(1)

The Treaty on the Functioning of the European Union (TFEU) provides for the establishment of an internal market and the institution of a system ensuring that competition in the internal market is not distorted. The establishment of common rules and practices in the Member States relating to the development of a framework for data governance should contribute to the achievement of those objectives, while fully respecting fundamental rights. It should also guarantee the strengthening of the open strategic autonomy of the Union while fostering international free flow of data.

(2)

Over the last decade, digital technologies have transformed the economy and society, affecting all sectors of activity and daily life. Data is at the centre of that transformation: data-driven innovation will bring enormous benefits to both Union citizens and the economy, for example by improving and personalising medicine, providing new mobility, and contributing to the communication of the Commission of 11 December 2019 on the European Green Deal. In order to make the data-driven economy inclusive for all Union citizens, particular attention must be paid to reducing the digital divide, boosting the participation of women in the data economy and fostering cutting-edge European expertise in the technology sector. The data economy has to be built in a way that enables undertakings, in particular micro, small and medium-sized enterprises (SMEs), as defined in the Annex to Commission Recommendation 2003/361/EC (3), and start-ups to thrive, ensuring data access neutrality and data portability and interoperability, and avoiding lock-in effects. In its communication of 19 February 2020 on a European strategy for data (the ‘European strategy for data’), the Commission described the vision of a common European data space, meaning an internal market for data in which data could be used irrespective of its physical storage location in the Union in compliance with applicable law, which, inter alia, could be pivotal for the rapid development of artificial intelligence technologies.

The Commission also called for the free and safe flow of data with third countries, subject to exceptions and restrictions for public security, public order and other legitimate public policy objectives of the Union, in line with international obligations, including on fundamental rights. In order to turn that vision into reality, the Commission proposed establishing domain-specific common European data spaces for data sharing and data pooling. As proposed in the European strategy for data, such common European data spaces could cover areas such as health, mobility, manufacturing, financial services, energy or agriculture, or a combination of such areas, for example energy and climate, as well as thematic areas such as the European Green Deal or European data spaces for public administration or skills. Common European data spaces should make data findable, accessible, interoperable and re-usable (the ‘FAIR data principles’), while ensuring a high level of cybersecurity. Where there is a level playing field in the data economy, undertakings compete on quality of services, and not on the amount of data they control. For the purposes of the design, creation and maintenance of the level playing field in the data economy, sound governance is needed in which relevant stakeholders of a common European data space need to participate and be represented.

(3)

It is necessary to improve the conditions for data sharing in the internal market, by creating a harmonised framework for data exchanges and laying down certain basic requirements for data governance, paying specific attention to facilitating cooperation between Member States. This Regulation should aim to develop further the borderless digital internal market and a human-centric, trustworthy and secure data society and economy. Sector-specific Union law can develop, adapt and propose new and complementary elements, depending on the specificities of the sector, such as the Union law envisaged on the European health data space and on access to vehicle data. Moreover, certain sectors of the economy are already regulated by sector-specific Union law, which includes rules relating to the sharing of or access to data across borders or across the Union, for example Directive 2011/24/EU of the European Parliament and of the Council (4) in the context of the European health data space, and relevant legislative acts in the field of transport, such as Regulations (EU) 2019/1239 (5) and (EU) 2020/1056 (6) and Directive 2010/40/EU (7) of the European Parliament and of the Council in the context of the European mobility data space.

This Regulation should therefore be without prejudice to Regulations (EC) No 223/2009 (8), (EU) 2018/858 (9) and (EU) 2018/1807 (10) as well as Directives 2000/31/EC (11), 2001/29/EC (12), 2004/48/EC (13), 2007/2/EC (14), 2010/40/EU, (EU) 2015/849 (15), (EU) 2016/943 (16), (EU) 2017/1132 (17), (EU) 2019/790 (18) and (EU) 2019/1024 (19) of the European Parliament and of the Council and any other sector-specific Union law that regulates access to and re-use of data. This Regulation should be without prejudice to Union and national law on the access to and use of data for the purpose of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, as well as international cooperation in that context.

This Regulation should be without prejudice to the competences of the Member States with regard to their activities concerning public security, defence and national security. The re-use of data protected for such reasons and held by public sector bodies, including data from procurement procedures falling within the scope of Directive 2009/81/EC of the European Parliament and of the Council (20), should not be covered by this Regulation. A horizontal regime for the re-use of certain categories of protected data held by public sector bodies, the provision of data intermediation services and of services based on data altruism in the Union should be established. Specific characteristics of different sectors may require the design of sectoral data-based systems, while building on the requirements of this Regulation. Data intermediation services providers that meet the requirements laid down in this Regulation should be able to use the label ‘data intermediation services provider recognised in the Union’. Legal persons that seek to support objectives of general interest by making available relevant data based on data altruism at scale and that meet the requirements laid down in this Regulation should be able to register as and use the label ‘data altruism organisation recognised in the Union’. Where sector-specific Union or national law requires public sector bodies, such data intermediation services providers or such legal persons (recognised data altruism organisations) to comply with specific additional technical, administrative or organisational requirements, including through an authorisation or certification regime, those provisions of that sector-specific Union or national law should also apply.

(4)

This Regulation should be without prejudice to Regulations (EU) 2016/679 (21) and (EU) 2018/1725 (22) of the European Parliament and of the Council and to Directives 2002/58/EC (23) and (EU) 2016/680 (24) of the European Parliament and of the Council and the corresponding provisions of national law, including where personal and non-personal data in a data set are inextricably linked. In particular, this Regulation should not be read as creating a new legal basis for the processing of personal data for any of the regulated activities, or as amending the information requirements laid down in Regulation (EU) 2016/679. The implementation of this Regulation should not prevent cross-border transfers of data in accordance with Chapter V of Regulation (EU) 2016/679. In the event of a conflict between this Regulation and Union law on the protection of personal data or national law adopted in accordance with such Union law, the relevant Union or national law on the protection of personal data should prevail. It should be possible to consider data protection authorities to be competent authorities under this Regulation. Where other authorities function as competent authorities under this Regulation, they should do so without prejudice to the supervisory powers and competences of data protection authorities under Regulation (EU) 2016/679.

(5)

Action at Union level is necessary to increase trust in data sharing by establishing appropriate mechanisms for control by data subjects and data holders over data that relates to them, and in order to address other barriers to a well-functioning and competitive data-driven economy. That action should be without prejudice to obligations and commitments in the international trade agreements concluded by the Union. A Union-wide governance framework should have the objective of building trust among individuals and undertakings in relation to data access, control, sharing, use and re-use, in particular by establishing appropriate mechanisms for data subjects to know and meaningfully exercise their rights, as well as with regard to the re-use of certain types of data held by the public sector bodies, the provision of services by data intermediation services providers to data subjects, data holders and data users, as well as the collection and processing of data made available for altruistic purposes by natural and legal persons. In particular, more transparency regarding the purpose of data use and conditions under which data is stored by undertakings can help increase trust.

(6)

The idea that data that has been generated or collected by public sector bodies or other entities at the expense of public budgets should benefit society has been part of Union policy for a long time. Directive (EU) 2019/1024 and sector-specific Union law ensure that the public sector bodies make more of the data they produce easily available for use and re-use. However, certain categories of data, such as commercially confidential data, data that are subject to statistical confidentiality and data protected by intellectual property rights of third parties, including trade secrets and personal data, in public databases are often not made available, not even for research or innovative activities in the public interest, despite such availability being possible in accordance with the applicable Union law, in particular Regulation (EU) 2016/679 and Directives 2002/58/EC and (EU) 2016/680. Due to the sensitivity of such data, certain technical and legal procedural requirements must be met before they are made available, not least in order to ensure the respect of rights others have over such data or to limit the negative impact on fundamental rights, the principle of non-discrimination and data protection. The fulfilment of such requirements is usually time- and knowledge-intensive. This has led to the insufficient use of such data. While some Member States are establishing structures, processes or legislation to facilitate that type of re-use, this is not the case across the Union. In order to facilitate the use of data for European research and innovation by private and public entities, clear conditions for access to and use of such data are needed across the Union.

(7)

There are techniques enabling analyses on databases that contain personal data, such as anonymisation, differential privacy, generalisation, suppression and randomisation, the use of synthetic data or similar methods and other state-of-the-art privacy-preserving methods that could contribute to a more privacy-friendly processing of data. Member States should provide support to public sector bodies to make optimal use of such techniques, thus making as much data as possible available for sharing. The application of such techniques, together with comprehensive data protection impact assessments and other safeguards, can contribute to more safety in the use and re-use of personal data and should ensure the safe re-use of commercially confidential business data for research, innovation and statistical purposes. In many cases the application of such techniques, impact assessments and other safeguards implies that data can be used and re-used only in a secure processing environment that is provided or controlled by the public sector body. There is experience at Union level with such secure processing environments that are used for research on statistical microdata on the basis of Commission Regulation (EU) No 557/2013 (25). In general, insofar as personal data are concerned, the processing of personal data should be based upon one or more of the legal bases for processing provided in Articles 6 and 9 of Regulation (EU) 2016/679.

(8)

In accordance with Regulation (EU) 2016/679, the principles of data protection should not apply to anonymous information, namely information which does not relate to an identified or identifiable natural person, or to personal data rendered anonymous in such a manner that the data subject is not or no longer identifiable. Re-identification of data subjects from anonymised datasets should be prohibited. This should not prejudice the possibility to conduct research into anonymisation techniques, in particular for the purpose of ensuring information security, improving existing anonymisation techniques and contributing to the overall robustness of anonymisation, undertaken in accordance with Regulation (EU) 2016/679.

(9)

In order to facilitate the protection of personal data and confidential data and to speed up the process of making such data available for re-use under this Regulation, Member States should encourage public sector bodies to create and make available data in accordance with the principle of ‘open by design and by default’ referred to in Article 5(2) of Directive (EU) 2019/1024 and to promote the creation and the procurement of data in formats and structures that facilitate anonymisation in that regard.

(10)

The categories of data held by public sector bodies which should be subject to re-use under this Regulation fall outside the scope of Directive (EU) 2019/1024 that excludes data which is not accessible due to commercial and statistical confidentiality and data that is included in works or other subject matter over which third parties have intellectual property rights. Commercially confidential data includes data protected by trade secrets, protected know-how and any other information the undue disclosure of which would have an impact on the market position or financial health of the undertaking. This Regulation should apply to personal data that fall outside the scope of Directive (EU) 2019/1024 insofar as the access regime excludes or restricts access to such data for reasons of data protection, privacy and the integrity of the individual, in particular in accordance with data protection rules. The re-use of data, which may contain trade secrets, should take place without prejudice to Directive (EU) 2016/943, which sets out the framework for the lawful acquisition, use or disclosure of trade secrets.

(11)

This Regulation should not create an obligation to allow the re-use of data held by public sector bodies. In particular, each Member State should therefore be able to decide whether data is made accessible for re-use, also in terms of the purposes and scope of such access. This Regulation should complement and be without prejudice to more specific obligations on public sector bodies to allow re-use of data laid down in sector-specific Union or national law. Public access to official documents may be considered to be in the public interest. Taking into account the role of public access to official documents and transparency in a democratic society, this Regulation should also be without prejudice to Union or national law on granting access to and disclosing official documents. Access to official documents may in particular be granted in accordance with national law without imposing specific conditions or by imposing specific conditions that are not provided by this Regulation.

