertaking but rather a programme that builds on the achievements of the preceding initiative and addresses its shortcomings. In line with the recommendations, the Circular Bio-based Europe Joint Undertaking should involve a wider range of stakeholders including the primary sector (namely agriculture, aquaculture, fisheries and forestry) as well as providers of waste, residues and side streams, regional authorities and investors to prevent market failures and unsustainable bio-based processes. To deliver on its objectives, it should only fund projects that respect principles of circularity, sustainability and planetary boundaries.

(47) The Circular Bio-based Europe Joint Undertaking should establish Deployment Groups that should serve as advisory bodies and actively participate in the strategic discussions that are to set the agenda for the partnership. It is crucial to include those advisory bodies in the governance structure to ensure wider participation and higher private investment in the circular bio-based sector. The Deployment Groups should in particular provide support to the strategic Governing Board meetings where industrial leaders and the stakeholders’ representatives together with high-level Commission representatives join the permanent Governing Board to discuss and set the strategic direction of the partnership.

(48) The main objective of the Clean Aviation Joint Undertaking should be to contribute to reducing the ecological footprint of aviation by accelerating the development of climate neutral aviation technologies for their earliest possible deployment, therefore significantly contributing to the ambitious environment impact mitigation goals of the European Green Deal and Regulation (EU) 2021/1119 of the European Parliament and of the Council (14) (‘European Climate Law’), that is to say a 55 % emissions reduction by 2030 compared to 1990 levels, and climate neutrality at the latest by 2050 in line with the Paris Agreement adopted under the United Nations Framework Convention on Climate Change (15). This objective can only be achieved through accelerating and optimising the research and innovation processes in aeronautics and by improving the global competitiveness of the Union aviation industry. The Clean Aviation Joint Undertaking should also ensure that cleaner aviation remains safe, secure and efficient for the transportation of passengers and goods by air.

(49) The Clean Aviation Joint Undertaking builds on the experience gained from the Clean Sky and Clean Sky 2 Joint Undertakings. The new European partnership should be more ambitious by focusing on developing breakthrough demonstrators. In line with the findings of the interim evaluation of the Clean Sky 2 Joint Undertaking, a new initiative should ensure that every demonstrator is on the critical path for the development of the next aircraft programmes in order for the technologies developed to really serve the key priority of earliest possible deployment. Therefore, the new joint undertaking should focus on increasing the visibility of its individual exploitation objectives and strengthening the monitoring, management and reporting capabilities of the joint undertaking to reflect the complexity of the research and innovation effort required for the European partnership to reach its objectives.

(50) The Clean Aviation Joint Undertaking should build on a strong leadership from the European aviation industry and a diverse membership base, bringing together a broad spectrum of stakeholders and ideas across Europe. With a view to identifying the most promising approaches and entities capable of pursuing them, the Commission launched a call for expression of ideas and potential members. The Governing Board should be allowed to select associated members based on the results of that call and future calls in order to provide for a swift expansion of the group of members.

(51) In order to maximise and accelerate the impact of the research and innovation activities undertaken by the Clean Aviation and Single European Sky ATM Research 3 Joint Undertakings on effective emission reduction and the digitalisation of the aviation industry, those joint undertakings should seek close collaboration with the European Union Aviation Safety Agency (EASA) in the work of the European partnership, ensuring an early exchange of knowledge on new technologies developed. That collaboration will be crucial to accelerate market uptake, by facilitating the certification process of resulting products and services as required by Regulation (EU) 2018/1139 of the European Parliament and of the Council (16).

(52) In order to maximise synergies between programmes at Union, national and regional level, the members of the states’ representatives group of the Clean Aviation Joint Undertaking should explore possibilities to provide financial support at national level to excellent proposals that were not selected for funding by the Clean Aviation Joint Undertaking due to oversubscription.

(53) Europe faces the challenge of having to play a leading role in accelerating the environmental transformation of the next generation of aircraft and internalising the societal costs of greenhouse gas emissions in the air transport business model while continuing to ensure a level playing field for European products in the global market. Therefore, the Clean Aviation Joint Undertaking should support the European representatives in international standardisation and international legislative efforts.

(54) Interest in hydrogen has evolved dramatically in the last five years, with all Member States having signed and ratified the United Nations Framework Convention on Climate Change (Paris Agreement) at the 21st Conference of the Parties (COP21). The European Green Deal aims to transform the Union into a fair and prosperous society with a modern, resource-efficient and competitive economy, where there are no net emissions of greenhouse gases at the latest by 2050. Priority areas include clean hydrogen, fuel cells, other alternative fuels and energy storage. Hydrogen is prominent in the communications from the Commission of 8 July 2020 on A hydrogen strategy for a climate-neutral Europe and on Powering a climate-neutral economy: EU Strategy for Energy System Integration, as well as for the launch of the European Clean Hydrogen Alliance that brings all stakeholders together to identify technology needs, investment opportunities and regulatory barriers to build a clean hydrogen ecosystem in the Union contributing to reducing the current dependence on fossil fuels and greenhouse gases emissions in relevant sectors. The Clean Hydrogen Joint Undertaking may enable the uptake of research and innovation (R&I) results by investment frameworks, such as the European Clean Hydrogen Alliance and Important Projects of Common European Interest (IPCEI) on Hydrogen.

