Index 
Texts adopted
Wednesday, 17 April 2019 - Strasbourg
Drafting or amendment of the title of a resolution tabled to wind up a debate (interpretation of Rule 149a(2) of the Rules of Procedure)
 Political declaration for the establisment of a political group (interpretation of Rule 32(5), first subparagraph, second indent, of the Rules of Procedure)
 Protocol to the EC-Denmark Agreement on the criteria and mechanisms for establishing the State responsible for examining a request for asylum and 'Eurodac' ***
 Establishing Horizon Europe – laying down its rules for participation and dissemination ***I
 Programme implementing Horizon Europe***I
 Market surveillance and compliance of products ***I
 Promoting fairness and transparency for business users of online intermediation services ***I
 Better enforcement and modernisation of EU consumer protection rules ***I
 Transparency and sustainability of the EU risk assessment in the food chain ***I
 Supplementary protection certificate for medicinal products ***I
 Space programme of the Union and European Union Agency for the Space Programme ***I
 Digital Europe programme for the period 2021-2027 ***I
 Fiscalis programme for cooperation in the field of taxation ***I
 Programme for the Environment and Climate Action (LIFE) ***I
 Justice programme ***I
 Rights and values programme ***I
 Number of inter-parliamentary delegations, delegations to joint inter-parliamentary committees and delegations to parliamentary cooperation committees and multilateral Parliamentary Assemblies
 Adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 TFEU - part II ***I
 Adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 TFEU - part I ***I
 Adapting a number of legal acts in the area of Justice providing for the use of the regulatory procedure with scrutiny to Article 290 TFEU ***I
 Implementation and financing of the EU general budget for 2019 in relation to the UK's withdrawal from the Union ***
 EU-Russia agreement on cooperation in science and technology ***
 Amendment of the European Investment Bank’s Statute *
 European Border and Coast Guard ***I
 Visa Code ***I
 Conservation and control measures applicable in the Regulatory Area of the Northwest Atlantic Fisheries Organisation ***I
 Rules facilitating the use of financial and other information ***I
 European Cybersecurity Industrial, Technology and Research Competence Centre and Network of National Coordination Centres ***I
 Connecting Europe Facility ***I
 Tackling the dissemination of terrorist content online ***I

Drafting or amendment of the title of a resolution tabled to wind up a debate (interpretation of Rule 149a(2) of the Rules of Procedure)
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European Parliament decision of 17 April 2019 concerning the drafting or amendment of the title of a resolution tabled to wind up a debate (interpretation of Rule 149a(2) of the Rules of Procedure) (2019/2020(REG))

The European Parliament,

–  having regard to the letter of 3 April 2019 from the Chair of the Committee on Constitutional Affairs,

–  having regard to Rule 226 of its Rules of Procedure,

1.  Decides to append the following interpretation to Rule 149a(2) of the Rules of Procedure:"“The drafting or amendment of the title of a resolution tabled to wind up a debate under Rules 123, 128 or 135 does not constitute a change to the agenda, provided that the title remains within the scope of the subject being debated.”"

2.  Instructs its President to forward this decision to the Council and the Commission, for information.


Political declaration for the establisment of a political group (interpretation of Rule 32(5), first subparagraph, second indent, of the Rules of Procedure)
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European Parliament decision of 17 April 2019 concerning the political declaration for the establisment of a political group (interpretation of Rule 32(5), first subparagraph, second indent, of the Rules of Procedure) (2019/2019(REG))

The European Parliament,

–  having regard to the letter of 3 April 2019 from the Chair of the Committee on Constitutional Affairs,

–  having regard to Rule 226 of its Rules of Procedure,

1.  Decides to append the following interpretation to Rule 32(5), first subparagraph, second indent, of the Rules of Procedure:"“The political declaration of a group shall set out the values that the group stands for and the main political objectives which its members intend to pursue together in the framework of the exercise of their mandate. The declaration shall describe the common political orientation of the group in a substantial, distinctive and genuine way.”"

2.  Instructs its President to forward this decision to the Council and the Commission, for information.


Protocol to the EC-Denmark Agreement on the criteria and mechanisms for establishing the State responsible for examining a request for asylum and 'Eurodac' ***
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European Parliament legislative resolution of 17 April 2019 on the draft Council decision on the conclusion of the Protocol to the Agreement between the European Community and the Kingdom of Denmark on the criteria and mechanisms for establishing the State responsible for examining a request for asylum lodged in Denmark or any other Member State of the European Union and "Eurodac" for the comparison of fingerprints for the effective application of the Dublin Convention regarding access to Eurodac for law enforcement purposes (15822/2018 – C8-0151/2019 – 2018/0423(NLE))
P8_TA(2019)0394A8-0196/2019

(Consent)

The European Parliament,

–  having regard to the draft Council decision (15822/2018),

–  having regard to the draft Protocol to the Agreement between the European Community and the Kingdom of Denmark on the criteria and mechanisms for establishing the State responsible for examining a request for asylum lodged in Denmark or any other Member State of the European Union and "Eurodac" for the comparison of fingerprints for the effective application of the Dublin Convention regarding access to Eurodac for law enforcement purposes (15823/2018),

–  having regard to the request for consent submitted by the Council in accordance with Article 87(2)(a), Article 88(2), first subparagraph, point (a) and Article 218(6), second subparagraph, point (a) of the Treaty on the Functioning of the European Union (C8-0151/2019),

–  having regard to Rule 99(1) and (4) and Rule 108(7) of its Rules of Procedure,

–  having regard to the recommendation of the Committee on Civil Liberties, Justice and Home Affairs (A8-0196/2019),

1.  Gives its consent to conclusion of the protocol;

2.  Instructs its President to forward its position to the Council, the Commission and the governments and parliaments of the Kingdom of Denmark and of the other Member States.


Establishing Horizon Europe – laying down its rules for participation and dissemination ***I
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Resolution
Consolidated text
European Parliament legislative resolution of 17 April 2019 on the proposal for a regulation of the European Parliament and of the Council establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination (COM(2018)0435 – C8-0252/2018 – 2018/0224(COD))
P8_TA(2019)0395A8-0401/2018

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2018)0435),

–  having regard to Article 294(2) and Articles 173(3), 182(1), 183 and 188 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0252/2018),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the letter from its President to the committee chairs of 25 January 2019 outlining the Parliament's approach to the Multiannual Financial Framework (MFF) post-2020 sectorial programmes,

–  having regard to the letter from the Council to the President of the European Parliament of 1 April 2019 confirming the common understanding reached between the co-legislators during negotiations,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on Industry, Research and Energy and the opinions of the Committee on Development, the Committee on Budgets, the Committee on Budgetary Control, the Committee on the Environment, Public Health and Food Safety, the Committee on Transport and Tourism, the Committee on Regional Development, the Committee on Agriculture and Rural Development and the Committee on Culture and Education (A8-0401/2018),

1.  Adopts its position at first reading hereinafter set out(1);

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 17 April 2019 with a view to the adoption of Regulation (EU) …/… of the European Parliament and of the Council establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination

P8_TC1-COD(2018)0224


(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 173(3), Article 182(1), Article 183, and the second paragraph of Article 188 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

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

Having regard to the opinion of the Committee of the Regions(3),

Acting in accordance with the ordinary legislative procedure(4),

Whereas:

(1)  It is the Union's objective to strengthen its scientific excellence and technological bases in which researchers, scientific knowledge and technology circulate freely and encourage its competitiveness, including in its industry, to strengthen the European Research Area while promoting all research and innovation activities to deliver on the Union's strategic priorities, and commitments which ultimately aim at promoting peace, the Union's values and the well-being of its peoples.

(2)  To deliver scientific, economic and societal impact in pursuit of this general objective and maximise the Union’s added value of its RDI investments, the Union should invest in research and innovation through Horizon Europe - a Framework Programme for Research and Innovation 2021-2027 (the ‘Programme’) to support the creation ▌ diffusion and transfer of high-quality knowledge and technologies in the Union, to strengthen the impact of research and innovation in addressing global challenges including the Sustainable Development Goals and climate change, and in developing, supporting and implementing Union policies, to support the uptake of innovative and sustainable solutions in the Union’s industry and society to create jobs and boost economic growth and industrial competitiveness; The Programme should foster all forms of innovation, ▌ strengthen market deployment of innovative solutions; and optimise the delivery of investments.

(2a)  The Programme should contribute to increasing public and private investment in R&I in Member States thereby helping to reach an overall investment of at least 3% of the Union’s GDP in research and development. The achievement of the target will require Member States and the private sector to complement the Programme with their own and reinforced investment actions in research, development and innovation.

(2b)  In view of achieving the objectives of this Programme and whilst respecting the principle of excellence, the Programme should aim to strengthen, among others, collaborative links in Europe, thereby contributing to reducing the R&I divide.

(3)  The promotion of research and innovation activities deemed necessary to help realise Union policy objectives should take into account the innovation principle ▌ a key driver in turning faster and more intensively the Union’s substantial knowledge assets into innovations.

(4)  The continuation of “Open Science, Open Innovation, Open to the World” while safeguarding the Union’s scientific and socio-economic interests should ensure excellence and impact of the Union's investment in research and innovation. and strengthen the R&I capacity of all Member States. That should ▌ lead to a balanced implementation of the Programme▌.

(5)  Open science ▌ has the potential to increase the quality, impact and benefits of science and to accelerate the advancement of knowledge by making it more reliable, more efficient and accurate, better understandable by society and responsive to societal challenges. Provisions should be laid down to ensure that beneficiaries provide open access to peer-reviewed scientific publications, research data and other research outputs in an open and non-discriminatory manner, free of charge and as early as possible in the dissemination process, and to enable their widest possible use and re-use. As far as research data is concerned, the principle should be “as open as possible, as closed as necessary”, thereby ensuring the possibility of exceptions taking into consideration the Union’s socio-economic interest, intellectual property rights, personal data protection and confidentiality, security concerns and other legitimate interests. More emphasis should ▌ be given to the responsible management of research data, which should comply with the FAIR principles of ‘Findability’, ‘Accessibility’, ‘Interoperability’ and ‘Reusability’, notably through the mainstreaming of Data Management Plans. Where appropriate, beneficiaries should make use of the possibilities offered by the European Open Science Cloud and the European Data Infrastructure and adhere to further open science principles and practices. Reciprocal open access should be encouraged in international S&T cooperation agreements and in relevant association agreements.

(5a)  SME beneficiaries are encouraged to make use of the existing instruments such as IPR SME Helpdesk that supports European Union small and medium sized enterprises to both protect and enforce their Intellectual Property (IP) rights through the provision of free information and services, in the form of confidential advice on intellectual property and related issues, plus training, materials and online resources.

(6)  The conception and design of the Programme should respond to the need for establishing a critical mass of supported activities, throughout the ▌ Union and through international cooperation, while encouraging the participation of all Member States in the Programme, in line with the UN Sustainable Development Goals (SDGs) and the Paris Agreement. Programme implementation should reinforce the pursuit of this aim.

(7)  Activities supported under the Programme should contribute towards the achievement of the Union's and the Programme’s objectives, ▌priorities and commitments, the monitoring and assessment of progress against those objectives,▌ priorities and commitments and for the development of revised or new priorities.

(7a)   The Programme should seek alignment with already existing European research and innovation roadmaps and strategies.

(8)  The Programme should maintain a balanced approach between bottom-up (investigator or innovator driven) and top-down (determined by strategically defined priorities) funding, according to the nature of the research and innovation communities that are engaged across the Union, the success rates per area of intervention, the types and purpose of the activities carried out, the subsidiarity principle and the impacts that are sought. The mix of these factors should determine the choice of approach for the respective parts of the Programme, all of which contribute to all of the Programme’s general and specific objectives.

(8-a)   The overall budget for the Widening participation and spreading excellence strand of the "Widening participation and strengthening the European Research Area" part of Horizon Europe should be at least 3.3% of the overall Horizon Europe budget. This budget should mainly benefit legal entities in the widening countries.

(8-b)  Excellence Initiatives should aim to strengthen research and innovation excellence in the eligible countries, including for instance supporting training to improve R&I managerial skills, prizes, strengthening innovation ecosystems as well as the creation of R&I networks, including on the basis of research infrastructures financed by the EU. Applicants need to clearly show that projects are linked with national and/or regional R&I strategies to be able to apply for funding under the widening participation and spreading excellence of the 'Widening participation and strengthening the European Research Area' part of Horizon Europe.

(8a)  A number of research and innovation actions should apply a Fast Track to Research and Innovation logic where time-to-grant should not exceed six months. This should allow a faster, bottom-up access to funds for small collaborative consortia covering actions from fundamental research to market application.

(8b)  The Programme should support all stages of research and innovation especially within collaborative projects. Fundamental research is an essential asset and an important condition for increasing the Union’s ability to attract the best scientists in order to become a global hub of excellence. The balance between basic and applied research should be ensured. Coupled with innovation, this will support the Union’s economic competitiveness, growth and jobs.

(8c)  In order to maximise the impact of Horizon Europe particular consideration should be given to multidisciplinary, interdisciplinary and transdisciplinary approaches as necessary elements for major scientific progress.

(8d)  The engagement with society is to be fostered through responsible research and innovation as a cross-cutting element with a view to build effective cooperation between science and society. It would allow all societal actors (researchers, citizens, policy makers, business, third sector organisations etc.) to work together during the whole research and innovation process in order to better align both the process and its outcomes with the values, needs and expectations of European society.

(9)  Research activities carried out under the pillar ''Excellent and Open Science' should be determined according to the needs and opportunities of science. The research agenda should be set in close liaison with the scientific communityand include emphasis on attracting new R&I talents, young researchers, while strengthening the ERA and avoiding brain drain. Research should be funded on the basis of excellence.

(10)  The pillar 'Global Challenges and European Industrial Competitiveness' should be established through clusters of research and innovation activities, in order to maximise integration across the respective work areas while securing high and sustainable levels of impact for the Union in relation to the resources that are expended. It will encourage cross-disciplinary, cross-sectoral, cross-policy and cross-border collaboration in pursuit of the UN SDGs and the Union’s commitments under the Paris Agreement and where needed to address societal challenges, and the competitiveness of the Union's industries therein. The activities under this pillar should cover the full range of research and innovation activities including R&D, piloting, demonstration, and support for public procurement, pre-normative research and standard setting, and market uptake of innovations to ensure that Europe stays at the cutting-edge of research in strategically defined priorities.

(11)  Full and timely engagement of industry in the Programme, at all levels from the individual entrepreneur and small and medium-sized enterprises to large scale enterprises, should ▌ specifically towards the creation of sustainable jobs and growth. ▌

(12)  It is important to support the Union’s industry to stay or become world leader in innovation, digitisation and decarbonisation, notably through investments in key enabling technologies that will underpin tomorrow's business. Key Enabling Technologies (KETs) are set to play a central role in Pillar II 'Global Challenges and European Industrial Competitiveness' and should be further connected to the Future and Emerging Technologies (FET) Flagships to allow research projects to cover the whole innovation chain. The Programme's actions should reflect the Union’s Industrial Policy Strategy so as to address market failures or sub-optimal investment situations, to boost investments in a proportionate and transparent manner, without duplicating or crowding out private financing and have a clear European added value and public return on investments. This will ensure consistency between the actions of the programme and EU RDI State aid rules, which should be revised in order to incentivise innovation.

(13)  The Programme should support research and innovation in an integrated manner, respecting all relevant provisions of the World Trade Organisation. The concept of research, including experimental development should be used in accordance with the Frascati Manual developed by the OECD, whereas the concept of innovation should be used in accordance with the Oslo Manual developed by the OECD and Eurostat, following a broad approach that covers social innovation, design and creativity. The OECD definitions regarding Technological Readiness Level (TRL) should be taken into account, as in the previous Framework Programme Horizon 2020 ▌. The work programme for a given call under the pillar 'Global Challenges and Industrial European Competitiveness' could allow grants for large-scale product validation and market replication.

(14)  The Commission's Communication on the interim evaluation of Horizon 2020 (COM(2018)0002) and the European Parliament’s report on the assessment of the implementation of Horizon 2020 in view of its interim evaluation and the Framework Programme 9 proposal (2016/2147(INI)) have provided a set of recommendations for this Programme, including its Rules for participation and dissemination, building on the lessons learnt from the previous Programme as well as input from EU institutions and stakeholders. Those recommendations include to invest more ambitiously in order to reach critical mass and maximise impact; to support breakthrough innovation; to prioritise Union research and innovation (R&I) investments in areas of high added value, notably through mission-orientation, full, well-informed and timely citizen involvement and wide communication; to rationalise the Union funding landscape, in order to fully use the R&I potential of all Member States including by streamlining the range of partnership initiatives and co-funding schemes; the development of more and concrete synergies between different Union funding instruments, notably with the aim of helping to mobilise under-exploited R&I potential across the Union; to better involve research infrastructures financed by the Union - especially from ERDF - into the Programme’s projects, to strengthen international cooperation and reinforce openness to third countries' participation while safeguarding the Union interest and broadening the participation of all Member States in the Programme; and to continue simplification based on implementation experiences from Horizon 2020.

(15)  Cohesion policy should continue to contribute to research and innovation. Therefore, special attention needs to be paid to the coordination and complementarity between the two Union policies. The Programme should seek alignment of rules and synergies with other Union programmes as referred to in Annex IV to this Regulation, from their design and strategic planning, to project selection, management, communication, dissemination and exploitation of results, to monitoring, auditing and governance. With a view to avoiding overlaps and duplication and increasing the leverage of Union funding, as well as decreasing administrative burden for the applicants and the beneficiaries, all types of synergies should follow the principle “one action follows one set of rules”:

   transfers from other Union programmes including the European Regional Development Fund (ERDF), to Horizon Europe activities can take place on a voluntary basis. In such cases they will follow Horizon Europe rules, but they will be used only for the benefit of the Member State or managing authority, as relevant, deciding to make the transfer;
   co-funding of an action by Horizon Europe and another Union programme could also be foreseen while not exceeding the total eligible costs of the action. In such cases, only Horizon Europe rules would apply and double audits should be avoided;
   Seals of Excellence should be awarded to all proposals which have passed the “excellence” threshold in Horizon Europe but cannot be financed due to budgetary constraints. In such cases, the rules of the Fund providing support should apply with the exception of state aid rules.

(16)  In order to achieve the greatest possible impact of Union funding and the most effective contribution to the Union's policy objectives and commitments, the Programme may enter into European Partnerships with private and/or public sector partners, on the basis of the outcome of the Strategic Planning. Such partners include public and private research and innovation stakeholders, competence centres, business incubators, science and technology parks, bodies with a public service foundations and civil society organisations and regional innovation ecosystems, where appropriate that support and/or carry out research and innovation, provided that desired impacts can be achieved more effectively in partnership than by the Union alone.

(17)  The Programme should strengthen cooperation between European Partnerships and private and/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

(17a)  'FET Flagships' have proven to be an effective and efficient instrument, delivering benefits for society in a joint, coordinated effort by the Union and its Member States. Activities carried out within the FET Flagships on Graphene, the Human Brain Project and Quantum Technology, which are supported under Horizon 2020, will continue being supported under Horizon Europe through calls for proposals included in the work programme. Preparatory actions supported under the FET Flagships part of Horizon 2020 will feed the Strategic Planning process under Horizon Europe and inform the work on missions, co-funded/co-programmed partnerships and regular calls for proposals.

(18)  The Joint Research Centre (JRC) should continue to provide Union policies with independent customer-driven scientific evidence and technical support throughout the whole policy cycle. The direct actions of the JRC should be implemented in a flexible, efficient and transparent manner, taking into account the relevant needs of the users of the JRC, the budgetary constraints and the needs of Union policies, and ensuring the protection of the financial interests of the Union. The JRC should continue to generate additional resources.

(19)  The pillar 'Innovative Europe' should establish a series of measures for integrated support to the needs of entrepreneurs and research-driven entrepreneurship aiming at realising and accelerating breakthrough innovation for rapid market growth as well as promoting the Union’s technological autonomy in strategic areas. It should attract innovative companies, including SMEs and start-ups, with potential for scaling up at international and at Union level and offer fast, flexible grants and co-investments, including with private investors. These objectives should be pursued through the creation of a European Innovation Council (EIC). This Pillar should also support the European Institute of Innovation and Technology (EIT)), the EIT Regional Innovation Scheme and European innovation ecosystems at large, throughout the Union, notably through co-funding partnerships with national and regional innovation support actors, both public and private.

(20)  In order to address the need to support investment in higher-risk and non-linear activities such as research and innovation, it is essential that Horizon Europe, in particular the EIC, as well as the EIT with its KICs, work in synergy with the financial products to be deployed under InvestEU. In that regard, the experience gained from the financial instruments deployed under Horizon 2020 such as InnovFin and the loan guarantee for SMEs, should serve as a strong basis to deliver this targeted support EIC should develop strategic intelligence and real time evaluation activities in order to timely manage and coordinate its various actions.

(21)  The EIC, together with other parts of the Horizon Europe, should stimulate all forms of innovation ranging from incremental to breakthrough and disruptive innovation targeting especially market-creating innovation. The EIC through its instruments – Pathfinder and Accelerator – should aim to identify, develop and deploy high risk innovations of all kinds including incremental with a main focus on breakthrough, disruptive and deep-tech innovations that have the potential to become market-creating innovations. Through coherent and streamlined support, the EIC should fill the current vacuum in public support and private investment for breakthrough innovation. The instruments of the EIC call for dedicated legal and management features in order to reflect its objectives, in particular market deployment activities.

(21a)  Within the meaning of this Regulation and in particular for the activities carried out under the EIC, a start-up is an SME in the early stage in its life cycle (including university spin-offs), which aims at innovative solutions and a scalable business model, and which is autonomous within the meaning of Article 3 of the Annex of Commission Recommendation 2003/361/EC(5); and a 'mid-cap' is a company that is not a micro, small- and medium-sized enterprise as defined in Commission Recommendation 2003/361/EC and that has a number of employees between 250 and 3000 where the staff headcount is calculated in accordance with Articles 3, 4, 5, and 6 of Title I of the Annex of that Recommendation; a small mid-cap is a mid-cap that has a number of employees up to 499.

(22)  Through EIC blended finance, the EIC Accelerator should bridge the “valley of death” between research, pre-mass commercialisation and the scaling-up of companies. In particular, the Accelerator should provide support to operations presenting such technological or market risks that they are not considered as bankable and cannot leverage significant investments from the market, hence complementing the InvestEU programme established by Regulation …(6).

(22a)  SMEs constitute a significant source of innovation and growth in Europe. Therefore, a strong participation of SMEs as defined in Commission Recommendation 2003/361/EC is needed in Horizon Europe. Building on best practices from Horizon 2020, Horizon Europe should continue to encourage SMEs participation to the Framework Programme in an integrated manner.

(22b)   While blended finance should be the main use of the EIC Accelerator budget, for the purpose of article 43, the grant-only support of the EIC Accelerator to SMEs, including start-ups, should correspond to that under the SME instrument budget of the previous Framework Programme Horizon 2020 established by Regulation (EU) No 1291/2013 of the European Parliament and the Council(7).

(22c)   In close synergy with InvestEU, the EIC Accelerator, in its blended finance and equity financial support forms, should finance SMEs, including start-ups, and, in exceptional cases, projects run by small mid-caps, which are either not yet able to generate revenues, or not yet profitable, or not yet able to attract sufficient investments to implement fully their projects' business plan. Such eligible entities will be considered as non-bankable, while a part of their investment needs could have been or could be provided by one or several investors such as a private or public bank, a family office, a venture capital fund, a business angel, etc. In this way, overcoming a market failure, the EIC Accelerator will finance promising but not yet bankable entities carrying out breakthrough market creating innovation projects. Once they will become bankable, those projects may, in a later stage of their development, be financed under InvestEU.

(23)  The EIT, primarily through its Knowledge and Innovation Communities (KICs) and the EIT Regional Innovation Scheme should aim at strengthening innovation ecosystems for the development of an overall Union capacity for innovation that tackle global challenges, by fostering the integration of business, research, higher education and entrepreneurship. In line with its founding act, the EIT Regulation(8) and the Strategic Innovation Agenda of the EIT(9), the EIT should foster innovation in its activities and should support the integration of higher education within the innovation ecosystem, in particular by: stimulating entrepreneurial education, fostering strong non-disciplinary collaborations between industry and academia; and identifying prospective skills for future innovators to address global challenges, which includes advanced digital and innovation skills. Support schemes provided by the EIT should benefit to EIC beneficiaries, while start-ups emerging from EIT KICs should have fast-track access to EIC actions. While the EIT’s focus on innovation ecosystems should make it naturally fit within the pillar 'Innovative Europe', it should also support all other pillars, as appropriate, the planning of its KICs should be aligned through the strategic planning process with the pillar 'Global Challenges and European Industrial Competitiveness'. Duplication between KICs and other instruments in the same field, in particular other Partnerships, should be avoided.

(24)  Ensuring and preserving a level playing field for companies that compete in a given market should be a key requirement for breakthrough or disruptive innovation to flourish thereby enabling in particular small and medium-size innovators to reap the benefits of their investment and to capture a share of the market. Similarly, a certain degree of openness in the innovation scale of funded actions - addressing a large network of beneficiaries - may contribute substantially to the building capacity of SMEs, as it provides them with the necessary means to attract investments and to thrive.

(25)  The Programme should promote and integrate cooperation with third countries and international organisations and initiatives based on Union’s interest, and mutual benefits and global commitments to implement the UN SDGs. International cooperation should aim to strengthen the Union's excellence in research and innovation ▌, attractiveness and economic and industrial competitiveness, to tackle global challenges, as embodied in the UN SDGs, and to support the Union's external policies. An approach of general opening for excellence in international participation and targeted international cooperation actions should be followed, ▌ appropriate eligibility criteria, considering different levels of R&I capacities, for funding of entities established in low to middle income countries need to be applied. At the same time, association of third countries to the Programme should be promoted where reciprocity is envisaged and where Union’s interest is safeguarded and increased participation of all Member States in the Programme is promoted.

(26)  With the aim of deepening the relationship between science and society and maximising benefits of their interactions, the Programme should engage and involve citizens and civil society organisations in co-designing and co-creating responsible research and innovation (RRI) agendas and contents, that meet citizens’ and civil society’s concerns, needs and expectations, promoting science education, making scientific knowledge publicly accessible, and facilitating participation of citizens and civil society organisations in its activities. The measures taken to improve the involvement of citizens and civil society should be monitored.

(26a)  Horizon Europe should support new technologies which contribute to overcoming obstacles, that prevent the access and the full participation of persons with disabilities and which consequently restrain the development of a truly inclusive society.

(27)  Pursuant to Article 349 of the TFEU, the Union's outermost regions are entitled to specific measures (taking into account their structural, social and economic situation) regarding access to horizontal Union programmes. The Programme should therefore take into account the specific characteristics of those regions in line with the Commission's Communication on 'A stronger and renewed strategic partnership with the EU's outermost regions' (COM(2017)0623) as endorsed by the Council on 12 April 2018 and where possible promote their participation in the Programme.

(28)  The activities developed under the Programme should aim at eliminating gender inequalities, avoiding gender bias, adequately integrating the gender dimension in research and innovation content, aiming at enhancing work-life balance, promoting equality between women and men including equal pay principles as referred to in Article 141(3) of the TFEU and in Directive 2006/54/EC on the implementation of the principle of equal opportunities and equal treatment of men and women in matters of employment and occupation, as well as ensuring accessibility of researchers with disabilities to research and innovation. ▌

(29)  In light of the specificities of the defence industry sector, the detailed provisions for Union funding to defence research projects should be fixed in the Regulation … establishing the European Defence Fund(10) which defines the rules of participation for defence research. Although synergies between Horizon Europe and the European Defence Fund could be encouraged while avoiding duplication, actions under Horizon Europe should have an exclusive focus on civilian applications.

(30)  This Regulation lays down a financial envelope for the Programme. The amount indicated for the specific programme referred to in Article 1(3)(a) is to constitute the prime reference amount, within the meaning of [reference to be updated as appropriate according to the new inter-institutional agreement: point 17 of the Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management(11)], for the European Parliament and the Council during the annual budgetary procedure.

(31)  Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (the ‘Financial Regulation’) (12) applies to this Programme, unless otherwise specified. It lays down rules on the implementation of the Union budget, including the rules on grants, prizes, procurement, indirect implementation, financial assistance, financial instruments and budgetary guarantees.

(31a)  Administrative simplification, in particular the reduction of the administrative burden for beneficiaries should be continuously sought throughout the Programme. The Commission should further simplify its tools and guidance in such a way that they impose a minimal burden on beneficiaries. In particular, the Commission should consider issuing an abridged version of the guidance.

(31b)  In order to ensure that Europe remains at the forefront of global research and innovation in the digital field and to take account of the necessity to step up investments to benefit from the growing opportunities of digital technologies, sufficient budget should be allocated to core digital priorities.

(32)  In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council(13), Council Regulation (Euratom, EC) No 2988/95(14),Council Regulation (Euratom, EC) No 2185/96(15) and Council Regulation (EU) 2017/1939(16), the financial interests of the Union are to be protected through proportionate measures, including the prevention, detection, correction and investigation of irregularities, including fraud, the recovery of funds lost, wrongly paid or incorrectly used and, where appropriate, the imposition of administrative sanctions. In particular, in accordance with Regulation (EU, Euratom) No 883/2013 and Regulation (Euratom, EC) No 2185/96 the European Anti-Fraud Office (OLAF) may carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. In accordance with Regulation (EU) 2017/1939, the European Public Prosecutor's Office (EPPO) may investigate and prosecute fraud and other criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council(17). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the Union’s financial interests, to grant the necessary rights and access to the Commission, OLAF, the EPPO and the European Court of Auditors (ECA) and to ensure that any third parties involved in the implementation of Union funds grant equivalent rights.

(33)  Pursuant to [reference to be updated as appropriate according to a new decision on OCTs: Article 94 of Council Decision 2013/755/EU(18)], persons and entities established in overseas countries and territories (OCTs) are eligible for funding subject to the rules and objectives of the Programme and possible arrangements applicable to the Member State to which the relevant overseas country or territory is linked. The Programme should take due account of the specific features of those territories in order to ensure their effective participation and to support cooperation and synergies, particularly in the outermost regions as well as with third countries in their neighbourhood.

(34)  Pursuant to paragraph 22 and 23 of the Inter-institutional agreement for Better Law-Making of 13 April 2016, there is a need to evaluate this Programme on the basis of information collected through specific monitoring requirements, while avoiding overregulation and administrative burdens, in particular on Member States and beneficiaries under the Programme. These requirements, where appropriate, can include measurable indicators, as a basis for evaluating the effects of the Programme on the ground.

(35)  In order to be able to supplement or amend the impact pathway indicators, where considered necessary, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(36)  Coherence and synergies between Horizon Europe and the EU's Space Programme will foster a globally competitive and innovative European space sector; reinforce Europe’s autonomy in accessing and using space in a secure and safe environment; and strengthen Europe’s role as a global actor. Breakthrough solutions in Horizon Europe will be supported by data and services made available by the Space Programme.

(36a)  The work programme should take into account the outcome of specific previous projects and the state of science, technology and innovation at national, Union and international level and of relevant policy, market and societal developments, for a particular action to be funded.

(37)  The rules for participation and dissemination should adequately reflect the needs of the Programme taking into account the concerns raised and the recommendations made by various stakeholders.

(38)  Common rules and requirement across the Programme should ensure simplified and common implementing tools including for monitoring and reporting an a coherent framework which facilitates participation in programmes financially supported by the budget of the Programme, including participation in programmes managed by funding bodies such as the EIT, joint undertakings or any other structures under Article 187 TFEU, and participation in programmes undertaken by Member States pursuant to Article 185 TFEU. Adopting specific rules should be possible but exceptions must be limited to when strictly necessary and duly justified.

(39)  Actions which fall within the scope of the Programme should respect fundamental rights and observe the principles acknowledged in particular by the Charter of Fundamental Rights of the European Union. Such actions should be in conformity with any legal obligation including international law and with any relevant Commission decisions such as the Commission notice of 28 June 2013(19), as well as with ethical principles, which include avoiding any breach of research integrity. The opinions of the European Group on Ethics in Science and New Technologies, the European Union Agency for Fundamental Rights and the European Data Protection Supervisor should be taken into account. Article 13 TFEU should also be taken into account in research activities, and the use of animals in research and testing should be reduced, with a view ultimately to replacing their use.

(40)  In line with the objectives of international cooperation as set out in Articles 180 and 186 TFEU, the participation of legal entities established in third countries and of international organisations should be promoted in the Union’s scientific, societal, economic and technological interests. The implementation of the Programme should be in conformity with the measures adopted in accordance with Articles 75 and 215 TFEU and should be in compliance with international law. For actions related to Union strategic assets, interests, autonomy or security, the participation to specific actions of the Programme may be limited to entities established in Member States only, or to entities established in specified associated or other third countries in addition to Member States.

(41)  Acknowledging climate change as one of the biggest global and societal challenges and reflecting the importance of tackling climate change in line with the Union's commitments to implement the Paris Agreement and the United Nations Sustainable Development Goals, this Programme will contribute to mainstream climate actions and to the achievement of an overall target of at least 25 % of the EU budget expenditures supporting climate objectives over the MFF 2021-2027 period, and an annual target of 30 % as soon as possible and at the latest by 2027. Climate mainstreaming shall be adequately integrated in research and innovation content and applied at all stages of the research cycle.

(41a)  In the context of the impact pathway related to climate, the Commission will report on outputs, innovations and aggregated estimated effects of projects that are climate-relevant, including by Programme part and by implementation mode. In its analysis the Commission should take account of the long-term economic, societal and environmental costs and benefits to European citizen resulting from Programme activities including the uptake of innovative climate mitigation and adaptation solutions, estimated impacts on jobs and company creation, economic growth in and competitiveness, clean energy, health to well-being (including air, soil and water quality). The results of this impact analysis should be made public, assessed in the context of Europe´s climate and energy goals and feedback into the subsequent strategic planning process and future work programmes.

(42)  Horizontal financial rules adopted by the European Parliament and the Council on the basis of Article 322 of the Treaty on the Functioning of the European Union apply to this Regulation. These rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, procurement, prizes, indirect implementation, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also concern the protection of the Union's budget in case of generalised deficiencies as regards the rule of law in the Member States, as the respect for the rule of law is an essential precondition for sound financial management and effective EU funding.

(43)  Use of sensitive background information or access by unauthorized individuals to sensitive results and research data may have an adverse impact on the interests of the Union or of one or more of the Member States. Thus handling of confidential data and classified information should be governed by all relevant Union law, including the Institutions' internal rules, such as Commission Decision (EU, Euratom) 2015/444(20), which lays down the provisions on security rules for protecting EU classified information.

(45)  It is necessary to establish the terms and conditions for providing Union funding to participants in actions under the Programme. Grants will be the main type of financing within the Programme. Other types of financing should be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver results, taking into account in particular the costs of controls, the administrative burden, and the expected risk of non-compliance. For grants, this should include a consideration of the use of lump sums, flat rates and scales of unit costs as set out in the Financial Regulation ▌, with a view to further simplification. Before any new costs reimbursement system could be deemed a real simplification for the beneficiaries, it should be preceded by an extensive and positive evaluation.

(47)  In accordance with Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (theFinancial Regulation’)(21), the Programme should provide the basis for a wider acceptance of the usual cost accounting practices of the beneficiaries as regards personnel costs and unit costs for internally invoiced goods and services (including for large research infrastructures as understood under Horizon 2020). The use of unit costs for internally invoiced goods and services calculated in accordance with the usual accounting practices of the beneficiaries combining actual direct costs and indirect costs should be an option which could be chosen by all beneficiaries. In this respect, beneficiaries should be able to include actual indirect costs calculated on the basis of allocation keys in such unit costs for internally invoiced goods and services.

(48)  The current system of reimbursement of actual personnel costs should be further simplified building on the project-based remuneration approach developed under Horizon 2020 and further aligned to the Financial Regulation, aiming to reduce the remuneration gap between EU researchers involved in the Programme.

(49)  The participant Guarantee Fund set up under Horizon 2020 and managed by the Commission has proved to be an important safeguard mechanism which mitigates the risks associated with the amounts due and not reimbursed by defaulting participants. Therefore, the Beneficiary Guarantee Fund, renamed Mutual Insurance Mechanism ("the Mechanism") should be continued and enlarged to other funding bodies in particular to initiatives pursuant to Article 185 of the TFEU. The Mechanism should be opened to beneficiaries of any other directly managed Union programme.

(50)   Rules governing the exploitation and dissemination of results should be laid down to ensure that beneficiaries protect, exploit, disseminate and provide access to those results as appropriate. More emphasis should be given to exploiting results and the Commission should identify and help maximise opportunities for beneficiaries to exploit results, in particular in the Union. Exploitation should be in consideration of the principles of this programme, including promoting innovation in the Union and strengthening the European Research Area.

(51)  The key elements of the proposal evaluation and selection system of the predecessor programme Horizon 2020 with its particular focus on excellence, ‘impact’ and ‘quality and efficiency of implementation’ criteria should be maintained. Proposals should continue to be selected based on the evaluation made by independent experts stemming from as many Member States as possible. The Commission should organise anonymous evaluation where appropriate and analyse its results in order to avoid selection bias. Where relevant, the necessity to ensure the overall coherence of the portfolio of projects should be taken into account by independent experts.

(52)  Systematic cross-reliance on audits and assessments – ▌with other Union programmes – should be implemented in accordance with Article 127 of the Financial Regulation for all parts of the Programme, in order to reduce administrative burden for beneficiaries of Union funds. Cross reliance should be explicitly provided for by considering also other elements of assurance such as systems and processes audits.

(53)  Specific challenges in the areas of research and innovation should be addressed by prizes, including through common or joint prizes where appropriate, organised by the Commission or funding body with other Union bodies, third countries, international organisations or non-profit legal entities. In particular, prizes should be awarded to projects attracting scientists to widening countries as well as to successful projects to increase their visibility and allow to increase the promotion of Union funded actions.

(54)  ▌ Financing types and the methods of implementation under this Regulation shall be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver results, taking into account, in particular, the costs of controls, the administrative burden, and the expected risk of non-compliance. This should include consideration of the use of lump sums, flat rates and scales of unit costs,

HAVE ADOPTED THIS REGULATION:

TITLE I

GENERAL PROVISIONS

Article 1

Subject matter

1.  This Regulation establishes Horizon Europe - the Framework Programme for Research and Innovation (‘the Programme’) and the rules for participation and dissemination in indirect actions under the Programme and determines the framework governing Union support to research and innovation activities.

2.  It lays down the objectives of the Programme, the budget for the period 2021 – 2027, the forms of Union funding and the rules for providing such funding.

3.  The Programme shall be implemented through:

(a)  the specific programme established by Decision …/…/EU(22);

(aa)  a financial contribution to the EIT established by Regulation (EC) No 294/2008;

(b)  the specific programme on defence research established by Regulation …/…/EU Regulation of the Euopean Parliament and of the Council establishing the European Defence Fund.

4.  The terms 'Horizon Europe', 'the Programme' and 'specific programme' used in this Regulation address matters relevant only to the specific programme described in paragraph 3(a), unless otherwise explicitly stated.

The EIT shall implement the Programme in line with its strategic objectives for the period 2021-2027, as laid down in the Strategic Innovation Agenda of the EIT, taking into account the strategic planning.

Article 2

Definitions

For the purposes of this Regulation, the following definitions apply:

(1)  'research infrastructures' mean facilities that provide resources and services for the research communities to conduct research and foster innovation in their fields. This definition includes the associated human resources, and it covers major equipment or sets of instruments; knowledge-related facilities such as collections, archives or scientific data infrastructures; computing systems, communication networks, and any other infrastructure, of a unique nature and open to external users, essential to achieve excellence in research and innovation. Where relevant, they may be used beyond research, for example for education or public services and they may be 'single sited', 'virtual' or 'distributed';

(2)  'smart specialisation strategy' has the same meaning as smart specialisation strategy as defined in Regulation (EU) No 1303/2013 of the European Parliament and of the Council(23) and fulfilling the enabling conditions set out in Regulation (EU) XX [Common Provisions Regulation];

(3)  'European Partnership' means an initiative where the Union, prepared with early involvement of Member States and/or Associated Countries, together with private and/or public partners (such as industry, universities, research organisations, bodies with a public service mission at local, regional, national or international level or civil society organisations including foundations and NGOs), commit to jointly support the development and implementation of a programme of research and innovation activities, including those related to market, regulatory or policy uptake;

(4)  'open access' means the practice of providing online access to research outputs resulting from actions funded under the Programme, ▌free of charge to the end-user, in accordance with Article 10 and 35(3) of this Regulation;

(4a)   'open science' means an approach to the scientific process based on open cooperative work, tools and diffusing knowledge, including the elements of article 10.

(5)  'mission' means a portfolio of excellence-based and impact-driven R&I actions across disciplines and sectors, intended to:

–  achieve ▌, within a set timeframe, a measurable goal that could not be achieved through individual actions,

–  have impact on society and policy-making through science and technology, and

–  be relevant for a significant part of the European population and a wide range of European citizens;

(6)  'pre-commercial procurement' means the procurement of research and development services involving risk-benefit sharing under market conditions, and competitive development in phases, where there is a clear separation of the research and development services procured from the deployment of commercial volumes of end-products;

(7)  'public procurement of innovative solutions' means procurement where contracting authorities act as a launch customer for innovative goods or services which are not yet available on a large-scale commercial basis, and may include conformity testing.

(8)  “access rights” means rights to use results or background under terms and conditions laid down in accordance with this Regulation;

(9)  “background” means any data, know-how or information whatever its form or nature, tangible or intangible, including any rights such as intellectual property rights, that is: (i) held by beneficiaries prior to their accession to the action; and (ii) identified by the beneficiaries in a written agreement as needed for implementing the action or for exploiting its results;

(10)  “dissemination” means the public disclosure of the results by appropriate means (other than resulting from protecting or exploiting the results), including by scientific publications in any medium;

(11)  “exploitation” means the use of results in further research and innovation activities other than those covered by the action concerned, including inter alia, commercial exploitation such as developing, creating, manufacturing and marketing a product or process, ▌creating and providing a service, or in standardisation activities;

(12)  “fair and reasonable conditions” means appropriate conditions, including possible financial terms or royalty-free conditions, taking into account the specific circumstances of the request for access, for example the actual or potential value of the results or background to which access is requested and/or the scope, duration or other characteristics of the exploitation envisaged;

(13)  “funding body” means a body or organisation, other than the Commission, as referred to in point (c) of Article 62(1) of the Financial Regulation, to which the Commission has entrusted budget implementation tasks under the Programme;

(14)  “international European research organisation” means an international organisation, the majority of whose members are Member States or associated countries, and whose principal objective is to promote scientific and technological cooperation in Europe;

(15)  'legal entity' means any natural or legal person created and recognised as such under national law, Union law or international law, which has legal personality and which may, acting in its own name, exercise rights and be subject to obligations, or an entity without a legal personality in accordance with Article 197(2)(c) of the Financial Regulation;

(15a)  ”widening countries”/“low R&I performing countries” means those countries where legal entities need to be established in order to be eligible as coordinators under ‘widening participation and spreading excellence’ strand of the Widening Participation and Strengthening ERA’ part of Horizon Europe. From the EU Member States, these countries are Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, Malta, Poland, Portugal, Romania, Slovakia and Slovenia, for the whole duration of the Programme. For associated countries, the list of eligible countries will be defined based on an indicator and published in the Work Programme. On the basis of Article 349 TFEU, legal entities from Outermost Regions will be also fully eligible as coordinators under this strand.

(16)  “non-profit legal entity” means a legal entity which by its legal form is non-profit-making or which has a legal or statutory obligation not to distribute profits to its shareholders or individual members;

(16a)  'SME' means micro-, small- and medium-sized enterprise as defined in Commission Recommendation 2003/361/EC;

(17)  'small mid-cap' means an entity that is not a micro-, small- and medium-sized enterprise (‘SME’) as defined in Commission Recommendation 2003/361/EC employing up to 499 employees ▌where the staff headcount is calculated in accordance with Articles 3, 4, 5 and 6 of Title I of the Annex of that Recommendation;

(18)  “results” means any tangible or intangible effect of the action, such as data, know-how or information, whatever its form or nature, whether or not it can be protected, as well as any rights attached to it, including intellectual property rights;

(18a)  'research outputs' mean results generated by the action to which access can be given in the form of scientific publications, data or other engineered outcomes and processes such as software, algorithms, protocols and electronic notebooks;

(19)  “seal of excellence” means a certified label which shows that a proposal submitted to a call for proposals exceeded all of the evaluation thresholds set out in the work programme, but could not be funded due to lack of budget available to that call in the work programme, but which might receive support from other Union or national sources of funding;

(19a)  ‘strategic R&I Plan’ means an implementing act laying out a strategy for realising content in the work programme covering a maximum period of four years, following a broad mandatory multi-stakeholder consultation process. It defines the priorities, suitable types of action and forms of implementation to use.

(20)  “work programme” means the document adopted by the Commission for the implementation of the specific programme(24) in accordance with its Article 12 or the equivalent document in content and structure adopted by a funding body.

(21)  "reimbursable advance" means the part of a Horizon Europe or EIC blended finance corresponding to a loan under Title X of the Financial Regulation, but that is directly awarded by the Union on a non-profit basis to cover the costs of activities corresponding to an innovation action, and to be reimbursed by the beneficiary to the Union under the conditions provided for in the contract;

(22)  “contract” means the agreement concluded between the Commission or a funding body with a legal entity implementing an innovation and market deployment action and supported by a Horizon Europe or EIC blended finance.

(23)  “classified information” means EU classified information a s defined in Article 3 of Commission Decision (EU, Euratom) 2015/444 as well as classified information of Member States, classified information of third countries with which the Union has a security agreement and classified information of international organisation with which the Union has a security agreement;

(24)  'Blending operation' means actions supported by the EU budget, including within blending facilities pursuant to Article 2(6) of the Financial Regulation, combining non-repayable forms of support and/or financial instruments from the EU budget with repayable forms of support from development or other public finance institutions, as well as from commercial finance institutions and investors.

(25)  Horizon Europe ▌blended finance” means financial support to a programme to provide support to innovation and market deployment activities, consisting in a specific combination of a grant or a reimbursable advance with an investment in equity or any other repayable form of support;

(25-a)  “EIC blended finance” means direct financial support delivered under the EIC to an innovation and market deployment action, consisting in a specific combination of a grant or a reimbursable advance with an investment in equity or any other repayable form of support”;

(25a)  ‘research and innovation action’ means an action primarily consisting of activities aiming to establish new knowledge and/or to explore the feasibility of a new or improved technology, product, process, service or solution. This may include basic and applied research, technology development and integration, testing, demonstration and validation on a small-scale prototype in a laboratory or simulated environment;

(25b)  ‘innovation action’ means an action primarily consisting of activities directly aimed at producing plans and arrangements or designs for new, altered or improved products, processes or services, possibly including prototyping, testing, demonstrating, piloting, large-scale product validation and market replication;

(25c)  ‘ERC frontier research (including ERC Proof of Concept)’ means principal investigator-led research actions, hosted by ERC only single or multiple beneficiaries;

(25d)  ‘training and mobility action’ means an action geared towards the improvement of skills, knowledge and career prospects of researchers based on mobility between countries, and, if relevant, between sectors or disciplines;

(25e)  ‘programme co-funding action’ means an action to provide multi-annual co-funding to a programme of activities established and/or implemented by entities managing and/or funding research and innovation programmes, other than Union funding bodies. Such a programme of activities may support networking and coordination, research, innovation, pilot actions, and innovation and market deployment actions, training and mobility actions, awareness raising and communication, dissemination and exploitation, any relevant financial support, such as grants, prizes, procurement, as well as Horizon Europe blended finance or a combination thereof. The programme co-fund action may be implemented by those entities directly or by third parties on their behalf;

(25f)  ‘pre-commercial procurement action’ means an action with the primary aim of realising pre-commercial procurement implemented by beneficiaries that are contracting authorities or contracting entities;

(25g)  ‘public procurement of innovative solutions action’ means an action with the primary aim of realising joint or coordinated public procurement of innovative solutions implemented by beneficiaries that are contracting authorities or contracting entities;

(25h)  ‘coordination and support action’ means an action contributing to the objectives of the Programme, excluding research and innovation activities, except when undertaken under the component "widening participation and spreading excellence" of the part "Widening Participation and strengthening the European Research Area"; and bottom-up coordination without co-funding of research activities from the EU that allows for cooperation between legal entities from Member States and Associated Countries in order to strengthen the European Research Area;

(25i)  "Inducement prize" means a prize to spur investment in a given direction, by specifying a target prior to the performance of the work

(25j)  "Recognition prize" in prize to reward past achievements and outstanding work after it has been performed

(25k)  "Innovation and market deployment action" means and action embedding an innovation action and other activities necessary to deploy an innovation in the market, including the scaling-up of companies, providing Horizon Europe blended finance (a mix of grant-type funding and private finance);

(25l)  "Indirect actions" means research and innovation activities to which the Union provides financial support and which are undertaken by participants;

(25m)  "Direct actions" means research and innovation activities undertaken by the Commission through its Joint Research Centre (JRC).

(27)  'procurement’ means procurement as defined in Article 2(49) of the Financial Regulation;

(28)  'affiliated entity’ means any legal entity as defined in Article 187(1) of the Financial Regulation;

(30)  'innovation ecosystem' means an ecosystem that brings together at EU level actors or entities whose functional goal is to enable technology development and innovation. They encompass relations between material resources (such as funds, equipment, and facilities), institutional entities (such as higher education institutions and support services, RTOs, companies, venture capitalists and financial intermediaries) and national, regional and local policy-making and funding entities.

Article 3

Programme objectives

1.  The Programme’s general objective is to deliver scientific, technological, economic and societal impact from the Union’s investments in research and innovation so as to strengthen the scientific and technological bases of the Union and foster its competitiveness in all Member States including in its industry, deliver on the Union strategic priorities and contribute to the realisation of EU objectives and policies, contribute to tackling global challenges, including the Sustainable Development Goals by following the principles of the Agenda 2030 and the Paris Agreement, and to strengthen the European Research Area. The Programme shall thus maximise Union added value by focusing on objectives and activities that cannot be effectively realised by Member States acting alone, but in cooperation.

2.  The Programme has the following specific objectives:

(a)  to develop, promote and advance scientific excellence, support the creation and diffusion of high-quality new fundamental and applied knowledge, skills, technologies and solutions, training and mobility of researchers, attract talent at all levels and contribute to full engagement of Union's talent pool in actions supported under this Programme;

(b)  to generate knowledge, strengthen the impact of research and innovation in developing, supporting and implementing Union policies and support the access to and uptake of innovative solutions in European industry, notably in SMEs, and society to address global challenges, including climate change and the Sustainable Development Goals;

(c)  to foster all forms of innovation, facilitate technological development, demonstration and knowledge and technology transfer, strengthen ▌deployment and exploitation of innovative solutions;

(d)   to optimise the Programme's delivery for strengthening and increasing the impact and attractiveness of the European Research Area, to foster the excellence-based participations from all Member States, including low R&I performing Member States, in Horizon Europe and to facilitate collaborative links in European research and innovation.

Article 4

Programme structure

1.  The Programme is structured in the following parts contributing to the general and specific objectives set out in Article 3:

(1)  Pillar I 'Excellent Science' ▌with the following components:

(a)  the European Research Council (ERC);

(b)  Marie Skłodowska-Curie Actions (MSCA);

(c)  research infrastructures.

(2)  Pillar II 'Global Challenges and European Industrial Competitiveness' with the following components, taking into account that social sciences and humanities (SSH) shall play an important role across all clusters:

(a)  cluster 'Health';

(b)  cluster 'Culture, creativity and inclusive society';

(ba)  cluster ‘Civil Security for Society’;

(c)   cluster 'Digital, ▌Industry and Space';

(d)  cluster 'Climate, Energy and Mobility';

(f)   cluster 'Food, Bioeconomy, Natural Resources, Agriculture and Environment';

(g)   non-nuclear direct actions of the Joint Research Centre (JRC).

(3)  Pillar III ‘Innovative Europe’ with the following components:

(a)  the European Innovation Council (EIC);

(b)  European innovation ecosystems;

(c)  the European Institute of Innovation and Technology (EIT) established by Regulation (EC) No 294/2008.

(4)  Part 'Widening participation and strengthening the European Research Area', ▌with the following components:

(a)  widening participation and spreading excellence;

(b)  reforming and enhancing the European R&I System.

2.  The broad lines of activities are set out in Annex I.

Article 5(25)

Defense research and development

1.  Activities to be carried out under the specific programme referred to in Article 1(3)(b) and which are laid down in Regulation establishing the European Defence Fund, shall have an exclusive focus on defence research and development, with the following objectives and broad lines of activities:

—  activities aiming to foster the competitiveness, efficiency and innovation capacity of the European defence, technological and industrial base.

2.  ▌This Regulation does not apply to the specific programme referred to in Article 1(3)(b), with the exception of this Article, Article 1 ▌and Article 9(1).

Article 6(26)

Strategic planning and implementation and forms of EU funding

1.  The Programme shall be implemented in direct management in accordance with the Financial Regulation or in indirect management with funding bodies referred to in Article 62(1)(c) of the Financial Regulation.

2.  The Programme may provide funding to indirect actions in any of the forms laid down in the Financial Regulation, in particular grants which shall be the main form of support in the programme. It may also provide financing through prizes, procurements and financial instruments within blending operations and equity support under the EIC Accelerator.

3.  The rules for participation and dissemination laid down in this Regulation shall apply to indirect actions.

4.  The main types of action to be used under the Programme are set out and defined in Article 2. The forms of funding, referred to in paragraph 2, shall be used in a flexible manner across all objectives of the Programme with their use being determined on the basis of the needs and the characteristics of the particular objectives.

5.  The Programme shall also support direct actions undertaken by the JRC. Where these actions contribute to initiatives established under Article 185 or Article 187 TFEU, this contribution shall not be considered as part of the financial contribution allocated to those initiatives.

6.  The implementation of the specific programme and the EIT's KICs shall be supported by a transparent and strategic▌ planning of research and innovation activities as laid down in the specific programme, in particular for the pillar 'Global Challenges and European Industrial Competitiveness'and cover also relevant activities in other pillars and the Widening Participation and Strengthening the European Research Area part.

The Commission shall ensure early involvement of the Member States and extensive exchanges with the European Parliament, complemented by consultation with stakeholders and the public at large.

The Strategic Planning shall ensure alignment with other relevant Union programmes and consistency with EU priorities and commitments and increase complementarity and synergies with national and regional funding programmes and priorities, thereby strengthening the ERA. Areas for possible missions and areas for possible institutionalised European Partnerships shall be established in Annex Va.

6a.  Where appropriate, in order to allow a faster access to funds for small collaborative consortia, a Fast Track to Research and Innovation Procedure (FTRI) may be proposed under some of the calls for proposals dedicated to select research and / or innovation actions Under the Global Challenges and European Industrial Competitiveness and the European Innovation Council Pathfinder parts of the Framework Programme.

A call under the FTRI Procedure shall have the following cumulative characteristics:

—  bottom-up calls for proposals

—  a shorter time-to-grant, not exceeding 6 months;

—  a support provided only to small collaborative consortia composed of maximum 6 different and independent eligible legal entities;

—  a maximum financial support per consortium not exceeding EUR 2.5 million.

The work programme shall identify the calls using the FTRI Procedure.

7.  Horizon Europe activities shall be ▌delivered through open, competitive calls for proposals, including within missions and European Partnerships, except for the activities referred to in Article 39 on Prizes.

Article 6a

Principles of the Programme

1.  Research and innovation activities carried out under the specific Programme referred to in Article 1(3)(a) and under the EIT shall have an exclusive focus on civil applications. Budgetary transfers between the amount allocated to the specific programme referred to in Article 1(3)(a) and the EIT and the amount allocated to the specific programme referred to in Article 1(3)(b) shall not be allowed and unnecessary duplication between the two programmes shall be avoided.

2.  Horizon Europe shall ensure a multidisciplinary approach and shall foresee, where appropriate, the integration of social sciences and humanities across all clusters and activities developed under the Programme, including specific calls on SSH related topics.

3.  The collaborative parts of the Programme shall ensure a balance between lower and higher TRLs thereby covering the whole value chain.

3a.  The Programme shall ensure the effective promotion and integration of cooperation with third countries and international organisations and initiatives based on mutual benefits, EU interests, international commitments and, where appropriate, reciprocity.

4.  The Programme shall assist widening countries to increase participation in Horizon Europe and to promote broad geographical coverage in collaborative projects, including through spreading scientific excellence, boosting new collaborative links, stimulating brain-circulation as well as through the implementation of Articles 20(3) and 45(4). Those efforts shall be mirrored by proportional measures by Member States, including on setting attractive salaries for researchers, with the support of Union, national and regional funds. Particular attention shall be paid to geographical balance, subject to the situation in the field of research and innovation concerned, evaluation panels and in bodies such as boards and expert groups, without undermining the excellence criteria.

5.  The Programme shall ensure the effective promotion of equal opportunities for all, and the implementation of gender mainstreaming, and of the gender dimension in the research and innovation content and shall aim to address the causes of gender imbalance. Particular attention shall be paid to ensuring to the extent possible gender balance, in evaluation panels and in other relevant advisory bodies such as boards and expert groups.

5a.  Horizon Europe shall be implemented in synergy with other Union funding programmes while seeking maximal administrative simplification. A non-exhaustive list of synergies with other Union funding programmes is included in Annex IV.

5b.  The Programme contributes to increasing public and private investment in R&I in Member States thereby helping to reach an overall investment of at least 3% of Union gross domestic product (GDP) in research and development.

6.  The Commission when implementing the programme shall aim at continuous administrative simplification and reduction of the burden for the applicants and beneficiaries.

7.  As part of the general Union objective of mainstreaming climate actions into EU sectoral policies and EU funds, actions under this Programme shall contribute at least 35% of the expenditure to climate objectives where appropriate. Climate mainstreaming shall be adequately integrated in research and innovation content.

8.  The programme shall promote co-creation and co-design through engagement of citizens and civil society.

9.  The programme shall ensure transparency and accountability of public funding in research and innovation projects, thereby preserving the public interest.

10.  The Commission or the relevant funding body shall ensure that sufficient guidance and information is made available to all potential participants at the time of publication of the call for proposals, in particular the applicable model grant agreement.

Article 7

Missions

1.  Missions shall be programmed within the pillar 'Global Challenges and European Industrial Competitiveness', but may also benefit from actions carried out within other parts of the Programme as well as complementary actions carried out under other Union funding programmes. Missions shall allow for competing solutions, resulting in pan-European added value and impact.

2.  The missions shall be defined and implemented in accordance with the Regulation and the Specific Programme, ensuring the active and early involvement of the Member States and extensive exchanges with the European Parliament. The missions, their objectives, budget, targets, scope, indicators and milestones shall be identified in the Strategic R&I Plans or the Work Programmes as appropriate. Evaluation of proposals under the missions shall be carried out in accordance with Article 26.

2a.  During the first three years of the programme, a maximum of 10% of the annual budget of Pillar II shall be programmed through specific calls for implementing the missions. For the remaining part of the programme, and only after a positive assessment of the mission selection and management process, this percentage may be increased. The Commission shall communicate the total budgetary share of each work programme dedicated to missions.

3.  Missions shall:

(a)  using SDGs as sources for their design and implementation, have a clear research and innovation content, EU-added value, and contribute to reaching Union priorities and commitments and Horizon Europe programme objectives laid down in Article 3;

(aa)  cover areas of common European relevance, be inclusive, encourage broad engagement and active participation of various types of stakeholders from public and private sectors, including citizens and end-users, and deliver R&I results that could benefit all Member States;

(b)  be bold and inspirational, hence have wide, scientific, technological, societal, economic, environmental or policy relevance and impact;

(c)  indicate a clear direction and objectives and be targeted, measurable, time-bound and have a clear budget frame;

(d)  be selected in a transparent manner and be centered on ambitious, excellence-based and impact-driven but realistic goals and research, development and innovation activities;

(da)  have the necessary scope, scale and mobilization of the resources and leverage of additional public and private funds required to deliver the mission outcome;

(e)  stimulate activity across disciplines (including Social Sciences and Humanities) and encompassing activities from a broad range of TRLs, including lower TRLs;

(f)  be open to multiple, bottom-up approaches and solutions taking into account human and societal needs and benefits and recognizing the importance of diverse contributions to achieve these missions.

(fa)  benefit from synergies in a transparent manner with other Union programmes as well as with national and, where relevant, regional innovation ecosystems.

4.  The Commission shall monitor and evaluate each mission in accordance with Articles 45 and 47 and Annex V to this Regulation, including progress towards short, medium and long-term targets, covering implementation, monitoring and phasing-out of the missions. An assessment of the first missions established under Horizon Europe shall take place no later than 2023 and before any decision is taken on creating new missions, continuing, terminating or redirecting ongoing missions. The results of this assessment shall be made public and shall include, but not limited to, the analysis of their selection process and of their governance, budget, focus and progress to date.

Article 7a

The European Innovation Council

1.  The Commission shall establish a European Innovation Council (EIC) as a centrally-managed "one stop shop" for implementing actions under Pillar III 'Innovative Europe‘ which relate to the EIC. The EIC shall mainly focus on breakthrough and disruptive innovation, targeting especially market-creating innovation, while also supporting all types of innovation, including incremental. The EIC shall operate according to the following principles: clear EU added value, autonomy, ability to take risk, efficiency, effectiveness, transparency and accountability.

2.  The EIC shall be open to all types of innovators including from individuals to universities, research organisations and companies (SMEs including start-ups and, in exceptional cases, small mid-caps) and from single beneficiaries to multi-disciplinary consortia. At least 70% of EIC budget shall be dedicated to SMEs, including start-ups.

3.  The EIC Board and management features of the EIC are defined in Decision (EU)... [Specific Programme] and its annexes.

Article 8

European Partnerships

1.  Parts of Horizon Europe may be implemented through European Partnerships. The involvement of the Union in European Partnerships may take any of the following forms:

(a)  participation in partnerships set up on the basis of memoranda of understanding and/or contractual arrangements between the Commission and the partners referred to in Article 2(3), specifying the objectives of the partnership, related commitments from all involved sides for financial and/or in-kind contributions of the partners, key performance and impact indicators, outputs to be delivered and reporting modalities.They include the identification of complementary research and innovation activities that are implemented by the partners and by the Programme (Co-programmed European Partnerships);

(b)  participation in and financial contribution to a programme of research and innovation activities, specifying the objectives, key performance and impact indicators, and outputs to be delivered, based on the commitment of the partners for financial and/or in-kind contributions and integration of their relevant activities using a Programme co-fund action (Co-funded European Partnerships);

(c)  participation in and financial contribution to research and innovation programmes undertaken by several Member States in accordance with Article 185 TFEU, or by bodies established pursuant to Article 187 TFEU, such as Joint Undertakings, or by the EIT Knowledge and Innovation Communities in compliance with the EIT Regulation (Institutionalised European Partnerships). Such partnerships shall be implemented only where other parts of the Horizon Europe programme, including other forms of European Partnerships would not achieve the objectives or would not generate the necessary expected impacts, and if justified by a long-term perspective and high degree of integration. Partnerships in accordance with Article 185 TFEU or pursuant to Article 187 TEFU shall implement a central management of all financial contributions, except in duly justified cases. In case of central financial management, project level contributions from one participating state will be made on the basis of the funding requested in proposals from entities established in that participating state, unless otherwise agreed among all participating states concerned.

The rules for such partnerships shall specify inter alia the objectives, key performance and impact indicators, and outputs to be delivered, as well as the related commitments for financial and/or in-kind contributions of the partners.