(12)

The re-use regime provided for in this Regulation should apply to data the supply of which forms part of the public tasks of the public sector bodies concerned under law or other binding rules in the Member States. In the absence of such rules, the public tasks should be defined in accordance with common administrative practice in the Member States, provided that the scope of the public tasks is transparent and subject to review. The public tasks could be defined generally or on a case-by-case basis for individual public sector bodies. As public undertakings are not covered by the definition of public sector body, the data held by public undertakings should not be covered by this Regulation. Data held by cultural establishments, such as libraries, archives and museums as well as orchestras, operas, ballets and theatres, and by educational establishments should not be covered by this Regulation since the works and other documents they hold are predominantly covered by third party intellectual property rights. Research-performing organisations and research-funding organisations could also be organised as public sector bodies or bodies governed by public law.

This Regulation should apply to such hybrid organisations only in their capacity as research-performing organisations. If a research-performing organisation holds data as a part of a specific public-private association with private sector organisations or other public sector bodies, bodies governed by public law or hybrid research-performing organisations, i.e. organised as either public sector bodies or public undertakings, with the main purpose of pursuing research, those data should also not be covered by this Regulation. Where relevant, Member States should be able to apply this Regulation to public undertakings or private undertakings that exercise public sector duties or provide services of general interest. The exchange of data, purely in pursuit of their public tasks, among public sector bodies in the Union or between public sector bodies in the Union and public sector bodies in third countries or international organisations, as well as the exchange of data between researchers for non-commercial scientific research purposes, should not be subject to the provisions of this Regulation concerning the re-use of certain categories of protected data held by public sector bodies.

(13)

Public sector bodies should comply with competition law when establishing the principles for re-use of data they hold, avoiding the conclusion of agreements which might have as their objective or effect the creation of exclusive rights for the re-use of certain data. Such agreements should be possible only where justified and necessary for the provision of a service or the supply of a product in the general interest. This may be the case where the exclusive use of the data is the only way to maximise the societal benefits of the data in question, for example where there is only one entity (which has specialised in the processing of a specific dataset) capable of providing the service or supplying the product which allows the public sector body to provide a service or supply a product in the general interest. Such arrangements should, however, be concluded in accordance with applicable Union or national law and be subject to regular review based on a market analysis in order to ascertain whether such exclusivity continues to be necessary. In addition, such arrangements should comply with the relevant State aid rules, as appropriate, and should be concluded for a limited duration which should not exceed 12 months. In order to ensure transparency, such exclusive agreements should be published online, in a form that complies with relevant Union law on public procurement. Where an exclusive right to re-use data does not comply with this Regulation, that exclusive right should be invalid.

(14)

Prohibited exclusive agreements and other practices or arrangements pertaining to the re-use of data held by public sector bodies which do not expressly grant exclusive rights but which can reasonably be expected to restrict the availability of data for re-use that have been concluded or were already in place before the date of entry into force of this Regulation should not be renewed after the expiry of their term. In the case of indefinite or longer-term agreements, they should be terminated within 30 months of the date of entry into force of this Regulation.

(15)

This Regulation should lay down conditions for re-use of protected data that apply to public sector bodies designated as competent under national law to grant or refuse access for re-use, and which are without prejudice to rights or obligations concerning access to such data. Those conditions should be non-discriminatory, transparent, proportionate and objectively justified, while not restricting competition, with a specific focus on promoting access to such data by SMEs and start-ups. The conditions for re-use should be designed in a manner promoting scientific research so that, for example, privileging scientific research should, as a rule, be considered to be non-discriminatory. Public sector bodies allowing re-use should have in place the technical means necessary to ensure the protection of rights and interests of third parties and should be empowered to request the necessary information from the re-user. Conditions attached to the re-use of data should be limited to what is necessary to preserve the rights and interests of third parties in the data and the integrity of the information technology and communication systems of the public sector bodies. Public sector bodies should apply conditions which best serve the interests of the re-user without leading to a disproportionate burden on the public sector bodies. Conditions attached to the re-use of data should be designed to ensure effective safeguards with regard to the protection of personal data. Before transmission, personal data should be anonymised, in order not to allow the identification of the data subjects, and data containing commercially confidential information should be modified in such a way that no confidential information is disclosed. Where the provision of anonymised or modified data would not respond to the needs of the re-user, subject to fulfilling any requirements to carry out a data protection impact assessment and consult the supervisory authority pursuant to Articles 35 and 36 of Regulation (EU) 2016/679 and where the risks to the rights and interests of data subjects have been found to be minimal, on-premise or remote re-use of the data within a secure processing environment could be allowed.

This could be a suitable arrangement for the re-use of pseudonymised data. Data analyses in such secure processing environments should be supervised by the public sector body, so as to protect the rights and interests of third parties. In particular, personal data should be transmitted to a third party for re-use only where a legal basis under data protection law allows such transmission. Non-personal data should be transmitted only where there is no reason to believe that the combination of non-personal data sets would lead to the identification of data subjects. This should also apply to pseudonymised data which retain their status as personal data. In the event of the reidentification of data subjects, an obligation to notify such a data breach to the public sector body should apply in addition to an obligation to notify such a data breach to a supervisory authority and to the data subject in accordance with Regulation (EU) 2016/679. Where relevant, the public sector bodies should facilitate the re-use of data on the basis of the consent of data subjects or the permission of data holders on the re-use of data pertaining to them through adequate technical means. In that respect, the public sector body should make best efforts to provide assistance to potential re-users in seeking such consent or permission by establishing technical mechanisms that permit transmitting requests for consent or permission from re-users, where practically feasible. No contact information should be given that allows re-users to contact data subjects or data holders directly. Where the public sector body transmits a request for consent or permission, it should ensure that the data subject or data holder is clearly informed of the possibility to refuse consent or permission.

(16)

In order to facilitate and encourage the use of data held by public sector bodies for the purposes of scientific research, public sector bodies are encouraged to develop a harmonised approach and harmonised processes to make that data easily accessible for the purposes of scientific research in the public interest. That could mean, inter alia, creating streamlined administrative procedures, standardised data formatting, informative metadata on the methodological and data collection choices and standardised data fields that enable the easy joining of data sets from different public sector data sources where relevant for the purposes of analysis. The objective of those practices should be to promote the publicly funded and produced data for the purposes of scientific research in accordance with the principle of ‘as open as possible, as closed as necessary’.

(17)

The intellectual property rights of third parties should not be affected by this Regulation. This Regulation should neither affect the existence or ownership of intellectual property rights of public sector bodies nor limit the exercise of those rights in any way. The obligations imposed in accordance with this Regulation should apply only insofar as they are compatible with international agreements on the protection of intellectual property rights, in particular the Berne Convention for the Protection of Literary and Artistic Works (Berne Convention), the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS Agreement) and the World Intellectual Property Organization Copyright Treaty (WCT), and Union or national intellectual property law. Public sector bodies should, however, exercise their copyright in a way that facilitates re-use.

(18)

Data subject to intellectual property rights as well as trade secrets should be transmitted to a third party only where such transmission is lawful by virtue of Union or national law or with the agreement of the rights holder. Where public sector bodies are holders of the right of the maker of a database provided for in Article 7(1) of Directive 96/9/EC of the European Parliament and of the Council (26) they should not exercise that right in order to prevent the re-use of data or to restrict re-use beyond the limits set by this Regulation.

(19)

Undertakings and data subjects should be able to have confidence in the fact that the re-use of certain categories of protected data which are held by the public sector bodies will take place in a manner that respects their rights and interests. Additional safeguards should therefore be put in place for situations in which the re-use of such public sector data takes place on the basis of a processing of the data outside the public sector, such as a requirement that public sector bodies ensure that the rights and interests of natural and legal persons are fully protected, in particular with regard to personal data, commercially sensitive data and intellectual property rights, in all cases, including where such data is transferred to third countries. Public sector bodies should not allow the re-use of information stored in e-health applications by insurance undertakings or any other service provider for the purpose of discriminating in the setting of prices, as this would run counter to the fundamental right of access to health.

(20)

Furthermore, in order to preserve fair competition and the open market economy it is of the utmost importance to safeguard protected data of non-personal nature, in particular trade secrets, but also non-personal data representing content protected by intellectual property rights from unlawful access that may lead to intellectual property theft or industrial espionage. In order to ensure the protection of the rights or interests of data holders, it should be possible to transfer non-personal data which is to be protected from unlawful or unauthorised access in accordance with Union or national law and which is held by public sector bodies to third countries, but only where appropriate safeguards for the use of data are provided. Such appropriate safeguards should include a requirement that the public sector body transmit protected data to a re-user only if that re-user makes contractual commitments in the interest of the protection of the data. A re-user that intends to transfer the protected data to a third country should comply with the obligations laid down in this Regulation even after the data has been transferred to the third country. To ensure the proper enforcement of such obligations, the re-user should also accept the jurisdiction of the Member State of the public sector body that allowed the re-use for the judicial settlement of disputes.

(21)

Appropriate safeguards should also be considered to be implemented where, in the third country to which non-personal data is being transferred, there are equivalent measures in place which ensure that data benefit from a level of protection similar to that applicable by means of Union law, in particular with regard to the protection of trade secrets and intellectual property rights. To that end, the Commission should be able to declare, by means of implementing acts, where justified because of the substantial number of requests across the Union concerning the re-use of non-personal data in specific third countries, that a third country provides a level of protection that is essentially equivalent to that provided by Union law. The Commission should assess the necessity of such implementing acts on the basis of information provided by the Member States through the European Data Innovation Board. Such implementing acts would reassure public sector bodies that re-use of data held by public sector bodies in the third country concerned would not compromise the protected nature of that data. The assessment of the level of protection afforded in the third country concerned should, in particular, take into consideration the relevant general and sectoral law, including on public security, defence, national security and criminal law, concerning access to and protection of non-personal data, any access by the public sector bodies of that third country to the data transferred, the existence and effective functioning of one or more independent supervisory authorities in the third country with responsibility for ensuring and enforcing compliance with the legal regime ensuring access to such data, the third country’s international commitments regarding the protection of data, or other obligations arising from legally binding conventions or instruments as well as from its participation in multilateral or regional systems.

The existence of effective legal remedies for data holders, public sector bodies or data intermediation services providers in the third country concerned is of particular importance in the context of the transfer of non-personal data to that third country. Such safeguards should therefore include the availability of enforceable rights and of effective legal remedies. Such implementing acts should be without prejudice to any legal obligation or contractual arrangements already undertaken by a re-user in the interest of the protection of non-personal data, in particular industrial data, and to the right of public sector bodies to oblige re-users to comply with conditions for re-use, in accordance with this Regulation.

(22)

Some third countries adopt laws, regulations and other legal acts which aim to directly transfer or provide governmental access to non-personal data in the Union under the control of natural and legal persons under the jurisdiction of the Member States. Decisions and judgments of third-country courts or tribunals or decisions of third-country administrative authorities requiring such transfer of or access to non-personal data should be enforceable where they are based on an international agreement, such as a mutual legal assistance treaty, in force between the requesting third country and the Union or a Member State. In some cases, situations may arise where the obligation to transfer or provide access to non-personal data arising from a third country law conflicts with a competing obligation to protect such data under Union or national law, in particular with regard to the protection of the fundamental rights of the individual or of the fundamental interests of a Member State related to national security or defence, as well as the protection of commercially sensitive data and the protection of intellectual property rights, including contractual undertakings regarding confidentiality in accordance with such law. In the absence of international agreements regulating such matters, the transfer of or access to non-personal data should be allowed only if, in particular, it has been verified that the third-country’s legal system requires the reasons and proportionality of the decision or judgment to be set out, that the decision or judgment is specific in character, and that the reasoned objection of the addressee is subject to a review by a competent third-country court or tribunal, which is empowered to take duly into account the relevant legal interests of the provider of such data.

Moreover, public sector bodies, natural or legal persons to which the right to re-use data was granted, data intermediation services providers and recognised data altruism organisations should ensure, where they sign contractual agreements with other private parties, that non-personal data held in the Union are accessed in or transferred to third countries only in accordance with Union law or the national law of the relevant Member State.