(55) Dedicated research and innovation activities related to hydrogen applications have been supported since 2008, mainly through the Fuel Cell and Hydrogen Joint Undertakings, namely FCH Joint Undertaking and FCH 2 Joint Undertaking, under the Seventh Framework Programme established by Decision No 1982/2006/EC of the European Parliament and of the Council (17) and Horizon 2020 as well as by traditional collaborative projects, covering all stages/fields of the hydrogen value chain. The Clean Hydrogen Joint Undertaking should strengthen and integrate Union scientific capacity to accelerate the development and improvement of advanced clean hydrogen applications ready for market, across energy, transport, building and industrial end-uses. That will only be possible if combined with strengthening competitiveness of the Union clean hydrogen value chain, and in particular SMEs.

(56) To achieve the scientific objectives of the Clean Hydrogen Joint Undertaking, all sectors concerned by the hydrogen economy should be given the possibility to get involved in preparing and implementing its Strategic Research and Innovation Agenda. Actions undertaken by the Clean Hydrogen Joint Undertaking should take into account disruptive technological trajectories alternative to mainstream technologies. The public sector should be involved, especially regional and national authorities, the latter being responsible for setting up climate policies and measures related to market mechanisms, to fill in the gaps between ready-to-market technology development and large-scale uptake.

(57) The Clean Hydrogen Joint Undertaking includes the research community as a member of the Hydrogen Europe Research association, and thus a body providing scientific advice should not be established.

(58) Since hydrogen can be deployed as a fuel or an energy carrier and for storing energy, it is essential that the clean hydrogen partnership establishes structured collaboration with many other European partnerships, in particular for end-use. The clean hydrogen European partnership should interact in particular with the zero emission road and waterborne transport, Europe’s railway, clean aviation, processes for the planet and clean steel European partnerships. For that purpose, a structure should be set up reporting to the Governing Board in order to ensure the cooperation and synergies between those partnerships in the domain of hydrogen. The Clean Hydrogen Joint Undertaking would be the only partnership focused on addressing hydrogen production technologies. Collaboration with end-use partnerships should in particular focus on demonstrating the technology and co-defining specifications.

(59) Railways contribute to the Single European Transport Area (SETA) and represent a fundamental element of the Union long-term sustainable development strategy policy. In terms of economic size, the direct gross added value of the European rail sector is EUR 69 billion and the indirect value amounts to EUR 80 billion. 1,3 million persons are directly employed in the rail sector and more than one million indirectly.

(60) The communication from the Commission of 10 March 2020 on a New Industrial Strategy for Europe underlines that sustainable and smart mobility industries, such as the rail industry, have both the responsibility and the potential to drive the digital and green transition, support Europe’s industrial competitiveness and improve connectivity. Therefore road, rail, aviation and waterborne transport should all contribute to a 90 % reduction in transport emissions by 2050. As a matter of priority, a substantial part of the 75 % of inland freight carried today by road should shift onto rail and inland waterways.

(61) The Shift2Rail Joint Undertaking was established in 2014 to manage the research, development and validation activities of the Shift2Rail preceding initiative by combining public and private sector funding provided by its members and by drawing on internal and external technical resources. It established new forms of collaboration, consistent with competition rules, between stakeholders from the entire rail value chain and from outside the traditional rail sector, and brought in the experience and expertise of the European Union Agency for Railways on issues relating to interoperability and safety.

(62) The objective of Europe’s Rail Joint Undertaking should be to deliver a high capacity integrated European railway network by eliminating barriers to interoperability and providing solutions for full integration, covering traffic management, vehicles, infrastructure and services, aiming to achieve faster uptake and deployment of projects and innovations. That should exploit the huge potential for digitalisation and automation to reduce rail’s costs, increase its capacity and enhance its flexibility and reliability, and should be based upon a solid reference functional system architecture shared by the sector, in coordination with the European Union Agency for Railways.

(63) The Europe’s Rail Joint Undertaking should define in its Master Plan its priority research and innovation activities, and overall system architecture and harmonised operational approach, including large-scale demonstration activities and flagship areas, required to accelerate the penetration of integrated, interoperable and standardised technological innovations necessary to support the Single European Railway Area.

(64) Rail is a complex system, with very close interactions between infrastructure managers, rail undertakings (train operators) and their respective equipment (infrastructure and rolling stock). It is impossible to deliver innovation without common specifications and strategy across the rail system. Therefore, the System Pillar of the Europe’s Rail Joint Undertaking, which will gather input from relevant stakeholders from both outside and within the joint undertaking, should enable the sector to converge on a single operational concept and system architecture, including the definition of the services, functional blocks and interfaces, which form the basis of rail system operations. It should provide the overall framework to ensure that research targets customer requirements and operational needs that are commonly agreed and shared. The output of the System Pillar should support interoperability for the whole railway network, including TEN-T core and comprehensive network, and main lines and regional lines not included in the TEN-T. The governance model and the decision-making process of the Europe’s Rail Joint Undertaking should reflect the Commission’s leading role in unifying and integrating Europe’s railway system, especially in rapidly and effectively delivering the single operational concept and system architecture, while involving the private partners in advisory and technical support roles.

(65) To ensure that the results of low technology readiness levels (TRLs) research are effectively used at higher TRLs, and in particular by the Europe’s Rail Joint Undertaking, the Europe’s Rail Joint Undertaking’s programme office should implement such activities.