2.  European Partnerships shall:

(a)  Be established for addressing European or global challenges only in cases where they will more effectively achieve objectives of Horizon Europe than the Union alone and when compared to other forms of support of the Framework programme. Those parts shall have an appropriate share of the budget of Horizon Europe. The majority of the budget in pillar II shall be allocated to actions outside of European partnerships;

(b)  Adhere to the principles of Union added value, transparency, openness, impact within and for Europe, strong leverage effect on sufficient scale, long-term commitments of all the involved parties, flexibility in implementation, coherence, coordination and complementarity with Union, local, regional, national and, where relevant, international initiatives or other partnerships and missions;

(c)  Have a clear life-cycle approach, be time limited and include conditions for phasing-out the Programme funding.

2.a.  European Partnerships according to Article 8(1)(a and b) of this Regulation shall be identified in Strategic R&I Plans before being implemented in work programmes.

Provisions and criteria for their selection, implementation, monitoring, evaluation and phasing-out are set out in Annex III.

Article 8a

Review of missions and partnership areas

No later than 2023, the Commission shall carry out a review of Annex Va as part of the overall monitoring of the programme, including missions and institutionalised European partnerships on the basis of article 185 TFEU or article 187 TFEU, and present a report on the main findings to the Council and the European Parliament.

Article 9

Budget

1.  The financial envelope for the implementation of the Framework Programme for the period 2021 – 2027 shall be EUR 120 000 000 000 in 2018 prices for the specific programme referred to in Article 1(3)(a) and, in addition, the amount for the specific programme referred to in Article 1(3)(b), as laid down in Regulation establishing the European Defence Fund.

2.  The indicative distribution of the amount referred to in paragraph 1, first half sentence, shall be:

(a)  27.42 % for Pillar I 'Excellent and Open Science' for the period 2021-2027, of which

(1)  17.64% for the European Research Council;

(2)  7.23% for Marie Skłodowska-Curie Actions;

(3)  2.55% for research infrastructures;

(b)  55.48% for Pillar II 'Global Challenges and European Industrial Competitiveness' for the period 2021-2027, of which

(1)  8.16% for cluster 'Health';

(2)  2.50% for cluster 'Inclusive and Secure Creative Society';

(2a)  2.00% for cluster ‘Secure Societies’;

(3)  15.94% for cluster 'Digital and, Industry and Space';

(4)  15.84% for cluster 'Climate, Energy and Mobility';

(5)  9.00% for cluster 'Food and, Natural Resources and Agriculture';

(6)  2.04% for for the non-nuclear direct actions of the Joint Research Centre (JRC);

(c)  12.71% for Pillar III ''Innovative Europe' for the period 2021-2027, of which:

(1)  8.71% for the European Innovation Council, (EIC) including up to 0.53% for European Innovation Ecosystems;

(2)  4% for the European Institute of Innovation and Technology (EIT);

(d)  4.39% for the Part 'Strengthening the European Research Area' with the following components:

(1)  4.00% for Spreading excellence' and widening participation across the Union;

(2)  '0.39% for reforming and enhancing the European R&I System'.

3.  In order to respond to unforeseen situations or to new developments and needs, the Commission may, within the annual budgetary procedure, deviate from the amounts referred to in paragraph 2 up to a maximum of 10%, including the allocation of the contributions from associated countries.

3c.  45% of the budget of cluster ‘Inclusive and Creative Society’ shall support research on cultural and creative sectors, including the Union’s cultural heritage, that shall include EUR 300 million to be earmarked for the creation of a European Cultural Heritage Cloud, as set out in Annex I to the Specific Programme following an impact assessment to be presented to the European Parliament.

3d.  At least EUR 1 billion shall aim to be dedicated to Quantum Research under the ‘Digital, Industry and Space’ cluster under Pillar II.

4.  The amount referred to in paragraph 1 for the specific programme referred to in Article 1(3)(a) and for the EIT, may also cover expenses for preparation, monitoring, control, audit, evaluation and other activities and expenditures necessary for managing and implementing the Programme, including all administrative expenditure, as well as evaluating the achievement of its objectives. The administrative expenses related to indirect actions shall not exceed 5% of the total amount under the Programme. It may moreover cover expenses relating to the studies, meetings of experts, information and communication actions, in so far as they are related to the objectives of the Programme, as well as expenses linked to information technology networks focusing on information processing and exchange, including corporate information technology tools and other technical and administrative assistance needed in connection with the management of the Programme.

5.  If necessary, appropriations may be entered in the budget beyond 2027 to cover the expenses provided for in paragraph 4, to enable the management of actions not completed by 31 December 2027.

6.  Budgetary commitments for actions extending over more than one financial year may be broken down over several years into annual instalments.

7.  Without prejudice to the Financial Regulation, expenditure for actions resulting from projects included in the first work programme may be eligible as from 1 January 2021.

Article 10

Open science

1.  The programme shall encourage open science as an approach to the scientific process based on cooperative work and diffusing knowledge, in particular in line with the following elements:

—  open access to scientific publications resulting from research funded under the Programme;

—  open access to research data, including those underlying scientific publications.

These elements shall be ensured in accordance with Article 35(3) of this regulation. The latter shall also be in line with the principle 'as open as possible, as closed as necessary';

1a.  The principle of reciprocity in open science shall be promoted and encouraged in all association and cooperation agreements with third countries, including agreements signed by funding bodies entrusted for indirect management of the Programme.

2.  Responsible management of research data shall be ensured in line with the principles ‘Findability’, ‘Accessibility’, ‘Interoperability’ and ‘Reusability’ (FAIR). Attention shall also be paid to the long-term preservation of data.

3.  Other open science practices ▌shall be promoted and encouraged, including for the benefit of SMEs.

Article 11

Complementary , combined and cumulative funding

1.   Horizon Europe shall be implemented in synergy with other Union funding programmes while seeking maximal administrative simplification. A non-exhaustive list of synergies with other funding programmes is included in Annex IV. A The Horizon Europe single set of rules shall apply for an RDI co-funded action.

2.   The Seal of Excellence shall be awarded for all parts of the Programme. Actions awarded a Seal of Excellence certification, or which comply with the following cumulative, comparative, conditions:

(a)  they have been assessed in a call for proposals under the Programme;

(b)  they comply with the minimum quality requirements of that call for proposals;

(c)  they may not be financed under that call for proposals due to budgetary constraints,

may receive support from national or regional funds, including from the European Regional Development Fund, the Cohesion Fund, the European Social Fund+ or the European Agricultural Fund for Rural Development, in accordance with paragraph 5 of Article [67] of Regulation (EU) XX [Common Provisions Regulation] and Article [8] or Regulation (EU) XX [Financing, management and monitoring of the Common Agricultural Policy], without requiring any further application and evaluation and provided that such actions are consistent with the objectives of the programme concerned. With the exception of state aid rules, the rules of the Fund providing support shall apply.

2a.   In accordance with Article 21 of Regulation (EU) XX [... Common Provisions Regulation], the managing authority, on a voluntary basis, may request the transfer of parts of its financial allocations to Horizon Europe. Transferred resources shall be implemented in accordance with the rules of Horizon Europe. In addition, the Commission shall ensure that such transferred funds are earmarked entirely for programmes and/or projects which will be implemented in the Member State or region, as applicable, they originated from.

2b.   With prior authorisation from the applicants, the Commission shall include the allocations referred to in this Article in the information system on selected projects in order to allow for a fast exchange of information and enable financing authorities to provide funding to the selected actions.

An action that has received a contribution from another Union programme may also receive a contribution under the Programme, provided that the contributions do not cover the same costs.

Article 12

Third countries associated to the Programme

1.  The Programme shall be open to association of the following third countries:

(a)  European Free Trade Association (EFTA) members which are members of the European Economic Area (EEA), in accordance with the conditions laid down in the EEA agreement;

(b)  acceding countries, candidate countries and potential candidates, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions, or similar agreements, and in accordance with the specific conditions laid down in agreements between the Union and those countries;

(c)  countries covered by the European Neighbourhood Policy, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions, or similar agreements, and in accordance with the specific conditions laid down in agreements between the Union and those countries;

(d)  third countries and territories that fulfil all of the following criteria:

i.  a good capacity in science, technology and innovation;

ii.  commitment to a rules-based open market economy, including fair and equitable dealing with intellectual property rights, respect of human rights, backed by democratic institutions;

iii.  active promotion of policies to improve the economic and social well-being of citizens.

Full or partial association to the Programme of each of the third countries under point(d) shall be based on an assessment of the benefits for the Union. It shall in particular be in accordance with the conditions laid down in a specific agreement covering the participation of the third country to any Union programme, provided that the agreement:

–  ensures a fair balance as regards the contributions and benefits of the third country participating in the Union programmes;

–   confers the right to coordinate an action under the Programme provided that it benefits the Union and that the protection of Union’s financial interest is ensured;

–  lays down the conditions of participation in the programmes, Programme including the calculation of financial contributions to individual (sub-) programmes and their administrative costs. These contributions shall constitute assigned revenues in accordance with Article 21(5) of the Financial Regulation;

–  does not confer to the third country a decisional power on the programme;

–  guarantees the rights of the Union to ensure sound financial management and to protect the Union’s financial interests.

2.  The scope of association of each third country to the Programme shall take into account the objective of driving economic growth in the Union through innovation and shall avoid the brain drain from the Union. Accordingly, with the exception of EEA members, acceding countries, candidate countries and potential candidates, mono-beneficiary parts of the Programme may be excluded from an association agreement for a specific country, in particular those dedicated to private entities.

3.  The association agreement shall, where appropriate, provide for and pursue reciprocal participation of legal entities established in the Union in equivalent programmes of associated countries in accordance with the conditions laid down therein.

4.  The association agreement conditions determining the level of financial contribution shall ensure an automatic correction, every two years of any significant imbalance compared to the amount that entities established in the associated country receive through participation in the Programme, taking into account the costs in the management, execution and operation of the Programme.

4a.  The contributions of all associated countries shall be included in the relevant parts of the Programme provided that the budget breakdown as specified in Article 9, paragraph 2 is respected. The Commission shall report to the Council and the Parliament during the annual budgetary procedure the total budget of each part of the Programme, identifying each of the associated countries, individual contributions and their financial balance.

TITLE II

RULES FOR PARTICIPATION AND DISSEMINATION

CHAPTER I

General provisions

Article 13

Funding bodies and direct actions of JRC

1.  Funding bodies may depart from the rules set out in this Title, except from Articles 14, 15 and 16, in duly justified cases and only if this is provided for in the basic act setting up the funding body or entrusting budget implementation tasks to it or, for funding bodies under Article 62(1)(c)(ii), (iii) or (v) of the Financial Regulation, if it is provided for in the contribution agreement and their specific operating needs or the nature of the action so require.

2.  The rules set out in this Title shall not apply to direct actions undertaken by the JRC.

Article 14

Eligible actions and ethical principles

1.  Without prejudice to paragraphs 2 ▌of this Article, only actions implementing the objectives referred to in Article 3 shall be eligible for funding.

The following fields of research shall not be financed:

(a)  activities aiming at human cloning for reproductive purposes;

(b)  activities intended to modify the genetic heritage of human beings which could make such changes heritable(27);

(c)  activities intended to create human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer.

2.  Research on human stem cells, both adult and embryonic, may be financed, depending both on the contents of the scientific proposal and the legal framework of the Member States involved. No funding shall be granted, neither within nor outside the EU, for research activities that are prohibited in all the Member States. No activity shall be funded in a Member State where such activity is forbidden.

Article 15

Ethics(28)

1.  Actions carried out under the Programme shall comply with ethical principles and relevant national, Union and international legislation, including the Charter of Fundamental Rights of the European Union and the European Convention on Human Rights and its Supplementary Protocols.

Particular attention shall be paid to the principle of proportionality, the right to privacy, the right to the protection of personal data, the right to the physical and mental integrity of a person, the right to non-discrimination, the need to ensure protection of the environment and high levels of human health protection.

2.  Entities participating in the action shall provide:

(a)  an ethics self-assessment identifying and detailing all the foreseeable ethics issues related to the objective, implementation and likely impact of the activities to be funded, including a confirmation of compliance with paragraph 1, and a description of how it will be ensured;

(b)  a confirmation that the activities will comply with the European Code of Conduct for Research Integrity published by All European Academies and that no activities excluded from funding will be conducted;

(c)  for activities carried out outside the Union, a confirmation that the same activities would have been allowed in a Member State; and

(d)  for activities making use of human embryonic stem cells, as appropriate, details of licensing and control measures that shall be taken by the competent authorities of the Member States concerned as well as details of the ethics approvals that shall be obtained before the activities concerned start.

3.  Proposals shall be systematically screened to identify those actions raising complex or serious ethics issues and submit them to an ethics assessment. The ethics assessment shall be carried out by the Commission unless it is delegated to the funding body. For actions involving the use of human embryonic stem cells or human embryos, an ethics assessment shall be mandatory. Ethics screenings and assessments shall be carried out with the support of ethics experts. The Commission and the funding bodies shall ensure the transparency of the ethics procedures without prejudice to the confidentiality of the content of the procedure.

4.  Entities participating in the action shall obtain all approvals or other mandatory documents from the relevant national, local ethics committees or other bodies such as data protection authorities before the start of the relevant activities. Those documents shall be kept on file and provided to the Commission or funding body upon request.

5.  If appropriate, ethics checks shall be carried out by the Commission or funding body. For serious or complex ethics issues, the checks shall be carried out by the Commission unless it is delegated to the funding body.

Ethics checks shall be carried out with the support of ethics experts.

6.  Actions which do not fulfil the ethical requirements referred to in paragraphs 1-4 and are thus not ethically acceptable and therefore shall be rejected or terminated once the ethical unacceptability has been established.

Article 16

Security

1.  Actions carried out under the Programme shall comply with the applicable security rules and in particular rules on protection of classified information against unauthorised disclosure, including compliance with any relevant national and Union law. In case of research carried out outside the Union using and/or generating classified information, it is necessary that, in addition to the compliance with those requirements, a security agreement shall have to be concluded between the Union and the third country in which the research is conducted.

2.  Where appropriate, proposals shall include a security self-assessment identifying any security issues and detailing how these issues will be addressed in order to meet the relevant national and Union law.

3.  Where appropriate, the Commission or funding body shall carry out a security scrutiny for proposals raising security issues.

4.  Where appropriate, the actions shall comply with Decision (EU, Euratom) 2015/444, and its implementing rules.

5.  Entities participating in the action shall ensure the protection against unauthorised disclosure of classified information used and/or generated by the action. They shall provide proof of personal and/or facility security clearance from the relevant national security authorities, prior to the start of the activities concerned.

6.  If external experts have to deal with classified information, the appropriate security clearance shall be required before those experts are appointed.

7.  Where appropriate, the Commission or funding body may carry out security checks.

▌Actions which do not comply with the security rules under this Article may be rejected or terminated at any time.

CHAPTER II

Grants

Article 17

Grants

Grants under the Programme shall be awarded and managed in accordance with Title VIII of the Financial Regulation, unless otherwise specified in this Chapter.

Article 18

Entities eligible for participation

1.  Any legal entity, regardless of its place of establishment, including legal entities from non-associated third countries or international organisation may participate in actions under the Programme, provided that the conditions laid down in this Regulation have been met together with any conditions laid down in the work programme or call.

2.  Entities shall be part of a consortium that shall include at least three independent legal entities each established in a different Member State or associated country and with at least one of them established in a Member State, unless:

(a)  the work programme provides otherwise, if duly justified;

3.  European Research Council (ERC) frontier research actions, European Innovation Council (EIC) actions, training and mobility actions or programme co-fund actions may be implemented by one or more legal entities, one of which must be established in a Member State or associated country on the basis of an agreement concluded in accordance with Article 12.

4.  Coordination and support actions may be implemented by one or more legal entities, which may be established in a Member State, or associated country or in another third country.

5.  For actions related to Union strategic assets, interests, autonomy or security, the work programme may provide that the participation can be limited to those legal entities established in Member States only, or to those legal entities established in specified associated or other third countries in addition to Member States.

6.  Where appropriate and duly justified, the work programme may provide for eligibility criteria in addition to those set out in paragraphs 2, 3, 4, and 5 according to specific policy requirements or to the nature and objectives of the action, including the number of legal entities, the type of legal entity and the place of establishment.

7.  For actions benefiting from amounts under Article 11, the participation shall be limited to a single legal entity established in the jurisdiction of the delegating Managing Authority, except if otherwise agreed with the Managing Authority and provided for in the work programme.

8.  Where indicated in the work programme, the JRC may participate in actions.

9.  The JRC, international European research organisations and legal entities created under Union law shall be deemed to be established in a Member State other than the ones in which other legal entities participating in the action are established.

10.  For European Research Council (ERC) frontier research actions, training and mobility actions and when provided for in the work programme, international organisations with headquarters in a Member State or associated country shall be deemed to be established in this Member State or associated country.

For other parts of the Programme, international organisations other than international European research organisations shall be deemed to be established in a non-associated third country.

Article 19

Entities eligible for funding

1.   Entities are eligible for funding if they are established in a Member State or associated country as referred to in Article 12.

For actions benefiting from amounts under Article 11(3), only entities established in the jurisdiction of the delegating Managing Authority shall be eligible for funding out of these amounts.

1b.  Low to middle income countries and exceptionally for other non-associated third countries they could be eligible for funding in an action if:

(a)  the third country is identified in the work programme; and

(b)  the Commission or funding body consider that its participation is essential for implementing the action;

2.  Entities established in other non-associated third country should ▌ bear the cost of their participation. R&D agreements between those non-associated third countries and the Union can be made wherever deemed useful, and co-funding mechanism similar to the ones agreed inside Horizon 2020 may be established. Those countries shall ensure reciprocal access for Union legal entities to those countries’ RDI funding programmes, as well as reciprocity in open access to scientific results and data and to fair and equitable terms for intellectual property rights.

3.  Affiliated entities are eligible for funding in an action if they are established in a Member State, or Associated country ▌.

3a.  The Commission shall report to the Parliament and the Council specifying, for each non-associated third country, the amount of the Union’s financial contributions provided to the participating entities and the amount of the financial contributions provided by the same country to Union entities participating in their activities.

Article 20

Calls for proposals

1.  ▌The content of the calls for proposals for all actions shall be included in the work programme.

3.  If necessary to achieve their objectives, calls may, in exceptional cases, be restricted to develop additional activities or to add additional partners to existing actions. In addition, the work programme may foresee the possibility for legal entities from low R&I performing Member States to join already selected collaborative R&I actions, subject to the agreement of the respective consortium and provided that legal entities from such Member States are not yet participating in it.

4.   A call for proposals is not required for coordination and support actions or programme co-fund actions which:

(a)  are to be carried out by the JRC or legal entities identified in the work programme; and

(b)  do not fall within the scope of a call for proposals, in accordance with Article 195(e) of the Financial Regulation.

5.   The work programme shall specify calls for which "Seals of Excellence" will be awarded. With prior authorisation from the applicant, information concerning the application and the evaluation may be shared with interested financing authorities, subject to the conclusion of confidentiality agreements.

Article 21

Joint calls

The Commission or funding body may issue a joint call for proposals with:

(a)  third countries, including their scientific and technological organisations or agencies;

(b)  international organisations;

(c)  non-profit legal entities.

In the case of a joint call, applicants shall fulfil the requirements under Article 18 of this Regulation and joint procedures shall be established for selection and evaluation of proposals. The procedures shall involve a balanced group of experts appointed by each party.

Article 22

Pre-commercial procurement and procurement of innovative solutions

1.  Actions may involve or have as their primary aim pre-commercial procurement or public procurement of innovative solutions that shall be carried out by beneficiaries which are contracting authorities or contracting entities as defined in Directives 2014/24/EU(29), 2014/25/EU(30) and 2009/81/EC(31).

2.  The procurement procedures:

(a)  shall comply with the principles of transparency, non- discrimination, equal treatment, sound financial management, proportionality and competition rules;

(b)  for pre-commercial procurement, where appropriate and without prejudice to the principles enumerated in point (a), a simplified and/or accelerated procedure may be used and may provide for specific conditions such as the place of performance of the procured activities being limited to the territory of the Member States and of Associated Countries.

(c)  may authorise the award of multiple contracts within the same procedure (multiple sourcing); and

(d)  shall provide for the award of the contracts to the tender(s) offering best value for money while ensuring absence of conflict of interest.

3.  The contractor generating results in pre-commercial procurement shall own at least the attached intellectual property rights. The contracting authorities shall enjoy at least royalty-free access rights to the results for their own use and the right to grant, or require the participating contractors to grant, non-exclusive licences to third parties to exploit the results for the contracting authority under fair and reasonable conditions without any right to sub-license. If a contractor fails to commercially exploit the results within a given period after the pre-commercial procurement as identified in the contract, the contracting authorities, after having consulted the contractor on the reasons for the non-exploitation, can require it to transfer any ownership of the results to the contracting authorities.

Article 24

Financial capacity of applicants

1.  In addition to the exceptions mentioned in Article 198(5) of the Financial Regulation, the financial capacity shall be verified only for the coordinator and only if the requested funding from the Union for the action is equal to or greater than EUR 500 000.

2.  However, if there are grounds to doubt the financial capacity or if there is a higher risk due to the participation in several ongoing actions funded by Union research and innovation programmes, the Commission or funding body shall verify also the financial capacity of other applicants or of coordinators below the threshold referred to in paragraph 1.

3.  If the financial capacity is structurally guaranteed by another legal entity, the financial capacity of the latter shall be verified.

4.  In case of weak financial capacity, the Commission or funding body may make participation of the applicant conditional on provision of a declaration on joint and several liability by an affiliated entity.

5.  The contribution to the Mutual Insurance Mechanism set out in Article 33 shall be considered a sufficient guarantee under Article 152 of the Financial Regulation. No additional guarantee or security may be accepted from beneficiaries or imposed upon them.

Article 25

Award criteria and selection

1.  A proposal shall be evaluated on the basis of the following award criteria:

(a)  excellence;

(b)  impact;

(c)  quality and efficiency of the implementation.

2.  Only the criterion referred to in point (a) of paragraph 1 shall apply to proposals for ERC frontier research actions.

3.  The work programme shall lay down further details of the application of the award criteria laid down in paragraph 1 including any weighting, thresholds and where relevant rules for dealing with ex-aequo proposals, taking into consideration the objectives of the call for proposals. The conditions for dealing with ex-aequo proposals may include, but not limited to, the following criteria: SMEs, gender, geographical diversity.

3a.  The Commission and other funding bodies shall take into account the possibility of a two-stage submission procedure and where appropriate, anonymised proposals may be evaluated during the first stage of evaluation based on one or more of the award criteria referred to in paragraph 1.

Article 26

Evaluation

1.  Proposals shall be evaluated by the evaluation committee which shall be composed of external independent experts.

For EIC activities, missions and in duly justified cases as set out in the work programme adopted by the Commission, the evaluation committee may be composed partially or, in the case of coordination and support actions, partially or fully of representatives of Union Institutions or bodies as referred to in Article 150 of the Financial Regulation.

The evaluation process may be followed by independent observers.

2.  Wherever applicable, the evaluation committee shall rank the proposals having passed the applicable thresholds, according to:

(a)   the evaluation scores;

(b)   their contribution to the achievement of specific policy objectives, including the constitution of a consistent portfolio of projects namely for EIC pathfinder activities, missions and in other duly justified cases as set out in the work programme adopted by the Commission in detail.

For EIC activities, missions and in other duly justified cases as set out in the work programme adopted by the Commission in detail, the evaluation committee may also propose ▌adjustments to the proposals in as far as needed for the consistency of the portfolio approach. These adjustments shall be in conformity with the conditions for participation and comply with the principle of equal treatment. The Programme Committee shall be informed of such cases.

2a.  The evaluation process shall be designed to avoid conflict of interest and bias. The transparency of the evaluation criteria and of the proposal scoring method shall be guaranteed.

3.  In accordance with Article 200 (7) of the Financial Regulation, applicants shall receive feedback at all stages of the evaluation and, where applicable, the reasons for rejection.

4.  Legal entities established in low R&I performing Member States who have participated successfully in the component "Widening Participation and Sharing Excellence" shall receive, upon request, a record of this participation that may accompany proposals to the collaborative parts of the programme that they coordinate.

Article 27

Evaluation review procedure, enquiries and complaints

1.  An applicant may request an evaluation review if it considers that the applicable evaluation procedure has not been correctly applied to its proposal(32).

2.  An evaluation review applies only to the procedural aspects of the evaluation, not to the evaluation of the merits of the proposal.

2a.  A request for review shall relate to a specific proposal and shall be submitted within 30 days after the communication of evaluation results.

An evaluation review committee shall provide an opinion on the procedural aspects, and shall be chaired by and include staff of the Commission or of the relevant funding body who were not involved in the evaluation of the proposals. The committee may recommend one of the following:

(a)  re-evaluation of the proposal primarily by evaluators not involved in the previous evaluation;

(b  confirmation of the initial evaluation.

3.  An evaluation review shall not delay the selection process for proposals that are not the subject of review.

3a.  The Commission shall ensure the existence of a procedure for participants to make direct enquiries and complaints about their involvement in Horizon Europe. Information on how to register enquiries or complaints shall be made available on-line.

Article 28

Time to grant

1.  By derogation from the first subparagraph of Article 194(2) of the Financial Regulation, the following periods shall apply:

(a)  for informing all applicants of the outcome of the evaluation of their application, a maximum period of five months from the final date for submission of complete proposals;

(b)  for signing grant agreements with applicants, a maximum period of eight months from the final date for submission of complete proposals.

2.  The work programme ▌ may establish shorter periods.

3.  In addition to the exceptions laid down in the second subparagraph of Article 194(2) of the Financial Regulation, the periods referred to in paragraph 1 may be exceeded for actions of the ERC, for missions and when actions are submitted to an ethics or security assessment.

Article 29

Implementation of the grant

1.  If a beneficiary fails to comply with its obligations regarding the technical implementation of the action, the other beneficiaries shall comply with those obligations without any additional Union funding, unless they are expressly relieved of that obligation. The financial responsibility of each beneficiary shall be limited to its own debt subject to the provisions relating to the Mutual Insurance Mechanism.

2.  The grant agreement may establish milestones and related pre-financing installments. If milestones are not met, the action may be suspended, amended or, if duly justified, be terminated.

3.  The action may also be terminated where expected results have lost their relevance for the Union due to scientific or technological reasons, or in the case of the EIC accelerator also due to economic reasons, or in the case of EIC and missions due to their relevance as part of a portfolio of actions. The Commission shall undergo a procedure with the action coordinator and if appropriate with external experts, before deciding to terminate an action, in accordance with Article 133 of the Financial Regulation.

Article 29a

Model Grant Agreement

1.  The Commission shall, in close cooperation with the Member States, draw up model grant agreements between the Commission or the relevant funding body and the beneficiaries in accordance with this Regulation. If a significant modification of a model grant agreement is required, inter alia in view of further simplification for beneficiaries, the Commission shall, in close cooperation with the Member States, revise it as appropriate.

2.  The grant agreement shall establish the rights and obligations of the beneficiaries and of either the Commission or the relevant funding body in compliance with this Regulation. It shall also establish the rights and obligations of legal entities which become beneficiaries during the implementation of the action, as well as the role and tasks of a consortium coordinator.

Article 30

Funding rates

1.  A single funding rate per action shall apply for all activities it funds. The maximum rate per action shall be fixed in the work programme.

2.  The Programme may reimburse up to 100 % of total eligible costs of an action, except for:

(a)  innovation actions: up to 70 % of the total eligible costs, except for non-profit legal entities where the Programme may reimburse up to 100 % of the total eligible costs;

(b)  programme co-fund actions: at least 30 % of the total eligible costs, and in identified and duly justified cases up to 70 %.

3.  The funding rates determined in this Article shall also apply for actions where flat rate, unit or lump sum financing is fixed for the whole or part of the action.

Article 31

Indirect costs

1.  Indirect eligible costs shall be determined by applying a flat rate of 25 % of the total direct eligible costs, excluding direct eligible costs for subcontracting, financial support to third parties and any unit costs or lump sums which include indirect costs.

Where appropriate, indirect costs included in unit costs or lump sums shall be calculated using the flat rate set out in paragraph 1, except for unit costs for internally invoiced goods and services which shall be calculated on the basis of actual costs, in accordance with the beneficiaries' usual costs accounting practice.

2.  However, if provided for in the work programme, indirect costs may be declared in the form of a lump sum or unit costs.

Article 32

Eligible costs

1.  In addition to the criteria set out in Article 186 of the Financial Regulation, for beneficiaries with project-based remuneration, costs of personnel are eligible up to the remuneration that the person would be paid for work in R&I projects funded by national schemes including social security charges and other costs linked to the remuneration of personnel assigned to the action, arising from national law or from the employment contract.

Project-based remuneration means remuneration that is linked to the participation of a person in projects, is part of the beneficiary’s usual remuneration practices and is paid in a consistent manner.

2.  By derogation from Article 190(1) of the Financial Regulation, costs of resources made available by third parties by means of in-kind contributions shall be eligible, up to the direct eligible costs of the third party.

3.  By derogation from Article 192 of the Financial Regulation, income generated by the exploitation of the results shall not be considered as receipts of the action.

3a.  Beneficiaries may use their usual accounting practices to identify and declare the costs incurred in relation to an action in compliance with all terms and conditions set out in the grant agreement, in line with this Regulation and Article 186 of Financial regulation.

4.  By derogation from Article 203(4) of the Financial Regulation, a certificate on the financial statements shall be mandatory at payment of the balance, if the amount claimed as actual costs and unit costs calculated in accordance with usual cost accounting practices is equal to or greater than EUR 325 000.

Certificates on financial statements may be produced by an approved external auditor or, in the case of public bodies, issued by a competent and independent public officer in line with Article 203, Para 4 of Financial regulation.

4a.  Where appropriate, for MSCA training and mobility grants, the EU contribution shall take due account of any additional costs of the beneficiary related to maternity or parental leave, sick leave, special leave or change of recruiting host organisation or family status of researcher during the lifetime of the grant agreement.

4b.  Costs related to open access including data management plans shall be eligible for reimbursement as further stipulated in the grant agreement.

Article 33

Mutual Insurance Mechanism

1.  A Mutual Insurance Mechanism (the 'Mechanism') is hereby established which shall replace and succeed the fund set up in accordance with Article 38 of Regulation (EU) No 1290/2013. The Mechanism shall cover the risk associated with non-recovery of sums due by the beneficiaries:

(a)  to the Commission under Decision No 1982/2006/EC,

(b)  to the Commission and Union bodies under "Horizon 2020",

(c)  to the Commission and funding bodies under the Programme.

The coverage of the risk regarding funding bodies referred to in point (c) of the first subparagraph may be implemented through an indirect coverage system set out in the applicable agreement and taking into account the nature of the funding body.

2.  The Mechanism shall be managed by the Union, represented by the Commission acting as executive agent. The Commission shall set up specific rules for the operation of the Mechanism.

3.  Beneficiaries shall make a contribution of 5 % of the Union funding for the action. On the basis of periodic transparent evaluations, this contribution may be raised by the Commission up to 8% or may be reduced under 5%. The beneficiaries' contribution to the Mechanism shall be offset from the initial pre-financing and be paid to the Mechanism on behalf of the beneficiaries, and shall in no circumstance exceed the amount of the initial pre-financing.

4.  The contribution of the beneficiaries shall be returned at the payment of the balance.

5.  Any financial return generated by the Mechanism shall be added to the Mechanism. If the return is insufficient, the Mechanism shall not intervene and the Commission or funding body shall recover directly from beneficiaries or third parties any amount owed.

6.  The amounts recovered shall constitute revenue assigned to the Mechanism within the meaning of Article 21(5) of the Financial Regulation. Once all grants whose risk is covered directly or indirectly by the Mechanism are completed, any sums outstanding shall be recovered by the Commission and entered into the budget of the Union, subject to decisions of the legislative authority.

7.  The Mechanism may be extended to beneficiaries of any other directly managed Union programme. The Commission shall adopt modalities for participation of beneficiaries of other programmes.

Article 34

Ownership and protection

1.  Beneficiaries shall own the results they generate. They shall ensure that any rights of their employees or any other parties in relation to the results can be exercised in a manner compatible with the beneficiaries’ obligations in accordance with the terms and conditions laid down in the grant agreement.

Two or more beneficiaries shall own results jointly if:

(a)  they have jointly generated them; and

(b)  it is not possible to:

(i)  establish the respective contribution of each beneficiary,

or

(ii)  separate them when applying for, obtaining or maintaining their protection.

The joint owners shall agree in writing on the allocation and terms of exercise of their joint ownership. Unless otherwise agreed in the Consortium Agreement or in the joint ownership agreement, each joint owner may grant non-exclusive licences to third parties to exploit the jointly-owned results (without any right to sub-license), if the other joint owners are given advance notice and fair and reasonable compensation. The joint owners may agree in writing to apply another regime than joint ownership.

2.  Beneficiaries having received Union funding shall adequately protect their results if protection is possible and justified, taking into account all relevant considerations, including the prospects for commercial exploitation and any other legitimate interests. When deciding on protection, beneficiaries shall also consider the legitimate interests of the other beneficiaries in the action.

Article 35

Exploitation and dissemination

1.  Each participant that has received Union funding shall use its best efforts to exploit the results it owns, or to have them exploited by another legal entity. Exploitation may be done directly by the beneficiaries or indirectly in particular through the transfer and licensing of results in accordance with Article 36.

The work programme may provide for additional exploitation obligations.

If despite a beneficiary's best efforts to exploit its results directly or indirectly no exploitation takes place within a given period as identified in the grant agreement, the beneficiary shall use an appropriate online platform as identified in the grant agreement to find interested parties to exploit those results. If justified on the basis of a request of the beneficiary, this obligation may be waived.

2.  Beneficiaries shall disseminate their results as soon as it is feasible, in a publicly available format, subject to any restrictions due to the protection of intellectual property, security rules or legitimate interests ▌.

The work programme may provide for additional dissemination obligations while safeguarding the Union’s economic and scientific interests.

3.  Beneficiaries shall ensure that open access to scientific publications applies under the terms and conditions laid down in the grant agreement. In particular, the beneficiaries shall ensure that they or the authors retain sufficient intellectual property rights to comply with their open access requirements.

Open access to research data shall be the general rule under the terms and conditions laid down in the grant agreement, ensuring the possibility of exceptions following the principle ‘as open as possible, as closed as necessary’, taking into consideration the legitimate interests of the beneficiaries including commercial exploitation and any other constraints, such as data protection rules, privacy, confidentiality, trade secrets, Union competitive interests, security rules or intellectual property rights.

The work programme may provide for additional incentives or obligations to adhere to open science practices.

4.  Beneficiaries shall manage all research data generated in a Horizon Europe action in line with the FAIR principles and in accordance with the terms and conditions laid down in the grant agreement and shall establish a Data Management Plan.

The work programme may provide, where justified, for additional obligations to use the European Open Science Cloud (EOSC) for storing and giving access to research data.

5.  Beneficiaries that intend to disseminate their results shall give advance notice to the other beneficiaries in the action. Any other beneficiary may object if it can show that the intended dissemination would significantly harm its legitimate interests in relation to its results or background. In such cases, the dissemination may not take place unless appropriate steps are taken to safeguard these legitimate interests.

6.  Unless the work programme provides otherwise, proposals shall include a plan for the exploitation and dissemination of the results. If the expected exploitation entails developing, creating, manufacturing and marketing a product or process, or in creating and providing a service, the plan shall include a strategy for such exploitation. If the plan provides for exploitation primarily in non-associated third countries, the legal entities shall explain how that exploitation is still in the Union interest.

The beneficiaries shall update the plan during and after the end of the action, in accordance with the grant agreement.

7.  For the purposes of monitoring and dissemination by the Commission or funding body, the beneficiaries shall provide any requested information regarding the exploitation and dissemination of their results, in accordance with the conditions laid down in the grant agreement. Subject to the legitimate interests of the beneficiaries, such information shall be made publicly available.

Article 36

Transfer and licensing

1.  Beneficiaries may transfer ownership of their results. They shall ensure that their obligations also apply to the new owner and that the latter has the obligation to pass them on in any subsequent transfer.

2.  Unless agreed otherwise in writing for specifically-identified third parties including Affiliated Entities or unless impossible under applicable law, beneficiaries that intend to transfer ownership of results shall give advance notice to any other beneficiary that still has access rights to the results. The notification must include sufficient information on the new owner to enable a beneficiary to assess the effects on its access rights.

Unless agreed otherwise in writing for specifically-identified third parties including Affiliated Entities, a beneficiary may object to the transfer if it can show that the transfer would adversely affect its access rights. In this case, the transfer may not take place until agreement has been reached between the beneficiaries concerned. The grant agreement shall lay down time limits in this respect.

3.  Beneficiaries may grant licences to their results or otherwise give the right to exploit them, including on an exclusive basis, if this does not affect compliance with their obligations. Exclusive licences for results may be granted subject to consent by all the other beneficiaries concerned that they will waive their access rights thereto.

4.  Where this is justified, the grant agreement shall lay down the right for the Commission or funding body to object to transfers of ownership of results, or to grants of an exclusive licence regarding results, if:

(a)  the beneficiaries generating the results have received Union funding;

(b)  the transfer or licence is to a legal entity established in a non-associated third country; and

(c)  the transfer or licence is not in line with Union interests.

If the right to object applies, the beneficiary shall give advance notice. The right to object may be waived in writing regarding transfers or grants to specifically identified legal entities if measures safeguarding Union interests are in place.

Article 37

Access rights

1.  The following access rights principles shall apply:

(a)  a request to exercise access rights or any waiving of access rights shall be made in writing;

(b)  unless otherwise agreed with the grantor, access rights do not include the right to sub-license;

(c)  the beneficiaries shall inform each other before their accession to the grant agreement of any restrictions to granting access to their background;

(d)  if a beneficiary is no longer involved in an action, it shall not affect its obligations to grant access;

(e)  if a beneficiary defaults on its obligations, the beneficiaries may agree that it no longer has access rights.

2.  Beneficiaries shall grant access to:

(a)  their results on a royalty-free basis to any other beneficiary in the action that needs it to implement its own tasks;

(b)  their background to any other beneficiary in the action that needs it to implement its own tasks, subject to any restrictions referred to in paragraph 1(c); that access shall be granted on a royalty-free basis, unless otherwise agreed by the beneficiaries before their accession to the grant agreement;

(c)  their results and, subject to any restrictions referred to in paragraph 1(c), to their background to any other beneficiary in the action that needs it to exploit its own results; that access shall be granted under fair and reasonable conditions to be agreed upon.

3.  Unless otherwise agreed by the beneficiaries, they shall also grant access to their results and, subject to any restrictions referred to in paragraph 1(c), to their background to a legal entity that:

(a)  is established in a Member State or associated country;

(b)  is under the direct or indirect control of another beneficiary, or is under the same direct or indirect control as that beneficiary, or is directly or indirectly controlling that beneficiary; and

(c)  needs the access to exploit the results of that beneficiary, in accordance with the beneficiary's exploitation obligations.

Access shall be granted under fair and reasonable conditions to be agreed upon.

4.  A request for access for exploitation purposes may be made up to one year after the end of the action, unless the beneficiaries agree on a different time-limit.

5.  Beneficiaries having received Union funding shall grant access to their results on a royalty-free basis to the Union institutions, bodies, offices or agencies for developing, implementing and monitoring Union policies or programmes. Access shall be limited to non-commercial and non-competitive use.

Such access rights shall not extend to the beneficiaries’ background.

In actions under the cluster ‘Civil security for Society’, beneficiaries having received Union funding shall also grant access to their results on a royalty-free basis to Member States' national authorities, for developing, implementing and monitoring their policies or programmes in that area. Access shall be limited to non-commercial and non-competitive use and shall be granted upon bilateral agreement defining specific conditions aimed at ensuring that those rights will be used only for the intended purpose and that appropriate confidentiality obligations will be in place. The requesting Member State, Union institution, body, office or agency shall notify all Member States of such requests.

6.  The work programme may provide, where appropriate, for additional access rights.

Article 38

Specific provisions ▌

Specific rules on ownership, exploitation and dissemination, transfer and licensing as well as access rights may apply for ERC actions, training and mobility actions, pre-commercial procurement actions, public procurement of innovative solutions actions, programme co-fund actions and coordination and support actions.

These specific rules shall be set out in the grant agreement and shall not change the principles and obligations on open access.

Article 39

Prizes

1.  Prizes under the Programme shall be awarded and managed in accordance with Title IX of the Financial Regulation, unless otherwise specified in this Chapter.

2.  Any legal entity, regardless of its place of establishment, may participate in a contest, unless otherwise provided in the work programme or rules of contests.

3.  The Commission or funding body may, where appropriate, organise prizes with:

(a)  other Union bodies;

(b)  third countries, including their scientific and technological organisations or agencies;

(c)  international organisations; or

(d)  non-profit legal entities.

4.  The work programme or rules of contest shall include obligations regarding communication, and where appropriate exploitation and dissemination, ownership and access rights including licensing provisions.

CHAPTER IV

Procurement

Article 40

Procurement

1.  Procurement under the Programme shall be awarded and managed in accordance with Title VII of the Financial Regulation, unless otherwise specified in this Chapter.

2.  Procurement may also take the form of pre-commercial procurement or procurement of innovative solutions carried out by the Commission or the funding body on its own behalf or jointly with contracting authorities from Member States and associated countries. In this case, the rules set out in Article 22 shall apply.

CHAPTER V

Blending operations and blended finance

Article 41

Blending operations

Blending operations decided under this Programme shall be implemented in accordance with the InvestEU Programme and Title X of the Financial Regulation.

Article 42

Horizon Europe and EIC Blended finance

1.  The grant and reimbursable advance components of Horizon Europe or EIC blended finance shall be subject to Articles 30 to 33.

2.  EIC blended finance shall be implemented in accordance with Article 43. The support under the EIC blended finance may be granted until the action can be financed as a blending operation or as a financing and investment operation fully covered by the EU guarantee under InvestEU. By derogation from Article 209 of the Financial Regulation, the conditions laid down in paragraph (2) and, in particular, paragraph (a) and (d), do not apply at the time of the award of EIC blended finance

3.  Horizon Europe blended finance may be awarded to a programme co-fund where a joint programme of Member States and associated countries provides for the deployment of financial instruments in support of selected actions. The evaluation and selection of such actions shall be made in accordance with Articles 11, 19, 20, 24, 25, and 26. The implementation modalities of the Horizon Europe blended finance shall comply with Article 29, by analogy Article 43(9) and with additional and justified conditions defined by the work programme.

4.  Repayments including reimbursed advances and revenues of Horizon Europe and EIC blended finance shall be considered as internal assigned revenues in accordance with Articles 21(3)(f) and 21(4) of Financial Regulation.

5.  Horizon Europe and EIC blended finance shall be provided in a manner that promotes the Union's competitiveness while not distorting competition in the internal market.

Article 42a

The Pathfinder

1.  The Pathfinder shall provide grants to high-risk cutting-edge projects, implemented by consortia or monobeneficiaries, aiming to develop radical innovations and new market opportunities. The Pathfinder shall provide support for the earliest stages of scientific, technological or deep-tech research and development, including proof of concept and prototypes for technology validation.

The Pathfinder shall be mainly implemented through an open call for bottom-up proposals with regular cut-off dates per year and shall also provide for competitive challenges to develop key strategic objectives calling for deep-tech and radical thinking.

2.  The Pathfinder's Transition activities shall help all types of researchers and innovators develop the pathway to commercial development in the Union, such as demonstration activities and feasibility studies to assess potential business cases, and support the creation of spin offs and start-ups.

(a)  the launch and the content of the calls for proposals shall be determined with regard to objectives and budget established by the work programme in relation with the concerned portfolio of actions;

(b)  Additional grants for a fixed amount not exceeding EUR 50 000 may be awarded to each proposal already selected under the EIC Pathfinder through a call for proposals, to carry out complementary activities, including urgent coordination and support actions, for reinforcing the portfolio’s community of beneficiaries, such as assessing possible spin-offs, potential market-creating innovations or developing a business plan. The Programme Committee established under the Specific Programme shall be informed of such cases.

3.  The award criteria as defined in Article 25 shall apply to the EIC Pathfinder.

Article 43

The Accelerator

1.  The EIC's Accelerator shall aim to support essentially market-creating innovation. It shall support only monobeneficiaries and mainly provide blended finance. Under certain conditions, it may also provide grant-only and equity-only supports.

The EIC Accelerator shall propose two types of support:

—  Blended finance support to SMEs including start-ups and, in exceptional cases, small midcaps carrying out breaktrough and disruptive non-bankable innovation.

—  A grant-only support to SMEs, including start-ups, carrying out any type of innovation ranging from incremental to breakthrough and disruptive innovation and aiming to subsequently scale up.

Equity-only support to non-bankable SMEs, including start-ups, which have already received a grant-only support, may also be provided.

Grant only support under the EIC Accelerator shall only be provided under the following cumulative conditions:

a)  the project shall include information on the capacities and willingness of the applicant to scale-up;

b)  the beneficiary can only be a start-up or an SME;

c)  a grant-only support under the EIC Accelerator can only be provided once to a beneficiary during Horizon Europe for a maximum of EUR 2.5 million.

1a.  The beneficiary of the EIC Accelerator shall be a legal entity qualifying as a start-up, an SME or in exceptional cases as a small mid-cap eager to scale-up, established in a Member State or associated country. The proposal may be submitted either by the beneficiary, or, subject to the prior agreement by the beneficiary, by one or more natural persons or legal entities intending to establish or support that beneficiary. In the latter case, the funding agreement will be signed with the beneficiary only.

2.  A single award decision shall cover and provide funding for all forms of Union contribution provided under EIC blended finance.

3.  Proposals shall be evaluated on their individual merit by external independent experts and selected in the context of a continuously open call with cut-off dates, based on Articles 24 to 26, subject to paragraph 4

4.  Award criteria shall be

(a)   excellence;

(b)   impact;

(c)   the level of risk of the action that would prevent investments, the quality and efficiency of the implementation, and the need for Union support.

5.  With the agreement of applicants concerned, the Commission or funding bodies implementing Horizon Europe (including EIT's KICs) may directly submit for evaluation under the last award criterion a proposal for an innovation and market deployment action which already fulfils the first two criteria, subject to the following cumulative conditions:

(a)   the proposal shall stem from any other action funded by Horizon 2020, from this Programme; or, subject to a pilot in the first Horizon Europe work programme, from a national and/or regional programmes, starting with the mapping of the demand for such a scheme. Detailed provisions shall be laid down in the Specific Programme.

(b)   be based on a previous project review not longer than 2 years ago assessing the excellence and the impact of the proposal and subject to conditions and processes further detailed in the work programme.

6.  A Seal of Excellence may be awarded subject to the following cumulative conditions:

(a)   the beneficiary is a start-up, an SME or a small mid-cap,

(b)   the proposal was eligible and has passed applicable thresholds for the first two award criteria referred to in paragraph 4,

(c)   for those activities that would be eligible under an innovation action.

7.  For a proposal having passed the evaluation, external independent experts shall propose a corresponding EIC Accelerator support, based on the risk incurred and the resources and time necessary to bring and deploy the innovation to the market.

The Commission may reject a proposal retained by external independent experts for justified reasons, including non-compliance with the objectives of Union policies. The Programme Committee shall be informed of the reasons for such rejections.

8.  The grant or the reimbursable advance component of the EIC Accelerator support shall not exceed 70% of the total eligible costs of the selected innovation action.

9.  Implementation modalities of the equity and repayable support components of the EIC Accelerator support shall be detailed in Decision [Specific programme].

10.  The contract for the selected action shall establish specific measurable milestones and the corresponding pre-financing and payments by instalments of the EIC Accelerator support.

In the case of EIC blended finance, activities corresponding to an innovation action may be launched and first pre-financing of the grant or the reimbursable advance paid, prior to the implementation of other components of the awarded EIC blended finance. The implementation of those components shall be subject to the achievement of specific milestones established in the contract.

11.  In accordance with the contract, the action shall be suspended, amended or if duly justified be terminated if measurable milestones are not met. It may also be terminated where the expected market deployment especially in the Union cannot be met.

In exceptional cases and upon advice by the EIC board, the Commission may decide to increase the EIC Accelerator support subject to a project review by external independent experts. The Programme Committee shall be informed of such cases.

Chapter VI

Experts

Article 44

Appointment of independent external experts

1.  Independent external experts shall be identified and selected on the basis of calls for applications from individuals and calls addressed to relevant organisations such as research agencies, research institutions, universities, standardisation organisations, civil society organisations or enterprises with a view to establishing a database of candidates.

By derogation from Article 237(3) of the Financial Regulation, the Commission or the relevant funding body may, exceptionally and in duly justified cases, select in a transparent manner any individual expert with the appropriate skills not included in the database provided that a call for expressions of interest has not identified suitable independent external experts.

Such experts shall declare their independence and capacity to support Horizon Europe objectives.

2.  In accordance with Article 237(2) and 237(3) of the Financial Regulation, independent external experts shall be remunerated based on standard conditions. If justified, and in exceptional cases an appropriate level of remuneration beyond the standard conditions based on relevant market standards, especially for specific high level experts, may be granted.

3.  In addition to paragraphs 2 and 3 of Article 38 of the Financial Regulation, the names of independent external experts evaluating grant applications, who are appointed in a personal capacity shall be published, together with their area of expertise, at least once a year on the internet site of the Commission or the funding body. Such information shall be collected, processed and published in accordance with the EU data protection rules.

3a.  The Commission or the relevant funding body shall take the appropriate measures to prevent conflicts of interest as regards the involvement of independent external experts in line with Articles 61 and 150(5) of the Financial Regulation.

The Commission or the relevant funding body shall ensure that an expert faced with a conflict of interest in relation to a matter on which the expert is required to provide an opinion does not evaluate, advise or assist on the specific matter in question.

3-b.  When appointing independent external experts, the Commission or the relevant funding body shall take appropriate measures to seek a balanced composition within the expert groups and evaluation panels in terms of skills, experience, knowledge, including in terms of specialisation, in particular on SSH, geographical diversity and gender, taking into account the situation in the field of the action.

3b.  Where appropriate, an adequate number of independent experts shall be ensured for each proposal in order to guarantee the quality of the evaluation.

3c.  The level of remuneration of all independent and external experts shall be made available to the European Parliament and the Council. It shall be covered by the expenses of the Programme.

TITLE III

PROGRAMME MONITORING, COMMUNICATION, EVALUATION AND CONTROL

Article 45

Monitoring and reporting

1.  The Commission shall monitor continuously the management and implementation of Horizon Europe, its specific programme and the activities of the EIT. In order to enhance transparency, this data shall also be made publicly available in an accessible manner on the Commission's webpage according to the latest update.

In particular, data for projects funded under ERC, European Partnerships, missions, EIC and EIT shall be included in the same database.

This shall include:

(i)  “Time-bound indicators to report on an annual basis on progress of the Programme towards the achievement of the objectives established in Article 3 and set in Annex V along impact pathways;”

(ii)  information on the level of mainstreaming social sciences and humanities, the ratio between lower and higher TRLs in collaborative research, the progress on widening countries participation, the geographical composition of consortia in collaborative projects, the evolution of researchers salaries, the use of two stage submission and evaluation procedure, the measures aimed at facilitating collaborative links in European research and innovation, the use of the evaluation review and the number and types of complaints, the level of climate mainstreaming and related expenditures, SME participation, private sector participation, gender participation in funded actions, evaluation panels, boards and advisory groups, the Seals of Excellence, the European Partnerships as well as the co-funding rate, the complementary and cumulative funding from other Union funds, research infrastructures, time-to-grant, the level of international cooperation, engagement of citizens’ and civil society participation.

(iii)  the levels of expenditure disaggregated at project level in order to allow for specific analysis, including per intervention area.

(iv)  the level of oversubscription, in particular the number of proposals and per call for proposals, their average score, the share of proposals above and below quality thresholds.

2.  The Commission is empowered to adopt delegated acts in accordance with Article 50 concerning amendments to Annex V to supplement or amend the impact pathway indicators, where considered necessary, and set baselines and targets.

3.  The performance reporting system shall ensure that data for monitoring programme implementation and results are collected efficiently, effectively and in a timely manner without increasing the administrative burden for beneficiaries. To that end, proportionate reporting requirements shall be imposed on recipients of Union funds, including at the level of researchers involved in the actions in order to be able to track their career and mobility, and (where relevant) Member States(33).

3a.  Qualitative analysis from the Commission and Union or national funding bodies shall complement as much as possible quantitative data.

4.  The measures aimed at facilitating collaborative links in European research and innovation shall be monitored and reviewed within the context of the work programmes.

Article 46

Information, communication, publicity and dissemination and exploitation

1.  The recipients of Union funding shall acknowledge the origin and ensure the visibility of the Union funding (in particular when promoting the actions and their results, including for prizes) by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public.

2.  The Commission shall implement information and communication actions relating to the Programme, and its actions and results. In addition, it shall provide timely and thorough information to Member States and beneficiaries. Evidence-based matchmaking services informed by analytics and network affinities shall be provided to interested entities in order to form consortia for collaborative projects, with particular attention to identifying networking opportunities for legal entities from low R&I performing Member States. On the basis of such analysis, targeted match-making events may be organised in function of specific calls for proposals. Financial resources allocated to the Programme shall also contribute to the corporate communication of the political priorities of the Union, as far as they are related to the objectives referred to in Article 3.

3.  The Commission shall also establish a dissemination and exploitation strategy for increasing the availability and diffusion of the Programme’s research and innovation results and knowledge to accelerate exploitation towards market uptake and boost the impact of the Programme. Financial resources allocated to the Programme shall also contribute to the corporate communication of the political priorities of the Union as well as information, communication, publicity, dissemination and exploitation activities as far as they are related to the objectives referred to in Article 3.

Article 47

Programme evaluation

1.  Programme evaluations shall be carried out in a timely manner to feed into the decision-making process on the programme, its successor and other initiatives relevant to research and innovation.

2.  The interim evaluation of the Programme shall be with the assistance of independent experts selected on the basis of a transparent process carried out once there is sufficient information available about the implementation of the Programme, but no later than four years after the start of the programme implementation. It shall include a portfolio analysis and an assessment of the long-term impact of previous Framework Programmes and shall form the basis to adjust programme implementation and/or review the programme, as appropriate. It shall assess the Programme’s effectiveness, efficiency, relevance, coherence, and Union added value.

3.  At the end of the implementation of the Programme, but no later than four years after the end of the period specified in Article 1, a final evaluation of the Programme shall be completed by the Commission. It shall include an assessment of the long-term impact of previous Framework Programmes.

4.  The Commission shall publish and communicate the conclusions of the evaluations accompanied by its observations and shall present them to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.

Article 48

Audits

1.  The control system for the Programme shall ensure an appropriate balance between trust and control, taking into account administrative and other costs of controls at all levels, especially for beneficiaries. Audit rules shall be clear, consistent and coherent throughout the Programme.

2.  The audit strategy for the Programme shall be based on the financial audit of a representative sample of expenditure across the Programme as a whole. The representative sample shall be complemented by a selection based on an assessment of the risks related to expenditure. Actions that receive joint funding from different Union programmes shall be audited only once, covering all involved programmes and their respective applicable rules.

3.  In addition, the Commission or funding body may rely on combined systems reviews at beneficiary level. These combined reviews shall be optional for certain types of beneficiaries and shall consist in a systems and process audit, complemented by an audit of transactions, carried out by a competent independent auditor qualified to carry out statutory audits of accounting documents in accordance with Directive 2006/43/EC(34). They may be used by the Commission or funding body to determine overall assurance on the sound financial management of expenditure and for reconsideration of the level of ex-post audits and certificates on financial statements.

4.  In accordance with Article 127 of the Financial Regulation, the Commission or funding body may rely on audits on the use of Union contributions carried out by other independent and competent persons or entities, including by other than those mandated by the Union Institutions or bodies.

5.  Audits may be carried out up to two years after the payment of the balance.

5a.  The Commission shall publish audit guidelines, aiming to ensure a reliable and uniform application and interpretation of the audit procedures and rules throughout the duration of the programme.

Article 49

Protection of financial interests of the Union

1.  The Commission or its representatives, and the Court of Auditors, shall have the power of audit or, in the case of international organisations, the power of verification in accordance with agreements reached with them, on the basis of documents and on-the-spot, over all grant beneficiaries, contractors and subcontractors who have received Union funds under this Regulation.

2.  The European Anti-Fraud Office (OLAF) may carry out administrative investigations, including on-the-spot checks and inspections, in accordance with the provisions and procedures laid down in Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council and Council Regulation (Euratom, EC) No 2185/96, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with Union funding or budgetary guarantees under this Regulation.

3.  Competent authorities of third countries and international organisations may also be required to cooperate with the European Public Prosecutor's Office (EPPO), in accordance with Mutual Legal Assistance Agreements, when it carries out investigations into criminal offences falling within its competence in accordance with Regulation (EU) 2017/1939.

4.  Without prejudice to paragraphs 1 and 2, cooperation agreements with third countries and with international organisations, contracts, grant agreements and other legal commitments, as well as agreements establishing a budgetary guarantee, resulting from the implementation of this Regulation shall contain provisions expressly empowering the Commission, the Court of Auditors and OLAF to conduct such audits, on-the-spot checks and inspections, according to their respective competences. This shall include provisions to ensure that any third parties involved in the implementation of Union funds or of a financing operation supported, in whole or in part, by a budgetary guarantee grant equivalent rights.

Article 50

Exercise of the delegation

1.  The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.  The power to adopt delegated acts referred to in Article 45(2) shall be conferred on the Commission until 31 December 2028.

3.  The delegation of power referred to in Article 45(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4.  Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

5.  As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6.  A delegated act adopted pursuant to Article 45(2) shall enter into force if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

TITLE IV

TRANSITIONAL AND FINAL PROVISIONS

Article 51

Repeal

Regulation (EU) No 1291/2013 and Regulation (EU) No 1290/2013 are repealed with effect from 1 January 2021.

Article 52

Transitional provisions

1.  This Regulation shall not affect the continuation or modification of the actions concerned, under Regulation (EU) No 1291/2013 and Regulation (EU) No 1290/2013, which shall continue to apply to those actions until their closure. Work plans and actions provided for in work plans adopted under Regulation (EU) No 1290/2013 and under the corresponding funding bodies' basic acts shall also continue to be governed by Regulation (EU) No 1290/2013 and those basic acts until their completion.

2.  The financial envelope for the Programme may also cover technical and administrative assistance expenses necessary to ensure the transition between the Programme and the measures adopted under its predecessor Regulation (EU) No 1291/2013.

Article 53

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at ...

For the European Parliament For the Council

The President The President

ANNEX I

BROAD LINES OF ACTIVITIES

The general and specific objectives set out in Article 3 shall be pursued across the Programme, through the areas of intervention and the broad lines of activity described in this Annex, as well as in Annex I to the Specific Programme.

(1)  Pillar I 'Excellent Science'

Through the following activities, this pillar shall, in line with Article 4, promote scientific excellence, attract the best talent to Europe, provide appropriate support to early stage researchers and support the creation and diffusion of scientific excellence, high-quality knowledge, methodologies and skills, technologies and solutions to global social, environmental and economic challenges. It shall also contribute to the other Programme's specific objectives as described in Article 3.

(a)  European Research Council: Providing attractive and flexible funding to enable talented and creative individual researchers, with an emphasis on early stage researchers, and their teams to pursue the most promising avenues at the frontier of science, regardless of their nationality and country of origin and on the basis of Union-wide competition based solely on the criterion of excellence.

Area of intervention: Frontier science

(b)  Marie Skłodowska-Curie Actions: Equipping researchers with new knowledge and skills through mobility and exposure across borders, sectors and disciplines, enhancing training and career development systems as well as structuring and improving institutional and national recruitment, taking into account the European Charter for Researchers and Code of Conduct for the recruitment of researchers; in so doing, the Marie Skłodowska-Curie Actions help to lay the foundations of Europe's excellent research landscape across the whole of Europe, contributing to boosting jobs, growth, and investment, and solving current and future societal challenges.

Areas of intervention: Nurturing excellence through mobility of researchers across borders, sectors and disciplines; fostering new skills through excellent training of researchers; strengthening human resources and skills development across the European Research Area; improving and facilitating synergies; promoting public outreach.

(c)  Research Infrastructures: Endowing Europe with world-class sustainable research infrastructures which are open, and accessible to the best researchers from Europe and beyond. Encouraging the use of existing research infrastructures, including those financed from ESIF. In so doing the potential of the research infrastructure to support scientific advance and innovation, and to enable open and excellent science, following the FAIR principles, will be enhanced, alongside activities in related Union policy and international cooperation.

Areas of intervention: Consolidating and developing the landscape of European research infrastructures; Opening, integrating and interconnecting research infrastructures; The innovation potential of European research infrastructures and activities for innovation and training; Reinforcing European research infrastructure policy and international cooperation;

(2)  Pillar II 'Global Challenges and European Industrial Competitiveness'

Through the following activities, this pillar shall, in line with Article 4, support the creation and better diffusion of high-quality new knowledge, technologies and sustainable solutions, reinforce the competitiveness of European industry, strengthen the impact of research and innovation in developing, supporting and implementing Union policies, and support the uptake of innovative solutions in industry, notably in SMEs and start-ups, and society to address global challenges. It shall also contribute to the other Programme's specific objectives as described in Article 3.

SSH shall be fully integrated across all clusters, including specific and dedicated activities.

To maximise impact flexibility and synergies, research and innovation activities shall be organised in six clusters, interconnected through pan-European research infrastructures, which individually and together will incentivise interdisciplinary, cross-sectoral, cross-policy, cross-border and international cooperation. Activities from a broad range of TRLs, including lower TRLs will be covered in this pillar of Horizon Europe.

Each cluster contributes towards several SDGs; and many SDGs are supported by more than one cluster.

The R&I activities shall be implemented in and across the following clusters:

(a)  Cluster 'Health': Improving and protecting the health and well-being of citizens at all ages, by generating new knowledge, developing innovative solutions, and ensuring to integrate where relevant a gender perspective to prevent, diagnose, monitor, treat and cure diseases and developing health technologies; mitigating health risks, protecting populations and promoting good health and well-being, also in the work place; making public health systems more cost-effective, equitable and sustainable; preventing and tackling poverty-related diseases; and supporting and enabling patients' participation and self-management.

Areas of intervention: Health throughout the life course; Environmental and social health determinants; Non-communicable and rare diseases; Infectious diseases, including poverty-related and neglected diseases; Tools, technologies and digital solutions for health and care, including personalised medicine; Health care systems.

(b)  Cluster 'Culture, creativity and inclusive society': Strengthening ▌democratic values, including rule of law and fundamental rights, safeguarding our cultural heritage, exploring the potential of cultural and creative sectors, and promoting socio-economic transformations that contribute to inclusion and growth, ▌including migration management and integration of migrants.

Areas of intervention: Democracy and governance; Culture, cultural heritage and creativity; Social and economic transformations.▌

(c)   Cluster‘Civil Security for Society’: Responding to the challenges arising from persistent security threats, including cybercrime, as well as natural and man-made disasters.

Areas of intervention: Disaster-resilient societies; Protection and security; Cybersecurity.

d)   Cluster 'Digital, Industry and Space': Reinforcing capacities and securing Europe's sovereignty in key enabling technologies for digitisation and production, and in space technology, all along the value chain, to build a competitive, digital, low-carbon and circular industry; ensure a sustainable supply of raw materials; develop advanced materials and provide the basis for advances and innovation in ▌global societal challenges.

Areas of intervention: Manufacturing technologies; Key digital technologies, including quantum technologies; Emerging enabling technologies; Advanced materials; Artificial intelligence and robotics; Next generation internet; Advanced computing and Big Data; Circular industries; Low carbon and clean industries; Space, including earth observation.