(23)

To foster further trust in the data economy of the Union, it is essential that the safeguards in relation to Union citizens, the public sector and undertakings that ensure control over their strategic and sensitive data are implemented and that Union law, values and standards are upheld in terms of, but not limited to, security, data protection and consumer protection. In order to prevent unlawful access to non-personal data, public sector bodies, natural or legal persons to which the right to re-use data was granted, data intermediation services providers and recognised data altruism organisations should take all reasonable measures to prevent access to the systems where non-personal data is stored, including encryption of data or corporate policies. To that end, it should be ensured that public sector bodies, natural or legal persons to which the right to re-use data was granted, data intermediation services providers and recognised data altruism organisations adhere to all relevant technical standards, codes of conduct and certifications at Union level.

(24)

In order to build trust in re-use mechanisms, it may be necessary to attach stricter conditions for certain types of non-personal data that may be identified as highly sensitive in future specific Union legislative acts, with regard to the transfer to third countries, if such transfer could jeopardise Union public policy objectives, in line with international commitments. For example, in the health domain, certain datasets held by actors in the public health system, such as public hospitals, could be identified as highly sensitive health data. Other relevant sectors include transport, energy, environment and finance. In order to ensure harmonised practices across the Union, such types of highly sensitive non-personal public data should be defined by Union law, for example in the context of the European health data space or other sectoral law. Those conditions attached to the transfer of such data to third countries should be laid down in delegated acts. Conditions should be proportionate, non-discriminatory and necessary to protect legitimate Union public policy objectives identified, such as the protection of public health, safety, the environment, public morality, consumer protection, privacy and personal data protection. The conditions should correspond to the risks identified in relation to the sensitivity of such data, including in terms of the risk of the re-identification of individuals. Such conditions could include terms applicable for the transfer or technical arrangements, such as the requirement to use a secure processing environment, limitations with regard to the re-use of data in third countries or categories of persons entitled to transfer such data to third countries or to access the data in the third country. In exceptional cases such conditions could also include restrictions to the transfer of the data to third countries to protect the public interest.

(25)

Public sector bodies should be able to charge fees for the re-use of data but should also be able to allow re-use at a discounted fee or free of charge, for example for certain categories of re-use such as non-commercial re-use for scientific research purposes, or re-use by SMEs and start-ups, civil society and educational establishments, so as to provide incentives for such re-use in order to stimulate research and innovation and support undertakings that are an important source of innovation and typically find it more difficult to collect relevant data themselves, in accordance with State aid rules. In that specific context, scientific research purposes should be understood to include any type of research-related purpose regardless of the organisational or financial structure of the research institution in question, with the exception of research that is being conducted by an undertaking with the aim of developing, enhancing or optimising products or services. Such fees should be transparent, non-discriminatory and limited to the necessary costs incurred and should not restrict competition. A list of categories of re-users to which a discounted fee or no charge applies, together with the criteria used to establish that list, should be made public.

(26)

In order to provide incentives for the re-use of specific categories of data held by public sector bodies, Member States should establish a single information point to act as an interface for re-users that seek to re-use that data. It should have a cross-sector remit, and should complement, if necessary, arrangements at the sectoral level. The single information point should be able to rely on automated means where it transmits enquiries or requests for re-use. Sufficient human oversight should be ensured in the transmission process. For that purpose existing practical arrangements such as open data portals could be used. The single information point should have an asset list containing an overview of all available data resources including, where relevant, those data resources that are available at sectoral, regional or local information points, with relevant information describing the available data. In addition, Member States should designate, establish or facilitate the establishment of competent bodies to support the activities of public sector bodies allowing re-use of certain categories of protected data. Their tasks may include granting access to data, where mandated under sectoral Union or national law. Those competent bodies should provide assistance to public sector bodies with state-of-the-art techniques, including on how to best structure and store data to make data easily accessible, in particular through application programming interfaces, as well as make data interoperable, transferable and searchable, taking into account best practices for data processing, as well as any existing regulatory and technical standards and secure data processing environments, which allow data analysis in a manner that preserves the privacy of the information.

The competent bodies should act in accordance with the instructions received from the public sector body. Such an assistance structure could assist the data subjects and data holders with management of the consent or permission for re-use, including consent and permission to certain areas of scientific research where in keeping with recognised ethical standards for scientific research. The competent bodies should not have a supervisory function, which is reserved for supervisory authorities under Regulation (EU) 2016/679. Without prejudice to the supervisory powers of data protection authorities, data processing should be carried out under the responsibility of the public sector body responsible for the register containing the data, which remains a data controller as defined in Regulation (EU) 2016/679 insofar as personal data are concerned. Member States should be able to have one or more competent bodies, which could act in different sectors. The internal services of public sector bodies could also act as competent bodies. A competent body could be a public sector body assisting other public sector bodies in allowing re-use of data, where relevant, or a public sector body allowing re-use itself. Assisting other public sector bodies should entail informing them, upon request, about best practices on how to fulfil the requirements laid down in this Regulation such as the technical means to make a secure processing environment available or the technical means to ensure privacy and confidentiality where access to re-use of data within the scope of this Regulation is provided.

(27)

Data intermediation services are expected to play a key role in the data economy, in particular in supporting and promoting voluntary data sharing practices between undertakings or facilitating data sharing in the context of obligations set by Union or national law. They could become a tool to facilitate the exchange of substantial amounts of relevant data. Data intermediation services providers, which may include public sector bodies, that offer services that connect the different actors have the potential to contribute to the efficient pooling of data as well as to the facilitation of bilateral data sharing. Specialised data intermediation services that are independent from data subjects, data holders and data users could have a facilitating role in the emergence of new data-driven ecosystems independent from any player with a significant degree of market power, while allowing non-discriminatory access to the data economy for undertakings of all sizes, in particular SMEs and start-ups with limited financial, legal or administrative means. This will be particularly important in the context of the establishment of common European data spaces, namely purpose- or sector-specific or cross-sectoral interoperable frameworks of common standards and practices to share or jointly process data for, inter alia, the development of new products and services, scientific research or civil society initiatives. Data intermediation services could include bilateral or multilateral sharing of data or the creation of platforms or databases enabling the sharing or joint use of data, as well as the establishment of specific infrastructure for the interconnection of data subjects and data holders with data users.

(28)

This Regulation should cover services which aim to establish commercial relationships for the purposes of data sharing between an undetermined number of data subjects and data holders on the one hand and data users on the other, through technical, legal or other means, including for the purpose of exercising the rights of data subjects in relation to personal data. Where undertakings or other entities offer multiple data-related services, only the activities which directly concern the provision of data intermediation services should be covered by this Regulation. The provision of cloud storage, analytics, data sharing software, web browsers, browser plug-ins or email services should not be considered to be data intermediation services within the meaning of this Regulation, provided that such services only provide technical tools for data subjects or data holders to share data with others, but the provision of such tools neither aims to establish a commercial relationship between data holders and data users nor allows the data intermediation services provider to acquire information on the establishment of commercial relationships for the purposes of data sharing. Examples of data intermediation services include data marketplaces on which undertakings could make data available to others, orchestrators of data sharing ecosystems that are open to all interested parties, for instance in the context of common European data spaces, as well as data pools established jointly by several legal or natural persons with the intention to license the use of such data pools to all interested parties in a manner that all participants that contribute to the data pools would receive a reward for their contribution.

This would exclude services that obtain data from data holders and aggregate, enrich or transform the data for the purpose of adding substantial value to it and license the use of the resulting data to data users, without establishing a commercial relationship between data holders and data users. This would also exclude services that are exclusively used by one data holder in order to enable the use of the data held by that data holder, or that are used by multiple legal persons in a closed group, including supplier or customer relationships or collaborations established by contract, in particular those that have as a main objective to ensure the functionalities of objects and devices connected to the Internet of Things.

(29)

Services that focus on the intermediation of copyright-protected content, such as online content-sharing service providers as defined in Article 2, point (6), of Directive (EU) 2019/790, should not be covered by this Regulation. Consolidated tape providers as defined in Article 2(1), point (35), of Regulation (EU) No 600/2014 of the European Parliament and of the Council (27) and account information service providers as defined in Article 4, point (19), of Directive (EU) 2015/2366 of the European Parliament and of the Council (28) should not be considered to be data intermediation services providers for the purposes of this Regulation. This Regulation should not apply to services offered by public sector bodies in order to facilitate either the re-use of protected data held by public sector bodies in accordance with this Regulation or the use of any other data, insofar as those services do not aim to establish commercial relationships. Data altruism organisations regulated by this Regulation should not be considered to be offering data intermediation services provided that those services do not establish a commercial relationship between potential data users, on the one hand, and data subjects and data holders who make data available for altruistic purposes, on the other. Other services that do not aim to establish commercial relationships, such as repositories that aim to enable the re-use of scientific research data in accordance with open access principles should not be considered to be data intermediation services within the meaning of this Regulation.

(30)

A specific category of data intermediation services includes providers of services that offer their services to data subjects. Such data intermediation services providers seek to enhance the agency of data subjects, and in particular individuals’ control over data relating to them. Such providers would assist individuals in exercising their rights under Regulation (EU) 2016/679, in particular giving and withdrawing their consent to data processing, the right of access to their own data, the right to the rectification of inaccurate personal data, the right of erasure or right ‘to be forgotten’, the right to restrict processing and the right to data portability, which allows data subjects to move their personal data from one data controller to the other. In that context, it is important that the business model of such providers ensures that there are no misaligned incentives that encourage individuals to use such services to make more data relating to them available for processing than would be in their interest. This could include advising individuals on the possible uses of their data and making due diligence checks on data users before allowing them to contact data subjects, in order to avoid fraudulent practices. In certain situations, it could be desirable to collate actual data within a personal data space so that processing can happen within that space without personal data being transmitted to third parties in order to maximise the protection of personal data and privacy. Such personal data spaces could contain static personal data such as name, address or date of birth as well as dynamic data that an individual generates through, for example, the use of an online service or an object connected to the Internet of Things. They could also be used to store verified identity information such as passport numbers or social security information, as well as credentials such as driving licences, diplomas or bank account information.

(31)

Data cooperatives seek to achieve a number of objectives, in particular to strengthen the position of individuals in making informed choices before consenting to data use, influencing the terms and conditions of data user organisations attached to data use in a manner that gives better choices to the individual members of the group or potentially finding solutions to conflicting positions of individual members of a group on how data can be used where such data relates to several data subjects within that group. In that context it is important to acknowledge that the rights under Regulation (EU) 2016/679 are personal rights of the data subject and that data subjects cannot waive such rights. Data cooperatives could also provide a useful means for one-person undertakings and SMEs which, in terms of knowledge of data sharing, are often comparable to individuals.

(32)

In order to increase trust in such data intermediation services, in particular related to the use of data and compliance with the conditions imposed by data subjects and data holders, it is necessary to create a Union-level regulatory framework which establishes highly harmonised requirements related to the trustworthy provision of such data intermediation services, and which is implemented by the competent authorities. That framework will contribute to ensuring that data subjects and data holders, as well as data users, have better control over access to and use of their data, in accordance with Union law. The Commission could also encourage and facilitate the development of codes of conduct at Union level, involving relevant stakeholders, in particular on interoperability. Both in situations where data sharing occurs in a business-to-business context and where it occurs in a business-to-consumer context, data intermediation services providers should offer a novel, ‘European’ way of data governance, by providing a separation in the data economy between data provision, intermediation and use. Data intermediation services providers could also make available specific technical infrastructure for the interconnection of data subjects and data holders with data users. In that regard, it is of particular importance to shape that infrastructure in such a way that SMEs and start-ups encounter no technical or other barriers to their participation in the data economy.