(66) Where necessary, in order to ensure swift transition and expansion of membership, the Governing Board of the Europe’s Rail Joint Undertaking should be allowed to select associated members on the basis of the results of a call for expression of interest launched by the Commission.

(67) In the context of the Commission’s priorities of the United Nations Sustainable Development Goals, in particular Sustainable Development Goal 3, and the joint communication from the Commission of 9 March 2020 entitled ‘Towards a Comprehensive Strategy with Africa’, the Union is committed to contribute to ensuring healthy lives and promoting well-being for all, to building an even stronger partnership between the two continents and to supporting the development of research and innovation capacities within Africa. The Global Health EDCTP3 Joint Undertaking should address the lack of appropriate diagnostics, treatments and vaccines, among other so-called health technologies, to address infectious diseases, such as HIV, malaria and tuberculosis but also other poverty-related and neglected infectious diseases, that are prevalent in Africa, especially in sub-Saharan Africa. The COVID-19 pandemic has revealed that, with the increased connectivity of different regions in the world, through world trade and tourism, infectious diseases can rapidly spread all over the world. Developing health technologies is therefore crucial to limit the spread of infectious diseases, as well as to fight them once they have spread, to protect the health of citizens in the countries concerned and in the Union. In order to achieve a stronger global health leadership than the preceding EDCTP2 initiative, the scope of the partnership should be extended to cover response to emerging infectious diseases threats, the increasing problems of antimicrobial resistance and non-communicable diseases co-morbidities.

(68) Tackling infectious diseases affecting sub-Saharan Africa with modern technology tools requires the involvement of a large set of actors and long-term commitments. The Global Health EDCTP3 Joint Undertaking should broker productive and sustainable North–South and South–South networking and cooperation, building relationships with multiple private and public sector organisations to strengthen project and institutional collaborations. The programme should also help to establish new North–South and South–South collaborations to conduct multi-country, multi-site studies in sub-Saharan Africa. In addition, a regular international conference, the European and Developing Countries Clinical Trials Partnership (EDCTP) Forum, should provide a platform for scientists and relevant networks from Europe, Africa and elsewhere to share findings and ideas, and to establish collaborative links.

(69) The Global Health EDCTP3 Joint Undertaking should build on the experience gained during the EDCTP and EDCTP2 programmes, achieving results by harnessing investments of the Union, the Member States, associated countries and African countries which could not have been achieved by individual countries or by the Union research framework programme alone. The EDCTP Association, representing the states participating in the programme, should contribute with additional activities and may contribute financially to the EDCTP3 Programme and its implementation. It should provide meaningful participation and involvement of the sub-Saharan countries in the decision-making process, which is essential for tackling the burden of diseases in sub-Saharan countries. The joint undertaking should include other international research funders, such as philanthropists, the pharmaceutical industry and other third countries, that should contribute to the partnership as contributing partners on an ad hoc basis. Furthermore, to increase the impact of the programme, the Global Health EDCTP3 Joint Undertaking should have, for specific calls, the possibility to identify legal entities that could participate in indirect actions. It should be possible to provide in the work programme that such legal entities would not be eligible for funding by the joint undertaking.

(70) The Global Health EDCTP3 Joint Undertaking includes Member States and associated countries as members of the EDCTP Association, and thus a states’ representatives group should not be established.

(71) It is essential that the research activities funded by Global Health EDCTP3 Joint Undertaking, or otherwise covered by its work programme, are in full compliance with the Charter of Fundamental Rights of the European Union, the European Convention on Human Rights and its Supplementary Protocols, ethical principles included in the World Medical Association’s Declaration of Helsinki of 2008, the standards of good clinical practice adopted by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, relevant Union legislation and local ethics requirements of the countries where the research activities are to be conducted. Furthermore, the Global Health EDCTP3 Joint Undertaking should require that the innovations and interventions developed based on results of the indirect actions supported by the programme be affordable and accessible for vulnerable populations.

(72) For the Global Health EDCTP3 Joint Undertaking to succeed and incentivise participation in the partnership, the joint undertaking funding should be restricted to legal entities established in Member States or associated countries or established in constituent states of the EDCTP Association, in accordance with the Horizon Europe Regulation. The entities established in sub-Saharan African and other third countries should still be able to participate in the calls without receiving funding. Additionally it should also be possible for entities established in other countries than members of the EDCTP3 Association to be eligible for funding in specific call topics or in the event of a call addressing a public health emergency, where it is provided for in the work programme. The Global Health EDCTP3 Joint Undertaking should take all appropriate measures, including contractual, to protect the financial interests of the Union. The conclusion of science and technology agreements with third countries should be sought. Before their conclusion, where entities established in a third country without such an agreement participate with funding in an indirect action, alternative measures to safeguard Union interests should be applied by the Global Health EDCTP3 Joint Undertaking, namely the financial coordinator of the action should be established in a Member State or associated country and the amount of pre-financing as well as liability provisions of the grant agreement should be adapted to adequately take the financial risks into account.