(e)  Cluster 'Climate, Energy and Mobility': Fighting climate change by better understanding its causes, evolution, risks, impacts and opportunities, by making the energy and transport sectors more climate and environment-friendly, more efficient and competitive, smarter, safer and more resilient, promote the use of renewable energy sources and energy efficiency, improve resilience of the Union to external shocks and adapt social behaviour in view of the SDGs.

Areas of intervention: Climate science and Solutions; Energy Supply; Energy Systems and Grids; Buildings and Industrial Facilities in Energy Transition; Communities and Cities; Industrial Competitiveness in Transport; Clean, Safe and Accessible Transport and Mobility; Smart Mobility; Energy Storage.

(f)   Cluster 'Food, Bioeconomy, Natural Resources, Agriculture and Environment': Protecting the environment, restoring, sustainably managing and using natural and biological resources from land, inland waters and sea to stop biodiversity erosion, to address food and nutrition security for all and the transition to a low carbon, resource efficient and circular economy and sustainable bioeconomy.

Areas of intervention: Environmental observation; Biodiversity and natural resources; Agriculture, forestry and rural areas; Seas, oceans and inland waters; Food systems; Bio-based innovation systems in the EU bioeconomy; Circular systems.

(g)   Non-nuclear direct actions of the Joint Research Centre: Generating high-quality scientific evidence for efficient and affordable good public policies. New initiatives and proposals for EU legislation need transparent, comprehensive and balanced evidence to be sensibly designed, whereas implementation of policies needs evidence to be measured and monitored. The JRC will provide Union policies with independent scientific evidence and technical support throughout the policy cycle. The JRC will focus its research on EU policy priorities.

Areas of intervention: Health; Culture, creativity and inclusive society; civil security for society; digital, industry and space; climate, energy and mobility; food, bioeconomy, natural resources, agriculture and environment; support to the functioning of the internal market and the economic governance of the Union; support to Member States with implementation of legislation and development of smart specialisation strategies; analytical tools and methods for policy making; knowledge management; knowledge and technology transfer; support to science for policy platforms.

(3)  Pillar III 'Innovative Europe'

Through the following activities, this pillar shall, in line with Article 4, foster all forms of innovation, including non-technological innovation, primarily within SMEs including start-ups, by facilitating technological development, demonstration and knowledge transfer, and strengthen ▌deployment of innovative solutions. It shall also contribute to the Programme's other specific objectives as described in Article 3. The EIC will be implemented primarily through two intrumentsthe Pathfinder, implemented mainly through collaborative research, and the Accelerator.

(a)  European Innovation Council: focusing mainly on breakthrough and disruptive innovation, targeting especially market-creating innovation, while also supporting all types of innovation, including incremental.

Areas of intervention: Pathfinder for advanced research, supporting future and emerging breakthrough, market-creating and/or deep tech technologies; The Accelerator, bridging the financing gap between late stages of research and innovation activities and market take-up, to effectively deploy breakthrough, market-creating innovation and scale up companies where the market does not provide viable financing; ▌additional EIC activities such as prizes and fellowships, and business added-value services.

(b)  European innovation ecosystems

Areas of intervention: Activities will include in particular connecting, where relevant in cooperation with the EIT, with ▌national and regional innovation actors and supporting the implementation of joint cross-border innovation programmes by Member States, Regions and associated countries, from the exchange of practice and knowledge on innovation regulation to the enhancement of soft skills for innovation to research and innovation actions, including open or user-led innovation, to boost the effectiveness of the European innovation system. This should be implemented in synergy inter alia with the ERDF support for innovation eco-systems and interregional partnerships around smart specialisation topics.

(c)  The European Institute of Innovation and Technology

Areas of intervention: Sustainable innovation ecosystems across Europe; Innovation and entrepreneurial skills in a lifelong learning perspective, including increasing capacities of higher education institutions across Europe; New solutions to market to address global ▌challenges ▌; Synergies and value added within Horizon Europe.

(4)  Part 'Widening participation and strengthening the European Research Area'

Through the following activities, this pillar shall pursue the specific objectives as set out in ▌Art 3(2)(d). It shall also contribute to the ▌other Programme's specific objectives as described in Article 3. While underpinning the entire Programme, this part will support activities that contribute to attracting talent, fostering brain circulation and preventing brain drain, a more knowledge-based and innovative and gender-equal Europe, at the front edge of global competition, fostering transnational cooperation and thereby optimising national strengths and potential across the whole Europe in a well-performing European Research Area (ERA), where knowledge and a highly skilled workforce circulate freely in a balanced manner, where the outcomes of R&I are widely disseminated to as well as understood and trusted by informed citizens and benefit society as a whole, and where EU policy, notably R&I policy, is based on high quality scientific evidence.

It shall also support activities aimed at improving the quality of proposals from legal entities from low R&I performing Member States, such as professional pre-proposal checks and advice, and boosting the activities of National Contact Points to support international networking, as well as activities aimed at supporting legal entities from low R&I performing Member States joining already selected collaborative projects in which legal entities from such Member States are not participating.

Areas of intervention: Widening participation and spreading excellence, including through Teaming, Twinning, ERA-Chairs, COST, Excellence initiatives and activities to foster brain circulation; Reforming and enhancing the European R&I system, including through for example supporting national research and innovation policy reform, providing attractive career environments, and supporting gender and citizen science.

ANNEX Ia

EUROPEAN INSTITUTE OF INNOVATION AND TECHNOLOGY (EIT)

The following shall apply in the implementation of the programme activities of the EIT:

1.  Rationale

As the report of the High Level Group on maximising the impact of EU research and innovation (the Lamy High Level Group) clearly states, the way forward is 'to educate for the future and invest in people who will make the change'. In particular, European higher education institutions are called to stimulate entrepreneurship, tear down disciplinary borders and institutionalise strong inter-disciplinary academia-industry collaborations. According to recent surveys, access to talented people is by far the most important factor influencing the location choices of European founders of start-ups. Entrepreneurship education, training opportunities and the development of creative skills play a key role in cultivating future innovators and in developing the abilities of existing ones to grow their business to greater levels of success. Access to entrepreneurial talent, together with access to professional services, capital and markets on the EU level, and bringing key innovation actors together around a common goal are key ingredients for nurturing an innovation ecosystem. There is a need to coordinate efforts across the EU.in order to create a critical mass of interconnected EU-wide entrepreneurial clusters and ecosystems.

The EIT is today’s Europe’s largest integrated innovation ecosystem which brings together partners from business, research, education and beyond. The EIT will continue to support its Knowledge and Innovation Communities (KICs), which are large-scale European partnerships addressing specific global challenges, and strengthen the innovation ecosystems around them. It will do so by fostering the integration of education, research and innovation of the highest standards, thereby creating environments conducive to innovation, and by promoting and supporting a new generation of entrepreneurs and stimulating the creation of innovative companies in close synergy and complementarity with the EIC.

Throughout Europe, efforts are still needed to develop ecosystems where researchers, innovators, industries and governments can easily interact. Innovation ecosystems, in fact, still do not work optimally due to a number of ▌ reasons such as:

–  Interaction among innovation players is still hampered by organizational, regulatory and cultural barriers between them;

–  Efforts to strengthen innovation ecosystems shall benefit from coordination and a clear focus on specific objectives and impact.

To address future societal challenges, embrace the opportunities of new technologies and contribute to environmentally friendly and sustainable economic growth, jobs, competitiveness and the well-being of Europe’s citizens, there is the need to further strengthen Europe’s capacity to innovate by: strenghtening existing and fostering the creation of new environments conducive to collaboration and innovation; strengthening the innovation capabilities of academia and the research sector; supporting a new generation of entrepreneurial people; stimulating the creation and the development of innovative ventures, as well as strengthening the visibility and recognition of EU funded research and innovation activities, in particular the EIT funding to the wider public.

The nature and scale of the innovation challenges require liaising and mobilising players and resources at European scale, by fostering cross-border collaboration. There is a need to break down silos between disciplines and along value chains and nurture the establishment of a favorable environment for an effective exchange of knowledge and expertise, and for the development and attraction of entrepreneurial talents. The Strategic Innovation Agenda of the EIT shall ensure coherence with the challenges of Horizon Europe, as well as complimentarity to the EIC.

2.  Areas of Intervention

2.1.  Sustainable innovation ecosystems across Europe

In accordance with the EIT regulation and the EIT Strategic Innovation Agenda, the EIT will play a reinforced role in strengthening sustainable challenges-based innovation ecosystems throughout Europe. In particular, the EIT will continue to operate primarily through its Knowledge and Innovation Communities (KICs), the large-scale European partnerships that address specific societal challenges. It will continue to strengthen innovation ecosystems around them, by opening them up and by fostering the integration of research, innovation and education. Furthermore, EIT will strenghten innovation ecosystems throughout Europe by expanding its Regional Innovation Scheme (EIT RIS). The EIT will work with innovation ecosystems that exhibit high innovation potential based on strategy, thematic alignment and envisaged impact, in close synergy with Smart Specialisation Strategies and Platforms.

–  Reinforcing the effectiveness and the openness to new partners of the existing KICs enabling the transition to self-sustainability in the long-term, and analyzing the need of setting up new ones to tackle global challenges. The specific thematic areas will be defined in the Strategic Innovation Agenda, taking into account the Strategic Planning;

–  Accelerating regions towards excellence in countries that are that are defined in the Strategic Innovation Agenda in close cooperation with structural funds and other relevant EU funding programmes where appropriate.

2.2.  Innovation and entrepreneurial skills in a lifelong learning perspective, including increasing capacities of higher education institutions across Europe

The EIT education activities will be reinforced to foster innovation and entrepreneurship through purposeful education and training. A stronger focus on human capital development will be grounded on the expansion of existing EIT KICs education programmes in the view of continuing to offer students and professionals high quality curricula based on innovation, creativity and entrepreneurship in line in particular with the EU industrial and skills strategy. This may include researchers and innovators supported by other parts of Horizon Europe, in particular MSCA. The EIT will also support the modernisation of higher education institutions across Europe and their integration in innovation ecosystems by stimulating and increasing their entrepreneurial potential and capabilities and encouraging them to better anticipate new skills requirements.

–  Development of innovative curricula, taking into account the future needs of society and industry, and cross-cutting programmes to be offered to students, entrepreneurs and professionals across Europe and beyond where specialist and sector specific knowledge is combined with ▌innovation-oriented and entrepreneurial skills, such as ▌high-tech skills related to digital and sustainable key enabling technologies;

–  Strengthening and expanding the EIT label in order to improve the visibility and the recognition of EIT of education programmes based on partnerships between different higher education institutions, research centres and companies while enhancing its overall quality by offering learning-by-doing curricula and purposeful entrepreneurship education as well as international, inter-organisational and cross-sectorial mobility;

–  Development of innovation and entrepreneurship capabilities of the higher education sector, by leveraging and promoting the EIT Community expertise in linking education, research and business;

–  Reinforcing the role of the EIT Alumni community as role model for new students and strong instrument to communicate EIT impact.

2.3.  New solutions to the market to address global challanges

The EIT will facilitate, empower and award entrepreneurs, innovators, researchers, educators, students and other innovation actors, while ensuring gender mainstreaming, to work together in cross-disciplinary teams to generate ideas and transform them into both incremental and disruptive innovations. Activities will be characterised by an open innovation and cross-border approach, with a focus on including relevant Knowledge Triangle activities that are pertinent to making them a success (e.g. project’s promoters can improve their access to: specifically qualified graduates, lead users, start-ups with innovative ideas, non-domestic firms with relevant complementary assets etc.).

–  Support the development of new products, services and markets opportunities where Knowledge Triangle actors will collaborate to bring solutions to global challenges;

—   Fully integrate the entire innovation value chain: from student to entrepreneur, from idea to product, from lab to customer. This include support for start-ups and scaling-up businesses.

–  Provision of high-level services and support to innovative businesses, including technical assistance to fine-tuning of products or services, substantive mentoring, support to secure target customers and raise capital, in order to swiftly reach the market and speed up their growth process.

2.4.  Synergies and value added within Horizon Europe

The EIT will step up its efforts to capitalise on synergies and complementarities between existing KICs and with different actors and initiatives at EU and global levels and extend its network of collaborating organisations at both strategic and operational levels, while avoiding duplications.

–  Close cooperation with the EIC and InvestEU in streamlining the support (i.e. funding and services) offered to ▌innovative ventures in both start-up and scale-up stages, in particular through KICs;

–  Planning and implementation of EIT activities in order to maximise synergies and complementarities with other parts of the Programme;

–  Engage with EU Member States, at both national and regional level, establishing a structured dialogue and coordinating efforts to enable synergies withnational and regional initiatives, including smart specialisation strategies, also considering through the implementation of the “European Innovation Ecosystems”, in order to identify, share and disseminate best practices and learnings;

–  Share and disseminate innovative practices and learnings throughout Europe and beyond, so as to contribute to innovation policy in Europe in coordination with other parts of Horizon Europe;

–  Provision of input to innovation policy discussions and contribution to the design and implementation of EU policy priorities by continuously working with all relevant European Commission services, other EU programmes and their stakeholders, and further exploring opportunities within policy implementing initiatives;

–  Exploitation of synergies with other EU programmes, including those supporting human capital development and innovation (e.g. COST, ESF+, ERDF, Erasmus +, Creative Europe and COSME Plus/Single Market, InvestEU);

–  Building strategic alliances with key innovation actors at EU and international level, and support to KICs to develop collaboration and linkages with key Knowledge Triangle partners from third countries, with the aim of opening new markets for KICs’-backed solutions and attract financing and talents from abroad. Participation of third countries shall be promoted with regard to the principles of reciprocity and mutual benefits.

ANNEX III

PARTNERSHIPS

European Partnerships shall be selected and implemented, monitored, evaluated, phased-out or renewed on the basis of the following criteria

1)  Selection

(a)  Demonstrating that the European Partnership is more effective in achieving the related objectives of the Programme through involvement and commitment of partners, in particular in delivering clear impacts for the EU and its citizens, notably in view of delivering on global challenges and research and innovation objectives, securing EU competitiveness, sustainability and contributing to the strengthening of the European Research and Innovation Area and, where relevant, international commitments;

In the case of institutionalised European Partnerships established in accordance with Article 185 TFEU, the participation of at least 40% of the EU Member States is mandatory;

(b)  Coherence and synergies of the European Partnership within the EU research and innovation landscape, following the Horizon Europe rules to the largest extent possible;

(c)  Transparency and openness of the European Partnership as regards the identification of priorities and objectives in terms of expected results and impacts and as regards the involvement of partners and stakeholders from across the entire value chain, from different sectors, backgrounds and disciplines, including international ones when relevant and not interfering with European competitiveness; clear modalities for promoting participation of SMEs and for desseminating and exploiting results, notably by SMEs, including through intermediary organisations;

(d)  Ex-ante demonstration of additionality and directionality of the European Partnership, including a common strategic vision of the purpose of the European Partnership. This vision will include in particular:

–  identification of measurable expected deliverables, outcomes, and impacts within specific timeframes, including key economic and/or societal value for the Union.

–  demonstration of ▌expected qualitative and significant quantitative leverage effects, including a method for the measurement of key performance indicators;

–  approaches to ensure flexibility of implementation and to adjust to changing policy, societal and/or market needs, or scientific advances, to increase policy coherence between regional, national and EU level;

–  exit-strategy and measures for phasing-out from the Programme.

(e)  Ex-ante demonstration of the partners’ long term commitment, including a minimum share of public and/or private investments;

In the case of institutionalised European Partnerships, established in accordance with article 185 or 187 TFEU, the financial and/or in-kind, contributions from partners other than the Union, will at least be equal to 50% and may reach up to 75% of the aggregated European Partnership budgetary commitments. For each such institutionalised European Partnership, a share of the contributions from partners other than the Union will be in the form of financial contributions. For partners other than the Union and Participating States, financial contributions should be aimed primarily at covering administrative costs as well as coordination and support and other non-competitive activities.

(ea)  In agreement with regional authorities, ERDF shall be accepted as a partial national contribution for Programme co-funding of actions involving Member States.

2)  Implementation:

(a)  Systemic approach ensuring active and early involvement of Member States and achievement of the expected impacts of the European Partnership through the flexible implementation of joint actions of high European added value also going beyond joint calls for research and innovation activities, including those related to market, regulatory or policy uptake;

(b)  Appropriate measures ensuring continuous openness of the initiative and transparency during implementation, notably for priority setting and for participation in calls for proposals, information on the functioning of the governance, visibility of the Union, communication and outreach measures, dissemination and exploitation of results, including clear open access/user strategy along the value chain; appropriate measures for informing SMEs and promoting their participation;

(c)  Coordination and/or joint activities with other relevant research and innovation initiatives to secure optimum level of interconnections and ensure effective synergies, inter alia to overcome potential implementation barriers at national level and increase cost-effectiveness;

(d)  ▌Commitments, ▌for financial and/or in-kind contributions, from each partner in accordance with national provisions throughout the lifetime of the initiative;

(e)  In the case of institutionalised European Partnership access to the results and other action related information for the Commission for the purpose of developing, implementing and monitoring of Union policies or programmes.

3)  Monitoring:

(a)  A monitoring system in line with the requirements set out in Article 45 to track progress towards specific policy ▌objectives, deliverables and key performance indicators allowing for an assessment over time of achievements, impacts and potential needs for corrective measures;

(b)  Periodic dedicated reporting on quantitative and qualitative leverage effects, including on committed and actually provided financial and in-kind contributions, visibility and positioning in the international context, impact on research and innovation related risks of private sector investments;

(c)  Detailed information on the evaluation process and results from all calls for proposals within partnerships, to be made available timely and accessible in a common e-database.

4)  Evaluation, phasing-out and renewal:

(a)  Evaluation of impacts achieved at Union and national level in relation to defined targets and key performance indicators, feeding into the Programme evaluation set out in Article 47, including an assessment of the most effective policy intervention mode for any future action; and the positioning of any possible renewal of a European Partnership in the overall European Partnerships landscape and its policy priorities;

(b)  In the absence of renewal, appropriate measures ensuring phasing-out of Framework Programme funding according to the ▌conditions and timeline agreed with the legally committed partners ex-ante, without prejudice to possible continued transnational funding by national or other Union programmes, and without prejudice to private investment and on-going projects.

ANNEX IV

SYNERGIES WITH OTHER PROGRAMMES

1.  Synergies with the European Agricultural Guarantee Fund and the European Agricultural Fund for Rural Development (Common Agricultural Policy-CAP) will ensure that:

(a)  research and innovation needs of the agricultural sector and rural areas within the EU are identified notably within the European Innovation Partnership "agricultural productivity and sustainability"(35) and taken into consideration in the Programme's strategic research and innovation planning process and the work programmes;

(b)  the CAP makes the best use of research and innovation results and promotes the use, implementation and deployment of innovative solutions, including those stemming from projects funded by the Framework Programmes for research and innovation and from the European Innovation Partnership "agricultural productivity and sustainability" and relevant EIT Knowledge and Innovation Communities (KICs);

(c)  the EAFRD supports the uptake and dissemination of knowledge and solutions stemming from the Programme's results leading to a more dynamic farming sector and new openings for the development of rural areas.

2.  Synergies with the European Maritime and Fisheries Fund (EMFF) will ensure that:

(a)  the Programme and the EMFF are largely interlinked as EU research and innovation needs in the field of marine and maritime policy will be translated through the Programme's strategic research and innovation planning process;

(b)  the EMFF supports the rolling out of novel technologies and innovative products, processes and services, in particular those resulting from the Programme in the fields of marine and maritime policy; the EMFF also promotes ground data collection and data processing and disseminates relevant actions supported under the Programme, which in turn contributes to the implementation of the Common Fisheries Policy, the EU Maritime Policy, International Ocean Governance and International commitments.

3.  Synergies with the European Regional Development Fund (ERDF) will ensure that:

(a)  arrangements for combined funding from ERDF and Horizon Europe are used to support activities providing a bridge between regional Operational Programmes, smart specialisations strategies and international excellence in research and innovation, including joint trans-regional/trans-national programmes and pan European Research Infrastructures, with the aim of strengthening the European Research Area;

(aa)  ERDF funds can be transferred on a voluntary basis to support activities under the Programme, in particular the Seal of excellence;

(b)  the ERDF focuses amongst others on the development and strengthening of regional and local research and innovation ecosystems and industrial transformation, including support to the take-up of results and the rolling out of novel technologies and innovative solutions from the Framework Programmes for research and innovation through the ERDF;

(ba)  existing regional ecosystems, platform networks and regional strategies are enhanced.

4.  Synergies with the European Social Fund Plus (ESF+) will ensure that:

(a)  the ESF+ can mainstream and scale up innovative curricula supported by the Programme, through national or regional programmes, in order to equip people with the skills and competences needed for the jobs of the future;

(b)  arrangements for complementary funding from ESF+ can be used on a voluntary basis to support activities of the Programme that promote human capital development in research and innovation with the aim of strengthening the European Research Area; [Am. 148]

(c)  the Health strand of the European Social Fund+ mainstreams innovative technologies and new business models and solutions, in particular those resulting from the Programmes, so to contribute to innovative, efficient and sustainable health systems of the Member States and facilitate access to better and safer healthcare for European citizens.

5.  Synergies with the Connecting Europe Facility (CEF) will ensure that:

(a)  research and innovation needs in the areas of transport, energy and in the digital sector within the EU are identified and established during the Programme's strategic research and innovation planning process;

(b)  the CEF supports the large-scale roll-out and deployment of innovative new technologies and solutions in the fields of transport, energy and digital physical infrastructures, in particular those resulting from the Framework Programmes for research and innovation;

(c)  the exchange of information and data between the Framework Programme and CEF projects will be facilitated, for example by highlighting technologies from the Framework Programme with a high market readiness that could be further deployed through the CEF.

6.  Synergies with the Digital Europe Programme (DEP) will ensure that:

(a)  whereas several thematic areas addressed by the Programme and DEP converge, the type of actions to be supported, their expected outputs and their intervention logic are different and complementary;

(b)  research and innovation needs related to digital aspects are identified and established in the Programme's strategic research and innovation plans; this includes research and innovation for High Performance Computing, Artificial Intelligence, Cybersecurity, Distributed Ledger Technologies, Quantum Technologies combining digital with other enabling technologies and non-technological innovations; support for the scale-up of companies introducing breakthrough innovations (many of which will combine digital and physical technologies; the integration of digital across all the pillar 'Global Challenges and European Industrial Competitiveness'; and the support to digital research infrastructures;

(c)  DEP focuses on large-scale digital capacity and infrastructure building in High Performance Computing, Artificial Intelligence, Cybersecurity, Distributed Ledger Technologies, Quantum Technologies and advanced digital skills aiming at wide uptake and deployment across Europe of critical existing or tested innovative digital solutions within an EU framework in areas of public interest (such as health, public administration, justice and education) or market failure (such as the digitisation of businesses, notably small and medium enterprises); DEP is mainly implemented through coordinated and strategic investments with Member States, notably through joint public procurement, in digital capacities to be shared across Europe and in EU-wide actions that support interoperability and standardisation as part of developing a Digital Single Market;

(d)  DEP capacities and infrastructures are made available to the research and innovation community, including for activities supported through the Programme including testing, experimentation and demonstration across all sectors and disciplines;

(e)  novel digital technologies developed through the Programme, are progressively be taken up and deployed by DEP;

(f)  the Programme's initiatives for the development of skills and competencies curricula, including those delivered at the co-location centres of the European Institute of Innovation and Technology Knowledge and Innovation Communities, are complemented by Digital Europe-supported capacity-building in advanced digital skills;

(g)  strong coordination mechanisms for strategic programming and operating procedures for both programmes are aligned, and their governance structures involve the respective Commission services as well as others concerned by the different parts of the respective programmes.

7.  Synergies with the Single Market Programme will ensure that:

(a)  the Single Market Programme addresses the market failures which affect all SMEs, and will promote entrepreneurship and the creation and growth of companies. Full complementarity exists between the Single Market Programme and the actions of both the EIT and the future European Innovation Council for innovative companies, as well as in the area of support services for SMEs, in particular where the market does not provide viable financing;

(b)  the Enterprise Europe Network may serve, as other existing SME support structures (e.g. National Contact Points, Innovation Agencies, DIH, Competence Centres, certified incubators), to deliver support services under the Horizon Europe programme, including the European Innovation Council.

8.  Synergies with the LIFE - Programme for Environment and Climate Action (LIFE) will ensure that:

Research and innovation needs to tackle environmental, climate and energy challenges within the EU are identified and established during the Programme’s strategic research and innovation planning process. LIFE will continue to act as a catalyst for implementing EU environment, climate and relevant energy policy and legislation, including by taking up and applying research and innovation results from the Programme and help deploying them at national and (inter-)regional scale where it can help address environmental, climate or clean energy transition issues. In particular LIFE will continue to incentivise synergies with the Programme through the award of a bonus during the evaluation for proposals which feature the uptake of results from the Programme. LIFE standard action projects will support the development, testing or demonstration of suitable technologies or methodologies for implementation of EU environment and climate policy, which can subsequently be deployed at large scale, funded by other sources, including by the Programme. The Programme’s EIT as well as the future European Innovation Council can provide support to scale up and commercialise new breakthrough ideas that may result from the implementation of LIFE projects.

9.  Synergies with the Erasmus Programme will ensure that:

(a)  combined resources from the Programme and the Erasmus Programme are used to support activities dedicated to strengthening and modernising European higher education institutions. The Programme will complement Erasmus programme support for the European Universities initiative, in particular its research dimension as part of developing new joint and integrated long term and sustainable strategies on education, research and innovation based on trans-disciplinary and cross-sectoral approaches to make the knowledge triangle a reality, providing impetus to economic growth; the EIT’s educational activities could be both inspirational to and interlinked with the European Universities initiative.

(b)  the Programme and the Erasmus Programme foster the integration of education and research through facilitating higher education institutions to formulate and set up common education, research and innovation strategies, to inform teaching with the latest findings and practices of research to offer active research experience to all students and higher education staff and in particular researchers, and to support other activities that integrate higher education, research and innovation.

10.  Synergies with the European Space Programme will ensure that:

(a)  research and innovation needs of the space upstream and downstream sector within the EU are identified and established as part of the Programme's strategic research and innovation planning process; space research actions implemented through Horizon Europe will be implemented with regard to procurement and eligibility of entities in line with the provisions of the Space Programme, where appropriate;

(b)  space data and services made available as a public good by the European Space Programme are used to develop breakthrough solutions through research and innovation, including in the Framework Programme, in particular for sustainable food and natural resources, climate monitoring, smart cities, automated vehicles, security and disaster management;

(c)  the Copernicus Data and Information Access Services contribute to the European Open Science Cloud and thus facilitate access to Copernicus data for researchers and scientists; research infrastructures, in particular in situ observing networks will constitute essential elements of the in situ observation infrastructure enabling the Copernicus services, and in turn, they benefit from information produced by Copernicus services.

11.  Synergies with the Neighbourhood, Development and International Cooperation Instrument (the 'External Instrument') will ensure that the Programme's research and innovation activities with the participation of Third Countries and targeted international cooperation actions seek alignment and coherence with parallel market uptake and capacity-building actions strands under the External Instrument, based on joint definition of needs and areas of intervention commonly defined during the Programme's strategic research and innovation planning process.

12.  Synergies with the Internal Security Fund and the instrument for border management as part of the Integrated Border Management Fund will ensure that:

(a)  the research and innovation needs in the areas of security and integrated border management are identified and established during the Programme's strategic research and innovation planning process;

(b)  the Internal Security Fund and the Integrated Border Management Fund support the deployment of innovative new technologies and solutions, in particular those resulting from the Framework Programmes for research and innovation in the field of security research.

13.  Synergies with the InvestEU Fund will ensure that:

(a)  the Programme provide out of its own budget Horizon Europe and EIC blended finance for innovators, characterised by a high level of risk and for which the market does not provide when relevant viable and sustainable financing, and at the same time will provide for appropriate coordination in support of the effective delivery and management of the private finance part of the blended finance through funds and intermediaries supported by InvestEU;

(b)  financial instruments for research and innovation and SMEs are grouped together under the InvestEU Fund, in particular through a dedicated R&I thematic window, and through products deployed under the SME window targeting innovative companies, in this way also helping to deliver the objectives of the Programme. Strong complementary links will be established between InvestEU and Horizon Europe.

14.  Synergies with the Innovation Fund under the Emission Trading Scheme (the 'Innovation Fund') will ensure that:

(a)  the Innovation Fund will specifically target innovation in low-carbon technologies and processes, including environmentally safe carbon capture and utilisation that contributes substantially to mitigate climate change, as well as products substituting carbon intensive ones, and to help stimulate the construction and operation of projects that aim at the environmentally safe capture and geological storage of CO2 as well as innovative renewable energy and energy storage technologies; An appropriate framework will be created to enable and to incentivise “greener” products with a sustainable added value for the customers/end-users.

(b)  the Programme will fund the development and, demonstration and implementation of technologies, including breakthrough solutions, that can deliver on EU a low-carbon economy and the Union’s decarbonisation, energy and industrial transformation objectives, especially in its Pillar 2 and through the EIT;

(c)  the Innovation Fund may, subject to fulfilment of its selection and award criteria, support the demonstration phase of eligible projects that may have received the. Projects receiving support from the Innovation Fund may be eligible for support from the Framework Programmes for research and innovation and vice versa. To complement Horizon Europe, the Innovation Fund may concentrate on close-to-the-market innovations contributing to a significant and fast reduction of CO2 emissions. Strong complementary links will be established between the Innovation Fund and Horizon Europe.

15.  Synergies with the Euratom Research and Training Programme will ensure that:

(a)  the Programme and the Euratom Research and Training Programme develop comprehensive actions supporting education and training (including Marie Skłodowska-Curie Actions) with the aim of maintaining and developing relevant skills in Europe;

(b)  the Programme and the Euratom Research and Training Programme develop joint research actions focussing on cross-cutting aspects of the safe and secure use of non-power applications of ionising radiation in sectors such as medicine, industry, agriculture, space, climate change, security and emergency preparedness and contribution of nuclear science.

16.  Potential synergies with the European Defence Fund will contribute to avoiding duplication.

16a.  Synergies with Creative Europe will support competitiveness and innovation, contributing to economic and social growth and promoting the effective use of public funds.

16b.  Synergies with any Important Projects of Common European Interest (IPCEI) may be envisaged.

ANNEX V

KEY IMPACT PATHWAY INDICATORS

Impact pathways, and related key impact pathway indicators, shall structure the monitoring of the Framework Programme’s (FP) progress towards its objectives as referred to in Article 3. The impact pathways are time-sensitive and reflect three complementary impact categories reflecting the non-linear nature of R&I investments: scientific, societal and technological/economic. For each of these impact categories, proxy indicators will be used to track progress distinguishing between the short, medium and longer terms, including beyond the Programme duration, with possibilities for breakdowns, including by Member States and associated countries. These indicators shall be compiled using quantitative and qualitative methodologies. Individual Programme parts will contribute to these indicators to a different degree and through different mechanisms. Additional indicators may be used to monitor individual programme parts, where relevant.

The micro-data behind the key impact pathway indicators will be collected for all parts of the Programme and all delivery mechanisms in a centrally managed and harmonised way and at the appropriate level of granularity with minimal reporting burden on the beneficiaries.

In addition and beyond key impact pathways indicators, data on the optimised delivery of the Programme for strenghtening the European Research Area, fostering the excellence-based participations from all Member States in the Programme as well as facilitating collaborative links in European research and innovation will be collected and reported in close to real-time as part of implementation and management data, referred to in Article 45. This will include, inter alia, the monitoring of collaborative links, network analytics, data on proposals, applications, participations and projects; applicants and participants (including the type of organization (such as Civil Society Organisations, SMEs and private sector), country (such as a specific classification for country groups such as Member States, associated countries and third countries), gender, role in project, scientific discipline/sector, including SSH); and the level of climate mainstreaming and related expenditures.

Scientific impact pathway indicators

The Programme is expected to have scientific impact by creating high-quality new knowledge, strengthening human capital in research and innovation, and fostering diffusion of knowledge and Open Science. Progress towards this impact will be monitored through proxy indicators set along the following three key impact pathways.

Societal impact pathway indicators

The Programme is expected to have societal impact by addressing the EU policy priorities and global challenges, including UN SDGs, following the principles of the Agenda 2030 and the goals of the Paris Agreement, through R&I, delivering benefits and impact through R&I missions and European Partnerships and strengthening the uptake of innovation in society ultimately contributing to people’s well-being. Progress towards this impact will be monitored through proxy indicators set along the following three key impact pathways.

Technological/Economic ▌ impact pathway indicators

The Programme is expected to have technological/economic ▌impact especially within the Union by influencing the creation and growth of companies, especially SMEs including start-ups, creating direct and indirect jobs especially within the Union, and by leveraging investments for research and innovation. Progress towards this impact will be monitored through proxy indicators set along the following three key impact pathways.

Annex V – table 1

Towards scientific

impact

Short-term

Medium-term

Longer-term

Creating high-quality new knowledge

Publications -

Number of FP peer reviewed scientific publications

Citations -

Field-Weighted Citation Index of FP peer reviewed

publications

World-class science -

Number and share of peer reviewed publications from

FP projects that are core contribution to scientific fields

Strengthening human capital in R&I

Skills -

Number of researchers involved in upskilling (training, mentoring/coaching, mobility and access to R&I infrastructures) activities in FP projects

Careers -

Number and share of

upskilled FP researchers with increased individual impact in their R&I field

Working conditions -

Number and share of upskilled FP researchers with improved working conditions, including researchers' salaries

Fostering diffusion of knowledge and Open Science

Shared knowledge -

Share of FP research outputs (open data/publication/ software etc.) shared through open

knowledge infrastructures

Knowledge diffusion -

Share of open access FP research outputs actively used/cited

New collaborations -

Share of FP beneficiaries having developed new transdisciplinary/ transsectoral collaborations with users of their open FP R&I outputs

Annex V – table 2

Towards societal

impact

Short-term

Medium-term

Longer-term

Addressing EU policy priorities and global challenges through R&I

Outputs -

Number and share of outputs aimed at addressing identified EU policy priorities and global challenges (including SDGs)

(multidimensional: for each identified priority)

Including: Number and share of climate-relevant outputs aimed at delivering on the EU's commitments under the Paris Agreement

Solutions -

Number and share of innovations and research results addressing identified EU policy priorities and global challenges (including SDGs)

(multidimensional: for each identified priority)

Including: Number and share of climate-relevant innovations and research results delivering on EU's commitments under the Paris Agreement

Benefits -

Aggregated estimated effects from use/exploitation of FP-funded results, on tackling identified EU policy priorities and global challenges (including SDGs), including contribution to the policy and law-making cycle (such as norms and standards) (multidimensional: for each identified priority)

Including: Aggregated estimated effects from use /exploitation of FP-funded climate-relevant results on delivering on the EU's commitments under the Paris Agreement including contribution to the policy and law-making cycle (such as norms and standards)

Delivering benefits and impact through R&I missions

R&I mission outputs -

Outputs in specific R&I

Missions

(multidimensional: for each identified mission)

R&I mission results -

Results in specific R&I

Missions

(multidimensional: for each identified mission)

R&I mission targets met -

Targets achieved in specific R&I missions

(multidimensional: for each identified mission)

Strengthening the uptake of research and innovation in society

Co-creation -

Number and share of FP projects where EU citizens and end-users contribute to the co-creation of R&I content

Engagement -

Number and share of FP beneficiary entities with

citizen and end-users engagement mechanisms after FP project

Societal R&I uptake -

Uptake and outreach of FP co-created scientific results and innovative solutions

Annex V – table 3

Towards technological / economic impact

Short-term

Medium-term

Longer-term

Generating innovation-based growth

Innovative outputs -

Number of innovative products, processes or methods from FP (by type of innovation) & Intellectual Property Rights (IPR) applications

Innovations -

Number of innovations from FP projects (by type of innovation) including from awarded IPRs

Economic growth -

Creation, growth & market shares of companies having developed FP innovations

Creating more and better jobs

Supported employment -

Number of FTE jobs created, and jobs maintained in beneficiary entities for the FP project (by type of job)

Sustained employment -

Increase of FTE jobs in beneficiary entities following FP project (by type of job)

Total employment

Number of direct & indirect jobs created or maintained due to diffusion of FP results (by type of job)

Leveraging investments in R&I

Co-investment -

Amount of public & private investment mobilised with the initial FP investment

Scaling-up -

Amount of public & private investment mobilised to exploit or scale-up FP results (including foreign direct investments)

Contribution to ‘3% target’ -

EU progress towards 3% GDP target due to FP

ANNEX Va

Areas for possible missions and areas for possible institutionalised European Partnerships to be established under Article 185 or 187 TFEU

In accordance with Article 7 and 8 of this Regulation, the areas for possible Missions and possible European Partnerships to be established under Articles 185 or 187 TFEU are set out in this Annex.

I.  Areas for possible Missions

Missions Area 1: Adaptation to Climate Change, including Societal Transformation

Mission Area 2: Cancer

Mission Area 3: Healthy Oceans, Seas, Coastal and Inland Waters

Mission Area 4: Climate-Neutral and Smart Cities

Mission Area 5: Soil Health and Food

Each mission will follow the principles set out in Article 7 paragraph 3 of this Regulation.

II.  Areas for possible institutionalised European Partnerships on the basis of Article 185 TFEU or Article 187 TFEU

Partnership Area 1: Faster development and safer use of health innovations for European patients, and global health.

Partnership Area 2: Advancing key digital and enabling technologies and their use, including but not limited to novel technologies such as Artificial Intelligence, photonics and quantum technologies.

Partnership Area 3: European leadership in Metrology including an integrated Metrology system.

Partnership Area 4: Accelerate competitiveness, safety and environmental performance of EU air traffic, aviation and rail.

Partnership Area 5: Sustainable, inclusive and circular bio-based solutions.

Partnership Area 6: Hydrogen and sustainable energy storage technologies with lower environmental footprint and less energy-intensive production.

Partnership Area 7: Clean, connected, cooperative, autonomous and automated solutions for future mobility demands of people and goods.

Partnership Area 8: Innovative and R&D intensive small and medium-sized enterprises.

The process of assessing the need for an institutionalised European partnership in one of the abovementioned Partnership Areas may result in a proposal on the basis of Article 185 TFEU or Article 187 TFEU, in accordance with the European Commission's right of initiative. Otherwise the respective Partnership Area can also be subject to a partnership following Article 8(1)(a) or Article 8(1)(b) of the Framework Programme or be implemented by calls for proposals within Horizon Europe.

As the possible areas for institutionalised European partnerships cover broad thematic fields, they can, based on the assessed needs, be implemented by more than one partnership.

(1) This position replaces the amendments adopted on 12 December 2018 (Texts adopted, P8_TA(2018)0509).
(2)OJ C […], […], p. […].
(3)OJ C […], […], p. […].
(4)Position of the European Parliament of 17 April 2019. The text highlighted in grey has not been agreed in the framework of interinstitutional negotiations.
(5) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).
(6)
(7) The following Commission declaration is expected to be published in the OJ C series once the final text of the Regulation is adopted:“The implementation of the EIC Accelerator shall comply with the terms established in article 43.1 and recital [X] of the Horizon Europe Regulation”.
(8) Regulation (EC) No 294/2008 of the European Parliament and of the Council of 11 March 2008 (OJ L 97, 9.4.2008, p. 1), as amended by Regulation (EU) No 1292/2013 of the European Parliament and of the Council of 11 December 2013 (OJ L 347, 20.12.2013, p. 174).
(9) Regulation (EU) of the European Parliament and of the Council.
(10)
(11)OJ C 373, 20.12.2013, p. 1.
(12) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
(13)Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999,(OJ L 248, 18.9.2013, p. 1.
(14)Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1).
(15)Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2).
(16)Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor’s Office (‘the EPPO’) (OJ L 283, 31.10.2017, p. 1).
(17)Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union's financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29).
(18)Council Decision 2013/755/EU of 25 November 2013 on the association of the overseas countries and territories with the European Union (Overseas Association Decision) (OJ L 344, 19.12.2013, p. 1).
(19)OJ C 205, 19.7.2013, p. 9.
(20) Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53).
(21) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
(22)
(23) Regulation (EU) No 1303/2013 of the European Parliament and of the Council of 17 December 2013 laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund and repealing Council Regulation (EC) No 1083/2006.
(24)OJ…
(25) The following Commission declaration is expected to be published in the OJ C series once the final text of this Regulation is adopted:“The Commission takes note of the compromise reached by the co-legislators on the wording of Article 5. In the Commission’s understanding the specific programme on defence research mentioned in Article 1(3)(b) is limited only to the research actions under the future European Defence Fund while the development actions are considered outside the scope of this Regulation”.
(26) A Commission declaration is expected to be published in the OJ C series once the final text of the Regulation is adopted, along these lines: "Upon request, the Commission intends to exchange views with the responsible Committee in the European Parliament on:(i) the list of potential partnerships candidates based on the Articles 185 and 187 TFEU which will be covered by (inception) impact assessments; (ii) the list of tentative missions identified by the Mission boards; (iii)the results of the Strategic Plan before its formal adoption, and (iv) it will present and share documents related to work programmes."
(27) Research relating to cancer treatment of the gonads can be financed
(28) Subject to the final legal act, the Commission will issue a statement on human embryonic stem cell research as in H2020 (Declaration 2013 / C 373/02).
(29) Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC. (OJ L 94, 28.03.2014, p. 65).
(30) Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (OJ L 94, 28.03.2014, p. 243).
(31) Directive 2009/81/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of procedures for the award of certain works contracts, supply contracts and service contracts by contracting authorities or entities in the fields of defence and security, and amending Directives 2004/17/EC and 2004/18/EC (OJ L 216, 20.08.2009, p. 76).
(32) The procedure will be explained in a document published before the start of the evaluation process.
(33) Provisions for the monitoring of the European Partnerships are set out in the Annex III of the Regulation.
(34) Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audits of annual accounts and consolidated accounts, amending Council Directive 78/660/EEC and 83/349/EEC and repealing Council Directive 84/253/EEC (OJ L 157, 9.6.2006, p. 87)
(35)Communication from the Commission to the European Parliament and the Council on the European Innovation Partnership 'Agricultural Productivity and Sustainability' (COM(2012)0079).


Programme implementing Horizon Europe***I
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Resolution
Consolidated text
European Parliament legislative resolution of 17 April 2019 on the proposal for a decision of the European Parliament and of the Council on establishing the specific programme implementing Horizon Europe - the Framework Programme for Research and Innovation (COM(2018)0436 – C8-0253/2018 – 2018/0225(COD))
P8_TA(2019)0396A8-0410/2018

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2018)0436)),

–  having regard to Article 294(2) and Articles 173(3) and 182(4) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0253/2018),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the letter from its President to the committee chairs of 25 January 2019 outlining the Parliament's approach to the Multiannual Financial Framework (MFF) post-2020 sectorial programmes,

–  having regard to the letter from the Council to the President of the European Parliament of 1 April 2019 confirming the common understanding reached between the co-legislators during negotiations,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on Industry, Research and Energy and the opinions of the Committee on Development, the Committee on Budgets, the Committee on Budgetary Control, the Committee on the Environment, Public Health and Food Safety, the Committee on Transport and Tourism and the Committee on Agriculture and Rural Development (A8-0410/2018),

A.  whereas a partial political agreement was found on the Specific Programme implementing the Horizon Europe Framework Programme; whereas that agreement is based on a significantly amended text compared to the Commission proposal; whereas this has a bearing on the legal basis; whereas the institutions exchanged views in that regard pursuant to the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(1); whereas the issue of the legal basis should therefore be adapted at a later stage of the procedure for this file;

1.  Adopts its position at first reading hereinafter set out(2);

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 17 April 2019 with a view to the adoption of Decision (EU) …/… of the European Parliament and of the Council on establishing the specific programme implementing Horizon Europe – the Framework Programme for Research and Innovation

P8_TC1-COD(2018)0225


(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 173(3) and 182(4) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee(3),

Having regard to the opinion of the Committee of the Regions(4),

Having regard to the European Parliament’s report on the assessment of Horizon 2020 implementation in view of its interim evaluation and the 9th Framework Programme proposal;

Acting in accordance with the ordinary legislative procedure(5),

Whereas:

(1)  In accordance with Article 182(3) of the Treaty on the Functioning of the European Union (TFEU), the Horizon Europe - Framework Programme for Research and Innovation ("Horizon Europe"), established by FP/RfP Regulation (EU) No … of the European Parliament and of the Council of…(6) , is to be implemented through specific programmes, which define the detailed rules for their implementation, fix their duration and provide for the means deemed necessary.

(2)  FP/RfP Regulation (EU) No … sets out the general and specific objectives of Horizon Europe, the structure and the broad lines of activities to be carried out, while this specific programme implementing Horizon Europe - the Framework Programme for Research and Innovation (the 'Specific Programme') should define the operational objectives and the activities which are specific to parts of Horizon Europe. The provisions on implementation set out in FP/RfP Regulation (EU) No … apply fully to the Specific Programme, including those relating to ethical principles.

(3)  In order to ensure uniform conditions for the implementation of the Specific Programme, implementing powers should be conferred on the Commission to adopt work programmes for the implementation of the Specific Programme. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council(7).

(4)  The Board of Governors of the Joint Research Centre (JRC), set up by Commission Decision 96/282/Euratom(8) has been consulted on the scientific and technological content of the Specific Programme on the non-nuclear direct actions of the JRC.

(5)  Reflecting the importance of tackling climate change in line with the Union's commitments to implement the Paris Agreement and the United Nations Sustainable Development Goals, this Specific Programme will contribute to mainstream climate actions and to the achievement of an overall target of at least 25 % of the EU budget expenditures supporting climate objectives over the MFF 2021-2027 period, and an annual target of 30 % as soon as possible and at the latest by 2027. Actions under this Specific Programme will contribute at least 35 % of the overall financial envelope of the Specific Programme to climate objectives. Relevant actions will be identified during the Specific Programme's preparation and implementation, and reassessed in the context of the relevant evaluations and review processes. Attention will be paid to coal- and carbon-intensive areas of the Union in transition.

(6)  The Specific Programme's actions should be used to address market failures or sub-optimal investment situations, in a proportionate manner, without duplicating or crowding out private financing and have a clear European added value.

(7)  Reflecting the important contribution that research and innovation should make to address challenges in food, agriculture, rural development and the bioeconomy, and to seize the corresponding research and innovation opportunities in close synergy with Common Agricultural Policy, relevant actions under the Specific Programme will be supported ▌in a dedicated cluster 'Food, Bioeconomy, Natural Resources, Agriculture and Environment' for the period 2021-2027.

(8)  The completion of the Digital Single Market and the growing opportunities from the convergence of digital and physical technologies requires a stepping up of investments. Horizon Europe will contribute to these efforts with a ▌(9) dedicated cluster to ensure that Europe remains at the forefront of global research and innovation in the digital field.

(9)  The types of financing and the methods of implementation under this Decision shall be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver results, taking into account, in particular, the costs of controls, the administrative burden, and the expected risk of non-compliance. For grants, this shall include consideration of the use of lump sums, flat rates and scales of unit costs.

(10)  Member States should be involved early in the process of defining missions.

HAVE ADOPTED THIS DECISION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter

This Decision establishes the specific programme implementing Horizon Europe - the Framework Programme for Research and Innovation (the ‘Specific Programme’), as set out in Article 1(3)(a) of the FP/RfP Regulation…/…/EU.

It lays down the operational objectives of the Specific Programme, the budget for the period 2021 – 2027, the rules for implementation of the Specific Programme and activities to be carried out under the Specific Programme.

Article 2

Operational objectives

1.  The Specific Programme shall contribute to the general and specific objectives set out in Article 3 of Regulation … FP/RfP Regulation

2.  The Specific Programme has the following operational objectives:

(a)   strengthening excellent basic and frontier research; reinforcing and spreading excellence, including by fostering wider participation throughout the Union;

(b)   reinforcing the link between research, innovation, and where appropriate, education and other policies, including complementarities with national and regional and EU research and innovation policies and activities;

(ba)   supporting the implementation of Union policy priorities including in particular the sustainable development goals and the Paris Agreement;

(c)   promoting responsible research and innovation, taking into account the precautionary principle;

(ca)   strengthening the gender dimension across the Programme;

(cb)   increasing collaboration links in European research and innovation and across sectors and disciplines, including social sciences and humanities;

(d)   strengthening international cooperation;

(da)   connecting and developing research infrastructures across the European Research Area and providing transnational access;

(e)   attracting talent, training and retaining researchers and innovators in the European Research Area, including through mobility▌;

(f)   fostering open science and ensuring visibility to the public and open access to scientific publications and research data, including appropriate exceptions;

(g)  encouraging exploitation of R&I results and actively disseminating and exploiting results, in particular for leveraging private investments and policy development;

(j)   delivering, through R&I missions, on ambitious goals within a set timeframe;

(k)   improving the relationship and interaction between science and society, including the visibility of science in society and science communication, and promoting the involvement of citizens and end-users in co-design and co-creation processes;

(m)  accelerating industrial transformation, including through improved skills for innovation;

(o)  stimulating R&I activities in SMEs and the creation and scale-up of innovative companies, in particular start-ups, SMEs, and in exceptional cases small mid-caps;

(p)   improving access to risk finance, including through synergies with InvestEU, in particular where the market does not provide viable financing.

3.  Within the objectives referred to in paragraph 2, account may be taken of new and unforeseen needs that arise during the period of implementation of the Specific Programme. That may, if duly justified, include responses to emerging opportunities, crises and threats, as well as responses to needs relating to the development of new Union policies.

Article 3

Structure

1.  In accordance with Article 4(1) of Regulation … FP/RfP Regulation, the Specific Programme shall consist of the following parts:

(1)  Pillar I 'Excellent Science' with the following components:

(a)  the European Research Council (ERC), as described in Annex I, Pillar I, section 1;

(b)  Marie Skłodowska-Curie Actions (MSCA), as described in Annex I, Pillar I, section 2;

(c)  research infrastructures, as described in Annex I, Pillar I, section 3;

(2)  Pillar II 'Global Challenges and European Industrial Competitiveness' with the following components:

(a)  cluster 'Health', as described in Annex I, Pillar II, section 1;

(b)  cluster 'Culture, Creativity and Inclusive ▌Society', as described in Annex I, Pillar II, section 2;

(c)  cluster 'Civil Security for Society', as described in Annex I, Pillar II, section 3;

(d)   cluster 'Digital, Industry and Space', as described in Annex I, Pillar II, section 4;

(e)   cluster 'Climate, Energy and Mobility', as described in Annex I, Pillar II, section 5;

(f)   cluster 'Food, Bioeconomy, Natural Resources, Agriculture and Environment' as described in Annex I, Pillar II, section 6;

(g)   non-nuclear direct actions of the Joint Research Centre (JRC), as described in Annex I, Pillar II, section 7;

(3)  Pillar III 'Innovative Europe' with the following components:

(a)  the European Innovation Council (EIC), as described in Annex I, Pillar III, section 1;

(b)  European innovation ecosystems, as described in Annex I, Pillar III, section 2;

(4)  Part 'Widening Participation and Strengthening the European Research Area' with the following components:

(a)  widening participation and spreading excellence, as described in Annex I, Part 'Strengthening the European Research Area', section 1;

(b)  reforming and enhancing the European R&I system, as described in Annex I, Part 'Strengthening the European Research Area', section 2.

2.  The activities to be carried out under the parts referred to in paragraph 1 are described in Annex I.

Article 4

Budget

1.  In accordance with Article 9(1)of Regulation … FP/RfP Regulation, the financial envelope for the implementation of the Specific Programme for the period 2021 to 2027 shall be EUR 120 000 000 000 in 2018 prices.

2.  The amount referred to in paragraph 1 of this Article shall be distributed among the components set out in Article 3(1) of this Decision in accordance with Article 9(2) of Regulation … FP/RfP Regulation. The arrangements of Article 9(3) to (8) of Regulation … FP/RfP Regulation shall apply.

CHAPTER II

IMPLEMENTATION AND PROGRAMMING

Article 4a

Strategic Plan

1.  In accordance with Article 6 paragraph 6 of the [Framework Programme Regulation], the implementation of the Specific Programme shall be facilitated by a multiannual Strategic Plan of research and innovation activities, also promoting consistency between the work programmes, EU priorities and national priorities. The result of the Strategic Planning Process shall be set out in a multiannual Strategic Plan, for preparing the content in the work programmes (as set out in Article 11) covering a maximum period of four years, while retaining sufficient flexibility to respond rapidly to new and emerging challenges, unexpected opportunities and crises.

2.  The Strategic Planning Process shall focus in particular on the 'Global challenges and European industrial competitiveness' pillar and cover also relevant activities in other pillars and the Widening Participation and Strengthening the European Research Area part.

The Commission shall ensure early involvement and extensive exchanges with the Member States, and extensive exchanges with the European Parliament, complemented by consultation with stakeholders and the public at large. This will contribute to a stronger engagement with citizens and civil society.

Member States may support the strategic planning process also through providing an overview of national consultations/citizens' contributions that feed into the Strategic Plan.

3.  The Strategic Plan shall be adopted by the Commission, by means of an implementing act, in accordance with the examination procedure referred to in Article 12(4). The Strategic Plan shall correspond to the objectives and activities described in Annex 1. This Implementing Act shall contain the following elements, relating to the period covered:

a.  Key strategic orientations for R&I support, including a description of expected impacts, cross-cluster issues and intervention areas covered.

b.  Identification of European Partnerships according to Article 8(1)(a and b) of the [FP Regulation].

ba.  Identification of Missions according to Article 5 of the Specific Programme and Article 7 and Annex Va of the Regulation establishing Horizon Europe.

c.  Areas for international cooperation, actions to be aligned with Research & Innovation of other nations and regions of the world at major scale, or actions to be carried out in cooperation with organisations in third countries.

d.  Specific issues, such as the balance between research and innovation; the integration of Social Sciences and Humanities; the role of Key Enabling Technologies and strategic value chains; gender equality, including the integration of gender dimension in the R&I content; adherence to the highest ethics and integrity standards; priorities for dissemination and exploitation.

4.  The Strategic Plan shall take into account an analysis covering at least the following elements:

a)  Political, socio-economic and environmental drivers which are relevant for the EU and Member States' policy priorities.

b)  The contribution of research and innovation to the realisation of EU policy objectives, while capitalizing on studies, other scientific evidence and relevant initiatives at EU and national level, including institutionalised partnerships according to article 8(1)(c)of the [Framework Programme Regulation].

c)  Evidence-base resulting from foresight activities, S&T and innovation indicators, international developments such as the implementation of the SDGs and feedback from implementation, including monitoring the implementation of specific measures with regard to widening participation and spreading excellence and participation of SMEs.

d)  Priorities with the potential to be implemented in synergy with other EU programmes.

e)  A description of the various approaches for stakeholder consultation and citizen engagement as part of the work to develop Work Programmes;

f)  Complementarity and synergies with planning of the KICs of the EIT in accordance with Regulation 294/2008/EC.

5.  The strategic planning process shall be complemented by a strategic coordinating process for European Partnerships, with participation of Member States and the Commission on equal footing. It shall function as an entry point for foresight analysis, analysis and advice on the portfolio development, possible setup, implementation, monitoring and phasing out of R&I partnerships and be guided by a comprehensive criteria framework, based on Annex III of the Horizon Europe Regulation.

Article 5

Missions

1.  Research and Innovation Missions may be established in the mission areas identified in Annex Va of the Regulation establishing Horizon Europe.

2.   For each mission, a mission board shall be established, unless existing advisory structures can be used, in which case the Programme Committee shall be informed in advance. The mission board shall be composed of a maximum of 15 independent high level individuals with broad expertise, including where appropriate SSH experts, from across Europe and beyond, including relevant end-users' representatives. The members of the mission boards shall be appointed by the Commission, following a transparent procedure for their identification, including an open call for expressions of interest. The Programme Committee shall be consulted on the identification and selection procedures, including the criteria used, in a timely manner. The term of office of mission board members shall be up to five years, renewable once.

3.   The mission board shall advise, without having decision-making powers, the Commission upon the following:

(a)  identification and design of one or more missions in the respective mission area according to the provisions and criteria as set out in Article 7 of [Framework Programme Regulation]

(b)   content of work programmes and their revision as needed for achieving the mission objectives, ▌with input from stakeholders and, where relevant, the public▌;

(c)   characteristics of project portfolios for missions;

(d)   adjustment actions, or termination if appropriate, based on implementation assessments according to the defined objectives of the mission;

(e)  selection of independent expert evaluators following the provisions of Article 44 [of the Framework Programme Regulation], briefing of expert evaluators and evaluation criteria and their weighting;

(f)   framework conditions which help achieve the objectives of the mission;

(g)   communication, including on the performance and the achievements of the mission.

(h)  policy coordination between relevant actors at different levels, in particular regarding synergies with other Union policies;

(i)  key performance indicators.

The advice of the mission boards shall be made public.

4.  For each Mission area, the Programme Committee shall be involved in the preparation and life cycle of the missions, taking into account relevant issues from the national context and opportunities to enhance alignment with activities on national level. Interactions with the mission boards shall take place in a timely and comprehensive manner.

5.  The work programme provided for in Article 11 shall include for each mission identified in the Strategic Plan, the design, the characteristics of their project portfolios and specific provisions to enable an efficient portfolio approach.

Article 6

European Research Council

1.  The Commission shall establish a European Research Council ("ERC"), for implementing the actions under Pillar I 'Excellent Science' which relate to the ERC. The ERC shall succeed the ERC set up by Decision C(2013)1895(10).

2.  The ERC shall be composed of the independent Scientific Council provided for in Article 7 and the dedicated implementation structure provided for in Article 8.

3.  The ERC shall have a President who shall be chosen from among senior and internationally respected scientists.

The President shall be appointed by the Commission following a transparent recruitment process involving an independent dedicated search committee, for a term of office limited to four years, renewable once. The recruitment process and the candidate selected shall have the approval of the Scientific Council.

The President shall chair the Scientific Council and shall ensure its leadership and liaison with the dedicated implementation structure, and represent it in the world of science.

4.  The ERC shall operate according to its core principles of scientific excellence, open science, autonomy, efficiency, effectiveness, transparency, accountability and research integrity. It shall ensure continuity with ERC actions conducted under Decision …/EC.

5.  The activities of the ERC shall support frontier research, in a bottom-up manner, carried out across all fields by principal investigators and their teams in competition at the European level, including early-stage career researchers.

6.  The Commission shall act as the guarantor of the autonomy and integrity of the ERC and shall ensure the proper execution of the tasks entrusted to it.

The Commission shall ensure that the implementation of the ERC actions is in accordance with the principles set out in paragraph 4 of this Article as well as with the overall strategy for the ERC, referred to in point (a) of Article 7(2), established by the Scientific Council.

Article 7

ERC Scientific Council

1.  The Scientific Council shall be composed of independent scientists, engineers and scholars of the highest repute and appropriate expertise, of both women and men in different age groups, ensuring a diversity of research areas and the variety of geographical origins, and acting in their personal capacity, independent of extraneous interests.

The members of the Scientific Council shall be appointed by the Commission, following an independent and transparent procedure for their identification agreed with the Scientific Council, including an open consultation of the scientific community and a report to the European Parliament and the Council.

Their term of office shall be limited to four years, renewable once, on the basis of a rotating system which shall ensure the continuity of the work of the Scientific Council.

2.  The Scientific Council shall establish:

(a)  the overall strategy for the ERC;

(b)  the work programme for the implementation of the ERC activities;

(c)  the methods and procedures for peer review and proposal evaluation on the basis of which the proposals to be funded are determined;

(d)  its position on any matter which from a scientific perspective may enhance achievements and impact of the ERC and the quality of the research carried out;

(e)  a code of conduct addressing, inter alia, the avoidance of conflict of interests.

The Commission shall depart from the positions established by the Scientific Council in accordance with points (a), (c), (d), and (e) of the first subparagraph only when it considers that the provisions of this Decision have not been respected. In that case, the Commission shall adopt measures to maintain continuity in the implementation of the specific programme and the achievements of its objectives, setting out the points of departure from the Scientific Council positions and duly motivating them.

3.  The Scientific Council shall act in accordance with the mandate set out in Pillar I of Annex I, section 1.

4.  The Scientific Council shall act exclusively in the interest of ▌the ERC, according to the principles set out in Article 6. It shall act with integrity and probity and carry out its work efficiently and with the greatest possible transparency.

Article 8

Dedicated ERC implementation structure

1.  The dedicated implementation structure shall be responsible for the administrative implementation and programme execution, as described in Pillar I of Annex I, section 1.3.2. It shall support the Scientific Council in the conduct of all of its tasks.

2.  The Commission shall ensure that the dedicated implementation structure follows strictly, efficiently and with the necessary flexibility the objectives and requirements of the ERC alone.

Article 9

European Innovation Council

1.  The EIC, as established according to Article 7a of the [Framework Programme Regulation] shall include the High Level Board ("EIC Board") provided for in Article 10.

2.   The Commission shall ensure that the implementation of the EIC▌:

(a)  is in accordance with the principles set out in paragraph 1 of this Article, taking due account of the opinion of the EIC Board on the overall strategy for the EIC, referred to Article 10(1)(a); and

(b)  does not lead to distortions of competition contrary to the common interest.

3.   For the purpose of managing EIC blended finance, the Commission shall make use of indirect management, or where this is not possible, may establish a special purpose vehicle, to be managed according to the applicable accountability rules. The Commission shall seek to ensure the participation of other public and private investors. Where this is not possible at the initial set up, the special purpose vehicle will be structured in such a way that it can attract other public or private investors in order to increase the leverage effect of the Union contribution.

4.   The Commission shall ensure effective complementarities between the EIC, the EIT and InvestEU.

Article 10

The EIC Board

1.  The EIC Board shall advise the Commission upon:

(a)  the overall strategy for the EIC component under Pillar III 'Innovative Europe';

(b)  the work programme for the implementation of the EIC actions;

(c)  the criteria for assessment of the innovativeness and risk profile of the proposals and the appropriate balance of grants, equity and other forms of financing for the EIC accelerator;

(d)  the identification of strategic portfolio of projects;

(e)  the profile of programme managers.

2.  The EIC Board may upon request address recommendations to the Commission on:

(a)  any matter which from an innovation perspective may enhance and foster innovation eco-systems across Europe, the achievements and impact of the objectives of the EIC component and the capacity of innovative firms to roll out their solutions;

(b)  identifying in cooperation with relevant Commission services and, where appropriate, national and regional authorities and other relevant entities, such as the EIT Governing Board, possible regulatory barriers faced by entrepreneurs, in particular those awarded support under the EIC component;

(c)  emerging technology trends from EIC's portfolio, to inform the programming in other parts of the Specific Programme;

(d)  identifying specific issues where advice from the EIC Board is needed.

The EIC Board shall act in the interest of achieving the objectives of the EIC component. It shall act with integrity and probity and carry out its work efficiently and with transparency.

The EIC Board shall act in accordance with its mandate set out in Pillar III of Annex I, section 1.

3.  The EIC Board shall be composed of 15 to 20 independent high level individuals drawn from various parts of Europe's innovation ecosystem, including entrepreneurs, corporate leaders, investors, public administration experts and researchers, including academic experts on innovation. It shall contribute to outreach actions, with EIC Board members striving to enhance the prestige of the EIC brand.

The members of the EIC Board shall be appointed by the Commission, following an open call for nominations or for expression of interests or both, whichever the Commission will find more appropriate, and taking into account the need for balance in expertise, gender, age and geographical distribution.

Their term of office shall be limited to two years, renewable twice, with a rolling appointments system (members appointed every two years).

4.  The EIC Board shall have a President who shall be appointed by the Commission following a transparent recruitment process. The President shall be a high profile public figure linked to the innovation world, with a solid understanding of R&D.

The President shall be appointed for a term of office limited to four years, renewable once.