Data intermediation services providers should be allowed to offer additional specific tools and services to data holders or data subjects for the specific purpose of facilitating the exchange of data, such as temporary storage, curation, conversion, anonymisation and pseudonymisation. Those tools and services should be used only at the explicit request or approval of the data holder or data subject and third-party tools offered in that context should not use data for other purposes. At the same time, data intermediation services providers should be allowed to adapt the data exchanged in order to improve the usability of the data by the data user where the data user so desires, or to improve interoperability by, for example, converting the data into specific formats.

(33)

It is important to enable a competitive environment for data sharing. A key element by which to increase the trust and control of data holders, data subjects and data users in data intermediation services is the neutrality of data intermediation services providers with regard to the data exchanged between data holders or data subjects and data users. It is therefore necessary that data intermediation services providers act only as intermediaries in the transactions, and do not use the data exchanged for any other purpose. The commercial terms, including pricing, for the provision of data intermediation services should not be dependent on whether a potential data holder or data user is using other services, including storage, analytics, artificial intelligence or other data-based applications, provided by the same data intermediation services provider or by a related entity, and if so to what degree the data holder or data user uses such other services. This will also require structural separation between the data intermediation service and any other services provided, so as to avoid conflicts of interest. This means that the data intermediation service should be provided through a legal person that is separate from the other activities of that data intermediation services provider. However, the data intermediation services providers should be able to use the data provided by the data holder for the improvement of their data intermediation services.

Data intermediation services providers should be able to put at the disposal of data holders, data subjects or data users their own or third-party tools for the purpose of facilitating the exchange of data, for example tools for the conversion or curation of data only at the explicit request or approval of the data subject or data holder. The third-party tools offered in that context should not use data for purposes other than those related to data intermediation services. Data intermediation services providers that intermediate the exchange of data between individuals as data subjects and legal persons as data users should, in addition, bear fiduciary duty towards the individuals, to ensure that they act in the best interest of the data subjects. Questions of liability for all material and immaterial damage and detriment resulting from any conduct of the data intermediation services provider could be addressed in the relevant contract, on the basis of national liability regimes.

(34)

Data intermediation services providers should take reasonable measures to ensure interoperability within a sector and between different sectors to ensure the proper functioning of the internal market. Reasonable measures could include following the existing, commonly-used standards in the sector where the data intermediation services providers operate. The European Data Innovation Board should facilitate the emergence of additional industry standards, where necessary. Data intermediation services providers should implement in due time the measures for interoperability between the data intermediation services adopted by the European Data Innovation Board.

(35)

This Regulation should be without prejudice to the obligation of data intermediation services providers to comply with Regulation (EU) 2016/679 and the responsibility of supervisory authorities to ensure compliance with that Regulation. Where data intermediation services providers process personal data, this Regulation should not affect the protection of personal data. Where the data intermediation services providers are data controllers or processors as defined in Regulation (EU) 2016/679 they are bound by the rules of that Regulation.

(36)

Data intermediation services providers are expected to have in place procedures and measures to impose penalties for fraudulent or abusive practices in relation to parties seeking access through their data intermediation services, including measures such as the exclusion of data users that breach the terms of service or infringe existing law.

(37)

Data intermediation services providers should also take measures to ensure compliance with competition law and have procedures in place to that effect. This applies in particular in situations where data sharing enables undertakings to become aware of market strategies of their actual or potential competitors. Competitively sensitive information typically includes information on customer data, future prices, production costs, quantities, turnovers, sales or capacities.

(38)

A notification procedure for data intermediation services should be established in order to ensure that data governance within the Union is based on trustworthy exchange of data. The benefits of a trustworthy environment would be best achieved by imposing a number of requirements for the provision of data intermediation services, but without requiring any explicit decision or administrative act by the competent authority for data intermediation services for the provision of such services. The notification procedure should not impose undue obstacles for SMEs, start-ups and civil society organisations and should comply with the principle of non-discrimination.

(39)

In order to support effective cross-border provision of services, the data intermediation services provider should be requested to send a notification only to the competent authority for data intermediation services from the Member State where its main establishment is located or where its legal representative is located. Such a notification should not entail more than a mere declaration of the intention to provide such services and should be completed only by providing the information set out in this Regulation. After the relevant notification the data intermediation services provider should be able to start operating in any Member State without further notification obligations.

(40)

The notification procedure laid down in this Regulation should be without prejudice to specific additional rules for the provision of data intermediation services applicable by means of sector-specific law.

(41)

The main establishment of a data intermediation services provider in the Union should be the place of its central administration in the Union. The main establishment of a data intermediation services provider in the Union should be determined in accordance with objective criteria and should imply the effective and real exercise of management activities. Activities of a data intermediation services provider should comply with the national law of the Member State in which it has its main establishment.

(42)

In order to ensure the compliance of data intermediation services providers with this Regulation, they should have their main establishment in the Union. Where a data intermediation services provider not established in the Union offers services within the Union, it should designate a legal representative. The designation of a legal representative in such cases is necessary, given that such data intermediation services providers handle personal data as well as commercially confidential data, which necessitates the close monitoring of the compliance of data intermediation services providers with this Regulation. In order to determine whether such a data intermediation services provider is offering services within the Union, it should be ascertained whether it is apparent that the data intermediation services provider is planning to offer services to persons in one or more Member States. The mere accessibility in the Union of the website or of an email address and other contact details of the data intermediation services provider, or the use of a language generally used in the third country where the data intermediation services provider is established, should be considered to be insufficient to ascertain such an intention. However, factors such as the use of a language or a currency generally used in one or more Member States with the possibility of ordering services in that language, or the mentioning of users who are in the Union, could make it apparent that the data intermediation services provider is planning to offer services within the Union.

A designated legal representative should act on behalf of the data intermediation services provider and it should be possible for competent authorities for data intermediation services to address the legal representative in addition to or instead of a data intermediation services provider, including in the case of an infringement, for the purpose of initiating enforcement proceedings against a non-compliant data intermediation services provider not established in the Union. The legal representative should be designated by a written mandate of the data intermediation services provider to act on the latter’s behalf with regard to the latter’s obligations under this Regulation.

(43)

In order to assist data subjects and data holders to easily identify, and thereby increase their trust in, data intermediation services providers recognised in the Union, a common logo recognisable throughout the Union should be established, in addition to the label ‘data intermediation services provider recognised in the Union’.

(44)

The competent authorities for data intermediation services designated to monitor compliance of data intermediation services providers with the requirements of this Regulation should be chosen on the basis of their capacity and expertise regarding horizontal or sectoral data sharing They should be independent of any data intermediation services provider as well as transparent and impartial in the exercise of their tasks. Member States should notify the Commission of the identity of those competent authorities for data intermediation services. The powers and competences of the competent authorities for data intermediation services should be without prejudice to the powers of the data protection authorities. In particular, for any question requiring an assessment of compliance with Regulation (EU) 2016/679, the competent authority for data intermediation services should seek, where relevant, an opinion or decision of the competent supervisory authority established pursuant to that Regulation.

(45)

There is a strong potential for objectives of general interest in the use of data made available voluntarily by data subjects on the basis of their informed consent or, where it concerns non-personal data, made available by data holders. Such objectives would include healthcare, combating climate change, improving mobility, facilitating the development, production and dissemination of official statistics, improving the provision of public services, or public policy making. Support to scientific research should also be considered to be an objective of general interest. This Regulation should aim to contribute to the emergence of sufficiently-sized data pools made available on the basis of data altruism in order to enable data analytics and machine learning, including across the Union. In order to achieve that objective, Member States should be able to have in place organisational or technical arrangements, or both, which would facilitate data altruism. Such arrangements could include the availability of easily useable tools for data subjects or data holders for giving consent or permission for the altruistic use of their data, the organisation of awareness campaigns, or a structured exchange between competent authorities on how public policies, such as improving traffic, public health and combating climate change, benefit from data altruism. To that end, Member States should be able to establish national policies for data altruism. Data subjects should be able to receive compensation related only to the costs they incur when making their data available for objectives of general interest.

(46)

The registration of recognised data altruism organisations and use of the label ‘data altruism organisation recognised in the Union’ is expected to lead to the establishment of data repositories. Registration in a Member State would be valid across the Union and is expected to facilitate cross-border data use within the Union and the emergence of data pools covering several Member States. Data holders could give permission to the processing of their non-personal data for a range of purposes not established at the moment of giving the permission. The compliance of such recognised data altruism organisations with a set of requirements as laid down in this Regulation should bring trust that the data made available for altruistic purposes is serving an objective of general interest. Such trust should result in particular from having a place of establishment or a legal representative within the Union, as well as from the requirement that recognised data altruism organisations are not-for-profit organisations, from transparency requirements and from specific safeguards in place to protect rights and interests of data subjects and undertakings.

Further safeguards should include making it possible to process relevant data within a secure processing environment operated by the recognised data altruism organisations, oversight mechanisms such as ethics councils or boards, including representatives from civil society to ensure that the data controller maintains high standards of scientific ethics and protection of fundamental rights, effective and clearly communicated technical means to withdraw or modify consent at any moment, on the basis of the information obligations of data processors under Regulation (EU) 2016/679, as well as means for data subjects to stay informed about the use of data they made available. Registration as a recognised data altruism organisation should not be a precondition for exercising data altruism activities. The Commission should, by means of delegated acts, prepare a rulebook in close cooperation with data altruism organisations and relevant stakeholders. Compliance with that rulebook should be a requirement for registration as a recognised data altruism organisation.

(47)

In order to assist data subjects and data holders to easily identify, and thereby to increase their trust in, recognised data altruism organisations, a common logo that is recognisable throughout the Union should be established. The common logo should be accompanied by a QR code with a link to the public Union register of recognised data altruism organisations.

(48)

This Regulation should be without prejudice to the establishment, organisation and functioning of entities that seek to engage in data altruism pursuant to national law and build on national law requirements to operate lawfully in a Member State as a not-for-profit organisation.

(49)

This Regulation should be without prejudice to the establishment, organisation and functioning of entities other than public sector bodies that engage in the sharing of data and content on the basis of open licenses, thereby contributing to the creation of common resources available to all. This should include open collaborative knowledge sharing platforms, open access scientific and academic repositories, open source software development platforms and open access content aggregation platforms.

(50)

Recognised data altruism organisations should be able to collect relevant data directly from natural and legal persons or to process data collected by others. Processing of collected data could be done by data altruism organisations for purposes which they establish themselves or, where relevant, they could allow the processing by third parties for those purposes. Where recognised data altruism organisations are data controllers or processors as defined in Regulation (EU) 2016/679, they should comply with that Regulation. Typically, data altruism would rely on consent of data subjects within the meaning of Article 6(1), point (a), and Article 9(2), point (a), of Regulation (EU) 2016/679 that should be in compliance with requirements for lawful consent in accordance with Articles 7 and 8 of that Regulation. In accordance with Regulation (EU) 2016/679, scientific research purposes could be supported by consent to certain areas of scientific research where in keeping with recognised ethical standards for scientific research or only to certain areas of research or parts of research projects. Article 5(1), point (b), of Regulation (EU) 2016/679 specifies that further processing for scientific or historical research purposes or statistical purposes should, in accordance with Article 89(1) of Regulation (EU) 2016/679, not be considered to be incompatible with the initial purposes. For non-personal data the usage limitations should be found in the permission given by the data holder.