(73) In the context of the Commission’s priorities of ‘An economy that works for people’ and ‘A Europe fit for the digital age’, the European industry, including SMEs, should become greener, more circular and more digital while remaining competitive on the global scale. The Commission has emphasised the role of medical devices and digital technologies addressing emerging challenges and the use of e-health services to provide high-quality health care, along with a call for ensuring the supply of affordable medicines to meet the Union’s needs, whilst supporting an innovative and world-leading European pharmaceutical industry. The Innovative Health Initiative Joint Undertaking aims to contribute to strengthening the competitiveness of the Union’s health industry, a cornerstone of the Union’s knowledge-based economy, to an increased economic activity in the development of health technologies, in particular of integrated health solutions, and thus serve as a tool for increasing technological leadership and fostering the digital transformation of our societies. Such political priorities can be achieved by bringing together the crucial players, namely academia, companies of various sizes and end-users of health innovations, under the umbrella of a public-private partnership in health research and innovation. The Innovative Health Initiative Joint Undertaking should help reach the objectives of the ‘Europe’s Beating Cancer Plan’ and the ‘European One Health Action Plan against Antimicrobial Resistance’. The Innovative Health Initiative Joint Undertaking should be in line with the communications from the Commission of 10 March 2020 on A New Industrial Strategy for Europe, of 10 March 2020 on An SME Strategy for a sustainable and digital Europe and of 25 November 2020 on the Pharmaceutical Strategy for Europe.

(74) The Innovative Health Initiative Joint Undertaking builds on the experience gained from the Innovative Medicine Initiative 2 Joint Undertaking (IMI2 Joint Undertaking) including the work done by that preceding initiative to combat the COVID-19 pandemic. In line with the recommendations of the interim evaluation of the IMI2 Joint Undertaking, a successor initiative needs to enable the active engagement of other industry sectors with the pharmaceutical industry to capitalise on their expertise in the development of new health care interventions. Therefore, the industry sectors need to cover the biopharmaceutical, biotechnology and medical technology sectors, including companies active in the digital area. The scope of the joint undertaking should cover prevention, diagnosis, treatment and disease management and must be established taking due account of the high burden for patients or society or both due to the severity of the disease or the number of people affected, as well as the high economic impact of the disease for patients and for health care systems. The funded actions must respond to the Union public health needs, supporting the development of future health innovations that are safe, people-centred, effective, cost-effective and affordable for patients and for health care systems.

(75) To ensure the best opportunity for generating new scientific ideas and successful research and innovation activities, the key actors in Innovative Health Initiative Joint Undertaking should be researchers from various types of entities, public and private. At the same time, end-users such as Union citizens, health care professionals and health care providers should provide input into the strategic design and activities of the joint undertaking, ensuring that it addresses their needs. Furthermore, Union-wide and national regulatory authorities, health technology assessment bodies and health care payers should also provide early input to the partnership’s activities, while ensuring the absence of any conflicts of interest, in order to increase the likelihood that the results of funded actions meet the requirements necessary for uptake and thus achieve the expected impacts. All such input should help better target research efforts towards areas of unmet need.

(76) Current health challenges and threats are global. Therefore, the Innovative Health Initiative Joint Undertaking should be open to participation by international academic, industrial and regulatory actors, in order to benefit from wider access to data and expertise, to respond to emerging health threats and to achieve the necessary societal impact, in particular improved health outcomes for Union citizens. At the same time, most of the partnership’s activities should be conducted in the Member States and in Horizon Europe associated countries.

(77) The partnership’s objectives should focus on the pre-competitive area, thereby creating a safe space for efficient collaboration between companies active in different health technologies. To reflect the integrative nature of the Innovative Health Initiative Joint Undertaking, help break the silos between health industry sectors and strengthen industry-academia collaborations, the majority of the projects funded by the Joint Undertaking should be cross-sectoral.

(78) The term Key Digital Technologies refers to electronic components and systems that underpin all major economic sectors. The Commission highlighted the need to master such technologies in Europe, in particular in the context of delivering on European policy priorities such as digital leadership. The importance of the area and the challenges faced by the stakeholders in the Union require urgent action in order to leave no weak link in Europe’s innovation and value chains. A mechanism at Union level should therefore be set up to combine and focus the provision of support to research and innovation in electronic components and systems by the Member States, the Union and the private sector.

(79) The Key Digital Technologies Joint Undertaking should address clearly defined topics that would enable European industries at large to design, manufacture and use the most innovative technologies in electronic components and systems. Structured and coordinated financial support at European level is necessary to help research teams and European industries maintain their current strengths at the leading edge in a highly competitive international context and close the gap in technologies that are critical for a digital transformation in Europe that reflects core Union values including privacy and trust, security and safety. Collaboration among stakeholders of the ecosystem, representing all segments of the value chains, is essential for the development of new technologies and the fast market uptake of innovation. Openness and flexibility to integrate relevant stakeholders, including in particular SMEs, in emerging or adjacent areas of technology or in both, is also vital.

(80) The Key Digital Technologies Joint Undertaking should combine the financial and technical means that are essential to master the escalating pace of innovation in this area, to generate important spill-overs for society, and to share risk-taking by aligning strategies and investments towards a common European interest. Therefore, the members of the Key Digital Technologies Joint Undertaking should be the Union, Member States and associated countries to Horizon Europe on a voluntary basis, and associations as private members representing their constituent entities. Participation of Member States will furthermore facilitate a coherent alignment with national programmes and strategies, reducing overlap and fragmentation of efforts while ensuring synergies across stakeholders and activities.