The President shall chair the EIC Board, prepare its meetings, assign tasks to members, and may establish dedicated sub-groups, in particular to identify emerging technology trends from EIC's portfolio. He or she shall represent the EIC in the world of innovation. He or she shall also promote the EIC, act as interlocutor with the Commission, through the relevant programme committees, with Member States. The Commission will provide for administrative support for the President to undertake his or her duties.

5.  A code of conduct addressing, inter alia, the avoidance of conflict of interests and breach of confidentiality shall be established by the Commission. Members of the EIC Board will accept the code of conduct upon assuming office.

Article 11

Work programmes

1.  The Programme shall be implemented by the work programmes referred to in paragraph 2 in accordance with Article 110 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (the ‘Financial Regulation’) (11). They shall set out the expected impact and be prepared following a strategic planning process as described in Annex I to this Decision. The Commission shall regularly and from an early stage inform the Committee referred to in Article 12 of the overall progress of the implementation of the indirect actions of the specific programme, including missions, also to allow the Committee to provide early appropriate input in the course of the strategic planning process and on the preparation of the work programmes, especially on missions.

Work programmes shall set out, where applicable, the overall amount reserved for blending operations.

2.  The Commission shall adopt separate work programmes, by means of implementing acts, for the implementation of actions under the following components, as set out in Article 3(1) of this Decision :

(a)  the ERC, where the work programme shall be established by the Scientific Council under point (b) of Article 7(2), in accordance with the advisory procedure referred to in Article 12(3). The Commission shall depart from the work programme established by the Scientific Council only when it considers that it is not in accordance with the provisions of this Decision. In that case, the Commission shall adopt the work programme by means of an implementing act in in accordance with the examination procedure referred to in Article 12(4). The Commission shall duly motivate this measure;

(b)  all clusters under the pillar 'Global Challenges and ▌Competitiveness of European Industry', MSCA, research infrastructures, support to innovation ecosystems, widening participation and spreading excellence, and reforming and enhancing the European R&I System, in accordance with the examination procedure referred to in Article 12(4);

(c)  the EIC, where the work programme shall be prepared following the advice of the EIC Board under point (b) of Article 10(1), in accordance with the examination procedure referred to in Article 12(4);

(d)  the JRC, where the multi-annual work programme shall take into account the opinion provided by the Board of Governors of the JRC referred to in Decision 96/282/Euratom.

3.  In addition to requirement in Article 110 of the Financial Regulation, the work programmes referred to in paragraph 2 of this Article shall, as appropriate, contain:

(a)  an indication of the amount allocated to each action and mission and an indicative implementation timetable;

(b)  for grants the priorities, the selection and award criteria and the relative weight of the different award criteria and the maximum rate of funding of the total eligible costs;

(c)  the amount allocated to blended finance in accordance with Articles 41 to 43 of Regulation … FP/RfP Regulation:

(d)  any additional obligations for beneficiaries, in accordance with Articles 35 and 37 of the FP/RfP Regulation.

4.  The Commission shall adopt, by means of implementing acts, in accordance with the examination procedure referred to in Article 12(4) the following measures:

(a)  the decision on the approval of the funding of indirect actions, where the estimated amount of the Union contribution under the specific programme is equal to or more than EUR 2,5 million, with the exception of actions under the specific objective "European Research Council (ERC)"; for funding of indirect actions in cluster 2 the decision on the approval of the funding of indirect actions, where the estimated amount of the Union contribution under the Specific Programme is equal to or more than EUR 1 million;

(b)  the decision on the approval of the funding of actions involving the use of human embryos and human embryonic stem cells and of actions under the cluster "Civil Security for Society" referred to in Article 3(1)(2)(c).

Article 12

Committee procedure

1.  The Commission shall be assisted by a committee(12). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2.  The committee shall meet in different configurations as set out in Annex II, having regard to the subject matter to be discussed.

3.  Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

4.  Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

5.  Where the opinion of the committee is to be obtained by written procedure, that procedure shall be terminated without result when, within the time-limit for delivery of the opinion, the chair of the committee so decides or a simple majority of committee members so request.

6.  In the case of the implementing acts to be adopted under Article 4a(3) where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.

7.  The Commission shall regularly inform the Committee of the overall progress of the implementation of the specific programme and shall provide it with timely information on all actions and components proposed or funded under Horizon Europe and its externalised parts, as specified in Annex III, including detailed information/analysis of the statistics of the individual calls.

CHAPTER III

TRANSITIONAL AND FINAL PROVISIONS

Article 13

Repeal

Decision 2013/743/EU is repealed with effect from 1 January 2021.

Article 14

Transitional provisions

1.  This Decision shall not affect the continuation or modification of the actions concerned, until their closure, under Decision 2013/743/EU, which shall continue to apply to the actions concerned until their closure.

Where necessary, any remaining tasks of the Committee established by Decision 2013/743/EU shall be undertaken by the Committee referred to in Article 12 of this Decision.

2.  The financial envelope for the Specific Programme may also cover technical and administrative assistance expenses necessary to ensure the transition between the Specific Programme and the measures adopted under its predecessor Decision 2013/743/EU.

Article 15

Entry into force

This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Decision is addressed to the Member States.

Done at …,

For the European Parliament For the Council

The President The President

ANNEX I

STRATEGIC PLANNING AND PROGRAMME ACTIVITIES

The following shall apply in the implementation of the Programme.

Strategic Planning

As laid down in Article 4 a, the implementation of the Specific Programme shall be facilitated by a multiannual strategic planning for research and innovation activities. The strategic planning process shall ▌focus in particular on the Global Challenges and European Industrial Competitiveness pillar, including relevant activities in other pillars and the Widening Participation and Strengthening the European Research Area part, also in close coordination and synergy with the planning of the KICs of the EIT established by Regulation 294/2008/EC.

The result of the Strategic Planning Process shall be set out in a Strategic Plan for realising content in the work programme.

The Strategic Planning process aims to:

–  implement Horizon Europe's programme-level objectives in an integrated manner and provide focus on impact for the Programme overall and coherence between its different pillars.

–   ▌promote synergies between Horizon Europe and other Union Programmes, including the [cohesion funds] and the Euratom programme, thus becoming a point of reference for research and innovation in all related programmes across the EU budget and non-funding instruments. ▌

–  help to develop and realise EU policy for the relevant areas covered, and complement policy development and implementation in the Member States.

–  reduce fragmentation of efforts and avoid duplication and overlaps between funding possibilities.

–  provide the frame for linking the direct research actions of the Joint Research Centre and other actions supported under the Programme, including the use of results and data for support to policy.

–  ensure a balanced and broad approach to research and innovation, at all stages of development, which is not only limited to fostering frontier research, the development of new products processes and services on the basis of scientific and technological knowledge and breakthroughs, but also incorporates the use of existing technologies in novel applications and continuous improvement and non-technological and social innovation.

–  ensure a systemic, cross-disciplinary, cross-sectoral and cross-policy approach to research and innovation in order to tackle challenges while also giving rise to new competitive businesses and industries, fostering competition, stimulating private investments and preserving the level playing field in the internal market.

OTHER PROGRAMME ACTIVITIES

In the 'Global Challenges and European Industrial Competitiveness' and the 'Innovative Europe' Pillars, research and innovation shall be complemented with activities which operate close to the end-users and the market, such as demonstration, piloting or proof-of-concept, excluding however commercialisation activities going beyond the research and innovation phase. This shall also include support to demand-side activities that help accelerate the deployment and diffusion of a broad range of innovations. Emphasis shall be put on non-prescriptive calls for proposals.

Under the 'Global Challenges and European Industrial Competitiveness' pillar, building on experience in Horizon 2020, the social sciences and the humanities shall be fully integrated across all clusters, including specific and dedicated activities. Likewise, activities involving marine and maritime research and innovation shall be implemented in a strategic and integrated manner in line with the EU Integrated Maritime Policy, the Common Fisheries Policy ▌and international commitments.

Activities carried out within the ▌FET Flagships▌ on Graphene, the Human Brain Project and Quantum Technology, which are supported under Horizon 2020, will continue being supported under Horizon Europe through calls for proposals included in the work programme▌. Preparatory actions supported under the FET Flagships part of Horizon 2020 will feed the Strategic Planning process under Horizon Europe and inform the work on missions, co-funded/co-programmed partnerships and regular calls for proposals.

Science and Technology Cooperation dialogues with the EU's international partners and policy dialogues with the main world regions shall make important contributions to the systematic identification of opportunities for cooperation which, when combined with differentiation by country/region, shall support priority setting. Early advice from the ERA-related advisory structure will continue to be sought.

Dissemination and Communication

Horizon Europe will provide dedicated support for open access to scientific publications, to knowledge repositories and other data sources. Dissemination and knowledge diffusion actions will be supported, also from cooperation with other EU programmes, including clustering and packaging results and data in languages and formats for target audiences and networks for citizens, industry, public administrations, academia, civil society organisations, and policy makers. For this purpose, Horizon Europe may make use of advanced technologies and intelligence tools.

There will be appropriate support for mechanisms to communicate the programme to potential applicants (e.g. National Contact Points).

The Commission will also implement information and communication activities relating to Horizon Europe, to promote the fact that results were obtained with the support of EU funding. They will also seek to raise public awareness on the importance of research and innovation and the broader impact and relevance of EU funded research and innovation, by means of e.g. publications, media relations, events, knowledge repositories, databases, multi-channel platforms, websites or a targeted use of social media. Horizon Europe will also provide support to the beneficiaries to communicate their work and its impact to society at large.

Exploitation and Market Uptake

The Commission will establish comprehensive measures for exploitation of Horizon Europe results and the knowledge produced. This will accelerate exploitation towards wide market uptake and boost the impact of the Programme.

The Commission will systematically identify and record the results of the research and innovation activities under the Programme and transfer or disseminate these results and knowledge produced in a non-discriminatory fashion to industry and enterprises of all sizes, public administrations, academia, civil society organisations and policy-makers, in order to maximise the European added value of the Programme.

International Cooperation

Greater impact will be obtained through aligning actions with other countries and regions of the world within strengthened international cooperation efforts ▌. Based on mutual benefit, partners from across the world will be invited to join EU efforts as an integral part of initiatives in support of EU action for sustainability, reinforced research and innovation excellence, and competitiveness.

International joint action will ensure effective tackling of global societal challenges and Sustainable Development Goals, access to the world's best talents, expertise and resources, and enhanced supply and demand of innovative solutions.

Working Methodologies for Evaluation

The use of high quality independent expertise in the evaluation process underpins the engagement of the programme across all stakeholders, communities and interests, and is a prerequisite for maintaining the excellence and relevance of the funded activities.

The Commission or funding body will ensure the impartiality of the process, and avoid conflicts of interest in line with Article 61 of the Financial Regulation. It shall also seek geographical diversity in the composition of evaluation committees, expert and advisory groups.

Exceptionally, when justified by the requirement to appoint the best available experts and/or by the limited size of the pool of qualified experts, independent experts assisting or being members of the evaluation committee may evaluate specific proposals for which they declare a potential interest. In this case, the Commission or funding body shall take all necessary remedial measures to ensure the integrity of the evaluation process. The evaluation process will be managed accordingly, including a stage involving an interaction between diverse experts. The evaluation committee will take into account the particular circumstances when identifying proposals for funding.

PILLAR I

EXCELLENT SCIENCE

The scientific, economic, social and cultural progress in all its forms depends on an adequate supply of excellent researchers; the search for breakthroughs in understanding and the acquisition of knowledge at all levels; the world class facilities needed to achieve this including physical and knowledge infrastructures for research and innovation as well as the means to openly disseminate and share knowledge (open science) methodologies and skills

The achievement of world leading innovation is linked to the advancements of open and excellent science ▌. Scientific and technological paradigm shifts, can be key drivers for productivity growth, competitiveness, wealth, sustainable development and social progress. Such paradigm shifts have historically tended to originate from the public-sector science base before going on to lay the foundations for whole new industries and sectors and for comprehensive societal progress.

Public investment in research, especially through universities and public research institutions (PRIs) and research facilities, often undertakes the longer-term, higher-risk research and complements the activities of the private sector. Besides this, it creates highly skilled human resources, knowhow and experience, new scientific instruments and methodologies, as well creating the networks which transmit the latest knowledge.

European science and European-based researchers have been and continue to be at the forefront in many areas. But this is not a position we can take for granted. ▌ The traditional challenge from countries such as the United States is now being joined by economic giants such as China and India, from the newly industrialising parts of the world in particular, and from all countries where governments recognise the manifold and abundant returns which derive from investing in research.

1.  EUROPEAN RESEARCH COUNCIL (ERC)

1.1.   Rationale

Although the EU remains the largest producer of scientific publications in the world, it has ▌, relative to its size, comparatively few centres of excellence that standout at the world level and with large areas of average and poor performance. Compared with the US and now China to some degree, the EU follows a 'distributed excellence model' in which resources are spread across a larger number of researchers and research institutions. Creating attractive conditions for the best researchers ▌will help Europe to raise its attractiveness in the global competition for scientific talent.

The global research landscape is evolving dramatically and becoming increasingly multipolar as a result of a growing number of emerging countries, in particular China, expanding their scientific production. So whereas the EU and the United States accounted for nearly two-thirds of world expenditure on research and development in 2000, this share had fallen to less than half by 2013.

The ERC supports the best researchers, including talented researchers who are at an early stage of their career, with flexible, long-term funding to pursue ground breaking, high-gain/high-risk research primarily in Europe. It operates autonomously led by an independent Scientific Council made up of scientists, engineers and scholars of the highest repute and appropriate expertise and diversity. The ERC is able to draw on a wider pool of talents and ideas than would be possible for any national scheme, reinforcing excellence through the way in which the best researchers and the best ideas compete against each other.

Frontier research funded by the ERC has a proven substantial direct impact in the form of advances at the frontiers of knowledge, opening the way to new and often unexpected scientific and technological results and new areas for research. In turn, this generates radically new ideas which drive innovation and business inventiveness and tackle societal challenges. The ERC also has a significant structural impact, driving up the quality of the European research system over and above the researchers and actions it funds directly. ERC-funded actions and researchers set an inspirational target for frontier research in Europe, raising its profile and making it more attractive for the best researchers worldwide as a place to work, and work with. The prestige of hosting ERC grant- holders creates competition between Europe's universities and research organisations to offer the most attractive conditions for top researchers and can indirectly help them to assess their relative strengths and weaknesses and bring about reforms.

▌The ERC funds a relatively small percentage of all European research, but from this achieves a ▌high scientific impact. The average citation impact of the research supported by the ERC is comparable to that of the world’s top elite research universities. The ERC’s research performance is extremely high when compared with the world’s largest research funders. The ERC funds a great deal of frontier research in many of the research areas that have received the highest numbers of citations, including those areas that are rapidly emerging. Although ERC funding is targeted to frontier research it has resulted in a substantial number of patents.

So there is clear evidence that the ERC attracts and funds excellent researchers through its calls and ERC actions are producing a substantial number of the most significant and high impact research findings worldwide in emerging areas leading to breakthroughs and major advances. The work of ERC grantees is also highly interdisciplinary and ERC grantees collaborate internationally and publish their results openly across all fields of research including the social sciences, research on the arts and the humanities.

There is also already evidence of the longer term impacts of ERC grants on careers, on training highly skilled recognised researchers and holders of doctoral degrees ▌, on raising the global visibility and prestige of European research and on national research systems through its strong benchmarking effect. This effect is particularly valuable in the EU's distributed excellence model because ERC funded status can replace and serve as a more accurate indicator of research quality than recognition based on the status of institutions. This allows ambitious individuals, institutions, regions and countries to seize the initiative and scale up the research profiles in which they are particularly strong.

1.2.  Areas of intervention

1.2.1.  Frontier Science

Research funded by the ERC is expected to lead to advances at the frontier of knowledge, with scientific publications of the highest quality▌ to achieve research results with high societal and economic potential impact and with the ERC setting a clear and inspirational target for frontier research across the EU, Europe and internationally. Aiming to make the EU a more attractive environment for the world's best scientists, the ERC will target a measurable improvement in the EU's share of the world's top 1 % most highly cited publications, and aim to increase in the number of excellent researchers including from outside Europe which it funds.

ERC funding shall be awarded in accordance with the following well-established principles. Scientific excellence shall be the sole criterion on which ERC grants are awarded. The ERC shall operate on a 'bottom-up' basis without predetermined priorities.

Broad Lines

–  Long-term funding to support excellent ideas of investigators of any age and gender, from any country in the world, and their research teams to pursue ground-breaking, high-gain/high-risk research;

–  Enabling starting and early-stage career researchers with excellent ideas to make the transition to being independent research leaders in their own right by providing adequate support at the critical stage when they are setting up or ▌consolidating their own research team or programme;

–  New ways of working in the scientific world, including the open science approach, with the potential to create breakthrough results and facilitate commercial and social innovation potential of funded research;

–  Sharing experience and best practices with regional and national research funding agencies and building links to other parts of the Framework Programme, in particular the MSCA, to promote the support of excellent researchers;

–  Raising the profile of frontier research in Europe and the visibility of ERC programmes to researchers across Europe and internationally.

1.3.  Implementation

1.3.1.  The Scientific Council

The Scientific Council is the guarantor of the quality of the activity from the scientific perspective and has full authority over decisions on the type of research to be funded.

In the context of the implementation of the framework programme and in order to carry out its tasks, as set out in Article 7, the Scientific Council will:

(1)  Scientific strategy:

—  establish the overall scientific strategy for the ERC, in the light of scientific opportunities and European scientific needs;

—  establish the work programme and develop the ERC's mix of support measures in line with its scientific strategy;

—  establish the necessary international cooperation initiatives including outreach activities, to increase the visibility of the ERC for the best researchers from the rest of the world, in line with its scientific strategy.

(2)  Scientific management, monitoring and quality control:

—  ensure a world-class peer review system based on scientific excellence and on fully transparent, fair and impartial treatment of proposals by establishing positions on implementation and management of calls for proposals, evaluation criteria, peer review processes including the selection of experts, the methods for peer review and proposal evaluation and the necessary implementing rules and guidelines, on the basis of which the proposals to be funded will be determined under the supervision of the Scientific Council;

—  experts shall be appointed on the basis of a proposal from the ERC Scientific Council in the case of ERC frontier research actions;

—  ensure that ERC grants are implemented according to simple, transparent procedures that maintain the focus on excellence, encourage initiative and combine flexibility with accountability by continuously monitoring the quality of the operations and implementation;

—  review and assess the ERC's achievements and the quality and impact of the research funded by the ERC and, accordingly, make recommendations and guidelines for corrective or future actions;

—  establish positions on any other matter affecting the achievements and impact of the ERC's activities and the quality of the research carried out.

(3)  Communication and dissemination:

—  raise the global profile and visibility of the ERC by conducting communication and outreach activities including scientific conferences to promote the ERC's activities and achievements and the results of the projects funded by the ERC with the scientific community, key stakeholders and the general public;

—  where appropriate, consult with the scientific, engineering and scholarly community, regional and national research funding agencies and other stakeholders;

—  regularly report to the Commission on its own activities.

The members of the Scientific Council shall be compensated for the tasks they perform by means of an honorarium and, where appropriate, reimbursement of travel and subsistence expenses.

The President of the ERC will reside in Brussels for the duration of the appointment and devote most of his/her working time(13) to ERC business. He/she will be remunerated at a level commensurate with the Commission's top management and will be provided by the Dedicated Implementation Structure with the necessary support to carry out his or her functions.

The Scientific Council shall elect from amongst its members three Vice-Chairs who shall assist the President in its representation and the organisation of its work. They may also hold the title of Vice-President of the ERC.

Support will be provided to the three Vice-Chairs to ensure adequate local administrative assistance at their home institutes.

1.3.2.  Dedicated Implementation Structure

The dedicated implementation structure will be responsible for all aspects of administrative implementation and programme execution, as provided for in the ERC work programme. It will, in particular, implement the evaluation procedures, peer review and selection process in accordance with the strategy established by the Scientific Council and will ensure the financial and scientific management of the grants. The dedicated implementation structure will support the Scientific Council in the conduct of all of its tasks as set out above including the development of its scientific strategy, its monitoring of the operations and its review and assessment of the ERC's achievements as well as its outreach and communications activities, provide access to the necessary documents and data in its possession, and keep the Scientific Council informed of its activities.

In order to ensure an effective liaison with the dedicated implementation structure on strategy and operational matters, the leadership of the Scientific Council and the Director of the dedicated implementation structure will hold regular coordination meetings.

The management of the ERC will be carried out by staff recruited for that purpose, including, where necessary, officials from the EU institutions, and will cover only the real administrative needs in order to assure the stability and continuity necessary for an effective administration.

1.3.3.  Role of the Commission

In order to fulfil its responsibilities as set out in Articles 6, 7 and 8 and in the context of its own responsibilities for budget execution, the Commission will:

–  ensure the continuity and renewal of the Scientific Council and provide support for a standing Identification Committee for the identification of future Scientific Council members;

–  ensure the continuity of the dedicated implementation structure and the delegation of tasks and responsibilities to it taking into account the views of the Scientific Council;

–  ensure that the dedicated implementation structure carries out the full range of its tasks and responsibilities;

–  appoint the Director and the members of the management of the dedicated implementation structure taking into account the views of the Scientific Council;

–  ensure the timely adoption of the work programme, the positions regarding implementing methodology and the necessary implementing rules including the ERC Rules of Submission and the ERC Model Grant Agreement, taking into account the positions of the Scientific Council;

–  regularly and in a timely manner inform and consult the Programme Committee on the implementation of the ERC activities;

–  as responsible for the overall implementation of the Research Framework Programme, monitor the dedicated implementation structure and evaluate its performance.

2.  MARIE SKŁODOWSKA-CURIE ACTIONS (MSCA)

2.1.  Rationale

Europe needs a highly-skilled and resilient human capital base in research and innovation that can easily adapt to and find sustainable solutions for current and future challenges, such as major demographic changes in Europe. To ensure excellence, researchers need to be mobile, collaborate and diffuse knowledge across countries, sectors and disciplines, with the right combination of knowledge and skills to tackle societal challenges and support innovation.

Europe is a scientific powerhouse with around 1.8 million researchers working in thousands of universities, research centres and ▌companies. However, it is estimated that the EU will need to train and employ at least one million new researchers by 2027 in order to achieve the targets beings set for increased investment in research and innovation. This need is particularly acute beyond the ▌academic sector (such as in industry and business, including SMEs, government, civil society organisations, cultural institutions, hospitals etc.) and requires collaboration between the different sectors to provide adequately trained new researchers. The EU must reinforce its efforts to entice more young women and men to a career in research, be more inclusive and promote better work/family life balance, attract researchers from third countries, retain its own researchers and reintegrate European researchers working elsewhere back to Europe. In addition, in order to more widely spread excellence, the conditions under which researchers perform must be further improved throughout the European Research Area (ERA). In this respect, stronger links are needed notably with the European Education Area (EEdA), the European Regional Development Fund (ERDF), and European Social Fund (ESF+).

These challenges can best be addressed at EU level due to their systemic nature and to the cross-country effort needed to solve them.

The Marie Skłodowska-Curie Actions (MSCA) focus on excellent research that is fully bottom-up, open to any field of research and innovation from basic research up to market take-up and innovation services. This includes research fields covered under the Treaty on the Functioning of the European Union and the Treaty establishing the European Atomic Energy Community (Euratom). If specific needs arise and additional funding sources become available, the MSCA may seek links to certain activities in specific challenges (incl. identified missions), types of research and innovation institutions, or geographical locations in order to respond to the evolution of Europe's requirements in terms of skills, research training, career development and knowledge sharing.

The MSCA are the main instrument at EU-level for attracting researchers from third countries to Europe, thus making a major contribution to global cooperation in research and innovation. Evidence shows that the MSCA not only have a positive impact on individuals, organisations, and at system level, but also yield high-impact and breakthrough research results while at the same time contributing significantly to societal as well as strategic challenges. Long-term investment in people pays off, as indicated by the number of Nobel Prize winners who have been either former MSCA fellows or supervisors.

Through global research competition between scientists and between host organisations from both the academic and non-academic sector, and through the creation and sharing of high-quality knowledge across countries, sectors and disciplines, the MSCA contribute notably to the goals of the 'Jobs, growth and investment' agenda, the EU Global Strategy and to the United Nations Sustainable Development Goals.

The MSCA contribute to making the ERA more effective, competitive and attractive on a global scale. This is achieved by focusing on a new generation of highly-skilled researchers and providing support for emerging talent from across the EU and beyond including fostering their transition to other components of the programme, such as ERC and EIT; by fostering the diffusion and application of new knowledge and ideas to European policies, the economy and society, inter alia through improved science communication and public outreach measures; by facilitating cooperation between research-performing organisations and by publishing following the principles of open science and FAIR data; and by having a pronounced structuring impact on the ERA, advocating an open labour market and setting standards for quality training, attractive employment conditions and open, transparent and merit-based recruitment for all researchers in line with the European Charter for Researchers and the Code of Conduct for the Recruitment of Researchers.

2.2.  Areas of Intervention

2.2.1.  Nurturing Excellence through Mobility of Researchers across Borders, Sectors and Disciplines

The EU must remain a reference point for excellent research and thus attractive for the most promising researchers, European and non-European alike, at all stages of their careers. This can be achieved by enabling researchers and research-related staff to move and collaborate between countries, sectors and disciplines and thus benefit from high-quality training and career opportunities. This will facilitate career moves between academia and other sectors as well as stimulate entrepreneurial activity.

Broad Lines

–  Mobility experiences within or outside Europe for the best or most promising researchers regardless of nationality to undertake excellent research and develop their skills as well as career and broaden their network in academia and other sectors (including research infrastructures).

2.2.2.  Fostering new Skills through Excellent Training of Researchers

The EU needs a strong, resilient and creative human resource base, with the right combination of skills to match the future needs of the labour market, to innovate and to convert knowledge and ideas into products and services for economic and social benefit. This can be achieved through training researchers to further develop their core research competences as well as enhance their transferable skills such as a creative, responsible, open-to-society and entrepreneurial mindset and awareness of sustainable development. This will allow them to face current and future global challenges, and improve their career prospects and innovation potential.

Broad Lines

–  Training programmes to equip researchers with a diversity of skills relevant to current and future global challenges.

2.2.3.  Strengthening Human Resources and Skills Development across the European Research Area

In order to foster excellence, promote cooperation between research-performing organisations and create a positive structuring effect, high-quality training and mentoring standards, good working conditions and effective career development of researchers need to be introduced across the ERA. If appropriate and justified by a study, support for researchers to return to their country of origin within and to the Union shall be provided within the context of the existing broad lines. This will help modernise or enhance research training programmes and systems as well as increasing institutions' ▌attractiveness worldwide.

Broad Lines

–  Training programmes to foster excellence and spread best practices across institutions, research infrastructures and research and innovation systems;

–  Inter- and transdisciplinary cooperation, production and diffusion of knowledge within the EU and with third countries.

2.2.4.  Improving and Facilitating Synergies

Synergies between research and innovation systems and programmes at EU, regional and national level need to be further developed. This can be achieved in particular through synergies ▌, complementarities with other parts of Horizon Europe such as the European Institute of Innovation and Technology (EIT) and other EU programmes, notably Erasmus and the ESF+, including via a Seal of Excellence.

Broad Lines

–  Training programmes and similar research career development initiatives supported through complementary public or private funding sources at regional, national or EU level.

2.2.5.  Promoting Public Outreach

The awareness of the programme’s activities and the public recognition of researchers need to be enhanced across the EU and beyond, to raise the global profile of the MSCA and to develop a better understanding of the impact of researchers’ work on citizens’ daily lives, and to encourage young people to embark on research careers. This can be achieved by working according to the open science principle which leads to better dissemination, exploitation and diffusion of knowledge and practices. Citizen science could play a valuable role as well.

Broad Lines

–  Public outreach initiatives to stimulate interest in research careers, especially amongst young people of all backgrounds;

–  Promotion activities to raise the global profile, visibility and awareness of the MSCA;

–  Diffusion and clustering of knowledge through cross-project collaboration, national contact points (NCP) projects and other networking activities such as an alumni service.

3.  RESEARCH INFRASTRUCTURES

3.1.  Rationale

State of the art research infrastructures provide key services to research and innovation communities, playing an essential role in extending the frontiers of knowledge and laying the basis for research and innovation contributions to tackle the global challenges and industrial competitiveness. Supporting research infrastructures at the EU level helps to mitigate what in many cases is the reality of scattered national and regional research infrastructures and pockets of scientific excellence, and so strengthening the ERA as well as increasing the ▌circulation of knowledge across silos. Scientific progress is increasingly dependent on the collaborations of research infrastructures and industry that develop the necessary instruments based on new key enabling technologies and other new technologies.

The overall aim is to endow Europe with world-class sustainable research infrastructures open and accessible to all researchers in Europe and beyond, which fully exploit their potential for scientific advance and innovation. Key objectives are to reduce the fragmentation of the research and innovation ecosystem, avoiding duplication of effort, and better coordinate the design, development, accessibility and use of research infrastructures, including those financed from ERDF. It is crucial to support open access to research infrastructures for all European researchers as well as, inter alia through the European Open Science Cloud (hereafter 'EOSC'), increased access to digital research resources, specifically stimulating the up-take of open science and open data practises.

It is also important to improve the long-term sustainability of research infrastructures as they are typically operational for several decades and therefore should produce plans to secure continuous and stable support.

Equally, the EU needs to tackle the rapid increase of global competition for talent by attracting third country researchers to work with European world-class research infrastructures. Increasing the competitiveness and innovation capabilities of European industry is also a major objective, supporting key technologies and services relevant for research infrastructures and their users, thus improving the conditions for supply of innovative solutions.

Past framework programmes have made a significant contribution towards the more efficient and effective use of national research infrastructures as well as developed with the European Strategy Forum on Research Infrastructures (ESFRI) a coherent and strategy-led approach to policy making on pan-European research infrastructures. This strategic approach has generated clear advantages, including reducing duplication of effort with more efficient overall use of resources, as well as standardising processes and procedures. Research mobility plays an important role in facilitating the use of research infrastructures, therefore synergies with national and European mobility schemes have to be considered.

EU supported activity will provide added value through: consolidating and optimising the existing research infrastructure landscape in Europe alongside efforts to develop new research infrastructures of pan-European importance and impact; ensuring similar sets of research infrastructures work together to address strategic issues affecting user communities; establishing the European Open Science Cloud (EOSC) as an effective scalable and sustainable environment for data-driven research; the interconnection of national and regional research and education networks, enhancing and securing high-capacity network infrastructure for massive amounts of data and access to digital resources across borders and domain boundaries; promoting the pan-European coverage of distributed research infrastructures, also to enable cross-country comparison of research data, e.g. in the SSH and environmental fields; fostering the interoperability of research infrastructures; enhancing and reinforcing knowledge transfer and training of high-skilled human resources; fostering the use and where relevant upgrading of existing world-class pan-European research infrastructures across Horizon Europe; overcoming barriers preventing the best research teams from accessing the best research infrastructures services in Europe; fostering the innovation potential of research infrastructures, focused on technology development and co-innovation as well as increased use of research infrastructures by industry.

And the international dimension of EU research infrastructures must be reinforced, fostering stronger cooperation with international counterparts and international participation in European research infrastructures for mutual benefit.

Activities will contribute to different Sustainable Development Goals (SDGs) such as: SDG 3 – Good Health and Well-Being for People; SDG 7 – Affordable and Clean Energy; SDG 9 – Industry Innovation and Infrastructure; SDG 13 – Climate Action.

3.2.  Areas of intervention

3.2.1.  Consolidating and Developing the Landscape of European Research Infrastructures

The establishment, operation and long-term sustainability of research infrastructures identified by ESFRI and other world-class research infrastructures of pan-European relevance is essential for the EU to ensure a leading position in frontier research, training and upskilling of researchers, the creation and use of knowledge and the competitiveness of its industries.

The European Open Science Cloud (EOSC) should become an effective and comprehensive delivery channel for research infrastructures services and should provide Europe's research communities with the next generation of data services for harvesting, storing, processing (e.g. analytics, simulation, visualisation services) and sharing big science data according to the FAIR principles. The EOSC should also provide researchers in Europe with access to the majority of data generated and collected by research infrastructures as well as to HPC and exascale resources, including those deployed under the European Data Infrastructure (EDI)(14).

The pan-European research and education network will link together and enable remote access to research infrastructures and research resources, by providing interconnectivity between universities, research institutes and research and innovation communities at EU level as well as international connections to other partner networks worldwide.

Broad Lines

–  The life-cycle of pan European research infrastructures through the design of new research infrastructures; their preparatory and implementation phase, their early-phase operation in complementarity with other funding sources, in case of the research infrastructures supported by structural funds, as well as the consolidation and optimisation of the research infrastructure ecosystem by streamlining the monitoring practice for ESFRI landmarks and other pan-European research infrastructures and facilitating service agreements, evolutions, mergers, pan-European coverage or decommissioning of pan-European research infrastructures;

–  The European Open Science Cloud, including: scalability and sustainability of the access channel; in cooperation with the Member States and the associated countries effective federation of European, national, regional and institutional resources; its technical and policy evolution to cope with new research needs and requirements (e.g. usage of sensitive data sets, privacy by design); data inter-operability and compliance with the FAIR principles; and a wide user base;

–  The pan-European research and education network underpinning the EOSC and EDI as well as enabling the delivery of HPC/data services in a cloud based environment capable of coping with extreme large data sets and computational processes.

3.2.2.  Opening, Integrating and Interconnecting Research Infrastructures

The research landscape will be improved through ensuring openness of key international, national and regional research infrastructures for all European researchers and integrating their services when necessary so as to harmonise access conditions, improve and enlarge service provision and encourage common development strategy of high tech components and advanced services through innovation actions.

Broad Lines

–  Networks that bring together national and regional funders of research infrastructures for the co-funding of trans-national access of researchers;

–  Networks of pan-European, national and regional research infrastructures addressing global challenges for the provision of access to researchers as well as for the harmonisation and improvement of the research infrastructures' services.

3.2.2a  The innovation potential of European Research Infrastructures and activities for Innovation and Training

To stimulate innovation both in the ▌research infrastructures themselves and in industries, R&D cooperation with industry will be fostered to develop Union capacities and demand for industrial supply in high-tech ▌areas such as scientific instrumentation ▌. In addition, the use of research infrastructures by industry, e.g. as experimental test facilities or knowledge-based centres, will be encouraged. The development and exploitation of research infrastructures will require appropriate skills for their managers, researchers, engineers and technicians, as well as users. For this purpose, Union funding will support the training of staff managing and operating research infrastructures of pan-European interest, the exchange of staff and best practices between facilities, and the adequate supply of human resources in key disciplines, including the emergence of specific education curricula. Synergies with the Marie Skłodowska-Curie actions will be encouraged.

Broad lines

–  Integrated networks of research infrastructures for the preparation and implementation of a common strategy/roadmap for technological development and instrumentation;

–  training of staff managing and operating research infrastructures of pan-European interest.

3.2.2b  Reinforcing European Research Infrastructure policy and International Cooperation

Support is needed so that policy makers, funding bodies or advisory groups such as ESFRI are well-aligned towards developing and implementing a coherent and sustainable long-term European strategy on research infrastructures.

Similarly, enabling strategic international cooperation will strengthen of the position of European research infrastructures at international level, ensuring their global networking ▌, interoperability and reach.

Broad Lines

–  Survey, monitoring and assessment of research infrastructures at EU level, as well as policy studies, communication and training actions, strategic international cooperation actions for research infrastructures, and specific activities of relevant policy and advisory bodies.

PILLAR II

GLOBAL CHALLENGES AND EUROPEAN INDUSTRIAL COMPETITIVENESS

The EU is confronted by many challenges, some of which ▌are also global challenges. The scale and complexity of the problems are vast, ▌ need to be tackled jointly and matched by adequate, properly trained and skilled human resources, by the appropriate amount of financial resources and a proportionate effort in order to find solutions. These are precisely the areas where the EU must work together; smart, flexible and joined-up for the benefit and well-being of all our citizens.

Greater impact can be obtained through aligning actions with other nations and regions of the world within ▌international cooperation along the lines indicated by the United Nations 2030 Agenda for Sustainable Development and the Sustainable Development Goals and the Paris climate agreement. Based on mutual benefit, partners from across the world will be invited to join EU efforts as an integral part of research and innovation for sustainable development.

Research and innovation are key drivers of sustainable and inclusive growth and technological and industrial competitiveness ▌. They will contribute to finding solutions to today’s problems, and the problems of tomorrow, in order to reverse as quickly as possible, the negative and dangerous trend that currently links economic development▌with the growing use of natural resources and growing social challenges. This will turn the challenges into new business opportunities and into rapid benefits for society.

The EU will benefit as user and producer of knowledge, technologies and industries showcasing how modern industrialised, sustainable, inclusive, creative, resilient, open and democratic society and economy can function and develop. The growing economic-environmental-social examples of the sustainable ▌economy of the future will be fostered and boosted, be they for: health and well-being for all; or resilient, creative and inclusive ▌societies; or societies strengthened by civil security; or available clean energy and mobility; or a digitised economy and society; or a transdisciplinary and creative industry; or space related, marine or land-based solutions; or a well-functioning bioeconomy, including food and nutrition solutions; sustainable use of natural resources▌, protection of the environment, climate change mitigation and adaptation, all generating wealth in Europe and offering higher quality jobs. Industrial transformation will be crucial, as well as developing EU innovative industrial value chains.

New technologies affect virtually all policy areas. For each separate technology there is often a combination of social and economic opportunities, opportunities for efficiency and quality and improvement of the government, consequences for employment and education, but also possible risks for safety, privacy and ethics.Technology policy therefore necessarily requires an integral weighing of interests, and cross-sectoral cooperation and strategy formulation.

Research and innovation under this pillar of Horizon Europe is grouped into integrated, non-siloed broad clusters of activities. Rather than addressing sectors, the investments aim at systemic changes for our society and economy along a sustainability vector. These will only be achieved if all actors, both private and public, engage in co-designing and co-creating research and innovation; bringing together end-users, scientists, technologists, producers, innovators, businesses, educators, policy-makers, citizens and civil society organisations. Therefore, none of the ▌clusters is intended for only one set of actors and all activities will be implemented primarily by collaborative research and innovation projects selected on the basis of competitive calls for proposals.

In addition to addressing global challenges, activities in the clusters will also develop and apply ▌key enabling and emerging technologies (either or not digital-based) as part of a common strategy to promote the EU's industrial and social leadership. Where appropriate this will use EU space-enabled data and services. All TRL levels up to 8 will be covered in this pillar of Horizon Europe without prejudice to Union competition law.

Actions will generate new knowledge and develop technological and non-technological solutions, bring technology from lab to market and to develop applications including pilot lines and demonstrators, and include measures to stimulate market uptake and to boost private sector commitment and incentives to standardisation activities within the Union. Technologies require critical mass of European researchers and industry to establish world leading eco-systems, that include state of the art technology infrastructures e.g. for testing. Synergies with other parts of Horizon Europe and the EIT, as well as other programmes will be maximised.

The clusters will boost the quick introduction of first-of-its-kind innovation in the EU through a broad range of embedded activities, including communication, dissemination and exploitation, standardisation as well as support to non-technological innovation and innovative delivery mechanisms, helping create innovation friendly societal, regulatory and market conditions such as the innovation deals. Pipelines of innovative solutions originating from research and innovation actions will be established and targeted to public and private investors as well as other relevant EU and national or regional programmes. Synergies will be developed with the third pillar of Horizon Europe in that perspective.

Gender equality is a crucial factor in order to obtain sustainable economic growth. It is therefore important to integrate a gender perspective in all global challenges.

1.  CLUSTER 'HEALTH'

1.1.  Rationale

The EU Pillar of Social Rights asserts that everyone has the right to timely access to affordable, preventive and curative health care that is safe and of good quality. This underlines the EU’s commitment to the UN’s Sustainable Development Goals calling for universal health coverage for all and at all ages by 2030, leaving no one behind, and ending preventable deaths.

A healthy population is vital for a stable, sustainable and inclusive society, and improvements in health are crucial in reducing poverty, in dealing with an ageing European society, in fostering social progress and prosperity, and in increasing economic growth. According to the OECD a 10% improvement in life expectancy is▌associated with a rise in economic growth of 0.3-0.4% a year. Life expectancy in the EU increased by 12 years since its establishment as a result of tremendous improvements achieved in the quality of life, environment, education, health and care of its people. In 2015, overall life expectancy at birth was 80.6 years in the EU compared to 71.4 years globally. In the past years, it increased in the EU on average by 3 months annually. Besides these improvements social and gender-specific differences in life expectancy can be observed between specific groups and across European countries.

Health ▌research and innovation have played a significant part in this achievement but also in improving productivity and quality in the health and care industry. However, the EU continues to face novel, newly emerging or persisting challenges that are threatening its citizens and public health, the sustainability of its health care and social protection systems, as well as the competitiveness of its health and care industry. Major health challenges in the EU include: accessibility and affordability of health and care; the lack of effective health promotion and disease prevention; the rise of non-communicable diseases; the increased cases of cancer; the increase of mental illness; the spread of antimicrobial drug resistance and the emergence of infectious epidemics; increased environmental pollution; the persistence of health inequalities among and within countries ▌disproportionally affecting people that are disadvantaged or in vulnerable stages of life; the detection, understanding, control, prevention and mitigation of health risks, including poverty-related aspects, in a rapidly changing social, urban, rural and natural environment; demographic change, including ageing-related issues, and the increasing costs for European health care systems▌ and the increasing pressure on the European health and care industry to remain competitive in and by developing health innovation vis-a-vis ▌emerging global players. In addition, vaccine hesitancy may decrease immunisation coverage among certain population groups.

These health challenges are complex, interlinked and global in nature and require multidisciplinary, technical and non-technical, cross-sectorial and transnational collaborations. Research and innovation activities will build close linkages between discovery, clinical, translational epidemiological, ethical, environmental and socio-economic research as well as with regulatory sciences. They will address areas of unmet clinical needs such as for example rare or hard to treat diseases (cancers, such as paediatric and lung cancer). They will harness the combined skills of academia, practitioners, regulatory bodies and industry and foster their collaboration with health services, social services, patients, policy-makers and citizens in order to leverage on public funding and ensure the uptake of results in clinical practice as well as in health care systems taking into account the competencies of Member States regarding the organisation and financing of their health systems. Full advantage will be taken of genomic and other multiomics frontier research, as well as the progressive introduction of personalised medicine approaches, relevant for addressing a variety of non-communicable diseases and the digitalisation in health and care.

Research and innovation will foster strategic collaboration at EU and international level in order to pool the expertise, capacities and resources needed to create scope, speed and economies of scale, ▌as well as to exploit synergies, avoid duplication of effort and share the expected benefits and financial risks involved. Synergies in health research and innovation in Horizon Europe shall be promoted, in particular with the Health Strand within the European Social Fund Plus.

Digital health solutions have created many opportunities to solve the problems of care services and to address other emerging issues of ageing society. Full advantage should be taken of the opportunities that digitalisation in health and care can provide without jeopardising the right to privacy and data protection. Digital devices and software have been developed to diagnose, treat and facilitate patients’ self-management of illness, including chronic diseases. Digital technologies are also increasingly used in medical training and education and for patients and other healthcare consumers to access, share and create health information.

The research and innovation activities of this global challenge will develop the knowledge base, exploit existing knowledge and technologies, consolidate and create the research and innovation capacity and develop the solutions needed for a more effective promotion of health and the integrated prevention, diagnosis, monitoring, treatment, rehabilitation and cure of diseases and (long-term and palliative) care. Results of research will be translated as recommendations for action and communicated with the relevant stakeholders. Improving health outcomes will in turn result in increased well-being and life expectancy, healthy active lives, improved quality of life and productivity▌, more healthy life years and sustainability of health and care systems. In line with articles 14 and 15 of the Regulation and the Charter for Human Rights and Fundamental Principles, ethics, protection of human dignity, gender and ethnical aspects and the needs of disadvantaged and vulnerable people will receive special attention.

Addressing major health challenges will support the EU’s commitment to the United Nation's 2030 Agenda for Sustainable Development and those in the context of other UN organisations and international initiatives, including the global strategies and plans of action of the World Health Organization (WHO). It will contribute to the EU's policy goals and strategies, notably to the EU Pillar of Social Rights, the EU Digital Single Market, the EU Directive on cross-border healthcare, and the European One Health Action Plan against antimicrobial resistance (AMR), and to the implementation of the relevant EU regulatory frameworks.▌

Activities will contribute directly to the following Sustainable Development Goal (SDGs) in particular: SDG 3 – Good Health and Well-Being for People; SDG13 – Climate Action.

1.2.  Areas of Intervention

1.2.1.  Health throughout the Life Course

People in vulnerable stages of life (perinatal, birth, infancy, childhood, adolescence, pregnancy, mature and late adulthood), including people with disabilities or injuries, have specific health needs that require better understanding and tailored solutions, taking gender and ethical aspects into consideration. This will allow reducing related health inequalities and improving health outcomes to the benefit of active and healthy ageing throughout the life course, including through a healthy start of life and diet reducing the risk of mental and physical diseases later in life. Prevention and communication will consider characteristics of specific audiences.

Broad Lines

–  Understanding the early development and the aging process throughout the life course;

–  pre- and neo-natal, maternal, paternal, infant and child health as well as the role of parents, family and educators;

–  Health needs of adolescents, including factors influencing mental health;

–  Health consequences of disabilities and injuries;

–  Research on measures to plan, implement and monitor rehabilitation throughout the life course and especially early individual rehabilitation programme (EIRP) for children affected by disabling pathologies;

–  Healthy ageing, independent and active life, including social participation for the elderly and/or disabled people;

–  Health education and ▌health literacy, including digital.

1.2.2.  Environmental and Social Health Determinants

Improved understanding of health drivers and risk factors determined by the social, cultural, economic and physical environment in people’s everyday life and at the workplace, including the health impact of digitalisation, human mobility (such as migration and travel), pollution, nutrition, climate change and other environmental issues, will contribute to identify, prevent and mitigate health risks and threats; to reducing death and illness from exposure to chemicals and environmental pollution; to supporting safe, environmental-friendly, healthy, resilient and sustainable living and working environments; to promoting healthy lifestyles and consumption behaviour; and to developing an equitable, inclusive and trusted society. This will also be based on population based cohorts, human biomonitoring and epidemiological studies.

Broad Lines

–  Technologies and methodologies for assessing hazards, exposures and health impact of chemicals, indoor and outdoor pollutants and other stressors related to climate change, workplace, lifestyle or the environment and combined effects of several stressors;

–  Environmental, occupational, socioeconomic, cultural, genetic and behavioural factors impacting physical and mental health and well-being of people and their interaction, with special attention to vulnerable and disadvantaged people, age-specific and gender-specific issues where relevant, and including the impact on health of the design of buildings, products and services;

–  Risk assessment, management and communication, supported by transdisciplinary approaches, where relevant, and improved tools for evidence-based decision-making, including replacement of and alternatives to animal testing;

–  Capacity and infrastructures to securely collect, share, use, re-use and combine data on all health determinants, including human exposure and ensure their connection with databases on environmental parameters, lifestyles, health status and diseases, at EU and international level;

–  Health promotion and primary prevention interventions, including occupational aspects.

1.2.3.  Non-Communicable and Rare Diseases

Non-communicable diseases (NCDs), including cancer, rare diseases, pose a major health and societal challenge and call for improved understanding and taxonomy, as well as more effective approaches ▌, including personalised medicine (also called "precision medicine") approaches, in prevention, diagnosis, monitoring, treatment, rehabilitation and cure as well as understanding of multimorbidities.

Broad Lines

–  Understanding the mechanisms underlying the development of non-communicable diseases, including Cardiovascular diseases;

–  Longitudinal population studies to support understanding health and disease parameters and help stratifying populations in support of the development of preventive medicine;

–   Diagnostic tools and techniques for earlier and more accurate diagnosis and for timely patient-adapted treatment, enabling delay and/or reversal of the progression of disease;

–   Prevention and screening programmes, in line with or going beyond WHO, UN and EU recommendations;

–   Integrated solutions for self-monitoring, health promotion, disease prevention, and management of chronic conditions and multi-morbidities, including neurodegenerative and cardiovascular diseases;

–   Treatments, cures or other therapeutic interventions, including both pharmacological and nonpharmacological treatments;

–   Palliative care;

–  Areas of high unmet clinical need, such as rare diseases, including paediatric cancers;

–   Assessment of comparative effectiveness of interventions and solutions, including based on Real World Data (RWD);

–   Implementation research to scale up health interventions and support their uptake in health policies and systems;

–  Development of research and improvement of information, care and treatment, including personalised medicine, for rare diseases.

1.2.4.  Infectious Diseases, including poverty-related and neglected diseases

Protecting people against cross-border health threats is a major challenge for public and global health, calling for effective international cooperation at EU and global level. This will involve understanding and prevention of, preparedness for, early detection of and research response to outbreaks, treatment and cure of infectious diseases, including poverty-related and neglected diseases, and also tackling antimicrobial resistance (AMR) following a 'One Health approach'.

Broad Lines

–  Understanding infection-related mechanisms;

–  Drivers for the emergence or re-emergence of infectious diseases and their spread, including transmission from animals to humans (zoonosis), or from other parts of the environment (water, soil, plants, food) to humans, as well as impact of climate change and ecosystems evolutions on the dynamics of infectious diseases;

–  Prediction, early and rapid detection, control and surveillance of infectious diseases, healthcare-associated infections and environmental related factors;

–  Combatting antimicrobial resistance, including epidemiology, prevention, diagnosis, as well as the development of new antimicrobials and vaccines;

–  Vaccines, including vaccine platform technologies, diagnostics, treatments and cures for infectious diseases, including co-morbidities and co-infections;

–  Addressing low vaccine uptake, understanding vaccine hesitancy and building vaccine confidence;

–  Effective health emergency preparedness, response and recovery measures and strategies, involving communities, and their coordination at regional, national and EU level;

–  Barriers to the implementation and uptake of medical interventions in clinical practice as well as in the healthcare system;

–  Trans-border aspects of infectious diseases and specific challenges in low- and middle-income countries (LMICs), such as AIDS, tuberculosis and tropical diseases, including malaria, also in relation to migratory flows and, in general, to increased human mobility.

1.2.5.  Tools, Technologies and Digital Solutions for Health and Care, including personalised medicine

Health technologies and tools are vital for public health and contributed to a large extent to the important improvements achieved in the quality of life, health and care of people, in the EU. It is thus a key strategic challenge to design, develop, deliver▌, implement and evaluate suitable, trustable, safe, user-friendly and cost-effective tools and technologies for health and care, taking due account of the needs of people with disabilities and the aging society. These include key enabling technologies from new biomaterials to biotechnology as well as single cell methods, multiomics and systems medicine approaches, artificial intelligence and other digital technologies, offering significant improvements over existing ones, as well as stimulating a competitive and sustainable health-related industry that creates high-value jobs. The European health-related industry is one of the critical economic sectors in the EU, accounting for 3% of GDP and 1.5 million employees. Relevant stakeholders need to be involved as early as possible, and the non-technological dimension will be taken into account, in order to ensure acceptability of new technologies, methodologies and tools. This includes citizens, health care providers and professionals.

Broad Lines

–  Tools and technologies for applications across the health spectrum and any relevant medical indication, including functional impairment;

–  Integrated tools, technologies, medical devices, medical imaging, biotechnology, nanomedicine and advanced therapies (including cellular and gene therapy), and digital solutions for human health and care, including artificial intelligence, mobile solutions and telehealth, while addressing, when relevant, cost-efficiency production aspects at an early stage (in order to optimize the industrialisation stage and the potential of innovation to become an affordable medicinal product);

–  Piloting, large-scale deployment, optimisation, and innovation procurement of health and care technologies and tools in real-life settings including clinical trials, implementation research including diagnostics based on personalised medicine;

–  Innovative processes and services for the development, manufacturing and rapid delivery of tools and technologies for health and care;

–  The safety, efficacy, cost-effectiveness, interoperability and quality of tools and technologies for health and care as well as their ethical, legal and social impact, including social acceptance issues;

–  Regulatory science and standards for health and care technologies and tools;

–  Health data management, including data interoperability, integration, analytical and visualisation methods, decision making processes, building on artificial intelligence, data mining, big data technologies, bioinformatics and high performance computing technologies to foster personalised medicine including prevention, and to optimise the health journey.

1.2.6.  Health Care Systems

Health systems are a key asset of the EU social systems, accounting for 24 million employees in the health and social work sector in 2017. It is a main priority of Member States to render health systems safe and secure, accessible for all, integrated, cost-effective, resilient, sustainable and trusted with timely and relevant services, as well as to reduce inequalities, including by unleashing the potential of data-driven and digital innovation for better health and person-centred care building on open and safe European data infrastructures. New opportunities such as 5G deployment, the concept of ‘digital twins’ and the Internet of Things will advance the digital transformation of health and care.

Broad Lines

–  Supporting the knowledge base for reforms in health systems and policies in Europe and beyond;

–  New models and approaches for health and care, including personalised medicine approaches, management and organisational aspects, and their transferability or adaptation from one country/region to another;

–  Improving health technology assessment;

–  Evolution of health inequality and effective policy response;

–  Future health workforce and its needs, including digital skills;

–  Improving timely, reliable, safe and trustworthy health information and use/reuse of health data, including electronic health records, with due attention to data protection, including the misuse of personal life style and health information, security, accessibility, interoperability, standards, comparability and integrity;

–  Health systems resilience in absorbing the impact of crises and to accommodate disruptive innovation;

–  Solutions for citizen and patient empowerment, self-monitoring, and interaction with health and social care professionals, for more integrated care and a user-centred approach, while considering equal access;

–  Data, information, knowledge and best practice from health systems research at EU-level and globally building on existing knowledge and databases.

2.  CLUSTER 'CULTURE, CREATIVITY AND ▌INCLUSIVE SOCIETY'

2.1.  Rationale

The EU stands for a unique way of combining economic growth with sustainable development goals and social policies, with high levels of social inclusion, shared values embracing democracy, human rights, gender equality and the richness of diversity. This model is constantly evolving and needs to deal with the challenges from amongst other things, globalisation and technological change and rising inequalities.

The EU must promote a model of inclusive and sustainable growth while reaping the benefits of technological advancements, enhancing trust in and promoting innovation of democratic governance, fostering education, combatting inequalities, unemployment, marginalisation, discrimination and radicalisation, guaranteeing human rights, fostering cultural diversity and European cultural heritage and empowering citizens through social innovation. The management of migration and the integration of migrants will also continue to be priority issues. The role of research and innovation in social sciences, humanities, and arts, as well as in the cultural and creative sectors, in responding to these challenges and achieving the EU’s goals is fundamental. In particular SSH aspects are included in all intervention areas of this cluster.

The magnitude, complexity, intergenerational and trans-national character of the challenges call for multi-layered EU action. Addressing such critical social, political, cultural and economic issues only at national level would carry the danger of inefficient use of resources, fragmented approaches and dissimilar standards of knowledge and capacity.

Research and Innovation activities in this Global Challenge will be overall aligned with the EU's priorities on Democratic Change; Jobs, Growth and Investment; Justice and Fundamental Rights; Migration; A Deeper and Fairer European Monetary Union; Digital Single Market. It will respond to the commitment of the Rome Agenda to work towards: "a social Europe" and "a Union which preserves our cultural heritage and promotes cultural diversity". It will also support the European Pillar of Social Rights, and the Global Compact for safe, orderly and regular migration. Synergies with the Justice Programme and with the Rights and Values Programme, which support activities in the area of access to justice, victims' rights, gender equality, non-discrimination, data protection and promotion of the European citizenship, as well as with the Creative Europe and Digital Europe programme, Erasmus, Erasmus+ and European Social Fund Plus, will be exploited.

Activities will contribute directly to the following Sustainable Development Goals (SDGs) in particular: SDG 1 - No Poverty; SDG 3 – Good Health and Well-Being for People; SDG 4 - Quality Education; SDG 5 - Gender Equality; SDG 8 – Decent Work and Economic Growth; SDG 9 – Industry, Innovation and Infrastructure; SDG 10 - Reducing Inequalities; SDG 11- Sustainable Cities and Communities; SDG 16 – Peace, Justice and Strong Institutions.

2.2.  Areas of Intervention

2.2.1.  Democracy and Governance

Trust in democracy and established political institutions seems to be receding. Disenchantment with politics is increasingly articulated by anti-establishment and populist parties and a resurgent nativism. This is compounded by socio-economic inequalities, high migration flows and security concerns, among others. Responding to present and future challenges requires new thinking on how democratic institutions at all levels must adapt in a context of greater diversity, global economic competition, rapid technological advancements and digitisation, with citizens' experience of democratic discourses, practices and institutions being crucial.

Broad Lines

–  The history, evolution and efficacy of democracies, at different levels and in different forms; the role of education, cultural and youth policies as cornerstones of democratic citizenship;

–  The role of social capital and access to culture in strengthening democratic dialogue and civic participation, open and trusting societies.

–  Innovative and responsible approaches to support the transparency, accessibility, responsiveness, accountability, trustworthiness, resilience, effectiveness and legitimacy of democratic governance in full respect of fundamental and human rights and of the rule of law;

–  Strategies to address populism, racism, polarisation, corruption, extremism, radicalisation, terrorism and to include, empower and engage citizens;

–  Analysis and development of social, economic and political inclusion and inter-cultural dynamics in Europe and beyond;

–  Better understand the role of journalistic standards and user-generated content in a hyper-connected society and develop tools to combat disinformation;

–  The role of multi-cultural including spiritual identities in relation to democracy, citizenship and political engagement, as well as EU founding values such as respect, tolerance, gender equality, cooperation and dialogue;

–  Support research to understand identity and belonging across communities, regions and nations;

–  The impact of technological and scientific advancements, including big data, online social networks and artificial intelligence on democracy, privacy and the freedom of speech;

–  Deliberative, participatory and direct democracy and governance and active and inclusive citizenship, including the digital dimension;

–  The impact of economic and social inequalities on political participation and democratic governance, and research on to what extent it can contribute to reversing inequalities and combatting all forms of discrimination including gender, to a more resilient democracy;

–  Human, social and political dimensions of criminality, dogmatism and radicalisation, in relation to those engaged or potentially engaged in such behaviour as well as to those affected or potentially affected;

–  Combatting disinformation, fake news and hate speech, and their impact in shaping the public sphere;

–  The EU as an international and regional actor in multilateral governance, including new approaches to science diplomacy.

–  Efficiency of justice systems and improved access to justice based on judiciary independence and principles and human rights, with fair, efficient and transparent procedural methods both in civil and criminal matters.

2.2.2.  Cultural Heritage

The European cultural and creative sectors build bridges between arts, culture, spiritual beliefs and experiences and cultural heritage, business and technology. Furthermore, Cultural and Creative Industries (CCIs) play a key role in reindustrialising Europe, are a driver for growth and are in a strategic position to trigger innovative spill-overs in other industrial sectors, such as tourism, retail, media and digital technologies and engineering. Cultural heritage forms an integral part of the cultural and creative sectors and is the fabric of our lives, meaningful to communities, groups and societies, giving a sense of belonging. It is the bridge between the past and the future of our societies. A better understanding of our cultural heritage and how it is perceived and interpreted are vital to creating an inclusive society in Europe and worldwide. It is also a driving force of European, national, regional and local economies and a powerful source of inspiration for creative and cultural industries. Accessing, conserving, safeguarding and restoring, interpreting and harnessing the full potential of our cultural heritage are crucial challenges now and for future generations. Cultural heritage, tangible and intangible, is the major input and inspiration for the arts, traditional craftsmanship, the cultural, creative and entrepreneurial sectors that are drivers of sustainable economic growth, new job creation and external trade. In this sense, both innovation and resilience of cultural heritage need to be considered in collaboration with local communities and relevant stakeholders. It also may serve as an agent of cultural diplomacy and as a factor of identity building and cultural and social cohesion.

Broad Lines

–  Heritage studies and sciences, with cutting edge technologies and innovative methodologies, including digital ones;

–  Access to and sharing of cultural heritage, with innovative patterns and uses and participatory management models;

–  Research for the accessibility of cultural heritage through new technologies, such as cloud services, including but not limited to a European cultural heritage collaborative space, as well as encouraging and facilitating transmission of know-how and skills. This will be preceded by an impact assessment;

–  Sustainable business models to strengthen the financial foundation of the heritage sector;

–  Connect cultural heritage with emerging creative sectors, including interactive media, and social innovation;

–  The contribution of cultural heritage to sustainable development through conservation, safeguarding, developing and regeneration of cultural landscapes, with the EU as a laboratory for heritage-based innovation and sustainable cultural tourism;

–  Conservation, safeguarding, enhancement, restoration and sustainable management of cultural heritage and languages including the use of traditional skills and crafts or cutting edge technologies including digital;

–  Influence of cultural memories, traditions, behavioural patterns, perceptions, beliefs, values, sense of belonging and identities. The role of culture and cultural heritage in multi-cultural societies and patterns of cultural inclusion and exclusion.

2.2.3.  Social and Economic Transformations

European societies are undergoing profound socio-economic and cultural transformations, especially as a result of globalisation and technological innovations. At the same time there has been an increase in income inequality in most European countries(15). Forward-looking policies are needed, with a view to promoting sustainable and inclusive growth, gender equality, well-being and reversing inequalities, boosting productivity (including advancements in its measurement), socio-spatial inequalities and human capital, understanding and responding to migration and integration challenges and supporting intergenerational solidarity, intercultural dialogue and social mobility. Accessible, inclusive and high quality education and training systems are needed for a more equitable and prosperous future.

Broad Lines

–  Knowledge base for advice on investments and policies especially education and training, for high value added skills, productivity, social mobility, growth, social innovation and job creation. The role of education and training to tackle inequalities and underpin inclusion, including school-failure prevention;

–  Social sustainability beyond GDP only indicators especially new economic and business models and new financial technologies;

–  Statistical and other economic tools for a better understanding of growth and innovation in a context of sluggish productivity gains and/or structural economic changes;

–  New governance models in emerging economic areas and market institutions;

–  New types of work, the role of work, upskilling, trends and changes in labour markets and income in contemporary societies, and their impacts on income distribution, work-life balance, working environments, non-discrimination including gender equality and social inclusion;

–  Greater understanding of the societal changes in Europe and their impact;

–  The effects of social, technological and economic transformations on access to safe, healthy, affordable and sustainable housing;

–  Tax and benefits systems together with social security and social investment policies with a view to reversing inequalities in a fair and sustainable way and addressing the impacts of technology, demographics and diversity;

–  Inclusive and sustainable development and growth models for urban, semi-urban and rural environments;

–  Understanding human mobility and its impacts in the context of social and economic transformations, considered in the global and local scales for better migration governance, respect of differences, long-term integration of migrants including refugees and impact of related policy interventions; respect of international commitments and human rights and issues of development aid and cooperation; greater, improved access to quality education, training, labour market, culture, support services, active and inclusive citizenship especially for the vulnerable, including migrants;

–  Tackling of major challenges concerning European models for social cohesion, immigration, integration, demographic change, ageing, disability, education, poverty and social exclusion;

–   Advanced strategies and innovative methods for gender equality in all social, economic and cultural domains, and to deal with gender biases and gender-based violence.

–  Education and training systems to foster and make the best use of the EU's digital transformation, also to manage the risks from global interconnectedness and technological innovations, especially emerging online risks, ethical concerns, socio-economic inequalities and radical changes in markets;

–  Modernisation of public authorities governance and management systems to engage citizens and meet their expectation regarding service provision, transparency, accessibility, openness, accountability and user centricity.