(51)

The competent authorities for the registration of data altruism organisations designated to monitor compliance of recognised data altruism organisations with the requirements of this Regulation should be chosen on the basis of their capacity and expertise. They should be independent of any data altruism organisation as well as transparent and impartial in the exercise of their tasks. Member States should notify the Commission of the identity of those competent authorities for the registration of data altruism organisations. The powers and competences of the competent authorities for the registration of data altruism organisations should be without prejudice to the powers of the data protection authorities. In particular, for any question requiring an assessment of compliance with Regulation (EU) 2016/679, the competent authority for the registration of data altruism organisations should seek, where relevant, an opinion or decision of the competent supervisory authority established pursuant to that Regulation.

(52)

To promote trust and bring additional legal certainty and user-friendliness to the process of granting and withdrawing consent, in particular in the context of scientific research and statistical use of data made available on an altruistic basis, a European data altruism consent form should be developed and used in the context of altruistic data sharing. Such a form should contribute to additional transparency for data subjects that their data will be accessed and used in accordance with their consent and also in full compliance with the data protection rules. It should also facilitate the granting and withdrawing of consent and be used to streamline data altruism carried out by undertakings and provide a mechanism allowing such undertakings to withdraw their permission to use the data. In order to take into account the specificities of individual sectors, including from a data protection perspective, the European data altruism consent form should use a modular approach allowing customisation for specific sectors and for different purposes.

(53)

In order to successfully implement the data governance framework, a European Data Innovation Board should be established, in the form of an expert group. The European Data Innovation Board should consist of representatives of the competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations of all Member States, the European Data Protection Board, the European Data Protection Supervisor, the European Union Agency for Cybersecurity (ENISA), the Commission, the EU SME Envoy or a representative appointed by the network of SME envoys, and other representatives of relevant bodies in specific sectors as well as bodies with specific expertise. The European Data Innovation Board should consist of a number of subgroups, including a subgroup for stakeholder involvement composed of relevant representatives of industry, such as health, environment, agriculture, transport, energy, industrial manufacturing, media, cultural and creative sectors, and statistics, as well as of research, academia, civil society, standardisation organisations, relevant common European data spaces and other relevant stakeholders and third parties, inter alia bodies with specific expertise such as national statistical offices.

(54)

The European Data Innovation Board should assist the Commission in coordinating national practices and policies on the topics covered by this Regulation, and in supporting cross-sector data use by adhering to the European Interoperability Framework principles and through the use of European and international standards and specifications, including through the EU Multi-Stakeholder Platform for ICT Standardisation, the Core Vocabularies and the CEF Building Blocks, and should take into account standardisation work taking place in specific sectors or domains. Work on technical standardisation could include the identification of priorities for the development of standards and establishing and maintaining a set of technical and legal standards for transmitting data between two processing environments that allows data spaces to be organised, in particular clarifying and distinguishing which standards and practices are cross-sectoral and which are sectoral. The European Data Innovation Board should cooperate with sectoral bodies, networks or expert groups, or other cross-sectoral organisations dealing with the re-use of data. Regarding data altruism, the European Data Innovation Board should assist the Commission in the development of the data altruism consent form, after consulting the European Data Protection Board. By proposing guidelines on common European data spaces, the European Data Innovation Board should support the development of a functioning European data economy on the basis of those data spaces, as set out in the European strategy for data.

(55)

Member States should lay down rules on penalties applicable to infringements of this Regulation and should take all measures necessary to ensure that they are implemented. The penalties provided for should be effective, proportionate and dissuasive. Large discrepancies between rules on penalties could lead to distortion of competition in the digital single market. The harmonisation of such rules could be of benefit in that regard.

(56)

In order to provide for an efficient enforcement of this Regulation and to ensure that data intermediation services providers and entities that wish to register as recognised data altruism organisations are able to access and complete the procedures of notification and registration fully online and in a cross-border manner, such procedures should be offered through the single digital gateway established pursuant to Regulation (EU) 2018/1724 of the European Parliament and of the Council (29). Those procedures should be added to the list of procedures included in Annex II to Regulation (EU) 2018/1724.

(57)

Regulation (EU) 2018/1724 should therefore be amended accordingly.

(58)

In order to ensure the effectiveness of this Regulation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission for the purpose of supplementing this Regulation by laying down special conditions applicable to transfers to third countries of certain non-personal data categories deemed to be highly sensitive in specific Union legislative acts and by establishing a rulebook for recognised data altruism organisations, with which those organisations are to comply, that provides for information, technical and security requirements as well as communication roadmaps and interoperability standards. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (30). 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.

(59)

In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to assist public sector bodies and re-users in their compliance with conditions for re-use set out in this Regulation by establishing model contractual clauses for the transfer by re-users of non-personal data to a third country, to declare that the legal, supervisory and enforcement arrangements of a third country are equivalent to the protection ensured under Union law, to develop the design of the common logo for data intermediation services providers and of the common logo for recognised data altruism organisations, and to establish and develop the European data altruism consent form. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (31).

(60)

This Regulation should not affect the application of the rules on competition, and in particular Articles 101 and 102 TFEU. The measures provided for in this Regulation should not be used to restrict competition in a manner contrary to the TFEU. This concerns in particular the rules on the exchange of competitively sensitive information between actual or potential competitors through data intermediation services.

(61)

The European Data Protection Supervisor and the European Data Protection Board were consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 and delivered their opinion on 10 March 2021.

(62)

This Regulation uses as its guiding principles the respect for the fundamental rights and principles recognised in particular by the Charter of Fundamental Rights of the European Union, including the right to privacy, the protection of personal data, the freedom to conduct a business, the right to property and the integration of persons with disabilities. In the context of the latter, the public service bodies and services under this Regulation should, where relevant, comply with Directives (EU) 2016/2102 (32) and (EU) 2019/882 (33) of the European Parliament and of the Council. Furthermore, Design for All in the context of information and communications technology, which is the conscious and systematic effort to proactively apply principles, methods and tools to promote universal design in computer-related technologies, including internet-based technologies, thus avoiding the need for a posteriori adaptations or specialised design, should be taken into account.

(63)

Since the objectives of this Regulation, namely the re-use, within the Union, of certain categories of data held by public sector bodies as well as the establishment of a notification and supervisory framework for the provision of data intermediation services, a framework for voluntary registration of entities which make data available for altruistic purposes and a framework for the establishment of a European Data Innovation Board, cannot be sufficiently achieved by the Member States, but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives,

(1)

The Commission, in its communication of 11 December 2019 entitled ‘The European Green Deal’ (the ‘European Green Deal’), set out a new growth strategy that aims to transform the Union into a fair and prosperous society, with a modern, resource-efficient and competitive economy, where the climate neutrality objective is met by 2050 at the latest and where economic growth is decoupled from resource use. In its communication of 17 September 2020 entitled ‘Stepping up Europe’s 2030 climate ambition – Investing in a climate-neutral future for the benefit of our people’, the Commission proposed to increase the greenhouse gas emissions reduction target to at least 55 % by 2030. That ambition was endorsed by the European Council on 11 December 2020 and the impact assessment accompanying that communication confirms that the energy mix of the future will be very different from the one of today and underpins the necessity to review and if necessary to revise the energy legislation. The current energy infrastructure investments are clearly insufficient to transform and build the energy infrastructure of the future. That also means infrastructure needs to be in place to support the European energy transition, including rapid electrification, scaling up of renewable and fossil fuel free electricity generation, the increased use of renewable and low-carbon gases, energy system integration and a higher uptake of innovative solutions.

(2)

The current binding Union level target for renewable energy for 2030 of at least 32 % of final energy consumption and a headline Union level target for energy efficiency of at least 32,5 % will be revised as part of the Union’s enhanced ambition enshrined in the Regulation (EU) 2021/1119 of the European Parliament and the Council (4) and the European Green Deal.

(3)

The Paris Agreement adopted under the United Nations Framework Convention on Climate Change (5) (the ‘Paris Agreement’) sets out a long-term goal to hold the increase in the global average temperature to well below 2 °C above pre-industrial levels and to pursue efforts to limit the temperature increase to 1,5 °C above pre-industrial levels, and stresses the importance of adapting to the adverse impacts of climate change and making finance flows consistent with a pathway towards low greenhouse gas emissions and climate-resilient development. On 12 December 2019, the European Council endorsed the objective of achieving a climate-neutral European Union by 2050, in line with the objectives of the Paris Agreement.

(4)

Regulation (EU) No 347/2013 of the European Parliament and of the Council (6) lays down guidelines for the timely development and interoperability of priority corridors and areas of trans-European energy infrastructure in order to achieve the energy policy objectives of the Treaty on the Functioning of the European Union (TFEU) to ensure the functioning of the internal energy market, security of supply and competitive energy markets in the Union, to promote energy efficiency and energy saving and the development of new and renewable forms of energy, and to promote the interconnection of energy networks. Regulation (EU) No 347/2013 puts in place a framework for Member States and relevant stakeholders to work together in a regional setting to develop better-connected energy networks with the aim to connect regions currently isolated from European energy markets, strengthen existing and promote new cross-border interconnections, and help integrate renewable energy. By pursuing those objectives, Regulation (EU) No 347/2013 contributes to smart, sustainable and inclusive growth and brings benefits to the entire Union in terms of competitiveness and economic, social and territorial cohesion.

(5)

The evaluation of Regulation (EU) No 347/2013 has clearly shown that the framework has effectively improved the integration of Member States’ networks, stimulated energy trade and hence contributed to the competitiveness of the Union. Projects of common interest in electricity and gas have strongly contributed to security of supply. For gas, the infrastructure is now better connected and supply resilience has improved substantially since 2013. Regional cooperation in regional groups and through cross-border cost allocation is an important enabler for project implementation. However, in many cases the cross-border cost allocation did not result in reducing the financing gap of the projects, as intended. While the majority of permitting procedures have been shortened, in some cases the process is still long. The financial assistance from the Connecting Europe Facility, established by Regulation (EU) No 1316/2013 of the European Parliament and of the Council (7), has been an important factor as grants for studies have helped projects to reduce risks in the early stages of development, while grants for works have supported projects addressing key bottlenecks that market finance could not sufficiently address.

(6)

In its resolution of 10 July 2020 on the revision of the guidelines for trans-European energy infrastructure (8), the European Parliament called for a revision of Regulation (EU) No 347/2013, taking into account, in particular, the Union’s 2030 targets for energy and climate and its 2050 climate neutrality objectives and the energy efficiency first principle.

(7)

The trans-European energy networks policy is a central instrument in the development of an internal energy market and necessary to achieve the objectives of the European Green Deal. To achieve higher levels of greenhouse gas emission reductions by 2030 and climate neutrality by 2050 at the latest, Europe will need a more integrated energy system, relying on higher levels of electrification based on additional renewable and low-carbon sources and the decarbonisation of the gas sector. The trans-European energy networks policy can ensure that the Union energy infrastructure development supports the required energy transition to climate neutrality in line with the energy efficiency first principle and technological neutrality while considering the potential for emission reduction in the end use. It can also ensure interconnections, energy security, market and system integration, and competition that benefits all Member States, as well as energy at an affordable price for households and undertakings.

(8)

While the objectives of Regulation (EU) No 347/2013 remain largely valid, the current trans-European energy networks framework does not yet fully reflect the expected changes to the energy system that will result from the new political context and in particular the upgraded Union 2030 targets for energy and climate and the 2050 climate neutrality objective under the European Green Deal. Therefore, among other aspects, both climate mitigation and climate adaptation objectives need to be adequately reflected in the revised trans-European energy networks framework. Besides the new political context and objectives, technological development has been rapid in the past decade. That development should be taken into account in the energy infrastructure categories covered by this Regulation, the selection criteria for projects of common interest as well as the priority corridors and areas. At the same time, the provisions of this Regulation should not affect a Member State’s right to determine the conditions for exploiting its energy resources, its choice between different energy sources and the general structure of its energy supply, in accordance with Article 194 TFEU.