(81) In implementing the contributions of the participating states to their national participants in indirect actions, the Key Digital Technologies Joint Undertaking should take into account that the participating states have to abide by strict national budgetary rules. In that respect, participating states should give indicative financial commitments prior to the adoption of each annual work programme and should conclude legally binding agreements with the joint undertaking, committing participating states to the payment arrangements of their contribution to indirect actions throughout the lifetime of the joint undertaking. Such agreements should be concluded in the context of the annual budgetary procedure and programming of the joint undertaking. The Governing Board should adopt the annual work programme taking due account of those indicative commitments. The Public Authorities Board should select proposals. Only after those steps, and in line with the joint undertaking’s financial rules, the authorising officer should make the budgetary and legal commitments for those indirect actions.

(82) As a continuation of the practice established in the ECSEL Joint Undertaking, a derogation from Article 34 of the Horizon Europe Regulation is necessary in order to allow different funding rates depending on the type of participant, in particular SMEs and non-profit legal entities, and the type of action, to be applied invariably across beneficiaries from all participating states. That should ensure the right balance of stakeholder participation in the actions funded by the Key Digital Technologies Joint Undertaking and foster a higher level of involvement of SMEs as recommended in the ECSEL Joint Undertaking interim evaluation.

(83) The Key Digital Technologies Joint Undertaking includes Member States and associated countries as members of the Public Authorities Board, and thus a state representative group should not be established.

(84) The Union’s Single European Sky legal framework established by Regulation (EC) No 549/2004 of the European Parliament and of the Council (18) seeks to reform the European air traffic management (ATM) system through institutional, operational, technological and regulatory actions with the aim of improving its performance in terms of capacity, safety, efficiency and environmental impact.

(85) The Single European Sky ATM Research and Development project (the ‘SESAR project’) established by Council Regulation (EC) No 219/2007 (19) aims to modernise ATM and to bundle technological and operational innovation in support of the Single European Sky. It aims to provide the technological solutions for a highly performing ATM by 2035 to enable an uncongested, even safer and more environmentally and climate friendly functioning of the air transport sector, in line with the European Green Deal and the European Climate Law. The SESAR project comprises three interrelated, continuous and evolving collaborative processes that define, develop and deploy innovative technological systems and operational procedures underlying the digital European sky defined in the European ATM Master Plan referred to in Council Decision 2009/320/EC (20).

(86) The European ATM Master Plan is the planning tool for ATM modernisation across Europe, connecting ATM research and innovation activities with deployment activities scenarios to achieve the Single European Sky performance objectives.

(87) The SESAR Joint Undertaking was established with the objective of managing the definition and development phases of the SESAR project, by combining public and private sector funding provided by its members and by drawing on internal and external technical resources, as well as to execute and update, when necessary, the European ATM Master Plan. It established a new and efficient form of collaboration between stakeholders in a sector where progress is only possible when all stakeholders implement new solutions in a synchronised manner. Given the successful establishment of the SESAR brand name, the new Single European Sky ATM Research 3 Joint Undertaking should continue to make use of it.

(88) The Single European Sky ATM Research 3 Joint Undertaking should build on the experience of the SESAR Joint Undertaking and continue its coordination role for ATM research in the Union. The main objectives of the Single European Sky ATM Research 3 Joint Undertaking should be to strengthen and further integrate the research and innovation capacity in Europe, helping to accelerate the digitalisation of the sector and rendering it more resilient and scalable to fluctuations in traffic. It should strengthen, through innovation, the competitiveness of manned and unmanned air transport and ATM services, to support economic recovery and growth. It should develop and accelerate the market uptake of innovative solutions to establish the Single European Sky airspace as the most efficient and environmentally friendly sky to fly in the world.

(89) The new Single European Sky ATM Research 3 Joint Undertaking should be able to develop and validate technical input assisting the Commission with regulatory activities in ATM, for example preparing all the technical documentation for the common projects established under a Regulation of the European Parliament and of the Council on the implementation of the Single European Sky, conducting technical studies or supporting standardisation activities. It should also ensure the stewardship of the European ATM Master Plan endorsed by Decision 2009/320/EC, including its monitoring, reporting and updating. In addition, the Commission should have votes in proportion to the Union contribution to the budget, and at least 25 % of votes. This set-up ensures that the Commission retains a strong ability to steer, from a policy perspective, the work carried out by the Joint Undertaking in relation to those tasks through the strengthened supervision mechanisms established for such bodies.

(90) Participation in the Single European Sky ATM Research 3 Joint Undertaking should be open to the widest possible range and representation of stakeholders from all Member States and countries associated to Horizon Europe, including SMEs, through different forms of participation. In particular, participation should ensure a proper balance between equipment manufacturers for both manned and unmanned aviation, airspace users, air navigation service providers, airports, military and professional staff associations, and offer opportunities to SMEs, academia and research organisations. With a view to identifying the most promising approaches and entities capable of pursuing them, the Commission launched a call for expression of interest for potential members. The Governing Board should be allowed to select associated members on the basis of the results of that call in order to provide for a swift expansion of the group of members.

(91) Route charges are entirely borne by airspace users, who contribute indirectly to the research and development efforts financed by major ATM stakeholders like air navigation service providers or the manufacturing industry building and equipping the aircrafts used by the airspace users. Therefore, airspace users should be given appropriate representation within the Single European Sky ATM Research 3 Joint Undertaking’s Governing Board.

(92) To ensure that the results of ATM exploratory (low TRLs) research are effectively used at higher TRLs, and in particular by the Single European Sky ATM Research 3 Joint Undertaking, the joint undertaking’s programme office should manage such activities.