3.  CLUSTER 'CIVIL SECURITY FOR SOCIETY'

3.1.  Rationale

European cooperation has contributed to an era of unprecedented peace, stability and prosperity on the European continent. However, Europe has to respond to the challenges arising from persistent threats to the security of our increasingly complex and digitalised society. Terrorist attacks and radicalisation, as well as cyber-attacks and hybrid threats, raise major security concerns and put particular strain on societies. New, emerging security threats caused by new technologies in the near future, also require attention. Future security and prosperity depend on improving the abilities to protect Europe against such threats. These cannot be dealt with purely by technological means but require knowledge about people, their history, culture and behaviour, and include ethical considerations regarding the balance between security and freedom. Moreover, Europe has to ensure its non-dependence on security-critical technologies and support the development of breakthrough security technologies.

European citizens, state institutions, EU bodies and the economy need to be protected from the continued threats of terrorism and organised crime, including firearms trafficking, drug trafficking and trafficking in human beings and trafficking of cultural goods. Human and social dimensions of criminality and violent radicalisation require better understanding so as to improve public policies in terms of security. Strengthening protection and security through better border management, including maritime and land borders, is also key. Cybercrime is on the increase and related risks are diversifying as the economy and society digitalise. Europe needs to continue its efforts to improve cybersecurity, digital privacy, personal data protection and combat the spread of false and harmful information in order to safeguard democratic, social and economic stability. Further efforts are required to limit the effects on lives and livelihoods of extreme weather events which are intensifying due to climate change, such as floods, storms, heat waves or droughts leading to forest fires, land degradation and other natural disasters, e.g. earthquakes. Disasters, whether natural or human-made, can put at risk important societal functions and critical infrastructures, such as communication, health, food, drinking water, energy supply, transport, security and government.

This requires both technical research and research into the human factors involved to improve disaster resilience, including, where appropriate, testing applications, training and cyber hygiene and education. More efforts are needed to evaluate the results of security research and promote their uptake.

This cluster will seek synergies, in particular with the following Programmes: Internal Security Fund, Integrated Border Management Fund and Digital Europe as well as improved research and innovation cooperation between intergovernmental agencies and organisations including through exchange and consultation mechanisms for example in the intervention area 'Protection and Security'.

Security research is part of the wider comprehensive EU response to security threats. It contributes to the capability development process by enabling the future availability of technologies, techniques and applications to fill capability gaps identified by policy-makers and practitioners and civil society organisations. Already, funding to research through the EU's framework programme has represented around 50% of total public funding for security research in the EU. Full use will be made of available instruments, including the European space programme (Galileo and EGNOS, Copernicus, Space Situational Awareness and Governmental Satellite Communications). Whereas research and innovation activities under this Programme will have an exclusive focus on civil applications, coordination with EU-funded defence research will be sought in order to strengthen synergies, recognizing that there are areas of dual-use technology. Duplication of funding is avoided. Cross-border collaboration contributes to developing a European single security market and improving industrial performance, underpinning the EU's autonomy. Due attention will be given to the human understanding and perception of security.

Security research responds to the commitment of the Rome Agenda to work towards "a safe and secure Europe", contributing to a genuine and effective Security Union

Activities will contribute directly to the following Sustainable Development Goals (SDGs) in particular: SDG 16 – Peace, Justice and Strong Institutions.

3.1.1.   Disaster-Resilient Societies

Disasters may arise from multiple sources, whether natural or human-made, including those from terrorist attacks, climate-related and other extreme events (including from sea level rises), from forest fires, heat waves, floods, droughts, desertification, earthquakes, tsunamis and volcanic events, from water crises, from space weather events, from industrial and transport disasters, from CBRN events, as well as those from resulting cascading risks. The aim is to prevent and reduce the loss of life, harm to health and the environment, trauma as well as economic and material damage from disasters, ensure food, medicine supply and services and water security as well as to improve the understanding and reduction of disaster risks and enhance post-disaster recovery. This implies covering the full spectrum of crisis management: from prevention and training, to crisis management and post-crisis management and resilience.

Broad Lines

–  Technologies, capabilities and governance for first responders for emergency operations in crisis, disaster and post-disaster situations and the initial phase of recovery;

–  The capacities of society to better prevent, manage and reduce disaster risk, including through nature-based solutions, by enhancing forecasting capabilities, prevention, preparedness and response to existing and new risks and domino effects, impact assessment and a better understanding of the human factor in risk management and risk communication strategies;

–  More effectively support the build-back-better philosophy of the Sendai Framework through better understanding of post-disaster recovery and research into more effective post-disaster risk assessment.

–  Interoperability of equipment and procedures to facilitate cross-border operational cooperation and an integrated EU market.

3.1.2.   Protection and Security

There is a need to protect citizens from and to respond to security threats from criminal including terrorist activities and hybrid threats; to protect people, public spaces and critical infrastructure, from both physical (including CBRN-E) attacks and cyber-attacks; to fight terrorism and violent radicalisation, including understanding and tackling terrorist ideas and beliefs; to prevent and fight serious crime, including cybercrime, and organised crime (such as piracy and counterfeiting of products); to support victims; to trace criminal financial flows; to develop new forensic capabilities; to support the use of data for law enforcement and to ensure the protection of personal data in law enforcement activities; to strengthen border protection capabilities, to support air, land and sea EU border management, for flows of people and goods and to understand the human factor in all these security threats and in their prevention and mitigation. It is essential to maintain flexibility to rapidly address new and unforeseen security challenges that may arise.

Broad Lines

–  Innovative approaches and technologies for security practitioners (such as police forces, fire brigades, medical services, border and coast guards, customs offices), in particular in the context of digital transformation and interoperability of security forces, operators of infrastructure, civil society organisations, and those managing open spaces;

–  Analysis of cross-border crime phenomena, advanced methods of fast, reliable, standardised and privacy enhanced data sharing and collection as well as best practices;

—  Human and socio-economic dimensions of criminality and violent radicalisation, in relation to those engaged or potentially engaged in such behaviour as well as to those affected or potentially affected, including understanding and tackling terrorist ideas and beliefs and crimes based on gender, sexual orientation or racial discrimination;

—  Analysis of security aspects of new technologies such as DNA-sequencing, genome editing, nanomaterials and functional materials, Artificial Intelligence, autonomous systems, drones, robotics, quantum computing, cryptocurrencies, 3D printing and wearables, blockchain, as well as improving awareness of citizens, public authorities and industry to prevent the creation of new security risks and to reduce existing risks, including from those new technologies;

–  Improved foresight and analysis capabilities for policy making and at strategic level on security threats;

–  Protection of critical infrastructures as well as open and public spaces from physical, digital and hybrid threats, including the effects of climate change;

–  Monitoring and combatting disinformation and fake news with implications for security, including developing capabilities to detect the sources of manipulation;

–  Technological development for civil applications with the scope to enhance, where appropriate, interoperability between civil protection and military forces;

–  Interoperability of equipment and procedures to facilitate cross-border, intergovernmental and inter-agency operational cooperation, and develop an integrated EU market;

–  Developing tools and methods for an effective and efficient Integrated Border Management, in particular to increase reaction capability and improved capacity to monitor movements across external borders to enhance risk detection, incident responding and crime prevention;

–  Detection of fraudulent activities at border crossing points and throughout the supply chain, including identifying forged or otherwise manipulated documents and detecting trafficking in human beings and illicit goods;

–  Ensuring the protection of personal data in law enforcement activities, in particular in view of rapid technological developments, including confidentiality and integrity of information and traceability and processing of all transactions;

–  Developing techniques for identifying counterfeit products, for enhancing protection of original parts and goods and for controlling transported products.

3.1.3.   Cybersecurity

Malicious cyber activities not only threaten our economies but also the very functioning of our democracies, our freedoms and our values. Cyber threats are often criminal, motivated by profit, but they can also be political and strategic. Our future security, freedom, democracy and prosperity depend on improving our ability to protect the EU against cyber threats. The digital transformation requires improving cybersecurity substantially, to ensure the protection of the huge number of IoT devices expected to be connected to the internet, and the safe operation of network and information systems, including for power grids, drinking water supply and distribution, vehicles and transport systems, hospitals, finances, public institutions, factories, homes. Europe must build resilience to cyber-attacks and create effective cyber deterrence, while making sure that data protection and the freedom of citizens are strengthened. It is in the Union's interest to ensure that it develops and retains essential cybersecurity strategic capacities in order to secure the Digital Single Market, and, in particular, to ensure the protection of critical networks and of information systems and to provide key cybersecurity services. The Union must be in a position to autonomously secure its digital assets and to compete on the global cybersecurity market.

Broad Lines

–  Technologies across the digital value chain (from secure components and quantum-resistant cryptography to self-healing software and networks);

–  Technologies, methods, standards and best practices to address cybersecurity threats, anticipating future needs, and sustaining a competitive European industry, including tools for electronic identification, threat detection, cyber hygiene, as well as training and education resources;

–  An open collaboration for European cybersecurity competence network and competence centre.

4.   CLUSTER 'DIGITAL, INDUSTRY AND SPACE'

4.1.   Rationale

To ensure industrial competitiveness and the capacity to address the global challenges ahead, the EU must increase its technological sovereignty and its scientific, technological and industrial capacities in the key areas that underpin the transformation of our economy, the work place and society.

EU industry provides one out of five jobs and two thirds of private sector R&D investments and generates 80% of EU exports. A new wave of innovation, involving a merging of physical and digital technologies, will trigger huge opportunities for EU industry and improve the quality of life for EU citizens.

Digitisation is a major driver. As it continues at a rapid pace across all sectors, investment in priority areas ranging from trustworthy artificial intelligence to next generation internet, high performance computing, photonics, quantum technologies, robotics and micro-/nano-electronics, becomes essential for the strength of our economy and the sustainability of our society. Investing, producing and using digital technologies provides a major boost to EU economic growth, amounting to an increase of 30% between 2001 and 2011 alone. In this context, the role of SMEs remains fundamental in the EU, both in terms of growth and jobs. Digital uptake among SMEs promotes competitiveness and sustainability.

Key enabling technologies(16) underpin the blending of the digital and the physical worlds, central to this new global wave of innovation. Investing in research, development, demonstration and deployment of key enabling technologies, and ensuring a secure, sustainable and affordable supply of raw and advanced materials, will secure EU strategic autonomy and help EU industry to significantly reduce its carbon and environmental footprints.

Specific future and emerging technologies will also be pursued as appropriate.

Space is of strategic importance; around 10% of the EU's GDP depends on the use of space services. The EU has a world-class space sector, with a strong satellite manufacturing industry and a dynamic downstream services sector. Space provides important tools for monitoring, communication, navigation, and surveillance and opens up many business opportunities especially in combination with digital technologies and other sources of data. The EU must make the most of these opportunities by fully exploiting the potential of its space programmes Copernicus, EGNOS and Galileo, and by protecting space and ground infrastructures against threats from space.

The EU has the unique chance of being a global leader and increase its share of world markets, by showcasing how digital transformation, leadership in key enabling and space technologies, the transition to a low-carbon, circular economy and competitiveness can reinforce each other through scientific and technological excellence.

To make the digitised, circular, low-carbon and low-emission economy a reality, action is needed at EU level because of the complexity of value chains, the systemic and multi-disciplinary nature of the technologies and their high development costs, and the cross-sectoral nature of the problems to be addressed. The EU must ensure that all industrial players, and society at large, can benefit from advanced and clean technologies and digitalisation. Developing technologies alone will not suffice. A societal understanding of these technologies and evolutions is crucial for engaging end users and behavioural change.

Industrially-oriented infrastructures, including pilot lines, will help EU businesses, and in particular SMEs, deploy these technologies and improve their innovation performance and may be facilitated also by other EU programmes.

A strong engagement of industry and civil society is essential for setting priorities and developing research and innovation agendas, increasing the leverage of public funding through private and public investments, and ensuring the better uptake of results. Societal understanding and acceptance, including consideration of the design of products, goods and services, are key ingredients for success, as well as a new agenda for industry-relevant skills and standardisation.

Bringing together activities on digital, key enabling and space technologies, as well as a sustainable supply of raw materials, will allow for a more systemic approach, and a faster and more profound digital and industrial transformation. It will ensure that research and innovation in these areas feed into, and contribute to the implementation of, the EU’s policies for industry, digitisation, environment, energy and climate, circular economy, raw and advanced materials and space.

Complementarity will be ensured with activities in particular under the Digital Europe Programme and the Space Programme, while respecting the delineation between Programmes and avoiding overlaps.

Activities will contribute directly to the following Sustainable Development Goals (SDGs) in particular: SDG 8 - Decent Work and Economic Growth; SDG 9 - Industry, Innovation and Infrastructure; SDG 12 - Responsible Consumption and Production; SDG-13 Climate Action.

4.2.   Areas of Intervention

4.2.1.   Manufacturing Technologies

Manufacturing is a key driver of employment and prosperity in the EU, producing over three quarters of the EU's global exports and providing over a 100 million direct and indirect jobs. The key challenge for EU manufacturing is to remain competitive at a global level with smarter and more customised products of high added value, produced at much lower energy and material resource costs as well as with a reduced carbon and environmental footprint. Creative and cultural inputs as well as perspectives from social sciences and humanities on the relation between technology and people in production will be vital to help generate added value. The impact on work life and employment will be studied as well.

Broad Lines

–  Breakthrough manufacturing technologies such as biotechnological production, additive manufacturing, industrial, collaborative, flexible and intelligent robotics, human integrated manufacturing systems, also promoted via an EU network of industrially-oriented infrastructures, which provide services to accelerate technological transformation and uptake by EU industry;

–  Breakthrough innovations using different enabling technologies across the value chain. Examples are converging technologies, artificial intelligence, digital twin, data analytics, control technologies, sensor technologies, industrial, collaborative and intelligent robotics, human-centred systems, biotechnological production, advanced batteries and hydrogen, including renewable based hydrogen, and fuel cell technologies, advanced plasma and laser technologies;

–  Skills, workspaces and businesses fully adapted to the new technologies, in line with European social values;

–  Flexible, high-precision, zero-defect, low-pollution and waste, sustainable and climate-neutral cognitive plants, in line with the circular economy approach, smart and energy efficient manufacturing systems meeting customer needs;

–  Breakthrough innovations in techniques for exploring construction sites, for full automation for on-site assembly and prefabricated components.

4.2.2.   Key Digital Technologies

Maintaining and autonomously developing strong design and production capacities in essential digital technologies such as micro- and nano-electronics, microsystems, photonics, software and cyber-physical systems, and their integration as well as advanced materials for these applications will be essential for a competitive citizen-centered and social EU.

Broad Lines

–  Micro- and nano-electronics, including design and processing concepts, components and manufacturing equipment responding to the specific requirements of digital transformation and global challenges, in terms of performance functionality, energy and material consumption and integration;

–  Efficient and secure sensing and actuating technologies and their co-integration with computational units as the enabler of industry and the Internet of Things, including innovative solutions on flexible and conformable materials for human-friendly interacting objects;

–  Technologies as complements or alternatives to nano-electronics, such as integrated quantum computing, transmission and sensing as well as neuromorphic computing components and spintronics;

–  Computing architectures and accelerators, low-power processors for a wide range of applications including neuromorphic computing powering artificial intelligence applications, edge computing, digitisation of industry, big data and cloud computing, smart energy and connected and automated mobility;

–  Computing hardware designs delivering strong guarantees of trusted execution, with built-in privacy and security protection measures for input/output data, quantum computing as well as processing instructions and adequate human machine interfaces;

–  Photonics technologies enabling applications with breakthrough advances in functionality, integration and performance;

–  System and control engineering technologies to support flexible, evolvable and fully autonomous systems for trustworthy applications interacting with the physical world and humans, including in industrial and safety critical domains;

–  Software technologies enhancing software quality, cybersecurity and reliability with improved service life, increasing development productivity, and introducing built-in artificial intelligence and resilience in software and their architecture;

–  Emerging technologies expanding digital technologies .

4.2.3.  Emerging enabling technologies

Key Enabling Technologies have demonstrated their potential to stimulate innovation in and across many sectors(17). To facilitate the development of new enabling technologies and feed the innovation pipeline, transformative research themes must be identified and supported from an early exploratory stage to demonstrations in pilot applications. Furthermore, emerging, often interdisciplinary, communities need to be assisted to reach the critical mass enabling them to systematically develop and mature promising technologies. The goal is to bring emerging enabling technologies to levels of maturity that allow inclusion into industrial research and innovation roadmaps.

Broad lines

—  support for future and emerging trends in key enabling technologies;

—  support for emerging communities involving a human-centred approach from the outset;

—  assessing the disruptive potential of new emerging industrial technologies, and their impact on people, industry, society and the environment, building interfaces with industrial roadmaps;

—  broaden the industrial basis for adopting technologies and innovation with breakthrough potential, including development of human resources and in the global context.

4.2.4.   Advanced Materials

The EU is a global leader in advanced materials and associated processes, which make up 20% of its industry base and form the root of nearly all value chains through the transformation of raw materials. To remain competitive and meet citizens’ needs for sustainable, safe and advanced materials, the EU must invest in research for novel materials, including bio-based ones and resource efficient innovative building materials, and must improve the durability and recyclability of materials, reduce the carbon and environmental footprint, and drive cross-sectoral industrial innovation by supporting new applications in all industry sectors. Furthermore, advanced materials have a tremendous impact regarding citizens’ needs.

Broad Lines

–  Materials (including polymers, bio-, nano-, two-dimensional, smart and multi- materials (including lignocelluloses), composites, metals and alloys) and advanced materials (e.g. quantum, responsive, photonic and superconducting materials) designed with new properties and functionalisation and meeting regulatory requirements (while not leading to increased environmental pressures during their whole life-cycle, from production to use or end-of-life);

–  Integrated materials processes and production following a customer-oriented and ethical approach, including pre-normative activities and life-cycle assessment, sourcing and management of raw materials, durability, reusability and recyclability, safety, risk assessment for human health and environment and risk management;

–  Advanced materials enablers like characterisation (e.g. for quality assurance), modelling and simulation, piloting and upscaling;

–  An EU innovation ecosystem of technology infrastructures(18), networked and accessible to all relevant stakeholders, identified and prioritised in agreement with Member States, which provide services to accelerate technological transformation and uptake by EU industry, notably by SMEs; this will cover all key technologies necessary to enable innovations in the field of materials;

–  Solutions based on advanced materials for cultural heritage, design, architecture and general creativity, with a strong user orientation, for adding value to industrial sectors and the creative industries.

4.2.5.   Artificial Intelligence and Robotics

Making any object and device intelligent and connected is one of the megatrends. Researchers and innovators developing Artificial Intelligence (AI) and offering applications in Robotics and other areas will be key drivers of future economic and productivity growth. Many sectors including health, manufacturing, ship-building, construction, service industries and farming will use and further develop this key enabling technology, in other parts of the Framework Programme. AI developments must be conducted openly across the EU, ensure the safety, the societal and environmental soundness of AI-based applications, consider ethical aspects from the outset, assess the risks and mitigate its potential for malicious use and unintended discrimination such as gender, racial or disability bias. It must also be ensured that AI is developed within a well-coordinated framework which respects the EU's values, ethical principles and the Charter of Fundamental Rights of the European Union. This Programme will be complemented by activities set out under the Digital Europe Programme.

Broad Lines

–  Enabling AI technologies such as explainable AI, ethical AI, human-controlled AI, unsupervised machine learning and data efficiency and advanced human-machine and machine-machine interactions;

–  Safe, smart, collaborative and efficient robotics and complex embodied and autonomous systems;

–  Human-centric AI technologies for AI-based solutions;

–  Developing and networking the research competences in the area of AI across Europe under an open collaborative perspective while also developing the capacity for closed testing;

–  The employment of AI and robotics to support people affected by disability, and inclusion of marginalised individuals;

–  Technologies for open AI platforms including software algorithms, data repositories, agent-based systems, robotics and autonomous systems platforms.

4.2.6.   Next Generation Internet

The Internet has become a key enabler of the digital transformation of all sectors of our economy and society. The EU needs to take the lead in driving the next generation Internet towards a human-centric ecosystem in line with our social and ethical values. Investing in technologies and software for the Next Generation Internet will improve EU industrial competitiveness in the global economy. Optimising EU wide take up will require large-scale cooperation across stakeholders. Ethical norms regulating next-generation internet should be also considered.

Broad Lines

–  Technologies and systems for trusted and energy-efficient smart network and service infrastructures (connectivity beyond 5G, software defined infrastructures, Internet of things, systems of systems, cloud infrastructures, next generation optical networks, quantum, cognitive clouds and quantum internet, integration of Satellite Communications), enabling real-time capabilities, virtualisation and decentralised management (ultrafast and flexible radio, edge computing, shared contexts and knowledge) to ensure scalable, efficient, reliable and trustworthy network performance suited for massive service deployment;

–  Next Generation Internet applications and services for consumers, industry and society building on trust, fairness, interoperability, better user control of data, transparent language access, new multi modal interaction concepts, inclusive and highly personalised access to objects, information and content, including immersive and trustworthy media, social media and social networking as well as business models for transactions and services over shared infrastructures;

–  Software-based middleware, including distributed ledger technologies such as blockchains, working in highly distributed environments, facilitating data mapping and data transfer across hybrid infrastructures with inherent data protection, embedding artificial intelligence, data analytics, security and control in Internet applications and services predicated on the free flow of data and knowledge.

4.2.7.  Advanced Computing and Big Data

High Performance Computing and Big Data have become indispensable in the new global data economy, where to out-compute is to out-compete. High Performance Computing and Big Data analytics shall be encouraged throughout the EU and are critical to support policy making, scientific leadership, innovation and industrial competitiveness, and to maintain national sovereignty while respecting ethical issues. These activities will be complemented by activities under the Digital Europe Programme.

Broad Lines

–  High Performance Computing (HPC): next generation of key exascale and post-exascale technologies and systems (e.g. low-power microprocessors, software, system integration); algorithms, codes and applications, and analytic tools and test-beds; industrial pilot test-beds and services; supporting research and innovation, and preferably participation by all the Member States, for a world-class HPC infrastructure, including the first hybrid HPC/Quantum computing infrastructures and for shared services in the EU;

–  Big Data: Extreme-performance data analytics; "Privacy by design" in the analysis of personal and confidential Big Data; technologies for full-scale data platforms for re-use of industrial, personal and open data; data management, interoperability and linking tools; data applications for global challenges; methods for data science;

–  Reduced carbon footprint of ICT processes, covering hardware, architecture, communication protocols, software, sensors, networks, storage and data centres, and including standardised assessments.

4.2.8.  Circular Industries

Europe is at the forefront of the global transition towards a circular economy. Europe's industry should become a circular industry: the value of resources, materials and products should be maintained much longer compared to today, even opening up new value chains. Engagement of citizens is crucial.

Primary raw materials will continue to play an important role in the circular economy and attention must be paid to their sustainable sourcing, usage and production. Safe and sustainable materials cycles shall be ensured. In addition, entirely new materials, including bio-based materials, products and processes should be designed for circularity. Building a circular industry will have several advantages for Europe: It will lead to a secure, sustainable and affordable supply of raw materials, which will in turn protect the industry against scarcity of resources and price volatility. It will also create new business opportunities and innovative, more resource and energy efficient ways of production. Research and development focused on developing less hazardous substances will be encouraged and stimulated.

The objective is to develop affordable breakthrough innovations and deploy a combination of advanced technologies and processes so as to extract maximum value from all resources.

Broad Lines

–  Industrial symbiosis with resource flows between plants across sectors and urban communities; processes and materials, to transport, transform, re-use and store resources, combining the valorisation of by-products, waste, waste-water and CO2;

–  Valorisation and life-cycle assessment of materials and product streams with use of new alternative feedstocks, resource control, material tracking and sorting (including validated testing methods and tools for risk assessment for human health and environment);

–  Eco-designed products, services and new business models for enhanced life-cycle performance, durability, upgradeability and ease of repair, dismantling, reuse and recycling;

–  Effective recycling industry, maximising potential and safety of secondary materials and minimising pollution (non-toxic material cycles), quality downgrading, and quantity dropouts after treatment;

–  Elimination or, if no alternative, safe handling of substances of concern in the production and end-of-life phases; safe substitutes, and safe and cost-efficient production technologies;

–  Sustainable supply and substitution of raw materials, including critical raw materials, covering the whole value chain.

4.2.9.  Low-Carbon and Clean Industries

Industrial sectors, including energy-intensive industries, such as steel, contribute millions of jobs and their competitiveness is key for the prosperity of our societies. However, they account for 20% of the global greenhouse gas emissions and have a high environmental impact (particularly in terms of air, water and soil pollutants).

Breakthrough technologies to achieve significant reductions in greenhouse gases and pollutants and EU’s energy demand, often combined with the technologies for circular industry above, will lead to strong industrial value chains, revolutionise manufacturing capacities and improve the global competitiveness of industry; and at the same time make key contributions to our targets for climate action and environmental quality.

Broad Lines

–  Process technologies, including heating and cooling, digital tools, automation and large-scale demonstrations for process performance and resource and energy efficiency; substantial reductions or avoidance of industrial emissions of greenhouse gases and pollutants, including particulate matter;

–  CO2 valorisation from industry and other sectors;

–  Conversion technologies for the sustainable utilization of carbon sources to increase resource efficiency and reduce emissions, including hybrid energy systems for the industry and energy sector with a decarbonisation potential;

–  Electrification and use of unconventional energy sources within industrial plants, and energy and resource exchanges between industrial plants (for instance via industrial symbiosis);

–  Industrial products that require low or zero carbon emissions production processes through the life cycle.

4.2.10.   Space, including Earth Observation

EU space systems and services reduce costs and improve efficiency, offer solutions to societal challenges, increase societal resilience, help monitoring and fighting climate change and foster a competitive and sustainable economy. EU support has been instrumental in helping to realise these benefits and impacts. Research and innovation activities should also support the evolution of the Union Space Programme which must remain at the forefront.

The EU will support synergies between space and key enabling technologies (advanced manufacturing, Internet of Things, big data, photonics, quantum technologies, robotics and artificial intelligence); foster a thriving and entrepreneurial and competitive upstream and downstream space sector, including industry and SMEs; boost application of space technologies, data and services in other sectors and help secure technological non-dependence in accessing and using space in a strategic, safe and secure manner; and will promote capacity building measures. Activities will be generally roadmap-based, taking account of the ESA harmonisation process and relevant Member States initiatives, and will be implemented with ESA and the EU Agency for the Space Programme, in accordance with the Regulation establishing the Space Programme for the European Union. However, the space part will also support bottom up calls to allow the emergence of future space technologies.

There is a need for a wider deployment, exploitation and update of new technologies and continued research and innovation to address gaps in Earth Observation (EO) on land and sea and in the atmosphere (e.g. healthy oceans and seas, ecosystem protection), benefiting from Copernicus and other relevant European programmes as essential sources and coordinating through the Global Earth Observation System of Systems (GEOSS) and its European component EuroGEOSS.

Broad Lines

–  European Global Navigation Satellite Systems (Galileo and EGNOS): innovative applications, global uptake including international partners, solutions improving robustness, authentication, integrity of services, development of fundamental elements such as chipsets, receivers and antennas, sustainability of supply chains, at cost-effective and affordable conditions, new technologies (e.g. quantum technologies, optical links, reprogrammable payloads), towards sustained exploitation of services for impact on societal challenges. Next generation systems development for new challenges such as security or autonomous driving;

–  European Earth Observation system (Copernicus): leveraging the full, free and open data policy, develop innovative applications, European and global uptake, including non-space actors and international partnerships, research needed to maintain, improve and expand core services and research for space data assimilation and exploitation, robustness and evolution of services, sustainability of supply chains, sensors, systems and mission concepts (e.g. High Altitude Platforms, drones, light satellites); calibration and validation; sustained exploitation of services and impact on societal challenges; Earth observation data processing techniques, including big data, computing resources and algorithmic tools. Next generation systems development for challenges such as climate change, polar and security; extension of the Copernicus product and service portfolio;

–  Space Situational Awareness: developments to support robust EU capacity to monitor and forecast the state of the space environment e.g. space weather, including radiation hazards, space debris and near Earth objects. Developments of sensors technologies and new service concepts, such as space traffic management, applications and services to secure critical infrastructure in space and on Earth;

–  Secure Satellite Communications for EU governmental actors: solutions supporting the EU’s autonomy for governmental users including associated user equipment and architectural, technological and system solutions for space and ground infrastructure;

–  Satellite Communications for citizens and businesses: integration of cost-effective, advanced satellite communications in the terrestrial networks to connect assets and people in underserved areas, as part of 5G-enabled ubiquitous connectivity, ▌Internet of Things (IoT), and contributing to the Next Generation Internet (NGI) infrastructure. Enhancing the ground segment and user equipment, standardisation and interoperability, and preparation of quantum key communication by satellite to ensure EU industrial leadership;

–  Non-dependence and sustainability of the supply chain: increased technology readiness levels in satellites and launchers; associated space and ground segments, and production and testing facilities in complementarity with ESA. To secure EU technological leadership and autonomy, improved supply chain sustainability at cost-effective and affordable conditions, reduced dependence on non-EU critical space technologies and improved knowledge of how space technologies can offer solutions to other industrial sectors and vice-versa;

–  Space systems: in-orbit validation and demonstration services, including rideshare services for light satellites; space demonstrators in areas such as hybrid, smart or reconfigurable satellites, in-orbit servicing, manufacturing and assembly, energy supply using diversified sources; new industrial processes and production tools; ground systems; breakthrough innovations, and technology transfer, in areas such as recycling, green space, sustainable and peaceful use of space resources, artificial intelligence, robotics, digitisation, cost-efficiency, miniaturisation;

–  Access to space: innovative technologies for increasing the technical compatibility and economic efficiency of European space launch systems, with regard to the launch of European Union satellites: low cost production processes, launcher reusability technologies and concepts for cost reduction; concepts for future launcher ground segments and adaptations of existing ground infrastructures (e.g. digitalisation, advanced data management); innovative space transportation services/concepts, including launch systems dedicated to light satellites (e.g. micro launchers), in complementarity with ESA.

–  Space science: exploitation of scientific data delivered by scientific and exploration missions, combined with the development of innovative instruments in an international and interdisciplinary environment; contribution to precursor scientific missions for the evolution of the Space Programme.

5.   CLUSTER 'CLIMATE, ENERGY AND MOBILITY'

5.1.   Rationale

The intersection of research and innovation on climate, energy and mobility will address in a highly integrated and effective way, one of the most important global challenges for the sustainability and future of our environment, economy and way of life.

To meet the objectives of the Paris Agreement the EU will need to transition to climate neutral, resource-efficient and resilient economies and societies. This will entail profound changes in technology, processes, products and services, to the ways in which businesses and consumers behave. The transformation of the energy market will take place through interaction of technology, infrastructure, the market as well as policy and regulatory frameworks, including new forms of governance. Pursuing efforts to limit the temperature increase to 1.5°C, requires rapid progress in decarbonising the energy▌, transport, buildings, industrial and agriculture sectors. New impetus is needed to accelerate the pace of developing next-generation breakthroughs as well as demonstrating and deploying cost-efficient innovative technologies and solutions, using also the opportunities provided by digital, bio and space technologies, as well as key enabling technologies and advanced materials. This will be pursued through an integrated approach encompassing decarbonisation, resource efficiency, improved recovery, reuse and recycling, reduction of air pollution, access to raw materials and circular economy in Horizon Europe.

Progress in these sectors - but also across the spectrum of EU industry including energy infrastructures, transport, agriculture and forestry, tourism, buildings, industrial processes and product use, waste management and recycling (19)- will require continued efforts to better understand the mechanisms and dynamics of climate change and the associated impacts across the economy and society, exploiting synergies with regional and national activities, other EU types of actions and international cooperation, including through Mission Innovation.

Over the past decades, considerable advances have been made in climate science, in particular in observations and data assimilation and climate modelling. However, the complexity of the climate-system and the need to support implementation of the Paris Agreement, the Sustainable Development Goals and EU policies necessitate a reinforced effort to fill the remaining knowledge gaps, further enhance spatial and temporal granularity of climate science while ensuring adequate interaction with citizens and other stakeholders.

The EU has established a comprehensive policy framework in the Energy Union strategy, with binding targets, legislative acts and research and innovation activities aiming to lead in developing and deploying efficient energy production systems based on renewable and alternative energy(20).

Transport, including vehicles, ensures the mobility of people and goods necessary for an integrated European single market, territorial cohesion and an open and inclusive society. At the same time, transport can have significant effects on human health, congestion, land, water, climate, air quality and noise, as well as safety resulting in numerous premature deaths and increased socio-economic costs. Demand for goods and mobility will continue to grow. Therefore, innovation will have to bridge growing demand with cleaner and more efficient mobility and transport systems that need to be also, safe, smart, secure, silent, reliable, accessible, inclusive and affordable, offering a seamless integrated door-to-door service to all.

Both sectors are major drivers of Europe’s economic competitiveness and growth. Transport is a fundamental sector for and of the economy with the EU being a world leader in vehicle, rail, aircraft and vessel design and manufacturing. It embraces a complex network of around 1.2 million private and public companies in the EU, employing around 10.5 million people. The sector is also important for the EU's international trade: in 2016, 17.2% of the EU's total exports of services were transport related. At the same time, the EU has upwards of 2 million people working in the field of renewables and energy efficiency, while patenting of innovative clean energy technologies, places the EU in second place worldwide.

The issues faced by the energy and transport sectors go therefore beyond the need for emission reduction. Effective solutions are needed to respond to changes in user behaviour and mobility patterns, globalisation, increasing international competition and an older, more urban and increasingly diverse, population. At the same time, the increasing penetration of digital and space-based technologies, automated vehicles, Artificial Intelligence, robotics, new market entrants, disruptive business models and the need for increased system resilience against multifaceted hazards (including cyber threats) bring substantive transformation and create challenges and opportunities for the competitiveness of the European transport and energy sectors.

Cities' ability to function will become dependent on technology and the liveability of cities will evolve around mobility, energy and resource efficiency, spatial planning and competition in space use. Developments will also be posing a challenge to the sustainability of existing social models and social participation, aspects of inclusion and accessibility as well as affordability.

Finding new ways to accelerate the deployment of renewable energy-based and energy efficient technologies (including through intermediate carriers such as power-to-gas and hydrogen) and other non-technological solutions for the decarbonisation of the European economy requires also increased demand for innovation. This can be stimulated through the empowerment of citizens, greening of public procurement as well as socio-economic and public sector innovation and will lead to approaches broader than technology-driven innovation. Socio-economic research covering inter alia user needs and patterns, foresight activities, environmental, regulatory, economic, social, cultural and behavioural aspects, business cases and models and pre-normative research for standard setting and market uptake innovation, will also facilitate actions fostering regulatory, financing and social innovation, skills, as well as engagement and empowerment of market players, consumers and citizens. A better coordination, complementarity and synergy between national and European research and innovation efforts by promoting information exchange and cooperation among EU countries, industries and research institutions will build on the achievements of e.g. the SET-Plan and the Strategic Transport Research and Innovation Agenda (STRIA). Complementarity between this cluster and the EU ETS Innovation Fund will be ensured.

Activities under this Cluster contribute in particular to the goals of the Energy Union, the Paris Agreement commitments as well as to those of the Digital Single Market, the Jobs, Growth and Investment agenda, the strengthening of the EU as a global actor, the new EU Industrial Policy Strategy, the Bioeconomy Strategy, the Circular Economy Action Plan, the European Battery Alliance Initiative, the Raw Materials Initiative, the Security Union and the Urban Agenda, as well as the Common Agricultural Policy of the EU as well as EU legal provisions to reduce noise and air pollution.

Activities will contribute directly to the following Sustainable Development Goals (SDGs) in particular: SDG 6 - Clean water and sanitation; SDG 7 - Affordable and Clean Energy; SDG 9 - Industry, Innovation and Infrastructure; SDG 11 - Sustainable Cities and Communities; SDG 12 – Responsible consumption and production; SDG 13 - Climate Action.

5.2.   Areas of Intervention

5.2.1.   Climate Science and Solutions

Effective implementation of the Paris Agreement has to be based on science, requiring continuously improving of our knowledge on the climate-earth system, as well as the mitigation and adaptations options available, allowing for a systemic and comprehensive picture of challenges and climate-responsible opportunities for the EU's economy and society. On this basis, science-based solutions for a cost-effective transition to a climate neutral, climate-resilient and resource-efficient society will be developed, considering behavioural, regulatory, socio-economic and governance aspects.

Broad Lines

–  Knowledge base on the current functioning and future evolution of the earth-climate and living system, as well as associated impacts, risks, and climate-responsible opportunities; effectiveness of different climate mitigation and adaptation solutions;

–  Integrated climate neutral pathways, mitigation actions and policies covering all sectors of the economy, compatible with Earth system analyses, the Paris Agreement and the United Nations Sustainable Development Goals;

–  Climate models, projections and techniques aiming to improve predictive capacity and climate services for businesses, public authorities and citizens, including cross-cutting aspects with air quality improvement;

–  Adaptation pathways and support policies for vulnerable ecosystems, urban areas, critical economic sectors and infrastructure in the EU (local/regional/national), including improved risk assessment tools; water cycle and adaptation to climate change, such as flooding and water scarcity.

5.2.2.   Energy Supply

The EU aims to be world leader in affordable, secure and sustainable energy technologies improving its competitiveness in global value chains and its position in growth markets. Diverse climatic, geographical, environmental and socio-economic conditions in the EU as well as the need to ensure climate resilience, energy security and access to raw materials, dictate a broad portfolio of energy solutions, including of non-technical nature. As regards renewable energy technologies, costs need to decrease further, performance must improve, integration into the energy system must be improved, breakthrough technologies need to be developed, benefiting also from advances in photonics, and hybrid solutions (e.g. for desalination) should be explored. As regards fossil fuels, decarbonising their usage is essential to meet the climate objectives.

Broad Lines

–  Renewable energy and energy conservation technologies and solutions for power generation, heating and cooling, sustainable transport fuels and intermediate carriers, at various scales and development stages, adapted to geographic and socio-economic conditions and markets, both within the EU and worldwide;

–  Disruptive renewable energy technologies for both existing and new applications and for breakthrough solutions including their environmental, economic and social impact;

–  Technologies and solutions to reduce greenhouse gas emissions from fossil fuel-based as well as from bio- and waste-to-energy-based approaches producing power, heating, cooling or biofuels including via carbon capture, utilisation and storage (CCUS) and studies of socio-economic and ecological feasibility.

5.2.3.   Energy Systems and Grids

The expected growth of variable electricity production and shift towards more electric heating, cooling and transport dictates the need for new approaches to manage energy grids. Next to decarbonisation, the goal is to ensure energy affordability, security, climate resilience, and stability of supply, achieved through investments in innovative network infrastructure technologies, increased flexibility of dispatchable power generation, notably from renewable sources and innovative system management as well as by facilitating actions fostering regulatory and social innovation, skills, and engaging and empowering market players, consumers and communities. Energy storage in different forms will play a key role in providing services to the grid, also improving and reinforcing network capacities and system flexibility. Exploiting synergies between different networks (e.g. electricity grids, heating and cooling networks, gas networks, transport recharging and refuelling infrastructure, hydrogen, including its infrastructure, and telecom networks) and actors (e.g. industrial sites, network operators, data centres, self-producers, consumers, renewable energy communities) as well as demand-response and developing and integrating European and international standards will be crucial for enabling the smart, integrated operation of the relevant infrastructures.

Broad Lines

–  Technologies and tools for networks to integrate renewables, storage solutions and new loads such as electro-mobility and heat pumps as well as the electrification of industrial processes;

–  Multidisciplinary approaches to regionally dependent climate change related impact to energy security, including adaptation of existing technologies, as well as transition into the new energy supply paradigms;

–  Pan-European energy network approaches to reliable energy supply, transmission and distribution;

–  Integrated approaches to match renewable energy production and consumption at local level including on islands or remote regions, based on new services and community initiatives;

–  Generation and network flexibility, interoperability and synergies between the different energy sources, networks, infrastructures and actors, also exploiting specific technologies;

—  Technologies, services and solutions empowering consumer to be an active market player.

5.2.4.   Buildings and Industrial Facilities in Energy Transition

Buildings and industry installations play an increasingly active role in their interaction with the energy system. Therefore, they are crucial elements in the transition to a carbon-neutral society based on renewable energy and increased energy efficiency.

Buildings are an important factor for quality of life of citizens. Integrating different technologies, appliances and systems and linking various energy uses, buildings as well as their inhabitants and users represent a very high potential for climate change mitigation, energy generation, energy savings, storage, system flexibility and efficiency improvements.

Industries, and especially those that are energy-intensive, could further improve energy efficiency, reduce their energy consumption and favour the integration of renewable energy sources. Industrial facilities’ role in the energy system is changing, due to the need to reduce emissions, based on direct or indirect electrification, also a source of materials for production processes (e.g. hydrogen). Industrial and manufacturing complexes where many different processes take place near to each other can optimise the exchange of flows of energy and other resources (raw materials) between them.

Broad Lines

–  Improve sector coupling: Processes, systems and business models supporting flexibility and efficiency of electricity and heat flows between an industrial plant or industrial clusters and the energy as well as transport system;

–  Tools and infrastructure for process control of production plants to optimise energy flows and materials in interaction with the energy system;

–  Relevant processes, design and materials, including low- and zero- emission industrial processes;

–  Flexibility and efficiency of electricity, feedstock and heat in industrial plants and the energy system;

–  Improved or new processes, design and materials to efficiently use, produce or store energy (including heat and cold) in sectors not covered by the “Digital, Industry and Space” cluster;

–  Strategies and low emission technologies for revitalising coal- and carbon-intensive areas in transition;

–  Smart buildings and large mobility hubs (ports, airports, logistic centres) as active elements of wider energy networks and of innovative mobility solutions;

–  Buildings life-cycle design, construction, operation, including heating and cooling and dismantling, taking into account circularity, energy and environmental performance, as well as indoor environmental quality, for energy and resource efficiency, for well-being and health impact on the inhabitants, climate resilience, carbon footprint and recycling; development and optimization of novel advanced materials to increase the energy, carbon and environmental performances of buildings over the life cycle;

–  New business models, approaches and services for renovation financing, enhancement of construction skills, engagement of buildings occupants and other market actors, addressing energy poverty and prenormative activities;

–  Energy performance of buildings monitoring and control technologies for optimising energy consumption and production of building as well as their interaction with the overall energy system;

–  Tools and smart appliances for energy efficiency gains in buildings;

–  Renovation processes of existing buildings towards 'Nearly Zero Energy Buildings' and innovative technologies, including social aspects, e.g. citizen empowerment, and consumer awareness and engagement.

5.2.5.   Communities and Cities

It is estimated that by 2050, more than 80% of the EU's population will live in urban areas, consuming the lion's share of available resources, including energy, and being areas particularly vulnerable to the adverse meteorological change impacts worsen by climate change and natural disasters already now and increasingly in the future. A key challenge is to significantly increase the overall energy and resource efficiency as well as climate-resilience of Europe's communities and cities in a systematic and holistic approach, targeting the building stock, energy systems, mobility, climate change, migration, as well as water, soil, air quality, waste and noise, taking into account Europe's cultural heritage, sustainable tourism management, social sciences, humanities and arts aspects, including lifestyle. Synergies with ERDF- funded urban policy and actions should be investigated and exploited.

Broad Lines

–  City/district energy/mobility systems towards the EU-wide deployment of carbon neutral, Positive Energy Districts and zero-emission mobility and logistics by 2050, boosting the global competitiveness of integrated EU solutions;

–  Systemic urban planning, infrastructures systems and services including mutual interfaces and interoperability, standardisation, nature-based solutions and the use of digital technologies and space based services and data, taking into account the effects of projected climate change and integrate climate resilience and the influence on air and water quality;

–  Quality of life for the citizens, safe, flexible, accessible and affordable energy and multi-modal mobility, urban social innovation and citizen engagement, cities' circular and regenerative capacity, urban metabolism and reduced environmental footprint and pollution;

–  Global cities research agenda; mitigation, adaptation and resilience strategy development, spatial planning and other relevant planning processes.

5.2.6.   Industrial Competitiveness in Transport

The shift towards clean technologies, connectivity and automation will depend on the timely design and manufacture of aircraft, vehicles and vessels developing new breakthrough technologies and concepts, integrating different technologies and accelerating their introduction and marketability. Increasing comfort, efficiency, affordability, while minimising lifecycle impact on the environment, human health and on energy use remain objectives of paramount importance. Innovative, highly capable transport infrastructure is essential for the proper functioning of all transport modes in view of increased mobility demand and rapidly changing technology regimes. An integrated approach to infrastructure and vehicle/vessel/aircraft development deserves particular attention also in order to provide high quality mobility services and to minimise energy environmental, economic and social impact.

Broad Lines

–  Merging of physical and digital vehicle/vessel/aircraft design, development and demonstration, manufacturing, operations, standardisation, certification and regulations and integration (including integration between digital design and digital manufacturing);

–  Vehicle/vessel/aircraft concepts and designs, including their spare parts and software and technology updates, software solutions; using improved materials and structures, recycling/reusing materials; efficiency, energy storage and recovery, safety and security features considering users’ needs, with less impact on climate, environment and health, including noise and air quality;

–  On-board technologies and sub-systems, including automated functions, for all modes of transport taking account of relevant infrastructure interface needs and exploring; technological synergies between modes; multi-modal transport systems; safety/accidence avoidance systems and enhancing cybersecurity; leveraging progress in information technologies, and in artificial intelligence; developing the human-machine interface;

–  New materials, techniques and methods of construction, operations and maintenance of infrastructures, ensuring reliable network availability, intermodal interfaces and multimodal interoperability, workforce safety, and full life-cycle approach;

–  Addressing issues of merging physical and digital infrastructure design and development, infrastructure maintenance, regeneration and upgrading transport integration, interoperability and intermodality, resilience to extreme weather events, including adaptation to climate change.

5.2.7.  Clean, Safe and Accessible Transport and Mobility

For the EU to reach its air quality, climate, and energy goals, including reaching net-zero emissions by 2050 as well as noise reduction, will require rethinking the whole mobility system including users’ needs and behaviours, vehicles, fuels, infrastructures as well as new mobility solutions. It will also require the deployment of low-emission alternative energies and market uptake of zero-emission vehicles/vessels/aircrafts. In addition to the effects of greenhouse gas emissions, transport contributes significantly to poor air quality and noise in Europe with negative consequences for the health of citizens and ecosystems. Building on progress with electrification and the use of batteries and fuel cells for cars, buses and light duty vehicles, accompanied by adequate standards, it is essential to accelerate research and innovation low-emission solutions for other road applications (long distance coaches, heavy freight vehicles and lorries) and other transport sectors such as aviation, rail, maritime and inland navigation . Transport safety research aims at reducing accident rates, fatalities and casualties in each mode and in the whole transport system by furthering knowledge and awareness and by developing technologies, products services and solutions that reconcile safety, efficiency, user-friendliness and climate change.

Broad Lines

–  Electrification of all transport modes including new battery, fuel cell and hybrid technologies for vehicle/vessel/aircraft powertrains and auxiliary systems, fast charging/refuelling, energy harvesting and user-friendly and easily accessible interfaces with the charging/refuelling infrastructure, ensuring interoperability and seamless services provision; development and deployment of competitive, safe, high-performing and sustainable batteries for low and zero-emission vehicles considering all the conditions of using and during the different phases of its life cycle; development and deployment of competitive, safe, high-performing and sustainable batteries for low and zero-emission vehicles;

–  Use of new and alternative sustainable fuels, including advanced bio-fuels and new, safe and smart vehicles/vessels/aircraft for existing and future mobility patterns and supporting infrastructure with reduced impact on the environment and public health; niche components and systems for environmentally friendly solutions (eg advanced data gathering systems, etc) technologies and user-based solutions for interoperability and seamless services provision;

–  Safe, accessible, inclusive and affordable mobility, reducing the harmful whilst enhancing the positive impact of mobility on social cohesion, the environment and human health, including shift to less polluting modes of transport and sharing schemes; Quality of life for the citizens, urban social innovation; the interest to reduce or to eliminate accidents and injuries in road transport.

–  Climate resilient mobility systems, including infrastructures and logistics, to assure better connectivity for persons and goods, both on short and long haul distances;

–  Systemic analysis of new mobility patterns and their impact on transport and citizens.

5.2.8.  Smart Mobility

Smart mobility will help ensure the efficiency, safety and resilience of door-to-door mobility and all its components, in particular by using digital technologies, advanced satellite navigation (EGNOS/Galileo), and artificial intelligence. New technologies will help to optimise the use and efficiency of transport infrastructure and networks, improving multi-modality and connectivity and creating more efficient freight transport and logistic supply chain that will strengthen EU competitiveness. New technologies will also contribute to increasing reliability, optimising traffic management and enable innovative transport solutions and services, thus reducing congestion and negative environmental impacts, providing better mobility and logistics services for citizens and businesses improving accessibility and social inclusion. Connected and automated mobility together with the enabling infrastructure will improve efficiency and safety in all transport modes.

Broad Lines

–  Digital network-and traffic management: advanced decision support systems; next generation traffic management (including multi-modal network and traffic management); contributing to seamless, multimodal and interconnected mobility for passengers and freight; use and limitations of big data; use of innovative satellite positioning/navigation (EGNOS/Galileo);

–  Single European Sky: on-board and on-the-ground solutions for simultaneously higher degrees of automation, connectivity, safety, interoperability, performance, emission reduction and service;

–  Rail technologies and operations for a high-capacity, silent, interoperable, and automated railway system;

–  Smart shipping solutions for safer, more efficient waterborne operations;

–  Large mobility hubs (e.g. railway stations, ports, airports, logistic centres) as active elements of innovative mobility solutions;

–  Waterborne technologies and operations for safe and automated transport systems seizing the opportunities provided by waterborne transport;

–  Connected, cooperative, interoperable and automated mobility systems and services, including technological solutions and non-technological issues, such as changes in user behaviour and mobility patterns.

5.2.9.  Energy Storage

Massive, smart, concentrated and decentralised storage solutions (comprising chemical, electrochemical, electrical, mechanical and thermal and new disruptive technologies) for the energy system will increase efficiency, flexibility, technology independence and accessibility as well as the security of supply. Low-emission, decarbonised transport will require a growing share of electrical and/or other alternatively fuelled vehicles, with better-performing and cheaper, lighter, highly recyclable and reusable batteries with a low environmental impact, as well as local provision of alternative/renewable fuels such as hydrogen, including renewable based hydrogen, and innovative solutions for on-site storage. Options for the sustainable and cost efficient large scale energy storage solutions are essential to optimize and balance the energy system in all sectors of production, infrastructure up to end-user applications. Attention should be paid to the risks of energy storage and other unwanted side effects.

Broad Lines

–  Technologies including liquid and gaseous renewable fuels and their associated value chains, as well as disruptive technologies, for daily to seasonal energy storage needs, including their impacts on the environment and climate;

–  Smart, sustainable and durable batteries and the EU value chain, including the use of advanced material solutions, design, energy-efficient large-scale battery cell production technologies, reuse and recycling methods as well as efficient operation at low temperatures and standardisation needs;

–  Hydrogen, in particular low carbon and renewable based hydrogen, including fuel cells, and the EU value chain from the design to end use across various applications.

6.  CLUSTER 'FOOD, BIOECONOMY, NATURAL RESOURCES, AGRICULTURE AND ENVIRONMENT'

6.1.   Rationale

Human activities are exerting increasing pressure on soils, seas and oceans, water, air, biodiversity and other natural resources. Nourishing the planet's growing human population is directly dependent on the health of natural systems and resources. Beyond its intrinsic value, a functioning and prosperous ecosystem is the very basis for all resources utilisation. However, combined with climate change, humankind's growing demand for natural resources creates environmental pressures that go far beyond sustainable levels, affecting ecosystems and their capacity to provide services for human well-being. The concepts of the circular economy, the sustainable bioeconomy(21) and the blue economy(22) provide an opportunity to balance environmental, social and economic goals and to set human activities on a path to sustainability.

Meeting the goals of sustainable development, guaranteeing the production and consumption of safe and healthy food, promoting sustainable practices in agriculture, aquaculture, fisheries and forestry, ensuring access to clean water, soil and air for all, cleaning up seas, oceans and inland waters preserving and restoring the planet’s vital natural systems and environment requires that we harness the potential of research and innovation. But the pathways for the transition to sustainability and ways to overcome resilient barriers are hardly understood. Making the transition to sustainable consumption and production and restoring planetary health requires investment in research and technologies, novel, high quality products and services, new business models, and social, territorial and environmental innovations. This creates new opportunities for a sustainable, resilient, innovative and responsible European bioeconomy, boosting resource efficiency, productivity and competitiveness, generating new and green jobs and growth and increasing social inclusion.

It is essential for Europe to use its natural resources more efficiently and in a sustainable manner.

Activities will build a knowledge base and deliver solutions to: protect, sustainably manage and use natural resources from land and sea(23) - and enhance the role of terrestrial and aquatic systems as carbon sinks; protect biodiversity, secure ecosystem services and ensure food and nutrition security, providing safe, healthy and nutritious diets; accelerate the transition from a fossil-based linear economy to a resource efficient, resilient, low emission, low-carbon circular economy, and supporting the development of a sustainable bioeconomy and the blue economy; and develop resilient and vibrant rural, mountain, coastal and urban areas.

These activities will help to maintain and enhance biodiversity and secure the long-term provision of ecosystem services, such as climate change adaptation and mitigation and carbon sequestration (both on land and sea). They will help reduce greenhouse gas (GHG) and other emissions, waste and pollution from primary production (both terrestrial and aquatic), the use of hazardous substances, processing, consumption and other human activities. They will trigger investments, supporting the shift towards a circular economy, sustainable bioeconomy and blue economy, whilst protecting environmental health and integrity.

Activities will also foster participatory approaches to research and innovation, including the multi-actor approach and develop knowledge and innovation systems at local, regional, national and European levels. Social innovation with citizens' engagement and trust in innovation will be crucial to encourage new governance, production, consumption patterns and skills.

As these challenges are complex, interlinked and global in nature, activities will follow a systemic approach, cooperating with Member States and international partners, with other funding sources and with other policy initiatives. This will involve user-driven exploitation of environmental big data sources, such as those from Copernicus, EGNOS/Galileo, INSPIRE, EOSC, GEOSS, CEOS, EMODnet.

Research and innovation activities under this Cluster contribute in particular to the implementation of the goals of: the Environment Action Programme, the Common Agricultural Policy, the Common Fisheries policy, the Food Law legislation, the Maritime policy, the Circular Economy Action Plan, the EU Bioeconomy Strategy, ▌the Biodiversity Strategy, the 2030 climate and energy framework and the EU 2050 long term vision for carbon neutrality(24), EU Arctic Policy as well as EU legal provisions to reduce air pollution. Beyond the general sources of external advice, specific consultations would be sought from Standing Committee on Agricultural Research (SCAR).

Activities will contribute directly to the following Sustainable Development Goals (SDGs) in particular: SDG 2 – Zero Hunger; SDG 3 – Good Health and Well-Being; SDG 6 - Clean Water and Sanitation; SDG 8 – Decent Work and Economic Growth; SDG 9 – Industry, Innovation, and Infrastructure; SDG 11 – Sustainable Cities and Communities; SDG 12 - Responsible Consumption and Production; SDG 13 – Climate Action; SDG 14 – Life Below Water; SDG 15 - Life on Land.

6.2.   Areas of intervention

6.2.1.   Environmental Observation

The capacity to observe the environment(25), including space-based, in-situ-based (air, sea, land) observation, and citizen observations underpins research and innovationfor the sustainable use and monitoring of food and natural resources, biomonitoring and environmental monitoring. Improved spatio-temporal coverage and sampling intervals at reduced cost, as well as big data access and integration from multiple sources provide new ways to monitor, understand and predict the Earth system. Research and innovation is needed to develop methods and technologies to improve quality as well as facilitate access and use of data.

Broad Lines

–  User driven and systemic approaches including open data, to environmental data and information for complex modelling and predictive systems, business opportunities from exploitation and valorisation of existing and new data;

–  Further development of products and services portfolio for environmental observations;

–  Biodiversity status, ecosystem protection, climate change mitigation and adaptation, food security, agriculture and forestry, land use and land use change, urban and peri-urban development, natural resources management, sea and ocean resources management and conservation, maritime security, long term environmental trends, changes in seasonal variability, ambient air and atmospheric changes and other relevant domains;

–  User oriented applications, to be delivered through the EuroGEOSS initiative, including their up scaling , to contribute to the preservation and management of European natural resources (including exploration of raw materials) and ecosystems services and their related value chain;

–  Implementation of the Global Earth Observation System of Systems of the GEO (Group on Earth Observations) initiative.

6.2.2.   Biodiversity and Natural Resources

Improved understanding, preservation and management of biodiversity and ecosystems, the multiple services they provide (in a context of combatting climate change and mitigating its impacts) and planetary 'boundaries' as well as solutions harnessing nature’s power and complexity is needed to address societal challenges, to enhance sustainability and to attain the EU objective of 'Living well within the limits of our planet' by 2050 as laid down in the 7th EU Environmental Action Programme. Due account must be taken of potential upstream impacts throughout whole value chains. International cooperation and contribution to international efforts and initiatives, such as the Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services (IPBES), are essential to achieve the objectives in this area. There is a need to better understand the governance of the transition to sustainability in the economic, social and natural system, from the local to the global level.

Broad Lines

–  The state and value of biodiversity, terrestrial, freshwater and marine ecosystems, natural capital and ecosystem services, including agro-ecosystems and the microbiome;

–  Holistic and systemic approaches within a socio-ecological framework for the links between biodiversity, ecosystems and ecosystems services and their causality relationships with drivers of change, across different scales and economic activities, including the socio economic aspects and governance of transition processes to sustainability;

–  Modelling of trends and integrated scenarios for biodiversity, ecosystem services and good quality of life at different scales and horizons; the potential contribution of biotopes and ecosystems as carbon sinks under various climate change scenarios; potential conflicts of interests in utilization of natural resources and services;

–  Ecotoxicology of compounds and new pollutants, their interactions, including combination effects, and environmental behaviour, and altered biochemical loops under changing climate, restoration of degraded areas;

–  Mainstreaming biodiversity and ecosystem services in decision-making frameworks and accounting systems of governments and businesses, as well as quantification of ecological, economic and societal benefits;

–  Adaptable and multi-functional nature-based solutions, addressing challenges in urban and peri-urban areas, rural and coastal and mountain areas related to climate change, natural disasters, biodiversity loss, ecosystem degradation, pollution, social cohesion and citizens’ health and well-being;

–  Multi-actor living labs approaches engaging authorities, stakeholders, business and civil society in co-designing and co-creating systemic solutions for the preservation, restoration and sustainable use of natural capital, and the governance of the transition to sustainability and sustainable management options in economic activities throughout whole value loops in different environmental, economic and social conditions.

6.2.3.   Agriculture, Forestry and Rural Areas

Resilient and sustainable agriculture and forestry provide economic, environmental and social benefits and is a prerequisite for continued food security. They feed into dynamic value chains, manage land and natural resources as well as deliver a range of vital public goods including carbon sequestration, biodiversity preservation, pollination and public health. Integrated and place-based approaches are needed to promote the multiple functions of agro- and forest (eco)systems taking into account the changing context for primary production, notably in relation to climate change and environment, resource availability, demography and consumption patterns. Quality and safety of agricultural products shall be ensured to enhance consumer confidence. Plant health and animal health and welfare shall also be ensured. It is also necessary to address the spatial, socio-economic and cultural dimension of agriculture and forestry activities and mobilise the potential of rural and coastal areas.

Broad Lines

–  Methods, technologies and tools for sustainable, resilient and productive agriculture and forestry, including adaptation to climate change;

–  Sustainable management and efficient use of natural resources (e.g. soils, water, nutrients and biodiversity including genetic resources) in agriculture and forestry; alternatives to non-renewable resources and adoption of circular economy principles, including through the reuse and recycling of waste and by-products;

–  Climate and environmental impact of activities in the primary sector; potential of agriculture and forestry as carbon sinks and for mitigation of greenhouse gas emissions including negative emission approaches; increasing adaptability of primary production to climate change;

–  Integrated approaches to tackling plant pests and diseases; control of contagious and zoonotic animal diseases and animal welfare; prevention strategies, control and diagnostic and alternatives to the use of contentious pesticides, antibiotics and other substances also to tackle resistance;

–  Antimicrobial resistance and threats from biological and agrochemical hazards, including pesticides, as well as chemical contaminants tackling the links between plant, animal, ecosystems and public health from One-Health and Global-Health perspectives;

–  The use and delivery of ecosystem services in agriculture and forestry systems applying ecological approaches and testing nature-based solutions from farm to landscape levels for an environmentally friendly agriculture; support to organic farming;

–  Agricultural and forestry systems from farm to landscape levels; the use and delivery of ecosystem services in primary production, e.g. through agro-ecology or through enhancing the role of forests in the prevention of floods and soil erosion;

–  Innovations in farming at the interfaces between agriculture, aquaculture, forestry and in urban and peri-urban areas;

–  New methods, technologies and tools for sustainable forest management and sustainable use of forest biomass;

–  Support to EU plant protein production for food, feed and environmental services;

–  Sustainable land use, rural development and territorial linkages; capitalising on the social, cultural, economic and environmental assets of rural areas for new services, business models, value chains and public goods;

–  Digital innovations in farming, forestry and across value chains and rural areas through the use of data and development of infrastructures, technologies (such as AI, robotics, precision farming and remote sensing) and governance models;

–  Agricultural and forestry knowledge and innovation systems and their interconnection at various scales; advice, building skills, participatory approaches and information sharing;

–  Fostering international partnerships for sustainable agriculture for food and nutrition security.

6.2.4.   Seas, Oceans and Inland Waters

The natural capital and ecosystem services of seas, in particular of semi-closed European seas, oceans, inland waters and wider coastal areas offer significant socio-economic and welfare benefits. This potential is at risk because of the severe pressure from human and natural stressors such as pollution, overfishing, climate change, sea-level rise, other water-use and extreme weather events. To prevent seas oceans from reaching a point of no return, and to restore a good status of inland waters; it is necessary to strengthen our knowledge and understanding in order to protect, restore and sustainably managemarine, inland and coastal ecosystems and prevent pollution, in a context of an improved and responsible governance framework. This will also include research to sustainably unlock the vast and unexploited economic potential of seas, oceans and inland waters aiming at producing more safe food, bio-based ingredients and raw material without increasing pressures on them, ▌as well as the potential of aquaculture in all forms to alleviate pressure on land, freshwater and ocean resources. There is a need for partnering approaches, including sea basin and macro-regional strategies, extending beyond the EU (e.g. in the Atlantic, the Mediterranean, the Baltic, the North Sea, the Black Sea, the Caribbean Sea and the Indian Ocean); and for contributing to International Ocean Governance commitments, initiatives like the United Nations Decade of Ocean Science for Sustainable Development and commitments linked to the conservation of marine biological diversity in areas beyond national jurisdiction.