(9)

Directives 2009/73/EC (9) and (EU) 2019/944 (10) of the European Parliament and of the Council provide for an internal market for energy. While there has been very significant progress in the completion of that market, there is still room for improvement by better utilising existing energy infrastructure, integrating the increasing amounts of renewable energy, and system integration.

(10)

The Union’s energy infrastructure should be upgraded in order to prevent technical failure and to increase its resilience against such failure, natural or man-made disasters, adverse effects of climate change and threats to its security, in particular as regards European critical infrastructures pursuant to Council Directive 2008/114/EC (11).

(11)

The Union’s energy infrastructure should be resilient to the unavoidable impacts that climate change is expected to create in Europe in spite of the mitigation efforts. Hence, strengthening the efforts on climate adaptation and mitigation, resilience building, disaster prevention and preparedness is crucial.

(12)

The development of trans-European energy infrastructure should take into account, where technically possible and most efficient, the possibility of repurposing existing infrastructure and equipment.

(13)

Security of supply, as a main driver behind the adoption of Regulation (EU) No 347/2013, has been significantly improved through projects of common interest. Moreover, the Commission’s impact assessment accompanying the Commission communication of 17 September 2020 entitled ‘Stepping up Europe’s 2030 climate ambition –Investing in a climate-neutral future for the benefit of our people’ expects the consumption of natural gas to be reduced significantly because its non-abated use is not compatible with carbon neutrality. On the other hand, the consumption of biogas, renewable and low-carbon hydrogen and synthetic gaseous fuels is expected to increase significantly towards 2050. For gas, the infrastructure is now better connected and supply resilience has improved substantially since 2013. The planning of energy infrastructure should reflect this changing gas landscape. However, not all Member States are yet connected sufficiently to the European gas network and island Member States in particular continue to face significant challenges in terms of security of supply and energy isolation. Although 78 % of gas projects that are projects of common interest are expected to be commissioned by the end of 2025, a number of them are experiencing significant delays, including due to permitting problems. This Regulation should therefore not negatively affect projects of common interest that have not yet been completed on the date of its entry into force. Therefore, projects of common interest included in the fifth Union list of projects of common interest established pursuant to Regulation (EU) No 347/2013, for which an application file has been accepted for examination by the competent authority should be able to maintain their rights and obligations as regards permitting for a period of four years after the date of entry into force of this Regulation.

(14)

The importance of smart electricity grids, which do not always include the crossing of a physical border, in achieving the Union’s energy and climate policy objectives was acknowledged in the Commission communication of 8 July 2020 entitled ‘Powering a climate-neutral economy: An EU Strategy for Energy System Integration’ (the ‘EU Strategy for Energy System Integration’). The criteria for that category should be simplified, should include technological developments regarding innovation and digital aspects and should enable energy system integration. Furthermore, the role of projects promoters should be clarified. Given the expected significant increase in power demand from the transport sector, in particular for electric vehicles along highways and in urban areas, smart grid technologies should also help to improve energy network related support for cross-border, high-capacity recharging to support the decarbonisation of the transport sector.

(15)

The EU Strategy for Energy System Integration also underlined the need for integrated energy infrastructure planning across energy carriers, infrastructures, and consumption sectors. Such system integration starts from the point of departure of applying the energy efficiency first principle and taking a holistic approach in policy and beyond individual sectors. It also addresses the decarbonisation needs of the hard to abate sectors, such as parts of industry or certain modes of transport, where direct electrification is, currently, technically or economically challenging. Such investments include hydrogen and electrolysers, which are progressing towards commercial large-scale deployment. The Commission communication of 8 July 2020 entitled ‘A hydrogen strategy for a climate-neutral Europe’ (the ‘Hydrogen Strategy’) gives priority to hydrogen production from renewable electricity, which is the cleanest solution and is most compatible with the Union’s climate neutrality objective. In a transitional phase however, other forms of low-carbon hydrogen are needed to more rapidly decarbonise existing hydrogen production, focusing on a diverse range of clean technologies, and to kick-start an economy of scale.

(16)

Moreover, in its Hydrogen Strategy the Commission concluded that, for the required deployment of hydrogen, a large-scale infrastructure network is an important element that only the Union and the internal market can offer. There is currently very limited dedicated infrastructure in place to transport and trade hydrogen across borders or to create hydrogen valleys. Such infrastructure should consist of a significant extent of assets converted from natural gas assets, complemented by new assets dedicated to hydrogen. Furthermore, the Hydrogen Strategy set a strategic goal to increase installed electrolyser capacity to 40 Gigawatts (GW) by 2030 in order to scale up the production of renewable hydrogen and facilitate the decarbonisation of fossil-fuel dependent sectors, such as industry or transport. Therefore, the trans-European energy networks policy should include new and repurposed hydrogen transmission infrastructure and storage as well as electrolyser facilities. Hydrogen transmission and storage infrastructure should also be included in the Union-wide ten-year network development plan so as to allow a comprehensive and consistent assessment of their costs and benefits for the energy system, including their contribution to sector integration and decarbonisation, with the aim of creating a hydrogen backbone for the Union.

(17)

Moreover, a new infrastructure category should be created for smart gas grids to support investments which integrate a plurality of low-carbon and particularly renewable gases such as biogas, biomethane, and hydrogen, in the gas network and help manage a resulting more complex system, building on innovative digital technologies.

(18)

Achieving climate neutrality by 2050 at the latest assumes that there will still be industrial processes that emit carbon dioxide. Such carbon dioxide is considered to be unavoidable when its production cannot be avoided despite optimisation, for example through energy efficiency or electrification integrating renewables. The development of carbon dioxide infrastructure should lead to a significant net reduction of otherwise unavoidable emissions in the absence of reasonable alternatives. Carbon dioxide capture is covered by Directive 2010/75/EU of the European Parliament and of the Council (12) for the purpose of carbon dioxide streams originating from the installations covered by that Directive, and for the purpose of geological storage pursuant to Directive 2009/31/EC of the European Parliament and of the Council (13).

(19)

Regulation (EU) No 347/2013 required a candidate project of common interest to prove a significant contribution to at least one criterion from a set of criteria in the process for the elaboration of the Union list of projects of common interest, which could have, but did not need to, include sustainability. That requirement, in line with the specific needs of the internal energy market at the time, enabled development of projects of common interest which addressed only security of supply risks even if they did not demonstrate benefits in terms of sustainability. However, given the evolution of the Union’s infrastructure needs, the decarbonisation goals and the European Council conclusions adopted on 21 July 2020, according to which Union expenditure should be consistent with Paris Agreement objectives and the ‘do no harm’ principle of the European Green Deal, sustainability in terms of the integration of renewable energy sources into the grid or the reduction of greenhouse gas emissions, as relevant, should be assessed in order to ensure that trans-European energy networks policy is coherent with the Union’s targets for energy and climate and 2050 climate neutrality objectives, taking into account the specificities of each Member State in reaching the climate neutrality objective. The sustainability of carbon dioxide transport networks is addressed by total expected project life-cycle greenhouse gas reductions and the absence of alternative technological solutions to achieve the same level of carbon dioxide reduction.

(20)

The Union should facilitate infrastructure projects linking the Union’s networks with third-country networks that are mutually beneficial and necessary for the energy transition and the achievement of the climate targets, and which also meet the specific criteria of the relevant infrastructure categories pursuant to this Regulation, in particular with neighbouring countries and with countries with which the Union has established specific energy cooperation. Therefore, this Regulation should include in its scope projects of mutual interest where they are sustainable and able to demonstrate significant net socioeconomic benefits at Union level and at least one third country. Such projects should be eligible for inclusion in the Union list of projects of common interest and projects of mutual interest (the ‘Union list’) provided that the policy framework has a high level of convergence and is supported by enforcement mechanisms, and should demonstrate a contribution to the Union’s and the third countries’ overall energy and climate policy objectives in terms of security of supply and decarbonisation.

A high level of convergence of the policy framework should be presumed for the European Economic Area or Energy Community Contracting Parties or can be demonstrated in the case of other third countries through bilateral agreements that include relevant provisions on climate and energy policy objectives on decarbonisation and further assessed by the appropriate regional group with the support of the Commission. In addition, the third country with which the Union cooperates in the development of projects of mutual interest should facilitate a similar timeline for accelerated implementation and other policy support measures, as provided for in this Regulation. Therefore, projects of mutual interest should be treated in the same manner as projects of common interest, with all provisions relative to projects of common interest applying also to projects of mutual interest, unless otherwise specified. Significant net socioeconomic benefits at Union level should be understood as improving interoperability and the functioning of the internal market, going beyond one Member State. As regards projects for storage of carbon dioxide, only projects necessary to allow the cross-border transport and storage of carbon dioxide should be eligible, provided that standards and safeguards preventing any leaks and concerning climate, human health and ecosystems as regards the safety and effectiveness of the permanent storage of carbon dioxide are at least at the same level as in the Union. It should be presumed that the European Economic Area meets those standards and safeguards.

(21)

Projects of mutual interest should be considered to be an additional tool to expand the scope of this Regulation to third countries beyond those projects of common interest that contribute to implementing an energy infrastructure priority corridor or area as set out in Annex I. Therefore, where a project with a third country contributes to implementing an energy infrastructure priority corridor or area, it should be eligible to apply for the status of a project of common interest under this Regulation. By the same principle, electricity interconnection projects with third countries that had attained the status of project of common interest under Regulation (EU) No 347/2013 may be selected as projects of common interest, provided that they undergo the selection process and that they fulfil the criteria for projects of common interest.

(22)

Furthermore, to achieve the Union’s 2030 targets for energy and climate and its 2050 climate neutrality objective, the Union needs to significantly scale up renewable electricity generation. The existing energy infrastructure categories for electricity transmission and storage are crucial for the integration of the significant increase in renewable electricity generation in the power grid. In addition, that requires stepping up investment in offshore renewable energy with the aim of reaching at least 300 GW of offshore wind generation installed in line with the Commission’s offshore renewable energy strategy set out in the Commission communication of 19 November 2020 entitled ‘An EU Strategy to harness the potential of offshore renewable energy for a climate neutral future’. That strategy includes radial links connecting new offshore wind capacities, as well as hybrid integrated projects. Coordinating long-term planning and development of offshore and onshore electricity grids should also be addressed. In particular, offshore infrastructure planning should move away from the project-by-project approach towards a coordinated comprehensive approach ensuring the sustainable development of integrated offshore grids in line with the offshore renewable potential of each sea basin, environmental protection and other uses of the sea. There should be an approach based on voluntary cooperation between Member States. Member States should remain responsible for approving the projects of common interest which are related to their territory and the related costs.

(23)

Relevant Member States should be able to assess the benefits and costs of the priority offshore grid corridors for renewable energy and carry out a preliminary cost-sharing analysis at priority offshore grid corridor level to underpin joint political commitments for offshore renewable energy development. The Commission, together with the Member States and the relevant transmission system operators (TSOs) and national regulatory authorities, should develop guidance for a specific cost-benefit and cost-sharing for the deployment of the integrated offshore network development plans which should enable Member States to carry out an adequate assessment.

(24)

The Union-wide ten-year network development plan process as basis for the identification of projects of common interest in the categories of electricity and gas has proven to be effective. However, while the European Network of Transmission System Operators for Electricity (the ‘ENTSO for Electricity’), the European Network of Transmission System Operators for Gas (the ‘ENTSO for Gas’) and TSOs have an important role to play in the process, more scrutiny is required, in particular as regards defining the scenarios for the future, identifying long-term infrastructure gaps and bottlenecks and assessing individual projects, to enhance trust in the process. Therefore, due to the need for independent validation, the Agency for the Cooperation of Energy Regulators (the ‘Agency’) and the Commission should have an increased role in the process, including in the process for drawing up the Union-wide ten-year network development plans pursuant to Regulations (EC) No 715/2009 (14) and (EU) 2019/943 (15) of the European Parliament and of the Council. The Union-wide ten-year network development plan process should benefit from the objective, science-based input from an independent scientific body such as the European Scientific Advisory Board on Climate Change and should be organised in the most effective manner.