(93) The Eurocontrol Agency possesses an appropriate infrastructure and the necessary administrative, IT, communications and logistics support services. The Single European Sky ATM Research 3 Joint Undertaking should benefit from such infrastructure and services from Eurocontrol. In this context, there are few potential synergies that could be gained from pooling administrative resources with other Joint Undertakings through a common back office. For this reason, the Single European Sky ATM Research 3 Joint Undertaking should opt out from the back office arrangements established by this Regulation.

(94) With the purpose of creating a broad stakeholder base for ensuring the Smart Networks and Services partnership’s objectives, the 6G Smart Networks and Services Industry Association (6G-IA)has been established building on the predecessor association. While the new industry association, in the first years following its establishment, is expected to have only a limited number of constituent and affiliated entities, it has the objective to include new members from stakeholder constituencies active in the Smart Network and Services value chain. Considering its expected modest size and the impact on its SMEs constituent entities, it is not sustainable for the association to contribute to 50 % of the administrative costs of the Smart Networks and Services Joint Undertaking over its lifetime, in particular in the first years following its establishment. Additionally, the crisis brought about by the COVID-19 pandemic and its impact on the economy has posed challenges for the European economic actors including in the field of information and communications technology. Therefore it should be ensured that the private partners of the joint undertaking are able to fulfil their commitments, while the conditions remain attractive and incentivise new partners to join the association. The minimum percentage of annual financial contribution to the administrative costs from members other than the Union should therefore be 20 % of the total annual administrative costs. In particular, it should be possible that SMEs constituent entities contribute less than bigger enterprises. The members of the joint undertaking other than the Union should endeavour to increase the number of constituent or affiliated entities in order to increase their contribution to 50 % of the administrative costs of the joint undertaking over its lifetime.

(95) In the context of Commission priorities for 2019-2024 ‘A Europe fit for the digital age’, ‘An economy that works for people’ and the policy objectives set out in the context of its communication on ‘Shaping Europe’s digital future’, Europe needs to develop critical digital infrastructures based on 5G networks and build its technological capacities towards 6G with a time horizon of 2030. In this context, the Commission has emphasised the strategic importance of a European partnership for Smart Networks and Services to provide secure connectivity-based services to consumers and businesses. Those priorities can be achieved by bringing together the key players, namely industry, academia and public authorities, under the umbrella of a European partnership that builds on the achievements of the 5G Infrastructure Public Private Partnership preceding initiative, which successfully developed 5G technology and standards.

(96) The Smart Networks and Services Joint Undertaking is designed to address policy issues in the field of digital infrastructure, to support 5G infrastructure deployment within the scope of the Connecting Europe Facility 2 (CEF2) Digital programme established by Regulation (EU) 2021/1153 of the European Parliament and of the Council (21) and to extend the technology scope of research and innovation for 6G networks. It should, with close involvement of the Member States, strengthen the response to Union policy and social needs regarding network energy efficiency, cybersecurity, technological leadership, privacy and ethics and should extend the research and innovation scope from networks to cloud-based service provisioning as well as components and devices enabling services for citizens and a broad range of economic sectors such as health care, transport, manufacturing and media.

(97) The public policy objectives related to Smart Networks and Services cannot be addressed solely by the industry and the Commission. Addressing them from a holistic and coordinated perspective requires in particular the strategic involvement of the Member States as part of the governance structure. Therefore, the Governing Board should take utmost account of the opinions of the states’ representatives group, in particular as regards strategic guidance concerning work programmes and funding decisions.

(98) Advanced 5G infrastructures will be the basis for developing the ecosystems for the digital and green transitions and, in the next step, for Europe’s position to adopt 6G technology. The CEF2 Digital programme as well as the Digital Europe Programme (DEP) established by Regulation (EU) 2021/694 of the European Parliament and of the Council (22) and InvestEU established by Regulation (EU) 2021/523 of the European Parliament and of the Council (23) offer opportunities for the development of 5G- and later 6G-based digital ecosystems. Taking into account the broad set of public and private stakeholders involved in such deployment projects, it is essential to coordinate the setting-up of a strategic agenda, the contribution to the programming and the stakeholder information and engagement related to such programmes. As a strategic basis for those tasks, the Smart Networks and Services Joint Undertaking should coordinate the development of Strategic Deployment Agendas for the relevant areas of deployment, such as 5G systems along roads and along railways. Those agendas should, inter alia, support setting out deployment roadmaps, the main options for cooperation models and other strategic issues.

(99) Article 20(3) of the Horizon Europe Regulation provides that, where appropriate, the Commission or funding body has to carry out a security scrutiny for proposals raising security issues.

(100) Pursuant to the Council Conclusions of 3 December 2019 and the Recommendation of 26 March 2019 on Cybersecurity of 5G networks for coordinated action at Union level, the Member States’ Cooperation Group on Network and Information Security published the EU toolbox of risk mitigating measures concerning cyber-security of 5G networks of January 2020 (the ‘toolbox’). The toolbox includes a set of strategic and technical measures as well as supporting actions in order to mitigate the main cybersecurity risks of 5G networks, which have been identified in the Union coordinated risk assessment report, and to provide guidance for the selection of measures that should be prioritised in mitigation plans at national and at Union level. The Commission Communication of 29 January 2020 on Implementing the EU toolbox endorses all measures and guidance set out in the toolbox and emphasises the need for restrictions, including necessary exclusions, concerning suppliers considered to be high risk based on the factors specified in the Union coordinated risk assessment as well as measures to avoid dependency on those suppliers. It also identifies a set of specific actions for the Commission, in particular to ensure that participation in Union funding programmes in relevant technology domains will be conditional on compliance with security requirements, by making full use of and further implementing security conditions. Therefore, the implementation of this Regulation should introduce appropriate provisions to reflect the security measures through actions funded by the SNS Joint Undertaking and, on the basis of its recommendations, by other funding bodies implementing other Union programmes in the area of smart networks and services.