Broad Lines

–  Sustainable fisheries and aquaculture in all forms, including alternative sources of protein with increased food security, food sovereignty and climate resilience; monitoring and management tools;

–  Strengthened resilience of marine and inland water ecosystems, including coral reefs thereby ensuring seas, ocean and river health, combating and mitigating the effects of natural and anthropic pressures like contaminants and marine litter (including plastics), eutrophication, invasive species, physical damage to the sea floor, overexploitation, including overfishing, underwater noise, acidification, seas, oceans and rivers warming, sea level rise, considering the intersection between land and sea, the cumulative impact of these issues and fostering a circular approach and a better understanding of ocean-human interactions;

–  Governance at global and regional levels to ensure conservation and sustainable use of the resources of seas, oceans and inland waters;

–  Technologies for the digital ocean (seafloor, water column and water surface) connecting services and communities in land-based, atmosphere, climate, space and weather related activities, and promoted through the Blue Cloud as part of the European Open Science Cloud;

–  Monitoring, risk-based assessment and predictive/forecasting capacities including sea-level rise and other natural hazards e.g. storms surges, tsunamis as well as cumulative impact of human activities;

–  Improve understanding of the hydrological cycle and regimes, hydromorphology at different scales and develop monitoring and predictive capacities for water availability and demand, floods and droughts, pollution and other pressures on water resources and aquatic environment. Exploit digital technologies to improve water resource monitoring and management;

–  Develop innovative solutions including societal governance, economic instruments and financing models, for smart water allocation addressing conflicts in water use, including exploiting the value in water, control of water pollutants, including plastics and microplastics and other emerging pollutants preferably at source, tackling other pressures on water resources, as well as water reuse, and protection and restoration of water ecosystems to good ecological status;

–  Sustainable blue value-chains, including the sustainable use of fresh water resources, the multiple-use of marine space and growth of the renewable energy sector from seas and oceans, including sustainable use of micro- and macro- algae;

–  Integrated approaches to sustainable management of inland and coastal waters which will contribute to environmental protection and adaptation to climate change;

–  Nature-based solutions derived from marine, coastal and inland water ecosystem dynamics, biodiversity and multiple ecosystem services, which will enable systemic approaches to sustainably use the resources of seas, in particular of semi-closed European seas, and oceans and of inland waters, contribute to environmental protection and restoration, coastal management, and adaptation to climate change;

–  Blue innovation including in the blue and digital economies, across coastline areas, coastal cities and ports in order to strengthen resilience of coastal areas and increase citizens' benefits;

–  Better understanding of the role of seas and oceans in climate change mitigation and adaptation.

6.2.5.   Food Systems

The combined effects of population growth, evolution of diets, resource scarcity and overexploitation, environmental degradation, climate change and migration create unprecedented challenges which require food system transformation (FOOD 2030).(26) Current food production and consumption are largely unsustainable while we are confronted with the double burden of malnutrition, characterised by the coexistence of undernutrition, obesity and other diet imbalances and metabolic disorders. Future food systems need to deliver on food security, and ensure sufficient safe, healthy and quality food for all, underpinned by resource efficiency, sustainability (including the reduction of GHG emissions, pollution, water and energy consumption as well as waste production), transparency, linking land and sea, reducing food waste, enhancing food production from inland waters, seas and oceans and encompassing the entire 'food value chain' from producers to consumers – and back again - ensuring resilience. This needs to go hand in hand with development of the food safety system of the future and the design, development and delivery of tools, technologies and digital solutions that provide significant benefits for consumers and improve the competitiveness and sustainability of the food value chain. Furthermore, there is a need to foster behavioural changes in food consumption and production patterns, taking into account cultural and social aspects, as well as to engage primary producers, industry (including SMEs), retailers, food service sectors, consumers, and public services.

Broad Lines

–  Evidence-based sustainable and healthy diets for people's well-being across their lifespan, including dietary patterns, improved nutritional quality of food and advances in understanding the impact of nutrition on health and well-being;

–  Personalised nutrition especially for vulnerable groups, to mitigate the risk factors for diet-related and non-communicable diseases;

–  Consumers' behaviour, lifestyle and motivations, including social and cultural aspects of food, promoting social innovation and societal engagement for better health and environmental sustainability throughout the entire food value chain, including retail patterns;

–  Modern food safety and authenticity systems, including traceability, improving food quality and enhancing consumer confidence in the food system;

–  Food system mitigation of and adaptation to climate change, including the exploration of the potential and use of the microbiome, of food crop diversity, and of alternative to animal proteins;

–  Environmentally sustainable, circular, resource efficient and resilient food systems, from land and sea, towards safe drinking water and maritime issues, zero food waste throughout the entire food system, through reuse of food and biomass, recycling of food waste, new food packaging, demand for tailored and local food;

–  Novel approaches, including digital tools and food systems for place-based innovation and empowerment of communities, fostering fair trade and pricing along the value chain, inclusiveness and sustainability through partnerships between industry (including SMEs and smallholders), local authorities, researchers and society.

6.2.6.   Bio-based Innovation Systems in the EU Bioeconomy

Innovation in the bioeconomy lays the foundations for the transition away from a fossil-based economy▌. Bio-based innovation is an important segment and enabler of the overall bioeconomy and encompasses the sustainable sourcing, industrial processing and conversion of biomass from land and sea into bio-based materials and products. Sustainability includes all its dimensions: ecological, social, economic and cultural aspects). It also capitalises on the potential of living resources, life sciences, digitalisation and biotechnologies for new discoveries, products, services and processes. Bio-based innovation, including (bio)processes and technologies, can bring new economic activities and employment to regions and cities, contribute to revitalising rural and coastal economies and communities and strengthen the circularity of the bioeconomy.

Broad Lines

–  Sustainable biomass sourcing, logistics and production systems, focusing on high-value applications and uses, social and environmental sustainability, impact on climate and biodiversity, circularity and overall resource efficiency, including water;

–  Life sciences and their convergence with digital technologies for understanding, prospecting and sustainably using biological resources;

–  Bio-based value chains, bio-based materials, including bio-inspired materials, chemicals, products, services and processes with novel qualities, functionalities and improved sustainability (including reducing emissions of greenhouse gases), fostering the development of (small and large scale) advanced biorefineries using a wider range of biomass; replacing current production of unsustainable products by outperforming biobased solutions for innovative market applications;

–  Biotechnology, including cross sectoral cutting-edge biotechnology, for application in competitive, sustainable and novel industrial processes, environmental services and consumer products(27);

–  Circularity of the bio-based sector within the bioeconomy through technological, systemic, social and business model innovation to radically increase the value generated per unit of biological resource, keeping the value of such resources in the economy for longer, preserving and enhancing natural capital, designing out waste and pollution, supporting the principle of the cascading use of sustainable biomass through research and innovation and taking into account the waste hierarchy;

–  Inclusive bioeconomy patterns with different actors participating in the creation of value, maximising societal impact and public engagement;

–  Increased understanding of the boundaries, metrics and indicators of the bioeconomy and its synergies and trade-offs with a healthy environment, and trade-offs between food and other applications.

6.2.7.   Circular Systems

Circular production and consumption systems will provide benefits to the European economy and global environment by reducing use and dependency on resources, decreasing greenhouse gas emissions and other negative environmental impacts and increasing the competitiveness of enterprises, and to European citizens by creating new job opportunities and reducing pressures on the environment and climate. Beyond industrial transformation, the transition to a low-emission, resource efficient, bio-based and circular economy, avoiding the use of hazardous substances will also need a broader system shift that requires systemic eco-innovative solutions, new business models, markets and investments, enabling infrastructure, social innovation changes in consumer behaviour, and governance models stimulating multi-stakeholder collaboration through the whole value chain to ensure that the intended system change achieves better economic, environmental and social outcomes(28). Opening for international cooperation will be important for comparability, generating and sharing knowledge and avoiding duplication of efforts, e.g. through international initiatives such as the International Resource Panel. Also, attention will be given to the social context of new knowledge and technology in this area and for its uptake and acceptance in society.

Broad Lines

–  Systemic transition to a resource-efficient, bio-based and circular economy, with new paradigms in consumer interaction, new business models for resource efficiency and environmental performance; products and services stimulating resource efficiency and elimination or substitution of hazardous substances during the whole lifecycle; systems for sharing, reuse, repair, remanufacturing, recycling and composting; economic, social, behavioural, regulatory and financial conditions and incentives for such transitions;

–  Metrics and indicators, based on a systemic approach, for measuring the circular economy and life cycle performance and enhancing social responsibility; governance systems which accelerate expansion of the circular economy, the bioeconomy and resource efficiency while creating markets for secondary materials; multi-stakeholder and cross-value chain collaboration; instruments for investment in the circular economy and bioeconomy;

–  Solutions for sustainable and regenerative development of cities, peri-urban areas and regions, integrating the circular economy transformation with nature-based solutions, technological, digital, social, cultural and territorial governance innovations;

–  Eco-innovation for prevention and remediation of environmental pollution from and exposure to hazardous substances and chemicals of emerging concern; looking also at the interface between chemicals, products and waste, and at sustainable solutions for primary and secondary raw materials production;

–  Circular use of water resources, including reduction of water demand, prevention of losses, water reuse, recycling and valorisation of wastewater▌. Innovative solutions for the challenges for the water-food-energy nexus addressing impacts of agricultural and energy water use and enabling synergistic solutions;

–  Sustainable subsurface management integrating geo-resources (energy, water, raw materials) and environmental conditions (natural hazards, anthropogenic impacts) across all relevant clusters, streamlining the positive contribution to a circular economy through pan-European geological knowledge and contributing towards an orchestrated science-based response to the Paris Agreement and to several UN Sustainable Development Goals;

–  Develop and improve solutions and infrastructures for facilitating access to drinking, irrigation and sanitation water, involving inter alia desalination, in order to enable more efficient, energy and CO2 friendly, as well as, circular use of water.

7.  NON-NUCLEAR DIRECT ACTIONS OF THE JOINT RESEARCH CENTRE

7.1.   Rationale

High-quality and trusted scientific evidence is essential for good public policies. New initiatives and proposals for EU legislation need transparent, comprehensive and balanced evidence, whereas implementation of policies needs evidence to measure and monitor their impact and progress.

The JRC adds value to EU policies because its science is excellent, multi-disciplinary and independent of national, private and other external interests. Serving all areas of EU policy, it provides the cross-sectoral support that policymakers need to tackle increasingly complex societal challenges. The JRC's independence from special interests combined with its scientific-technical reference role enable it to facilitate consensus building between stakeholders and other actors such as citizens, and policy makers. With its capacity to respond rapidly to policy needs, the JRC's activities are complementary with indirect actions aiming at supporting longer term policy objectives.

The JRC performs its own research and is a strategic manager of knowledge, information, data and competences to deliver high quality and relevant evidence for smarter policies. To achieve this, the JRC works together with the best organisations world-wide, and with international, national and regional experts and stakeholders. Its research contributes to the general objectives and priorities of Horizon Europe, provides independent scientific knowledge, advice and technical support for EU policies throughout the policy cycle, and is focussed on European policy priorities, supporting a Europe that is safe and secure, prosperous and sustainable, social and stronger on the global scene.

7.2.  Areas of intervention

7.2.1.  Strengthening the knowledge base for policy making

Knowledge and data are growing exponentially. If policy makers are to make sense and use of them they must be reviewed and filtered. There is also a need for cross-cutting scientific methods and analytical tools for use by all Commission services, especially to anticipate upcoming societal challenges and support better regulation. This includes innovative processes to engage stakeholders and citizens in policy-making issues and various tools of impact and implementation assessment.

Broad Lines

–  Modelling, micro-economic evaluation, risk assessment methodologies, quality assurance tools for measurements, design of monitoring schemes, indicators and scoreboards, sensitivity analysis and auditing, lifecycle assessment, data and text mining, (big) data analytics and applications, design thinking, horizon scanning, anticipation and foresight studies, behavioural research, and stakeholders and citizen engagement;

–  Knowledge and competence centres;

–  Communities of practice and knowledge sharing platforms;

–  Data management, data sharing and coherence;

–  Analysis of EU and national research and innovation policies, including the ERA.

7.2.2.   Global Challenges

The JRC will contribute to the specific EU policies and commitments addressed by the seven Global Challenges clusters, notably the EU's commitment to the Sustainable Development Goals.

Broad Lines

1.  Health

–  Scientific and technical policy support for improved public health and health care systems, including medical devices and health technology assessments, databases, digitisation including for accelerating interoperability;

–  Safety assessment methods for potential health and environmental risks posed by chemical substances and pollutants;

–  EU Reference Laboratory for Alternatives to Animal Testing;

–  Quality assurance tools such as certified reference materials for health biomarkers;

–  Research on newly emerging health issues and health threats.

2.  Culture, creativity and inclusive society

–  Research on inequality, poverty and exclusion, social mobility, cultural diversity, and skills; migration, assessment of social, demographic and technological transformations on the economy and on society;

–  Research on good governance and democracy;

–  Support to the safeguarding, preservation and management of cultural heritage;

–  Knowledge centre for migration and demography.

3.  Civil security for society

–  Knowledge centre for disaster risk management;

–  Support to security policies in the areas of protection of critical infrastructures and public spaces, CBRN-E (Chemical, Biological, Radiological, Nuclear, and Explosive materials) and hybrid threats, border protection and document security, and information and intelligence for countering terrorism;

–  Technologies for CBRN-E materials detection, biometric systems, and intelligence-gathering techniques;

–  Support to the EU's security position in the world; assessment of competitiveness and innovation of the Union security industry; exploitation of security-defence synergies;

–  Research for reinforced Cybersecurity capabilities, cyber-resilience, and cyber-deterrence.

4.   Digital, Industry and Space

–  Implications of digitisation, with a focus on new and emerging ICT technologies such as machine learning and artificial computing, distributed ledgers, Internet of Things, and High-Performance Computing;

–  Digitisation in individual sectors, such as energy, transport, construction, service industry, health and care and government;

–  Industrial metrology and quality assurance tools for smart manufacturing;

–  Research on Key Enabling Technologies;

–  Research on best available techniques and environmental management practices, techno-economic analyses and life cycle assessment of industrial processes, chemicals management, waste management, water reuse, raw materials, critical raw materials and quality criteria for recovered materials, all supporting circular economy;

–  Analysis of security of supply of raw materials, including the critical raw materials, in relation to primary and secondary resources information and data update of the Raw Materials Information System;

–  Implementation of Copernicus actions;

–  Technical and scientific support for applications of the EU Global Navigation Satellite System Programmes.

5.   Climate, Energy and Mobility

–  Support to implementation of the EU climate, energy and transport policies, transition to a low-carbon economy and strategies for decarbonisation towards 2050; analysis of integrated national climate and energy plans; assessment of decarbonisation pathway in all sectors, including agriculture and Land Use Land Use Change and Forestry;

–  Assessment of risks in vulnerable ecosystems and critical economic sectors and infrastructure, with focus on adaptation strategies;

–  Analysis of the R&I dimension of Energy Union; assessment of EU competitiveness in the global clean energy market;

–  Assessment of deployment potential of smart energy technologies and sector coupling solutions to enable smooth and cost efficient energy transition.

–  Assessment of deploying renewables and clean energy production technologies;

–  Analysis of energy use of buildings, smart and sustainable cities, and industries;

–  Technical and socio-economic analysis of energy storage, particularly sector coupling and batteries;

–  Analysis of the EU's energy security of supply, including energy infrastructure, and energy markets;

–  Support to energy transition, including the Covenant of Mayors, clean energy for EU Islands, sensitive regions, and Africa;

–  Integrated analysis for deployment of Cooperative, Connected and Automated Mobility;

–  Integrated analysis for development and deployment of electric driving, including the next generation of battery technologies;

–  Harmonised test procedures and market surveillance for CO2 and air pollutant emissions from vehicles, assessment of innovative technologies;

–  Assessment of smart transport, traffic management systems and congestion indicators;

–  Analyses of alternative fuels and related infrastructure needs.

6.  Food, bioeconomy, natural resources, agriculture and environment

–  Research on land, soil, forests, air, water, marine resources, raw materials and biodiversity to support the effective preservation, restoration and sustainable use of natural capital, including sustainable resources management in Africa;

–  Knowledge centre for global food nutrition security;

–  Assessment of climate change and potential mitigation and adaptation measures for agricultural and fisheries policies, including food security;

–  Monitoring and forecasting of agricultural resources in EU, enlargement and neighbourhood countries;

–  Research for sustainable and economically thriving aquaculture and fisheries, and for Blue Growth and the Blue Economy;

–  Validated methods, laboratory proficiency tests and new analytical tools for implementing food safety policies;

–  EU Reference Laboratories on Feed Additives, Genetically Modified Organisms and Food Contact Materials;

–  Knowledge centre for food fraud and quality;

–  Knowledge centre for bioeconomy.

7.2.3.  Innovation, economic development, and competitiveness

The JRC will contribute to knowledge-based innovation and technology transfer.. It will support the functioning of the internal market and the economic governance of the Union. It will contribute to development and monitoring of policies targeting a more social and sustainable Europe. It will support the EU's external dimension and international goals and help in promoting good governance. A well-functioning internal market with a strong economic governance and fair social system will foster knowledge-based innovation and competitiveness.

Broad Lines

–  Economic, trade, financial and fiscal analysis;

–  Pre-normative research and testing for harmonisation and standardisation;

–  Production of certified reference materials;

–  Market surveillances activities;

–  Management of intellectual property rights;

–  Promotion of technology transfer cooperation.

7.2.4.   Scientific Excellence

The JRC shall pursue excellence and integrity in research and extensive collaboration with top level research institutions worldwide. It will carry out research in emerging fields of science and technology and promote open science and open data as well as knowledge transfer.

Broad Lines

–  Exploratory research programmes;

–  Dedicated collaborative and exchange programmes with research institutions and scientists;

–  Access to JRC research infrastructures;

–  Training of scientists and national experts;

–  Open science and open data.

7.2.5.   Territorial development and support for Member States and Regions

The JRC will contribute to regional and urban policies, with focus on innovation-led territorial development, and with a view to reducing disparities between regions. It will also offer technical assistance to Member States and third countries and support the implementation of European legislation and actions.

Broad Lines

–  Implementation of regional and urban policies, smart specialisation strategies, strategies for economic transformation of regions in transition, integrated urban development strategies and data;

–  Capacity building of local and regional actors for implementation of macro-regional strategies;

–  Knowledge centre for territorial policies;

–  'On demand' advice and tailored support to Member States, regions or cities, including through a virtual network of Science4Policy Platforms.

PILLAR III

Innovative Europe

Innovation in all its forms is a key driver for the EU to continue delivering prosperity to its citizens and meeting challenges of the future. Implementing it requires a systemic, cross-cutting and multifaceted approach. Europe's economic progress, social welfare and quality of life rely on its ability to boost productivity and growth, which, in turn, depends heavily on its ability to innovate. Innovation is also key to solving the major challenges that lie ahead for the EU. Innovation has to be responsible, ethical and sustainable.

Like in the case of its predecessor, innovation is at the heart of Horizon Europe. The quest for acceleration of knowledge transfer and new ideas, products and processes is driving Horizon Europe objectives and implementing modalities, from strategic programming to calls, and is present from the onset to the end of any project supported, from 'blue-sky' research to industrial or technological roadmaps and missions.

Yet, innovation deserves specific measures, as the EU must decisively enhance the conditions and environment for European innovation to thrive, so that ideas are quickly shared between actors in the innovation ecosystem, and new ideas and technologies swiftly transformed into the products and services needed for the EU to deliver.

Recent decades have seen the emergence of major and global new markets in health care, media, entertainment, communication and retail, based on breakthrough innovations in ICT, biotech, green-tech internet and the platform economy. Further downstream in the innovation process, these market-creating innovations, which impact the EU economy as a whole, are deployed by fast growing and often new companies which, however, seldom originate and scale-up in the EU.

A new global wave of breakthrough innovation is coming up, one that will be based on more 'deep-tech' technologies such as block-chain, artificial intelligence, genomics/multiomics and robotics, and other technologies, which may also emerge from individual innovators and communities of citizens. They have in common that they are taking shape at the intersection between different scientific disciplines, technological solutions and economic sectors offering radically new combinations of products, processes, services and business models, and have the potential to open up new markets worldwide. Additional critical sectors such as manufacturing, financial services, transport or energy will also be impacted.

Europe has to ride that wave. It is well positioned as the new wave comes in 'deep-tech' areas, in which Europe has already significantly invested notably in the KETs, has therefore some competitive advantages regarding science and knowledge, including in terms of human resources, and can build on close public-private cooperation (e.g. in health care or energy).

For Europe to lead that new wave of breakthrough innovation, the following underlying challenges need to be met:

–  Increase risk finance to overcome financing gaps: Europe's innovators suffer from a low supply of risk finance. Private venture capital is key to turning breakthrough innovations into world-leading companies but, in Europe, it is less than a quarter of the amounts raised in the US and in Asia. Europe must bridge the 'Valleys of death', whereby ideas and innovations fail to reach the market due to the gap between public support and private investment, in particular with regard to high-risk breakthrough innovations that have to be supported by long-term investments;

–  Facilitate the access to research results, improve the transformation of science into innovation and accelerate the transfer of ideas, technologies and talent from the research base into start-ups and industry;

–  Further support the development of all forms of innovation, including user-driven, consumer-driven service and inclusive social innovation;

–  Speed up business transformation: European economy is lagging behind in embracing new technologies and scaling up: 77% of the young and big R&D companies are in US or Asia and only 16% are based in Europe;

–  Enhance and simplify the European landscape for funding and supporting research and innovation: the multitude of funding sources provides a complex landscape for innovators. EU intervention has to cooperate and coordinate with other initiatives at European, national and regional level, public and private, to better enhance and align supporting capacities, avoid duplication of activities and provide for an easy-to-navigate landscape for any European innovator;

–  Overcome fragmentation to the innovation ecosystem. While Europe is home to a growing number of hotspots, these are not well connected. Companies with international growth potential have to cope with fragmentation of national markets with their diverse languages, business cultures and regulations. The EU has a role to play in supporting effective collaboration between national and regional ecosystems, so that companies, and SMEs in particular, can access the best knowledge, expertise, infrastructures and services across Europe. The EU shall support collaboration between ecosystems, including through regulation, so that interoperability between different technologies and practical solutions is improved.

In order to cope with that new global wave of breakthrough innovation, EU support to innovators requires an agile, simple, seamless and tailored approach. Policy to develop and deploy breakthrough innovations and scale-up companies has to be bold in taking risks and must take into account the above-mentioned challenges and add value to related innovation activities implemented by individual Member States or regions.

Horizon Europe's Innovative Europe pillar, in cooperation with other EU policies and in particular the InvestEU Programme, is designed to deliver such tangible results. It builds on lessons learned and on experience gained under the previous framework programmes, in particular from activities such as Future Emerging Technologies (FET), Fast Track to Innovation (FTI) and the SME Instrument, but also private and corporate finance (such as FP7 RSFF, Horizon 2020 InnovFin), gathered and streamlined within the 'EIC pilot' activities launched for the period 2018-2020.

Based on these experiences, this Pillar provides for the launch of the European Innovation Council (EIC), which will mainly promote breakthrough and disruptive technologies and innovation targeting especially market-creating innovation, while also supporting all types of innovations, including incremental, especially within SMEs including start-ups, and in exceptional cases small mid-caps with rapid scale-up potential at EU and global level and with dedicated types of actions and activities:

–  Supporting the development of future and emerging breakthrough innovations, including “deep-tech” innovations as well as non-technological innovations;

–  Bridging financing gaps in the development, deployment and scaling up of market-creating innovations;

–  Leverage private capital and investment;

–  Increasing the impact and visibility of EU innovation support.

This pillar shall also provide for the activities developed under the European Institute of Innovation and Technology (EIT), in particular through its Knowledge and Innovation Communities (KICs). Additionally, systematic synergies shall be ensured between the EIC and the EITInnovative companies stemming from an EIT KIC may be chanelled to the EIC to create a pipeline of not yet bankable innovations, while high potential innovative companies funded by the EIC that are not already engaged in one of the EIT KICs may be offered access to this additional support.

Whilst the EIC and the EIT KICs may directly support innovations across the EU, the overall environment from which European innovations nurture and emerge must be further developed and enhanced: findings in fundamental research are seeds for market-creating innovations. It must be a common European endeavour to support innovation all across Europe, and in all dimensions and forms, including through complementary EU and national and regional policies (including through effective synergies with ERDF and smart specialisation strategies) and resources whenever possible. Hence, this Pillar provides also for

–  renewed and reinforced coordination and cooperation mechanisms with Member States and Associated Countries, but also with private initiatives, in order to support all actors of the European innovation ecosystems, including at regional and local level;

–  

–  Additionally, as a continued effort to enhance risk-finance capacities for research and innovation in Europe , this pillar will closely link with the InvestEU programme. Building on the successes and the experiences gained under Horizon 2020 InnovFin, as well as under EFSI, the InvestEU Programme will enhance access to risk finance for bankable entities, as well as for investors.

1.  THE EUROPEAN INNOVATION COUNCIL (EIC)

1.1.  Areas of Intervention

The EIC shall operate according to the following principles: clear EU added value, autonomy, ability to take risks, efficiency, effectiveness, transparency and accountability. The EIC will act as the one-stop-shop for all types of innovators including from individuals to universities, research organisations and companies (SMEs, including start-ups, and, in exceptional cases, small mid-caps). Depending of its schemes, it will provide support to single beneficiaries and multi-disciplinary consortia.

The objectives of the EIC ▌are:

–  to identify, develop and deploy high risk innovations of all kinds including incremental with a strong focus on breakthrough, disruptive ▌and deep-tech innovations that have the potential to become market-creating innovations, and

–  support the rapid scale-up of innovative companies mainly SMEs, including start-ups and in exceptional cases small mid-caps at EU and international levels along the pathway from ideas to market.

Where relevant, the EIC shall contribute to the activities supported under other parts of Horizon Europe, in particular in Pillar II.

The EIC will be implemented primarily through two complementary types of action, namely the Pathfinder for advanced research, for the early stages of technology development, and the Accelerator for innovation and market deployment actions, including the pre-mass commercialisation stages and company growth. With the idea to offer a single one-stop shop and a single process of support for high risk innovations carried out by start-ups, SMEs and, in exceptional cases, small midcaps, the Accelerator will notably award two types of support: mainly blended finance (combining grants with equity investments) ▌as well as grants, optionally followed by equity support. In addition, it will also channel access to loans and guarantees, notably those provided under the InvestEU programme.

These two complementary types of actions will share common characteristics. They will:

–  Support high-risk innovations where the risks, whether financial, technological/scientific, market and/or regulatory, cannot be borne by the market alone or yet supported by financial instruments under InvestEU;

–  Mainly focus on high-risk breakthrough and/or deep-tech innovations, while also supporting other forms of innovation, including incremental, that have the potential to create new markets or contribute to resolving global challenges;

–  Be mainly bottom-up, open to innovations from all fields of science, technology and applications in any sector, while also enabling targeted support for emerging breakthrough, market-creating and/or deep-tech technologies of potential strategic significance in terms of economic and/or social impact. The Commission services will evaluate this potential strategic impact on the basis of recommendations from the independent experts, from the EIC programme managers and, where appropriate, from the EIC Advisory Board;

–  Encourage innovations that cut across different scientific, technological (e.g. combining physical and digital) fields and sectors ;

–  Be centred on innovators, simplifying procedures and administrative requirements, making use of interviews to help assess applications, and ensuring fast decision making;

–  Implemented with the aim of significantly enhancing the European innovation ecosystem;

–  Be managed pro-actively with milestones or other predefined criteria to gauge progress and the possibility to, after a thorough assessment, with the possible use of independent experts, reorient, reschedule or terminate the projects where needed.

As well as financial support, innovators will have access to EIC business advisory services providing to projects coaching, mentoring and technical assistance, and pairing innovators with peers, industrial partners and investors. Innovators will also have facilitated access to expertise, facilities (including innovation hubs(29) and open innovation testbeds) and partners from across EU supported activities (including those of the EIT, in particular through its KICs. The Commission will ensure seamless continuity between the EIT, the EIC, and InvestEU, to deliver complementarity and synergies.

To allow the strengthening of the European innovation ecosystem, particular attention will be paid to ensuring proper and efficient complementarity with individual or networked Member States or interregional initiatives, including in the form of European Partnership.

1.1.1.  The Pathfinder for Advanced Research

The Pathfinder's will provide grants to high-risk cutting-edge projects exploring new and deep-tech areas aiming to develop into potentially radical innovative technologies of the future and new market opportunities. Merging them into a single model with a unique set of criteria. It will build on the experience from the Future and Emerging Technology (FET) schemes supported under FP7 and Horizon 2020, including the Horizon 2020 FET-Innovation Launchpad, as well as the Horizon 2020 SME Instrument Phase 1.

The Pathfinder overall objective will be to nurture potential market creating innovation out of breakthrough ▌ideas, and bring them to demonstration stage or development of business cases or strategies for further take-up by the Accelerator or any other market deployment solution. To that end, the Pathfinder will ▌support the earliest stages of scientific and technological research and development, including proof of concept and prototypes for technology validation.

In order to be fully open to broad-sweeping explorations, opportunities of serendipity and unexpected ideas, concepts and discoveries, the Pathfinder will be mainly implemented through a continuous and competitive open call with cut-off dates for bottom-up proposals. While maintaining its mainly bottom-up nature, the Pathfinder will also provide for competitive challenges to develop key strategic objectives(30) calling for deep-tech and radical thinking. The topics for those challenges will be determined in the work programmes. Regrouping of selected projects into thematic or objective driven portfolios will allow establishing critical mass of efforts and structuring new multidisciplinary research communities.

These portfolios of selected projects▌ will be further developed and enhanced, each along a vision developed with their innovators, but also shared with the research and innovation community at large. The Pathfinder's Transition activities will be implemented to help researchers and innovators develop the pathway to commercial development, such as demonstration activities and feasibility studies to assess potential business cases, and support the creation of spin offs and start-ups. These Pathfinder's Transition activities may also consist of complementary grants to top-up or enlarge the scope of previous and on-going actions, to bring in new partners, to enable collaboration within the portfolio and to develop its multidisciplinary community.

The Pathfinder will be open to all types of innovators, from individuals to universities, research organisations and companies, in particular startups and SMEs, and focusing on multi-disciplinary consortia. In the case of single beneficiary projects, mid-caps and larger companies will not be permitted. The Pathfinder will be implemented mainly through collaborative research and in close coordination with other parts of Horizon Europe, in particular with the European Research Council (ERC), the Marie Skłodowska-Curie Actions (MSCA), the European Ecosystem part of Pillar III and the Knowledge and Innovation Communities (KICs) of the European Institute of Innovation and Technology (EIT) activities to identify radical new ideas and concepts with breakthrough potential.

1.1.2.  The Accelerator

Available private and corporate financing remains scarce between late stage of research and innovation activities and market take-up for high-risk(31) and therefore not 'bankable' or investors-attractive breakthrough and market-creating innovations. In order to bridge the 'valley of death' for any type of high-risk innovations, including in particular breakthrough and 'deep tech' innovations that are key to Europe’s future growth, public support must develop a radically new approach. Where the market does not provide viable financial solutions, public support should provide for a specific risk-sharing mechanism, bearing more if not all of the initial risk of potential breakthrough market-creating innovations to attract alternate private investors in a second stage, as operations unfold and the risk is reduced until the company carrying the innovative project becomes bankable.

Consequently the Accelerator will provide financial support to SMEs including start-ups and ▌, in exceptional cases, small mid-caps that have the ambition to develop and deploy in EU and international markets their breakthrough innovations and to scale up rapidly. For that purpose it will build on the experience from the Phases 2 and 3 of Horizon 2020 SME Instrument and from Horizon 2020 InnovFin, including through the addition of non-grant components and the ability to support larger and longer investments.

The Accelerator shall mainly provide support in the form of EIC blended finance, as well as grants and equity. The EIC blended finance shall be a mix of:

–  Grant or reimbursable advance(32), to cover innovation activities;

–  Support for investment in equity(33) or other repayable forms (loans, guarantees, etc.), so as to bridge innovation activities with effective market deployment, including scale-up, in a manner that does not crowd out private investments or distorts competition in the internal market. In case a project is deemed bankable from its initial selection (due diligence), or where the level of risk has been sufficiently reduced, it will channel the selected/supported company to access to debt financing (e.g. loans or guarantees) and on equity financing provided by the InvestEU programme.

Blended financial support will be awarded through a single process and with a single decision, providing the supported innovator with a single global commitment to financial resources covering the various stages of innovation down to market deployment including pre-mass commercialisation. The full implementation of the awarded support will be subject to milestones and review. The combination and volume of financing will be adapted to the needs of the firm, its size and stage, the nature of the technology/innovation and the length of the innovation cycle. It will cover financing needs until replacement by alternative sources of investment.

The EIC Accelerator will also provide support in the form of grants to SMEs, including start-ups, to carry out a range of innovation types, from incremental to breakthrough and disruptive innovation, who are aiming to subsequently scale up.

The support will be provided through the same continuously open and bottom-up call as the one used for the blended-finance support. A start-up or an SME may benefit only once during Horizon Europe from grant-only support from the EIC that will not exceed EUR 2.5 million. Proposals shall include detailed information on the capacities of the applicant to scale up.

For projects that have benefitted from a grant-only support, the Accelerator may subsequently upon the request of the beneficiaries provide them with finance support (e.g. "an equity support only"), through its “Special Purpose Vehicle” (SPV) subject to the due diligence results of the latter.

When selected projects are receiving a grant component support for its research and innovation activities; the activities may be implemented in collaboration with public or private research organisations, for example through subcontracting, to ensure that the beneficiary can have optimal access to technical and business expertise. This will allow the beneficiary to develop with a strong foundation in the existing knowledge, expertise and ecosystems across Europe.

Where the various risks are reduced (financial, scientific/technological, market, management, regulatory, etc.), the relative importance of the reimbursable advance component is expected to increase.

While the EU may bear alone the initial risk of selected innovation and market deployment actions, the aim will be to de-risk these and stimulate, from the out-set and during the development of the action, co-investments from alternative sources and even substitutive investors. In that event co-investment objectivesand times schedule will be agreed with the co-investor(s) and the beneficiaries/supported companies.

The Accelerator will mainly operate through a continuously open, and bottom-up call, with cut-off dates, targeting SMEs including start-ups and in exceptional cases small-mid-caps, including young and female innovators managing or holding key skills in these companies. This open and bottom-up call may be complemented by targeted support for on emerging breakthrough▌, market-creating and/or deep-tech innovations of potential strategic significance in terms of economic and/or social impact, while maintaining the predominantly bottom up nature of the Accelerator. The topics for this targeted support will be described in the work programmes. Investors, including public innovation agencies, may also submit proposals, but the support shall be awarded directly to the company carrying the innovative project they are interested in.

The Accelerator will also allow for ▌take-up of innovations stemming from Pathfinder-supported projects ▌and from other pillars of the EU Framework Programmes(34), in order to support them to reach the market. This identification of projects supported in other pillars of Horizon Europe and also previous Framework Programmes will be based on pertinent methodologies, such as the Innovation Radar.

In addition, for scale up purpose and in compliance with Article 43.5(a) of Regulation [Framework programme], subject to an initial mapping exercise, successful proposals from eligible national or regional programmes could also have access to the Accelerator evaluation phase under the following cumulative and sequential conditions:

(a)  in close cooperation with Member States, the Commission will perform an in-depth mapping of eligible national or regional programmes to identify the demand for such a scheme. The results of this mapping will be published on the Participants portal and updated regularly.

(b)  A pilot, based on this mapping, will be launched in the first Horizon Europe work programme. Under this pilot, the following conditions must be met:

—  the national or regional evaluation procedures shall be certified by the Commission according to criteria included in the Horizon Europe Work Programme;

—  the Commission shall ensure equal treatment with other proposals in the evaluation of proposals submitted under the EIC Accelerator. In particular all eligible proposals shall have to comply with a selection test, on a strictly equal footing, consisting of a face-to-face interview with a jury consisting of external independent experts.

1.1.3.  Additional EIC activities

Additionally, EIC will also implement:

–  Highly recommended to all selected start-ups and SMEs, and in exceptional cases small mid-caps, although not mandatory, EIC business acceleration services in support of Pathfinder and Accelerator activities and actions. The aim will be to connect the EIC Community of funded innovators, including funded Seal of Excellence, to investors, partners and public buyers. It will provide a range of coaching and mentoring services to EIC actions. It will provide innovators with access to international networks of potential partners, including industrial ones, to complement a value chain or develop market opportunities, and find investors and other sources of private or corporate finance. Activities will include live events (e.g. brokerage events, pitching sessions) but also, the development of matching platforms or use of existing ones, in close relation with financial intermediaries supported by the InvestEU and with the EIB Group. These activities will also encourage peer exchanges as a source of learning in innovation ecosystem, making particular good use of Members of the ▌EIC Board and EIC Fellows;

–  EIC Fellowship to honour the EU's leading innovators. They will be awarded by the Commission on the advice of the High Level Advisory Board to recognise them as ambassadors for innovation;

–  EIC Challenges, i.e. inducement prizes, to help develop novel solutions to global challenges, bring in new actors and develop new communities. Other EIC ▌prizes will include iCapital, the Climate innovation prize, the Social Innovation Inducement Prize, and the Women Innovators' Prize.(35) The design of its prizes will be linked to the EIC and to other parts of the EU Framework Programme, including missions and to other relevant funding bodies. Opportunities for cooperation with organisations able to provide complementary support (such as enterprises, universities, research organisations, business accelerators, charities and foundations) will be explored.

–  EIC Innovative Procurement, to procure prototypes, or develop first purchase programme to facilitate the testing and acquisition of pre-market innovative technologies by national, regional or local public entities, collectively whenever possible.

1.2.  Implementation

To reflect its innovator-centric approach and novel types of actions, the implementation of the EIC calls for the deployment of specific management features▌.

1.2.1.  The EIC Board

The High Level Advisory EIC Board ▌("EIC Board") shall assist the Commission in implementing the EIC. As well as advising on the EIC work programmes, the EIC Board shall take an active role in advising on the process of project selection and the management and following up actions. It will have a communication function, with members playing an ambassadorial role helping to stimulate innovation across the EU. Communication channels will include attendance at key innovation events, social media, constitution of an EIC community of innovators, engaging with key media with a focus on innovation, common events with incubators and acceleration hubs.

The EIC Board shall provide advice to the Commission regarding innovation trends or initiatives needed to enhance and foster the EU innovation ecosystem, including potential regulatory barriers. The EIC Board's advice shall also identify emerging areas of innovation likely to be taken into account in the activities under the Global Challenges and European Industrial Competitiveness pillar and missions. In this way, and in coordination with the relevant programme committee configuration, the EIC Board is expected to contribute to the overall coherence of the Horizon Europe programme.

Based on the advice of the EIC Board, the Commission will:

–  provide potential applicants with detailed information in advance of calls for proposals, to include

—  the requirements of the different supporting schemes;

—  how the proposed forms of financial support (blended finance, grant, equity, loan and guarantee) will be provided and implemented;

—  clear differentiation between the targeted groups and their distinct needs, according to EIC schemes;

—  definition of the innovation objectives in terms of product, process, marketing and services;

–  establish a solid monitoring of the implementation of the EIC schemes with the objective to ensure quick policy learning and to develop innovation patterns. For this purpose, indicators will be selected and implemented to measure the expected and achieved innovation in terms of product, process, marketing and services;

–  ensure complementarity and cooperation between the EIC and the EIT with the aim to avoid duplication;

–  disseminate detailed information on existing tools to attract risk capital investors in case of highly risky projects.

1.2.2.  EIC programme managers

The Commission will take a pro-active approach to the management of high risk projects, through access to the necessary expertise.

The Commission will appoint on a temporary basis a number of EIC programme managers to assist it with business- and technology-based vision and operational guidance. The Programme Committee will be informed on the appointments.

Programme managers will come from multiple spheres, including companies, universities, national laboratories and research centers. They will bring deep expertise from personal experience and years in the field. They will be recognised leaders, either having managed multidisciplinary research teams or directing large institutional programs, and know the importance of communicating their visions tirelessly, creatively, and broadly. Lastly, they will have experience in overseeing important budgets, which require sense of responsibility.

Programme managers will be expected to boost the impact of EIC funding by fostering an « active management » culture, combining a sound technological knowledge with a hands-on approach involving development at portfolio and projects levels of vision-based budgets, timelines and milestones EIC projects must meet to receive continued funding.

In particular, programme managers ▌oversee the implementation of Pathfinder and Accelerator calls, and provide opinion to the expert evaluation ▌committees, based on clear and fair criteria and in view of a consistent strategic portfolio of projects, expected to make essential contributions to the emergence of potential societal or economic market creating innovations.

Programme managers will have the task of nurturing Pathfinder portfolios by developing together with beneficiaries a common vision and a common strategic approach that leads to a critical mass of effort. This will involve the enhancement of new, recently developed fields of research, and the building up and structuring of new communities, with the objective of bringing cutting-edge breakthrough ideas into genuine and mature market creating innovations. Programme managers will implement transition activities, further developing portfolio with relevant additional activities and partners, and closely monitoring potential spin-offs and start-ups.

To allow more flexibility, programme managers will review Pathfinder and Accelerator’s projects, for each milestone or predefined criteria at relevant intervals according to the project development, to assess whether they should be continued, reoriented or terminated according to defined methods and procedures for project management. Where relevant, such assessments may involve independent external experts. In accordance with staff regulations, the Commission will ensure that there is no conflict of interest, nor breach of confidentiality, of programme managers in the execution of all their tasks.

Given the high risk nature of the actions, it is expected that a significant number of projects will not reach completion. Budget decommitted from such terminations will be used to support other EIC actions and shall be communicated in a timely manner to the Programme Committee.

1.2.3.  Implementation of the EIC blended finance

The Commission will manage all operational elements of Accelerator projects, including the grant or other non-repayable forms of support.

For the purpose of managing EIC blended finance, the Commission shall establish a special purpose vehicle (EIC SPV).

The Commission shall seek to ensure the participation of other public and private investors. Where this is not possible at the initial set up, the special purpose vehicle will be structured in such a way that it can attract other public or private investors in order to increase the leverage effect of the Union contribution.

The investment strategy of the EIC SPV will be endorsed by the Commission. The EIC SPV shall define and implement an exit strategy for its equity participations, which will include the possibility to propose the transfer of (a share) of an investment operation to the implementing partners supported under the InvestEU programme, where appropriate and for operations whose risks have been sufficiently lowered so that they meet criteria of Article 209(2) of the Financial Regulation. The Programme Committee will be informed accordingly.

The EIC SPV will perform due diligence, and negotiate technical terms of each investment in compliance with the principles of additionality and prevention of conflict of interests with other activities of the investees and of other counterparts. The EIC SPV will proactively leverage public and/or private investments into individual Accelerator’s operations.

2.  EUROPEAN INNOVATION ECOSYSTEMS

2.1.  Rationale

To fully harness the potential of innovation involving researchers, entrepreneurs, industry and society at large, the EU, together with the Member States, must improve the environment within which innovation can flourish at all levels. This will mean contributing to the development of an effective innovation ecosystem at EU level, and encouraging cooperation, networking, and the exchange of ideas and knowledge, developing open innovation processes in organisations, funding and skills among national, regional and local innovation ecosystems, in order to support all types of innovation, reach out to all innovators across the EU and provide them with adequate support.

The EU and Member States must also aim to develop ecosystems that support social innovation and public sector innovation, in addition to innovation in private enterprises. Indeed, the government sector must innovate and renew itself in order to be able to support the changes in regulation and governance required to support the large-scale deployment of innovations, including new technologies and a growing public demand for the more efficient and effective delivery of services. Social innovations are crucial to enhance the welfare of our societies.

To attain these objectives, activities will be implemented to complement and to ensure synergies with the EIC’s types of action, as well as with the activities of the EIT, with activities undertaken under other pillars of Horizon Europe and with activities implemented by Member States and Associated Countries, but also by private initiatives.

2.2.  Areas of intervention

As a first step the Commission will organise an EIC Forum of Member States and Associated countries’ public authorities and bodies in charge of ▌innovation policies and programmes, with the aim of promoting coordination and dialogue on the development of the EU's innovation ecosystem. The EIC Board and the EIT Board will also be associated. Within this EIC Forum, the Commission will:

–  Discuss the development of innovation-friendly regulation, through the continued application of the Innovation Principle(36) and development of innovative approaches to public procurement including developing and enhancing the Public Procurement of Innovation (PPI) instrument to drive innovation. The Observatory of Public Sector Innovation will also continue to support internal government innovation efforts, alongside the revamped Policy Support Facility;

–  Promote the alignment of research and innovation agendas with EU efforts to consolidate an open market for capital flows and investment, such as the development of key framework conditions in favour of innovation under the Capital Markets Union;

–  Enhance coordination between national and regional innovation programmes and innovation activities under Horizon Europe, including notably the EIC and the EIT, so as to stimulate operational synergies and avoid overlaps, by sharing data on programmes and their implementation, resources and expertise, analysis and monitoring of technological and innovation trends, ▌interconnecting respective innovators' communities;

–  Establish a joint communication strategy on innovation in the EU. It will aim at stimulating the EU's most talented innovators, entrepreneurs, particularly young ones, SMEs and start-ups, throughout the EU. It will stress the EU added-value that technical, non-technical, and social innovators can bring to EU citizens by developing their idea/vision into a thriving enterprise (social value/impact, jobs and growth, societal progression).

The EU will also, in synergy with other Horizon Europe activities, including those of the EIC and EIT, and with the regional smart specialisation strategies:

–  Promote and co-fund joint innovation programmes managed by authorities in charge of public national, regional or local innovation policies and programmes, to which private entities supporting innovation and innovators may be associated. Such demand-driven joint programmes may target, among others, early stage and feasibility study support, academia-enterprise cooperation, support to high-tech SMEs' collaborative research, technology and knowledge transfer, internationalisation of SMEs, market analysis and development, digitalisation of low-tech SMEs, support the development and interconnection of open innovation infrastructures, such as pilots, demonstrators, maker spaces and testbeds, financial instruments for close to market innovations activities or market deployment, social innovation. They may also include joint public procurement initiatives, enabling innovations to be commercialised in the public sector, in particular in support of the development of new policy. This could be particularly effective to stimulate innovation in public service areas and to provide market opportunities to European innovators;

–  Support also joint programmes for mentoring, coaching, technical assistance and other services that are delivered close to innovators, by networks such as National Contact Points, Enterprise Europe Network (EEN), clusters, pan-European platforms such as Startup Europe, regional or local innovation actors, public but also private, in particular incubators and innovation hubs that could moreover be interconnected to favour partnering between innovators. Support may also be given to promote soft skills for innovation, including to networks of vocational institutions and in close cooperation with the European Institute of Innovation and Technology and its KICs;

–  Improve data and knowledge about innovation support, including mapping of support schemes, establishing data sharing platforms, benchmarking and evaluation of support schemes.

The EU will also launch actions necessary to further monitor and nurture the overall innovation landscape and innovation management capacity in Europe.

The ecosystem support activities will be implemented by the Commission, supported by an executive agency for the evaluation process.

PART - WIDENING PARTICIPATION AND STRENGTHENING THE EUROPEAN RESEARCH AREA

This part of the Programme shall implement concrete measures in support of widening participation and strengthening the European Research Area. It shall aim to strengthen collaborate links across Europe and open up European R&I networks, contribute to improving research management capacities in the widening countries, support national policy reforms as well as exploit the potential of the Union’s talent pool by targeted actions.

The EU has a history of world-class scientific and technological achievements, but its research and innovation potential fails to be fully exploited. Despite much progress in developing the European Research Area (ERA), including the ERA roadmap and national ERA action plans, Europe has still a fragmented research and innovation landscape, and all Member States face bottlenecks in their research and innovation systems which require policy reforms. In some areas, progress is too slow to catch-up with an increasingly dynamic research and innovation ecosystem(37).

The level of research and innovation investment in Europe is still far below the policy objective of 3% of GDP and continues to grow less than our main competitors such as US, Japan, China or South-Korea.

Meanwhile, there is a growing disparity in Europe between the R&I-leading and the R&I-lagging countries and regions. Change, for example through more and better links between research and innovation actors across Europe, is needed if Europe as a whole is to capitalise on excellence from across the continent, maximise the value of public and private investments, and their impacts on productivity, economic growth, job creation and well-being. In addition, there is a need for structural R&I policy reforms and better national and regional as well as institutional cooperation in the production and diffusion of high-quality knowledge.

In addition, research and innovation are seen by some as distant and elitist without clear benefits for citizens, instilling attitudes that hamper the creation and uptake of innovative solutions, and scepticism about evidence-based public policies. This requires both better linkages between scientists, researchers, innovators, entrepreneurs, citizens and policy-makers, and more robust approaches to pooling scientific evidence itself in a changing society.

The EU now needs to raise the bar on the quality and impact of its research and innovation system, requiring a revitalised European Research Area (ERA)(38), across the European Union and Associated Countries, better supported by the EU's research and innovation Framework Programme and national and regional programmes. Specifically, a well-integrated yet tailored set of EU measures(39) is needed, combined with reforms and performance enhancements at national level (to which the Smart Specialisation Strategies supported under the European Regional Development Fund as well as the Policy Support Facility can contribute) and, in turn, effective institutional changes within research funding and performing organisations, including universities, leading to outstanding knowledge production. By combining efforts at EU level, synergies can be exploited across Europe and the necessary scale can be found to make support to national policy reforms more efficient and impactful.

The activities supported under this part specifically address ERA policy priorities, while generally underpinning all parts of Horizon Europe. Activities may also be established to foster brain circulation across ERA through mobility of researchers and innovators, taking fully into account current imbalances, and to create and develop networks of scholars, scientists, researchers and innovators to put all their (intangible) assets to the service of the ERA and by supporting the development of domain-specific science roadmaps.

The goal is for an EU where knowledge and a highly skilled workforce circulate freely, research outputs are shared rapidly and efficiently, researchers benefit from attractive careers and gender equality is ensured, where Member States and Associated Countries develop common strategic research agendas, aligning national plans, defining and implementing joint programmes, and where the outcomes of research and innovation are understood and trusted by informed citizens and benefit society as a whole.

This part will contribute de facto to all Sustainable Development Goals (SDGs), but directly to the following: SDG 4 - Quality Education; SDG 5 - Gender Equality; SDG 9 - Industry, Innovation and Infrastructure; SDG 17 - Partnership for the Goals.

1.  WIDENING PARTICIPATION AND SPREADING EXCELLENCE

Reducing disparities and the existing divide in research and innovation performance by sharing knowledge and expertise across the EU will help widening countries and ▌the EU outermost regions, to attain a competitive position in the global value chains and the Union to fully benefit from R&I potential of all Member States.

Further action, for example through the promotion of openness and diversity of project consortia, is therefore needed to counter the trend for closed collaborations, which can exclude large number of promising institutions and individuals, including newcomers, and to exploit the potential of the EU's talent pool by maximising and sharing the benefits of research and innovation across the EU.

Within the broad areas of activities, the funding lines will facilitate specific research elements customised to the particular needs of the actions.

Broad Lines

–  Teaming, to create new centres of excellence or upgrade existing ones in eligible countries, building on partnerships between leading scientific institutions and partner institutions;

–  Twinning, to significantly strengthen universities or research organisations from ▌eligible countries in a defined field, by linking it with internationally-leading research institutions from other Member States or Associated Countries;

–  ERA Chairs, to support universities or research organisations from eligible countries to attract and maintain high quality human resources under the direction of an outstanding researcher and research manager (the 'ERA Chair holder'), and to implement structural changes to achieve excellence on a sustainable basis;

–  European Cooperation in Science and Technology (COST), involving ambitious conditions regarding the inclusion of eligible countries, and other measures to provide scientific networking, capacity building and career development support to young and advanced researchers from these target countries, through actions of high scientific quality and relevance. 80% of the total budget of COST will be devoted to actions fully aligned with the objectives of this intervention area, including funding for new activities and services;

–  Activities aimed at improving the quality of proposals from legal entities from low R&I performing Member States, such as professional pre-proposal checks and advice, and boosting the activities of National Contact Points to support international networking, as well as activities following Article 20(3) of the [Regulation] and evidence-based matchmaking services following Article 46(2) of the [Regulation];

–  Activities may be established to foster brain circulation of researchers of all ages and at all levels right across ERA (for instance grants to enable researchers of any nationality to acquire and transfer new knowledge and to work on research and innovation in Widening countries) and better exploitation of existing (and possibly jointly managed) research infrastructures in the targeted countries through mobility of researchers and innovators. Activities may also be established to foster initiatives on excellence.

This intervention area will support the Horizon Europe specific objectives: Facilitate full engagement of Europe’s talent pool in supported actions; Spread and connect excellence across the EU; Reinforce the creation of high quality knowledge; Increase cross-sectorial, cross-disciplinary cross-border cooperation.

2.  REFORMING AND ENHANCING THE EU RESEARCH AND INNOVATION SYSTEM

Policy reforms at national level will be mutually reinforced and complemented through the development of EU-level policy initiatives, research, networking, partnering, coordination, data collection and monitoring and evaluation.

Broad Lines

–  Strengthening the evidence base for research and innovation policy, for a better understanding of the different dimensions and components of national and regional research and innovation ecosystems, including drivers, impacts, associated polices;

–  Foresight activities, to anticipate emerging needs and trends, in coordination and co-design with national agencies and future-oriented stakeholders and citizens, in a participative manner, building on advances in forecasting methodology, making outcomes more policy relevant, while exploiting synergies across and beyond the programme;

–  Support for policy makers, funding bodies, research performing organisations (including universities) or advisory groups working on ERA and ERA related policies or implementing coordination and support measures supporting the ERA to ensure that these are to be well-aligned towards developing and implementing a coherent and long-term sustaining ERA. Such support may take the form of Coordination and Support Actions (CSAs) in a bottom-up and competitive way to support programme level collaboration between research and innovation programme of Member States, Associated Countries and civil society organisations such as foundations, on priorities of their choice, with a clear focus on the implementation of transnational joint activities including calls. It will be based on clear commitments from participating programmes to pool resources and ensure complementarity between activities and policies with those of the Framework Programme and relevant European Partnership Initiatives;

–  Accelerating the transition towards open science, by monitoring, analysing and supporting the development and uptake of open science policies and practices(40), including the FAIR principles, at the level of Member States, regions, institutions and researchers, in a way that maximises synergies and coherence at EU level;

–  Support to national research and innovation policy reform, including though a strengthened set of services of the Policy Support Facility (PSF)(41) (i.e. peer reviews, specific support activities, mutual learning exercises and the knowledge centre) to Member States and Associated Countries, operating in synergy with the European Regional Development Fund, the Structural Reform Support Service (SRSS) and the Reform Delivery Tool;

–  Providing researchers with attractive career environments, skills and competences needed in the modern knowledge economy(42). Linking the ERA and the European Higher Education Area by supporting the modernisation of universities and other research and innovation organisations, through recognition and reward mechanisms to spur actions at national level, as well as incentives promoting the adoption of open science practices, responsible R&I, entrepreneurship (and links to innovation ecosystems), trans-disciplinarity, citizen engagement, international and inter-sectoral mobility, gender equality plans, diversity and inclusion strategies, and comprehensive approaches to institutional changes. In that context, as a follow-up of the pilot actions launched under Erasmus▌+ 2014-20 on European Universities▌, Horizon Europe will, where appropriate, complement in a synergetic way the support provided by the ERASMUS' programme to European Universities, providing support on their research and innovation dimension▌. This will contribute to developing new joint and integrated long term and sustainable strategies on education, research and innovation based on trans-disciplinary and cross-sectoral approaches to make the knowledge triangle a reality, providing impetus to sustainable economic growth, while avoiding overlaps with EIT KICs.

–  Citizen science, supporting all types of formal, non-formal and informal science education, ensuring a more effective and responsible engagement of citizens, regardless of age, background or abilities, in the co-design of research and innovation agenda settings and policy, in the co-creation of scientific content and innovation through transdisciplinary activities;

–  Supporting and monitoring gender equality and as well as other forms of diversity in scientific careers and in decision making, including in advisory bodies, as well as the integration of the gender dimension in research and innovation content;

–  Ethics and integrity, to further develop a coherent EU framework in adherence with the highest ethics standards and the European Code of Conduct for Research Integrity, the European Charter for Researchers and the Code of Conduct for the Recruitment of Researchers, providing the training opportunities in these areas;

–  Supporting international cooperation, through bilateral, multilateral and bi-regional policy dialogues with third countries, regions and international fora will facilitate mutual learning and priority setting, promote reciprocal access and monitor impact of cooperation;

–  Scientific input to other policies, through the creation and maintenance of advisory and monitoring structures and processes to ensure that EU policy-making is based on the best available scientific evidence and high-level scientific advice;

–  EU research and innovation programme implementation, including the collection and analysis of evidence for the monitoring, evaluation, design and impact assessment of the Framework Programmes;

–  The Commission will ensure support for NCPs inter-alia through regular meetings before calls, training, coaching, strengthening dedicated support structures and facilitating trans-national cooperation among them (e.g. building on activities of National Contact Points in previous Framework Programmes); The Commission will develop minimum standards, in agreement with Member States representatives, for the operation of these support structures, including their role, structure, modalities, flow of information from the Commission before calls for proposals, and avoidance of conflicts of interest;

–  Dissemination and exploitation of research and innovation results, data and knowledge, including through dedicated support to beneficiaries; fostering synergies with other EU programmes; targeted communication activities to raise the awareness of the broader impact and relevance of EU funded research and innovation, as well as science communication.

ANNEX II

Programme Committee configurations

List of configurations of the Programme Committee in accordance with Article 12(2):

1.  Strategic configuration: Strategic overview of the implementation of the whole programme, coherence across the individual work programmes of the different parts of the programme, including missions ▌

2.  European Research Council (ERC) ▌

2a.   Marie Skłodowska-Curie Actions (MSCA)

3.  Research Infrastructures

4.  Health

5.  Culture, creativity and Inclusive Society

5a.  Civil Security for Society

6.   Digital, Industry and Space

7.  Climate, Energy and Mobility

8.  Food, Bioeconomy, Natural Resources, Agriculture and Environment

9.  The European Innovation Council (EIC) and European Innovation ecosystems

9a.  Widening participation and strengthening the European Research Area

Ad-hoc meetings could be organised within the clusters and/or with different Programme Committee configurations and/or with Committees established by other acts on horizontal and/or cross-cutting issues, such as space and mobility.

ANNEX III

Information to be provided by the Commission in accordance with Article 12(6)

1.  Information on individual projects, enabling the monitoring of the entire lifetime of each proposal, covering in particular:

—  submitted proposals,

—  evaluation results for each proposal,

—  grant agreements,

—  terminated projects in accordance with Article 29(2) and (3) and Article 43(11) of the Regulation (Horizon Europe)

—  completed projects.

2.  Information on the outcome of each call and project implementation, covering in particular:

—  results of each call,

—  evaluation scores of proposals and deviations from these in their ranking list, based on their contribution to the achievement of specific policy objectives, including the constitution of a consistent portfolio of projects in accordance with Article 26(2) of the Regulation (Horizon Europe),

—  requested adjustments to the proposals in accordance with Article 26(2) of the Regulation (Horizon Europe),

—  outcome of negotiations on grant agreements,

—  project implementation, including payment data and outcome of projects,

—  proposals retained by independent experts evaluation, but rejected by the Commission in accordance with Article 43(7) of the Regulation (Horizon Europe).

3.  Information on programme implementation, including relevant information at the level of the framework programme, the specific programme, each specific objective and related themes and the JRC, as part of the annual monitoring along the impact pathways defined in Annex V to the Regulation, as well as the synergies with other relevant Union programmes.

4.  Information on the execution of the Horizon Europe budget, including information on COST, on commitments and payments for all European Partnerships, including KICs, as well as financial balances between the EU and all associated countries.

(1) OJ L 123, 12.5.2016, p. 1.
(2) This position replaces the amendments adopted on 12 December 2018 (Texts adopted, P8_TA(2018)0510).
(3)OJ C […], […], p. […].
(4)OJ C […], […], p. […].
(5) Position of the European Parliament of 17 April 2019. The text highlighted in grey has not been agreed in the framework of interinstitutional negotiations.
(6)OJ C […], […], p. […].
(7)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(8)Commission Decision 96/282/Euratom of 10 April 1996 on the reorganization of the Joint Research Centre (OJ L 107, 30.4.1996, p. 12).
(9)
(10)OJ C 373, 20.12.2013, p. 23.
(11) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
(12)With a view to facilitating the implementation of the programme, for each meeting of the Programme Committee as defined in the agenda, the Commission will reimburse, in accordance with its established guidelines, the expenses of one representative per Member State, as well as one expert/adviser per Member State for those agenda items where a Member State requires specific expertise.
(13)In principle at least 80 %.
(14)The European Data Infrastructure will underpin the European Open Science cloud by providing world-class High Performance Computing capability, high speed connectivity and leading-edge data and software services.
(15)OECD Understanding The Socio-Economic Divide in Europe, 26 January 2017.
(16)The Key Enabling Technologies of the future include advanced materials and nanotechnology, photonics and micro- and nano-electronics, life science technologies, advanced manufacturing and processing, artificial intelligence and digital security and connectivity.
(17) "Re-finding industry - defining innovation" Report of the High-Level Strategy Group on Industrial Technologies, Brussels April 2018.
(18)These are public or private facilities that provide resources and services primarily for the European industry to test and validate key enabling technologies and products. Such infrastructures may be single sited, virtual or distributed, and must be registered in a Member State or a third country associated to the Programme.
(19)Substantial reduction of greenhouse gas emissions in other sectors is addressed in other Parts of Pillar II and Horizon Europe in general.
(20) The term "alternative energy" does not include energy produced from nuclear energy sources.
(21)The bioeconomy covers all sectors and systems that rely on biological resources (animals, plants, micro-organisms and derived biomass, including organic waste), their functions and principles. It includes and interlinks: land and marine ecosystems and the services they provide; all primary production sectors that use and produce biological resources (agriculture, forestry, fisheries and aquaculture); and all economic and industrial sectors that use biological resources and processes to produce food, feed, bio-based products, energy and services. Biomedicines and health biotechnology are excluded.
(22) ‘Sustainable blue economy’ means all sectoral and cross-sectoral economic activities throughout the single market related to oceans, seas, coasts and inland waters, covering the Union's outermost regions and landlocked countries, including emerging sectors and non-market goods and services and being consistent with Union environmental legislation.'
(23)The expression ‘land and sea’ includes ‘inland waters’ throughout the text of Cluster 6.
(24)COM(2018)0773: A Clean Planet for all. A European strategic long-term vision for a prosperous, modern, competitive and climate neutral economy.
(25) Environmental Observation accessible e.g. through the Copernicus component of the Union Space programme and other relevant European programmes, as well as the GEO initiative will support research and innovation under other intervention areas within this Global Challenge as well as other relevant parts of Horizon Europe.
(26)SWD(2016)0319: European Research and Innovation for Food and Nutrition Security.
(27)Health biotechnology applications will be addressed by the Health cluster under this pillar.
(28)The activities in Circular Systems Area of Intervention are complementary to those of Low-Carbon and Clean Industry in the Digital and Industry cluster.
(29)Innovation Hub is an umbrella term for a broad variety of skills. It can serve as an active partner, a community, a knowledge center, a facilitator or a connector that offers access to latest knowledge and expertise on digital and related enabling technologies necessary for companies to become more competitive with regard to production, services and business processes.
(30)Relevant topics may be identified in the context of the Horizon Europe Strategic planning.
(31)Typically as a combination of scientific/technological risks, management/financial risks, market/economical risks and regulatory risks. Unforeseen additional risks may also be taken into account.
(32)As an alternative to a grant when risk is deemed lower than average, a reimbursable advance shall be paid back to the EU on an agreed schedule and then becomes an interest-free loan. In case the beneficiary is not able to reimburse, but can continue its activity, the reimbursable advance shall be transformed into equity. In case of bankruptcy, the reimbursable advance becomes just a grant.
(33)As a principle, the EU is not expected to hold more than a minority of voting rights in companies supported. In exceptional cases, the EU may secure the acquisition of a blocking minority to protect European interests in essential areas, e.g. cyber security.
(34)Such as ERC Proof of Concept, from projects supported under the 'Global Challenges and Industrial Competitiveness" Pillar, startups emerging from the KICs of the European Institute of Innovation and Technology. Applications shall also stem from Horizon 2020 activities, particularly project selected under Horizon 2020 SME Phase 2 and related Seal of Excellence financed by Member States, (existing and future) European Partnerships.
(35)To ensure seamless continuity, the EIC prizes will take over the management of prizes launched under Horizon 2020. In addition, the EIC Board shall provide for the design and implementation of new inducement prizes and recognition awards.
(36) Commission Communication of 15 May 2018 'A renewed European Agenda for Research and Innovation - Europe's chance to shape its future' (COM(2018)0306, Council Decision of 27 May 2016 (8675/16 RECH 127 COMPET 212 MI 300 POGEN 34).
(37)The ERA progress report of 2018.
(38)Council Conclusions on the ERA Roadmap, 19 May 2015 [To be updated as necessary].
(39)TFEU Article 181.2.
(40)The policies and practices to be addressed range from sharing research outputs as early and widely as possible through commonly agreed formats and a shared infrastructure (e.g. the European Open Science Cloud), citizen science, and developing and using new, broader approaches and indicators for evaluating research and rewarding researchers.
(41)The Policy Support Facility (PSF), launched under Horizon 2020. The PSF works on a demand-driven basis and it offers, on a voluntary basis, high level expertise and tailor-made advice to national public authorities. Through its services, it has already been instrumental in provoking policy change in countries such as Poland, Bulgaria, Moldova or Ukraine and in bringing forward policy changes, driven by exchanges of good practice, in areas such as R&D tax incentives, open science, performance-based funding of public research organisations and the inter-operability of national research and innovation programmes.
(42)Including notably the European Charter for researchers, the code of conduct for the recruitment of researchers, EURAXESS and RESAVER Pension Fund.