(25)

In carrying out their tasks preceding the adoption of the Union-wide ten-year network development plans, the ENTSO for Electricity and ENTSO for Gas should conduct an extensive consultation process involving all relevant stakeholders. The consultation should be open and transparent and should be organised in a timely manner to allow for stakeholders’ feedback in the preparation of key phases of the Union-wide ten-year network development plans, such as the scenario development, infrastructure gaps identification and the cost-benefit analysis methodology for project assessment. The ENTSO for Electricity and the ENTSO for Gas should give due consideration to the input received from stakeholders during consultations and should explain how they took that input into account.

(26)

In line with the conclusions of the 2020 Energy Infrastructure Forum, it is necessary to ensure that all relevant sectors, such as gas, electricity, and transport, are considered in an integrated perspective in the planning processes of all onshore and offshore, transmission and distribution infrastructure. In order to comply with the Paris Agreement and to achieve the Union’s 2030 climate objectives, the 2040 offshore energy development objectives, and in line with the Union’s objective to achieve climate neutrality by 2050 at the latest, trans-European energy networks framework should rely on a smarter, more integrated, long-term and optimised ‘one energy system’ view through deployment of a framework that enables greater coordination of infrastructure planning across various sectors and creates an opportunity to optimally integrate various coupling solutions involving various network elements between various infrastructures. This should be secured by developing a progressively integrated model that enables consistency between single-sector methodologies based on common assumptions and reflects interdependencies.

(27)

It is important to ensure that only infrastructure projects for which no reasonable alternative solutions exist may receive the status of project of common interest. To that end, the energy efficiency first principle should be taken into account in the infrastructure gaps identification report developed in line with this Regulation and the work of the regional groups in establishing the regional lists of proposed projects. In line with the energy efficiency first principle, all relevant alternatives to new infrastructure for ensuring future infrastructure needs, that could contribute to addressing the infrastructure gap identification, should be considered.

The regional groups, assisted by the national regulatory authorities, should consider the assumptions and outcomes of the infrastructure gaps assessment developed in line with this Regulation and ensure that the energy efficiency first principle is fully reflected in the selection process for projects of common interest. In addition, during project implementation, project promoters should report on the compliance with environmental legislation and demonstrate that projects do ‘no significant harm’ to the environment within the meaning of Article 17 of Regulation (EU) 2020/852 of the European Parliament and of the Council (16). For existing projects of common interest having reached sufficient maturity, this will be taken into account during project selection for subsequent Union list by the regional groups.

(28)

To ensure voltage and frequency stability, particular attention should be given to the stability of the European electricity network under the changing conditions, especially in view of the growing share of flexibility options, such as sustainable energy storage, and renewable electricity. Efforts to maintain and ensure a satisfactory level of planned low-carbon energy production, in order to ensure security of supply for citizens and businesses, should be given particular priority.

(29)

Following close consultations with all Member States and stakeholders, the Commission has identified 14 trans-European energy infrastructure priorities, the implementation of which is essential for the achievement of the Union’s 2030 targets for energy and climate and its 2050 climate neutrality objective. Those priorities cover various geographic regions or thematic areas in the field of electricity transmission and storage, offshore grids for renewable energy, hydrogen transmission and storage, electrolysers, smart gas grids, smart electricity grids, and the transport and storage of carbon dioxide.

(30)

Projects of common interest should comply with common, transparent and objective criteria in view of their contribution to the energy policy objectives. In order to be eligible for inclusion in the Union lists, electricity, and hydrogen projects should be part of the latest available Union-wide ten-year network development plan. As hydrogen infrastructure is not currently included in the Union-wide ten-year network development plan, that requirement for hydrogen projects should apply only from 1 January 2024 for the purposes of the second Union list that will be established pursuant to this Regulation.

(31)

Regional groups should be established for the purpose of proposing and reviewing projects of common interest, leading to the establishment of regional lists of projects of common interest. In order to ensure broad consensus, those regional groups should ensure close cooperation between Member States, national regulatory authorities, project promoters and relevant stakeholders. In the context of that cooperation, national regulatory authorities should, where necessary, advise the regional groups, inter alia, on the feasibility of the regulatory aspects of proposed projects and on the feasibility of the proposed timetable for regulatory approval.

(32)

In order to increase the efficiency of the process, cooperation between the regional groups should be strengthened and further encouraged. It is necessary that the Commission play an important role in facilitating that cooperation with a view to addressing the possible impact of projects on other regional groups.

(33)

A new Union list should be established every two years. Projects of common interest that have been completed or that no longer fulfil the relevant criteria and requirements as set out in this Regulation should not appear on the following Union list. For that reason, existing projects of common interest that are to be included in the following Union list should be subject to the same selection process for the establishment of regional lists and for the establishment of the Union list applied to proposed projects. However, the administrative burden should be reduced to the extent possible, for example by using information submitted previously and by taking account of the annual reports of the project promoters. To that end, existing projects of common interest that have made significant progress should benefit from a streamlined inclusion process in the Union-wide ten-year network development plan.

(34)

Projects of common interest should be implemented as quickly as possible and should be closely monitored and evaluated, while duly observing the requirements for stakeholder participation and environmental legislation and keeping the administrative burden for project promoters to a minimum. The Commission should nominate European coordinators for projects facing particular difficulties or delays. The progress in the implementation of the specific projects as well as the fulfilment of the obligations pertaining to this Regulation should be taken into account in the selection process for subsequent Union lists for those projects.

(35)

The permit granting process should neither lead to administrative burdens which are disproportionate to the size or complexity of a project, nor create barriers to the development of the trans-European networks and market access.

(36)

The planning and implementation of Union projects of common interest in the areas of energy, transport and telecommunication infrastructure should be coordinated to generate synergies where it is feasible from an overall economic, technical, environmental, climate or spatial planning point of view and with due regard to the relevant safety aspects. Thus, during the planning of the various European networks, it should be possible to give preference to integrating transport, communication and energy networks in order to ensure that as little land as possible is taken up. A common vision of the networks is necessary for energy system integration in the various sectors, whilst ensuring, where possible, that existing or disused routes are reused, in order to reduce to a minimum any negative social, economic, environmental, climate and financial impact.

(37)

Projects of common interest should be given priority status at national level to ensure rapid administrative treatment and urgent treatment in all judicial and dispute resolution procedures relating to them. They should be considered by competent authorities as being in the public interest. For reasons of overriding public interest, projects which have an adverse impact on the environment should be authorised where all the conditions set out in Directive 2000/60/EC of the European Parliament and of the Council (17) and Council Directive 92/43/EEC (18) are met.

(38)

It is essential that stakeholders, including civil society, be provided with information and be consulted, in order to ensure the success of projects and to limit objections to them.

(39)

In order to reduce complexity, increase efficiency and transparency, and help enhance cooperation among Member States, there should be a competent authority or authorities integrating or coordinating all permit granting processes.

(40)

In order to simplify and expedite the permit granting process for offshore grids for renewable energy, unique points of contact should be designated for cross-border offshore projects on the Union list reducing administrative burden for project developers. The unique points of contact should reduce complexity, increase efficiency and speed up the permit granting process for offshore transmission assets often crossing many jurisdictions.

(41)

Despite the existence of established standards ensuring the participation of the public in environmental decision-making procedures, which apply fully to projects of common interest, additional measures are still required under this Regulation to ensure the highest possible standards of transparency and public participation in all relevant issues in the permit granting process for projects of common interest. Where already covered by national rules under the same or higher standards as in this Regulation, the pre-consultation ahead of the permitting procedure should become optional and avoid duplication of legal requirements.

(42)

The correct and coordinated implementation of Directives 2001/42/EC (19) and 2011/92/EU (20) of the European Parliament and of the Council and where applicable, of the United Nations Economic Commission for Europe Convention on access to information, public participation in decision-making and access to justice in environmental matters (21), signed in Aarhus on 25 June 1998 (the ‘Aarhus Convention’), and of the Convention on environmental impact assessment in a transboundary context (22), signed in Espoo on 25 February 1991 (the ‘Espoo Convention’), should ensure the harmonisation of the main principles for the assessment of environmental and climate effects, including in a cross-border context. The Commission has issued guidance to support Member States in defining adequate legislative and non-legislative measures to streamline the environmental assessment procedures for energy infrastructure and to ensure the coherent application of environmental assessment procedures required under Union law for projects of common interest. Member States should coordinate their assessments of projects of common interest, and provide for joint assessments, where possible. Member States should be encouraged to exchange best practice and administrative capacity-building in the permit granting processes.

(43)

It is important to streamline and improve the permit granting process, while respecting, to the extent possible and with due regard to the principle of subsidiarity, national competences and procedures for the construction of new energy infrastructure. Given the urgency of developing energy infrastructures, the simplification of the permit granting process should set a clear time limit for the decision of the relevant authorities regarding the construction of the project. That time limit should stimulate a more efficient definition and handling of procedures, and should under no circumstances compromise the high standards for the protection of the environment in line with environmental legislation and public participation. This Regulation should establish maximum time limits. However, Member States can strive to achieve shorter time limits where feasible and, in particular, as regards projects such as smart grids, which may not require as complex a permitting process as that for transmission infrastructure. The competent authorities should be responsible for ensuring compliance with the time limits.

(44)

Member States should be able to include in comprehensive decisions, where appropriate, decisions taken in the context of negotiations with individual landowners to grant access to, ownership of, or a right to occupy, property in the context of spatial planning, which determines the general land use of a defined region, including other developments such as highways, railways, buildings and nature protection areas and which is not undertaken for the specific purpose of the planned project and granting of operational permits. In the context of the permit granting process, a project of common interest should be able to include related infrastructure to the extent that it is essential for the construction or functioning of the project. This Regulation, in particular the provisions on permit granting, public participation and the implementation of projects of common interest, should apply without prejudice to Union and international law, including provisions to protect the environment and human health, and provisions adopted under the Common Fisheries Policy and Integrated Maritime Policy, in particular Directive 2014/89/EU of the European Parliament and of the Council (23).

(45)

The costs of the development, construction, operation and maintenance of projects of common interest should in general be borne fully by the users of the infrastructure. The cost allocation should ensure that end-users are not disproportionately burdened, especially if that could lead to energy poverty. Projects of common interest should be eligible for cross-border cost allocation where an assessment of market demand, or of the expected effects on tariffs, indicates that costs cannot be expected to be recovered by the tariffs paid by the infrastructure users.

(46)

The discussion of the appropriate allocation of costs should be based on the analysis of the costs and benefits of an infrastructure project carried out on the basis of a harmonised methodology for energy-system-wide analysis, using all relevant scenarios established in the framework of the Union-wide ten-year network development plans prepared pursuant to Regulations (EC) No 715/2009 and (EU) 2019/943, and reviewed by the Agency and additional scenarios for network development planning, allowing a robust analysis of the contribution of the project of common interest to the Union energy policy of decarbonisation, market integration, competition, sustainability and security of supply. That analysis can take into consideration indicators and corresponding reference values for the comparison of unit investment costs. Where additional scenarios are used, those should be consistent with the Union’s 2030 targets for energy and climate and its 2050 climate neutrality objective and should be subject to a comprehensive consultation and scrutiny process.