(101) The joint undertakings under Horizon 2020 were set up for a period up to 31 December 2024. The joint undertakings should provide continued support to the respective research programmes by implementing the remaining actions initiated or continued under Council Regulations (EC) No 219/2007,(EU) No 557/2014 (24), (EU) No 558/2014 (25), (EU) No 559/2014 (26), (EU) No 560/2014 (27), (EU) No 561/2014 (28) and (EU) No 642/2014 (29) and in accordance with those Regulations until their winding-up. In the interest of legal certainty and clarity those Regulations should therefore be repealed.

(102) The Union should act only where there is a demonstrable advantage that action at Union level is more effective than action taken at national, regional or local level. The joint undertakings focus on areas where there is a demonstrable added value in acting at the Union level due to the scale, speed and scope of the efforts needed for the Union to meet its long-term TFEU objectives and deliver on its strategic policy priorities and commitments. In addition, the proposed joint undertakings should be seen as complementary to and should reinforce national and sub-national activities in the same area.

(103) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States, but can rather, by reason of avoiding unnecessary duplication, retaining critical mass and ensuring that public financing is used in an optimal way, be better achieved at the Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (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.

(104) In order to ensure continuity in providing support in the relevant policy areas, this Regulation should enter into force as a matter of urgency on the day of its publication,

HAS ADOPTED THIS REGULATION:

PART ONE

COMMON PROVISIONS

TITLE I

GENERAL PROVISIONS

Article 1 Subject matter This Regulation sets up nine joint undertakings within the meaning of Article 187 TFEU for the implementation of institutionalised European partnerships referred to in Article 10(1), point (c), of the Horizon Europe Regulation. It determines their objectives and tasks, membership, organisation and other operating rules.

Article 2 Definitions For the purposes of this Regulation, the following definitions apply: 1. ‘member other than the Union’ means any participating state, private member or international organisation that is a member of a joint undertaking; 2. ‘founding member’ means any legal entity established in a Member State, a country associated to Horizon Europe, or an international organisation that is identified as a member of a joint undertaking in this Regulation or in one of its Annexes; 3. ‘associated member’ means any legal entity established in a Member State, a country associated to Horizon Europe, or an international organisation that accedes to a joint undertaking by signing a letter of commitment in accordance with Article 6(3) and subject to an approval in accordance with Article 7; 4. ‘participating state’ means any Member State or country associated to Horizon Europe upon notification of its participation in the activities of the relevant joint undertaking by means of a letter of commitment; 5. ‘private member’ means any legal entity established under public or private law that is a member of a joint undertaking other than the Union, participating states or international organisations; 6. ‘constituent entities’ means the entities that constitute a private member of a joint undertaking, where the private member is an association according to that member’s statutes; 7. ‘contributing partner’ means any country, international organisation or legal entity other than a member of a joint undertaking, or a constituent entity of a member or an affiliated entity of either, that supports the objectives of a joint undertaking in its specific area of research and whose application has been approved in accordance with Article 9; 8. ‘in-kind contributions to operational activities’ means contributions by private members, constituent entities or the affiliated entities of either, by international organisations and by contributing partners, consisting of the eligible costs incurred by them in implementing indirect actions less the contribution of that joint undertaking and of the participating states of that joint undertaking to those costs; 9. ‘additional activity’ means an activity, included in the annual additional activities plan annexed to the main part of the work programme, that does not receive financial support from the joint undertaking but contributes to its objectives and is directly linked to the uptake of results from projects under that joint undertaking or its preceding initiatives or that has a significant Union added value; 10. ‘in-kind contributions to additional activities’ means contributions by the private members, constituent entities or the affiliated entities of either, and by international organisations, consisting of the costs incurred by them in implementing additional activities less any contribution to those costs from the Union and from the participating states of that joint undertaking; 11. ‘preceding initiative’ means any partnership in one of the areas covered by a joint undertaking that received financial support from one of the previous Union framework programmes for research; 12. ‘Strategic Research and Innovation Agenda’ means the document covering the duration of Horizon Europe that identifies the key priorities and the essential technologies and innovations required to achieve the objectives of a joint undertaking; 13. ‘work programme’ means the document referred to in Article 2, point (25), of the Horizon Europe Regulation; 14. ‘conflict of interest’ means a situation involving a financial actor or other person as referred to in Article 61 of Regulation (EU, Euratom) 2018/1046; 15. ‘newcomer’ means an entity that is, for the first time, a beneficiary of a grant awarded by an individual joint undertaking or its preceding initiative and that is not a founding member of that joint undertaking or its preceding initiative.