Market surveillance and compliance of products ***I
PDF 122kWORD 52k
Resolution
Text
European Parliament legislative resolution of 17 April 2019 on the proposal for a regulation of the European Parliament and of the Council laying down rules and procedures for compliance with and enforcement of Union harmonisation legislation on products and amending Regulations (EU) No 305/2011, (EU) No 528/2012, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and (EU) 2017/1369 of the European Parliament and of the Council, and Directives 2004/42/EC, 2009/48/EC, 2010/35/EU, 2013/29/EU, 2013/53/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU and 2014/90/EU of the European Parliament and of the Council (COM(2017)0795 – C8-0004/2018 – 2017/0353(COD))
P8_TA(2019)0397A8-0277/2018

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2017)0795),

–  having regard to Article 294(2) and Articles 33, 114 and 207 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0004/2018),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the reasoned opinion submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Swedish Parliament, asserting that the draft legislative act does not comply with the principle of subsidiarity,

–  having regard to the opinion of the European Economic and Social Committee of 23 May 2018(1),

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 15 February 2019 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on the Internal Market and Consumer Protection and the opinion of the Committee on the Environment, Public Health and Food Safety (A8-0277/2018),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 17 April 2019 with a view to the adoption of Regulation (EU) 2019/… of the European Parliament and of the Council on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011

P8_TC1-COD(2017)0353


(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2019/1020.)

(1) OJ C 283, 10.8.2018, p. 19.


Promoting fairness and transparency for business users of online intermediation services ***I
PDF 120kWORD 44k
Resolution
Text
European Parliament legislative resolution of 17 April 2019 on the proposal for a regulation of the European Parliament and of the Council on promoting fairness and transparency for business users of online intermediation services (COM(2018)0238 – C8-0165/2018 – 2018/0112(COD))
P8_TA(2019)0398A8-0444/2018

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2018)0238),

–  having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0165/2018),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 19 September 2018(1),

–  after consulting the Committee of the Regions,

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 20 February 2019 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on the Internal Market and Consumer Protection and the opinions of the Committee on Legal Affairs, the Committee on Industry, Research and Energy and the Committee on Transport and Tourism (A8-0444/2018),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 17 April 2019 with a view to the adoption of Regulation (EU) 2019/… of the European Parliament and of the Council on promoting fairness and transparency for business users of online intermediation services

P8_TC1-COD(2018)0112


(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2019/1150.)

(1) OJ C 440, 6.12.2018, p. 177.


Better enforcement and modernisation of EU consumer protection rules ***I
PDF 121kWORD 60k
Resolution
Text
European Parliament legislative resolution of 17 April 2019 on the proposal for a directive of the European Parliament and of the Council amending Council Directive 93/13/EEC of 5 April 1993, Directive 98/6/EC of the European Parliament and of the Council, Directive 2005/29/EC of the European Parliament and of the Council and Directive 2011/83/EU of the European Parliament and of the Council as regards better enforcement and modernisation of EU consumer protection rules (COM(2018)0185 – C8-0143/2018 – 2018/0090(COD))
P8_TA(2019)0399A8-0029/2019

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2018)0185),

–  having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0143/2018),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the reasoned opinions submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Austrian Federal Council and the Swedish Parliament, asserting that the draft legislative act does not comply with the principle of subsidiarity,

–  having regard to the opinion of the European Economic and Social Committee of 20 September 2018(1),

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 29 March 2019 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on the Internal Market and Consumer Protection (A8-0029/2019),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 17 April 2019 with a view to the adoption of Directive (EU) 2019/… of the European Parliament and of the Council amending Council Directive 93/13/EEC and Directives 98/6/EC, 2005/29/EC and 2011/83/EU of the European Parliament and of the Council as regards better enforcement and modernisation of Union consumer protection rules

P8_TC1-COD(2018)0090


(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Directive (EU) 2019/2161.)

(1) OJ C 440, 6.12.2018, p. 66.


Transparency and sustainability of the EU risk assessment in the food chain ***I
PDF 125kWORD 58k
Resolution
Text
European Parliament legislative resolution of 17 April 2019 on the proposal for a Regulation of the European Parliament and of the Council on the transparency and sustainability of the EU risk assessment in the food chain amending Regulation (EC) No 178/2002 [on general food law], Directive 2001/18/EC [on the deliberate release into the environment of GMOs], Regulation (EC) No 1829/2003 [on GM food and feed], Regulation (EC) No 1831/2003 [on feed additives], Regulation (EC) No 2065/2003 [on smoke flavourings], Regulation (EC) No 1935/2004 [on food contact materials], Regulation (EC) No 1331/2008 [on the common authorisation procedure for food additives, food enzymes and food flavourings], Regulation (EC) No 1107/2009 [on plant protection products] and Regulation (EU) No 2015/2283 [on novel foods] (COM(2018)0179 – C8-0144/2018 – 2018/0088(COD)
P8_TA(2019)0400A8-0417/2018

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2018)0179),

–  having regard to Article 294(2) and Articles 43, 114 and 168(4)(b) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0144/2018),

–  having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis,

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 19 September 2018(1),

–  having regard to the opinion of the Committee of the Regions of 10 October 2018(2),

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 15 February 2019 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rules 59 and 39 of its Rules of Procedure,

–  having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Fisheries and the Committee on Legal Affairs (A8-0417/2018),

1.  Adopts its position at first reading hereinafter set out(3);

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 17 April 2019 with a view to the adoption of Regulation (EU) 2019/… of the European Parliament and of the Council on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC

P8_TC1-COD(2018)0088


(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2019/1381.)

(1) OJ C 440, 6.12.2018, p. 158.
(2) OJ C 461, 21.12.2018, p. 225.
(3) This position replaces the amendments adopted on 11 December 2018 (Texts adopted, P8_TA(2018)0489).


Supplementary protection certificate for medicinal products ***I
PDF 121kWORD 45k
Resolution
Text
European Parliament legislative resolution of 17 April 2019 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (COM(2018)0317 – C8-0217/2018 – 2018/0161(COD))
P8_TA(2019)0401A8-0039/2019

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2018)0317),

–  having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0217/2018),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 19 September 2018(1),

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 20 February 2019 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on Legal Affairs and also the opinions of the Committee on International Trade and the Committee on the Environment, Public Health and Food Safety (A8-0039/2019),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 17 April 2019 with a view to the adoption of Regulation (EU) 2019/… of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products

P8_TC1-COD(2018)0161


(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2019/933.)

(1) OJ C 440, 6.12.2018, p. 100.


Space programme of the Union and European Union Agency for the Space Programme ***I
PDF 509kWORD 182k
Resolution
Consolidated text
European Parliament legislative resolution of 17 April 2019 on the proposal for a regulation of the European Parliament and of the Council establishing the space programme of the Union and the European Union Agency for the Space Programme and repealing Regulations (EU) No 912/2010, (EU) No 1285/2013, (EU) No 377/2014 and Decision 541/2014/EU (COM(2018)0447 – C8-0258/2018 – 2018/0236(COD))
P8_TA(2019)0402A8-0405/2018

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2018)0447),

–  having regard to Article 294(2) and Article 189(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0258/2018),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 17 October 2018(1),

–  having regard to the opinion of the Committee of the Regions of 6 December 2018(2),

–  having regard to the letter from its President to the committee chairs of 25 January 2019 outlining the Parliament's approach to the Multiannual Financial Framework (MFF) post-2020 sectorial programmes,

–  having regard to the letter from the Council to the President of the European Parliament of 1 April 2019 confirming the common understanding reached between the co-legislators during negotiations,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on Industry, Research and Energy and the opinions of the Committee on Budgets, the Committee on the Environment, Public Health and Food Safety, the Committee on Transport and Tourism and the Committee on Agriculture and Rural Development (A8-0405/2018),

1.  Adopts its position at first reading hereinafter set out(3);

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 17 April 2019 with a view to the adoption of Regulation (EU) /… of the European Parliament and of the Council establishing the space programme of the Union and the European Union Agency for the Space Programme and repealing Regulations (EU) No 912/2010, (EU) No 1285/2013, (EU) No 377/2014 and Decision 541/2014/EU

P8_TC1-COD(2018)0236


(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 189(2) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Acting in accordance with the ordinary legislative procedure(4),

Whereas:

(1)  Space technology, data and services have become indispensable in the daily lives of Europeans and play an essential role in preserving many strategic interests. The Union’s space industry is already one of the most competitive in the world. However, the emergence of new players and the development of new technologies are revolutionising traditional industrial models. It is therefore crucial that the Union remains a leading international player with extensive freedom of action in the space domain, that it encourages scientific and technical progress and support the competitiveness and innovation capacity of space sector industries within the Union, in particular small and medium-sized enterprises, start-ups and innovative businesses.

(2)  The possibilities that space offers for the security of the Union and its Member States should be exploited as referred to in particular in the Global Strategy for the European Union's Foreign and Security Policy of June 2016, while retaining the civil nature of the programme and respecting the possible neutrality or non-alignment provisions stipulated in the constitutional law of Member States. The space sector’s development has historically been linked to security. In many cases, the equipment, components and instruments used in the space sector as well as space data and services are dual-use ▌. However, the Union’s security and defence policy is determined within the framework of the Common Foreign and Security Policy, in accordance with Title V TEU.

(3)  The Union has been developing its own space initiatives and programmes since the end of the 1990s, namely the European Geostationary Navigation Overlay Service (EGNOS) and then Galileo and Copernicus, which respond to the needs of Union citizens and the requirements of public policies. ▌ The continuity of those initiatives should be ensured and the services they provide should be improved, so that they meet the new needs of users, remain at the forefront in view of new technology development and the transformations in the digital and information and communications technology domains ▌ and are able to meet political priorities such as climate change, including monitoring changes in the polar region, transport, security and defence.

(3a)  Synergies between the transport, space and digital sector needs to be exploited in order to foster the broader use of new technologies (such as e-call, digital tachograph, traffic supervisions and management, autonomous driving, unmanned vehicles and drones) and tackle the needs of secure and seamless connectivity, robust positioning, inter modality and interoperability, thus enhancing the competitiveness of transport services and industry.

(3b)  To fully reap the benefits of the Programme, in all Member States and by all their citizens, it is also essential to promote the use and the uptake of the data, information and services provided, as well as the support the development of downstream applications based on those data, information and services. To that end, the Member States, the Commission and the responsible entities could notably periodically run the information campaigns regarding the benefits of the Programme.

(4)  To achieve the objectives of freedom of action, independence and security, a prerequisite is for the Union to benefit from an autonomous access to Space and be able to use it safely. It is therefore essential that the Union supports autonomous, reliable and cost-effective access to space, especially as regards critical infrastructure and technology, public security and the security of the Union and its Member States. The Commission should therefore have the possibility to aggregate launch services at European level, both for its own needs and, at their request, for those of other entities, including Member States, in conformity with the provisions of Article 189(2) of the Treaty. To remain competitive in a fast evolving market, it is also crucial that the Union continues to have access to modern, efficient and flexible launch infrastructure facilities and to benefit from appropriate launch systems. Therefore, without prejudice to measures taken by Member States and the European Space Agency, the Programme might support adaptations to the space ground infrastructure, including new developments, which are necessary for the implementation of the Programme and adaptations, including technology development, to space launch systems which are necessary for launching satellites, including alternative technologies and innovative systems, for the implementation of the Programme's components. Those activities should be implemented in accordance with the Financial Regulation and ▌ with the view of achieving a better cost efficiency for the Programme. In view that there is no dedicated budget, the actions in support of access to space would be without prejudice to the implementation of the Programme components.

(5)  To strengthen the competitiveness of the Union space industry and gain capacities in designing, building and operating its own systems, the Union should support the creation, growth, and development of the entire space industry. The emergence of a business- and innovation-friendly model should be supported at European, regional and national levels by initiatives such as space hubs that bring together the space, digital and other sectors, as well as users. Those space hubs should aim to foster entrepreneurship and skills while pursuing synergies with the digital innovation hubs. The Union should foster the creation and expansion of Union-based space companies to help them succeed, including by supporting them in accessing risk finance in view of the lack, within the Union, of appropriate access to private equity for space start-ups and by fostering demand (first contract approach).

(5xx)  The space value chain is generally segmented as: i) upstream, comprising activities leading to an operational space system, including development, manufacturing and launch activities and the operations of such system; and ii) downstream, covering the provision of space-related services, and products to the users. Digital platforms are also an important element supporting the development of the space sector, allowing access to data and products as well as toolboxes, storage and computing facilities.

(5x)  In the area of space, the Union exercises its competences in accordance with article 4(3) TFEU. The Commission should ensure the coherence of activities performed in the context of the programme.

(5a)  Whereas a number of Member States have a tradition of active space related industries, the need to develop and mature space industries in Member States with emerging capabilities and the need to respond to the challenges to the traditional space industries posed by “New Space” should be recognised. Actions to develop space industry capacity across the Union and facilitate collaboration across space industry active in all Member States should be promoted.

(5b)  Actions under the Programme should build on and benefit from existing national and European capacities (i.e. capacities which exist at the time the action is being carried out).

(6)  Owing to its coverage and its potential to help resolve global challenges, ▌ space activities have a strong international dimension. In close coordination with the Member States, and with their agreement, the relevant bodies of the EU Space Programme might participate in matters pertaining to the Space Programme, in international cooperation and to collaborate in relevant sectoral UN bodies. For matters relating to the Space Programme of the Union ("Programme"), the Commission might coordinate, on behalf of the Union, and in its field of competence, activities on the international scene ▌, in particular to defend the interests of the Union and its Member States in international fora, including in the area of frequencies as regards the Programme, without prejudice to Member States competence in this area. It is particularly important that the Union, represented by the Commission, collaborates in the bodies of the International Cospas-Sarsat Programme.

(6a)  International cooperation is paramount to promote the role of the Union as a global actor in the space sector and the Union's technology and industry, fostering a fair competition at international level, bearing in mind the need to ensure the reciprocity of the rights and obligations of the parties, and to encourage cooperation in the field of training. International cooperation is a key element of the Space Strategy for Europe. The Commission will use the EU space programme to contribute to and benefit from international efforts through initiatives, to promote European technology and industry internationally (for example bi-lateral dialogues, industry workshops, support for SME internationalisation), and to facilitate access to international markets and foster fair competition, also leveraging economic diplomacy initiatives. European space diplomacy initiatives should be in full coherence and complementarity with the existing EU policies, priorities and instruments, while, the Union has a key role to play together with the Union Member States to remain at the forefront of the international scene.

(7)  Without prejudice to the competence of Member States, the Commission should promote, alongside ▌ the High Representative and in close coordination with Member States, responsible behaviour in space when implementing the programme, including to reduce space debris proliferation and explore the possibility for accession of the European Union to the relevant UN Treaties and Conventions and make, if necessary, appropriate proposals.

(8)  The Programme shares similar objectives with other Union programmes, notably Horizon Europe, InvestEU Fund, European Defence Fund and Funds under Regulation (EU) [Common Provisions Regulation]. Therefore, cumulative funding from those programmes should be foreseen, provided they do cover the same costs, in particular through arrangements for complementary funding from Union programmes where management modalities permit - either in sequence, in an alternating way, or through the combination of funds including for the joint funding of actions, allowing, where possible, innovation partnerships and blending operations. During the implementation of the Programme, the Commission should therefore promote synergies with other related Union programmes and financial instruments, which would allow, where possible, use of access to risk finance, innovation partnerships, cumulative or blended funding. It should also ensure synergies and coherence between the solutions developed under those programmes, notably Horizon Europe, and the solutions developed under the Space Programme.

(8a)  In accordance with Article 191(3) of the Financial Regulation, in no circumstances are the same costs to be financed twice by the Union budget, for example by both Horizon Europe and the Space Programme.

(9)  The policy objectives of this Programme will also be addressed as eligible areas for financing and investment operations through financial instruments and budgetary guarantee of the InvestEU Fund, in particular under its sustainable infrastructure and research, innovation and digitisation policy windows. Financial support should be used to address market failures or sub-optimal investment situations, in a proportionate manner and actions should not duplicate or crowd out private financing or distort competition in the internal market. Actions should have a clear European added value.

(10)  Coherence and synergies between Horizon Europe and the Programme will foster a competitive and innovative European space sector; reinforce Europe’s autonomy in accessing and using space in a secure and safe environment; and strengthen Europe’s role as a global actor. Breakthrough solutions in Horizon Europe will be supported by data and services made available by the Programme to the research and innovation community.

(10a)  To maximise the socio-economic return from the Programme, it is essential to maintain state-of-the-art systems, to upgrade them to meet evolving users' needs and that new developments occur in the space-enabled downstream applications sector. The Union should support activities relating to research and technology development, or the early phases of evolution relating to the infrastructures established under the Programme, as well as the research and development activities relating to applications and services based on the systems established under the programme, thereby stimulating upstream and downstream economic activities. The appropriate instrument at Union level to finance those research and innovation activities is Horizon Europe established by Regulation (EU) No XXX/XXXX. However, a very specific part of development activities should be financed from the budget allocated to the Galileo and EGNOS components under this Regulation, notably where such activities concern fundamental elements such as Galileo-enabled chipsets and receivers, which will facilitate the development of applications across different sectors of the economy. Such financing should nevertheless not jeopardise the deployment or exploitation of the infrastructures established under the Programmes.

(10x)  To ensure the competitiveness of the European space industry in the future, the Programme should support the development of advanced skills in space-related fields and support education and training activities, promoting equal opportunities, including gender equality, in order to realise the full potential of Union citizens in that area.

(10b)  Infrastructure dedicated to the Programme may require additional research and innovation, which may be supported under Horizon Europe, aiming for coherence with activities in this domain by the European Space Agency. Synergies with Horizon Europe should ensure that research and innovation needs of the space sector are identified and established as part of the strategic research and innovation planning process. Space data and services made freely available by the Programme will be used to develop breakthrough solutions through research and innovation, including in Horizon Europe, in support to the Union policy priorities. The strategic planning process under Horizon Europe will identify research and innovation activities that should make use of Union-owned infrastructures such as Galileo, EGNOS and Copernicus. Research infrastructures, in particular in situ observing networks will constitute essential elements of the in situ observation infrastructure enabling the Copernicus Services.

(11)  It is important that the Union own all tangible and intangible assets created or developed through public procurement that it finances as part of its space programme. In order to ensure full compliance with any fundamental rights relating to ownership, the necessary arrangements should be made with any existing owners. Such ownership by the Union should be without prejudice to the possibility for the Union, in accordance with this Regulation and where it is deemed appropriate on the basis of a case-by-case assessment, to make those assets available to third parties or to dispose of them.

(11a)  To encourage the widest possible use of the services offered by the Programme, it would be useful to stress that data, information and services are provided without warranty without prejudice to obligations imposed by legally binding provisions.

(11b)  The Commission, in performing certain of its tasks of a non-regulatory nature, may have recourse, as required and insofar as necessary, to the technical assistance of certain external parties. Other entities involved in the public governance of the Programme may also make use of the same technical assistance in performing tasks entrusted to them under this Regulation.

(12)  This Regulation lays down a financial envelope for the Programme which is to constitute the prime reference amount, within the meaning of point 17 of the Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, for the European Parliament and the Council during the annual budgetary procedure.

(13)  Reflecting the importance of tackling climate change in line with the Union's commitments to implement the Paris Agreement and the United Nations Sustainable Development Goals, this Programme will contribute to mainstream climate actions and to the achievement of an overall target of 25 % of the EU budget expenditures supporting climate objectives. Relevant actions will be identified during the Programme's preparation and implementation, and reassessed in the context of the relevant evaluations and review processes.

(14)  ▌ Revenue generated by the components of the Programme should accrue to the Union in order to partially offset the investments that it has already made, and that revenue should be used to support the achievements of the objectives of the Programme. For the same reason, it should be possible to provide for a revenue-sharing mechanism in contracts concluded with private sector entities.

(15)  As the Programme is, in principle, financed by the Union, procurement contracts concluded under this programme for activities financed by the Programme should comply with Union rules. In that context, the Union should also be responsible for defining the objectives to be pursued as regards public procurement. It is to be noted that the Financial Regulation provides that, on the basis of the results of an ex ante assessment, the Commission may rely on the systems and the procedures of the persons or entities implementing Union funds. Specific adjustments necessary to these systems and procedures, as well as the arrangements for the prolongation of the existing contracts, should be defined in the corresponding financial framework partnership agreement or contribution agreement.

(16)  The Programme relies on complex and constantly changing technologies. The reliance on such technologies results in uncertainty and risk for public contracts concluded under this programme, insofar as those contracts involve long-term commitments to equipment or services. Specific measures concerning public contracts are therefore required in addition to the rules laid down in the Financial Regulation. It should thus be possible to award a contract in the form of a conditional stage-payment contract, introduce an amendment, under certain conditions, in the context of its performance, or impose a minimum level of subcontracting, notably in order to enable the participation of small and medium-sized enterprises and start-ups. Lastly, given the technological uncertainties that characterise the components of the Programme, contract prices cannot always be forecast accurately and it should therefore be possible to conclude contracts without stipulating a firm fixed price and to include clauses to safeguard the financial interests of the Union.

(16a)  To foster public demand and public sector innovation, the Programme should promote the use of data, information and services of the Programme to support the development of customised solutions by industry and SMEs at local and regional levels through space-related innovation partnerships, as referred to in point 7 of Annex 1 of the Financial Regulation, allowing to cover all stages from development up to deployment and procurement of customised interoperable space solutions for public services.

(17)  In order to meet the objectives of the Programme, it is important to be able to call, where appropriate, on capacities offered by Union public and private entities active in the space domain and also to be able to work at international level with third countries or international organisations. For that reason, provision must be made for the possibility of using all the relevant tools and management methods provided for by Treaty and the Financial Regulation ▌ and joint procurement procedures.

(18)  On grants more specifically, experience has shown that user and market uptake and general outreach work better in a decentralized manner than top-down by the Commission. Vouchers, which are a form of financial support from a grant beneficiary to third parties, have been among the actions with the highest success rate to new entrants and small and medium-sized enterprises. However, they have been hindered by the ceiling on financial support imposed by the Financial Regulation. This ceiling should therefore be raised for the EU Space Programme in order to keep pace with the growing potential of market applications in the space sector.

(19)  The types of financing and the methods of implementation under this Regulation should be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver results, taking into account, in particular, the costs of controls, the administrative burden, and the expected risk of non-compliance. This should include consideration of the use of lump sums, flat rates and unit costs, as well as financing not linked to costs as referred to in [Article 125(1)] of the Financial Regulation.

(20)  Regulation (EU, Euratom) No [the new FR] (the ‘Financial Regulation’) applies to this Programme. It lays down rules on the implementation of the Union budget, including the rules on grants, prizes, procurement, indirect implementation, financial assistance, financial instruments and budgetary guarantees.

(21)  Pursuant to [reference to be updated as appropriate according to a new decision on OCTs: Article 88 of Council Decision …/…/EU], persons and entities established in overseas countries and territories (OCTs) should be eligible for funding subject to the rules and objectives of the Programme and possible arrangements applicable to the Member State to which the relevant overseas country or territory is linked.

(22)  Horizontal financial rules adopted by the European Parliament and the Council on the basis of Article 322 of the Treaty on the Functioning of the European Union apply to this Regulation. These rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, procurement, prizes, indirect implementation, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also concern the protection of the Union's budget in case of generalised deficiencies as regards the rule of law in the Member States, as the respect for the rule of law is an essential precondition for sound financial management and effective EU funding.

(23)  In accordance with Regulation (EU, Euratom) No 2018/1046 of the European Parliament and of the Council(5) (the Financial Regulation”), Council Regulation (EC, Euratom) No 2988/95(6), and Council Regulation (Euratom, EC) No 2185/96(7), the financial interests of the Union are to be protected through proportionate measures, including the prevention, detection, correction and investigation of irregularities and fraud, the recovery of funds lost, wrongly paid or incorrectly used and, where appropriate, the imposition of administrative sanctions. In particular, in accordance with Regulation (EU, Euratom) No 883/2013 and Regulation (Euratom, EC) No 2185/96, the European Anti-Fraud Office (OLAF) may carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. In accordance with Regulation (EU) 2017/1939, the European Public Prosecutor's Office (“the EPPO”) may investigate and prosecute fraud and other criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council(8). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the Union’s financial interests, to grant the necessary rights and access to the Commission, OLAF, the EPPO and the European Court of Auditors (ECA) and to ensure that any third parties involved in the implementation of Union funds grant equivalent rights.

(24)  Third countries which are members of the ▌ EEA ▌ may participate in Union programmes in the framework of the cooperation established under the EEA agreement, which provides for the implementation of the programmes by a decision under that agreement. Third countries may also participate on the basis of other legal instruments. A specific provision should be introduced in this Regulation to grant the necessary rights for and access to the authorizing officer responsible, ▌ OLAF ▌ as well as the European Court of Auditors to comprehensively exert their respective competences.

(25)  Sound public governance of the Programme requires the clear distribution of responsibilities and tasks among the different entities involved to avoid unnecessary overlap and reduce cost overruns and delays. All the actors of the governance should support, in their field of competence and in accordance with their responsibilities, the achievement of objectives of the Programme.

(26)  Member States have long been active in the field of space. They have systems, infrastructure, national agencies and bodies linked to space. They can therefore make a big contribution to the Programme, especially its implementation ▌. They might cooperate ▌ with the Union to promote the Programme’s services and applications. The Commission might be able to mobilise the means at Member States' disposal, benefit from their assistance and, subject to mutually agreed conditions, entrust the Member States with non-regulatory tasks in the execution of the Programme ▌. Moreover, the Member States concerned should take all necessary measures to ensure the protection of the ground stations established on their territories. In addition, Member States and the Commission should work together and with appropriate international bodies and regulatory authorities to ensure that the frequencies necessary for the Programme are available and protected at the adequate level to allow for the full development and implementation of applications based on the services offered, in compliance with Decision No 243/2012/EU of the European Parliament and of the Council of 14 March 2012 establishing a multiannual radio spectrum policy programme(9).

(26a)  In certain duly justified circumstances, the Agency might entrust specific tasks to Member States or group of Member States. That entrustment should be limited to activities the Agency is not in the capacity to execute itself and should not prejudice the governance of the Programme and the allocation of tasks as defined in this Regulation.

(27)  As promoter of the Union’s general interest, it falls to the Commission to supervise the implementation of the Programme, assume overall responsibility and promote their use. In order to optimise the resources and competences of the various stakeholders, the Commission should be able to delegate certain tasks. Moreover the Commission is the best placed to determine the main requirements necessary to implement systems and services evolution

(28)  The mission of the European Union Agency for the Space Programme ("the Agency"), which replaces and succeeds the European GNSS Agency established by Regulation (EU) No 912/2010, is to contribute to the Programme, particularly as regards security accreditation as well as market and downstream applications development. Certain tasks linked to those areas should therefore be assigned to the Agency. In relation to security in particular, and given its experience in this area, the Agency should be responsible for the security accreditation tasks for all the Union actions in the space sector. Building on its positive track-record in promoting the user and market uptake of Galileo and EGNOS, the Agency should also be entrusted with user uptake activities relating to the Programme’s components other than Galileo and EGNOS, as well as downstream application development activities for all the Programme’s components. This would allow taking benefit of economies of scale and providing an opportunity for the development of applications based on several Programme’s components (integrated applications) Those activities should however not prejudice the service and user uptake activities entrusted by the Commission to Copernicus entrusted entities. The entrustment of downstream applications development to the Agency does not prevent other entrusted entities to develop downstream applications. Furthermore, it should perform the tasks which the Commission confers on it by means of one or more contribution agreements under a financial framework partnership agreement covering ▌ other specific tasks associated with the programme. When entrusting tasks to the Agency, adequate human, administrative and financial resources should be made available.

(28a)  Galileo and EGNOS are complex systems that require intensive coordination. Considering that Galileo and EGNOS are Union components, that coordination should be performed by a Union institution or a Union body. Building on the expertise developed in the past years, the Agency is the most appropriate body to coordinate all the operational tasks relating to the exploitation of those systems, except for the international cooperation. The Agency should therefore be entrusted with the management of the exploitation of EGNOS and Galileo. Nevertheless, this does not mean that the Agency should perform alone all the tasks relating to the exploitation of the systems. It could rely on the expertise of other entities, in particular the European Space Agency. This should include the activities on systems evolution, design and development of parts of the ground segment and satellites which should be entrusted to the European Space Agency. The allocation of tasks to other entities builds on the competence of such entities and should avoid duplication of work.

(29)  The European Space Agency is an international organisation with extensive expertise in the space domain and which entered into a Framework Agreement with the European Community in 2004. It is therefore an important partner in the implementation of the Programme, with which ▌ appropriate relations should be established. In this regard, and in compliance with the Financial Regulation, the Commission should conclude a financial framework partnership agreement with the European Space Agency and the Agency that governs all financial relations between the Commission, the Agency and the European Space Agency and ensures their consistency and conform to the Framework Agreement concluded between the European Community and the European Space Agency, in particular with Articles 2 and 5 thereof. However, as the European Space Agency is not a Union body and is not subject to Union law, it is essential provides that the European Space Agency takes appropriate measures to ensure the protection of the interests of the Union and its Member States and as regards budget implementation, tasks entrusted to it complies with the decisions taken by the Commission. The agreement should also contain all the clauses necessary to safeguard the Union’s financial interests.

(30)  The functioning of SATCEN as a European autonomous capability providing access to information and services resulting from exploitation of relevant space assets and collateral data was already acknowledged in the implementation of Decision No 541/2014/EU.

(31)  To structurally embed the user representation in the governance of GOVSATCOM and to aggregate user needs and requirements across national and civil-military boundaries, the relevant Union entities with close user-ties, such as the European Defence Agency, the European Border and Coast Guard Agency, the European Maritime Safety Agency, the European Fisheries Control Agency, the European Union Agency for Law Enforcement Cooperation, the Military Planning and Conduct Capability/Civilian Planning and Conduct Capability and the Emergency Response Coordination Centre may have coordinating roles for specific user groups. At an aggregated level the Agency should coordinate user-related aspects for the civilian ▌ user communities and may monitor operational use, demand, conformance to requirements and evolving needs and requirements.

(32)  Owing to the importance of space-related activities for the Union economy and the lives of Union citizens, the dual-use nature of the systems and of the applications based on those systems, achieving and maintaining a high degree of security should be a key priority for the Programme, particularly in order to safeguard the interests of the Union and of its Member States, including in relation to classified and other sensitive non-classified information.

(33)  Without prejudice to Member States' prerogatives in the area of national security, the Commission and the High Representative, each within their respective area of competence, should ensure the security of the Programme in accordance with this Regulation and, where relevant, Council Decision 201x/xxx/CFSP(10).

(33a)  Given the specific expertise of EEAS and its regular contact with administrations of third countries and international organisations, the EEAS may assist the Commission in performing certain of its tasks relating to the security of the Programme in the field of external relations, in accordance with Council Decision 2010/427/EU.

(34)  Without prejudice to the sole responsibility of the Member States in the area of national security, as provided for in Article 4(2) TEU, and to the right of the Member States to protect their essential security interests in accordance with Article 346 TFEU, a specific governance of security should be established to ensure a smooth implementation of the Programme. That governance ▌ should be based on three key principles. Firstly, it is imperative that Member States’ extensive, unique experience in security matters be taken into consideration to the greatest possible extent. Secondly, in order to prevent conflicts of interest and any shortcomings in applying security rules, operational functions must be segregated from security accreditation functions. Thirdly, the entity in charge of managing all or part of the components of the Programme is also the best placed to manage the security of the tasks entrusted to it. The security of the Programme will build upon the experience gained in the implementation of Galileo, EGNOS and Copernicus over the past years. Sound security governance also requires that roles be appropriately distributed among the various players. As it is responsible for the Programme, the Commission, without prejudice to Member States prerogatives in the area of national security, should determine the general security requirements applicable to each of the programme’s components.

(34x)  The cybersecurity of European space infrastructures, both ground and space, is key to ensuring the continuity of the operations of the systems and service continuity. The need to protect the systems and their services againts cyberattacks, including by making use of new technologies, should therefore be duly taken into account when establishing security requirements.

(34a)  A security monitoring structure should be identified by the Commission when appropriate after the risk and threat analysis. This security monitoring body should be the entity responding to instructions developed under the scope of Decision 201x/xxx/CFSP. For Galileo, that body should be the Galileo Security Monitoring Centre. With regard to the implementation of Decision 20xx/xxx/CFSP, the role of the Security Accreditation Board will be limited to providing the Council and/or the HR with inputs linked to the security accreditation of the system.

(35)  In view of the uniqueness and complexity of the Programme and its link to security, recognised and well established principles should be followed for security accreditation. It is thus indispensable that security accreditation activities be carried out on the basis of collective responsibility for the security of the Union and its Member States, by endeavouring to build consensus and involving all those concerned with the issue of security, and that a procedure for permanent risk monitoring be put in place. It is also imperative that technical security accreditation activities be entrusted to professionals who are duly qualified in the field of accrediting complex systems and who have an adequate level of security clearance.

(35x)  EU classified information (EUCI) is to be handled in accordance with the security rules as set out in Commission Decision (EU, Euratom) 2015/444 and Council Decision 2013/488/EU. In accordance with the Council Decision, the Member States are to respect the principles and minimum standards laid down therein, in order to assure that an equivalent level of protection is afforded to EUCI.

(36)  To ensure the secure exchange of information, appropriate agreements should be established to ensure the protection of EU classified information provided to third countries and international organisations in the context of the Programme.

(37)  One of the main objectives of the Programme consists in ensuring its security and strategic autonomy, strengthening its capacity to act in numerous sectors, in particular security, and taking advantage of the possibilities that space offers for the security of the Union and its Member States. This objective requires strict rules on the eligibility of the entities that may take part in activities financed under the Programme which require access to EU classified information (EUCI) or to sensitive non-classified information.

(37a)  In the context of the Programme, there is some information which, although not classified, is to be handled according to acts already in force or to national laws, rules and regulations, including through distribution limitations.

(38)  A growing number of key economic sectors, in particular transport, telecommunications, agriculture and energy, increasingly use satellite navigation and Earth observation systems. The Programme should exploit the synergies between those sectors, taking into consideration the benefits that space technologies bring to those sectors, support the development of compatible equipment and promote the development of relevant standards and certifications. Synergies between space activities and activities linked to the security and defence of the Union and its Member States are also increasing. Having full control of satellite navigation should therefore guarantee the Union's technological independence, including in the longer term for the components of infrastructure equipment, and ensure its strategic autonomy.

(39)  The aim of Galileo is to establish and operate the first global satellite navigation and positioning infrastructure specifically designed for civilian purposes, which can be used by a variety of public and private actors in Europe and worldwide. Galileo functions independently of other existing or potential systems, thus contributing amongst other things to the strategic autonomy of the Union. The second generation of the system should be progressively rolled out before 2030, initially with reduced operational capacity.

(40)  The aim of EGNOS is to improve the quality of open signals from existing global navigation satellite systems, in particular those emitted by the Galileo system. The services provided by EGNOS should cover, as a priority, the Member States’ territories geographically located in Europe, including for this purpose Cyprus, the Azores, the Canary Islands and Madeira by the end of 2026. In the aviation domain, all those territories should benefit from EGNOS for air navigation services for all the performance levels supported by EGNOS. Subject to technical feasibility and, for the safety of life, on the basis of international agreements, the geographical coverage of the services provided by EGNOS could be extended to other regions of the world. Without prejudice to Regulation (EU) 2018/1139 and the necessary monitoring of Galileo service quality for aviation purposes, it should be noted that while the signals emitted by Galileo may effectively be used to facilitate the positioning of aircraft, in all phase of flight, through the necessary augmentation system (local, regional, on board avionics) only local or regional augmentation systems such as EGNOS in Europe may constitute air-traffic management (ATM) services and air navigation services (ANS). The EGNOS safety-of-life service should be provided in compliance with applicable ICAO standards.

(41)  It is imperative to ensure the sustainability ▌ of the ▌ Galileo and EGNOS systems and the continuity, availability, accuracy, reliability and security of their services. In a changing environment and rapidly developing market, their development should also continue and new generations of these systems, including associated space and ground segment evolution, should be prepared.

(43)  The term ‘commercial service’ used in Regulation (EU) No 1285/2013 of the European Parliament and of the Council of 11 December 2013 on the implementation and exploitation of European satellite navigation systems and repealing Council Regulation (EC) No 876/2002 and Regulation (EC) No 683/2008 of the European Parliament and of the Council(11) is no longer suited in the light of the evolution of that service. Instead two separate services have been identified, namely the high-accuracy service and the authentication service(12).

(44)  In order to optimise the use of the services provided, the services provided by Galileo and EGNOS should be compatible and interoperable with one another, including at users' level, and, insofar as possible, with other satellite navigation systems and with conventional means of radio navigation where such compatibility and interoperability is laid down in an international agreement, without prejudice to the objective of strategic autonomy of the Union.

(45)  Considering the importance for Galileo and EGNOS of their ground-based infrastructure and the impact thereof on their security, the determination of the location of the infrastructure should be made by the Commission. The deployment of the ground-based infrastructure of the systems should continue to follow an open and transparent process, which could involve the Agency where appropriate based on its field of competence.

(46)  To maximise the socio-economic benefits of Galileo and EGNOS, while contributing to Union's strategic autonomy, notably in sensitive sectors and in the area of safety and security, the use of the services provided by EGNOS and Galileo in other Union policies should be promoted also by regulatory means where this is justified and beneficial. Measures to encourage the use of those services in all Member States are also an important part of the process.

(47)  Copernicus should ensure an autonomous access to environmental knowledge and key technologies for Earth observation and geo-information services, thereby supporting the Union to achieve independent decision-making and actions in the fields of the environment, climate change, marine, maritime, agriculture and rural development, preservation of cultural heritage, civil protection, land and infrastructure monitoring, security, as well as the digital economy, among others.

(47b)  The Programme’s components should stimulate the application of digital technology in space systems, data and service distribution, downstream development. In that context the particular attention should be given to the initiatives and actions proposed by the Commission in its Communication of 14 September 2016 entitled 'Connectivity for a Competitive Digital Single Market – Towards a European Gigabit Society' and Communication of 14 September 2016 entitled '5G for Europe: An Action Plan'.

(48)  Copernicus should build on, ensure continuity with and enhance the activities and achievements under Regulation (EU) No 377/2014 of the European Parliament and of the Council(13) establishing the Union Earth observation and monitoring programme (Copernicus) as well as Regulation (EU) No 911/2010 of the European Parliament and of the Council on the European Earth monitoring programme (GMES) and its initial operations(14) establishing the predecessor Global Monitoring for Environment and Security (GMES) programme and the rules for implementation of its initial operations, taking into account recent trends in research, technological advances and innovations impacting the Earth observation domain, as well as developments in big data analytics and Artificial Intelligence and related strategies and initiatives at Union level(15). For the development of new assets, the Commission should work closely with Member States, the European Space Agency, EUMETSAT and, where appropriate, other entities owning relevant space and in situ assets. To the greatest extent possible, it should make use of capacities for space-borne observations of the Member States, the European Space Agency, EUMETSAT(16), as well as other entities, including commercial initiatives in Europe, thereby also contributing to the development of a viable commercial space sector in Europe. Where feasible and appropriate, it should also make use of the available in situ and ancillary data provided mainly by the Member States in accordance with Directive 2007/2/EC(17). The Commission should work together with the Member States and the European Environment Agency to ensure an efficient access and use of the in-situ data sets for Copernicus.

(49)  Copernicus should be implemented in accordance with the objectives of Directive 2003/98/EC of the European Parliament and of the Council on the re-use of public sector information amended by Directive 2013/37/EU of the European Parliament and of the Council of 26 June 2013 amending Directive 2003/98/EC on the re-use of public sector information(18), in particular transparency, the creation of conditions conducive to the development of services, and contributing to economic growth and job creation in the Union. Copernicus data and Copernicus information should be available freely and openly.

(49a)  The full potential of Copernicus for the Union society and economy should be fully unleashed beyond direct beneficiaries by means of an intensification of user uptake measures, which requires further action to render the data usable by non-specialists and thereby stimulate growth, job creation and knowledge transfers.

(50)  Copernicus is a user-driven programme. Its evolution should therefore be based on the evolving requirements of the Copernicus core users, while also recognising the emergence of new user communities either public or private. Copernicus should base itself on an analysis of options to meet evolving user needs, including those related to implementation, and monitoring of Union policies which require the continuous, effective involvement of users, particularly regarding the definition and validation of requirements.

(51)  Copernicus is already operational. It is therefore important to ensure the continuity of the infrastructure and services already in place, whilst adapting to the changing user needs, market environment, notably the emergence of private actors in space (“New Space”) and socio-political developments for which a rapid response is needed. This requires an evolution of the functional structure of Copernicus to better reflect the shift from the first stage of operational services to the provision of advanced and more targeted services to new user communities and the fostering of added-value downstream markets. To this end, its further implementation should adopt an approach following the data value chain, i.e. data acquisition, data and information processing, distribution and exploitation, user ▌ market uptake and capacity building activities, while the strategic planning process under Horizon Europe will identify research and innovation activities that should make use of Copernicus.

(52)  With regard to data acquisition, the activities under Copernicus should aim at completing and maintaining the existing space infrastructure, preparing the long-term replacement of the satellites at the end of their lifetime, as well as initiating new missions addressing in particular new observation systems to support meeting the challenge of global climate change (e.g. anthropogenic CO2 and other greenhouse gas emissions monitoring). Activities under Copernicus should expand their global monitoring coverage over the polar regions and support environmental compliance assurance, statutory environmental monitoring and reporting and innovative environmental applications in agriculture, forest, water and marine resources management and cultural heritage (e.g. for crops monitoring, water management and enhanced fire monitoring). In doing so, Copernicus should leverage and take maximum advantage of the investments made under the previous funding period (2014-2020), including those made by Member States, ESA and EUMETSAT, while exploring new operational and business models to further complement the Copernicus capacities. Copernicus might also build on successful partnerships with Member States to further develop its security dimension under appropriate governance mechanisms, in order to respond to evolving user needs in the security domain.

(53)  As part of the data and information processing function, Copernicus should ensure the long-term sustainability and further development of ▌ Copernicus services, providing information in order to satisfy public sector needs and those arising from the Union’s international commitments, and to maximise opportunities for commercial exploitation. In particular, Copernicus should deliver, at the local, national, European and global scale, information on the composition of the atmosphere and air quality; information on the state and dynamics of the oceans; information in support of land and ice monitoring supporting the implementation of local, national and Union policies; information in support of climate change adaptation and mitigation; geospatial information in support of emergency management, including through prevention activities, environmental compliance assurance, as well as civil security including support for the Union's external action. The Commission should identify appropriate contractual arrangements fostering the sustainability of service provision.

(54)  In the implementation of the Copernicus Services, the Commission should rely on competent entities, relevant Union agencies, groupings or consortia of national bodies, or any relevant body potentially eligible for a contribution agreement. In the selection of these entities, the Commission should ensure that there is no disruption in the operations and provision of services and that, where security-sensitive data is concerned, the entities concerned have early warning and crisis monitoring capabilities within the context of the Common Foreign and Security Policy (CFSP) and, in particular, of the Common Security and Defence Policy (CSDP). In accordance with Article 154 of the Financial Regulation, persons and entities entrusted with the implementation of Union funds are obliged to respect the principle of non-discrimination towards all Member States; this principle should be ensured through the relevant contribution agreements relating to the provision of the Copernicus services.

(55)  The implementation of the Copernicus services should facilitate the public uptake of services as users would be able to anticipate the availability and evolution of services as well as cooperation with Member States and other parties. To this end, the Commission and its entrusted entities providing services should engage closely with core user communities across Europe in further developing the Copernicus services and information portfolio to ensure that evolving public sector and policy needs are met and thus the uptake of Earth observation data can be maximised. The Commission and Member States should work together to develop the in-situ component of Copernicus and to facilitate the integration of in-situ datasets with space datasets for upgraded Copernicus services.

(55a)  Copernicus’s free, full and open data policy has been evaluated as one of the most successful elements of Copernicus’ implementation and has been instrumental in driving strong demand for its data and information, establishing Copernicus as one of the largest EO data provider in the world. There is a clear need to guarantee the long-term and secure continuity of the free, full and open data provision and access should be safeguarded in order to realise the ambitious goals as set out in the Space Strategy for Europe (2016). Copernicus data is created primarily for the benefit of European citizens, and by making this data freely available worldwide collaboration opportunities are maximized for EU businesses and academics and contribute to an effective European space ecosystem. Should any limitation be placed on the access to Copernicus data and information, it should be in line with the Copernicus data policy as defined in this Regulation and Commission Delegated Regulation (EU) No 1159/2013.

(56)  The data and information produced in the framework of Copernicus should be made available on a full, open and free-of-charge basis subject to appropriate conditions and limitations, in order to promote their use and sharing, and to strengthen the European Earth observation markets, in particular the downstream sector, thereby enabling growth and job creation in the Union. Such provision should continue to provide data and information with high levels of consistency, continuity, reliability, and quality. This calls for large-scale and user-friendly access to, processing and exploitation of Copernicus data and information, at various timeliness levels, for which the Commission should continue to follow an integrated approach, both at EU and Member States level, enabling also integration with other sources of data and information. Therefore the Commission should take the necessary measures to ensure that Copernicus data and information is easily and effieciently accessible and usable, notably by promoting the Data and Information Access Services (DIAS) within Member States and when possible fostering interoperability between the existing European EO data infrastructures to establish synergies with these assets in order to maximise and strengthen market uptake of Copernicus data and information.

(57)  The Commission should work with data providers to agree licensing conditions for third-party data to facilitate their use within Copernicus, in compliance with this Regulation and applicable third-party rights. As some Copernicus data and Copernicus information, including high-resolution images, may have an impact on the security of the Union or its Member States, in duly justified cases, measures in order to deal with risks and threats to the security of the Union or its Member States may be adopted.

(58)  The provisions of legal acts adopted under previous regulations without ending date should remain valid unless in contradiction with the new regulation. This concerns in particular the Commission Delegated Regulation (EU) No 1159/2013 establishing the registration and licensing conditions for GMES users and defining criteria for restricting access to GMES dedicated data and GMES service information(19).

(59)  To promote and facilitate the use of Earth observation data and technologies both by local, regional or national authorities, by small and medium-sized enterprises, scientists and researchers, dedicated networks for Copernicus data distribution, including national and regional bodies such as Copernicus Relays and Copernicus Academies, should be promoted through user uptake activities. To this end, the Commission and the Member States should strive to establish closer links between Copernicus and Union and national policies in order to drive the demand for commercial applications and services and enable enterprises, particular small and medium-sized enterprises and start-ups, to develop applications based on Copernicus data and information aiming at developing a competitive Earth observation data eco-system in Europe.

(60)  In the international domain, Copernicus should provide accurate and reliable information for cooperation with third countries and international organisations, and in support of the Union’s external and development cooperation policies. Copernicus should be considered as a European contribution to the Global Earth Observation System of Systems (GEOSS), the Committee on Earth Observation Satellites (CEOS), the Conference of the Parties (COP) to the 1992 United Nations Framework Convention on Climate Change (UNFCCC), the achievement of the United Nations Sustainable Development Goals (SDG) and the Sendai Framework for Disaster Risk Reduction. It should establish or maintain appropriate cooperation with relevant sectoral UN bodies and the World Meteorological Organisation.

(61)  In the implementation of Copernicus, the Commission should rely, where appropriate, on European international organisations with which it has already established partnerships, in particular the European Space Agency for the development, coordination, implementation and evolution of the space components, access to third party data where appropriate and when not undertaken by other entities the operation of dedicated missions. In addition, the Commission should rely on EUMETSAT for the operation of dedicated missions or parts thereof and, where appropriate, access to contributing mission data in accordance with its expertise and mandate.

(61a)  In the domain of services, the Commission should take appropriate benefit from the specific capacities provided by Union Agencies such as the European Environment Agency, the European Maritime Safety Agency, the European Border and Coast Guard Agency, SATCEN and the European investments made already in marine environment monitoring services through Mercator Ocean. On security, a comprehensive approach at Union level will be sought with the High Representative. The Joint Research Centre (JRC) of the Commission has been actively involved from the start of the GMES initiative and has supported developments for Galileo and space weather. Under Regulation (EU) No 377/2014; the JRC is managing the Copernicus emergency management service and the global component of the Copernicus land monitoring service; it is contributing to the review of the quality and fitness for purpose of data and information, and to the future evolution. The Commission should continue relying on JRC's scientific and technical advice for the implementation of the Programme.

(62)  Following the requests of the European Parliament and of the Council and, the Union established a support framework for space surveillance and tracking (SST) by means of Decision No 541/2014/EU of the European Parliament and of the Council of 16 April 2014 establishing a Framework for Space Surveillance and Tracking Support. Space debris has become a serious threat to the security, safety and sustainability of space activities. The SST is therefore primordial to preserve the continuity of the Programme's components and their contributions to Union policies. By seeking to prevent the proliferation of space debris, SST contributes to ensuring the sustainable and guaranteed access to and use of space, which is a global common objective. In that context, it could support the preparation of European earth orbit 'clean-up' projects.

(63)  The SST should further develop the performance and autonomy of SST capabilities. To this end, it should lead to the establishment of an autonomous European catalogue of space objects, building on data from the network of SST sensors. Where appropriate, the Union could consider making some of its data available for commercial, non-commercial and research purposes. The SST should also continue to support operation and delivery of SST services. As SST services are user-driven ▌, appropriate mechanisms should be put in place to collect user requirements, including those relating to security and the transmission of relevant information to and from public institutions to improve the effectiveness of the system, while respecting national safety and security policies.

(64)  The delivery of SST services should be based on a cooperation between the Union and the Member States and on the use of existing as well as future national expertise and assets, including those developed through the European Space Agency or by the Union. It should be possible to provide financial support for the development of new SST sensors. Recognising the sensitive nature of the SST, the control over national sensors and their operations, maintenance and renewal and the processing of data leading to the provision of SST services should remain with the participating Member States.

(65)  Member States with adequate ownership or access to SST capabilities should be able to participate in the delivery of the SST services. Participating Member States in the SST Consortium established under the Decision No 541/2014/EU should be deemed to comply with these criteria. Those Member States should submit a single joint proposal and demonstrate compliance with further elements related to the operational set up. ▌ Appropriate rules should be established for the selection and organisation of Member States participants.

(65a)  Implementing powers should be conferred on the Commission to define the detailed procedures and elements for establishing the participation of Member States. Where no joint proposal has been submitted or where the Commission considers that such proposal does not comply with the criteria set, the Commission may launch a second step for the participation of Member States. The procedures and elements for that second step should define the orbits to be covered, and take into account the need to maximise the participation of Member States in the provision of SST services. Where those procedures and elements foresee the possibility for the Commission to select several proposals to cover all the orbits, appropriate coordination mechanisms between the groups of Member States and an efficient solution to cover all the SST services should also be provided.

(66)  Once SST is set up, it should respect the principles of complementarity of activities and continuity of high quality user-driven SST services, and be based on the best expertise. SST should therefore avoid unnecessary duplication. Redundant capabilities should ▌ ensure SST services’ continuity, quality and robustness. The activities of the Expert Teams should help avoiding these unnecessary duplications.

(67)  In addition, the SST should be conducive to existing mitigation measures, such as the COPUOS Space Debris Mitigation Guidelines ▌ and draft Guidelines for the Long-term Sustainability of Outer Space Activities, or other initiatives, to ensure the safety, security and sustainability of outer space activities. With a view to reducing risks of collision, the SST would also seek synergies with initiatives of active removal and passivation measures of space debris. The SST should contribute to ensuring the peaceful use and exploration of outer space. The increase in space activities may have implication on the international initiatives in the area of the space traffic management. The Union should monitor those developments and may take them into consideration in the context of the mid-term review of the current multiannual financial framework.

(68)  SST, space weather and NEO activities should have regard to cooperation with international partners, in particular the United States of America, international organisations and other third parties, particularly to avoid collisions in space, to prevent the proliferation of space debris and to increase preparedness to effects of extreme space weather events and near-Earth objects

(69)  The Security Committee of the Council recommended the creation of a risk management structure to ensure that data security issues are duly taken into account in the implementation of Decision No 541/2014/EU. For that purpose and taking account of the work already performed, the appropriate risk management structures and procedures should be established by the participating Member States.

(70)  Extreme and major space weather events may threaten the safety of citizens and disrupt the operations of space-based and ground-based infrastructure. A space weather sub-component should therefore be established as part the Programme with an aim of assessing the space weather risks and corresponding user needs, raising the awareness of space weather risks, ensuring the delivery of user-driven space weather services, and improving Member States’ capabilities to produce space weather service. The Commission should prioritise the sectors to which the operational space weather services are to be provided taking into account the user needs, risks and technological readiness. In the long term, the needs of other sectors may be addressed. The delivery of services at Union level according to the users' needs will require targeted, coordinated and continued research and development activities to support space weather services evolution. The delivery of the space weather services should build on the existing national and Union capabilities and enable a broad participation of Member States, European and international organisations, and involvement of the private sector.

(71)  The Commission White Paper on the future of Europe(20), the Rome Declaration of the Heads of State and Government of 27 EU Member States(21), and several European Parliament resolutions, recall that the EU has a major role to play in ensuring a safe, secure and resilient Europe that is capable to address challenges such as regional conflicts, terrorism, cyber threats, and growing migration pressures. Secure and guaranteed access to satellite communications is an indispensable tool for security actors, and pooling and sharing of this key security resource at Union level strengthens a Union that protects its citizens.

(72)  The European Council of 19-20 December 2013(22) in its conclusions welcomed in the area of Satellite Communication the preparations for the next generation of Governmental Satellite Communication (GOVSATCOM) through close cooperation between the Member States, the Commission and the European Space Agency. GOVSATCOM has also been identified as one of the elements of the Global Strategy for the European Union's Foreign and Security Policy of June 2016. GOVSATCOM should contribute to the EU response to Hybrid Threats, provide support to the EU Maritime Strategy and to the EU Arctic Policy.

(73)  GOVSATCOM is a user-centric programme with a strong security dimension. The use-cases may be analysed by the relevant actors for three main families: i) crisis management, which may include civilian and military Common Security and Defence missions and operations, natural and man-made disasters, humanitarian crises, and maritime emergencies; ii) surveillance, which may include border surveillance, pre-frontier surveillance sea-border surveillance, maritime surveillance, surveillance of illegal trafficking; and iii) key infrastructures, which may include diplomatic network, police communications, digital infrastructure (e. g. data centres, servers), critical infrastructures (e.g. energy, transport, water barriers such as dams) and space infrastructures.

(73a)  GOVSATCOM capacity and services will be used in security and safety critical missions and operations by Union and Member State actors. Therefore an appropriate level of non-dependence from third parties (third states and entities from third states) is needed, covering all GOVSATCOM elements, such as space and ground technologies at component, subsystem and system level, manufacturing industries, owners and operators of space systems, physical location of ground system components.

(74)  Satellite communications is a finite resource limited by the satellite capacity , frequency and geographic coverage. Therefore, in order to be cost-effective and to capitalise on economies of scale, GOVSATCOM needs to optimise the match between the GOVSATCOM demand by authorised users, and the supply provided under GOVSATCOM contracts for satellite capacities and services. Since the demand and the potential supply both change with time, this requires constant monitoring and flexibility to adjust GOVSATCOM services. ▌

(75)  Operational requirements will be derived on the basis of the use-case analysis. From those operational requirements, in combination with security requirements, the service portfolio should be developed. The service portfolio should establish the applicable baseline for the services to be provided through GOVSATCOM. In order to maintain the best possible match between the demand and supplied services, the GOVSATCOM service portfolio may need to be regularly updated.

(76)  In the first phase of GOVSATCOM (roughly until 2025) existing capacity will be used. In that context, the Commission should procure EU GOVSATCOM capacities from Member States with national systems and space capacities and from commercial satellite communication or service providers, taking into account the essential security interests of the Union. In this first phase services will be introduced in a stepped approach ▌. If in the course of the first phase a detailed analysis of future supply and demand reveals that this approach is insufficient to cover the evolving demand, the decision may be taken to move to a second phase and develop additional bespoke space infrastructure or capabilities through one or several public-private partnerships, e.g. with Union satellite operators.

(77)  In order to optimise the available satellite communication resources, to guarantee access in unpredictable situations, such as natural disasters, and to ensure operational efficiency and short turn-around times, the necessary ground segment (Hubs and potential other ground elements) is required. The latter should be designed on the basis of operational and security requirements. In order to mitigate risks the Hub may consist of several physical sites. Other ground segment elements, such as anchoring stations, may be needed.

(78)  For users of satellite communications the user equipment is the all-important operational interface. The EU GOVSATCOM approach should make it possible for most users to continue to use their existing user equipment for GOVSATCOM services ▌.

(79)  In the interest of operational efficiency users have indicated that it is important to aim for interoperability of user equipment, and user equipment that can make use of different satellite systems. Research and development in this domain may be required.

(80)  At implementation level the tasks and responsibilities should be distributed amongst specialised entities, such as the European Defence Agency, the EEAS, the European Space Agency, the Agency, and other Union agencies in such a manner to ensure that they align with their principal role, especially for user related aspects.

(81)  The competent GOVSATCOM authority has an important role to monitor that users, and other national entities that play a role in GOVSATCOM, comply with the sharing and prioritisation rules and security procedures as laid down in the security requirements. A Member State which has not designated a competent GOVSATCOM authority should in any event designate a point of contact for the management of any detected jamming affecting GOVSATCOM.

(81a)  Member States, the Council, the Commission and the EEAS may become GOVSATCOM participants, insofar as they choose to authorise GOVSATCOM users or provide capacities, sites or facilities. Considering that it is a Member State’s choice whether they authorise GOVSATCOM users or provide capacities, sites or facilities, Member States cannot be obliged to become GOVSATCOM participants or to host GOVSATCOM infrastructure. The GOVSATCOM component of the Programme is therefore without prejudice to the right of Member States not to participate in GOVSATCOM, including in accordance with its national law or constitutional requirements in relation to policies concerning non-alignment and non-participation in military alliances.

(82)  In order to ensure uniform conditions for the implementation of this Regulation, implementing powers regarding operational requirements for services provided under GOVSATCOM should be conferred on the Commission. It will give the possibility to the Commission to define technical specifications for use-cases related to crisis management, surveillance and key infrastructure management, including diplomatic communication networks. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.

(83)  In order to ensure uniform conditions for the implementation of this Regulation, implementing powers regarding the service portfolio for services provided under GOVSATCOM, should be conferred on the Commission. It will give the possibility to the Commission to define attributes, including geographic coverage, frequency, bandwidth, user equipment, and security features. Those powers should be exercised in accordance with Regulation (EU) No 182/2011.

(84)  In order to ensure uniform conditions for the implementation of this Regulation, implementing powers regarding the sharing and prioritisation rules for the use of pooled GOVSATCOM satellite communication capacities, should be conferred on the Commission. When defining the sharing and prioritisation rules, the Commission should take into account the operational and security requirements and an analysis of risks and expected demand by GOVSATCOM participants. Although GOVSATCOM services should in principle be provided on a free-of-charge basis to GOVSATCOM users, if that analysis concludes on a shortage of capacities and in order to avoid a distorsion of the market, a pricing policy might be developed as part of those detailed rules on sharing and prioritisation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011.

(85)  In order to ensure uniform conditions for the implementation of this Regulation, implementing powers regarding the location of the ground segment infrastructure for GOVSATCOM, should be conferred on the Commission. It will give the possibility to the Commission take into account the operational and security requirements, as well as existing infrastructure for the selection of such locations. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.

(87)  Regulation (EU) No 912/2010 established a Union agency, called the European GNSS Agency, to manage certain aspects of the Galileo and EGNOS satellite navigation programmes. The present Regulation provides in particular that the European GNSS Agency will be entrusted with new tasks, not only in respect of Galileo and EGNOS but also for other components of the Programme, especially security accreditation. The name, tasks and organisational aspects of the European GNSS Agency must therefore be adapted accordingly.

(87a)  The seat of the Agency is located in Prague in accordance with Decision 2010/803/EU. For the implementation of the Agency's tasks, staff of the Agency might be located in one of the Galileo or EGNOS ground based centres referred to in Commission Implementing Decision (EU) 2016/413 to execute Programme activities provided for in the relevant agreement. In addition, for the Agency to operate in the most efficient and effective manner, a limited number of staff could be assigned to local offices in one or more Member States. The location of staff outside the seat of the Agency or Galileo and EGNOS sites should not lead to transfer of core of the Agency's activities to such local offices.

(88)  In view of its extended scope, which will no longer be limited to Galileo and EGNOS, the name of the European GNSS Agency should henceforth be changed. However, the continuity of the activities of the European GNSS Agency, including continuity as regards rights and obligations, staff and the validity of any decisions taken, should be ensured under the Agency.

(89)  Given the Agency’s mandate and the role of the Commission in implementing the Programme, it is appropriate to provide that some of the decisions taken by the Administrative Board should not be adopted without the favourable vote of the representatives of the Commission.

(90)  Without prejudice to the powers of the Commission, the Administrative Board, the Security Accreditation Board and the Executive Director shall be independent in the performance of their duties and shall act in the public interest.

(91)  It is possible, and indeed probable, that some components of the Programme will be based on the use of sensitive or security-related national infrastructure. In this case, for reasons of national security, it is necessary to stipulate that meetings of the Administrative Board and Security Accreditation Board be attended ▌ by the representatives of the Member States and the representatives of the Commission, on a need to know basis. In the Administrative Board, only those representatives of Member States which possess such infrastructure and a representative of the Commission are to take part in voting. The rules of procedure of the Administrative Board and of the Security Accreditation Board should set out the situations in which this procedure applies.

(94)  Pursuant to paragraphs 22 and 23 of the Inter-Institutional agreement on Better Law-Making of 13 April 2016, there is a need to evaluate the Programme on the basis of information collected through specific monitoring requirements, while avoiding overregulation and administrative burdens, in particular on Member States. These requirements can, where appropriate, include measurable indicators, as a basis for evaluating the effects of the programme.

(94a)  The use of Copernicus and Galileo based services is predicted to have a major impact in the European economy in general. However, ad hoc measurements and case studies seem to dominate the picture today. The Commission, through Eurostat, should define relevant statistical measurements and indicators that would form the basis for monitoring the impact of the EU space activities in a systematic and authoritative way.

(95)  In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011. The Commission should be assisted by a Committee which should meet in specific configuration.