(47)

In an increasingly integrated internal energy market, clear and transparent rules for cost allocation across borders are necessary in order to accelerate investment in cross-border infrastructure and in projects with a cross-border impact. It is essential to ensure a stable financing framework for the development of projects of common interest while minimising the need for financial support, and at the same time to encourage interested investors, with appropriate incentives and financial mechanisms. In deciding on cross-border cost allocation, national regulatory authorities should allocate efficiently incurred investment costs, as relevant in view of their national approaches and methodologies for similar infrastructure, across borders in their entirety and include them in the national tariffs, and, afterwards, if relevant, determine whether their impact on national tariffs could represent a disproportionate burden for consumers in their respective Member States. The national regulatory authorities should avoid the risks of double support for projects by taking into account actual or estimated charges and revenues. Those charges and revenues should be taken into account only in so far as they relate to the projects, and are designed to cover the costs concerned.

(48)

There is a need for cross-border projects that have a positive effect on the Union’s power grid, such as smart electricity grids or electrolysers, without involving a physical common border.

(49)

The internal energy market legislation requires that tariffs for access to networks provide appropriate incentives for investment. However, several types of projects of common interest are likely to have externalities that might not be fully captured in, and recovered through, the regular tariff system. In applying the internal energy market legislation, national regulatory authorities should ensure a stable and predictable regulatory and financial framework with incentives for projects of common interest, including long-term incentives, that are commensurate with the level of specific risk of the project. That framework should apply in particular to cross-border projects, innovative transmission technologies for electricity allowing for the large scale integration of renewable energy, of distributed energy resources or of demand response in interconnected networks, and energy technology and digitalisation projects, which are either likely to incur higher risks than similar projects located within one Member State or which promise higher benefits for the Union. Moreover, projects with high operational expenditure should also have access to appropriate incentives for investment. In particular, offshore grids for renewable energy, which serve the dual functionality of electricity interconnectors and connecting renewable offshore generation projects, are likely to incur higher risks than comparable onshore infrastructure projects, due to their intrinsic connection to generation assets which brings regulatory risks, financing risks such as the need for anticipatory investments, market risks and risks pertaining to the use of new innovative technologies.

(50)

This Regulation should apply only to the granting of permits for projects of common interest, public participation therein and their regulatory treatment. Member States should nevertheless be able to adopt national provisions to apply the same or similar rules to other projects that do not have the status of projects of common interest within the scope of this Regulation. As regards the regulatory incentives, Member States should be able to adopt national provisions to apply the same or similar rules to projects of common interest falling under the category of electricity storage.

(51)

Member States that currently do not attribute the highest possible national significance to energy infrastructure projects as regards the process of permit granting, should be encouraged to consider introducing such a high national significance, in particular by evaluating whether that would lead to a quicker permit granting process.

(52)

Member States that do not currently have in place accelerated or urgent judicial procedures applicable to energy infrastructure projects should be encouraged to consider introducing such procedures, in particular by evaluating whether that would lead to the quicker implementation of such projects.

(53)

Regulation (EU) No 347/2013 has demonstrated the added value of leveraging private funding through significant Union financial assistance to allow the implementation of projects of European significance. In the light of the economic and financial situation and budgetary constraints, targeted support, through grants and financial instruments, should continue under the multiannual financial framework, in order to maximise the benefits to Union citizens and to attract new investors into the energy infrastructure priority corridors and areas set out in an annex to this Regulation, while keeping the budgetary contribution of the Union to a minimum.

(54)

Projects of common interest should be eligible for Union financial assistance for studies and, under certain conditions, for works pursuant to Regulation (EU) 2021/1153 of the European Parliament and of the Council (24) in the form of grants or in the form of innovative financial instruments to ensure that tailor-made support can be provided to those projects of common interest which are not viable under the existing regulatory framework and market conditions. It is important to avoid any distortion of competition, in particular between projects contributing to the achievement of the same Union priority corridor. Such financial assistance should ensure the necessary synergies with the Structural Funds, in order to finance smart energy distribution networks, and with the Union renewable energy financing mechanism established by Commission Implementing Regulation (EU) 2020/1294 (25), pursuant to Article 33(1) of Regulation (EU) 2018/1999 of the European Parliament and of the Council (26).

A three-step logic should apply to investments in projects of common interest. First, the market should have the priority to invest. Second, if investments are not made by the market, regulatory solutions should be explored, the relevant regulatory framework should be adjusted if necessary, and the correct application of the relevant regulatory framework should be ensured. Third, where the first two steps are not sufficient to deliver the necessary investments in projects of common interest, it should be possible to grant Union financial assistance where the project of common interest fulfils the applicable eligibility criteria. Projects of common interest may also be eligible under the InvestEU programme, which is complementary to grant financing.

(55)

The Union should facilitate energy projects in disadvantaged, less connected, peripheral, outermost or isolated regions so as to enable access to the trans-European energy networks in order to accelerate the decarbonisation process and reduce dependency on fossil fuels.

(56)

Where there is no TSO in a Member State, the references to TSOs throughout this Regulation should apply mutatis mutandis to distribution system operators (DSO).

(57)

Grants for works related to projects of mutual interest should be available under the same conditions as for other categories where they contribute to the Union’s overall energy and climate policy objectives and where the decarbonisation objectives of the third country are consistent with the Paris Agreement.

(58)

Regulations (EC) No 715/2009, (EU) 2019/942 (27), and (EU) 2019/943 of the European Parliament and of the Council and Directives 2009/73/EC and (EU) 2019/944 should therefore be amended accordingly.

(59)

Whereas the repurposing of the natural gas infrastructure aims to decarbonise the gas networks, allowing the dedicated use of pure hydrogen, a transitional period could allow for the transport or storage of a predefined blend of hydrogen with natural gas or biomethane. The blending of hydrogen with natural gas or biomethane could be used in the scaling up of the hydrogen production capacity and facilitating the transport of hydrogen. To ensure the transition to hydrogen, the project promoter should demonstrate, including through commercial contracts, how, by the end of the transitional period, the natural gas assets will become dedicated hydrogen assets and how the use of hydrogen will be enhanced during the transitional period. In the context of the monitoring exercise, the Agency should verify the timely transition of the project to a dedicated hydrogen asset. Any financing of those projects pursuant to Regulation (EU) 2021/1153 during the transitional period should be subject to a condition in the grant agreement to repay the financing in the case of a delay of the timely transition of the project to a dedicated hydrogen asset, and to adequate provisions allowing for the enforcement of that condition.

(60)

In line with the European Council conclusions of 4 February 2011 that no Member State should remain isolated from the European gas and electricity networks after 2015 or see its energy security jeopardised by lack of the appropriate connections, this Regulation aims to ensure access to the trans-European energy networks by ending the energy isolation of Cyprus and Malta, that are still not interconnected to the trans-European gas network. That objective should be attained by allowing projects under development or planning that have been granted the status of project of common interest under Regulation (EU) No 347/2013 to maintain their status until Cyprus and Malta are interconnected to the trans-European gas network. Apart from contributing to the development of the renewable energy market, the flexibility and resilience of the energy system, and the security of supply, those projects will ensure access to future energy markets, including hydrogen, and contribute to achieving the Union’s overall energy and climate policy objectives.

(61)

Projects of common interest should not be eligible for Union financial assistance where the project promoters, operators or investors are in one of the situations of exclusion referred to in Article 136 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (28), such as in cases of a conviction for fraud, corruption or conduct related to a criminal organisation. It should be possible to remove a project of common interest from the Union list if its inclusion in that list was based on incorrect information which was a determining factor for that inclusion, or if the project does not comply with Union law. For a project of common interest located in the Member States benefiting from a derogation under this Regulation, those Member States should ensure, when supporting any applications for financing pursuant to Regulation (EU) 2021/1153 for such projects, that the projects do not benefit directly or indirectly persons or entities that are in one of the situation of exclusion as referred to in Article 136 of Regulation (EU, Euratom) 2018/1046.

(62)

In order to ensure the timely development of essential energy infrastructure projects for the Union, the fifth Union list of projects of common interest should remain in force until the first Union list of projects of common interest and projects of mutual interest established pursuant to this Regulation enters into force. Moreover, to enable the development, monitoring and financing of the projects of common interest on the fifth Union list, certain provisions of Regulation (EU) No 347/2013 should also remain in force and produce effects until the entry into force of the first Union list of projects of common interest and projects of mutual interest established pursuant to this Regulation.

(63)

Regulation (EU) No 347/2013 should therefore be repealed.

(64)

In order to ensure that the Union list is limited to projects which contribute the most to the implementation of the strategic energy infrastructure priority corridors and areas set out in an annex to this Regulation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend the annexes to this Regulation so as to establish and review the Union list, while respecting the right of the Member States to approve projects on the Union list related to their territories. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (29). The Commission, when preparing and drawing up delegated acts, should ensure the simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. Where they consider this necessary, the European Parliament and the Council may each send experts to meetings of the Commission expert groups dealing with the preparation of delegated acts to which Member States’ experts are invited.

The discussions in the regional groups are instrumental for the Commission to adopt the delegated acts establishing the Union lists. Therefore, it is appropriate, to the extent possible and compatible with the framework of this Regulation, that the European Parliament and the Council be informed about, and may send experts to, the meetings of regional groups in accordance with the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. Taking into account the need to ensure the achievement of the objectives of this Regulation and, in view of the number of projects on Union lists so far, the total number of projects on the Union list should remain manageable, and therefore should not significantly exceed 220.

(65)

Since the objectives of this Regulation, namely the development and interoperability of trans-European energy networks and connection to such networks that contribute to ensuring climate change mitigation, in particular achieving the Union’s 2030 targets for energy and climate and its climate neutrality objective by2050 at the latest, and to ensuring interconnections, energy security, market and system integration, competition that benefits all Member States, and affordable energy prices, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the proposed action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives,

(1)

The Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Ukraine, of the other part (2) (the ‘Association Agreement’) constitutes the basis of the relationship between the Union and Ukraine. In accordance with Council Decision 2014/668/EU (3), Title IV of the Association Agreement, which relates to trade and trade-related matters, has been applied provisionally since 1 January 2016, and entered into force on 1 September 2017, following ratification by all Member States.

(2)

The Association Agreement expresses the desire of the Parties to the Association Agreement (the ‘Parties’) to strengthen and widen relations in an ambitious and innovative way, to facilitate and achieve gradual economic integration, and to do so in compliance with the rights and obligations arising out of the World Trade Organization membership of the Parties.

(3)

Article 2 of the Association Agreement establishes, among other things, respect for democratic principles, human rights and fundamental freedoms, as well as the promotion of respect for the principles of sovereignty and territorial integrity, inviolability of borders, and independence as essential elements of the Association Agreement.

(4)

Article 25 of the Association Agreement provides for the progressive establishment of a free trade area between the Parties in accordance with Article XXIV of the General Agreement on Tariffs and Trade 1994 (‘GATT 1994’). To that end, Article 29 of the Association Agreement provides for the progressive elimination of customs duties in accordance with the Schedules included therein and for the possibility of accelerating and broadening the scope of such elimination. Article 48 of the Association Agreement provides that the public interest is to be considered before applying anti-dumping measures between the Parties.

(5)

Russia’s unprovoked and unjustified war of aggression against Ukraine since 24 February 2022 has had a profoundly negative impact on the ability of Ukraine to trade with the rest of the world, both because of the destruction of production capacity and the unavailability of a significant proportion of means of transport due to the closure of access to the Black Sea. Under such exceptional circumstances and to mitigate the negative economic impact of Russia’s war of aggression against Ukraine, it is necessary to accelerate the development of closer economic relations between the Union and Ukraine in order to provide quick support to the Ukrainian authorities and population. It is therefore necessary and appropriate to stimulate trade flows and to grant concessions in the form of trade-liberalisation measures for all products, in line with the acceleration of the elimination of customs duties on trade between the Union and Ukraine.