Article 3 Establishment 1. The following joint undertakings are set up as Union bodies for a period ending on 31 December 2031 and financed under the MFF 2021-2027: (a) the Circular Bio-based Europe Joint Undertaking; (b) the Clean Aviation Joint Undertaking; (c) the Clean Hydrogen Joint Undertaking; (d) the Europe’s Rail Joint Undertaking; (e) the Global Health EDCTP3 Joint Undertaking; (f) the Innovative Health Initiative Joint Undertaking; (g) the Key Digital Technologies Joint Undertaking; (h) the Single European Sky ATM Research 3 Joint Undertaking; (i) the Smart Networks and Services Joint Undertaking. 2. The Union bodies referred to in paragraph 1 shall be collectively referred to as the ‘joint undertakings’. 3. In order to take into account the duration of Horizon Europe, calls for proposals under the joint undertakings shall be launched at the latest by 31 December 2027. In duly justified cases, calls for proposals may be launched by 31 December 2028, at the latest. 4. The joint undertakings shall have legal personality. In each of the Member States, they shall enjoy the most extensive legal capacity accorded to legal persons under the laws of that Member State. They may, in particular, acquire or dispose of movable and immovable property and may be a party to legal proceedings. 5. The seat of the joint undertakings shall be in Brussels, Belgium. 6. Unless specified otherwise, the provisions set out in Part One and Part Three shall apply to all joint undertakings. The provisions set out in Part Two shall apply to individual joint undertakings, as appropriate. 7. For the purposes of Parts One and Three and unless specified otherwise, a reference to an individual joint undertaking or body shall denote a reference to each joint undertaking or each equivalent body of the individual joint undertakings and its competences in relation to other bodies of the same joint undertaking.

TITLE II

FUNCTIONING OF THE JOINT UNDERTAKINGS

CHAPTER 1

Objectives and tasks

Article 4 Objectives and principles 1. The joint undertakings referred to in Article 3 of this Regulation shall contribute to the general and specific objectives of the Horizon Europe Regulation as set out in Article 3 thereof. 2. The joint undertakings shall, through the involvement and commitment of partners in designing and implementing a programme of research and innovation activities with European added value, deliver collectively on the following general objectives: (a) strengthening and integrating the scientific, innovation and technological capacities and facilitating collaborative links across the Union to support the creation and diffusion of high-quality new knowledge and skills, in particular with a view to delivering on global challenges, securing and enhancing Union competitiveness, European added value, resilience and sustainability and contributing to a reinforced European Research Area (ERA); (b) securing sustainability-driven global leadership and resilience of Union value chains in key technologies and industries in line with the industrial and SMEs strategies for Europe, the European Green Deal, the European Recovery Plan and other relevant Union policies; (c) developing and accelerating the uptake of innovative solutions throughout the Union addressing climate, environmental, health, digital and other global challenges contributing to Union strategic priorities, accelerating the economic growth of the Union and fostering the innovation ecosystem, while reaching the United Nations Sustainable Development Goals and achieving climate neutrality in the Union at the latest by 2050, in line with the Paris Agreement, thereby improving the quality of life of European citizens. 3. The joint undertakings shall deliver on the following specific objectives: (a) enhance the critical mass and scientific and technological capabilities and competences in collaborative, cross-sectoral, cross policy, cross-border and interdisciplinary research and innovation across the Union as well as facilitate their integration into European ecosystems; (b) accelerate the green and digital transitions as well as economic, social and societal transformations in areas and sectors of strategic importance for Union priorities, in particular to reduce greenhouse gas emissions by 2030 in accordance with the climate and energy targets set in line with the European Green Deal and the European Climate Law; (c) enhance the research and innovation capabilities and performance of existing and new European innovation ecosystem and economic value chains, including in start-ups and SMEs; (d) accelerate the deployment, uptake and diffusion of innovative solutions, technologies, services and skills in reinforced European research and innovation ecosystems and industrial ecosystems, including through wide and early engagement and co-creation with end-users, including SMEs and start-ups, citizens and regulatory and standardisation bodies; (e) deliver environmental, energy, resource-saving, societal, circularity and productivity improvements in new products, technologies, applications and services by exploiting Union capabilities and resources. 4. The joint undertakings shall also have the additional objectives set out in Part Two. 5. In the implementation of the Horizon Europe Regulation, the joint undertakings shall respect the principles set out in Article 7 of that Regulation. 6. The joint undertakings shall adhere to the conditions and criteria for European partnerships set out in Article 10 of and Annex III to the Horizon Europe Regulation.

Article 5 Operational objectives and tasks 1. The joint undertakings shall adhere to the following operational objectives in accordance with the criteria set out in Annex III to the Horizon Europe Regulation, and contribute to the operational objectives of Horizon Europe set out in the Specific Programme implementing Horizon Europe: (a) reinforce and spread excellence, including by fostering wider participation and boosting collaborative links throughout the Union; (b) strengthen scientific excellence, including by considering, where relevant, state-of-the-art basic and frontier research findings in the implementation of their activities; (c) stimulate research and innovation activities in SMEs and contribute to the creation and scaling-up of innovative companies, in particular start-ups, SMEs and, in exceptional cases, small mid-caps; (d) reinforce the link between research, innovation and, where appropriate, education, training and other policies, including complementarities with national, regional and Union research and innovation policies and activities; (e) strengthening gender mainstreaming, including the integration of gender dimension in the research and innovation content; (f) increase collaboration links in European research and innovation and across sectors and disciplines, including so