(95a)  Since the Programme's components are user driven, they require the continuous, effective involvement of users for their implementation and development, particularly regarding the definition and validation of service requirements. In order to increase the value for the users, their input should be actively sought through regular consultation with end-users from the public and private sectors of the Union's Member States and where appropriate international organisations. For that purpose, a working group (the ‘User Forum’) should be set up to assist the Programme Committee with the identification of user requirements, and the verification of service compliance, as well as the identification of gaps in services provided. The rules of procedure of the Committee should establish the organisation of that working group to take into account the specificities of each component and each service within the components. Whenever possible, Member States should contribute to the User Forum based on a systematic and coordinated consultation of users at national level.

(96)  As sound public governance requires uniform management of the Programme, faster decision-making and equal access to information, representatives of the entities entrusted with tasks related to this programme might be able to take part as observers in the work of the committee established in application of Regulation (EU) No 182/2011. For the same reasons, representatives of third countries and international organisations who have concluded an international agreement with the Union, relating to the Programme or its components or sub-components, might be able to take part in the work of the committee subject to security constraints and as provided for in the terms of such agreement. The representatives of entities entrusted with tasks related to the Programme, third countries and international organisations are not entitled to take part in committee voting procedures. The conditions for the participation of observers and ad hoc participants should be laid down in the rules of procedure of the Committees.

(97)  In order to ensure effective assessment of progress of the Programme towards the achievement of its objectives, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending Annex X to review or complement the indicators where considered necessary and to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(98)  Since the objective of this Regulation cannot be sufficiently achieved by the Member States since it goes beyond the financial and technical capacities of any single Member State, and can therefore, by reason of its scale and effects, be better achieved by action at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(99)  In order to ensure uniform conditions for the implementation of the Programme's security requirements, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council. Member States should be able to exert a maximum of control over the programme's security requirements. When adopting implementing acts in the area of security of the Programme, the Commission should be assisted by a committee composed of Member States' representatives meeting in a dedicated security configuration. Those implementing acts should be adopted in accordance with the examination procedure set out in Regulation (EU) No 182/2011. In view of the sensitivity of security matters, the chair should endeavour to find solutions which command the widest possible support within the committee. The Commission should not adopt implementing acts determining the general security requirements of the programme in cases where no opinion is delivered by the committee,

HAVE ADOPTED THIS REGULATION:

TITLE I

GENERAL PROVISIONS

Article 1

Subject matter

1.  This Regulation establishes the space programme of the Union (‘Programme’). It lays down the objectives of the Programme, the budget for the period 2021 – 2027, the forms of Union funding and the rules for providing such funding, as well as the rules for the implementation of the Programme.

2.  This Regulation establishes the European Union Agency for the Space Programme ('Agency') that replaces and succeeds the European GNSS Agency established by Regulation (EU) No 912/2010 and lays down the rules of operation of the Agency.

Article 2

Definitions

For the purpose of this Regulation, the following definitions shall apply:

(0)  Space surveillance and tracking (SST) system means a network of ground-based and space-based sensors capable of surveying and tracking space objects, together with processing capabilities aiming to provide data, information and services on space objects that orbit around the Earth;

(1)  ‘spacecraft’ means an orbiting object designed to perform a specific function or mission (e.g. communications, navigation or Earth observation), including ▌ satellites ▌ launcher upper stages, re-entry vehicle. A spacecraft that can no longer fulfil its intended mission is considered non- functional. Spacecraft in reserve or standby modes awaiting possible reactivation are considered functional;

(2)  ‘space weather events’ means naturally occurring variations in the space environment at the Sun and around the Earth. Space weather effects include solar flares, solar energetic particles, variations in the solar wind, ▌ coronal mass ejections, geomagnetic storms and dynamics, ▌radiation storms and ionospheric disturbances ▌ potentially impacting Earth and space-based infrastructures;

(3)  ‘near earth objects’ (NEO) means natural objects in the solar system approaching the Earth;

(4)  ‘space object’ means any man-made object in outer space;

(5)  ‘space situational awareness’ ('SSA') means a holistic approach, including comprehensive knowlegde and understanding, of the main space hazards, encompassing collision between space objects, fragmentation and reentry of space objects into the atmosphere, space weather phenomena, and near earth objects;

(6)  'blending operation' means actions supported by the EU budget, including within blending facilities pursuant to Article 2(6) of the Financial Regulation, combining non-repayable forms of support and/or financial instruments and/or budgetary guarantees from the EU budget with repayable forms of support from development or other public finance institutions, as well as from commercial finance institutions and investors;

(7)  'legal entity' means any natural or legal person created and recognised as such under national law, Union law or international law, which has legal personality and which may, acting in its own name, exercise rights and be subject to obligations, or an entity without a legal personality in accordance with Article 197(2)(c) of the Financial Regulation;

(8)  'third country' means a country that is not a Member State of the Union;

(9)  ‘SST information’ means processed SST data which is readily meaningful to the recipient;

(10)  ‘SST data’ means physical parameters of space objects, including space debris, acquired by SST sensors or orbital parameters of space objects derived from SST sensors' observations in the framework of the space surveillance and tracking ('SST') component;

(11)  ‘return link’ means a service contributing to the global monitoring service of aircraft, monitoring defined by the International Civil Aviation Organisation;

(12)  ‘Copernicus sentinels’ means the Copernicus dedicated satellites, spacecraft or spacecraft payloads for space-borne Earth observation;

(13)  ‘Copernicus data’ means data provided by the Sentinels, including their metadata;

(14)  ‘Copernicus third-party data and information’ means spatial data and information licensed or made available for use by Copernicus which originate from sources other than the Sentinels;

(14a)  Copernicus Services’ mean value-added services of general and common interest to the Union and Member States, which are financed by the Programme and which transform Earth Observation data, in situ data and other ancillary data into processed, aggregated and interpreted information tailored to the needs of Copernicus users;

(15)  ‘Copernicus in situ data’ means observation data from groundborne, seaborne or airborne sensors, as well as reference and ancillary data licensed or provided for use in Copernicus;

(16)  ‘Copernicus information’ means information generated by the Copernicus Services following processing or modelling, including their metadata;

(17)  ‘fiduciary entity’ means a legal entity that is independent from the Commission or a third party and that receives data from the Commission or that third party for the purpose of safe storage and treatment of that data;

(18)  ‘space debris’ means any space object including spacecraft or fragments and elements thereof in Earth's orbit or re-entering Earth's atmosphere, that are non-functional or no longer serve any specific purpose, including parts of rockets or artificial satellites, or inactive artificial satellites;

(19)  ‘SST sensor’ means a device or a combination of devices, ground-based or space-based radars, lasers and telescopes, that is able to perform space surveillance or tracking and can measure physical parameters related to space objects, such as size, location and velocity;

(19a)  'GOVSATCOM participant' means a Member States, Council, the Commission and EEAS, as well as Union agencies, third countries and international organisations, in so far as such agencies, third countries and international organisations have been duly authorised;

(20)  ‘GOVSATCOM user’ means a Union or Member State public authority, a body entrusted with the exercise of public authority, or a natural or legal person, dully authorised and entrusted with tasks relating to the supervision and management of' security-critical missions, operations and infrastructures;

(20a)  ‘GOVSATCOM Hub’ means an operational centre with the main function to link in a secure manner the GOVSATCOM users to the providers of GOVSATCOM capacity and services, and thereby optimise the supply and demand at any given moment.

(21)  ‘GOVSATCOM use-case’ means an operational scenario in a particular environment in which GOVSATCOM ▌ services are required;

(21a)  EU classified information (EUCI)' means any information or material designated by a EU security classification, the unauthorised disclosure of which could cause varying degrees of prejudice to the interests of the European Union or of one or more of the Member States;

(22)  ‘sensitive non-classified information’ means non-classified information within the meaning of Article 9 of Commission Decision (EU, Euratom) 2015/443, which creates an obligation to protect sensitive non-classified information applying solely to the European Commission and to Union agencies and bodies obliged by law to apply the security rules of the Commission;

(23)  'Copernicus users' means:

'Copernicus core users' which benefit from Copernicus data and Copernicus information and have the additional role of driving the evolution of Copernicus, are the Union institutions and bodies and European national, or regional public bodies in the Union or Copernicus Participating States entrusted with a public service mission for the definition, implementation, enforcement or monitoring of civilian public policies, among others environmental, civil protection, safety, including safety of infrastructure, or security policies;‘other Copernicus users’ which benefit from Copernicus data and Copernicus information and include in particular research and education organisations, commercial and private bodies, charities, non-governmental organisations, and international organisations;

(24)  'Copernicus Participating States' means third countries which contribute financially and participate in Copernicus under the terms of an international agreement concluded with the Union.

Article 3

Components of the Programme

The Programme shall consist of the following components:

(a)  an autonomous civil global navigation satellite system (GNSS) under civil control comprising a constellation of satellites, centres and a global network of stations on the ground, offering positioning, navigation and timing services and ▌ integrating the needs and requirements of security (‘Galileo’);

(b)  a civil regional satellite navigation system under civil control which consists of centres and stations on the ground and several transponders installed on geosynchronous satellites and which augments and corrects the open signals emitted by Galileo and other GNSSs, inter alia for air-traffic management, air navigation services and other transport systems ('European Geostationary Navigation Overlay Service or ‘EGNOS’);

(c)  an operational, autonomous, user-driven, civil Earth observation system under civil control, building on the existing national and European capacities, offering geo-information data and services, comprising satellites, ground infrastructure, data and information processing facilities, and distribution infrastructure, based on a full, free and open data policy and, where appropriate, integrating the needs and requirements of security (‘Copernicus’);

(d)  a space surveillance and tracking system aiming to improve, operate and provide data, information and services related to the surveillance and tracking of space objects that orbit around the Earth ('SST' sub-component) and complemented by observational parameters related to space weather events ('SWE' sub-component) and the risk monitoring of near earth objects ('NEOs sub-component') approaching the Earth (Space Situational Awareness, ‘SSA’);

(e)  a ▌ satellite communications service under civil and governmental control enabling the provision of satellite communications capacities and services to Union and Member State authorities managing security critical missions and infrastructures (‘GOVSATCOM’).

▌ The Programme shall include additional measures for ensuring efficient and autonomous access to space for the Programme and for fostering an innovative and competitive European space sector, upstream and downstream, strenghtening the Union's space ecosystem and reinforcing the Union as a global player.

Article 4

Objectives

1.  The Programme shall have the following general objectives:

(a)  provide, or contribute to the provision of, high-quality and up-to-date and, where appropriate, secure space-related data, information and services without interruption and wherever possible at global level, meeting existing and future needs and able to support the Union's political priorities and related evidence-based and independent decision making, inter alia for climate change and, transport, security ▌;

(b)  maximise the socio-economic benefits, in particular by fostering the development of an innovative and competitive European upstream and downstream sectors, including small and medium-sized enterprises and start-ups, thereby enabling growth and job creation in the Union and promoting the widest possible uptake and use of the data, information and services provided by the Programme's components both within and outside the Union; while ensuring synergies and complementarity with the Union's research and technological development activities carried out under the Horizon Europe Regulation;

(c)  enhance safety, the security of the Union and its Member States, and reinforce its ▌ autonomy, in particular in terms of technologies ▌;

(d)  promote the role of the Union global actor in the space sector, encourage international cooperation, reinforce European space diplomacy, including by fostering the principles of reciprocity and fair competition and strengthen its role in tackling global challenges, supporting global initiatives, including with regards to ▌ sustainable development, and raising awareness of space as a common heritage of humankind;

(e)  enhance safety, security and sustainability of all outer space activities pertaining to space objects and debris proliferation, as well as space environment, by implementing appropriate measures, including development and deployment of technologies for spacecraft disposal at the end of operational lifetime and for space debris disposal.

(6a)  International cooperation is paramount and is a key element of the Space Strategy for Europe and to promote the role of the Union as a global actor in the space sector. The Commission will use the Programme to contribute to and benefit from international efforts through space diplomacy initiatives to promote European technology and industry internationally (for example bi-lateral dialogues, industry workshops, support for SME internationalisation) and to facilitate access to international markets and foster fair competition, also leveraging economic diplomacy initiatives. European space diplomacy initiatives should be in full coherence and complementarity with the existing EU policies, priorities and instruments, while, the Union has a key role to play together with the Union Member States to remain at the forefront of the international scene.

2.  The Programme shall have the following specific objectives:

(a)  for Galileo and EGNOS: to provide long-term, state-of-the-art and, ▌secure positioning, navigation and timing services whilst ensuring service continuity and robustness;

(b)  for Copernicus: to deliver accurate and reliable Earth Observation data, information and services integrating other data sources, supplied on a long-term sustainable basis, to support the formulation, implementation and monitoring of the Union and its Member States' policies and actions based on user requirements;

(c)  for Space Situational Awareness ('SSA'): to enhance SST capabilities to monitor, track and identify space objects, and space debris with the aim to further increase the performance and autonomy of SST capabilities at Union level, to provide space weather services and to map and network Member States NEO capacities;

(d)  for GOVSATCOM: to ensure the long-term availability of reliable, secure and cost-effective satellite communications services for GOVSATCOM users;

(e)  to support an autonomous, secure and cost-efficient capability to access space, taking into account the essential security interests of the Union;

(f)  to foster the development of a strong Union space economy including by supporting the space ecosystem and by reinforcing competitiveness, innovation, entrepreneurship, skills and capacity building in all Member States and Union regions, with particular regard to small and medium-sized enterprises and start-ups or legal and natural persons from the Union active or wishing to become active in that sector ▌.

Article 5

Access to space

1.  The Programme shall support the procurement and aggregation of launching services for the needs of the Programme and, at their request, the aggregation for Member States and international organisations.

2.  In synergies with other Union programmes and funding schemes, and without prejudice to the European Space Agency's activities in the area of access to space, the Programme may support:

(a)  adaptations, including technology development, to space launch systems which are necessary for launching satellites, including alternative technologies and innovative systems on access to space, for the implementation of the Programme components;

(b)  adaptations to the space ground infrastructure, including new developments, which are necessary for the implementation of the Programme.

Article 6

Actions in support of an innovative and competitive Union space sector

1.   The Programme shall promote capacity building across the Union and thus support:

(a)  innovation activities for making best use of space technologies, infrastructure or services and measures to facilitate the uptake of innovative solutions resulting from research and innovation activities and support the development of the downstream sector, in particular through synergies with other Union Programmes and financial instruments, including Invest EU;

(b)  activities aiming to foster public demand and public sector innovation, to realise the full potential of public services for citizens and businesses;

(c)  entrepreneurship, including from early stage to scaling-up, in accordance with Article 21, by relying on other access to finance provisions as referred to in Article 18 and Chapter I of Title III, and by using a first contract approach;

(d)  the emergence of a business friendly space ecosystem through cooperation between undertakings in the form of a network of space hubs bringing together, at regional and national levels, actors from the space, digital and other sectors, as well as users, that network of hubs shall aim to provide support, facilities and services to citizens and companies to foster entrepreneurship and skills and to enhance synergies in the downstream sector and to foster cooperation with the digital innovation hubs established under the Digital Europe Programme;

(e)  provision of education and training activities, including for professionals, entrepreneurs, graduates and students, notably through synergies with national and regional initiatives, for the development of advanced skills;

(f)  access to processing and testing facilities for private and public sector professionals, students and entrepreneurs;

(g)  certification and standardisation activities;

(h)  reinforcement of the European supply chains across the Union through wide participation of enterprises, in particular small and medium-sized enterprises and start-ups, in all components of the programme, notably through the provisions of Article 14, and measures to underpin their competitiveness at global level.

2.  When implementing activities referred to in paragraph 1, the need to develop capacity in Member States with an emerging space industry shall be supported, in order to provide equal opportunity to all Member States to participate in the space programme.

Article 7

Third countries and international organisations associated to the Programme

1.  The Programme's components, with the exception of the SST and GOVSATCOM, shall be open to the following third countries:

(a)  European Free Trade Association (EFTA) members which are members of the European Economic Area (EEA), in accordance with the conditions laid down in the EEA agreement;

(b)  acceding countries, candidate countries and potential candidates, in accordance with the general principles and general terms and conditions for their participation in Union programmes established in the respective framework agreements and Association Council decisions, or similar agreements, and in accordance with the specific conditions laid down in agreements between the Union and them;

(c)  countries covered by the European Neighbourhood Policy, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and association council decisions, or similar agreements, and in accordance with the specific conditions laid down in agreements between the Union and those countries.

2.  The Programme's components, with the exception of the SST, shall also be open to any third country or international organisation, in accordance with the conditions laid down in a specific agreement covering the participation of the third country or of the international organisation to any Union programme, provided that the agreement:

(a)  ensures a fair balance as regards the contributions and benefits of the third country or international organisation participating in the Union programmes;

(b)  lays down the conditions of participation in the programmes, including the calculation of financial contributions to individual programmes and their administrative costs. These contributions shall constitute assigned revenues in accordance with Article [21(5)] of [the new Financial Regulation];

(c)  does not confer to the third country or international organisation a decisional power on the programme or, where appropriate, access to sensitive or classified information;;

(d)  guarantees the rights of the Union to ensure sound financial management and to protect its financial interests.

(da)  preserves, where appropriate, the strategic and sovereign interests of the Union in all relevant areas, including European technological or industrial strategic autonomy;

3.  The Programme's components shall only be open to the third countries and international organisations referred to in paragraphs 1 and 2 provided that the essential security interests of the Union and its Member States are preserved.

Article 8

Access to SST, GOVSATCOM and PRS by third countries or international organisations

1.  Third countries or international organisations may become GOVSATCOM participant referred to in Article 67 or obtain access to the services provided by the SST only where, in accordance with the procedure provided for in Article 218 of the Treaty on the Functioning of the European Union, they enter into an agreement laying down the terms and conditions of the detailed rules for access to such data, information, capacities and services, and the framework for exchanging and protecting classified information.

2.  The access of third countries or international organisations to the Public Regulated Service provided by Galileo shall be governed by Article 3(5) of Decision No 1104/2011/EU of the European Parliament and of the Council(23).

Article 9

Ownership and use of assets

1.  The Union shall be the owner of all tangible and intangible assets created or developed under the Programme's components. To that aim, the Commission shall take the necessary steps to ensure that relevant contracts, agreements and other arrangements relating to those activities which may result in the creation or development of such assets contain provisions ensuring such an ownership regime regarding those assets.

2.  Paragraph 1 shall not apply to the tangible and intangible assets created or developed under the Programme's components, where the activities which may result in the creation or development of such assets:

(a)  are carried out pursuant to grants or prizes fully financed by the Union;

(b)  are not fully financed by the Union, or

(c)  relate to the development, manufacture or use of PRS receivers incorporating EUCI, or components of such receivers.

3.  The Commission shall take the necessary steps to ensure that the contracts, agreements or other arrangements relating to the activities referred to in the second paragraph contain provisions setting out the appropriate ownership and use regime for those assets and, as regards point (c) that the Union can freely use and grant the use of the PRS receivers in accordance with Decision 1104/2011/EU.

4.  The Commission shall seek to conclude contracts or other arrangements with third parties with regard to:

(a)  pre-existing ownership rights in respect of tangible and intangible assets created or developed under the Programme's components;

(b)  the acquisition of the ownership or license rights in respect of other tangible or intangible assets necessary for the implementation of the Programme.

5.  The Commission shall ensure, by means of an appropriate framework, the optimal use of the tangible and intangible assets referred to in paragraphs 1 and 2 owned by the Union.

6.  In particular, where those assets consist of intellectual property rights, the Commission shall manage those rights as effectively as possible, taking account of the need to protect and give value to them, of the legitimate interests of all stakeholders concerned and of the need for harmonious development of markets and new technologies and for the continuity of the services provided by the Programme's components. To that end, it shall ensure in particular that the relevant contracts, agreements and other arrangements include the possibility of transferring those rights to third parties or granting third-party licences for those rights, including to the creator of that intellectual property right and that the Agency can freely enjoy those rights where necessary for carrying out its tasks under this Regulation. The financial framework partnership agreement referred to in Article 29(3a) or the contribution agreements referred to in Article 32(1) shall contain relevant provisions to allow the use of those rights by the European Space Agency and the other entrusted entities where necessary to perform their tasks under this Regulation and the conditions for that use.

Article 10

Warranty

Without prejudice to the obligations imposed by legally binding provisions, the services, data and information provided by the Programme's components shall be provided without any express or implied warranty as regards their quality, accuracy, availability, reliability, speed and suitability for any purpose. ▌ The Commission shall take the necessary steps to ensure that the users of those services, data and information are duly informed▌.

TITLE II

BUDGETARY CONTRIBUTION AND MECHANISMS

Article 11

Budget

1.  The financial envelope for the implementation of the Programme for the period 2021 – 2027, including for the associated risks, shall be EUR 16,9 billion in current prices.

The ▌ distribution of the amount referred to in the first subparagraph shall be broken down in the following categories of expenditure:

(a)  for Galileo and EGNOS: EUR 9,7 billion;

(b)  for Copernicus: EUR 6 billion;

(c)  for SSA/GOVSATCOM: EUR 1,2 billion.

2.  Additional measures as foreseen by Article 3, namely activities referred to in Article 5 and in Article 6, shall be financed under the Programme's components.

3.  The Union budgetary appropriations assigned to the Programme shall cover all the activities required to fulfil the objectives referred to in Article 4. Such expenditure may cover:

(a)  studies and meetings of experts, in particular compliance with its cost and time constraints;

(b)  information and communication activities, including corporate communication on the policy priorities of the Union where they are directly linked to the objectives of this Regulation, with a particular view to creating synergies with other Union policies;

(c)  the information technology networks whose function it is to process or exchange information, and the administrative management measures, including in the field of security, implemented by the Commission;

(d)  technical and administrative assistance for the implementation of the Programme, such as preparatory, monitoring, control, audit and evaluation activities including corporate information technology systems.

4.  Actions that receive cumulative funding from different Union programmes shall be audited only once, covering all involved programmes and their respective applicable rules.

5.  The budget commitments relating to the Programme and which cover activities extending over more than one financial year may be broken down over several years into annual instalments.

6.  Resources allocated to Member States under shared management may, at their request, be transferred to the Programme. The Commission shall implement those resources directly in accordance with point (a) of Article 62(1) of the Financial Regulation or indirectly in accordance with point (c) of that Article. Where possible those resources shall be used for the benefit of the Member State concerned.

Article 12

Assigned revenue

1.  The revenue generated by the components of the Programme shall be paid into the Union budget and used to finance the component which generated the revenue.

2.  The Member States may endow a component of the Programme with an additional financial contribution on condition that such additional elements do not create any financial or technical burden or any delay for the component concerned. The Commission shall decide, in accordance with the examination procedure referred to in Article 107 (3), whether those conditions have been met.

3.  The additional funding referred to in this Article shall be treated as external assigned revenue in accordance with [Article 21(2)] of the Financial Regulation.

Article 13

Implementation and forms of EU funding

1.  The Programme shall be implemented in direct management in accordance with the Financial Regulation or in indirect management with bodies referred to in [Article 62(1)(c)] of the Financial Regulation.

2.  The Programme may provide funding in any of the forms laid down in the Financial Regulation, in particular grants, prizes and procurement. It may also provide financing in the form of financial instruments within blending operations.

3.  Where the Copernicus budget is implemented by indirect management the procurement rules of the entities entrusted with budget implementation tasks may apply to the extent allowable under Articles 62 and 154 of the Financial Regulation. Specific adjustments necessary to those rules shall be defined in the relevant contribution agreements.

TITLE III

FINANCIAL PROVISIONS

CHAPTER I

Procurement

Article 14

Principles of procurement

1.  The contracting authority shall act in accordance with the following principles in procurement procedures for the purpose of the Programme:

(a)  to promote in all Member States throughout the Union and, throughout the supply chain, the widest and most open participation possible of all economic operators, in particular start-ups, new entrants and small and medium sized enterprises ▌, including the requirement of sub-contracting by the tenderers;

(b)  to ensure effective competition and, where possible, avoid reliance on a single provider, in particular for critical equipment and services, taking into account the objectives of technological independence and continuity of services;

(c)  by derogation from Article 167 of the Financial Regulation, to use, wherever appropriate, multiple supply sources in order to ensure better overall control of all the components of the Programme, their cost and schedule;

(cc)  to follow the principles of open access and fair competition throughout the industrial supply chain, tendering on the basis of the provision of transparent and timely information, clear communication of the applicable procurement rules and procedures, selection and award criteria and any other relevant information allowing a level-playing field for all potential bidders, including SMEs and start-ups;

(d)  to reinforce the autonomy of the Union, in particular in technological terms;

(e)  to comply with the security requirements of the components of the Programme and to contribute to the protection of the essential security interests of the Union and its Member States;

(ee)  to promote service continuity and reliability;

(f)  to satisfy appropriate social and environmental criteria.

2.  The procurement Board, within the Commission, shall scrutinise the procurement process concerning all components of the programme and monitor the contractual implementation of the EU budget delegated to entrusted entities. Representative of the entrusted entities shall be invited as appropriate.

Article 15

Conditional stage-payment contracts

1.  With regard to operational and infrastructure-specific activities, the contracting authority may award a contract in the form of a conditional stage-payment contract in accordance with this article.

2.  A conditional stage-payment contract shall include a fixed stage which results in a firm commitment to provide the works, supplies or services contracted for that stage, and one or more stages which are conditional in terms of both budget and execution. The tender documents refer to the specific features of conditional stage-payment contracts. In particular, they shall specify the subject-matter of the contract, the price or the arrangements for determining the price and the arrangements for the provision of works, supplies and services at each stage.

3.  The fixed stage obligations shall be part of a consistent whole; the same is true for the obligations under each conditional stage, taking into account the obligations under the previous stages.

4.  Performance of each conditional stage shall be subject to a decision by the contracting authority, notified to the contractor in accordance with the contract.

Article 16

Cost-reimbursement contracts

1.  The contracting authority may opt for a full or partial cost-reimbursement based contract under the conditions laid down in paragraph 3.

The price to be paid shall consist in the reimbursement of all direct costs actually incurred by the contractor in performing the contract, such as expenditure on labour, materials, consumables, and use of the equipment and infrastructures necessary to perform the contract, indirect costs, a fixed profit, and an appropriate incentive fee ▌ based on achieving objectives in respect of performance and delivery schedules.

2.  Cost reimbursement contracts shall stipulate a maximum ceiling price.

3.  The contracting authority may opt for a full or partial cost-reimbursement contract in cases where it is difficult or unsuitable to provide an accurate fixed price due to the uncertainties inherent in performance of the contract because:

(a)  the contract has very complex features or features which require the use of a new technology and, therefore, includes a significant number of technical risks; or

(b)  the activities subject to the contract must, for operational reasons, start immediately even though it is not yet possible to determine a firm fixed price in full due to significant risks or because the performance of the contract depends in part on the performance of other contracts.

4.  The ceiling price for a full or partial cost-reimbursement contract shall be the maximum price payable. The contract price may be amended in accordance with [Article 172] of the Financial Regulation.

Article 17

Subcontracting

1.  To encourage new entrants, small and medium enterprises and start-ups and their cross border participation, and to offer the widest possible geographic coverage while protecting the Union's ▌ autonomy, the contracting authority shall request that the tenderer subcontract part of the contract by competitive tendering at the appropriate levels of subcontracting to companies other than those which belong to the tenderer's group.

3.  Any derogation from a request in accordance with paragraph 1 shall be justified by the tenderer.

4.  For contracts above ten million Euro, the contracting authority shall aim at ensuring that at least 30% of the value of the contract is subcontracted by competitive tendering at various levels to companies outside the group of the prime contractor, notably in order to enable the cross-border participation of SMEs. The Commission shall inform the Committee referred to in Article 107 (1) on the fullfilment of this objective for contracts signed after the entry into force of this Regulation.

CHAPTER II

Grants, prizes and blending operations

Article 18

Grants and prizes

1.  The Union may cover up to 100% of the eligible costs, without prejudice to the co-financing principle.

2.  By way of derogation from [Article 181(6)] of the Financial Regulation when applying flat rates, the authorising officer responsible may authorise or impose funding of the beneficiary’s indirect costs up to a maximum of 25 % of ▌ total eligible direct ▌ costs for the action.

3.  Notwithstanding paragraph 2, indirect costs may be declared in the form of a lump sum or unit costs when provided for in the work programme referred to in Article 100.

4.  By way of derogation from [Article 204] of the Financial Regulation, the maximum amount of financial support that can be paid to a third party shall not exceed EUR 200 000.

Article 19

Joint calls for grants

The Commission or an entrusted entity in the context of the Programme may issue a joint call for proposals with entities, bodies or persons referred to in Article 62(1)(c) of the Financial Regulation.

In the case of a joint call, the rules referred to in Title VIII of the Financial Regulation shall apply. The evaluation procedures shall ▌ involve a balanced group of experts appointed by each party. The evaluation committees shall comply with Article 150 of the Financial Regulation.

The grant agreement shall specify the arrangement applicable to intellectual property rights.

Article 20

Grants for pre-commercial procurement and procurement of innovative solutions

1.  Actions may involve or have as their primary aim pre-commercial procurement or public procurement of innovative solutions that shall be carried out by beneficiaries which are contracting authorities or contracting entities as defined in Directives 2014/24/EU, 2014/25/EU and 2009/81/EC of the European Parliament and of the Council.

2.  The procurement procedures:

(a)  shall comply with the principles of transparency, non- discrimination, equal treatment, sound financial management, proportionality and competition rules;

(b)  for pre-commercial procurement, may provide for specific conditions such as the place of performance of the procured activities being limited to the territory of the Member States and of associated countries;

(c)  may authorise the award of multiple contracts within the same procedure (multiple sourcing); and

(d)  shall provide for the award of the contracts to the tender(s) offering best value for money while ensuring absence of conflict of interest.

3.  The contractor generating results in pre-commercial procurement shall own at least the attached intellectual property rights. The contracting authorities shall enjoy at least royalty-free access rights to the results for their own use and the right to grant, or require the participating contractors to grant, non-exclusive licences to third parties to exploit the results for the contracting authority under fair and reasonable conditions without any right to sub-license. If a contractor fails to commercially exploit the results within a given period after the pre-commercial procurement as identified in the contract, the contracting authorities may require it to transfer any ownership of the results to the contracting authorities.

Article 21

Blending operations

Blending operations decided under this Programme shall be implemented in accordance with the [InvestEU regulation] and Title X of the Financial Regulation.

CHAPTER IV

Other financial provisions

Article 22

Cumulative, complementary and combined funding

1.  An action that has received a contribution from another Union programme may also receive a contribution under the Programme, provided that the contributions do not cover the same costs. The rules of each contributing Union programme shall apply to its respective contribution to the action. The cumulative funding shall not exceed the total eligible costs of the action and the support from the different Union programmes may be calculated on a pro-rata basis in accordance with the documents setting out the conditions for support.

2.  Actions awarded a Seal of Excellence certification, or which shall comply with the following cumulative conditions:

(a)  they have been assessed in a call for proposals under the Programme;

(b)  they comply with the minimum quality requirements of that call for proposals;

(c)  they may not be financed under that call for proposals due to budgetary constraints;

may receive support from the European Regional Development Fund, the Cohesion Fund, the European Social Fund+ or the European Agricultural Fund for Rural Development, in accordance with paragraph 5 of Article [67] of Regulation (EU) XX [Common Provisions Regulation] and Article [8] or Regulation (EU) XX [Financing, management and monitoring of the Common Agricultural Policy], provided that such actions are consistent with the objectives of the programme concerned. The rules of the Fund providing support shall apply.

Article 24

Joint procurement

1.  In addition to the provisions of [Article 165] of the Financial Regulation, the Commission and/or the Agency may carry out joint procurement procedures with the European Space Agency or other international organisations involved in implementing the components of the Programme.

2.  The procurement rules applicable in [Article 165] of the Financial Regulation shall apply by analogy provided that in any case the procedural provisions applicable to the Union institutions are applied.

Article 25

Protection of essential security interests

Where necessary for the protection of the essential security interest of the Union and its Member States, in particular with regard to the need to preserve the integrity and resilience of the Union systems, as well as the autonomy of the industrial basis on which they rely, the Commission shall set the requisite eligibility conditions applicable to the procurement, grants or prizes covered by this Title. Particular regard shall be had, for that purpose, to the need for eligible undertakings to be established in a Member State, to commit to carry out any relevant activities inside the Union ▌. Those conditions shall be included in the documents relating to the procurement, grant or prize, as applicable. In the case of procurement, the conditions shall apply to the full life cycle of the resulting contract..

Article 26

Protection of the financial interests of the Union

Where a third country participates in the Programme by a decision under an international agreement or by virtue of any other legal instrument, the third country shall grant the necessary rights and access required for the authorising officer responsible, ▌ OLAF and the European Court of Auditors to comprehensively exert their respective competences. In the case of OLAF, such rights shall include the right to carry out investigations, including on-the-spot checks and inspections, provided for in Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council concerning investigations conducted by the European Anti-Fraud Office ▌.

TITLE IV

GOVERNANCE OF THE PROGRAMME

Article 27

Principles of governance

The governance of the Programme shall be based on the following principles:

(a)  clear distribution of tasks and responsibilities between the entities involved in the implementation of each component and measure of the Programme, in particular between the Member States, the Commission, the Agency and the European Space Agency and the European Organisation for the Exploitation of Meteorological Satellites, building on their respective competence and avoiding any overlap in tasks and responsibilities;

(aa)  pertinence of the governance structure to the specific needs of each component and measure of the Programme as appropriate;

(b)  strong control of the Programme, including strict adherence to cost, schedule and performance by all the entities, within their respective roles and tasks in accordance with this Regulation;

(c)  transparent and cost-efficient management;

(cc)  service continuity and necessary infrastructure continuity, including protection from relevant threats;

(d)  systematic and structured consideration of the needs of users of the data, information and services provided by the Programme's components, as well as of related scientific and technological evolutions ▌;

(e)  constant efforts to control and reduce risks.

Article 28

Role of the Member States

1.  The Member States may participate in the Programme. Member States who participate in the Programme shall contribute with their technical competence, know-how and assistance, in particular in the field of safety and security, and/or, where appropriate and possible, by making available to the Union the data, information, services and infrastructure in their possession or located on their territory, including by ensuring an efficient and obstacle free access and use of in-situ data and cooperating with the Commission to improve the availability of in-situ data required by the Programme, taking into account applicable licences and obligations.

2.  The Commission may entrust, by means of contribution agreements, specific tasks to Member State organizations, where such organisations have been designated by the Member State concerned. The Commission, by means of implementing act, acting in accordance with the advisory procedure referred to in Article 107(2), shall adopt the contribution decisions regarding the contribution agreements.

2a.  In certain duly justified circumstances, for the tasks referred to in Article 30, the Agency may entrust, by means of contribution agreements, specific tasks to Member State organizations, where such organisations have been designated by the Member State concerned.

2aa.   The Member States shall take all the necessary measures to ensure the smooth functioning of the Programme ▌, including by helping to protect, at the adequate level, the frequencies required for this programme.

2b.  The Member States and the Commission may cooperate to widen the uptake of data, information and services provided by the programme.

2c.  Whenever possible, the contribution of Member States to the User Forum referred to in Article 107 shall be based on a systematic and coordinated consultation of end user communities at national level, in particular regarding Galileo, EGNOS and Copernicus

3.  The Member States and Commission shall cooperate in order to develop the in-situ component and ground calibration services necessary for the uptake of space systems and to facilitate the use of in-situ and reference data sets to their full potential, building on existing capacities.

4.  In the field of security, the Member States shall perform the tasks referred to in Article 34(4).

Article 29

Role of the Commission

1.  The Commission shall have overall responsibility for the implementation of the Programme, including in the field of security, without prejudice to Member States' prerogatives in the area of national security. It shall, in accordance with this Regulation, determine the priorities and long-term evolution of the Programme, in line with the user requirements, and shall supervise its implementation, without prejudice to other policies of the Union.

2.  The Commission shall manage any component or sub-component of the Programme ▌ not entrusted to another entity, in particular GOVSATCOM, NEO, space weather and the activites referred to in Art. 54(d).

3.  The Commission shall ensure a clear division of tasks and responsibilities between the various entities involved in the Programme and coordinate the activities of those entities. The Commission shall also ensure that all the entrusted entities involved in the implementation of the programme protect the interest of the Union, guarantee the sound management of the Union's funds and comply with the Financial Regulation and this Regulation.

3a.  The Commission, shall conclude with the Agency and, taking into account the 2004 Framework agreement, the European Space Agency, a Financial Framework Partnership Agreement as provided for in [Article 130] of the Financial Regulation and referred to in Article 31a.

4.  When necessary for the smooth functioning of the Programme and the smooth provision of the services provided by the Programme's components, the Commission shall, by means of delegated acts, determine the high-level requirements for the implementation of and evolution of those components and of the services they provide after having consulted users and all the other relevant stakeholders, including the downstream sector. When determining those high-level requirements, the Commission shall avoid reducing the general security level and to meet a backward compatibility imperative.

Those delegated acts shall be adopted in accordance with Article 21.

5.  The Commission shall ▌ ensure that the uptake and use of the data and services provided by the Programme's components in the public and private sectors is promoted and maximised, without prejudice to the tasks of the Agency or of other entrusted entities, including by supporting appropriate development of those services and user-friendly interfaces, and by fostering a stable long-term environment. It shall develop appropriate synergies between the applications of the various components of the Programme. It shall ensure complementarity, consistency, synergies and links between the Programme and other Union actions and programmes.

6.  Where appropriate, the Commission shall ensure the coherence of activities performed in the context of the Programme with activities carried out in the field of space ▌ at Union, national or international level. It shall encourage cooperation between the Member States and, when pertinent to the Programme, facilitate convergence of their technological capacities and developments in the space domain. To this end, the Commission shall, where appropriate and in their field of competence, cooperate with the Agency and the European Space Agency.

7.  The Commission shall inform the Committee referred to in article 107 of the interim and final results of the evaluation of any procurement tenders and of any contracts with public and private entities, including subcontracts.

Article 30

Role of the Agency

1.  The Agency shall have the following own tasks:

(a)  ensure, through its Security Accreditation Board, the security accreditation of all the components of the Programme in accordance with Chapter II of Title V;

(b)  perform other tasks referred to in Article 34(2) and (3);

(c)  undertake communication, market development and promotion activities ▌ of the services offered by Galileo and EGNOS, in particular activities relating to the market uptake and users needs' coordination;

(ca)  undertake communication, promotion and market development activities of data, information and services offered by Copernicus, without prejudice to the activities performed by other entrusted entities and the Commission;

(d)  provide ▌ expertise to the Commission, including for the preparation of the downstream space-related research priorities.

2.  The Commission shall entrust the following tasks to the Agency:

(a)  managing the exploitation of EGNOS and Galileo, covering the actions referred to in Article 43;

(b)  overarching coordination of user-related aspects of GOVSATCOM in close collaboration with Member States, other entities, relevant Union agencies and EEAS for crisis management missions and operations;

(c)  implementing activities relating to the development of downstream applications based on the components of the Programme, including fundamental elements and integrated applications based on the data and services provided by Galileo, EGNOS and Copernicus, including where funding have been made available for such activities in the context of the Horizon Europe Programme established under Regulation xx or where necessary to fulfill the objectives referred to in Article 4(1)(b);

(d)  undertake activities related to user uptake of data, information and services, offered by the programme’s components other than Galileo and EGNOS, without prejudice to Copernicus activities and Services entrusted to other entities;

(e)  specific actions referred to in Article 6.

3.  The Commission may, on the basis of the assessments referred to in Article 102(6), entrust other tasks, to the Agency, provided that they do not duplicate activities performed by another entrusted entities in the context of the Programme and provided that they aim to improve the efficiency of the implementation of the Programme's activities.

3a.  Whenever activities are entrusted to the Agency, appropriate financial, human and administrative resources shall be ensured for their implementation.

5.  By way of derogation from Art 62(1) of the Financial Regulation and subject to the Commission’s assessment of the protection of the Union’s interests, the Agency may entrust, by means of contribution agreements, specific activities to other entities, in areas of their respective competence, under the conditions of indirect management applying to the Commission.

Article 31

Role of the European Space Agency

1.  Provided that the interest of the Union is protected, the European Space Agency shall be entrusted with the following tasks:

(a)  as regards Copernicus: coordination of the space component and the implementation for the Copernicus space component and its evolution, design, development ▌ and construction of the Copernicus space infrastructure, including the operations of that infrastructure and related procurement, except when this is done by other entities, and, where appropriate, access to third party data;

(b)  as regards Galileo and EGNOS: systems evolution, design and development, of parts of the ground segment and ▌ of satellites, including testing and validation;

(c)  as regards all the components of the Programme with upstream research and development activities in its fields of expertise.

1a.  On the basis of an assessment by the Commission, the European Space Agency may be entrusted with other tasks based of the needs of the programme, provided that they do not duplicate activities performed by another entrusted entity in the context of the Programme and provided that they aim to improve the efficiency of the implementation of the Programme's activities.

4.  Without prejudice to the financial framework partnership agreement referred to in Article 31a, the Commission or the Agency may request the European Space Agency to provide technical expertise and the information necessary to perform the tasks which are assigned to them by this Regulation under conditions to be mutually agreed.

Article 31a

The financial framework partnership agreement

1.  The ▌financial framework partnership agreement referred to in Article 29(3a) shall:

a)  clearly define the roles, responsibilities and obligations of the Commission, the Agency and the European Space Agency with regard to each component of the Programme and necessary coordination and control mechanisms;

b)  require that the European Space Agency applies the Union security rules defined in the security agreements entered into between the Union, and its Institutions and Agencies, with ESA, in particular with regard to the processing of classified information;

c)  stipulate the conditions of the management of funds entrusted to the European Space Agency, particularly with regard to public procurement, including the application of Union procurement rules when procuring in the name and on behalf of the Union or the application of the rules of the entrusted entity in accordance with Article 154 of the Financial Regulation, management procedures, the expected results measured by performance indicators, applicable measures in the event of deficient or fraudulent implementation of the contracts in terms of costs, schedule and results, as well as the communication strategy and the rules regarding ownership of all tangible and intangible assets; these conditions shall be in conformity with Titles III and V of this Regulation and with the Financial Regulation;

d)   require that, whenever a Tender Evaluation Board is established by the Agency or the European Space Agency for a procurement action performed under the FFPA, experts from the Commission and, where relevant, the other entrusted entity shall participate as member in the Tender Evaluation Board meetings. Such participation shall be without prejudice to the technical independence of the Tender Evaluation Board ▌;

e)   establish the monitoring and control measures, which shall include, in particular, a cost forecast system, the systematic provision of information to the Commission or, where appropriate, to the Agency, on costs and schedule, and in the event of a discrepancy between the planned budgets, performance and schedule, corrective action ensuring performance of the tasks ▌ within ▌ the allocated budgets ▌;

f)   establish the principles for the remuneration of the European Space Agency for each component of the programme, which shall be commensurate with the conditions under which the actions are implemented, taking due account of situations of crisis and fragility, and, where appropriate, be performance based; the remuneration shall only cover general overheads which are not associated with the activities entrusted to the European Space Agency by the Union;

(g)  provide that the European Space Agency takes appropriate measures to ensure the protection of the interests of the Union and to comply with the decisions taken by the Commission for each componet in application of this Regulation.

2.  Without prejudice to the financial framework partnership agreement referred to in Article 31a, the Commission or the Agency may ask the European Space Agency to provide technical expertise and the information necessary to perform the tasks which are assigned to them by this Regulation. The conditions for such requests and their implementation shall be mutually agreed.

Article 32

Role of EUMETSAT and other entities

1.  The Commission may entrust, in full or in part, by means of contribution agreements the implementation of the following tasks to entities other than those referred to in Article 30 and 31, including :

(a)  the upgrading, operations preparation and operation of the Copernicus space infrastructure or parts thereof and, where appropriate, managing access to contributing mission data, which may be entrusted to EUMETSAT;

(b)  the implementation of the Copernicus services or parts thereof to relevant agencies, bodies or organisations, managing also the relevant third party information acquisition.

2.  The criteria for the selection of such entrusted entities shall, in particular, reflect their ability to ensure the continuity and, where appropriate, the security of the operations with no or minimal disruption of Programme activities.

2a.  Whenever possible, the conditions of the contribution agreements referred to in the first paragraph shall be coherent with the conditions of the FFPA referred to in Article 31a(1).

3.  The Programme Committee shall be consulted on the contribution decision regarding the contribution agreement referred to in paragraph 1 of this Article in accordance with the advisory procedure referred to in Article 107(2). The Programme Committee shall be informed in advance of the contribution agreements to be concluded by the Union, represented by the Commission, and the Entities referred to in paragraph 1.

TITLE V

SECURITY OF THE PROGRAMME

CHAPTER I

Security of the Programme

Article 33

Principles of security

1.  The security of the Programme shall be based on the following principles:

(a)  to take account of the experience of the Member States in the field of security and draw inspiration from their best practices;

(b)  to use ▌ the ▌ security rules of the Council and of the Commission, which provide, among others, for a separation between operational functions and those associated with accreditation.

2.  This Regulation shall be without prejudice to the sole responsibility of the Member States for national security, as provided for in Article 4(2) TEU, and to the right of the Member States to protect their essential security interests in accordance with Article 346 TFEU.

Article 34

Governance of security

1.  The Commission, in its field of competence, with the support of the Agency, shall ensure a high degree of security with regard to, in particular:

(a)  the protection of infrastructure, both ground and space, and of the provision of services, particularly against physical or cyber-attacks, including interference with data streams;

(b)  the control and management of technology transfers;

(c)  the development and preservation within the Union of the competence and know-how acquired;

(d)  the protection of sensitive non-classified and classified information.

To that end, the Commission shall ensure that a risk and threat analysis is performed for each Programme's component. Based on that risk and threat analysis, it shall determine by the end of 2023, by means of implementing acts, for each component of the Programme, the general security requirements. In doing so, the Commission shall take account of the impact of those requirements on the smooth functioning of that component, in particular in terms of cost, risk management and schedule, and shall ensure not to reduce the general level of security or undermine the functioning of the existing equipment based on that component and take into account cybersecurity risks. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).

After the entry into force of this Regulation, the Commission shall communicate an indicative list of implementing acts to be submitted to and discussed by the Programme Committee in security configuration. This list shall be accompanied by an indicative timetable for submission.

2.  The entity responsible for the management of a component of the Programme shall be responsible for ▌ the operational security of that component and shall, to that end, carry out risk and threat analysis and all the necessary activities to ensure and monitor the security of that component, in particular setting of technical specifications and operational procedures, and monitor their compliance with the general security requirements referred to in paragraph 1. Pursuant to Article 30, for Galileo and EGNOS that entity shall be the Agency.

2a.  Based on the risk and threat analysis, the Commission shall, where appropriate, identify a structure to monitor security and to follow the instructions developed under the scope of Decision 201x/xxx/CFSP.(24) The structure shall operate in accordance with the security requirements referred to in paragraph 1. For Galileo, that structure shall be the Galileo Security Monitoring Centre.

3.  The Agency shall:

(a)  ensure the security accreditation of all the components of the Programme in accordance with Chapter II of this Title and without prejudice to the competences of the Member States;

(b)  ensure the operation of the Galileo Security Monitoring Centre in accordance with the requirements referred to in paragraph 2 and the instructions developed under the scope of Decision 2014/496/CFSP;

(c)  perform the tasks assigned to it under Decision No 1104/2011/EU;

(d)  provide the Commission with its technical expertise and supply any information necessary for the performance of its tasks under this Regulation.

4.  The Member States shall:

(a)  take measures which are at least equivalent to those necessary for the protection of European critical infrastructures within the meaning of Council Directive 2008/114/EC of 8 December 2008 on the identification and designation of European critical infrastructures and the assessment of the need to improve their protection(25) and to those necessary for the protection of their own national critical infrastructures in order to ensure the protection of the ground infrastructure on the ground which form an integral part of the Programme and which are located on their territory;

(b)  perform the security accreditation tasks referred to in Article 41.

5.  The entities involved in the Programme shall take all the ▌ necessary measures, also in light of the issues identified in the risk analysis, to ensure the security of the Programme.

Article 34a

Security of systems and services deployed

Whenever the security of the Union or its Member States may be affected by the operation of the systems, the procedures set out in Council Decision XXXX/XX/CFSP shall apply.

CHAPTER II

Security accreditation

Article 35

Security Accreditation Authority

The Security Accreditation Board established within the Agency shall be the security accreditation authority for all the components of the Programme.

Article 36

General principles of security accreditation

Security accreditation activities for all the components of the Programme shall be conducted in accordance with the following principles:

(a)  security accreditation activities and decisions shall be undertaken in a context of collective responsibility for the security of the Union and of the Member States;

(b)  efforts shall be made for decisions within the Security Accreditation Board to be reached by consensus;

(c)  security accreditation activities shall be carried out using a risk assessment and management approach, considering risks to the security of the component as well as the impact on cost or schedule of any measure to mitigate the risks, taking into account the objective not to lower the general level of security of this component;

(d)  security accreditation decisions of the Security Accreditation Board shall be prepared and taken by professionals who are duly qualified in the field of accrediting complex systems, have an appropriate level of security clearance and act objectively;

(e)  efforts shall be made to consult all relevant parties with an interest in security issues for this component;

(f)  security accreditation activities shall be carried out by all relevant stakeholders of the component according to a security accreditation strategy, without prejudice to the role of the Commission;

(g)  security accreditation decisions of the Security Accreditation Board shall, following the process defined in the relevant security accreditation strategy defined by that Board, be based on local security accreditation decisions taken by the respective national security accreditation authorities of the Member States;

(h)  a permanent, transparent and fully understandable monitoring process shall ensure that the security risks for the component are known, that security measures are defined to reduce such risks to an acceptable level in view of the security needs of the Union and of its Member States and for the smooth running of the component and that those measures are applied in accordance with the concept of defence in depth. The effectiveness of such measures shall be continuously evaluated. The process relating to security risk assessment and management shall be conducted as an iterative process jointly by the stakeholders of the component;

(i)  security accreditation decisions shall be taken by the Security Accreditation Board in a strictly independent manner, including with regard to the Commission and the other bodies responsible for the implementation of the component and for the provision of related services, and with regard to the Executive Director and the Administrative Board of the Agency;

(j)  security accreditation activities shall be carried out with due regard for the need for adequate coordination between the Commission and the authorities responsible for implementing security provisions;

(k)  the security accreditation of EGNOS performed by the Security Accreditation Board shall be without prejudice to the accreditation activities performed, for aviation, by the European Aviation Safety Agency.

Article 37

Tasks of the Security Accreditation Board

1.  The Security Accreditation Board shall perform its tasks without prejudice to the responsibilities of the Commission or to those entrusted to the Agency’s other bodies, in particular for matters relating to security, and without prejudice to the competences of the Member States as regards security accreditation.

2.  The Security Accreditation Board shall have the following tasks:

(a)  defining and approving a security accreditation strategy setting out:

i)  the scope of the activities necessary to perform and maintain the accreditation of the components of the Programme or of parts of these components and any interconnections between them and other systems or components;

ii)  a security accreditation process for the components of the Programme or parts of these components, with a degree of detail commensurate with the required level of assurance and clearly stating the accreditation conditions;

iii)  an accreditation schedule compliant with the phases of the components of the Programme, in particular as regards the deployment of infrastructure, service provision and evolution;

iv)  the principles of security accreditation for networks connected to systems set up under the components of the Programme or for parts of these components and for equipment connected to systems established by these components, which shall be performed by the national entities of the Member States competent in security matters;

(b)  taking security accreditation decisions, in particular on the approval of satellite launches, the authorisation to operate the systems set up under the components of the Programme or the elements of these components in their different configurations and for the various services they provide, up to and including the signal in space, and the authorisation to operate the ground stations. As regards the networks and the equipment connected to the PRS service referred to in Article 44 , or to any other secure service stemming from the components of the Programme, the Security Accreditation Board shall take decisions only on the authorisation of bodies to develop or manufacture sensitive PRS technologies, PRS receivers or PRS security modules, or any other technology or equipment which has to be checked under the general security requirements referred to in Article 34(1), taking into account the advice provided by national entities competent in security matters and the overall security risks;

(c)  examining and, except as regards documents which the Commission is to adopt under Article 34(1) of this Regulation and Article 8 of Decision No 1104/2011/EU, approving all documentation relating to security accreditation;

(d)  advising, within its field of competence, the Commission on the production of draft texts for acts referred to in Article 34(1) of this Regulation and Article 8 of Decision No 1104/2011/EU, including for the establishment of security operating procedures (SecOps), and providing a statement with its concluding position;

(e)  examining and approving the security risk assessment drawn up in accordance with the monitoring process referred to in Article 36(h), taking into account compliance with the documents referred to in point (c) of this paragraph and those drawn up in accordance with Article 34(1) of this Regulation, and with Article 8 of Decision No 1104/2011/EU; and cooperating with the Commission to define risk mitigation measures;

(f)  checking the implementation of security measures in relation to the security accreditation of the components of the Programme by undertaking or sponsoring security assessments, inspections, audits or reviews, in accordance with Article 41(b) of this Regulation;

(g)  endorsing the selection of approved products and measures which protect against electronic eavesdropping (TEMPEST) and of approved cryptographic products used to provide security for the components of the Programme;

(h)  approving or, where relevant, participating in the joint approval, together with the relevant entities competent in security matters, of the interconnection between the systems established under the components of the Programme or the parts of these components and other systems;

(i)  agreeing with the relevant Member State the template for access control referred to in Article 41(c);

(j)  preparing risk reports and informing the Commission, the Administrative Board and the Executive Director of its risk assessment and advising them on residual risk treatment options for a given security accreditation decision;

(k)  assisting, in close liaison with the Commission, the Council and the High Representative in the implementation of Decision 2014/496/CFSP upon a specific request from the Council and/or the High Representative;

(l)  carrying out the consultations which are necessary to perform its tasks;

(m)  adopting and publishing its rules of procedure.

3.  Without prejudice to the powers and responsibilities of the Member States, a special subordinate body representing the Member States shall be set up under the supervision of the Security Accreditation Board to perform in particular the following tasks:

(a)  the management of flight keys and other keys necessary for the functioning of Galileo;

(b)  the verification of the establishment and enforcement of procedures for accounting, secure handling, storage and distribution of the PRS keys of Galileo.

Article 38

Composition of the Security Accreditation Board

1.  The Security Accreditation Board shall be composed of a representative of each Member State, a representative of the Commission and a representative of the High Representative of the Union for Foreign Affairs and Security Policy ('High Representative'). The term of office of the members of the Security Accreditation Board shall be four years and shall be renewable.

2.  Participation in SAB meetings shall be based on the need-to-know-principle. Where appropriate, representatives of the European Space Agency and representatives of the Agency not involved in security accreditation may be invited to attend the meetings of the Security Accreditation Board as observers. On an exceptional basis, representatives of Union Agencies, third countries or international organisations may also be invited to attend meetings as observers for matters directly relating to those third countries or international organisations, especially matters concerning the infrastructure belonging to them or established on their territory. Arrangements for such participation of representatives of third countries or international organisations and the conditions therefore shall be laid down in the relevant agreements and shall comply with the rules of procedure of the Security Accreditation Board.

Article 39

Voting rules of the Security Accreditation Board

If consensus according to the general principles referred to in Article 36 cannot be reached, the Security Accreditation Board shall take decisions on the basis of qualified majority voting, in accordance with Article 16 of the Treaty on European Union. The representative of the Commission and the representative of the High Representative shall not vote. The Chairperson of the Security Accreditation Board shall sign, on behalf of the Security Accreditation Board, the decisions adopted by the Security Accreditation Board.

Article 40

Communication and impact of decisions of the Security Accreditation Board

1.  The decisions of the Security Accreditation Board shall be addressed to the Commission.

2.  The Commission shall keep the Security Accreditation Board continuously informed of the impact of any decisions envisaged by the Security Accreditation Board on the proper conduct of the components of the Programme, and of the implementation of residual risk treatment plans. The Security Accreditation Board shall take note of any such information from the Commission.

3.  The Commission shall keep the European Parliament and the Council informed, without delay, of the impact of the adoption of the security accreditation decisions on the proper conduct of the components of the Programme. If the Commission considers that a decision taken by the Security Accreditation Board may have a significant effect on the proper conduct of these components, for example in terms of costs, schedule or performance, it shall immediately inform the European Parliament and the Council.

4.  The Administrative Board shall be kept periodically informed of the evolution of the work of the Security Accreditation Board.

5.  The timetable for the work of the Security Accreditation Board shall not hamper the timetable of activities provided in the work programme referred to in Article 100.

Article 41

Role of the Member States in security accreditation

Member States shall:

(a)  transmit to the Security Accreditation Board all information they consider relevant for the purposes of security accreditation;

(b)  permit duly authorised persons appointed by the Security Accreditation Board, in agreement with and under the supervision of national entities competent in security matters, to have access to any information and to any areas and/or sites related to the security of systems falling within their jurisdiction, in accordance with their national laws and regulations, and without any discrimination on ground of nationality of nationals of Member States, including for the purposes of security inspections, audits and tests as decided by the Security Accreditation Board and of the security risk monitoring process referred to in Article 36(h). These audits and tests shall be performed in accordance with the following principles:

i)  the importance of security and effective risk management within the entities inspected shall be emphasised;

ii)  countermeasures to mitigate the specific impact of loss of confidentiality, integrity or availability of classified information shall be recommended;

(c)  each be responsible for devising a template for access control, which is to outline or list the areas/sites to be accredited, and which shall be agreed in advance between the Member States and the Security Accreditation Board, thereby ensuring that the same level of access control is being provided by all Member States;

(d)  be responsible, at local level, for the accreditation of the security of sites that are located within their territory and form part of the security accreditation area for the components of the Programme, and report, to this end, to the Security Accreditation Board.

CHAPTER III

Protection of classified information

Article 42

Protection of ▌ classified information

Within the scope of this Regulation:

(a)  the exchange of ▌classified information related to the Programme shall be subject to the existence of an international agreement between the Union and a third country or international organisation on the exchange of classified information or, where applicable, an arrangement entered into by the competent Union Institution or body and the relevant authorities of a third country or international organisation on the exchange of classified information, and to the conditions laid down therein;

(c)  natural persons resident in and legal persons established in third countries may deal with European Union classified information regarding the Programme only where they are subject, in those countries, to security regulations ensuring a degree of protection at least equivalent to that provided by the Commission's rules on security set out in Commission Decision (EU, Euratom) 2015/444 and by the security rules of the Council set out in the Annexes to Decision 2013/488/EU. The equivalence of the security regulations applied in a third country or international organisation shall be defined in a security of information agreement, including industrial security matters if relevant, concluded between the Union and that third country or international organisation in accordance with the procedure provided for in Article 218 TFEU and taking into account Article 13 of Decision 2013/488/EU;

(d)  without prejudice to Article 13 of Decision 2013/488/EU and to the rules governing the field of industrial security as set out in Commission Decision (EU, Euratom) 2015/444, a natural person or legal person, third country or international organisation may be given access to European Union classified information where deemed necessary on a case-by-case basis, according to the nature and content of such information, the recipient's need-to-know and the degree of advantage to the Union.

TITLE VI

Galileo and EGNOS

Article 43

Eligible actions

The exploitation of Galileo and EGNOS shall cover the following eligible actions:

(a)  the management, operation, maintenance, continuous improvement, evolution and protection of the space-based infrastructure, including upgrades and obsolescence management;

(b)  the management, operation, maintenance, continuous improvement, evolution and protection of the ground-based infrastructure, in particular ground based centres and stations referred to in Decision (EU) 2016/413 or (EU) 2017/1406, networks, including upgrades and obsolescence management;

(c)  the development of future generations of the systems and the evolution of the services provided by Galileo and EGNOS, without prejudice to future decisions on the Union financial perspectives, including by taking into account the needs of relevant stakeholders;

(ca)  support the development of Galileo and EGNOS downstream applications and the development and evolution of fundamental technological elements, such as Galileo-enabled chipsets and receivers;

(d)  the support of certification and standardisation activities related to Galileo and EGNOS, in particular in the transport sector;

(e)  the continuous provision ▌ of the services provided by Galileo and EGNOS and, in complementarity with Member States and private sector initiatives, the market development of those services, in particular, in order to maximise the socio-economic benefits referred to in Article 4(1);

(f)  cooperation with other regional or global satellite navigation systems, including to facilitate compatibility and interoperability;

(g)  ▌ elements to monitor the reliability of the systems and their exploitation, and the performance of the services;

(h)  ▌ activities related to the provision of services and to the coordination of the extension of their coverage.

Article 44

Services provided by Galileo

1.  The services provided by Galileo shall comprise:

(a)  a Galileo open service (GOS), which shall be free of charge for users and provides positioning and synchronisation information intended mainly for high-volume satellite navigation applications for use by consumers;

(b)  a high-accuracy service (HAS), which shall be free of charge for users and shall provide, through additional data disseminated in a supplementary frequency band, high-accuracy positioning and synchronisation information intended mainly for satellite navigation applications for professional or commercial use;

(c)  a signal authentication service (SAS), based on the encrypted codes contained in the signals, intended mainly for satellite navigation applications for professional or commercial use;

(d)  a public regulated service (PRS), which shall be restricted to government-authorised users ▌, for sensitive applications which require a high level of service continuity, including in the area of security and defence, using strong, encrypted signals; it shall be free of charge for the Member States, the Council, the Commission, EEAS and, where appropriate, duly authorised Union agencies; the question of whether to charge the other PRS participants referred to in Article 2 of Decision No 1104/2011/EU shall be assessed on a case-by-case basis and appropriate provisions shall be specified in the agreements concluded pursuant to Article 3(5) of that Decision; access to PRS shall be regulated in accordance with Decision 1104/2011/EU applicable to the Member States, the Council, the Commission, the EEAS and Union agencies;

(e)  an emergency service (ES), which shall be free of charge for users, and broadcast, through emitting signals, warnings regarding natural disasters or other emergencies in particular areas; it shall be provided in cooperation with Member States national civil protection authorities, where appropriate;

(f)  a timing service (TS), which is free of charge to the user and provides an accurate and robust reference time as well as realization of the coordinated universal time, facilitating the development of timing applications based on Galileo and the use in critical applications.

2.  Galileo shall also contribute to:

(a)  the search and rescue support service (SAR) of the COSPAS-SARSAT system by detecting distress signals transmitted by beacons and relaying messages to them via a ‘return link’;

(b)  integrity-monitoring services standardized at the Union or international level for use by safety-of-life services, on the basis the signals of Galileo open service and in combination with EGNOS and other satellite navigation systems;

(c)  space weather information via the GNSS Service Centre(26) and early warning services provided via the Galileo ground-based infrastructure, intended mainly to reduce the potential risks to users of the services provided by Galileo and other GNSSs related to space ▌.

Article 45

Services provided by EGNOS

1.  The services provided by EGNOS shall comprise:

(a)  an EGNOS open service (EOS), which shall be free of charge for the users, and shall provide positioning and synchronisation information intended mainly for high-volume satellite navigation applications for use by consumers;

(b)  EGNOS data access service (EDAS), which shall be free of charge for users and shall provide positioning and synchronisation information intended mainly for satellite navigation applications for professional or commercial use, offering improved performance and data with greater added value than those obtained through the EOS;

(c)  a safety-of-life (SoL) service, which shall be free of direct user charges and shall provide positioning and time synchronisation information with a high level of continuity, availability and accuracy, including an integrity message alerting users to any failure in, or out-of-tolerance signals emitted by, Galileo and other GNSSs which it augments in the coverage area, intended mainly for users for whom safety is essential, in particular in the sector of civil aviation for the purpose of air navigation services, according to ICAO standards, or other transport sectors.

2.  The services referred to in paragraph 1 shall be provided as a priority on the territory of all Member States geographically located in Europe, including for this purpose Cyprus, the Azores, the Canary Islands and Madeira, by the end of 2026.

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